Structured telephone support (STS) for adult patients with chronic heart failure

Collection summary

Health problem and current use of technology (CUR)

According to the European Society of Cardiology, heart failure is a clinical syndrome in which patients have typical symptoms and signs resulting from an abnormality of cardiac structure or function. Although often life threatening, typical symptoms and signs resulting from an abnormality of cardiac structure or function, i.e. heart failure, leading to failure of the heart to deliver oxygen at a rate corresponding to the needs of the body are usually less dramatic than those associated with a myocardial infarction {77}.

HF is a large and global public health problem that will become more important with the aging of the world population. Up to one person in five is expected to develop HF at some point in their life in economically developed countries {70}.

Telemedicine is an approach using remote monitoring e.g. by structured telephone support of prognostic factors in order to promote an early identification of clinical deterioration in HF patients, prevent hospital readmission for acute decompensated HF, and avoid further complications {3}. Signs and symptoms reported by patients are collected by a healthcare professional who subsequently enters and stores the data into a monitoring system. The data are then reviewed by healthcare professionals, usually physicians or nurses. Appropriate action can be initiated, and deterioration can be rapidly detected, which leads to decrease in unnecessary hospital visits, a decrease in hospital (re-)admissions, an improved quality of life. {75}. The highest risk period for hospital readmission is the first few weeks after discharge {90}. Overall, telemonitoring has the potential to improve patient safety and quality of care {21}.

Substantial heterogeneity among studies was noted {119}, the content of the telemedicine interventions vary between patient groups and with regard to duration and content.

Most studies report care provided by a multidisciplinary team, but a great deal of heterogeneity regarding the professionals involved was described. Collaboration between primary care and secondary care was scarcely reported. In almost all the studies, nurses played a coordinating or leading role, but description of the specialization of clinical background were lacking. A different variation of systems for telemonitoring was found, ranging from assessment of symptoms and/or vital signs to data transmission and automatic alarms. {51}

Generally, telemedicine and telemonitoring can be seen as relatively new, currently as an adjunct to current care with the chance of more patient-self-care-involvement and improved quality of therapeutic monitoring, but without a clear unique idea where it should lead to and how it should be implemented.

Structured telephone support may not be not suitable for every patient diagnosed with HF.

Patients with cognitive impairment, a mental illness, a life expectancy less than one year, hearing impairment, language barrier or another chronic disease are often not eligible for a telemonitoring intervention such as structured telephone support {93}.

Description and technical characteristics of technology (TEC)

The non-invasive telemedicine/telemonitoring mainly contains the following aspects (seperately or combined):

• patient education
• self-care supportive strategies
• monitoring and (daily) transmission of vital parameters and weight
• telephone-follow up
• medication management (adherence),
• fluid management (adherence)
• problem solving
• exercise recommendation
• diet adeherence
• goal setting

Usual care mainly consists of

• standard post-discharge care without intensified attendance at cardiology clinics
• clinic-based CHF disease management programme
• home visiting

There is no consensus definition of the fundamental terms utilized.

Telemedicine/ telemonitoring interventions can be used in all different settings (outpatient, outpatient clinic, hospital based, home, mixed setting), they are mainly provided in outpatient organisations, the most important part ist the additional setting at the patients‘ home.

The reference values for heart failure diagnostic (- monitoring) are mainly a) mortality and b) hospitalisation (rate).

The needs for a sustainable telemonitoring include

• Qualified professionals (human resources) doing the monitoring/ statistics/emergency prioritisation
• Economic resources to provide the infrastructure for data transmission (GSM network, analogue phoneline, internet, software) and telephone support, documentation, home visits, etc.
• Transparent selection of patients who benefit best

Information to patients outside the target group and the general public should focus on the reasons and the explanation for inclusion or exclusion of people/ patients for access to structured telephone support. People should be informed that structured telephone support is not suitable for all individuals nor is it appropriate under all medical circumstances

There is also an „upcoming“ topic called mHealth meaning mobile health through mobile phones and similar devices using software applications (apps). There is increasing interest on mhealth, especially with the hope of easy and equal acces for information, tele-diagnostic or –care aspects and data collection and use for health purpose. Some major aspects are to be worked out (like network issues, data security, information quality, legal and regulatory aspects etc.) and are aim within the EU horizon 2020.

Safety (SAF)

To determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure /New York Heart Association (NYHA) I-IV, without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure/ improves clinical outcomes and quality of life, has impact on patients’ satisfaction and function, change in management or utilization of health service and patients’ and technical safety (technical reliability), in comparison with current practice, a systematic literature search according to the predefined search strategy (not limited by publication date but limited to English language), was performed according to the Cochrane methodology, in standard medical and HTA databases.  References have been included or excluded according to the overall research question, Population-Intervention-Control-Outcome (PICO)-scheme, and the predefined inclusion/exclusion criteria. One hundred full-text articles were assessed for eligibility and after the exclusion of 76 full-text articles, five high quality SRs and 19 full text published RCTs were included in our SR. Of the included RCTs, only three were judged to be of low risk of bias.

In the most recent SR no evidence on potential harms was found on STS interventions. None of 19 included RCTs specifically mentioned adverse events (AEs) as primary or secondary outcomes. In only one RCT which specifically mentioned AEs no adverse events were reported and only one RCT provided explanation on the reason why it did not monitor AEs. Since little evidence was identified on the potential harms of STS, it was not possible to assess overall benefits and harms of STS in adults with chronic heart failure.

The sources were not sufficient to answer the questions on STS safety in patients with chronic heart failure. No evidence was found to answer technical safety.

Clinical effectiveness (EFF)

To determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure /New York Heart Association (NYHA) I-IV, without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure/ improves clinical outcomes and quality of life, has impact on patients’ satisfaction and function, change in management or utilization of health service and patients’ and technical safety (technical reliability), in comparison with current practice, a systematic literature search according to the predefined search strategy (not limited by publication date but limited to English language), was performed according to the Cochrane methodology, in standard medical and HTA databases.  References have been included or excluded according to the overall research question, Population-Intervention-Control-Outcome (PICO)-scheme, and the predefined inclusion/exclusion criteria. One hundred full-text articles were assessed for eligibility and after the exclusion of 76 full-text articles, five high quality SRs and 19 full text published RCTs were included in our SR. Of the included RCTs, only three were judged to be of low risk of bias.

STS produced a mortality benefit and reduced HF-specific readmission rates. For the outcomes QoL and utilization the evidence was insufficient. Yet, the majority of studies presented statistically significant QoL improvements. A majority of the RCTs found no significant difference in the number of emergency room visits in either group. No evidence found to answer some assessment element questions, related on outcomes such as work ability, return to previous living conditions, activities of daily living, worthwhile of STS and willing to use STS again.

STS reduces HF-specific readmission and mortality. A majority of the studies presented statistically significant improvements in QoL. Some research gaps and transferability issues were recognized. Further research is needed on effects of STS on QoL and utilization outcomes as well as patient satisfaction during long term follow-up.

Costs and economic evaluation (ECO)

It became apparent from the results of our systematic literature search and our review of the results from other domains that the meaning of the term Structured telephone support (STS) varies quite widely across the studies. Hence, there is no explicit definition STS and, instead, the term is refers to a diverse set of approaches to care management for adults with chronic heart failure using telephonic networks.

Depending on the approach taken to STS, a range of different pieces of information can be collected by telephone from patients, and any such information can be handled and utilised by the management team or system in a large number of ways.

Therefore, one main result of the ECO domain is that variation in the nature of the intervention poses major challenges to undertaking meaningful examination of intervention costs and to undertaking economic evaluations.

If each type of STS intervention, has both different components and consequences, this has a significant effect on ability to make meaningful estimates of costs and to undertake robust economic evaluations. For this reason, we do not summarise the results of the studies per se but, instead, briefly describe those studies found.

Ethical analysis (ETH)

The current domain outlines some ethical issues arising from the use of the particular technology, i.e.  structured telephone support for adult patients suffering from CHF. Together with all the clinical efforts in the management of this devastating condition, part of the recent research has been concentrated on finding low-cost therapeutic alternatives as telemedicine and further understanding of the psychological, ethical, legal and social aspects of handling the particular technology and its impact on the patients themselves, their families and friends, the healthcare personnel and the healthcare providers as well as the society as a whole.

In compliance with the preliminarily outlined domain framework, the following issues have been considered in the text – all of them abiding by the generally accepted ethical principles: beneficence/nonmaleficence; autonomy; respect for persons and justice and equity:

• Improving patients’ quality of life;
• Challenges associated with the digital gap;
• Challenges posed by the remote interaction between a physician and a patient;
• Fair and balanced distribution of resources;
• Equal access to treatment;
• Stigmatization.

As already mentioned, on the agenda stand many ethical challenges, with the border between the benefits and harms associated with telemedicine remaining vague and fluid rather than sharply defined. This is due to the virtual environment, where electronically mediated communication replaces personal interaction and physical contact.

Since the issues discussed are highly controversial, the current text does not pretend to be a detailed or comprehensive analysis but provides some thoughts and reflections. Instead of giving certain prescriptions, the authors aim at providing a balance between norms and values through the consideration of social, political, cultural, legal, religious and economic aspects arising from the opposition to the generally accepted environmental values, healthcare system goals and the application of new technologies.

A particular problem that could affect the quality and nature of the conclusions in the text stems from the fact that, like many other innovations in the healthcare field, almost all of the studies from the available literature, assessing the positive and negative impact of telemedicine, focus primarily on the purely economic, technical and clinical parameters, particularly emphasizing on cost reduction and technological efficiency but ignoring the ethical considerations at the same time.

Generally, scientific literature demonstrates that the effect of telemedicine on patient-centered care varies more or less. Some studies see the negatives, but most find neutral or positive effects. In view of all these and acknowledging some of the literature gaps already mentioned, the authors may conclude that the basis of empirical studies is still too poor to allow any solid conclusions at this stage.

Organisational aspects (ORG)

When planning the introduction of a TM intervention in general, there are several questions that need to be addressed concerning: the choice of patients targeted by these programmes; the parameters that will be monitored; the more efficient way to monitor them; the training of patients and healthcare personnel; how to organize the response of the health care professionals to data obtained from monitoring to optimize patient care. Possibly management will need to deal with (de)employment of new resources, new information systems, new equipment for STS provisions, new administrative leadership and new group culture that promotes quality improvement.

STS can be carried out in very different settings, from primary care to tertiary care. There is little information in the studies on the changes of the workflow – usually for the STS an additional nurse was used who had access to patient data, carried out the STS, monitored the patient, recorded the symptoms and data and reinforced and adapted the plan of care for the patient.

In STS the most important thing is training and education of nurses and patients and communication. The STS support starts being planned while the patient is in hospital through education and meeting with the HF nurse. Education and practising with the technology follows and the materials are given to the patients as well as explained to the relatives. At the point of discharge the timing of the first call is agreed. The frequency of calls varies greatly among the studies but in common the calls are weekly at least first two weeks after discharge and then get biweekly until two months after discharge. After that they become monthly. The number of telephone contacts per week should not be too high, not even in the first week as this may affect adherence. Adherence is reported from 55,1% to 84% across the studies, adaptation to the technology to 90% or higher, more than 90% of patietns are statisfied with the use of technology.

 It is not clear how long the intervention should last: there are different periods, going from 3 months up to 2 years after the discharge. It is not clear when the effect is biggest, possibly within first 3 months. A published communication strategy is important, including patient support strategy, communication between patient: nurse, patient: medical doctor, patient: pharmacist, the brochures, diaries to record daily control measurements, web pages with disease information and with instructions, instructions for family members  to share a best practise. In general, STS provides greater access to care in geographical terms and no specific problems were mentioned regarding financial accessibility.

In spite of various methods of costs calculation, which makes them highly incomparable, it is posisble to establish that the average costs of intervention across the studies amounted from $23,6 to $443, the reported savings amounted from $30,9 to $536 per patient per month. None of the studies analyzed a shift of cost, from specialits to HF nurse to GP.

Eligibility to new technology depends on an assessment of the general practitioner of a patient’s condition and the patient's willingness and ability to participate. Access to new technologies depends on support of healthcare providers as they are rarely reimbursed.

Social aspects (SOC)

The aspects related to patients’ quality of life and satisfaction with STS, patients’ views, perceptions and probable improvements in self care allowed by the use of this intervention, are an important part of the success of this technology.

In the studies where quality of life (QoL) is measured with standardised instruments, there is a significant improvement of QoL in the intervention group or no difference between the usual care and the intervention. Pandor’s systematic review shows that 4 studies which had quality of life as a secondary outcome and where about STS, reported improvements in QoL, with significant improvements in physical [Angermann, 2011] and overall [Barth, 2001, Wakefiled, 2008] measures, but one study found no significant differences between the groups [Riegel, 2006]. Oher (primary) studies we selected gave scattered results. Dunagan et al. 2005 found that nurse-administered, telephone-based disease management intervention had some impact on functional status and quality of life. Piotrowicz et al. 2015 found that the in the intervention group there was a similar improvement in total QoL index as in the control group. Patients who underwent home-based tele rehabilitation observed an improvement mainly in the mental categories. On the other hand Ramachandran et al, 2007 found and increase in quality of life, as a whole and in many dimensions the intervention group that persisted over time. For Jerant 2003 telenursing at least did not have any large negative impact on patient satisfaction or health status. In the study by Boyne et al. 2014 authors conclusions says that tailored telemonitoring was found to educate patients with HF and to improve their self-care abilities and sense of self-efficacy. Domingues and collegues state that in thier study (2011) the educational nursing intervention performed during the hospitalization period brought improved knowledge of HF and self-care in all patients regardless of telephone contac.

The organisational differences among the variuos STS interventions in the selected studies (programs offering exercise, education and behavioral interventions on patients’ psychological outcomes, or monitoring systems of vital signs led by nurses or physician etc.) can help to explain those differences in findings and results and make trasferability and comparability of them difficoult.

To have a deeper understanding about how patients experience the care when it is moved outside of the hospital to their homes with  the support of STS, we also selected qualitative studies which allow to highlight perceptions of patients about complex interventions. From this perspective selected qualitative studies show that there can be positive and negative aspects in using telemedicine and its application such as STS. Lynga et al. 2013 interviews to patients who used the intervention showed, that  the technology was easy to perform, made patients active in their own care, and increased their self-care activities. However, there were concerns of potential deterioration: transmission of body weight reminded patients of illness, deterioration in their health, increase of diuretic dose (inconvenience in the patient’s daily life) and some experienced also a perception of fear that affected their psychological well being.

As regard tro the barriers to the use of the technology, digital divide related to the age or socio-economical status which could avoid patients to use the facilities related to the intervention, we could not retrive definitive and conclusive studies. The qualitative literature that gave an answer to this reaserch question would show digital divide due to age as not being a relevant problem. Seto et al. shows that relatives of those not technology-accustomed would be able to provide support to patient [Seto 2012]. Bond, 2014 finds that most people found the telehealth system easy to use and in the study of Prescher, 2013 most of the patients reported an easy and robust handling of the devices. Nontheless more quantitative studies about the influence of age, gender etc. on the use of STS should be developed to better understand implications of thoses macrosocial variables on the use of STS.

Legal aspects (LEG)

For the implementation of telemonitoring one has to look at least for existing property rights on the used system, the implemented software, existing patents, and to secure/regulate the permission for use.

For structured telephone support as a telemonitoring approach for patients with chronic heart failure there is a need of patient-cooperation which implies the will of the patient to take this kind of healthcare.

Data networks and data communication between providers of tele-healthcare and patients have to secure and protect data sources according to legal data protection regulations.

In any case the data protection should be on awareness, especially with low-level support via usual telephone or cell phone line. The informed consent with the patient and the (written) agreement are necessary.

Limited access to structured telephone support as a telemonitoring service for special persons have to be based on the balance between evidence of best outcome rates, economic calculations for the costs and reduction of possible disadvantages due to i.e. lack of compliance. The decision for inclusion/ exclusion into a structured telephone support service  has to be transparent.

Usually there is no health care tourism expected for structured telephone support for chronic heart failure patients. In case of (emergency) treatment abroad and re-transfer into the home-country the appropriate information and continuity of care has to be guaranteed. The routine provision of structured telephone support across borders (in our outside Europe) is expected to be limited by language.

There seem to be no major differences in product safety aspects comparing structured telephone support with usual care. The product safety and responsibility duties have to be followed in both settings. If telemonitoring/ stuctured telephone support is newly implemented there should be appropriate awareness for the safety structure to be equal/similar (or better) as in ”usual care”

Within structured telephone support provided by a physical person (like a nurse) and/or a group of professionals evaluating deterioration from the collected data by STS, the guarantee for quality can be given via the professional licencing regulations as it is handled within hospitals.

The Directive on public contracting assures price control of servies in case of contracting the whole STS service or in case of material purchasing for HF patients at home. Pricining within reimbursement system for STS (like DRG) is subject to national legislation. The pricing within DRG system must therefore take into account all national legislation and regulation, like national policy on wages or depreciation. However,  when the material costs are built into DRG, again the procedures for the public contracting is important, in case of STS it oculd apply to the telephone lines and various equipment that is given to HF patients to monitor their health status at home  (scales, meters for circumference of ankles etc).

Within medical services and/or medical devices advertising is regulated by local governments to prevent misinterpretation about the device or service.

There is still legal uncertainty within the provision of structured telephone support for patients with chronic heart failure in terms of

• Cross border healthcare services
• Funding aspects
• Reimbursement
• Procurement
• Sustainable business models
• Data protection via telephone line
• Provider responsibilities

For the provision of telemedical services/ STS several different legal regulations have to be followed, like:

• Occupational laws
• Hospital legislations
• Good clinical practice
• Health telematic law
• Data protection law
• E-government law
• Consumer protection law
• Signature law
• E-commerce-law
• Telecommunication law
• Copyright/ patent protection
• Media law

(list not exhaustive)

Collection methodology

Objective

To produce a Core Health Technology Assessment (HTA) assessing the effects of Structured telephone support (STS) for adult patients with chronic heart failure based on the EUnetHTA Core Model and working within the a mixed Collaborative Model organisational framework.

Methods

The work was based on the HTA Core Model application for Medical and Surgical Interventions (2.0)  , which was developed during the EUnetHTA Joint Actions 1 and 2.

The first phase was the selection of the technology to be assessed using the Core Model; this phase was carried out through a three-step process that is described in our MSP.

Then a check of Partners’ availability to assume responsibility for taking the lead in one of the nine evaluation domains was carried out. At the same time, the nine domain teams were built-up in accordance with partners’ preferences and some general guidelines (see the MSP).

Finally the specific work plan was shared, according with the general WP4 3-year work plan and objectives. This specific work plan included the phases scheduled in the “HTA Core Model Handbook” (Production of Core HTAs and structured HTA information).

An editorial team was set up for discussion and major decisions on basic principles and solutions related to the content of core HTA. The editorial team was chaired by Tom Jefferson (Agenas) and composed of all the primary investigators of the domains.

To allow collaboration between partners a draft protocol for Core Model use was agreed by the researchers involved. The research questions for each of the nine domains of the Core Model were formulated and the corresponding relevant assessment elements (AEs) were selected. The legal domain was included in the assessment.

The research strategy was carried out by Agenas with input from the other partners.

Evidence from published and manufacturer sources was identified, retrieved, assessed, and included according to pre-specified criteria, and summarised to answer each AE. Domain assessments were done by a single agency and by different investigators from different agencies, in a mixed organisational model. The final text has not been proof read.

Introduction to collection

This brief document provides background information on the preparation and development of the Core HTA on Structured telephone support (STS) for adult patients with chronic heart failure. The core HTA document was produced during the course of the second EUnetHTA Joint Action (JA2) 2012-2015.

The idea behind EUnetHTA’s Core Model is to provide a framework for structuring relevant HTA information while at the same time facilitating local use and adaptation of the information or guiding its production.

The Model is based on nine dimensions or “domains” of evaluation:

1. Health Problem and Current Use of the Technology (CUR)
2. Description and technical characteristics of technology (TEC)
3. Safety (SAF)
4. Effectiveness (EFF)
5. Costs and economic evaluation (ECO)
6. Ethical analysis (ETH)
7. Organisational aspects (ORG)
8. Social aspects (SOC)
9. Legal aspects

The Core Model application for Medical and Surgical Interventions (2.0)  was tested by assessing the effects of Structured telephone support (STS) for adult patients with chronic heart failure. We produced a Core HTA structured as in the nine documents that follow, one for each domain.

This Core HTA was prepared using an experimental Collaborative Model (COLMOD) in which groups of researchers from different HTA Institutions produced the domain texts. For the Core HTA on Structured telephone support (STS) for adult patients with chronic heart failure the experimental organisational model added an element of challenge but probably helped to forge strong links across participants.

In the next few months an intensive validation programme including interviews and consultations will elicit comments and feedback both from those who contributed to the Core HTA and from those who read a Core HTA for the first time. As scheduled in the 3-year work plan, the Core HTA will be sent to the Stakeholder Advisory Group (SAG) for feedback before the final Public Consultation, during which the Core HTA will be made publicly available.

The results from the Validation and SAG consultation should provide useful information to improve the product.

Scope

Technology	Structured telephone support (STS) for adult patients with chronic heart failure Description Telemonitoring via structured telephone support with focus on patient reported signs (symptoms of congestion, peripheral edema, pulmonary congestion, dyspnea on exertion, abdominal fullness), medication adherence, physiological data (like heart rate, blood pressure, body weight – measured by the patient with home-device), activity level; done in regular schedules using risk stratification (with fixed algorithm by call center staff or experience-based by specialized staff); done by dedicated call centers, center-based staff, nurses, AND reduced visits to a GP or heart center
Intended use of the technology	Prevention Remote transmission of information to alleviate symptoms, relieve suffering and allow timely treatment for chronic heart failure Target condition Chronic cardiac failure Target condition description Heart failure is a condition in which the heart has lost the ability to pump enough blood to the body's tissues. With too little blood being delivered, the organs and other tissues do not receive enough oxygen and nutrients to function properly. Target population Target population sex: Any. Target population age: adults and elderly. Target population group: Patients who have the target condition. Target population description Patients with chronic heart failure (CHF; defined as I50 http://www.icd10data.com/ICD10CM/Codes/I00-I99/I30-I52/I50-/I50 ) AND hospitalization due to heart failure at least once  AND without implanted devices
Comparison	Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) Description Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)
Outcomes	Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms

Health Problem and Current Use of the Technology

Authors: Ingrid Wilbacher, Nadine Berndt, Francesca Gillespie

Summary

CUR1: For which health conditions and for what purposes is structured telephone support (STS) for adult patients with chronic heart failure used?

Structured telephone support, as subject of the current Core HTA, is one specific type of remote heart failure monitoring. It is monitoring and/or self-care management using simple telephone technology, usually initiated by a healthcare professional (e.g. nurse, physician, social worker or pharmacist), and in which data is stored by a computer.

Telemedicine is an approach using remote monitoring e.g. by structured telephone support of prognostic factors in order to promote an early identification of clinical deterioration in HF patients, prevent hospital readmission for acute decompensated HF, and avoid further complications {3}. Signs and symptoms reported by patients are collected by a healthcare professional who subsequently enters and stores the data into a monitoring system. The data are then reviewed by healthcare professionals, usually physicians or nurses. Appropriate action can be initiated, and deterioration can be rapidly detected, which leads to decrease in unnecessary hospital visits, a decrease in hospital (re-)admissions, an improved quality of life. {75}. The highest risk period for hospital readmission is the first few weeks after discharge {90}. Overall, telemonitoring has the potential to improve patient safety and quality of care {21}.

CUR2: What kind of variations in use are there across countries/regions/settings?

There were 62 studies from Europe cited in the reviews. Out of the 62 European studies 16 mentioned educational strategies within the telemedicinal programme. The involved persons were cardiologists (3 studies), multidisciplinary teams at least for the care plan (25 studies), physician-/primary care led (1 study each), nurse-led (4 studies), not mentioned in the reviews (32 studies).

The transfer mode was in 17 studies via telephone/ cell phone transmission, in 4 studies through implantable devices, 1 study describes interactive videoconferencing, transtelephonic monitoring, 1 study described hospital-at-home service, 2 studies just described non-invasive telemonitoring, in 36 the transfer mode was not clear.

Most studies report care provided by a multidisciplinary team, but a great deal of heterogeneity regarding the professionals involved was described. Collaboration between primary care and secondary care was scarcely reported. In almost all the studies, nurses played a coordinating or leading role, but description of the specialization of clinical background were lacking. Almost all programmes also had physicians involved, which could be cardiologists, and/or primary care physicians or other specialists such as geriatricians or internists. Additionally, other professionals (i.e. psychologist, dietician, physical therapist, social worker, pharmacist) were involved in the programmes, mostly as a member of the multidisciplinary team or occasionally as the main provider of an intervention (e.g. a pharmacist). A different variation of systems for telemonitoring was found, ranging from assessment of symptoms and/or vital signs to data transmission and automatic alarms. {51}

Substantial heterogeneity among studies was noted {119}, the content of the telemedicine interventions vary between patient groups and with regard to duration and content.

CUR3 / ORG1: Who decides which people are eligible for structured telephone support (STS) for adult patients with chronic heart failure and on what basis?

Three of the reviews reported eligibility and exclusion criteria for patients included in the studies, but there was no answer on who decides or who should decide to use telemedicine for what patient.

CUR4: Is structured telephone support (STS) for adult patients with chronic heart failure a new, innovative mode of care, an add-on to or modification of a standard mode of care or replacement of a standard mode of care?

Eight of the included reviews try to look at the indicators for novelty and how they lead to a novel attitude – like including the patient - and new settings – like different patient- and physician roles - of health care. They still describe telemedicine as „changing modality“, „promising“, „complementary“, „potentially“, „modality“, and a common insecurity about what exactly is defined as telemedicine and what kind of programmes were modified into telemedicine (like disease management programmes which are technically supported) seems to occur.

Generally, telemedicine and telemonitoring can be seen as relatively new, currently as an adjunct to current care with the chance of more patient-self-care-involvement and improved quality of therapeutic monitoring, but without a clear unique idea where it should lead to and how it should be implemented.

CUR5: What is the target population in this current assessment of structured telephone support for adult patients with chronic heart failure?

In this current assessment of structured telephone support for adult patients with chronic heart failure, the target population is patients who have signs or symptoms of HF, or an underlying non-diagnosed abnormality of the cardiac structure that is likely to lead to HF.

According to the large number of studies that have been conducted on the clinical effectiveness of telemonitoring in HF patients, the appropriate target population of telemonitoring generally concerns elderly, with a definitive clinical diagnosis of HF, with a mean age generally around the 70s (patients may also be significantly younger or older), or with chronic HF, often who have had a cardiovascular hospitalization or a hospitalization for HF within the previous 12 months, who have been discharged to home, often with moderate or severe symptoms of HF (New York Heart Association, NYHA class II-IV), a LVEF ≤ 30 %, and who are administered diuretics, ACE inhibitors and beta blockers.

Structured telephone support may not be not suitable for every patient diagnosed with HF. According to Koehler et al. 2011 {64}, telemonitoring is particularly suitable for patients who are recently hospitalized due to HF, medically unstable, or classified being in the NYHA Class II and III. Koehler also recommends performing telemonitoring during the 12 event-free months after hospitalization for HF {64}.

Guidelines of the ESC recommend remote monitoring of patients reporting symptoms (including drug adverse effects) and signs of HF (Class I recommendation, Level of Evidence: C) {19}.

Patients with cognitive impairment, a mental illness, a life expectancy less than one year, hearing impairment, language barrier or another chronic disease are often not eligible for a telemonitoring intervention such as structured telephone support {93}. This has been confirmed by Paré et al. 2010 {92} who outlined on the basis of their systematic review on the clinical effects of home telemonitoring in the context of diabetes, asthma, HF and hypertension that telemonitoring likely to not be suitable for everyone, because most studies excluded patients with a moderate to severe cognitive, physical, visual or hearing disability. Patients who did not own a phone or who a very short life expectancy (less than 1 year) were often excluded as well. The beneficial effects on state of health are observed mostly among those patients whose health state is rather serious {92}.

CUR6: How many people belong to the target population?

HF is a large and global public health problem that will become more important with the aging of the world population. The number of patients with HF is predicted to increase considerably in countries with fast ageing populations, like Japan. Up to one person in five is expected to develop HF at some point in their life in economically developed countries {70}. In 2007, it was already estimated that approximately 1–2 % of the adult population in developed countries had HF and that the incidence approached on average 5–10 per 1000 persons per year with a significantly higher incidence in higher age groups {82}.

 

In 2011, it was estimated that 26 million adults worldwide were living with HF {6}, leading some to describe it as a global pandemic {2}. Of these patients at least 15 million are European {19}, whereas almost 7 million Americans ≥ 20 years of age have HF {120}. According to the AHA, at least 850.000 patients are yearly newly diagnosed with HF in the US with the incidence approaching 1 per 100 people 65 years of age and older.  %Data on the incidence and prevalence of HF in the developing world are largely absent, but it is estimated that there is also an increasing number of patients with HF in the developing countries due to the emerging pandemic of cardiovascular diseases {78}.  % % %

HF is a condition that becomes more common with increasing age. In North America and Europe, persons 50 years of age or under are hardly ever found to have HF {32},{7},{107}, and more than 80 % are 65 years of age or older {6}. Hence, particularly in those older than 50 years of age the prevalence and incidence increase progressively with age. Generally speaking, in 2007 the prevalence was estimated to be 10-20 % in persons with the age between 70 and 80 while it was rising significantly to ≥10 % among persons 70 years of age or older {82}. In the Dutch Rotterdam study, the prevalence of HF was 1 % in the age group of 55-64 years, 3 % in the age group of 65-74 years and 13 % in the age group of 75-85 years {81}. Moreover, according US estimates, the remaining lifetime risk for development of new HF remains at 20 % at 80 years of age, even in the face of a much shorter life expectancy {83}.  

 

Overall, the prevalence of systolic HF and diastolic HF is estimated to be equal between men and women. According to the ESC (2012), at least half of patients with HF have a low or reduced ejection fraction. HF with a preserved ejection fraction or diastolic HF is present in approximately 50 % the patients with HF {77},{29}. In younger age groups, systolic HF occurs more frequently in men than in women because myocardial infarction occurs at an earlier age in men. Diastolic HF is more common in the elderly, in women, in individuals with longstanding hypertension, diabetes, renal failure, anemia, and atrial fibrillation {19}. Studies show that the accuracy of the diagnosis of HF by clinical means alone is often inadequate. This applies particularly to female, elderly, and obese patients, leading to a potential underrepresentation of the patients who have HF {106},{60},{77}.

 

The globally increasing prevalence of HF is not merely due to the ageing of the population. It is also due to improvements in the treatment of acute coronary syndromes, effective prevention in those at high risk or those who have already survived a first coronary event, a longer survival of cardiac patients and HF patients, and the increasing epidemiology of cardiovascular diseases in the developing countries  {84},{100},{116}. An increase in risk factors for HF such as diabetes, sedentary behavior and obesity also contribute to the increasing pool of HF patients. Factors that on the other hand decrease the incidence of HF are a decline in the number of new cases with myocardial infarction, a decline in the severity of acute myocardial infarction and the improvement of care {40},{85}. The improvement of care for hypertension and coronary artery disease, particularly in Western Countries, also account for a decreasing incidence {86}.

Although various studies have been conducted in the past to capture the epidemiology of HF, there is still a scarcity of epidemiological data. The absence of gold-standard criteria for the diagnosis of HF, together with a lack of agreement on a definition of HF itself, explains why studies fail to use a uniform assessment of HF.

CUR7: What is the disease or health condition in the scope of this assessment?

According to the European Society of Cardiology, heart failure is a clinical syndrome in which patients have typical symptoms and signs resulting from an abnormality of cardiac structure or function. Although often life threatening, typical symptoms and signs resulting from an abnormality of cardiac structure or function, i.e. heart failure, leading to failure of the heart to deliver oxygen at a rate corresponding to the needs of the body are usually less dramatic than those associated with a myocardial infarction {77}.

The current 10^th edition of the International Classification (ICD) system classifies heart failure as an intermediate, not underlying cause of death. It is described as congestive heart failure including congestive heart disease and right ventricular failure. It is also defined as left ventricular failure including cardiac asthma, left heart failure, and oedema of lung and pulmonary oedema with mention of heart disease (unspecified) or heart failure. Heart failure (unspecified) can be due to cardiac, heart or myocardial failure not otherwise specified. Heart failure is further defined as the incidence of heart failure due to rheumatic heart disease, hypertensive heart disease, ischemic heart disease and inflammatory heart disease. Complicating abortion or ectopic or molar pregnancy, obstetric surgery and procedures are excluded. Moreover, heart failure due to hypertension (with renal disease), heart failure following cardiac surgery or due to presence of cardiac prosthesis, and neonatal cardiac failure are excluded from the classical definition of heart failure by the ICD-10 {113}.

CUR8: What are the known risk factors for the disease or health condition?

Risk factors for HF (AHA):

-increasing age (AHA);

-male gender (AHA);

-African American race (AHA);

-hypertension (AHA);

-obesity (AHA);

-low socio-economic status (AHA);

-cigarette smoking (AHA);

-history of atrial fibrillation (AHA);

-diagnosis of CHD (AHA);

-atherosclerosis {115},{77};

-low level of adiponectin and a high level of pro-B-type natriuretic peptide (BNP) in the bloodstream {83};

-increased urinary albumin excretion, an elevated serum γ-glutamyl transferase, higher levels of hematocrit, increased circulating concentrations of resistin, cystatin C, inflammatory markers (interleukin-6 and tumor necrosis factor-α) and low serum albumin levels {83};

-previous recognized or unrecognized viral infection {77};

-increased alcohol intake {77};

-chemotherapy {77};

-‘idiopathic’ dilated cardiomyopathy.

Risk factors for hospitalization in heart failure {30}:

-higher age;

-nonwhite race;

-low socio-economic status;

-lack of employment ;

-living alone, smoking;

-ischemic etiology;

-low systolic blood pressure;

-higher NYHA class (III or IV);

-prior HF hospitalization;

-presence of hypertension;

-diabetes mellitus;

-anemia;

-hyponatremia;

-history of renal insuffiency;

-worsening renal function;

-chronic obstructive pulmonary disease;

-obstructive sleep apnea;

-depression;

-low quality of life;

-absence of emotional support or social network;

-low adherence to therapies (Giamouzis et al., 2011).

Risk factors for hospital readmission among older persons with a new onset of HF {8}:

• diabetes mellitus;

• NYHA class III or IV;

• chronic kidney disease;

• reduced ejection fraction (< 45 %);

• muscle weakness;

• slow gait;

• having a depression.

 

Greater survival for patients with established CHF (“reverse epidemiology”) {54}:

• obesity;

• < >< >

  Substantial heterogeneity in the results {33};

• Telehealth programmes demonstrated clinical effectiveness in patients with CHF compared with usual care {114};

• It was not clear as to the extent to which these effects were due to tele-monitoring per se or to the improvement in access to care{44};

• Despite the beneficial effects reported by meta-analyses of small non-controlled studies, major randomized controlled trials have failed to demonstrate a positive impact of this strategy {102};

• Prior to being accepted as a standard of care, more evidence from large, randomized clinical trials is required {34};

• Structured telephone support and telemonitoring are effective in reducing the risk of all-cause mortality and CHF-related hospitalisations; in patients with CHF; they improve quality of life, reduce costs, and evidence-based prescribing {48};

• The present review demonstrated that home telemonitoring is generally clinically effective, and no patient adverse events were reported in the included studies {93};

• Telemonitoring appears to be an acceptable method for monitoring of HF patients {75}.

 CUR12: What are the differences in the management for different stages of the disease or health condition?

There is interest in new approaches of telemonitoring {1}, but at the moment there is no guideline recommendation available (possible) {45,24,1,110,3,33,44} for telemonitoring in general but for multidisciplinary CHF management programmes {87}.

CUR13: How is the disease or health condition currently diagnosed according to published guidelines and in practice?

Most guidelines agree on three essential stages of care for patients with heart failure:

-Diagnosis (should be timely and accurate);

-Treatment (should be appropriate to each patient and available urgently if necessary);

-Longterm management (should include follow-up, monitoring and support).

Disagree is observed on which diagnostic tools should be used for all patients with suspected heart failure and in which order.

Especially for invasive diagnostics there are some differences and challenges according to the interpretation of the diagnostic and prognostic value.

CUR14: How is the disease or health condition currently managed according to published guidelines and in practice?

Global assessment

-Despite clear recommendations regarding evidence-based medications, many patients with heart failure do not receive a prescription for potentially beneficial medication because they do not always comply with guidelines {45}

Europe

-In Europe prescription doses are often below those recommended {26},{28},{65};

-In Europe guidelines incorporate follow-up, monitoring  and support, however, about a quarter (7/26) of the countries reported having heart failure management programmes in more than 30 % ot their hospitals {49}  and even when in place, they are not always used.

USA

-In the US most hospital had fewer than half of 10 key recommended practices in place and fewer than 3 % had 10 in place {4};

-In the US more than a quarter of patients with heart failure did not receive an appropriate prescription {26},{28},{65}.

Australia

• A recent Australian consensus statement {88}report that the management of chronic heart failure remains a pressing problem, with many apparent indicators of poor case detection, including discordant management with evidence-based treatment, recurrent hospital admission, and disconnected care issues these that are amplified among marginalised populations.

 

CUR15: What is the marketing authorisation status of Telemonitoring in home care for patients with chronic cardiovascular diseases?

For equipment used as „telemedicine“ or „telemonitoring“ in a (community-)setting and/or within a disease management programme the devices seem to be individually created for the local need and based on a software for data-collection via mobile App, internet or as a database where data are written in while telephone interviews.

There is a database for medical devices within the EU (http://ec.europa.eu/health/medical-devices/market-surveillance-vigilance/eudamed/index_en.htm) which is access-restricted.

CUR16: What is the reimbursement status of structured telephone support (STS) for adult patients with chronic heart failure across countries?

This question is left un-answered. Due to the situation of high complexity among the use and settings within the terminus of „telemonitoring/ telemedicine“ and the new or developmental status of the intervention(s) no explicit answer can be provided in the frame of an HTA.

Introduction

The present domain describes the current state of the health condition, i.e. chronic heart failure and the current state of the health technology, i.e. structured telephone support under consideration for this Core HTA. HF is generally characterized by an underlying cardiac dysfunction that impairs the ability of the left ventricle to either fill with blood or contract to eject blood. It is not a disease but a collection of signs, symptoms, and pathophysiology. Typical symptoms are dyspnea or fatigue. Different stages of chronic HF are distinguished, particularly earlier and later stages, and acute and chronic stages {47}{86}. Patients diagnosed with HF have a high risk of readmission especially in the first weeks after hospital discharge. HF is associated with significant reduced quality of life, morbidity, and mortality {90}.

In 2011, it was estimated that 26 million adults worldwide were living with HF {6}, leading some to describe it as a global pandemic {2}. Due to the aging population, an improved survival after a cardiac event and better treatment of HF, the prevalence rates of HF are expected to rise {75}. Particularly in those older than 50 years of age the prevalence and incidence of HF increase progressively. Up to one person in five is expected to develop HF at some point in their life in economically developed countries {70}.

HF puts a considerable burden on the healthcare systems around the globe, largely due to high hospital (re)admission rates, and long hospital stays. The rising healthcare costs, rapid advances in communication and diagnostic technology, and the availability of low-cost telemedicine equipment are important factors that have significantly contributed to the increasing use of telemedicine for the provision of care {71}. A range of different technological modalities for monitoring and/or self-care management exists in telemedicine, including structured telephone support {13}.

Structured telephone support is one specific type of remote heart failure monitoring. It is monitoring and/or self-care management using simple telephone technology, usually initiated by a healthcare professional (e.g. nurse, physician, social worker or pharmacist) who collects relevant patient data and stores them in a computer. Data can hence be reviewed by the healthcare professional and if necessary, action can immediately be untaken {47},{ 99}(Chaudry et al., 2007).

For the PICO question as defined in October 2014, we focused on adult persons (aged 16 or more) suffering from congestive heart failure getting home-telemonitoring (defined as domiciliary detection, recognition, identification, location and transmission of vital functions and other biological information) compared to no home telemonitoring. After the PICO was adjusted in the beginning of 2015, we focused on adult patients with chronic heart failure receiving structured telephone support (STS) compared to no structured telephone support. 

This domain provides basic information about heart failure and telemonitoring aspects.

Methodology

Frame

The collection scope is used in this domain.

Technology	Structured telephone support (STS) for adult patients with chronic heart failure Description Telemonitoring via structured telephone support with focus on patient reported signs (symptoms of congestion, peripheral edema, pulmonary congestion, dyspnea on exertion, abdominal fullness), medication adherence, physiological data (like heart rate, blood pressure, body weight – measured by the patient with home-device), activity level; done in regular schedules using risk stratification (with fixed algorithm by call center staff or experience-based by specialized staff); done by dedicated call centers, center-based staff, nurses, AND reduced visits to a GP or heart center
Intended use of the technology	Prevention Remote transmission of information to alleviate symptoms, relieve suffering and allow timely treatment for chronic heart failure Target condition Chronic cardiac failure Target condition description Heart failure is a condition in which the heart has lost the ability to pump enough blood to the body's tissues. With too little blood being delivered, the organs and other tissues do not receive enough oxygen and nutrients to function properly. Target population Target population sex: Any. Target population age: adults and elderly. Target population group: Patients who have the target condition. Target population description Patients with chronic heart failure (CHF; defined as I50 http://www.icd10data.com/ICD10CM/Codes/I00-I99/I30-I52/I50-/I50 ) AND hospitalization due to heart failure at least once  AND without implanted devices
Comparison	Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) Description Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)
Outcomes	Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms

Assessment elements

	Topic	Issue	Relevant	Research questions or rationale for irrelevance
A0001	Utilisation	For which health conditions and for what purposes is the technology used?	yes	For which health conditions and for what purposes is structured telephone support (STS) for adult patients with chronic heart failure used?
A0012	Utilisation	What kind of variations in use are there across countries/regions/settings?	yes	What kind of variations in use are there across countries/regions/settings?
G0009	Utilisation	Who decides which people are eligible for the technology and on what basis?	yes	Who decides which people are eligible for structured telephone support (STS) for adult patients with chronic heart failure and on what basis?
F0001	Utilisation	Is the technology a new, innovative mode of care, an add-on to or modification of a standard mode of care or replacement of a standard mode of care?	yes	Is Structured telephone support (STS) for adult patients with chronic heart failure a new, innovative mode of care, an add-on to or modification of a standard mode of care or replacement of a standard mode of care?
A0011	Utilisation	How much is the technology utilised currently and in the future?	no	Overlapping with Question B0003
B0003	Utilisation	What is the phase of development and implementation of the technology and the comparator(s)?	no	This overlaps with the "management" in the CUR domain and will be answered there
A0007	Target Population	What is the target population in this current assessment of the technology?	yes	What is the target population in this current assessment of Structured telephone support (STS) for adult patients with chronic heart failure?
A0023	Target Population	How many people belong to the target population?	yes	How many people belong to the target population?
A0002	Target Condition	What is the disease or health condition in the scope of this assessment?	yes	What is the disease or health condition in the scope of this assessment?
A0003	Target Condition	What are the known risk factors for the disease or health condition?	yes	What are the known risk factors for the disease or health condition?
A0004	Target Condition	What is the natural course of the disease or health condition?	yes	What is the natural course of the disease or health condition?
A0005	Target Condition	What are the symptoms and burden of disease for the patient at different stages of the disease?	yes	What are the symptoms and burden of disease for the patient at different stages of the disease?
A0009	Target Condition	What aspects of the consequences / burden of disease are targeted by the technology?	yes	What aspects of the consequences / burden of disease are targeted by Structured telephone support (STS) for adult patients with chronic heart failure?
A0006	Target Condition	What are the consequences of the disease or the health condition for the society (i.e. the burden of the disease)?	no	We will answer the epidemiological aspects in A0023
A0017	Current Management of the Condition	What are the differences in the management for different stages of the disease or health condition?	yes	What are the differences in the management for different stages of the disease or health condition?
A0024	Current Management of the Condition	How is the disease or health condition currently diagnosed according to published guidelines and in practice?	yes	How is the disease or health condition currently diagnosed according to published guidelines and in practice?
A0025	Current Management of the Condition	How is the disease or health condition currently managed according to published guidelines and in practice?	yes	How is the disease or health condition currently managed according to published guidelines and in practice?
A0018	Current Management of the Condition	What are the other typical or common  alternatives to the current technology?	no	The comparator is defined in the PICO. The different telemedical tools are not seen as "alternatives".
A0020	Regulatory Status	What is the marketing authorisation status of the technology?	yes	What is the marketing authorisation status of Structured telephone support (STS) for adult patients with chronic heart failure?
A0021	Regulatory Status	What is the reimbursement status of the technology across countries?	yes	What is the reimbursement status of Structured telephone support (STS) for adult patients with chronic heart failure across countries?

Methodology description

Information sources

The basic common project search was used for this domain, added by guidelines and references found within the search results (handsearch). Methodological differences are mentioned in each assessment element.

Quality assessment tools or criteria

For the basic description of the health problem and the current management options within this domain a descriptive review without data use was provided, therefore no quality assessment about the studies’ methodology was done.

Analysis and synthesis

The common literature search that was done by the project leaders’ librarian for this Core HTA was scanned, in case articles were selected as being relevant based upon their title and abstract they were read in fulltext from all three authors,  and relevant answers for the assessment element questions were extracted. The three authors divided the questions into three parts. Each part had a main researcher and was checked by the other two. The draft document was sent to the domain reviewers, and their feedback was considered and implemented.

Result cards

Utilisation

Target Population

Target Condition

Current Management of the Condition

Regulatory Status

Discussion

We found clear descriptions and stages for heart failure, despite the fact that HF is more or less a range of (increasingly frequent) symptoms than a disease with a certain cause and treatment. There is a long list of underlying risk factors for developing and worsening the condition which also can be used as monitoring indicators for deterioration. In 2007, it was already estimated that approximately 1–2 % of the adult population in developed countries had HF and that the incidence approached on average 5–10 per 1000 persons per year with a significantly higher incidence in higher age groups {82}.

 

However, available epidemiological data in HF are not comprehensive since they only describe a fraction of patients with this syndrome. Due to the absence of gold-standard criteria for the diagnosis of HF and the lack of agreement on a definition of HF, there are considerable variations in the estimates of HF. Moreover, the highly selected hospitalized patients, retrospective analysis, and other non-cardiac related may bias the real estimates {116},{82}.

 

The condition starts symptom-free and is worsening by impairment in daily living (physical activity) due to increasingly frequent symptoms. The stages/ classes are described in detail (ESC, NYHA, ACC/AHA, Killip).

For telemonitoring there is a long list on expectations for potential advantages within the care of chronically ill patients (with HF). The idea is to shift a part of care (the observation of deterioration) towards the patient self- or homecare. Studies from Europe mainly highlight educational strategies within the telemedicinal programme. The involved health professionals are cardiologists, multidisciplinary teams and physician-/nurse- primary care. At the moment there is no guideline recommendation available for telemonitoring in general but for multidisciplinary CHF management programmes. The transfer mode described for telemonitoring is mainly via telephone/ cell phone transmission, or through implantable devices, interactive videoconferencing, transtelephonic monitoring are other options. Substantial heterogeneity among studies was noted. Telemonitoring is mainly described as new and additive technology, especially for Europe, although the history of telemedicine started in 1987 in the US.

Telemonitoring may not be suitable for every patient. It is particularly suitable for patients who are recently hospitalized due to HF, medically unstable, or classified being in the NYHA Class II and III. Guidelines of the ESC recommend remote monitoring of patients reporting symptoms (including drug adverse effects) and signs of HF (Class I recommendation, Level of Evidence: C). Patients with cognitive impairment, a mental illness, a life expectancy less than one year, language barrier or another chronic disease are often not eligible for a telemonitoring intervention {93},{92}. Patients who do not own a phone were often excluded from the studies as well. The beneficial effects on state of health are observed mostly among those patients whose health state is rather serious {92}.

Most guidelines agree on three essential stages of care for patients with heart failure, which are a timely accurate diagnosis, appropriate treatment and long-term management, but there is disagree observed on which diagnostic tools should be used for all patients with suspected heart failure and in which order. Especially for invasive diagnostics there are some differences and challenges according to the interpretation of the diagnostic and prognostic value.

For the invasive device-monitoring there are companies mentioned in the included studies which provide their registration status online. For other equipment used as „telemedicine“ or „telemonitoring“ in a (community-)setting and/or within a disease management programme the devices seem to be individually created for the local need and based on a software for data-collection via a telephone app, internet or as a database where data are written in while telephone interviews. Due to restricted access for the European registries and some no-name descriptions of the content of telemonitoring, the registration could not be followed for all systems found in the studies. Also the reimbursement status was not evaluated due to the huge heterogeneity of different products and different product-combinations.

We did not restrict the included studies in this domain by study-methodology, because we wanted to provide a basic overview. For some of the assessment elements we had to exceed the common basic literature search.

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Appendices

The used strategies described as telemonitoring for the European studies in the used reviews

Study	country	found where?	who?	what?	transfer mode	education?
Aguado 2010	Spain	Jaarsma 2013	multidisciplinary team	multidisciplinary team care plan educational strategies optimized treatments increased access to care		yes
Aimonino 2007	Italy	Jaarsma 2013	physician-led	multidisciplinary team educational strategies optimized treatments increased access to care	hospital-at-home-service	yes
Aldamiz-Echevarria 2007	Spain	Feltner 2014		home-visiting programmes
Angermann 2011	Germany	Pandor 2013		symptoms and medication monitoring	telephone	yes
Antonicelli 2008	Italy	Conway 2014; Gorthi 2014; Jaarsma 2013; Pandor 2013; Xiang 2013	multidisciplinary team	BP, HR, weight, 24h urine output, and ECG; care plan educational strategies optimized treatments increased access to care; telemonitoring; Disease Management Programmes	non-invasive Telemonitoring
Antonicelli 2010	Italy	Giamouzis 2012		weight, blood pressure, heart rate, 24h urine, weekly ECG	telephone
Balk 2008	NL	Conway 2014; Gorthi 2014; Jaarsma 2013;  Xiang 2013	multidisciplinary team	care plan educational strategies increased access to care; scale, medication, dispenser; Disease Management Programmes; Teleguidance	non-invasive Telemonitoring
Barlow 2007	UK	Schmidt 2010		home-telemonitoring
Blue 2001	Scotland	Whellan 2005, Jerant 2005, Gorthi 2014, Jaarsma 2013, Xiang 2013	multidisciplinary team, nurse-led	care plan educational strategies optimized treatments, case management, DMP		yes
Bondmass 2001	Europe	Jerant 2005	multidisciplinary team		telephone
Boyne 2011	NL	Xiang 2013		scale, pulse monitoring
Brotons 2009	Spain	Jaarsma 2013	multidisciplinary team	multidisciplinary team care plan educational strategies optimized treatments increased access to care		yes
Cabezas 2006	Spain	Feltner 2014		structured  support	telephone
Capomolla 2002	Italy	Jerant 2005, Gorthi 2014, Whellan 2005	cardiologist	Disease Management Programmes Using Outpatient Visits	telephone
Capomolla 2004	Italy	Conway 2014, Clark 2007, Pandor 2013, Gorthi 2014, Xiang 2013		weight, systolic BP, HR, vital signs (including weight, systolic blood pressure, heart rate), DMP	interactive voice response
Cleland 2005	Europe, Germany, NL, UK	Conway 2014, Jaarsma 2013, Chaudry 2007, Xiang 2013, Giamouzis 2012, Gorthi 2014, Pandor 2013, Clark 2007	nurse, multidisciplinary team	education and monitoring; weight, BP, and ECG; increased access to care;weight	telephone	yes
Cline 1998	Sweden	Gorthi 2014, Whellan 2005	cardiologist	Disease Management Programmes Using Outpatient Visits
Dar 2009	UK	Feltner 2014, Giamouzis 2012, Gorthi 2014, Jaarsma 2013, Pandor 2013, Xiang 2013	multidisciplinar team	weight, blood pressure, heart rate, pulse oximetry;  care plan optimized treatments educational strategies increased access to care; DMP	telephone
de la Porte 2007	NL	Gorthi 2014		Disease Management Programmes Using Outpatient Visits
de Lusignan 2001	UK	Jerant 2005, Conway 2014, Clark 2007, Xiang 2013		multidisciplinary clinic; pulse, BP, weight; vital signs (pulse, blood pressure, weight) and clinical status;	interactive videoconferencing, transtelephonic monitoring
Del Sindaco 2007	Italy	Jaarsma 2013	multidisciplinary team	care plan optimized treatments educational strategies increased access to care, hybrid DM programme		yes
Dendale 2011	Belgium	Pandor 2013		weight, blood pressure, heart rate; scale, pulse	cell phone transmission
Ekman 1998	Sweden	Jerant 2005, Feltner 2014, Gorthi 2014, Whellan 2005	Primary care physician	outpatient clinic-based interventions	telephone
Giordano 2009	Italy	Conway 2014; Giamouzis 2012; Gorthi 2014, Jaarsma 2013, Xiang 2013	multidisciplinary team	one-led ECG, weight, blood pressure, ECG, drug dosage, education and monitoring; adherence to diet and treatment, monitoring of symptoms, control of fluid retention, and daily physical activity; multidisciplinary team care plan optimized treatments educational strategies increased access to care;	telephone	yes
Holland 2007	UK	Feltner 2014, Gorthi 2014, Jaarsma 2013	multidisciplinary team	educational strategies increased access to care, home-visiting programmes, Disease Management Programmes		yes
Jaarsma 1999	NL	Feltner 2014, Gorthi 2014, Jaarsma 2013, Whellan 2005, Jerant 2005	multidisciplinary team, nurse-led	Disease Management Programmes Using Home Visits		yes
Jolly 2009	UK	Xiang 2013		scale monitoring
Kielblock 2007	Germany	Conway 2014, Pandor 2013, Xiang 2013		weight, scale telemonitoring
Klersy 2009	Italy	Schmidt 2010, Sousa 2014		technology assisted strategies	telephone, technology (?)
Koehler 2011	Germany	Giamouzis 2012, Gorthi 2014		weight, blood pressure, ECG, drug dosage; Disease Management Programmes	cell phone transmission
Koronowski 1995	Israel	Jaarsma 2013	multidisciplinary team	intensive home-care surveillance
Landolina 2012	Italy	Gorthi 2014		Disease Management Programmes Using Invasive Hemodynamic Monitoring
Ledwidge 2002	Ireland	Gorthi 2014		Disease Management Programmes Using Outpatient Visits
Linne 2006	Sweden	Feltner 2014				yes
Lynga 2012	Sweden	Xiang 2013		scale monitoring
MacDonald 2002	Ireland	Whellan 2005	cardiologist	clinic follow up, cardiologist supervision
Martinez-Fernandez 2006	Spain	Schmidt 2010		home monitoring
Massie 2001	Italy	Jerant 2005	multidisciplinary team	standard telephone calls, transtelephonic monitoring	telephone
McDonald 2001	Ireland	Feltner 2014		outpatient clinic-based interventions
McDonald 2002	Ireland	Feltner 2014,Jerant 2005	multidisciplinary team	outpatient clinic-based interventions	telephone
Mendoza 2009	Spain	Jaarsma 2013	multidisciplinary team	increased access to care, hospital at home model
Mortara 2004	Europe	Jaarsma 2013	multidisciplinary team	optimized treatments educational strategies increased access to care		yes
Mortara 2009	Europe, Italy, UK, Poland	Conway 2014, Gorthi 2014, Giamouzis 2012, Xiang 2013		education and monitoring; weight, systolic BP, HR, and symptoms, respiration rate, and physical activity; weight, BP, and symptoms; asthenia score, oedema score, changes in therapy, blood results;	telephone call, interactive voice response
Nucifora 2006	Italy	Feltner 2014				yes
Peters-Klimm 2010	Germany	Jaarsma 2013	multidisciplinary team	care plan  educational strategies increased access to care, HF case management		yes
Piotrowicz 2010	Poland	Jaarsma 2013	multidisciplinary team	care plan educational strategies increased access to care; new home TeleCardia Rehab programme		yes
Robinson 2004	Germany	Jaarsma 2013	multidisciplinary team	care plan increased access to care, telehomecare
Rondinini 2008	Italy	Jaarsma 2013	multidisciplinary team, domiciliary-based nurse-led strategy	care plan educational strategies increased access to care		yes
Scherr 2009	Austria	Giamouzis 2012, Pandor 2013, Xiang 2013		weight, blood pressure, heart rate, dosage of medication; scale, medication dispenser, pulse monitoring	cell phone transmission
Schmidt 2007	Germany	Schmidt 2010		telemedicine
Stromberg 2003	Sweden	Feltner 2014, Gorthi 2014, Jerant 2005	multidisciplinary clinic	Disease Management programmes Using Outpatient Visits	telephone
Thompson 2005	UK	Feltner 2014, Jaarsma 2013	multidisciplinary team	optimized treatments educational strategies increased access to care, home-visiting programmes ,
TIM-HF 2011, Koehler 2010	Germany	Sousa 2014		TM (daily ECG, blood pressure, weight) sent to telemedical centers
Van Veldhuisen 2011	NL	Gorthi 2014		Disease Management programmes Using Invasive Hemodynamic Monitoring
Vavouranakis 2003	Greece	Jaarsma 2013	multidisciplinary team	optimized treatments educational strategies increased access to care
Villani 2007	Italy	Xiang 2013		scale, symptoms, pulse, urine output
Wierzchowiecki 2006	Poland	Jaarsma 2013	multidisciplinary team	care plan optimized treatments educational strategies increased access to care
Zugck 2008	Germany	Xiang 2013		scale, ECG, SPO2 monitoring

Description and technical characteristics of technology

Authors: Ingrid Wilbacher, Valentina Prevolnik Rupel

Summary

TEC1: Who manufactures Telemonitoring in home care for patients with chronic cardiovascular diseases?

We did not answer this question in the TEC domain. Please find the overlapping results in CUR_ 15

TEC2: What kind of qualification and quality assurance processes are needed for the use or maintenance of Telemonitoring in home care for patients with chronic cardiovascular diseases?

The answer was created out of statements in nine of the included studies from the general literature search and an additional unstructured search in google for more information.

The studies providing information about the staff qualification mainly content of

-management according to a multidisciplinary/ physicians care plan

-provision of monitoring and reaction in case of abnormities by nurses

The results of the survey with 15 experts in Germany {1} provide a conclusive overview of expected skills:

-methodological competence (analytical thinking, ability of reflexion, autonomy, linguistic, anamnestic competence, ability of abstraction, ability of reaction)

-social competence (empathy, communication skills, politeness, social sensitivity, authority, motivation skills, kindness)

-professionality (basic medical knowledge, secure technical skills, practical medicinal experience, knwoledge of basic health legislation, knwoledge about the health system, psychological motivational skills, knowledge in quality management)

-personal competence (self-knowledge, psychical capacity, steadiness, distress-resistancy, learning motivation, professional distance, IT-skills)

Structural quality:

-How telemonitoring or telemedicine is implemented and to whom varies (see also CUR and LEG domain).

Process quality:

-The quality assurance seems to be lacking.

 

TEC3: What kind of training and information should be provided for the patient who uses Telemonitoring in home care for patients with chronic cardiovascular diseases, or for his family?

In the ten included studies for this question the following training/ patient education aspects were adressed:

1. General heart failure education

-detection of deterioration

-use of medication

-diet

-physcial activity/ exercise training

-Smoking cessation

2.telemonitoring specific training

-training to use devices (technically)

-training to manage the information (empowerment and self-care), interpret the vital signals and efficiently utilize them

3.Other training/ education

-coping with difficult emotions

-relaxation and cognitive symptom management techniques

-lifestyle aspects: alcohol intake, sexual activity

-necessity of vaccinations

-capabilities of patients to travel or work

-coping with individual problems, often related to comorbid conditions

-training of relatives/ caregivers

How is the training suggested to be provided:

-could be carried out in groups of 10-15 people, where patients can assist and help each other

-through leaflets and online manuals, depending on the service

TEC4: What information of Telemonitoring in home care for patients with chronic cardiovascular diseases should be provided for patients outside the target group and the general public?

Information to patients outside the target group and the general public should therefore focus on the reasons and the explanaition for inclusion or exclusion of people/ patients for access to structured telephone support. People should be informed that structured telephone support is not suitable for all individuals nor is it appropriate under all medical circumstances

TEC5: What is Telemonitoring in home care for patients with chronic cardiovascular diseases and the comparator(s)?

 

The non-invasive telemedicine/telemonitoring contains the following aspects (seperately or combined):

-remote access control (transfer of physiological data)

-nurse-led management program after hospital discharge

-disease management program (including cardiologists, nurses, GPs)

-patient education

-regular outpatient contact

-self-care supportive strategies

-case management interventions

-monitoring and (daily) transmission of vital parameters and weight

-telephone-follow up

-home-visits

-remote consultation with a nurse by video-camera

-weigh daily and respond to questions concerning heart failure symptoms

-daily data-transfer to a secure Internet site

-response to questions from a computerized interactive voice response system

-medication management (adherence),

-fluid management (adherence)

-problem solving

-exercise recommendation

-diet adeherence

-goal setting

-structured telephone support

-human-to-human contact (HH) or human-to-machine interface (HM)

 

Usual care

-standard post-discharge care without intensified attendance at cardiology clinics

-clinic-based CHF disease management programme

-home visiting

There is no consensus definition of the fundamental terms utilized.

There is also an „upcoming“ topic called mHealth meaning mobile health through mobile phones and similar devices using software applications (apps). There is increasing interest on mhealth, especially with the hope of easy and equal acces for information, tele-diagnostic or –care aspects and data collection and use for health purpose. Some major aspects are to be worked out (like network issues, data security, information quality, legal and regulatory aspects etc.) and are aim within the EU horizon 2020.

TEC6: In what context and level of care are Telemonitoring in home care for patients with chronic cardiovascular diseases and the comparator used?

Conclusion: telemedicine/ telemonitoring interventions can be used in all different settings (outpatient, outpatient clinic, hospital based, home, mixed setting), they are mainly provided in outpatient organisations, the most important part ist the additional setting at the patients‘ home.

TEC7: Are the reference values or cut-off points clearly established?

The reference values for heart failure diagnostic (- monitoring) are mainly a) mortality and b) hospitalisation (rate).

There are more clearly established results for the diagnostic accuracy within monitoring the implantable device-based indicators, alone or combined with weight and symptoms.

 

The reference values used for telemedical approaches with structured interviews are more or less standardized (like in www. klinik.uni-wuerzburg.de/medizin1/inh-heartnetcarehf { Rec #: 200}, but there is also a subjective category which cannot be clear established, like „listening into a patients‘ kind of reporting“, „detecting differences within a knwon patient“, that require a human sense approach.

The reference value of „mortality“ and „hospitalisation“ requires a competent listening/ monitoring person who decides when the emergency chain has to be initiated.

TEC8: What material investments are needed to use Telemonitoring in home care for patients with chronic cardiovascular diseases?

Despite the implantable devices, further materials are needed for telemonitoring/ telemedicine:

Patients home

-patient near unit (funk transmission)

-telephone/ cell phone with telephone line

-scale

-camera

-PC with internet

Data transfer

-Secure data sending line (internet)

-Telephone line

-Secured technical interoperability/ adaptiveness

Receiver of data/ care center/ nurse

-PC, software

-Telephone

-Usual office infrastructure

-Ev. car for home visits

There is a need for further research in knowledge representation, and the used data analysis methods. Current barriers for adaptation include uncertainty about the response protocols, payment systems, and prescribing protocols. {29}

TEC9: What kind of special premises are needed to use Telemonitoring in home care for patients with chronic cardiovascular diseases and the comparator(s)?

No special premises were found in the literature.

TEC10: What equipment and supplies are needed to use Telemonitoring in home care for patients with chronic cardiovascular diseases and the comparator?

We provide the answer within TEC 8

TEC11: What kind of data and records are needed to monitor the use of Telemonitoring in home care for patients with chronic cardiovascular diseases and the comparator?

The needs for a sustainable telemonitoring include

-Qualified professionals (human resources) doing the monitoring/ statistics/emergency prioritisation

-Economic resources to provide the infrastructure for data transmission (GSM network, analogue phoneline, internet, software) and telephone support, documentation, home visits, etc.

-Transparent selection of patients who benefit best

TEC12: What kind of registers are needed to monitor the use Telemonitoring in home care for patients with chronic cardiovascular diseases and comparator?

There are no specific registries to monitor or register the use of structured telephone support  for heart failure specifically. If a national registry is already existing and/or the EU registry is used/ planned to be used there needs to be no further register installed for telemonitoring in heart failure patients.

The telemonitoring aspects – at least „on telemonitoring yes/no“, what kind of telemonitoring is used, entry-exit date – can be easily added into an existing registry.

Introduction

In this domain we aim to explain what is meant by „structured telephone support (STS) within telemonitoring“, to detect whether „telemedicine“ means the same as „telemonitoring“or something different, what wordings and explanations are currently in use and what do they mean.  We aim to describe the forms of existing telemonitoring technologies, their use and functioning as well as major issues that stem from the use of these technologies. Also exsposed are the preconditions for the use of telemonitoring, educational needs on the side of patients and families as well as professional teams. Regarding the use of telemonitoring all forms of telemonitoring devices are categorized according to their settings etc. The reference values that trigger the interventions are looked into and material investments as well as necessary equipment and supplies for the use of telemonitoring by STS are researched. The registers are listed to monitor the use of the technology and comparator. 

Methodology

Frame

The collection scope is used in this domain.

Technology	Structured telephone support (STS) for adult patients with chronic heart failure Description Telemonitoring via structured telephone support with focus on patient reported signs (symptoms of congestion, peripheral edema, pulmonary congestion, dyspnea on exertion, abdominal fullness), medication adherence, physiological data (like heart rate, blood pressure, body weight – measured by the patient with home-device), activity level; done in regular schedules using risk stratification (with fixed algorithm by call center staff or experience-based by specialized staff); done by dedicated call centers, center-based staff, nurses, AND reduced visits to a GP or heart center
Intended use of the technology	Prevention Remote transmission of information to alleviate symptoms, relieve suffering and allow timely treatment for chronic heart failure Target condition Chronic cardiac failure Target condition description Heart failure is a condition in which the heart has lost the ability to pump enough blood to the body's tissues. With too little blood being delivered, the organs and other tissues do not receive enough oxygen and nutrients to function properly. Target population Target population sex: Any. Target population age: adults and elderly. Target population group: Patients who have the target condition. Target population description Patients with chronic heart failure (CHF; defined as I50 http://www.icd10data.com/ICD10CM/Codes/I00-I99/I30-I52/I50-/I50 ) AND hospitalization due to heart failure at least once  AND without implanted devices
Comparison	Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) Description Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)
Outcomes	Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms

Assessment elements

	Topic	Issue	Relevant	Research questions or rationale for irrelevance
A0022	Other	Who manufactures the technology?	yes	Who manufactures structured telephone support (STS) for adult patients with chronic heart failure?
B0012	Training and information needed to use the technology	What kind of qualification and quality assurance processes are needed for the use or maintenance of the technology?	yes	What kind of qualification and quality assurance processes are needed for the use or maintenance of Structured telephone support (STS) for adult patients with chronic heart failure?
B0014	Training and information needed to use the technology	What kind of training and information should be provided for the patient who uses the technology, or for his family?	yes	What kind of training and information should be provided for the patient who uses Structured telephone support (STS) for adult patients with chronic heart failure, or for his family?
B0015	Training and information needed to use the technology	What information of the technology should be provided for patients outside the target group and the general public?	yes	What information of Structured telephone support (STS) for adult patients with chronic heart failure should be provided for patients outside the target group and the general public?
B0013	Training and information needed to use the technology	What kind of training and information is needed for the personnel/carer using this technology?	yes
B0001	Features of the technology	What is this technology and the comparator(s)?	yes	What is Structured telephone support (STS) for adult patients with chronic heart failure and the comparator(s)?
B0005	Features of the technology	In what context and level of care are the technology and the comparator used?	yes	In what context and level of care are Structured telephone support (STS) for adult patients with chronic heart failure and the comparator used?
B0018	Features of the technology	Are the reference values or cut-off points clearly established?	yes	Are the reference values or cut-off points clearly established?
B0002	Features of the technology	What is the approved indication and claimed benefit of the technology and the comparator(s)?	no	This is overlapping with the CUR domain and will be answered there. The indication is selected within the PICO definition
B0003	Features of the technology	What is the phase of development and implementation of the technology and the comparator(s)?	no	This overlaps with the "management" in the CUR domain and will be answered there
B0004	Features of the technology	Who performs or administers the technology and the comparator(s)?	no	This overlaps with the "management" in the CUR domain and will be answered there
B0007	Investments and tools required to use the technology	What material investments are needed to use the technology?	yes	What material investments are needed to use Structured telephone support (STS) for adult patients with chronic heart failure?
B0008	Investments and tools required to use the technology	What kind of special premises are needed to use the technology and the comparator(s)?	yes	What kind of special premises are needed to useStructured telephone support (STS) for adult patients with chronic heart failure and the comparator(s)?
B0009	Investments and tools required to use the technology	What equipment and supplies are needed to use the technology and the comparator?	yes	What equipment and supplies are needed to use Structured telephone support (STS) for adult patients with chronic heart failure and the comparator?
B0010	Investments and tools required to use the technology	What kind of data and records are needed to monitor the use of the technology and the comparator?	yes	What kind of data and records are needed to monitor the use of Structured telephone support (STS) for adult patients with chronic heart failure and the comparator?
B0011	Investments and tools required to use the technology	What kind of registers are needed to monitor the use the technology and comparator?	yes	What kind of registers are needed to monitor the use Structured telephone support (STS) for adult patients with chronic heart failure and comparator?

Methodology description

Domain frame

To answer the questions in the assessment elements we mainly used the basic literature search provided for the whole project. For some answers additional handsearch was used, and for some AEs we did a google search in other resources than scientific literature (i.e. for TEC_11).

The extracted studies and the reason for not using them is provided in the annex 1 at the end of the domain report. The issue (research question) specific methods will be reported later in the methods field of the result card.

Information sources

Common basic project literature search

Handsearch (additional reference found/ provided)

Google (for registries)

Quality assessment tools or criteria

We did not rate the quality of the included studies, but mentioned whether the information was extracted from systematic reviews or single studies (i.e. RCTs) or other resources.

Analysis and synthesis

Two investigators divided the amount of studies by alphabeth, each scanned the half of the studies and double-checked the other.

Result cards

Other

Training and information needed to use the technology

Features of the technology

Investments and tools required to use the technology

Discussion

We found a wide range of interpretation of what is meant by telemonitoring/ telemedicine in the included literature. There are variations  of telemonitoring like disease management programs, hospital based external monitoring structure, data-transfer and reaction by staff and/or device, structured or unstructured telephone support and involvement of professionals (i.e. cardiologist, nurse, GP).

The non-invasive monitoring, which includes structured telephone support  gives the impression to be often implemented from „bottom up“ with therefore different solutions, contents and settings – as appropriate to the innovative bottom-up idea.

There is a need of  a structured care outside the hospital for patients who do not need continous in-hospital care but should be monitored for a sudden deterioration or emergency-situation.. The solution of a high-frequent GP contact is not feasible as the number of control visits would increase enormously due to increase in chronic diseases.  

The idea of a monitoring at distance saves time and efforts, but the solution seems to lack in structural and surrounding details like „whom to involve“, „how to train whom“ and „what should be done with the data“ (data security, data secure transfer, transmisson line system, etc.), influencing the studies outcomes.

We did not restrict the included studies in this TEC domain by study-methodology, because we wanted to have a valid description of projects and implemented system approaches for telemonitoring.

For structured telephone support it has to be taken into account

• Who calls whom when for what

• Who collects what data for what purpose

• What happens with the data

• Who reacts on the collected information and when and how

• Is there a need of technical support or function maintainance

• Is the target group of heart failure patients ready for the planned intervention (i.e. what kind of telephone are they able to use)

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Appendices

Annex 1

Excluded literature from the basic literature search

Source	EndNote Number	P People aged 16 or more with CHF (defined as I50	I Home telemonitoring (defined as domiciliary detection, recognition, identification, location and transmission of vital functions and other biological information of a person )	C No home telemonitoring	O Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL, harms, device use	D Evidence synthesis studies (SRs, HTA reports) [updating RCTs i.e. RCT fitting the PICO which have been published after the last search date of the latest SR/HTA document ]	CUR_TEC domain?	other reason for exclusion
Mair F.S. Does remote monitoring improve outcome in patients with chronic heart failure? Commentary. Nat. Clin. Pract. Cardiovasc. Med. 2007; 4(11):588-9.	Rec #: 1260					no
Redman B.K. Ethically problematic assumptions regarding patient self management and barriers to improved outcomes. Expert Rev. Pharmacoecon. Outcomes Res. 2006; 6(5):489-94.	Rec #: 1450						no
Costa A.P., Hirdes J.P. Clinical characteristics and service needs of alternate-level-of-care patients waiting for long-term care in Ontario hospitals. Healtc. Policy 2010; 6(1):32-46. Rec #: 1400	Rec #: 1400		no
Agarwal R, Bills JE, Hecht TJ, Light RP. Role of home blood pressure monitoring in overcoming therapeutic inertia and improving hypertension control: a systematic review and meta-analysis. Hypertension 2011; 57(1):29-38.	Rec #: 460	no
Mengden T, Ewald S, Kaufmann S, vor dem Esche J, Uen S, Vetter H. Telemonitoring of blood pressure self measurement in the OLMETEL study. Blood Press Monit 2004; 9(6):321-5.	Rec #: 650	no
Omboni S, Gazzola T, Carabelli G, Parati G. Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. J Hypertens 2013; 31(3):455-67; discussion 467-8.	Rec #: 380	no
Omboni S, Guarda A. Impact of home blood pressure telemonitoring and blood pressure control: a meta-analysis of randomized controlled studies. Am J Hypertens 2011; 24(9):989-98.	Rec #: 450	no
Parati G, de Leeuw P, Illyes M et al. Blood pressure measurement in research. Blood Press Monit 2002; 7(1):83-7.	Rec #: 670	no
Shepperd S. Hospital at home: The evidence is not compelling. Ann. Intern. Med. 2005; 143(11):840-1.	Rec #: 1470					no
Zartner P, Handke R, Photiadis J, Brecher AM, Schneider MB. Performance of an autonomous telemonitoring system in children and young adults with congenital heart diseases. Pacing Clin Electrophysiol 2008; 31(10):1291-9.	Rec #: 600	no
Jaana M, Pare G. Home telemonitoring of patients with diabetes: a systematic assessment of observed effects. J Eval Clin Pract 2007; 13(2):242-53.	Rec #: 620	no
Baztan J.J., Suarez-Garcia F.M., Lopez-Arrieta J., Rodriguez-Manas L., Rodriguez-Artalejo F. Effectiveness of acute geriatric units on functional decline, living at home, and case fatality among older patients admitted to hospital for acute medical disorders: Meta-analysis. BMJ (Online) 2009; 338(7690):334-6.	Rec #: 1440		no
Crawford-Faucher A. Home- and center-based cardiac rehabilitation equally effective. Am. Fam. Phys. 2010; 82(8):994-5.	Rec #: 1390		no
Hwang R, Redfern J, Alison J. A narrative review on home-based exercise training for patients with chronic heart failure (Provisional abstract). Physical Therapy Reviews .	Rec #: 890		no
Hwang R., Marwick T. Efficacy of home-based exercise programmes for people with chronic heart failure: A meta-analysis. Eur. J. Cardiovasc. Prev. Rehabil. 2009; 16(5):527-35.	Rec #: 1420		no
Daskalopoulou SS, Khan NA, Quinn RR et al. The 2012 Canadian hypertension education program recommendations for the management of hypertension: blood pressure measurement, diagnosis, assessment of  risk, and therapy. Can J Cardiol 2012; 28(3):270-87.	Rec #: 740	no
McKinstry B, Hanley J, Wild S et al. Telemonitoring based service redesign for the management of uncontrolled hypertension: multicentre randomised controlled trial. BMJ 2013; 346:f3030.	Rec #: 360	no
Inglis Sally C, Clark Robyn A, McAlister Finlay A et al. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database of Systematic Reviews . CD007228	Rec #: 780							double
Feltner C, Jones CD, Cene CW et al. Transitional care interventions to prevent readmissions for persons with heart failure: a systematic review and meta-analysis. Ann Intern Med 2014; 160(11):774-84.	Rec #: 10							double
Chien C L, Lee C M, Wu Y W, Chen T A, Wu Y T. Home-based exercise increases exercise capacity but not quality of life in people with chronic heart failure: a systematic review (Structured abstract). Australian Journal of Physiotherapy .	Rec #: 900		no
Taylor Rod S, Dalal Hayes, Jolly Kate, Moxham Tiffany, Zawada Anna. Home-based versus centre-based cardiac rehabilitation. Cochrane Database of Systematic Reviews .	Rec #: 930		no
Chaudhry S.I., Phillips C.O., Stewart S.S. et al. Telemonitoring for Patients With Chronic Heart Failure: A Systematic Review. J. Card. Fail. 2007; 13(1):56-62.	Rec #: 1300							double
Samartzis L., Dimopoulos S., Tziongourou M., Nanas S. Effect of psychosocial interventions on quality of life in patients with chronic heart failure: A meta-analysis of randomized controlled trials. J. Card. Fail. 2013; 19(2):125-34.	Rec #: 1040						no
Clark R.A., Inglis S.C., Mcalister F.A. et al. Remote (non-invasive) monitoring in heart failure: Effect on length of stay, quality of life, knowledge, adherance and satisfaction in 8,323 heart failure patients: A systematic review. Eur. Heart J. 2010; 31:944-5.	Rec #: 1190						no
Clark R.A., Inglis S.C., Mcalister F.A. et al. Results from a systematic review and meta-analysis of remote (non-invasive) monitoring in 8,323 heart failure patients on length of stay, quality of life, knowledge, compliance and satisfaction. Eur. J. Heart Fail. Suppl. 2010; 9:S51-S52.	Rec #: 1210						no
Clark A.M., Spaling M., Harkness K. et al. Determinants of effective heart failure self-care: A systematic review of patients' and caregivers' perceptions. Heart 2014; 100(9):716-21.	Rec #: 1330						no
Kraai I.H., Luttik M.L.A., De Jong R.M. et al. Measuring patient satisfaction of heart failure patients with telemonitoring: A systematic review. Eur. J. Cardiovasc. Nurs. 2011; 10:S31.	Rec #: 1160						no
Aballea S., Verpillat P., Neine M.-E., Goryakin Y., Toumi M. Development of a model predicting the medico-economic impact of telemonitoring for patients with heart failure in france. Pharmacoepidemiol. Drug Saf. 2012; 21:16.	Rec #: 1100						no
Brennan A., Thokala P., Baalbaki H., Stevens J.W., Wang J., Pandor A. Telemonitoring after discharge with heart failure-costeffectiveness modelling of alternative service designs. Value Health 2012; 15(7):A360.	Rec #: 1090						no
Burri H, Sticherling C, Wright D, Makino K, Smala A, Tilden D. Cost-consequence analysis of daily continuous remote monitoring of implantable cardiac defibrillator and resynchronization devices in the UK. Europace 2013; 15(11):1601-8.	Rec #: 60						no
Klersy C, De Silvestri A, Gabutti G et al. Economic impact of remote patient monitoring: an integrated economic model derived from a meta-analysis of randomized controlled trials in heart failure. Eur J Heart Fail 2011; 13(4):450-9.	Rec #: 150						no
Thokala P., Baalbaki H., Brennan A. Telemonitoring after discharge from hospital with heart failure - Cost-effectiveness modelling of alternative service designs. Value Health 2013; 16(7):A530.	Rec #: 1000						no
Thokala P., Brennan A., Baalbaki H. Cost-effectiveness modelling of telemonitoring after discharge from hospital with heart failure. Value Health 2013; 16(3):A290.	Rec #: 1030						no
Conway A, Inglis SC, Chang AM, Horton-Breshears M, Cleland JG, Clark RA. Not all systematic reviews are systematic: a meta-review of the quality of systematic reviews for non-invasive remote monitoring in heart failure. J Telemed Telecare 2013; 19(6):326-37.	Rec #: 20	other source						double with Rec#1020
Feltner C, Jones CD, Cene CW et al. 2014. Transitional care interventions to prevent readmissions for persons with heart failure: a systematic review and meta-analysis. Ann Intern Med. 2014 Jun 3;160(11):774-84. doi: 10.7326/M14-0083.	Rec #: 260							double with REC#950
Inglis SC, Clark RA, McAlister FA et al. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev 2010; (8):CD007228.	Rec #: 490							double with Rec#1240
Pandor A. Home telemonitoring or structured telephone support programmes for patients with heart failure. Health Technol. Assess. 2013; 17(32).	Rec #: 1010							double with Rec#1010
Rychlik R., Rulhoff H. Socioeconomic relevance of selected treatment strategies in patients with chronic heart failure. Expert Rev. Pharmacoecon. Outcomes Res. 2005; 5(3):277-86.	Rec #: 1510						no
Kitsiou S, Pare G, Jaana M. Systematic reviews and meta-analyses of home telemonitoring interventions for patients with chronic diseases: a critical assessment of their methodological quality. J Med Internet Res 2013; 15(7):e150.	Rec #: 340	no	no	no	no	no	no	critical appraisal of systematic reviewing
Abu-Awwad R., Alkhatib Y., Bukannan A. et al. Telemonitoring in patients with heart failure: A single-center experience. J. Gen. Intern. Med. 2012; 27:S313.	Rec #: 1110							only abstract available
Clark A.L. Heart failure. Arch. Cardiol. Mex. 2011; 81(4):383-90.	Rec #: 1130		no			no
Cleland J.G.F., Coletta A.P., Buga L. et al. Clinical trials update from the American Heart Association Meeting 2010: EMPHASIS-HF, RAFT, TIM-HF, Tele-HF, ASCEND-HF, ROCKET-AF, and PROTECT. Eur. J. Heart Fail. 2011; 13(4):460-5.	Rec #: 1150							only abstract, refers to '130
Cleland JG, Coletta AP, Clark AL. Clinical trials update from the joint European Society and World Congress of Cardiology meeting: PEP-CHF, ACCLAIM and the HHH study. Eur J Heart Fail 2006; 8(6):658-61.	Rec #: 640					no		only abstract
Grustam AS, Severens JL, van Nijnatten J, Koymans R, Vrijhoef HJ. Cost-effectiveness of telehealth interventions for chronic heart failure patients: a literature review. Int J Technol Assess Health Care 2014; 30(1):59-68.	Rec #: 310							cost domain
Jaarsma T., Van Veldhuisen D.J., Gustafsson F., Arnold J.M.O. Heart failure management: How much COACH-ing is needed? (multple letters). Eur. Heart J. 2005; 26(3):314-5.	Rec #: 1520	no	no	no	no	no	no	letter to the editor
Oxberry SG, Johnson MJ. Review of the evidence for the management of dyspnoea in people with chronic heart failure. Curr Opin Support Palliat Care 2008; 2(2):84-8.	Rec #: 610						no	no informatio for cur, tec or leg
Seto E. Cost comparison between telemonitoring and usual care of heart failure: a systematic review. Telemed J E Health 2008; 14(7):679-86.	Rec #: 210						no	no informatio for cur, tec or leg
Stamp KD, Machado MA, Allen NA. Transitional care programs improve outcomes for heart failure patients (Provisional abstract). J Cardiovasc Nurs .	Rec #: 880						no	no informatio for cur, tec or leg
Stewart S. Comprehensive care in heart failure: Where to from here? Evid.-Based Healthc. Public Health 2005; 9(6):396-7.	Rec #: 1490						no	no informatio for cur, tec or leg
Van Spall H.G.C., Mytton O., Coppiens M., Shiga T., Haynes B., Connolly S. Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure (HF): A meta-analysis. Cardiology 2014; 128:470.	Rec #: 940							only abstract available
Whellan DJ, Adams S, Bowerman L. Review of advanced heart failure device diagnostics examined in clinical trials and the potential benefit from monitoring capabilities. Prog Cardiovasc Dis 2011; 54(2):107-14.	Rec #: 760		no
Winkler S., Koehler F. A Meta-Analysis of Remote Monitoring of Heart Failure Patients. J. Am. Coll. Cardiol. 2010; 55(14):1505-6.	Rec #: 1220					editorial	no	no informatio for cur, tec or leg
Zhang Y., Mabote T., Atkin P. et al. Outcome of patients discharged after an episode of worsening heart failure into a heart failure specialist service supported by home telemonitoring. Eur. J. Heart Fail. Suppl. 2012; 11:S35-S36.	Rec #: 1120							only abstract available
Duffy JR, Hoskins LM, Chen MC. Nonpharmacological strategies for improving heart failure outcomes in the community: a systematic review. J Nurs Care Qual 2004; 19(4):349-60.	Rec #: 240	other source	no
Casas J.P., Kwong J., Ebrahim S. Telemonitoring for chronic heart failure: not ready for prime time. Cochrane Database Syst Rev 2011; 2011:ED000008.	Rec #: 1370							Editorial
Metra M., Nodari S., Bardonali T., Milani P., Dei Cas L. Clinical trials update from the World Congress of Cardiology 2006. Expert Opin. Pharmacother. 2007; 8(6):881-9.	Rec #: 1290		no
Brignole M, Auricchio A, Baron-Esquivias G et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the  Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J 2013; 34(29):2281-329.	Rec #: 50		no					implantable devices overview

 

Safety

Authors: Mirjana Huic, Pernilla Östlund, Romana Tandara Hacek, Jelena Barbaric, Marius Ciutan, Silvia Florescu, Silvia Gabriela Scintee

Summary

Aim: To determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure (New York Heart Association (NYHA) I-IV), without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure has impact on patients’ and technical safety (technical reliability).

Methods: A systematic literature search, according to the predefined search strategy (not limited by publication date but limited to English language), was performed according to the Cochrane methodology, in standard medical and HTA databases. Relevant references (after duplicates were removed) were screened and assessed for eligibility independently by two reviewers. References have been included or excluded according to the overall research question, Population-Intervention-Control-Outcome (PICO)-scheme (as described in Project Scope), and the predefined inclusion/exclusion criteria. The quality of the included systematic reviews (SRs) was assessed using AMSTAR tool {Shea 2007}. The results from the included SRs were included according to the methodology suggested by Whitlock 2008 { } and Robinson 2014 { } on how to integrate existing SRs into new SRs. Risk of bias of included RCTs was evaluated independently by two reviewers using the Cochrane risk of bias checklist and EUnetHTA methods guidelines on internal validity of RCTs. Data extraction was performed by one reviewer on pre-defined extraction tables and double-checked regarding completeness and accuracy by a second reviewer. Any differences in extraction results were discussed to achieve consensus; any disagreements were resolved by a third reviewer. Quantitative synthesis from existing SRs were used and presented in Result section when available for specific assessment element questions. No new meta-analysis was performed. Primary outcomes were adverse events (AE): frequency of any AE, serious-SAE, most frequent AE; and discontinuation due AE. A secondary outcome was technical safety (technical reliability).

Results: 591 records were identified through database searching and 28 additional records were identified through other sources; 428 remained after duplicates were removed. One hundred full-text articles were assessed for eligibility and after the exclusion of 76 full-text articles, five high quality SRs and 19 full text published RCTs were included in our SR. Of the included RCTs, only three were judged to be of low risk of bias. In the most recent SR no evidence on potential harms was found on STS interventions. None of 19 included RCTs specifically mentioned adverse events (AEs) as primary or secondary outcomes. In only one RCT which specifically mentioned AEs no adverse events were reported and only one RCT provided explanation on the reason why it did not monitor AEs.

Conclusion: The sources were not sufficient to answer the questions on STS safety in patients with chronic heart failure. No evidence was found to answer technical safety.

Introduction

The Safety Domains describes the direct and indirect harms of a technology for patients, staff and environment, and how to reduce the risk of harms {HTA Core Model Handbook Online, Version 1.5}.

Aim of this assessment was to determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure (New York Heart Association (NYHA) I-IV), without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure, has impact on patients’ and technical safety (technical reliability).

More specifically our primary outcomes were adverse events (AE): any AE, serious-SAE, most frequent AE; and discontinuation due AE. A secondary outcome was technical safety (technical reliability).

For this relative effectiveness assessment we planned to find and update recent, high quality systematic review (SR), with PICO (Patient-Intervention-Comparison-Outcome) scheme relevant for this assessment. Whitlock et al. 2008 { } and Robinson et al. 2014 { } in their published articles, regarding how to integrate existing systematic reviews into new systematic reviews, found that consensus among systematic review organizations and the Evidence-based Practice Centers (EPCs) about some aspects of incorporating existing systematic reviews already exist, but areas of uncertainty remain: how to synthesize, grade the strength of, and present bodies of evidence composed of primary studies and existing systematic reviews. According their published data, use of existing systematic reviews may include: (1) using the existing systematic review(s)’ listing of included studies as a quality check for the literature search and screening strategy conducted for the new review (Scan References); (2) using the existing systematic review(s) to completely or partially provide the body of included studies for one or more Key Questions in the new review (Use Existing Search); (3) using the data abstraction, risk of bias assessments, and/or analyses from existing systematic reviews for one or more Key Questions in the new review (Use Data Abstraction/Syntheses), or (4) using the existing systematic review(s), including conclusions, to fully or partially answer one or more Key Questions in the new review (Use Complete Review).

Methodology

Frame

The collection scope is used in this domain.

Technology	Structured telephone support (STS) for adult patients with chronic heart failure Description Telemonitoring via structured telephone support with focus on patient reported signs (symptoms of congestion, peripheral edema, pulmonary congestion, dyspnea on exertion, abdominal fullness), medication adherence, physiological data (like heart rate, blood pressure, body weight – measured by the patient with home-device), activity level; done in regular schedules using risk stratification (with fixed algorithm by call center staff or experience-based by specialized staff); done by dedicated call centers, center-based staff, nurses, AND reduced visits to a GP or heart center
Intended use of the technology	Prevention Remote transmission of information to alleviate symptoms, relieve suffering and allow timely treatment for chronic heart failure Target condition Chronic cardiac failure Target condition description Heart failure is a condition in which the heart has lost the ability to pump enough blood to the body's tissues. With too little blood being delivered, the organs and other tissues do not receive enough oxygen and nutrients to function properly. Target population Target population sex: Any. Target population age: adults and elderly. Target population group: Patients who have the target condition. Target population description Patients with chronic heart failure (CHF; defined as I50 http://www.icd10data.com/ICD10CM/Codes/I00-I99/I30-I52/I50-/I50 ) AND hospitalization due to heart failure at least once  AND without implanted devices
Comparison	Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) Description Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)
Outcomes	Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms

Assessment elements

	Topic	Issue	Relevant	Research questions or rationale for irrelevance
C0001	Patient safety	What kind of harms can use of the technology cause to the patient; what are the incidence, severity and duration of harms?	yes	What is the frequency of all AEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)? What is the frequency of discontinuation of Structured telephone support (STS) due to adverse events in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)? What is the frequency of and what are the serious-SAEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)? What is the frequency of SAE leading to deaths with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)? What are the most frequent AEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
C0005	Patient safety	Are there susceptible patient groups that are more likely to be harmed through use of the technology?	yes	Are there susceptible patient groups that are more likely to be harmed through use of the home telemonitoring Structured telephone support (STS)
C0007	Patient safety	Are there special issues in the use of the technology that may increase the risk of harmful events?	yes	Are there special issues in the use of the Structured telephone support (STS) that may increase the risk of harmful events?
C0002	Patient safety	Are the harms related to dosage or frequency  of applying the technology?	no	Not important for STS.
C0004	Patient safety	How does the frequency or severity of harms change over time or in different settings?	no	Not important for STS.
C0006	Patient safety	What are the consequences of false positive, false negative and incidental findings generated by using the technology from the viewpoint of patient safety?	no	Not important for Structured telephone support (STS).
C0008	Patient safety	How safe is the technology in relation to the comparator(s)?	no	Duplication of C0001, please see C0001.
C0060	Safety risk management	How does the safety profile of the technology vary between different generations, approved versions  or products?	yes	How does the safety profile of the Structured telephone support (STS) vary between two different approach (human to human or human to machine interface)?
C0062	Safety risk management	How can one reduce safety risks for patients (including technology-, user-, and patient-dependent aspects)?	yes	How can one reduce safety risks for adults with chronic heart failure (including technology-, user-, and patient-dependent aspects)?
C0061	Safety risk management	Can different organizational settings increase or decrease harms?	no	Not relevant for STS.
C0063	Safety risk management	How can one reduce safety risks for professionals (including technology-, user-, and patient-dependent aspects)?	no	Not important for STS.
C0064	Safety risk management	How can one reduce safety risks for environment (including technology-, user-, and patient-dependent aspects)	no	Not important for STS.
C0020	Occupational safety	What kind of occupational harms can occur when using the technology?	no	Not important for STS.
C0040	Environmental safety	What kind of risks for public and environment may occur when using the technology?	no	Not important for STS.

Methodology description

A systematic literature search, according the predefined search strategy (Appendix 1) (not limited by publication date but limited to English language), was performed according to the Cochrane methodology {Higgins 2011}, in standard medical and HTA databases.

Information sources

Specifically, the following databases were searched: MEDLINE accessed through OVID or Pubmed; CINAHL with Full Text (EBSCOhost), SCI-EXPANDED (Web of Science^TM Core Collection) and Cochrane Library searching the following databases: The Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Database of Systematic Reviews (Cochrane Reviews), The Database of Abstracts of Reviews of Effects (DARE) and The Health Technology Assessment Database (HTA).

This was complemented by hand search of the following websites: http://www.cadth.ca/en/products/health-technology-assessment; http://www.york.ac.uk/inst/crd/publications.htm; http://guidance.nice.org.uk/Date; http://hta.lbg.ac.at; http://kce.fgov.be; http://www.hiqa.ie/; http://www.agenas.it. The reference lists of relevant systematic reviews and health technology assessment reports were checked for relevant studies.

In addition, the following clinical trials registries were assessed, for registered ongoing clinical trials or results posted: ClinicalTrials.gov, ISRCTN, EU Clinical Trials Register, and International Clinical Trials Registry Platform (ICTRP).

Relevant references (after duplicates were removed) were screened and assessed for eligibility independently by two reviewers. References have been included or excluded according to the overall research question, Population-Intervention-Control-Outcome (PICO)-scheme (as described in Project Scope),  and the inclusion/exclusion criteria listed below:

Q What are the effects of Structured telephone support (STS) on adults with chronic heart failure?

P Individuals aged 16 or more with chronic heart failure (New York Heart Association (NYHA) I-IV), without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure

I Structured telephone support (STS)

C Usual care (UC) without Structured telephone support (STS)

O Domain Specific Outcomes: Adverse events (AE) (frequency of any AE, serious-SAE, most frequent AE; discontinuation due AE); technical safety (technical reliability)

Study Design 

D Evidence synthesis studies (SRs, HTA reports) [updating RCTs i.e. RCT fitting the PICO which have been published after the last search date of the latest SR/HTA document]

Inclusion criteria:

1. SRs and HTAs and RCTs comparing chronic heart failure patients management /New York Heart Association (NYHA) I-IV, without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure/ delivered via structured telephone support with usual care;
2. Patients should be randomized to structured telephone support or usual care without structured telephone support (STS);
3. One or more of the SAF outcomes were reported;
4. Sufficient methodological details are reported to allow critical appraisal of study quality;
5. Publication in English;
6. Report on humans only.

Exclusion criteria:

Primary or secondary studies which:

1) Do not involve adult patients with CHF /New York Heart Association (NYHA) I-IV, without implantable cardiac defibrillators (ICDs), CRTs or pacemakers, who have been admitted to hospital at least once for chronic heart failure/;  

2)  Do not compare CHF management delivered via structured telephone support with usual care in patients with CHF living within the community;

3) Home visits were performed as part of the intervention or by the clinical staff involved in the intervention

4) Do not provide data for our outcomes of interest in an extractable format;

5) Papers with RCTs without sufficient methodological details to allow critical appraisal of study quality;

6) The papers (publications) published in a language other than English; 

7) Duplicate of original publication.

Differences in selection results were discussed in order to achieve consensus; a third reviewer were involved in case of disagreement. The study selection process was presented according to the PRISMA flowchart {Liberati 2009} (Appendix 2).

Finding and updating a recent, high quality SR (with PICO scheme relevant for this relative effectiveness assessment) was planned. The publications by Whitlock et al. 2008 { } and Robinson et al. 2014 { }, regarding how to integrate existing SRs into new SRs, were used. To answer our research questions all four approaches in using existing systematic reviews, described in Robinson et al. 2014 { }, were used: (1) using the existing SR(s)’ listing of included studies as a quality check for the literature search and screening strategy conducted for the new review (Scan References); (2) using the existing SR(s) to completely or partially provide the body of included studies for one or more Key Questions in the new review (Use Existing Search); (3) using the data abstraction, risk of bias assessments, and/or analyses from existing SRs for one or more Key Questions in the new review (Use Data Abstraction/Syntheses), and (4) using the existing SR(s), including conclusions, to fully or partially answer one or more Key Questions in this SR (Use Complete Review).

Quality assessment tools or criteria

The quality of the included systematic review was assessed using AMSTAR {Shea 2007}.

Risk of bias was evaluated independently by two reviewers using the Cochrane risk of bias checklist and EUnetHTA methods guidelines on internal validity of RCTs {Higgins 2011; EUnetHTA 2013}

Direct evidence related to primary outcomes of our assessment was planned to assess by using the GRADE-methodology {Guyatt 2008}. This approach specifies four levels of quality:

High: further research is very unlikely to change our confidence in the estimate of effect;

Moderate: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimates;

Low: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate;

Very low: we are very uncertain about the estimate.

Analysis and synthesis

Data extraction was performed by one reviewer on pre-defined extraction tables and double-checked regarding completeness and accuracy by a second reviewer. Any differences in extraction results were discussed to achieve consensus; a third reviewer was involved in case of disagreement.

The following information was extracted from included secondary studies (SRs or HTAs):Study general information: Author; Year of publication; Reference number; Study objectives; Study characteristics: Study types included in the review; Number of studies included in the review; Review timeframe; Comparison(s); Patients groups (number of patients and health technology used) in the included studies; Outcomes and follow-up: Main outcomes reported; Main study findings; Conclusions: Authors' conclusions. Please look in EFF Domain (Appendix 3)

The following information was extracted from included primary studies:

Data on Study characteristics (study design, registration number, country and centre, study period, ethics committee approval, sponsor, study methodology); Patient characteristics (age, gender, NYHA I-IV); Outcomes; Intervention; Comparator; Flow of patients; Statistical analysis; Results on primary and secondary outcomes; and Conflict of interest data were extracted. Please look in EFF Domain (Appendix 4)

Quantitative synthesis from existing SRs were used and presented in Resut section wherever appropiate. No new meta-analysis was performed.  

Result cards

Patient safety

Safety risk management

Discussion

Aim of this relative effectiveness assessment was to determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure (New York Heart Association (NYHA) I-IV), without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure has impact on patients’ and technical safety (technical reliability).

More specifically, our primary outcomes were adverse events (AE): any AE, serious-SAE, most frequent AE and discontinuation due AE. A secondary outcome was technical safety (technical reliability).

Five existing SRs have been integrated {Feltner et al, 2014; Kotb et al, 2015; Pandor et al, 2013; Inglis et al, 2011; Clark et al, 2007} according to the methodology described in Whitlock et al. 2008 { } and Robinson et al. 2014 { }, into this SR. Additionally, 19 RCTs have been included to answer domain assessment element questions that were not answered by the five SRs. We were faced with already recognized areas of uncertainty: how to appropriately synthesize, grade the strength of, and present bodies of evidence composed of primary studies and existing systematic reviews.

In the most recent SR and HTA {Feltner et al, 2014}  no evidence on potential harms was found on STS interventions.

Also none of 19 included RCTs specifically predefined adverse events (AEs) as primary or secondary outcomes. The same is true for one identified trial in publicly available clinical trial register. Only one RCT specifically mentioned AEs Chaudhry et al, 2010 { } and only one RCT provide explanation the reason why they did not monitor AEs Sisk et al, 2006 { }. Chaudhry et al, 2010 { } in 6 months treatment period, multicenter, randomized, single-blind, low risk of bias controlled trial  with aim  to assess whether telemonitoring would reduce the combined end point of readmission or death from any cause among patients recently hospitalized for heart failure no adverse events were reported. Authors discussed that the primary anticipated adverse event associated with telemonitoring was a delay in seeking care for urgent or emergency situations because of a belief that the telemonitoring data would immediately alert clinicians. Sisk et al, 2006 { }, explained that since both nurse management and usual care involved only services delivered in routine practice, the study did not monitor adverse effects.

Kidholm et al, 2012 { } provide a Model for Assessment of Telemedicine Applications, MAST, a structure for future assessment of telemedicine applications. MAST was tested during 2010–13 in twenty studies of telemedicine applications in nine European countries in the EC project Renewing Health on different chronic diseases: Diabetes Mellitus type 2, COPD and Congestive Heart Failure  {Kidholm et al, 2014}.

In RCT assessed remote monitoring of CHF (only 29 patients were analysed in the control group and 30 in the telemonitoring group) safety data was not mentioned {Dafouluas et al, 2014}.

The whole data of Renewing Health project, on telemonitoring application in patients with all three chronic diseases, has demonstrated that the telemedicine services tested are safe as usual care {Kidholm et al, 2014}.

 

The findings of our literature search are consistent with other studies who address outcomes reporting bias on safety outcomes.

McLean et al, 2013 { } in their systematic review of systematic review with aim to generate a high level synthesis of the evidence on telehealth care applications showed that there was very little in the systematic reviews specifically concerning patient safety. It was not clear whether adverse events did not occur or whether there was a lack of reporting.

Several studies non-specifically connected with telemedicine interventions have documented underreporting of low-grade AEs, recurrent AEs and inconsistent and incomplete characterization and reporting of high-grade AEs {Scharf et al, 2006; Ethgen et al, 2009; Pitrouet al, 2009}.

 

In study published by Saini et al, 2014 { } with aim to determine the extent and nature of selective non-reporting of harm outcomes in clinical studies that were eligible for inclusion in a cohort of systematic reviews outcome reporting bias for harms was evident in nearly two thirds of all primary studies included in systematic reviews.

 

In contrast, in the sample of the RCTs analysed in study published by Huic et al, 2011 { } in which technologies other than pharmaceuticals were presented in 30% of total sample,  serious and non-serious AEs were mentioned in more than 80% of the published articles.

 

In our assessment the sources were not sufficient to answer the questions due the fact that little evidence was identified on the potential harms of STS. No RCTs were found at all to answer some assessment element questions, like technical safety. Possible limitation of our assessment is that we looked only for SRs and RCTs, and not for prospective observational comparative studies or registries data.

The poor reporting of harms data (safety data is inadequately reported or not reported at all) has major implications for proper judging the benefit-risk ratio.

Limitations of data from published studies are obvious, so further research is needed on safety of STS interventions in chronic heart failure patients. Due another limitation - narrow scope of our assessment, our results are not applicable to patients with chronic heart failure with implantable cardioverter-defibrillators (ICDs), cardiac resynchronisation therapy defibrillators (CRT-Ds) or pacemakers. Hindricks et al. 2014 and Parthiban et al. 2015 recently published data on remote monitoring in this selected group of patients { }.

Several methodological issues should be solved when conducting the RCTs like masking outcome assessment as well as clear description of usual care. Pragmatic RCTs as well as observational real world data should also address this issue. Data reporting should be according evidence-based reporting guidelines, specifically CONSORT Statement extension on better reporting of harms in RCTs and trials assessing nonpharmacologic treatments {Ioannidis et al, 2004; Boutron et al, 2008}.

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Appendices

Please see the appendices in EFF Domain

Appendix 1. Search strategy, June 2015

Appendix 2. Flow chart of study selection

Appendix 3. Characteristics of included secondary studies: Systematic reviews/HTA, main study findings and authors conclusions. Assessing the quality of included SRs – AMSTAR Criteria

Appendix 4. RCTs included in SR of effectiveness and safety: Evidence tables and Risk of bias tables

Appendix 5. List of included studies (RCTs) in the secondary studies (SRs or HTAs)

Appendix 6. List of included studies (RCTs) in this Systematic review of Clinical Effectiveness/Safety with Follow-up duration and Risk of bias

Appendix 7. List of Ongoing RCTs in clinical trials registries

Clinical Effectiveness

Authors: Mirjana Huic, Pernilla Östlund, Romana Tandara Hacek, Jelena Barbaric, Marius Ciutan, Cristina Mototolea, Silvia Gabriela Scintee

Summary

Aim: To determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure (New York Heart Association (NYHA) I-IV), without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure improves clinical outcomes and quality of life, has impact on patients’ satisfaction and function, and change in management or utilization of health service compared with current practice.

Methods: A systematic literature search, according to the predefined search strategy (not limited by publication date but limited to English language), was performed according to the Cochrane methodology, in standard medical and HTA databases. Relevant references (after duplicates were removed) were screened and assessed for eligibility independently by two reviewers. References have been included or excluded according to the overall research question, Population-Intervention-Control-Outcome (PICO)-scheme (as described in Project Scope), and the predefined inclusion/exclusion criteria. The quality of the included systematic reviews (SRs) was assessed using AMSTAR tool {Shea 2007}. The results from the included SRs were included according to the methodology suggested by Whitlock 2008 { } and Robinson 2014 { } on how to integrate existing SRs into new SRs. Risk of bias of included RCTs was evaluated independently by two reviewers using the Cochrane risk of bias checklist and EUnetHTA methods guidelines on internal validity of RCTs. Data extraction was performed by one reviewer on pre-defined extraction tables and double-checked regarding completeness and accuracy by a second reviewer. Any differences in extraction results were discussed to achieve consensus; any disagreements were resolved by a third reviewer. Quantitative synthesis from existing SRs were used and presented in Result section when available for specific assessment element questions. No new meta-analysis was performed. Primary outcomes were mortality (overall and disease-specific), morbidity (disease-specific symptoms, disease progression) and Health-related quality of life (HRQoL). Secondary outcomes were impact on re-hospitalization rate (disease-specific, all-cause); emergency room visit rate; cardiology visit rate; primary care visit rate; body functions; work ability; return to previous living conditions; activities of daily living and patient satisfaction (worthwhile use, willing to use again).

Results: 591 records were identified through database searching and 28 additional records were identified through other sources; 428 remained after duplicates were removed. One hundred full-text articles were assessed for eligibility and after the exclusion of 76 full-text articles, five high quality SRs and 19 full text published RCTs were included in our SR. Of the included RCTs, only three were judged to be of low risk of bias. STS produced a mortality benefit and reduced HF-specific readmission rates. For the outcomes QoL and utilization the evidence was insufficient. Yet, the majority of studies presented statistically significant QoL improvements. A majority of the RCTs found no significant difference in the number of emergency room visits in either group. Since little evidence was identified on the potential harms of STS (described in the Safety Domain), it was not possible to assess overall benefits and harms of STS in adults with chronic heart failure. No evidence found to answer some assessment element questions, related on outcomes such as work ability, return to previous living conditions, activities of daily living, worthwhile of STS and willing to use STS again.

Conclusion: STS reduces HF-specific readmission and mortality. A majority of the studies presented statistically significant improvements in QoL. Some research gaps and transferability issues were recognized. Further research is needed on effects of STS on QoL and utilization outcomes as well as patient satisfaction during long term follow-up.

Introduction

The Clinical Effectiveness Domains describes the range and size of beneficial health effects expected through the use of the technology {HTA Core Model Handbook Online, Version 1.5}. The two key elements are that effective interventions should be directly compared and studied in patients who are typical of day-to-day health care settings {HTA Core Model Application for Pharmaceuticals, 2.0}.

The aim of this relative effectiveness assessment was to determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure (New York Heart Association (NYHA) I-IV), without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure, improves clinical outcomes and quality of life, has impact on patients’ satisfaction and function, and change in management or utilization of health service compared with current practice.

Primary outcomes were mortality (overall and disease-specific), morbidity (disease-specific symptoms, progression) and Health-related quality of life (HRQL).

Secondary outcomes were impact on re-hospitalization rate (disease-specific, all-cause); emergency room visit rate; cardiology visit rate; primary care visit rate; body function; work ability; return to previous living conditions; activities of daily living and patient satisfaction (worthwhile use, willing to use again).

For this relative effectiveness assessment we planned to find and update recent, high quality systematic review (SR), with PICO (Patient-Intervention-Comparison-Outcome) scheme relevant for this assessment. Whitlock et al. 2008 { } and Robinson et al. 2014 { } in their published articles, regarding how to integrate existing systematic reviews into new systematic reviews, found that consensus among systematic review organizations and the Evidence-based Practice Centers (EPCs) about some aspects of incorporating existing systematic reviews already exist, but areas of uncertainty remain: how to synthesize, grade the strength of, and present bodies of evidence composed of primary studies and existing systematic reviews. According their published data, use of existing systematic reviews may include: (1) using the existing systematic review(s)’ listing of included studies as a quality check for the literature search and screening strategy conducted for the new review (Scan References); (2) using the existing systematic review(s) to completely or partially provide the body of included studies for one or more Key Questions in the new review (Use Existing Search); (3) using the data abstraction, risk of bias assessments, and/or analyses from existing systematic reviews for one or more Key Questions in the new review (Use Data Abstraction/Syntheses), or (4) using the existing systematic review(s), including conclusions, to fully or partially answer one or more Key Questions in the new review (Use Complete Review).

Methodology

Frame

The collection scope is used in this domain.

Technology	Structured telephone support (STS) for adult patients with chronic heart failure Description Telemonitoring via structured telephone support with focus on patient reported signs (symptoms of congestion, peripheral edema, pulmonary congestion, dyspnea on exertion, abdominal fullness), medication adherence, physiological data (like heart rate, blood pressure, body weight – measured by the patient with home-device), activity level; done in regular schedules using risk stratification (with fixed algorithm by call center staff or experience-based by specialized staff); done by dedicated call centers, center-based staff, nurses, AND reduced visits to a GP or heart center
Intended use of the technology	Prevention Remote transmission of information to alleviate symptoms, relieve suffering and allow timely treatment for chronic heart failure Target condition Chronic cardiac failure Target condition description Heart failure is a condition in which the heart has lost the ability to pump enough blood to the body's tissues. With too little blood being delivered, the organs and other tissues do not receive enough oxygen and nutrients to function properly. Target population Target population sex: Any. Target population age: adults and elderly. Target population group: Patients who have the target condition. Target population description Patients with chronic heart failure (CHF; defined as I50 http://www.icd10data.com/ICD10CM/Codes/I00-I99/I30-I52/I50-/I50 ) AND hospitalization due to heart failure at least once  AND without implanted devices
Comparison	Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) Description Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)
Outcomes	Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms

Assessment elements

	Topic	Issue	Relevant	Research questions or rationale for irrelevance
D0001	Mortality	What is the expected beneficial effect of the intervention on overall mortality?	yes	What is the effects of Structured telephone support (STS) on overall mortality in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
D0002	Mortality	What is the expected beneficial effect on the disease-specific mortality?	yes	What is the effects of Structured telephone support (STS) on disease-specific mortality in adults with chronic heart failure, compared to standard care without Structured telephone support (STS) ?
D0003	Mortality	What is the effect of the technology on the mortality due to causes other than the target disease?	no	Relevant only for the target disease.
D0005	Morbidity	How does the technology affect symptoms and findings (severity, frequency) of the target condition?	yes	How does Structured telephone support (STS) affect disease-specific symptoms and findings (severity, frequency) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
D0006	Morbidity	How does the technology affect the progression (or recurrence) of the target condition?	yes	How does Structured telephone support (STS) affect the progression of chronic heart failure of adults patients, compared to standard care without Structured telephone support (STS)?
D0010	Change-in management	How does the technology modify the need for hospitalization?	yes	Does Structured telephone support (STS) impact on the re-hospitalization rate (disease-specific and all-cause) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
D0023	Change-in management	How does the technology modify the need for other technologies and use of resources?	yes	Does Structured telephone support (STS) impact on the emergency room visit rate (disease-specific) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)? Does Structured telephone support (STS) impact on the cardiology visit rate (disease-specific) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)? Does Structured telephone support (STS) impact on the primary care visit rate (disease-specific) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
D0012	Health-related Quality of life	What is the effect of the technology on generic health-related quality of life?	yes	What is the effect of Structured telephone support (STS) on generic health-related quality of life of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
D0013	Health-related Quality of life	What is the effect of the technology on disease specific quality of life?	yes	What is the effect of Structured telephone support (STS) on disease specific quality of life of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
D0011	Function	What is the effect of the technology on patients’ body functions	yes	What is the effect of Structured telephone support (STS) on body functions of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
D0014	Function	What is the effect of the technology on work ability?	yes	What is the effect of Structured telephone support (STS) on work ability of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
D0015	Function	What is the effect of the technology on return to previous living conditions?	yes	What is the effect of Structured telephone support (STS) on return to previous living conditions of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
D0016	Function	How does use of the technology affect activities of daily living?	yes	How does Structured telephone support (STS) affects activities of daily living of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
D0017	Patient satisfaction	Was the use of the technology worthwhile?	yes	Was the use of Structured telephone support (STS) worthwhile?
D0018	Patient satisfaction	Is the patient willing to use the technology again?	yes	Are adults with chronic heart failure willing to use the Structured telephone support (STS) again?
D0029	Benefit-harm balance	What are the overall benefits and harms of the technology in health outcomes?	yes	What are the overall benefits and harms of the Structured telephone support (STS) in adults with chronic heart failure?
C0006	Patient safety	What are the consequences of false positive, false negative and incidental findings generated by using the technology from the viewpoint of patient safety?	no	Not important for Structured telephone support (STS).

Methodology description

A systematic literature search, according the predefined search strategy (Appendix 1) (not limited by publication date but limited to English language), was performed according to the Cochrane methodology {Higgins 2011}, in standard medical and HTA databases.

Information sources

Specifically, the following databases were searched: MEDLINE accessed through OVID or Pubmed; CINAHL with Full Text (EBSCOhost), SCI-EXPANDED (Web of Science^TM Core Collection) and Cochrane Library searching the following databases: The Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Database of Systematic Reviews (Cochrane Reviews), The Database of Abstracts of Reviews of Effects (DARE) and The Health Technology Assessment Database (HTA).

This was complemented by hand search of the following websites: http://www.cadth.ca/en/products/health-technology-assessment; http://www.york.ac.uk/inst/crd/publications.htm; http://guidance.nice.org.uk/Date; http://hta.lbg.ac.at; http://kce.fgov.be; http://www.hiqa.ie/; http://www.agenas.it. The reference lists of relevant systematic reviews and health technology assessment reports were checked for relevant studies.

In addition, the following clinical trials registries were assessed, for registered ongoing clinical trials or results posted: ClinicalTrials.gov, ISRCTN, EU Clinical Trials Register, and International Clinical Trials Registry Platform (ICTRP).

Relevant references (after duplicates were removed) were screened and assessed for eligibility independently by two reviewers. References have been included or excluded according to the overall research question, Population-Intervention-Control-Outcome (PICO)-scheme (as described in Project Scope),  and the inclusion/exclusion criteria listed below:

Q What are the effects of Structured telephone support (STS) on adults with chronic heart failure?

P Individuals aged 16 or more with chronic heart failure (New York Heart Association (NYHA) I-IV), without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure

I Structured telephone support (STS)

C Usual care (UC) without Structured telephone support (STS)

O Domain Specific Outcomes: mortality (overall and disease-specific); morbidity (disease-specific symptoms, progression); re-hospitalization rate (disease-specific, all-cause); emergency room visit rate; cardiology visit rate; primary care visit rate; Health-related quality of life (HRQL): both generic and disease-specific; body function; work ability; return to previous living conditions; activities of daily living; patient satisfaction (worthwhile use, willing to use again)

Study Design 

D Evidence synthesis studies (SRs, HTA reports) [updating RCTs i.e. RCT fitting the PICO which have been published after the last search date of the latest SR/HTA document]

 

Inclusion criteria:

1) SRs and HTAs and RCTs comparing chronic heart failure patients management /New York Heart Association (NYHA) I-IV, without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure/ delivered via structured telephone support with usual care;

2) Patients are randomized to structured telephone support or usual care without structured telephone support (STS);

3) One or more of the EFF outcomes were reported;

4) Sufficient methodological details are reported to allow critical appraisal of study quality;

5) Publication in English;

6) Report on humans only.

 

Exclusion criteria:

Primary or secondary studies which:

1) Do not involve adult patients with CHF /New York Heart Association (NYHA) I-IV, without implantable cardiac defibrillators (ICDs), CRTs or pacemakers, who have been admitted to hospital at least once for chronic heart failure/;  

2)  Do not compare CHF management delivered via structured telephone support with usual care in patients with CHF living within the community;

3) Home visits were performed as part of the intervention or by the clinical staff involved in the intervention

4) Do not provide data for our outcomes of interest in an extractable format;

5) Papers with RCTs without sufficient methodological details to allow critical appraisal of study quality;

6) The papers (publications) published in a language other than English; 

7) Duplicate of original publication.

 

Differences in selection results were discussed in order to achieve consensus; a third reviewer were involved in case of disagreement. The study selection process was presented according to the PRISMA flowchart {Liberati 2009} (Appendix 2).

Finding and updating a recent, high quality SR (with PICO scheme relevant for this relative effectiveness assessment) was planned. The publications by Whitlock et al. 2008 { } and Robinson et al. 2014 { }, regarding how to integrate existing SRs into new SRs, were used. To answer our research questions all four approaches in using existing systematic reviews, described in Robinson et al. 2014 { }, were used: (1) using the existing SR(s)’ listing of included studies as a quality check for the literature search and screening strategy conducted for the new review (Scan References); (2) using the existing SR(s) to completely or partially provide the body of included studies for one or more Key Questions in the new review (Use Existing Search); (3) using the data abstraction, risk of bias assessments, and/or analyses from existing SRs for one or more Key Questions in the new review (Use Data Abstraction/Syntheses), and (4) using the existing SR(s), including conclusions, to fully or partially answer one or more Key Questions in this SR (Use Complete Review).

Quality assessment tools or criteria

(Write your text here)

The quality of the included SR was assessed using AMSTAR {Shea 2007}.

Risk of bias of included RCTs was evaluated independently by two reviewers using the Cochrane risk of bias checklist and EUnetHTA methods guidelines on internal validity of RCTs {Higgins 2011; EUnetHTA 2013}.

Direct evidence on primary outcomes was planned to be assessed by using the GRADE-methodology {Guyatt 2008}. This approach specifies four levels of quality:

High: further research is very unlikely to change our confidence in the estimate of effect;

Moderate: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimates;

Low: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate;

Very low: we are very uncertain about the estimate.

Analysis and synthesis

(Write your text here)

Data extraction was performed by one reviewer on pre-defined extraction tables and double-checked regarding completeness and accuracy by a second reviewer. Any differences in extraction results were discussed to achieve consensus; a third reviewer was involved in case of disagreement.

The following information was extracted from included secondary studies (SRs or HTAs):Study general information: Author; Year of publication; Reference number; Study objectives; Study characteristics: Study types included in the review; Number of studies included in the review; Review timeframe; Comparison(s); Patients groups (number of patients and health technology used) in the included studies; Outcomes and follow-up: Main outcomes reported; Main study findings; Conclusions: Authors' conclusions. (Appendix 3)

The following information was extracted from included primary studies:

Data on Study characteristics (study design, registration number, country and centre, study period, ethics committee approval, sponsor, study methodology); Patient characteristics (age, gender, NYHA I-IV); Outcomes; Intervention; Comparator; Flow of patients; Statistical analysis; Results on primary and secondary outcomes; and Conflict of interest data were extracted. (Appendix 4)

Quantitative synthesis from existing SRs were used and presented in Result section wherever appropiate. No new meta-analysis was performed.

Result cards

Mortality

Morbidity

Change-in management

Health-related Quality of life

Function

Patient satisfaction

Benefit-harm balance

Discussion

The aim of this relative effectiveness assessment was to determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure (New York Heart Association (NYHA) I-IV) and without implantable cardiac defibrillators (ICDs), CRTs or pacemakers who have been admitted to hospital at least once for chronic heart failure, improves clinical outcomes and quality of life, has impact on patients’ satisfaction and function, and change in management or utilization of health service compared with current practice.

Five existing SRs have been integrated {Feltner et al, 2014; Kotb et al, 2015; Pandor et al, 2013; Inglis et al, 2011; Clark et al, 2007} according to the methodology described in Whitlock et al. 2008 { } and Robinson et al. 2014 { }, into this SR. Additionally, 19 RCTs have been included to answer domain assessment element questions that were not answered by the five SRs. We were faced with already recognized areas of uncertainty: how to appropriately synthesize, grade the strength of, and present bodies of evidence composed of primary studies and existing systematic reviews.

STS produced a mortality benefit and reduced HF-specific readmission rates. In the most recent SR and HTA published by Feltner et al, 2014 { }, STS interventions produced a mortality benefit, with  RR (95% CI) 0.74 (0.56–0.97), in time period of 3-6 months, with Number needed to treat (NNT) of 27. Kotb et al, 2015 { } in Network meta-analysis (NMA), reported that structured telephone support significantly reduced the odds of mortality (Odds Ratio 0.80; 95% Credible Intervals [0.66 to 0.96]) compared to usual care. Pandor et al, 2013 { } with data from 11 studies evaluated STS, with duration of follow-up ranged from 6 months to 18 months, found that compared with usual care, STS HH was beneficial (but not statistically significant) in reducing all-cause mortality [hazard ratio (HR) 0.77, 95% credible interval (CrI) 0.55 to 1.08]. No favourable effect on mortality was observed with STS HM.

A majority of the studies (included in five published SRs) reported significantly lower HF-specific re-hospitalisation rate in STS group {Feltner 2014, Kotb 2015, Pandor 2013, Inglis 2011, Clark 2007}. Feltner et al, 2014 { } reported that 14 patients needed to be treated with structured telephone support (STS) interventions to reduced HF-specific readmission (NNT of 14). When sensitivity analysis was done including only RCT with follow-up period longer than 6 months this difference was not statisticaly significant anymore {Inglis 2011}. Two recently published RCTs  {Angermann 2012, Krum 2013} with 6 and 12 months follow-up period, reported non-significant difference in HF-specific re-hospitalization between STS and Usual care groups.

Few RCTs measured QoL or function using the same measures at similar time points; the limited data showed conflicting results. Insufficient evidence was found to answer questions related with utilization outcomes as well, so the evidence base was inadequate to make final conclusion for these outcomes. However, a majority of the studies presented statistically significant QoL improvements. Data found on the emergency room (ER) visit rate in STS group comparing with usual care was conflicting, but a majority of the results found no significant difference in the number of emergency room visits in either group. The same is true for the the most recent SR and HTA published by Feltner et al, 2014 { }; STS interventions had no effect on the rate of ER visits over 3 to 6 months. According the number of general practitioners visits, Krum et al, 2013 { }, during 12 months period, showed reduction in the utilization of general practitioners, with the control group visiting their general practitioner more than twice as often as the intervention group.

Since little evidence identified on the potential harms of STS {Chaudhry et al, 2010}, as described in Safety Domain, it was not possible to answer on overall benefits and harms of the Structured telephone support (STS) in adults with chronic heart failure.

We could not find answers to some of the assessment element questions, such as work ability, return to previous living conditions, activities of daily living, worthwhile of STS and willing to use STS again. For example no SRs, HTAs or RCTs have addressed the question “Was the use of Structured telephone support (STS) worthwhile?”. Indirect answers could be found in further RCTs (included in Inglis et al SR, published 2011 { }); showing that satisfaction (acceptance) of patients receiving health care via technology was rated between 76% to 100% {Clark 2007b; Krum 2009; Cleland 2005}. In the work by Laramee et al, 2003 { } patients in the intervention group were significantly more satisfied with their care in 13 of 16 items than the usual care group (P=.01). In RCT published by Riegel et al, 2002 { } patients in the intervention group were significantly more satisfied at 6 months with their care in STS than the usual care group (22.88±2.85 vs 6.17±4.87).

Out of 19 RCTs included in our new SR only three RCTs were judged as low risk of bias {DeBusk 2004, GESICA 2005, Chaudhry 2010},

Direct evidence on primary outcomes was not assessed by using the GRADE-methodology {Guyatt 2008} as planned, because of heterogeneity of follow up periods and quantitative synthesis from existing SRs was used and presented in the result section for specific outcomes.

Further research is needed on effects of STS on QoL and utilization outcomes as well as long term follow-up of patient satisfaction. Several methodological issues should be solved in future research on STS on QoL and utilization outcomes, like masking outcome assessment as well as clear description of usual care and long term follow up (12 month or longer). For answering questions related to patient satisfaction, other study designs than RCT could be appropriate; this part of assessment could be completely covered by Social aspects (SOC) Domain of the future versions of the full Core HTA Model.

Some methodological limitations that may affect comparability and applicability of the data reported in RCTs and SRs could be listed, such as different approaches of usual care as well of structured telephone support (different telephone follow-up, information or education provided pre-discharge, etc.); different providers of STS interventions (provided by pharmacist, physicians or nurses) and their experience in providing the STS.

The STS interventions presented in this assessment are applicable only to patients who are discharged to their home; it remains unclear whether STS interventions would benefit patients who are discharged to another institution. Also, due another limitation - narrow scope of our assessment, our results are not applicable to patients with chronic heart failure with implantable cardioverter-defibrillators (ICDs), cardiac resynchronisation therapy defibrillators (CRT-Ds) or pacemakers. Hindricks et al. 2014 and Parthiban et al. 2015 recently published data on remote monitoring in this selected group of patients { }. Due the fact that RCTs included in our assessment were published in a time  period ranging from 1999 to 2013, “usual care” in trials published earlier probably is not the same as “usual care”used in the most recent RCTs. Moreover, in general, trials did not report details of usual care. It also remains unclear if STS interventions in adults with chronic heart failure (who have been admitted to hospital at least once for chronic heart failure) will lead to different outcomes in rural or urban settings.

Authors of this assessment found some difficulties in full Core HTA Model, previously recognized, which will be solved in future versions of the Core Model (for example possible overlaps or duplication with other Domains assessment elements questions, need for grouping some of assessment element questions to avoid unnecessary slicing, as well as some problems with format of reporting). 

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Appendices

Appendix 1.     Search strategy, June 2015

Appendix 2. Flow chart of study selection

Figure 1. Flow chart of study selection, according to the PRISMA flowchart {Liberati 2009}

 

Appendix 3. Characteristics of included secondary studies: Systematic reviews/HTA, main study findings and authors conclusions

 

Appendix 4. RCTs included in SR of effectiveness and safety: Evidence tables and Risk of bias tables

Appendix 5.  List of included studies (RCTs) in the secondary studies (SRs or HTAs)

Appendix 6. List of included studies (RCTs) in this Systematic review of Clinical Effectiveness/Safety with Follow-up duration and Risk of bias

Appendix 7.  List of Ongoing RCTs in clinical trials registries

 

 

Costs and economic evaluation

Authors: Neill Booth, Taru Haula and Heidi Stuerzlinger (supported by Ingrid Rosian-Schikuta).

Summary

In this summary, as set out in the guidance for undertaking this pilot assessment using the HTA Core Model 2.0, we only summarise the results of the ECO domain. The results themselves can be found from the Results Card –section of the ECO domain. Details on the aim of the ECO domain and its research questions can be found from the ECO Introduction. Details on the methods used can be found from the ECO Methodolgy sections, and discussion can be found from the ECO discussion -section and from the Collection summary.

It became apparent from the results of our systematic literature search (see the Methodology section below) and our review of the results from other domains that the meaning of the term Structured telephone support (STS) varies quite widely across the studies. Hence, there is no explicit definition STS and, instead, the term is refers to a diverse set of approaches to care management for adults with chronic heart failure using telephonic networks. Depending on the approach taken to STS, a range of different pieces of information can be collected by telephone from patients, and any such information can be handled and utilised by the management team or system in a large number of ways. Therefore, one main result of the ECO domain is that variation in the nature of the intervention poses major challenges to undertaking meaningful examination of intervention costs and to undertaking economic evaluations. If each type of STS intervention, has both different components and consequences, this has a significant effect on ability to make meaningful estimates of costs and to undertake robust economic evaluations. For this reason, we do not summarise the results of the studies per se but, instead, briefly describe those studies found.

Four published pieces of research from the systematic review were found to be useful in this domain ({1, 3, 4 & 5}, see also Appendix ECO-2: PRISMA 2009 Flow Diagram). One of these, a European economic evaluation by Klersy et al. (2011) {1}, was only used to describe costs and three of these were also used to produce the results pertaining to economic evaluation {3, 4 & 5}. The first of the included economic evaluations is a North American modelling study published in 2009 by Miller et al. (2009) {3}, it estimates the cost-effectiveness for a subset of the patients with chronic heart failure, namely for patients with systolic heart failure. The second was a cost-effectiveness study by Klersy et al. (2011) {1} and reported an analysis which combined evidence on both remote monitoring (RM) and on STS. However, as this article included information from cardiovascular implantable electronic devices, it was, as an example of an economic evaluation, classified as being outside the scope of this pilot assessment using the HTA Core Model 2.0. One additional study, Herbert et al. (2008) {2}, was found through the search of the references of the papers retrieved following the systematic search. Although this study reported a trial-based cost-effectiveness analysis, it was excluded due to its focus on a very specific, non-European ethnic population. The third and fourth economic evaluations were pieces of British research by Pandor et al. (2013) {4} and Thokala et al. (2013) {5}.  It both of these it was noted that clear descriptions of STS interventions and usual care were not provided in many of the studies they reviewed and that this has potentially major implications for the robustness of analyses of costs, outcomes, and economic efficiency.

Introduction

The ‘Costs and economic evaluation’ -domain (ECO) within the HTA Core Model 2.0 aims to provide information about the relative costs and ‘cost-effectiveness’ of the health-care technologies under assessment {6}. This pilot assessment presents information on costs and economic evaluation about structured telephone support (STS) and ‘usual care’ for adults with chronic heart failure (i.e., patients with New York Heart Association (NYHA) Functional Classification I to IV and without implantable cardiac defibrillators, cardiac resynchronisation therapy devices or pacemakers) who have been admitted to hospital at least once for chronic heart failure). As set out in the TEC -domain, STS refers to a specific set of approaches to remote heart-failure monitoring or self-care management. Often using simple telephone technology, STS contacts can be planned according to a schedule, or initiated by a computerised system or by a healthcare professional (e.g., nurse, physician, social worker or pharmacist). As part of a wide variety of approaches to STS, different types of patient data are collected and stored electronically. In the case of a STS human-to-machine interfaces (HM) this can be done by a computerised system or, in the case of a STS human-to-human interactions (HH), this can be done by a healthcare professional. Data can then be reviewed by healthcare professionals and, if necessary and possible, action can be undertaken. Extensive details concerning usual care are not, in general, well reported in the clinical effectiveness literature (see EFF discussion).

Within the constraints of this HTA Core Model 2.0 pilot assessment we surveyed the potential for the creation of a costing template or a model to assess budget impact (e.g., a cost template for Budget Impact Analysis (BIA)). However, after systematically searching the literature and reviewing the information from the CUR, TEC, SAF, EFF, SOC and ORG domains, it was clear that it would not be viable to attempt to produce a useful BIA costing template or a de novo economic model. This was mainly due to the diverse nature of the interventions covered by the label STS, and due to a lack of robust evidence on both costs and effectiveness. Therefore, in what follows we report a qualitative analysis of the available information, starting with the information on costs, we offer as full an answer as we can to the research questions which deal with costs, i.e., in ECO1, ECO2 and ECO3. In ECO4 we report findings from the literature and from other domains, such as SAF and EFF on the effectiveness of ‘STS’ versus ‘usual care’. In ECO 5 we describe some of the information from the economic evaluation literature relating to ‘STS’ versus ‘usual care’, and in ECO6, ECO7 and ECO8 we extend this qualitative assessment of the available information.

Methodology

Frame

The collection scope is used in this domain.

Technology	Structured telephone support (STS) for adult patients with chronic heart failure Description Telemonitoring via structured telephone support with focus on patient reported signs (symptoms of congestion, peripheral edema, pulmonary congestion, dyspnea on exertion, abdominal fullness), medication adherence, physiological data (like heart rate, blood pressure, body weight – measured by the patient with home-device), activity level; done in regular schedules using risk stratification (with fixed algorithm by call center staff or experience-based by specialized staff); done by dedicated call centers, center-based staff, nurses, AND reduced visits to a GP or heart center
Intended use of the technology	Prevention Remote transmission of information to alleviate symptoms, relieve suffering and allow timely treatment for chronic heart failure Target condition Chronic cardiac failure Target condition description Heart failure is a condition in which the heart has lost the ability to pump enough blood to the body's tissues. With too little blood being delivered, the organs and other tissues do not receive enough oxygen and nutrients to function properly. Target population Target population sex: Any. Target population age: adults and elderly. Target population group: Patients who have the target condition. Target population description Patients with chronic heart failure (CHF; defined as I50 http://www.icd10data.com/ICD10CM/Codes/I00-I99/I30-I52/I50-/I50 ) AND hospitalization due to heart failure at least once  AND without implanted devices
Comparison	Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) Description Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)
Outcomes	Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms

Assessment elements

	Topic	Issue	Relevant	Research questions or rationale for irrelevance
E0001	Resource utilization	What types of resources are used when delivering the assessed technology and its comparators (resource-use identification)?	yes	What types of resources are used when delivering Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, usual care' without STS (resource-use identification)?
E0002	Resource utilization	What amounts of resources are used when delivering the assessed technology and its comparators (resource-use measurement)?	yes	What amounts of resources are used when delivering Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS (resource-use measurement)?
E0009	Resource utilization	What were the measured and/or estimated costs of the assessed technology and its comparator(s) (resource-use valuation)?	yes	What were the measured and/or estimated costs of Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS (resource-use valuation)?
E0005	Measurement and estimation of outcomes	What is(are) the measured and/or estimated health-related outcome(s) of the assessed technology and its comparator(s)?	yes	What is (are) the measured and/or estimated health-related outcome(s) of Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS?
E0006	Examination of costs and outcomes	What are the estimated differences in costs and outcomes between the technology and its comparator(s)?	yes	What are the estimated differences in costs and outcomes between Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS?
E0010	Characterising uncertainty	What are the uncertainties surrounding the costs and economic evaluation(s) of the technology and its comparator(s)?	yes	What are the uncertainties surrounding the costs and economic evaluation(s) of Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS?
E0011	Characterising heterogeneity	To what extent can differences in costs, outcomes, or ‘cost effectiveness’ be explained by variations between any subgroups using the technology and its comparator(s)?	yes	To what extent can differences in costs, outcomes, or ‘cost effectiveness’ be explained by variations between any subgroups using Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS?
E0012	Validity of the model(s)	To what extent can the estimates of costs, outcomes, or economic evaluation(s) be considered as providing valid descriptions of the technology and its comparator(s)?	yes	To what extent can the estimates of costs, outcomes, or economic evaluation(s) be considered as providing valid descriptions of Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS?

Methodology description

A systematic literature search was conducted in May 2015 by information specialist Jaana Isojärvi (THL, Finland) to find published studies on the costs and economic evaluation of structured telephone support for adult patients with chronic heart failure.

 

Information sources

The following databases were searched:

•           Centre for Reviews and Dissemination (HTA, NHS EED, DARE)

•           Cochrane Database of Systematic Reviews

•           Cochrane Central Register of Controlled Trials

•           MEDLINE (via Ovid)

•           NLM PubMed

•           SCOPUS

•           Journals@Ovid Full Text

•           CINAHL (via EBSCOhost)

•           PsycInfo (via EBSCOhost)

•           Web of Science

•           CEA Registry

A methodological search filter based on the filter developed in Healthcare Improvement Scotland was used. The systematic search strategy for this domain is presented in Appendix ECO-1.

In addition to database searches, we looked at the search results from Clinical Effectiveness, Safety and Social Aspects domains as well as the results from the searches undertaken according to the scope of the whole assessment using the HTA Core Model 2.0.

Articles that fit with the agreed PICO structure and presented estimations of outcomes and costs were searched using a two-stage process. All titles and abstracts were examined for inclusion by at least two reviewers and those chosen for potential inclusion were then examined as full-text articles by the same reviewers. Any disagreements were resolved through deliberation. In the end, four articles relevant for the questions in ECO domain were included from the 55 potentially relevant records identified through searching the databases and other sources. A flow-chart prepared according to the 2009 PRISMA statement is presented in Appendix ECO-2. Although the methodological quality of the included studies was not formally assessed, we undertook to describe the available information concerning costs and to describe relevant information from economic evaluations, using the method outlined in the section ‘Quality assessment tools or criteria’ below.

 

Quality assessment tools or criteria

We utilised the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement checklist ({7}) in the following way: each item in the checklist was examined by two authors for coherence between the reporting in the economic evaluations reviewed and the CHEERS checklist -items and any disagreements were resolved through discussions (see Appendix ECO-3). Although the CHEERS checklist is primarily intended for researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication, when reviewing existing literature it has a potential role in identifying issues which may make the use of information from any economic evaluation less appropriate when undertaking assessment using the HTA Core Model 2.0.

 

Analysis and synthesis

The ECO -domain authors had the intention to produce a costing template for budget impact analysis (BIA) modelling, but due to a lack of robust evidence on costs (e.g., as noted by the ORG domain) and a lack of robust evidence on effectiveness (e.g., as noted by the SAF and EFF domains), the ECO -domain authors could not justify attempting to produce a de novo health-economic model or a costing template. Therefore, in what follows we report a qualitative analysis of the information which was available, starting with the information on costs. We offer as full an answer as we can to the research questions which deal with costs, i.e., in ECO1, ECO2 and ECO3. In ECO4 we report findings from the literature and from other domains, such as SAF and EFF on the effectiveness of ‘STS’ versus ‘usual care’. In ECO5 we describe some of the information from the economic evaluation literature relating to ‘STS’ versus ‘usual care’, and in ECO6, ECO7 and ECO8, go on to try to extend this qualitative assessment of the available information.

Result cards

Resource utilization

Measurement and estimation of outcomes

Examination of costs and outcomes

Characterising uncertainty

Characterising heterogeneity

Validity of the model(s)

Discussion

Because of the results presented in ECO1, ECO2, ECO3, ECO4, ECO5 and ECO6 serious doubts are raised about the extent to which the estimates of costs, health-related outcomes, and economic evaluations can be considered as providing valid descriptions of structured telephone support (STS) for adult patients with chronic heart failure compared with its comparator, 'usual care' without STS

The other issue which has an effect on the interpretation of the findings in all the result cards of this domain is the varied definition of ‘STS’ and ‘usual care’ in the literature and its relationship to the way in which ‘STS’ and ‘usual care’ are defined in the scope of this pilot assessment using the HTA Core Model 2.0.

Perhaps the most serious doubts about the cost-effectiveness information are raised by the fact that individual patient-level data was not used and no adjustment was made for potential biases arising from study quality of the studies included in the NMA in the study by Pandor et al (2013) {4} and Thokala et al (2013) {5}. Further, the study by Miller et al. (2009) {3} mainly uses information from Galbreath et al. 2004 {8}, which is classed in EFF1 as having a high risk of bias, and the potential extent of the effect on results of structural uncertainty is not described. The quality of evidence in much of the available scientific literature is poor, therefore, more studies on all aspects of costs related to STS would be needed to reach an unbiased conclusion. Further, the lack of information concerning subgroups was noted, for example, by Pandor et al. (2013) {4}. They suggested that future studies should publish data in such a way as to identify which patient subgroups benefited most from the intervention.

Although analyses of subgroups of interventions can be undertaken, there is little peer-reviewed information available to support such analysis, such as robust estimates of the cost of software acquisition and maintenance when using different STS interventions. More importantly, perhaps, robust estimates of the impact of different types of STS on subsequent healthcare costs, as well as estimates of the impacts on costs outside the healthcare sector, are not available.

References

1. Klersy C, De Silvestri A, Gabutti G, Raisaro A, Curti M, Regoli F, et al. Economic impact of remote patient monitoring: an integrated economic model derived from a meta-analysis of randomized controlled trials in heart failure. European Journal of Heart Failure. 2011;13(4):450-9.
2. Hebert PL, Sisk JE, Wang JJ, Tuzzio L, Casabianca JM, Chassin MR, et al. Cost-Effectiveness of Nurse-Led Disease Management for Heart Failure in an Ethnically Diverse Urban Community. Annals of Internal Medicine. 2008;149(8):540-8.
3. Miller G, Randolph S, Forkner E, Smith B, Galbreath AD. Long-term cost-effectiveness of disease management in systolic heart failure. Medical decision making : an international journal of the Society for Medical Decision Making. 2009 May-Jun;29(3):325-33.
4. Pandor A, Thokala P, Gomersall T, Baalbaki H, Stevens JW, Wang J, et al. Home telemonitoring or structured telephone support programmes after recent discharge in patients with heart failure: systematic review and economic evaluation. Health technology assessment (Winchester, England). 2013;17(32):1-207, v-vi.
5. Thokala P, Baalbaki H, Brennan A, Pandor A, Stevens JW, Gomersall T, et al. Telemonitoring after discharge from hospital with heart failure: Cost-effectiveness modelling of alternative service designs. BMJ Open. 2013;3(9).
6. EUnetHTA Joint Action 2, Work Package 8. HTA Core Model ® version 2.0. A pdf-format file is available from http://www.corehta.info/BrowseModel.aspx; 2013.
7. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) Statement. Int J Technol Assess Health Care. 2013 Apr;29(2):117-22.
8. Galbreath AD, Krasuski RA, Smith B, Stajduhar KC, Kwan MD, Ellis R, et al. Long-Term Healthcare and Cost Outcomes of Disease Management in a Large, Randomized, Community-Based Population With Heart Failure. Circulation. 2004 December 7, 2004;110(23):3518-26.
9. Cleland JGF, Louis AA, Rigby AS, Janssens U, Balk AHMM. Noninvasive Home Telemonitoring for Patients With Heart Failure at High Risk of Recurrent Admission and Death: The Trans-European Network-Home-Care Management System (TEN-HMS) study. J Am Coll Cardiol. 2005;45(10):1654-64.
10. Bergmo TS. Can economic evaluation in telemedicine be trusted? A systematic review of the literature. Cost effectiveness and resource allocation. 2009;7:18.
11. Riegel B, Carlson B, Kopp Z, LePetri B, Glaser D, Unger A. Effect of a standardized nurse case-management telephone intervention on resource use in patients with chronic heart failure. Archives of Internal Medicine. 2002;162(6):705-12.
12. Feltner C, Jones CD, Cené CW, Zheng ZJ, Sueta CA, Coker-Schwimmer EJL, et al. Transitional care interventions to prevent readmissions for persons with heart failure: A systematic review and meta-analysis. Annals of Internal Medicine. 2014;160(11):774-84.
13. Krum H, Forbes A, Yallop J, Driscoll A, Croucher J, Chan B, et al. Telephone Support to Rural and Remote Patients with Heart Failure: The Chronic Heart Failure Assessment by Telephone (CHAT) study. Cardiovascular Therapeutics. 2013;31(4):230-7.
14. Dar O, Riley J, Chapman C, Dubrey SW, Morris S, Rosen SD, et al. A randomized trial of home telemonitoring in a typical elderly heart failure population in North West London: results of the Home-HF study. European Journal of Heart Failure. 2009;11(3):319-25.
15. Grustam AS, Severens JL, van Nijnatten J, Koymans R, Vrijhoef HJM. Cost-effectiveness of telehealth interventions for chronic heart failure patients: A literature review. International Journal of Technology Assessment in Health Care. 2014;30(01):59-68.

Appendices

 

 

Appendix ECO-1: ECO domain literature search strategies

 

Appendix ECO-2: PRISMA 2009 Flow Diagram

 

Appendix ECO-3: CHEERS coherence table

 

Appendix ECO-4: Potential cost drivers for ‘STS’ and ‘usual care’

Ethical analysis

Authors: Plamen Dimitrov, Gottfried Endel, Anelia Koteva

Summary

STS assessment in adult patients suffering from CHF has been developed in compliance with the fundamental ethical principles: beneficence/nonmaleficence, autonomy, respect for persons and justice and equity. Identified and discussed are the challenges that the use of this technology may provoke for both the patients themselves and their families, on the one hand as well as for the medical staff and healthcare system management, on the other hand.

Scientific literature demonstrates that the effect of telemedicine on patient-centered care varies more or less. Some studies see the negatives, but most find neutral or positive effects. The basis of empirical studies, however, is still too poor to allow any solid conclusions.

As will be discussed later in the text, on the agenda stand many ethical challenges, with the border between the benefits and harms associated with telemedicine remaining vague and fluid rather than sharply defined. This is due to the virtual environment, where electronically mediated communication replaces personal interaction and physical contact, thus posing several challenges:

• When shifting the physician-patient relationship from the conventional face-to-face communication to the electronically mediated one, these relations are frequently transformed towards the introduction of new social and interpersonal dynamics. This results in redefining the roles and responsibilities of both patients and health professionals;
• The context of indirect, distant relations between a physician and a patient raises the question of the legal regulation of possible mistakes and abuses of health personnel. There is no clarity as to who bears the legal responsibility and under what circumstances one should be liable to court. Therefore, practicing telemedicine should be accompanied by a proper legal and regulatory framework, stipulating clear standards and rules, compliant with the rights of patients, while at the same time maintaining parity between professional and ethical standards applied to all aspects of physician’s practice;
• The digital gap expansion generated by the lack of established telecommunications infrastructure in rural and some urban areas may be another issue. Too often restrictions are associated with not only limited access to network environment but also with a deficit of knowledge, skills, experience, familiarity and a sense of comfort when handling new technologies. Telemedicine is totally dependent on digitization and could not exist isolated from it. Here of crucial importance is to distinguish between the concepts of “availability” and “accessibility” since both terms are not necessarily interchangeable in meaning. Although some resources may be available, they may as well be inaccessible for a number of reasons (as mentioned).

Introduction

The current domain outlines some ethical issues arising from the use of the particular technology, i.e.  structured telephone support for adult patients suffering from CHF. Together with all the clinical efforts in the management of this devastating condition, part of the recent research has been concentrated on finding low-cost therapeutic alternatives as telemedicine and further understanding of the psychological, ethical, legal and social aspects of handling the particular technology and its impact on the patients themselves, their families and friends, the healthcare personnel and the healthcare providers as well as the society as a whole.

Since the issues discussed are highly controversial, the ethical analysis does not give certain prescriptions but aims at providing a balance between norms and values through the consideration of social, political, cultural, legal, religious and economic aspects arising from the opposition to the generally accepted environmental values, healthcare system goals and the application of new technologies.

The following areas have been debated:

• Improving patients’ quality of life;
• Challenges associated with the digital gap;
• Challenges posed by the remote interaction between a physician and a patient;
• Fair and balanced distribution of resources;
• Equal access to treatment;
• Stigmatization.

Methodology

Frame

The collection scope is used in this domain.

Technology	Structured telephone support (STS) for adult patients with chronic heart failure Description Telemonitoring via structured telephone support with focus on patient reported signs (symptoms of congestion, peripheral edema, pulmonary congestion, dyspnea on exertion, abdominal fullness), medication adherence, physiological data (like heart rate, blood pressure, body weight – measured by the patient with home-device), activity level; done in regular schedules using risk stratification (with fixed algorithm by call center staff or experience-based by specialized staff); done by dedicated call centers, center-based staff, nurses, AND reduced visits to a GP or heart center
Intended use of the technology	Prevention Remote transmission of information to alleviate symptoms, relieve suffering and allow timely treatment for chronic heart failure Target condition Chronic cardiac failure Target condition description Heart failure is a condition in which the heart has lost the ability to pump enough blood to the body's tissues. With too little blood being delivered, the organs and other tissues do not receive enough oxygen and nutrients to function properly. Target population Target population sex: Any. Target population age: adults and elderly. Target population group: Patients who have the target condition. Target population description Patients with chronic heart failure (CHF; defined as I50 http://www.icd10data.com/ICD10CM/Codes/I00-I99/I30-I52/I50-/I50 ) AND hospitalization due to heart failure at least once  AND without implanted devices
Comparison	Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) Description Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)
Outcomes	Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms

Assessment elements

	Topic	Issue	Relevant	Research questions or rationale for irrelevance
F0010	Beneficence/nonmaleficence	What are the known and estimated benefits and harms for patients when implementing or not implementing the technology?	yes	What are the known and estimated benefits and harms for patients when implementing or not implementing STS?
F0011	Beneficence/nonmaleficence	What are the benefits and harms of the technology for other stakeholders (relatives, other patients, organisations, commercial entities, society, etc.)?	yes	What are the benefits and harms of STS for other stakeholders (relatives, other patients, organisations, commercial entities, society, etc.)?
F0100	Beneficence/nonmaleficence	What is the severity level of the condition that the technology is directed to?	no	This question is the subject of discussion in the "CUR"-domain and it is extraneous to clarify the ethical considerations of technology and therefore does not belong in this domain.
F0003	Beneficence/nonmaleficence	Are there any other hidden or unintended consequences of the technology and its applications for different stakeholders (patients/users, relatives, other patients, organisations, commercial entities, society etc.)?	no	The answer to this question overlaps with regard to the answers to the previous two questions
F0005	Autonomy	Is the technology used for patients/people that are especially vulnerable?	yes	Is STS used for patients/people that are especially vulnerable?
F0004	Autonomy	Does the implementation or use of the technology affect the patient´s capability and possibility to exercise autonomy?	yes	Does the implementation or use of STS affect the patient´s capability and possibility to exercise autonomy?
F0006	Autonomy	Is there a need for any specific interventions or supportive actions concerning information in order to respect patient autonomy when the technology is used?	yes	Is there a need for any specific STSs or supportive actions concerning information in order to respect patient autonomy when STS is used?
F0007	Autonomy	Does the implementation or withdrawal of the technology challenge or change professional values, ethics or traditional roles?	yes	Does the implementation or withdrawal of STS challenge or change professional values, ethics or traditional roles?
F0009	Respect for persons	Does the implementation or use of the technology affect the user´s moral, religious or cultural integrity?	yes	Does the implementation or use of STS affect the user´s moral, religious or cultural integrity?
F0101	Respect for persons	Does the technology invade the sphere of privacy of the patient/user?	yes	Does STS invade the sphere of privacy of the patient/user?
F0008	Respect for persons	Does the implementation or use of the technology affect human dignity?	no	Human dignity is legal category and not ethical. It is defined as "fundamental and inalienable human right" and therefore subject to the law, not ethics
F0012	Justice and Equity	How does implementation or withdrawal of the technology affect the distribution of health care resources?	yes	How does implementation or withdrawal of STS affect the distribution of health care resources?
F0013	Justice and Equity	How are technologies with similar ethical issues treated in the health care system?	yes	How are technologies with similar ethical issues treated in the health care system?
H0012	Justice and Equity	Are there factors that could prevent a group or persons to participate?	yes	Are there socio cultural factors that could prevent a group CHF patients (defined by e.g. age, ethnicity, income, geographic area, working staus, geneder etc.) to use Structured telephone support (STS)?
F0014	Legislation	Does the implementation or use of the technology affect the realisation of basic human rights?	yes	Does the implementation or use of STS affect the realisation of basic human rights?
F0016	Legislation	Can the use of the technology pose ethical challenges that have not been considered in the existing legislations and regulations?	no
F0017	Ethical consequences of the HTA	What are the ethical consequences of the choice of end-points, cut-off values and comparators/controls in the assessment?	yes	What are the ethical consequences of the choice of end-points, cut-off values and comparators/controls in the assessment?
F0102	Ethical consequences of the HTA	Does the economic evaluation of the technology contain any ethical problems?	yes	Does the economic evaluation of STS contain any ethical problems?
F0103	Ethical consequences of the HTA	What are the ethical consequences of the assessment of the technology?	yes	What are the ethical consequences of the assessment of STS?

Methodology description

The Ethical Domain has been developed in compliance with the fundamental ethical principles, basically following the method of principalism. Consistently presented are ethical arguments related to the autonomy and benefits for the patient as well as possible limitations pertaining to the implementation of the technology discussed, without aiming to give a precise answer or “ethical prescription”, as already said.

The domain comprises 19 issues grouped into 5 sections, as listed below:

• Section 1 – Beneficence/Nonmaleficence;
• Section 2 – Autonomy;
• Section 3 – Respect for Persons;
• Section 4 – Justice and Equity;
• Section 5 – Legislation.

We have answered 15 issues. The other 4 issues we consider either irrelevant or have marked them as a “skipped issue”. More specifically unanswered are:

• Issue 3 (marked as irrelevant);
• Issue 4 (marked as irrelevant);
• Issue 11 (marked as irrelevant);
• Issue 16 (marked as skipped).

Literature

The text is based on 24 literary sources, as shown in the references. All of them are in the English language, no Cyrillic information sources have been used.

The literature has been obtained by searching the Internet engine Google, Google scholar and PubMed by key words for each aspect concerned. No other scientific databases have been used.

Nevertheless, we believe that the literature provides a great variety of views that have been reflected in the current analysis. Since the issues are of highly controversial nature, the current text does not pretend to be a detailed or comprehensive analysis but provides some thoughts and reflections. Official  sources such as reports of the WHO, statements, guidelines of the American Telemedicine Association, research papers as well as various peer-reviewed articles in specialized medical journals, primarily focusing on cardiology, ethics, medical informatics, telemedicine and telecare, etc., have been thoroughly reviewed and helped in the understanding of the topic. All citations have been marked by pointing the authors of the source, its title, place and date of publication as well as by a link to the information source itself, basically in a pdf-format. All of the sources, on which the analysis is based, are as of recent years.

Result cards

Beneficence/nonmaleficence

Autonomy

Respect for persons

Justice and Equity

Legislation

Ethical consequences of the HTA

Discussion

In recent years, health vocabulary has been enriched with several new concepts resulting from the penetration of information and communication technologies in public life, particularly in the health field, and the subsequent transformation of the organization of healthcare provision. Neologisms, such as “telemedicine”, “telehealth” and “e-health”, have appeared, whose semantic distinction as of today is not clear enough insofar as they are often considered synonyms. The complexity in determining their terminological scope is largely reinforced by the lack of a universal definition for the three concepts.

On the Etymology of Concepts. Operational Definitions

“Tele-“ (derived from Greek, meaning “far away”, “from a distance”). As already mentioned, there is a great variety of definitions in the available literature, but as they are not a particular focus of the present analysis and serve only to make terminological clarity, the paper will only consider two of them. For example, the American Telemedicine Association provides the following definition: “Telemedicine is the remote delivery of healthcare services and clinical information using telecommunications technology. This includes a wide array of clinical services using Internet, wireless, satellite and telephone media”^[1], while the World Health Organization expands the scope of telemedicine as follows: “The delivery of healthcare services, where distance is a critical factor, by all healthcare professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of healthcare providers, all in the interests of advancing the health of individuals and their communities”^[2].

From what has been pointed out one can make the impression that the second definition extends the focus from the purely clinical aspects, typical of telemedicine, to the various non-clinical applications, including prevention, public health, research, health education, etc. With the involvement of an ever growing group of health professionals (not restricted to physicians only) and the emergence of increasingly sophisticated ICT, telemedicine acquires new dimensions approaching it to what is meant by the term “telehealth” (referred to as in the WHO definition above).

Despite the lack of a single, universal understanding of telemedicine/telehealth, experts in the field unite themselves around some common components for all definitions:

1. ICT use;
2. Geographical distance among participants;
3. Use in the context of health/medicine.

One of the problems that could affect the quality and nature of the conclusions in the material stems from the fact that, like many other innovations in the healthcare field, almost all of the studies from the available literature, assessing the positive and negative impact of telemedicine, focus primarily on the purely economic, technical and clinical parameters, particularly emphasizing on cost reduction and technological efficiency but ignoring the ethical considerations at the same time. The latter, however, is an essential element of any general assessment of a new technology, without whose thorough clarification and its understanding remains impossible further incorporation into future guidelines, standards of care and policies.

While collecting and reviewing specialized literature, another major gap has been found – lack of sufficient empirical studies dealing specifically with the advantages and disadvantages of implementing teletechnologies in clinical practice, with emphasis on just general theoretical philosophical and ethical concepts instead. Therefore, since the exact benefits and harms of telemedicine remain unknown at this stage, they require additional empirical confirmation or denial so that decision-makers could reach a grounded, reasoned decision on the selection of a concrete health technology and its further implementation into routine medical practice.

The available literature is concentrated in two key papers representing meta-analyses of data from randomized controlled trials comparing the two forms of remote monitoring – telemonitoring and structured telephone support in terms of clinical or cost effectiveness indicators^[3],[4]. Quite vaguely mentioned has been their acceptability to patients and patients’ level of satisfaction. Also a bias in patient selection has been identified – only persons with skills and affinity to modern communication have been included.

Like the majority of the available empirical material on teletechnologies, ethical aspects have been neglected. A significant disadvantage of the meta-analyses used is their failure to strictly define the scope of the term “structured telephone support”. Despite the operational definition provided, it cannot be codified and equally applicable to all types of structured telephone support; rather, each of the authors of the studies, included in the meta-analyses, gives his/her own understanding of what is meant by the term and its boundaries. The adjective “structured” implies regularity of telephone contacts with their initiation on the part of healthcare personnel, but the limits of the scope are higly blurred, at times closely approaching each other and even further confusing them by mixing structured telephone support with telemonitoring through the transfer of electronically registered and traceable physiological indicators – all of these made possible by the use of mobile applications. This poses the question of to what extent structured telephone support should be confined to traditional landlines and won’t it be more correct with a view to the overwhelming digital environment for the analyses to be based on data including mobile telephones, as well.

 

[1] “Telemedicine Frequently Asked Questions (FAQs)”, available at: http://www.americantelemed.org/about-telemedicine/faqs#.VR0dHPyUc4i .

 

[2] “Telemedicine: Opportunities and Developments in Member States” (Report on the Second Global Survey on eHealth), Global Observatory for e-Health Series – volume 2, World Health Organization, 2010, p. 9, available at: http://www.who.int/goe/publications/goe_telemedicine_2010.pdf .

[3] Inglis, S., R. Clark, F. McAlister, J. Ball, C. Lewinter, D. Cullington, S. Stewart, J. Cleland, “Structured Telephone Support or Telemonitoring Programmes for Patients with Chronic Heart Failure (Review)”, the Cochrane Collaboration, published in the Cochrane Library, 2010, issue 8, available at: http://www.iat.eu/ehealth/downloads/441_Cochrane.pdf .

 

[4] Pandor, A., P. Thokalla, T. Gomersall, H. Baalbaki, J. Stevens, J. Wang, R. Wong, A. Brennan, P. Fitzgerald, “Home Telemonitoring or Structured Telephone Support Programmes after Recent Discharge in Patients with Heart Failure: Systematic Review and Economic Evaluation”, National Institute for Health Research, United Kingdom, Health Technology Assessment, volume 17, issue 32, August 2013, available at: http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0007/76588/FullReport-hta17320.pdf .

References

1. Bauer, K., “The Ethical Implications of Telemedicine and the Internet for Home Healthcare” (Doctoral Dissertation), University of Tennessee, Knoxville, May 2002, available at: http://trace.tennessee.edu/cgi/viewcontent.cgi?article=3531&context=utk_graddiss ;
2. “Clinical Telehealth in Quėbec: An Ethical Perspective. Summary and Recommendations”, Position statement adopted at the 67th meeting of the Commission de l’éthique en science et en technologie, 28 March 2014, Gouvernement du Québec, Bibliothèque nationale du Québec Library and Archives Canada, available at: http://www.ethique.gouv.qc.ca/en/assets/documents/Telesante/Telehealth_summary_EN.PDF ;
3. “Core Operational Guidelines for Telehealth Services Involving Provider-Patient Interactions”, American Telemedicine Association, May 2014, available at: http://www.americantelemed.org/docs/default-source/standards/core-operational-guidelines-for-telehealth-services.pdf?sfvrsn=6 ;
4. “Examples of Research Outcomes: Telemedicine’s Impact on Healthcare Cost and Quality”, American Telemedicine’s Association, April 2013, available at: http://www.americantelemed.org/docs/default-source/policy/examples-of-research-outcomes---telemedicine's-impact-on-healthcare-cost-and-quality.pdf ;
5. Fleming, D., “Telehealth: The Ethical Challenges of a New Technology”, Center for Health Ethics, Department of Health Management and Informatics, University of Missouri School of Medicine, Columbia, MO, available at: http://ethics.missouri.edu/docs/telehealth_challenges.pdf ;
6. Hale, T., J. Kvedar, “Privacy and Security Concerns in Telehealth”, AMA Journal of Ethics (formerly “Virtual Mentor”), December 2014, vol. 16, number 12: 981-985, available at: http://journalofethics.ama-assn.org/2014/12/jdsc1-1412.html ;
7. Harman, L., C. Flite, K. Bond, “Electronic Health Records: Privacy, Confidentiality, and Security”, AMA Journal of Ethics (formerly “Virtual Mentor”), September 2012, vol. 14, number 9: 712-719, available at: http://journalofethics.ama-assn.org/2012/09/stas1-1209.html ;
8. Inglis, S., R. Clark, F. McAlister, J. Ball, C. Lewinter, D Cullington, S. Stewart, J. Cleland, “Structured Telephone Support or Telemonitoring Programmes for Patients with Chronic Heart Failure (Review)”, the Cochrane Collaboration, published in the Cochrane Library, 2010, issue 8, available at: http://www.iat.eu/ehealth/downloads/441_Cochrane.pdf ;
9. Jack, C., M. Mars, “Telemedicine: A Need for Ethical and Legal Guidelines in South Africa”, South African Family Practice, August, 2014 50:2, 60-60d, DOI: 10.1080/20786204.2008.10873698, available at: http://www.tandfonline.com/doi/pdf/10.1080/20786204.2008.10873698 ;
10. Marziali, E., J. Serafini, L. McCleary, “A Systematic Review of Practice Standards and Research Ethics in Technology-based Home Health Care Intervention Programs for Older Adults”, Journal of Aging and Health, December 2005, 17(6):679-96, available at: http://www.ncbi.nlm.nih.gov/pubmed/16377767 ;
11. Mehta, Sh., “Telemedicine’s Potential Ethical Pitfalls”, AMA Journal of Ethics (formerly “Virtual Mentor”), December 2014, vol. 16, number 12: 1014-1017, available at:  http://journalofethics.ama-assn.org/2014/12/msoc1-1412.html ;
12. Miller, St., Al. MacGregor, “Ethical Dimensions of Meaningful Use Requirements for Electronic Health Records”, AMA Journal of Ethics (formerly “Virtual Mentor”), March 2011, vol. 13, number 3: 176-180, available at: http://journalofethics.ama-assn.org/2011/03/pfor1-1103.html ;
13. Pandor, A., P. Thokala, T. Gomersall, H. Baalbaki, J. Stevens, J. Wang, R. Wong, A. Brennan, P. Fitzgerald, “Home Telemonitoring or Structured Telephone Support Programmes after Recent Discharge in Patients with Heart Failure: Systematic Review and Economic Evaluation”, National Institute for Health Research, United Kingdom, Health Technology Assessment, volume 17, issue 32, August 2013, available at: http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0007/76588/FullReport-hta17320.pdf ;
14. Paré, G., M. Jaana, Cl. Sicotte, “Systematic Review of Home Telemonitoring for Chronic Diseases: The Evidence Base”, Journal of the American Medical Informatics Association, May-June 2007, 14 (3): 269-277, doi: 10.1197/jamia.M2270, available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2244878/ ;
15. Perry, J., St. Beyer, J. Francis, P. Holmes, “Ethical Issues in the Use of Telecare”, Adults’ Services Report 30, Social Care Institute for Excellence, May 2010, Great Britain, available at: http://lx.iriss.org.uk/sites/default/files/resources/report30.pdf ;
16. Sarhan, F., “Telemedicine in Healthcare 2: The Legal and Ethical Aspects of Using New Technology”,  Nursing Times; 105: 43, 2 November 2009, available at: http://www.nursingtimes.net/nursing-practice/specialisms/management/telemedicine-in-healthcare-2-the-legal-and-ethical-aspects-of-using-new-technology/5008068.article ;
17. Schmidt, S., Andr. Schuchert, Th. Krieg, M. Oeff, “Home Telemonitoring in Patients With Chronic Heart Failure: A Chance to Improve Patient Care?”, Deutsches Ärzteblatt International, February 2010, 2010; 107(8): 131-138; DOI: 10.3238/arztebl.2010.0131, available at:  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2840250/ and http://www.aerzteblatt.de/int/archive/article/67896/Home-Telemonitoring-in-Patients-With-Chronic-Heart-Failure-A-Chance-to-Improve-Patient-Care ;
18.  Stanberry, B., “Legal and Ethical Aspects of Telemedicine”, Journal of Telemedicine and Telecare, 2006, 12(4):166-75, available at: http://jtt.sagepub.com/content/12/4/166.short ;
19. Stroetmann, K., L. Kubitschke, S. Robinson, V. Stroetmann, K. Cullen, D. McDaid, “How Can Telehealth Help in the Provision of Integrated Care?”, Policy Brief 13, World Health Organization, Regional Office for Europe and European Observatory on Health Systems and Policies, 2010, available at: http://www.euro.who.int/__data/assets/pdf_file/0011/120998/E94265.pdf ;
20.  “Telehealth” (Wikipedia), available at: http://en.wikipedia.org/wiki/Telehealth ;
21.  “Telemedicine” (Wikipedia), available at: http://en.wikipedia.org/wiki/Telemedicine ;
22. “Telemedicine Frequently Asked Questions (FAQs)”, American Telemedicine Association, available at: http://www.americantelemed.org/about-telemedicine/faqs#.VRxUKfysX84 \ ;
23. “Telemedicine: Opportunities and Developments in Member States” (Report on the Second Global Survey on eHealth), Global Observatory for eHealth Series – volume 2, World Health Organization, 2010, available at: http://www.who.int/goe/publications/goe_telemedicine_2010.pdf ;
24. “What Is Telemedicine?”, American Telemedicine Association, available at: http://www.americantelemed.org/about-telemedicine/what-is-telemedicine#.VRxTr_ysX84 .

Organisational aspects

Authors: Valentina Prevolnik Rupel, Taja Čokl, Eleftheria Karampli

Summary

ORG1: How does Telemonitoring in home care for patients with chronic cardiovascular diseases affect the current work processes?

As most of the studies are conducted in controlled academic environment or non realistic setting, it might be that additional option should be considered in real setting, like hiring a nurse, use of low cost telephone service, use more time for outcomes dissemination and results discussion in a team. STS can be carried out in very different settings, from primary care to tertiary care. There is little information in the studies on the changes of the workflow – usually for the STS an additional nurse was used who had access to patient data, carried out the STS, monitored the patient, recorded the symptoms and data and reinforced and adapted the plan of care for the patient. The other medical professions did not get involved in STS directly, only indirectly, through the STS nurse, who coordinated all the activities and services around the patient. No study specifically recorded the (decrease or increase of) workload for other specialists in case a STS nurse was involved in the work. One study {6} describes how to manage human resources and the division of roles between nurses. During the 2007 calendar year, there were 1.356 patients visits to the HF clinic and telephone calls accounted for an additional 1.914 patient encounters in 2007. One full-time nurse practitioner, one clinical nurse specialist (working 0,7 of a full-time equivalent), and one registered nurse (vacation replacement) provided the nursing interventions with the telephone visits. Nurse spent 24 % of their working hours doing 1.914 telephone calls in one year.

ORG 2: What kind of patient/participant flow is associated with Telemonitoring in home care for patients with chronic cardiovascular diseases?

 

STS replaced historical program of doctor’s visits for HF patients after discharge. In interventions utilizing STS, the patient is monitored remotely while being at home (including a relative’s home, nursing home or residential care home). The patients are contacted in regular time intervals via telephone by either healthcare personnel (e.g. specialized HF nurses) or an automated telephone-based interactive response system. The STS support starts being planned while the patient is in hospital through education and meeting with the HF nurse. Education and practising with the technology follows and the materials are given to the patients as well as explained to the relatives. At the point of discharge the timing of the first call is agreed. The frequency of calls varies greatly among the studies but in common the calls are weekly at least first two weeks after discharge and then get biweekly until two months after discharge. After that they become monthly. It is not clear how long the intervention should last: there are different periods, going from 3 months up to 2 years after the discharge. It is not clear when the effect is biggest, possibly within first 3 months.

ORG3: What kind of involvement has to be mobilized for patients/participants and important others?

Please find the overlapping results also in TEC3: What kind of training and information should be provided for the patient who uses Telemonitoring in home care for patients with chronic cardiovascular diseases, or for his family?

ORG4: What is the process ensuring proper education and training of the staff?

Proper education and training of the staff is ensured through the courses for nurses on HF (formal HF certification) and on the remote monitoring, which is assured by telemedicine providers in case any devices for home symptoms measurements are included. As far as the STS itself, no specific training were found to be offered to staff in the literature.

ORG5: What kind of co-operation and communication of activities have to be mobilised?

In the heart of communication and cooperation strategy in the studies there is always a nurse. A consistent nurse case manager who cares for the patient and connects family, tries to understand goals and specific outcomes, provides information and monitors patient and communicates and cooperates with other members of health team to help them understand the patient {240}. A published communication strategy is important, including patient support strategy, communication between patient: nurse, patient: medical doctor, patient: pharmacist, the brochures, diaries to record daily control measurements, web pages with disease information and with instructions, instructions for family members  to share a best practise.

ORG6: How is the quality assurance and monitoring system of Telemonitoring in home care for patients with chronic cardiovascular diseases organised?

Please find the overlapping results in TEC2: What kind of qualification and quality assurance processes are needed for the use or maintenance of Telemonitoring in home care for patients with chronic cardiovascular diseases?

ORG7: What are the processes ensuring access to care of Telemonitoring in home care for patients with chronic cardiovascular diseases for patients/participants?

In general, RM including STS provides greater access to care in geographical terms. In most of the studies the problems with accessability to phone line were not reported. Careful planning of STS is necessary among specific population that might have issues in moving around and having lower access to phone lines. Also, the number of telephone contacts per week should not be too high, not even in the first week as this may affect adherence. The problems might arise on the side of physicians as patients might relocate to more developed health care centres with remote monitoring programs posing financial risk for smaller providers.

Speaking in terms of financial accessability, no specific problems were mentioned on the side of the patient. On the side of the provider, the current reimbursement structures basically do not support STS and hence act as a disincentive to providers wanting to offer RM incl. STS to patients sustaining HF. Innovative reimbursement schemes such as coverage with evidence in development are suggested in the literature.

ORG8: What are the likely budget impacts of implementing the technologies being compared?

While some studies reported  {2} no statistically significant difference in healthcare costs (either total costs or all-cause hospital costs), other studies reported important and significant reductions in costs. While the average costs of intervention across the studies amounted from $23,6 to $443, the reported savings amounted from $30,9 to $536 per patient per month. The savings across studies were reported in various ways which makes them hardly comparable (percentage reduction in inpatient costs, percentage reduction in overall costs, percentage reduction in total health expenditures, reduction in different currencies per patient, per nurse, per year, per month, per 6 months...). However, more important than this is the method of costs calculation that varies widely across the studies. More or less, only direct costs are included, mostly connected to reduction in hospitalizations. More than 70 % of the studies did not take into account expenses in one of the following categories:  healthcare sector, other sectors, patient/family expenses or productivity losses. None of the studies analyzed a shift of cost, from specialits to HF nurse to GP, for instance. In 80% of the studies the source and methods of the evaluations were not clear. Authors mostly focused on direct costs while omitting indirect and intangible costs {310}. Principally, the costs were missing across majority of the studies and those of the intervention overheads, training of personnel, and patient related costs.  There is a difficulty in capturing all of the effects of telehealth intervention. Thus the cost effectiveness evidence for specific implementations in the field of telehealth is limited. Problems with telehealth interventions reside in absence of quality data and appropriate measures. The quality of economic data is especially questionnable. The quality of evidence in the scientific literature is poor. More studies on all costs are needed to reach the unbiased conclusion. 

ORG9: What management problems and opportunities are attached to Telemonitoring in home care for patients with chronic cardiovascular diseases?

The use of RM has improved as a possible way to improve the management of patients with HF by allowing more frequent assessment of patients without the need for FTF clinical reviews {100}. When planning the introduction of a RM intervention in general, there are several questions that need to be addressed concerning: the choice of patients targeted by these programmes; the parameters that will be monitored; the more efficient way to monitor them; the training of patients and healthcare personnel; how to organize the response of the health care professionals to data obtained from monitoring to optimize patient care {1430}{1}. Possibly management will need to deal with (de)employment of new resources, new information systems, new equipment for STS provisions, new administrative leadership and new group culture that promotes quality improvement {15}{40}.

CUR3 / ORG10: Who decides which people are eligible for Telemonitoring in home care for patients with chronic cardiovascular diseases and on what basis?

Eligibility to new technology depends on an assessment of the general practitioner of a patient’s condition and the patient's willingness and ability to participate. Access to new technologies depends on support of healthcare providers. In real-world settings, patient selection will be critical for the acceptance and compliance with the programme. Patient selection criteria might include the degree to which the patient is willing to incorporate these technologies into their care or patients at high-risk {40}. Having  an access to a touchtone telephone is an essential inclusion criterion {1} . By Dunagan et al {10} cognitive or psychologic impairment as well as inability to hear and understand English spoken over the telephone were included as non-eligibility criteria.

ORG11: How is Telemonitoring in home care for patients with chronic cardiovascular diseases accepted?

Adherence to STS programs differs in HM to HH STS programs, it seems that interpersonal interaction with a care provider is an important active component of STS (adherence is higher in HH than HM STS) {40}. Adherence is reported from 55,1% to 84% across the studies, adaptation to the technology to 90% or higher, more than 90% of patietns are statisfied with the use of technolgy. Acceptance of automated voice interactive system was poor, mostly due to technical failures. Patients were generally very satisfied with various STS programs across studies.

 

The clinicians, on the other hand, have several reservations, such as potential increased clinical workload, medicolegal issues, and worries of difficulty of use for some patients due to lack of visual acuity or manual dexterity. The clinicians believed that the telephone interactions is as effective as face-to-face interactions. The clinicians fear that system would result in a significant increase in their workload {91}.

ORG12: How are the other interest groups taken into account in the planning / implementation of Telemonitoring in home care for patients with chronic cardiovascular diseases?

No other interest groups except those mentioned in other assessment elements, are taken into account in the planning / implementation of Telemonitoring in home care for patients with chronic cardiovascular diseases.

Introduction

In this domain we aim to explain the impact of STS on providers (their work processes, education and training of staff, management strategies, acceptance), on patients (patient flow, patient involvement, access to STS, eligibility and acceptance) as well as on health care system (budget impact, quality assurance and monitoring). From oragnizational aspect the most important issue is ensuring optimal organization on the side of provider by assigning a trained heart failure (HF) nurse to carry our STS program through proper communication that assures maximum acceptance, adherence and satisfaction by patients. According to the opinion of medical staff, lack of proper reimbursement in most health care systems makes the management of STS programs challenging. It needs to take into account evidence based findings on best result technology, social and organizational issues to achieve maximum results.

Methodology

Frame

The collection scope is used in this domain.

Technology	Structured telephone support (STS) for adult patients with chronic heart failure Description Telemonitoring via structured telephone support with focus on patient reported signs (symptoms of congestion, peripheral edema, pulmonary congestion, dyspnea on exertion, abdominal fullness), medication adherence, physiological data (like heart rate, blood pressure, body weight – measured by the patient with home-device), activity level; done in regular schedules using risk stratification (with fixed algorithm by call center staff or experience-based by specialized staff); done by dedicated call centers, center-based staff, nurses, AND reduced visits to a GP or heart center
Intended use of the technology	Prevention Remote transmission of information to alleviate symptoms, relieve suffering and allow timely treatment for chronic heart failure Target condition Chronic cardiac failure Target condition description Heart failure is a condition in which the heart has lost the ability to pump enough blood to the body's tissues. With too little blood being delivered, the organs and other tissues do not receive enough oxygen and nutrients to function properly. Target population Target population sex: Any. Target population age: adults and elderly. Target population group: Patients who have the target condition. Target population description Patients with chronic heart failure (CHF; defined as I50 http://www.icd10data.com/ICD10CM/Codes/I00-I99/I30-I52/I50-/I50 ) AND hospitalization due to heart failure at least once  AND without implanted devices
Comparison	Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) Description Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)
Outcomes	Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms

Assessment elements

	Topic	Issue	Relevant	Research questions or rationale for irrelevance
G0001	Health delivery process	How does the technology affect the current work processes?	yes	How does structured telephone support (STS) for adult patients with chronic heart failure affect the current work processes?
G0100	Health delivery process	What kind of patient/participant flow is associated with the new technology?	yes	What kind of patient/participant flow is associated with structured telephone support (STS) for adult patients with chronic heart failure?
G0002	Health delivery process	What kind of involvement has to be mobilized for patients/participants and important others?	yes	What kind of involvement has to be mobilized for patients/participants and important others?
G0003	Health delivery process	What is the process ensuring proper education and training of the staff?	yes	What is the process ensuring proper education and training of the staff?
G0004	Health delivery process	What kind of co-operation and communication of activities have to be mobilised?	yes	What kind of co-operation and communication of activities have to be mobilised?
G0012	Health delivery process	How is the quality assurance and monitoring system of the new technology organised?	yes	How is the quality assurance and monitoring system of structured telephone support (STS) for adult patients with chronic heart failure organised?
G0101	Structure of health care system	What are the processes ensuring access to care of the new technology for patients/participants?	yes	What are the processes ensuring access to care of structured telephone support (STS) for adult patients with chronic heart failure for patients/participants?
G0005	Structure of health care system	How does de-centralisation or centralization requirements influence the implementation of the technology?	no	As telemonitoring is provided at patients' home and is monitored by the unit defined in the system, the level of de/centralization has no impact on the implementation.
G0007	Process-related costs	What are the likely budget impacts of implementing the technologies being compared?	yes	What are the likely budget impacts of implementing the technologies being compared?
G0006	Process-related costs	What are the processes related to purchasing and setting up the new technology?	no	Investments in premises and equipment (except phone lines/broadbands) are not necessary and not mentioned in the literature, which clearly follows from TEC domain. This is the reason we find this question irrelevant.
G0008	Management	What management problems and opportunities are attached to the technology?	yes	What management problems and opportunities are attached to structured telephone support (STS) for adult patients with chronic heart failure?
G0009	Management	Who decides which people are eligible for the technology and on what basis?	yes	Who decides which people are eligible for structured telephone support (STS) for adult patients with chronic heart failure and on what basis?
G0010	Culture	How is the technology accepted?	yes	How is structured telephone support (STS) for adult patients with chronic heart failure accepted?
G0011	Culture	How are the other interest groups taken into account in the planning / implementation of the technology?	yes	How are the other interest groups taken into account in the planning / implementation of structured telephone support (STS) for adult patients with chronic heart failure?

Methodology description

To answer the questions in the assessment elements we mainly used the basic literature search provided for the whole project. Additionally, two more systematic searches were used: one performed by ORG and ECO domains (described in methodology of ECO domain) and one perfomed by EFF, SAF and ECO domains (described in SAF domain). For some answers (ORG4) an additional handsearch was performed.  

Information sources

·         Common basic project literature search

·         Specific literature search performed together with ECO domain

·         Specific literature search performed in SAF, EFF and ECO domain

·         Handsearch (additional reference found/ provided)

·         Google

Quality assessment tools or criteria

We did not rate the quality of the included studies, but mentioned whether the information was extracted from systematic reviews or single studies (i.e. RCTs) or other resources. The basis for inclusion and exclusion of the studies is described in other domains with whom the search was perfomed and was based on the contents of the abstract (we checked the relevance of topic for our AEs and PICO). Quality assessment of the literature was not performed in ORG domain - however, no separate search was performed within the domain as well. We found the opposing results based on the same articles cited in 2 articles – in such cases the original articles was searched for and the results were checked.

Analysis and synthesis

Three investigators divided the amount of studies among themselves, each scanned one third of the studies and double-checked the other two thirds. The investigators in the further process divided the questions (each investigator 4 questions) and we wrote and wrapped them up based on the findings from the literature. The whole document was checked before sent to internal reviewers. The comments from internal reviewers were divided among investigators according to the separate questions and reacted to accordingly. The whole process was coordinated with ECO, TEC and LEG domain through PI s of each domain. The classification of literature was prepared in other domains and not in Org and is therefore not presented here. 

Result cards

Health delivery process

Structure of health care system

Process-related costs

Management

Culture

Discussion

ORG1: How does Telemonitoring in home care for patients with chronic cardiovascular diseases affect the current work processes?

As most of the studies are conducted in controlled academic environment or non realistic setting, it might be that additional option should be considered in real setting, like hiring a nurse, use of low cost telephone service, use more time for outcomes dissemination and results discussion in a team. STS can be carried out in very different settings, from primary care to tertiary care. There is little information in the studies on the changes of the workflow – usually for the STS an additional nurse was used who had access to patient data, carried out the STS, monitored the patient, recorded the symptoms and data and reinforced and adapted the plan of care for the patient. The other medical professions did not get involved in STS directly, only indirectly, through the STS nurse, who coordinated all the activities and services around the patient. No study specifically recorded the (decrease or increase of) workload for other specialists in case a STS nurse was involved in the work. One study {6} describes how to manage human resources and the division of roles between nurses. During the 2007 calendar year, there were 1.356 patients visits to the HF clinic and telephone calls accounted for an additional 1.914 patient encounters in 2007. One full-time nurse practitioner, one clinical nurse specialist (working 0,7 of a full-time equivalent), and one registered nurse (vacation replacement) provided the nursing interventions with the telephone visits. Nurse spent 24 % of their working hours doing 1.914 telephone calls in one year.

ORG 2: What kind of patient/participant flow is associated with Telemonitoring in home care for patients with chronic cardiovascular diseases?

 

STS replaced historical program of doctor’s visits for HF patients after discharge. In interventions utilizing STS, the patient is monitored remotely while being at home (including a relative’s home, nursing home or residential care home). The patients are contacted in regular time intervals via telephone by either healthcare personnel (e.g. specialized HF nurses) or an automated telephone-based interactive response system. The STS support starts being planned while the patient is in hospital through education and meeting with the HF nurse. Education and practising with the technology follows and the materials are given to the patients as well as explained to the relatives. At the point of discharge the timing of the first call is agreed. The frequency of calls varies greatly among the studies but in common the calls are weekly at least first two weeks after discharge and then get biweekly until two months after discharge. After that they become monthly. It is not clear how long the intervention should last: there are different periods, going from 3 months up to 2 years after the discharge. It is not clear when the effect is biggest, possibly within first 3 months.

ORG3: What kind of involvement has to be mobilized for patients/participants and important others?

Please find the overlapping results also in TEC3: What kind of training and information should be provided for the patient who uses Telemonitoring in home care for patients with chronic cardiovascular diseases, or for his family?

ORG4: What is the process ensuring proper education and training of the staff?

Proper education and training of the staff is ensured through the courses for nurses on HF (formal HF certification) and on the remote monitoring, which is assured by telemedicine providers in case any devices for home symptoms measurements are included. As far as the STS itself, no specific training were found to be offered to staff in the literature.

ORG5: What kind of co-operation and communication of activities have to be mobilised?

In the heart of communication and cooperation strategy in the studies there is always a nurse. A consistent nurse case manager who cares for the patient and connects family, tries to understand goals and specific outcomes, provides information and monitors patient and communicates and cooperates with other members of health team to help them understand the patient {240}. A published communication strategy is important, including patient support strategy, communication between patient: nurse, patient: medical doctor, patient: pharmacist, the brochures, diaries to record daily control measurements, web pages with disease information and with instructions, instructions for family members  to share a best practise.

ORG6: How is the quality assurance and monitoring system of Telemonitoring in home care for patients with chronic cardiovascular diseases organised?

Please find the overlapping results in TEC2: What kind of qualification and quality assurance processes are needed for the use or maintenance of Telemonitoring in home care for patients with chronic cardiovascular diseases?

ORG7: What are the processes ensuring access to care of Telemonitoring in home care for patients with chronic cardiovascular diseases for patients/participants?

In general, RM including STS provides greater access to care in geographical terms. In most of the studies the problems with accessability to phone line were not reported. Careful planning of STS is necessary among specific population that might have issues in moving around and having lower access to phone lines. Also, the number of telephone contacts per week should not be too high, not even in the first week as this may affect adherence. The problems might arise on the side of physicians as patients might relocate to more developed health care centres with remote monitoring programs posing financial risk for smaller providers.

Speaking in terms of financial accessability, no specific problems were mentioned on the side of the patient. On the side of the provider, the current reimbursement structures basically do not support STS and hence act as a disincentive to providers wanting to offer RM incl. STS to patients sustaining HF. Innovative reimbursement schemes such as coverage with evidence in development are suggested in the literature.

ORG8: What are the likely budget impacts of implementing the technologies being compared?

While some studies reported  {2} no statistically significant difference in healthcare costs (either total costs or all-cause hospital costs), other studies reported important and significant reductions in costs. While the average costs of intervention across the studies amounted from $23,6 to $443, the reported savings amounted from $30,9 to $536 per patient per month. The savings across studies were reported in various ways which makes them hardly comparable (percentage reduction in inpatient costs, percentage reduction in overall costs, percentage reduction in total health expenditures, reduction in different currencies per patient, per nurse, per year, per month, per 6 months...). However, more important than this is the method of costs calculation that varies widely across the studies. More or less, only direct costs are included, mostly connected to reduction in hospitalizations. More than 70 % of the studies did not take into account expenses in one of the following categories:  healthcare sector, other sectors, patient/family expenses or productivity losses. None of the studies analyzed a shift of cost, from specialits to HF nurse to GP, for instance. In 80% of the studies the source and methods of the evaluations were not clear. Authors mostly focused on direct costs while omitting indirect and intangible costs {310}. Principally, the costs were missing across majority of the studies and those of the intervention overheads, training of personnel, and patient related costs.  There is a difficulty in capturing all of the effects of telehealth intervention. Thus the cost effectiveness evidence for specific implementations in the field of telehealth is limited. Problems with telehealth interventions reside in absence of quality data and appropriate measures. The quality of economic data is especially questionnable. The quality of evidence in the scientific literature is poor. More studies on all costs are needed to reach the unbiased conclusion. 

ORG9: What management problems and opportunities are attached to Telemonitoring in home care for patients with chronic cardiovascular diseases?

The use of RM has improved as a possible way to improve the management of patients with HF by allowing more frequent assessment of patients without the need for FTF clinical reviews {100}. When planning the introduction of a RM intervention in general, there are several questions that need to be addressed concerning: the choice of patients targeted by these programmes; the parameters that will be monitored; the more efficient way to monitor them; the training of patients and healthcare personnel; how to organize the response of the health care professionals to data obtained from monitoring to optimize patient care {1430}{1}. Possibly management will need to deal with (de)employment of new resources, new information systems, new equipment for STS provisions, new administrative leadership and new group culture that promotes quality improvement {15}{40}.

CUR3 / ORG10: Who decides which people are eligible for Telemonitoring in home care for patients with chronic cardiovascular diseases and on what basis?

Eligibility to new technology depends on an assessment of the general practitioner of a patient’s condition and the patient's willingness and ability to participate. Access to new technologies depends on support of healthcare providers. In real-world settings, patient selection will be critical for the acceptance and compliance with the programme. Patient selection criteria might include the degree to which the patient is willing to incorporate these technologies into their care or patients at high-risk {40}. Having  an access to a touchtone telephone is an essential inclusion criterion {1} . By Dunagan et al {10} cognitive or psychologic impairment as well as inability to hear and understand English spoken over the telephone were included as non-eligibility criteria.

ORG11: How is Telemonitoring in home care for patients with chronic cardiovascular diseases accepted?

Adherence to STS programs differs in HM to HH STS programs, it seems that interpersonal interaction with a care provider is an important active component of STS (adherence is higher in HH than HM STS) {40}. Adherence is reported from 55,1% to 84% across the studies, adaptation to the technology to 90% or higher, more than 90% of patietns are statisfied with the use of technolgy. Acceptance of automated voice interactive system was poor, mostly due to technical failures. Patients were generally very satisfied with various STS programs across studies.

 

The clinicians, on the other hand, have several reservations, such as potential increased clinical workload, medicolegal issues, and worries of difficulty of use for some patients due to lack of visual acuity or manual dexterity. The clinicians believed that the telephone interactions is as effective as face-to-face interactions. The clinicians fear that system would result in a significant increase in their workload {91}.

ORG12: How are the other interest groups taken into account in the planning / implementation of Telemonitoring in home care for patients with chronic cardiovascular diseases?

No other interest groups except those mentioned in other assessment elements, are taken into account in the planning / implementation of Telemonitoring in home care for patients with chronic cardiovascular diseases.

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Social aspects

Authors: Alessandra Lo Scalzo, Ingrid Wilbacher

Summary

The aspects related to patients’ quality of life and satisfaction with STS, patients’ views, perceptions and probable improvements in self care allowed by the use of this intervention, are an important part of the success of this technology.

In the studies where quality of life (QoL) is measured with standardised instruments, there is a significant improvement of QoL in the intervention group or no difference between the usual care and the intervention. Pandor’s systematic review shows that 4 studies which had quality of life as a secondary outcome and where about STS, reported improvements in QoL, with significant improvements in physical [Angermann, 2011] and overall [Barth, 2001, Wakefiled, 2008] measures, but one study found no significant differences between the groups [Riegel, 2006]. Oher (primary) studies we selected gave scattered results. Dunagan et al. 2005 found that nurse-administered, telephone-based disease management intervention had some impact on functional status and quality of life. Piotrowicz et al. 2015 found that the in the intervention group there was a similar improvement in total QoL index as in the control group. Patients who underwent home-based tele rehabilitation observed an improvement mainly in the mental categories. On the other hand Ramachandran et al, 2007 found and increase in quality of life, as a whole and in many dimensions the intervention group that persisted over time. For Jerant 2003 telenursing at least did not have any large negative impact on patient satisfaction or health status. In the study by Boyne et al. 2014 authors conclusions says that tailored telemonitoring was found to educate patients with HF and to improve their self-care abilities and sense of self-efficacy. Domingues and collegues state that in thier study (2011) the educational nursing intervention performed during the hospitalization period brought improved knowledge of HF and self-care in all patients regardless of telephone contac.

The organisational differences among the variuos STS interventions in the selected studies (programs offering exercise, education and behavioral interventions on patients’ psychological outcomes, or monitoring systems of vital signs led by nurses or physician etc.) can help to explain those differences in findings and results and make trasferability and comparability of them difficoult.

To have a deeper understanding about how patients experience the care when it is moved outside of the hospital to their homes with  the support of STS, we also selected qualitative studies which allow to highlight perceptions of patients about complex interventions. From this perspective selected qualitative studies show that there can be positive and negative aspects in using telemedicine and its application such as STS. Lynga et al. 2013 interviews to patients who used the intervention showed, that  the technology was easy to perform, made patients active in their own care, and increased their self-care activities. However, there were concerns of potential deterioration: transmission of body weight reminded patients of illness, deterioration in their health, increase of diuretic dose (inconvenience in the patient’s daily life) and some experienced also a perception of fear that affected their psychological well being.

As regard tro the barriers to the use of the technology, digital divide related to the age or socio-economical status which could avoid patients to use the facilities related to the intervention, we could not retrive definitive and conclusive studies. The qualitative literature that gave an answer to this reaserch question would show digital divide due to age as not being a relevant problem. Seto et al. shows that relatives of those not technology-accustomed would be able to provide support to patient [Seto 2012]. Bond, 2014 finds that most people found the telehealth system easy to use and in the study of Prescher, 2013 most of the patients reported an easy and robust handling of the devices. Nontheless more quantitative studies about the influence of age, gender etc. on the use of STS should be developed to better understand implications of thoses macrosocial variables on the use of STS.

Introduction

Structured telephone support for adult patients with chronic heart failure is an application of telemedicine whose results largely depend on the patients acceptance of this different way of caring for their disease. Its characteristics, such as the indirect or at distance contact that the health professional has with the patient, mediated by the telephone, which does not allow a personal face to face visit, can be seen at the same time as a positive or a negative factor, this depending on the patient’s preference. In turn this preference and acceptance can be related to macro social variables as gender, age, literacy, ethnicity etc. and on the patients’ own psychlogical structure and personal/social/familiy life.

HF Patients who are telemonitored via STS could positively modify their perceptions of quality of life (both social life and individual well being, by e.g. reducing anxiety and feeling more secure) and their self-care behaviors such as obtaining daily weights, doing physical activity, eating a low salt diet, and being in compliance with medication regimes.  Those two aspects can be seen as strictly related according to some authors. Indeed the decrease in QoL for HF patients has been associated mainly to the frequent hospital admissions and this imposes the most relevant personal, social and economic burden [Ferrante et al. 2010]. Since hospital admissions are mainly due to preventable causes (diet, treatment concompliance, inappropriate social support, delayed medical consultation for symptom sof HF progessions) any interventions like telephone support that aim to affect thoses prevenatable causes by enhancing self care behaviors can also enhance quality of life. Quality of life is determined by different components, at individual level and at social level. Anxiety, well being, feeling more secure and monitored, being able to have normal social reletionship at familial, work and firendships level, experiencing a better mental and physical health thanks to any interventions, are some of the aspects that will be analysed in this domain.

 

According to Paradis et al. 2010 the theory of HF Self-care grounded on the principles that patients are the main actors in health decision making and that they should have the tools to manage their health problems, is based on 3 concepts: the concept of self-care maintenance, which includes symptom monitoring and treatment adherence; the concept of self-care management, which includes symptom recognition and evaluation and treatment initiation and evaluation; and the concept of self-care confidence, which is the patients’ perceived capacity to perform self-care. According to the theory, maintenance of self-care will lead to management of self-care, and these two processes will be facilitated if the patient has confidence in performing self-care behaviors. Thus, improving HF patients’ conviction and confidence in their self-care capabilities by education, information and STS monitoring, could improve their health.

 

Including this isues of this domain in the HTA on STS is thus relevant as patient-reported outcomes are to be considered, being integral part of the succes of the technology. What is generally called patient satisfaction is in itself an indicator of quality of care and, e.g., in terms of cost-benefit a satisfied patient can have fewer complaints, fewer second opinions, and fewer repeated investigations, this affecting patients’ adherence to medical treatment regimens [Kraii et al. 2011]. Those aspects related to the patients quality of life with STS and its acceptance and views about it, and the comfort with a program of selfcare and information delivered (training program, check of vital signs etc.) are thus the focus of this chapter.

Methodology

Frame

The collection scope is used in this domain.

Technology	Structured telephone support (STS) for adult patients with chronic heart failure Description Telemonitoring via structured telephone support with focus on patient reported signs (symptoms of congestion, peripheral edema, pulmonary congestion, dyspnea on exertion, abdominal fullness), medication adherence, physiological data (like heart rate, blood pressure, body weight – measured by the patient with home-device), activity level; done in regular schedules using risk stratification (with fixed algorithm by call center staff or experience-based by specialized staff); done by dedicated call centers, center-based staff, nurses, AND reduced visits to a GP or heart center
Intended use of the technology	Prevention Remote transmission of information to alleviate symptoms, relieve suffering and allow timely treatment for chronic heart failure Target condition Chronic cardiac failure Target condition description Heart failure is a condition in which the heart has lost the ability to pump enough blood to the body's tissues. With too little blood being delivered, the organs and other tissues do not receive enough oxygen and nutrients to function properly. Target population Target population sex: Any. Target population age: adults and elderly. Target population group: Patients who have the target condition. Target population description Patients with chronic heart failure (CHF; defined as I50 http://www.icd10data.com/ICD10CM/Codes/I00-I99/I30-I52/I50-/I50 ) AND hospitalization due to heart failure at least once  AND without implanted devices
Comparison	Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) Description Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)
Outcomes	Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms

Assessment elements

	Topic	Issue	Relevant	Research questions or rationale for irrelevance
H0006	Individual	How do patients, citizens and the important others using the technology react and act upon the technology?	yes	How adult patients with CHF (and their important others) who uses Structured telephone support (STS) react and act upon this technology and how this affects their satisfaction, quality of life, empowerment?
H0004	Individual	What kind of changes may the use of the technology generate in the individual's role in the major life areas?	yes	What kind of changes may the use of Structured telephone support (STS) generate in the patients' social life (changes in work, travel ability, family life, patient/physician relationship)
H0012	Individual	Are there factors that could prevent a group or persons to participate?	yes	Are there socio cultural factors that could prevent a group CHF patients (defined by e.g. age, ethnicity, income, geographic area, working staus, geneder etc.) to use Structured telephone support (STS)?
H0003	Individual	What kind of support and resources are needed for the patient or citizen as the technology is introduced?	yes	What kind of support and resources (e.g. ergonomic changes) are needed for the patient as STS is introduced? This imlies a descriptive response.
H0100	Individual	What kind of changes do patients or citizens expect?	no	Selection of H0006 is enough as it includes this question
H0002	Individual	Who are the important others that may be affected, in addition to the individual using the technology?	no	This question just implies for investigators of SOC to list the probable important other that can be affected. This is something that is preliminary when answering to H0006.
H0007	Information exchange	What is the knowledge and understanding of the technology in patients and citizens?	yes	What is the knowledge and understanding of Structured telephone support (STS) in CCD patients?
H0013	Information exchange	What are the social obstacles or prospects in the communication about the technology?	no	Selection of AE H0007 is enough
H0001	Major life areas	Which social areas does the use of the technology influence?	no	This AE is important, but subsumable in H0004. So we exclude this as we alredy selected the H0004. Experinece with the production of other core hTA suggests that it is better to stay strict in the selection of AEs, since at the end of the work you usually find many INTRA domain overlaps.
H0011	Major life areas	What kinds of reactions and consequences can the introduction of the technology cause at the overall societal level?	no	I would stay more focused on the effects of the STS on the CHF patients and important others, and would not deal with overall society/citizens perspective. That is a perspective of people which is not involved in the actual use of this technology.
H0009	Major life areas	What influences patients’ or citizens’ decisions to use the technology?	no	By selecting AE H0001-H0006-H0012 and H0007 we alreday try to answer to this question (which is very generic) in a more detailed manner (individual/familial/social factors and factors releted to communication/information that can influence the use of STS).

Methodology description

A review of the literature about structured telephone support and the quality of life, self care, emopowerment, acceptance and impact of gender, age, etc. was performed. We aimed at identifying, first good quality secondary literature (HTA reports, quantitative or qualitative systematic reviews) that included the above outcomes and that could be updated. In the absence of existing reviews we identified primary studies, both qualitative and quantitative.

Information sources

Searches have been run on: Medline, Embase, Cochrane Library, PsycoINFO, CINAHL, CRD database. We searched articles in English published from 1995 to 2015 (see Appendix 1 for the Search Strategy). We retrieved 497 references, 17 were doubles We excluded 394 articles on the basis of the abstract and selected 78 studies for the full text reading. Records were read and excluded in double.

Inclusion criteria

We included studies about individuals aged 16 or more with chronic heart failure who have been admitted to hospital at least once for chronic heart failure (excluding recipients of implantable cardiac defibrillators, CRTs  or pacemakers), that focussed on structured telephone support and had as an outcome the following domain specific outcomes: patients preferences, views, satisfaction, acceptance, adaptation, adherence, compliance, quality of life, worries, anxiety, confidence,work/family/social life, effect of ethnicity/gender/social and economic status/working status/urban–rural areas on the use of the technology, patient-physician communication/information.

Study Designs

We aimed at including systematic reviews (quantitative) on quality of life with STS and qualitative systematic reviews on patients perceptions/views. We selected primary studies with a quantitative design to update and/or integrate the retrived systematic reviews and selected the relevant qualitative studies for the qualitative part. After the full text reading of the selected articles we excluded 33 studies for the following reasons 1) not our population (5) 2) not our intervention (17) 3) not our outcomes (6) 4) opinions/case/protocols (3)  5) Not in english/not available (2) (see Appendix 2 ). Studies eventually  included were 34 (see Appendix 3. In applying the above general inclusion criteria we needed to be more strict in case of some assessment elements which implied a quantitative response, and less strict (e.g. in the study design) for those assessment elements that allowed more descriptive answers (e.g. reasoning by analogy for tecnhnology and include not comparative study designs etc.). This has been explained in the methods section of each AE’s results card.  

 

Quality assessment tools or criteria

We used the quality checklists AMSTAR for systematic reviews, the CONSORT for RCTs, STROBE for observational studies and the Cochrane guidance for assessments for qualitative studies. See Appendix 4 for the included studies’ quality assessment.

Analysis and synthesis

For each AE’s Results card we gave a qualitative report of the main results of the included secondary and primarty studies that provided an answer to it. 

Result cards

Individual

Information exchange

Discussion

There was a high focus within the included studies on quality of life for the participants within STS projects.

Nontheless evidence is scattered about improvements in QoL and Self-care abilities and sense of self-efficacy in the intervention group: some studies show a significant improvement, others found no difference. Differences in interventions characteristics and organisational factors ca explain this.  For the impact of age, economic status, ethnicity  and other macrosocial variables on patients perceptions of STS we could not find definitive conclusions. Qualitative literature suggests that digital divide due to age is not a relevant problem, above all in near future as new generations, who are accustumed to new technologies, get older and enter the HF more at risk age. In depth understanding of pateints perceptins of this interventions highlights some positive and negative aspects of the intervention: perceptions of being safer and well cared, easy intergartion of selfcare activities and telemonitoring in everyday life, increased empowerment but also, for some patients, increase awarness about their daily health (e.g. weighting everyday) made increase concerns of potential deterioration in HF.

References

1. Achelrod D. Policy expectations and reality of telemedicine - a critical analysis of health care outcomes, costs and acceptance for congestive heart failure. J Telemed Telecare. 2014;20(4):192-200.
2. Bohme S, Geiser C, Muhlenhoff T, Holtmann J, Renneberg B. Telephone counseling for patients with chronic heart failure: results of an evaluation study. Int J Behav Med. 2012;19(3):288-97.
3. Bond CS, Worswick L. Self Management and Telehealth: Lessons Learnt from the Evaluation of a Dorset Telehealth Program. Patient. 2014.
4. Brandon AF, Schuessler JB, Ellison KJ, Lazenby RB. The effects of an advanced practice nurse led telephone intervention on outcomes  of patients with heart failure. Appl Nurs Res. 2009;22(4):e1-7.
5. Ciere Y, Cartwright M, Newman SP. A Systematic Review Of The Mediating Role Of Knowledge, Self-Efficacy And Self-Care Behaviour In Telehealth Patients With Heart Failure. J Telemed Telecare. 2012;18(7):384-91.
6. Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007;334(7600):942.
7. Clark RA, Inglis SC, McAlister FA, Cleland JGF, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. 2007;334(7600):942.
8. Clark RA, Yallop JJ, Piterman L, Croucher J, Tonkin A, Stewart S, et al. Adherence, adaptation and acceptance of elderly chronic heart failure patients to receiving healthcare via telephone-monitoring. Eur J Heart Fail. 2007;9(11):1104-1
9. Clarke M, Shah A, Sharma U. Systematic review of studies on telemonitoring of patients with congestive heart  failure: a meta-analysis. J Telemed Telecare. 2011;17(1):7-14.
10. Cui Y, Doupe M, Katz A, Nyhof P, Forget EL. Economic evaluation of Manitoba Health Lines in the management of congestive heart failure. Healthc Policy. 2013;9(2):36-50.
11. Domingues FB, Clausell N, Aliti GB, Dominguez DR, Rabelo ER. Education and telephone monitoring by nurses of patients with heart failure: randomized clinical trial. Arq Bras Cardiol. 2011;96(3):233-9.
12. Dunagan WC, Littenberg B, Ewald GA, Jones CA, Emery VB, Waterman BM, et al. Randomized trial of a nurse-administered, telephone-based disease management program for patients with heart failure. J Card Fail. 2005;11(5):358-6
13. Ferrante D, Varini S, Macchia A, Soifer S, Badra R, Nul D, et al. Long-term results after a telephone intervention in chronic heart failure: DIAL (Randomized Trial of Phone Intervention in Chronic Heart Failure) follow-up. J Am Coll Cardiol. 2010;56(5):372-8.
14. Garc¡a-Lizana F, Sarr¡a-Santamera A. New technologies for chronic disease management and control: A systematic review. 2007; 13(2):62-8.
15. Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, et al. STRUCTURED TELEPHONE SUPPORT OR TELEMONITORING PROGRAMMES FOR PATIENTS WITH CHRONIC HEART FAILURE. Cochrane Database Syst Rev. 2010(8):CD007228.
16. Inglis sc, clark ra, mcalister fa, stewart s, cleland jg. which components of heart failure programmes are effective? a systematic review and meta-analysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: abridged cochrane review. eur j heart fail. 2011;13(9):1028-40.
17. Jerant a.f., azari r., martinez c., nesbitt t.s. a randomized trial of telenursing to reduce hospitalization for heart failure: patient-centered outcomes and nursing indicators. home health care serv q 2003; 22
18. Kraai ih, luttik ml, de jong rm, jaarsma t, hillege hl. heart failure patients monitored with telemedicine: patient satisfaction, a review of the literature. j card fail. 2011;17(8):684-90.
19. Lind l, karlsson d. telehealth for "the digital illiterate"--elderly heart failure patients experiences. stud health technol inform. 2014;205:353-7.
20. Lynga p, fridlund b, langius-eklof a, bohm k. perceptions of transmission of body weight and telemonitoring in patients with heart failure? Int J Qual Stud Health Well-being. 2013;8:21524.
21. Martinez A, Everss E, Rojo-Alvarez JL, Figal DP, Garcia-Alberola A. A SYSTEMATIC REVIEW OF THE LITERATURE on home monitoring for patients with heart  failure. J Telemed Telecare. 2006;12(5):234-41.
22. Nanevicz T, Piette J, Zipkin D, Serlin M, Ennis S, De Marco T, et al. The feasibility of a telecommunications service in support of outpatient congestive heart failure care in a diverse patient population. Congest Heart Fail. 2000;6(3):140-5.
23. Pandor A, Gomersall T, Stevens JW, Wang J, Al-Mohammad A, Bakhai A, et al. remote monitoring after recent hospital discharge in patients with heart failure: a systematic review and network meta-analysis. heart. 2013;99(23):1717-26.
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25. Piotrowicz E, Stepnowska M, Leszczynska-Iwanicka K et al2015. Quality of life in heart failure patients undergoing home-based telerehabilitation versus outpatient rehabilitation - a randomized controlled study
26. Prescher S, Deckwart O, Winkler S, Koehler K, Honold M, Koehler F. Telemedical care: feasibility and perception of the patients and physicians: a survey-based acceptance analysis of the Telemedical Interventional Monitoring in  Heart Failure (TIM-HF) trial. Eur J Prev Cardiol. 2013;20(2 Suppl):18-24.
27. Ramachandran K, Husain N, Maikhuri R et al. 2007. Impact of a comprehensive telephone-based disease management programme on quality-of-life in patients with heart failure.
28. Riegel B, Carlson B, Glaser D, Romero T. Randomized controlled trial of telephone case management in Hispanics of Mexican  origin with heart failure. J Card Fail. 2006;12(3):211-9.
29. Riley JP, Gabe JP, Cowie MR. Does telemonitoring in heart failure empower patients for self-care? A qualitative study. J Clin Nurs. 2013;22(17-18):2444-55.
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31. Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Perceptions and experiences of heart failure patients and clinicians on the use of mobile phone-based telemonitoring. 2012;14(1):180-9.
32. Seto E, Leonard KJ, Masino C, Cafazzo JA, Barnsley J, Ross HJ. Attitudes of heart failure patients and health care providers towards mobile phone-based remote monitoring. 2010;12(4):56-65.
33. Wakefield B.J., Holman J.E., Ray A. et al. 2009Outcomes of a home telehealth intervention for patients with heart failure.
34. Wakefield BJ, Ward MM, Holman JE, Ray A, Scherubel M, Burns TL, et al. Evaluation of home telehealth following hospitalization for heart failure: a randomized trial. Telemed J E Health. 2008;14(8):753-61.

Appendices

APPENDIX 1 – Search strategy for the Social Domain

Searches has to be run on: Medline, Embase, Cochrane Library, PsycINFO, CINAHL, CRD database.  English only. Time: 1995-2015

Keywords for Population and Disease

P: Adults with chronic heart failure (with previous hospital stay due to chronic  heart failure)

I/C: telemonitoring via structured telephone support  (non invasive telemonitoring via structured telephone support human to human or human to machine) VS standard of care

Keywords for outcomes/AEs:

• Patients preferences/views/satisfaction/acceptance/ Acceptability/ Adaptation/Adherence/compliance/quality of life/Health Related Quality of Life/worries/anxiety/confidence/
• Travel abilities/work/family life/social life/leisure time/lifestyle/daily activities/ patient’s everyday life/changes in daily routines
• Access, accessibility ethnicity/gender/social and economic status/working status/urban–rural areas
• Patients information/communications/patient-physician communication/information

Design: SR, HTA, RCTs, Qualitative studies (interviews, focus groups), observational studies, Patient Related Outcomes studies

3th june 2015 (date for latest updating)

 

Cochrane

Heart Failure, MESH descriptor  explode all trees. Entry terms: Cardiac Failure Heart Decompensation Decompensation, Heart Heart Failure, Right-Sided Heart Failure, Right Sided Right-Sided Heart Failure Right Sided Heart Failure Myocardial Failure Congestive Heart Failure Heart Failure, Congestive Heart Failure, Left-Sided Heart Failure, Left Sided Left-Sided Heart Failure Left Sided Heart Failure OR Heart AND (Failure OR Attack) OR CHF OR HF OR congestive heart failure

AND

“Remote Sensing Technology”, MESH descriptor Explode all tree: Entry terms: Remote Sensing Technologies Technologies, Remote Sensing Technology, Remote Sensing OR “telemedicine” MESH descriptor Explode all tree. Entru terms: Telehealth eHealth Mobile Health Health, Mobile OR MeSH descriptor “home care services” this term only OR MeSH descriptor” Home Care Services, Hospital-Based” this term only OR “remote monitoring” OR Telemonitoring OR “Home monitoring” OR teleconsultation OR tele-monitoring OR “distance monitoring” OR “telemedicine system” OR “home care” OR Tele*: (title/astract/keyword) AND (monitoring OR contact OR support OR homecare) (title/astract/keyword Telephone-monitoring: title/astract/keyword OR Telephone-support: (title/astract/keyword OR Telephone-contact* (title/astract/keyword OR “Post-discharge monitoring” : (title/astract/keyword OR “tele-watch”  :title/astract/keyword OR “tele home care”title/astract/keyword OR “tele homecare” : title/astract/keyword OR smartphone: title/astract/keyword OR smartphone-based: title/astract/keyword OR telecardiology: title/astract/keyword OR telecoaching: title/astract/keyword

AND

MESH descriptor: “quality of life” OR MESH descriptor:  “activities of daily living” OR MESH descripto: “leisure activities” OR MESH descriptor: “Return to work” OR MESH descriptor: “Physician-Patient Relations” OR MESH descriptor: “Patient Satisfaction” OR  "length of stay"   Ricerca in [Title/Abstract/keyword] per   “quality of life” OR QoL  OR HRQOL  “patient* preferences OR  satisfaction OR worries OR anxiety OR comfort   (Patients AND (“travel abilities” Or freedom OR “family life” OR “social life” OR “leisure time” OR lifestyle OR “daily activities”)) OR   (Patients AND  (preferences OR views OR satisfaction OR worries OR acceptance OR acceptability)  OR adaptation OR adherence OR confidence OR compliance  OR “social and economic status” OR “working status” OR un-employement OR “employement status” OR “working status” OR   “patient’s everyday life” OR “changes in daily routines” OR Access OR  accessibility OR ethnicity OR gender OR  OR “urban areas” OR “rural areas” OR information OR communications OR information OR comfort OR  Social Support

NOT

ehealth OR  web-based OR  "web based" OR  internet OR web OR  computer OR internet-based

 

 

 

 

 

 

 

 

MEDLINE

 

Heart Failure, MESH descriptor, explode all trees. Entry terms: Cardiac FailureHeart Decompensation Decompensation, HeartHeart Failure, Right-Sided Heart Failure, Right Sided Right-Sided Heart Failure Right Sided Heart Failure Myocardial Failure Congestive Heart Failure Heart Failure, Congestive Heart Failure, Left-Sided Heart Failure, Left Sided Left-Sided Heart Failure Left Sided Heart Failure OR heart adj6 failure OR cardiac adj6 failure OR Heart AND (failure OR attack) OR CHF OR HF OR “Cardiac Failure” OR “Heart Decompensation” OR “Decompensation, Heart” OR “Myocardial Failure” OR “Congestive Heart Failure” OR “Heart Failure, Congestive”

AND

“Remote Sensing Technology” MESH descriptor Explode all tree: Entry terms: Remote Sensing Technologies Technologies, Remote Sensing Technology, Remote Sensing OR “telemedicine” MESH descriptor  Explode all tree. Entru terms: Telehealth eHealth Mobile Health Health, Mobile OR MeSH descriptor “home care services” this term only OR MeSH descriptor” Home Care Services, Hospital-Based” this term only OR “remote monitoring” OR Telemonitoring OR “Home monitoring” OR teleconsultation OR tele-monitoring OR “distance monitoring” OR “telemedicine system” OR “home care” OR teleconsultation OR tele-consultation OR "cell phone"[MeSH Terms] OR "telephone"[MeSH Terms] OR Tele*: title/astract AND (monitoring OR contact OR support OR homecare) Telephone-monitoring: title/abstract OR Telephone-support: title/astract OR Telephone-contact* : title/astract OR “Post-discharge monitoring” : title/astract OR smartphone OR smartphone-based: “tele-watch”  : title/astract OR “tele home care” : title/astract OR “tele homecare” : title/astract OR Telecardiology: title/astract OR Telecoaching: title/abstract OR

AND

MESH descriptor: “quality of life” OR MESH descriptor:  “activities of daily living” OR MESH descripto: “leisure activities” OR MESH descriptor: “Return to work” OR MESH descriptor: “Physician-Patient Relations” OR MESH descriptor: “Patient Satisfaction” OR "length of stay"   Ricerca in [Title/Abstrac] per   “quality of life” OR QoL  OR HRQOL  “patient* preferences OR comfort   (Patients AND (“travel abilities” Or freedom OR “family life” OR “social life” OR “leisure time” OR lifestyle OR “daily activities”)) OR   (Patients AND  (preferences OR views OR satisfaction OR worries OR acceptance OR acceptability)  OR adaptation OR adherence OR confidence OR compliance  OR “social and economic status” OR “working status” OR un-employement OR “employement status” OR “working status” OR   “patient’s everyday life” OR “changes in daily routines” OR Access OR  accessibility OR ethnicity OR gender OR  OR “urban areas” OR “rural areas” OR information OR communications OR information OR  Social Support

NOT

ehealth OR  web-based OR  "web based" OR  internet OR web OR computer OR internet-based

EMBASE

“Congestive heart failure”/exp   OR  “heart failure” /exp   OR ’congestive cardiomyopathy’/exp   OR CHF   OR HF   OR  “cardiac failure”/exp   OR “cardiac insufficiency”/exp

AND

'telemonitoring'/exp OR Teleconsultation/exp OR Telemedicine/exp OR telecommunications/exp Or  telecare$.tw OR  telecardiol$.tw. OR  telemonitor$.tw. OR teleconsult$.tw OR telecare$.tw OR homecare$.tw OR home care$.tw OR "cell phone" OR telephone  OR Telephone-monitoring OR telephone-support OR  telephone-contact OR “Post-discharge monitoring” OR smartphone OR  smartphone-based OR  “tele-watch” OR  “tele home care” OR  “tele homecare”  OR  Telecardiology OR  Telecoaching  OR tele*     .

AND

EMTREE TERM: 'quality of life'/exp OR EMTREE TERM: work capacity/exp OR EMTREE TERM: 'life satisfaction'/exp OR EMTREE TERM: 'patient satisfaction'/exp OR EMTREE TERM: 'patient information'/exp OR EMTREE TERM: 'social aspects and related phenomena'/exp OR "length of stay"   “quality of life” OR QoL OR “Travel abilities”  OR recreation or work or “family life” OR “social life” OR “leisure time” OR lifestyle” OR “daily activities” OR “patient* preferences OR satisfaction OR worries OR anxiety OR “working staus” OR un-employment” OR employment  OR –“SF-36 mental score”  OR “SF-36 physical score” OR (Patients and (“travel abilities” Or freedom OR word OR “family life” OR “social life” OR “leisure time” OR lifestyle OR “daily activities”)) OR (Patients AND  (preferences OR views OR satisfaction OR worries OR anxiety OR religion OR ethnic  OR gender OR “social and economic status” OR “working status” OR un-employement OR “employement status” OR “working status” OR ((urban or rural) and patients) OR i((nformation OR communication OR information) AND  (patients OR physician) OR Self-Care OR comfort OR  Social Support

NOT

ehealth OR  web-based OR  "web based" OR  internet OR web OR computer OR internet-based

Cinhal

(MH“Congestive heart failure”)   OR (MH “heart failure” )   OR “congestive cardiomyopathy”    OR  cardiomyopathy   OR CHF   OR HF   OR  cardiac and (failure or insufficiency)

AND

"cell phone" OR telephone  OR Telephone-monitoring OR telephone-support OR  telephone-contact OR “Post-discharge monitoring” OR smartphone OR  smartphone-based OR  “tele-watch” OR  “tele home care” OR  “tele homecare”  OR  Telecardiology OR  Telecoaching  OR tele*

AND

(MH "Quality of Working Life") OR (MH "Employment Status") OR (MH "Job Satisfaction") OR (MH "Job Re-Entry") OR (MH "Self Employment") OR (MH  "Work Experiences") OR (MH " OR "quality of life" OR QoL  OR HRQOL ) OR preferences OR views OR satisfaction OR worries OR anxiety OR religion OR ethnic  OR “social and economic status” OR “working status” OR un-employement OR “employement status” OR   Patients  AND (urban or rural) OR information OR communication OR "leisure activities" OR "work retun"  OR 'social aspects” OR “social activities” OR “rural areas” OR "length of stay"

 

Psychinfo

Congestive heart failure OR   heart failure OR congestive cardiomyopathy OR CHF OR HF OR  cardiac and (failure or insufficiency)

 AND

"cell phone" OR telephone  OR Telephone-monitoring OR telephone-support OR  telephone-contact OR “Post-discharge monitoring” OR smartphone OR

 smartphone-based OR  “tele-watch” OR  “tele home care” OR  “tele homecare”  OR  Telecardiology OR  Telecoaching  OR tele*

AND

 quality of life OR preferences OR job satisfaction life OR satisfaction working OR social OR employement OR worries OR anxiety OR communicationOR information OR social status OR working status OR urban areas OR rural areas OR social aspects or leisure activities

APPENDIX 2 List of excluded studies with reasons

Excluded not our population

Barlow J, Singh D, Bayer S, Curry R. A Systematic Review Of The Benefits Of Home Telecare For Frail Elderly People And Those With Long-Term Conditions. 2007;13(4):172-9.

Barnason S, Zimmerman L, Nieveen J, Schmaderer M, Carranza B, Reilly S. Impact of a home communication intervention for coronary artery bypass graft patients with ischemic heart failure on self-efficacy, coronary disease risk factor modification, and functioning. Heart Lung. 2003;32(3):147-58.

Bekelman DB, Hooker S, Nowels CT et al. Feasibility and acceptability of a collaborative care intervention to improve symptoms and quality of life in chronic heart failure: mixed methods pilot trial. J Palliat Med 2014; 17(2):145-5

O'Neil, Hawkes A.L. Atherton J.J. et al. Telephone-delivered health coaching improves anxiety outcomes after myocardial infarction: The 'ProActive Heart' trial. Eur J Prev Cardiol. 2014;21(1):30-8.

Keeling A.W., Dennison P.D. Nurse-initiated telephone follow-up after acute myocardial infarction: A pilot study. HEART LUNG J. CRIT. CARE 1995; 24(1):45-9.

Excluded not our intervention

Blum K, Gottlieb SS. The effect of a randomized trial of home telemonitoring on medical costs, 30-day  readmissions, mortality, and health-related quality of life in a cohort of community-dwelling heart failure patients. J Card Fail 2014; 20(7):513-21

Boyne JJ, Vrijhoef HJ, Spreeuwenberg M, De Weerd G, Kragten J, Gorgels AP. Effects of tailored telemonitoring on heart failure patients' knowledge, self-care, self-efficacy and adherence: a randomized controlled trial. Eur J Cardiovasc Nurs. 2014;13(3):243-52

Cardozo L, Steinberg J. Telemedicine for recently discharged older patients. Telemed J E Health. 2010;16(1):49-55.

Clark AP, McDougall G, Riegel B, Joiner-Rogers G, Innerarity S, Meraviglia M, et al. Health Status and Self-care Outcomes After an Education-Support Intervention for People With Chronic Heart Failure. J Cardiovasc Nurs. 2014.

Dansky KH, Vasey J, Bowles K. Use of telehealth by older adults to manage heart failure. Res Gerontol Nurs 2008; 1(1):25-32.

Dinesen B, Nohr C, Andersen SK, Sejersen H, Toft E. Under surveillance, yet looked after: telehomecare as viewed by patients and their spouse/partners. Eur J Cardiovasc Nurs. 2008;7(3):239-46.

Domingo M, Lupon J, Gonzalez B, Crespo E, Lopez R, Ramos A, et al. Evaluation of a telemedicine system for heart failure patients: feasibility, acceptance rate, satisfaction and changes in patient behavior: results from the CARME (CAtalan Remote Management Evaluation) study. Eur J Cardiovasc Nurs. 2012;11(4):410-8.

Fairbrother P, Ure J, Hanley J, McCloughan L, Denvir M, Sheikh A, et al. Telemonitoring for chronic heart failure: the views of patients and healthcare professionals - a qualitative study. J Clin Nurs. 2014;23(1-2):132-44.

Konstam V, Gregory D, Chen J et al. Health-related quality of life in a multicenter randomized controlled comparison  of telephonic disease management and automated home monitoring in patients recently hospitalized with heart failure: SPAN-CHF II trial. J Card Fail 2011; 17(2):151-7.

Louis AA, Turner T, Gretton M, Baksh A, Cleland JG. A Systematic Review Of Telemonitoring For The Management Of Heart Failure. Eur J Heart Fail. 2003;5(5):583-90.

Mayour R, Welstand J, Tyndel S, J Setting up and auditing guideline- and evidence-based cardiac rehabilitation. Eur J Cardiovasc Nurs. 2005;4(1):23-8.

Obeh B, Kayyali R, Nabhani-Gebara S, Philip N, Robinson P, Wallace CR. Evaluation of a Telehealth Service for COPD and HF patients: Clinical outcome and patients' perceptions. J Telemed Telecare. 2015.

Paradis V, Cossette S, Frasure-Smith N, Heppell S, Guertin MC. The efficacy of a motivational nursing intervention based on the stages of change on self-care in heart failure patients. J Cardiovasc Nurs. 2010;25(2):130-41.

Schwarz KA, Mion LC, Hudock D, Litman G. Telemonitoring of heart failure patients and their caregivers: a pilot randomized controlled trial. Prog Cardiovasc Nurs. 2008;23(1):18-26.

Shaw JD, O'Neal DJr, Siddharthan K, Neugaard BI. Pilot program to improve self-management of  patients with heart failure by redesigning care coordination. Nurs Res Pract. 2014;2014:836921.

Takeda A, Taylor Stephanie JC, Taylor Rod S, Khan F, Krum H, Underwood M, et al. Clinical Service Organisation For Heart Failure: Structured Telephone Support Or Telemonitoring Programmes For Patients With Chronic Heart Failure. Cochrane Database of Systematic Reviews: Cochrane Database of Systematic Reviews.

Young B, Purden M, Sauve N, Dufour L, Common C. A "basket of care" for heart failure patients managing at home: evaluating a community-based nursing intervention from a patient's perspective. Can J Cardiovasc Nurs. 2008;18(4):10-9.

Roth A, Korb H, Gadot R, Kalter E. Telecardiology for patients with acute or chronic cardiac complaints: the 'SHL' experience in Israel and Germany. Int J Med Inform. 2006;75(9):643-5.

Hobban MB, Fedor M, Reeder S, Chernick M. The effect of telemonitoring at home on quality of life and self-care behaviors of patients with heart failure. Home Healthc Nurse. 2013;31(7):368-77.

Mittag O., China C., Hoberg E. et al. 2006Outcomes of cardiac rehabilitation with versus without a follow-up intervention rendered by telephone (Luebeck follow-up trial): Overall and gender-specific effects.

Nanevicz

Hawkes, T.A. P, J. A, R.S. W, C.B. T, A. ON, et al. Effect of a telephone-delivered coronary heart disease secondary prevention program (proactive heart) on quality of life and health behaviours: primary outcomes of a randomised controlled trial. Int J Behav Med. 2013;20(3):413-24.

Quinn C. 2006Low-technology heart failure care in home health: improving patient outcomes.

Radhakrishnan K, Jacelon C2012Impact of telehealth on patient self-management of heart failure: a review of literature.

Saunders MM. Perspectives from family caregivers receiving home nursing support: findings from a qualitative study of home care patients with heart failure. Home Healthc Nurse. 2012;30(2):82-90.

Wang XH, Qiu JB, Ju Y et al, 2014. Reduction of heart failure rehospitalization using a weight management education  intervention.

Whitten P., Mickus M. 2007. Home telecare for COPD/CHF patients: outcomes and perceptions.

Excluded not our outcomes

Galbreath A.D., Krasuski R.A., Smith B. et al. Long-term healthcare and cost outcomes of disease management in a large, randomized, community-based population with heart failure. Circulation 2004; 110(23):3518-26.

Guiraud T, Granger R, Gremeaux V et al. Telephone support oriented by accelerometric measurements enhances adherence to physical activity recommendations in noncompliant patients after a cardiac rehabilitation program. Arch Phys Med Rehabil 2012; 93(12):2141-7.

Maric B, Kaan A, Ignaszewski A, Lear SA. A SYSTEMATIC REVIEW OF TELEMONITORING TECHNOLOGIES IN HEART FAILURE. Eur J Heart Fail. 2009;11(5):506-17.

Paget T, Jones C, Davies M, Evered C, Lewis C. Using home telehealth to empower patients to monitor and manage long term conditions. Nurs Times. 2010;106(45):17-9.

Rahimpour M, Lovell NH, Celler BG, McCormick J. Patients' perceptions of a home telecare system. Int J Med Inform. 2008;77(7):486-98.

Riegel B, Carlson B, Glaser D, Romero T. Randomized controlled trial of telephone case management in Hispanics of Mexican  origin with heart failure. J Card Fail. 2006;12(3):211-9.

Shearer NB, Cisar N, Greenberg EA. 2007. A telephone-delivered empowerment intervention with patients diagnosed with heart failure.

Sohn S, Helms TM, Pelleter JT, Muller A, Krottinger AI, Schoffski O. 2012. Costs and benefits of personalized healthcare for patients with chronic heart failure in the care and education program "Telemedicine for the Heart".

Venter A, Burns R, Hefford M, Ehrenberg N2012Results of a telehealth-enabled chronic care management service to support people with long-term conditions at home.

Letter to editors/protocols/abstract/editorial

Grancelli HO, Ferrante DC. Telephone interventions for disease management in heart failure. BMJ. 2007;334(7600):910-1.

Piette JD, Rosland A-M, Marinec NS, Bernstein SJ, Silveira MJ. Engagement with automated patient monitoring and self-management support calls: Experience with a thousand chronically ill patients. 2013;51(3):216-23.

Saxon LA, Boehmer JP, Neuman S, Mullin CM. Remote Active Monitoring in Patients with Heart Failure (RAPID-RF): design and rationale. J Card Fail. 2007;13(4):241-6.

Excluded not English text

Brotons C, Falces C, Alegre J et al. Randomized clinical trial of the effectiveness of a home-based intervention in patients with heart failure: the IC-DOM study. Rev Esp Cardiol 2009; 62(4):400-8.

Not available

Riegel B, Carlson B, Kopp Z, LePetri B, Glaser D, Unger A. Effect of a standardized nurse case-management telephone intervention on resource use in patients with chronic heart failure. Arch Intern Med. 2002;162(6):705-12.

APPENDIX 3 List of included studies

1. Achelrod D. Policy expectations and reality of telemedicine - a critical analysis of health care outcomes, costs and acceptance for congestive heart failure. J Telemed Telecare. 2014;20(4):192-200.
2. Bohme S, Geiser C, Muhlenhoff T, Holtmann J, Renneberg B. Telephone counseling for patients with chronic heart failure: results of an evaluation study. Int J Behav Med. 2012;19(3):288-97.
3. Bond CS, Worswick L. Self Management and Telehealth: Lessons Learnt from the Evaluation of a Dorset Telehealth Program. Patient. 2014.
4. Brandon AF, Schuessler JB, Ellison KJ, Lazenby RB. The effects of an advanced practice nurse led telephone intervention on outcomes  of patients with heart failure. Appl Nurs Res. 2009;22(4):e1-7.
5. Ciere Y, Cartwright M, Newman SP. A Systematic Review Of The Mediating Role Of Knowledge, Self-Efficacy And Self-Care Behaviour In Telehealth Patients With Heart Failure. J Telemed Telecare. 2012;18(7):384-91.
6. Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007;334(7600):942.
7. Clark RA, Inglis SC, McAlister FA, Cleland JGF, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. 2007;334(7600):942.
8. Clark RA, Yallop JJ, Piterman L, Croucher J, Tonkin A, Stewart S, et al. Adherence, adaptation and acceptance of elderly chronic heart failure patients to receiving healthcare via telephone-monitoring. Eur J Heart Fail. 2007;9(11):1104-1
9. Clarke M, Shah A, Sharma U. Systematic review of studies on telemonitoring of patients with congestive heart  failure: a meta-analysis. J Telemed Telecare. 2011;17(1):7-14.
10. Cui Y, Doupe M, Katz A, Nyhof P, Forget EL. Economic evaluation of Manitoba Health Lines in the management of congestive heart failure. Healthc Policy. 2013;9(2):36-50.
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APPENDIX 4 – Quality Assessment of included studies

For the quality assessment of the included studies we used

• The AMSTAR guideline for systematic reviews {1}
• The CONSORT 2010 checklist for RCTs {2}
• The STROBE checklist for observational studies {3}
• The Cochrane guideline for critical appraisal of qualitative studies {4}

The different checklists were merged by using the percentage rates of „yes“, „no“ or „n.a.“ of the checklists divided per number of items.

Results

Green – low bias risk, yellow – unclear bias risk, red – high bias risk

Basic list to the graph about the Quality assessment of included studies for SOC domain STS for patient with CHF 2015

	checklist used	yes	no	n.a.	total	yes %	n.a. %	no %
Achelrod 2014	AMSTAR	5	4	1	10	50,0	10,0	40,0
Martinez 2006	AMSTAR	10	1	0	11	90,9	0,0	9,1
Ciere 2012	AMSTAR	7	2	2	11	63,6	18,2	18,2
Garcia 2007	AMSTAR	4	7	0	11	36,4	0,0	63,6
Inglis 2011	AMSTAR	10	0	1	11	90,9	9,1	0,0
Kraii 2011	AMSTAR	6	5	0	11	54,5	0,0	45,5
Pandor 2013 (24)	AMSTAR	10	1	0	11	90,9	0,0	9,1
Pandor 2013 (23)	AMSTAR