Please find the overlapping results in CUR_ 15 What is the marketing authorisation status of Telemonitoring in home care for patients with chronic cardiovascular diseases?

Additionally to the basic literature search a qualitative handsearch (google; keywords: telemonitoring, telemedicine, qualification) was done adding two studies, the results are provided in descriptive way.

Literature included for this AE: Whellan 2005 {66}, Jaarsma 2013 {37}, Radhakrishnan 2012 {52}, MAST report {47}, Wakefield 2013 {65}, Clark 2011 {72}, Grustam 2014 {28}, Chaudhry 2007 {6}, Cleland 2010 {12}, BUDYCH {70}.

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

The studies providing information about the staff qualification mainly contains information on:

-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 {70} 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 medical experience, knwoledge of basic health legislation, knowledge 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. The quality assurance seems to be lacking.

Structural quality:

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

-Process quality:Marketing authorisation and licensing is partly provided (and discussed in CUR and LEG domains) and differs among health systems and continents. A regulative norm should be able to distinguish between technical and staff-related quality aspects. {15}

Technological usability, responsible innovation, health literacy, behaviour change, caregiver perspectives and motivational issues of professionals influence the efficient use of telemedicine. {47}

The professional knowledge about how and when to react on monitored data is a crucial aspect within telemonitoring (and monitoring at all).

The healthcare professional should not over-react to the risk identification, as this could lead to increased clinical activity and hospitalization without improving outcome.  High quality professional education should lead to a  sufficient rather than just a more frequent decision-making. {15}

Some expect that over the next decades the number of patients with heart failure increases, and the number of cardiologists decreases.{57},{24}Study results are discussed with a focus on a possible bias if only cardiologists or primary health care physiscians supervised the call-center and disease management interventions. In the review of Whellan {66} it is stated, that the outcomes of the postdischarge interventions depend on the type of provider, providing supervision: number of hospitalisationsin case of  cardiologist supervision decrease, which is not true for those supervised by primary health care physicians. The author himself is a cardiologist. The Heart Failure Association of European Society of Cardiology also addressed the need for appropriate education and training of healthcare professionals recently. {72}{66}Telemonitoring produces a lot of data, if a large number of patients transmit quantities of data daily. Resources to deal with the high amount of data adequately and process them automatically have to be provided.The final goal of remote monitoring is likely to be further empowerment of the patient. Primary care physicians are described as being responsible, cardiologist as to supervise the drug prescription and titration, in some cases nurses adjust diuretics, angiotensin-converting enzyme inhibitors, or beta blockers under the supervision of a cardiologist. Patient education to patients (and families) is provided by nurses or in some cases pharmacists. {72}.

In the WHARF trial, cardiac nurses reviewed data whereas the patients' physicians took the  responsibility for acting on the regularly updated information. {6}

Specific training for nurses is mostly described{37} in general terms such as for example:

• "a specific HF programme based on AHCPR guidelines","trained nurses",

• "advanced practice nurse",

• "one day training course".

• "Nurses underwent brief training programme regarding problems and treatment options associated with this particular group of patients".

The way how to train practitioners (nurses) is described varying {37} between

• „interactive“,

• “ role playing and audio taping“,

• “ increase the skills in communicating“ and

• „motivating the patients to treatment instructions adherence“,

• „2-months orientation and training programme“,

• „developing competences related to detection of deterioration in HF in elderly patients“,

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  „optimal therapeutic management“,

• „educational and behavioural strategies in the home“,

• „address patients and caregivers unique learning skills“.

 For other healthcare providers, specific training is even less well described {37} such as:

• " a highly scripted training process"

• " combined experience and completed a one-year clinical residency in home care". {37}

Provided  services (by nurses) include:

• reviewing transmitted clinical data {52}

• assessing individuals, coaching, and installing telehealth. { 52}

• supervising automatic patient data transmission by means of telemonitoring devices {8}

• providing telephone support and education. {28}

• playing a coordinating or leading role {37}

• telephone based monitoring and education {6}

• using a software program to determine call frequency {6}

• using a standardized algorithm to adjust diuretic doses or recommend urgent medical visits {6}

• making the phone calls could adjust the medication over the phone or organized clinic appointments {15}

• visiting and monitored patients' clinical status and educating them about heart failure and pharmacologic management {6}

• initiating and regulating medications for heart failure {6}

The telemedicine providers were  described {37} as:

• homecare nurses, {37}

• hospital nurses, {37}

• HF nurses, {37}

• cardiac rehabilitation nurses, {37}

• research nurses, {37}

• practice nurses{37}

• district nurses {37}

• registered nurses {65}

• advanced practice nurses who were considered specialists for HF patients {65}

• cardiologist {37}

• primary care physicians {37}

• other specialists such as geriatricians or internists {37}

• teams with different profiles like „collaboration between the primary care physician and cardiologist, trained doctor's assistant and a primary care physician or physician, physiotherapist, ECG technician and a psychologist“ {37}

• additional involvement of other professionals (psychologist, dietician, physical therapist, social worker, pharmacist) {37}

• nurses trained in management of heart failure {6}

The description of the specialization or clinical background are lacking within the studies. {37},  {15}

Physicians were rarely directly involved in intervention delivery. Furthermore, information about patient progress during the study was sent to physicians in fewer than half of the studies.“ {65} {15}„In TIM-HF trial monitoring was done by call centres that were otherwise not directly involved with the patients' care.“ {12}

Qualification requirements found in the handsearch:

The basic literature search and one additional reference were used. Forteen studies ({3}, {37}, {15}, {16},{22}, {32}, {31},{11},{17},{27}, {58}, {59}, {43},{47})  provided answer to this question, whereas 12 of them are systematic reviews, one an RCT {43}, and one an HTA {47}.

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

General heart failure education

-detection of deterioration

-use of medication

-diet

-physcial activity/ exercise training

-Smoking cessation

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

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 provided:

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

-through leaflets and online manuals, depending on the service

• home visits
• videophone
• telephone calls or letters to the patient at home
• 1-hours, in-person patient education program with usual discharge care
• by technology through predischarge viewing of an educational CD-RIM
• video to be viewed at home
• predischarge nurse-led intensive education about HF symptoms and treatment followed by 1 telephone to reinformce education

Patient education

Fiveof the included reviews adressed

• education on HF in general {37} {16} {31} {11}

-detection of deterioration {37}

• advice and instruction on use of medication {37} {16} {31}
• diet {37} {16} {31}
•  physcial activity/ exercise training {37} {31}
• symptom monitoring and self-management advice {16} {31} {11}
• training in the use of equipment {11} {15}

One systematic review also adressed

-Smoking cessation coping with difficult emotions {37}

- communication with family and healthcare providers, using relaxation and cognitive symptom management techniques {37}

-alcohol intake {37}

-sexual activity {37}

-necessity of vaccinations {37}

-capabilities of patients to travel {37}

-individual problems related to comorbid conditions{37}

Implementation of education:

• home visits {16}
• videophone {16}
• home physiological monitoring {16}
• telephone calls or letters to the patient at home{16}
• 1-hours, in-person patient education program with usual discharge care {3}
• HF education delivered by technology through predischarge viewing of an educational CD-ROM {58}
• a 60-minute video that was intended to be viewed at home {59}
• predischarge nurse-led intensive education about HF symptoms and treatment followed by 1 telephone call 3 to 5 days after discharge to reinforce education {43}
• in groups of 10-15 people, where patients can assist and help each other{47}
• through leaflets and online manuals {47}

Statements about patient education among the included studies:

• Education and training is seen as the basic for effective monitoring and decision making. {47}
• the greatest benefit in terms of education and medication patterns is accrued within a few weeks and that long-term monitoring is redundant {32} {31}
•  Eliminating the travel time for nurses by using tele-education could help reduce workload {11}
• knowledge allows the patients to take greater responsibility for their own care and management {11}
•  increased patient empowerment can help reduce reliance on the nurse {11}
• The caregiver and relatives can also be important, as they can assist the patient with monitoring and help if needed {47}

Evaluation of patient education:

„Moreover, although the provision of education during remote follow-up would theoretically lead to improved self-care in patients with heart failure, a recent review that focused specifically on this issue noted that results from trials are equivocal.“ {17}

„As early as 2002, Krumholz et al identified education as a key point in global management of HF; leading a 37% reduction (P=0,004) if readmission to the hospital for HF or for cardiovascular disease.“ {27}

Nine studies out of the general literature search and one additional reference provided answer for this question ({54}, {47},{20},{26},{27},{29},{31},{9},{32},{7})

The informed consent of a patient using telemonitoring can be shown in the level of participation and compliance. The effectiveness of telemonitoring is directly related to attitudinal and behavioural aspects like

-Compliance with symptom entry

-Compliance with data transmission

-Awareness for an earlier detection of decompensation

-Positive attitude to empowerment

-Satisfaction with self-competence

To reach a higher level of compliance the MAST study reports

-A regularly feedback about the monitoring results

-Daily videoconferencing for follow-up was accepted and clinically useful

-tele-consultations, as they resulted in 76% of the patients feeling safer or more secure

-both verbal and nonverbal communication

-There is a need to rethink how communication and feedback is given to the patients

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{15}

The reported effects and impacts of telemonitoring can be divided into five categories: {54}

• data quality

• patient clinical condition

• patient attitude and behavior

• clinical effectiveness

• economic viability

The most commonly assessed telemonitoring effects are at the attitudinal and/or behavioral level (like medication compliance, compliance with symptoms entry and data transmission, awareness, empowerment, satisfaction). {54}

Attitudinal and behavioral changes can be achieved with  

• feedback to patients with telemedicine services {47}

• a regular follow-up about every 3-4 month {47},videoconferencing for follow-up {47}

• tele-consultations (resulting in 76% of the patients feeling safer or more secure after discharge) that offer both verbal and nonverbal communication {47}

• the way of information and feedback communication taking into account the needed levels in different generations of care levels {47}

Patient empowerment due to self-mangement can

• decrease in heart failure hospitalization risk and a reduction in mortality {33}, {15}{32}

• lead to a better drug therapy and compliance {15}

• lead to an earlier detection of decompensation, so that interventions can be made that reduce the need for subsequent hospitalization {15}

• Reported benefits for the patients‘ psychological well-being, and safety {20}

• patients require fewer overall visits to the follow-up clinic {20}

• RM detects clinical abnormalities that would be either completely missed by less frequent in-office visits, or detected significantly without continuous remote monitoring data assessment.  {20}

Recommendations and statements among the included studies

• The Heart Failure Society of America and The European Society of Cardiology heart Failure Association recommend enrollments in disease management programs (DMP) for patients with HF who have been recently hospitalized or for high-risk HF patients. {26}Dedicated telemonitoring for heart failure may be a practical adjunct in selective centres and patients on top of usual care, but it should never replace it as a standard of care because sicentific evidence remains conflicting, insufficient and heterogeneous. {27}{27}

• Telemonitoring is not suitable for all individuals nor is it appropriate under all medical circumstances. Knowing the aim of the intervention for a specific patient is a key success factor. {29}

  The knowledge about HF can be increased by TM, but the evidence is conflicting (2 hospitals measured increased knowledge for patients, one showed no difference to the control group in the proportion of correct answers to questions about medication in three groups (i.e. telephone, videophone, control) at 90- and 180 days) {7}

We used the description out of  studies (47},{27},{22}, {15}), 21 from the general literature search, 3 from handsearch and one additional reference. The studies used are provided in the table below.

Definitions

Telemonitoring using structured telephone support is intended to remove time and distance barriers  for the delivery of healthcare services. (The American Nurses Association)

Technology

Using structured telephone support means that the patient stays at home and is instructed to measure and observe the symptoms related to the heart disease. Several measuring devices can be in use, like a scale, a blood pressure device, a 2 channel ECG, a pedometer, etc.) {47}.

The transfer of the measured data is done by telephone, meaning a contact between health care providers and patient, where the observation of symptoms is asked by the healthcare providers and reported by the patient. Within this telephone call the healthcare provider documents the physiological data reported and can ask additional questions, give advice, treatment instructions, medication support and provide education or information accordingly. {27}

The structured telephone support is scheduled regularly and follows a pre-defined system of what is asked and what kind of advice is given. Beside the structure of the monitoring for patients with chronic heart failure the telephone support allows additional individual questions from patients and health care providers. {27} {22} {15}

The data are documented by the health care providers using a kind of database, an interactive option to view the data by both, patients and personnel can be added, requiring an internet connection and a computer on both sides. {47} The internet connection has to be secured within the frame of health care data protection.

Structured telephone support is a modality to replace direct physical patient-physician contact by contact via telephone for monitoring, education, or self-management or various combination using simple telephone technology after discharge in a structured format {22}.

Comparator

Usual care as the comparator requires a careful awareness for temporal changes of standard of care that might have affected the results. The management of care for HF patients changed within the last 15 years and usual care now includes multidiciplinary care, education of the patient and guideline conform medication. {27}

Most trials do not describe specific details of UC but provide explanations like »standard discharge instructions« or »follow up with outpatient provider as usual«. The follow-up setting (primary care or follow-up in a specialty clinic) or the timing of outpatient follow-up in the usual care group are rarely defined. {22}.

Depending on the area, organization and setting „Usual care“ differs between the studies. Usual care also can include  regular specialist CHF department visits and extensive information on the disease and training to the patient. {11}.

The contents of standard and usual care vary among studies, and could include regular visits to outpatient clinics,  training, education or information on disease-specific self-care behaviour, hospital follow-up by nurse and cardiologist and care within primary care providers, with or without home visits to assess vital signs and medication adherence. {7}

Limitations

The limitations of telephone support models are that the telephone calls are primarily initiated by the professional at the preset times (usually protocol driven) and they are thus unable to detect more rapid changes in the condition. {15}.

Descriptions and definitions

The following table lists the descriptions and explanations found in the studies included.

Excursus on mHealth

Structured telephone support includes

• Human to human service - landline phone line/ telephone call by nurse (other healthcare provider) - mobile phone/ telephone call by nurse (other healthcare provider)

• Human to machine service - smart phone/ table/ App for bluetooth transfer (i.e. from scale)

„m-health“

• focuses on the human to machine part

For this excursus we did an additional google search (unscientific information collection) with keyword „mhealth“ and a short Pubmed search (broad search for scientific overview) with keyword „mhealth, mobile health AND chronic heart disease“ (– no results found despite some related to „telemedicine“ which is already covered by the general literature search).

Definition of mobile health

Mobile health (short “mhealth”) means the use of mobile devices like mobile phones, smartphones, tablet computers or PDAs (personal digital assitant) {73}  {74}  for health services or information {3}, whereas “health” could be meant as lifestyle, prevention, diagnostic assessment, monitoring, support, collecting data for health research, delivery of healthcare information, direct provision of care, reminder of medication time, behaviour, etc. {75} {76} Mobile health also includes the application software (Apps) and the transmitters (like sensors in bracelets or watches). {76}

Mobile technologies enable physicians and other healthcare providers to reach their patients more timely or even in regional distance. The way of communication includes SMS, e-mail, visualizing static text, visual image information and tagging voices. With the use of GPS a geographical mapping component can be added which is now already used for emergency services. The support function can include a decision algorithm out of the collected data. Data collection requires a device for collecting the data (mobile phone, etc.) and a software to house the information. {73}

Current status

There is a rapidly rising market for apps, mainly available for smartphones, and the market of apps is dominated by individuals (30%) or very small companies with 2-9 employees (34%).{77}

Recent estimations count about 97.000 available mhealth apps on the global market, 70% of them target the wellness and fitness segments, 30% target health professionals, access to patient data, patient consultation and monitoring, diagnostic imaging and pharmaceutical information. {84} {78}

Increasing data collection and -use needs a storage capacity to handle the huge amount of data, secure cloud solutions are already worked on within the European Commission cloud computing strategy. {79} {80}

Within Europe a third of people do have internet access through mobile phones, with significant differences between member states (Sweden 63%, Bulgaria 13%, Portugal 16%). {81}

mHealth depends on high capacity and flexible networks. The Commission recently adopted a legislative package (Connected Continent: Building a Telecoms Single Market) {82}, which recognises the need of high-speed and high-quality networks for eHealth at a greater degree of harmonisation. Under Horizon 2020 EU funding will be provided for mHealth with intended support, digital health literacy, and equal access to healthcare. {83} 

Conclusion

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.

The basic literature search was used. Additionally the resulst of Assessment Element TEC5 (B0001) were used to categorize into the settings.

The following studies provided information about the context: {54},{27},{47},{66},{53},{37},{18},{21},{72},{9},{7},{15}

Conclusion: telemedicine/ telemonitoring interventions can be used in all different settings, they are mainly provided in outpatient organisations, the most important part is the additional setting at the patients‘ home.

 A change into multidisciplinary management of HF patients was observed over the last 15 years. {27} Education is seen as one of the key points leading a 37% reduction (P=0.004) of readmission to the hospital for HF or for cardiovascular disease. {42} Telemonitoring aims to shift the focus on control of the disease towards the patient who is supported by the care team. A good relationship between care providers and patients is important. {27} Tele-healthcare can also be seen as an intensification of more conventional methods of delivering care towards optimal comprehensive care as recommeded by guidelines. {27}

The primary function of telemedicine is to provide specialist consultation to distant communities, rather than to provide support for self-management of chronic disease. However, home telecare is a rapidly evolving domain and increasingly focused on supporting the patient rather than the health professionals. Home telemonitoring is used for different modalities and encompasses the use of audio, video, and other telecommunication technologies to monitor patient status at a distance. {49},{,35},{44}, {18} It can be seen as an automated process for the transmission of data on a patient’s health status from home to the respective health care setting. {54} {72}. Hence, telemonitoring does not involve the electronic transmission of data by a health care professional at the patient’s location. {54} {15}.

The tele monitoring interventions are heterogeneous in terms of monitored parameters and HF (heart failure) selection criteria and lack detail in the components of the care packages and usual care {53}

Also the telemedicine equipment varies in the different projects, as do the roles, numbers and education of healthcare professionals, which also makes it difficult to generalise the results from one project to another. The legal framework diverge from country/region to country/region {47} and has to be carefully studied and compared to those of the countries/regions where the studies took place.

 There seems to be potential for self care at home to reduce mortality and morbidity and to improve symptoms in patients suffering from HF, whereas lack of knowledge about disease-specific self-care behaviours is associated with non-adherence to recommended self-care practices. {37}In Europe HF clinics are common and often situated at the hospital or at primary health care centre. Very few of the HF management programmes offer home care and there is a lack of  collaboration across the primary-secondary care interface and a lack of continuity of care. {37}

„Monitoring is not a treatment but rather a different way of systematically organizing effective care.“ {9}.

This continuity of care is seen to be achieved by nurses acting as case manager for the patients at home and in liason among members of the health care team. {21}.

Settings  {21}{72}{9}{7}{15}

Five studies  provided an overview of reference measurements in a more detailed way than „guideline conformity“: {27},{20},{26},{15},{29}

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

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 known 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.

The accuracy for detection of alerts depends on the predefined algorithm within the telemonitoring tool or process. {20}. Several indicators to identify patients at risk of worsening heart failure are available and combined differently, like weight, blood pressure, quality of life, patient activity, increase in pacing tresholds, increase in the percentage of right ventricular pacing, decrease in the left ventricular pacing, artrial and ventricluar tachyarrythmia, thoracic impedance, heart rate variability, respiratory rate.  Commercially available methods include assessment of weight as well as intrathoracic impedance. {1}. Speed of weight gain is more sensitive and specific for heart failure decompensation than absolute weight change, with an increase of more than 2 kg over a period of 72 hours being considered clinically significant. Despite the widespread use of weight monitoring, its accuracy is limited. A weight gain of greater than 2 kg over 48-72 h has good specificity but poor sensitivity for predicting clinical deterioration. In case of weight change all the other symptoms and physiological measurements have to be taken into account to reflect the overall heart failure status. Arrhythmia is common in patients with heart failure, but adding a single-lead ECG monitoring to external monitoring equipment increases the complexity of monitoring without evidence of additional benefit.“ {15}.

Currently available diagnostics provide valuable data in patient evaluation and enable physicians to identify those patients at greater risk of heart failure decompensation, but they have not yet been shown to impact patient outcomes and are often not sufficiently accurate for therapy adjustment. Effective adjustment of medical therapy relies on an accurate assessment of several parameters and involves in person care, telehomecare, and the emerging intervention of telemedicine or remote monitoring. Telemonitoring of basic physiological parameters did not reach the expectations now. {27}

There is a need for individual baselines and for using trend and multiple signals. Most current TM systems use simple thresholds as the basis for triggering an alert that are barely adequate as the basis for reliable triggering. {29}.

• We used information provided by the studies {25},{29},{17},{5},{26},{20} of the basic literature search.
• We used the table of different telemonitoring appraoches and linked suggested needs for material investments in a qualitative way due to our best knoewledge.

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}

Telemonitoring involves transmission of physiological data…from a measuring device (self measuring or data input manually) to a central server. The transmission works via telephone, satellite, or broadband capabilities, and the interpretation is done by the health care team. More complex information technology infrastructure is required to facilitate telemonitoring as opposed to a simple telephone call, which might limit the extent to which telemonitoring can be made available for heart failure patients to access. Several studies show that even a required IT infrastructure is not limiting the use and implementation of telemonitoring. {17}.

In most of the studies a domestic telephone line or cell phones were used for data transmission {44}, {41}{25}

A trial from Argentina indicate both the relevance and the capacity to implement telemonitoring interventions in middle-income countries. India and China both expect to find technological solutions to healthcare delivery problems, and telemonitoring is an attractive option. {5}{26}{20}

There was no answer in the literature about special premises needed. The thoughts of {29} and from the assessment element  TEC8 are taken.

As the remote TM is used in homes and is coordinated in usual facilities by nurse or other coordinator, TM fits in with the usual working environment and no information on special premises were found in the literature.

Double with TEC 8, please see there.

With the knowledge we got out of the literature we created a list of aspects, which could help to specify the best implementation strategy for each setting if they were included in the study data. The studies screened for this review provide wide knowledge about structured telephone support and telemonitoring aspects, but there is a lack of comparable structure to filter out what kind of supprot is needed for whom, how long and what can be expected.

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

The implementation and sustainability of telemonitoring approaches is influenced on how much and what is used on devices and human resources. {25}

For the monitoring of the intervention data should be provided about

Used technical equipment

-What kind of equipment is used

-How frequently is it used

-Are there different provider for the equipment (i.e. the patient provides the telephone connection at home and pays the fee; the cardiological unit provides the database and the data storage; the health system provides the server; etc.)

Involved staff

-What kind of professionals are involved

-How many hours are they involved (by profession and patient)

-What kind of (additional) qualification do they have

-Is the involved staff from different organisations/ settings (and if yes, which ones)

Patients characteristics

-Clinical selection parameters (depending on the heart failure diagnosis)

-Statistical selection parameters (age, gender, region, etc.)

-Social selection criteria (ability to communicate, compliance, ability to use the devices/ telephone, financial aspects, availability of relatives)

Other

-Number of emergency situations

-Number of emergency- failures

-Causes of

A google-handsearch was done to detect already existing national and EU registers. Keywords used were „heart failure registry“, „heart registry“, heart failure audit“ and the several EU/ EUnetHTA country-names.

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.

Several existing heart registries were found among Europe.

There are already existing European registries which can be participated in.