Disclaimer
This information collection is a core HTA, i.e. an extensive analysis of one or more health technologies using all nine domains of the HTA Core Model. The core HTA is intended to be used as an information base for local (e.g. national or regional) HTAs.

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

Structured telephone support (STS) for adult patients with chronic heart failure compared to Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) in the prevention of Chronic cardiac failure in adults and elderly with chronic heart failure (CHF) AND hospitalization due to heart failure at least once AND without implanted devices

(See detailed scope below)

HTA Core Model Application for Medical and Surgical Interventions (2.0)
Core HTA
Published
Tom Jefferson (Agenas - Italy), Marina Cerbo (Agenas - Italy), Nicola Vicari (Agenas - Italy)
Neill Booth (THL - Finland), Plamen Dimitrov (NCPHA - Bulgaria), Mirjana Huic (AAZ - Croatia), Valentina Rupel (IER - Slovenia), Alessandra Lo Scalzo (Agenas - Italy), Ingrid Wilbacher (HVB - Austria)
Agenas - Agenzia nazionale per i servizi sanitari regionali
AAZ (Croatia), Agenas (Italy), ASSR RER (Italy), Avalia-t (Spain), CEM (Luxembourg), GÖG (Austria), HVB (Austria), IER (Slovenia), ISC III (Spain), NCPHA (Bulgaria), NIPH (Slovenia), NSPH (Greece), NSPH MD (Romania), SBU (Sweden), SNHTA (Switzerland), THL (Finland), UTA (Estonia).
9.9.2014 11.18.00
4.12.2015 17.51.00
Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 3 October 2022]. Available from: http://corehta.info/ViewCover.aspx?id=305

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

<< Costs and economic evaluationOrganisational aspects >>

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.

TechnologyStructured 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 technologyPrevention

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

ComparisonUsual 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

TopicIssue RelevantResearch questions or rationale for irrelevance
F0010Beneficence/nonmaleficenceWhat are the known and estimated benefits and harms for patients when implementing or not implementing the technology?yesWhat are the known and estimated benefits and harms for patients when implementing or not implementing STS?
F0011Beneficence/nonmaleficenceWhat are the benefits and harms of the technology for other stakeholders (relatives, other patients, organisations, commercial entities, society, etc.)?yesWhat are the benefits and harms of STS for other stakeholders (relatives, other patients, organisations, commercial entities, society, etc.)?
F0100Beneficence/nonmaleficenceWhat is the severity level of the condition that the technology is directed to?noThis 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.
F0003Beneficence/nonmaleficenceAre 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.)?noThe answer to this question overlaps with regard to the answers to the previous two questions
F0005AutonomyIs the technology used for patients/people that are especially vulnerable?yesIs STS used for patients/people that are especially vulnerable?
F0004AutonomyDoes the implementation or use of the technology affect the patient´s capability and possibility to exercise autonomy?yesDoes the implementation or use of STS affect the patient´s capability and possibility to exercise autonomy?
F0006AutonomyIs there a need for any specific interventions or supportive actions concerning information in order to respect patient autonomy when the technology is used?yesIs there a need for any specific STSs or supportive actions concerning information in order to respect patient autonomy when STS is used?
F0007AutonomyDoes the implementation or withdrawal of the technology challenge or change professional values, ethics or traditional roles?yesDoes the implementation or withdrawal of STS challenge or change professional values, ethics or traditional roles?
F0009Respect for personsDoes the implementation or use of the technology affect the user´s moral, religious or cultural integrity?yesDoes the implementation or use of STS affect the user´s moral, religious or cultural integrity?
F0101Respect for personsDoes the technology invade the sphere of privacy of the patient/user?yesDoes STS invade the sphere of privacy of the patient/user?
F0008Respect for personsDoes the implementation or use of the technology affect human dignity?noHuman dignity is legal category and not ethical. It is defined as "fundamental and inalienable human right" and therefore subject to the law, not ethics
F0012Justice and EquityHow does implementation or withdrawal of the technology affect the distribution of health care resources?yesHow does implementation or withdrawal of STS affect the distribution of health care resources?
F0013Justice and EquityHow are technologies with similar ethical issues treated in the health care system?yesHow are technologies with similar ethical issues treated in the health care system?
H0012Justice and EquityAre there factors that could prevent a group or persons to participate?yesAre 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)?
F0014LegislationDoes the implementation or use of the technology affect the realisation of basic human rights?yesDoes the implementation or use of STS affect the realisation of basic human rights?
F0016LegislationCan the use of the technology pose ethical challenges that have not been considered in the existing legislations and regulations?no
F0017Ethical consequences of the HTAWhat are the ethical consequences of the choice of end-points, cut-off values and comparators/controls in the assessment?yesWhat are the ethical consequences of the choice of end-points, cut-off values and comparators/controls in the assessment?
F0102Ethical consequences of the HTADoes the economic evaluation of the technology contain any ethical problems?yesDoes the economic evaluation of STS contain any ethical problems?
F0103Ethical consequences of the HTAWhat are the ethical consequences of the assessment of the technology?yesWhat 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

Result card for ETH1: "What are the known and estimated benefits and harms for patients when implementing or not implementing STS?"

View full card
ETH1: What are the known and estimated benefits and harms for patients when implementing or not implementing STS?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ETH2: "What are the benefits and harms of STS for other stakeholders (relatives, other patients, organisations, commercial entities, society, etc.)?"

View full card
ETH2: What are the benefits and harms of STS for other stakeholders (relatives, other patients, organisations, commercial entities, society, etc.)?
Result
Comment

Importance: Unspecified

Transferability: Unspecified

Autonomy

Result card for ETH3: "Is STS used for patients/people that are especially vulnerable?"

View full card
ETH3: Is STS used for patients/people that are especially vulnerable?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ETH4: "Does the implementation or use of STS affect the patient&#180;s capability and possibility to exercise autonomy?"

View full card
ETH4: Does the implementation or use of STS affect the patient&#180;s capability and possibility to exercise autonomy?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ETH5: "Is there a need for any specific STSs or supportive actions concerning information in order to respect patient autonomy when STS is used?"

View full card
ETH5: Is there a need for any specific STSs or supportive actions concerning information in order to respect patient autonomy when STS is used?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ETH6: "Does the implementation or withdrawal of STS challenge or change professional values, ethics or traditional roles?"

View full card
ETH6: Does the implementation or withdrawal of STS challenge or change professional values, ethics or traditional roles?
Result

Importance: Unspecified

Transferability: Unspecified

Respect for persons

Result card for ETH7: "Does the implementation or use of STS affect the user&#180;s moral, religious or cultural integrity?"

View full card
ETH7: Does the implementation or use of STS affect the user&#180;s moral, religious or cultural integrity?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ETH8: "Does STS invade the sphere of privacy of the patient/user?"

View full card
ETH8: Does STS invade the sphere of privacy of the patient/user?
Result

Importance: Unspecified

Transferability: Unspecified

Justice and Equity

Result card for ETH9: "How does implementation or withdrawal of STS affect the distribution of health care resources?"

View full card
ETH9: How does implementation or withdrawal of STS affect the distribution of health care resources?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ETH10: "How are technologies with similar ethical issues treated in the health care system?"

View full card
ETH10: How are technologies with similar ethical issues treated in the health care system?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ETH11 / SOC3: "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)?"

View full card
ETH11 / SOC3: 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)?
Method
Short Result
Result

Importance: Important

Transferability: Partially

Legislation

Result card for ETH12: "Does the implementation or use of STS affect the realisation of basic human rights?"

View full card
ETH12: Does the implementation or use of STS affect the realisation of basic human rights?
Result

Importance: Unspecified

Transferability: Unspecified

Ethical consequences of the HTA

Result card for ETH13: "What are the ethical consequences of the choice of end-points, cut-off values and comparators/controls in the assessment?"

View full card
ETH13: What are the ethical consequences of the choice of end-points, cut-off values and comparators/controls in the assessment?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ETH14: "Does the economic evaluation of STS contain any ethical problems?"

View full card
ETH14: Does the economic evaluation of STS contain any ethical problems?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ETH15: "What are the ethical consequences of the assessment of STS?"

View full card
ETH15: What are the ethical consequences of the assessment of STS?
Result

Importance: Unspecified

Transferability: Unspecified

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 .

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