Structured telephone support (STS) for adult patients with chronic heart failure<< Costs and economic evaluationOrganisational aspects >>
Authors: Plamen Dimitrov, Gottfried Endel, Anelia Koteva
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).
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;
The collection scope is used in this domain.
|Technology||Structured telephone support (STS) for adult patients with chronic heart failure
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 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)
Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)
Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms
||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?|
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).
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 card for ETH1: "What are the known and estimated benefits and harms for patients when implementing or not implementing STS?"
ETH1: What are the known and estimated benefits and harms for patients when implementing or not implementing STS?
New Ethical Challenges Posed by the Intersection of Medicine, Telecommunications and Home
Although met with initial enthusiasm for their potential to bring a number of improvements and positive changes in the way healthcare is provided, teletechnology-related opportunities should not be overemphasized, especially in the context of scarce empirical material. 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 high ambivalence, interrelation and two-way impact hamper them from being placed in a dichotomous category as either benefits or harms, but for the purposes of the present paper such a categorization will be made.
In the literature the benefits associated with the provision of medical/health services at a distance through the use of ICT are widely recognized , where the benefits can be viewed from several points: 1.) for patients; 2.) for health personnel and healthcare providers; 3.) for the families and relatives of patients and 4.) for society as a whole.
As far as the focus is on the positive and negative impact for patients solely, here an attempt will be made to present both sides.
Anticipated Benefits and Positive Effects for Patients-Recipients of Telecare:
In general, the expected effects are oriented in the direction of improving patients’ health status and quality of life through:
- Overcoming/Minimizing temporal and geographical boundaries – teletechnologies allow transfer of synchronized real-time information, thus making it possible to deliver the right care at the right time and in the right place for an individual patient (especially useful in emergency situations);
- Applicability in remote, hardly accessible and isolated regions; reducing transportation costs to the hospital and avoiding difficult and inconvenient travelling for patients in serious condition or those living in very remote areas. On the other hand, the decrease in travelling costs and time may reciprocally increase their time spent on pleasant daily activities, hobbies, household chores, etc.;
- Ensuring equal access to medical care for patients living in isolated areas;
- Reducing the risk of complications; decreasing rehospitalization and repeated invasive procedures or at least achieving prolonged remission periods;
- Increasing patients’ confidence/tranquility in obtaining an adequate advice and/or qualified care; the remote monitoring system may serve as a reminder of getting certain prescribed medications by controlling their intake and the one of regular meals (for lonely patients or those exhibiting cognitive problems);
- Avoiding the “white coat syndrome”;
- Potential improvement in verbal sharing on the part of anxious or easily disturbed patients, who generally tend to avoid face-to-face communication;
- Highly promising sector for improved patient access to services and information as well as expanding the scope of services provided;
- Facilitating the management, storage and transmission of health information;
- Opportunities for patients to be treated in the comfort of their own home combined with lower costs as a result of the replacement of institutional care with homecare;
- Opportunities for patients, their families and friends to access unlimited online health information and resources about certain diseases, potential therapies and specific healthcare providers (partially applicable in the case of mobile phones/smartphones). In the majority of cases, patients may get access to the same medical information that healthcare providers normally are entitled to. Although too much medical information that may be hard to understand by a layman could be as dangerous as a total lack of information, it may also be true that most verified and accurately presented information could often produce better informed patients and families, providing more power in their hands as to the selection of specific healthcare professionals and the decision-making process – this is the result of the ongoing changes in recent years, thanks to the mass media and education, demystification of medical practices and adoption of liberal democracy values and market culture, the corollary of which is the growing desire of patients for more control over their own health together with the recognition of their active role. Due to the process of “importing” medical culture from clinical into home environment, with an increasing number of medical procedures being carried out in the homes of patients and their families, thus leading to a close acquaintance and better understanding of medical technology and procedures, it may be quite unlikely to expect that patients would remain just passive recipients of care;
- The culture of modernity as well as the growing share of noncommunicable diseases (NCDs) have led to transition from paternalism towards greater equality and autonomy of patients, indicative of which are the desire to control one’s own health and daily schedule, combined with a growing trend of empowerment and “self-care”, assuming more personal health responsibilities for the patient and diminishing the role of the physician by placing doctor’s functions as secondary, supporting;
- Shifting health services from previously primarily clinical to domestic environment may minimize the intrusion of outsiders into the house. Therefore, remote consultations are of key significance to the maintenance of the physical privacy and integrity over the non-public and intimate sphere that home implies, thus reducing undesired penetration of healthcare professionals within its boundaries;
- Avoiding the depressing clinical atmosphere that normally makes patients feel helpless in managing their condition;
- Communication with the patient through a variety of means: 1.) telephone: highly effective communication tool allowing flexibility and enabling both sides to keep one another mutually cognizant of therapeutic advances and complications. To a certain extent telephone may replace unnecessary, unwanted and expensive clinical visits. The phone could also be an excellent instrument in maintaining empathy by conveying the emotional nuances in the tone of voice and an adequate tool for articulating time-sensitive information crucial to the health of home patients; 2.) online groups for mutual support and medical websites: their value is in providing the chronically ill and their family caregivers with places for virtual meetings for sharing personal experiences, information and mutual support. By providing psychosocial support online groups have the potential to reduce social isolation, improve adherence to the therapy as well as reduce costs as a result of the increased welfare of persons (applicable in the case of smartphones);
- Computerized patient records: its advantages are related to the opportunity for home patients to view, modify, correct their file and have a personal copy of it (applicable to the use of smartphones);
- Structured telephone support contributes in preventing the trend of leaving elderly parents in nursing homes through the reduction of fear and anxiety of family caregivers and allowing the elderly to remain in the comfort of their own home, thereby reducing the costs associated with institutional care.
Expected Negative Implications, Inconveniencies and Harms to Patients-Recipients of Telecare:
- Telemedicine poses the risk of dehumanizing medical profession through the modification of the physician-patient relationship and by weakening the preliminarily built mutual trust and empathy, shifting all these at the background while undermining the importance of the patient individual approach at the same time. The fear is that the machines will create a cold and impersonal abyss between the clinician and the patient, with the doctor simply being seen as a mechanic repairing the human body insofar as he/she treats the disease itself but not the person. Here the conflict between medicine as science and medicine as an art is clearly manifested. A view of the human should be adopted that is not fragmented but calls for more holism and comprehensiveness. In the context of electronic environment, personal interaction between both parties in the relationship is minimized, with the interaction being reduced to an abstract and digitized patient data set. Main drawbacks are the undervalued affective aspects of the bilateral relationship where, instead, the role of scientific facts is favorized and doctors are perceived as only technicians responsible for the diagnosis and therapeutic options; although the verbal element in the communication regarding the choice and implementation of a structured telephone support is not completely lost, a serious disadvantage may pertain to healthcare taken not by the clinician-therapist, to whom the patient is accustomed and has built a relationship of trust but by a completely unknown healthcare staff – most frequently an unfamiliar nurse charged with the duty to conduct the telephone interviews;
- The association between the quality of clinical communication and positive health outcomes should not be underestimated. The more cumbersome and insufficient communication is (which is more or less true for the structured form that healthcare is provided in), the less likely patients are to be improved;
- The prevalence of information over humans and their relations may prove problematic in ethical terms, particularly in the context of telemedicine, where empathy is less valued compared to timely and accurate health service;
- Disadvantages of some of the communication tools: 1.) telephone: highly vulnerable as far as unauthorized third parties may intercept unprotected information that is being transmitted through the mobile network as well as anyone having access to the healthcare provider’s account could log in, alter and answer the patient on the pretext of being an authoritative figure (applicable to mobile devices/smartphones); 2.) interactive video connection, also accompanied by some restrictions: by changing the temporal and spatial organization of movements, typical of a video picture, some non-verbal gestures, body positions and movements can be underestimated (for example: some facial expressions, subtle glances, etc.), to the extent that the gesture one produces may be transformed, distorted and received in quite a different manner by the other in the interaction. Similarly, when communicating via landlines that do not permit a video image, some nonverbal bodily characteristics, particularly delicate facial expressions bearing relevant information, may remain hidden for both parties in the communication process and therefore undervalued;
- The concerns related to privacy and confidentiality of identifiable personal information will be discussed in detail in the next section; here they will be mentioned only briefly. Generally, they are concentrated around the risk of leakage of information to third parties in the process of collecting, handling, transmitting and storage of information, all mediated by mobile devices and applications, unauthorized access to personal data, security breaches, abuse of one’s official position, being the target of hacker attacks, data manipulation and destruction, technical errors, etc., resulting in diminished public confidence in the new technologies in the field of medicine. A reasonable question arises as to whether the fine membrane separating the public from the private sphere won’t be dissolved as well as won’t the overuse of medical equipment result in too great and undesirable medicalisation of the intimate space called “home”: 1.) the issue of “cookies” allowing to track users’ IP addresses when visiting certain websites and online servers installed by web developers and sponsors (applicable in the case of smartphones). This potential lack of anonymity could be especially problematic for patients suffering from socially stigmatized conditions; 2.) electronic information can be more easily accessed (including anonymously), altered, viewed, copied, disclosed or deleted in comparison with traditional paper records; 3.) at risk is the information privacy of patients since personal physiological data may leak electronically and be shared with other clinicians and researchers; 4.) it is by the malefactor’s wish that only basic information that has been consistently collected about a specific person through cookies may be sufficient to restore the victim’s full medical profile, this time bringing his/her individual characteristics; 5.) next, medical websites and online groups for mutual support also face serious problems concerning the accuracy and quality of medical information (for example: anyone can put a badge on the Internet claiming that he/she is a doctor, i.e. self-proclaim himself/herself as such) (applicable when using smartphones); 6.) even assuming that all medical information generated on medical websites and online groups for mutual support is accurate, patients and their family caregivers can easily be overwhelmed by too much medical information that they have not been trained to read and comprehend, which may be attributed to their lack of knowledge of research methodology and statistical data interpretation making it hard for them to compare the results of several medical studies (applicable to smartphones);
- The “One size fits all.” principle is not valid. One should abstain from giving standardized regulations and prescriptions; the approach to the patient should be individual since what may be good and beneficial for one person may be detrimental to another. Everyone has his/her own preferences and needs that have to be respected and taken into consideration by the medical personnel, with the service provided to be tailored to patients’ individual characteristics and needs. E-health may increase marginalization of groups. The “digital divide” brings additional groups to the risk of marginalization;
- New may not be necessarily best – both practice and time prove this. Instead of blindly believing that new is always better, one must balance the enthusiasm for the potential of telemedicine against the recognition of the need for scientific (evidence-based) verification and evaluation. Therefore, hasty adoption on the basis of only early and insufficient empirical data, whose effectiveness has been demonstrated as limited, may not be the right point;
- Lack of trained personnel to work with telemedical technologies; people are still to be taught, but learning takes time and enough practice. The issue of applying teletechnologies in medicine is an interdisciplinary, multi-faceted field, which requires the need of broadening the narrow knowledge of the medical staff involved in the teletechnology application. Since of crucial significance are the privacy issues, the staff is required to have expertise on legal and ethical matters, as well;
- A humane field as medicine claims to be must not tolerate universalization, generalization and unification. Historically, universalization has always led to depersonalization;
- Excessive technologization in the field of medicine implies another drawback – lowering the clinical skills of the physician insofar as the doctors rely solely on technology, thus “forgetting” how to perform a simple routine physical examination, for example. Instead of the clinician it is the technology that is in charge of conducting a patient’s check-up and setting his/her diagnosis;
- If fallen in the wrong hands, any tool could cause damage, which in turn necessitates the presence of detailed regulations and guidelines for the application of the new technology;
- In the cases, in which risk is overestimated, telemedicine can restrict the freedom of the patient that may lead to strengthening his/her social isolation. Therefore, the right balance between patient’s autonomy and ensuring his/her health protection needs to be found;
- Despite the tendency of favorizing the automatization of most tasks, the need for patients to trust their doctors will never disappear as far as confidence in the physician is believed to be a key component of therapy. Often downplayed, the good character and virtues of a doctor are deemed crucial in the moral practice of medicine and the lack of the relevant emotional relationships between patients and healthcare providers could be interpreted as an unacceptable moral defect in clinical medicine.
Result card for ETH2: "What are the benefits and harms of STS for other stakeholders (relatives, other patients, organisations, commercial entities, society, etc.)?"
ETH2: What are the benefits and harms of STS for other stakeholders (relatives, other patients, organisations, commercial entities, society, etc.)?
Positive Implications for Healthcare Personnel/Healthcare Providers:
- The automatization of processes in caring for patients suffering from noncommunicable diseases using ICT may substantially facilitate the exchange of information, automate routine practice and ease documentation flow, thereby improving patient clinical care. Electronic health records are purposefully designed to reduce the time for consultation, facilitating the management of patient information and decreasing the burdens pertaining to documentation procedures;
- To the extent that telemedicine is less dependent on the physical presence of healthcare professionals, overcoming geographical barriers saves time and travel costs to the patient’s home by minimizing unwanted and costly home visits, thereby allowing healthcare professionals to use ICT for diagnosis, treatment and monitoring of patients from a distance;
- The exponential growth of teletechnologies allows the development of a fully-integrated healthcare system as well as more flexibility, and enables physicians’ connection in a network with clinicians from other specialties so as to discuss complicated clinical cases and provide the best evidence-based care (more globally viewed and applicable to mobile communication);
- Modern technological facilities that healthcare professionals are provided with enable them to remotely analyze the physiological and psychological functions of their patients by exchanging with one another high resolution images, real-time sound and video. Facilitated is the establishment of an objective scientific nosology, allowing physicians to diagnose a disease based on objective evidence and not on subjective patient’s reporting. Doctors do not need sharing on behalf of the patient since the medical tool acts as a lens, through which the doctor sees the disease exempted from patient interpretations (applicable to smartphones).
Negative Effects for Healthcare Staff/Healthcare Providers:
- 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, whose direct manifestation is the transition from paternalism to autonomy and equality. For many theorists, medical anthropologists and experts in bioethics the gradual equalization of power positions in the doctor-patient relationship has been and continues to be a consequence of the culture of modernity. As a result of the increasingly informed public and the unprecedented growth in medical knowledge over the past few decades, due to the role of media and education, the image of medicine has begun to demystify itself, becoming more accessible to laymen. This situation, supported by the desire of modern individuals to control their own lives, has modified the relationship in the direction of greater equality between the two parties, with the net effect of modernity being the progressively trimmed authority and prestige of physicians in favor of more equal interactions between a patient and a doctor. Placing restrictions on the professional autonomy of healthcare personnel has forced it to compete in providing a better health product or service. Additionally, in an effort to control healthcare costs, health organizations have further limited the power and prestige of medical staff compelling doctors to comply their therapeutic decisions with cost guidelines and restrictions;
- On the other hand, the “importing” of medical culture in the home of patients as well as the access to vast medical information (including specialized medical articles, virtual books, the possibilities offered by online groups for mutual support and the e-mail, enabling the sharing of therapies workable in a particular case, personal preferences and opinions on certain healthcare providers, etc.) may question the authority and professional expertise of those healthcare providers. Doctors and traditional health personnel will therefore be viewed as one of the numerous sources of medical knowledge, though not the most reliable one (applicable to smartphone use);
- The circumstance that patients may in many cases have access to the same volume of information (if not even more) as doctors have, forcing the latter to acquire more medical knowledge than their predecessors and orienting them to increasingly narrower specializations;
- Need of additional training and certification for doctors and other health staff to work in telemedicine environment, facing them with the challenge of entering new and unknown professional depths and learning in detail medical informatics and legal matters in order to provide adequate care, i.e. this brings on the agenda the need of a broader interdisciplinary view requiring further qualification and gaining new multi-faceted knowledge and skills;
- Lengthening and hindering the documentation process when using traditional paper patient records, not an electronic one. Extending the time spent on the telephone (referring to some cases when using landline telephones for communication);
- Excessive technologization in the field of medicine implies another drawback – lowering the clinical skills of the physician insofar as the doctors rely solely on technology, thus “forgetting” how to perform a simple routine physical examination, for example. Instead of the clinician it is the technology that is in charge of conducting a patient’s check-up and setting his/her diagnosis;
- Too wide range of physiological indicators to be monitored, because of which in order to avoid information overload, doctors should select from the set of biometric markers being monitored only those relevant parameters that are of greatest importance to them (applicable to smartphones).
Positive Effects for the Families and Relatives of Patients-Recipients of Telecare:
The benefits are somewhat commensurate with the ones to patients. In particular, the positive effects are as follows:
- Overcoming some of the drawbacks of institutional care by reducing the intrusion of outsiders in the home, thereby preserving its intimate space by preventing or decreasing unwanted home visits on the part of health professionals for monitoring the patient’s condition; most physical privacy guaranteed by teleconsultations has the potential to protect the intimate and non-public space of the home, enhancing the autonomy, tranquility and well-being of both patients and their families;
- More flexibility and independence in daily activities together with reduced travelling costs and time of family caregivers – time that can be spent on working, engaging in pleasant activities, household chores, gardening, grandchildren, etc.;
- Contributing in preventing the trend of abandonment of elderly parents in nursing homes by allowing them to remain in the comfort of their own home through the reduction of family caregivers’ anxiety and lowering the costs associated with institutional care;
- Access to vast health information and resources combined with opportunities to get familiar with the medical terminology and medical procedures, particularly when shifting them from clinical to home environment – a fact that alone may increase the confidence, self-esteem and independence of families and relatives taking care of patients with NCDs, and turns them into active participants in the therapeutic process as opposed to just passive recipients.
Negative Implications for the Families and Relatives of Patients-Recipients of Telecare:
- Although security breaches are a relatively uncommon phenomenon, their potential for damage is enormous, especially when the security of socially stigmatizing health information has been compromised. Patients and their families may not only lose their privacy but also be subjected to social ostracism, discrimination at work, extortion, etc.;
- Insufficient knowledge, skills and equipment by home caregivers to provide adequate care;
- Neglecting the needs, desires and claims of family members regarding the therapeutic modalities as far as healthcare professionals traditionally presume patient’s interests to dominate those of the family. Another problem is that clinicians fail to listen sufficiently to the voice of family caregivers and relatives, who are perceived as solely external and secondary figures to let them have their opinion. However, as the chosen therapy is not encapsulated on the patient only but may indirectly affect the habits, lifestyle, financial status, emotional and psychological well-being of family caregivers, as well, they should not be excluded from the decision-making process;
- The access to the vast sea of medical information and resources can result in overloading family caregivers with too much medical terminology and data, for the interpretation and understanding of which family members lack the necessary biomedical background – they have a deficit of knowledge of research methodology and statistical data interpretation making it hard for them to compare the results of several medical studies;
- Dependence of the care and support provided by the family on the biological progression of the disease, varying primarily from its stage and the availability of caregivers, ready to bear the burden in the event of impossibility by the patient. This may affect the division of labor in the household as well as the social contacts, etc.
Positive Impact on Society:
- Highly promising sector because of its potential to reduce healthcare costs, improve patient access to services, expand the scope of services, enhance the quality of care and facilitate the management of information flow (for example: patient records today are interactive with an option to be accessed by multiple public stakeholders and users of the documentation – not only physicians but also various funding organizations – applicable when using smartphones);
- Opportunities for controlling patients’ condition and consulting them “at the right time” as well as reduced duration of inpatient treatment and lowering the number of outpatient visits;
- Prerequisites for the establishment of a consistent and universal telecommunications infrastructure, an integrated healthcare system, greater connectivity and flexibility. Improving communication between health professionals and healthcare coordination, making it possible to attract additional specialists from various fields and reach greater professional expertise in quite rare and complicated cases (more globally viewed);
- Digitization contributes in decreasing information transfer costs as far as the process is less dependent on geographical barriers (when using mobile communication);
- With the increased share of generations living longer but in poorer quality life, healthcare costs are expected to rise in proportion to the growing number of the elderly chronically ill persons. Telemedicine constitutes an alternative to overcoming this flaw by making it possible to minimize institutional costs as patients are taken out of the expensive hospitals;
- Structured telephone support could be a practical solution for non-serviced rural areas given the need to control health costs, the closure of rural clinics and the practical difficulties in recruiting health professionals in rural areas. However, whether it will actually become such a decision, depends on the creation of an adequate telecommunications infrastructure in rural regions, bridging the digital gap (applicable to smartphones);
- Improving the qualification of human resources in healthcare in various areas including deepening physicians’ knowledge and skills pertaining to information systems necessary for the implementation of their daily clinical tasks (viewed more globally);
- Remote care is often seen as equivalent to expensive and cumbersome high-tech medical equipment, intimidating in its complexity;
- To summarize, the overall synergistic effect of the implementation of these innovations is the introduction of the progressive liberal democracy principles in a rigid field such as medicine and the transition from paternalism towards a greater equality between patients and healthcare providers.
Negative Implications for Society and Barriers to Telemedicine’s Full Potential:
- Digital gap expansion generated by the lack of established telecommunications infrastructure in rural and some urban areas. 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;
- Rigidity of the medical community manifested in health professionals’ resistance to innovation. Physicians are less willing to accept a technology, promoting greater self-care by the patient since doctors view this as a challenge to their traditional role and position of control and power. Reluctance to make major investments in a sector that may trim their professional autonomy and authority;
- Growing “technological imperative”/”technological fix” that seeks solutions to complex moral issues through technologies, not through patients and healthcare professionals. In modern technological and scientific supremacy, the human element is undermined, which is also evident from the principles of contemporary medical training, encouraging technological spread, thus ignoring physical and psychological contact;
- Reinforcing public distrust with regard to the security and reliability of the transmitted and stored computer-based health information – the debate on ensuring privacy and confidentiality tends to polarize in two directions – on the one hand, the easier traffic of medical information poses personal privacy and confidentiality with serious risks, whereas on the other hand, the overall progress in health reforms is dependent on and unthinkable without the adoption of teletechnologies and e-health;
- Especially problematic would be the disclosure of socially stigmatizing health information, which may result in discrimination at work, social isolation or may be harmful to the reputation of the person concerned. On the other hand, without preliminarily guaranteed privacy and confidentiality by healthcare providers, there is a fear that patients would not seek treatment, revealing otherwise physically and psychologically intimate details about themselves, whereas these details are considered necessary ingredients of trust and openness of communication. The absence of these two conditions will not only result in negative effects for patients but will also be detrimental to the public confidence in the medical and health institutions;
- Telemedical realities call for revision of the concept of confidentiality and its consideration as prima facie moral right as far as other social goods, such as medical research and public health, require placing limits on the privacy of health information and allowing exceptions when other moral values or social goods are threatened (for example: as stipulated under law in case of infectious diseases, child abuse, etc.);
- Cases of unauthorized access to medical information tend to have isolated nature, being usually committed by one person; however, many are the examples of privacy and confidentiality violations by authorized persons, who have been legally entitled to access personal medical information (referred to as an “authorized abuse”). Given its daily and continuous, rather than sporadic, character, the second category may presuppose more hazards. Even seemingly legal, it may be of highly questionable moral nature;
- Ethically problematic would be a situation in which empathy is less valued compared to timely and accurate health service (quite typical at the current stage);
- 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;
- Need to allocate additional funds and develop training programmes for the human resources engaged in the provision of the new healthcare services (already discussed);
- Balancing between the two manifestations of medicine – medicine as a science and medicine as an art – is quite a difficult task. Increasingly more weight is given to science in the face of standardized clinical guidelines and practice manuals, automated procedures and technology compared to the expertise, intuition and autonomous judgment of an individual health professional. Unlike constantly changing medical science, art of medicine embodies universal, sustainable, immutable categories, such as the experience of the disease, the feeling of vulnerability, dependence, the very sense of caring. Therefore, both the art and science of health are desirable and necessary in providing a technically robust health system and the establishment of adequate ethical relationships;
- A problem may be caused by the narrow interpretation of the term “quality of care” that is often understood as the ability of a new medical technology to improve care and outcome for the patient. Sometimes, however, the adoption of a new medical technology by healthcare professionals could stem from their own faith or belief, rather than actually being the demonstration of improved patient care. Moreover, broadly speaking, quality refers to not only to the delivering of services so as to avoid any errors but also to providing them in a competent, compassionate and respectful way – that is why, the question of whether telemedicine enhances or reduces the quality of health services hasn’t been answered yet;
- Despite the fact that many studies focus on the advantages of teleinnovations, some significant drawbacks are still neglected – for example, the increased access to health services is unlikely to be a good long-term solution since it makes health services more expensive at general level by involving more people in the healthcare system, thereby leading to a growth in the percentage of utilization, i.e. even if healthcare expenditures per capita showed a downward trend, there would still be a threat of a rise in the aggregate (total) health expenditures. If this proves to be true, it is very unlikely that telemedicine will be an economical solution;
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(continues from "Result" section)
- Risk of dehumanization, depersonalization and alienation generated by the growing medicalization of the electronically mediated environment and downplaying the role and importance of the physical contact with the patient. Despite the domination of technologies and the automatization of most tasks, patients will always need to trust their doctors as far as having confidence in a particular physician may be crucial in one’s therapy. Therefore, the recommendations are oriented to refraining from using telemedicine as an end in itself and avoiding turning it into a substitute for the traditional care and human contact. It should be justified only as a complementary tool to conventional care and solely for patients, with whom a clinician has already established a bilateral relationship of trust. However in the long run, it might be a substitute.
- Excessive technologization in the field of medicine implies another drawback – lowering the clinical skills of the physician insofar as the doctors rely solely on technology, thus “forgetting” how to perform a simple routine physical examination, for example. Instead of the clinician it is the technology that is in charge of conducting a patient’s check-up and setting his/her diagnosis;
- Due to the rapid pace of innovation all regulations quickly become obsolete and cannot serve adequately at any time, while legislation is more cumbersome and subject to slower amendments;
- 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.
Result card for ETH3: "Is STS used for patients/people that are especially vulnerable?"
ETH3: Is STS used for patients/people that are especially vulnerable?
Yes, since it generally refers to the case of elderly persons with accompanying diseases (comorbidity) and having initial or more pronounced cognitive impairments. Difficulties in the selected telephone mode of communication may also be expected in patients with hearing or visual problems. Combined with the typical risk of privacy violations of the telemedicine , this vulnerability increases.
In general, to the answer to this question are valid all previous comments debating the negative implications.
Result card for ETH4: "Does the implementation or use of STS affect the patient´s capability and possibility to exercise autonomy?"
ETH4: Does the implementation or use of STS affect the patient´s capability and possibility to exercise autonomy?
Patient autonomy is a cornerstone principle of medical ethics and widely discussed issue in specialized literature. In general, patient autonomy can be defined as self-determination, an expression of one’s own will, based on the ability of a person to guide and manage his/her own life in accordance with rational principles and rules, thus allowing him/her to consciously accept or refuse medical interventions. The right to self-determination is ensured by the presence of valid consent by adherence to the principle of voluntariness and after the patient has been thoroughly introduced to the objective, nature of the procedures, potential risks, duration, anticipated effect of the intervention, etc.
In the context of telemedicine practice, the major obstacle to the patient’s ability to exercise autonomy, as mentioned above, may be the advanced age, frequently accompanied by additional factors, such as comorbidity and the aged-physiologically determined less or more severe mental limitations as well as present or expected to emerge auditory or visual deficits. Moreover, when there is a decline in cognitive functions, reflecting on the comprehension of perceived information, medical specialists are required to explain to patients thoroughly, calmly and patiently all the details on the chosen procedure.
Although patient autonomy is considered to be a key point and prerequisite for any medical intervention and has therefore been well debated in the literature on bioethics, data on ethical aspects regarding the application of specific telemedicine practices are scarce at best or missing, thereby resulting in too general conclusions, not grounded on a solid empirical base.
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?"
ETH5: Is there a need for any specific STSs or supportive actions concerning information in order to respect patient autonomy when STS is used?
In a virtual environment, in which physical contact is often replaced by an intelligent software intermediary among the parties and explicit boundaries are transformed into blurred and fluid ones, would somewhat be unrealistic the notion of total, intact autonomy. The very nature of the new environment poses ethical challenges to the protection of the privacy of personal space.
While security breaches are relatively uncommon, their potential for damage is enormous, especially when the security of socially stigmatizing health information has been compromised that could directly or indirectly affect the socioeconomic status of patients and their families, denigrating their reputation, subjecting them to social ostracism, discrimination at work, extortion, etc. In such situations, where the health information being protected carries social stigma and penalties, it is the ethical importance of privacy protection that stands out the most.
Not only in this concrete case but also in overall telemedicine reality, an adequate approach would not be seeking universality in the new conditions but instead elaborating procedural criteria to determine what must remain private and confidential by permitting individual patients and their family caregivers to decide for themselves what they would like to keep private and confidential. This manifestation of flexible thinking should be reflected in the design and practice of informed consent, with the latter not perceived within the conventional narrow framework of a single act but viewed as an ongoing process with options for revision, if necessary.
Traditional informed consent, conceived as a single event, is the preferred option in cases of single clinical encounters or in periods of initiation, termination or modification of therapy. In this context, the consent shall be deemed a discrete/isolated event as contrasted to an ongoing process.
In the new realities associated with NCDs, however, the traditional model is not applicable and must be replaced with the concept of informed consent of an ongoing process as far as caring for a patient presumes an extended period of time characterized by a multiplicity of procedures, therapies and technologies. An advantage of this second model is the recognition of the fact that patients may not always be able to fully and immediately understand information regarding their diagnoses and treatment modalities. Furthermore, the procedural approach provides patients with the opportunity to reflect on treatment options in light of their own values, allowing them enough time for rethinking and judging on the selected treatment. In addition, a procedural approach is also useful in that it gives both patients and physicians more time and opportunities to reach an agreement, especially in the case of different opinions on the optimal course of action. Particularly in remote medical practice, that flexibility of the informed consent can be illustrated by a revision of the informed consent in accordance with the dynamic nature of the condition. Additionally, with a view to the rapid technological development, further clarifications to the patient and his/her training in the course of therapy may be required.
These are just a few of a number of proposals that the community of ethicists, lawyers, physicians, IT specialists, politicians, etc. need to focus on in order to articulate them into further measures, ensuring users’ autonomy and privacy, while broadly speaking – help increase public confidence in the health institutions and telemedicine practice.
The remaining measures are directly related to information protection and generally refer to establishing control over the collection, transmission, storage and use of personally identifiable data in an uncertain electronic environment:
- Health information may be disclosed for health purposes with only limited exceptions. However, using health information for purposes not related to health, such as hiring or dismissal, shall be prohibited;
- Disclosure of patient information to outside parties only with the permission of the patient or if enshrined in law. Necessity to regulate the cases, in which information may be disclosed: for treatment, payment or administrative purposes, etc. Guarantees for its protection by the recipients through measures against accidental or intentional disclosure as well as informing patients about the purposes, for which the information is being used or disclosed to third parties;
- Need for strict allocation of responsibilities for all persons involved (equipment manufacturers, system installers, operators, clinicians), each with a concretely assigned task, for example: who is in charge of permanent care, of consultations, of laboratory tests, etc.;
- Limiting information access to only a narrow range of authorized persons by defining different access levels in the chain in order to avoid potential threat of blurring/overlapping of responsibilities among the individuals monitoring the patient’s condition by precisely defining the roles of each of them (for example: a nurse, a clinician, a patient, etc.). In the case of medical practice, its administrator must allocate usernames and passwords with the requirement to change passwords at regular intervals, containing a minimum number of characters as well as add biometric scanners, allowing palm, finger, retina or facial recognition, etc., if necessary. Likewise, a patient should be entitled to view, possess a copy of and alter information in his/her records but only in a reproducible way – it has to be seen that a change was made and what was the content before;
- An awareness of responsibility for improper or illegal viewing and changing data. Criminalization of the act and/or, when necessary, subjecting it to civil penalties/penalty payments;
- Usage of specific technical means to prevent unauthorized or accidental access and disclosure of confidential health information – universal technological approaches in this relation may be electronic passwords, “firewalls”, an antivirus software and a software detecting outsider’s intrusion (digital signatures and time stamps as well as data encryption permitting encoding and decoding of information). Need to provide an additional protection when sharing clinical information through mobile phones. This is especially necessary with regard to cell phones since they do not normally run encrypted data and can easily be lost, stolen, damaged. Another good approach would be the use of the still unpopular tool, known as “audit trails”, borrowed from the financial accounting field. Audit trails allow precise tracking of all activity by generating a date and time stamps on each entry with a list of what, how long and by whom has been viewed as well as what pieces of information have been printed and the exact location and a computer, from which a request has been sent, flagging any suspicious activity;
- Identifying weaknesses in the security system as well as assessment of the threats and risks that are to be articulated in the development of measures, concrete policies and privacy and information security procedures.
The ICT introduction in the intimate home sphere may be seen both ways – on the one hand, new technologies contribute to the enhancement of patient autonomy and well-being, while on the other hand, may produce just the opposite effect on this same autonomy. The adoption of telemedicine should therefore not be an end in itself but a product of a clear public vision of providing really good care.
Result card for ETH6: "Does the implementation or withdrawal of STS challenge or change professional values, ethics or traditional roles?"
ETH6: Does the implementation or withdrawal of STS challenge or change professional values, ethics or traditional roles?
Yes, particularly if referring to the transformed patient-physician relationship. Personal contact is lost, there is a lack of an intimate face-to-face conversation as well as the very feeling of being examined at the time of the visit are all gone. This could weaken the patient’s trust in the physician/staff monitoring his/her condition. The current issue has been thoroughly discussed so far in the previous sections and therefore needs no further comment.
Respect for persons
Result card for ETH7: "Does the implementation or use of STS affect the user´s moral, religious or cultural integrity?"
ETH7: Does the implementation or use of STS affect the user´s moral, religious or cultural integrity?
The accessible literature that has been reviewed suggests no answer to this question, but here probably could be drawn an analogy with the reflections made in the paper on Alzheimer’s disease therapy.
Given the widespread use of mobile phones as of today, smartphones, respectively, it is unlikely, however, still possible that with regard to some ethnic groups, cultures and religious movements, the application of the technology might be problematic because of their denial or non-acceptance of new technologies, or since traditional decisions as to one’s relatives’ health should be made by the family, not by the patient alone. In this aspect, a conflict may be expected regarding the autonomy of the patient, resulting in its reduction. Therefore, individual autonomy depends largely on the people around him/her, their affiliation to a particular social group or community and cultural values, as well.
Result card for ETH8: "Does STS invade the sphere of privacy of the patient/user?"
ETH8: Does STS invade the sphere of privacy of the patient/user?
The answer to this question might be quite simple and intuitive – yes! The issue has already been widely debated since it is central to teletechnology.
Justice and Equity
Result card for ETH9: "How does implementation or withdrawal of STS affect the distribution of health care resources?"
ETH9: How does implementation or withdrawal of STS affect the distribution of health care resources?
One of the key principles in bioethics is the principle of justice linked to law and equality. From an ethical point of view, it can be considered in three different ways and subdivided into three distinct categories, respectively: fair allocation of scarce resources (distributive justice); respect for people’s rights (rights-based justice) and compliance with morally acceptable laws (legal justice). Although the right to equal treatment, respectively, equal access to treatment has been formally enshrined in many constitutions, actually, many factors, such as age, place of residence, social status, ethnicity, culture, sexual preference, disability, legal capacity, health budgets, treatment price, insurance coverage, etc. may limit access to treatment. Justice in these cases, without neglecting or underestimating the right of equal access for all, requires that the individual’s needs be balanced with the needs of the general public.
In general, distributive justice in healthcare, which is being discussed in the present section, involves the application of fair standards that make quality healthcare both available and accessible to people in an effective way. A health system is deemed fair or equal in the cases when: 1.) persons are not deprived of health services based on criteria, such as class, race, gender and geography, and 2.) persons may be entitled to a guaranteed adequate level of care without exceptional harms/burdens.
A problem may be caused by the narrow interpretation of the term “quality of care” that is often understood as the ability of a new medical technology to improve care and outcome for the patient. Broadly speaking, quality refers to not only delivering services so as to avoid any errors but also providing them in a competent, compassionate and respectful way – that is why, the question of whether telemedicine enhances or reduces the quality of health services hasn’t been answered yet.
Next, 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 (for example: the digital gap generated by the lack of established telecommunications infrastructure in rural and some urban communities, where 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; availability of health services in a particular community or region, meanwhile making them inaccessible to some people due to inadequate transportation, etc.).
Given the nature of structured telephone support, substantial conflicts regarding the financing of the selected technology are quite unlikely to be expected insofar as the adopted practice of telephone interviews between the healthcare staff and the patient, whether conducted by landline or through the use of mobile phones, does not presume a requirement for supplementary personal financial contributions by patients on additional installation of telemetry devices payable by the patients themselves and is therefore not an extra financial burden to them.
An essential variable in the equation of distributive justice is efficiency/effectiveness – due to limited health resources and their high demand, signs of inefficiency/ineffectiveness, such as duplicate services, overspendings, errors, etc. should be minimized.
With a view to healthcare distributive justice turning into reality, none of the components already discussed should be pursued for their own sake, while being at the expense of others. What is more, both the democratization and stratification potential of distributive justice must be considered, whose overcoming requires constant trade-offs (for example: increased access to medical services and health information but instead – decreased quality of the bilateral relationship, indicative of which is the lack of face-to-face clinical encounters as well as patient access to vast medical information but unreliable and of questionable quality at the same time).
Therefore, in view of the above considerations and in order to ensure fair and reasonable healthcare spending, it is necessary that decisions are made on a case-by-case basis, particularly in situations characterized by limited resources, unequal opportunities and/or other moral discrepancies.
Result card for ETH10: "How are technologies with similar ethical issues treated in the health care system?"
ETH10: How are technologies with similar ethical issues treated in the health care system?
Telemedicine is successfully applied with regard to patients suffering from diabetes, respiratory diseases, dementia, mental health problems, risk pregnancy, etc. The concrete teletechnology is used either more widely or isolatedly/segregatedly in some states, including European ones (Germany, England, Scotland, Italy, Spain, Denmark, Sweden, etc.). In the above countries, ethical issues are resolved on a case-by-case basis in compliance with their national legislation.
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)?"
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)?
We used the domain specific search (described above in the Domain Methodology section) including studies relevant to thisoutcomes but with no restriction of the study design and broader criteria (technology, population) as evidence on that question was poor and scarce. The results are given in a descriptive way summarising the text contents of the studies that gave some information specifically on age, ethnicity, income, geographic area, working staus, gender etc. to use Structured telephone support (STS)?
Age-related technical illiteracy, more severe health status, ethnic minority with language problems were find to be reported as possible barriers to access for telemonitoring. No primary study on STS was found to have as a primary outcome the realtionship among the use of STS and the above social variables. In some studies the participation to study- and control group showed differences in terms of income, employness, education or income status. For the being elderly barriers and age illiteracy it has been highlighted that common use of the new technologies such as the internet etc. started about 20 years ago and has rapidly spread among the population so that in the future the elderly will more and more be less digitally illiterate, this allowing the age-barrier being less and less relevant. More studies focussed on understanding the actual existence and the effects of those barriers, are needed.
- Yes, as already mentioned, some ethnic groups (cultural or religious), though unlikely, might refuse such interference;
- In rare cases there is a risk of damaging the socially disadvantaged segments of the population, leading in turn to a prerequisite for social discrimination by making telemedicine a potential new form of access discrimination;
- In comorbid older patients, having more or slightly pronounced mental deficiency, handling smartphones would pose some difficulties due to the need of specific technical knowledge and skills. This technology may prove inaccessible to other groups, as well, particularly those with visual or auditory impairments.
From SOC Domain Team:
A lack of effect for the intervention could be the cohort of HF patients which is usually older and has a special experience with their nature of illness. These are not the baby boomers more experienced with technology and with more sophisticated means of monitoring their health as they age. [Schwarz 2008] In opposite to this the study of Lind  asked for the experiences in using the telemonitoring structure for daily reporting of the health status and patients answered that they quickly were able to manage it and felt empowered and increased their own participation. Fourteen patients (11 men, mean/median age 84/83 years at inclusion) diagnosed with HF, NYHA class II-IV, with a median of two previous hospital admissions during the last 12 months were included in the study. Authors analysis of the interviews allowed to focus on the fact that technology in general, including computers and mobile phones, was regarded at the beginning as “not interesting” and “a bit scaring” but digital illiterate patients expressed admitted that they were going to miss a lot of information this way. During the study the patients began using new daily routines for the reporting of assessments and measurements, and they thought that handling the equipment digital pen was an easy task. According to Lind et al. the HF patients in their study had no experiences of using the internet but quickly accepted and managed to handle the digital pen technology for daily reporting of their health status, making them more empowered and increased their own participation. The study shows that, „given that technologies are tailored to specific patient groups, even “the digital illiterate” may use“ them. [Lind 2014].
In thier qualitative study Lynga et al. did a typology of the patients and linked their habitual status to the telehealth results. There were different ways in understanding the telemonitoring in a dominating or non-dominating way. The five women show a higher summary of points (1 or 2 crosses on table 1) in the habitual category than the 15 men (7/5 versus 12/15, respectively) leading to the assumption that they got the daily weight measure easily into daily routine.
The study of Seto  mentioned the young average age of their study participants and the possible bias by positive attitudes towardas telehealth, „however, the participation refusal rate was very low, which suggests that the bias was minimal. Finally, the mobile phone-based remote monitoring system that was proposed to the participants had functionality that was beyond what is available in current best practice“. [Seto 2010]
Seto  also mentioned the lack of continuity for telemonitoring patients going on vacation without bringing the monitoring equipment with them. On average, every phone call was associated with an increase in perceived health, indicating that the overall process was responsible for the improvement of participants’ health states. Considering the fact that there were significantly more contacts for participants with poorer initial perceived health, it was suspected that there is an effect of severity (NYHA stage) on the outcome variables. However, there wasn’t any evidence for a negative impact of NYHA status on participants’ development over the course of counseling. [Boehme 2012]. The study participants in the study of Brandon 2009 all (100%) had annual income levels < 20.000 $ (median income in this county = 30.952 $), were mainly (7/10 in the intervention group, 8/10 in the control group) high school (with or without degree) or lower level, only 30% of the participants had some college or postgraduate study. In the intervention group 70% were female. There was also an option for cardiac rehabilitation education after discharge from hospital only for those patients who had access to transportation. [Brandon 2009]
Result card for ETH12: "Does the implementation or use of STS affect the realisation of basic human rights?"
ETH12: Does the implementation or use of STS affect the realisation of basic human rights?
The answer to this question could be quite simple and intuitive. However, the issue is more appropriate to be dealt with in the Legal Domain.
Although health professionals are morally obligated under the Hippocratic Oath to protect patient confidentiality, with the latter understood back then as a sacred obligation or an absolute right, modern healthcare fails to see the concept of confidentiality as a sacred category. What is more, a conflict appears between the limits of confidentiality and the common good, where one is often at the expense of the other. In order to balance the two concepts, a trade-off position should be adopted, allowing exceptions or confidentiality infringement in particular situations of competing health interests, such as a threat to other moral values or social benefits (for example: public health, medical research, child abuse, infectious diseases as stipulated under law, etc.), patient’s authorization for disclosure of information and more broadly speaking – maximizing overall public health. Next, in order to cure their patients, healthcare workers must sometimes compromise (override) their privacy, entering their intimate sphere and questioning them on their lifestyle and personal habits.
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.
Existing standards related to the classical face-to-face medical care must be adapted to the new healthcare models, with the regulations comprising: a license for practicing this type of service by medical specialists; a mechanism for physician’s selection by the patient (identified or random); identification standard of the provider and the patient upon relationship establishment; standard for evaluation and treatment of the patient; measures for securing and protecting patient’s data as well as data of the doctors providing the service; continuity of care; a mechanism for access to archived data; quality and surveillance mechanisms.
It is necessary that the following aspects are also defined and specified:
- Type of medical services provided;
- Information on the medical staff (qualification, license, professional experience);
- Confidentiality conditions – to whom may be disclosed health information regarding the patient and for what purposes, especially in the case of using mobile devices;
- Patients’ rights with regard to the service;
- Procedures for coordination of services in case of technical problems;
- Access and timely information as well as information on any additional or altered personal health data of patients;
- Provided feedback regarding the quality of information/service;
- Providing a mechanism for registering complaints about services delivered, etc.
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?"
ETH13: What are the ethical consequences of the choice of end-points, cut-off values and comparators/controls in the assessment?
There is no clear formulation of the question. It should be noted that for the same reason this issue has already been initially rejected as irrelevant and not worthy of discussion. The problem has not been dealt with in the available literature.
Result card for ETH14: "Does the economic evaluation of STS contain any ethical problems?"
ETH14: Does the economic evaluation of STS contain any ethical problems?
Since the issue is not necessarily associated with the pre-installation of specific devices in the home of patients and the costs of the selected technology are generally covered by private (non-budgetary) funds paid for the private purchase of landline or mobile phones, no significant conflict of interest in terms of financing should be expected.
Result card for ETH15: "What are the ethical consequences of the assessment of STS?"
ETH15: What are the ethical consequences of the assessment of STS?
With a view to the above, no considerable ethical consequences of the technology assessment are to be expected.
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”, 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”.
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:
- ICT use;
- Geographical distance among participants;
- 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,. 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.
 “Telemedicine Frequently Asked Questions (FAQs)”, available at: http://www.americantelemed.org/about-telemedicine/faqs#.VR0dHPyUc4i .
 “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 .
 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 .
 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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