Ethical assessment of virtual consultation services: scoping review and development of a practical ethical checklist
Madeleine Reid 1 , Tania Moerenhout
2 *
1
2
Abstract
The use of telephone and video consultations has vastly increased since the onset of the COVID-19 pandemic. Health care providers in traditional clinical practices have embraced these virtual consultations as an alternative to face-to-face consultations, but there has also been a simultaneous increase in services offered directly to consumers via commercial entities. One of the main challenges in telemedicine (and the broader field of digital health) is how to conduct a meaningful ethical assessment of such services.
This article presents a novel framework for practical ethical analysis of direct-to-consumer virtual general practitioner consultation services in Aotearoa New Zealand.
First, a scoping review of academic and policy documents identified the core ethical challenges arising from virtual consultations. Second, a qualitative analysis was conducted to translate the main ethical themes and subthemes into practical questions to assess virtual general practice services.
A total of 49 relevant documents were selected for review. The six key ethical themes related to telemedicine were: privacy, security, and confidentiality; equity; autonomy and informed consent; quality and standards of care; patient empowerment; and continuity of care. A practical ethical checklist consisting of 25 questions was developed from these themes and their subthemes.
The checklist provides an accessible way of incorporating ethics into technology assessment and can be used by all relevant stakeholders, including patients, health care providers, and developers. Application of the framework contributes to improving the quality of virtual consultation services with a specific focus on ethics.
Keywords: clinical ethics, digital health ethics, direct-to-consumer, ethical technology assessment, scoping review, telemedicine, telehealth, video consultations, virtual consultation services.
| WHAT GAP THIS FILLS |
| What is already known: Telephone and video consultations are widely used in general practice. Evaluating these virtual services from an ethical perspective is challenging yet essential to ensure good quality of care. |
| What this study adds: We developed a practical ethical checklist for direct-to-consumer telemedicine services that should make ethical assessment more accessible for all stakeholders. |
Introduction
Telemedicine is defined by the World Health Organization (WHO) as ‘the delivery of health care services, where distance is a critical factor, by all health-care professionals using information and communications technologies for the exchange of valid information for diagnosis [and] treatment and prevention of disease and injuries …’1 Online consultations between health care professionals and patients, whether by phone or video, fall under the umbrella of telemedicine. This article examines ethical considerations of video and telephone (ie virtual, online) primary care consultations between a GP and patient specifically focusing on direct-to-consumer (DTC) services. With the onset of the COVID-19 pandemic, online consultations became widespread as restrictions on movement and social distancing requirements limited in-person doctor visits. Today, telemedicine has remained prevalent, with many GPs in Aotearoa New Zealand (NZ) offering their patients the option of a video or telephone consultation. Such online consultations give patients a level of flexibility as they can happen from their homes without the need to travel or organise child or elder care.2 In addition to GPs using telemedicine within their usual practice, several DTC GP consultation services have been established. DTC virtual consultation services provide care to patients through either a video consultation, phone call, or instant messaging. Typically, patients will sign up through the service’s website or app and book an appointment with a GP through this system. Patients may retain enrolment with their usual general practice or enrol with the DTC service, depending on how the system is organised. These services generally advertise themselves as more flexible, offering convenience to patients due to their ability to conduct a consultation in a place of the patient’s choice, as well as offering appointment times outside of regular working hours. The greater flexibility of these DTC services can reduce a number of barriers to patients accessing health care,3 such as remote location, lack of enrolment, or inflexible appointment times clashing with personal commitments.2 However, it is imperative that these services are ethically robust, offer the same standard of care, and avoid widening existing health disparities in NZ. The Medical Council of New Zealand (MCNZ) states that the standard of care provided through telemedicine, which encompasses ethical practice, should be equivalent to in-person care.4 But how can virtual consultation services be assessed from an ethical perspective?
Ethical assessment of digital health services remains challenging. Usually, health technologies are assessed through frameworks in the field of health technology assessment (HTA). A HTA is used to evaluate the implications of new health technologies and interventions and often focuses primarily on their cost and effectiveness as metrics.5 However, health technologies have moral and social consequences, and HTA methods focused primarily on cost or effectiveness are not likely to capture the information needed to evaluate ethical implications.6 Ethical considerations are less often included in HTAs, with several authors examining why this is the case. Refolo et al. (2016) surmised that it may be because the ethics of a given technology is difficult to assess quantitatively,7 while Hofmann (2014) discussed health technology assessors as not often being suitably familiar with ethics, as well as the absence of a common ethical assessment methodology.8 Ethical technology assessment (eTA) has been proposed as a tool for identifying potential risks and harms of new technologies at an early stage, based on a checklist that considers nine crucial ethical aspects of technology.9 The eTA framework is not committed to any particular moral theory and does not provide a point-wise evaluation of a specific technology, which is both a strength and a weakness as it may make application of the framework (by IT developers and health care professionals alike) more challenging. Other technology assessment methods have been developed to address ethical questions, such as responsible research and innovation, value-sensitive design, etc.10 A recent mapping of artificial intelligence (AI) ethics guidelines identified 84 documents, with reasonable agreement on which ethical principles matter but a lack of clarity on how such guidelines should be implemented.11,12 Telehealth services can also be evaluated from a clinical perspective. Both the MCNZ and the Royal New Zealand College of General Practitioners (RNZCGP) have published statements on telehealth that provide guidance to practitioners and address risks and challenges.3,4 However, these are currently not integrated into existing evaluation models such as the Foundation Standard of the RNZCGP,13 and the standard is designed to assess traditional general practice services rather than virtual(-first) services. Overall, explicitly integrating ethics into the technological and clinical evaluation of telehealth services remains challenging. In this project, we chose to develop a practical ethical checklist (PEC) specifically tailored to virtual consultation services in NZ, based on a literature review, that can be applied by both developers and users of these systems.
Methods
This project consisted of three steps: a scoping review of the literature, extracting relevant ethical themes from the selected articles, and generating a practical ethical checklist.
A scoping review method was chosen as it allows the mapping and summarising of evidence in a complex and heterogeneous field.14 We adhered to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) extension for scoping reviews (see Supplementary File S1).15 The central question was: What are key ethical issues relating to telemedicine, with a focus on virtual consultation services? Relevant literature was identified through PubMed, Scopus, Web of Science, and EMBASE database searches. The search terms ‘telemedicine’, ‘telehealth’, ‘remote consultation’, and ‘virtual consultation’ were combined with ‘ethic*’ and ‘bioethic*’. These terms were used in three separate searches, each with one of ‘equity’, ‘framework’, and ‘checklist’ or ‘guideline’. Given its importance to the NZ context, equity was included as a specific search term.16,17 Search results were filtered by language (English) and the date range 2016–2022 to ensure the included literature was up-to-date. The titles and abstracts of the results of each search were screened, and those not relevant to the review question were excluded, along with study protocols and duplicates. Criteria for inclusion were articles relating to ethics, virtual consultations, and clinical interactions, excluding research-centred publications and any articles with a focus on minors or paediatrics. Both authors screened the search results of one database (Web of Science) based on title and abstract. Articles with disagreement were checked by both authors and full texts were considered if needed. One author (M. R.) then screened the results of the other databases and the other (T. M.) verified the screening for accuracy.15 Additional manual searching was also performed for relevant policy documents, including guidelines and position statements in NZ. The literature review protocol was not published, but the literature review process was supported by one of the University’s expert librarians.
Second, a descriptive qualitative analysis of the included literature was conducted to extract the key ethical themes related to telemedicine. Both authors screened the selected articles and provided a summary and key findings for each (see Supplementary File S2). By this process, themes and subthemes were identified, including a frequency count of those identified themes.14 Lastly, the themes were used to create a PEC consisting of 25 questions. These questions were primarily based on the themes and subthemes identified in the literature and were formulated through collaborative discussion between both authors. Because this study did not involve research participants, it was exempt from ethics committee review.
Results
Scoping review
From 1833 articles, 49 relevant eligible studies and policy documents were selected based on the inclusion criteria (see Fig. 1). Of these 49 selected documents, 15 originated in NZ, Australia, Europe, and the UK, and 20 studies were conducted in or from North America.
The analysis of the literature revealed seven core themes: privacy, security, and confidentiality (n = 40); equity (n = 33); autonomy and informed consent (n = 30); quality and standards of care (n = 25); the patient–doctor relationship (n = 18); patient empowerment (n = 14); and continuity of care (n = 9). The patient–doctor relationship was excluded as a theme from further analysis and the PEC. It mainly focused on overarching concerns related to loss of human contact, lack of body language and non-verbal cues, trust, and the impact of telemedicine on building or maintaining a therapeutic relationship. Most of these are captured in other themes (continuity of care), while others (such as trust) are more generic telemedicine-related concerns. The following six themes were explored in further detail.
Privacy, security, and confidentiality in telemedicine was the most prominent theme in the literature. Sub-themes included secure storage and transmission of patient data and seeking patient consent to transfer any data,18–30 as well as management of third-party access to patient data.31–33
Much of the literature considering equity in the context of telemedicine acknowledged the potential to widen some disparities despite it also having the potential to promote equity. One of the main threats to equity is the so-called ‘digital divide’, which was mainly discussed in the context of older people and disadvantaged groups.3,19,21–24,26,28,29,31,33–43 This divide may manifest itself in a lack of access to digital technology and/or poor digital literacy. In addition, concerns over the usability of telemedicine itself were raised, specifically for those living with disabilities or cognitive impairments22,23,35,41,43 and for those experiencing language barriers.38,39
The two main issues raised in the literature were adequate disclosure of information and issues around Terms and Conditions. First, providing sufficient information to patients to allow them to be fully informed was discussed. This could include information about how the service will work, collection and use of patient data, and the limitations of telemedicine.18,20,21,25,27–29,32,36,42–51 Such limitations include the digital nature of telemedicine posing risks to data privacy and security, and restricted physical examination options, which may affect the quality of care provided. In addition, the issue was raised of services disclosing how they store patient data and with whom (if anyone) the data is shared.18,21,29 Second, it was discussed how Terms and Conditions may be problematic if they are written in language that is vague or difficult to understand, or if a blanket agreement is necessary to access care through the service.18,22,23,48
The literature emphasised the importance of the quality of care and standards of practice provided through telemedicine being equal to what is offered in person.4,18,19,22,23,28–30,36,47,50–52 Key concerns raised regarding the quality of care were ensuring appropriate licensing, registration, and competence of the health care professionals who provide it,20,22,23,53 and the limitations on physical examinations through a virtual consultation.18,25,47
Patient empowerment is the process by which patients are enabled to take responsibility for, and have control over, their own health and wellbeing. Patient empowerment is thus usually considered under the broader principle of autonomy; however, given the emphasis on patient empowerment within telemedicine, it was considered a separate theme. Key subthemes of patient empowerment related to having the option of an in-person appointment available as an alternative to telemedicine,27,52 enabling patients’ access to their personal data,19,23,26 and patient co-design of or input into telemedicine services.26–28,34,35,37,54,55
Two main areas were identified in the literature regarding continuity of care in telemedicine. First, informational continuity, ie adequate documentation of virtual consultations and patient-consented transfer of this record to their usual health care provider.36,51,54 Second, relational continuity, which is the existence of any follow-up or continuing relationship between health care provider and patient, especially given the frequently one-off nature of virtual consultation services.43,47,49,54
Practical ethical checklist
Specific questions that applied to DTC virtual consultation services were derived from the themes and subthemes above. This framework comprises 25 practical questions based on the core issues identified under each theme. The questions are written in a way that can be used by developers, patients, and health care professionals to screen the information about the DTC virtual consultation service that is available in the public domain (mainly on websites). The PEC is shown in Table 1.
Discussion
Statement of principal findings
This project developed a PEC for DTC virtual consultation services in NZ based on a scoping review of the literature. Six themes and subthemes on the most pertinent ethical considerations were translated into a PEC consisting of 25 questions that can be applied to publicly available information on DTC virtual consultation services to conduct an ethical evaluation.
Strengths and weaknesses of the PEC
Our PEC for virtual consultations has clear benefits. It provides an accessible way of incorporating ethics into technology assessment, making it easily accessible to all involved stakeholders. It focuses on ethical aspects, which may be overlooked in clinical and technological evaluations. It is specific to one type of technology, making it highly specific and practical: primary health care providers, patients, and technology developers could use the questions to evaluate these services from an ethical perspective. It does not require prior knowledge. The method we used of literature review, identification of themes, and development of questions can be transferred to other technologies. However, this is also where its limitations can be found. This method is based on a scoping literature review and does not include stakeholder engagement: ideally, the PEC should be developed in conversation with technology developers, clinicians, and patients and their whānau (family), including Māori and non-Māori participants and Māori consultation. Through this process, other relevant values and principles that were not included based on the literature review may be identified. We conducted a scoping review of the international literature and added documents that applied specifically to NZ through a manual search – stakeholder engagement could ensure the checklist is even more focused on the local context.
Strengths and weaknesses in relation to other studies
Heintz et al. (2015) and Assasi et al. (2016) have also constructed ethical evaluation tools for health care technology.56,57 Heintz et al. included questions on equality and justice, autonomy, privacy, and cost-effectiveness as ethical themes, and reviewed resources and organisation, professional values, and long-term consequences.56 Assasi et al. did not provide clear instructions on how to perform an ethical analysis but rather assumed ‘that HTA team members who are responsible for the analysis of ethics data have the knowledge and skills to take on this important task’.57 Overall, there are two quite different approaches to ethical analysis and evaluation of health care technologies among the different frameworks.10 One requires developers and ethics experts to conduct an in-depth examination of ethical tensions and challenges. The other approach provides technology-specific, practical questions that are accessible to a broader audience, including technology developers, clinicians, and patients. We opted for the latter, where the weakness may be that some of the depth of the ethical reflection will be lost. However, creating an ethical checklist does not necessarily mean it should be reduced to a ‘tick the box’ exercise. Rather, we would like to see it being used to identify areas for improvement to start a process of meaningful change from a technology perspective and to encourage public debate on what ethical, high-quality virtual care should look like.
Implications for health policy and clinical practice
DTC virtual consultation services still represent only a small section of the current NZ telehealth landscape. However, new and emerging telehealth solutions do not always fit into existing evaluative frameworks, and in this sense, these services provide a useful case study showing how we can respond in a timely and agile manner to new developments. The current MCNZ and RNZCGP statements on telehealth have been integrated into our checklist. We argue the checklist can have merit as an integrated component of (future) clinical and technological assessment frameworks of DTC virtual consultation services, thus ensuring ethical considerations are taken into account, and are accessible to a broad audience. Moreover, the method we used (ideally expanded with stakeholder engagement) can serve as a model to further extend such ethical evaluation to other digital health services.
Unanswered questions and future research
New digital health technologies are being developed and implemented at a fast pace without having proper regulation and evaluation frameworks in place. These technologies present new clinical, legal, and ethical challenges and risks. Further research should focus on how we can put frameworks in place to ensure the development and implementation of digital health technology that is ethical and safe, improves the quality of care provided to patients, and reduces inequities. This will require building bridges between clinical and technological approaches.
Conclusion
This project has developed a framework of six themes and 25 questions to assess the ethical aspects of DTC virtual consultation services based on the results of a scoping literature review. The resulting PEC is tailored to the New Zealand context and allows general practitioners, other health care workers, and patients to screen teleconsultation services without requiring extensive ethical expertise. Ultimately, this PEC can improve the quality of virtual care, which will only become more relevant in the coming years.
Data availability
A supplementary file with a summary and theme identification for each of the 49 selected articles is available and can be requested from the authors.
Declaration of funding
Madeleine Reid received a 2022 Ethics Summer Studentship grant from the Health Research Council New Zealand for this project.
Acknowledgements
We acknowledge Thelma Fisher, Bioethics Librarian, who assisted in developing our PRISMA scoping review search strategy. We would also like to thank Chris Paton, Senior Lecturer, for his contribution to the initial design of the study.
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