Ethical and Information Governance Considerations for Promoting Digital Social Interventions in Primary Care.

Promoting online peer support beyond the informal sector to statutory health services requires ethical considerations and evidence-based knowledge about its impact on patients, health care professionals, and the wider health care system. Evidence on the effectiveness of digital interventions in primary care is sparse, and definitive guidance is lacking on the ethical concerns arising from the use of social media as a means for health-related interventions and research. Existing literature examining ethical issues with digital interventions in health care mainly focuses on apps, electronic health records, wearables, and telephone or video consultations, without necessarily covering digital social interventions, and does not always account for primary care settings specifically. Here we address the ethical and information governance aspects of undertaking research on the promotion of online peer support to patients by primary care clinicians, related to medical and public health ethics.

'Can you recommend any good STI apps?' A review of content, accuracy and comprehensiveness of current mobile medical applications for STIs and related genital infections.

OBJECTIVE: Seeking sexual health information online is common, and provision of mobile medical applications (apps) for STIs is increasing. Young people, inherently at higher risk of STIs, are avid users of technology, and apps could be appealing sources of information. We undertook a comprehensive review of content and accuracy of apps for people seeking information about STIs. METHODS: Search of Google Play and iTunes stores using general and specific search terms for apps regarding STIs and genital infections (except HIV), testing, diagnosis and management, 10 September 2014 to 16 September 2014. We assessed eligible apps against (1) 19 modified Health on The Net (HON) Foundation principles; and (2) comprehensiveness and accuracy of information on STIs/genital infections, and their diagnosis and management, compared with corresponding National Health Service STI information webpage content. RESULTS: 144/6642 apps were eligible. 57 were excluded after downloading. 87 were analysed. Only 29% of apps met ≥6 HON criteria. Content was highly variable: 34/87 (39%) covered one or two infections; 40 (46%) covered multiple STIs; 5 (6%) focused on accessing STI testing. 13 (15%) were fully, 46 (53%) mostly and 28 (32%) partially accurate. 25 (29%) contained ≥1 piece of potentially harmful information. Apps available on both iOS and Android were more accurate than single-platform apps. Only one app provided fully accurate and comprehensive information on chlamydia. CONCLUSIONS: Marked variation in content, quality and accuracy of available apps combined with the nearly one-third containing potentially harmful information risks undermining potential benefits of an e-Health approach to sexual health and well-being.

'Autism and the good life': a new approach to the study of well-being.

Medical, psychological, educational and social interventions to modify the behaviour of autistic people are only justified if they confer benefit on those people. However, it is not clear how 'benefit' should be understood. Most such interventions are justified by referring to the prospect that they will effect lasting improvements in the well-being and happiness of autistic people, so they can lead good lives. What does a good life for an autistic person consist in? Can we assume that his or her well-being is substantively the same as the well-being of non-autistic individuals? In this paper, we argue that, as it stands, the current approach to the study of well-being is for the most part unable to answer these questions. In particular, much effort is needed in order to improve the epistemology of well-being, especially so if we wish this epistemology to be 'autism-sensitive'. Towards the end of the paper, we sketch a new, autism-sensitive approach and apply it in order to begin answering our initial questions.

The eClinical Care Pathway Framework: a novel structure for creation of online complex clinical care pathways and its application in the management of sexually transmitted infections.

BACKGROUND: Despite considerable international eHealth impetus, there is no guidance on the development of online clinical care pathways. Advances in diagnostics now enable self-testing with home diagnosis, to which comprehensive online clinical care could be linked, facilitating completely self-directed, remote care. We describe a new framework for developing complex online clinical care pathways and its application to clinical management of people with genital chlamydia infection, the commonest sexually transmitted infection (STI) in England. METHODS: Using the existing evidence-base, guidelines and examples from contemporary clinical practice, we developed the eClinical Care Pathway Framework, a nine-step iterative process. Step 1: define the aims of the online pathway; Step 2: define the functional units; Step 3: draft the clinical consultation; Step 4: expert review; Step 5: cognitive testing; Step 6: user-centred interface testing; Step 7: specification development; Step 8: software testing, usability testing and further comprehension testing; Step 9: piloting. We then applied the Framework to create a chlamydia online clinical care pathway (Online Chlamydia Pathway). RESULTS: Use of the Framework elucidated content and structure of the care pathway and identified the need for significant changes in sequences of care (Traditional: history, diagnosis, information versus Online: diagnosis, information, history) and prescribing safety assessment. The Framework met the needs of complex STI management and enabled development of a multi-faceted, fully-automated consultation. CONCLUSION: The Framework provides a comprehensive structure on which complex online care pathways such as those needed for STI management, which involve clinical services, public health surveillance functions and third party (sexual partner) management, can be developed to meet national clinical and public health standards. The Online Chlamydia Pathway's standardised method of collecting data on demographics and sexual behaviour, with potential for interoperability with surveillance systems, could be a powerful tool for public health and clinical management.

Non-randomised feasibility study testing a primary care intervention to promote engagement in an online health community for adults with troublesome asthma: protocol.

INTRODUCTION: In the UK, approximately 4.3 million adults have asthma, with one-third experiencing poor asthma control, affecting their quality of life, and increasing their healthcare use. Interventions promoting emotional/behavioural self-management can improve asthma control and reduce comorbidities and mortality. Integration of online peer support into primary care services to foster self-management is a novel strategy. We aim to co-design and evaluate an intervention for primary care clinicians to promote engagement with an asthma online health community (OHC). Our protocol describes a 'survey leading to a trial' design as part of a mixed-methods, non-randomised feasibility study to test the feasibility and acceptability of the intervention. METHODS AND ANALYSIS: Adults on the asthma registers of six London general practices (~3000 patients) will be invited to an online survey, via text messages. The survey will collect data on attitudes towards seeking online peer support, asthma control, anxiety, depression, quality of life, information on the network of people providing support with asthma and demographics. Regression analyses of the survey data will identify correlates/predictors of attitudes/receptiveness towards online peer support. Patients with troublesome asthma, who (in the survey) expressed interest in online peer support, will be invited to receive the intervention, aiming to reach a recruitment target of 50 patients. Intervention will involve a one-off, face-to-face consultation with a practice clinician to introduce online peer support, sign patients up to an established asthma OHC, and encourage OHC engagement. Outcome measures will be collected at baseline and 3 months post intervention and analysed with primary care and OHC engagement data. Recruitment, intervention uptake, retention, collection of outcomes, and OHC engagement will be assessed. Interviews with clinicians and patients will explore experiences of the intervention. ETHICS AND DISSEMINATION: Ethical approval was obtained from a National Health Service Research Ethics Committee (reference: 22/NE/0182). Written consent will be obtained before intervention receipt and interview participation. Findings will be shared via dissemination to general practices, conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05829265.

Why national eHealth programs need dead philosophers: Wittgensteinian reflections on policymakers' reluctance to learn from history.

CONTEXT: Policymakers seeking to introduce expensive national eHealth programs would be advised to study lessons from elsewhere. But these lessons are unclear, partly because a paradigm war (controlled experiment versus interpretive case study) is raging. England's $20.6 billion National Programme for Information Technology (NPfIT) ran from 2003 to 2010, but its overall success was limited. Although case study evaluations were published, policymakers appeared to overlook many of their recommendations and persisted with some of the NPfIT's most criticized components and implementation methods. METHODS: In this reflective analysis, illustrated by a case fragment from the NPfIT, we apply ideas from Ludwig Wittgenstein's postanalytic philosophy to justify the place of the "n of 1" case study and consider why those in charge of national eHealth programs appear reluctant to learn from such studies. FINDINGS: National eHealth programs unfold as they do partly because no one fully understands what is going on. They fail when this lack of understanding becomes critical to the programs' mission. Detailed analyses of the fortunes of individual programs, articulated in such a way as to illuminate the contextualized talk and action ("language games") of multiple stakeholders, offer unique and important insights. Such accounts, portrayals rather than models, deliver neither statistical generalization (as with experiments) nor theoretical generalization (as with multisite case comparisons or realist evaluations). But they do provide the facility for heuristic generalization (i.e., to achieve a clearer understanding of what is going on), thereby enabling more productive debate about eHealth programs' complex, interdependent social practices. A national eHealth program is best conceptualized not as a blueprint and implementation plan for a state-of-the-art technical system but as a series of overlapping, conflicting, and mutually misunderstood language games that combine to produce a situation of ambiguity, paradox, incompleteness, and confusion. But going beyond technical "solutions" and engaging with these language games would clash with the bounded rationality that policymakers typically employ to make their eHealth programs manageable. This may explain their limited and contained response to the nuanced messages of in-depth case study reports. CONCLUSION: The complexity of contemporary health care, combined with the multiple stakeholders in large technology initiatives, means that national eHealth programs require considerably more thinking through than has sometimes occurred. We need fewer grand plans and more learning communities. The onus, therefore, is on academics to develop ways of drawing judiciously on the richness of case studies to inform and influence eHealth policy, which necessarily occurs in a simplified decision environment.

Acceptability of financial incentives to improve health outcomes in UK and US samples.

In an online study conducted separately in the UK and the US, participants rated the acceptability and fairness of four interventions: two types of financial incentives (rewards and penalties) and two types of medical interventions (pills and injections). These were stated to be equally effective in improving outcomes in five contexts: (a) weight loss and (b) smoking cessation programmes, and adherence in treatment programmes for (c) drug addiction, (d) serious mental illness and (e) physiotherapy after surgery. Financial incentives (weekly rewards and penalties) were judged less acceptable and to be less fair than medical interventions (weekly pill or injection) across all five contexts. Context moderated the relative preference between rewards and penalties: participants from both countries favoured rewards over penalties in weight loss and treatment for serious mental illness. Only among US participants was this relative preference moderated by perceived responsibility of the target group. Overall, participants supported funding more strongly for interventions when they judged members of the target group to be less responsible for their condition, and vice versa. These results reveal a striking similarity in negative attitudes towards the use of financial incentives, rewards as well as penalties, in improving outcomes across a range of contexts, in the UK and the USA. The basis for such negative attitudes awaits further study.

Personal financial incentives in health promotion: where do they fit in an ethic of autonomy?

AIM: This paper reviews the ethical controversy concerning the use of monetary incentives in health promotion, focussing specifically on the arguments relating to the impact on personal autonomy of such incentives. BACKGROUND: Offering people small amounts of money in the context of health promotion and medical care has been attempted in a number of settings in recent years. This use of personal financial incentives has attracted a degree of ethical controversy. One form of criticism is that such schemes interfere with the autonomy of the patient or citizen in an illegitimate way. METHODS: This paper presents a thematic analysis of the main arguments concerning personal autonomy and the use of monetary incentives in behaviour change. RESULTS: The main moral objections to the uses of incentives are that they may be in general or in specific instances paternalistic, coercive, involve bribery, or undermine the agency of the person. CONCLUSION: While incentive schemes may engage these problems on occasion, there is no good reason to think that they do so inherently and of necessity. We need better behavioural science evidence to understand how incentives work, in order to evaluate their moral effects in practice.

Epistemologic inquiries in evidence-based medicine.

BACKGROUND: Since the term "evidence-based medicine" (EBM) first appeared in the scientific literature in 1991, the concept has had considerable influence in many parts of the world. Most professional societies, the public,and funding agencies have accepted EBM with remarkable enthusiasm. The concept of evidence-based practice is now applied in management, education, criminology, and social work. Yet, EBM has attracted controversy: its critics allege that EBM uses a narrow concept of evidence and a naive conception of the relationships between evidence, theory, and practice. They also contend that EBM presents itself as a radical restructuring of medical knowledge that discredits more traditional ways of knowing in medicine, largely in the interests of people with a particular investment in the enterprise of large-scale clinical trials. Because EBM proposes aspecific relationship between theory, evidence, and knowledge, its theoretical basis can be understood as an epistemological system. Undertaking epistemological inquiry is important because the adoption of a particular epistemological view defines how science is conducted. METHODS: In this paper, we challenge this critical view of EBM by examining how EBM fits into broad epistemological debates within the philosophy of science. We consider how EBM relates to some classical debates regarding the nature of science and knowledge. We investigate EBM from the perspective of major epistemological theories (logical-positivism/inductivism, deductivism/falsificationism/theory-ladeness of observations, explanationism/holism, instrumentalism, underdetermination theory by evidence). RESULTS: We first explore the relationship between evidence and knowledge and discuss philosophical support for the main way that evidence is used in medicine: (1) in the philosophical tradition that "rational thinkers respect their evidence," we show that EBM refers to making medical decisions that are consistent with evidence, (2) as a reliable sign, symptom, or mark to enhance reasonableness or truthfulness of some particular claim ("evidence as a guide to truth"), and (3) to serve as a neutral arbiter among competing views. Our analysis indicates that EBM does not have a rigorous epistemological stance. In fact, EBM enthusiastically draws on all major traditions of philosophical theories of scientific evidence. CONCLUSIONS: Our findings indicate that EBM should not be construed as a new scientific or philosophical theory that changes the nature of medicine or our understanding thereof. Rather, we should consider EBM as a continuously evolving heuristic structure for optimizing clinical practice.

Virtual community consultation? Using the literature and weblogs to link community perspectives and health technology assessment.

BACKGROUND: Community views, expressed in social impact assessments and collected through community consultation, should play an important role in health technology assessment (HTA). Yet HTA methodologists have been slow to include outcomes of these forms of inquiry in analyses, in part because collecting community views is time-consuming and resource intensive. OBJECTIVE: To explore how community views sourced from published studies, grey literature and informal internet web pages can inform HTA. METHODS: A technology reviewed by Adelaide HTA in 2004 was selected: retinal photography for detection of diabetic retinopathy. Published literature, 'grey' literature and informal web pages were searched to examine the availability of evidence about service community and user community views with respect to this technology. Particular efforts were made to source evidence relating to rural, remote and Aboriginal populations. RESULTS: We found that journal articles, reports from the grey literature and informal internet web pages (including blogs and discussion forums) can provide valuable insight into community views. Although there was little empirical evidence relating to the experience of diabetes and diabetes management in rural, remote and Aboriginal communities, there were indications that some evidence may be transferable from other populations. CONCLUSIONS: Community perspectives on selected health technologies can be gauged from available resources in published and grey literature and perspectives collected in this way can provide insight into whether the introduction of the technology would be acceptable to the community. The limitations of this approach are discussed.

Written work: the social functions of Research Ethics Committee letters.

Research Ethics Committees (RECs) are increasingly institutionalised as a feature of research practice, but have remained strangely neglected by social scientists. In this paper, we argue that analysis of letters from RECs to researchers offers important insights into how RECs operate. We report a traditional content analysis and an ethnographic content analysis of 141 letters to researchers, together with an analysis of the organisational and institutional arrangements for RECs in the UK. We show that REC letters perform three important social functions. First, they define what is deemed by a REC to be ethical practice for any particular application, and confer authority on that definition. They do this actively, through comments on particular aspects of proposals, and passively, through silences about other aspects. Second, they provide an account of the work of the REC, and function as a form of institutional display. Third, they specify the nature of the relationship between the REC and the applicant, casting the applicant in a supplicant role and requiring forms of docility. Writing and reading REC letters require highly specific competences, and engage both parties in a Bourdieusian "game" that discourages challenges from researchers. The authority of RECs' decisions derives not from their appeal to the moral superiority of any ethical position, but through their place in the organisational structure and the social positioning of the parties to the process thus implied. Letters are the critical point at which RECs act on researchers and their projects.

Beyond "misunderstanding": written information and decisions about taking part in a genetic epidemiology study.

Although the need to obtain "informed" consent is institutionalised as a principle of ethical practice in research, there is persistent evidence that the meanings people attribute to research tend to be substantially at variance with what might be deemed "correct". One dominant account in the ethics literature has been to treat apparent "misunderstandings" as a technical problem, to be fixed through improving the written information given to research candidates. We aimed to explore theoretically and empirically the role of written information in "informing" participants in research. We conducted a qualitative study involving semi-structured interviews with 29 unpaid healthy volunteers who took part in a genetic epidemiology study in Leicestershire, UK. Data analysis was based on the constant comparative method. We found that people may make sense of information about research, including the content of written information, in complex and unexpected ways. Many participants were unable to identify precisely the aim of the study in which they had participated, saw their participation as deriving from a moral imperative, and had understandings of issues such as feedback of DNA results that were inconsistent with what had been explained in the written information about the study. They had high levels of confidence in the organisations conducting the research, and consequently had few concerns about their participation. These findings, which suggest that some "misunderstanding" may be a persistent and incorrigible feature of people's participation in research, raise questions about the principle of informed consent and about the role of written information. These questions need to be addressed through engagement and dialogue between the research, research participants, social science, and ethics communities.

Scientific or social priorities for brain science?--making a difference.

How we ought to prioritise research spending is a difficult problem. On the one hand, we may wish to target research resources on the problems of most pressing social need, but this may be to pose questions which science is not in a position to answer. On the other hand, we may wish to target research resources on the problems which are for scientific reasons most interesting or most tractable, accepting that this might not be to target the most pressing social needs. Current thinking is that research priorities can be set most fairly not by specifying principles of justice in research spending, but rather by making the decision-making process more open, transparent and perhaps democratic. This can involve patient or citizen involvement in research programme design or research funding decision-making.

The eSexual Health Clinic system for management, prevention, and control of sexually transmitted infections: exploratory studies in people testing for Chlamydia trachomatis.

BACKGROUND: Self-directed and internet-based care are key elements of eHealth agendas. We developed a complex online clinical and public health intervention, the eSexual Health Clinic (eSHC), in which patients with genital chlamydia are diagnosed and medically managed via an automated online clinical consultation, leading to antibiotic collection from a pharmacy. Partner notification, health promotion, and capture of surveillance data are integral aspects of the eSHC. We aimed to assess the safety and feasibility of the eSHC as an alternative to routine care in non-randomised, exploratory proof-of-concept studies. METHODS: Participants were untreated patients with chlamydia from genitourinary medicine clinics, untreated patients with chlamydia from six areas in England in the National Chlamydia Screening Programme's (NCSP) online postal testing service, or patients without chlamydia tested in the same six NCSP areas. All participants were aged 16 years or older. The primary outcome was the proportion of patients with chlamydia who consented to the online chlamydia pathway who then received appropriate clinical management either exclusively through online treatment or via a combination of online management and face-to-face care. We captured adverse treatment outcomes. FINDINGS: Between July 21, 2014, and March 13, 2015, 2340 people used the eSHC. Of 197 eligible patients from genitourinary medicine clinics, 161 accessed results online. Of the 116 who consented to be included in the study, 112 (97%, 95% CI 91-99) received treatment, and 74 of those were treated exclusively online. Of the 146 eligible NCSP patients, 134 accessed their results online, and 105 consented to be included. 93 (89%, 95% CI 81-94) received treatment, and 60 were treated exclusively online. In both groups, median time to collection of treatment was within 1 day of receiving their diagnosis. 1776 (89%) of 1936 NCSP patients without chlamydia accessed results online. No adverse events were recorded. INTERPRETATION: The eSHC is safe and feasible for management of patients with chlamydia, with preliminary evidence of similar treatment outcomes to those in traditional services. This innovative model could help to address growing clinical and public health needs. A definitive trial is needed to assess the efficacy, cost-effectiveness, and public health impact of this intervention. FUNDING: UK Clinical Research Collaboration.

Antiretroviral treatment for injecting drug users in developing and transitional countries 1 year before the end of the "Treating 3 million by 2005. Making it happen. The WHO strategy" ("3 by 5").

OBJECTIVE: To describe and estimate the availability of antiretroviral treatment (ART) to injecting drug users (IDUs) in developing and transitional countries. METHODS: Literature review of grey and published literature and key informants' communications on the estimated number of current/former injecting drug users (IDUs) receiving ART and the proportion of human immunodeficiency virus (HIV) attributed to injecting drug use (IDU), the number of people in ART and in need of ART, the number of people living with HIV/acquired immunodeficiency syndrome (AIDS) (PLWHA) and the main source of ART. RESULTS: Data on former/current IDUs on ART were available from 50 countries (in 19 countries: nil IDUs in treatment) suggesting that approximately 34 000 IDUs were receiving ART by the end of 2004, of whom 30 000 were in Brazil. In these 50 countries IDUs represent approximately 15% of the people in ART. In Eastern European and Central Asia IDU are associated with > 80% of HIV cases but only approximately 2000 (14%) of the people in ART. In South and South-East Asia there were approximately 1700 former/current IDUs receiving ART ( approximately 1.8% of the people in ART), whereas the proportion of HIV cases associated to IDU is > 20% in five countries (and regionally ranges from 4% to 75%). DISCUSSION: There is evidence that the coverage of ART among current/former IDUs is proportionally substantially less than other exposure categories. Ongoing monitoring of ART by exposure and population subgroups is critical to ensuring that scale-up is equitable, and that the distribution of ART is, at the very least, transparent.

Individual freedom versus collective responsibility: an ethicist's perspective.

Philosophical theories of collective action have produced a number of alternative accounts of the rationality and morality of self-interest and altruism. These have obvious applications to communicable disease control, the avoidance of antibiotic resistance, the responsibility of healthcare professionals to patients with serious communicable diseases, and the sharing of personal data in epidemiological research.