Meaningful patient and public involvement in digital health innovation, implementation and evaluation: A systematic review.

INTRODUCTION: The importance of meaningfully involving patients and the public in digital health innovation is widely acknowledged, but often poorly understood. This review, therefore, sought to explore how patients and the public are involved in digital health innovation and to identify factors that support and inhibit meaningful patient and public involvement (PPI) in digital health innovation, implementation and evaluation. METHODS: Searches were undertaken from 2010 to July 2020 in the electronic databases MEDLINE, EMBASE, PsycINFO, CINAHL, Scopus and ACM Digital Library. Grey literature searches were also undertaken using the Patient Experience Library database and Google Scholar. RESULTS: Of the 10,540 articles identified, 433 were included. The majority of included articles were published in the United States, United Kingdom, Canada and Australia, with representation from 42 countries highlighting the international relevance of PPI in digital health. 112 topic areas where PPI had reportedly taken place were identified. Areas most often described included cancer (n = 50), mental health (n = 43), diabetes (n = 26) and long-term conditions (n = 19). Interestingly, over 133 terms were used to describe PPI; few were explicitly defined. Patients were often most involved in the final, passive stages of an innovation journey, for example, usability testing, where the ability to proactively influence change was severely limited. Common barriers to achieving meaningful PPI included data privacy and security concerns, not involving patients early enough and lack of trust. Suggested enablers were often designed to counteract such challenges. CONCLUSIONS: PPI is largely viewed as valuable and essential in digital health innovation, but rarely practised. Several barriers exist for both innovators and patients, which currently limits the quality, frequency and duration of PPI in digital health innovation, although improvements have been made in the past decade. Some reported barriers and enablers such as the importance of data privacy and security appear to be unique to PPI in digital innovation. Greater efforts should be made to support innovators and patients to become meaningfully involved in digital health innovations from the outset, given its reported benefits and impacts. Stakeholder consensus on the principles that underpin meaningful PPI in digital health innovation would be helpful in providing evidence-based guidance on how to achieve this. PATIENT OR PUBLIC CONTRIBUTION: This review has received extensive patient and public contributions with a representative from the Patient Experience Library involved throughout the review's conception, from design (including suggested revisions to the search strategy) through to article production and dissemination. Other areas of patient and public contributor involvement include contributing to the inductive thematic analysis process, refining the thematic framework and finalizing theme wording, helping to ensure relevance, value and meaning from a patient perspective. Findings from this review have also been presented to a variety of stakeholders including patients, patient advocates and clinicians through a series of focus groups and webinars. Given their extensive involvement, the representative from the Patient Experience Library is rightly included as an author of this review.

Use and usability of GP online services: a mixed-methods sequential study, before and during the COVID-19 pandemic, based on qualitative interviews, analysis of routine eConsult usage and feedback data, and assessment of GP websites in Devon and Cornwall, England.

OBJECTIVES: We explored use and usability of general practitioner (GP) online services. SETTING: Devon and Cornwall, England. DESIGN: Mixed-methods sequential study based on qualitative interviews, analysis of routine eConsult usage and feedback data, and assessment of GP websites. METHODS: First, we interviewed 32 staff and 18 patients from seven practices in June 2018. Second, we used routinely collected consultation meta-data and, third, patient feedback data for all practices using eConsult from June 2018 to March 2021. Lastly, we examined GP websites' usability in January 2020 and September 2021. RESULTS: Interviews suggested practices infrequently involved patients in eConsult implementation. Some patients 'gamed' the system to achieve what they wanted. Usage data showed a major increase in eConsult resulting from COVID-19. Women used eConsult twice as much as men. Older had similar eConsult consultation rates to younger patients. Patient feedback forms were completed for fewer than 3% of consultations. Patients were mostly satisfied with eConsult but some had concerns about its length and repetitiveness, lack of continuity over time and between eConsult and medical records. We did not find clear evidence that patients' suggested improvements were acted on. Finally, few GP websites met accessibility guidelines and may hinder access to online national services such as eConsult. CONCLUSION: Given that, face to face, older people consult more, usage data suggest that older people have reduced online access. That the female-to-male ratio of eConsult use use was even greater than 'traditional' face-to-face ratio was unexpected and needs further research. Although eConsult collects and uses routine patient feedback to improve the system, more open systems for patient feedback, such as Care Opinion, may be more effective in helping online systems evolve. Lastly, we question the need for GP websites and suggest that national or regional services are better placed to maintain accessible services.

Rapid systematic review of respiratory rate as a vital sign of clinical deterioration in COVID-19.

OBJECTIVES: This meta-analysis aimed to establish a clinical evidence base for respiratory rate (RR) as a single predictor of early-onset COVID-19. The review also looked to determine the practical implementation of mobile respiratory rate measuring devices where information was available. METHODS: We focused on domestic settings with older adults. Relevant studies were identified through MEDLINE, Embase, and CENTRAL databases. A snowballing method was also used. Articles published from the beginning of the COVID-19 pandemic (2019) until Feb 2022 were selected. Databases were searched for terms related to COVID-19 and respiratory rate measurements in domestic patients. RESULTS: A total of 2,889 articles were screened for relevant content, of which 60 full-text publications were included. We compared the Odds Ratios and statistically significant results of both vital signs. CONCLUSION: Multinational studies across dozens of countries have shown respiratory rate to have predictive accuracy in detecting COVID-19 deterioration. However, considerable variability is present in the data, making it harder to be sure about the effects. There is no meaningful difference in data quality in terms of variability (95% CI intervals) between vital signs as predictors of decline in COVID-19 patients. Contextual and economic factors will likely determine the choice of measurement used.

GP trainee responses to using SHERPA for multimorbidity consultations.

UK general practitioner (GP) trainees are taught a consultation model which elicits the patients' main reason for consulting 'today'. This approach will often miss important issues for the increasing number of patients with multimorbidity. We developed the SHERPA model as a person-centred biopsychosocial framework for consulting patients with multimorbidity to address this. We aimed to examine GPs trainees' responses to SHERPA when integrated into their vocational training. The research design was qualitative and participants were GPs trainees in vocational training from one UK training location. GP trainees were introduced to the SHERPA model through interactive workshops. Qualitative data were collected from 16 participants, through four hours of teaching observation, 24 feedback templates, six practical applications of SHERPA and eight one-to-one interviews. Data were transcribed, and, using the Framework approach, systematically analysed, focussing on trainees' learning and application of the model. The results demonstrated that all participants engaged well with the teaching sessions, brought observations from their own experience, and reflected on particularly complex consultations. Half of the participants applied SHERPA successfully with their patients, particularly repeat attenders. Barriers to this approach were: selecting appropriate patients; perceived time pressure; lack of familiarity using the model; viewing SHERPA as 'additional', rather than integral, to shared decision-making in complex situations. The SHERPA model was viewed as helpful by these GP trainees for patients with whom they had established a relationship. Earlier introduction and regular support from trainers, where trainees reflect on experience of SHERPA, could increase confidence in using this method.

'You're just a locum': professional identity and temporary workers in the medical profession.

Internationally, there has been substantial growth in temporary working, including in the medical profession where temporary doctors are known as locums. There is little research into the implications of temporary work in health care. In this paper, we draw upon theories concerning the sociology of the medical profession to examine the implications of locum working for the medical profession, healthcare organisations and patient safety. We focus particularly on the role of organisations in professional governance and the positioning of locums as peripheral to or outside the organisation, and the influence of intergroup relationships (in this case between permanent and locum doctors) on professional identity. Qualitative semi-structured interviews were conducted between 2015 and 2017 in England with 79 participants including locum doctors, locum agency staff, and representatives of healthcare organisations who use locums. An abductive approach to analysis combined inductive coding with deductive, theory-driven interpretation. Our findings suggest that locums were perceived to be inferior to permanently employed doctors in terms of quality, competency and safety and were often stigmatised, marginalised and excluded. The treatment of locums may have negative implications for collegiality, professional identity, group relations, team functioning and the way organisations deploy and treat locums may have important consequences for patient safety.

Barriers and Enablers in Implementing Electronic Consultations in Primary Care: Scoping Review.

BACKGROUND: Often promoted as a way to address increasing demands, improve patient accessibility, and improve overall efficiency, electronic consultations are becoming increasingly common in primary care, particularly in light of the current COVID-19 pandemic. However, despite their increasing use, a theoretically informed understanding of the factors that support and inhibit their effective implementation is severely limited. OBJECTIVE: With this scoping review, we sought to identify the factors that support and inhibit the implementation of electronic consultations in primary care. METHODS: In total, 5 electronic databases (PubMed, Medline, Embase, CINAHL, and PsycINFO) were systematically searched for studies published in 2009-2019 that explored the impact and/or implementation of electronic consultations in primary care. Database searches were supplemented by reference list and grey literature searches. Data were analyzed using inductive thematic analysis and synthesized using Normalization Process Theory (NPT). RESULTS: In total, 227 articles were initially identified and 13 were included in this review. The main factors found to hinder implementation included awareness and expectations; low levels of engagement; perceived suitability for all patient groups, conditions, and demographics; cost; and other contextual factors. Reports of information technology reliability and clinical workload duplication (as opposed to reduction) also appeared detrimental. Conversely, the development of protocols and guidance; patient and staff education; strategic marketing; and patient and public involvement were all identified as beneficial in facilitating electronic consultation implementation. CONCLUSIONS: This review highlights the need for proactive engagement with patients and staff to facilitate understanding and awareness, process optimization, and delivery of coherent training and education that maximizes impact and success. Although the necessity to use online methods during the COVID-19 pandemic may have accelerated awareness, concerns over workload duplication and inequality of access may remain. Future research should explore health inequalities in electronic consultations and their economic impacts from multiple perspectives (eg, patient, professional, and commissioner) to determine their potential value. Further work to identify the role of meaningful patient involvement in digital innovation, implementation, and evaluation is also required following the rapid digitization of health and social care.

Reviving clinical governance? A qualitative study of the impact of professional regulatory reform on clinical governance in healthcare organisations in England.

BACKGROUND: Until recently, processes of professional regulation and organisational clinical governance in the UK have been largely separate. However, the introduction of medical revalidation in 2012 means that all doctors have to demonstrate periodically to the regulator that they are up to date and fit to practise, and as part of this process doctors must engage with clinical governance activities in the organisations in which they work. OBJECTIVE: To explore how the recent implementation of medical revalidation has affected the arrangements for clinical governance in healthcare organisations in England. DESIGN: Thematic analysis of interviews with 62 senior clinicians and non-clinicians in management or senior administrative roles, from a range of healthcare organisations in England. RESULTS: Revalidation has engendered changes to clinical governance systems, resulting in: increased doctor engagement with clinical governance activities; new or improved systems for access to clinical governance data for doctors and leaders within healthcare organisations; and more leverage - through the Responsible Officer role - to enforce engagement with clinical governance. Organisational context has been an important mediator of the impact of revalidation on clinical governance. CONCLUSION: Revalidation has increased alignment between systems for organisational and professional oversight and accountability, resulting in increased scrutiny of clinical practice. However, it is still a matter of conjecture whether this will in turn lead to improvements in medical performance.

Reflective Practice for Patient Benefit: An Analysis of Doctors' Appraisal Portfolios in Scotland.

INTRODUCTION: Reflective practice has become the cornerstone of continuing professional development for doctors, with the expectation that it helps to develop and sustain the workforce for patient benefit. Annual appraisal is mandatory for all practicing doctors in the United Kingdom as part of medical revalidation. Doctors submit a portfolio of supporting information forming the basis of their appraisal discussion where reflection on the information is mandated and evaluated by a colleague, acting as an appraiser. METHODS: Using an in-depth case study approach, 18 online portfolios in Scotland were examined with a template developed to record the types of supporting information submitted and how far these showed reflection and/or changes to practice. Data from semistructured interviews with the doctors (n = 17) and their appraisers (n = 9) were used to contextualize and broaden our understanding of the portfolios. RESULTS: Portfolios generally showed little written reflection, and most doctors were unenthusiastic about documenting reflective practice. Appraisals provided a forum for verbal reflection, which was often detailed in the appraisal summary. Portfolio examples showed that reflecting on continued professional development, audits, significant events, and colleague multisource feedback were sometimes considered to be useful. Reflecting on patient feedback was seen as less valuable because feedback tended to be uncritical. DISCUSSION: The written reflection element of educational portfolios needs to be carefully considered because it is clear that many doctors do not find it a helpful exercise. Instead, using the portfolio to record topics covered by a reflective discussion with a facilitator would not only prove more amenable to many doctors but would also allay fears of documentary evidence being used in litigation.

Reforming regulatory relationships: The impact of medical revalidation on doctors, employers, and the General Medical Council in the United Kingdom.

In 2012, medical regulation in the United Kingdom was fundamentally changed by the introduction of revalidation - a process by which all licensed doctors are required to regularly demonstrate that they are up to date and fit to practice in their chosen field and are able to provide a good level of care. This paper examines the implications of revalidation on the structure, governance, and performance management of the medical profession, as well as how it has changed the relationships between the regulator, employer organizations, and the profession. We conducted semi-structured interviews with clinical and non-clinical staff from a range of healthcare organizations. Our research suggests that organizations have become intermediaries in the relationship between the General Medical Council and doctors, enacting regulatory processes on its behalf and extending regulatory surveillance and oversight at local level. Doctors' autonomy has been reduced as they have become more accountable to and reliant on the organizations that employ them.

Policing the profession? Regulatory reform, restratification and the emergence of Responsible Officers as a new locus of power in UK medicine.

Doctors' work and the changing, contested meanings of medical professionalism have long been a focus for sociological research. Much recent attention has focused on those doctors working at the interface between healthcare management and medical practice, with such 'hybrid' doctor-managers providing valuable analytical material for exploring changes in how medical professionalism is understood. In the United Kingdom, significant structural changes to medical regulation, most notably the introduction of revalidation in 2012, have created a new hybrid group, Responsible Officers (ROs), responsible for making periodic recommendations about the on-going fitness to practise medicine of all other doctors in their organisation. Using qualitative data collected in a 2015 survey with 374 respondents, 63% of ROs in the UK, this paper analyses the RO role. Our findings show ROs to be a distinct emergent group of hybrid professionals and as such demonstrate restructuring within UK medicine. Occupying a position where multiple agendas converge, ROs' work expands professional regulation into the organisational sphere in new ways, as well as creating new lines of continuous accountability between the wider profession and the General Medical Council as medical regulator. Our exploration of ROs' approaches to their work offers new insights into the on-going development of medical professionalism, pointing to the emergence of a distinctly regulatory hybrid professionalism shaped by co-existing professional, managerial and regulatory logics, in an era of strengthened governance and complex policy change.

The Evolving Purposes of Medical Revalidation in the United Kingdom: A Qualitative Study of Professional and Regulatory Narratives.

PURPOSE: Previous research found professionalism and regulation to be competing discourses when plans for medical revalidation in the United Kingdom were being developed in 2011. The purpose of this study was to explore how these competing discourses developed and how the perceived purposes of revalidation evolved as the policy was implemented. METHOD: Seventy-one interviews with 60 UK policy makers and senior health care leaders were conducted during the development and implementation of revalidation: 31 in 2011, 26 in 2013, and 14 in 2015. Interviewees were selected using purposeful sampling. Across all interviews, questions focused around three areas: individual roles in relation to revalidation; interviewees' understanding of revalidation, its purpose, and aims; and predictions or experiences of revalidation's impact. The first two interview sets also included questions about measurement and evaluation of revalidation. Data were analyzed using the constant comparative method to understand changes and continuities. RESULTS: Two main discourses regarding the purpose of revalidation were present across the implementation period: professionalism and regulation. The nature of the relationship between these two purposes and how they were described changed over time, with the separate discourses converging, and early concerns about actual or potential conflict being replaced by perceptions of coexistence or codependency. CONCLUSIONS: The changing nature of the discourse about revalidation suggests that early concerns about adverse consequences were not borne out as organizations and professionals engaged with implementation and experienced the realities of revalidation in practice. Reconciling professional and regulatory narratives was arguably necessary to the effective implementation of revalidation.

The implementation of medical revalidation: an assessment using normalisation process theory.

BACKGROUND: Medical revalidation is the process by which all licensed doctors are legally required to demonstrate that they are up to date and fit to practise in order to maintain their licence. Revalidation was introduced in the United Kingdom (UK) in 2012, constituting significant change in the regulation of doctors. The governing body, the General Medical Council (GMC), envisages that revalidation will improve patient care and safety. This potential however is, in part, dependent upon how successfully revalidation is embedded into routine practice. The aim of this study was to use Normalisation Process Theory (NPT) to explore issues contributing to or impeding the implementation of revalidation in practice. METHODS: We conducted seventy-one interviews with sixty UK policymakers and senior leaders at different points during the development and implementation of revalidation: in 2011 (n = 31), 2013 (n = 26) and 2015 (n = 14). We selected interviewees using purposeful sampling. NPT was used as a framework to enable systematic analysis across the interview sets. RESULTS: Initial lack of consensus over revalidation's purpose, and scepticism about its value, decreased over time as participants recognised the benefits it brought to their practice (coherence category of NPT). Though acceptance increased across time, revalidation was not seen as a legitimate part of their role by all doctors. Key individuals, notably the Responsible Officer (RO), were vital for the successful implementation of revalidation in organisations (cognitive participation category). The ease with which revalidation could be integrated into working practices varied greatly depending on the type of role a doctor held and the organisation they work for and the provision of resources was a significant variable in this (collective action category). Formal evaluation of revalidation in organisations was lacking but informal evaluation was taking place. Revalidation had not yet reached the stage where feedback was being used for improvement (reflexive monitoring category). CONCLUSIONS: Requiring all organisations to use the same revalidation model made revalidation easy to integrate into existing work for some but problematic for others. In order for revalidation to be fully embedded and successful, impeding factors, such as a lack of resources, need to be addressed.

Implementing medical revalidation in the United Kingdom: Findings about organisational changes and impacts from a survey of Responsible Officers.

Objective To describe the implementation of medical revalidation in healthcare organisations in the United Kingdom and to examine reported changes and impacts on the quality of care. Design A cross-sectional online survey gathering both quantitative and qualitative data about structures and processes for medical revalidation and wider quality management in the organisations which employ or contract with doctors (termed 'designated bodies') from the senior doctor in each organisation with statutory responsibility for medical revalidation (termed the 'Responsible Officer'). Setting United Kingdom Participants Responsible Officers in designated bodies in the United Kingdom. Five hundred and ninety-five survey invitations were sent and 374 completed surveys were returned (63%). Main outcome measures The role of Responsible Officers, the development of organisational mechanisms for quality assurance or improvement, decision-making on revalidation recommendations, impact of revalidation and mechanisms for quality assurance or improvement on clinical practice and suggested improvements to revalidation arrangements. Results Responsible Officers report that revalidation has had some impacts on the way medical performance is assured and improved, particularly strengthening appraisal and oversight of quality within organisations and having some impact on clinical practice. They suggest changes to make revalidation less 'one size fits all' and more responsive to individual, organisational and professional contexts. Conclusions Revalidation appears primarily to have improved systems for quality improvement and the management of poor performance to date. There is more to be done to ensure it produces wider benefits, particularly in relation to doctors who already perform well.

The (re)-introduction of semiotics into medical education: on the works of Thure von Uexküll.

Thure von Uexküll's reputation as a pioneer in biosemiotics and also in psychosomatic medicine is well documented. It is easy to see these disciplines reflected in his notable publications, both in English and in German. However, if one spares the time to filter through all of his articles, monographs, conference papers and editorials in English and in German, a notable gap arises in his English language publications: that of clinical education. This gap in the English language literature may seem unimportant in and of itself, but it speaks volumes when we consider the total absence of medical semiotics in the curriculum of medical schools in the English speaking world. This runs in stark contrast to the strong traditions of psychosomatic medicine in Germany, which Thure von Uexküll largely helped to instil. Do the works of Thure von Uexküll offer a possible step towards a resurrection of medical semiotics in clinical education? This chapter attempts to explore the lesser known German literature on clinical education that Thure von Uexküll produced, and explore the role semiotics can play in Medical Education in the English speaking world. While also seeking to contrast this literature with other existing approaches in British and American medical schools who have attempted to reintroduce medical humanities and reflexive thinking into clinical education.