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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
Case study research for better evaluations of complex interventions: rationale and challenges
Background: The need for better methods for evaluation in health research has been widely recognised. The ‘complexity turn’ has drawn attention to the limitations of relying on causal inference from randomised controlled trials alone for understanding whether, and under which conditions, interventions in complex systems improve health services or the public health, and what mechanisms might link interventions and outcomes. We argue that case study research—currently denigrated as poor evidence—is an under-utilised resource for not only providing evidence about context and transferability, but also for helping strengthen causal inferences when pathways between intervention and effects are likely to be non-linear. Main body: Case study research, as an overall approach, is based on in-depth explorations of complex phenomena in their natural, or real-life, settings. Empirical case studies typically enable dynamic understanding of complex challenges and provide evidence about causal mechanisms and the necessary and sufficient conditions (contexts) for intervention implementation and effects. This is essential evidence not just for researchers concerned about internal and external validity, but also research users in policy and practice who need to know what the likely effects of complex programmes or interventions will be in their settings. The health sciences have much to learn from scholarship on case study methodology in the social sciences. However, there are multiple challenges in fully exploiting the potential learning from case study research. First are misconceptions that case study research can only provide exploratory or descriptive evidence. Second, there is little consensus about what a case study is, and considerable diversity in how empirical case studies are conducted and reported. Finally, as case study researchers typically (and appropriately) focus on thick description (that captures contextual detail), it can be challenging to identify the key messages related to intervention evaluation from case study reports. Conclusion: Whilst the diversity of published case studies in health services and public health research is rich and productive, we recommend further clarity and specific methodological guidance for those reporting case study research for evaluation audiences.
Expanding video consultation services at pace and scale in scotland during the covid-19 pandemic: national mixed methods case study
Background: Scotland-a country of 5.5 million people-has a rugged geography with many outlying islands, creating access challenges for many citizens. The government has long sought to mitigate these through a range of measures including an ambitious technology-enabled care program. A strategy to develop a nationwide video consultation service began in 2017. Our mixed methods evaluation was commissioned in mid-2019 and extended to cover the pandemic response in 2020. Objective: To draw lessons from a national evaluation of the introduction, spread, and scale-up of Scotland's video consultation services both before and during the pandemic. Methods: Data sources comprised 223 interviews (with patients, staff, technology providers, and policymakers), 60 hours of ethnographic observation (including in-person visits to remote settings), patient and staff satisfaction surveys (n=20,349), professional and public engagement questionnaires (n=5400), uptake statistics, and local and national documents. Fieldwork during the pandemic was of necessity conducted remotely. Data were analyzed thematically and theorized using the Planning and Evaluating Remote Consultation Services (PERCS) framework which considers multiple influences interacting dynamically and unfolding over time. Results: By the time the pandemic hit, there had been considerable investment in material and technological infrastructure, staff training, and professional and public engagement. Scotland was thus uniquely well placed to expand its video consultation services at pace and scale. Within 4 months (March-June 2020), the number of video consultations increased from about 330 to 17,000 per week nationally. While not everything went smoothly, video was used for a much wider range of clinical problems, vastly extending the prepandemic focus on outpatient monitoring of chronic stable conditions. The technology was generally considered dependable and easy to use. In most cases (14,677/18,817, 78%), patients reported no technical problems during their postconsultation survey. Health care organizations' general innovativeness and digital maturity had a strong bearing on their ability to introduce, routinize, and expand video consultation services. Conclusions: The national-level groundwork before the pandemic allowed many services to rapidly extend the use of video consultations during the pandemic, supported by a strong strategic vision, a well-resourced quality improvement model, dependable technology, and multiple opportunities for staff to try out the video option. Scotland provides an important national case study from which other countries may learn.
Orthodoxy, illusio, and playing the scientific game: a Bourdieusian analysis of infection control science in the COVID-19 pandemic
Background: Scientific and policy bodies’ failure to acknowledge and act on the evidence base for airborne transmission of SARS-CoV-2 in a timely way is both a mystery and a scandal. In this study, we applied theories from Bourdieu to address the question, “How was a partial and partisan scientific account of SARS-CoV-2 transmission constructed and maintained, leading to widespread imposition of infection control policies which de-emphasised airborne transmission?”. Methods: : From one international case study (the World Health Organisation) and three national ones (UK, Canada and Japan), we selected a purposive sample of publicly available texts including scientific evidence summaries, guidelines, policy documents, public announcements, and social media postings. To analyse these, we applied Bourdieusian concepts of field, doxa , scientific capital, illusio, and game-playing. We explored in particular the links between scientific capital, vested interests, and policy influence. Results: : Three fields—political, state (policy and regulatory), and scientific—were particularly relevant to our analysis. Political and policy actors at international, national, and regional level aligned—predominantly though not invariably—with medical scientific orthodoxy which promoted the droplet theory of transmission and considered aerosol transmission unproven or of doubtful relevance. This dominant scientific sub-field centred around the clinical discipline of infectious disease control, in which leading actors were hospital clinicians aligned with the evidence-based medicine movement. Aerosol scientists—typically, chemists, and engineers—representing the heterodoxy were systematically excluded from key decision-making networks and committees. Dominant discourses defined these scientists’ ideas and methodologies as weak, their empirical findings as untrustworthy or insignificant, and their contributions to debate as unhelpful. Conclusion: The hegemonic grip of medical infection control discourse remains strong. Exit from the pandemic depends on science and policy finding a way to renegotiate what Bourdieu called the ‘rules of the scientific game’—what counts as evidence, quality, and rigour.
Rapid evidence review to inform safe return to campus in the context of coronavirus disease 2019 (COVID-19)
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is transmitted predominantly through the air in crowded and unventilated indoor spaces among unvaccinated people. Universities and colleges are potential settings for its spread. Methods: An interdisciplinary team from public health, virology, and biology used narrative methods to summarise and synthesise evidence on key control measures, taking account of mode of transmission. Results: Evidence from a wide range of primary studies supports six measures. Vaccinate (aim for > 90% coverage and make it easy to get a jab). Require masks indoors, especially in crowded settings. If everyone wears well-fitting cloth masks, source control will be high, but for maximum self-protection, respirator masks should be worn. Masks should not be removed for speaking or singing. Space people out by physical distancing (but there is no 'safe' distance because transmission risk varies with factors such as ventilation, activity levels and crowding), reducing class size (including offering blended learning), and cohorting (students remain in small groups with no cross-mixing). Clean indoor air using engineering controls ventilation (while monitoring CO 2 levels), inbuilt filtration systems, or portable air cleaners fitted with high efficiency particulate air [HEPA] filters). Test asymptomatic staff and students using lateral flow tests, with tracing and isolating infectious cases when incidence of coronavirus disease 2019 (COVID-19) is high. Support clinically vulnerable people to work remotely. There is no direct evidence to support hand sanitising, fomite controls or temperature-taking. There is evidence that freestanding plastic screens, face visors and electronic air-cleaning systems are ineffective. Conclusions: The above six evidence-based measures should be combined into a multi-faceted strategy to maximise both student safety and the continuation of in-person and online education provision. Staff and students seeking to negotiate a safe working and learning environment should collect data (e.g. CO 2 levels, room occupancy) to inform conversations.
Miasmas, mental models and preventive public health: Some philosophical reflections on science in the COVID-19 pandemic
When the history of the COVID-19 pandemic is written, it is likely to show that the mental models held by scientists sometimes facilitated their thinking, thereby leading to lives saved, and at other times constrained their thinking, thereby leading to lives lost. This paper explores some competing mental models of how infectious diseases spread and shows how these models influenced the scientific process and the kinds of facts that were generated, legitimized and used to support policy. A central theme in the paper is the relative weight given by dominant scientific voices to probabilistic arguments based on experimental measurements versus mechanistic arguments based on theory. Two examples are explored: the cholera epidemic in nineteenth century London - in which the story of John Snow and the Broad Street pump is retold - and the unfolding of the COVID-19 pandemic in 2020 and early 2021 - in which the evidence-based medicine movement and its hierarchy of evidence features prominently. In each case, it is shown that prevailing mental models - which were assumed by some to transcend theory but were actually heavily theory-laden - powerfully shaped both science and policy, with fatal consequences for some.
An early warning risk prediction tool (recap-v1) for patients diagnosed with covid-19: Protocol for a statistical analysis plan
Background: Since the start of the COVID-19 pandemic, efforts have been made to develop early warning risk scores to help clinicians decide which patient is likely to deteriorate and require hospitalization. The RECAP (Remote COVID-19 Assessment in Primary Care) study investigates the predictive risk of hospitalization, deterioration, and death of patients with confirmed COVID-19, based on a set of parameters chosen through a Delphi process performed by clinicians. We aim to use rich data collected remotely through the use of electronic data templates integrated in the electronic health systems of several general practices across the United Kingdom to construct accurate predictive models. The models will be based on preexisting conditions and monitoring data of a patient's clinical parameters (eg, blood oxygen saturation) to make reliable predictions as to the patient's risk of hospital admission, deterioration, and death. Objective: This statistical analysis plan outlines the statistical methods to build the prediction model to be used in the prioritization of patients in the primary care setting. The statistical analysis plan for the RECAP study includes the development and validation of the RECAP-V1 prediction model as a primary outcome. This prediction model will be adapted as a three-category risk score split into red (high risk), amber (medium risk), and green (low risk) for any patient with suspected COVID-19. The model will predict the risk of deterioration and hospitalization. Methods: After the data have been collected, we will assess the degree of missingness and use a combination of traditional data imputation using multiple imputation by chained equations, as well as more novel machine-learning approaches to impute the missing data for the final analysis. For predictive model development, we will use multiple logistic regression analyses to construct the model. We aim to recruit a minimum of 1317 patients for model development and validation. We will then externally validate the model on an independent dataset of 1400 patients. The model will also be applied for multiple different datasets to assess both its performance in different patient groups and its applicability for different methods of data collection. Results: As of May 10, 2021, we have recruited 3732 patients. A further 2088 patients have been recruited through the National Health Service Clinical Assessment Service, and approximately 5000 patients have been recruited through the DoctalyHealth platform. Conclusions: The methodology for the development of the RECAP-V1 prediction model as well as the risk score will provide clinicians with a statistically robust tool to help prioritize COVID-19 patients.
Vaccinating adolescents against SARS-CoV-2 in England: a risk–benefit analysis
Objective: To offer a quantitative risk–benefit analysis of two doses of SARS-CoV-2 vaccination among adolescents in England. Setting: England. Design: Following the risk–benefit analysis methodology carried out by the US Centers for Disease Control, we calculated historical rates of hospital admission, Intensive Care Unit admission and death for ascertained SARS-CoV-2 cases in children aged 12–17 in England. We then used these rates alongside a range of estimates for incidence of long COVID, vaccine efficacy and vaccine-induced myocarditis, to estimate hospital and Intensive Care Unit admissions, deaths and cases of long COVID over a period of 16 weeks under assumptions of high and low case incidence. Participants: All 12–17 year olds with a record of confirmed SARS-CoV-2 infection in England between 1 July 2020 and 31 March 2021 using national linked electronic health records, accessed through the British Heart Foundation Data Science Centre. Main outcome measures: Hospitalisations, Intensive Care Unit admissions, deaths and cases of long COVID averted by vaccinating all 12–17 year olds in England over a 16-week period under different estimates of future case incidence. Results: At high future case incidence of 1000/100,000 population/week over 16 weeks, vaccination could avert 4430 hospital admissions and 36 deaths over 16 weeks. At the low incidence of 50/100,000/week, vaccination could avert 70 hospital admissions and two deaths over 16 weeks. The benefit of vaccination in terms of hospitalisations in adolescents outweighs risks unless case rates are sustainably very low (below 30/100,000 teenagers/week). Benefit of vaccination exists at any case rate for the outcomes of death and long COVID, since neither have been associated with vaccination to date. Conclusions: Given the current (as at 15 September 2021) high case rates (680/100,000 population/week in 10–19 year olds) in England, our findings support vaccination of adolescents against SARS-CoV2.
Orthodoxy, illusio, and playing the scientific game: A Bourdieusian analysis of infection control science in the COVID-19 pandemic
Background: Scientific and policy bodies' failure to acknowledge and act on the evidence base for airborne transmission of SARS-CoV-2 in a timely way is both a mystery and a scandal. In this study, we applied theories from Bourdieu to address the question, 'How was a partial and partisan scientific account of SARS-CoV-2 transmission constructed and maintained, leading to widespread imposition of infection control policies which de-emphasised airborne transmission?'. Methods: From one international case study (the World Health Organisation) and four national ones (UK, Canada, USA and Japan), we selected a purposive sample of publicly available texts including scientific evidence summaries, guidelines, policy documents, public announcements, and social media postings. To analyse these, we applied Bourdieusian concepts of field, doxa, scientific capital, illusio, and game-playing. We explored in particular the links between scientific capital, vested interests, and policy influence. Results: Three fields-political, state (policy and regulatory), and scientific-were particularly relevant to our analysis. Political and policy actors at international, national, and regional level aligned-predominantly though not invariably-with medical scientific orthodoxy which promoted the droplet theory of transmission and considered aerosol transmission unproven or of doubtful relevance. This dominant scientific sub-field centred around the clinical discipline of infectious disease control, in which leading actors were hospital clinicians aligned with the evidence-based medicine movement. Aerosol scientists-typically, chemists, and engineers-representing the heterodoxy were systematically excluded from key decision-making networks and committees. Dominant discourses defined these scientists' ideas and methodologies as weak, their empirical findings as untrustworthy or insignificant, and their contributions to debate as unhelpful. Conclusion: The hegemonic grip of medical infection control discourse remains strong. Exit from the pandemic depends on science and policy finding a way to renegotiate what Bourdieu called the 'rules of the scientific game'-what counts as evidence, quality, and rigour.
Of lamp posts, keys, and fabled drunkards: A perspectival tale of 4 guidelines
Background: Evidence-based medicine is the application of research findings to inform individual clinical decisions. There is a tension—both philosophical and practical—between the average result from a population study and the circumstances and needs of an individual patient. This personal account of “evidence-based” trauma care illustrates and explores this tension. The case: The author, a keen athlete, describes her experience of a high-impact cycle accident that led to limb fractures (which were diagnosed and treated according to evidence-based guidelines) and also an occult injury to the cervical spine (which was not diagnosed at the time). Some evidence-based guidelines are reviewed and applied to the case. The clinical record described the cycle accident as a “fall.” Initial assessment directed the clinicians' gaze to the obvious injuries, whose treatment was straightforward. On admission, the patient (aged 55 years at the time) was offered “falls prevention” via a guideline-based checklist. Several months later, neurological sequelae indicated possible damage to the cervical spine. But the NICE Guideline recommending cervical spine imaging in cases of high-impact trauma had not been considered—perhaps because the clinical narrative had been prematurely assigned to the script of “older person with fall.” Furthermore, the author, who was (appropriately) treated with neurosurgery, was surprised at the response of clinical colleagues, based on application of an irrelevant section of a guideline, that her cervical discectomy was “nonevidence based.” Nonsteroidal anti-inflammatory drugs for postoperative pain were indicated in this patient even though they were not recommended for the average patient. Conclusion: As Sir John Grimley Evans' warned, we should avoid using evidence-based guidelines in the manner of the fabled drunkard who searched under the lamp post for his key because that was where the light was, even though he knew he had lost his key somewhere else.
Real-world implementation of video outpatient consultations at macro, meso, and micro levels: Mixed-method study
Background: There is much interest in virtual consultations using video technology. Randomized controlled trials have shown video consultations to be acceptable, safe, and effective in selected conditions and circumstances. However, this model has rarely been mainstreamed and sustained in real-world settings. Objective: The study sought to (1) define good practice and inform implementation of video outpatient consultations and (2) generate transferable knowledge about challenges to scaling up and routinizing this service model. Methods: A multilevel, mixed-method study of Skype video consultations (micro level) was embedded in an organizational case study (meso level), taking account of national context and wider influences (macro level). The study followed the introduction of video outpatient consultations in three clinical services (diabetes, diabetes antenatal, and cancer surgery) in a National Health Service trust (covering three hospitals) in London, United Kingdom. Data sources included 36 national-level stakeholders (exploratory and semistructured interviews), longitudinal organizational ethnography (300 hours of observations; 24 staff interviews), 30 videotaped remote consultations, 17 audiotaped face-to-face consultations, and national and local documents. Qualitative data, analyzed using sociotechnical change theories, addressed staff and patient experience and organizational and system drivers. Quantitative data, analyzed via descriptive statistics, included uptake of video consultations by staff and patients and microcategorization of different kinds of talk (using the Roter interaction analysis system). Results: When clinical, technical, and practical preconditions were met, video consultations appeared safe and were popular with some patients and staff. Compared with face-to-face consultations for similar conditions, video consultations were very slightly shorter, patients did slightly more talking, and both parties sometimes needed to make explicit things that typically remained implicit in a traditional encounter. Video consultations appeared to work better when the clinician and patient already knew and trusted each other. Some clinicians used Skype adaptively to respond to patient requests for ad hoc encounters in a way that appeared to strengthen supported self-management. The reality of establishing video outpatient services in a busy and financially stretched acute hospital setting proved more complex and time-consuming than originally anticipated. By the end of this study, between 2% and 22% of consultations were being undertaken remotely by participating clinicians. In the remainder, clinicians chose not to participate, or video consultations were considered impractical, technically unachievable, or clinically inadvisable. Technical challenges were typically minor but potentially prohibitive. Conclusions: Video outpatient consultations appear safe, effective, and convenient for patients in situations where participating clinicians judge them clinically appropriate, but such situations are a fraction of the overall clinic workload. As with other technological innovations, some clinicians will adopt readily, whereas others will need incentives and support. There are complex challenges to embedding video consultation services within routine practice in organizations that are hesitant to change, especially in times of austerity.
Spread, Scale-up, and Sustainability of Video Consulting in Health Care: Systematic Review and Synthesis Guided by the NASSS Framework (Preprint)
BACKGROUND COVID-19 has thrust video consulting into the limelight, as health care practitioners worldwide shift to delivering care remotely. Evidence suggests that video consulting is acceptable, safe, and effective in selected conditions and settings. However, research to date has mostly focused on initial adoption, with limited consideration of how video consulting can be mainstreamed and sustained. OBJECTIVE This study sought to do the following: (1) review and synthesize reported opportunities, challenges, and lessons learned in the scale-up, spread, and sustainability of video consultations, and (2) identify transferable insights that can inform policy and practice. METHODS We identified papers through systematic searches in PubMed, CINAHL, and Web of Science. Included articles reported on synchronous, video-based consultations that had spread to more than one setting beyond an initial pilot or feasibility stage, and were published since 2010. We used the Nonadoption, Abandonment, and challenges to the Scale-up, Spread, and Sustainability (NASSS) framework to synthesize findings relating to 7 domains: an understanding of the health condition(s) for which video consultations were being used, the material properties of the technological platform and relevant peripherals, the value proposition for patients and developers, the role of the adopter system, organizational factors, wider macro-level considerations, and emergence over time. RESULTS We identified 13 papers describing 10 different video consultation services in 6 regions, covering the following: (1) video-to-home services, connecting providers directly to the patient; (2) hub-and-spoke models, connecting a provider at a central hub to a patient at a rural center; and (3) large-scale top-down evaluations scaled up or spread across a national health administration. Services covered rehabilitation, geriatrics, cancer surgery, diabetes, and mental health, as well as general specialist care and primary care. Potential enablers of spread and scale-up included embedded leadership and the presence of a telehealth champion, appropriate reimbursement mechanisms, user-friendly technology, pre-existing staff relationships, and adaptation (of technology and services) over time. Challenges tended to be related to service development, such as the absence of a long-term strategic plan, resistance to change, cost and reimbursement issues, and the technical experience of staff. There was limited articulation of the challenges to scale-up and spread of video consultations. This was combined with a lack of theorization, with papers tending to view spread and scale-up as the sum of multiple technical implementations, rather than theorizing the distinct processes required to achieve widespread adoption. CONCLUSIONS There remains a significant lack of evidence that can support the spread and scale-up of video consulting. Given the recent pace of change due to COVID-19, a more definitive evidence base is urgently needed to support global efforts and match enthusiasm for extending use.
Clinical guidelines and the pursuit of reducing epistemic uncertainty. An ethnographic study of guideline development panels in three countries
Purpose: To explore, from a philosophy of knowledge perspective, the contribution of the guideline development process to reducing epistemic uncertainty in clinical decision-making – defined as the challenge of applying evidence to patients, dealing with conflicting information and determining the level of confidence in a medical conclusion. Methods: Longitudinal ethnographic study of national guideline development panels. Fieldnotes were collected from 19 panel meetings in UK, Netherlands and Norway (~120 h of observation) between September 2016 and February 2019. Draft guidelines, review protocols and background material were collated (~200 documents). Data were analyzed thematically to gain familiarity and then theorized using concepts of knowledge development and use and clinical decision-making. Results: Guideline development panels in all three countries wrestled with epistemic tensions – notably between the desire to “purify” an assumed external truth (for example by limiting included evidence to high-quality randomized controlled trials) and a more pragmatic and pluralist approach that drew on a wider range of evidence including qualitative research, real-world data, clinical experience and patient testimony. Detailed analysis of the process by which particular guideline recommendations were constructed allowed us to draw out the implications of these tensions for guideline users in clinical practice. Conclusion: Guideline development panels apply multiple – often conflicting – understandings of knowledge, inference and truth in an attempt to reduce epistemic uncertainty. Guidelines makers, clinicians, scientists and students should engage critically and reflexively with the philosophical assumptions that underpin guideline development and inductive inference to build capability to deal with clinical complexity.
Video Consultations Between Patients and Clinicians in Diabetes, Cancer, and Heart Failure Services: Linguistic Ethnographic Study of Video-Mediated Interaction (Preprint)
BACKGROUND Video-mediated clinical consultations offer potential benefits over conventional face-to-face in terms of access, convenience, and sometimes cost. The improved technical quality and dependability of video-mediated consultations has opened up the possibility for more widespread use. However, questions remain regarding clinical quality and safety. Video-mediated consultations are sometimes criticized for being not as good as face-to-face, but there has been little previous in-depth research on their interactional dynamics, and no agreement on what a good video consultation looks like. OBJECTIVE Using conversation analysis, this study aimed to identify and analyze the communication strategies through which video-mediated consultations are accomplished and to produce recommendations for patients and clinicians to improve the communicative quality of such consultations. METHODS We conducted an in-depth analysis of the clinician-patient interaction in a sample of video-mediated consultations and a comparison sample of face-to-face consultations drawn from 4 clinical settings across 2 trusts (1 community and 1 acute care) in the UK National Health Service. The video dataset consisted of 37 recordings of video-mediated consultations (with diabetes, antenatal diabetes, cancer, and heart failure patients), 28 matched audio recordings of face-to-face consultations, and fieldnotes from before and after each consultation. We also conducted 37 interviews with staff and 26 interviews with patients. Using linguistic ethnography (combining analysis of communication with an appreciation of the context in which it takes place), we examined in detail how video interaction was mediated by 2 software platforms (Skype and FaceTime). RESULTS Patients had been selected by their clinician as <i>appropriate</i> for video-mediated consultation. Most consultations in our sample were technically and clinically unproblematic. However, we identified 3 interactional challenges: (1) opening the video consultation, (2) dealing with disruption to conversational flow (eg, technical issues with audio and/or video), and (3) conducting an examination. Operational and technological issues were the exception rather than the norm. In all but 1 case, both clinicians and patients (deliberately or intuitively) used established communication strategies to successfully negotiate these challenges. Remote physical examinations required the patient (and, in some cases, a relative) to simultaneously follow instructions and manipulate technology (eg, camera) to make it possible for the clinician to see and hear adequately. CONCLUSIONS A remote video link alters how patients and clinicians interact and may adversely affect the flow of conversation. However, our data suggest that when such problems occur, clinicians and patients can work collaboratively to find ways to overcome them. There is potential for a limited physical examination to be undertaken remotely with some patients and in some conditions, but this appears to need complex interactional work by the patient and/or their relatives. We offer preliminary guidance for patients and clinicians on what is and is not feasible when consulting via a video link. INTERNATIONAL REGISTERED REPORT RR2-10.2196/10913