TRIPLE C reporting principles for case study evaluations of the role of context in complex interventions.

BACKGROUND: Guidance and reporting principles such as CONSORT (for randomised trials) and PRISMA (for systematic reviews) have greatly improved the reporting, discoverability, transparency and consistency of published research. We sought to develop similar guidance for case study evaluations undertaken to explore the influence of context on the processes and outcomes of complex interventions. METHODS: A range of experts were recruited to an online Delphi panel, sampling for maximum diversity in disciplines (e.g. public health, health services research, organisational studies), settings (e.g. country), and sectors (e.g. academic, policy, third sector). To inform panel deliberations, we prepared background materials based on: [a] a systematic meta-narrative review of empirical and methodological literatures on case study, context and complex interventions; [b] the collective experience of a network of health systems and public health researchers; and [c] the established RAMESES II standards (which cover one kind of case study). We developed a list of topics and issues based on these sources and encouraged panel members to provide free text comments. Their feedback informed development of a set of items in the form of questions for potential inclusion in the reporting principles. We circulated these by email, asking panel members to rank each potential item twice (for relevance and validity) on a 7-point Likert scale. This sequence was repeated twice. RESULTS: We recruited 51 panel members from 50 organisations across 12 countries, who brought experience of a range of case study research methods and applications. 26 completed all three Delphi rounds, reaching over 80% consensus on 16 items covering title, abstract, definitions of terms, philosophical assumptions, research question(s), rationale, how context and complexity relates to the intervention, ethical approval, empirical methods, findings, use of theory, generalisability and transferability, researcher perspective and influence, conclusions and recommendations, and funding and conflicts of interest. CONCLUSION: The 'Triple C' (Case study, Context, Complex interventions) reporting principles recognise that case studies are undertaken in different ways for different purposes and based on different philosophical assumptions. They are designed to be enabling rather than prescriptive, and to make case study evaluation reporting on context and complex health interventions more comprehensive, accessible and useable.

Theorising the shift to video consulting in the UK during the COVID-19 pandemic: Analysis of a mixed methods study using practice theory.

We studied video consulting in the National Health Service during 2020-2021 through video interviews, an online survey and online discussions with people who had provided and participated in such consultations. Video consulting had previously been used for selected groups in limited settings in the UK. The pandemic created a seismic shift in the context for remote consulting, in which video transformed from a niche technology typically introduced by individual clinicians committed to innovation and quality improvement to offering what many felt was the only safe way to deliver certain types of healthcare. A new practice emerged: a co-constitution of technology and healthcare made possible by new configurations of equipment, connectivity and physical spaces. Despite heterogeneous service settings and previous experiences of video consulting, we found certain kinds of common changes had made video consulting possible. We used practice theory to analyse these changes, interpreting the commonalities found in our data as changes in purpose, material arrangements and a relaxing of rules about security, confidentiality and location of consultations. The practice of video consulting was equivocal. Accounts of, and preferences for, video consulting varied as did the extent to which it was sustained after initial take-up. People made sense of video consulting in different ways, ranging from interpreting video as offering a new modality of healthcare for the future to a sub-optimal, temporary alternative to in-person care. Despite these variations, video consulting became a recognisable social phenomenon, albeit neither universally adopted nor consistently sustained. The nature of this social change offers new perspectives on processes of implementation and spread and scale-up. Our findings have important implications for the future of video consulting. We emphasise the necessity for viable material arrangements and a continued shared interpretation of the meaning of video consulting for the practice to continue.

Planning and Evaluating Remote Consultation Services: A New Conceptual Framework Incorporating Complexity and Practical Ethics.

Establishing and running remote consultation services is challenging politically (interest groups may gain or lose), organizationally (remote consulting requires implementation work and new roles and workflows), economically (costs and benefits are unevenly distributed across the system), technically (excellent care needs dependable links and high-quality audio and images), relationally (interpersonal interactions are altered), and clinically (patients are unique, some examinations require contact, and clinicians have deeply-held habits, dispositions and norms). Many of these challenges have an under-examined ethical dimension. In this paper, we present a novel framework, Planning and Evaluating Remote Consultation Services (PERCS), built from a literature review and ongoing research. PERCS has 7 domains-the reason for consulting, the patient, the clinical relationship, the home and family, technologies, staff, the healthcare organization, and the wider system-and considers how these domains interact and evolve over time as a complex system. It focuses attention on the organization's digital maturity and digital inclusion efforts. We have found that both during and beyond the pandemic, policymakers envisaged an efficient, safe and accessible remote consultation service delivered through state-of-the art digital technologies and implemented via rational allocation criteria and quality standards. In contrast, our empirical data reveal that strategic decisions about establishing remote consultation services, allocation decisions for appointment type (phone, video, e-, face-to-face), and clinical decisions when consulting remotely are fraught with contradictions and tensions-for example, between demand management and patient choice-leading to both large- and small-scale ethical dilemmas for managers, support staff, and clinicians. These dilemmas cannot be resolved by standard operating procedures or algorithms. Rather, they must be managed by attending to here-and-now practicalities and emergent narratives, drawing on guiding principles applied with contextual judgement. We complement the PERCS framework with a set of principles for informing its application in practice, including education of professionals and patients.

Achieving Spread, Scale Up and Sustainability of Video Consulting Services During the COVID-19 Pandemic? Findings From a Comparative Case Study of Policy Implementation in England, Wales, Scotland and Northern Ireland.

Requirements for physical distancing as a result of COVID-19 and the need to reduce the risk of infection prompted policy supporting rapid roll out of video consulting across the four nations of the UK-England, Northern Ireland, Scotland and Wales. Drawing on three studies of the accelerated implementation and uptake of video consulting across the four nations, we present a comparative and interpretive policy analysis of the spread and scale-up of video consulting during the pandemic. Data include interviews with 59 national level stakeholders, 55 health and social care staff and 30 patients, 20 national documents, responses to a UK-wide survey of NHS staff and analysis of routine activity data. Sampling ensured variations in geography, clinical context and adoption progress across the combined dataset. Comparative analysis was guided by theory on policy implementation and crisis management. The pandemic provided a "burning platform" prompting UK-wide policy supporting the use of video consulting in health care as a critical means of managing the risk of infection and a standard mode of provision. This policy push facilitated interest in video consulting across the UK. There was, however, marked variation in how this was put into practice across the four nations. Pre-existing infrastructure, policies and incentives for video consulting in Scotland, combined with a collaborative system-level approach, a program dedicated to developing video-based services and resourcing and supporting staff to deliver them enabled widespread buy-in and rapid spread. In England, Wales and Northern Ireland, pre-existing support for digital health (e.g., hardware, incentives) and virtual care, combined with reduced regulation and "light touch" procurement managed to override some (but by no means all) cultural barriers and professional resistance to implementing digital change. In Northern Ireland and Wales, limited infrastructure muted spread. In all three countries, significant effort at system level to develop, review and run video consulting programs enabled a substantial number of providers to change their practice, albeit variably across settings. Across all four nations ongoing uncertainty, potential restructuring and tightening of regulations, along with difficulties inherent in addressing inequalities in digital access, raise questions about the longer-term sustainability of changes to-date.

Autologous cancer cell vaccination, adoptive T-cell transfer, and interleukin-2 administration results in long-term survival for companion dogs with osteosarcoma.

BACKGROUND: Osteosarcoma (OSA) in dogs is an aggressive bone tumor with frequent chemotherapy failure and translational relevance for human health. HYPOTHESIS/OBJECTIVES: We hypothesized that dogs with OSA could be treated safely by ex vivo activated T-cells that were generated by autologous cancer vaccination and supported by interleukin-2 (IL-2) treatment with survival more than twice that reported for amputation alone. ANIMALS: Osteosarcoma-bearing dogs (n = 14) were enrolled in a single-arm prospective trial after complete staging before amputation. Four healthy dogs also were treated in a safety study. METHODS: Autologous cancer cell vaccinations were administered intradermally and dogs underwent leukapheresis. Mononuclear cell products were stimulated ex vivo with a T-cell-activating agent. Activated product was transfused and 5 SC IL-2 injections were administered q48h. Dogs were monitored for metastasis by thoracic radiography every 3 months. RESULTS: Autologous cancer cell vaccine and activated cellular therapy (ACT) products were successfully generated. Toxicity was minimal after premedicants were instituted before ACT. With premedication, all toxicities were grade I/II. Median disease-free interval for all dogs was 213 days. One dog developed cutaneous metastasis but then experienced spontaneous complete remission. Median survival time for all dogs was 415 days. Five dogs survived >730 days. CONCLUSIONS AND CLINICAL IMPORTANCE: This immunotherapy protocol without cytotoxic chemotherapy is safe and tolerable. Compared to historical amputation reports, survival was notably prolonged in this group of patients. Additional prospective studies are warranted to elucidate active immunologic mechanisms and further improve disease response and survival.

Patients' attitudes to the summary care record and HealthSpace: qualitative study.

OBJECTIVE: To document the views of patients and the public towards the summary care record (SCR, a centrally stored medical record drawn from the general practice record) and HealthSpace (a personal health organiser accessible through the internet from which people can view their SCR), with a particular focus on those with low health literacy, potentially stigmatising conditions, or difficulties accessing health care. DESIGN: 103 semistructured individual interviews and seven focus groups. SETTING: Three early adopter primary care trusts in England where the SCR and HealthSpace are being piloted. All were in areas of relative socioeconomic deprivation. PARTICIPANTS: Individual participants were recruited from general practice surgeries, walk-in centres, out of hours centres, and accident and emergency departments. Participants in focus groups were recruited through voluntary sector organisations; they comprised advocates of vulnerable groups and advocates of people who speak limited English; people with HIV; users of mental health services; young adults; elderly people; and participants of a drug rehabilitation programme. METHODS: Participants were asked if they had received information about the SCR and HealthSpace and about their views on shared electronic records in different circumstances. RESULTS: Most people were not aware of the SCR or HealthSpace and did not recall receiving information about it. They saw both benefits and drawbacks to having an SCR and described a process of weighing the former against the latter when making their personal choice. Key factors influencing this choice included the nature of any illness (especially whether it was likely to lead to emergency care needs); past and present experience of healthcare and government surveillance; the person's level of engagement and health literacy; and their trust and confidence in the primary healthcare team and the wider NHS. Overall, people with stigmatising illness were more positive about the SCR than people who claimed to speak for "vulnerable groups." Misconceptions about the SCR were common, especially confusion about what data it contained and who would have access to it. Most people were not interested in recording their medical data or accessing their SCR via HealthSpace, but some saw the potential for this new technology to support self management and lay care for those with chronic illness. CONCLUSION: Despite an extensive information programme in early adopter sites, the public remains unclear about current policy on shared electronic records, though most people view these as a positive development. The "implied consent" model for creating and accessing a person's SCR should be revisited, perhaps in favour of "consent to view" at the point of access.

Story-based scales: development and validation of questionnaires to measure subjective health status and cultural adherence in British Bangladeshis with diabetes.

Questionnaires that measure subjective health status are increasingly used in clinical trials. But scales based on the quantification of subjective traits ("rate your feelings on a scale of 1 to 5") and initially developed in western population samples may not be valid for use in minority ethnic groups, even if accurately translated. The measurement of cultural adaptation and assimilation in immigrant groups is important for health research but has well documented methodological challenges. The aim of this study was to develop valid and reliable questionnaires to measure subjective health status and cultural adherence in a minority ethnic group, using the story as the unit of inquiry. The design was a multi-phase study involving (a) narrative interview, (b) vignette construction, (c) questionnaire development, and (d) questionnaire validation in relation to two scales (well-being and cultural adherence) in British Bangladeshis with diabetes. Using data from in-depth narrative interviews (i.e., a non-directive research technique in which the participant is invited to "tell me the story about your diabetes, starting with when you first noticed anything wrong", and the only prompts used are "tell me more about that" or "what happened next?"; Greenhalgh, Helman, & Chowdhury, 1998; Muller, 1999), we constructed culturally congruent vignettes to depict different subjective health states and behaviours. We refined these items in focus group interviews and validated the instruments on 98 Bangladeshi participants, randomly sampled from GP diabetes registers in inner London and interviewed by a Bangladeshi anthropologist. We used factor analysis to explore the underlying structure in the responses to questionnaire items, plus Cronbach alpha tests to measure internal consistency of scales. The questionnaires were acceptable and credible to Bangladeshi participants with diabetes. Ninety of 98 participants were able and willing to complete them with interviewer assistance. Following factor analysis, we produced two definitive instruments. The well-being scale was a single-factor model with four story-based items (measuring depression, anxiety, physical energy, and social activities), with a Cronbach's alpha of .92. The cultural adherence scale was a single-factor model with five items (measuring religious restrictions, ethnic practices, and social ties), with a Cronbach's alpha of .83. In conclusion, this study has produced two important outputs: (a) easy-to-administer, story-based questionnaires that measure well-being and cultural adherence, which are specific to British Bangladeshis with diabetes; (b) a general method for developing story-based instruments to quantify the subjective experience of illness and adherence to cultural norms, which potentially has applications beyond the study population.