Contributors are representative, as long as they agree: How confirmation logic overrides effort to achieve synthesis in applied health research.

INTRODUCTION: The paradox of representation in public involvement in research is well recognized, whereby public contributors are seen as either too naïve to meaningfully contribute or too knowledgeable to represent 'the average patient'. Given the underlying assumption that expertise undermines contributions made, more expert contributors who have significant experience in research can be a primary target of criticism. We conducted a secondary analysis of a case of expert involvement and a case of lived experience, to examine how representation was discussed in each. METHODS: We analysed a case of a Lived Experience Advisory Panel (LEAP) chosen for direct personal experience of a topic and a case of an expert Patient and Public Involvement (PPI) panel. Secondary analysis was of multiple qualitative data sources, including interviews with the LEAP contributors and researchers, Panel evaluation data and documentary analysis of researcher reports of Panel impacts. Analysis was undertaken collaboratively by the author team of contributors and researchers. RESULTS: Data both from interviews with researchers and reported observations by the Panel indicated that representation was a concern for researchers in both cases. Consistent with previous research, this challenge was deployed in response to contributors requesting changes to researcher plans. However, we also observed that when contributor input could be used to support research activity, it was described unequivocally as representative of 'the patient view'. We describe this as researchers holding a confirmation logic. By contrast, contributor accounts enacted a synthesis logic, which emphasized multiplicity of viewpoints and active dialogue. These logics are incompatible in practice, with the confirmation logic constraining the potential for the synthesis logic to be achieved. CONCLUSION: Researchers tend to enact a confirmation logic that seeks a monophonic patient voice to legitimize decisions. Contributors are therefore limited in their ability to realize a synthesis logic that would actively blend different types of knowledge. These different logics hold different implications regarding representation, with the synthesis logic emphasizing diversity and negotiation, as opposed to the current system in which 'being representative' is a quality attributed to contributors by researchers. PATIENT OR PUBLIC CONTRIBUTION: Patient contributors are study coauthors, partners in analysis and reporting.

Understanding How the Design and Implementation of Online Consultations Affect Primary Care Quality: Systematic Review of Evidence With Recommendations for Designers, Providers, and Researchers.

BACKGROUND: Online consultations (OCs) allow patients to contact their care providers on the web. Worldwide, OCs have been rolled out in primary care rapidly owing to policy initiatives and COVID-19. There is a lack of evidence regarding how OC design and implementation influence care quality. OBJECTIVE: We aimed to synthesize research on the impacts of OCs on primary care quality, and how these are influenced by system design and implementation. METHODS: We searched databases from January 2010 to February 2022. We included quantitative and qualitative studies of real-world OC use in primary care. Quantitative data were transformed into qualitative themes. We used thematic synthesis informed by the Institute of Medicine domains of health care quality, and framework analysis informed by the nonadoption, abandonment, scale-up, spread, and sustainability framework. Strength of evidence was judged using the GRADE-CERQual approach. RESULTS: We synthesized 63 studies from 9 countries covering 31 OC systems, 14 (22%) of which used artificial intelligence; 41% (26/63) of studies were published from 2020 onward, and 17% (11/63) were published after the COVID-19 pandemic. There was no quantitative evidence for negative impacts of OCs on patient safety, and qualitative studies suggested varied perceptions of their safety. Some participants believed OCs improved safety, particularly when patients could describe their queries using free text. Staff workload decreased when sufficient resources were allocated to implement OCs and patients used them for simple problems or could describe their queries using free text. Staff workload increased when OCs were not integrated with other software or organizational workflows and patients used them for complex queries. OC systems that required patients to describe their queries using multiple-choice questionnaires increased workload for patients and staff. Health costs decreased when patients used OCs for simple queries and increased when patients used them for complex queries. Patients using OCs were more likely to be female, younger, and native speakers, with higher socioeconomic status. OCs increased primary care access for patients with mental health conditions, verbal communication difficulties, and barriers to attending in-person appointments. Access also increased by providing a timely response to patients' queries. Patient satisfaction increased when using OCs owing to better primary care access, although it decreased when using multiple-choice questionnaire formats. CONCLUSIONS: This is the first theoretically informed synthesis of research on OCs in primary care and includes studies conducted during the COVID-19 pandemic. It contributes new knowledge that, in addition to having positive impacts on care quality such as increased access, OCs also have negative impacts such as increased workload. Negative impacts can be mitigated through appropriate OC system design (eg, free text format), incorporation of advanced technologies (eg, artificial intelligence), and integration into technical infrastructure (eg, software) and organizational workflows (eg, timely responses). TRIAL REGISTRATION: PROSPERO CRD42020191802; https://tinyurl.com/2p84ezjy.

The impact of a combinatorial digital and organisational intervention on the management of long-term conditions in UK primary care: a non-randomised evaluation.

BACKGROUND: Better management of long-term conditions remains a policy priority, with a focus on improving outcomes and reducing use of expensive hospital services. A number of interventions have been tested, but many have failed to show benefit in rigorous comparative research. In 2016, the NHS Test Beds scheme was launched to implement and test interventions combining digital technologies and pathway redesign in routine health care settings, with each intervention comprising multiple innovations to better realise benefit from their 'combinatorial' effect. We present the evaluation of one of the NHS Test Beds, which combined risk stratification algorithms, practice-based quality improvement and health monitoring and coaching to improve management of long-term conditions in a single health economy in the north-west of England. METHODS: The NHS Test Bed was implemented in one clinical commissioning group in the north-west of England (patient population 235,800 served by 36 general practices). Routine administrative data on hospital use (the primary outcome) and a selection of secondary outcomes (data from both hospital and primary care) were collected in the intervention site, and from a comparator area in the same region. We used difference-in-differences analysis to compare outcomes in the NHS Test Bed area and the comparator after initiation of the combinatorial intervention. RESULTS: Tests confirmed the existence of parallel trends in the intervention and comparator sites for hospital outcomes for the period April 2016 to March 2017, and for some of the planned primary care outcomes. Based on 10 months of post-intervention secondary care data and 13 months post-intervention primary care data, we found no significant impact on primary outcomes between the intervention and comparator site, and a significant impact on only one secondary outcome. CONCLUSION: A combinatorial digital and organisational intervention to improve the management of long-term conditions was implemented across a whole health economy, but we found no evidence of a positive impact on health care utilisation outcomes in hospital and primary care.

Improvement capability and performance: a qualitative study of maternity services providers in the UK.

OBJECTIVE: We explore variations in service performance and quality improvement across healthcare organisations using the concept of improvement capability. We draw upon a theoretically informed framework comprising eight dimensions of improvement capability, firstly to describe and compare quality improvement within healthcare organisations and, secondly to investigate the interactions between organisational performance and improvement capability. DESIGN: A multiple qualitative case study using semi-structured interviews guided by the improvement capability framework. SETTING: Five National Health Service maternity services sites across the UK. We focused on maternity services due to high levels of variation in quality and the availability of performance metrics which enabled us to select organisations from across the performance spectrum. PARTICIPANTS: About 52 hospital staff members across the five case studies in positions relevant to the research questions, including midwives, obstetricians and clinical managers/leaders. MAIN OUTCOME MEASURE: A qualitative analysis of narratives of quality improvement and performance in the five case studies, using the improvement capability framework as an analytic device to compare and contrast cases. RESULTS: The improvement capability framework has utility in analysing quality improvement within and across organisations. Qualitative differences in the configurations of improvement capability were identified across all providers but were particularly striking between higher and lower performing organisations. CONCLUSIONS: The improvement capability framework is a useful tool for healthcare organisations to assess, manage and develop their own improvement capabilities. We identified an interaction between performance and improvement capability; higher performing organisations appeared to have more developed improvement capabilities, though the meaning of this relationship requires further research.

Patient experiences of an online consultation system: a qualitative study in English primary care post-COVID-19.

BACKGROUND: Online consultation systems (OCSs) allow patients to contact their healthcare teams online. Since 2020 they have been rapidly rolled out in primary care following policy initiatives and the COVID-19 pandemic. In-depth research of patients' experiences using OCSs is lacking. AIM: Explore patients' experiences of using an OCS. DESIGN AND SETTING: Qualitative study in English GP practices using the Patchs OCS (www.Patchs.ai) from March 2020 to July 2022. METHOD: Thematic analysis of 25 patient interviews and 21 467 written comments from 11 851 patients who used the OCS from nine and 240 GP practices, respectively. RESULTS: Patients cited benefits of using the OCS as speed, flexibility, and efficiency. Nevertheless, some patients desired a return to traditional consultation methods. GP practices often did not clearly advertise the OCS or use it as patients expected, which caused frustration. Patients reported advantages of having a written record of consultations and the opportunity to communicate detailed queries in free text. Views differed on how the OCS influenced clinical safety and discussions of sensitive topics. Patients who struggled to communicate in traditional consultations often preferred using the OCS, and male patients reported being more likely to use it. CONCLUSION: Globally, this is the largest in-depth study of patient experiences of an OCS. It contributes new knowledge that the patient experience of using OCSs can be influenced by previously unreported patient characteristics and the conditions they consult about. Further, it contributes recommendations on the design and implementation of the OCS in practice.

"Attending to History" in Major System Change in Healthcare in England: Specialist Cancer Surgery Service Reconfiguration.

BACKGROUND: The reconfiguration of specialist hospital services, with service provision concentrated in a reduced number of sites, is one example of major system change (MSC) for which there is evidence of improved patient outcomes. This paper explores the reconfiguration of specialist oesophago-gastric (OG) cancer surgery services in a large urban area of England (Greater Manchester, GM), with a focus on the role of history in this change process and how reconfiguration was achieved after previous failed attempts. METHODS: This study draws on qualitative research from a mixed-methods evaluation of the reconfiguration of specialist cancer surgery services in GM. Forty-six interviews with relevant stakeholders were carried out, along with ~160 hours of observations at meetings and the acquisition of ~300 pertinent documents. Thematic analysis using deductive and inductive approaches was undertaken, guided by a framework of 'simple rules' for MSC. RESULTS: Through an awareness of, and attention to, history, leaders developed a change process which took into account previous unsuccessful reconfiguration attempts, enabling them to reduce the impact of potentially challenging issues. Interviewees described attending to issues involving competition between provider sites, change leadership, engagement with stakeholders, and the need for a process of change resilient to challenge. CONCLUSION: Recognition of, and response to, history, using a range of perspectives, enabled this reconfiguration. Particularly important was the way in which history influenced and informed other aspects of the change process and the influence of stakeholder power. This study provides further learning about MSC and the need for a range of perspectives to enable understanding. It shows how learning from history can be used to enable successful change.

Prereferral rectal artesunate for treatment of severe childhood malaria: a cost-effectiveness analysis.

BACKGROUND: Severely ill patients with malaria with vomiting, prostration, and altered consciousness cannot be treated orally and need injections. In rural areas, access to health facilities that provide parenteral antimalarial treatment is poor. Safe and effective treatment of most severe malaria cases is delayed or not achieved. Rectal artesunate interrupts disease progression by rapidly reducing parasite density, but should be followed by further antimalarial treatment. We estimated the cost-effectiveness of community-based prereferral artesunate treatment of children suspected to have severe malaria in areas with poor access to formal health care. METHODS: We assessed the cost-effectiveness (in international dollars) of the intervention from the provider perspective. We studied a cohort of 1000 newborn babies until 5 years of age. The analysis assessed how the cost-effectiveness results changed with low (25%), moderate (50%), high (75%), and full (100%) referral compliance and intervention uptake. FINDINGS: At low intervention uptake and referral compliance (25%), the intervention was estimated to avert 19 disability-adjusted life-years (DALYs; 95% CI 16-21) and to cost I$1173 (95% CI 1050-1297) per DALY averted. Under the full uptake and compliance scenario (100%), the intervention could avert 967 DALYs (884-1050) at a cost of I$77 (73-81) per DALY averted. INTERPRETATION: Prereferral artesunate treatment is a cost-effective, life-saving intervention, which can substantially improve the management of severe childhood malaria in rural African settings in which programmes for community health workers are in place. FUNDING: The Disease Control Priorities Project; Fogarty International Center; US National Institutes of Health; and the Peter Paul Career Development Professorship, Boston University.

Challenges implementing a carer support intervention within a national stroke organisation: findings from the process evaluation of the OSCARSS trial.

OBJECTIVES: To examine the implementation of an intervention to support informal caregivers and to help understand findings from the Organising Support for Carers of Stroke Survivors (OSCARSS) cluster randomised controlled trial (cRCT). DESIGN: Longitudinal process evaluation using mixed methods. Normalisation process theory informed data collection and provided a sensitising framework for analysis. SETTING: Specialist stroke support services delivered primarily in the homes of informal carers of stroke survivors. PARTICIPANTS: OSCARSS cRCT participants including carers, staff, managers and senior leaders. INTERVENTION: The Carer Support Needs Assessment Tool for Stroke (CSNAT-Stroke) intervention is a staff-facilitated, carer-led approach to help identify, prioritise and address support needs. RESULTS: We conducted qualitative interviews with: OSCARSS cRCT carer participants (11 intervention, 10 control), staff (12 intervention, 8 control) and managers and senior leaders (11); and obtained 140 responses to an online staff survey over three separate time points. Both individual (carer/staff) and organisational factors impacted implementation of the CSNAT-Stroke intervention and how it was received by carers. We identified four themes: staff understanding, carer participation, implementation, and learning and support. Staff valued the idea of a structured approach to supporting carers, but key elements of the intervention were not routinely delivered. Carers did not necessarily identify as 'carers', which made it difficult for staff to engage them in the intervention. Despite organisational enthusiasm for OSCARSS, staff in the intervention arm perceived support and training for implementation of CSNAT-Stroke as delivered primarily by the research team, with few opportunities for shared learning across the organisation. CONCLUSIONS: We identified challenges across carer, staff and organisation levels that help explain the OSCARSS cRCT outcome. Ensuring training is translated into practice and ongoing organisational support would be required for full implementation of this type of intervention, with emphasis on the carer-led aspects, including supporting carer self-identification. TRIAL REGISTRATION NUMBER: ISRCTN58414120.

Organising Support for Carers of Stroke Survivors (OSCARSS): a cluster randomised controlled trial with economic evaluation.

OBJECTIVE: Investigated clinical effectiveness and cost-effectiveness of a person-centred intervention for informal carers/caregivers of stroke survivors. DESIGN: Pragmatic cluster randomised controlled trial (cRCT) with economic and process evaluation. SETTING: Clusters were services, from a UK voluntary sector specialist provider, delivering support primarily in the homes of stroke survivors and informal carers. PARTICIPANTS: Adult carers in participating clusters were referred to the study by cluster staff following initial support contact. INTERVENTIONS: Intervention was the Carer Support Needs Assessment Tool for Stroke: a staff-facilitated, carer-led approach to help identify, prioritise and address the specific support needs of carers. It required at least one face-to-face support contact dedicated to carers, with reviews as required. Control was usual care, which included carer support (unstructured and variable). OUTCOME MEASURES: Participants provided study entry and self-reported outcome data by postal questionnaires, 3 and 6 months after first contact by cluster staff. PRIMARY OUTCOME: 3-month caregiver strain (Family Appraisal of Caregiving Questionnaire, FACQ). SECONDARY OUTCOMES: FACQ subscales of caregiver distress and positive appraisals of caregiving, mood (Hospital Anxiety and Depression Scale) and satisfaction with stroke services (Pound). The economic evaluation included self-reported healthcare utilisation, intervention costs and EQ-5D-5L. RANDOMISATION AND MASKING: Clusters were recruited before randomisation to intervention or control, with stratification for size of service. Cluster staff could not be masked as training was required for participation. Carer research participants provided self-reported outcome data unaware of allocation; they consented to follow-up data collection only. RESULTS: Between 1 February 2017 and 31 July 2018, 35 randomised clusters (18 intervention; 17 control) recruited 414 cRCT carers (208 intervention; 206 control). Study entry characteristics were well balanced. PRIMARY OUTCOME MEASURE: intention-to-treat analysis for 84% retained participants (175 intervention; 174 control) found mean (SD) FACQ carer strain at 3 months to be 3.11 (0.87) in the control group compared with 3.03 (0.90) in the intervention group, adjusted mean difference of -0.04 (95% CI -0.20 to 0.13). Secondary outcomes had similarly small differences and tight CIs. Sensitivity analyses suggested robust findings. Intervention fidelity was not achieved. Intervention-related group costs were marginally higher with no additional health benefit observed on EQ-5D-5L. No adverse events were related to the intervention. CONCLUSIONS: The intervention was not fully implemented in this pragmatic trial. As delivered, it conferred no clinical benefits and is unlikely to be cost-effective compared with usual care from a stroke specialist provider organisation. It remains unclear how best to support carers of stroke survivors. To overcome the implementation challenges of person-centred care in carers' research and service development, staff training and organisational support would need to be enhanced. TRIAL REGISTRATION NUMBER: ISRCTN58414120.

Implementing major system change in specialist cancer surgery: The role of provider networks.

OBJECTIVE: Major system change (MSC) has multiple, sometimes conflicting, goals and involves implementing change across a number of organizations. This study sought to develop new understanding of how the role that networks can play in implementing MSC, using the case of centralization of specialist cancer surgery in London, UK. METHODS: The study was based on a framework drawn from literature on networks and MSC. We analysed 100 documents, conducted 134 h of observations during relevant meetings and 81 interviews with stakeholders involved in the centralization. We analysed the data using thematic analysis. RESULTS: MSC in specialist cancer services was a contested process, which required constancy in network leadership over several years, and its horizontal and vertical distribution across the network. A core central team composed of network leaders, managers and clinical/manager hybrid roles was tasked with implementing the changes. This team developed different forms of engagement with provider organizations and other stakeholders. Some actors across the network, including clinicians and patients, questioned the rationale for the changes, the clinical evidence used to support the case for change, and the ways in which the changes were implemented. CONCLUSIONS: Our study provides new understanding of MSC by discussing the strategies used by a provider network to facilitate complex changes in a health care context in the absence of a system-wide authority.

Cost-effectiveness projections of single and combination therapies for visceral leishmaniasis in Bihar, India.

OBJECTIVES: To assess the cost-effectiveness of current monotherapies and prospective combinations for treating visceral leishmaniasis (VL) in Bihar, India in terms of years of life lost (YLL) averted as well as deaths averted. METHODS: We employed two methods to estimate the number of avertable deaths in our analysis: one using estimated mortality, the other using direct incidence estimates for VL. Costs of care are based on an average private hospital in Bihar, and data on drug costs were obtained both locally and from the World Health Organization. RESULTS: The cost of monotherapies per averted YLL ranged from US$2 for paromomycin in an outpatient setting to US$20-22 for AmBisome at 20 mg/kg. The corresponding costs per death averted ranged from US$53-54 to US$523-527. Combinations ranged US$5-8 per YLL averted and US$124-213 per death averted. CONCLUSION: The available treatments for VL are cost-effective, and our mortality and incidence-based methods produce consistent estimates. The combinations considered here were more cost-effective than most monotherapies. Having multiple treatment options and combining drugs are also likely to reduce drug pressure and prolong the drugs' life-span of effective use.

Global investments in TB control: economic benefits.

The Global Plan to Stop TB calls for significant financial resources to meet the Millennium Development Goals for tuberculosis. However, it is unclear whether the economic benefits of TB control exceed the costs. Using an epidemiological model, we find that the economic benefits of the Global Plan relative to sustained DOTS (a commonly used treatment method) were unambiguously greater than the incremental costs in all nine high-burden countries in Africa and in Afghanistan, Pakistan, and Russia. Benefit-cost ratios of sustaining DOTS at current levels relative to having no DOTS exceeded 1 in all twenty-two high-burden, TB-endemic countries and sub-Saharan Africa.