"We have to change our mindsets": a qualitative study of barriers and facilitators in research collaboration across integrated care system organisations.

The introduction of Integrated Care Systems (ICS) in England aimed to increase joint planning and delivery of health and social care, and other services, to better meet the needs of local communities. There is an associated duty to undertake collaborative research across ICS partners to inform this new integrated approach, which might be challenging given that organisations span health, local authority, voluntary and community sector, and research. This study aimed to explore the appetite for collaborative Research and Innovation (R&I) across ICSs, potential barriers and solutions. This qualitative study involved semi-structured interviews with 24 stakeholders who held senior positions within organisations across two ICS areas (Staffordshire and Stoke-on-Trent; Shropshire, Telford and Wrekin). Interview transcripts were analysed using inductive and deductive analysis, first mapping to the Theoretical Domains Framework (TDF), then considering key influences on organisational behaviour in terms of Capability, Opportunity and Motivation from the COM-B Behaviour Change Wheel. There were fundamental limitations on organisational opportunities for collaborative R&I: a historical culture of competition (rather than collaboration), a lack of research culture and prioritisation, compounded by a challenging adverse economic environment. However, organisations were motivated to undertake collaborative R&I. They recognised the potential benefits (e.g., skill-sharing, staff development, attracting large studies and funding), the need for collaborative research that mirrors integrated care, and subsequent benefits for care recipients. Related barriers included negative experiences of collaboration, fear of failing and low confidence. Capability varied across organisations in terms of research skills and confidence, which reflected the range of partners (from local authorities to NHS Trusts, primary care, and academic institutions). These findings indicate a need to shift from a culture of competition to collaboration, and to help organisations across ICS to prioritise research, and share resources and skills to mitigate the limiting effects of a constrained economic environment. This could be further explored using a systems change approach, to develop the collaborative research efforts alongside the overarching move towards integrated care.

An evaluation of a public partnership project between academic institutions and young people with Black African, Asian and Caribbean heritage.

BACKGROUND: This project (named Reinvent) aimed to promote Public Involvement (PI) in health research. Academics worked with a community group, the Eloquent Praise & Empowerment Dance Company, to develop a community partnership with young people from Black African, Asian and Caribbean heritage communities. The goal of this paper is to evaluate the Reinvent project for key learnings on how to engage and build partnerships with young people from Black African, Asian and Caribbean heritage communities. METHODS: Reinvent developed a steering group which consisted of five young people, one academic, a Race Equality Ambassador and the Director of Eloquent. The steering group co-produced an agenda for two workshops and the evaluation tools used. The content of the workshops included drama exercises, discussions on physical and mental health, nutrition and school-life, short introductions to the concepts of research and PI, and group work to critique and improve a video currently used to promote PI in health research to young people. The evaluation tools included using the 'Cube' evaluation framework, video-blogging and collecting anonymous feedback. Findings The responses to the 'Cube' evaluation framework were positive across all four domains (agenda, voice, contribute change) in both workshops. A few of the young people described having a better understanding of the meaning and practice of PI in a video-blog. The anonymous feedback suggested that the workshops had increased young people's confidence in sharing their thoughts and opinions about health and PI. CONCLUSION: Reinvent has shown that academic institutions and young people from an under-served community can partner to co-design workshops and apply evaluation tools. Working with young people in an environment in which they were comfortable, and by researchers joining in with the activities that the young people enjoyed (such as dance), enabled more informal and open conversations to develop. More work is needed to build upon this project so that young people can feel confident and supported to get involved in PI activities relating to research.

Applying the consolidated framework for implementation research to evaluate the community rapid intervention service.

BACKGROUND: Developed in 2019, the Community Rapid Intervention Service (CRIS) is a community intervention service aiming to prevent hospital admissions. CRIS provides a response within two hours to patients with sub-acute medical needs in their usual place of residence. This evaluation aimed to identify challenges and facilitators to implementation of the service, with a view to informing future service development, optimising patient care and disseminating learning to other areas looking to implement similar services. METHODS: This study used the Consolidated Framework for Implementation Research (CFIR) as an evaluation framework. We conducted semi-structured interviews with local healthcare system leaders, clinicians that worked within the CRIS, and clinicians who interfaced with the CRIS. The CFIR was used to guide data collection and analysis. Two Community of Practice (CoP) meetings were held to gather stakeholders' perspectives of the evaluation. RESULTS: Three key themes were identified from the analysis of 13 interviews: contextual factors influencing implementation, service identity and navigating complexity. Contextual factors such the influence of the Covid 19 pandemic upon health services and the expansion of the CRIS were discussed by participants. The adaptability of the service was deemed both a facilitator and challenge of implementation. Ways to build-on and improve the existing CRIS model were suggested. CONCLUSION: This evaluation has shown that the CRIS may need to be redefined with clarity provided as to how the service interfaces with other urgent and planned care offered in acute, primary, community and social services. Structuring the evaluation around the CFIR was helpful in identifying facilitators and challenges that influenced the implementation of the CRIS.

Experience of implementing and delivering group consultations in UK general practice: a qualitative study.

BACKGROUND: Group consultations are a relatively new concept in UK primary care and are a suggested solution to current workload pressures in general practice. Little is known about the experience of implementing and delivering this approach from staff and organisational perspectives. AIM: To explore the experience of implementing and delivering group consultations in general practice. DESIGN AND SETTING: Qualitative telephone interview study. METHOD: Topic guides explored the perspectives and experiences of general practice staff on the implementation and delivery of group consultations. Data analysis adopted principles of the Framework Method underpinned by Normalisation Process Theory. RESULTS: Interviews were conducted with 8 GPs, 8 practice nurses, 1 nurse associate, 1 practice pharmacist, 1 deputy practice manager, and 1 healthcare assistant. Four themes were identified: sense making of group consultations; the work associated with initiating group consultations; the experiences of operationalising group consultations; and sustaining change. Group consultations made sense to participants as a mechanism to reduce burden on primary care, enhance multidisciplinary working, and provide patient-centred care. Implementation required strong leadership from a 'champion', and a facilitator had a pivotal role in operationalising the approach. The associated workload was often underestimated. Barriers to embedding change included achieving whole practice buy-in, competing practice priorities, and system-level flexibility. CONCLUSION: General practice clinicians enjoyed group consultations, yet significant work is required to initiate and sustain the approach. An implementation plan considering leadership, roles and responsibilities, and wider organisational support is required at the outset. Further research or evaluation is needed to measure process outcomes.

Health Utility Values Associated with Surgical Site Infection: A Systematic Review.

BACKGROUND: Surgical site infection (SSI) is a costly postoperative complication whose impact on patients' health-related quality of life is highly uncertain and has not been summarized to date. OBJECTIVE: The objective was to summarize the evidence base on SSI health utility values reported in patient-level studies and decision models. METHODS: A systematic review of SSI utility values reported in patient-level and decision modeling studies was carried out. Studies in which utility values for SSI were either invoked (e.g., model-based economic evaluations) or elicited (e.g., valuation exercises), or at least one non-preference-based instrument was administered to patients with SSI after open surgery were included. Mapping algorithms were used, where appropriate, to calculate utilities from primary data. Results were summarized narratively, and the quality of the utility values used in the included modeling studies was assessed. RESULTS: Of 6552 records identified in the database search, 28 studies were included in the review: 19 model-based economic evaluations and 9 patient-level studies. SSI utility decrements ranged from 0.04 to 0.48, of which 19 ranged from 0.1 to 0.3. SSI utility decrements could be calculated for three patient-level studies, and their values ranged from 0.05 (7 days postoperatively) to 0.124 (1 year postoperatively). In most modeling studies, SSI utilities were informed by authors' assumptions or by secondary sources. CONCLUSIONS: SSI may substantially affect patients' health utility and needs to be considered when modeling decision problems in surgery. The evidence base for SSI utilities is of questionable quality and skewed toward orthopedic surgery. Further research must concentrate on producing reliable estimates for patients without orthopedic problems.

Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols.

BACKGROUND: Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. METHODS AND FINDINGS: We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the 'Standard Protocol Items: Recommendations for Interventional Trials' (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16-41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4-18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively 'complete' using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. CONCLUSIONS: The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols.

Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.

BACKGROUND: Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers. METHODS AND FINDINGS: We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency. CONCLUSIONS: PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in appropriate trial protocols, in order to facilitate rigorous collection/reporting of PRO data, to effectively inform patient care.

Patient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standards.

PURPOSE: To develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs. METHODS: A Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership. Respondents were asked to rate candidate standards on a 4-point Likert scale based on their perceived value in reporting studies in which HRQL was a study outcome (primary or secondary). Results were synthesized into draft reporting guidelines, which were further reviewed by the membership to inform the final guidance. RESULTS: Forty-six existing candidate standards for reporting HRQL results in RCTs were synthesized to produce a 40 item survey that was completed electronically by 161 respondents. The majority of respondents rated all 40 items to be either 'essential' or 'desirable' when HRQL was a primary RCT outcome. Ratings changed when HRQL was a secondary study outcome. Feedback on the survey findings resulted in the Task Force generalizing the guidance to include patient-reported outcomes (PROs). The final guidance, which recommends standards for use in reporting PROs generally, and more specifically, for PROs identified as primary study outcomes, was approved by the ISOQOL Board of Directors. CONCLUSIONS: ISOQOL has developed a suite of recommended standards for reporting PRO results of RCTs. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy.

Population health status of South Asian and African-Caribbean communities in the United Kingdom.

BACKGROUND: Population health status scores are routinely used to inform economic evaluation and evaluate the impact of disease and/or treatment on health. It is unclear whether the health status in black and minority ethnic groups are comparable to these population health status data. The aim of this study was to evaluate health-status in South Asian and African-Caribbean populations. METHODS: Cross-sectional study recruiting participants aged ≥ 45 years (September 2006 to July 2009) from 20 primary care centres in Birmingham, United Kingdom.10,902 eligible subjects were invited, 5,408 participated (49.6%). 5,354 participants had complete data (49.1%) (3442 South Asian and 1912 African-Caribbean). Health status was assessed by interview using the EuroQoL EQ-5D. RESULTS: The mean EQ-5D score in South Asian participants was 0.91 (standard deviation (SD) 0.18), median score 1 (interquartile range (IQR) 0.848 to 1) and in African-Caribbean participants the mean score was 0.92 (SD 0.18), median 1 (IQR 1 to 1). Compared with normative data from the UK general population, substantially fewer African-Caribbean and South Asian participants reported problems with mobility, usual activities, pain and anxiety when stratified by age resulting in higher average health status estimates than those from the UK population. Multivariable modelling showed that decreased health-related quality of life (HRQL) was associated with increased age, female gender and increased body mass index. A medical history of depression, stroke/transient ischemic attack, heart failure and arthritis were associated with substantial reductions in HRQL. CONCLUSIONS: The reported HRQL of these minority ethnic groups was substantially higher than anticipated compared to UK normative data. Participants with chronic disease experienced significant reductions in HRQL and should be a target for health intervention.

Optimisation of solvent desorption conditions for chemical warfare agent and simulant compounds from Porapak Q using experimental design. I. Methyl salicylate and di(propylene glycol) monomethyl ether.

Factorial design (FD) was applied in order to develop an optimised method for the detection of chemical warfare (CW) agent simulant compounds on Porapak Q. Application of FD allowed study of the adsorption/desorption mechanism of analytes. Di(propylene glycol) monomethyl ether (DPM) and methyl salicylate (MS) were selected for study as both compounds are employed in agent simulation trials but are currently analysed by different methods. An analytical method for simultaneous determination of both compounds was developed using solvent desorption. The optimised method identified non-polar interactions as the primary adsorption/desorption mechanism. Steel tubes were shown to be more suited for sampling of simulants, due to lower variability in recovery compared to glass tubes. Atmospheric detection limits for both simulants were estimated to be 0.2 mg m(-3) allowing the trace analysis of these compounds by gas chromatography with flame ionisation detection (GC-FID).