Collaborative working within UK NHS secondary care and across sectors for COPD and the impact of peer review : qualitative findings from the UK National COPD Resources and Outcomes Project

Introduction: We investigated the effects on collaborative work within the UK National Health Service (NHS) of an intervention for service quality improvement: informal, structured, reciprocated, multidisciplinary peer review with feedback and action plans. The setting was care for chronic obstructive pulmonary disease (COPD). Theory and methods: We analysed semi-structured interviews with 43 hospital respiratory consultants, nurses and general managers at 24 intervention and 11 control sites, as part of a UK randomised controlled study, the National COPD Resources and Outcomes Project (NCROP), using Scott’s conceptual framework for action (inter-organisational, intra-organisational, inter-professional and inter-individual). Three areas of care targeted by NCROP involved collaboration across primary and secondary care. Results: Hospital respiratory department collaborations with commissioners and hospital managers varied. Analysis suggested that this is related to team responses to barriers. Clinicians in unsuccessful collaborations told ‘atrocity stories’ of organisational, structural and professional barriers to service improvement. The others removed barriers by working with government and commissioner agendas to ensure continued involvement in patients’ care. Multidisciplinary peer review facilitated collaboration between participants, enabling them to meet, reconcile differences and exchange ideas across boundaries. Conclusions: The data come from the first randomised controlled trial of organisational peer review, adding to research into UK health service collaborative work, which has had a more restricted focus on inter-professional relations. NCROP peer review may only modestly improve collaboration but these data suggest it might be more effective than top-down exhortations to change when collaboration both across and within organisations is required

Pain management for chronic musculoskeletal conditions : the development of an evidence-based and theory-informed pain self-management course

Objective: To devise and test a self-management course for chronic pain patients based on evidence and underpinned by theory using the Medical Research Council (MRC) framework for developing complex interventions. Design: We used a mixed method approach. We conducted a systematic review of the effectiveness of components and characteristics of pain management courses. We then interviewed chronic pain patients who had attended pain and self-management courses. Behavioural change theories were mapped onto our findings and used to design the intervention. We then conducted a feasibility study to test the intervention. Setting: Primary care in the inner city of London, UK. Participants: Adults (18 years or older) with chronic musculoskeletal pain. Outcomes: Related disability, quality of life, coping, depression, anxiety, social integration and healthcare resource use. Results: The systematic reviews indicated that group-based courses with joint lay and healthcare professional leadership and that included a psychological component of short duration (<8 weeks) showed considerable promise. The qualitative research indicated that participants liked relaxation, valued social interaction and course location, and that timing and good tutoring were important determinants of attendance. We used behavioural change theories (social learning theory and cognitive behaviour approaches (CBA)) to inform course content. The course addressed: understanding and accepting pain, mood and pain, unhelpful thoughts and behaviour, problem solving, goal setting, action planning, movement, relaxation and social integration/reactivation. Attendance was 85%; we modified the recruitment of patients, the course and the training of facilitators as a result of testing. Conclusions: The MRC guidelines were helpful in developing this intervention. It was possible to train both lay and non-psychologists to facilitate the courses and deliver CBA. The course was feasible and well received

Fidelity in complex behaviour change interventions : a standardised approach to evaluate intervention integrity

Objectives: The aim of this study was to (1) demonstrate the development and testing of tools and procedures designed to monitor and assess the integrity of a complex intervention for chronic pain (COping with persistent Pain, Effectiveness Research into Self-management (COPERS) course); and (2) make recommendations based on our experiences. Design: Fidelity assessment of a two-arm randomised controlled trial intervention, assessing the adherence and competence of the facilitators delivering the intervention. Setting: The intervention was delivered in the community in two centres in the UK: one inner city and one a mix of rural and urban locations. Participants: 403 people with chronic musculoskeletal pain were enrolled in the intervention arm and 300 attended the self-management course. Thirty lay and healthcare professionals were trained and 24 delivered the courses (2 per course). We ran 31 courses for up to 16 people per course and all were audio recorded. Interventions: The course was run over three and a half days; facilitators delivered a semistructured manualised course. Outcomes: We designed three measures to evaluate fidelity assessing adherence to the manual, competence and overall impression. Results: We evaluated a random sample of four components from each course (n=122). The evaluation forms were reliable and had good face validity. There were high levels of adherence in the delivery: overall adherence was two (maximum 2, IQR 1.67–2.00), facilitator competence exhibited more variability, and overall competence was 1.5 (maximum 2, IQR 1.25–2.00). Overall impression was three (maximum 4, IQR 2.00–3.00). Conclusions: Monitoring and assessing adherence and competence at the point of intervention delivery can be realised most efficiently by embedding the principles of fidelity measurement within the design stage of complex interventions and the training and assessment of those delivering the intervention. More work is necessary to ensure that more robust systems of fidelity evaluation accompany the growth of complex interventions

Effectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS)

Introduction: Chronic musculoskeletal pain is a common condition that often responds poorly to treatment. Self-management courses have been advocated as a non-drug pain management technique, although evidence for their effectiveness is equivocal. We designed and piloted a self-management course based on evidence for effectiveness for specific course components and characteristics. Methods/analysis: COPERS (coping with persistent pain, effectiveness research into self-management) is a pragmatic randomised controlled trial testing the effectiveness and cost-effectiveness of an intensive, group, cognitive behavioural-based, theoretically informed and manualised self-management course for chronic pain patients against a control of best usual care: a pain education booklet and a relaxation CD. The course lasts for 15 h, spread over 3 days, with a –2 h follow-up session 2 weeks later. We aim to recruit 685 participants with chronic musculoskeletal pain from primary, intermediate and secondary care services in two UK regions. The study is powered to show a standardised mean difference of 0.3 in the primary outcome, pain-related disability. Secondary outcomes include generic health-related quality of life, healthcare utilisation, pain self-efficacy, coping, depression, anxiety and social engagement. Outcomes are measured at 6 and 12 months postrandomisation. Pain self-efficacy is measured at 3 months to assess whether change mediates clinical effect. Ethics/dissemination: Ethics approval was given by Cambridgeshire Ethics 11/EE/046. This trial will provide robust data on the effectiveness and cost-effectiveness of an evidence-based, group self-management programme for chronic musculoskeletal pain. The published outcomes will help to inform future policy and practice around such self-management courses, both nationally and internationally. Trial registration: ISRCTN24426731

What do we want to get out of this?:a critical interpretive synthesis of the value of process evaluations, with a practical planning framework

BACKGROUND: Process evaluations aim to understand how complex interventions bring about outcomes by examining intervention mechanisms, implementation, and context. While much attention has been paid to the methodology of process evaluations in health research, the value of process evaluations has received less critical attention. We aimed to unpack how value is conceptualised in process evaluations by identifying and critically analysing 1) how process evaluations may create value and 2) what kind of value they may create. METHODS: We systematically searched for and identified published literature on process evaluation, including guidance, opinion pieces, primary research, reviews, and discussion of methodological and practical issues. We conducted a critical interpretive synthesis and developed a practical planning framework. RESULTS: We identified and included 147 literature items. From these we determined three ways in which process evaluations may create value or negative consequences: 1) through the socio-technical processes of ‘doing’ the process evaluation, 2) through the features/qualities of process evaluation knowledge, and 3) through using process evaluation knowledge. We identified 15 value themes. We also found that value varies according to the characteristics of individual process evaluations, and is subjective and context dependent. CONCLUSION: The concept of value in process evaluations is complex and multi-faceted. Stakeholders in different contexts may have very different expectations of process evaluations and the value that can and should be obtained from them. We propose a planning framework to support an open and transparent process to plan and create value from process evaluations and negotiate trade-offs. This will support the development of joint solutions and, ultimately, generate more value from process evaluations to all. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-022-01767-7

Reply: Cognitive behavioural therapy sessions approach ineffective for anxiety and depression in COPD: is the door closed for good?

Our trial does not support using a CBA approach to alleviate mild/moderate anxiety and/or depression in people with moderate/severe COPD. New approaches are needed to relieve the substantial mental health burden in these patients with complex needs. https://bit.ly/3TkkDt

Supported self-management for people with type 2 diabetes:a meta-review of quantitative systematic reviews

OBJECTIVES: Self-management support aims to give people with chronic disease confidence to actively manage their disease, in partnership with their healthcare provider. A meta-review can inform policy-makers and healthcare managers about the effectiveness of self-management support strategies for people with type 2 diabetes, and which interventions work best and for whom. DESIGN: A meta-review of systematic reviews of randomised controlled trials (RCTs) was performed adapting Cochrane methodology. SETTING AND PARTICIPANTS: Eight databases were searched for systematic reviews of RCTs from January 1993 to October 2016, with a pre-publication update in April 2017. Forward citation was performed on included reviews in Institute for Scientific Information (ISI) Proceedings. We extracted data and assessed quality with the Revised-Assessment of Multiple Systematic Reviews (R-AMSTAR). PRIMARY AND SECONDARY OUTCOME MEASURES: Glycaemic control as measured by glycated haemoglobin (HbA1c) was the primary outcome. Body mass Index, lipid profiles, blood pressure and quality of life scoring were secondary outcomes. Meta-analyses reporting HbA1c were summarised in meta-forest plots; other outcomes were synthesised narratively. RESULTS: 41 systematic reviews incorporating data from 459 unique RCTs in diverse socio-economic and ethnic communities across 33 countries were included. R-AMSTAR quality score ranged from 20 to 42 (maximum 44). Apart from one outlier, the majority of reviews found an HbA1c improvement between 0.2% and 0.6% (2.2-6.5 mmol/mol) at 6 months post-intervention, but attenuated at 12 and 24 months. Impact on secondary outcomes was inconsistent and generally non-significant. Diverse self-management support strategies were employed; no single approach appeared optimally effective (or ineffective). Effective programmes tended to be multi-component and provide adequate contact time (>10 hours). Technology-facilitated self-management support showed a similar impact as traditional approaches (HbA1c MD -0.21% to -0.6%). CONCLUSIONS: Self-management interventions using a range of approaches improve short-term glycaemic control in people with type 2 diabetes including culturally diverse populations. These findings can inform researchers, policy-makers and healthcare professionals re-evaluating the provision of self-management support in routine care. Further research should consider implementation and sustainability.MC is supported by the Scottish School of Primary Care (academic fellowship in general practice)

The lived experience of chronic headache : a systematic review and synthesis of the qualitative literature

Objective To systematically review the qualitative literature of the lived experience of people with a chronic headache disorder. Background Chronic headaches affect 3%–4% of the population. The most common chronic headache disorders are chronic migraine, chronic tension-type headache and medication overuse headache. We present a systematic review and meta-ethnographic synthesis of the lived experience of people with chronic headache. Methods We searched seven electronic databases, hand-searched nine journals and used a modified Critical Appraisal Skills Programme checklist to appraise study quality. Following thematic analysis we synthesised the data using a meta-ethnographic approach. Results We identified 3586 unique citations; full texts were examined for 86 studies and 4 were included in the review. Included studies differed in their foci: exploring, patient-centred outcomes, chronic headache as a socially invisible disease, psychological processes mediating impaired quality of life, and the process of medication overuse. Initial thematic analysis and subsequent synthesis gave three overarching themes: ‘headache as a driver of behaviour’ (directly and indirectly), ‘the spectre of headache’ and ‘strained relationships’. Conclusion This meta-synthesis of published qualitative evidence demonstrates that chronic headaches have a profound effect on people’s lives, showing similarities with other pain conditions. There were insufficient data to explore the similarities and differences between different chronic headache disorders

Novel three-day, community-based, nonpharmacological group intervention for chronic musculoskeletal pain (COPERS): a randomised clinical trial

Background Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited, and there is growing concern about the adverse effects of these treatments, including opioid dependence. Nonpharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically based group pain management support intervention for chronic musculoskeletal pain. Methods and Findings We conducted a multi-centre, pragmatic, randomised, controlled effectiveness and cost-effectiveness (cost–utility) trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 mo duration between August 1, 2011, and July 31, 2012, and randomised participants 1.33:1 to intervention (403) or control (300). Intervention participants were offered a participative group intervention (COPERS) delivered over three alternate days with a follow-up session at 2 wk. The intervention introduced cognitive behavioural approaches and was designed to promote self-efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain-related disability at 12 mo (Chronic Pain Grade [CPG] disability subscale); secondary outcomes included the CPG disability subscale at 6 mo and the following measured at 6 and 12 mo: anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), pain acceptance (Chronic Pain Acceptance Questionnaire), social integration (Health Education Impact Questionnaire social integration and support subscale), pain-related self-efficacy (Pain Self-Efficacy Questionnaire), pain intensity (CPG pain intensity subscale), the census global health question (2011 census for England and Wales), health utility (EQ-5D-3L), and health care resource use. Analyses followed the intention-to-treat principle, accounted for clustering by course in the intervention arm, and used multiple imputation for missing or incomplete primary outcome data. The mean age of participants was 59.9 y, with 81% white, 67% female, 23% employed, 85% with pain for at least 3 y, and 23% on strong opioids. Symptoms of depression and anxiety were common (baseline mean HADS scores 7.4 [standard deviation 4.1] and 9.2 [4.6], respectively). Overall, 282 (70%) intervention participants met the predefined intervention adherence criterion. Primary outcome data were obtained from 88% of participants. There was no significant difference between groups in pain-related disability at 6 or 12 mo (12 mo: difference −1.0, intervention versus control, 95% CI −4.9 to 3.0), pain intensity, or the census global health question. Anxiety, depression, pain-related self-efficacy, pain acceptance, and social integration were better in the intervention group at 6 mo; at 12 mo, these differences remained statistically significant only for depression (−0.7, 95% CI −1.2 to −0.2) and social integration (0.8, 95% CI 0.4 to 1.2). Intervention participants received more analgesics than the controls across the 12 mo. The total cost of the course per person was £145 (US$214). The cost–utility analysis showed there to be a small benefit in terms of quality-adjusted life years (QALYs) (0.0325, 95$277], 95% CI −£125 [−US$184] to £501 [US$738]), resulting in an incremental cost-effectiveness ratio of £5,786 (US$8,521) per QALY. Limitations include the fact that the intervention was relatively brief and did not include any physical activity components. Conclusions While the COPERS intervention was brief, safe, and inexpensive, with a low attrition rate, it was not effective for reducing pain-related disability over 12 mo (primary outcome). For secondary outcomes, we found sustained benefits on depression and social integration at 6 and 12 mo, but there was no effect on anxiety, pain-related self-efficacy, pain acceptance, pain intensity, or the census global health question at 12 mo. There was some evidence that the intervention may be cost-effective based on a modest difference in QALYs between groups. Trial registration ISRCTN Registry 2442673

CHESS process evaluation results report

Executive Summary Purpose: The purpose of this report is to present the findings from the CHESS trial process evaluation. These results are being presented to the CHESS Chief Investigator and the CHESS team before the main trial outcomes are presented. These results will form the basis of the process evaluation interpretation of the CHESS outcome as well as a process evaluation paper. Background: This process evaluation is for the Chronic Headache Education and Self-management Study (CHESS) RCT, which is evaluating an education and self-management group behavioural intervention for people with chronic headache. Chronic headache is defined as headaches which are present for 15 or more days per month. The most common types are chronic migraine and chronic tension type and medication overuse headaches. Methods: Our process evaluation was guided by the MRC framework and explored components proposed by Steckler and Linnan including Context, Reach, Recruitment, Dose delivered, Dose receive, intervention fidelity and Implementation. We employed a mixed methods approach. Using both quantitative and qualitative data. Quantitatively we explored: Reach/context, recruitment, dose delivered, dose received and fidelity. In addition to this we included the experiences of both participants and intervention facilitators about their involvement in the trial. By bringing together both the qualitative and quantitative results where we explored both early implementation (4-months) and implementation overall; looking for facilitators and barriers. Results: Reach/Context results show that we reached a diverse population that was representative of national averages in terms of ethnic mix and levels of deprivation, with a good mix of rural and suburban areas. Recruitment proved to be consistent across the study with an average of 2% (31,020) of the populations from the 164 GP practices being identified as potential participants. The study team struggled to recruit all headache types and the study became predominantly populated with those reporting migraine. The research team identified 31,020 people from GP searches and contacted, of these 7% (2178) were interested in CHESS, but of these only 47% (1034) were eligible, 68% (706) were randomised. There is a slight trend towards better recruitment and randomisation in less deprived areas. The study team successfully delivered 42 (2-day) group sessions. A total of 380 participants were invited to attend the two-day group sessions and the 1-2-1 discussions with a nurse. 288 (76%) attended at least part of the two-day course. 92 (24%) were not exposed to the CHESS intervention at all. Of the 288 who did attend the group sessions 227 (79%) attended both days whilst 61 (21%) only attended day one. Of the 288 who took part in groups 261 (91%) had a one-to-one interaction with the nurse. Overall 380/261 (69%) achieved the predefined minimum dose (attended at least some of the course and the 1-2-1 discussion with the nurse). Only 217 (57%) fully adhered to the intervention. In terms of fidelity the intervention was delivered well with adherence being slightly better than competence. (Adherence 0.83% (0.67, 1.00) Competence 70% (0.50, 0.90)). Interviews with participants gave us an insight into the lives of people who live with chronic headache. 31 participated in the interview study covering both the intervention and control arms. Participants provided their thoughts and feelings about the interventions, both control and active, with generally favourable comments. A sample of participants (n = 117) who were in the intervention arm provided detailed feedback on the 2-day group session and the nurse 1-2-1. Results were generally positive with high levels of satisfaction with the course overall and the facilitators. Venues, relaxation and taster sessions and the mindfulness received less favourable satisfaction scores. Interviewees were largely positive about the group sessions with them generally liking the group format, however some sessions were more popular than others For example, the lifestyle session, stress and anxiety and sleep sessions and overall felt it were useful to raise awareness of how these may affect headaches. Whilst the Mindfulness and relaxation for headaches Taster activity and the managing setbacks session were not well liked. Comments on the 1-2-1 sessions again were generally positive. Focus groups with the facilitators offered provided views from their perspective. Fourteen interviewees contributed to a longitudinal examination of their experiences of the trial and its impact on their lives with chronic headache. These showed similarities and differences between the intervention and control arm participants. Again these interviews highlight the complexity of living with chronic headache. In the intervention arm participants described having made, or making, changes to their lives and headache management that could be attributed to CHESS. But equally there is evidence of similar improvements in control participants. Conclusion: The results of the PE, reveal that the CHESS study was well conducted and it reached out to a diverse population across different geographical settings. Recruitment was successful. However, the PE does highlight that this is a complex population that may be hard to reach. The intervention components (2-day course and 1-2-1 sessions) were delivered with fidelity and, in most cases, were well received. We have results that will help interpret the outcome results from the main trial and we are making a number of recommendations