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Objective: Africa contributes significantly to the increasing global prevalence (>37 ​%), unmet need and treatment burden for people with osteoarthritis. Despite this, little research has examined the expressed needs of patients with osteoarthritis (OA) and joint pain in West-Africa. This study aimed to explore lived experiences, expressed needs and current care gaps for people living with osteoarthritis in low-health resource contexts using Nigeria as a case study. Design: Qualitative study using Focus Groups. People aged 45 years and over living with osteoarthritis and joint pain were recruited at local health services or via wide advertisements in the community. Discussions were recorded and transcribed verbatim. Data were analyzed using thematic analysis (inductive approach). Results: Three focus groups were conducted with people living with osteoarthritis (n ​= ​30, age range 45–90 years) across socio-demographic strata. Participants described their experiences of living with osteoarthritis as emotionally, physically, and socio-economically challenging. Four main themes (and 14 sub-themes) were identified. Participants expressed the need for an information and health education campaign and access to appropriate health professionals (especially physiotherapists) for providing support, guidance, and assistance with self-management. Conclusions: The provision of an accessible, and contextually appropriate patient education package, in line with evidence-based recommendations is a critical need for people living with osteoarthritis in Nigeria. This will promote evidence-based care for OA in low-resource settings, empowering patients to self-manage and reducing confusion related to inconsistent advice and mixed messages about cause, healthcare access and OA care.

Background: There is evidence that engaging in research is directly associated with better performance. If this relationship is to be strengthened, it is necessary to understand the mechanisms that might underlie that relationship. Aim: To explore the perspectives of staff and wider stakeholders about mechanisms by which research activity may impact on the performance of general practices. Design & setting: Qualitative study using semi-structured interviews with general practice professionals and wider stakeholders in England. Method: Individual interviews with 41 purposively sampled staff in ‘research-ready’ or ‘research-active’ general practices, and 21 other stakeholders. Interviews were independently coded by three researchers using a framework approach. Results: Participants described potential ‘direct’ and ‘indirect’ impacts on their work. ‘Direct’ impacts included improved knowledge and skills that could change practice work (for example, additional records searches for particular conditions); bringing in additional resources (for example, access to investigations or staff); and improving relationships with patients. ‘Indirect’ impacts included job satisfaction (for example, perception of practice as a centre of excellence and innovation, and the variety afforded by research activity reducing burnout); and staff recruitment (increasing the attractiveness of the practice as a place to work). Responders identified few negative impacts. Conclusion: Staff and stakeholders identified a range of potential impacts of research activity on practice performance, with impacts on their working lives most salient. Negative impacts were not generally raised. Nevertheless, responders generally discussed potential impacts rather than providing specific examples of those impacts. This may reflect the type of research activity conducted in general practice, often led by external collaborators.

Abstract Background In response to the COVID-19 pandemic, the World Health Organization established a number of key recommendations such as educational activities especially within primary care practices (PCPs) which are a key component of this strategy. This paper aims to examine the educational activities of PCPs during COVID-19 pandemic and to identify the factors associated with these practices across 38 countries. Methods A "Patient Education (PE)" score was created based on responses to six items from the self-reported questionnaire among PCPs (n = 3638) compiled by the PRICOV-19 study. Statistical analyses were performed on 3638 cases, with PCPs with missing PE score values were excluded. Results The PE score features a mean of 2.55 (SD = 0.68) and a median of 2.50 (2.16 – 3.00), with a maximum of 4.00, and varies quite widely between countries. Among all PCPs characteristics, these factors significantly increase the PE score: the payment system type (with a capitation payment system or another system compared to the fee for service), the perception of average PCP with patients with chronic conditions and the perception of adequate governmental support. Conclusion The model presented in this article is still incomplete and requires further investigation to identify other configuration elements favorable to educational activities. However, the results already highlight certain levers that will enable the development of this educational approach appropriate to primary care.

Abstract 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.

Abstract Objectives To evaluate the impact a novel education programme - to improve research engagement, awareness, understanding and confidence - had on a diverse health and social care workforce. Barriers and facilitators to engagement were explored together with research capacity-building opportunities and ways to embed a research culture. The programme is entitled ‘Supporting The Advancement of Research Skills’ (STARS programme); the paper reports findings from a health and social care setting in England, UK. Methods A four-level outcome framework guided the approach to evaluation and was further informed by key principles of research capacity development and relevant theory. Quantitative data were collected from learners before and after engagement; these were analysed descriptively. Semi-structured online interviews were conducted with learners and analysed thematically. A purposive sample was achieved to include a diversity in age, gender, health and social care profession, and level of attendance (regular attendees, moderate attendees and non-attenders). Results The evaluation spanned 18 half-day workshops and 11 seminars delivered by expert educators. 165 (2% of total staff at Midlands Partnership University NHS Foundation Trust (MPFT)) staffs booked one or more education sessions; 128 (77%) including Allied Health Professionals (AHPs), psychologists, nursing and midwifery, and social workers attended one or more session. Key themes of engagement with teaching sessions, relevance and impact of training and promoting a research active environment were identified with relevant sub-themes. Positive impacts of training were described in terms of research confidence, intentions, career planning and application of research skills as a direct result of training. Lack of dedicated time for research engagement, work pressures and time commitments required for the programme were key barriers. Facilitators that facilitated engagement are also described. Conclusions Findings demonstrate the impact that a free, virtual and high-quality research education programme had at individual and organisational levels. The programme is the product of a successful collaboration between health and social care and academic organisations; this provides a useful framework for others to adapt and adopt. Key barriers to attendance and engagement spoke to system-wide challenges that an education programme could not address in the short-term. Potential solutions are discussed in relation to protecting staff time, achieving management buy-in, recognising research champions, and having a clear communication strategy.

Introduction and objectives There is an unmet need to develop high-quality evidence addressing tuberculosis (TB)-related mental health comorbidity, particularly in the context of lower-middle-income countries. This study aims to examine the effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) versus enhanced treatment as usual (ETAU) in improving depressive symptoms in people with TB and comorbid depression, enhancing adherence with anti-TB treatment (ATT) and its implementation in the real-world setting of Pakistan.Methods We will conduct a pragmatic parallel arm randomised control trial with an internal pilot. A brief psychological intervention based on CBT has been developed using a combination of qualitative and ethnographic studies. The inbuilt pilot trial will have a sample size of 80, while we plan to recruit 560 (280 per arm) participants in the definitive trial. Participants who started on ATT within 1 month of diagnosis for pulmonary and extrapulmonary TB or multidrug resistant TB (MDR-TB) and meeting the criteria for depression on Patient Health Questionnaire-9 (PHQ-9) will be randomised with 1:1 allocation to receive six sessions of CBT (delivered by TB healthcare workers) or ETAU. Data on the feasibility outcomes of the pilot will be considered to proceed with the definitive trial. Participants will be assessed (by a blinded assessor) for the following main trial primary outcomes: (1) severity of depression using PHQ-9 scale (interviewer-administered questionnaire) at baseline, weeks 8, 24 and 32 postrandomisation and (2) ATT at baseline and week 24 at the end of ATT therapy.Ethics and dissemination Ethical approval has been obtained from Keele University Research Ethics Committee (ref: 2023-0599-792), Khyber Medical University Ethical Review Board (ref: DIR/KMU-EB/CT/000990) and National Bioethics Committee Pakistan (ref: No.4–87/NBC-998/23/587). The results of this study will be reported in peer-reviewed journals and academic conferences and disseminated to stakeholders and policymakers.Trial registration number ISRCTN10761003.

Abstract Background Conducting effective and translational research can be challenging and few trials undertake formal reflection exercises and disseminate learnings from them. Following completion of our multicentre randomised controlled trial, which was impacted by the COVID-19 pandemic, we sought to reflect on our experiences and share our thoughts on challenges, lessons learned, and recommendations for researchers undertaking or considering research in primary care. Methods Researchers involved in the Prediction of Undiagnosed atriaL fibrillation using a machinE learning AlgorIthm (PULsE-AI) trial, conducted in England from June 2019 to February 2021 were invited to participate in a qualitative reflection exercise. Members of the Trial Steering Committee (TSC) were invited to attend a semi-structured focus group session, Principal Investigators and their research teams at practices involved in the trial were invited to participate in a semi-structured interview. Following transcription, reflexive thematic analysis was undertaken based on pre-specified themes of recruitment, challenges, lessons learned, and recommendations that formed the structure of the focus group/interview sessions, whilst also allowing the exploration of new themes that emerged from the data. Results Eight of 14 members of the TSC, and one of six practices involved in the trial participated in the reflection exercise. Recruitment was highlighted as a major challenge encountered by trial researchers, even prior to disruption due to the COVID-19 pandemic. Researchers also commented on themes such as the need to consider incentivisation, and challenges associated with using technology in trials, especially in older age groups. Conclusions Undertaking a formal reflection exercise following the completion of the PULsE-AI trial enabled us to review experiences encountered whilst undertaking a prospective randomised trial in primary care. In sharing our learnings, we hope to support other clinicians undertaking research in primary care to ensure that future trials are of optimal value for furthering knowledge, streamlining pathways, and benefitting patients.

Abstract Background Armed conflicts impact on the health and well-being of everyone, but its effect on adolescent mental health is a significant, yet under-explored area in global health. Mental health disorders which develop during adolescence often lead to behavioural problems, risky decision-making, under-age substance use and can adversely impact on educational attainment. This study aimed to estimate the prevalence of common mental disorders, substance use and their correlates with social support and resilience among adolescents (age 12–19 years) in Vavuniya; a post-conflict region of Sri Lanka. Methods A population-based cross-sectional study was conducted, with a modified cluster sampling method used for participant selection. Eight culturally adapted instruments were used for data collection. A total of 585 adolescents participated in the study. Analyses were performed using SPSS Version 23 statistical software package. All statistical tests were two-sided (p

Objectives To determine General Practice (GP) recording of carer status and the number of patients self-identifying as carers, while self-completing an automated check-in screen prior to a GP consultation.Design A descriptive cross-sectional study.Setting 11 GPs in the West Midlands, England. Recruitment commenced in September 2019 and concluded in January 2020.Participants All patients aged 10 years and over, self-completing an automated check-in screen, were invited to participate during a 3-week recruitment period.Primary and secondary outcome measures The current coding of carers at participating GPs and the number of patients identifying themselves as a carer were primary outcome measures. Secondary outcome measures included the number of responses attained from automated check-in screens as a research data collection tool and whether carers felt supported in their carer role.Results 80.3% (n=9301) of patients self-completing an automated check-in screen participated in QUantifying the identification Of carers in general practice (STATUS QUO Study) (62.6% (n=5822) female, mean age 52.9 years (10–98 years, SD=20.3)). Prior to recruitment, the clinical code used to denote a carer was identified in 2.7% (n=2739) of medical records across the participating GPs.10.1% (n=936) of participants identified themselves as a carer. They reported feeling supported with their own health and social care needs: always 19.3% (n=150), a lot of the time 13.2% (n=102), some of the time 40.8% (n=317) and never 26.7% (n=207).Conclusions Many more participants self-identified as a carer than were recorded on participating GP lists. Improvements in the recording of the population’s caring status need to be actioned, to ensure that supportive implementation strategies for carers are effectively received. Using automated check-in facilities for research continues to provide high participation rates.

Introduction Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.Methods and analysis A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews.Ethics approval and dissemination Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country.Trial registration number ISRCTN18010240.

Background Back pain frequently affects older people. Knowledge about back pain in older people and evidence to inform clinical care was lacking, particularly for older people with neurogenic claudication due to spinal stenosis, which is a debilitating condition. Objectives To understand and reduce the burden of back pain on older people by increasing knowledge about back pain in older people and developing evidence-based treatment strategies. Design We completed six work packages. These were not undertaken chronologically as there was overlap between work packages. Work package 1: Refine a physiotherapy intervention for neurogenic claudication. Work package 2: Feasibility of the Oxford Pain Activity and Lifestyle cohort study and Better Outcomes for Older people with Spinal Trouble randomised controlled trial. Work package 3: Development of a prognostic tool to identify when older people are at risk of mobility decline using data from the Oxford Pain Activity and Lifestyle cohort study. Work package 4: A randomised controlled trial of physiotherapy for neurogenic claudication and nested longitudinal qualitative study (Better Outcomes for Older people with Spinal Trouble randomised controlled trial). Work package 5: Predictors of participants’ response to treatment – prespecified subgroup analyses. Work package 6: Implementation planning. Setting Primary care and National Health Service Community and Secondary Care Trusts. Participants Community-dwelling adults over the age of 65 years and registered with primary care practices. Better Outcomes for Older people with Spinal Trouble trial participants reported back and/or leg pain consistent with neurogenic claudication. Interventions The Better Outcomes for Older people with Spinal Trouble programme was a physiotherapy-delivered combined physical and psychological group intervention for older people with neurogenic claudication. The comparator was a physiotherapy assessment and tailored advice (best practice advice). Main outcome measures The primary outcome for the Oxford Pain Activity and Lifestyle prognostic tool was mobility decline based on the EQ-5D-5L Mobility Question. The primary outcome for the Better Outcomes for Older people with Spinal Trouble trial was the Oswestry Disability Index at 12 months. Other outcomes included the Oswestry Disability Index walking item, 6-minute walk test and falls. The economic analyses used the EuroQol EQ-5D-5L to measure quality of life. Results Among Oxford Pain Activity and Lifestyle participants, 34% (1786/5304) reported back pain. A further 19.5% (1035/5304) reported back pain and associated leg pain, with 11.2% (n = 594/5304) reporting symptoms consistent with neurogenic claudication. Participants with back pain had worse quality of life compared to those without back pain and reported more adverse health states such as falls, frailty, low walking confidence and mobility decline. Those with neurogenic claudication were worst affected. At 2 years’ follow-up, among those reporting back pain at baseline, only 23% (489/2100) no longer reported symptoms. Recovery was lowest among participants reporting neurogenic claudication at baseline, with 90% still reporting symptoms. At 2 years’ follow-up, 18.6% of Oxford Pain Activity and Lifestyle participants reported mobility decline. Back pain with/without leg pain was not an independent predictor of mobility decline, but lower limb pain and the report of severe pain were independent predictors. Other predictors included slow walking pace, balance difficulties, low walking confidence, walking ability worse than last year, self-reported general health and comorbidity. In the Better Outcomes for Older people with Spinal Trouble trial, there was no significant difference in Oswestry Disability Index scores between treatment groups at 12 months (adjusted mean difference −1.4, 95% confidence interval −4.03 to 1.17), but at 6 months, scores favoured the Better Outcomes for Older people with Spinal Trouble programme (adjusted mean difference −3.7, 95% confidence interval −6.27 to −1.06). The Better Outcomes for Older people with Spinal Trouble programme resulted in greater improvements in the 6-minute walk test (mean difference 21.7 m, 95% confidence interval 5.96 to 37.38 m) and walking item (mean difference −0.2, 95% confidence interval −0.45 to −0.01) and reduced falls risk (odds ratio 0.6, 95% confidence interval 0.40 to 0.98) compared to best practice advice at 12 months. The probability that the Better Outcomes for Older people with Spinal Trouble programme is cost-effective ranged between 67% and 83% (National Health Service and Personal Social Services perspective) and between 79% and 89% (societal perspective) across cost-effectiveness thresholds between £15,000 and £30,000 per quality-adjusted life-year. From the embedded qualitative study, the Better Outcomes for Older people with Spinal Trouble programme was acceptable to participants, and enjoyable. Limitations Many of the data collected were self-reported and thus may be subject to recall bias or may have resulted in misclassification of participants. Conclusions Back pain is a substantial problem for older people, with the majority reporting persistent symptoms. We have developed an effective intervention to improve mobility and reduce falls in older people with neurogenic claudication; however, more effective interventions are needed for back pain generally. We have identified a set of self-reported questions that predict mobility decline in older people, so clinicians and their patients and families know when intervention is needed. Future work Develop and evaluate treatments for older people with back pain. Optimisation of the Better Outcomes for Older people with Spinal Trouble programme to better target pain-related disability. External validation of the Oxford Pain Activity and Lifestyle prognostic tool. Study registration This trial is registered as BOOST trial ISRCTN12698674. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: PTC-RP-PG-0213-20002) and is published in full in Programme Grants for Applied Research; Vol. 11, No. 9. See the NIHR Funding and Awards website for further award information. Plain language summary Back pain is a common problem for older people. This research aimed to increase our understanding of back pain in older people and to develop treatments to reduce the burden caused by back pain. The research was arranged in six work packages, and we completed three linked studies. Study 1: We enrolled 5409 older people in a cohort study. Participants answered questions about back pain, their health, mobility, falls and quality of life on enrolment and at 1 and 2 years’ follow-up. Back pain was reported by half of the participants, and 20% also reported leg pain. Back pain with/without leg pain is associated with reduced quality of life but also with being frail, falling and having walking problems. After 2 years, 77% of participants still reported being troubled by this pain. We developed a tool to identify when older people were at risk of reduced walking ability and to understand whether back pain was important here. Back and leg pain were not specifically linked to reduced walking, but severe pain was, suggesting that regardless of the type of pain, it needs to be treated. This tool could be used by clinicians and patients to know when they are at risk of reduced walking ability and to seek treatment. Study 2: We developed a group physiotherapy programme (the Better Outcomes for Older people with Spinal Trouble programme) for older people with a back-related condition called neurogenic claudication which results in pain spreading from the back into the legs and difficulties standing and walking. We tested the programme in a randomised controlled trial. The Better Outcomes for Older people with Spinal Trouble programme resulted in long-term improvements in walking, reduced falls, and short-term improvements in pain and disability. It is likely to be good value for the National Health Service. Study 3: We interviewed participants taking part in the Better Outcomes for Older people with Spinal Trouble trial to understand their experiences of the trial and whether the treatments helped. The Better Outcomes for Older people with Spinal Trouble programme was acceptable to participants, and they found it enjoyable. We are working with patient representatives and clinicians to make the Better Outcomes for Older people with Spinal Trouble programme available in routine care. Scientific summary Background Back pain (BP) is a common problem for older people but despite this, many older people either do not consult or general practitioners do not prioritise BP treatment for them due to the perception that nothing can be done. Many clinical trials exclude older people, and little attention has been paid to understanding the presentation of BP in older people and developing effective treatments. Older adults also experience leg pain referred from the lumbar spine. A common clinical presentation of spinal-related leg pain in older adults is neurogenic claudication (NC). It presents as symptoms radiating from the spine into the buttocks and legs which are provoked by walking or standing and relieved by sitting or lumbar flexion, often accompanied by BP. NC is particularly problematic for older people as it can cause severe pain and discomfort and substantially affect an individual’s confidence and ability to walk. Symptoms are thought to arise from pressure on nerves and blood vessels caused by degenerative changes narrowing the volume of the lumbar spinal canal. Narrowing may or may not be evident on imaging but when present, the condition is termed lumbar spinal stenosis. Physiotherapy is recommended prior to surgical intervention, but high-quality evidence to guide conservative care, including primary care management or physiotherapy, was lacking. Thus, we focused on NC to develop and test a physiotherapy intervention. We aimed to conduct a series of linked studies to increase knowledge and understanding about BP in older people and reduce the burden on older people by developing evidence-based treatment strategies. Objectives To describe the presentation and impact of BP in community-dwelling older adults. To refine a physiotherapy intervention for older people with NC and to evaluate the clinical and cost-effectiveness of this intervention in a randomised controlled trial (RCT). To understand the trial participants’ experiences, including acceptability and impact of the interventions. To understand the role of low BP in mobility decline through the development of a prognostic tool to predict when older people are at risk of mobility decline. To integrate findings into an implementation package. Methods We undertook three studies. A large population-based cohort study of community-dwelling older people recruited from primary care practices [the Oxford Pain Activity and Lifestyle (OPAL) cohort study]. We recruited older adults from primary care practices who were identified through electronic record searches and randomly selected eligible participants from two stratified age bands (65–74 and ≥ 75 years). In total, 5409 individuals (42.1% of eligible participants) from 35 general practices agreed to participate and followed up for 2 years by postal questionnaire. Participants provided data including demographics, socioeconomic factors, comorbidities, pain including low BP and its impact, other pain problems, physical activity, mobility, falls, frailty and quality of life. At baseline, we investigated the prevalence of BP and related leg pain within the cohort and estimated the association between different back and leg pain presentations and age-related adverse health states, including falls, frailty and mobility decline, using regression analyses. At 2 years, we estimated recovery rates. We investigated the role of back and leg pain in mobility decline by developing a prediction model for mobility decline at 2 years’ follow-up. Thirty-one candidate self-reported baseline predictors were prespecified. Missing data were imputed. Least Absolute Shrinkage and Selection Operator regression was used to select potential predictors. Model performance was assessed by calculating c-statistic, Brier score and decision-curve analysis. Models were internally validated using bootstrapping. The Better Outcomes for Older people with Spinal Trouble (BOOST) RCT of physiotherapy interventions for NC. We evaluated the clinical and cost-effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and tailored advice [best practice advice (BPA)] for older people with NC. Participants were identified from spinal clinics (community and secondary care) and general practice records, and were randomised 2:1 to the BOOST programme or BPA. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data were also collected at 6 months. Other outcomes included ODI walking item, 6-minute walk test (6MWT) and falls. The primary analysis was intention-to-treat. Prespecified subgroup analyses were also undertaken based on magnetic resonance imaging (MRI) parameters and other baseline factors including age, sex, frailty and physical capacity. The base-case economic evaluation was an intention-to-treat analysis conducted from a UK NHS and personal social services (PSS) perspective and separately from a societal perspective. Costs (2018–19 prices) were collected prospectively over 12 months. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit (INMB) of the BOOST programme in comparison to BPA. A longitudinal qualitative study embedded within the BOOST RCT. Embedded within the BOOST RCT was a longitudinal qualitative study. Semistructured interviews with participants were undertaken at baseline, 1 month after receiving their intervention and at 12 months. We analysed 30 sets of three interviews. We undertook an inductive thematic analysis and comparatively analysed data from the three time points to explore patients’ experiences with the trial interventions, including the impact on symptoms and their experiences of long-term exercise adherence. Results Oxford Pain Activity and Lifestyle cohort study Among OPAL participants, 34% (1786/5304) reported BP. A further 19.5% (1035/5304) reported BP and associated leg pain, with 11.2% (n = 594/5304) reporting symptoms consistent with NC. Participants with BP had worse quality of life compared to those without BP. All BP presentations were significantly associated with adverse health states. Those with NC were most affected. In particular, there was greater relative risk (RR) of low walking confidence [RR 3.11, 95% confidence interval (CI) 2.56 to 3.78], frailty (RR 1.88, 95% CI 1.67 to 2.11) and mobility decline (RR 1.74, 95% CI 1.54 to 1.97) compared to no BP. Of the participants reporting BP at baseline, 2139/2859 (74.8%) returned the 2-year follow-up questionnaire, and 23% of respondents no longer reported back or leg symptoms (489/2100). Recovery was highest among those reporting only BP at baseline (27.4%) and lowest among those reporting NC at baseline (10.9%). Participants reporting NC at baseline were most affected by symptoms at follow-up, reporting BP more frequently, with the highest proportion reporting very or extremely troublesome BP. They reported the highest pain interference ratings at follow-up, with the greatest proportion reporting severe interference with activity (26%). At baseline, the majority of OPAL participants reported no mobility problems (60.7%; 3146/5184) and 5.4% (280/5184) reported severe mobility problems. Two-year follow-up data were provided by 4115/5184 (79.4%) participants, with 18.6% (n = 765/4115) reporting mobility decline. We examined the univariable relationship between the baseline variables and the 2-year outcome. Nearly all the selected baseline factors had a univariate relationship with the outcome. Among those with mobility decline at 2 years, there were more reports of back and leg pain and greater numbers reporting multisite pain and widespread pain at baseline. The biggest difference in pain presentation was lower limb pain at baseline, which was reported by 68% of participants with mobility decline at follow-up, compared to 56% without. Baseline pain severity was also associated with mobility decline at follow-up. The multivariable analyses found that in addition to mobility status (no problems or mild problems) at baseline, 13 variables were identified as predictors of mobility decline at 2 years in ≥ 80% of the multiple imputed data sets. BP with/without leg pain was not an independent predictor of mobility decline, but lower limb pain and the report of severe pain were independent predictors. Demographic and socioeconomic factors (older age and those who perceived their income as inadequate) were also identified. There were multiple factors related to mobility, including participants who reported a slow usual walking pace, had difficulty maintaining their balance, had low confidence to walk long distances, rated their walking as worse compared to last year and reported sometimes using a walking aid outside, which were associated with a decline in mobility after 2 years. General health-related factors associated with decline in mobility at 2 years were having a higher body mass index, greater number of health conditions, problems in daily life due to physical tiredness, and poor self-reported general health. The multivariable model revealed a median c-statistic of 0.740 (range 0.737–0.743), indicating moderately good discrimination. The median Brier score was 0.136 (range 0.135–0.137). We developed a point scoring system to facilitate use in clinical practice. Better Outcomes for Older people with Spinal Trouble randomised controlled trial We analysed data from 435 trial participants with an average age of 74.9 years [standard deviation (SD) 6.0 years], and 57% (246/435) were female. At baseline, participants reported moderate disability levels [mean ODI 33 (SD 13.9)]. Their walking was markedly reduced [mean 6MWT 255 m (SD 99.1 m)] compared to healthy older adults. The primary outcome was obtained for 88.0% (383/435) and 87.4% (380/435) of participants at 6 months and 12 months, respectively, with 93.0% (403/435) contributing data to the primary analysis. There was no significant difference in ODI scores between treatment groups at 12 months [adjusted mean difference (MD) −1.4, 95% CI −4.03 to 1.17)], but at 6 months, ODI scores favoured the BOOST programme (adjusted MD –3.7, 95% CI –6.27 to –1.06). At 12 months, the BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7 m, 95% CI 5.96 to 37.38 m) and ODI walking item (MD –0.2, 95% CI –0.45 to –0.01) and reduced falls risk (odds ratio 0.6, 95% CI 0.40 to 0.98) compared to BPA. No serious adverse events were related to either treatment. The economic analyses showed that the mean NHS and PSS costs over 12 months were £19,752 [standard error (SE) £118] in the BOOST arm versus £1827 (SE £169) in the BPA arm (p = 0.474). Mean (SE) QALY estimates were 0.620 (0.009) versus 0.599 (0.006), respectively (p = 0.093). The probability that the BOOST programme is cost-effective ranged between 67% and 83% (NHS and PSS perspective) and between 79% and 89% (societal perspective) across cost-effectiveness thresholds. INMBs ranged between £145 and £464 at cost-effectiveness thresholds between £15,000 and £30,000 per QALY. The Better Outcomes for Older people with Spinal Trouble qualitative study Interviews from 16 men and 14 women were included in this analysis. Fourteen participants were allocated to BPA and 16 were allocated to the BOOST programme. The symptoms of NC manifested both physically and psychologically, limiting participants’ ability to perform everyday activities as well their wider participation in social, leisure and recreational activities. Participants adopted coping strategies to minimise the impact of NC. Participants in the BOOST programme appeared more satisfied with their treatment compared to those allocated to BPA. Dissatisfaction among BPA participants seemed to arise from lack of feedback and follow-up. BOOST participants benefited from peer support and discussions. Most participants felt the exercises were appropriate and helpful, although this did not necessarily translate to improvements in pain. Dissatisfaction with the BOOST programme was mostly related to lack of pain relief. Pain remained a substantial problem for some participants. BOOST programme participants also talked about other improvements from the exercises, including improved posture, strength and confidence, highlighting the broader benefits of the BOOST programme. These types of changes were less evident in the narratives of BPA participants. BOOST participants reported benefit from the cognitive–behavioural component, including helping them to find their own solutions, manage flare-ups and understand the importance of long-term exercise. Reasons for stopping the home exercises were similar between treatment arms. These included competing priorities, lack of motivation and aggravation of pain. Adaptations allowed some BOOST participants to continue at least some of the exercises even when they were difficult. Participant narratives provided insight into ways to optimise the BOOST programme to improve long-term exercise adherence, including additional support to provide motivation for ongoing exercises (by the physiotherapist or by linking to exercise opportunities in the community), provide greater guidance on how to adapt exercises if they are painful, and to help plan integration into everyday life or transition to activities they enjoy. We have developed a package of implementation for the BOOST programme. Feedback from interview participants, patient and public involvement representatives and clinicians who delivered the BOOST programme and ongoing analyses of BOOST data will inform further refinement of the programme to better target pain-related disability. Conclusions Back pain is a substantial and persistent problem for older people, associated with reduced quality of life and age-related adverse health states. The impact is greatest on those with NC, but other presentations should not be ignored due to the high proportion of participants who reported ongoing symptoms. We developed a programme that successfully improved mobility and reduced falls among older people with NC, and future iterations of the programme will aim to reduce long-term pain-related disability. As it stands, the BOOST programme has a high probability of being cost-effective. There is a need to develop other interventions for the large number of older adults affected by BP, especially for those with more severe symptoms. Back and leg pain were not independent predictors of mobility decline, but severe pain was a predictor. This highlights a broader need to manage pain better in older people regardless of the type or presentation of pain. The developed prognostic tool has the potential to help clinicians, older people and their families to identify when an older person is at risk of declining mobility and to take preventative actions. We developed a scoring system so that it could be easily implemented in clinical practice, and future research will focus on external validation of this tool. Study registration This trial is registered as BOOST trial ISRCTN12698674. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: PTC-RP-PG-0213-20002) and is published in full in Programme Grants for Applied Research; Vol. 11, No. 9. See the NIHR Funding and Awards website for further award information.

Background: The range and scope of electronic health record (EHR) data assets in the UK has recently increased, which has been mainly in response to the COVID-19 pandemic. Summarising and comparing the large primary care resources will help researchers to choose the data resources most suited to their needs. Aim: To describe the current landscape of UK EHR databases and considerations of access and use of these resources relevant to researchers. Design & setting: Narrative review of EHR databases in the UK. Method: Information was collected from the Health Data Research Innovation Gateway, publicly available websites and other published data, and from key informants. The eligibility criteria were population-based open-access databases sampling EHRs across the whole population of one or more countries in the UK. Published database characteristics were extracted and summarised, and these were corroborated with resource providers. Results were synthesised narratively. Results: Nine large national primary care EHR data resources were identified and summarised. These resources are enhanced by linkage to other administrative data to a varying extent. Resources are mainly intended to support observational research, although some can support experimental studies. There is considerable overlap of populations covered. While all resources are accessible to bona fide researchers, access mechanisms, costs, timescales, and other considerations vary across databases. Conclusion: Researchers are currently able to access primary care EHR data from several sources. Choice of data resource is likely to be driven by project needs and access considerations. The landscape of data resources based on primary care EHRs in the UK continues to evolve.

Objectives In low/middle-income countries (LMICs), more than half of patients with first-episode psychosis initially seek treatment from traditional and religious healers as their first care. This contributes to an excessively long duration of untreated psychosis (DUP). There is a need for culturally appropriate interventions to involve traditional and spiritual healers to work collaboratively with primary care practitioners and psychiatrists through task-shifting for early detection, referral and treatment of first episode of psychosis.Methods To prevent the consequences of long DUP in adolescents in LMICs, we aim to develop and pilot test a culturally appropriate and context-bespoke intervention. Traditional HEalers working with primary care and mental Health for early interventiOn in Psychosis in young pErsons (THE HOPE) will be developed using ethnographic and qualitative methods with traditional healers and caregivers. We will conduct a randomised controlled cluster feasibility trial with a nested qualitative study to assess study recruitment and acceptability of the intervention. Ninety-three union councils in district Peshawar, Pakistan will be randomised and allocated using a 1:1 ratio to either intervention arm (THE HOPE) or enhanced treatment as usual and stratified by urban/rural setting. Data on feasibility outcomes will be collected at baseline and follow-up. Patients, carers, clinicians and policymakers will be interviewed to ascertain their views about the intervention. The decision to proceed to the phase III trial will be based on prespecified stop–go criteria.Ethics and dissemination Ethical approval has been obtained from Keele University Ethical Review Panel (ref: MH210177), Khyber Medical University Ethical Review Board (ref: DIR/KMU-EB/IG/001005) and National Bioethics Committee Pakistan (ref no. 4-87/NBC-840/22/621). The results of THE HOPE feasibility trial will be reported in peer-reviewed journals and academic conferences and disseminated to local stakeholders and policymakers.Trial registration number ISRCTN75347421.

Background: While there is a substantial body of knowledge about acute COVID-19, less is known about long-COVID, where symptoms continue beyond 4 weeks. Aim: To describe longer-term effects of COVID-19 infection in children and young people (CYP) and identify their needs in relation to long-COVID. Design & setting: This study comprises an observational prospective cohort study and a linked qualitative study, identifying participants aged 8–17 years in the West Midlands of England. Method: CYP will be invited to complete online questionnaires to monitor incidences and symptoms of COVID-19 over a 12-month period. CYP who have experienced long-term effects of COVID will be invited to interview, and those currently experiencing symptoms will be asked to document their experiences in a diary. Professionals who work with CYP will be invited to explore the impact of long-COVID on the wider experiences of CYP, in a focus group. Descriptive statistics will be used to describe the incidence and rates of resolution of symptoms, and comparisons will be made between exposed and non-exposed groups. Logistic regression models will be used to estimate associations between candidate predictors and the development of long-COVID, and linear regression will be used to estimate associations between candidate predictors. Qualitative data will be analysed thematically using the constant comparison method. Conclusion: This study will describe features and symptoms of long-COVID and explore the impact of long-COVID within the lives of CYP and their families, to provide better understanding of long-COVID and inform clinical practice.

BackgroundThe recent global outbreak of mpox (monkeypox) has already been declared a public health emergency of international concern by the World Health Organization. Given the health, social, and economic impacts of the COVID-19 pandemic, there is understandable concern and anxiety around the emergence of another infectious disease—especially one about which little is known. ObjectiveWe used Google Trends to explore online health information seeking patterns for mpox in endemic and nonendemic countries and investigated the impact of the publication of the first in-country case on internet search volume. MethodsGoogle Trends is a publicly accessible and free data source that aggregates worldwide Google search data. Google search data were used as a surrogate measure of online health information seeking for 178 days between February 18 and August 18, 2022. Searching data were downloaded across this time period for nonendemic countries with the highest case count (United States, Spain, Germany, United Kingdom, and France) and 5 endemic countries (Democratic Republic of Congo, Nigeria, Ghana, Central African Republic, and Cameroon). Joinpoint regression analysis was used to measure changes in searching trends for mpox preceding and following the announcement of the first human case. ResultsOnline health information seeking significantly increased after the publication of the first case in all the nonendemic countries—United States, Spain, Germany, United Kingdom, and France, as illustrated by significant joinpoint regression models. Joinpoint analysis revealed that models with 3 significant joinpoints were the most appropriate fit for these data, where the first joinpoint represents the initial rise in mpox searching trend, the second joinpoint reflects the start of the decrease in the mpox searching trend, and the third joinpoint represents searching trends’ return to searching levels prior to the first case announcement. Although this model was also found in 2 endemic countries (ie, Ghana and Nigeria), it was not found in Central African Republic, Democratic Republic of Congo, or Cameroon. ConclusionsFindings demonstrate a surge in online heath information seeking relating to mpox after the first in-country case was publicized in all the nonendemic countries and in Ghana and Nigeria among the endemic counties. The observed increases in mpox searching levels are characterized by sharp but short-lived periods of searching before steep declines back to levels observed prior to the publication of the first case. These findings emphasize the importance of the provision of accurate, relevant online public health information during disease outbreaks. However, online health information seeking behaviors only occur for a short time period, and the provision of accurate information needs to be timely in relation to the publication of new case-related information.

Objectives To investigate the usefulness of using automated appointment check-in screens to collect brief research data from patients, prior to their general practice consultation.Design A descriptive, cross-sectional study.Setting Nine general practices in the West Midlands, UK. Recruitment commenced in Autumn 2018 and was concluded by 31 March 2019.Participants All patients aged 18 years and above, self-completing an automated check-in screen prior to their general practice consultation, were invited to participate during a 3-week recruitment period.Primary and secondary outcome measures The response rate to the use of the automated check-in screen as a research data collection tool was the primary outcome measure. Secondary outcomes included responses to the two research questions and an assessment of impact of check-in completion on general practice operationalisationResults Over 85% (n=9274) of patients self-completing an automated check-in screen participated in the Automated Check-in Data Collection Study (61.0% (n=5653) women, mean age 55.1 years (range 18–98 years, SD=18.5)). 96.2% (n=8922) of participants answered a ‘clinical’ research question, reporting the degree of bodily pain experienced during the past 4 weeks: 32.9% (n=2937) experienced no pain, 28.1% (n=2507) very mild or mild pain and 39.0% (n=3478) moderate, severe or very severe pain. 89.3% (n=8285) of participants answered a ‘non-clinical’ research question on contact regarding future research studies: 46.9% (n=3889) of participants responded ‘Yes, I’d be happy for you to contact me about research of relevance to me’.Conclusions Using automated check-in facilities to integrate research into routine general practice is a potentially useful way to collect brief research data from patients. With the COVID-19 pandemic initiating an extensive digital transformation in society, now is an ideal time to build on these opportunities and investigate alternative, innovative ways to collect research data.Trial registration number ISRCTN82531292.

BackgroundIntermediate care is often defined as healthcare occurring somewhere between traditional primary (community) and secondary (hospital) care settings. High quality intermediate care is important in dementia, may prevent caregiver burnout and also lead to optimal care for people with dementia. However, very little is known about the point of intermediate care for persons with dementia in Europe.Research questionsWhat intermediate care services exist and how are they utilized in the care of people with dementia in Europe?ObjectiveThis study aims at describing the point of view of General Practitioners on intermediate care services for people with dementia across Europe.MethodsKey informant survey was sent to GPs via a self-developed questionnaire with space for open ended comments. 16 European countries participated to this cross-sectional mixed method study. Given the volunteer nature of the study, no minimum sample size requirements were applied to participation. Convenience sampling technique was used to address variations due to regional variations and regulations within the same country. Descriptive analyses of all intermediate care facilities groups by countries were performed. Qualitative analyses approach was used for the optional-free text to exemplify and/or complete the reasons contained in the closed response categories.ResultsThe questionnaire was sent to 16 European countries. 583 questionnaires were analyzed. The responding physicians were 48 (± 11) years old on average and they had been in practice for an average of 18 (+ /11) years. The types of intermediate care considered were integrated at-home services, respite and relief services, day care centers and nursing homes. Their availability was considered very inhomogeneous by the majority of respondents. The main benefits of intermediate care cited were better medical care for the patient (78%), better quality of life for the caregiver (67%), prevention of the caregiver burden (73%) and a break for the caregiver (59%). The reported difficulties were: accessing these facilities due to limited financial support (76%) and cumbersome administrative procedures (67%). Many other facets of our findings were captured in the qualitative themes that emerged.ConclusionIntermediate care in Europe is diverse and heterogeneous. Major concerns of GPs are about the cost issues and the cumbersome administrative procedures to access them.

Background: Practitioner expressions of optimism and empathy may improve treatment engagement, adherence, and patient satisfaction but are not delivered consistently amid the challenges of everyday clinical practice. Aim: To explore primary care practitioner (PCP) views about optimistic and empathic communication in consultations; and to identify behavioural, attitudinal, and/or contextual issues likely to encourage or deter PCPs from practising such communication. Design & setting: Qualitative interview study with 20 PCPs (GPs, practice nurses, and primary care physiotherapists). Method: Semi-structured telephone interviews with 20 PCPs. Data were analysed thematically. Results: A conceptual mismatch between optimism and patient expectations became apparent; when asked how PCPs communicate about the likely effects of a treatment, answers were focussed around managing patient expectations. When prompted, it became clear PCPs were open to communicating optimistically with patients, but emphasised the need for realism. Concerns arose that patients may not be receptive to optimistic messages, especially when holding negative expectations. PCPs felt that expressing empathy is fundamental to all clinical consultations, noting that it can be challenging. Some PCPs worried that increasing expressions of empathy might increase their risk of clinician burnout and felt guilty about (appropriately) communicating empathy while maintaining some emotional distance. Conclusion: PCPs agreed expressing realistic optimism during consultations could aid communication and would constitute a novel change to practice. PCPs strive for clinical empathy but can struggle to manage emotional self-protection. Specific training to help PCPs express realistic optimism and empathy, and better utilise efficient non-verbal skills could help these issues.

Objectives The aim of this study was to explore the agency of older adults and their strategies to restructure ways of being and belonging in a rapidly and radically changed social environment during the UK’s first COVID-19 lockdown in Spring 2020.Design Qualitative study consisting of semi-structured interviews. Findings were derived from a thematic analysis of interview transcripts. We also established a patient and public involvement and engagement group who advised on study design, interview topic guide and interpretation of findings.Setting Interviews were conducted online with older adults in the UK through their platform of choice in Spring 2020 in England, UK.Participants We conducted 28 interviews (16 women, 12 men) with older adults over the age of 70 years. Our participants were mostly white, middle class adults.Results From the data, we constructed three strategies that older adults used to employ agency and create spaces of belonging in their social networks despite lockdown restrictions. First, participants created a sense of belonging by being ‘good’ members of society who were knowledgeable about COVID-19. Second, older adults created new ways to socially engage with the wider community. Finally, older adults actively restructured social networks to preserve a sense of belonging.Conclusions Older adults are actively and creatively carving a space of belonging during the societal upheaval in response to the COVID-19 lockdown and public health restrictions. Rather than internalising potential exclusionary messages based on their age, older adults instead used their agency to reimagine and transform spheres of belonging.

Abstract Background General practitioners (GPs) should regularly review patients’ medications and, if necessary, deprescribe, as inappropriate polypharmacy may harm patients’ health. However, deprescribing can be challenging for physicians. This study investigates GPs’ deprescribing decisions in 31 countries. Methods In this case vignette study, GPs were invited to participate in an online survey containing three clinical cases of oldest-old multimorbid patients with potentially inappropriate polypharmacy. Patients differed in terms of dependency in activities of daily living (ADL) and were presented with and without history of cardiovascular disease (CVD). For each case, we asked GPs if they would deprescribe in their usual practice. We calculated proportions of GPs who reported they would deprescribe and performed a multilevel logistic regression to examine the association between history of CVD and level of dependency on GPs’ deprescribing decisions. Results Of 3,175 invited GPs, 54% responded (N = 1,706). The mean age was 50 years and 60% of respondents were female. Despite differences across GP characteristics, such as age (with older GPs being more likely to take deprescribing decisions), and across countries, overall more than 80% of GPs reported they would deprescribe the dosage of at least one medication in oldest-old patients (> 80 years) with polypharmacy irrespective of history of CVD. The odds of deprescribing was higher in patients with a higher level of dependency in ADL (OR =1.5, 95%CI 1.25 to 1.80) and absence of CVD (OR =3.04, 95%CI 2.58 to 3.57). Interpretation The majority of GPs in this study were willing to deprescribe one or more medications in oldest-old multimorbid patients with polypharmacy. Willingness was higher in patients with increased dependency in ADL and lower in patients with CVD.

Abstract Background Osteoarthritis is a leading cause of pain and disability worldwide. Despite research supporting best practice, evidence-based guidelines are often not followed. Little is known about the implementation of non-surgical models of care in routine primary care practice. From a knowledge mobilisation perspective, the aim of this study was to understand the uptake of a clinical innovation for osteoarthritis and explore the journey from a clinical trial to implementation. Methods This study used two methods: secondary analysis of focus groups undertaken with general practice staff from the Managing OSteoArthritis in ConsultationS research trial, which investigated the effectiveness of an enhanced osteoarthritis consultation, and interviews with stakeholders from an implementation project which started post-trial following demand from general practices. Data from three focus groups with 21 multi-disciplinary clinical professionals (5–8 participants per group), and 13 interviews with clinical and non-clinical stakeholders, were thematically analysed utilising the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, in a theoretically informative approach. Public contributors were involved in topic guide design and interpretation of results. Results In operationalising implementation of an innovation for osteoarthritis following a trial, the importance of a whole practice approach, including the opportunity for reflection and planning, were identified. The end of a clinical trial provided opportune timing for facilitating implementation planning. In the context of osteoarthritis in primary care, facilitation by an inter-disciplinary knowledge brokering service, nested within an academic institution, was instrumental in supporting ongoing implementation by providing facilitation, infrastructure and resource to support the workload burden. ‘Instinctive facilitation’ may involve individuals who do not adopt formal brokering roles or fully recognise their role in mobilising knowledge for implementation. Public contributors and lay communities were not only recipients of healthcare innovations but also potential powerful facilitators of implementation. Conclusion This theoretically informed knowledge mobilisation study into the uptake of a clinical innovation for osteoarthritis in primary care has enabled further characterisation of the facilitation and recipient constructs of i-PARIHS by describing optimum timing for facilitation and roles and characteristics of facilitators.

Introduction Osteoarthritis (OA) is one of the leading chronic conditions in the older population. People with OA are more likely to have one or more other chronic conditions than those without. However, the temporal associations, clusters of the comorbidities, role of analgesics and the causality and variation between populations are yet to be investigated. This paper describes the protocol of a multinational study in four European countries (UK, Netherlands, Sweden and Spain) exploring comorbidities in people with OA.Methods and analysis This multinational study will investigate (1) the temporal associations of 61 identified comorbidities with OA, (2) the clusters and trajectories of comorbidities in people with OA, (3) the role of analgesics on incidence of comorbidities in people with OA, (4) the potential biomarkers and causality between OA and the comorbidities, and (5) variations between countries.A combined case–control and cohort study will be conducted to find the temporal association of OA with the comorbidities using the national or regional health databases. Latent class analysis will be performed to identify the clusters at baseline and joint latent class analysis will be used to examine trajectories during the follow-up. A cohort study will be undertaken to evaluate the role of non-steroidal anti-inflammatory drugs (NSAIDs), opioids and paracetamol on the incidence of comorbidities. Mendelian randomisation will be performed to investigate the potential biomarkers for causality between OA and the comorbidities using the UK Biobank and the Rotterdam Study databases. Finally, a meta-analyses will be used to examine the variations and pool the results from different countries.Ethics and dissemination Research ethics was obtained according to each database requirement. Results will be disseminated through the FOREUM website, scientific meetings, publications and in partnership with patient organisations.

Objectives To explore barriers and facilitators to COVID-19, influenza, and pneumococcal vaccine uptake in immunosuppressed adults with immune-mediated inflammatory diseases (IMIDs). Methods Recruiting through national patient charities and a local hospital, participants were invited to take part in an in-depth, one-to-one, semi-structured interview with a trained qualitative researcher between November 2021 and January 2022. Data were analysed thematically in NVivo, cross-validated by a second coder and mapped to the SAGE vaccine hesitancy matrix. Results Twenty participants (75% female, 20% non-white) were recruited. Barriers and facilitators spanned contextual, individual/group and vaccine/vaccination-specific factors. Key facilitators to all vaccines were higher perceived infection risk and belief that vaccination is beneficial. Key barriers to all vaccines were belief that vaccination could trigger IMID flare, and active IMID. Key facilitators specific to COVID-19 vaccines included media focus, high incidence, mass-vaccination programme with visible impact, social responsibility, and healthcare professionals’ (HCP) confirmation of the new vaccines’ suitability for their IMID. Novel vaccine technology was a concern, not a barrier. Key facilitators of influenza/pneumococcal vaccines were awareness of eligibility, direct invitation, and, clear recommendation from trusted HCP. Key barriers of influenza/pneumococcal vaccines were unaware of eligibility, no direct invitation or recommendation from HCP, low perceived infection risk, and no perceived benefit from vaccination. Conclusions Numerous barriers and facilitators to vaccination, varying by vaccine-type, exist for immunosuppressed-IMID patients. Addressing vaccine benefits and safety for IMID-patients in clinical practice, direct invitation, and public-health messaging highlighting immunosuppression as key vaccination-eligibility criteria may optimise uptake, although further research should assess this.

Introduction People presenting with shoulder pain considered to be of musculoskeletal origin is common in primary care but diagnosing the cause of the pain is contentious, leading to uncertainty in management. To inform optimal primary care for patients with shoulder pain, the study aims to (1) to investigate the short-term and long-term outcomes (overall prognosis) of shoulder pain, (2) estimate costs of care, (3) develop a prognostic model for predicting individuals’ level and risk of pain and disability at 6 months and (4) investigate experiences and opinions of patients and healthcare professionals regarding diagnosis, prognosis and management of shoulder pain.Methods and analysis The Prognostic And Diagnostic Assessment of the Shoulder (PANDA-S) study is a longitudinal clinical cohort with linked qualitative study. At least 400 people presenting to general practice and physiotherapy services in the UK will be recruited. Participants will complete questionnaires at baseline, 3, 6, 12, 24 and 36 months. Short-term data will be collected weekly between baseline and 12 weeks via Short Message Serevice (SMS) text or software application. Participants will be offered clinical (physiotherapist) and ultrasound (sonographer) assessments at baseline. Qualitative interviews with ≈15 dyads of patients and their healthcare professional (general practitioner or physiotherapist).Short-term and long-term trajectories of Shoulder Pain and Disability Index (using SPADI) will be described, using latent class growth analysis. Health economic analysis will estimate direct costs of care and indirect costs related to work absence and productivity losses. Multivariable regression analysis will be used to develop a prognostic model predicting future levels of pain and disability at 6 months using penalisation methods to adjust for overfitting. The added predictive value of prespecified physical examination tests and ultrasound findings will be examined. For the qualitative interviews an inductive, exploratory framework will be adopted using thematic analysis to investigate decision making, perspectives of patients and clinicians on the importance of diagnostic and prognostic information when negotiating treatment and referral options.Ethics and dissemination The PANDA-S study has ethical approval from Yorkshire and The Humber-Sheffield Research Ethics Committee, UK (18/YH/0346, IRAS Number: 242750). Results will be disseminated through peer-reviewed publications, social and mainstream media, professional conferences, and the patient and public involvement and engagement group supporting this study, and through newsletters, leaflets and posters in participating sites.Trial registration number ISRCTN46948079.

Background: Empathic communication and positive messages are important components of “placebo” effects and can improve patient outcomes, including pain. Communicating empathy and optimism to patients within consultations may also enhance the effects of verum, i.e., non-placebo, treatments. This is particularly relevant for osteoarthritis, which is common, costly and difficult to manage. Digital interventions can be effective tools for changing practitioner behavior. This paper describes the systematic planning, development and optimization of an online intervention—“Empathico”–to help primary healthcare practitioners enhance their communication of clinical empathy and realistic optimism during consultations.Methods: The Person-Based Approach to intervention development was used. This entailed integrating insights from placebo and behavior change theory and evidence, and conducting primary and secondary qualitative research. Systematic literature reviews identified barriers, facilitators, and promising methods for enhancing clinical empathy and realistic optimism. Qualitative studies explored practitioners' and patients' perspectives, initially on the communication of clinical empathy and realistic optimism and subsequently on different iterations of the Empathico intervention. Insights from the literature reviews, qualitative studies and public contributor input were integrated into a logic model, behavioral analysis and principles that guided intervention development and optimization.Results: The Empathico intervention comprises 7 sections: Introduction, Empathy, Optimism, Application of Empathico for Osteoarthritis, Reflection on my Consultations, Setting Goals and Further Resources. Iterative refinement of Empathico, using feedback from patients and practitioners, resulted in highly positive feedback and helped to (1) contextualize evidence-based recommendations from placebo studies within the complexities of primary healthcare consultations and (2) ensure the intervention addressed practitioners' and patients' concerns and priorities.Conclusions: We have developed an evidence-based, theoretically-grounded intervention that should enable practitioners to better harness placebo effects of communication in consultations. The extensive use of qualitative research throughout the development and optimization process ensured that Empathico is highly acceptable and meaningful to practitioners. This means that practitioners are more likely to engage with Empathico and make changes to enhance their communication of clinical empathy and realistic optimism in clinical practice. Empathico is now ready to be evaluated in a large-scale randomized trial to explore its impact on patient outcomes.

Abstract Background Antibiotic-induced disturbances of the human microbiota have been implicated in the development of chronic autoimmune conditions. This study aimed to assess whether antibiotic use is associated with the onset of rheumatoid arthritis (RA). Methods A nested case-control study was conducted utilising data from the primary care Clinical Practice Research Datalink (CPRD). Patients with an incident diagnosis of RA were identified (1995–2017). Each case was matched on age, gender, and general practice to ≥ 5 controls without RA. Conditional logistic regression was used to examine previous antibiotic prescriptions and RA onset after controlling for confounding factors. Results We identified 22,677 cases of RA, matched to 90,013 controls, with a median follow-up of 10 years before RA diagnosis. The odds of developing RA were 60% higher in those exposed to antibiotics than in those not exposed (OR 1.60; 95% CI 1.51–1.68). A dose- or frequency-dependent association was observed between the number of previous antibiotic prescriptions and RA. All classes of antibiotics were associated with higher odds of RA, with bactericidal antibiotics carrying higher risk than bacteriostatic (45% vs. 31%). Those with antibiotic-treated upper respiratory tract (URT) infections were more likely to be RA cases. However, this was not observed for URT infections not treated with antibiotics. Antifungal (OR = 1.27; 95% CI 1.20–1.35) and antiviral (OR = 1.19; 95% CI 1.14–1.24) prescriptions were also associated with increased odds of RA. Conclusion Antibiotic prescriptions are associated with a higher risk of RA. This may be due to microbiota disturbances or underlying infections driving risk. Further research is needed to explore these mechanisms.

Abstract Background The presence of additional chronic conditions has a significant impact on the treatment and management of type 2 diabetes (T2DM). Little is known about the patterns of comorbidities in this population. The aims of this study are to quantify comorbidity patterns in people with T2DM, to estimate the prevalence of six chronic conditions in 2027 and to identify clusters of similar conditions. Methods We used the Clinical Practice Research Datalink (CPRD) linked with the Index of Multiple Deprivation (IMD) data to identify patients diagnosed with T2DM between 2007 and 2017. 102,394 people met the study inclusion criteria. We calculated the crude and age-standardised prevalence of 18 chronic conditions present at and after the T2DM diagnosis. We analysed longitudinally the 6 most common conditions and forecasted their prevalence in 2027 using linear regression. We used agglomerative hierarchical clustering to identify comorbidity clusters. These analyses were repeated on subgroups stratified by gender and deprivation. Results More people living in the most deprived areas had ≥ 1 comorbidities present at the time of diagnosis (72% of females; 64% of males) compared to the most affluent areas (67% of females; 59% of males). Depression prevalence increased in all strata and was more common in the most deprived areas. Depression was predicted to affect 33% of females and 15% of males diagnosed with T2DM in 2027. Moderate clustering tendencies were observed, with concordant conditions grouped together and some variations between groups of different demographics. Conclusions Comorbidities are common in this population, and high between-patient variability in comorbidity patterns emphasises the need for patient-centred healthcare. Mental health is a growing concern, and there is a need for interventions that target both physical and mental health in this population.

Background Brace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients’ clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists.Methods and analysis A multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions.Ethics and dissemination North West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders.Trial registration number ISRCTN28555470.

Introduction There is a significant treatment gap, with only a few community-based services for people with schizophrenia in low-income and middle-income countries. Poor treatment adherence in schizophrenia is associated with poorer health outcomes, suicide attempts and death. We previously reported the effectiveness of supervised treatment in outpatients for schizophrenia (STOPS) for improving treatment adherence in patients with schizophrenia. However, STOPS was evaluated in a tertiary care setting with no primary care involvement, limiting its generalisability to the wider at-risk population. We aim to evaluate the effectiveness of STOPS+ in scaling up the primary care treatment of schizophrenia to a real-world setting.Methods and analysis The effectiveness of the STOPS+ intervention in improving the level of functioning and medication adherence in patients with schizophrenia in Pakistan will be evaluated using a cluster randomised controlled trial design. We aim to recruit 526 participants from 24 primary healthcare centres randomly allocated in 1:1 ratio to STOPS+ intervention and enhanced treatment as usual arms. Participants will be followed-up for 12 months postrecruitment. The sample size is estimated for two outcomes (1) the primary clinical outcome is level of functioning, measured using the Global Assessment of Functioning scale and (2) the primary process outcome is adherence to treatment regimen measured using a validated measure. An intention-to-treat approach will be used for the primary analysis.Ethics and dissemination Ethical approval has been obtained from Keele University Ethical Review Panel (ref: MH-190017) and Khyber Medical University Ethical Review Board (ref: DIR-KMU-EB/ST/000648). The results of the STOPS+ trial will be reported in peer-reviewed journals and academic conferences and disseminated to local stakeholders and policymakers.Trial registration number ISRCTN93243890.

Abstract Background and aim Comorbidities are known to exist in many rheumatological conditions. Polymyalgia rheumatica (PMR) is a common inflammatory rheumatological condition affecting older people which, prior to effective treatment, causes severe disability. Our understanding of associated comorbidities in PMR is based only on case reports or series and small cohort studies. The objective of this study is to review systematically the existing literature on the comorbidities associated with PMR. Methods MEDLINE, EMBASE, PsycINFO and CINAHL databases were searched for original observational research from inception to November 2016. Papers containing the words ‘Polymyalgia Rheumatica’ OR ‘Giant Cell Arteritis’ OR the terms ‘PMR’ OR ‘GCA’ were included. Article titles were reviewed based on pre-defined criteria by two reviewers. Following selection for inclusion, studies were quality assessed using the Newcastle–Ottawa tool and data were extracted. Results A total of 17,329 papers were reviewed and 41 were incorporated in this review, including three published after the search took place. Wide variations were found in study design, comorbidities reported and populations studied. Positive associations were found between PMR diagnosis and stroke, cardiovascular disease, peripheral arterial disease, diverticular disease and hypothyroidism. Two studies reported a positive association between PMR and overall malignancy rate. Seven studies reported an association between PMR and specific types of cancer, such as leukaemia, lymphoma, myeloproliferative disease and specified solid tumours, although nine studies found either no or negative association between cancer and PMR. Conclusion Quantification of the prevalence of comorbidities in PMR is important to accurately plan service provision and enable identification of cases of PMR which may be more difficult to treat. This review highlights that research into comorbidities in PMR is, overall, methodologically inadequate and does not comprehensively cover all comorbidities. Future studies should consider a range of comorbidities in patients with a validated diagnosis of PMR in representative populations.

Abstract Background Evidence on the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis is limited and conflicting. The primary objective of the Hip Injection Trial (HIT) is to compare pain intensity over 6 months, in people with hip OA between those receiving an ultrasound-guided intra-articular hip injection of corticosteroid with 1% lidocaine hydrochloride plus best current treatment with those receiving best current treatment alone. Secondary objectives are to determine specified comparative clinical and cost-effectiveness outcomes, and to explore, in a linked qualitative study, the lived experiences of patients with hip OA and experiences and impact of, ultrasound-guided intra-articular hip injection. Methods The HIT trial is a pragmatic, three-parallel group, single-blind, superiority, randomised controlled trial in patients with painful hip OA with a linked qualitative study. The current protocol is described, in addition to details and rationale for amendments since trial registration. 204 patients with moderate-to-severe hip OA will be recruited. Participants are randomised on an equal basis (1:1:1 ratio) to one of three interventions: (1) best current treatment, (2) best current treatment plus ultrasound-guided intra-articular hip injection of corticosteroid (triamcinolone acetonide 40 mg) with 1% lidocaine hydrochloride, or (3) best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride alone. The primary endpoint is patient-reported hip pain intensity across 2 weeks, 2 months, 4 months and 6 months post-randomisation. Recruitment is over 29 months with a 6-month follow-up period. To address the primary objective, the analysis will compare participants’ ‘average’ follow-up pain NRS scores, based on a random effects linear repeated-measures model. Data on adverse events are collected and reported in accordance with national guidance and reviewed by external monitoring committees. Individual semi-structured interviews are being conducted with up to 30 trial participants across all three arms of the trial. Discussion To ensure healthcare services improve outcomes for patients, we need to ensure there is a robust and appropriate evidence-base to support clinical decision making. The HIT trial will answer important questions regarding the clinical and cost-effectiveness of intra-articular corticosteroid injections. Trial registration ISRCTN: 50550256, 28th July 2015.

Abstract Background Platelet-rich plasma (PRP) is a concentrate of autologous blood growth factors which has been shown to provide some symptomatic relief in early osteoarthritis (OA) of the knee. The objective of this study was to test the feasibility and efficacy potential of platelet rich plasma (PRP) in primary care. Methods Feasibility study to assess safety of the intervention procedures and assess primary and secondary outcome measures. Consecutive patients presenting with symptomatic knee OA were recruited in a primary care setting in Ireland. All participants received three injections of PRP 4 weeks apart. The following self-reported clinical outcomes were evaluated before and after therapy (4 months): Pain and disability (ICOAP questionnaire); health utility (EUROQol); adverse events; patient satisfaction and goal-orientated outcomes. Results Seventeen potential patients were identified of whom 14 were eligible to participate. Twelve consented and completed the intervention and all outcome measures. There were no losses to follow-up. One patient reported pain and stiffness for 2 days after the first injection but did complete the study. No growth was detected from nine consecutive samples sent for microbiology analysis. Changes in constant, intermittent and total pain scores were reported; pain fully resolved in two patients. In addition, health utility, patient satisfaction and goal-orientated outcomes also demonstrated improvement. Conclusions Platelet-rich plasma therapy is a simple and minimally invasive intervention which is feasible to deliver in primary care to treat osteoarthritis of the knee joint. Well-designed randomised controlled trials are needed to measure outcomes, durability of effect and cost effectiveness.

Abstract Background Glucocorticoids are associated with increased fracture risk and are the mainstay of treatment in polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). However, fracture risk in these conditions has not been previously quantified. The aim of this study was to quantify the risk of fracture among patients with PMR and GCA. Methods A retrospective cohort study was conducted using primary care records from the UK-based Clinical Practice Research Datalink. Individuals aged 40 years and over, with incident diagnoses of PMR or GCA were separately identified from 1990–2004 and followed up until 2015. For each exposed individual, four age-, sex- and practice-matched controls were randomly selected. Incidence rates of fracture per 10,000 person-years were calculated for each disease group and hazard rates were compared to the unexposed using Cox regression models. Results Overall, 12,136 and 2673 cases of PMR and GCA, respectively, were identified. The incidence rate of fracture was 148.05 (95% CI 141.16–155.28) in PMR and 147.15 (132.91–162.91) in GCA per 10,000 person-years. Risk of fracture was increased by 63% in PMR (adjusted hazard ratio 1.63, 95% CI 1.54–1.73) and 67% in GCA (1.67, 1.49–1.88) compared to the control populations. Fewer than 13% of glucocorticoid-treated cases were prescribed bisphosphonates. Conclusions This study reports, for the first time, a similar increase in fracture risk for patients with PMR and GCA. More needs to be done to improve adherence to guidelines to co-prescribe bisphosphonates. Further research needs to identify whether lower glucocorticoid starting doses and/or aggressive dose reduction reduces fracture risk.

Abstract Background To examine the frequency of possible giant cell arteritis (GCA) symptoms (including headache, temporal/scalp tenderness, jaw claudication and visual symptoms) in newly diagnosed polymyalgia rheumatica (PMR) patients in UK primary care. Methods The PMR Cohort Study is a primary care inception cohort of 652 adults with newly diagnosed polymyalgia rheumatica (PMR). At baseline, participants were asked to report (yes/no) on the presence of seven potential GCA symptoms: sudden headache, tender scalp, disturbed/double vision, jaw claudication, fever, appetite loss and unintentional weight loss. Results Of the 652 patients, 405 (62%) were female, with a mean (SD) age of 72.5 (8.9) years. Sudden headache was the commonest symptom in 161 patients (24.7%). The least commonly reported symptom was jaw claudication in 66 (10.1%) patients. Females had a higher prevalence of headache, tender scalp and jaw pain. Sudden onset headache and fever were commoner in younger patients, (OR (95% CI) per 10 year age band increase: headache 0.76 (0.62–0.92), fever 0.63 (0.49, 0.79)). In those reporting sudden headache (n = 161), 19.9% (n = 32) also reported double/disturbed vision and a tender scalp, whilst 11.8% (n = 19) reported double/disturbed vision and jaw pain. Conclusion The data suggests possible GCA symptoms are common in PMR patients, particularly sudden headache, appetite loss and weight loss. These symptomatic PMR patients warrant careful monitoring and consideration for early referral to specialist services.

Abstract Background The development of a patient-reported outcome measure (PROM) for polymyalgia rheumatica (PMR), a condition that causes pain, stiffness and disability, is necessary as there is no current validated disease-specific measure. Initial literature synthesis and qualitative research established a conceptual framework for the condition along with a list of symptoms and effects of PMR that patients felt were important to them. These findings were used to derive the candidate items for a patient-completed questionnaire. We aim to establish the face validity of this initial “long form” of a PROM. Methods People with a current or previous diagnosis of PMR were recruited both from the community and from rheumatology clinics. They were asked to complete the PMR questionnaire along with the QQ-10 questionnaire, which is a measure used to assess the face validity, feasibility and utility of patient healthcare questionnaires. Results A total of 28 participants with an age range of 59–85 years and a length of time since diagnosis from 4 months to 18 years completed the QQ-10. The overall mean “value” score was 79% (SD 12), and the mean “burden” score was 21% (SD 18). The free-text comments were analysed thematically and were found to focus on layout, content, where in the clinical pathway the questionnaire would be most beneficial, specific items missing and other areas for consideration. Conclusions The high mean value score and low burden score indicate that the questionnaire has good face validity and is acceptable to patients. The questionnaire now needs to undergo further psychometric evaluation and refinement to develop the final tool for use in clinical practice and research.

Abstract Background An association has been suggested between gout and erectile dysfunction (ED), however studies quantifying the risk of ED amongst gout patients are lacking. We aimed to precisely determine the population-level absolute and relative rate of ED reporting among men with gout over a decade in England. Methods We utilised the UK-based Clinical Practice Research Datalink to identify 9653 men with incident gout age- and practice-matched to 38,218 controls. Absolute and relative rates of incident ED were calculated using Cox regression models. Absolute rates within specific time periods before and after gout diagnosis were compared to control using a Poisson regression model. Results Overall, the absolute rate of ED post-gout diagnosis was 193 (95% confidence interval (CI): 184–202) per 10,000 person-years. This corresponded to a 31% (hazard ratio (HR): 1.31 95%CI: 1.24–1.40) increased relative risk and 0.6% excess absolute risk compared to those without gout. We did not observe statistically significant differences in the risk of ED among those prescribed ULT within 1 and 3 years after gout diagnosis. Compared to those unexposed, the risk of ED was also high in the year before gout diagnosis (relative rate = 1.63 95%CI 1.27–2.08). Similar findings were also observed for severe ED warranting pharmacological intervention. Conclusions We have shown a statistically significant increased risk of ED among men with gout. Our findings will have important implications in planning a multidisciplinary approach to managing patients with gout.

Abstract Background Sciatica has a substantial impact on patients, and is associated with high healthcare and societal costs. Although there is variation in the clinical management of sciatica, the current model of care usually involves an initial period of ‘wait and see’ for most patients, with simple measures of advice and analgesia, followed by conservative and/or more invasive interventions if symptoms fail to resolve. A model of care is needed that does not over-treat those with a good prognosis yet identifies patients who do need more intensive treatment to help with symptoms, and return to everyday function including work. The aim of the SCOPiC trial (SCiatica Outcomes in Primary Care) is to establish whether stratified care based on subgrouping using a combination of prognostic and clinical information, with matched care pathways, is more effective than non-stratified care, for improving time to symptom resolution in patients consulting with sciatica in primary care. We will also assess the impact of stratified care on service delivery and evaluate its cost-effectiveness compared to non-stratified care. Methods/Design Multicentre, pragmatic, parallel arm randomised trial, with internal pilot, cost-effectiveness analysis and embedded qualitative study. We will recruit 470 adult patients with sciatica from general practices in England and Wales, over 24 months. Patients will be randomised to stratified care or non-stratified care, and treated in physiotherapy and spinal specialist services, in participating NHS services. The primary outcome is time to first resolution of sciatica symptoms, measured on a 6-point ordered categorical scale, collected using text messaging. Secondary outcomes include physical function, pain intensity, quality of life, work loss, healthcare use and satisfaction with treatment, and will be collected using postal questionnaires at 4 and 12-month follow-up. Semi-structured qualitative interviews with a subsample of participants and clinicians will explore the acceptability of stratified care. Discussion This paper presents the details of the rationale, design and processes of the SCOPiC trial. Results from this trial will contribute to the evidence base for management of patients with sciatica consulting in primary care. Trial registration ISRCTN75449581 , date: 20.11.2014.

BackgroundThe best management of hypertension in frail oldest-old (≥80 years of age) remains unclear and we still lack guidelines that provide specific recommendations. Our study aims to investigate guideline use in general practitioners (GPs) and to examine if guideline use relates to different decisions when managing hypertension in frail oldest-old.Design/settingCross-sectional study among currently active GPs from 29 countries using a case-vignettes survey.MethodsGPs participated in a survey with case-vignettes of frail oldest-olds varying in systolic blood pressure (SBP) levels and cardiovascular disease (CVD). GPs from 26 European countries and from Brazil, Israel and New Zealand were invited. We compared the percentage of GPs reporting using guidelines per country and further stratified on the most frequently mentioned guidelines. To adjust for patient characteristics (SBP, CVD and GPs' sex, years of experience, prevalence of oldest-old and location of their practice), we used a mixed-effects regression model accounting for clustering within countries.ResultsOverall, 2,543 GPs from 29 countries were included. 59.4% of them reported to use guidelines. Higher guideline use was found in female (p = 0.031) and less-experienced GPs (pConclusionMany GPs reported using guidelines to manage hypertension in frail oldest-old patients, however guideline users did not decide differently from non-users concerning hypertension treatment decisions. Instead of focusing on the fact if GPs use guidelines or not, we as a scientific community should put an emphasis on what guidelines suggest in frail and oldest-old patients.

Introduction Worldwide, 10%–20% of children and adolescents experience mental health conditions. However, most such disorders remain undiagnosed until adolescence or adulthood. Little is known about the factors that influence mental health in children and adolescents, especially in low and middle-income countries (LMIC), where environmental threats, such as poverty and war, may affect optimal neurodevelopment. Cohort studies provide important information on risks and resilience across the life course by enabling tracking of the effects of early life environment on health during childhood and beyond. Large birth cohort studies, including twin cohorts that can be aetiologically informative, have been conducted within high-income countries but are not generalisable to LMIC. There are limited longitudinal birth cohort studies in LMIC.Methods We sought to enhance the volume of impactful research in Sri Lanka by establishing a Centre of Excellence for cohort studies. The aim is to establish a register of infant, child and adolescent twins, including mothers pregnant with twins, starting in the districts of Colombo (Western Province) and Vavuniya (Northern Province). We will gain consent from twins or parents for future research projects. This register will provide the platform to investigate the aetiology of mental illness and the impact of challenges to early brain development on future mental health. Using this register, we will be able to conduct research that will (1) expand existing research capacity on child and adolescent mental health and twin methods; (2) further consolidate existing partnerships and (3) establish new collaborations. The initiative is underpinned by three pillars: high-quality research, ethics, and patient and public involvement and engagement (PPIE).Ethics and dissemination Ethical approval for this study was obtained from the Ethics Review Committee of Sri Lanka Medical Association and Keele University’s Ethical Review Panel. In addition to journal publications, a range of PPIE activities have been conducted.

Introduction To investigate if β-adrenoreceptor blocking drug (β-blocker) prescription reduces the risk of knee or hip osteoarthritis, total joint replacement and analgesic prescription.Setting Primary care.Methods and analysis This is a cohort study using data from the Clinical Practice Research Datalink. Two separate analyses will be performed. Study 1 will be on the association between β-blocker prescription and incident knee/hip osteoarthritis. Inclusion criteria will be age ≥40 years. Exposed participants will be those with ≥2 continuous β-blocker prescriptions, and the index date will be the date of the first prescription of β-blocker. Unexposed participants will include up to four controls matched for age, sex, general practice surgery and propensity score for β-blocker prescription. Exclusion criteria will include contraindications to β-blockers, consultations for osteoarthritis or potent analgesic prescription before the index date. Outcomes will be knee osteoarthritis (primary outcome), hip osteoarthritis, knee pain and hip pain. Study 2 will be on the association between β-blocker prescription and total joint replacement and analgesic prescription in people with osteoarthritis. Inclusion criteria will be age ≥40 years, knee or hip osteoarthritis, and index date will be as in study 1. Unexposed participants will be as in study 1, additionally matched for consultation for knee or hip osteoarthritis prior to the index date. Exclusion criteria will include contraindications to β-blockers and osteoarthritis in other joints prior to the index date. Outcomes will be total knee replacement (primary outcome), total hip replacement and new analgesic prescription.Statistical analysis Kaplan-Meier curves will be plotted, and Cox proportional HRs and 95% CIs will be calculated. Stratified analysis will be performed by class of β-blocker, intrinsic sympathomimetic effect and indication(s) for prescription.Ethics and dissemination This study was ethically approved by the Independent Scientific Advisory Committee of the Medicines and Healthcare Authority (Ref 18_227R). The results of this study will be published in peer-reviewed journals and presented at conferences.Summary This prospective cohort study will evaluate the analgesic potential of commonly used drugs for osteoarthritis pain.

Background: Patients with inflammatory rheumatic conditions such as rheumatoid arthritis, polymyalgia rheumatica and ankylosing spondylitis are at increased risk of common comorbidities such as cardiovascular disease, osteoporosis and anxiety and depression which lead to increased morbidity and mortality. These associated morbidities are often un-recognized and under-treated. While patients with other long-term conditions such as diabetes are invited for routine reviews in primary care, which may include identification and management of co-morbidities, at present this does not occur for patients with inflammatory conditions, and thus, opportunities to diagnose and optimally manage these comorbidities are missed. Objective: To evaluate the feasibility and acceptability of a nurse-led integrated care review (the INtegrating and improving Care for patients with infLammatory rheUmatological DisordErs in the community (INCLUDE) review) for people with inflammatory rheumatological conditions in primary care. Design: A pilot cluster randomized controlled trial will be undertaken to test the feasibility and acceptability of a nurse-led integrated primary care review for identification, assessment and initial management of common comorbidities including cardiovascular disease, osteoporosis and anxiety and depression. A process evaluation will be undertaken using a mixed methods approach including participant self-reported questionnaires, a medical record review, an INCLUDE EMIS template, intervention fidelity checking using audio-recordings of the INCLUDE review consultation and qualitative interviews with patient participants, study nurses and study general practitioners (GPs) Discussion: Success of the pilot study will be measured against the engagement, recruitment and study retention rates of both general practices and participants. Acceptability of the INCLUDE review to patients and practitioners and treatment fidelity will be explored using a parallel process evaluation. Trial Registration: ISRCTN12765345.

Background: Osteoarthritis (OA) is the most common long-term condition managed in UK general practice. However, care is suboptimal despite evidence that primary care and community-based interventions can reduce OA pain and disability. Objectives: The overall aim was to improve primary care management of OA and the health of patients with OA. Four parallel linked workstreams aimed to (1) develop a health economic decision model for estimating the potential for cost-effective delivery of primary care OA interventions to improve population health, (2) develop and evaluate new health-care models for delivery of core treatments and support for self-management among primary care consulters with OA, and to investigate prioritisation and implementation of OA care among the public, patients, doctors, health-care professionals and NHS trusts, (3) determine the effectiveness of strategies to optimise specific components of core OA treatment using the example of exercise and (4) investigate the effect of interventions to tackle barriers to core OA treatment, using the example of comorbid anxiety and depression in persons with OA. Data sources: The North Staffordshire Osteoarthritis Project database, held by Keele University, was the source of data for secondary analyses in workstream 1. Methods: Workstream 1 used meta-analysis and synthesis of published evidence about effectiveness of primary care treatments, combined with secondary analysis of existing longitudinal population-based cohort data, to identify predictors of poor long-term outcome (prognostic factors) and design a health economic decision model to estimate cost-effectiveness of different hypothetical strategies for implementing optimal primary care for patients with OA. Workstream 2 used mixed methods to (1) develop and test a ‘model OA consultation’ for primary care health-care professionals (qualitative interviews, consensus, training and evaluation) and (2) evaluate the combined effect of a computerised ‘pop-up’ guideline for general practitioners (GPs) in the consultation and implementing the model OA consultation on practice and patient outcomes (parallel group intervention study). Workstream 3 developed and investigated in a randomised controlled trial (RCT) how to optimise the effect of exercise in persons with knee OA by tailoring it to the individual and improving adherence. Workstream 4 developed and investigated in a cluster RCT the extent to which screening patients for comorbid anxiety and depression can improve OA outcomes. Public and patient involvement included proposal development, project steering and analysis. An OA forum involved public, patient, health professional, social care and researcher representatives to debate the results and formulate proposals for wider implementation and dissemination. Results: This programme provides evidence (1) that economic modelling can be used in OA to extrapolate findings of cost-effectiveness beyond the short-term outcomes of clinical trials, (2) about ways of implementing support for self-management and models of optimal primary care informed by National Institute for Health and Care Excellence recommendations, including the beneficial effects of training in a model OA consultation on GP behaviour and of pop-up screens in GP consultations on the quality of prescribing, (3) against adding enhanced interventions to current effective physiotherapy-led exercise for knee OA and (4) against screening for anxiety and depression in patients with musculoskeletal pain as an addition to current best practice for OA. Conclusions: Implementation of evidence-based care for patients with OA is feasible in general practice and has an immediate impact on improving the quality of care delivered to patients. However, improved levels of quality of care, changes to current best practice physiotherapy and successful introduction of psychological screening, as achieved by this programme, did not substantially reduce patients’ pain and disability. This poses important challenges for clinical practice and OA research. Limitations: The key limitation in this work is the lack of improvement in patient-reported pain and disability despite clear evidence of enhanced delivery of evidence-based care. Future work recommendations: (1) New thinking and research is needed into the achievable and desirable long-term goals of care for people with OA, (2) continuing investigation into the resources needed to properly implement clinical guidelines for management of OA as a long-term condition, such as regular monitoring to maintain exercise and physical activity and (3) new research to identify subgroups of patients with OA as a basis for stratified primary care including (i) those with good prognosis who can self-manage with minimal investigation or specialist treatment, (ii) those who will respond to, and benefit from, specific interventions in primary care, such as physiotherapy-led exercise, and (iii) develop research into effective identification and treatment of clinically important anxiety and depression in patients with OA and into the effects of pain management on psychological outcomes in patients with OA. Trial registration: Current Controlled Trials ISRCTN06984617, ISRCTN93634563 and ISRCTN40721988. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research Programme and will be published in full in Programme Grants for Applied Research Programme; Vol. 6, No. 4. See the NIHR Journals Library website for further project information.

The original article [1] contains an omitted grant acknowledgement and affiliation as relates to the contribution of co-author, Rafael Perera-Salazar. As such, the following two amendments should apply to the original article: