EULAR recommendations for the involvement of patient research partners in rheumatology research: 2023 update.

BACKGROUND: Since the publication of the 2011 European Alliance of Associations for Rheumatology (EULAR) recommendations for patient research partner (PRP) involvement in rheumatology research, the role of PRPs has evolved considerably. Therefore, an update of the 2011 recommendations was deemed necessary. METHODS: In accordance with the EULAR Standardised Operational Procedures, a task force comprising 13 researchers, 2 health professionals and 10 PRPs was convened. The process included an online task force meeting, a systematic literature review and an in-person second task force meeting to formulate overarching principles (OAPs) and recommendations. The level of agreement of task force members was assessed anonymously (0-10 scale). RESULTS: The task force developed five new OAPs, updated seven existing recommendations and formulated three new recommendations. The OAPs address the definition of a PRP, the contribution of PRPs, the role of informal caregivers, the added value of PRPs and the importance of trust and communication in collaborative research efforts. The recommendations address the research type and phases of PRP involvement, the recommended number of PRPs per project, the support necessary for PRPs, training of PRPs and acknowledgement of PRP contributions. New recommendations concern the benefits of support and guidance for researchers, the need for regular evaluation of the patient-researcher collaboration and the role of a designated coordinator to facilitate collaboration. Agreements within the task force were high and ranged between 9.16 and 9.96. CONCLUSION: The updated EULAR recommendations for PRP involvement are more substantially based on evidence. Together with added OAPs, they should serve as a guide for researchers and PRPs and will ultimately strengthen the involvement of PRPs in rheumatology research.

Series: Public engagement with research. Part 2: GPs and primary care researchers working inclusively with minoritised communities in health research to help address inequalities.

Public engagement in health research is vital for addressing health disparities and promoting inclusivity among minoritised communities who often face barriers to accessing healthcare. Minoritised communities are groups, which have been made minorities by a dominant culture, race, ethnic group and/or social class and may experience health inequalities as a result. By incorporating diverse perspectives and lived experiences of minoritised communities, this approach aims to achieve contextually relevant research outcomes that reduce health inequalities and improve overall well-being. However, underrepresentation and lack of inclusivity challenges persist, necessitating the establishment of inclusive partnerships and grassroots participatory methodologies.To foster inclusive public engagement, it is important to overcome structural and cultural barriers, address socioeconomic challenges, and build trust with minoritised communities. This can be achieved by promoting a cultural shift that values inclusivity, providing comprehensive training to researchers, and collecting rigorous data on engagement demographics for transparency and accountability. Involving minoritised communities in decision-making through participatory research approaches enhances trust and yields successful outcomes. Additionally, allocating sufficient resources, collaborating in co-production, and prioritising the diverse needs and perspectives of stakeholders contribute to fostering inclusive public engagement in research.Overall, inclusive engagement practices particularly in primary care research have the potential to reduce health inequalities and cater to the unique requirements of minoritised communities, thereby creating more impactful outcomes and promoting equitable healthcare access.

There is an important need to engage with minoritised communities in primary care researchEngaging diverse communities in research helps produce relevant research to address health inequalities.The exclusion of minoritised communities from research can be addressed by taking action towards more inclusive engagement.

Series: Public engagement with research. Part 3: Sharing power and building trust through partnering with communities in primary care research.

BACKGROUND: This article focuses on potential strategies to support primary care researchers in working in partnership with the public and healthcare professionals. Partnership working can potentially to improve the relevance and usefulness of research and ensure better research and health outcomes. DISCUSSION: We describe what we mean by partnership working and the importance of reflecting on power and building trusting relationships. To share power in partnership working, it is essential to critically reflect on the multiple dimensions of power, their manifestations, and your own power. Power can influence relationships and therefore, it is essential to build trust with partners. Next, we outline how the context of primary care research and decisions about who you work with and how to work together, are vital considerations that are imbued with power. Lastly, we suggest different ways of working in partnership to address different dimensions of power. We provide examples from primary care research across Europe regarding how to recognise, tackle, and challenge, invisible, hidden and visible power. CONCLUSION: We conclude by proposing three calls to actions to encourage researchers working in primary care to consider the multiple dimensions of power and move towards partnership working. First is to use participatory methods to improve the inclusivity of your research. Second is to include patients and the public in decisions about the design, delivery and development of research and its outcomes. Third is to address various systemic and institutional barriers which hinder partnership working.

Partnership approaches to primary care research can potentially improve the relevance, usefulness and inclusivity of research.Working in partnership involves researchers and the public sharing power in important research decisions and building trusting relationships.Recognising and addressing power differentials and building trusting relationships requires time and effort.

Using the UK standards for public involvement to evaluate the public involvement sections of annual reports from NIHR managed research centres.

BACKGROUND: Within the United Kingdom (UK), the National Institute for Health and Care Research is the largest funder of health and social care research, and additionally funds research centres that support the development and delivery of research. Each year, award-holders of these research centres are required to write a report about their activities, including a summary of Patient and Public Involvement and Engagement (PPIE) activities. This study aimed to evaluate the PPIE sections of annual reports to identify best practice and challenges; this could inform future delivery of PPIE activities. METHODS: A framework documentary analysis informed by the six UK Standards for Public Involvement ('Inclusive opportunities', 'Working together', 'Support and learning', 'Communications', 'Impact' and 'Governance') was conducted on 112 reports. A quality improvement framework ('Insights') was used to evaluate quality as one of: 'Welcoming', 'Listening', 'Learning' and 'Leading'. Recommendations from this review were co-developed with stakeholders and public contributors. RESULTS: Reports documented varying levels of quality in PPIE activities which spanned across all six UK Standards. Award-holders either intended to, or were actively working towards, increasing access and inclusivity of public involvement opportunities. Methods of working with public contributors were varied, including virtual and in-person meetings. Most award-holders offered PPIE support and learning opportunities for both public contributors and staff. Some award-holders invited public contributors to co-produce communication plans relating to study materials and research findings. The impact of public involvement was described in terms of benefits to public contributors themselves, and on an organisation and project level. Many award-holders reported inviting public contributors to share decision-making within and about governance structures. CONCLUSIONS: This evaluation identified that most annual reports contained evidence of good quality PPIE practice with learning from public contributors. Using the UK Standards and Insights framework enabled exploration of the breadth and quality of PPIE activities. Recommendations include the need for a platform for centres to access and share PPIE best practice and for centres to collaborate with local and national partners to build relationships with the public through inclusive community engagement.

WHAT DID WE DO?: Within the United Kingdom (UK) the National Institute for Health and Care Research (NIHR) is the largest funder of health and social care research. The NIHR also funds research centres that support the delivery of research studies. Each year, award-holders of these research centres are required to write a report describing their activities. These reports include activities related to Patient and Public Involvement and Engagement (PPIE). We aimed to evaluate the PPIE sections of these reports to identify best practice and challenges. This could, in turn, inform and aid researchers to enhance their PPIE approaches and improve how they work with the public in research. HOW DID WE DO IT?: We looked at 112 reports using the six UK Standards for Public Involvement (these include: 'Inclusive opportunities', 'Working together', 'Support and learning', 'Communications', 'Impact' and 'Governance'). We used a quality improvement framework named 'Insights' to categorise PPIE practice into one of four levels of increasing quality: 'Welcoming', 'Listening', 'Learning' and 'Leading'. WHAT ARE THE FINDINGS?: PPIE activities, of varying quality, covered all six UK Standards. A number of award-holders either intended, or were actively working towards, increasing access and inclusivity of public involvement opportunities. Methods of working with public contributors were varied. Most award-holders offered support and learning opportunities for both PPIE members and staff. Some award-holders invited PPIE members to co-produce communication plans relating to study materials and research findings. The impact of public involvement was described in terms of benefits to PPIE members themselves, and on a project and award-holder level. Many award-holders reported inviting public contributors to share decision-making within and about governance structures. WHAT'S THE BIGGER PICTURE?: This evaluation identified that the Insights framework was useful in determining the quality of PPIE activities relating to each UK Standard. Recommendations for improving the quality of future PPIE activities were co-developed with staff from different research centres, senior leaders within the NIHR, PPIE leads and public contributors.

The INSIGHT project: reflections on the co-production of a quality recognition programme to showcase excellence in public involvement in health and care research.

BACKGROUND: The quality of Patient and Public Involvement (PPI) in healthcare research varies considerably and is frequently tokenistic. We aimed to co-produce the Insight | Public Involvement Quality Recognition and Awards programme, based on the UK Standards for Public Involvement (UKSPI) alongside an incremental scale designed by Expert Citizens (a lived experience-led community group), to incentivise and celebrate continuous improvement in PPI. METHODS: We used Task and Finish Groups (19/44 [43%] public contributor membership) to co-produce the programme which we piloted in three organisations with different healthcare research models. We used surveys and review sessions to capture learning and reflections. RESULTS: We co-created: (1) A Quality descriptor matrix comprising four incremental quality levels (Welcoming, Listening, Learning, Leading) for each UKSPI standard. (2) An assessment framework including guidance materials, self-assessment form and final report template. (3) An assessor training package. (4) The quality awards event format and nomination form. These materials were modified based on pilot-site feedback. Of survey respondents: 94.4% felt they had made at least 'Some' personal contribution (half said 'Quite a lot'/'A great deal'), 88.9% said they were 'Always'/'Often' able to express their views freely and, 100% stated the programme would have 'A lot of impact'/'Quite a bit of impact'. During the project, we identified the importance of taking time to explain project aims and contributor roles, adapting to the needs of individual contributors and, using smaller bespoke sessions outside the main Task and Finish Groups. CONCLUSIONS: We co-produced and piloted a quality recognition programme to incentivise and celebrate continuous quality improvement in PPI. One public contributor stated, "I feel strongly that the Insight framework and awards will raise awareness of the [public involvement] work going on in many community settings. [It] is likely to result in better sharing of positive practice, incentivising research groups of any size to start work or to improve the quality of [PPI] could be one of the main benefits. I'm excited that if this initiative takes off, regionally and then in the longer term nationally, it could be a significant step in advancing the [public] voice."

How researchers involve members of the public in health research varies widely. We developed a scheme that encourages researchers from any health research organisation to improve the quality of public involvement. We used joint workshops with researchers, health workers and members of the public to design the scheme. We then tested it in three research organisations. We recorded the experience of people taking part in the project to learn what went well and what could be improved. We looked at the six areas covered in the UK Standards for Public Involvement. For each area, we worked together to define four levels (Welcoming, Listening, Learning, Leading) of increasing quality. We designed the materials needed for organisations to take part in the scheme. We also created a training pack for assessors and the format of a celebration event. We modified the materials after testing them. We asked those who took part in the project, half of whom were lay members, what they thought. 94% felt they had made at least some personal contribution. 89% said they were often or always able to express their views freely. Everyone thought the project would have some degree of impact. Overall, those members of the public who took part said they enjoyed the process and felt that their views were listened to. Along the way, we learned that it was important to carefully explain the project's aims, be clear about roles and have 1to1 discussions outside the main workshops.

Series: Public engagement with research. Part 4: Maximising the benefits of involving the public in research implementation.

This final article in the four-part series focuses on the often neglected yet important role of the public in implementing research in General Practice and Primary Care more broadly. Experience in implementation of findings from research with public engagement in Primary Care has highlighted how partnership working with patients and the public is important in transitioning from 'what we know' from the evidence-base to 'what we do' in practice. Factors related to Primary Care research that make public engagement important are highlighted e.g. implementing complex interventions, implementing interventions that increase health equity, implementing interventions in countries with different primary healthcare system strengths. Involvement of patients and public can enhance the development of modelling and simulation included in studies on systems modelling for improving health services. We draw on the emerging evidence base to describe public engagement in implementation and offer some guiding principles for engaging with the public in the implementation in General Practice and Primary Care in general. Illustrative case studies are included to support others wishing to offer meaningful engagement in implementing research evidence.

Series: Public engagement with research. Part 1: The fundamentals of public engagement with research.

BACKGROUND: In the first of a four-part series, we describe the fundamentals of public engagement in primary care research. OBJECTIVES: The article's purpose is to encourage, inform and improve the researcher's awareness about public engagement in research. For a growing number of researchers, funders and patient organisations in Europe, public engagement is a moral and ethical imperative for conducting high-quality research. DISCUSSION: Starting with an explanation of the role of public engagement in research, we highlight its diversity and benefits to research, researchers and the public members involved. We summarise principles of good practice and provide valuable resources for researchers to use in their public engagement activities. Finally, we discuss some of the issues encountered when researchers collaborate with members of the public and provide practical steps to address them. Case studies of real-life situations are used to illustrate and aid understanding. CONCLUSION: We hope this article and the other papers in this series will encourage researchers to better consider the role and practice of public engagement and the potential added value to research that collaborating with the public could provide.

The effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome: 24-month follow-up of a randomized trial.

OBJECTIVES: This follow-up study of the INSTinCTS (INjection vs SplinTing in Carpal Tunnel Syndrome) trial compared the effects of corticosteroid injection (CSI) and night splinting (NS) for the initial management of mild-to-moderate CTS on symptoms, resource use and carpal tunnel surgery, over 24 months. METHODS: Adults with mild-to-moderate CTS were randomized 1:1 to a local corticosteroid injection or a night splint worn for 6 weeks. Outcomes at 12 and 24 months included the Boston Carpal Tunnel Questionnaire (BCTQ), hand/wrist pain intensity numeric rating scale (NRS), the number of patients referred for and undergoing CTS surgery, and healthcare utilization. A cost-utility analysis was conducted. RESULTS: One hundred and sixteen participants received a CSI and 118 a NS. The response rate at 24 months was 73% in the CSI arm and 71% in the NS arm. By 24 months, a greater proportion of the CSI group had been referred for (28% vs 20%) and undergone (22% vs 16%) CTS surgery compared with the NS group. There were no statistically significant between-group differences in BCTQ score or pain NRS at 12 or 24 months. CSI was more costly [mean difference £68.59 (95% CI: -120.84, 291.24)] with fewer quality-adjusted life-years than NS over 24 months [mean difference -0.022 (95% CI: -0.093, 0.045)]. CONCLUSION: Over 24 months, surgical intervention rates were low in both groups, but less frequent in the NS group. While there were no differences in the clinical effectiveness of CSI and NS, initial treatment with CSI may not be cost-effective in the long-term compared with NS.

Estimating the population health burden of musculoskeletal conditions using primary care electronic health records.

OBJECTIVES: Better indicators from affordable, sustainable data sources are needed to monitor population burden of musculoskeletal conditions. We propose five indicators of musculoskeletal health and assessed if routinely available primary care electronic health records (EHR) can estimate population levels in musculoskeletal consulters. METHODS: We collected validated patient-reported measures of pain experience, function and health status through a local survey of adults (≥35 years) presenting to English general practices over 12 months for low back pain, shoulder pain, osteoarthritis and other regional musculoskeletal disorders. Using EHR data we derived and validated models for estimating population levels of five self-reported indicators: prevalence of high impact chronic pain, overall musculoskeletal health (based on Musculoskeletal Health Questionnaire), quality of life (based on EuroQoL health utility measure), and prevalence of moderate-to-severe low back pain and moderate-to-severe shoulder pain. We applied models to a national EHR database (Clinical Practice Research Datalink) to obtain national estimates of each indicator for three successive years. RESULTS: The optimal models included recorded demographics, deprivation, consultation frequency, analgesic and antidepressant prescriptions, and multimorbidity. Applying models to national EHR, we estimated that 31.9% of adults (≥35 years) presenting with non-inflammatory musculoskeletal disorders in England in 2016/17 experienced high impact chronic pain. Estimated population health levels were worse in women, older aged and those in the most deprived neighbourhoods, and changed little over 3 years. CONCLUSION: National and subnational estimates for a range of subjective indicators of non-inflammatory musculoskeletal health conditions can be obtained using information from routine electronic health records.

Improving osteoarthritis management in primary healthcare: results from a quasi-experimental study.

BACKGROUND: To improve quality of care for patients with hip and knee osteoarthritis (OA), general practitioners (GPs) and physiotherapists (PTs) in a Norwegian municipality initiated an intervention. The intervention aimed to increase provision of core OA treatment (information, exercise, and weight control) prior to referral for surgery, rational use of imaging for assessing OA and improve communication between healthcare professionals. This study assessed the effectiveness of this intervention. METHODS: Forty-eight PTs and one hundred one GPs were invited to the intervention that included two interactive workshops outlining best practice and an accompanying template for PT discharge reports. Using interrupted time series research design, the study period was divided into three: pre-implementation, transition (implementation) and post-implementation. Comparing the change between pre- and post-implementation, the primary outcome was patient-reported quality of OA care measured with the OsteoArthritis Quality Indicator questionnaire. Secondary outcomes were number of PT discharge reports, information included in GP referral letters to orthopaedic surgeon, the proportion of GP referral letters indicating use of core treatment, and the use of imaging within OA assessment. Analyses involved linear mixed and logistic regression models. RESULTS: The PT workshop had 30 attendees, and 31 PTs and 33 GPs attended the multidisciplinary workshop. Two hundred eight and one hundred twenty-five patients completed the questionnaire during pre- and post-implementation, respectively. The adjusted model showed a small, statistically non-significant, increase in mean total score for quality of OA care (mean change = 4.96, 95% CI -0.18, 10.12, p:0.057), which was mainly related to items on OA core treatment. Patients had higher odds of reporting receipt of information on treatment alternatives (odds ratio (OR) 1.9, 95% CI 1.08, 3.24) and on self-management (OR 2.4, 95% CI 1.33, 4.32) in the post-implementation phase. There was a small, statistically non-significant, increase in the proportion of GP referral letters indicating prior use of core treatment modalities. There were negligible changes in the number of PT discharge reports, in the information included in the GP referral letters, and in the use of imaging for OA assessment. CONCLUSION: This study suggests that a primary care intervention including two inter-active workshops can shift the quality of care towards best practice recommendations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02876120 .

Facilitating personal development for public involvement in health-care education and research: A co-produced pilot study in one UK higher education institute.

BACKGROUND: Public involvement in the education of students enrolled on higher education programmes has gained impetus. For students enrolled on professional health-care programmes and health-related modules in the UK, there is also a requirement by professional bodies to include "service user" involvement in preparation for entry to a professional health-care register and continuing professional development. Actively involving patients and members of the public in research is also a requirement by many research funders. In this article, the term Patient and Public Involvement (PPI) will be used throughout to include lay members, volunteers, user and carers. OBJECTIVES: A unique pilot study was introduced across a health faculty to integrate PPI in a deliberate way. It aimed to provide an educational, focused programme of events that was meaningful to develop and inform peoples' knowledge, skills and confidence for their involvement in the health faculty. DESIGN: PPI members volunteered to sit on a steering group to determine the educational journey; the outcomes of three focus groups with PPI members (N = 32) and academics informed the programme content which included a range of workshops covering the exploration of public roles and barriers to involvement, introduction to research and interviewing skills. RESULTS: The workshops were well attended, and outcomes indicated the importance of co-production when designing, delivering and evaluating programmes. DISCUSSION: Co-production underpinned this pilot study, resulting in a programme which was meaningfully received by public contributors. RECOMMENDATIONS: Co-production was seen as integral to this research to ensure that outcomes were indeed "fit for purpose".

Public priorities for osteoporosis and fracture research: results from a focus group study.

Four focus groups were conducted with members of the public to identify important areas for future osteoporosis research. Participants identified priorities to increase public awareness of osteoporosis, reduce delays in diagnosis, improve communication between healthcare providers and to improve follow-up and information provision about causes of osteoporosis, medication harms and prognosis. PURPOSE: Patients and the public must be involved in setting research agendas to ensure relevant and impactful questions are prioritised. This study aimed to understand what people living with osteoporosis and fragility fractures felt was important to research, to inform the content of a national survey on research priorities in this area. METHODS: Focus groups were conducted with members of the public with experience of osteoporosis or fragility fractures. The topic guide was co-developed with a patient and public involvement research user group, and explored participants' experiences of osteoporosis including diagnosis, management and effect upon their lives, what aspects of their ongoing care was most important to them and what about their care or condition could be improved. Focus groups were audio-recorded, transcribed and analysed thematically. RESULTS: A total of twenty-three participants were recruited to four focus groups. Analysis identified two main themes: challenges in living with osteoporosis and healthcare services for osteoporosis. Information needs was a further cross-cutting theme. Participants called for increased public awareness of osteoporosis and wanted healthcare services to address conflicting messages about diet, exercise and medication. Participants described long delays in diagnosis, poor communication between primary and secondary care and the need for structured follow-up as important areas for future research to address. CONCLUSION: The findings from this study provide an understanding of research priorities from the perspective of patients and the public, have informed the content of a national survey and have implications for patient education, health services research and policy.

The extent, quality and impact of patient and public involvement in primary care research: a mixed methods study.

PLAIN ENGLISH SUMMARY: In the UK, more patients go to primary care than other parts of the health service. Therefore it is important for research into primary care to include the insights and views of people who receive these services. To explore the extent, quality and impact of patient and public involvement (PPI) in primary care research, we examined documents of 200 projects and surveyed 191 researchers.We found that about half of studies included PPI to develop research ideas and during the study itself. Common activities included designing study materials, advising on methods, and managing the research. Some studies did not undertake the PPI activities initially planned and funded for. PPI varied by study design, health condition and study population. We found pockets of good practice: having a PPI budget, supporting PPI contributors, and PPI informing recruitment issues. However, good practice was lacking in other areas. Few projects offered PPI contributors training, used PPI to develop information for participants about study progress and included PPI to advise on publishing findings.Researchers reported beneficial impacts of PPI. Most impact was reported when the approach to PPI included more indicators of good practice. The main cost of PPI for researchers was their time. Many reported difficulties providing information about PPI.In partnership with PPI contributors, we have used these findings to develop:a new Cost and Consequences Framework for PPI highlighting financial and non-financial costs, benefits and harms of PPIFifteen co-produced recommendations to improve the practice and delivery of PPI. ABSTRACT: Background: To improve the lives of patients in primary care requires the involvement of service users in primary care research. We aimed to explore the extent, quality and impact of patient and public involvement (PPI) in primary care research.Methods: We extracted information about PPI from grant applications, reports and an electronic survey of researchers of studies funded by the NIHR School for Primary Care Research (SPCR). We applied recognised quality indicators to assess the quality of PPI and assessed its impact on research.Results: We examined 200 grant applications and reports of 181 projects. PPI was evident in the development of 47 (24%) grant applications. 113 (57%) grant applications included plans for PPI during the study, mostly in study design, oversight, and dissemination. PPI during projects was reported for 83 (46%) projects, including designing study materials and managing the research. We identified inconsistencies between planned and reported PPI. PPI varied by study design, health condition and study population.Of 46 (24%) of 191 questionnaires completed, 15 reported PPI activity. Several projects showed best practice according to guidelines, in terms of having a PPI budget, supporting PPI contributors, and PPI informing recruitment issues. However few projects offered PPI contributors training, used PPI to develop information for participants about study progress, and had PPI in advising on dissemination.Beneficial impacts of PPI in designing studies and writing participant information was frequently reported. Less impact was reported on developing funding applications, managing or carrying out the research. The main cost of PPI for researchers was their time. Many researchers found it difficult to provide information about PPI activities.Our findings informed:a new Cost and Consequences Framework for PPI in primary care research highlighting financial and non-financial costs, plus the benefits and harms of PPIFifteen co-produced recommendations to improve PPI in research and within the SPCR.Conclusions: The extent, quality and impact of PPI in primary care research is inconsistent across research design and topics. Pockets of good practice were identified making a positive impact on research. The new Cost and Consequences Framework may help others assess the impact of PPI.

Development and initial cohort validation of the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways.

OBJECTIVES: Current musculoskeletal outcome tools are fragmented across different healthcare settings and conditions. Our objectives were to develop and validate a single musculoskeletal outcome measure for use throughout the pathway and patients with different musculoskeletal conditions: the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ). SETTING: A consensus workshop with stakeholders from across the musculoskeletal community, workshops and individual interviews with a broad mix of musculoskeletal patients identified and prioritised outcomes for MSK-HQ inclusion. Initial psychometric validation was conducted in four cohorts from community physiotherapy, and secondary care orthopaedic hip, knee and shoulder clinics. PARTICIPANTS: Stakeholders (n=29) included primary care, physiotherapy, orthopaedic and rheumatology patients (n=8); general practitioners, physiotherapists, orthopaedists, rheumatologists and pain specialists (n=7), patient and professional national body representatives (n=10), and researchers (n=4). The four validation cohorts included 570 participants (n=210 physiotherapy, n=150 hip, n=150 knee, n=60 shoulder patients). OUTCOME MEASURES: Outcomes included the MSK-HQ's acceptability, feasibility, comprehension, readability and responder burden. The validation cohort outcomes were the MSK-HQ's completion rate, test-retest reliability and convergent validity with reference standards (EQ-5D-5L, Oxford Hip, Knee, Shoulder Scores, and the Keele MSK-PROM). RESULTS: Musculoskeletal domains prioritised were pain severity, physical function, work interference, social interference, sleep, fatigue, emotional health, physical activity, independence, understanding, confidence to self-manage and overall impact. Patients reported MSK-HQ items to be 'highly relevant' and 'easy to understand'. Completion rates were high (94.2%), with scores normally distributed, and no floor/ceiling effects. Test-retest reliability was excellent, and convergent validity was strong (correlations 0.81-0.88). CONCLUSIONS: A new musculoskeletal outcome measure has been developed through a coproduction process with patients to capture prioritised outcomes for use throughout the pathway and with different musculoskeletal conditions. Four validation cohorts found that the MSK-HQ had high completion rates, excellent test-retest reliability and strong convergent validity with reference standards. Further validation studies are ongoing, including a cohort with rheumatoid/inflammatory arthritis.

Patient and public involvement in primary care research - an example of ensuring its sustainability.

BACKGROUND: The international literature on patient and public involvement (PPI) in research covers a wide range of issues, including active lay involvement throughout the research cycle; roles that patients/public can play; assessing impact of PPI and recommendations for good PPI practice. One area of investigation that is less developed is the sustainability and impact of PPI beyond involvement in time-limited research projects. METHODS: This paper focuses on the issues of sustainability, the importance of institutional leadership and the creation of a robust infrastructure in order to achieve long-term and wide-ranging PPI in research strategy and programmes. RESULTS: We use the case of a Primary Care Research Centre to provide a historical account of the evolution of PPI in the Centre and identified a number of key conceptual issues regarding infrastructure, resource allocation, working methods, roles and relationships. CONCLUSIONS: The paper concludes about the more general applicability of the Centre's model for the long-term sustainability of PPI in research.

Patient-reported quality indicators for osteoarthritis: a patient and public generated self-report measure for primary care.

PLAIN ENGLISH SUMMARY: People with osteoarthritis desire high quality care, support and information. However, the quality of care for people with OA in general practice is not routinely collected. Quality Indicators can be used to benefit patients by measuring whether minimum standards of quality care are being met from a patient perspective. The aim of this study was to describe how a Research User Group (RUG) worked alongside researchers to co-produce a set of self-reported quality indicators for people with osteoarthritis when visiting their general practitioner or practice nurse (primary care). These were required in the MOSAICS study, which developed and evaluated a new model of supported self-management of OA to implement the NICE quality standards for OA. This article describes the public involvement in the MOSAICS study. This was 1) the co-development by RUG members and researchers of an Osteoarthritis Quality Indicators United Kingdom (OA QI (UK)) questionnaire for use in primary care, and 2) the comparison of the OA QI (UK) with a similar questionnaire developed in Norway. This study shows how important and effective a research user group can be in working with researchers in developing quality care indicators for osteoarthritis for use in a research study and, potentially, routine use in primary care. The questionnaire is intended to benefit patients by enabling the assessment of the quality of primary care for osteoarthritis from a patient's perspective. The OA QI (UK) has been used to examine differences in the quality of osteoarthritis care in four European countries. ABSTRACT: Background People with osteoarthritis (OA) desire high quality care, support and information about OA. However, the quality of care for people with OA in general practice is not routinely collected. Quality Indicators (QI) can be used to benefit patients by measuring whether minimum standards of quality care (e.g. NICE quality standards) are being met from a patient perspective. A Research User Group (RUG) worked with researchers to co-produce a set of self-report, patient-generated QIs for OA. The QIs were intended for use in the MOSAICS study, which developed and evaluated a new model of supported self-management of OA to implement the NICE guidelines. We report on 1) the co-development of the OA QI (UK) questionnaire for primary care; and 2) the comparison of the content of the OA QI (UK) questionnaire with a parallel questionnaire developed in Norway for the Musculoskeletal Pain in Ullensaker (MUST) study. Methods Researchers were invited to OA RUG meetings. Firstly, RUG members were asked to consider factors important to patients consulting their general practitioner (GP) for OA and then each person rated their five most important. RUG members then discussed these in relation to a systematic review of OA QIs in order to form a list of OA QIs from a patient perspective. RUG members suggested wording and response options for a draft OA QI (UK) questionnaire to assess the QIs. Finally RUG members commented on draft and final versions of the questionnaire and how it compared with a translated Norwegian OA-QI questionnaire. Results RUG members (5 males, 5 females; aged 52-80 years) attended up to four meetings. RUG members ranked 20 factors considered most important to patients consulting their GP for joint pain. Following discussion, a list of eleven patient-reported QIs for OA consultations were formed. RUG members then suggested the wording and response options of 16 draft items - four QIs were split into two or more questionnaire items to avoid multiple dimensions of care quality within a single item. On comparison of this to the Norwegian OA-QI questionnaire, RUG members commented that both questionnaires contained seven similar QIs. The RUG members and researchers agreed to adopt the Norwegian OA-QI wording for four of these items. RUG members also recommended adopting an additional seven items from the Norwegian OA-QI with some minor word changes to improve their suitability for patients in the UK. One other item from the draft OA QI (UK) questionnaire was retained and eight items were excluded, resulting in a 15-item final version. Conclusions This study describes the development of patient-reported quality indicators for OA primary care derived by members of a RUG group, working in partnership with the research team throughout the study. The OA QI (UK) supports the NICE quality standards for OA and they have been successfully used to assess the quality of OA consultations in primary care in the MOSAICS study. The OA QI (UK) has the potential for routine use in primary care to assess the quality of OA care provided to patients. Ongoing research using both the UK and Norwegian OA-QI questionnaires is assessing the self-reported quality of OA care in different European populations.

Evaluation of the Post Stroke Checklist: a pilot study in the United Kingdom and Singapore.

BACKGROUND: There is currently no standardized process for long-term follow-up care. As a result, management of poststroke care varies greatly, and the needs of stroke survivors are not fully addressed. The Post Stroke Checklist was developed by the Global Stroke Community Advisory Panel as a means of standardizing long-term stroke care. Since its development, the Post Stroke Checklist has gained international recognition from various stroke networks and is endorsed by the World Stroke Organization to support improved stroke survivor follow-up and care. AIMS: The aim of this study was to evaluate the feasibility and usefulness of the Post Stroke Checklist in clinical practice and assess its relevance to stroke survivors in pilot studies in the United Kingdom and Singapore. METHODS: The Post Stroke Checklist was administered to stroke survivors in the United Kingdom (n = 42) and Singapore (n = 100) by clinicians. To assess the feasibility of the Post Stroke Checklist in clinical practice, an independent researcher observed the assessment and made notes relating to the patient-clinician interaction and their interpretations of the Post Stroke Checklist items. Patient and clinician satisfaction with the Post Stroke Checklist was assessed by three questions, responded to on a 0-10 numerical rating scale. Clinicians also completed a Pragmatic Face and Content Validity test to evaluate their overall impressions of the Post Stroke Checklist. In the United Kingdom, a subset of patients (n = 14) took part in a concept elicitation interview prior to being administered the Post Stroke Checklist, followed by a cognitive debriefing interview to assess relevance and comprehension of the Post Stroke Checklist. RESULTS: The Post Stroke Checklist identified frequently reported problems for stroke survivors including cognition (reported by 47·2% of patients), mood (43·7%), and life after stroke (38%). An average of 3·2 problems per patient was identified across both countries (range 0-10). An average of 5 and 2·6 problems per patient were identified in the United Kingdom and Singapore, respectively. The average time taken to administer the Post Stroke Checklist was 17 mins (standard deviation 7·5) in Singapore and 13 mins (standard deviation 7·6) in the United Kingdom. Satisfaction ratings were high for patients (8·6/10) and clinicians (7·7/10), and clinician feedback via the Pragmatic Face and Content Validity test indicated that the Post Stroke Checklist is 'useful', 'informative', and 'exhaustive'. All concepts measured by the Post Stroke Checklist were spontaneously discussed by patients during the concept elicitation interviews, suggesting that the Post Stroke Checklist is relevant to stroke survivors. Cognitive debriefing data indicated that the items were generally well understood and relevant to stroke. Minor revisions were made to the Post Stroke Checklist based on patient feedback. CONCLUSIONS: The findings suggest that the Post Stroke Checklist is a feasible and useful measure for identifying long term stroke care needs in a clinical practice setting. Pilot testing indicated that the Post Stroke Checklist is able to identify a wide range of unmet needs, and patient and clinician feedback indicated a high level of satisfaction with the Post Stroke Checklist assessment. The items were generally well understood and considered relevant to stroke survivors, indicating the Post Stroke Checklist is a feasible, useful, and relevant measure of poststroke care.

The Caregiver Burden Questionnaire for Heart Failure (CBQ-HF): face and content validity.

BACKGROUND: A new caregiver burden questionnaire for heart failure (CBQ-HF v1.0) was developed based on previously conducted qualitative interviews with HF caregivers and with input from HF clinical experts. Version 1.0 of the CBQ-HF included 41 items measuring the burden associated with caregiving in the following domains: physical, emotional/psychological, social, and impact on caregiver's life. Following initial development, the next stage was to evaluate caregivers' understanding of the questionnaire items and their conceptual relevance. METHODS: To evaluate the face and content validity of the new questionnaire, cognitive interviews were conducted with caregivers of heart failure patients. The cognitive interviews included a "think aloud" exercise as the patient completed the CBQ-HF, followed by more specific probing questions to better understand caregivers' understanding, interpretation and the relevance of the instructions, items, response scales and recall period. RESULTS: Eighteen caregivers of heart failure patients were recruited. The mean age of the caregivers was 50 years (SD = 10.2). Eighty-three percent of caregivers were female and most commonly the patient was either a spouse (44%) or a parent (28%). Among the patients 55% were NYHA Class 2 and 45% were NYHA Class 3 or 4. The caregiver cognitive interviews demonstrated that the CBQ-HF was well understood, relevant and consistently interpreted. From the initial 41 item questionnaire, fifteen items were deleted due to conceptual overlap and/or item redundancy. The final 26-item CBQ-HF (v3.0) uses a 5-point Likert severity scale, assessing 4 domains of physical, emotional/psychological, social and lifestyle burdens using a 4-week recall period. CONCLUSIONS: The CBQ-HF (v3.0) is a comprehensive and relevant measure of subjective caregiver burden with strong content validity. This study has established that the CBQ-HF (v3.0) has strong face and content validity and should be valuable as an outcomes measure to help understand and monitor the relationship between patient heart failure severity and caregiver burden. A Translatability AssessmentSM of the measure has since been performed confirming the cultural appropriateness of the measure and psychometric validation is planned for the future to further explore the reliability, and validity of the new questionnaire in a larger caregiver sample.

Sustaining patient and public involvement in research: A case study of a research centre.

The literature on patient and public involvement (PPI) in research covers a wide range of topics. However, one area of investigation that appears under developed is the sustainability and impact of PPI beyond involvement in time-limited research projects. This paper presents a case study of PPI development in one primary care research centre in England, and its approach to making this sustainable using documentary sources and material from a formal evaluation. We provide narrative accounts of the set-up, operation and main processes of PPI, and its perceived impact. PPI requires a long-term perspective with participation and trust growing over time, and both users and researchers learning what approaches work best. PPI is a complex interplay of clarity of purpose, defined roles and relationships, organised support (paid PPI staff) and a well-funded infrastructure. 'Soft systems' are equally important such as flexible and informal approaches to meetings, adapting timetables and environments to meet the needs of lay members and to create spaces for relationships to develop between researchers and lay members that are based on mutual trust and respect. This case study highlights that the right combination of ethos, flexible working practices, leadership, and secure funding goes a long way to embedding PPI beyond ad hoc involvement. This allows PPI in research to be integrated in the infrastructure and sustainable.