Search

Objective To describe factors associated with change in health-related quality of life (HRQOL) in people living with gout in primary care. Methods In a UK prospective cohort study, adults with a diagnosis of gout registered with 20 general practices completed the Gout Impact Scale (GIS; scale 0–100), 36-item Short Form Physical Function subscale (PF-10; 0–100) and HAQ Disability Index (HAQ-DI; 0–3) via postal questionnaires at baseline and 6, 12, 24 and 36 months. Linear mixed modelling was used to investigate factors associated with changes in HRQOL over 3 years. Results A total of 1184 participants responded at baseline (adjusted response 65.6%); 990 (83.6%) were male, with a mean age of 65.6 years (s.d. 12.5). A total of 818, 721, 696 and 605 responded at 6, 12, 24 and 36 months, respectively. Factors associated with worse disease-specific and generic HRQOL over 3 years were flare frequency (five or more flares; GIS subscales, PF-10), oligo/polyarticular flares (GIS subscales, PF-10, HAQ-DI), worse pain (GIS subscales, PF-10, HAQ-DI), body pain (GIS subscales, PF-10, HAQ-DI) and more severe depression (GIS subscales, PF-10, HAQ-DI) (P ≤ 0.05). More severe anxiety was associated with worse disease-specific HRQOL only (GIS subscales). Older age (PF-10), being female (PF-10, HAQ-DI) and BMI (HAQ-DI) were associated with worse generic HRQOL (P ≤ 0.05). Conclusion Gout-specific, comorbid and sociodemographic factors were associated with change in HRQOL over a 3-year period, highlighting people at risk of worse outcomes who could be targeted for interventions.

Objectives To determine the impact of polymyalgia rheumatica (PMR) on intimate and sexual relationships over time. Methods The PMR Cohort study (UKCRN ID16477) is a longitudinal study of patients with incident PMR in English primary care. Participants were sent questions about their PMR symptoms, treatments and overall health, including an item about how their PMR symptoms affected intimate and sexual relationships. The proportion reporting the relevance of intimate and sexual relationships, the effect of PMR on these relationships and the associations with PMR symptoms and general health were explored. Results 652/739 patients (response 90.1%) completed the baseline survey, with 446/576 (78.0%) responding at two years. Mean age of responders was 72.4 years. 62.2% were female. 363/640 (56.7%) participants reported that intimate and sexual relationships were not relevant to them at baseline. 113/277 (40.8%) reported that PMR had a large effect on intimate relationships. This proportion decreased over time in those responding to 12- and 24-month surveys, but continued to be associated with younger age, male gender, worse PMR symptoms, poorer physical function and worse mental health. Conclusion Intimate and sexual relationships are increasingly recognised as important for healthy ageing and health professionals should consider this as part of a holistic approach to the management of PMR. Lay summary What does this mean for patients? Polymyalgia rheumatica (PMR) is a condition that affects older people. It causes pain and stiffness in the hips and shoulders, as well as making people feel very tired. It can stop people from doing routine things that they previously did with no problem (e.g. walking upstairs, getting out of a car). We know very little about how PMR affects people’s personal lives. Therefore, we sent a questionnaire to 652 people in England with newly diagnosed PMR. One question asked people whether their PMR affected their “intimate and sexual relationships”. We asked the same question again 1 and 2 years later. Just over half of people said this wasn’t relevant for them. For people where it mattered to them, 4 in 10 said PMR had a large effect on their relationships. Men, people who were younger, those with worse PMR symptoms and worse mental health were more likely to report a negative effect of PMR on their relationships. The proportion of people reporting a problem reduced over time, as people’s PMR symptoms improved. We suggest that doctors should consider people’s intimate and sexual relationships as part of their care for people with PMR.

Background/Aims Polymyalgia rheumatica (PMR) is a common inflammatory rheumatological condition in older adults, characterised by pain and stiffness in the shoulder and hip girdles. The mainstay of treatment is oral glucocorticoids (GCs). Classically, treatment is tapered to a stop over two years, but there is growing evidence this does not happen in practice. International guidelines recommend early referral to specialist services for patients at risk of prolonged treatment. However, they do not specify who these patients are. This study considers the factors at, and shortly after, diagnosis that might be associated with prolonged glucocorticoid treatment, and therefore who may benefit from early specialist review. Methods 652 people with incident PMR were recruited from English general practice between 2012 and 2014. They completed up to seven questionnaires over two years and a further long-term follow-up questionnaire (LTFUQ) 4.5-6.5 years after diagnosis. The first seven questionnaires have previously been used to allocate people to pain-stiffness trajectory classes. In the LTFUQ, participants reported current symptoms and other general health and lifestyle characteristics, as well as whether they were still taking GCs and whether they self-managed their GC use. Characteristics of those having successfully stopped GCs were compared to those still taking them. Results A median 5.16 years after diagnosis, 179 people responded to the LTFUQ. Of these, 67 (40.1%) were still on GCs with a mean daily dose of 5mg (1.5, 9). Those still taking GCs were more likely to be older (72.5 vs 70.2 years, p = 0.035), to live alone (31.8% v 15.0%, p = 0.01), and to report having self-managed their GCs (39.1% versus 11.0%, p < 0.0001). They were also more likely to have reported sustained pain-stiffness symptoms in the first two years, as defined by their trajectory class in earlier work (trajectory class [n{%} still treated]; partial recovery, sustained moderate symptoms [23 {34.3%}]; recovery before worsening [17 {25.4%}]; rapid and sustained recovery [15 {22.4%}]; Slow and continuous recovery [11 {16.34%}]). Conclusion PMR is not always the typically-described, time-limited condition. There are few patient characteristics that are associated with prolonged treatment early in the disease course, but those who are older and have sustained or recurrent pain and stiffness over two years appear to be at greater risk of remaining on GCs. Whilst accurate prediction of long-term treatment need is not possible from our data, people with sustained symptoms may benefit from specialist review to ensure diagnostic accuracy and consider need for additional therapies to reduce their GC burden. Disclosure S. Muller: None. S.L. Hider: None. B. Singh Sokhal: None. S.A. Lawton: None. T. Helliwell: None. C.D. Mallen: None.

Objectives PMR is a common inflammatory condition in older adults, characterized by bilateral hip and shoulder pain and stiffness. Reducing oral glucocorticoids, classically used for ≤2 years, are the mainstay of treatment. This study considers the factors early in the disease course that might be associated with prolonged treatment. Methods Six hundred and fifty-two people with incident PMR were recruited from English general practices (2012–2014). Participants completed seven questionnaires over 2 years (used to allocate people to pain–stiffness trajectories) and a further long-term follow-up (LTFU) questionnaire a median of 5.16 years after diagnosis. Characteristics of those still taking and having ceased glucocorticoids were described and compared using Kruskal–Wallis and χ2 and Student’s 2-sample t-tests as appropriate. Results Of the 197 people completing the LTFUQ questionnaire, 179 people reported ever having taken glucocorticoids. Of these, 40.1% were still on treatment, with a median (quartile 1, quartile 3) daily dose of 5 (1.5, 9) mg. People still taking glucocorticoids were more likely to be older (72.5 vs 70.2 years, P = 0.035), live alone (31.8 vs 15.0%, P = 0.01) and have self-managed their glucocorticoid dose (39.1 vs 11.0%, P Conclusions PMR is not always a time-limited condition. Few patient characteristics are associated with prolonged treatment early in the disease course, but those who are older and who have sustained symptoms might be at greater risk. Although accurate prediction is not yet possible, clinicians should monitor people with PMR carefully to manage symptoms and reduce the cumulative glucocorticoid dose.

Background Multimorbidity is increasingly the norm; however, primary care remains focused on single diseases. Osteoarthritis, anxiety, and depression are frequently comorbid with other long-term conditions (LTCs), but rarely prioritized by clinicians. Objectives To test the feasibility of a randomized controlled trial (RCT) of an intervention integrating case-finding and management for osteoarthritis, anxiety, and depression within LTC reviews. Methods A pilot stepped-wedge RCT across 4 general practices recruited patients aged ≥45 years attending routine LTC reviews. General practice nurses provided usual LTC reviews (control period), then, following training, delivered the ENHANCE LTC review (intervention period). Questionnaires, an ENHANCE EMIS-embedded template and consultation audio-recordings, were used in the evaluation. Results General practice recruitment and training attendance reached prespecified success criteria. Three hundred and eighteen of 466 (68%) of patients invited responded; however, more patients were recruited during the control period (206 control, 112 intervention). Eighty-two percent and 78% returned their 6-week and 6-month questionnaires, respectively. Integration of the ENHANCE LTC review into routine LTC reviews varied. Case-finding questions were generally used as intended for joint pain, but to a lesser extent for anxiety and depression. Initial management through referrals and signposting were lacking, and advice was more frequently provided for joint pain. The stepped-wedge design meant timing of the training was challenging and yielded differential recruitment. Conclusion This pilot trial suggests that it is feasible to deliver a fully powered trial in primary care. Areas to optimize include improving the training and reconsidering the stepped-wedge design and the approach to recruitment by targeting those with greatest need. Trial registration ISRCTN registry (ISRCTN: 12154418). Date registered: 6 August 15. Date first participant was enrolled: 13 July 2015. https://www.isrctn.com/ISRCTN12154418?q=depression%20schizophrenia&filters=conditionCategory:Not%20Applicable&sort=&offset=5&totalResults=9&page=1&pageSize=20&searchType=basic-search.

Background Plantar heel pain (PHP) is common and impacts negatively on physical function and quality of life. Initial treatment usually comprises analgesia and self-management advice (SMA), with referral to a physiotherapist or podiatrist recommended only when symptoms persist. Systematic reviews highlight limitations of existing evidence for the effectiveness of exercises and orthoses. The objective of the TREADON pilot and feasibility trial was to inform the design of a future main trial to compare the clinical and cost-effectiveness of self-management advice (SMA), individualised exercises and foot orthoses for PHP. Methods This was a four-arm randomised feasibility and pilot trial with 12-week follow-up. Adults aged ≥ 18 years with PHP were identified from primary care by general practice consultation, retrospective general practice medical record review or a population survey. Participants were randomised to either (i) SMA, (ii) SMA plus individualised exercises (SMA-exercises), (iii) SMA plus prefabricated foot orthoses (SMA-orthoses) or (iv) SMA plus combined individualised exercises and prefabricated foot orthoses (SMA-combined). Feasibility outcomes were recruitment; retention; intervention adherence, credibility and satisfaction; performance of three potential primary outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Foot Pain and Disability Index-pain subscale (MFPDI-pain)); and parameters for informing the main trial sample size calculation. Results Eighty-two participants were recruited. All three identification methods met the target number of participants. Retention at 12 weeks was 67%. All interventions were successfully delivered as per protocol. Adherence (range over 12 weeks 64–100%) and credibility (93%) were highest in the SMA-combined arm. Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%). Responsiveness (baseline to 12 weeks) was higher for FFI-pain (standardised response mean 0.96) and pain NRS (1.04) than MFPDI-pain (0.57). Conservative sample size parameter estimates for standard deviation were pain NRS 2.5, FFI-pain 25 and MFPDI-pain 4, and baseline-outcome correlations were 0.5–0.6, 0.4 and Conclusions We demonstrated the feasibility of conducting a future main randomised clinical trial comparing the clinical and cost-effectiveness of SMA, exercises and/or foot orthoses for PHP. Trial registration number ISRCTN 12160508. Prospectively registered 5th July 2016.

BackgroundBrace 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 analysisA 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 disseminationNorth 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 numberISRCTN28555470.

Atrial fibrillation (AF) is associated with an increased risk of stroke, enhanced stroke severity, and other comorbidities. However, AF is often asymptomatic, and frequently remains undiagnosed until complications occur. Current screening approaches for AF lack either cost-effectiveness or diagnostic sensitivity; thus, there is interest in tools that could be used for population screening. An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF. Therefore, the aim of the trial is to assess the effectiveness of this risk prediction algorithm combined with diagnostic testing for the identification of AF in a real-world primary care setting. Eligible participants (aged ≥30 years and without an existing AF diagnosis) registered at participating UK general practices will be randomised into intervention and control arms. Intervention arm participants identified at highest risk of developing AF (algorithm risk score ≥ 7.4%) will be invited for a 12‑lead electrocardiogram (ECG) followed by two-weeks of home-based ECG monitoring with a KardiaMobile device. Control arm participants will be used for comparison and will be managed routinely. The primary outcome is the number of AF diagnoses in the intervention arm compared with the control arm during the research window. If the trial is successful, there is potential for the risk prediction algorithm to be implemented throughout primary care for narrowing the population considered at highest risk for AF who could benefit from more intensive screening for AF. Trial Registration: NCT04045639.

Background Gout affects 2.5% of adults in the UK but is often poorly managed. It can impair health-related quality of life (HRQOL), yet little is known about which people with gout are at risk of worse outcomes. We investigated factors associated with change in HRQOL over a three-year period in people living with gout in primary care. Methods People with gout registered with 20 general practices in the West Midlands completed the Gout Impact Scale (GIS), Short-Form-36 Physical Function subscale (PF10) and health assessment questionnaire disability index (HAQ-DI) at five time-points (baseline & 6, 12, 24 and 36 months) via postal questionnaire. Linear mixed modelling (LMM) with multivariate adjustment for baseline and time-varying covariates was used to investigate gout-specific, comorbid and socio-demographic factors associated with change in the Concern Overall (GIS-CO), PF10 and HAQ-DI over three years. Higher scores are worse for GIS-CO and HAQ-DI, but better for PF10. Results Of 1,184 baseline respondents, 818 (80%), 721 (73%), 696 (75%), 605 (68%) responded at 6, 12, 24 and 36 months respectively. Mean age (SD) at baseline was 65.6 (12.5) years. 990 (84%) were male, 494 (42%) reported >2 gout flares in the previous year, 624 (54%) were taking allopurinol and 318 (27%) had an eGFR Conclusion Gout-specific, comorbid and socio-demographic factors associated with change in HRQOL over a three-year period in people living with gout in primary care were identified, highlighting people at risk of worse outcomes over three years and at greatest need of urate-lowering therapy and other targeted interventions. Disclosures L. Watson None. J. Belcher None. E. Nicholls None. P. Chandratre None. M. Blagojevic-Bucknall None. S. Hider None. S.A. Lawton None. C.D. Mallen None. S. Muller None. K. Rome None. E. Roddy None.

Objectives To investigate potential subgroups of primary care–diagnosed patients with PMR based on self-reported pain and stiffness severity over time. Methods A total of 652 people with an incident PMR diagnosis were recruited from English general practices and completed a baseline postal questionnaire. They were followed up with a further six questionnaires over a 2 year period. A total of 446 people completed the 2 year follow-up. Pain and stiffness were reported on a 0–10 numerical rating scale. Latent class growth analysis was used to estimate the joint trajectories of pain and stiffness over time. A combination of statistical and clinical considerations was used to choose the number of clusters. Characteristics of the classes were described. Results Five clusters were identified. One cluster represented the profile of ‘classical’ PMR symptoms and one represented sustained symptoms that may not be PMR. The other three clusters displayed a partial recovery, a recovery followed by worsening and a slow, but sustained recovery. Those displaying classical PMR symptoms were in better overall health at diagnosis than the other groups. Conclusion PMR is a heterogeneous condition, with a number of phenotypes. The spectrum of presentation, as well as varying responses to treatment, may be related to underlying health status at diagnosis. Future research should seek to stratify patients at diagnosis to identify those likely to have a poor recovery and in need of an alternative treatment pathway. Clinicians should be aware of the different experiences of patients and monitor symptoms closely, even where there is initial improvement.

BackgroundPolymyalgia rheumatica (PMR) is one of the most common inflammatory arthritic disorders seen in older individuals. Most patients with PMR are diagnosed and managed exclusively in general practice, yet primary care-focused research is lacking.AimTo identify and explore the challenges of diagnosis and management of PMR in general practice.Design and settingA multi-methods study in UK primary care.MethodThe multi-methods study comprised two complementary studies: a national questionnaire survey of 5000 randomly selected GPs from across the UK; and a qualitative semi-structured telephone interview study of UK GPs. Simple descriptive statistics were used to analyse questionnaire data. A thematic approach was used to analyse verbatim transcripts of the GP interviews.ResultsIn total, 1249 (25%) GPs responded to the questionnaire survey. From this total, 24 GPs were interviewed for the qualitative study. Features used by GPs to identify PMR were largely in line with current guidance. Diagnosis was found to be challenging, with GPs relying heavily on response to treatment with glucocorticoids. Investigations advised by current British PMR guidance to attempt to rule out other causes for symptoms were not routinely requested. Concerns surrounding ongoing treatment with glucocorticoids were widespread in relation to both potential adverse effects and ongoing monitoring.ConclusionFocused strategies to investigate and therefore exclude non-PMR differential diagnoses are required for patients with new-onset suspected PMR symptoms. Additionally, ongoing active review for alternative causes for symptoms as well as vigilance for treatment complications needs to be implemented.

Background Long-term conditions (LTCs) are important determinants of quality of life and healthcare expenditure worldwide. Whilst multimorbidity is increasingly the norm in primary care, clinical guidelines and the delivery of care remain focused on single diseases, resulting in poorer clinical outcomes. Osteoarthritis, and anxiety and/or depression frequently co-occur with other LTCs, yet are seldom prioritized by the patient or clinician, resulting in higher levels of disability, poorer prognosis, and increased healthcare costs. Objective To examine the feasibility and acceptability of an integrated approach to LTC management, tackling the under-diagnosis and under-management of osteoarthritis-related pain and anxiety and/or depression in older adults with other LTCs in primary care. Design The ENHANCE study is a pilot stepped-wedge cluster randomized controlled trial to test the feasibility and acceptability of a nurse-led ENAHNCE LTC review consultation for identifying, assessing, and managing joint pain, and anxiety and/or depression in patients attending LTC reviews. Specific objectives (process evaluation and research outcomes) will be achieved through a theoretically informed mixed-methods approach using participant self-reported questionnaires, a medical record review, an ENHANCE EMIS template, qualitative interviews, and audio recordings of the ENHANCE LTC review. Discussion Success of the pilot trial will be measured against the level of the primary care team engagement, assessment of training delivery, and degree of patient recruitment and retention. Patient satisfaction and treatment fidelity will also be explored. ISRCTN registry number: 12154418.

Musculoskeletal pain is a common cause of work absence and early intervention is advocated to prevent the adverse health and economic consequences of longer-term absence. This cluster randomised controlled trial investigated the effect of introducing a vocational advice service, into primary care to provide occupational support. Six general practices were randomised, patients were eligible if they were consulting their general practitioner (GP) with musculoskeletal pain, were employed and struggling at work or absent from work

Background Co-morbid osteoarthritis (OA), anxiety and depression are undermanaged in primary care yet have significant impact on pain, disability and outcomes of other long-term conditions (LTCs). Objectives To test the feasibility and acceptability of integrating case-finding and initial management for OA, anxiety and depression within extended primary care practice nurse (PN)-led LTC review consultations. Methods A stepped wedge pilot trial with process evaluation. PNs gave a study pack to patients age ≥45 years attending routine LTC reviews (asthma, COPD, hypertension, ischaemic heart disease, diabetes). The intervention included case finding questions (Generalized Anxiety Disorder (GAD2), Whooley 2-item depression, diagnosing OA clinically (hands, hips, knees or feet)) followed by further assessments (anxiety (GAD7), depression (PHQ9), joint examination). PNs completed an electronic patient record and initiated management. Pre-determined success criteria were to recruit 4 practices; deliver training to 2 PNs per practice, recruit 50% of those invited, ensure 75% follow up (6 week, 6 month), and the satisfaction (GPAQ) of intervention patients to be at least as acceptable as that of control patients. 24 audio recorded consultations provided insight into fidelity of intervention delivery. Results Four practices were recruited. PNs were sequentially trained in practice prior to switching to intervention. Of the 474 people invited, 319 responded (207 control, 112 intervention) (67%). 83% and 79% of participants returned 6 week and 6 month questionnaires respectively. Demographic characteristics, general health, pain intensity, anxiety and depression scores were similar across arms. Overall, self-reported health (EQ5D5L) was high (median 0.84; IQR 0.72, 0.94). 14% of participants reported moderate to severe depression (PHQ9). Median GPAQ scores were similar (control 1.00 (IQR: 1.00, 1.29), intervention 1.00 (IQR: 1.00, 1.14)). 96% of those in the intervention arm reported being asked about joint pain, 93% reported being asked about mood. Audio recordings revealed that case finding questions were used as intended in most consultations (joint pain 20/24 consultations, anxiety 15/24, depression 6/24). One referral to physiotherapy and none to primary care mental health services were recorded by the PNs. Conclusions Recruitment and follow up were good. However, to target those who may benefit from the intervention, changes to the target population and eligibility criteria are required. There was reasonable delivery of the case finding questions, but limited referral and signposting, highlighting areas to optimise ahead of a main trial. Acknowledgements ELH, CJ, CCG, ALE and CDM are part funded by NIHR Collaborations for Leadership in Applied Health Research and Care West Midlands. CDM is funded by NIHR School for Primary Care Research, NIHR Research Professorship in General Practice (NIHR-RP-2014–04–026). KSD is part-funded by an NIHR Knowledge Mobilisation Research Fellowship (KMRF-2014–03–002). Views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health. Disclosure of Interest None declared

BACKGROUND: The aim was to characterise the sociodemographic, general health and polymyalgia rheumatica (PMR)-specific features of participants in a large inception cohort of patients with PMR diagnosed in UK primary care. METHODS: Patients (n = 739) with a new diagnosis of PMR were referred into the study and mailed a questionnaire detailing their general health and sociodemographic characteristics in addition to the symptoms of and treatment for PMR. Characteristics of responders and non-responders were compared and descriptive statistics were used to characterise the health of the cohort. RESULTS: A total of 654 individuals responded to the questionnaire (adjusted response 90.1 %). Responders and non-responders were similar in age, gender and deprivation (based on postcode). The mean (standard deviation) age of the recruited cohort was 72.4 (9.3) years; 62.2 % were female. The sample reported high levels of pain and stiffness (8 out of 10 on numerical rating scales) and reported stiffness that lasted throughout the day. High levels of functional impairment, fatigue, insomnia and polypharmacy were also reported. Overall, women reported worse general and PMR-specific health than did men. CONCLUSIONS: This first primary care cohort of patients with incident PMR is similar in demographic terms to cohorts recruited in secondary care. However, the extent of symptoms, particularly reported stiffness, is higher than has been described previously. Given the majority of patients with PMR are exclusively managed in primary care, this cohort provides important information on the course of PMR in the community that will help clinicians managing this painful and disabling condition.

Background\ud Recruiting patients to research and collecting study data in a primary care setting, combined with maximising retention rates from a primary care population can be challenging and requires recruitment and retention methods which are innovative, efficient and transferrable.\ud \ud Objective\ud To apply low resource intensive and rapidly implemented recruitment and retention innovations for use in primary care settings that ensure patient recruitment and follow-up targets are achieved.\ud \ud Methods\ud A range of innovative recruitment and retention strategies are utilised by Keele CTU including; electronic aide-memoires linked to Read codes; physical aide-memoire prompts in consulting rooms; automated referral methods; postcard, repeat, email, SMS and minimum data collection reminder mailings; death and departure auditing.\ud \ud Results\ud Methods used; sustain routine care whilst simultaneously screening for research data and participants; provide flexible instruments compatible with all general practice infrastructures; increase clinical precision in identifying suitable participants; automates recording of study data collection; ensures minimal impact on consultation time; contribute towards the delivery of excellent retention rates.\ud \ud Conclusions\ud Recruitment aide-memoires, automated innovations and retention strategies can all be embedded easily into a primary care setting. These tools, without over burdening the busy primary care practitioner, result in simple and effective methods of prompting patient recruitment and retention. Excellent recruitment and retention rates are possible, despite encountering differences in primary care infrastructure. Such methods should be utilised more widely to facilitate primary care research, if this is where many conditions are diagnosed and managed.

Background\ud Musculoskeletal pain is a major contributor to short and long term work absence. Patients\ud seek care from their general practitioner (GP) and yet GPs often feel ill-equipped to deal with\ud work issues. Providing a vocational case management service in primary care, to support\ud patients with musculoskeletal problems to remain at or return to work, is one potential\ud solution but requires robust evaluation to test clinical and cost-effectiveness.\ud Methods/Design\ud This protocol describes a cluster randomised controlled trial, with linked qualitative\ud interviews, to investigate the effect of introducing a vocational advice service into general\ud practice, to provide a structured approach to managing work related issues in primary care\ud patients with musculoskeletal pain who are absent from work or struggling to remain in work.\ud General practices (n = 6) will be randomised to offer best current care or best current care\ud plus a vocational advice service. Adults of working age who are absent from or struggling to\ud remain in work due to a musculoskeletal pain problem will be invited to participate and 330\ud participants will be recruited. Data collection will be through patient completed\ud questionnaires at baseline, 4 and 12 months. The primary outcome is self-reported work\ud absence at 4 months. Incremental cost-utility analysis will be undertaken to calculate the cost\ud per additional QALY gained and incremental net benefits. A linked interview study will\ud explore the experiences of the vocational advice service from the perspectives of GPs, nurse\ud practitioners (NPs), patients and vocational advisors.\ud Discussion\ud This paper presents the rationale, design, and methods of the Study of Work And Pain\ud (SWAP) trial. The results of this trial will provide evidence to inform primary care practice\ud and guide the development of services to provide support for musculoskeletal pain patients\ud with work-related issues.\ud Trial registration\ud Current Controlled Trials ISRCTN52269669.