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Abstract Background Polymyalgia Rheumatica (PMR) is the commonest inflammatory condition seen in older patients in primary care. To date, however, research has been focused on secondary care cohorts rather than primary care where many patients are exclusively managed. This two year prospective inception cohort study of PMR patients will enable us to understand the full spectrum of this condition. Methods Patients diagnosed with PMR in primary care will be identified via Read codes and mailed a series of postal questionnaires over a two-year period to assess their levels of pain, stiffness and functioning, as well as medication usage and other health-related and socio-demographic characteristics. In addition, participants will be asked for permission to link their survey data to their general practice electronic medical record and to national mortality and cancer registers. Discussion This will be the first large-scale, prospective, observational cohort of PMR patients in primary care. The combination of survey data with medical records and national registers will allow for a full investigation of the natural history and prognosis of this condition in the primary care setting, in which the majority of patients are treated, but where little research on the treatment and outcome of consultation has been undertaken. This will provide information that may lead to improved primary care management of PMR.

Abstract Background Tennis elbow is a common and often extremely painful musculoskeletal condition, which has considerable impact on individuals as well as economic implications for healthcare utilization and absence from work. Many management strategies have been studied in clinical trials. Whilst corticosteroid injections offer short term pain relief, this treatment is unpleasant and is used with caution due to an associated high risk of pain recurrence in the long term. Systematic reviews conclude that there is no clear and effective treatment for symptoms of pain in the first 6 weeks of the condition. There is a clear need for an intervention that is acceptable to patients and provides them with effective short-term pain relief without increasing the risk of recurrence. Transcutaneous electrical nerve stimulation (TENS) is an inexpensive, non-invasive, non-pharmacological form of analgesia that is commonly used in the treatment of pain. TENS has very few contraindications and is simple to apply. It also benefits from being patient controlled, thereby promoting self-management. This study aims to assess the effectiveness, in terms of pain relief, and cost-effectiveness of a self-management package of treatment that includes TENS. Methods/Design The design of the study will be a two-group pragmatic randomized clinical trial. 240 participants aged 18 years and over with tennis elbow will be recruited from 20-30 GP practices in Staffordshire, UK. Participants are to be randomized on a 1:1 basis to receive either primary care management (standard GP consultation, medication, advice and education) or primary care management with the addition of TENS, over 6 weeks. Our primary outcome measure is average intensity of elbow pain in the past 24 hours (0-10 point numerical rating scale) at 6 weeks. Secondary outcomes include pain and limitation of function, global assessment of change, days of sick leave, illness perceptions, and overall health status. A cost-effectiveness analysis will also be performed. Patient adherence and satisfaction data will be collected at 6 weeks, 6 months and 12 months by postal questionnaire. A diary will also be completed for the first 2 weeks of treatment. Clinical effectiveness and cost-effectiveness analyses will be carried out using an intention-to-treat approach as the primary analysis. Discussion This paper presents detail on the rationale, design, methods and operational aspects of the trial. Trial registration Current Controlled Trials. ISRCTN87141084

Abstract Background Musculoskeletal conditions represent a common reason for consulting general practice yet with the exception of low back pain, relatively little is known about the prognosis of these disorders. Recent evidence suggests that common 'generic' factors may be of value when assessing prognosis, irrespective of the location of the pain. This study will test a generic assessment tool used as part of the general practice consultation to determine prognosis of musculoskeletal complaints. Methods/Design Older adults (aged 50 years and over) presenting to six general practices with musculoskeletal complaints will be assessed as part of the routine consultation using a generic assessment of prognosis. Participants will receive a self-completion questionnaire at baseline, three, six and 12 months post consultation to gather further data on pain, disability and psychological status. The primary outcome measure is participant's global rating of change. Discussion Prognosis is considered to be a fundamental component of scientific medicine yet prognostic research in primary care settings is currently neglected and prognostic enquiry is disappearing from general medical textbooks. This study aims to address this issue by examining the use of generic prognostic factors in a general practice setting.

Objective To examine the association between obesity and patient-reported outcome measures (PROMs) in a primary care-based cohort of people with PMR. Methods The PMR Cohort Study recruited people with incident PMR from 382 general practices. Self-completed questionnaires (0, 12, 24 months) captured a range of PROMs for pain, stiffness, anxiety, depression, fatigue, function and quality of life, alongside data on BMI. People were categorized as underweight/normal weight (BMI < 25kg/m2), overweight (25–29.99 kg/m2) or obese (≥30 kg/m2). Piecewise, multilevel, linear mixed-effects regression models examined relationships between BMI categories and PROMs over time, adjusting for confounding variables. Chi-squared tests examined the relationship between obesity and glucocorticoid persistence. Results 644 people with PMR were included. At baseline, 33.9% were normal/underweight, 40.6% overweight and 25.5% obese. Compared with normal/underweight people, those with obesity had significantly worse scores for the following: pain and stiffness at 12 months; fatigue at 12 and 24 months; depression at baseline; physical function at all time points; and quality of life at baseline and 12 months. They also had significantly smaller improvements in stiffness (1.13 units on an 11-point numeric rating scale; P  =   0.001) and physical function (0.14 units measured using the modified Health Assessment Questionnaire; P  =   0.025) between 0 and 12 months. BMI categories did not relate to persistent glucocorticoid use at 12 months (P  =   0.110) or 24 months (P  =   0.166). Conclusion Obesity associates with poorer outcomes for a range of PROMs in people with PMR. Consideration should be given to providing weight management support to people with PMR and obesity. [ABSTRACT FROM AUTHOR]

Introduction: Regular review of patients prescribed opioids for persistent non-cancer pain (PCNP) is recommended but not routinely undertaken. The PROMPPT (P roactive clinical R eview of patients taking O pioid M edicines long-term for persistent P ain led by clinical P harmacists in primary care T eams) research programme aims to develop and test a pharmacist-led pain review (PROMPPT) to reduce inappropriate opioid use for persistent pain in primary care. This study explored the acceptability of the proposed PROMPPT review to inform early intervention development. Methods: Interviews (n = 15) and an online discussion forum (n = 31) with patients prescribed opioids for PCNP and interviews with pharmacists (n = 13), explored acceptability of a proposed PROMPPT review. A prototype PROMPPT review was then tested and refined through 3 iterative cycles of in-practice testing (IPT) (n = 3 practices, n = 3 practice pharmacists, n = 13 patients). Drawing on the Theoretical Framework of Acceptability (TFA), a framework was generated (including a priori TFA constructs) allowing for deductive and inductive thematic analysis to identify aspects of prospective and experienced acceptability. Results: Patients felt uncertain about practice pharmacists delivering the proposed PROMPPT review leading to development of content for the invitation letter for IPT (introducing the pharmacist and outlining the aim of the review). After IPT, patients felt that pharmacists were suited to the role as they were knowledgeable and qualified. Pharmacists felt that the proposed reviews would be challenging. Although challenges were experienced during delivery of PROMPPT reviews, pharmacists found that they became easier to deliver with time, practise and experience. Recommendations for optimisations after IPT included development of the training to include examples of challenging consultations. Conclusions: Uptake of new healthcare interventions is influenced by perceptions of acceptability. Exploring prospective and experienced acceptability at multiple time points during early intervention development, led to mini-optimisations of the prototype PROMPPT review ahead of a non-randomised feasibility study. [ABSTRACT FROM AUTHOR]

Objectives Despite little evidence that analgesics are effective in inflammatory arthritis (IA), studies report substantial opioid prescribing. The extent this applies to other analgesics is uncertain. We undertook a comprehensive evaluation of analgesic prescribing in patients with IA in the Clinical Practice Research Datalink Aurum to evaluate this. Methods From 2004 to 2020, cross-sectional analyses evaluated analgesic prescription annual prevalence in RA, PsA and axial spondyloarthritis (axSpA), stratified by age, sex, ethnicity, deprivation and geography. Joinpoint regression evaluated temporal prescribing trends. Cohort studies determined prognostic factors at diagnosis for chronic analgesic prescriptions using Cox proportional hazards models. Results Analgesic prescribing declined over time but remained common: 2004 and 2020 IA prescription prevalence was 84.2/100 person-years (PY) (95% CI 83.9, 84.5) and 64.5/100 PY (64.2, 64.8), respectively. In 2004, NSAIDs were most prescribed (56.1/100 PY; 55.8, 56.5), falling over time. Opioids were most prescribed in 2020 (39.0/100 PY; 38.7, 39.2). Gabapentinoid prescribing increased: 2004 prevalence 1.1/100 PY (1.0, 1.2); 2020 prevalence 9.9/100 PY (9.7, 10.0). Most opioid prescriptions were chronic (2020 prevalence 23.4/100 PY [23.2, 23.6]). Non-NSAID analgesic prescribing was commoner in RA, older people, females and deprived areas/northern England. Conversely, NSAID prescribing was commoner in axSpA/males, varying little by deprivation/geography. Peri-diagnosis was high-risk for starting chronic opioid/NSAID prescriptions. Prognostic factors for chronic opioid/gabapentinoid and NSAID prescriptions differed, with NSAIDs having no consistently significant association with deprivation (unlike opioids/gabapentinoids). Conclusion IA analgesic prescribing of all classes is widespread. This is neither evidence-based nor in line with guidelines. Peri-diagnosis is an opportune moment to reduce chronic analgesic prescribing. [ABSTRACT FROM AUTHOR]

Objectives To examine the cross-sectional association between health literacy and gout characteristics. Methods In a primary care cohort of adults living with gout, the prevalence of poor health literacy was defined using the Single-Item Literacy Screener (SILS). Multiple logistic regression was used to obtain adjusted odds ratios (ORs) for the cross-sectional associations between health literacy and individual gout characteristics (frequency of flares, age at gout onset, history of oligo-/polyarticular flares, allopurinol use, allopurinol dose and serum urate level) with 95% CIs and adjustment for age, sex, deprivation and further education. Results Of 551 participants [mean age 54.4 years (s. d. 11.2), 498 (90.4%) male], 163 (30.1%) reported two or more flares in the previous 12 months. Fifty-one (9.4%) had poor health literacy. Poor health literacy was associated with having two or more flares in the preceding 12 months [adjusted OR 4.10 (95% CI 2.04, 8.19)] and a history of oligo-/polyarticular flares [OR 1.93 (95% CI 1.06, 3.55)]. No associations were identified between health literacy and age at gout onset [OR 0.99 (95% CI 0.96, 1.01)], allopurinol use [OR 0.88 (95% CI 0.46, 1.65)] or dose [OR 1.00 OR (95% CI 1.00, 1.00)] or serum urate [most recent serum urate OR 1.0 (95% CI 1.00, 1.00)]. Conclusions Frequent flares and a history of oligo-/polyarticular flares were associated with poor health literacy. Since health literacy is an important determinant of health outcomes, it is important to consider health literacy when providing information and education to people with gout. [ABSTRACT FROM AUTHOR]

Background There is no evidence base to support the use of 6-monthly monitoring blood tests for the early detection of liver, blood and renal toxicity during established anti-tumour necrosis factor alpha (TNFα) treatment. Objectives To evaluate the incidence and risk factors of anti-TNFα treatment cessation owing to liver, blood and renal side-effects, and to estimate the cost-effectiveness of alternate intervals between monitoring blood tests. Methods A secondary care-based retrospective cohort study was performed. Data from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR) were used. Patients with at least moderate psoriasis prescribed their first anti-TNFα treatment were included. Treatment discontinuation due to a monitoring blood test abnormality was the primary outcome. Patients were followed-up from start of treatment to the outcome of interest, drug discontinuation, death, 31 July 2021 or up to 5 years, whichever came first. The incidence rate (IR) and 95% confidence intervals (CIs) of anti-TNFα discontinuation with monitoring blood test abnormality was calculated. Multivariate Cox regression was used to examine the association between risk factors and outcome. A mathematical model evaluated costs and quality-adjusted life years (QALYs) associated with increasing the length of time between monitoring blood tests during anti-TNFα treatment. Results The cohort included 8819 participants [3710 (42.1%) female, mean (SD) age 44.76 (13.20) years] that contributed 25 058 person-years (PY) of follow-up and experienced 125 treatment discontinuations owing to a monitoring blood test abnormality at an IR of 5.85 (95% CI 4.91–6.97)/1000 PY. Of these, 64 and 61 discontinuations occurred within the first year and after the first year of treatment start, at IRs of 8.62 (95% CI 6.74–11.01) and 3.44 (95% CI 2.67–4.42)/1000 PY, respectively. Increasing age (in years), diabetes and liver disease were associated with anti-TNFα discontinuation after a monitoring blood test abnormality [adjusted hazard ratios of 1.02 (95% CI 1.01–1.04), 1.68 (95% CI 1.00–2.81) and 2.27 (95% CI 1.26–4.07), respectively]. Assuming a threshold of £20 000 per QALY gained, no monitoring was most cost-effective, but all extended periods were cost-effective vs. 3- or 6-monthly monitoring. Conclusions Anti-TNFα drugs were uncommonly discontinued owing to abnormal monitoring blood tests after the first year of treatment. Extending the duration between monitoring blood tests was cost-effective. Our results produce evidence for specialist society guidance to reduce patient monitoring burden and healthcare costs. [ABSTRACT FROM AUTHOR]