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This study analyzed the characteristics, management, and outcomes of patients with poly- myalgia rheumatica (PMR) hospitalized with acute myocardial infarction (AMI), including sensitivity analysis for presence of giant cell arteritis (GCA). Using the National Inpatient Sample (January 2004 to September 2015) and International Classification of Diseases, Ninth Revision, all AMI hospitalizations were stratified into main groups: PMR and no-PMR ; and subsequently, PMR, PMR with GCA, and GCA and no-PMR. Outcomes were all- cause mortality, major adverse cardiovascular/cerebrovascular events (MACCEs), major bleeding, and ischemic stroke as well as coronary angiography (CA) and percutaneous coronary intervention (PCI). Multivariable logistic regression was used to determine adjusted odds ratios with 95% confidence interval (95% CI). A total of 7, 622, 043 AMI hospitalizations were identified, including 22, 597 patients with PMR (0.3%) and 5, 405 patients with GCA (0.1%). Patients with PMR had higher rates of mortality (5.8% vs 5.4%, p = 0.013), MACCEs (10.2% vs 9.2%, p

Background The safety and immunogenicity profile of COVID-19 vaccines when administered concomitantly with seasonal influenza vaccines have not yet been reported. We therefore aimed to report the results of a substudy within a phase 3 UK trial, by evaluating the safety, immunogenicity, and efficacy of NVX-CoV2373 when co-administered with licensed seasonal influenza vaccines. Methods We did a planned exploratory substudy as part of the randomised, observer-blinded, placebo-controlled, phase 3 trial of the safety and efficacy of the COVID-19 vaccine (NVX-CoV2373) by co-administrating the influenza vaccine at four study hospitals in the UK. Approximately, the first 400 participants meeting the main study entry criteria—with no contraindications to influenza vaccination—were invited to join the substudy. Participants of the main study were randomly assigned (1:1) to receive two intramuscular injections of either NVX-CoV2373 (5 μg) or placebo (normal saline) 21 days apart; participants enrolled into the substudy were co-vaccinated with a single (0·5 mL) intramuscular, age-appropriate (quadrivalent influenza cell-based vaccine [Flucelvax Quadrivalent; Seqirus UK, Maidenhead] for those aged 18–64 years and adjuvanted trivalent influenza vaccine [Fluad; Seqirus UK, Maidenhead] for those ≥65 years), licensed, influenza vaccine on the opposite deltoid to that of the first study vaccine dose or placebo. The influenza vaccine was administered in an open-label manner and at the same time as the first study injection. Reactogenicity was evaluated via an electronic diary for 7 days after vaccination in addition to monitoring for unsolicited adverse events, medically attended adverse events, and serious adverse events. Immunogenicity was assessed with influenza haemagglutination inhibition and SARS-CoV-2 anti-spike protein IgG assays. Vaccine efficacy against PCR-confirmed, symptomatic COVID-19 was assessed in participants who were seronegative at baseline, received both doses of study vaccine or placebo, had no major protocol deviations affecting the primary endpoint, and had no confirmed cases of symptomatic COVID-19 from the first dose until 6 days after the second dose (per-protocol efficacy population). Immunogenicity was assessed in participants who received scheduled two doses of study vaccine, had a baseline sample and at least one post-vaccination sample, and had no major protocol violations before unmasking (per-protocol immunogenicity population). Reactogenicity was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo and had data collected for reactogenicity events. Safety was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo. Comparisons were made between participants of the substudy and the main study (who were not co-vaccinated for influenza). This study is registered with ClinicalTrials.gov, number NCT04583995. Findings Between Sept 28, 2020, and Nov 28, 2020, a total of 15 187 participants were randomised into the main phase 3 trial, of whom 15 139 received treatment (7569 received dose one of NVX-CoV2373 and 7570 received dose one of placebo). 431 participants were co-vaccinated with a seasonal influenza vaccine in the substudy (217 received NVX-CoV2373 plus the influenza vaccine and 214 received placebo plus the influenza vaccine). In general, the substudy participants were younger, more racially diverse, and had fewer comorbid conditions than those in the main study. Reactogenicity events were more common in the co-administration group than in the NVX-CoV2373 alone group: tenderness (113 [64·9%] of 174 vs 592 [53·3%] of 1111) or pain (69 [39·7%] vs 325 [29·3%]) at injection site, fatigue (48 [27·7%] vs 215 [19·4%]), and muscle pain (49 [28·3%] vs 237 [21·4%]). Incidences of unsolicited adverse events, treatment-related medically attended adverse events, and serious adverse events were low and balanced between the co-administration group and the NVX-CoV2373 alone group. No episodes of anaphylaxis or deaths were reported within the substudy. Co-administration resulted in no change to influenza vaccine immune response although a reduction in antibody responses to the NVX-CoV2373 vaccine was noted. NVX-CoV2373 vaccine efficacy in the substudy (ie, participants aged 18 to

Background/Aims Giant cell arteritis (GCA) is considered a medical emergency, and relapses are common, affecting around 50% of patients. Many of the early symptoms of GCA are non-specific and highly prevalent in older people, making the diagnosis challenging. The Clinical Practice Research Datalink (CPRD) is a large primary care database that provides the opportunity to study large numbers of people with GCA. General practitioners commonly identify suspected GCA and refer patients to secondary care for specialist evaluation and diagnostic confirmation. We sought to understand how primary and secondary care records correspond. Methods A retrospective observational study was undertaken using data from 2003 to 2020 by linking CPRD Aurum to Hospital Episode Statistics (HES) Admitted Patient Care (APC) and Outpatient (OP) data. We included all permanently registered patients aged 50 years and over in CPRD Aurum who could be linked to HES datasets. We identified individuals with a SNOMED code for GCA in CPRD Aurum and compared them to a list of patients who received an ICD-10 code for GCA in HES APC and OP datasets. We then restricted our comparison to the time-periods 90 and 180 days before or after the first record of GCA in the CPRD Aurum dataset (index code). Results We identified 18,806 individuals with a SNOMED code for GCA in the CPRD Aurum dataset between 2003 and 2020. 9755 (51.87%) of these individuals also received at least one secondary care code for GCA in the HES APC and OP data. 3914 (20.86%) and 4573 (24.37%) individuals received at least one secondary care code for GCA within 90 and 180 days, respectively, of the index primary care code. 7520 (58.96%) of those with two codes in primary care also had at least one code in secondary care, and 6090 (61.09%) of those with three codes. Conclusion Approximately one-half of individuals with an index code in primary care had a secondary care code for GCA. However, less than a quarter of patients had secondary care codes within 90 and 180 days of their index code in primary care. Given that it is unlikely that coding in either primary or secondary care is inaccurate, we conclude that this method of comparing GCA diagnoses is not a suitable approach to assess the accuracy of primary care coding. Further research could explore alternative approaches to understanding the quality of the coding of GCA in primary and secondary care data. Disclosure N. Padmanabhan: Other; NP is an NIHR Academic Clinical Fellow. S. Muller: Other; SM is part-funded by the NIHR Applied Research Collaboration West Midlands (ARC WM). J. Bailey: None. T. Helliwell: None. S.L. Mackie: Consultancies; SLM has provided consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie and AstraZeneca. Other; SLM has given talks on behalf of her institution for Pfizer, Vifor and UCB. In all cases fees were paid to her institution and no personal fees were received, SLM was supported by Roche to attend EULAR2019 and by Pfizer to attend ACR2021 virtually, SLM has been an investigator on clinical trials for Sanofi and GSK. As a research grant co-applicant, SLM has received research funding (partial salary support) from Vifor, paid to her institution. C.D. Mallen: Other; CDM is funded by the NIHR School for Primary Care Research and the NIHR Applied Research Collaboration West Midlands (ARC WM). E. Roddy: None.

Objectives To explore current management practices for PMR by general practitioners (GPs) and rheumatologists including implications for clinical trial recruitment. Methods An English language questionnaire was constructed by a working group of rheumatologists and GPs from six countries. The questionnaire focused on: 1: Respondent characteristics; 2: Referral practices; 3: Treatment with glucocorticoids; 4: Diagnostics; 5: Comorbidities; and 6: Barriers to research. The questionnaire was distributed to rheumatologists and GPs worldwide via members of the International PMR/Giant Cell Arteritis Study Group. Results In total, 394 GPs and 937 rheumatologists responded to the survey. GPs referred a median of 25% of their suspected PMR patients for diagnosis and 50% of these were returned to their GP for management. In general, 39% of rheumatologists evaluated patients with suspected PMR >2 weeks after referral, and a median of 50% of patients had started prednisolone before rheumatologist evaluation. Direct comparison of initial treatment showed that the percentage prescribing >25 mg prednisolone daily for patients was 30% for GPs and 12% for rheumatologists. Diagnostic imaging was rarely used. More than half (56%) of rheumatologists experienced difficulties recruiting people with PMR to clinical trials. Conclusion This large international survey indicates that a large proportion of people with PMR are not referred for diagnosis, and that the proportion of treatment-naive patients declined with increasing time from referral to assessment. Strategies are needed to change referral and management of people with PMR, to improve clinical practice and facilitate recruitment to clinical trials.

ObjectivesTo investigate the usefulness of using automated appointment check-in screens to collect brief research data from patients, prior to their general practice consultation.DesignA descriptive, cross-sectional study.SettingNine general practices in the West Midlands, UK. Recruitment commenced in Autumn 2018 and was concluded by 31 March 2019.ParticipantsAll patients aged 18 years and above, self-completing an automated check-in screen prior to their general practice consultation, were invited to participate during a 3-week recruitment period.Primary and secondary outcome measuresThe response rate to the use of the automated check-in screen as a research data collection tool was the primary outcome measure. Secondary outcomes included responses to the two research questions and an assessment of impact of check-in completion on general practice operationalisationResultsOver 85% (n=9274) of patients self-completing an automated check-in screen participated in the Automated Check-in Data Collection Study (61.0% (n=5653) women, mean age 55.1 years (range 18–98 years, SD=18.5)). 96.2% (n=8922) of participants answered a ‘clinical’ research question, reporting the degree of bodily pain experienced during the past 4 weeks: 32.9% (n=2937) experienced no pain, 28.1% (n=2507) very mild or mild pain and 39.0% (n=3478) moderate, severe or very severe pain. 89.3% (n=8285) of participants answered a ‘non-clinical’ research question on contact regarding future research studies: 46.9% (n=3889) of participants responded ‘Yes, I’d be happy for you to contact me about research of relevance to me’.ConclusionsUsing automated check-in facilities to integrate research into routine general practice is a potentially useful way to collect brief research data from patients. With the COVID-19 pandemic initiating an extensive digital transformation in society, now is an ideal time to build on these opportunities and investigate alternative, innovative ways to collect research data.Trial registration numberISRCTN82531292.

BackgroundThe Valneva COVID-19 vaccine (VLA2001; Valneva Austria, Vienna, Austria) is an inactivated whole-virus, adjuvanted SARS-CoV-2 vaccine. We aimed to assess the safety and immunogenicity of primary vaccination with VLA2001 versus the ChAdOx1-S (Oxford-AstraZeneca) adenoviral-vectored vaccine.MethodsIn this immunobridging phase 3 trial (COV-COMPARE), participants aged 18 years and older who were medically stable (as determined by an investigator) were enrolled at 26 sites in the UK. In the double-blind, randomised, controlled arm of the trial, participants aged 30 years and older were randomly assigned (2:1) to receive two doses of VLA2001 (0·5 mL; with 33 antigen units [AU] per dose) or ChAdOx1-S (0·5 mL; with 2·5 × 108 infectious units per dose) on days 1 and 29. In another arm, participants aged 18–29 years received two doses of VLA2001 (same dose) open label on days 1 and 29. The primary immunogenicity outcome was the immune response of a two-dose schedule of VLA2001 on day 43, in adults aged 30 years and older, versus two doses of ChAdOx1-S via superiority of geometric mean titres (GMTs) of neutralising antibodies (GMT ratio of >1 at a two-sided significance level of 5%) and non-inferiority of the seroconversion rate (non-inferiority margin of –10% for the lower limit of the 95% CI for the difference between groups). The primary safety outcome was the frequency and severity of any adverse events in all participants up to day 43. Safety was assessed in all participants who received at least one dose of vaccine. GMTs were assessed in a subset of participants aged 30 years and older who were seronegative at baseline, had at least one evaluable antibody titre measurement after vaccination, and had no confirmed COVID-19 during the study (immunogenicity population); and seroconversion was assessed in the per-protocol population, which comprised the immunogenicity population but excluding any participants with major protocol violations. For each timepoint, only participants with available data were included in the analysis. This study is registered with ClinicalTrials.gov, NCT04864561, and is ongoing.FindingsBetween April 28 and June 3, 2021, 4181 individuals were screened and 4017 enrolled, of whom 2975 (74%) were aged 30 years or older and randomly assigned to receive VLA2001 (n=1978) or ChAdOx1-S (n=997), and 1042 (26%) were aged 18–29 years (all received open-label VLA2001). 4012 participants received at least one dose of vaccine (1040 in the open-label VLA2001 group, 1977 in the randomised VLA2001 group, and 995 in the ChAdOx1-S group). The immunogenicity population comprised 492 participants in the randomised VLA2001 group and 498 in the ChAdOx1-S group; three participants in the VLA2001 group were excluded from the per-protocol population. VLA2001 induced higher neutralising GMTs than did ChAdOx1-S (803·5 [95% CI 748·5–862·6] vs 576·6 [543·6–611·7]; GMT ratio 1·39 [95% CI 1·25–1·56]; pInterpretationVLA2001 has a favourable tolerability profile and met superiority criteria for neutralising antibodies and non-inferiority criterion for seroconversion rates compared with ChAdOx1-S. The data presented here formed the basis of successful marketing approval for use of VLA2001 in primary vaccination in the EU, the UK, Bahrain, and United Arab Emirates.

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.

BACKGROUND: The UK government reclassified gabapentin and pregabalin as ‘controlled drugs’ from April 2019. This study aimed to describe the trends in gabapentinoid prescribing before and immediately after reclassification, in the UK Clinical Practice Research Datalink, an electronic primary care health record broadly representative of the UK. METHODS: Separately for gabapentin and pregabalin, we calculated annual incident and prevalent prescribing rates from year of UK approval (April 1997 and 2004 respectively) to September 2019, and monthly incident and prevalent prescribing rates (October 2017–September 2019). Significant changes in temporal trends were determined using joinpoint regression. We also described potential prescribing indications, prior pain-related prescribing, and co-prescribing with potentially interacting medicines. FINDINGS: Incident gabapentin prescribing increased annually, peaking in 2016–17, at 625/100,000 patient years before falling steadily to 2019. Incident pregabalin prescribing peaked at 329/100,000 patient years in 2017–18 and did not fall significantly until 2019. Prevalent gabapentin and pregabalin prescribing increased annually to 2017–18 and 2018–19 respectively, before plateauing. Gabapentinoids were commonly co-prescribed with opioids (60%), antidepressants (52%), benzodiazepines (19%), and Z-drugs (10%). INTERPRETATION: Following a dramatic rise, incident gabapentinoid prescribing has started to fall but the specific impact of reclassification on prescribing rates remains unclear. Limited change in prevalent gabapentinoid prescribing during the 6 months following their reclassification as controlled drugs suggests little immediate impact on continued gabapentinoid prescribing for existing users. FUNDING: 10.13039/501100000272National Institute for Health and Care Research (NIHR) 10.13039/501100009128Research for Patient Benefit Programme. 10.13039/501100000272NIHR Applied Research Collaboration West Midlands. 10.13039/501100013374NIHR School for Primary Care Research.

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.

Summary The COVID-19 pandemic signalled a radical shift in health and social care services globally. In UK, many of the people with existing social care needs were identified as ‘clinically vulnerable’ to COVID-19. Those at greatest risk were encouraged to adhere to additional public health measures that inadvertently exacerbated social disadvantages. Social workers were challenged to ‘dig deep’ to continue to provide services as usual. However, problems implementing new ways of working were reported but not examined in-depth through research. Our study explored experiences and perceptions of social workers responding to the first wave (April–July 2020) of COVID-19, in England, UK. Interviews with thirteen social workers, all working in the West Midlands region, were conducted via telephone or online video. Transcripts were analysed using reflexive thematic analysis. We use ‘managing uncertainty’ as a central concept underpinning the four themes identified after analysis: (1) providing social care at a physical distance, (2) negotiating home/work boundaries, (3) managing emerging risks and (4) long-term implications for social work. We discuss our findings in the context of resilience and organisational adaptation. Social workers in our study demonstrated resilience in action and rapid adaptation to new practices, but equally expressed concern about short-term efficiencies being prioritised over individual service user needs., The COVID-19 pandemic signalled a dramatic shift in how health and social care services were delivered to members of the public. Social workers reported challenges implementing new ways of working during the first wave of COVID-19. However, such challenges received little coverage in the media or in research. This article explores the views and experiences of social workers responding to the first COVID-19 wave in England, UK (April–July 2020). Telephone and online interviews were carried out with thirteen social workers active in the West Midlands region. Social workers shared experiences of how they managed uncertainty—a core theme in the study. Interviewees described managing the uncertainty of: (1) providing social care at a physical distance, (2) negotiating home/work boundaries, (3) managing emerging risks and (4) contemplating the future of social work practice. Our study demonstrates how social work professionals adapted rapidly to new practices during the first wave. However, social workers raised concerns about the impact of short-term solutions on long-term needs of service users. Implications for research and practice are discussed with reference to key literature.

Evidence from the Global Burden of Disease studies suggests that osteoarthritis (OA) is a significant cause of disability globally; however, it is less clear how much of this burden exists in low-income and lower middle-income countries. This study aims to determine the prevalence of OA in people living in low-income and lower middle-income countries. Four electronic databases (MEDLINE, EMBASE, CINAHL and Web of Science) were systematically searched from inception to October 2018 for population-based studies. We included studies reporting the prevalence of OA among people aged 15 years and over in low-income and lower middle-income countries. The prevalence estimates were pooled across studies using random effects meta-analysis. Our study was registered with PROSPERO, number CRD42018112870.The search identified 7414 articles, of which 356 articles were selected for full text assessment. 34 studies were eligible and included in the systematic review and meta-analysis. The pooled prevalence of OA was 16·05% (95% confidence interval (CI) 12·55–19·89), with studies demonstrating a substantial degree of heterogeneity (I2 = 99·50%). The pooled prevalence of OA was 16.4% (CI 11·60–21.78%) in South Asia, 15.7% (CI 5·31–30·25%) in East Asia and Pacific, and 14.2% (CI 7·95–21·89%) in Sub Saharan Africa. The meta-regression analysis showed that publication year, study sample size, risk of bias score and country-income categories were significantly associated with the variations in the prevalence estimates. The prevalence of OA is high in low-income and lower middle-income countries, with almost one in six of the study participants reported to have OA. With the changing population demographics and the shift to the emergence of non-communicable diseases, targeted public health strategies are urgently needed to address this growing epidemic in the aging population. Supplementary Information The online version contains supplementary material available at 10.1007/s00296-021-04838-y.

To estimate the prevalence of burnout among primary health-care professionals in low- and middle-income countries and to identify factors associated with burnout.We systematically searched nine databases up to February 2022 to identify studies investigating burnout in primary health-care professionals in low- and middle-income countries. There were no language limitations and we included observational studies. Two independent reviewers completed screening, study selection, data extraction and quality appraisal. Random-effects meta-analysis was used to estimate overall burnout prevalence as assessed using the Maslach Burnout Inventory subscales of emotional exhaustion, depersonalization and personal accomplishment. We narratively report factors associated with burnout.The search returned 1568 articles. After selection, 60 studies from 20 countries were included in the narrative review and 31 were included in the meta-analysis. Three studies collected data during the coronavirus disease 2019 pandemic but provided limited evidence on the impact of the disease on burnout. The overall single-point prevalence of burnout ranged from 2.5% to 87.9% (43 studies). In the meta-analysis (31 studies), the pooled prevalence of a high level of emotional exhaustion was 28.1% (95% confidence interval, CI: 21.5-33.5), a high level of depersonalization was 16.4% (95% CI: 10.1-22.9) and a high level of reduced personal accomplishment was 31.9% (95% CI: 21.7-39.1).The substantial prevalence of burnout among primary health-care professionals in low- and middle-income countries has implications for patient safety, care quality and workforce planning. Further cross-sectional studies are needed to help identify evidence-based solutions, particularly in Africa and South-East Asia.Estimer la prévalence de l’épuisement professionnel (burnout) chez les professionnels des soins de santé primaires dans les pays à revenu faible ou intermédiaire et identifier les facteurs associés à l’épuisement professionnel.Nous avons effectué une recherche systématique dans neuf bases de données jusqu’en février 2022 afin d’identifier les études portant sur l’épuisement chez les professionnels des soins de santé primaires dans les pays à revenu faible ou intermédiaire. Il n’y avait aucune limitation linguistique et nous avons inclus des études observationnelles. Deux examinateurs indépendants ont effectué le screening, la sélection des études, l’extraction des données et l’évaluation de la qualité. Une méta-analyse à effets aléatoires a été utilisée pour estimer la prévalence globale de l’épuisement professionnel, évaluée à l’aide des sous-échelles d’épuisement émotionnel, de dépersonnalisation et d’accomplissement personnel du Maslach Burnout Inventory. Voici un rapport narratif des facteurs associés à l’épuisement professionnel.Nos recherches ont permis d’identifier 1568 articles. Après sélection, 60 études provenant de 20 pays ont été incluses dans l’examen narratif, et 31 ont été incluses dans la méta-analyse. Trois études ont recueilli des données pendant la pandémie de Covid-19, mais ont fourni des preuves limitées de l’impact de cette maladie sur l’épuisement professionnel. La prévalence globale à point unique de l’épuisement professionnel variait de 2,5 à 87,9% (43 études). Dans la méta-analyse (31 études), la prévalence collective d’un niveau élevé d’épuisement émotionnel était de 28,1% (intervalle de confiance (IC) à 95%: 21,5–33,5), un niveau élevé de dépersonnalisation était de 16,4% (IC à 95%: 10,1–22,9) et un niveau élevé d’accomplissement personnel réduit était de 31,9% (IC à 95%: 21,7–39,1).La prévalence notable de l’épuisement professionnel chez les professionnels des soins de santé primaires dans les pays à revenu faible ou intermédiaire a des implications pour la sécurité des patients, la qualité des soins et la planification des effectifs. D’autres études transversales sont nécessaires pour aider à identifier des solutions empiriques, en particulier en Afrique et en Asie du Sud-Est.Estimar la prevalencia del desgaste profesional entre los profesionales de la atención primaria de salud en los países de ingresos bajos y medios e identificar los factores que se asocian a este síndrome.Se realizaron búsquedas sistemáticas en nueve bases de datos hasta febrero de 2022 para identificar estudios que investigaran el desgaste profesional en profesionales de la atención primaria de países de ingresos bajos y medios. No hubo limitaciones de idioma y se incluyeron estudios observacionales. Dos revisores independientes completaron el cribado, la selección de estudios, la extracción de datos y la evaluación de la calidad. Se utilizó el metanálisis de efectos aleatorios para estimar la prevalencia global del desgaste profesional, evaluada mediante las subescalas de agotamiento emocional, despersonalización y realización personal del Maslach Burnout Inventory. En este documento, se describen los factores asociados al síndrome de desgaste profesional.La búsqueda arrojó 1568 artículos. Tras la selección, se incluyeron 60 estudios de 20 países en la revisión narrativa y 31 en el metanálisis. Tres estudios recopilaron datos durante la pandemia de la enfermedad por coronavirus de 2019, pero proporcionaron pruebas limitadas sobre el impacto de la enfermedad en el desgaste profesional. La prevalencia global de un único punto sobre el desgaste profesional osciló entre el 2,5 y el 87,9 % (43 estudios). En el metanálisis (31 estudios), la prevalencia conjunta de un nivel alto de agotamiento emocional fue del 28,1 % (intervalo de confianza del 95 %, IC: 21,5-33,5), un nivel alto de despersonalización fue del 16,4 % (IC del 95 %: 10,1-22,9) y un nivel alto de disminución de la realización personal fue del 31,9 % (IC del 95 %: 21,7-39,1).La considerable prevalencia del desgaste profesional entre los profesionales de la atención primaria en los países de ingresos bajos y medios tiene implicaciones para la seguridad de los pacientes, la calidad de la atención y la planificación del personal. Se necesitan más estudios transversales para ayudar a identificar soluciones fundamentadas en la evidencia, en especial en África y Asia Sudoriental.تقدير مدى انتشار الإرهاق بين أخصائيي الرعاية الصحية الأولية في الدول ذات الدخل المنخفض والدخل المتوسط، وتحديد العوامل المرتبطة بالإرهاق. الطريقة قمنا بالبحث بشكل منهجي في تسع قواعد للبيانات حتى فبراير/شباط 2022، لتحديد الدراسات التي تقوم بالاستقصاء في الإنهاك لدى أخصائيي الرعاية الأولية في الدول ذات الدخل المنخفضة والدخل المتوسطة. لم تكن هناك قيود تتعلق باللغة، وقمنا بتضمين دراسات قائمة على الملاحظات. قام اثنان من المراجعين المستقلين بإكمال عمليات الفحص، وتحديد الدراسة، واستخراج البيانات، وتقييم الجودة. تم استخدام التحليل التلوي للتأثيرات العشوائية لتقدير مدى انتشار الإرهاق الكلي كما تم تقييمه باستخدام المقاييس الفرعية Maslach Burnout Inventory للإرهاق العاطفي، وفقدان الشخصية، والإنجاز الشخصي. نحن نقوم بالإبلاغ عن العوامل المرتبطة بالإرهاق عن طريق السرد. النتائج أسفر البحث عن 1568 مقالةً. بعد الاختيار، تم تضمين 60 دراسةً من 20 دولة في المراجعة السردية، وتضمين 31 دراسة في التحليل التلوي. جمعت ثلاث دراسات البيانات أثناء جائحة مرض فيروس كورونا 2019، ولكنها قدمت أدلة محدودة على تأثير المرض على الإرهاق. تراوح معدل الانتشار الكلي للإرهاق في نقطة واحدة من 2.5 إلى 87.9% (43 دراسة). في التحليل التلوي (31 دراسة)، كان معدل الانتشار المجمع لمستوى عالٍ من الإرهاق العاطفي هو 28.1% (بفاصل ثقة مقداره 95%: 21.5 إلى 33.5)، ومستوى عالٍ من فقدان الشخصية هو 16.4% (بفاصل ثقة مقداره 95%: 10.1 إلى 22.9)، ومستوى عالٍ من الإنجاز الشخصي هو 31.9% (بفاصل ثقة مقداره 95%: 21.7 إلى 39.1). الاستنتاج إن الانتشار الكبير للإرهاق بين أخصائيي الرعاية الصحية الأولية في الدول ذات الدخل المنخفض والدخل المتوسط، له آثار على سلامة المرضى، وجودة الرعاية، وتخطيط القوى العاملة. هناك حاجة إلى مزيد من الدراسات المقطعية للمساعدة في تحديد الحلول القائمة على الأدلة، وخاصة في أفريقيا وجنوب شرق آسيا.评估低收入和中等收入国家初级医疗护理工作者的职业倦怠率，并确定引起职业倦怠的相关因素。.我们系统地搜索了截至 2022 年 2 月的九个数据库，以确定调查低收入和中等收入国家初级医疗护理工作者职业倦怠情况的研究。搜集的研究没有语言限制，而且我们纳入了观察性研究。由两位独立评审员完成了筛查、研究选择、数据提取和质量评估。我们采用随机效应元分析法来评估整体职业倦怠率，并使用《马氏职业倦怠量表》作为子量表来评估情绪疲劳、人格解体和个人成就感的情况。我们对于职业倦怠相关的因素进行了叙述性报告。.搜索出 1568 篇论文。经过筛选，来自 20 个国家的 60 项研究被纳入叙述性回顾，31 项研究被纳入元分析。有三项研究收集了新型冠状病毒肺炎大流行期间的数据，但该疾病对职业倦怠的影响方面的证据有限。职业倦怠的总体单点流行率范围为 2.5% 至 87.9%（43 项研究）。在元分析（31 项研究）中，严重级别情绪疲劳的综合流行率为 28.1% （95% 置信区间，CI：21.5–33.5），严重级别人格解体的流行率为 16.4% (95% CI: 10.1-22.9），个人成就感严重缺失的流行率为 31.9% (95% CI: 21.7-39.1）。.低收入和中等收入国家初级医疗护理工作者的高职业倦怠率对患者安全、护理质量和人力规划会产生影响。需要开展进一步的横断面研究来帮助确定有证据支持的解决方案，特别是在非洲和东南亚地区。.Оценить распространенность профессионального выгорания среди специалистов первичной медико-санитарной помощи в странах с низким и средним уровнем дохода, а также выявить факторы, связанные с профессиональным выгоранием.Авторы провели систематический поиск по девяти базам данных, собранных до февраля 2022 года, и выявили исследования о профессиональном выгорании среди специалистов первичной медико-санитарной помощи в странах с низким и средним уровнем дохода. Языковых ограничений не было. Были включены обсервационные исследования. Два независимых эксперта провели скрининговое обследование, отбор исследований, извлечение данных и оценку качества. Для оценки общей распространенности профессионального выгорания использовался метаанализ случайных эффектов с помощью подшкал опросника выгорания Маслач для определения эмоционального истощения, деперсонализации и личных достижений. Авторы описательно сообщают о факторах, связанных с профессиональным выгоранием.В результате поиска обнаружено 1568 статей. После завершения отбора 60 исследований из 20 стран были включены в описательный анализ, а 31 – в метаанализ. Три исследования собрали данные во время пандемии коронавирусной инфекции 2019 года, но представили ограниченные данные о влиянии болезни на профессиональное выгорание. Общая распространенность профессионального выгорания колебалась от 2,5 до 87,9% (43 исследования). В метаанализе (31 исследование) общая распространенность высокого уровня эмоционального истощения составила 28,1% (95%-й ДИ: 21,5–33,5), высокий уровень деперсонализации составил 16,4% (95%-й ДИ: 10,1–22,9), а высокий уровень снижения личных достижений составил 31,9% (95%-й ДИ: 21,7–39,1).Значительная распространенность эмоционального выгорания среди специалистов первичной медико-санитарной помощи в странах с низким и средним уровнем дохода влияет на безопасность пациентов, качество медицинской помощи и планирование трудовых ресурсов. Необходимы дальнейшие поперечные исследования для поиска основанных на фактических данных решений, особенно в Африке и Юго-Восточной Азии.

Objective To determine whether a diagnosis of polymyalgia rheumatica (PMR) is associated with premature mortality. Methods We extracted anonymised electronic medical records of patients over the age of 40 years, who were eligible for linkage with the Office for National Statistics (ONS) Death Registration dataset, from the Clinical Practice Research Datalink from 1990-2016. Patients with PMR were individually matched by age, sex and registered General Practice with up to 5 controls without PMR. The total number and proportion of deaths and mortality rates were calculated. The mortality rate ratio (MRR), with 95% confidence interval (CI), adjusted for age, sex, region, smoking status, body mass index (BMI), and alcohol consumption, was calculated using Poisson regression. The twenty most common causes of death were tabulated. Results 18,943 patients with PMR were matched to 87,801 controls. Mean (standard deviation) follow-up after date of diagnosis was 8.0 (4.4) years in patients with PMR, and 7.9 (4.6) in controls. PMR was not associated with an increase in the risk of death (adjusted MRR 1.00 [95% CI 0.97, 1.03]) compared to matched controls. Causes of death were broadly similar between patients with PMR and controls, although patients with PMR were slightly more likely to have a vascular cause of death recorded (24% vs 23%). Conclusions A diagnosis with PMR does not appear to increase the risk of premature death. Minor variations in cause of death were observed, but overall this study is reassuring for patients with PMR and clinicians.

Objectives: To determine the burden of comorbidities, including glucocorticoid (GC) related adverse effects, in patients with polymyalgia rheumatica (PMR) before and after diagnosis.\ud \ud Methods: We extracted anonymised electronic medical records of patients over the age of 40 years from the Clinical Practice Research Datalink from 1990-2016. Patients with PMR were individually matched on age, sex and registered General Practice to between three and five controls. The prevalence, cumulative probability and likelihood of a range of comorbidities was estimated. Odds ratios (ORs) and hazard ratios (HRs) were calculated using conditional logistic regression and Cox proportional hazards regression respectively, adjusted for a wide range of covariates.\ud \ud Results: 31,984 patients with PMR were matched to 149,436 controls. PMR was prospectively associated with vascular disease (adjusted HR 1.23 [95% confidence interval (CI) 1.19, 1.28]), as well as respiratory (HR 1.25 [1.18, 1.32]), renal (HR 1.34 [1.30, 1.39]), and autoimmune diseases (HR 4.68 [4.35, 5.03]). Conversely, before PMR diagnosis, the risk of cancer (adjusted OR [OR] 0.89 [0.86, 0.93]) and neurological disease (OR 0.36 [0.33, 0.40]) was significantly lower. Patients with PMR had an increased risk of comorbidities associated with glucocorticoid (GC) use.\ud \ud Conclusions\ud Patients with PMR have a high comorbidity burden, both before and after diagnosis. Whilst further work is needed to more fully understand these associations, clinicians should be aware of the high prevalence of comorbid conditions in this group and the impact that treatment with glucocorticoids may have on comorbidity.

Background Obesity predisposes to a pro-inflammatory state. Studies have reported worse clinical outcomes in patients with inflammatory arthritis who are obese. The relationship between obesity and outcomes in patients with polymyalgia rheumatica (PMR), another common inflammatory rheumatic condition, has not been assessed. We examined this in a cohort study of primary care-recruited patients with PMR. Methods The PMR Cohort Study is an inception cohort of patients with incident PMR, recruited from 382 general practices. Self-completed questionnaires at 0, 12, and 24-months captured: (a) PMR-related pain (0-10 numeric rating scale [NRS]); (b) PMR-related stiffness (0-10 NRS); (c) anxiety (GAD7); (d) depression (PHQ8); (e) fatigue (FACIT-Fatigue); (f) function (mHAQ); (g) quality of life (EQ-5D-3L). Height was self-reported at baseline, and weight at baseline, 12 and 24 months. Patients were categorised as underweight (BMI Results 652 patients were included (62% female). At baseline, mean age was 72 years, median BMI 26.6 (IQR 24.0-30.2), 34% were normal/under-weight, 40% overweight, and 26% obese. Compared to normal/underweight patients, obese patients had the following significantly poorer outcomes (P Conclusion Obesity is associated with poorer outcomes in patients with PMR. Consideration should be given to providing weight management support to patients with PMR and obesity. Further research should examine the impacts of weight-based steroid dosing on outcomes. Disclosures I.C. Scott None. R. Bajpai None. S.L. Hider None. T. Helliwell None. S. Muller None. C.D. Mallen None.

Background Giant cell arteritis (GCA) is the most common form of medium and large vessel vasculitis. Diagnosis remains difficult since there are a multitude of symptoms experienced by patients with GCA and if not promptly identified or treated, patients with GCA are at risk of irreversible visual loss. Therefore, a clear understanding of recent trends in incidence is important for clinicians, researchers and policy-holders to better understand and address future healthcare resource needs. Our objective was to estimate the annual UK incidence of GCA and assess whether this is changing over time. Methods We used the Clinical Practice Research Datalink (CPRD), a database of routinely recorded primary care records from across the UK. CPRD is representative of the UK population and contains patient information from approximately 15% of the UK population. For each year from 1992-2017, the number of patients with a first Read coded record of GCA in that year, and aged 40 years or older at the time of diagnosis, was determined. The annual denominator population included the registered practice population without a prior record of GCA, aged 40 years or older. Annual incidence per 10,000 person-years (P-Y) at risk was derived overall and stratified by age, gender and region of the UK. Trends over time were modelled using Joinpoint regression. To be confident of the primary care diagnosis of GCA, a sensitivity analysis was undertaken which included a prescription of corticosteroids alongside the GCA Read code. Results There was a decrease in annual incidence of GCA in the UK between 1992 and 2017. Incidence was highest in 1994 (2.29/10,000 P-Y; 95% CI: 1.96, 2.67). This decreased to 1.51/10,000 P-Y in 2006, after which the incidence rates stabilised. Incidence rates for women were higher than men, irrespective of year. Incidence peaked between 70 and 89 years of age, with females aged 70-79 having the highest overall incidence rate of 5.20/10,000 P-Y (95% CI: 5.00, 5.40). The region of the UK with the highest incidence rate of GCA from 2015-2017 was Yorkshire & the Humber with 2.63/10,000 P-Y. The regions with the lowest incidence of 1.13/10,000 P-Y were the North East and West Midlands. Sensitivity analysis gave similar patterns. Conclusion The incidence of GCA in the UK has decreased slightly in recent years, which may reflect developments in more definitive early GCA diagnosis through fast-track clinics and improvements in imaging. However, further research into the presenting features of GCA in primary care is required. A set of early clinical features and comorbidities that are positively associated and predictive of a subsequent diagnosis of GCA would improve diagnosis and avert significant complications associated with delayed treatment. Disclosures L.A. Barnett None. T. Helliwell None. K. Jordan None. J. Prior None.

Background The diagnosis of giant cell arteritis (GCA) remains challenging due to the varied number and type of clinical features (symptoms and comorbidities) that patients with GCA can present with. Prompt diagnosis is important, as if left undiagnosed and untreated, some patients may experience irreversible sight loss. Given the rarity of GCA and that many of the presenting clinical features may pertain to other, more prevalent illnesses in the typical age range for GCA, diagnostic delay is common. Such delay may increase the risk of GCA related complications. The aim of this study was to quantify the association between a diagnosis of GCA and the clinical features observed prior to diagnosis. Methods Patients with a coded record of GCA and aged 40 years or older at the time of diagnosis, were identified from the Clinical Practice Research Datalink (CPRD) between 1990 and 2017. CPRD is a large, national UK database of primary care records. Every GCA case was matched to 5 controls with no GCA diagnosis, by year of birth, gender and practice. Clinical features linked to GCA in previous research studies were identified in the patient’s primary care records at any time prior to GCA diagnosis. Conditional logistic regression was used to determine associations between clinical features and a subsequent diagnosis of GCA, adjusting for Body Mass Index, smoking status, and alcohol consumption. Results 9,205 patients with GCA were included, the majority of which were female (70.9%). 15 clinical features were examined. For example, 53.3% of GCA cases had a recorded consultation for headache prior to diagnosis (38.4% within six months prior to diagnosis), compared to 9.9% of controls; 3.2% of cases had recorded jaw pain (0.3% within six months prior to diagnosis) compared to 0.5% of controls; 39.4% of cases had a diagnosis for hypertension prior to their diagnosis of GCA. GCA cases were more likely than controls to have recorded consultations for headache (adjusted OR 10.57; 95% CI: 9.93, 11.25), jaw pain (5.37; 4.47, 6.44) and hypertension (1.33; 1.26, 1.40). Other clinical features that were statistically significantly associated with GCA included fever, anxiety/depression, and PMR. Cancer was the only clinical feature not associated with GCA. Conclusion Symptoms such as headache, jaw pain and hypertension are highly prevalent in GCA, but are also common symptoms in the usual age group affected by GCA and common features of many conditions. In isolation and considering the rarity of GCA in the UK population, these symptoms may not be immediately attributed to GCA by the diagnosing GP. It is therefore necessary to conduct further research where clinical features are not treated independently, but as groups or clusters, which together may more accurately help clinicians to diagnose GCA early. Disclosures L.A. Barnett None. T. Helliwell None. K.P. Jordan None. J.A. Prior None.

The aim of this study was to systematically consider the evidence for polymyalgia rheumatica (PMR) as a paraneoplastic disease. A systematic review of Medline and Embase was conducted from their inception to February 2017. Risk of bias was assessed using the Newcastle-Ottawa tool. Data were extracted regarding the PMR-cancer association, the types of cancer associated with PMR and the presentation of PMR patients subsequently diagnosed with cancer. Twenty-three full text articles were reviewed from the 1174 unique references identified in the search. Nine articles were included in the final review. There was some evidence of an association between PMR and cancer in the short-term (first 6 to 12 months after diagnosis), but no evidence of an association after this time. Limited evidence suggests that lymphoma, prostate and haematological cancers may be those cancers more commonly diagnosed in those with PMR. There was little evidence to suggest what presenting features may be associated with the development of cancer. There is little evidence of PMR as a true paraneoplastic disease. However, there is reason to be cautious when making the diagnosis of PMR. Clinicians should be aware of this potential association both prior to making a diagnosis and throughout the course of the condition.

Objectives To examine national-level differences in management strategies and outcomes in patients with autoimmune rheumatic disease (AIRD) with acute myocardial infarction (AMI) from 2004 through 2014. Methods All AMI hospitalizations were analyzed from the National Inpatient Sample, stratified according to AIRD diagnosis into 4 groups: no AIRD, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and systemic sclerosis (SSC). The associations between AIRD subtypes and (1) receipt of coronary angiography and percutaneous coronary intervention (PCI) and (2) clinical outcomes were examined compared with patients without AIRD. Results Of 6,747,797 AMI hospitalizations, 109,983 patients (1.6%) had an AIRD diagnosis (RA: 1.3%, SLE: 0.3%, and SSC: 0.1%). The prevalence of RA rose from 1.0% (2004) to 1.5% (2014), and SLE and SSC remained stable. Patients with SLE were less likely to receive invasive management (odds ratio [OR] [95% CI]: coronary angiography—0.87; 0.84 to 0.91; PCI—0.93; 0.90 to 0.96), whereas no statistically significant differences were found in the RA and SSC groups. Subsequently, the ORs (95% CIs) of mortality (1.15; 1.07 to 1.23) and bleeding (1.24; 1.16 to 1.31) were increased in patients with SLE; SSC was associated with increased ORs (95% CIs) of major adverse cardiovascular and cerebrovascular events (1.52; 1.38 to 1.68) and mortality (1.81; 1.62 to 2.02) but not bleeding or stroke; the RA group was at no increased risk for any complication. Conclusion In a nationwide cohort of AMI hospitalizations we found lower use of invasive management in patients with SLE and worse outcomes after AMI in patients with SLE and SSC compared with those without AIRD.

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.

Permanent vision loss is one of the most serious complications of giant cell arteritis (GCA) and therefore prompt diagnosis is paramount. However, diagnosis of GCA remains challenging due to its frequently non-specific presentation. Our aim was to identify differences in the characteristics of GCA patients with, and without, current visual symptoms. A cross-sectional survey was mailed to patients with a GCA Read code entered in their GP electronic medical record. Responders were categorised as those currently reporting a visual symptom or not. We compared general and GCA-specific characteristics in these two groups. The association of diagnostic delay with subsequent experience of visual symptoms was examined using unadjusted and adjusted linear regression analysis. 318 GCA patients responded to the survey (59.6%). Responders were predominantly female (69.8%), with a mean age of 73.7 years (SD 8.2). 28% reported current visual symptoms. There was no statistically significant difference in the general characteristics between those with and without visual symptoms. Of GCA-specific characteristics, pre-GCA diagnosis of diplopia (p = 0.018), temporary (p ≤ 0.001) or permanent visual problems (p = 0.001) and hoarseness (p = 0.004) were more common among those reporting current visual symptoms. There was no association between the extent of diagnostic delay and reporting of current visual symptoms. Though we found few characteristics to distinguish between GCA patients with or without current visual symptoms, diagnostic delay was not associated with current visual symptoms. Our findings highlighted the continued difficulty for clinicians to identify GCA patients at the highest risk of visual complications.

Background Antibiotic-induced disturbances of the human microbiota have been implicated in the development of chronic autoimmune conditions. This study aimed to assess whether antibiotic use is associated with the onset of rheumatoid arthritis (RA). Methods A nested case-control study was conducted utilising data from the primary care Clinical Practice Research Datalink (CPRD). Patients with an incident diagnosis of RA were identified (1995–2017). Each case was matched on age, gender, and general practice to ≥ 5 controls without RA. Conditional logistic regression was used to examine previous antibiotic prescriptions and RA onset after controlling for confounding factors. Results We identified 22,677 cases of RA, matched to 90,013 controls, with a median follow-up of 10 years before RA diagnosis. The odds of developing RA were 60% higher in those exposed to antibiotics than in those not exposed (OR 1.60; 95% CI 1.51–1.68). A dose- or frequency-dependent association was observed between the number of previous antibiotic prescriptions and RA. All classes of antibiotics were associated with higher odds of RA, with bactericidal antibiotics carrying higher risk than bacteriostatic (45% vs. 31%). Those with antibiotic-treated upper respiratory tract (URT) infections were more likely to be RA cases. However, this was not observed for URT infections not treated with antibiotics. Antifungal (OR = 1.27; 95% CI 1.20–1.35) and antiviral (OR = 1.19; 95% CI 1.14–1.24) prescriptions were also associated with increased odds of RA. Conclusion Antibiotic prescriptions are associated with a higher risk of RA. This may be due to microbiota disturbances or underlying infections driving risk. Further research is needed to explore these mechanisms. Electronic supplementary material The online version of this article (10.1186/s12916-019-1394-6) contains supplementary material, which is available to authorized users.

Primary care is key to the early diagnosis and ongoing care of people with inflammatory rheumatic diseases. Primary care is usually the first point of call for health problems and is the setting wh...

We aimed to examine the association between pain, stiffness and fatigue in newly diagnosed polymyalgia rheumatica (PMR) patients using baseline data from a prospective cohort study. Fatigue is a known, but often ignored symptom of PMR. Newly diagnosed PMR patients were recruited from general practice and mailed a baseline questionnaire. This included a numerical rating scale for pain and stiffness severity, manikins identifying locations of pain and stiffness and the FACIT-Fatigue questionnaire. A total of 652 PMR patients responded (88.5%). The mean age of responders was 72.6 years (SD 9.0) and the majority were female (62.0%). Manikin data demonstrated that bilateral shoulder and hip pain and stiffness were common. The mean fatigue score (FACIT) was 33.9 (SD 12.4). Adjusted regression analysis demonstrated that a higher number of pain sites (23–44 sites) and higher pain and stiffness severity were associated with greater levels of fatigue. In newly diagnosed PMR patients, fatigue was associated with PMR symptom severity.

Background and aim Comorbidities are known to exist in many rheumatological conditions. Polymyalgia rheumatica (PMR) is a common inflammatory rheumatological condition affecting older people which, prior to effective treatment, causes severe disability. Our understanding of associated comorbidities in PMR is based only on case reports or series and small cohort studies. The objective of this study is to review systematically the existing literature on the comorbidities associated with PMR. Methods MEDLINE, EMBASE, PsycINFO and CINAHL databases were searched for original observational research from inception to November 2016. Papers containing the words ‘Polymyalgia Rheumatica’ OR ‘Giant Cell Arteritis’ OR the terms ‘PMR’ OR ‘GCA’ were included. Article titles were reviewed based on pre-defined criteria by two reviewers. Following selection for inclusion, studies were quality assessed using the Newcastle–Ottawa tool and data were extracted. Results A total of 17,329 papers were reviewed and 41 were incorporated in this review, including three published after the search took place. Wide variations were found in study design, comorbidities reported and populations studied. Positive associations were found between PMR diagnosis and stroke, cardiovascular disease, peripheral arterial disease, diverticular disease and hypothyroidism. Two studies reported a positive association between PMR and overall malignancy rate. Seven studies reported an association between PMR and specific types of cancer, such as leukaemia, lymphoma, myeloproliferative disease and specified solid tumours, although nine studies found either no or negative association between cancer and PMR. Conclusion Quantification of the prevalence of comorbidities in PMR is important to accurately plan service provision and enable identification of cases of PMR which may be more difficult to treat. This review highlights that research into comorbidities in PMR is, overall, methodologically inadequate and does not comprehensively cover all comorbidities. Future studies should consider a range of comorbidities in patients with a validated diagnosis of PMR in representative populations. Electronic supplementary material The online version of this article (10.1186/s13075-018-1757-y) contains supplementary material, which is available to authorized users.

AimThe aim of this study was to assess the provision of information to, and seeking of information by, patients newly diagnosed with polymyalgia rheumatica (PMR) in primary care.BackgroundPMR is an inflammatory rheumatological condition of older people that can be treated with long-term oral glucocorticoids. Management usually requires the patient to understand the potential complications of treatment and the disease, as well as involvement in reducing treatment dose. This may be complex for patients to understand.MethodData are taken from the baseline phase of the PMR Cohort study, which recruited newly diagnosed patients with PMR from UK primary care. Participants provided information on their PMR symptoms, general health and sociodemographics. They also completed items regarding information provision by their doctor at diagnosis, its usefulness and their own search for information.FindingsA total of 652 people responded to the baseline survey. In all, 399 (62.7%) had received written information from their doctor; 237 (98%) found it useful; 265 (42.9%) would have liked more information; and 311 (48.4%) sought out more information. Those who were not given information and did not seek it out tended to be older and have poorer internet access.Information provided at diagnosis to patients with PMR is useful, but more than a third did not receive any. This is concerning when PMR requires self-management and vigilance for red flags. Doctors should make use of the resources already available to them to support patients and should specifically ensure that these are available to more elderly patients and those without internet access.

ObjectivePolymyalgia rheumatica (PMR) is the most common inflammatory rheumatic disease in older people. Contemporary estimates of the incidence and prevalence are lacking, and no previous study has assessed treatment patterns at a population level. This study aims to address this.MethodsWe extracted anonymised electronic medical records of patients over the age of 40 years from the Clinical Practice Research Datalink in the period 1990–2016. The absolute rate of PMR per 100 000 person-years was calculated and stratified by age, gender and calendar year. Incidence rate ratios were calculated using a Poisson regression model. Among persons with PMR, continuous and total duration of treatment with glucocorticoids (GC) were assessed.Results5 364 005 patients were included who contributed 44 million person-years of follow-up. 42 125 people had an incident diagnosis of PMR during the period. The overall incidence rate of PMR was 95.9 per 100 000 (95% CI 94.9 to 96.8). The incidence of PMR was highest in women, older age groups and those living in the South of England. Incidence appears stable over time. The prevalence of PMR in 2015 was 0.85 %. The median (IQR) continuous GC treatment duration was 15.8 (7.9–31.2) months. However, around 25% of patients received more than 4 years in total of GC therapy.ConclusionsThe incidence rates of PMR have stabilised. This is the first population-based study to confirm that a significant number of patients with PMR receive prolonged treatment with GC, which can carry significant risks. The early identification of these patients should be a priority in future research.

BACKGROUND: Previous studies that quantified the risk of fracture among patients with gout and assessed the potential effect of urate-lowering therapy have provided conflicting results. Our study aims to provide better estimates of risk by minimizing the effect of selection bias and confounding on the observed association. METHODS: We used data from the Clinical Practice Research Datalink, which records primary care consultations of patients from across the United Kingdom. We identified patients with incident gout from 1990 to 2004 and followed them up until 2015. Each patient with gout was individually matched to 4 controls on age, sex and general practice. We calculated absolute rate of fracture and hazard ratios (HRs) using Cox regression models. Among patients with gout, we assessed the impact of urate-lowering therapy on fracture, and used landmark analysis and propensity score matching to account for immortal time bias and confounding by indication. RESULTS: We identified 31 781 patients with incident gout matched to 122 961 controls. The absolute rate of fracture was similar in both cases and controls (absolute rate = 53 and 55 per 10 000 person-years, respectively) corresponding to an HR of 0.97 (95% confidence interval 0.92–1.02). Our finding remained unchanged when we stratified our analysis by age and sex. We did not observe statistically significant differences in the risk of fracture among those prescribed urate-lowering therapy within 1 and 3 years after gout diagnosis. INTERPRETATION: Overall, gout was not associated with an increased risk of fracture. Urate-lowering drugs prescribed early during the course of disease had neither adverse nor beneficial effect on the long-term risk of fracture.

Objective.The Outcome Measures in Rheumatology (OMERACT) polymyalgia rheumatica (PMR) working group aims to develop a core set of outcome measures to be used in clinical trials for PMR. Previous reports from OMERACT 11 included a qualitative study of the patient experience and a preliminary literature review.Methods.A 3-round Delphi survey of clinicians and patients with PMR was undertaken to identify a candidate core domain set for PMR research. Additionally, a literature review of outcome measures and their respective measurement instruments was undertaken. Meetings of patient research partners and clinicians were convened to review face validity of the provisional core domain set, which was subsequently presented and discussed at the OMERACT 12 congress.Results.Of the 60 clinicians taking part in round 1, 55 took part in round 2 and 51 in round 3. Of the 55 patients who took part in round 1, 46 and 35 took part in subsequent rounds. In total, 91% of participants in round 3 deemed the resulting draft core domain set reasonable. The literature review identified 28 studies for full review. Measurement instruments for each proposed domain were identified. Clinicians are highly aware of glucocorticoid-related adverse effects, but there is relatively little evidence about their true prevalence and severity, especially in PMR.Conclusion.A provisional core domain set, presented for clinical trials in PMR, comprises acute phase markers, physical function, death, glucocorticoid-related adverse events, and development of giant cell arteritis. Measurement instruments are suggested that may cover each domain, but these require formal validation for clinical trials in PMR.

This study aimed to examine fracture risk in patients with late-onset psoriasis. A cohort study was conducted using primary care records from the Clinical Practice Research Datalink. Psoriasis patients had a 10% increased risk of fracture compared to matched controls (hazard ratio (HR) = 1.10; 95% confidence interval (CI) 1.04, 1.16). This study aimed to examine fracture risk in patients with late-onset psoriasis and investigate the effect of methotrexate on fracture risk. A cohort study was conducted using primary care records from the UK-based Clinical Practice Research Datalink. Individuals aged 40 years and over, with incident (new onset) diagnoses of psoriasis, were identified from 1990 to 2004 and followed up until 2015. For each exposed individual, up to four age-, gender-, and practice-matched controls were randomly selected. Incidence rates of fragility fracture (hip, vertebral, spine, radius or unspecified site) per 10,000 person-years were calculated and hazard rates were compared to the unexposed using Cox regression models. The risk of fracture was also estimated, within the exposed group for patients receiving/not receiving methotrexate. Twenty-four thousand two hundred nineteen patients with psoriasis and 94,820 controls were identified. The absolute rate of fracture in psoriasis patients was 58 per 10,000 person-years (95% CI 55, 61) and 53 per 10,000 person-years in the matched controls (CI 52, 54). Psoriasis patients had a 10% increased risk of fracture compared to their matched controls (HR = 1.10; 95% CI 1.04, 1.16). Methotrexate use was not associated with increased risk (HR = 0.91; 95% CI 0.72, 1.15). Identifying additional clinical factors associated with increased fracture risk is important in improving fracture risk stratification. Further work is needed to determine the relationship between age of onset of psoriasis and fracture risk, explore causative explanations, and identify if existing fracture risk stratification tools underestimate fracture risk in patients with psoriasis.

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 To examine the frequency of possible giant cell arteritis (GCA) symptoms (including headache, temporal/scalp tenderness, jaw claudication and visual symptoms) in newly diagnosed polymyalgia rheumatica (PMR) patients in UK primary care. Methods The PMR Cohort Study is a primary care inception cohort of 652 adults with newly diagnosed polymyalgia rheumatica (PMR). At baseline, participants were asked to report (yes/no) on the presence of seven potential GCA symptoms: sudden headache, tender scalp, disturbed/double vision, jaw claudication, fever, appetite loss and unintentional weight loss. Results Of the 652 patients, 405 (62%) were female, with a mean (SD) age of 72.5 (8.9) years. Sudden headache was the commonest symptom in 161 patients (24.7%). The least commonly reported symptom was jaw claudication in 66 (10.1%) patients. Females had a higher prevalence of headache, tender scalp and jaw pain. Sudden onset headache and fever were commoner in younger patients, (OR (95% CI) per 10 year age band increase: headache 0.76 (0.62–0.92), fever 0.63 (0.49, 0.79)). In those reporting sudden headache (n = 161), 19.9% (n = 32) also reported double/disturbed vision and a tender scalp, whilst 11.8% (n = 19) reported double/disturbed vision and jaw pain. Conclusion The data suggests possible GCA symptoms are common in PMR patients, particularly sudden headache, appetite loss and weight loss. These symptomatic PMR patients warrant careful monitoring and consideration for early referral to specialist services. Electronic supplementary material The online version of this article (10.1186/s41927-017-0007-2) contains supplementary material, which is available to authorized users.

ObjectivesClinical management of giant cell arteritis (GCA) involves balancing the risks and burdens arising from the disease with those arising from treatment, but there is little research on the nature of those burdens. We aimed to explore the impact of giant cell arteritis (GCA) and its treatment on patients’ lives.MethodsUK patients with GCA participated in semi-structured telephone interviews. Inductive thematic analysis was employed.Results24 participants were recruited (age: 65–92 years, time since diagnosis: 2 months to >6 years). The overarching themes from analysis were: ongoing symptoms of the disease and its treatment; and ‘life-changing’ impacts. The overall impact of GCA on patients’ lives arose from a changing combination of symptoms, side effects, adaptations to everyday life and impacts on sense of normality. Important factors contributing to loss of normality were glucocorticoid-related treatment burdens and fear about possible future loss of vision.ConclusionsThe impact of GCA in patients’ everyday lives can be substantial, multifaceted and ongoing despite apparent control of disease activity. The findings of this study will help doctors better understand patient priorities, legitimise patients’ experiences of GCA and work with patients to set realistic treatment goals and plan adaptations to their everyday lives.

Background Glucocorticoids are associated with increased fracture risk and are the mainstay of treatment in polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). However, fracture risk in these conditions has not been previously quantified. The aim of this study was to quantify the risk of fracture among patients with PMR and GCA. Methods A retrospective cohort study was conducted using primary care records from the UK-based Clinical Practice Research Datalink. Individuals aged 40 years and over, with incident diagnoses of PMR or GCA were separately identified from 1990–2004 and followed up until 2015. For each exposed individual, four age-, sex- and practice-matched controls were randomly selected. Incidence rates of fracture per 10,000 person-years were calculated for each disease group and hazard rates were compared to the unexposed using Cox regression models. Results Overall, 12,136 and 2673 cases of PMR and GCA, respectively, were identified. The incidence rate of fracture was 148.05 (95% CI 141.16–155.28) in PMR and 147.15 (132.91–162.91) in GCA per 10,000 person-years. Risk of fracture was increased by 63% in PMR (adjusted hazard ratio 1.63, 95% CI 1.54–1.73) and 67% in GCA (1.67, 1.49–1.88) compared to the control populations. Fewer than 13% of glucocorticoid-treated cases were prescribed bisphosphonates. Conclusions This study reports, for the first time, a similar increase in fracture risk for patients with PMR and GCA. More needs to be done to improve adherence to guidelines to co-prescribe bisphosphonates. Further research needs to identify whether lower glucocorticoid starting doses and/or aggressive dose reduction reduces fracture risk. Electronic supplementary material The online version of this article (doi:10.1186/s12916-017-0987-1) contains supplementary material, which is available to authorized users.