Publications by authors named "Christian Mallen"

255 Publications

Misdiagnosis of acute myocardial infarction: A systematic review of the literature.

Crit Pathw Cardiol 2021 Feb 17. Epub 2021 Feb 17.

School of Medicine, Keele University, Stoke-on-Trent, UK Department of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK ACALM Study Unit, Aston Medical School, UK Norwich Medical School, University of East Anglia, Norwich, UK.

Despite the availability of tests to diagnose acute myocardial infarction (AMI), cases are still missed. We systematic reviewed the literature to determine how missed AMI has been defined, the reported rates of misdiagnosed AMI, the outcomes patients with misdiagnosed AMI have, what diagnosis was initially suspected in missed AMI cases, and what factors are associated with misdiagnosed AMI. We searched MEDLINE and EMBASE in September 2020 for studies that evaluated missed AMI. Data was extracted from studies that met the inclusion criteria and the results were narratively synthesized. A total of 15 studies were included in this review. The number of patients with missed AMI in individual studies ranged from 64 to 4,707. There was no consistently used definition for misdiagnosed AMI but most studies reported rates of approximately 1-2%. Compared to AMI that was recognized, one study found no difference in mortality for misdiagnosed AMI at 30 days and 1 year. The common initial misdiagnoses that subsequently had AMI were ischemic heart disease, non-specific chest pain, gastrointestinal disease, musculoskeletal pain and arrhythmias. Reasons for missed AMI include incorrect electrocardiogram interpretation and failure to order appropriate diagnostic tests. Hospitals in rural areas and those with a low proportion of classical chest pain patients that turned out to have AMI were at greater risk of missed AMI. Misdiagnosed AMI is an unfortunate part of everyday clinical practice and better training in electrocardiogram interpretation and education about atypical presentations of AMI may reduce the number of misdiagnosed AMI.
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http://dx.doi.org/10.1097/HPC.0000000000000256DOI Listing
February 2021

Using Google Trends to assess the impact of Global Public Health Days on online health information-seeking behaviour in Arabian Peninsula.

J Egypt Public Health Assoc 2021 Feb 17;96(1). Epub 2021 Feb 17.

School of Primary, Community and Social Care, Keele University, Keele, ST5 5BG, UK.

Background: Global Public Health Days (GPHD) are public health interventions which serve to improve public awareness of specific health conditions. Google Trends is a publicly available tool that allows the user to view the popularity of a searched keyword during a specified time period and across a predetermined region. Our objective was to use Google Trends to assess the impact of four GPHD (World Heart Day, World Mental Health Day, World Diabetes Day and World Hypertension Day) on online health information-seeking behaviour (OHISB), 4 weeks before and a week after the GPHD, across six countries of the Arabian Peninsula (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates).

Methods: Relative Search Volume (RSV) was extracted for the aforementioned countries from 28 days before the GPHD and 7 days afterwards. Statistical analysis, undertaken using joinpoint regression software, showed that GPHD have significant changes for Saudi Arabia (Diabetes, Mental Health and Heart day) and UAE (Mental Health day) but were short-lived with a fall in RSV of up to 80% after peak interest.

Conclusion: GPHD appears to be effective in some countries while further research is needed to investigate the reason of its limitations.
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http://dx.doi.org/10.1186/s42506-020-00063-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7889764PMC
February 2021

Temporal relationship between osteoarthritis and comorbidities: a combined case control and cohort study in the UK primary care setting.

Rheumatology (Oxford) 2021 Jan 28. Epub 2021 Jan 28.

Academic Rheumatology, Division of Rheumatology, Orthopaedics and Dermatology, University of Nottingham, UK.

Objective: To determine the burden of comorbidities in osteoarthritis (OA) and their temporal relationships in the UK.

Methods: The Clinical Practice Research Datalink (CPRD) GOLD was used to identify people with incident OA and age, gender and practice matched non-OA controls from UK primary care. Controls were assigned the same index date as matched cases (date of OA diagnosis). Associations between OA and 49 individual comorbidities and multimorbidity (≥2 comorbidities excluding OA) both before and after OA diagnosis were estimated, adjusting for covariates, using odds ratios (aOR) and hazard ratios (aHR) respectively.

Results: During 1997-2017, we identified 221 807 incident OA cases and 221 807 matched controls. Of 49 comorbidities examined, 38 were associated with OA both prior to, and following, the diagnosis of OA, and 2 (dementia and SLE) were associated with OA only following the diagnosis of OA. People with OA had higher risk of developing heart failure (aHR 1.63; 95% CI 1.56-1.71), dementia (aHR 1.62; 95% CI 1.56-1.68), liver diseases (aHR 1.51; 95% CI 1.37-1.67), irritable bowel syndrome (aHR 1.51; 95% CI 1.45-1.58), gastrointestinal bleeding (aHR 1.49; 95% CI 1.39-1.59), 10 musculoskeletal conditions and 25 other conditions following OA diagnosis. The aOR for multimorbidity prior to the index date was 1.71 (95% CI 1.69-1.74), whereas the aHR for multimorbidity after the index date was 1.29 (95% CI 1.28-1.30).

Conclusions: People with OA are more likely to have other chronic conditions both before and after the OA diagnosis. Further study on shared aetiology and causality of these associations is needed.
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http://dx.doi.org/10.1093/rheumatology/keab067DOI Listing
January 2021

General practitioners' deprescribing decisions in older adults with polypharmacy: a case vignette study in 31 countries.

BMC Geriatr 2021 Jan 7;21(1):19. Epub 2021 Jan 7.

Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.

Background: General practitioners (GPs) should regularly review patients' medications and, if necessary, deprescribe, as inappropriate polypharmacy may harm patients' health. However, deprescribing can be challenging for physicians. This study investigates GPs' deprescribing decisions in 31 countries.

Methods: In this case vignette study, GPs were invited to participate in an online survey containing three clinical cases of oldest-old multimorbid patients with potentially inappropriate polypharmacy. Patients differed in terms of dependency in activities of daily living (ADL) and were presented with and without history of cardiovascular disease (CVD). For each case, we asked GPs if they would deprescribe in their usual practice. We calculated proportions of GPs who reported they would deprescribe and performed a multilevel logistic regression to examine the association between history of CVD and level of dependency on GPs' deprescribing decisions.

Results: Of 3,175 invited GPs, 54% responded (N = 1,706). The mean age was 50 years and 60% of respondents were female. Despite differences across GP characteristics, such as age (with older GPs being more likely to take deprescribing decisions), and across countries, overall more than 80% of GPs reported they would deprescribe the dosage of at least one medication in oldest-old patients (> 80 years) with polypharmacy irrespective of history of CVD. The odds of deprescribing was higher in patients with a higher level of dependency in ADL (OR =1.5, 95%CI 1.25 to 1.80) and absence of CVD (OR =3.04, 95%CI 2.58 to 3.57).

Interpretation: The majority of GPs in this study were willing to deprescribe one or more medications in oldest-old multimorbid patients with polypharmacy. Willingness was higher in patients with increased dependency in ADL and lower in patients with CVD.
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http://dx.doi.org/10.1186/s12877-020-01953-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7792080PMC
January 2021

A pilot study of a nurse-led integrated care review (the INCLUDE review) for people with inflammatory rheumatological conditions in primary care: feasibility study findings.

Pilot Feasibility Stud 2021 Jan 6;7(1). Epub 2021 Jan 6.

School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.

Background: People with inflammatory rheumatological conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica and giant cell arteritis are at an increased risk of common comorbidities including cardiovascular disease, osteoporosis and mood problems, leading to increased morbidity and mortality. Identifying and treating these problems could lead to improved patient quality of life and outcomes. Despite these risks being well-established, patients currently are not systematically targeted for management interventions for these morbidities. This study aimed to assess the feasibility of conducting a randomised controlled trial (RCT) of a nurse-led integrated care review in primary care to identify and manage these morbidities.

Methods: A pilot cluster RCT was delivered across four UK general practices. Patients with a diagnostic Read code for one of the inflammatory rheumatological conditions of interest were recruited by post. In intervention practices (n = 2), eligible patients were invited to attend the INCLUDE review. Outcome measures included health-related quality of life (EQ-5D-5L), patient activation, self-efficacy and treatment burden. A sample (n = 24) of INCLUDE review consultations were audio-recorded and assessed against a fidelity checklist.

Results: 453/789 (57%) patients responded to the invitation, although 114/453 (25%) were excluded as they either did not fulfil eligibility criteria or failed to provide full written consent. In the intervention practices, uptake of the INCLUDE review was high at 72%. Retention at 3 and 6 months both reached pre-specified success criteria. Participants in intervention practices had more primary care contacts than controls (mean 29 vs 22) over the 12 months, with higher prescribing of all relevant medication classes in participants in intervention practices, particularly so for osteoporosis medication (baseline 29% vs 12 month 46%). The intervention was delivered with fidelity, although potential areas for improvement were identified.

Conclusions: The findings of this pilot study suggest it is feasible to deliver an RCT of the nurse-led integrated care (INCLUDE) review in primary care. A significant morbidity burden was identified. Early results suggest the INCLUDE review was associated with changes in practice. Lessons have been learnt around Read codes for patient identification and refining the nurse training.

Trial Registration: ISRCTN, ISRCTN12765345.
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http://dx.doi.org/10.1186/s40814-020-00750-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7786467PMC
January 2021

Comparing the use of direct observation, standardized patients and exit interviews in low- and middle-income countries: a systematic review of methods of assessing quality of primary care.

Health Policy Plan 2020 Dec 12. Epub 2020 Dec 12.

Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.

Clinical records in primary healthcare settings in low- and middle-income countries (LMIC) are often lacking or of too poor quality to accurately assess what happens during the patient consultation. We examined the most common methods for assessing healthcare workers' clinical behaviour: direct observation, standardized patients and patient/healthcare worker exit interview. The comparative feasibility, acceptability, reliability, validity and practicalities of using these methods in this setting are unclear. We systematically review and synthesize the evidence to compare and contrast the advantages and disadvantages of each method. We include studies in LMICs where methods have been directly compared and systematic and narrative reviews of each method. We searched several electronic databases and focused on real-life (not educational) primary healthcare encounters. The most recent update to the search for direct comparison studies was November 2019. We updated the search for systematic and narrative reviews on the standardized patient method in March 2020 and expanded it to all methods. Search strategies combined indexed terms and keywords. We searched reference lists of eligible articles and sourced additional references from relevant review articles. Titles and abstracts were independently screened by two reviewers and discrepancies resolved through discussion. Data were iteratively coded according to pre-defined categories and synthesized. We included 12 direct comparison studies and eight systematic and narrative reviews. We found that no method was clearly superior to the others-each has pros and cons and may assess different aspects of quality of care provision by healthcare workers. All methods require careful preparation, though the exact domain of quality assessed and ethics and selection and training of personnel are nuanced and the methods were subject to different biases. The differential strengths suggest that individual methods should be used strategically based on the research question or in combination for comprehensive global assessments of quality.
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http://dx.doi.org/10.1093/heapol/czaa152DOI Listing
December 2020

Acute Myocardial Infarction in Autoimmune Rheumatologic Disease: A Nationwide Analysis of Clinical Outcomes and Predictors of Management Strategy.

Mayo Clin Proc 2021 02 26;96(2):388-399. Epub 2020 Nov 26.

Keele Cardiovascular Research Group, Centre for Prognosis Research, Institutes of Applied Clinical Science and Primary Care and Health Sciences, Keele University, UK; Department of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK; Department of Medicine (Cardiology), Thomas Jefferson University Hospital, Philadelphia, PA. Electronic address:

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.
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http://dx.doi.org/10.1016/j.mayocp.2020.04.044DOI Listing
February 2021

Missed acute myocardial infarction: an underrecognized problem that contributes to poor patient outcomes.

Coron Artery Dis 2020 Nov 13. Epub 2020 Nov 13.

School of Medicine, Keele University.

Ischemic heart disease is the number one killer in the world. While improvements in the management of acute myocardial infarction (AMI) have resulted in lower mortality rates, there are still cases where AMI is missed with rates varying depending on the setting where the evaluation took place, the population sample, the definition of missed AMI and timing of evaluation. There is consistent evidence that missed AMI is associated with increased risk of complications and mortality. Many factors contribute to missed AMI which include patient factors, clinician factors and institutional factors. While several studies have been conducted to evaluate missed AMI, there is considerable heterogeneity in methodology, which has resulted in variable rates of missed AMI and the factors associated with missed AMI. In this review, we provide an overview on missed AMI discussing rates reported in the literature, why it is important, reasons why it occurs, some of the challenges in evaluating missed AMI and what could potentially be done to reduce these undesirable outcomes for patients.
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http://dx.doi.org/10.1097/MCA.0000000000000975DOI Listing
November 2020

Understanding the uptake of a clinical innovation for osteoarthritis in primary care: a qualitative study of knowledge mobilisation using the i-PARIHS framework.

Implement Sci 2020 10 28;15(1):95. Epub 2020 Oct 28.

Impact Accelerator Unit, Versus Arthritis Primary Care Centre, School of Medicine, Keele University, Staffordshire, ST5 5BG, UK.

Background: Osteoarthritis is a leading cause of pain and disability worldwide. Despite research supporting best practice, evidence-based guidelines are often not followed. Little is known about the implementation of non-surgical models of care in routine primary care practice. From a knowledge mobilisation perspective, the aim of this study was to understand the uptake of a clinical innovation for osteoarthritis and explore the journey from a clinical trial to implementation.

Methods: This study used two methods: secondary analysis of focus groups undertaken with general practice staff from the Managing OSteoArthritis in ConsultationS research trial, which investigated the effectiveness of an enhanced osteoarthritis consultation, and interviews with stakeholders from an implementation project which started post-trial following demand from general practices. Data from three focus groups with 21 multi-disciplinary clinical professionals (5-8 participants per group), and 13 interviews with clinical and non-clinical stakeholders, were thematically analysed utilising the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, in a theoretically informative approach. Public contributors were involved in topic guide design and interpretation of results.

Results: In operationalising implementation of an innovation for osteoarthritis following a trial, the importance of a whole practice approach, including the opportunity for reflection and planning, were identified. The end of a clinical trial provided opportune timing for facilitating implementation planning. In the context of osteoarthritis in primary care, facilitation by an inter-disciplinary knowledge brokering service, nested within an academic institution, was instrumental in supporting ongoing implementation by providing facilitation, infrastructure and resource to support the workload burden. 'Instinctive facilitation' may involve individuals who do not adopt formal brokering roles or fully recognise their role in mobilising knowledge for implementation. Public contributors and lay communities were not only recipients of healthcare innovations but also potential powerful facilitators of implementation.

Conclusion: This theoretically informed knowledge mobilisation study into the uptake of a clinical innovation for osteoarthritis in primary care has enabled further characterisation of the facilitation and recipient constructs of i-PARIHS by describing optimum timing for facilitation and roles and characteristics of facilitators.
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http://dx.doi.org/10.1186/s13012-020-01055-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7594414PMC
October 2020

Research in the time of COVID.

Authors:
Christian Mallen

Eur J Gen Pract 2020 Dec;26(1):154-155

School of Medicine, Keele University.

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http://dx.doi.org/10.1080/13814788.2020.1838184DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7594737PMC
December 2020

Identification of undiagnosed atrial fibrillation patients using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI): Study protocol for a randomised controlled trial.

Contemp Clin Trials 2020 Dec 19;99:106191. Epub 2020 Oct 19.

Department of Haematological Medicine, Guys and St Thomas' NHS Foundation Trust, King's College London, London, UK. Electronic address:

Atrial fibrillation (AF) is associated with an increased risk of stroke, enhanced stroke severity, and other comorbidities. However, AF is often asymptomatic, and frequently remains undiagnosed until complications occur. Current screening approaches for AF lack either cost-effectiveness or diagnostic sensitivity; thus, there is interest in tools that could be used for population screening. An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF. Therefore, the aim of the trial is to assess the effectiveness of this risk prediction algorithm combined with diagnostic testing for the identification of AF in a real-world primary care setting. Eligible participants (aged ≥30 years and without an existing AF diagnosis) registered at participating UK general practices will be randomised into intervention and control arms. Intervention arm participants identified at highest risk of developing AF (algorithm risk score ≥ 7.4%) will be invited for a 12‑lead electrocardiogram (ECG) followed by two-weeks of home-based ECG monitoring with a KardiaMobile device. Control arm participants will be used for comparison and will be managed routinely. The primary outcome is the number of AF diagnoses in the intervention arm compared with the control arm during the research window. If the trial is successful, there is potential for the risk prediction algorithm to be implemented throughout primary care for narrowing the population considered at highest risk for AF who could benefit from more intensive screening for AF. Trial Registration: NCT04045639.
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http://dx.doi.org/10.1016/j.cct.2020.106191DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7571442PMC
December 2020

Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT.

Health Technol Assess 2020 10;24(49):1-130

Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.

Background: Sciatica has a substantial impact on patients and society. Current care is 'stepped', comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics.

Objectives: The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care.

Design: This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial.

Setting: Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK.

Participants: Eligible patients were aged ≥ 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery.

Interventions: In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service.

Main Outcome Measures: The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost-utility analysis was undertaken over 12 months. A qualitative study explored patients' and clinicians' views of the fast-track care pathway to a spinal specialist.

Results: A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46;  = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy.

Conclusions: The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration.

Limitations: Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results.

Future Work: Other approaches to stratified care may provide superior outcomes for sciatica.

Trial Registration: Current Controlled Trials ISRCTN75449581.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 49. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta24490DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7681342PMC
October 2020

Clinical features and outcomes of adults with coronavirus disease 2019: A systematic review and pooled analysis of the literature.

Int J Clin Pract 2020 Sep 23:e13725. Epub 2020 Sep 23.

Department of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK.

Background: The 2019 coronavirus disease (COVID-19) has become a global pandemic and the published literature describing the virus has grown exponentially.

Methods: We conducted a systematic review of the literature to identify the symptoms, comorbidities present, radiological features and outcomes for adults testing positive for COVID-19 admitted to hospital. The results across multiple studies were numerically pooled to yield total estimated.

Results: A total of 45 studies were included in this review with 14 358 adult participants (average age 51 years, male 51%). The pooled findings suggest that the most common symptom among patients was fever (81.2%) followed by cough (62.9%), fatigue (38.0%) and anorexia/loss of appetite (33.7%). The comorbidities that were most prevalent among patients with the virus were hypertension (19.1%), cardiovascular disease (17.9%), endocrine disorder (9.3%) and diabetes (9.2%). Abnormal chest X-ray findings were present in 27.7% of patients and ground-glass opacity was demonstrated on chest computerized tomography in 63.0% of patients. The most frequent adverse outcomes were acute respiratory distress syndrome (27.4%), acute cardiac injury (16.2%) and acute kidney injury (12.6%). Death occurred in 8.2% of patients and 16.3% required intensive care admission and 11.7% had mechanical ventilation. Bacterial or secondary infections affected 8.5% of patients and 6.9% developed shock.

Conclusions: COVID-19 most commonly presents with fever, cough, fatigue and anorexia and among patients with existing hypertension and cardiovascular disease. It is important as serious adverse outcomes can develop such as acute respiratory distress syndrome, acute cardiac injury, acute kidney injury and death.
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http://dx.doi.org/10.1111/ijcp.13725DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7536970PMC
September 2020

Cohort profile: Oxford Pain, Activity and Lifestyle (OPAL) Study, a prospective cohort study of older adults in England.

BMJ Open 2020 09 3;10(9):e037516. Epub 2020 Sep 3.

Centre for Rehabilitation Research in Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

Purpose: The 'Oxford Pain, Activity and Lifestyle' (OPAL) Cohort is a longitudinal, prospective cohort study of adults, aged 65 years and older, living in the community which is investigating the determinants of health in later life. Our focus was on musculoskeletal pain and mobility, but the cohort is designed with flexibility to include new elements over time. This paper describes the study design, data collection and baseline characteristics of participants. We also compared the OPAL baseline characteristics with nationally representative data sources.

Participants: We randomly selected eligible participants from two stratified age bands (65-74 and 75 and over years). In total, 5409 individuals (42.1% of eligible participants) from 35 general practices in England agreed to participate between 2016 and 2018. The majority of participants (n=5367) also consented for research team to access their UK National Health Service (NHS) Digital and primary healthcare records.

Findings To Date: Mean participant age was 74.9 years (range 65-100); 51.5% (n=2784/5409) were women. 94.9% of participants were white, and 28.8% lived alone. Over 83.0% reported pain in at least one body area in the previous 6 weeks. Musculoskeletal symptoms were more prevalent in women (86.4%). One-third of participants reported having one or more falls in the last year. Most participants were confident in their ability to walk outside. The characteristics of OPAL Cohort participants were broadly similar to the general population of the same age.

Future Plans: Postal follow-up of the cohort is being undertaken at annual intervals, with data collection ongoing. Linkage to NHS hospital admission data is planned. This English prospective cohort offers a large and rich resource for research on the longitudinal associations between demographic, clinical, and social factors and health trajectories and outcomes in community-dwelling older people.
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http://dx.doi.org/10.1136/bmjopen-2020-037516DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7473632PMC
September 2020

Latent Class Growth Analysis of Gout Flare Trajectories: A Three-Year Prospective Cohort Study in Primary Care.

Arthritis Rheumatol 2020 11 3;72(11):1928-1935. Epub 2020 Oct 3.

Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.

Objective: To investigate the existence of distinct classes of gout flare trajectories and compare their gout-specific, comorbid, and sociodemographic characteristics.

Methods: In a prospective cohort study, adults with gout who were registered with 20 general practices self-reported the number of gout flares experienced at baseline and after 6, 12, 24, and 36 months via postal questionnaires. Latent class growth analysis (LCGA) was used to identify distinct gout flare trajectory classes. Statistical criteria and clinical interpretability were used to decide the optimal number of classes. Baseline comorbidities, medications, and sociodemographic and gout-specific characteristics of members of each class were described.

Results: A total of 1,164 participants (mean ± SD age 65.6 ± 12.5 years; 972 [84%] male) were included. Six latent gout flare trajectory classes were identified: "frequent and persistent" (n = 95), "gradually worsening" (n = 276), "frequent then improving" (n = 14), "moderately frequent" (n = 287), "moderately frequent then improving" (n = 143), and "infrequent" (n = 349). The "frequent and persistent" trajectory had the most class members classified as obese and, along with the "gradually worsening" class, the highest proportion who were socioeconomically deprived. The "frequent and persistent," "gradually worsening," and "frequent then improving" classes had the highest proportions of class members with an estimated glomerular filtration rate <60 ml/minute/1.73 m . The "infrequent" gout flare class was associated with more frequent allopurinol use and lower urate levels.

Conclusion: Six distinct gout flare trajectories were identified. Infrequent flares were associated with allopurinol use and lower serum urate levels, supporting the use of urate-lowering therapy to reduce flare frequency. The characteristics of flare trajectory classes could help to target interventions and improve patient care.
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http://dx.doi.org/10.1002/art.41476DOI Listing
November 2020

Mortality among patients with polymyalgia rheumatica: A retrospective cohort study.

Arthritis Care Res (Hoboken) 2020 Aug 2. Epub 2020 Aug 2.

Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.

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.
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August 2020

Outcomes Measured in Polymyalgia Rheumatica and Measurement Properties of Instruments Considered for the OMERACT Core Outcome Set: A Systematic Review.

J Rheumatol 2020 Aug 1. Epub 2020 Aug 1.

This work was supported by a Wellcome Trust PhD Programme for Primary Care Clinicians [203921/Z/16/Z], which supports Helen Twohig. CDM is funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands, the NIHR School for Primary Care Research and a NIHR Research Professorship in General Practice (NIHRRP- 2014-04-026). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. 1H. Twohig, MRCP, MRCGP, S. Muller, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK; 2C. Owen, MBBS (Hons), FRACP, Department of Rheumatology, Austin Health, and Department of Medicine, University of Melbourne, Melbourne, Australia; 3C.D. Mallen, FRCGP, PhD, S. Hider, FRCP, PhD, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, and Midlands Partnership Foundation Trust, Staffordshire, UK; 4C. Mitchell, FRCGP, MD, Academic Department of Primary Medical Care, University of Sheffield, Sheffield, UK; 5C. Hill, FRACP, MD, Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, and Discipline of Medicine, The University of Adelaide, Adelaide, Australia; 6B. Shea, PhD, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; 7S.L. Mackie, MRCP, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Woodhouse, Leeds, UK. S.L. Mackie declares consultancy to Roche, Chugai, and Sanofi on behalf of University of Leeds (no money paid to her directly in last 3 years); Patron of PMRGCAuk; current or recent site investigator on clinical trials for GSK and Sanofi; and EULAR2019 attendance supported by Roche. S. Muller is a trustee of PMRGCAuk. Address correspondence to Dr. H. Twohig, Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK. Email: Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 13, 2020.

Objective: To systematically identify the outcome measures and instruments used in clinical studies of polymyalgia rheumatica (PMR) and to evaluate evidence about their measurement properties.

Methods: Searches based on the MeSH term "polymyalgia rheumatica" were carried out in 5 databases. Two researchers were involved in screening, data extraction, and risk of bias assessment. Once outcomes and instruments used were identified and categorized, key instruments were selected for further review through a consensus process. Studies on measurement properties of these instruments were appraised against the COSMIN-OMERACT (COnsensus-based Standards for the selection of health Measurement Instruments-Outcome Measures in Rheumatology) checklist to determine the extent of evidence supporting their use in PMR.

Results: Forty-six studies were included. In decreasing order of frequency, the most common outcomes (and instruments) used were markers of systemic inflammation [erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)], pain [visual analog scale (VAS)], stiffness (duration in minutes), and physical function (elevation of upper limbs). Instruments selected for further evaluation were ESR, CRP, pain VAS, morning stiffness duration, and the Health Assessment Questionnaire. Five studies evaluated measurement properties of these instruments, but none met all of the COSMIN-OMERACT checklist criteria.

Conclusion: Measurement of outcomes in studies of PMR lacks consistency. The critical patient-centered domain of physical function is poorly assessed. None of the candidate instruments considered for inclusion in the core outcome set had high-quality evidence, derived from populations with PMR, on their full range of measurement properties. Further studies are needed to determine whether these instruments are suitable for inclusion in a core outcome measurement set for PMR.
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http://dx.doi.org/10.3899/jrheum.200248DOI Listing
August 2020

Improving Empathy in Healthcare Consultations-a Secondary Analysis of Interventions.

J Gen Intern Med 2020 10 14;35(10):3007-3014. Epub 2020 Jul 14.

University of Oxford , Oxford, UK.

A recent systematic review of randomised trials suggested that empathic communication improves patient health outcomes. However, the methods for training healthcare practitioners (medical professionals; HCPs) in empathy and the empathic behaviours demonstrated within the trials were heterogeneous, making the evidence difficult to implement in routine clinical practice. In this secondary analysis of seven trials in the review, we aimed to identify (1) the methods used to train HCPs, (2) the empathy behaviours they were trained to perform and (3) behaviour change techniques (BCTs) used to encourage the adoption of those behaviours. This detailed understanding of interventions is necessary to inform implementation in clinical practice. We conducted a content analysis of intervention descriptions, using an inductive approach to identify training methods and empathy behaviours and a deductive approach to describe the BCTs used. The most commonly used methods to train HCPs to enhance empathy were face-to-face training (n = 5), role-playing (n = 3) and videos (self or model; n = 3). Duration of training was varied, with both long and short training having high effect sizes. The most frequently targeted empathy behaviours were providing explanations of treatment (n = 5), providing non-specific empathic responses (e.g. expressing understanding) and displaying a friendly manner and using non-verbal behaviours (e.g. nodding, leaning forward, n = 4). The BCT most used to encourage HCPs to adopt empathy behaviours was "Instruction on how to perform behaviour" (e.g. a video demonstration, n = 5), followed by "Credible source" (e.g. delivered by a psychologist, n = 4) and "Behavioural practice" (n = 3 e.g. role-playing). We compared the effect sizes of studies but could not extrapolate meaningful conclusions due to high levels of variation in training methods, empathy skills and BCTs. Moreover, the methods used to train HCPs were often poorly described which limits study replication and clinical implementation. This analysis of empathy training can inform future research, intervention reporting standards and clinical practice.
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http://dx.doi.org/10.1007/s11606-020-05994-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7572919PMC
October 2020

Managing hypertension in frail oldest-old-The role of guideline use by general practitioners from 29 countries.

PLoS One 2020 10;15(7):e0236064. Epub 2020 Jul 10.

Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.

Background: The best management of hypertension in frail oldest-old (≥80 years of age) remains unclear and we still lack guidelines that provide specific recommendations. Our study aims to investigate guideline use in general practitioners (GPs) and to examine if guideline use relates to different decisions when managing hypertension in frail oldest-old.

Design/setting: Cross-sectional study among currently active GPs from 29 countries using a case-vignettes survey.

Methods: GPs participated in a survey with case-vignettes of frail oldest-olds varying in systolic blood pressure (SBP) levels and cardiovascular disease (CVD). GPs from 26 European countries and from Brazil, Israel and New Zealand were invited. We compared the percentage of GPs reporting using guidelines per country and further stratified on the most frequently mentioned guidelines. To adjust for patient characteristics (SBP, CVD and GPs' sex, years of experience, prevalence of oldest-old and location of their practice), we used a mixed-effects regression model accounting for clustering within countries.

Results: Overall, 2,543 GPs from 29 countries were included. 59.4% of them reported to use guidelines. Higher guideline use was found in female (p = 0.031) and less-experienced GPs (p<0.001). Across countries, we found a large variation in self-reported guideline use, ranging from 25% to 90% of the GPs, but there was no difference in hypertension treatment decisions in frail oldest-old patients between GPs that did not use and GPs that used guidelines, irrespective of the guidelines they used.

Conclusion: Many GPs reported using guidelines to manage hypertension in frail oldest-old patients, however guideline users did not decide differently from non-users concerning hypertension treatment decisions. Instead of focusing on the fact if GPs use guidelines or not, we as a scientific community should put an emphasis on what guidelines suggest in frail and oldest-old patients.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236064PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7351187PMC
September 2020

Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial.

Lancet Rheumatol 2020 Jul 25;2(7):e401-e411. Epub 2020 Jun 25.

Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.

Background: Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the clinical and cost-effectiveness of stratified care versus non-stratified usual care for patients presenting with sciatica in primary care.

Methods: We did a two-parallel arm, pragmatic, randomised controlled trial across three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire). Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery. Patients were recruited from general practices and randomly assigned (1:1) by a remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation. In the stratified care arm, a combination of prognostic and clinical criteria associated with referral to spinal specialist services were used to allocate patients to one of three groups for matched care pathways. Group 1 was offered brief advice and support in up to two physiotherapy sessions; group 2 was offered up to six physiotherapy sessions; and group 3 was fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomisation. The primary outcome was self-reported time to first resolution of sciatica symptoms, defined as "completely recovered" or "much better" on a 6-point ordinal scale, collected via text messages or telephone calls. Analyses were by intention to treat. Health-care costs and cost-effectiveness were also assessed. This trial is registered on the ISRCTN registry, ISRCTN75449581.

Findings: Between May 28, 2015, and July 18, 2017, 476 patients from 42 general practices around three UK centres were randomly assigned to stratified care or usual care (238 in each arm). For the primary outcome, the overall response rate was 89% (9467 of 10 601 text messages sent; 4688 [88%] of 5310 in the stratified care arm and 4779 [90%] of 5291 in the usual care arm). Median time to symptom resolution was 10 weeks (95% CI 6·4-13·6) in the stratified care arm and 12 weeks (9·4-14·6) in the usual care arm, with the survival analysis showing no significant difference between the arms (hazard ratio 1·14 [95% CI 0·89-1·46]). Stratified care was not cost-effective compared to usual care.

Interpretation: The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes. These results do not support a transition to this stratified care model for patients with sciatica.

Funding: National Institute for Health Research.
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http://dx.doi.org/10.1016/S2665-9913(20)30099-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7323615PMC
July 2020

Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial.

Lancet Rheumatol 2020 Jul 25;2(7):e401-e411. Epub 2020 Jun 25.

Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.

Background: Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the clinical and cost-effectiveness of stratified care versus non-stratified usual care for patients presenting with sciatica in primary care.

Methods: We did a two-parallel arm, pragmatic, randomised controlled trial across three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire). Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery. Patients were recruited from general practices and randomly assigned (1:1) by a remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation. In the stratified care arm, a combination of prognostic and clinical criteria associated with referral to spinal specialist services were used to allocate patients to one of three groups for matched care pathways. Group 1 was offered brief advice and support in up to two physiotherapy sessions; group 2 was offered up to six physiotherapy sessions; and group 3 was fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomisation. The primary outcome was self-reported time to first resolution of sciatica symptoms, defined as "completely recovered" or "much better" on a 6-point ordinal scale, collected via text messages or telephone calls. Analyses were by intention to treat. Health-care costs and cost-effectiveness were also assessed. This trial is registered on the ISRCTN registry, ISRCTN75449581.

Findings: Between May 28, 2015, and July 18, 2017, 476 patients from 42 general practices around three UK centres were randomly assigned to stratified care or usual care (238 in each arm). For the primary outcome, the overall response rate was 89% (9467 of 10 601 text messages sent; 4688 [88%] of 5310 in the stratified care arm and 4779 [90%] of 5291 in the usual care arm). Median time to symptom resolution was 10 weeks (95% CI 6·4-13·6) in the stratified care arm and 12 weeks (9·4-14·6) in the usual care arm, with the survival analysis showing no significant difference between the arms (hazard ratio 1·14 [95% CI 0·89-1·46]). Stratified care was not cost-effective compared to usual care.

Interpretation: The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes. These results do not support a transition to this stratified care model for patients with sciatica.

Funding: National Institute for Health Research.
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http://dx.doi.org/10.1016/S2665-9913(20)30099-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7323615PMC
July 2020

Initial analgesic prescriptions for osteoarthritis in the United Kingdom, 2000-2016.

Rheumatology (Oxford) 2021 Jan;60(1):147-159

Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital.

Objectives: To examine trends in the initial prescription of commonly-prescribed analgesics and patient- as well as practice-level factors related to their selection in incident OA.

Methods: Patients consulting with incident clinical OA between 2000-2016 were identified within The Health Improvement Network in the United Kingdom (UK) general practice. Excluded were patients who had history of cancer or were prescribed the analgesics of interest within 6 months before diagnosis of OA. Initial analgesic prescription included oral non-selective NSAID, oral selective cyclooxygenase-2 inhibitor, topical NSAID, paracetamol, topical salicylate or oral/transdermal opioid within 1 month after OA diagnosis.

Results: ∼44% of patients with incident OA (n = 125 696) were prescribed one of these analgesics. Incidence of oral NSAID prescriptions decreased whereas other analgesic prescriptions, including oral opioid prescriptions, increased (all P-for-trend < 0.001). Patients with a history of gastrointestinal disease were more likely to receive topical NSAIDs, paracetamol or oral/transdermal opioids. Only 38% of patients with history of gastrointestinal disease and 21% of patients without it had co-prescription of gastroprotective agent with oral NSAIDs. Oral/transdermal opioid prescription was higher among the elderly (≥65 years), women, obesity, current smoker, and patients with gastrointestinal, cardiovascular or chronic kidney disease. Prescription of oral opioids increased with social deprivation (P-for-trend < 0.05) and was highest in Scotland, whereas transdermal opioid prescription was highest in Northern Ireland (all P-for-homogeneity-test < 0.05).

Conclusion: The initial prescription pattern of analgesics for OA has changed over time in the UK. Co-prescription of gastroprotective agents with oral NSAIDs remains suboptimal, even among those with prior gastrointestinal disease.
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http://dx.doi.org/10.1093/rheumatology/keaa244DOI Listing
January 2021

Corrigendum to: Statin use and risk of joint replacement due to osteoarthritis and rheumatoid arthritis: a propensity-score matched longitudinal cohort study.

Rheumatology (Oxford) 2020 10;59(10):3120

Academic Rheumatology Department, Division of Rheumatology, Orthopaedics and Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.

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http://dx.doi.org/10.1093/rheumatology/keaa223DOI Listing
October 2020

Rheumatic Conditions as Risk Factors for Self-Harm: A Retrospective Cohort Study.

Arthritis Care Res (Hoboken) 2021 01;73(1):130-137

Keele University, Newcastle, UK.

Objective: To examine the risk of self-harm in rheumatic conditions.

Methods: We conducted a retrospective cohort study using data from the Clinical Practice Research Datalink. Patients with ankylosing spondylitis, fibromyalgia, osteoarthritis, or rheumatoid arthritis were identified from 1990 to 2016 and matched to patients without these conditions. Incident self-harm was defined by medical record codes following a rheumatic diagnosis. Incidence rates (per 10,000 person-years) were reported for each condition, both overall and year-on-year (2000-2016). Cox regression analysis determined risk (hazard ratio [HR] and 95% confidence interval [95% CI]) of self-harm for each rheumatic cohort compared to the matched unexposed cohort. Initial crude analysis was subsequently adjusted and stratified by age and sex. Due to nonproportionality over time, osteoarthritis was also stratified by disease duration (<1 year, ≥1 to <5 years, ≥5 to <10 years, and ≥10 years).

Results: The incidence of self-harm was highest in patients with fibromyalgia (HR 25.12 [95% CI 22.45-28.11] per 10,000 person-years) and lowest for osteoarthritis (HR 6.48 [95% CI 6.20-6.76]). There was a crude association with each rheumatic condition and self-harm, except for ankylosing spondylitis. Although attenuated, these associations remained after adjustment for fibromyalgia (HR 2.06 [95% CI 1.60-2.65]), rheumatoid arthritis (HR 1.59 [95% CI 1.20-2.11]), and osteoarthritis (1 to <5 years HR 1.12 [95% CI 1.01-1.24]; ≥5 to <10 years HR 1.35 [95% CI 1.18-1.54]). Age and sex were weak effect modifiers for these associations.

Conclusion: Primary care patients with fibromyalgia, osteoarthritis, or rheumatoid arthritis (but not ankylosing spondylitis) are at increased risk of self-harm compared to people without these rheumatic conditions. Clinicians need to be aware of the potential for self-harm in patients with rheumatic conditions (particularly fibromyalgia), explore mood and risk with them, and offer appropriate support and management.
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http://dx.doi.org/10.1002/acr.24345DOI Listing
January 2021

Comorbidities in patients with polymyalgia rheumatica prior to and following diagnosis: A case control and cohort study.

Semin Arthritis Rheum 2020 08 26;50(4):663-672. Epub 2020 May 26.

Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.

Objectives: To determine the burden of comorbidities, including glucocorticoid (GC) related adverse effects, in patients with polymyalgia rheumatica (PMR) before and after diagnosis.

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.

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.

Conclusions: 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.
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http://dx.doi.org/10.1016/j.semarthrit.2020.05.003DOI Listing
August 2020

Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial.

JMIR Res Protoc 2020 Jul 5;9(7):e17939. Epub 2020 Jul 5.

Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.

Background: Musculoskeletal (MSK) pain is a major cause of pain and disability. We previously developed a prognostic tool (Start Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision making using matched treatments. A logical next step is to determine whether prognostic stratified care has benefits for a broader range of common MSK pain presentations.

Objective: This study seeks to determine, in patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain), whether stratified care involving the use of the Keele Start MSK Tool to allocate individuals into low-, medium-, and high-risk subgroups, and matching these subgroups to recommended matched clinical management options, is clinical and cost-effective compared with usual nonstratified primary care.

Methods: This is a pragmatic, two-arm parallel (stratified vs nonstratified care), cluster randomized controlled trial, with a health economic analysis and mixed methods process evaluation. The setting is UK primary care, involving 24 average-sized general practices randomized (stratified by practice size) in a 1:1 ratio (12 per arm) with blinding of trial statistician and outcome data collectors. Randomization units are general practices, and units of observation are adult MSK consulters without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template. The intervention is supported by an EMR template (computer-based) housing the Keele Start MSK Tool (to stratify into prognostic subgroups) and the recommended matched treatment options. The primary outcome using intention-to-treat analysis is pain intensity, measured monthly over 6 months. Secondary outcomes include physical function and quality of life, and an anonymized EMR audit to capture clinician decision making. The economic evaluation is focused on the estimation of incremental quality-adjusted life years and MSK pain-related health care costs. The process evaluation is exploring a range of potential factors influencing the intervention and understanding how it is perceived by patients and clinicians, with quantitative analyses focusing on a priori hypothesized intervention targets and qualitative approaches using focus groups and interviews. The target sample size is 1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons.

Results: Trial recruitment commenced on May 18, 2018, and ended on July 15, 2019, after a 14-month recruitment period in 24 GP practices. Follow-up and interview data collection was completed in February 2020.

Conclusions: This trial is the first attempt, as far as we know, at testing a prognostic stratified care approach for primary care patients with MSK pain. The results of this trial should be available by the summer of 2020.

Trial Registration: ISRCTN Registry ISRCTN15366334; http://www.isrctn.com/ISRCTN15366334.

International Registered Report Identifier (irrid): DERR1-10.2196/17939.
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http://dx.doi.org/10.2196/17939DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7381066PMC
July 2020

Development and validation of the DIabetes Severity SCOre (DISSCO) in 139 626 individuals with type 2 diabetes: a retrospective cohort study.

BMJ Open Diabetes Res Care 2020 05;8(1)

NIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, Manchester Academic Health Science Centre (MAHSC), The University of Manchester, Manchester, UK.

Objective: Clinically applicable diabetes severity measures are lacking, with no previous studies comparing their predictive value with glycated hemoglobin (HbA). We developed and validated a type 2 diabetes severity score (the DIabetes Severity SCOre, DISSCO) and evaluated its association with risks of hospitalization and mortality, assessing its additional risk information to sociodemographic factors and HbA.

Research Design And Methods: We used UK primary and secondary care data for 139 626 individuals with type 2 diabetes between 2007 and 2017, aged ≥35 years, and registered in general practices in England. The study cohort was randomly divided into a training cohort (n=111 748, 80%) to develop the severity tool and a validation cohort (n=27 878). We developed baseline and longitudinal severity scores using 34 diabetes-related domains. Cox regression models (adjusted for age, gender, ethnicity, deprivation, and HbA) were used for primary (all-cause mortality) and secondary (hospitalization due to any cause, diabetes, hypoglycemia, or cardiovascular disease or procedures) outcomes. Likelihood ratio (LR) tests were fitted to assess the significance of adding DISSCO to the sociodemographics and HbA models.

Results: A total of 139 626 patients registered in 400 general practices, aged 63±12 years were included, 45% of whom were women, 83% were White, and 18% were from deprived areas. The mean baseline severity score was 1.3±2.0. Overall, 27 362 (20%) people died and 99 951 (72%) had ≥1 hospitalization. In the training cohort, a one-unit increase in baseline DISSCO was associated with higher hazard of mortality (HR: 1.14, 95% CI 1.13 to 1.15, area under the receiver operating characteristics curve (AUROC)=0.76) and cardiovascular hospitalization (HR: 1.45, 95% CI 1.43 to 1.46, AUROC=0.73). The LR tests showed that adding DISSCO to sociodemographic variables significantly improved the predictive value of survival models, outperforming the added value of HbA for all outcomes. Findings were consistent in the validation cohort.

Conclusions: Higher levels of DISSCO are associated with higher risks for hospital admissions and mortality. The new severity score had higher predictive value than the proxy used in clinical practice, HbA. This reproducible algorithm can help practitioners stratify clinical care of patients with type 2 diabetes.
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http://dx.doi.org/10.1136/bmjdrc-2019-000962DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7228474PMC
May 2020

Using Google Trends to assess the impact of global public health days on online health information seeking behaviour in Central and South America.

J Glob Health 2020 Jun;10(1):010403

School of Primary, Community and Social Care, Keele University, Staffordshire, UK.

Background: Public health awareness can help prevent illness and result in earlier intervention when it does occur. For this reason, health promotion and disease awareness campaigns have great potential to alleviate the global burden of disease. Global Public Health Days (GPHD) are frequently implemented with this intent, but research evaluating their effectiveness, especially in the developing world setting, is scant.

Objectives: We aimed to evaluate the impact of four GPHDs (World Cancer Day, World Diabetes Day, World Mental Health Day, World AIDS Day) on online health information seeking behaviour (OHISB) in five Central and South American (CSA) countries which differ in their stage of economic development and epidemiological transition (Uruguay, Chile, Brazil, Colombia, Nicaragua).

Methods: Google Trends data was used as a 'surrogate' of OHISB. This was measured on the 28 days leading up to the GPHD, on the date of the GPHD, and on the seven days following it. The Joinpoint regression programme was used to perform a time trend analysis on the Google Trends data. This allowed us to identify statistically significant time points of a change in trend, which reflect significant 'changes' to OHISB.

Results: GPHDs were inconsistently effective at influencing internet search query activity in the studied countries. In situations where an effect was significant, this impact was consistently short-term, with Relative Search Volume level returning to precampaign levels within 7 days of the GPHD.

Conclusions: Our findings imply the need to revise GPHDs or create alternative health awareness campaigns, perhaps with a more long-term approach and tailored to the specific health needs of the CSA population. Developing effective preventive strategies is vital in helping combat the rising threat of NCDs in this region.
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http://dx.doi.org/10.7189/jogh.10.010403DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7182390PMC
June 2020

Family medicine in times of 'COVID-19': A generalists' voice.

Eur J Gen Pract 2020 12;26(1):58-60

Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.

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http://dx.doi.org/10.1080/13814788.2020.1757312DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7241505PMC
December 2020

Mortality in patients with gout treated with allopurinol: a systematic review and meta-analysis.

Arthritis Care Res (Hoboken) 2020 Apr 14. Epub 2020 Apr 14.

School of Primary, Community and Social Care, Keele University, Keele, UK.

Background: Urate-lowering therapy (predominantly allopurinol) is highly effective as a treatment for gout, but its wider long-term effects remain unclear. This systematic review and meta-analysis aimed to ascertain the association between allopurinol use in patients with gout and mortality.

Method: MEDLINE, EMBASE, CINAHL and the Cochrane Library were searched from inception to August 2018. Articles eligible for inclusion used a cohort design and examined cardiovascular or all-cause mortality in patients diagnosed with gout and prescribed allopurinol. Information on study characteristics, design, sample size and mortality risk estimates were extracted. Article quality was assessed using the Newcastle-Ottawa Scale. Included articles were described in a narrative synthesis and (where possible) risk estimate data were pooled.

Results: Four articles reported a hazard ratio (HR) risk estimate for all-cause mortality in patients with gout using allopurinol, two of these also reported cardiovascular mortality. Two articles found allopurinol to be protective in patients with gout, one found no statistically significant association and one found no statistically significant effect of escalation of allopurinol dosage on all-cause or cardiovascular-related mortality. Data pooling was possible for all-cause mortality and found no association between allopurinol use in patients with gout and all-cause mortality compared to patients with gout not using allopurinol (adjusted HR 0.80 (95%CI (0.60, 1.05).

Conclusions: There was no significant association between all-cause mortality and allopurinol use in people with gout. However, the number of included studies was small, suggesting that further studies are needed.
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http://dx.doi.org/10.1002/acr.24205DOI Listing
April 2020