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Home-based rehabilitation programme compared with traditional physiotherapy for patients at risk of poor outcome after knee arthroplasty: the CORKA randomised controlled trial.

OBJECTIVES: To evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy. DESIGN: A prospective, single-blind, two-arm randomised controlled superiority trial. SETTING: 14 National Health Service physiotherapy departments in the UK. PARTICIPANTS: 621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool. INTERVENTIONS: A multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy. MAIN OUTCOME MEASURES: The primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance. RESULTS: 621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4-7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2-6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points; 95% CI -0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions. CONCLUSIONS: The CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group. TRIAL REGISTRATION NUMBER: ISRCTN13517704.

Anti-TNF (adalimumab) injection for the treatment of adults with frozen shoulder during the pain predominant stage protocol for a multi-centre, randomised, double blind, parallel group, feasibility trial.

OBJECTIVES: The Anti-Freaze-F trial will assess the feasibility of conducting a large randomised controlled trial to assess whether intra-articular injection of anti-TNF (adalimumab) can reduce pain and improve function in people with pain predominant early stage frozen shoulder. METHODS AND ANALYSIS: We are conducting a multi-centre, randomised feasibility study, with an embedded qualitative sub-study. We will recruit adults ≥18 years with a new episode of shoulder pain attributable to early stage frozen shoulder, recruited from at least five UK NHS musculoskeletal and related physiotherapy services. Participants (n=84) will be randomised (centralised computer generated 1:1 allocation) to receive either: 1) intra-articular injection of anti-TNF (adalimumab 160mg) or 2) placebo injection (saline [0.9% sodium chloride]), both under ultrasound guidance. A second injection of the allocated treatment (adalimumab 80mg) or equivalent volume of placebo will be administered 2-3 weeks later. All participants will receive a physiotherapy advice leaflet providing education and advice about frozen shoulder and pain management. The primary feasibility objectives are: 1) the ability to screen and identify potential participants with pain predominant early stage frozen shoulder; 2) willingness of eligible participants to consent and be randomised to intervention; 3) practicalities of delivering the intervention, including time to first injection and number of participants receiving second injection; 4) standard deviation of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months (i.e. 12 weeks) post-randomisation in order to estimate the sample size for a definitive trial. We will also assess follow up rates and viability of patient-reported outcome measures and range of shoulder motion for a definitive trial. Research Ethics Committee approval (REC 21/NE/0214). TRIAL REGISTRATION NUMBER: ISRCTN 27075727; EudraCT number: 2021-003509-23; ClinicalTrials.gov NCT05299242.

Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT.

BACKGROUND: Over 100,000 primary knee arthroplasty operations are undertaken annually in the UK. Around 15-30% of patients do not report a good outcome. Better rehabilitation strategies may improve patient-reported outcomes. OBJECTIVES: To compare the outcomes from a traditional outpatient physiotherapy model with those from a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty. DESIGN: An individually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study. SETTING: The trial took place in 14 NHS physiotherapy departments. PARTICIPANTS: People identified as being at high risk of a poor outcome after knee arthroplasty. INTERVENTIONS: A multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy. MAIN OUTCOME MEASURES: The primary outcome was the Late Life Function and Disability Instrument at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function); Knee injury and Osteoarthritis Outcome Score; Quality of Life subscale; Physical Activity Scale for the Elderly; EuroQol-5 Dimensions, five-level version; and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance. Data on the use of health-care services, time off work and informal care were collected using participant diaries. RESULTS: In total, 621 participants were randomised. A total of 309 participants were assigned to the COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme, receiving a median of five treatment sessions (interquartile range 4-7 sessions). A total of 312 participants were assigned to usual care, receiving a median of four sessions (interquartile range 2-6 sessions). The primary outcome, Late Life Function and Disability Instrument function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual-care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference 0.49 points, 95% confidence interval -0.89 to 1.88 points; p = 0.48). There were no statistically significant differences between the groups in any of the patient-reported or physical secondary outcome measures at 6 or 12 months post randomisation. The health economic analysis found that the CORKA intervention was cheaper to provide than usual care (£66 less per participant). Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant). Adopting a societal perspective, CORKA had a 75% probability of being cost-effective at a threshold of £30,000 per quality-adjusted life-year. Adopting the narrower health and social care perspective, CORKA had a 43% probability of being cost-effective at the same threshold. LIMITATIONS: The interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded. CONCLUSIONS: This randomised controlled trial found no important differences in outcomes when post-arthroplasty rehabilitation was delivered using a home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model. However, the health economic evaluation found that when adopting a societal perspective, the CORKA home-based intervention was cost-saving and more effective than, and thus dominant over, usual care, owing to reduced time away from paid employment for this group. Further research could look at identifying the risk of poor outcome and further evaluation of a cost-effective treatment, including the workforce model to deliver it. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13517704. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 65. See the NIHR Journals Library website for further project information.

Anti-TNF (adalimumab) injection for the treatment of adults with frozen shoulder during the pain predominant stage protocol for a multi-centre, randomised, double blind, parallel group, feasibility trial

<ns4:p><ns4:bold>Objectives:</ns4:bold> The Anti-Freaze-F trial will assess the feasibility of conducting a large randomised controlled trial to assess whether intra-articular injection of anti-TNF (adalimumab) can reduce pain and improve function in people with pain predominant early stage frozen shoulder.</ns4:p><ns4:p> <ns4:bold>Methods and analysis:</ns4:bold> We are conducting a multi-centre, randomised feasibility study, with an embedded qualitative sub-study. We will recruit adults ≥18 years with a new episode of shoulder pain attributable to early stage frozen shoulder, recruited from at least five UK NHS musculoskeletal and related physiotherapy services. Participants (n=84) will be randomised (centralised computer generated 1:1 allocation) to receive either: 1) intra-articular injection of anti-TNF (adalimumab 160mg) or 2) placebo injection (saline [0.9% sodium chloride]), both under ultrasound guidance. A second injection of the allocated treatment (adalimumab 80mg) or equivalent volume of placebo will be administered 2-3 weeks later. All participants will receive a physiotherapy advice leaflet providing education and advice about frozen shoulder and pain management. The primary feasibility objectives are: 1) the ability to screen and identify potential participants with pain predominant early stage frozen shoulder; 2) willingness of eligible participants to consent and be randomised to intervention; 3) practicalities of delivering the intervention, including time to first injection and number of participants receiving second injection; 4) standard deviation of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months from baseline in order to estimate the sample size for a definitive trial. We will also assess follow up rates and viability of patient-reported outcome measures and range of shoulder motion for a definitive trial.  Research Ethics Committee approval (REC 21/NE/0214).</ns4:p><ns4:p> <ns4:bold>Trial registration number:</ns4:bold> ISRCTN 27075727; EudraCT number: 2021-003509-23; ClinicalTrials.gov NCT05299242.</ns4:p>

plaTform fOr Urinary tract infection diagnostiC evAluatioN (TOUCAN): a protocol for a prospective diagnostic accuracy study of point-of-care testing in patients suspected of acute uncomplicated urinary tract infection in primary care clinics in England.

INTRODUCTION: Acute uncomplicated urinary tract infection (UTI) is a common condition with potentially serious sequelae that is mostly diagnosed and managed in primary care settings. Around half of all women have a UTI in their lifetime, and a quarter experience an infection caused by organisms resistant to more than one antibiotic. Reducing inappropriate prescribing of antibiotics is a core tenet of antimicrobial stewardship. However, current diagnostics for UTI are unfit for purpose in acute (highest prescribing) settings, being too slow to inform the required immediate decision-making and often confounded by sample contamination.Rapid point-of-care diagnostic tests (POCTs) that facilitate timely decision-making are potential solutions to this problem. Several such tests have reached advanced stages of technology readiness, but their diagnostic performance has not been evaluated in primary care with clinical users. To progress novel tests towards implementation, a diagnostic field study is required, to allow for parallel and sequential evaluation of multiple tests in a primary care population. METHODS AND ANALYSIS: We will recruit participants assigned female at birth from primary care clinics in England who contact their clinic with symptoms of acute uncomplicated UTI. Eligible participants will complete a short questionnaire to capture symptoms and symptom severity and will provide a urine sample. Samples will be split and initially tested using novel index tests (POCTs) and conventional urinalysis 'dipstick' at the primary care clinic. The second part of the sample will be processed at a National Health Service-based reference laboratory using a modified reference standard including microscopy, microbiological culture, pathogen speciation and antimicrobial susceptibility testing. The UTI reference standard culture, although based on the national methods, is modified to provide accurate bacterial counts, better to define a microbiological diagnosis of UTI. Susceptibility testing will be performed using 'gold-standard' methods, not usually performed in diagnostic laboratories. The primary outcome will be the diagnostic performance (sensitivity, specificity, positive and negative predictive values) of POCTs for detection of UTI and antimicrobial susceptibility for POCTs that include antimicrobial susceptibility testing. Secondary outcomes will include the symptom profile of patients presenting with uncomplicated UTI, a theoretical determination of how use of POCT results might change prescribing, an understanding of POCT failure rate and qualitative capture of the experiences of those using the POCT to deliver the study in primary care clinics. ETHICS AND DISSEMINATION: Ethical approval was received from the London Central Research Ethics Committee (23/LO/0371) and the UK Health Research Authority. We will publish the findings of The plaTform fOr Urinary tract infection diagnostiC evAluatioN evaluations in peer-reviewed medical journals and more broadly following a dissemination plan formulated by a communications specialist in consultation with patients and the public. TRIAL REGISTRATION NUMBER: ISRCTN80937472.

Effect of antihypertensive deprescribing on hospitalisation and mortality: long-term follow-up of the OPTiMISE randomised controlled trial.

BACKGROUND: Deprescribing of antihypertensive medications is recommended for some older patients with low blood pressure and frailty. The OPTiMISE trial showed that this deprescribing can be achieved with no differences in blood pressure control at 3 months compared with usual care. We aimed to examine effects of deprescribing on longer-term hospitalisation and mortality. METHODS: This randomised controlled trial enrolled participants from 69 general practices across central and southern England. Participants aged 80 years or older, with systolic blood pressure less than 150 mm Hg and who were receiving two or more antihypertensive medications, were randomly assigned (1:1) to antihypertensive medication reduction (removal of one antihypertensive) or usual care. General practitioners and participants were aware of the treatment allocation following randomisation but individuals responsible for analysing the data were masked to the treatment allocation throughout the study. Participants were followed up via their primary and secondary care electronic health records at least 3 years after randomisation. The primary outcome was time to all-cause hospitalisation or mortality. Intention-to-treat analyses were done using Cox regression modelling. A per-protocol analysis of the primary outcome was also done, excluding participants from the intervention group who did not reduce treatment or who had medication reinstated during the initial trial 12-week follow-up period. This study is registered with the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT2016-004236-38) and the ISRCTN Registry (ISRCTN97503221). FINDINGS: Between March 20, 2017, and Sept 30, 2018, a total of 569 participants were randomly assigned. Of these, 564 (99%; intervention=280; control=284) were followed up for a median of 4·0 years (IQR 3·7-4·3). Participants had a mean age of 84·8 years (SD 3·4) at baseline and 273 (48%) were women. Medication reduction was sustained in 109 participants at follow-up (51% of the 213 participants alive in the intervention group). Participants in the intervention group had a larger reduction in antihypertensives than the control group (adjusted mean difference -0·35 drugs [95% CI -0·52 to -0·18]). Overall, 202 (72%) participants in the intervention group and 218 (77%) participants in the control group experienced hospitalisation or mortality during follow-up (adjusted hazard ratio [aHR] 0·93 [95% CI 0·76 to 1·12]). There was some evidence that the proportion of participants experiencing the primary outcome in the per-protocol population was lower in the intervention group (aHR 0·80 [0·64 to 1·00]). INTERPRETATION: Half of participants sustained medication reduction with no evidence of an increase in all-cause hospitalisation or mortality. These findings suggest that an antihypertensive deprescribing intervention might be safe for people aged 80 years or older with controlled blood pressure taking two or more antihypertensives. FUNDING: British Heart Foundation and National Institute for Health and Care Research.

Effect of antihypertensive deprescribing on serious adverse events, mortality, and cardiovascular disease: Long-term follow-up of the OPTiMISE randomised controlled trial

Community-based rehabilitation after knee arthroplasty: a randomised controlled trial with economic evaluations (CORKA trial): ISRCTN: 13517704

Anti-tumour necrosis factor therapy for early-stage Dupuytren's disease (RIDD): a phase 2b, randomised, double-blind, placebo-controlled trial.

BACKGROUND: Dupuytren's disease is a common fibrotic condition that causes the fingers to flex irreversibly into the palm. Treatments for late-stage disease all have limitations, and there is no approved treatment for early-stage disease. We identified tumour necrosis factor as a therapeutic target in Dupuytren's disease, and in a dose ranging trial found 40 mg adalimumab in 0·4 mL to be most efficacious. Here we aimed to assess the effects of intranodular injection of adalimumab in early-stage disease. METHODS: In this phase 2b, randomised, double-blind, placebo-controlled trial adults with early-stage Dupuytren's disease and an established clinically distinct nodule with a clear history of progression in the preceding 6 months were recruited from two clinical centres in the UK and were randomly assigned 1:1 to receive four injections of adalimumab or saline every 3 months. Participants and assessors were masked. The primary outcome was nodule hardness measured with a durometer at 12 months. Data were analysed by linear mixed effects regression models in the intention-to-treat population with multiple imputation for missing primary outcome data. The trial is registered at the ISRCTN registry, ISRCTN 27786905 and is complete. FINDINGS: Between Feb 17, 2017, and Jan 11, 2019, 284 participants were screened in the UK and 140 were enrolled. 47 (34%) participants were female and 93 (66%) were male. Mean age of participants was 59·7 years (SD 10·0). Primary outcome data were available from 113 participants. Nodule hardness was lower (-4·6 AU [95% CI -7·1 to -2·2], p=0·0002) in the adalimumab compared with the saline group at 12 months. There were no related serious adverse events; the most common adverse events were minor injection site reactions. INTERPRETATION: Intranodular injections of adalimumab in participants with early-stage Dupuytren's disease resulted in softening and reduction in size of the nodules. Longer follow-up would be required to assess the effect of tumour necrosis factor inhibition on disease progression, extension deficit and hand function.

Epidemiology of acute flexor tendon injury and an analysis of outcomes - a study of 91,239 patients in England and Wales.

The purpose of this study was to investigate the epidemiology of flexor tendon injuries and operative complications post-repair on a national scale. Using Hospital Episode Statistics data we identified a total of 91,239 patients in England who underwent a flexor tendon repair in the 20-year period between 1 April 1998 and 31 March 2018. Individuals were more likely to be male (74.6%) and of lower socioeconomic status. Median age was 31 years and patients had few medical comorbidities. After primary repair, 3.1% of patients required a revision repair within 90 days and 2.8% tenolysis within two years. Complications other than rupture, adhesions and wound site infection were rare. This study has shown that flexor tendon repair is primarily a procedure of working-age men, with rupture and adhesions the most common complication. The complication rate is less than previously reported in the literature.Level of evidence: III.

Epidemiology of upper limb necrotising fasciitis in England: A national study (1998-2018).

BACKGROUND: Necrotising fasciitis (NF) is a surgical emergency characterised by rapidly progressive infection of the subcutaneous tissues and fascial planes, leading to widespread fascial necrosis and systemic toxicity. Although NF can affect any part of the body, the upper limbs are a notable site, accounting for 27% of cases. Antibiotics and surgical debridement form the basis of treatment. METHODOLOGY: We conducted a retrospective study on NF of the upper limb requiring surgical intervention from 1998-2018 using data from Hospital Episode Statistics. Age, sex, deprivation index, length of stay (LOS) and complications were analysed. RESULTS: We identified 728 patients, comprising 468 males and 260 females, with a mean age of 54.97 years (95% CI: 53.76-56.17 years). The incidence of NF in the upper limb increased from 0.0035 per 100,000 in 1998 to 0.01 per 100,000 in 2018. Lower index of multiple deprivation scores correlated with higher NF prevalence, with 67.32% (n=474) presenting scores between 0 and 5. The average LOS was 27.55 days (95% CI: 25.08-30.02 days). Complications within 30 days of surgery included 8 (1.10%) cases of renal failure, 8 (1.10%) urinary tract infections (UTIs), and 103 (14%) deaths. Meanwhile, 90-day complications included 23 (3.15%) cases of renal failure, 6 (0.82%) pulmonary embolisms, 22 (3.02%) UTI, and 113 (16%) deaths. CONCLUSION: This study highlights the impact of upper limb NF and provides crucial insights into its incidence, demographic correlations, and clinical outcomes, which can inform clinical management.

The burden of hand trauma surgery on primary care in the United Kingdom: a nation-wide analysis of antibiotic and opioid prescriptions.

Although surgical site infection (SSI) risk after hand trauma surgery is around 5%, the severity of these infections is not known. The risk of superficial SSI in a cohort study was evaluated using NHS UK-wide primary care records (n = 641,223), using the Clinical Practice Research Datalink GOLD database. Within this cohort, a subcohort of those who had undergone a hand surgery operation for trauma were identified (n = 3,088). Antibiotic and analgesic prescriptions were analysed at 30 and 90 days postoperatively. By 30 days, 6.2% had been prescribed antibiotics appropriate for SSI, rising to 14.4% (CI [13.2 to 15.8]) by 90 days. By 30 days, 10% had been prescribed opioid analgaesia and by 90 days this had increased to 13.8%. Antibiotics prescriptions for SSI in primary care are substantially higher than the NICE estimate for SSI overall and the expected risk in hand trauma. The implications of this study are that many patients are receiving treatment for SSI in primary care and may be in more pain, for longer, than we expect. Further exploration of this is warranted and future research in hand trauma surgery should capture adverse events occurring outside of the hospital environment.Level of evidence: II.

Facilitating clinical trials in hip fracture in the UK : the role and potential of the National Hip Fracture Database and routinely collected data.

AIMS: The aim of this study was to evaluate the suitability, against an accepted international standard, of a linked hip fracture registry and routinely collected administrative dataset in England to embed and deliver randomized controlled trials (RCTs). METHODS: First, a bespoke cohort of individuals sustaining hip fractures between 2011 and 2016 was generated from the National Hip Fracture Database (NHFD) and linked to individual Hospital Episode Statistics (HES) records and mortality data. Second, in order to explore the availability and distribution of outcomes available in linked HES-Office of National Statistics (ONS) data, a more contemporary cohort with incident hip fracture was identified within HES between January 2014 and December 2018. Distributions of the outcomes within the HES-ONS dataset were reported using standard statistical summaries; descriptive characteristics of the NHFD and linked HES-ONS dataset were reported in line with the Clinical Trials Transformation Initiative recommendations for registry-enabled trials. RESULTS: Case ascertainment of the NHFD likely exceeds 94%. The assessment of the robustness, relevance, and reliability of the datasets was favourable. Outcomes from the HES-ONS dataset were concordant with other contemporaneous prospective cohort studies with bespoke data collection frameworks. CONCLUSION: Our findings support the feasibility of the NHFD and HES-ONS to support a registry-embedded, data-enabled RCT.

Time Series Methods to Assess the Impact of Regulatory Action: A Study of UK Primary Care and Hospital Data on the Use of Fluoroquinolones.

PURPOSE: To illustrate the interest in using interrupted time series (ITS) methods, this study evaluated the impact of the UK MHRA's March 2019 Risk Minimisation Measures (RMM) on fluoroquinolone usage. METHODS: Monthly and quarterly fluoroquinolone use incidence rates from 2012 to 2022 were analysed across hospital care (Barts Health NHS Trust), primary care (Clinical Practice Research Datalink (CPRD) Aurum and CPRD GOLD), and linked records from both settings (East Scotland). Rates were stratified by age (19-59 and ≥ 60 years old). Seasonality-adjusted segmented regression and ARIMA models were employed to model quarterly and monthly rates, respectively. RESULTS: Post-RMM, with segmented regression, both age groups in Barts Health experienced nearly complete reductions (> 99%); CPRD Aurum saw 20.19% (19-59) and 19.29% ( ≥ $$ \ge $$  60) reductions; no significant changes in CPRD GOLD; East Scotland had 45.43% (19-59) and 41.47% ( ≥ $$ \ge $$  60) decreases. Slope analysis indicated increases for East Scotland (19-59) and both CPRD Aurum groups, but a decrease for CPRD GOLD's ≥ $$ \ge $$  60; ARIMA detected significant step changes in CPRD GOLD not identified by segmented regression and noted a significant slope increase in Barts Health's 19-59 group. Both models showed no post-modelling autocorrelations across databases, yet Barts Health's residuals were non-normally distributed with non-constant variance. CONCLUSIONS: Both segmented regression and ARIMA confirmed the reduction of fluoroquinolones use after RMM across four different UK primary care and hospital databases. Model diagnostics showed good performance in eliminating residual autocorrelation for both methods. However, diagnostics for hospital databases with low incident use revealed the presence of heteroscedasticity and non-normal white noise using both methods.

The association of bariatric surgery and carpal tunnel syndrome: A propensity score-matched cohort study.

OBJECTIVES: To test the hypothesis that weight loss following bariatric surgery is associated with a reduced risk of developing carpal tunnel syndrome (CTS) compared with obese patients who do not undergo bariatric surgery. METHODS: We performed a cohort study using data from the Swedish nationwide healthcare registries. Patients aged 18-79 years who underwent bariatric surgery from 2006 to 2019 were propensity score (PS)-matched to up to 2 obese bariatric surgery-free patients ("unexposed patients"). Cox proportional hazard regression was used to calculate hazard ratios (HR) with 95% confidence intervals (CIs) to compare the incidence of CTS among bariatric surgery patients to obese unexposed patients both overall and divided by subgroups of age, sex, bariatric surgery type, and duration of follow-up. RESULTS: In total, 40,619 bariatric surgery patients were PS-matched to 63,540 obese unexposed patients who did not undergo surgery. Bariatric surgery was not associated overall with CTS (HR 0.98, 95% CI 0.91-1.05). There was a 23% decreased risk of CTS incidence observed within >1-3 years after bariatric surgery (HR 0.77, 95% CI 0.68-0.88). Decreased CTS risks were observed among bariatric surgery patients aged 18-34 years (HR 0.87, 95% CI 0.74-1.01) and those who underwent sleeve gastrectomy (HR 0.81, 95% CI 0.63-1.03), but these risks did not reach significance level compared with obese unexposed patients. However, there was a 20% increased CTS risk after 6 years (HR 1.20, 95% CI 1.05-1.36). CONCLUSION: Our results suggest that marked weight does not have a lasting impact on the reduction of CTS incidence.

Statistics for the hand surgeon. Part 2: avoiding common pitfalls.

In this second of a two-part article, we describe some of the common statistical pitfalls encountered in hand surgery research. These include dichotomania, the 'Table 2 fallacy', p-hacking, regression to the mean, overfitting and unaccounted data clustering. We explain the impact of these pitfalls on hand surgery research and describe techniques to avoid them. The aim of this two-part article was to provide a starting point for hand surgeons to refer to when conducting or analysing research and provide resources and references for interested readers to explore.

Preventable hand injuries: A national audit.

Little is known of the scale of avoidable injuries presenting to medical services on a national level in the UK. This study aimed to assess the type and incidence of preventable wrist and hand injuries (as defined by the core research team) at a national level in the UK. 28 UK hospitals undertook a service evaluation of all hand trauma cases presenting to their units over a 2 week period in early 2021 identifying demographical and aetiological information about injuries sustained. 1909 patients were included (184 children) with a median age of 40 (IQR 25-59) years. The commonest five types of injury were fractures of the wrist; single phalangeal or metacarpal fractures; fingertip injuries; and infection, with the most common mechanisms being mechanical falls and manual labour. This is the first extensive survey of preventable hand injuries in the UK, identifying a need for further work into prevention to reduce healthcare burden and cost. 50% of injuries presenting to hand surgeons are preventable, with the most common injuries being single fractures of the wrist, phalanx and metacarpal. Few preventable injuries were related to alcohol or narcotic intoxication. Further research is needed to identify how to initiate injury prevention measures for hand injuries, particularly focussed towards hand fracture prevention.

Statistics for the hand surgeon. Part 1: principles and application to hand surgery research.

Hand surgeons have the potential to improve patient care, both with their own research and by using evidenced-based practice. In this first part of a two-part article, we describe key steps for the analysis of clinical data using quantitative methodology. We aim to describe the principles of medical statistics and their relevance and use in hand surgery, with contemporaneous examples. Hand surgeons seek expertise and guidance in the clinical domain to improve their practice and patient care. Part of this process involves the critical analysis and appraisal of the research of others.

Development and external validation of prediction models for adverse health outcomes in rheumatoid arthritis: A multinational real-world cohort analysis.

BACKGROUND: Identification of rheumatoid arthritis (RA) patients at high risk of adverse health outcomes remains a major challenge. We aimed to develop and validate prediction models for a variety of adverse health outcomes in RA patients initiating first-line methotrexate (MTX) monotherapy. METHODS: Data from 15 claims and electronic health record databases across 9 countries were used. Models were developed and internally validated on Optum® De-identified Clinformatics® Data Mart Database using L1-regularized logistic regression to estimate the risk of adverse health outcomes within 3 months (leukopenia, pancytopenia, infection), 2 years (myocardial infarction (MI) and stroke), and 5 years (cancers [colorectal, breast, uterine] after treatment initiation. Candidate predictors included demographic variables and past medical history. Models were externally validated on all other databases. Performance was assessed using the area under the receiver operator characteristic curve (AUC) and calibration plots. FINDINGS: Models were developed and internally validated on 21,547 RA patients and externally validated on 131,928 RA patients. Models for serious infection (AUC: internal 0.74, external ranging from 0.62 to 0.83), MI (AUC: internal 0.76, external ranging from 0.56 to 0.82), and stroke (AUC: internal 0.77, external ranging from 0.63 to 0.95), showed good discrimination and adequate calibration. Models for the other outcomes showed modest internal discrimination (AUC < 0.65) and were not externally validated. INTERPRETATION: We developed and validated prediction models for a variety of adverse health outcomes in RA patients initiating first-line MTX monotherapy. Final models for serious infection, MI, and stroke demonstrated good performance across multiple databases and can be studied for clinical use. FUNDING: This activity under the European Health Data & Evidence Network (EHDEN) has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 806968. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.

A Virtual Fracture Clinic Pathway for Managing Suspected Paediatric Scaphoid Fractures.

INTRODUCTION: The mismanagement of an occult scaphoid fracture is a significant concern in patients presenting with anatomical snuffbox tenderness and no radiographic signs of injury. AIM: This study investigated whether a virtual fracture clinic (VFC) could improve care efficiency and expedite management decisions surrounding suspected pediatric scaphoid fractures. METHOD: Data was reviewed for patients referred via the VFC for suspected scaphoid fractures at a local trauma unit over 19 months. Patients received an "appointment" in VFC. Based on their notes and imaging, patients were referred to an outpatient clinic for repeat radiographs within two weeks (if initial radiographs demonstrated no fracture). Patients with unremarkable second x-rays were contacted and informed to mobilize and return if the pain persisted at four weeks. RESULTS: The pathway received 175 referrals; 114 male, 61 female, mean age 14 years, range 9-17) with 42 scaphoid fractures diagnosed, 35 (83.3%) on first x-ray, and 7 (16.7%) occult fractures. The pathway managed all patients as intended; 71 patients were seen face-to-face in the clinic due to age or pathology picked up on the first x-ray, and 104 required repeat radiographs. Following the second radiograph, 78 patients were discharged directly. Twenty-six patients required further review in a face-to-face clinic after their second radiograph. CONCLUSION: VFC appears to be a safe and efficient method of managing patients with suspected scaphoid fractures on short-term follow-up analysis. This cohort presents no 'missed' injuries and therefore appears safe compared to conventional treatment pathways.