104 research outputs found
Ultrasound-detected pathologies cluster into groups with different clinical outcomes: data from 3000 community referrals for shoulder pain
Background Ultrasound is increasingly used to evaluate shoulder pain but the benefits of this are unclear. This study examined whether ultrasound-defined pathologies have implications for clinical outcomes. Methods We extracted reported pathologies from 3000 ultrasound scans of people with shoulder pain referred from primary care. Latent class analysis (LCA) identified whether individual pathologies clustered in groups. Optimal group number was determined by the minimum Bayesian information criterion. A questionnaire was sent to all patients scanned over a 12-month period (n=2322). Data collected included demographics, treatments received, current pain and function. The relationship between pathology-defined groups and clinical outcomes was examined. Results LCA revealed four groups: 1. bursitis with limited inflammation elsewhere (n=1280); 2. bursitis with extensive inflammation (n=595); 3. rotator cuff tears (n=558); 4. limited pathology (n=567). 777 (33%) completed questionnaires; median (IQR) duration post-ultrasound scan was 25 (22, 29) months. Subsequent injections were most common in groups 1 & 2 (groups 1-4: 76%; 67%; 48%; 61%); surgery was most common in group 3 (23%; 21%; 28%; 16%). Shoulder Pain and Disability Index scores were highest in group 3 (median 48 and 30 respectively) and lowest in group 4 (32 and 9). Patients in group 4 who had surgery reported poor outcomes. Conclusion In a community-based population, ultrasound identified clusters of pathologies. Our retrospective data suggests these groups have different treatment pathways and outcomes. This requires replication in a prospective study to determine the value of a pathology-based classification in people with shoulder pain
Decision-making behaviour in fish : the effects of internal state and external conditions
EThOS - Electronic Theses Online ServiceGBUnited Kingdo
Ultrasound to identify systemic lupus erythematosus patients with musculoskeletal symptoms who respond best to therapy: the US Evaluation For mUsculoskeletal Lupus longitudinal multicentre study
Objectives:
To determine whether SLE patients with inflammatory joint symptoms and US synovitis/tenosyovitis achieve better clinical responses to glucocorticoids compared with patients with normal scans. Secondary objectives included identification of clinical features predicting US synovitis/tenosynovitis.
Methods:
In a longitudinal multicentre study, SLE patients with physician-diagnosed inflammatory joint pain received intramuscular methylprednisolone 120 mg once. Clinical assessments, patient-reported outcomes and bilateral hand/wrist USs were collected at 0, 2 and 6 weeks. The primary outcome (determined via internal pilot) was the early morning stiffness visual analogue scale (EMS-VAS) at 2 weeks, adjusted for baseline, comparing patients with positive (greyscale ≥2 and/or power Doppler ≥1) and negative US. Post hoc analyses excluded FM.
Results:
Of 133 patients, 78 had a positive US. Only 53 (68%) of these had one or more swollen joint. Of 66 patients with one or more swollen joint, 20% had a negative US. A positive US was associated with joint swelling, symmetrical small joint distribution and serology. The primary endpoint was not met: in the full analysis set (N = 133) there was no difference in baseline-adjusted EMS-VAS at week 2 [−7.7 mm (95% CI −19.0, 3.5); P = 0.178]. After excluding 32 patients with FM, response was significantly better in patients with a positive US at baseline [baseline-adjusted EMS-VAS at 2 weeks −12.1 mm (95% CI −22.2, −0.1); P = 0.049]. This difference was greater when adjusted for treatment [−12.8 mm (95% CI −22, −3); P = 0.007]. BILAG and SLEDAI responses were higher in US-positive patients.
Conclusion:
In SLE patients without FM, those with a positive US had a better clinical response to therapy. Imaging-detected synovitis/tenosynovitis may be considered to decide on therapy and enrich clinical trials
Concurrent validation of activity monitor–based step counts in people with polymyalgia rheumatica
RE: The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: Explanation and Elaboration
[no abstract
Concurrent validation of activity monitor based step-counts in people with Polymyalgia Rheumatica
Background: Physical activity is both a therapeutic intervention and an important outcome in people with rheumatic and musculoskeletal disease (RMDs). Subjective methods are prone to response bias and underestimate low-intensity activities, which are common in older adults. Activity monitors may provide an objective solution by measuring step-count, but limited previous research has identified reduced accuracy in people with RMDs. This study aimed to evaluate the concurrent validity of the ActiGraph with both standard and Low Frequency Extension (LFE) algorithms; Fitbit-Zip in both recommended positions; and explore which factors influence device error in people with polymyalgia rheumatica (PMR).
Methods: The ActiGraph (±LFE), Fitbit-Zip (waist) and Fitbit-Zip (shirt) were concurrently evaluated using a two-minute-walk-test (2MWT) and stairs test in people with PMR (>1 month glucocorticoid treatment). Participants walked at their normal pace and with any assistive devices required. A GAITRite instrumented walkway collected temporal and spatial gait parameters. Gold standard step-counts were derived from a mean of three manual counts taken from half speed video replays by two investigators. Bland-Altman plots describing the mean bias (95% confidence intervals (CI)) and 95% limits of agreement (LoA) were used to determine monitor accuracy. Spearman’s rho described association of step-count differences with demographic, clinical, and gait parameters.
Results: Data was collected on 27 PMR patients (24 female; mean (SD) age 69.2 (8.8); BMI 28.3 (5.6) kg/m2; median (IQR) steroid dose 9.0 (5.0, 12.5) mg/day; Health Assessment Questionnaire (HAQ) 0.63 (0.13, 1.25); FACIT-F 38 (33, 45)). The median (IQR) gold standard step-counts were; 2MWT 206 (197, 220); stairs 15 (15, 16). All monitors systematically underestimated 2MWT step-counts. The Fitbit-Zip (waist) achieved closest agreement to the gold standard step-count in the 2MWT (mean (95%CI) bias 10 (-3, 23), 95%LoA -55, 74). Conversely, the ActiGraph (LFE) performed best during the stairs test (mean (95%CI) bias 0 (-1, 1), 95%LoA -5, 5 followed closely by the Fitbit-Zip (waist) (mean (95%CI) bias 1 (-1, 3), 95%LoA -8, 10). The LoA were particularly influenced by 2 outliers: one participant had a severe level of impairment (HAQ=2.13), which affected all accelerometers during both tests. The second was a Fitbit-Zip (waist) measurement on the stairs test, which was out by an order of magnitude, possibly due to operator error. On all devices, step count difference correlated negatively with gait velocity (rho=-.37 to -.58) and stride length (rho=-.31 to -.72) and positively with HAQ scores (rho=.32 to .57) and duration of double-limb support phase (rho=.33 to .61).
Conclusion: Close agreement with the gold standard step-counts suggests the Fitbit-Zip (waist) is a reliable measure of physical activity in people with PMR receiving treatment. The ActiGraph however, cannot be recommended without activation of LFE filter. Device performance reduces in participants with higher levels of functional impairment
Effect of a treatment strategy utilising golimumab, methotrexate and corticosteroids versus methotrexate and corticosteroids in early, untreated psoriatic arthritis (GOLMePsA): a single-centre, double-blind, parallel-group, randomised controlled trial
Background: The optimal treatment strategy in early psoriatic arthritis remains unknown. We aimed to assess whether the combination of methotrexate and golimumab plus corticosteroids is superior to methotrexate plus corticosteroids in reducing disease activity in early, untreated psoriatic arthritis.
Methods: We did a double-blind, randomised, placebo-controlled, parallel-group, single-centre study in adults with treatment-naïve active psoriatic arthritis. Participants were required to have been diagnosed up to 24 months before enrolment and had to be naïve to conventional synthetic, biologic, or targeted synthetic disease-modifying antirheumatic drugs or systemic treatments before enrolment. Participants were randomly assigned (1:1) to receive either combination therapy of golimumab and methotrexate or placebo and methotrexate, stratified by the number of involved peripheral joints at baseline. Investigators and participants were masked to treatment allocation. At baseline, all participants received methylprednisolone (120 mg intramuscular administration, single dose) and commenced weekly methotrexate (increased to 25 mg within 28 days). Golimumab or placebo were administered by subcutaneous injections every 4 weeks. By week 24, additional methylprednisolone was permitted once (totalling up to 240 mg exposure). The primary endpoint was the difference in mean Psoriatic Arthritis Disease Activity Score (PASDAS) at week 24 in the intention-to-treat population, compared using analysis of covariance via multiple linear regression. People with lived experience of psoriatic arthritis were involved in the design and conduct the study. The study was registered with EudraCT, 2013-004122-28, and is complete.
Findings: Between Nov 3, 2015 and Jan 26, 2022, 106 people were assessed for eligibility, 22 were excluded, and 84 were randomly assigned (43 to the golimumab and methotrexate group and 41 to the placebo and methotrexate group). 46 (55%) participants were male and 38 (45%) were female. The mean age was 42·5 years (SD 12·4) and 61 (73%) participants were White and seven (8%) were from any Asian, Black, or other ethnic background. PASDAS did not differ between treatment groups at week 24 (unadjusted mean 3·09 [SD 1·32] in the placebo and methotrexate group and 2·70 [1·38] in the golimumab and methotrexate group; adjusted difference –0·55 [95% CI –1·12 to 0·03]; p=0·064). More participants in the placebo and methotrexate group received additional corticosteroids before week 24 (20 [49%] of 41 vs nine [21%] of 43; odds ratio 0·28 [95% CI 0·11 to 0·72]; p=0·009). Similar numbers of participants had adverse events (38 [93%] of 41 in the placebo and methotrexate group vs 41 [95%] of 43 in the golimumab and methotrexate group; risk difference 0·03 [95% CI –0·09 to 0·15]), although altered laboratory investigations and infections occurred more frequently in the golimumab and methotrexate group. No deaths, serious, or unexpected adverse events occurred.
Interpretation: Both interventions led to improved disease activity in patients with early, untreated psoriatic arthritis, without a clinically or statistically significant difference in PASDAS between treatment groups at week 24. Participants in the placebo and methotrexate group required more rescue corticosteroids. Sustained results were observed at week 52 in both groups, without serious or unexpected adverse events
A home exercise programme is no more beneficial than advice and education for people with neurogenic claudication: results from a randomised controlled trial.
ObjectiveTo compare the effectiveness of a physiotherapy programme with a control treatment of advice and education in patients with neurogenic claudication symptoms.DesignPragmatic randomised controlled clinical trial.SettingPrimary care-based musculoskeletal service.PatientsAdults aged 50 or over with neurogenic claudication symptoms causing limitation of walking.InterventionsCondition-specific home exercises combined with advice and education, or advice and education alone.Main outcome measuresThe primary outcome was the difference in improvement of symptom severity scores on the Swiss Spinal Stenosis Scale at eight weeks. Secondary outcomes included measures of physical function, pain and general well-being at eight weeks and 12 months.ResultsThere was no significant difference between groups in the Swiss Spinal Stenosis symptom severity scale at eight weeks (t = 0.47, p = 0.643): mean change (SD) control group -0.18 (0.47), treatment group -0.10 (0.66), difference (95% CI) 0.08 (-0.19, 0.35); baseline-adjusted difference 0.06 (-0.19, 0.31)]. An unplanned subgroup analysis suggested that for patients with the top 25% of baseline symptom severity scores, the physiotherapy exercise programme resulted in an improvement in the primary outcome, and modest but consistently better secondary outcomes at both time-points compared to the control group. The effectiveness in different subgroups requires further direct evaluation.ConclusionsIn the treatment of patients with neurogenic claudication symptoms, a physiotherapist-prescribed home exercise programme is no more effective than advice and education.Ethical approvalThe study was approved by Leeds Central Ethics Committee and informed consent was given by all participating patients.CopyrightThe Corresponding Author has the right to grant on behalf of all authors and does grant on behalf of all authors, a worldwide licence to the Publishers and its licensees in perpetuity, in all forms, formats and media (whether known now or created in the future), to i) publish, reproduce, distribute, display and store the Contribution, ii) translate the Contribution into other languages, create adaptations, reprints, include within collections and create summaries, extracts and/or, abstracts of the Contribution, iii) create any other derivative work(s) based on the Contribution, iv) to exploit all subsidiary rights in the Contribution, v) the inclusion of electronic links from the Contribution to third party material where-ever it may be located; and, vi) licence any third party to do any or all of the above.Trial registrationISRCTN 78288224 - doi10.1186/ISRCTN35836727; UKCRN 4814
RIPOSTE: A framework for improving the design and analysis of laboratory-based research
Lack of reproducibility is an ongoing problem in some areas of the biomedical sciences. Poor experimental design and a failure to engage with experienced statisticians at key stages in the design and analysis of experiments are two factors that contribute to this problem. The RIPOSTE (Reducing IrreProducibility in labOratory STudiEs) framework has been developed to support early and regular discussions between scientists and statisticians in order to improve the design, conduct and analysis of laboratory studies and, therefore, reduce irreproducibility. This framework is intended for use during the early stages of a research project, when specific questions or hypotheses are proposed. The essential points within the framework are explained and illustrated using three examples (a medical equipment test, a macrophage study and a gene expression study). Sound study design minimises the possibility of bias being introduced into experiments and leads to higher quality research with more reproducible results
- …
