The REPORT guide is a “How to” guide to help you report your clinical research in an effective an... more The REPORT guide is a “How to” guide to help you report your clinical research in an effective and transparent way. It is intended to supplement established first choice reporting tools, such as CONSORT, by adding tacit knowledge (i.e., learned, informal, or implicit knowledge) about reporting topics that we have struggled with as authors or see others struggle with as journal reviewers or editors. We focus on the randomised controlled trial, but the guide also applies to other study designs. Topics included in the REPORT guide cover reporting checklists, trial report structure, choice of title, writing style, trial registry and reporting consistency, spin or reporting bias, transparent data presentation (figures), open access considerations, data sharing, and more. Preprint (open access): https://doi.org/10.31219/osf.io/qsxdz
Objective.Adaptive trial design was developed initially for oncology to improve trial efficiency.... more Objective.Adaptive trial design was developed initially for oncology to improve trial efficiency. If optimized for rheumatology, it may improve trial efficiency by reducing sample size and time.Methods.A systematic review assessed design of phase II clinical trials in rheumatoid arthritis.Results.Fifty-six trials were reviewed. Most trials had 4 groups (1 control and 3 intervention), with an average group size of 34 patients. American College of Rheumatology 20 measured at 16 weeks was the most commonly used primary endpoint.Conclusion.The next step is to undertake a systematic review of adaptive designs used in early-phase trials in nonrheumatic conditions.
To test the reliability of the consensus-based ultrasound (US) definitions of elementary gout les... more To test the reliability of the consensus-based ultrasound (US) definitions of elementary gout lesions in patients. Eight patients with microscopically proven gout were evaluated by 16 sonographers for signs of double contour (DC), aggregates, erosions, and tophi in the first metatarsophalangeal joint and the knee bilaterally. The patients were examined twice using B-mode US to test agreement and inter- and intraobserver reliability of the elementary components. The prevalence of the lesions were DC 52.8%, tophus 61.1%, aggregates 29.8%, and erosions 32.4%. The intraobserver reliability was good for all lesions except DC, where it was moderate. The best reliability per lesion was seen for tophus (κ 0.73, 95% CI 0.61-0.85) and lowest for DC (κ 0.53, 95% CI 0.38-0.67). The interobserver reliability was good for tophus and erosions, but fair to moderate for aggregates and DC, respectively. The best reliability was seen for erosions (κ 0.74, 95% CI 0.65-0.81) and lowest for aggregates (κ...
... Mário Lenza1, Rachelle Buchbinder2, Robin Christensen3, Nigel CA Hanchard4, Flávio Faloppa1 .... more ... Mário Lenza1, Rachelle Buchbinder2, Robin Christensen3, Nigel CA Hanchard4, Flávio Faloppa1 ... inflammation and cellular changes in the tendons such as disorganisation of the architecture of collagen (Biberthaler 2003; Levy 2008; Lewis 2009; Nirschl 1989; Rees 2008). ...
Introduction. The Manchester Foot Pain and Disability Index (MFPDI) is a 19-item questionnaire fo... more Introduction. The Manchester Foot Pain and Disability Index (MFPDI) is a 19-item questionnaire for the assessment of disability caused by foot pain. The aim was to develop a Danish language version of the MFPDI (MFPDI-DK) and evaluate its reproducibility and construct validity. Methods. A Danish version was created, following a forward-backward translation procedure. A sample of 84 adult patients with foot pain was recruited. Participants completed two copies of the MFPDI-DK within a 24- to 48-hour interval, along with the Medical Outcomes Study Short Form 36 (SF-36), and a pain Visual Analog Scale (VAS). Reproducibility was assessed using the intraclass correlation coefficient (ICC) and 95% limits of agreement (Bland-Altman plot). Construct validity was evaluated with Pearson’s Rho, using a priori hypothesized correlations with SF-36 subscales and VASmean. Results. The MFPDI-DK showed very good reliability with an ICC of 0.92 (0.88–0.95). The 95% limits of agreement ranged from −6....
The REPORT guide is a “How to” guide to help you report your clinical research in an effective an... more The REPORT guide is a “How to” guide to help you report your clinical research in an effective and transparent way. It is intended to supplement established first choice reporting tools, such as CONSORT, by adding tacit knowledge (i.e., learned, informal, or implicit knowledge) about reporting topics that we have struggled with as authors or see others struggle with as journal reviewers or editors. We focus on the randomised controlled trial, but the guide also applies to other study designs. Topics included in the REPORT guide cover reporting checklists, trial report structure, choice of title, writing style, trial registry and reporting consistency, spin or reporting bias, transparent data presentation (figures), open access considerations, data sharing, and more. Preprint (open access): https://doi.org/10.31219/osf.io/qsxdz
Objective.Adaptive trial design was developed initially for oncology to improve trial efficiency.... more Objective.Adaptive trial design was developed initially for oncology to improve trial efficiency. If optimized for rheumatology, it may improve trial efficiency by reducing sample size and time.Methods.A systematic review assessed design of phase II clinical trials in rheumatoid arthritis.Results.Fifty-six trials were reviewed. Most trials had 4 groups (1 control and 3 intervention), with an average group size of 34 patients. American College of Rheumatology 20 measured at 16 weeks was the most commonly used primary endpoint.Conclusion.The next step is to undertake a systematic review of adaptive designs used in early-phase trials in nonrheumatic conditions.
To test the reliability of the consensus-based ultrasound (US) definitions of elementary gout les... more To test the reliability of the consensus-based ultrasound (US) definitions of elementary gout lesions in patients. Eight patients with microscopically proven gout were evaluated by 16 sonographers for signs of double contour (DC), aggregates, erosions, and tophi in the first metatarsophalangeal joint and the knee bilaterally. The patients were examined twice using B-mode US to test agreement and inter- and intraobserver reliability of the elementary components. The prevalence of the lesions were DC 52.8%, tophus 61.1%, aggregates 29.8%, and erosions 32.4%. The intraobserver reliability was good for all lesions except DC, where it was moderate. The best reliability per lesion was seen for tophus (κ 0.73, 95% CI 0.61-0.85) and lowest for DC (κ 0.53, 95% CI 0.38-0.67). The interobserver reliability was good for tophus and erosions, but fair to moderate for aggregates and DC, respectively. The best reliability was seen for erosions (κ 0.74, 95% CI 0.65-0.81) and lowest for aggregates (κ...
... Mário Lenza1, Rachelle Buchbinder2, Robin Christensen3, Nigel CA Hanchard4, Flávio Faloppa1 .... more ... Mário Lenza1, Rachelle Buchbinder2, Robin Christensen3, Nigel CA Hanchard4, Flávio Faloppa1 ... inflammation and cellular changes in the tendons such as disorganisation of the architecture of collagen (Biberthaler 2003; Levy 2008; Lewis 2009; Nirschl 1989; Rees 2008). ...
Introduction. The Manchester Foot Pain and Disability Index (MFPDI) is a 19-item questionnaire fo... more Introduction. The Manchester Foot Pain and Disability Index (MFPDI) is a 19-item questionnaire for the assessment of disability caused by foot pain. The aim was to develop a Danish language version of the MFPDI (MFPDI-DK) and evaluate its reproducibility and construct validity. Methods. A Danish version was created, following a forward-backward translation procedure. A sample of 84 adult patients with foot pain was recruited. Participants completed two copies of the MFPDI-DK within a 24- to 48-hour interval, along with the Medical Outcomes Study Short Form 36 (SF-36), and a pain Visual Analog Scale (VAS). Reproducibility was assessed using the intraclass correlation coefficient (ICC) and 95% limits of agreement (Bland-Altman plot). Construct validity was evaluated with Pearson’s Rho, using a priori hypothesized correlations with SF-36 subscales and VASmean. Results. The MFPDI-DK showed very good reliability with an ICC of 0.92 (0.88–0.95). The 95% limits of agreement ranged from −6....
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