Quality of surgical randomized controlled trials in hand surgery: a systematic review

We assessed the quantity, quality and trends of randomized controlled trials comparing hand surgical interventions. Study characteristics were collected for 125 randomized controlled trials comparing hand surgical interventions. The Jadad scale (0–5), which assesses methodological quality of trials, was calculated. Logistic regressions were conducted to determine associations with the Jadad score. The studies were published between 1981 and 2015, with an increase over time, most often in Journal of Hand Surgery (European). Mean study size was 68 patients. Mean Jadad score was 2.1, without improvement over time. Thirty percent conducted a power analysis and 8% an intention-to-treat analysis. Studies conducted in the United Kingdom and with smaller sample sizes, power analysis and intention-to-treat analysis were associated with a higher Jadad score. The quantity of trials has increased over time while methodological quality has remained low, indicating a need to improve quality of trials in hand surgery literature.

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Reporting of Randomized Controlled Trials in Cleft Lip and Palate: A 10-Year Review

The Cleft Palate-Craniofacial Journal ◽

10.1597/14-267 ◽

2017 ◽

Vol 54 (2) ◽

pp. 142-152 ◽

Cited By ~ 4

Author(s):

Joseph Hardwicke ◽

Mohammad Nassimizadeh ◽

Bruce Richard

Keyword(s):

Randomized Controlled Trials ◽

Cleft Lip ◽

Cleft Lip And Palate ◽

Journal Article ◽

Controlled Trials ◽

Jadad Score ◽

Quality Of Reporting ◽

Randomized Controlled ◽

The Mean

Objectives Reviews of the quality of reporting of randomized controlled trials (RCTs) have recently been conducted in different surgical specialties. In this review of RCTs relating to cleft lip, cleft palate, and cleft lip and palate (CL/P), we investigate the quality of reporting against the Consolidated Standards of Reporting Trials (CONSORT) checklist. Design A systematic review of CL/P RCTs published from 2004 to 2013, with the included articles scored against the CONSORT checklist. Patients, Participants The literature search identified 174 articles. Studies were selected for participants with CL/P who were involved in an RCT with prospective data collection and reported in a full journal article. A total of 6352 participants were included from 65 CUP RCTs during the study period. Main Outcome Measures The methodological quality of RCTs was assessed using the CONSORT checklist and Jadad scale. Results The mean CONSORT score was 15.8, and the mean Jadad score was 3.3. There was a significant positive correlation between the CONSORT and Jadad score ( P < .0001, ρ = .47). The only significant correlation showed that with an increasing number of authors, both the CONSORT and the Jadad score increased. Conclusion This analysis has shown that that there are deficiencies in the transparent reporting of factors such as randomization implementation, blinding, and participant flow. Interventions, outcomes, and the interpretation of results are well presented. We would recommend that RCTs are conceived and undertaken using the CONSORT checklist and reported in a clear and reproducible manner.

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The Quality of Randomized Controlled Trials in High-impact Rheumatology Journals, 1998–2018

The Journal of Rheumatology ◽

10.3899/jrheum.191306 ◽

2020 ◽

Vol 47 (9) ◽

pp. 1446-1449

Author(s):

Michael S. Putman ◽

Ashley Harrison Ragle ◽

Eric M. Ruderman

Keyword(s):

Randomized Controlled Trials ◽

Patient Reported Outcome Measures ◽

High Impact ◽

Controlled Trials ◽

Industry Funding ◽

Primary Analysis ◽

Randomized Controlled ◽

Patient Reported ◽

Over Time

Objective.Well-designed randomized controlled trials (RCT) mitigate bias and confounding, but previous evaluations of rheumatology trials found high rates of methodological flaws. Outside of rheumatoid arthritis, no studies in the modern era have assessed the quality of rheumatology RCT over time or regarding industry funding.Methods.We identified all RCT published in 3 high-impact rheumatology journals from 1998, 2008, and 2018. Quality metrics derived from a modified Jadad scale were analyzed by year of publication and by funding source.Results.Ninety-six publications met inclusion criteria; 82 of these described the primary analysis of an RCT. Over time (1998–2008–2018), trials were less likely to adequately report dropouts and withdrawals (100% vs 82% vs 60%; p < 0.01) or include an active comparator (44% vs 12% vs 13%; p = 0.01). Later trials were more likely to evaluate biologic therapy (11% vs 38% vs 83%; p < 0.01) and report adequate randomization procedures (39% vs 29% vs 60%; p = 0.04). Seventy-nine percent of trials received industry funding. Industry-funded trials were more likely to report double-blinding (86% vs 53%; p < 0.01), patient-reported outcome measures (77% vs 41%; p < 0.01), and intention-to-treat analyses (86% vs 65%; p = 0.04).Conclusion.Industry-funded trials comprise the majority of RCT published in high-impact rheumatology journals and more frequently report metrics associated with RCT quality. RCT assessing active comparators and nonbiologic therapies have become less common in high-impact rheumatology journals.

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Methodological and Reporting Quality of Noninferiority Randomized Controlled Trials Comparing Antibiotic Therapies: A Systematic Review

Clinical Infectious Diseases ◽

10.1093/cid/ciaa1353 ◽

2020 ◽

Author(s):

Anthony D Bai ◽

Adam S Komorowski ◽

Carson K L Lo ◽

Pranav Tandon ◽

Xena X Li ◽

...

Keyword(s):

Systematic Review ◽

Pharmaceutical Industry ◽

Randomized Controlled Trials ◽

Reporting Quality ◽

Controlled Trials ◽

Intention To Treat ◽

Randomized Controlled ◽

Noninferiority Trials ◽

Noninferiority Margin

Abstract Background Antibiotic noninferiority randomized controlled trials (RCTs) are used for approval of new antibiotics and making changes to antibiotic prescribing in clinical practice. We conducted a systematic review to assess the methodological and reporting quality of antibiotic noninferiority RCTs. Methods We searched MEDLINE, Embase, the Cochrane Database of Systematic Reviews, and the Food and Drug Administration drug database from inception until November 22, 2019, for noninferiority RCTs comparing different systemic antibiotic therapies. Comparisons between antibiotic types, doses, administration routes, or durations were included. Methodological and reporting quality indicators were based on the Consolidated Standards of Reporting Trials reporting guidelines. Two independent reviewers extracted the data. Results The systematic review included 227 studies. Of these, 135 (59.5%) studies were supported by pharmaceutical industry. Only 83 (36.6%) studies provided a justification for the noninferiority margin. Reporting of both intention-to-treat (ITT) and per-protocol (PP) analyses were done in 165 (72.7%) studies. The conclusion was misleading in 34 (15.0%) studies. The studies funded by pharmaceutical industry were less likely to be stopped early because of logistical reasons (3.0% vs 19.1%; odds ratio [OR] = 0.13; 95% confidence interval [CI], .04–.37) and to show inconclusive results (11.1% vs 42.9%; OR = 0.17; 95% CI, .08–.33). The quality of studies decreased over time with respect to blinding, early stopping, reporting of ITT with PP analysis, and having misleading conclusions. Conclusions There is room for improvement in the methodology and reporting of antibiotic noninferiority trials. Quality can be improved across the entire spectrum from investigators, funding agencies, as well as during the peer-review process. There is room for improvement in the methodology and reporting of antibiotic noninferiority trials including justification of noninferiority margin, reporting of intention-to-treat analysis with per-protocol analysis, and having conclusions that are concordant with study results. PROSPERO registration number CRD42020165040.

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Reported quality of randomized controlled trials of physiotherapy interventions has improved over time

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2010.08.009 ◽

2011 ◽

Vol 64 (6) ◽

pp. 594-601 ◽

Cited By ~ 58

Author(s):

Anne M. Moseley ◽

Robert D. Herbert ◽

Christopher G. Maher ◽

Catherine Sherrington ◽

Mark R. Elkins

Keyword(s):

Randomized Controlled Trials ◽

Controlled Trials ◽

Randomized Controlled ◽

Over Time

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Levels of evidence and quality of randomized controlled trials in hand and wrist surgery: an analysis of two major hand surgery journals

Journal of Hand Surgery (European Volume) ◽

10.1177/1753193413495369 ◽

2013 ◽

Vol 39 (8) ◽

pp. 900-902 ◽

Cited By ~ 5

Author(s):

S. F. Post ◽

R. W. Selles ◽

D. A. McGrouther ◽

M. J. P. F. Ritt ◽

S. E. R. Hovius ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Hand Surgery ◽

Controlled Trials ◽

Levels Of Evidence ◽

Randomized Controlled ◽

Surgery Journals

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An assessment of the quality of rotator cuff randomized controlled trials: utilizing the Jadad score and CONSORT criteria

Journal of Shoulder and Elbow Surgery ◽

10.1016/j.jse.2013.01.017 ◽

2013 ◽

Vol 22 (9) ◽

pp. 1180-1185 ◽

Cited By ~ 29

Author(s):

Frank McCormick ◽

Gregory L. Cvetanovich ◽

Jaehon M. Kim ◽

Joshua D. Harris ◽

Anil K. Gupta ◽

...

Keyword(s):

Rotator Cuff ◽

Randomized Controlled Trials ◽

Controlled Trials ◽

Jadad Score ◽

Randomized Controlled

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The Consolidated Standards of Reporting Trials (CONSORT): Better Presentation of Surgical Trials in the Journal of Hand Surgery

Journal of Hand Surgery (European Volume) ◽

10.1016/j.jhsb.2004.09.015 ◽

2004 ◽

Vol 29 (6) ◽

pp. 621-624 ◽

Cited By ~ 12

Author(s):

S. SAUERLAND ◽

T. R. C. DAVIS

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Hand Surgery ◽

Controlled Trials ◽

Scientific Validity ◽

Intention To Treat ◽

Randomized Controlled ◽

Study Results ◽

Methodological Aspects ◽

Treat Analysis

To assure readers that study results are scientifically valid, the methods of a clinical trial should be described adequately. Since randomization, blinding, and intention-to-treat-analysis are major bias-reducing techniques, these aspects should be reported most accurately. The Consolidated standards of reporting trials (CONSORT) are recommendations to improve the reporting of trials. CONSORT requires that trial authors describe basic methodological aspects that readers need to appraise the strengths of report ed clinical trials. This article presents the CONSORT recommendations and explains some of their main aspects. From now on, the Journal of Hand Surgery will use CONSORT to assist authors of randomized controlled trials in improving the description of their studies. We believe that this decision increases the scientific validity of study reports and helps readers when critically appraising articles.

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Standards for reporting randomized controlled trials in neurosurgery

Journal of Neurosurgery ◽

10.3171/2010.8.jns091770 ◽

2011 ◽

Vol 114 (2) ◽

pp. 280-285 ◽

Cited By ~ 33

Author(s):

Erin N. Kiehna ◽

Robert M. Starke ◽

Nader Pouratian ◽

Aaron S. Dumont

Keyword(s):

New England ◽

Randomized Controlled Trials ◽

Controlled Trials ◽

Jadad Score ◽

Quality Of Reporting ◽

Medical Journals ◽

Journal Editors ◽

Randomized Controlled ◽

Neurosurgical Patients

Object The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. Methods The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. Results In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39–44) compared with those published in neurosurgical journals (mean 26.4, range 17–38; p < 0.0001). Jadad scores were also significantly higher for the major medical journals (mean 3.42, range 2–5) than neurosurgical journals (mean 2.45, range 1–5; p = 0.05). Conclusions Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could improve the methodology and reporting of RCTs in neurosurgery.

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