A review of trauma and orthopaedic randomised clinical trials published in high-impact general medical journals

Abstract Introduction The recent past has seen a significant increase in the number of trauma and orthopaedic randomised clinical trials published in “the big five” general medical journals. The quality of this research has, however, not yet been established. Methods We therefore set out to critically appraise the quality of available literature over a 10-year period (April 2010–April 2020) through a systematic search of these 5 high-impact general medical journals (JAMA, NEJM, BMJ, Lancet and Annals). A standardised data extraction proforma was utilised to gather information regarding: trial design, sample size calculation, results, study quality and pragmatism. Quality assessment was performed using the Cochrane Risk of Bias 2 tool and the modified Delphi list. Study pragmatism was assessed using the PRECIS-2 tool. Results A total of 25 studies were eligible for inclusion. Over half of the included trials did not meet their sample size calculation for the primary outcome, with a similar proportion of these studies at risk of type II error for their non-significant results. There was a high degree of pragmatism according to PRECIS-2. Non-significant studies had greater pragmatism that those with statistically significant results (p < 0.001). Only 56% studies provided adequate justification for the minimum clinically important difference (MCID) in the population assessed. Overall, very few studies were deemed high quality/low risk of bias. Conclusions These findings highlight that there are some important methodological concerns present within the current evidence base of RCTs published in high-impact medical journals. Potential strategies that may improve future trial design are highlighted. Level of evidence Level 1.

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SYSTEMATIC REVIEW PROTOCOL: The reporting standards of Randomised Clinical Trials in leading medical journals between 2019-2020

10.1101/2020.07.06.20147074 ◽

2020 ◽

Author(s):

Mairead McErlean ◽

Jack Samways ◽

Peter Godolphin ◽

Yang Chen

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Medical Specialty ◽

Randomised Clinical Trials ◽

Reporting Standards ◽

Systematic Review Protocol ◽

Quality Of Reporting ◽

Medical Journals ◽

Review Protocol

This is a systematic review protocol which outlines the basis and methodology for our intended review which at the time of writing is in the study screening phase. Our aim is to answer the fundamental questions:To systematically identify RCTs published in the four leading medical journals between January 1st 2019 to May 31st 2020.To assess the quality of reporting of such RCTs using the CONSORT 2010 statement.To identify any association with medical specialty or size or type of RCT and the rate of adherence to the CONSORT 2010 statement.

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An Evaluation of the Quality of Clinical Trials in Anesthesia

Anesthesiology ◽

10.1097/00000542-200111000-00007 ◽

2001 ◽

Vol 95 (5) ◽

pp. 1068-1073 ◽

Cited By ~ 28

Author(s):

Hwee Leng Pua ◽

Jerrold Lerman ◽

Mark W. Crawford ◽

James G. Wright

Keyword(s):

Clinical Trials ◽

Sample Size ◽

Type I Error ◽

Sample Size Calculation ◽

Adverse Outcomes ◽

Random Allocation ◽

Type I ◽

Trial Methodology ◽

Eligibility Criteria

Background The authors evaluated the quality of clinical trials published in four anesthesia journals during the 20-yr period from 1981-2000. Methods Trials published in four major anesthesia journals during the periods 1981-1985, 1991-1995, and the first 6 months of 2000 were grouped according to journal and year. Using random number tables, four trials were selected from all of the eligible clinical trials in each journal in each year for the periods 1981-1985 and 1991-1995, and five trials were selected from all of the trials in each journal in the first 6 months of 2000. Methods and results sections from the 160 trials from 1981-1985 and 1991-1995 were randomly ordered and distributed to three of the authors for blinded review of the quality of the study design according to 10 predetermined criteria (weighted equally, maximum score of 10): informed consent and ethics approval, eligibility criteria, sample size calculation, random allocation, method of randomization, blind assessment of outcome, adverse outcomes, statistical analysis, type I error, and type II error. After these trials were evaluated, 20 trials from the first 6 months of 2000 were randomly ordered, distributed, and evaluated as described. Results The mean (+/- SD) analysis scores pooled for the four journals increased from 5.5 +/- 1.4 in 1981-1985 to 7.0 +/- 1.1 in 1991-1995 (P < 0.00001) and to 7.8 +/- 1.5 in 2000. For 7 of the 10 criteria, the percentage of trials from the four journals that fulfilled the criteria increased significantly between 1981-1985 and 1991-1995. During the 20-yr period, the reporting of sample size calculation and method of randomization increased threefold to fourfold, whereas the frequency of type I statistical errors remained unchanged. Conclusion Although the quality of clinical trials in four major anesthesia journals has increased steadily during the past two decades, specific areas of trial methodology require further attention.

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Information on adverse events in randomised clinical trials assessing drug interventions published in four medical journals with high impact factors

International Journal of Risk & Safety in Medicine ◽

10.3233/jrs-140609 ◽

2014 ◽

Vol 26 (1) ◽

pp. 9-22 ◽

Cited By ~ 9

Author(s):

Cátia Bauer Maggi ◽

Isabel Heinzmann Griebeler ◽

Tatiane da Silva Dal Pizzol

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

High Impact ◽

Randomised Clinical Trials ◽

Impact Factors ◽

Medical Journals ◽

Drug Interventions

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Does evidence support physiotherapy management of adult female chronic pelvic pain? A systematic review

Scandinavian Journal of Pain ◽

10.1016/j.sjpain.2011.12.002 ◽

2012 ◽

Vol 3 (2) ◽

pp. 70-81 ◽

Cited By ~ 12

Author(s):

S. Loving ◽

J. Nordling ◽

P. Jaszczak ◽

T. Thomsen

Keyword(s):

Clinical Trials ◽

Pelvic Pain ◽

Chronic Pelvic Pain ◽

Intervention Studies ◽

Clinical Intervention ◽

Evidence Base ◽

Risk Of Bias ◽

Randomised Clinical Trials ◽

Multidisciplinary Intervention

AbstractBackground and purposeChronic pelvic pain (CPP) is a debilitating condition among women with a major impact on health-related quality of life, work productivity and health care utilisation. The exact prevalence of chronic pelvic pain is not known, but 3.8% is commonly suggested. Musculoskeletal dysfunction is frequently cited as a possible aetiology. Physiotherapy is therefore recommended as one treatment modality. The aim of this systematic review was to source and critically evaluate the evidence for an effect of physiotherapy on pain, physical activity and quality of life in the treatment of female CPP.MethodsElectronic databases, conference proceedings, text books and clinical guidelines were searched for quantitative, observational, and prospective clinical intervention studies of female chronic pelvic pain where physiotherapy was a sole or significant component of the intervention. Trial inclusion, data extraction according to predefined criteria and risk of bias assessment were performed by two independent authors. Methodological quality of the included clinical intervention studies was assessed using The Cochrane Collaboration’s tool for assessing risk of bias. Review Manager (RevMan) version 5.0 was used for data analysis. Effect estimates (relative risk, mean difference and mean change) with 95% confidence intervals were calculated for the above outcomes. For significant outcomes the numbers needed to treat were calculated.ResultsThe search strategy identified 3469 potential articles. Of these, 11 articles, representing 10 studies, met the inclusion criteria. There were 6 randomised clinical trials, 1 cohort study and 3 case series. Methodological quality was dependent on study type. Accordingly, level of evidence was judged higher in randomised clinical trials than in the other study types. Physiotherapy treatments varied between studies and were provided in combination with psychotherapeutic modalities and medical management. This did not allow for the ‘stand-alone’ value of physiotherapy to be determined. Heterogeneity across the studies, with respect to participants, interventions, outcome measures and times of follow-up, prevented meta-analysis. Narrative synthesis of the results, based on effect estimates and clinically relevant pain improvement, disclosed some evidence to support an effect of multidisciplinary intervention and Mensendieck somatocognitive therapy on female chronic pelvic pain.ConclusionChronic pelvic pain in women is a major health care problem with no specific therapies and poor prognosis. There seems to be some evidence to support the use of a multidisciplinary intervention in the management of female chronic pelvic pain. Somatocognitive therapy is a new approach that appears to be promising and randomised clinical trials are underway in order to establish its evidence base.ImplicationsBased on the findings of this review, recommendations for physiotherapy in chronic pelvic pain clinical guidelines, textbooks and narrative reviews should be interpreted with caution due to the lack of a sufficient evidence base. Only small and largely non-randomised studies have been undertaken of physiotherapeutic interventions and this greatly limits the available evidence on which to base clinical practice. High quality randomised clinical trials are therefore urgently needed.

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