Quality of reporting in surgical randomized clinical trials

Yu, Jiajie; Li, X; Li, Y; Sun, Xin

doi:10.1002/bjs.10331

Cited by 38 publications

(27 citation statements)

References 31 publications

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“…There are previous reviews that have assessed changes in the quality of reporting of trials (e.g. [ 14 – 18 ]). In those concerning the reporting of the trial methods, improvements have been found [ 14 – 16 ].…”

Section: Discussionmentioning

confidence: 99%

Description of complex interventions: analysis of changes in reporting in randomised trials since 2002

Candy

Vickerstaff

Jones

et al. 2018

Trials

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BackgroundInadequate description of non-pharmacological complex interventions in trial publications means that they cannot be replicated or assessed for generalisability. There are published guidelines on how to describe an intervention, such as those from the CONSORT Group. However, there have been few evaluations of whether intervention reporting is improving.MethodsWe aimed to assess whether descriptions of multicomponent, non-pharmacological interventions evaluated in randomised trials are improving. To do so, we chose trials of educational and psychotherapeutic interventions to promote adherence to therapy, and compared those published between 2002 and 2007 (Time-1) with those between 2010 and 2015 (Time-2). These time periods were chosen to concord with the publication in 2008 of the CONSORT extension statement of reporting guidelines for non-pharmacological treatment which included items on intervention description. We assessed 19 items, based on the CONSORT Statement and the more recent Template for Intervention Description and Replication Checklist (TIDieR). Two reviewers independently extracted data. We created a quality score of the eight items we considered key information for replication and assessment of generalisability (setting, provider, recipient, comparator, intervention intensity, how it was conducted, existence of a manual or protocol, and detail of whether there was an assessment of fidelity). Score per item was ‘1’ if reported adequately and ‘0’ if not.ResultsOf the eligible trials, 42 were published in Time-1 and 134 published in Time-2. The trials included were published in 112 peer-reviewed journals, 52 of these journals currently require authors to follow the CONSORT Statements, while only one recommended adherence to the TIDieR.Most items of CONSORT and TIDieR were reported by more than half of the trials at both time points. Few trials reported fidelity. A large proportion of the trials did not report the existence of a manual or protocol, or what the comparator group received. We found no statistically significant improvement in the eight-item quality score (Time-1: mean 5.71 (standard deviation (SD) 1.09), Time-2: 5.87 (SD 1.28), p = 0.49).ConclusionsWe found no overall evidence that reporting the specifics of multicomponent, non-pharmacological interventions is improving. Details to replicate interventions remain lacking, impairing best implementation or meaningful further research. Editorial endorsement of reporting checklists needs to be more extensive.

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Section: Discussionmentioning

confidence: 99%

Description of complex interventions: analysis of changes in reporting in randomised trials since 2002

Candy

Vickerstaff

Jones

et al. 2018

Trials

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“…A SR was defined as described in the Cochrane handbook (version 5.1.0) 1 , as an article with clearly stated objectives with an explicitly reproducible methodology, systematic search methods, assessment of the validity of included studies and methods of synthesis. The definition of a surgical intervention has been described elsewhere 16 .…”

Section: Methodsmentioning

confidence: 99%

Quality of reporting of systematic reviews and meta-analyses of surgical randomized clinical trials

Chen

et al. 2020

BJS Open

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Background: Well designed and conducted systematic reviews are essential to clinical practice. Surgical intervention is more complex than medical intervention when considering special items related to procedures. There has been no cross-sectional study of the reporting quality of systematic reviews of surgical randomized trials focused on special items relating to surgical interventions. Methods: A cross-sectional survey of systematic reviews of surgical randomized trials published in 2007 and 2017 was undertaken via a PubMed search. Quality of reporting was assessed by the PRISMA checklist, with intervention details containing 27 items. Univariable and multivariable linear regression was used to explore factors in the checklist as indicators of reporting quality.Results: A total of 204 systematic reviews were identified. The median score for the PRISMA checklist was 22 (i.q.r. 20-24), and systematic reviews published in 2017 had a significantly higher median score than those from 2007 (22 (i.q.r. 21-24) versus 20 (17-22); P < 0⋅001). Among the 27 items, 15 were reported adequately and three were reported poorly (in less than 50 per cent of reports). The proportion of other items reported ranged from 54⋅4 to 77⋅9 per cent. In multivariable analysis, systematic reviews published in 2017 (coefficient 0⋅59, 95 per cent c.i. 0⋅50 to 0⋅69) and Cochrane reviews (coefficient 0⋅67, 0⋅55 to 0⋅81) were associated with better reporting.Conclusion: The quality of reporting of systematic reviews of surgical randomized trials has improved in the past 10 years. Some information relating to specific surgical interventions is, however, still reported poorly.

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“…Network Meta-analyses, methodological systematic reviews or systematic reviews reported as conference abstracts and research letters were excluded. A systematic review was de ned as described in the Cochrane handbook (version 6, 2019) [24] and the de nitions of surgical intervention and device have been described elsewhere [25]. A COI disclosure was de ned as whether a COI disclosure was stated or not.…”

Section: Eligibility Criteriamentioning

confidence: 99%

Identifying conflict of interest disclosure in systematic reviews of surgical interventions and devices: a cross-sectional survey

Hirst

et al. 2020

Preprint

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Background Conflict of interest (COI) is an important source of bias in research and disclosure is the most frequent strategy to manage COI. Considering the importance of systematic reviews (SRs) and the prevalence of COI is varying among different research fields and the, we conducted a survey to identify the range of conflict of interest in SRs assessing surgical intervention and devices, and explored the association between COI disclosure and conclusion. Methods We retrieved SRs of surgical interventions and devices published in 2017 via PubMed. Information regarding general characteristics, funding source and COI disclosure were extracted. We conducted a descriptive analyses of study characteristics of included systematic reviews. The difference between groups in the authors’ conclusions were compared using the Chi-square test. Results were expressed as odds ratio and its 95% confidence interval. Results 155 SRs were finally identified in 2017, more than half of SRs (58.7%) reported their funding source and 94.2% reported authors’ COI disclosure. Among 146 SRs that stated COI disclosures, only 35 (22.6%) SRs declared at least one author had a COI. More than 40 terms were used to describe COI. Cochrane SRs were more likely to provide a detail description of COI comparing with those in non-CSR (48.0% versus 25.4%, P = 0,023). No association between positive conclusion and COI disclosure was found (P = 0.484, OR = 0.43, 95%CI: 0.08, 2.16). In the subgroup analyses, SRs stating no COI disclosure were more likely to report positive conclusion than those stating at least one type of COI, but the difference is not significantly different (P = 0.406, OR = 1.38, 95%CI: 0.64, 2.98) Conclusion A high rate of COI disclosure without any detailed information. Although little impact of COI disclosure on author’ conclusions in SRs was found for limited sample, clear description of all potential COI is the best way to enhance the credibility of published scholarship and unbiased evidence-informed decision.

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Quality of reporting in surgical randomized clinical trials

Abstract: The quality of reporting in surgical trials has improved in the past decade. Overall quality, however, remains suboptimal, particularly in relation to details regarding surgical interventions and management.

Cited by 38 publications

References 31 publications

Description of complex interventions: analysis of changes in reporting in randomised trials since 2002

Description of complex interventions: analysis of changes in reporting in randomised trials since 2002

Quality of reporting of systematic reviews and meta-analyses of surgical randomized clinical trials

Identifying conflict of interest disclosure in systematic reviews of surgical interventions and devices: a cross-sectional survey

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