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Cochrane Collaboration Systematic Reviews may be based on trials not approved by a research ethics committee.

ABSTRACT: Systematic reviews (SR) may potentially contain reports of primary trials with ethical problems. The Cochrane Collaboration SRs are considered as the highest standard in evidence-based health care resources. All SRs completed during the last 5 years (2013-2017) under the management of the Oral Health Group of the Cochrane Collaboration were identified. All primary trials included in the Oral Health Group SRs were identified and examined to establish their status regarding pre-hoc approval of an independent ethics committee (EC), often termed Institutional Review Board (IRB) before commencing recruitment of trial participants. Ninety-five SRs contained 960 primary trials, of which 272 (28.3%) were not examined by the author of this paper. Amongst the remaining 688 primary trials, 198 (29%) contained no reference to study conduct approval by a research ethics committee. The majority of primary studies referred to an EC/IRB approval with or without identifying the name of the ethics committee (n = 401, 58%), whereas some papers identified both the committee name and a protocol or reference number of the EC/IRB approval (n = 89, 13%). The Cochrane Collaboration, along with other developers of SRs, should adopt the policy established by COPE with regard to what to do if one suspect an ethical problem, that is, request evidence of EC/IRB approval. All stakeholders should rest assured that clinical policies and practices based on SRs are based on ethically sound clinical research.

SUBMITTER: Jokstad A

PROVIDER: S-EPMC5839214 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Cochrane Collaboration Systematic Reviews may be based on trials not approved by a research ethics committee.

Jokstad Asbjørn A

Clinical and experimental dental research 20171027 5

Systematic reviews (SR) may potentially contain reports of primary trials with ethical problems. The Cochrane Collaboration SRs are considered as the highest standard in evidence-based health care resources. All SRs completed during the last 5 years (2013-2017) under the management of the Oral Health Group of the Cochrane Collaboration were identified. All primary trials included in the Oral Health Group SRs were identified and examined to establish their status regarding pre-hoc approval of an ...[more]

PMID: 29744198

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Project description:This research-on-research study describes efforts to develop non-Cochrane systematic reviews (SRs) by analyzing demographical and time-course collaborations between international institutions using protocols registered in the International Prospective Register of Systematic Reviews (PROSPERO) or published in scientific journals. We have published an a priori protocol to develop this study. Protocols published in scientific journals were searched using the MEDLINE and Embase databases; the query terms "Systematic review" [Title] AND "protocol" [Title] were searched from February 2011 to December 2017. Protocols registered at PROSPERO during the same period were obtained by web scraping all non-Cochrane records with a Python script. After excluding protocols that had a fulfillment or duplication rate of less than 90%, they were classified as published "only in PROSPERO", "only in journals", or in "journals and PROSPERO". Results of data and metadata extraction using text mining processes were curated by two reviewers. These Datasets and R scripts are freely available to facilitate reproducibility. We obtained 20,814 protocols of non-Cochrane SRs. While "unique protocols" by reviewers' institutions from 60 countries were the most frequent, a median of 6 (2-150) institutions from 130 different countries were involved in the preparation of "collaborative protocols". The highest Ranked countries involved in overall protocol production were the UK, the U.S., Australia, Brazil, China, Canada, the Netherlands, Germany, and Italy. Most protocols were registered only in PROSPERO. However, the number of protocols published in scientific journals (924) or in both PROSPERO and journals (807) has increased over the last three years. Syst Rev and BMJ Open published more than half of the total protocols. While the more productive countries were involved in "unique" and "collaborative protocols", less productive countries only participated in "collaborative protocols" that were mainly published in PROSPERO. Our results suggest that, although most countries were involved in solitary production of protocols for non-Cochrane SRs during the study period, it would be useful to develop new strategies to promote international collaborations, especially with less productive countries.

Project description:OBJECTIVES:Assess the frequency and reasons for disagreements in risk of bias assessments for randomised controlled trials (RCTs) included in more than one Cochrane review. DESIGN:Research on research study, using cross-sectional design. DATA SOURCES:2796 Cochrane reviews published between March 2011 and September 2014. DATA SELECTION:RCTs included in more than one review. DATA EXTRACTION:Risk of bias assessment and support for judgement for five key risk of bias items. DATA SYNTHESIS:For each item, we compared risk of bias assessment made in each review and calculated proportion of agreement. Two reviewers independently analysed 50% of all disagreements by comparing support for each judgement with information from study report to evaluate whether disagreements were related to a difference in information (eg, contact the study author) or a difference in interpretation (same support for judgement but different interpretation). They also identified main reasons for different interpretation. RESULTS:1604 RCTs were included in more than one review. Proportion of agreement ranged from 57% (770/1348 trials) for incomplete outcome data to 81% for random sequence generation (1193/1466). Most common source of disagreement was difference in interpretation of the same information, ranging from 65% (88/136) for random sequence generation to 90% (56/62) for blinding of participants and personnel. Access to different information explained 32/136 (24%) disagreements for random sequence generation and 38/205 (19%) for allocation concealment. Disagreements related to difference in interpretation were frequently related to incomplete or unclear reporting in the study report (83% of disagreements related to different interpretation for random sequence generation). CONCLUSIONS:Risk of bias judgements of RCTs included in more than one Cochrane review differed substantially. Most disagreements were related to a difference in interpretation of an incomplete or unclear description in the study report. A clearer guidance on common causes of incomplete information may improve agreement.

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Cochrane Collaboration Systematic Reviews may be based on trials not approved by a research ethics committee.

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Cochrane Collaboration Systematic Reviews may be based on trials not approved by a research ethics committee.

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