Selective outcome reporting in randomized clinical trials of dental implants

Daniel Isaac Sendyk · Emanuel Silva Rovai · Nathalia Vilela · Maria Cristina Zindel Deboni · Cláudio Mendes Pannuti

35 citations0/0 files storedJournal Of Clinical Periodontology

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Meta-analysis and systematic reviews Dental Implant Techniques and Outcomes Pharmaceutical industry and healthcare

Abstract

AIM: Selective outcome reporting (SOR) is a type of bias that occurs when the primary outcome of a trial protocol is changed or omitted in the paper. The purpose of this study was to evaluate the prevalence of SOR in publications of randomized clinical trials (RCT) concerning dental implants. MATERIALS AND METHODS: Two reviewers independently screened protocols registered at ClinicalTrials.gov until February/2019. If the protocol met the eligibility criteria, the reviewers tried to identify the corresponding publication. Data extraction was carried out by the same reviewers. Primary and secondary outcomes were recorded for each trial and compared to outcomes previously described in protocols. RESULTS: A total of 49 protocols were included. SOR was identified in 27 (55.1%) trials. The major discrepancies were as follows: protocol-defined primary outcome omitted in the publication (n = 6, 12.2%), new primary outcome introduced (n = 8, 16.3%), discrepancy in the primary outcome time frame (n = 17, 34.7%) and new secondary outcome introduced (n = 31, 63.3%). SOR was significantly associated with industry funding (p = 0.04) and timing of registration (p = 0.04). CONCLUSIONS: Our results indicate a high rate of SOR in dental implants clinical trials. Use of registry data during the peer-review process may help decreasing SOR.

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References

2013SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials 2004Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials 2016What does research reproducibility mean?2010The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews 2009Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials 2004Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors 2015Comparison of registered and published outcomes in randomized controlled trials: a systematic review 2011Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists

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