Selective Outcome Reporting (SOR) in Pediatric Dentistry restorative treatment randomized clinical trials - A meta-research.

BackgroundSelective outcome reporting (SOR) is a type of bias that occurs when the primary outcome of a randomized clinical trial (RCT) is omitted or changed prospectively. We evaluated the prevalence of SOR in RCTs on restorative caries treatment in primary teeth.MethodsWe conducted an electronic search on ClinicalTrials.gov and the World Health Organization (WHO) platform up to April/2021. We included RCT protocols that tested restorative treatments in primary teeth and excluded any protocol that has not resulted in at least one publication in a peer-reviewed scientific journal. The Chi-square test was used to detect the association between SOR and other variables (α = 5%).ResultsOut of 294 potential protocols, thirty were included. We found 34 corresponding publications and had the one that seemed to report the primary outcome and longest follow-up, resulting in 30 publications. SOR was observed in 53.3% (n=16) of the published trials and was significantly associated with the discrepancy in the follow-up period (p=0.017).ConclusionThere is a considerable prevalence of selective outcome reporting (SOR) on restorative trials in primary teeth. Properly pre-registered protocols and assessing them for the peer review processes will help decrease SOR.Practical implicationsRestorative treatment trials in primary teeth that selectively modify outcomes of interest have been shown to distort the treatment effect. Practitioners should avoid using restorative treatments based on misleading results in clinical practice.

A survey of knowledge, perceptions and use of core outcome sets among clinical trialists

Background Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by reducing heterogeneity of outcome measurement and reporting and potentially minimising selective outcome reporting. Examining what researchers involved in trials know and think about COS is essential to increase awareness and promote COS uptake. The aim of this study is therefore to examine clinical trialists’ knowledge, perceptions and experiences of COS. Methods An online survey design was used. Participants were clinical trialists, operationalised for the current study as researchers named as the contact person on a trial registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository between 1 January 2019 and 21 July 2020. Survey items assessed clinical trialists’ familiarity with and understanding of COS, along with experiences of COS use and development. Results Of 1913 clinical trialists contacted to participate, 62 (3%) completed the survey. Forty (65%) participants were familiar with COS and, of those familiar with COS, 21 (55%) had been involved in a trial that used a COS. Of clinical trialists who used COS in a trial(s), less than half (n = 9, 41%) reported that all COS outcomes were used. The main barriers to using COS are poor knowledge about COS (n = 43, 69%) and difficulties identifying relevant COS (n = 42, 68%). Clinical trialists also reported perceptions of COS as restrictive and often containing too many outcomes. The main enablers to using COS are clear understanding (n = 51, 82%) and perceived importance of COS (n = 44, 71%). Conclusions Enhancing clinical trialists’ use of all COS outcomes is needed to reduce outcome heterogeneity and enhance comparability across trial findings. Enhancing awareness of COS importance among researchers and funders is needed to ensure that COS are developed and used by clinical trialists. Education and training may further promote awareness and understanding of COS.

Trial registration and selective outcome reporting in 585 clinical trials investigating drugs for prevention of postoperative nausea and vomiting

Background Selective outcome reporting in clinical trials introduces bias in the body of evidence distorting clinical decision making. Trial registration aims to prevent this bias and is suggested by the International Committee of Medical Journal Editors (ICMJE) since 2004. Methods The 585 randomized controlled trials (RCTs) published between 1965 and 2017 that were included in a recently published Cochrane review on antiemetic drugs for prevention of postoperative nausea and vomiting were selected. In a retrospective study, we assessed trial registration and selective outcome reporting by comparing study publications with their registered protocols according to the ‘Cochrane Risk of bias’ assessment tool 1.0. Results In the Cochrane review, the first study which referred to a registered trial protocol was published in 2004. Of all 585 trials included in the Cochrane review, 334 RCTs were published in 2004 or later, of which only 22% (75/334) were registered. Among the registered trials, 36% (27/75) were pro- and 64% (48/75) were retrospectively registered. 41% (11/27) of the prospectively registered trials were free of selective outcome reporting bias, 22% (6/27) were incompletely registered and assessed as unclear risk, and 37% (10/27) were assessed as high risk. Major outcome discrepancies between registered and published high risk trials were a change from the registered primary to a published secondary outcome (32%), a new primary outcome (26%), and different outcome assessment times (26%). Among trials with high risk of selective outcome reporting 80% favoured at least one statistically significant result. Registered trials were assessed more often as ‘overall low risk of bias’ compared to non-registered trials (64% vs 28%). Conclusions In 2017, 13 years after the ICMJE declared prospective protocol registration a necessity for reliable clinical studies, the frequency and quality of trial registration in the field of PONV is very poor. Selective outcome reporting reduces trustworthiness in findings of clinical trials. Investigators and clinicians should be aware that only following a properly registered protocol and transparently reporting of predefined outcomes, regardless of the direction and significance of the result, will ultimately strengthen the body of evidence in the field of PONV research in the future.

A Survey of Knowledge, Perceptions and Use of Core Outcome Sets among Clinical Trialists

Introduction: Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by reducing heterogeneity of outcome measurement and reporting, and potentially minimising selective outcome reporting. Examining what researchers involved in trials know and think about COS is essential to increase awareness and promote COS uptake. The aim of this study is therefore to examine clinical clinical trialists’ knowledge, perceptions and experiences of COS. Methods: An online survey design was used. Participants were clinical trialists, operationalised for the current study as researchers named as the contact person on a trial registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository between 01/01/2019 and 21/07/2020. Survey items assessed clinical trialists’ familiarity with, and understanding of COS, along with experiences of COS use and development. Results: Of 1913 clinical trialists contacted to participate, 62 (3%) completed the survey. 65% of participants were familiar with COS and, of those familiar with COS, 55% had been involved in a trial that used a COS. Of clinical trialists who used COS in a trial(s), less than half (41%) reported that all COS outcomes were used. The main barriers to using COS are poor knowledge about COS (69%) and difficulties identifying relevant COS (68%). Clinical trialists also reported perceptions of COS as restrictive and often containing too many outcomes. The main enablers to using COS are clear understanding (82%) and perceived importance of COS (71%). Conclusion: Education and training can further promote awareness and understanding of COS. Enhancing clinical trialists’ use of all COS outcomes is needed to reduce outcome heterogeneity and enhance comparability across trial findings. Enhancing awareness of COS importance among researchers and funders is needed to ensure that COS are developed and used by clinical trialists.