Dataset Information

Selective outcome reporting in paediatric dentistry restorative treatment randomised clinical trials-A meta-research.

ABSTRACT:

Background

Selective outcome reporting (SOR) is a bias that occurs when the primary outcome of a randomised clinical trial (RCT) is omitted or changed.

Aim

To evaluate the prevalence of SOR in RCTs on restorative treatment in primary teeth.

Design

We conducted an electronic search on ClinicalTrials.gov and the World Health Organization platform (International Clinical Trials Registry Platform) on 1^st of April 2021, with no registry time or language restrictions. We included RCT protocols that evaluated restorative treatments in primary teeth and excluded trials that did not have a complete publication in a scientific journal. The chi-squared test was used to identify the association between SOR and variables as a discrepancy in the follow-up period, the timing of registration, the type of sponsorship and the type of study design (α = 5%).

Results

Of the 294 identified protocols, 30 were included in the study. 83.3% of trials were registered retrospectively. SOR was observed in 53.3% (n = 16) of the published trials and was significantly associated with a discrepancy in the follow-up period (p = .017).

Conclusions

The high prevalence of SOR in RCTs on restorative treatment proves that this is a prominent threat. A proper preregistered protocol, declaration of any protocol deviation and allowance of stakeholders to compare the protocol with that of the submitted papers will achieve transparency.

SUBMITTER: Elagami RA

PROVIDER: S-EPMC10087835 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Selective outcome reporting in paediatric dentistry restorative treatment randomised clinical trials-A meta-research.

Elagami Rokaia Ahmed RA Tedesco Tamara Kerber TK Pannuti Claudio Mendes CM da Silva Gabriela Seabra GS Braga Mariana Minatel MM Mendes Fausto Medeiros FM Raggio Daniela Prócida DP

International journal of paediatric dentistry 20220726 1

<h4>Background</h4>Selective outcome reporting (SOR) is a bias that occurs when the primary outcome of a randomised clinical trial (RCT) is omitted or changed.<h4>Aim</h4>To evaluate the prevalence of SOR in RCTs on restorative treatment in primary teeth.<h4>Design</h4>We conducted an electronic search on ClinicalTrials.gov and the World Health Organization platform (International Clinical Trials Registry Platform) on 1<sup>st</sup> of April 2021, with no registry time or language restrictions. ...[more]

PMID: 35838202

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Project description:ObjectiveTo compare effect estimates of randomised clinical trials that use routinely collected data (RCD-RCT) for outcome ascertainment with traditional trials not using routinely collected data.DesignMeta-research study.Data sourceStudies included in the same meta-analysis in a Cochrane review.Eligibility criteria for study selectionRandomised clinical trials using any type of routinely collected data for outcome ascertainment, including from registries, electronic health records, and administrative databases, that were included in a meta-analysis of a Cochrane review on any clinical question and any health outcome together with traditional trials not using routinely collected data for outcome measurement.Review methodsEffect estimates from trials using or not using routinely collected data were summarised in random effects meta-analyses. Agreement of (summary) treatment effect estimates from trials using routinely collected data and those not using such data was expressed as the ratio of odds ratios. Subgroup analyses explored effects in trials based on different types of routinely collected data. Two investigators independently assessed the quality of each data source.Results84 RCD-RCTs and 463 traditional trials on 22 clinical questions were included. Trials using routinely collected data for outcome ascertainment showed 20% less favourable treatment effect estimates than traditional trials (ratio of odds ratios 0.80, 95% confidence interval 0.70 to 0.91, I2=14%). Results were similar across various types of outcomes (mortality outcomes: 0.92, 0.74 to 1.15, I2=12%; non-mortality outcomes: 0.71, 0.60 to 0.84, I2=8%), data sources (electronic health records: 0.81, 0.59 to 1.11, I2=28%; registries: 0.86, 0.75 to 0.99, I2=20%; administrative data: 0.84, 0.72 to 0.99, I2=0%), and data quality (high data quality: 0.82, 0.72 to 0.93, I2=0%).ConclusionsRandomised clinical trials using routinely collected data for outcome ascertainment show smaller treatment benefits than traditional trials not using routinely collected data. These differences could have implications for healthcare decision making and the application of real world evidence.

Project description:IntroductionSystematic reviews collate trial data to provide evidence to support clinical decision-making. For effective synthesis, there must be consistency in outcome reporting. There is no agreed set of outcomes for reporting the effect of burn care interventions. Issues with outcome reporting have been identified, although not systematically investigated. This study gathers empirical evidence on any variation in outcome reporting and assesses the need for a core outcome set for burn care research.MethodsElectronic searches of four search engines were undertaken from January 2012 to December 2016 for randomised controlled trials (RCTs), using medical subject headings and free text terms including 'burn', 'scald' 'thermal injury' and 'RCT'. Two authors independently screened papers, extracted outcomes verbatim and recorded the timing of outcome measurement. Duplicate outcomes (exact wording ± different spelling), similar outcomes (albumin in blood, serum albumin) and identical outcomes measured at different times were removed. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included trials. Outcomes were classified into domains. Bias was reduced using five researchers and a patient working independently and together.Results147 trials were included, of which 127 (86.4%) were RCTs, 13 (8.8%) pilot studies and 7 (4.8%) RCT protocols. 1494 verbatim clinical outcomes were reported; 955 were unique. 76.8% of outcomes were measured within 6 months of injury. Commonly reported outcomes were defined differently. Numbers of unique outcomes per trial varied from one to 37 (median 9; IQR 5,13). No single outcome was reported across all studies demonstrating inconsistency of reporting. Outcomes were classified into 54 domains. Numbers of outcomes per domain ranged from 1 to 166 (median 11; IQR 3,24).ConclusionsThis review has demonstrated heterogeneity in outcome reporting in burn care research which will hinder amalgamation of study data. We recommend the development of a Core Outcome Set.Prospero registration numberCRD42017060908.

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Dataset Information

Selective outcome reporting in paediatric dentistry restorative treatment randomised clinical trials-A meta-research.

Background

Aim

Design

Results

Conclusions

Publications

Selective outcome reporting in paediatric dentistry restorative treatment randomised clinical trials-A meta-research.

Similar Datasets

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