Selective outcome reporting in root coverage randomized clinical trials

2021 ◽  
Author(s):  
Daniel Isaac Sendyk ◽  
Nathalia Vilela Souza ◽  
João Batista César Neto ◽  
Dimitris N. Tatakis ◽  
Cláudio Mendes Pannuti
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Root Coverage ◽  
Selective Outcome Reporting ◽  
Outcome Reporting

The Effect of Time on Root Coverage Outcomes: A Network Meta-analysis

2019 ◽  
Vol 98 (11) ◽  
pp. 1195-1203 ◽  
Author(s):  
L. Tavelli ◽  
S. Barootchi ◽  
F. Cairo ◽  
G. Rasperini ◽  
K. Shedden ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Small Sample ◽  
Enamel Matrix Derivative ◽  
Critical Element ◽  
Root Coverage ◽  
Treatment Approaches ◽  
Gingival Margin ◽  
The Stability

The stability of root coverage outcomes has gained a great deal of interest. However, insufficient evidence is available, mainly due to limited direct comparisons among different techniques and the small sample size among clinical trials. Therefore, the aim of this study was to propose a mixed-models network meta-analysis (NMA) that includes the novelty of assessing time on root coverage outcomes while simultaneously comparing different surgical approaches. A literature search was performed by 2 individual reviewers to identify randomized clinical trials (RCTs) reporting the outcomes of root coverage procedures of at least 2 time points to estimate the slopes of different treatment approaches. The primary outcomes were the changes in slopes for recession depth (REC), keratinized tissue width (KTW), and clinical attachment level. Sixty RCTs with a total of 2,554 gingival recessions (1,864 patients) were included in the NMA. Connective tissue graft (CTG) and enamel matrix derivative (EMD) approaches provided superior initial REC reduction compared to flap advancement alone. However, only CTG-based procedures were effective in maintaining the stability of the gingival margin over time, while EMD, acellular dermal matrix, collagen matrix, and flap alone showed a similar tendency for gingival recession recurrence. Baseline REC and KTW at the earliest postoperative recall were predictors for the stability of the gingival margin. In addition, a geographic center effect on the treatment slopes was observed for REC and KTW. While limitations of the present linear mixed-modeling approach should be considered as it refers to estimation and comparison of time slopes based on an examined while linear framework, the designed NMA showed to be an effective tool for the simultaneous comparison of multiple treatment approaches while taking into account the critical element of time.

scholarly journals Primary outcome reporting in adolescent depression clinical trials needs standardization

2020 ◽  
Author(s):  
Andrea Monsour ◽  
Emma J. Mew ◽  
Sagar Patel ◽  
Alyssandra Chee-a-tow ◽  
Leena Saeed ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Outcome Assessment ◽  
Adolescent Depression ◽  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Outcome Measurement ◽  
Measurement Instrument ◽  
Outcome Reporting ◽  
Meta Analyses

Abstract Background: Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. Methods: RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as “fully reported”, “partially reported”, or “not reported” for each checklist item, as applicable. Results: Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6-17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time. Conclusions: Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed. Trial registration: Not applicable

scholarly journals Publication bias in clinical trials

2009 ◽  
Author(s):  
Martin Fenner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
England Journal ◽  
New England ◽  
Cancer Patients ◽  
Publication Bias ◽  
Secondary Outcome ◽  
Selective Outcome Reporting ◽  
Outcome Reporting

Last week the New England Journal of Medicine (NEJM) published a paper on selective outcome reporting in clinical trials (Vedula et al. 2009). The primary and secondary outcome(s) of a clinical trial could for example be survival in cancer patients or ...

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

2021 ◽  
Author(s):  
Rokaia Ahmed Elagami ◽  
Tamara Kerber Tedesco ◽  
Claudio Mendes Pannuti ◽  
Gabriela Seabra da Silva ◽  
Mariana Minatel Braga ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Primary Teeth ◽  
Randomized Clinical Trials ◽  
Scientific Journal ◽  
Pediatric Dentistry ◽  
World Health ◽  
Selective Outcome Reporting ◽  
Restorative Treatment ◽  
Outcome Reporting

Abstract 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.

scholarly journals Primary outcome reporting in adolescent depression clinical trials needs standardization

2020 ◽  
Author(s):  
Andrea Monsour ◽  
Emma J. Mew ◽  
Sagar Patel ◽  
Alyssandra Chee-a-tow ◽  
Leena Saeed ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Outcome Assessment ◽  
Adolescent Depression ◽  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Outcome Measurement ◽  
Measurement Instrument ◽  
Outcome Reporting ◽  
Meta Analyses

Abstract Background : Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. Methods : RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as “fully reported”, “partially reported”, or “not reported” for each checklist item, as applicable. Results : Eighteen RCTs were included. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6-17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). Conclusions : Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed. Trial registration: Not applicable

Sign in / Sign up

Export Citation Format

Share Document