Selective outcome reporting in randomized clinical trials of dental implants

To determine the marginal bone loss and the survival, success and failure rates of narrow dental implants, a systematic literature search was carried out in the MEDLINE (Pubmed), Cochrane, Scopus, and Scielo databases for articles published between 2010 and 2021. The exclusion criteria were: systematic reviews, case reports, expert opinions; animal studies; samples of less than 10 subjects; follow-up periods of less than 36 months; smokers of minimum 10 cigarettes/day; and articles about mini-implants for orthodontic anchorage. Meta-analyses were performed to assess marginal bone loss and implant survival, success, and failure rates. Fifteen studies were included: 7 clinical trials, 3 randomized clinical trials, 3 cohort studies, and 2 case series. The total number of subjects was 773, in whom 1245 implants were placed. The survival rate for the narrow diameter implants was 97%, the success rate 96.8%, and the failure rate 3%. Marginal bone loss was 0.821 mm. All these data were evaluated at 36 months. Based on the literature, it can be considered that there is sufficient evidence to consider small diameter implants a predictable treatment option. These show favorable survival and success rates and marginal bone loss. All of them are comparable to those of standard diameter dental implants.

Download Full-text

Primary outcome reporting in adolescent depression clinical trials needs standardization

10.21203/rs.2.21217/v2 ◽

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

Download Full-text

Publication bias in clinical trials

10.53731/r294649-6f79289-8cw3m ◽

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 ...

Download Full-text

Role of Dental Implant Homecare in Mucositis and Peri-implantitis Prevention: A Literature Overview

The Open Dentistry Journal ◽

10.2174/1874210601913010470 ◽

2019 ◽

Vol 13 (1) ◽

pp. 470-477

Author(s):

Vittorio Checchi ◽

Fabrizio Racca ◽

Davide Bencivenni ◽

Laura Lo Bianco

Keyword(s):

Clinical Trials ◽

Home Care ◽

Cohort Studies ◽

Dental Implants ◽

Randomized Clinical Trials ◽

Current Knowledge ◽

Good Evidence ◽

Inclusion Criteria ◽

Dental Floss ◽

Care Practices

Background: Correlation between high plaque index and inflammatory lesions around dental implants has been shown and this highlights the importance of patient plaque control. Until now, knowledge of peri-implant home care practices has been based on periodontal devices. Objective: The aim of this overview is to identify the presence of scientific evidence that peri-implant homecare plays a role in mucositis and peri-implantitis prevention. Methods: Different databases were used in order to detect publications reflecting the inclusion criteria. The search looked into peri-implant homecare studies published from 1991 to 2019 and the terms used for the identification of keywords were: Dental implants, Brush, Interproximal brushing, Interdental brushing, Power toothbrush, Cleaning, Interdental cleaning, Interspace cleaning, Flossing, Super floss, Mouth rinses, Chlorhexidine. The type of studies included in the selection for this structured review were Randomized Clinical Trials, Controlled Clinical Trials, Systematic Reviews, Reviews, Cohort Studies and Clinical cases. Results: Seven studies fulfilled all the inclusion criteria: 3 RCTs, one Consensus report, one cohort study, one systematic review and one review. Other 14 studies that partially met the inclusion criteria were analyzed and classified into 3 different levels of evidence: good evidence for RCTs, fair evidence for case control and cohort studies and poor evidence for expert opinion and case report. Conclusion: Not much research has been done regarding homecare implant maintenance. Scientific literature seems to show little evidence regarding these practices therefore most of the current knowledge comes from the periodontal literature. Manual and powered toothbrushes, dental floss and interdental brushes seem to be useful in maintaining peri-implant health. The use of antiseptic rinses or gels does not seem to have any beneficial effects. It can be concluded that to better understand which are the most effective home care practices to prevent mucositis and peri-implantitis in implant-rehabilitated patients, new specific high evidence studies are needed.

Download Full-text

Response to: stated conclusion about industry funding is opposite to what the paper's data show: letter regarding “Selective outcome reporting in obesity clinical trials: a cross-sectional review”

Clinical Obesity ◽

10.1111/cob.12212 ◽

2017 ◽

Vol 7 (6) ◽

pp. 403-403

Author(s):

Andrew Ross ◽

Matt Vassar

Keyword(s):

Clinical Trials ◽

Selective Outcome Reporting ◽

Industry Funding ◽

Cross Sectional ◽

Outcome Reporting

Download Full-text

Peer reviewed evaluation of registered end-points of randomised trials (the PRE-REPORT study): protocol for a stepped-wedge, cluster-randomised trial

BMJ Open ◽

10.1136/bmjopen-2018-028694 ◽

2019 ◽

Vol 9 (5) ◽

pp. e028694

Author(s):

Christopher W Jones ◽

Amanda Adams ◽

Mark A Weaver ◽

Sara Schroter ◽

Benjamin S Misemer ◽

...

Keyword(s):

Clinical Trials ◽

Peer Review ◽

Primary Outcome ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Selective Outcome Reporting ◽

Outcome Reporting ◽

Cluster Randomised ◽

Peer Reviewers

IntroductionClinical trials are critical to the advancement of medical knowledge. However, the reliability of trial conclusions depends in part on consistency between pre-planned and reported study outcomes. Unfortunately, selective outcome reporting, in which outcomes reported in published manuscripts differ from pre-specified study outcomes, is common. Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts. However, the persistently high rate of selective outcome reporting among published clinical trials indicates that the current peer review process at most journals does not effectively address the problem of selective outcome reporting.Methods and analysisPRE-REPORT is a stepped-wedge cluster-randomised trial that will test whether providing peer reviewers with a summary of registered, pre-specified primary trial outcomes decreases inconsistencies between prospectively registered and published primary outcomes. Peer reviewed manuscripts describing clinical trial results will be included. Eligible manuscripts submitted to each participating journal during the study period will comprise each cluster. After an initial control phase, journals will transition to the intervention phase in random order, after which peer reviewers will be emailed registry information consisting of the date of registration and any prospectively defined primary outcomes. Blinded outcome assessors will compare registered and published primary outcomes for all included trials. The primary PRE-REPORT outcome is the presence of a published primary outcome that is consistent with a prospectively defined primary outcome in the study’s trial registry. The primary outcome will be analysed using a mixed effect logistical regression model to compare results between the intervention and control phases.Ethics and disseminationThe Cooper Health System Institutional Review Board determined that this study does not meet criteria for human subject research. Findings will be published in peer-reviewed journals.Trial registration numberISRCTN41225307; Pre-results.

Download Full-text