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Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

ABSTRACT: To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time.We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics.Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955-2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias.The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent methodology and detailed reporting of trials are still needed.

SUBMITTER: Saltaji H

PROVIDER: S-EPMC5741237 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

Saltaji Humam H Armijo-Olivo Susan S Cummings Greta G GG Amin Maryam M Flores-Mir Carlos C

PloS one 20171222 12

<h4>Objectives</h4>To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time.<h4>Methods</h4>We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characte ...[more]

PMID: 29272315

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Project description:Background and objectivesSurvey research is an important research method used to determine individuals' attitudes, knowledge, and behaviors; however, as with other research methods, inadequate reporting threatens the validity of results. This study aimed to describe the quality of reporting of surveys published between 2001 and 2011 in the field of nephrology.Design, setting, participants, & measurementsThe top nephrology journals were systematically reviewed (2001-2011: American Journal of Kidney Diseases, Nephrology Dialysis Transplantation, and Kidney International; 2006-2011: Clinical Journal of the American Society of Nephrology) for studies whose primary objective was to collect and report survey results. Included were nephrology journals with a heavy focus on clinical research and high impact factors. All titles and abstracts were screened in duplicate. Surveys were excluded if they were part of a multimethod study, evaluated only psychometric characteristics, or used semi-structured interviews. Information was collected on survey and respondent characteristics, questionnaire development (e.g., pilot testing), psychometric characteristics (e.g., validity and reliability), survey methods used to optimize response rate (e.g., system of multiple contacts), and response rate.ResultsAfter a screening of 19,970 citations, 216 full-text articles were reviewed and 102 surveys were included. Approximately 85% of studies reported a response rate. Almost half of studies (46%) discussed how they developed their questionnaire and only a quarter of studies (28%) mentioned the validity or reliability of the questionnaire. The only characteristic that improved over the years was the proportion of articles reporting missing data (2001-2004: 46.4%; 2005-2008: 61.9%; and 2009-2011: 84.8%; respectively) (P<0.01).ConclusionsThe quality of survey reporting in nephrology journals remains suboptimal. In particular, reporting of the validity and reliability of the questionnaire must be improved. Guidelines to improve survey reporting and increase transparency are clearly needed.

Project description:BACKGROUND: Although randomized clinical trials (RCTs) are considered the gold standard of evidence, their reporting is often suboptimal. Trial registries have the potential to contribute important methodologic information for critical appraisal of study results. METHODS AND FINDINGS: The objective of the study was to evaluate the reporting of key methodologic study characteristics in trial registries. We identified a random sample (n = 265) of actively recruiting RCTs using the World Health Organization International Clinical Trials Registry Platform (ICTRP) search portal in 2008. We assessed the reporting of relevant domains from the Cochrane Collaboration's 'Risk of bias' tool and other key methodological aspects. Our primary outcomes were the proportion of registry records with adequate reporting of random sequence generation, allocation concealment, blinding, and trial outcomes. Two reviewers independently assessed each record. Weighted overall proportions in the ICTRP search portal for adequate reporting of sequence generation, allocation concealment, blinding (including and excluding open label RCT) and primary outcomes were 5.7% (95% CI 3.0-8.4%), 1.4% (0-2.8%), 41% (35-47%), 8.4% (4.1-13%), and 66% (60-72%), respectively. The proportion of adequately reported RCTs was higher for registries that used specific methodological fields for describing methods of randomization and allocation concealment compared to registries that did not. Concerning other key methodological aspects, weighted overall proportions of RCTs with adequately reported items were as follows: eligibility criteria (81%), secondary outcomes (46%), harm (5%) follow-up duration (62%), description of the interventions (53%) and sample size calculation (1%). CONCLUSIONS: Trial registries currently contain limited methodologic information about registered RCTs. In order to permit adequate critical appraisal of trial results reported in journals and registries, trial registries should consider requesting details on key RCT methods to complement journal publications. Full protocols remain the most comprehensive source of methodologic information and should be made publicly available.

Dataset Information

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

Publications

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

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