Evidence map›Paper›PMID 29272315›Full record

ArticlePloS one2017

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

Humam Saltaji, Susan Armijo-Olivo, Greta G Cummings, Maryam Amin, Carlos Flores-Mir

Abstract readHistorical Article
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Does immediate dentin sealing influence postoperative sensitivity in teeth restored with indirect restorations? A systematic review and meta-analysis.Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.] · 2022
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  8. Quality Assessment of Studies Included in Cochrane Oral Health Systematic Reviews: A Meta-Research.International journal of environmental research and public health · 2021
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  10. Methodological Errors in Clinical Studies Published by Medical Journals of Ex-Yugoslav Countries.Acta informatica medica : AIM : journal of the Society for Medical Informatics of Bosnia & Herzegovina : casopis Drustva za medicinsku informatiku BiH · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Humam SaltajiSchool of Dentistry, University of Alberta, Edmonton, Alberta, Canada.ORCID 0000-0002-8978-458X
Susan Armijo-OlivoFaculty of Rehabilitation Medicine, University of Alberta, Edmonton, Alberta, Canada.
Greta G CummingsFaculty of Nursing, University of Alberta, Edmonton, Alberta, Canada.
Maryam AminSchool of Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Carlos Flores-MirSchool of Dentistry, University of Alberta, Edmonton, Alberta, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo 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.

methodsWe 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.

resultsSequence 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.

conclusionsThe 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.

Indexed as

DentistryObserver VariationRandomized Controlled Trials as TopicChi-Square DistributionHistory, 20th CenturyHistory, 21st CenturyHumansLogistic ModelsResearch Design

Identifiers

PMID29272315
PMCPMC5741237

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.