Evidence map›Paper›PMID 34747036›Full record

ArticleJournal of clinical periodontology2022

Evidence and risk indicators of non-random sampling in clinical trials in implant dentistry: A systematic appraisal.

Jun-Yu Shi, Xiao Zhang, Shu-Jiao Qian, Shi-Min Wei, Kai-Xiao Yan, Min Xu, Hong-Chang Lai, Maurizio S Tonetti

Open access · hybridAbstract read
In one paragraph

Article in Journal of clinical periodontology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.8field-weighted citation impact, top 13% of its field
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

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
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

8 authors at 1 institution in 1 country.

Jun-Yu ShiShanghai PerioImplant Innovation Center, Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0002-8241-2572
Xiao ZhangShanghai PerioImplant Innovation Center, Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0001-6514-8813
Shu-Jiao QianShanghai PerioImplant Innovation Center, Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shi-Min WeiShanghai PerioImplant Innovation Center, Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Kai-Xiao YanShanghai PerioImplant Innovation Center, Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Min XuShanghai PerioImplant Innovation Center, Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Hong-Chang LaiShanghai PerioImplant Innovation Center, Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Maurizio S TonettiShanghai PerioImplant Innovation Center, Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0002-2743-0137
Shanghai Jiao Tong University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimAnalysis of distribution of p-values of continuous differences between test and controls after randomization provides evidence of unintentional error, non-random sampling, or data fabrication in randomized controlled trials (RCTs). We assessed evidence of highly unusual distributions of baseline characteristics of subjects enrolled in clinical trials in implant dentistry. MATERIALS AND

methodsRCTs published between 2005 and 2020 were systematically searched in Pubmed, Embase, and Cochrane databases. Baseline patient data were extracted from full text articles by two independent assessors. The hypothesis of non-random sampling was tested by comparing the expected and the observed distribution of the p-values of differences between test and controls after randomization.

resultsOne-thousand five-hundred and thirty-eight unique RCTs were identified, of which 409 (26.6%) did not report baseline characteristics of the population, and 671 (43.6%) reported data in forms other than mean and standard deviation and could not be used to assess their random sampling. Four-hundred and fifty-eight trials with 1449 baseline variables in the form of mean and standard deviation were assessed. The study observed an over-representation of very small p-values [<.001, 1.38%, 95% confidence interval (CI) 0.85-2.12 compared to the expected 0.10%, 95% CI 0.00-0.26]. No evidence of over-representation of larger p-values was observed. Unusual distributions were present in 2.38% of RCTs and more frequent in non-registered trials, in studies supported by non-industry funding, and in multi-centre RCTs.

conclusionsThe inability to assess random sampling due to insufficient reporting in 26.6% of trials requires attention. In trials reporting suitable baseline data, unusual distributions were uncommon, and no evidence of data fabrication was detected, but there was evidence of non-random sampling. Continued efforts are necessary to ensure high integrity and trust in the evidence base of the field.

Indexed as

Clinical Trials as TopicDentistryResearch DesignHumansRisk Factorsdata integrityimplant dentistrynon-random samplingrandomized clinical trialsrisk of bias

Identifiers

PMID34747036
PMCPMC9299163
OpenAlexW3214160526

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.