Evidence map›Paper›PMID 32650340›Full record

ArticlePloS one2020

The effect of the CONSORT statement on the amount of "unclear" Risk of Bias reporting in Cochrane Systematic Reviews.

Maaike M Rademaker, Geerte G J Ramakers, Adriana L Smit, Lotty Hooft, Inge Stegeman

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In one paragraph

Article in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  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

5 authors.

Maaike M RademakerDivision of Surgical Specialties, Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.ORCID 0000-0002-4904-1394
Geerte G J RamakersDivision of Surgical Specialties, Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Adriana L SmitDivision of Surgical Specialties, Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Lotty HooftCochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Inge StegemanDivision of Surgical Specialties, Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve clarity and consistency of transparency of reporting in Randomized Controlled Trials (RCTs). The Cochrane Risk of Bias (RoB) tool for RCTs helps authors to judge the RoB. as ''low", "high" or "unclear".

objectiveIn this study we aimed to assess whether the implementation and updates of the CONSORT statement influenced the trend of "unclear" RoB scores of RCTs included in Cochrane systematic reviews.

methodsAll Cochrane reviews published in December to October 2016 were retrieved. The publication year of RCTS included in the reviews were sorted into time frames (≤1995, 1996-2000, 2001-2009 and ≥2010) based on the release- and updates of the CONSORT statement (1996, 2001 and 2010). The association between "unclear" RoB versus "low or high" RoB and the year of publication in different time frames were calculated using a binary logistic regression.

resultsData was extracted from 64 Cochrane reviews, with 989 RCTS (6471 items). The logistic regression showed that the odds of RCTs published ≥2010, compared to ≤1995 were more likely not to report an "unclear" RoB for the total data (Odds Ratio (OR) 0.69 (95% Confidence interval: 0.59-0.80)), random sequence generation (OR 0.32 (0.22-0.47), allocation concealment (0.64 (0.43-0.95)) and incomplete outcome data (OR 0.60 (0.39-0.91)).

conclusionA slight decrease of "unclear" RoB reporting over time was found. To improve quality of reporting authors are encouraged to adhere to reporting guidelines.

Indexed as

Randomized Controlled Trials as TopicSystematic Reviews as TopicBiasReference StandardsResearch Design

Identifiers

PMID32650340
PMCPMC7351499

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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.