Evidence map›Paper›PMID 32284390›Full record

ArticleBMJ open2020

Definitions of blinding in randomised controlled trials of interventions published in high-impact anaesthesiology journals: a methodological study and survey of authors.

Antonija Penić, Dinka Begić, Karolina Balajić, Martin Kowalski, Ana Marušić, Livia Puljak

Abstract read
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Blinding in Clinical Trials: Seeing the Big Picture.Medicina (Kaunas, Lithuania) · 2021
    Review
  8. 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

6 authors.

Antonija PenićVujanovic Pharmacy, Sinj, Croatia.
Dinka BegićDepartment of Endocrinology, University Hospital Tuzla, Tuzla, Bosnia and Herzegovina.
Karolina BalajićDepartment of Reasearch in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.
Martin KowalskiDepartment of Reasearch in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.
Ana MarušićDepartment of Reasearch in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.ORCID 0000-0001-6272-0917
Livia PuljakCenter for Evidence-Based Medicine and Health Care, Catholic University of Croatia, Zagreb, Province, Croatia livia.puljak@gmail.com.ORCID 0000-0002-8467-6061

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo analyse the completeness of reporting of blinding in randomised controlled trials (RCTs) of interventions in anaesthesiology, the actual blinding status of various persons associated with an RCT and trial authors' interpretation of blinding terminology related to RCTs.

methodsThis was a methodological study and a cross-sectional survey. We analysed reporting related to blinding in published RCTs of interventions published in seven highly cited anaesthesiology journals from 2014 to 2016 and registered protocols in ClinicalTrials.gov. We surveyed corresponding authors of included RCTs about their definitions of blinding. The primary outcome was the number of RCTs that explicitly described who was blinded in a trial. Secondary outcomes were definitions of blinding terminology in the trials; trial authors' interpretation of blinding terminology; discrepancies in the blinding description within registered protocols and between registered protocols and publications.

resultsOut of 622 analysed RCTs, 38% were not explicitly described as either open label or blinded studies and 10% did not report any information about blinding or lack of blinding. Only one manuscript fully reported the status of blinding for various individuals that may be involved with a trial. The most common descriptor was that a trial was double-blind. We found discrepant information regarding blinding in the majority of registered protocols. Even when there were no discrepancies in the registration, we found discrepancies in the reporting of blinding between the majority of registered protocols and published manuscripts. The survey of authors (40 responses from 231 eligible authors; 17% response rate) of analysed RCTs showed that they differed in how they defined different levels of blinding in trials.

conclusionsReporting of the blinding status of key individuals involved in analysed anaesthesiology RCTs was insufficient. For reporting guidelines, peer reviewers and editors should insist on clear information on who was blinded in a trial instead of using the term 'double-blind' for different blinding practices.

Indexed as

AnesthesiologyDouble-Blind MethodRandomized Controlled Trials as TopicResearch ReportSingle-Blind MethodTerminology as TopicDocumentationHumansPeriodicals as TopicResearch DesignSurveys and QuestionnairesClinical trialsepidemiologystatistics & research methods

Identifiers

PMID32284390
PMCPMC7200040

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.