Evidence map›Paper›PMID 27377062›Full record

ArticleBMC medicine2016

Association between trial registration and treatment effect estimates: a meta-epidemiological study.

Agnès Dechartres, Philippe Ravaud, Ignacio Atal, Carolina Riveros, Isabelle Boutron

Abstract read
In one paragraph

Article in BMC medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 7 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

30 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Agnès DechartresCentre de Recherche Epidémiologie et Statistique, INSERM U1153, Hôpital Hôtel-Dieu, 1 place du Parvis Notre Dame, 75004, Paris, France. agnes.dechartres@aphp.fr.
Philippe RavaudCentre de Recherche Epidémiologie et Statistique, INSERM U1153, Hôpital Hôtel-Dieu, 1 place du Parvis Notre Dame, 75004, Paris, France.
Ignacio AtalCentre de Recherche Epidémiologie et Statistique, INSERM U1153, Hôpital Hôtel-Dieu, 1 place du Parvis Notre Dame, 75004, Paris, France.
Carolina RiverosCentre de Recherche Epidémiologie et Statistique, INSERM U1153, Hôpital Hôtel-Dieu, 1 place du Parvis Notre Dame, 75004, Paris, France.
Isabelle BoutronCentre de Recherche Epidémiologie et Statistique, INSERM U1153, Hôpital Hôtel-Dieu, 1 place du Parvis Notre Dame, 75004, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo increase transparency in research, the International Committee of Medical Journal Editors required, in 2005, prospective registration of clinical trials as a condition to publication. However, many trials remain unregistered or retrospectively registered. We aimed to assess the association between trial prospective registration and treatment effect estimates.

methodsThis is a meta-epidemiological study based on all Cochrane reviews published between March 2011 and September 2014 with meta-analyses of a binary outcome including three or more randomised controlled trials published after 2006. We extracted trial general characteristics and results from the Cochrane reviews. For each trial, we searched for registration in the report's full text, contacted the corresponding author if not reported and searched ClinicalTrials.gov and the International Clinical Trials Registry Platform in case of no response. We classified each trial as prospectively registered (i.e. registered before the start date); retrospectively registered, distinguishing trials registered before and after the primary completion date; and not registered. Treatment effect estimates of prospectively registered and other trials were compared by the ratio of odds ratio (ROR) (ROR <1 indicates larger effects in trials not prospectively registered).

resultsWe identified 67 meta-analyses (322 trials). Overall, 225/322 trials (70 %) were registered, 74 (33 %) prospectively and 142 (63 %) retrospectively; 88 were registered before the primary completion date and 54 after. Unregistered or retrospectively registered trials tended to show larger treatment effect estimates than prospectively registered trials (combined ROR = 0.81, 95 % CI 0.65-1.02, based on 32 contributing meta-analyses). Trials unregistered or registered after the primary completion date tended to show larger treatment effect estimates than those registered before this date (combined ROR = 0.84, 95 % CI 0.71-1.01, based on 43 contributing meta-analyses).

conclusionsLack of trial prospective registration may be associated with larger treatment effect estimates.

Indexed as

Biomedical ResearchClinical Trials as TopicBiasClinical ProtocolsHumansMeta-Analysis as TopicPublicationsResearch DesignTreatment OutcomeBiasClinicalTrials.govMeta-analysisMeta-epidemiologyRandomised controlled trialRegistration

Identifiers

PMID27377062
PMCPMC4932748

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.