Evidence map›Paper›PMID 28720618›Full record

SynthesisBMJ open2017

Interpretation of CIs in clinical trials with non-significant results: systematic review and recommendations.

Jennifer S Gewandter, Michael P McDermott, Rachel A Kitt, Jenna Chaudari, James G Koch, Scott R Evans, Robert A Gross, John D Markman, Dennis C Turk, Robert H Dworkin

Erratum issuedAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  16. Biostatistics: essential concepts for the clinician.Dental press journal of orthodontics · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Jennifer S GewandterDepartment of Anesthesiology, University of Rochester, Rochester, New York, USA.
Michael P McDermottDepartment of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, USA.
Rachel A KittDepartment of Anesthesiology, University of Rochester, Rochester, New York, USA.
Jenna ChaudariDepartment of Anesthesiology, University of Rochester, Rochester, New York, USA.
James G KochDepartment of Anesthesiology, University of Rochester, Rochester, New York, USA.
Scott R EvansDepartment of Biostatistics, Harvard University, Boston, Massachusetts, USA.
Robert A GrossDepartment of Neurology, University of Rochester, Rochester, New York, USA.
John D MarkmanDepartment of Neurosurgery, University of Rochester, Rochester, New York, USA.
Dennis C TurkDepartment of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.
Robert H DworkinDepartment of Anesthesiology, University of Rochester, Rochester, New York, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesInterpretation of CIs in randomised clinical trials (RCTs) with treatment effects that are not statistically significant can distinguish between results that are 'negative' (the data are not consistent with a clinically meaningful treatment effect) or 'inconclusive' (the data remain consistent with the possibility of a clinically meaningful treatment effect). This interpretation is important to ensure that potentially beneficial treatments are not prematurely abandoned in future research or clinical practice based on invalid conclusions.

designSystematic review of RCT reports published in 2014 in

results85 of 99 articles with statistically non-significant results reported CIs for the treatment effect. Only 17 of those 99 articles interpreted the CI. Of the 22 articles in which CIs indicated an inconclusive result, only four acknowledged that the study could not rule out a clinically meaningful treatment effect.

conclusionsInterpretation of CIs is important but occurs infrequently in study reports of trials with treatment effects that are not statistically significant. Increased author interpretation of CIs could improve application of RCT results. Reporting recommendations are provided.

Indexed as

Data Interpretation, StatisticalHumansRandomized Controlled Trials as Topicclinical trial interpretationclinical trialsreporting

Identifiers

PMID28720618
PMCPMC5726092

What OpenQuestion holds

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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.