Evidence map›Paper›PMID 26244868›Full record

ArticlePloS one2015

Likelihood of Null Effects of Large NHLBI Clinical Trials Has Increased over Time.

Robert M Kaplan, Veronica L Irvin

Abstract read
In one paragraph

Article in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 88 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 10 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

88 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  5. The effects of school-based interventions on physiological stress in adolescents: A meta-analysis.Stress and health : journal of the International Society for the Investigation of Stress · 2022
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  7. Probiotics for treating acute infectious diarrhoea.The Cochrane database of systematic reviews · 2020
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  10. Meta-Analysis of the Effect of Red on Perceived Attractiveness.Evolutionary psychology : an international journal of evolutionary approaches to psychology and behavior
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28 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors.

Robert M KaplanAgency for Healthcare Research and Quality, U.S. Department of Health and Human Services, Rockville, Maryland, United States of America.
Veronica L IrvinOregon State University, Corvallis, Oregon, United States of America.

Funding

Intramural NIH HHS
6 · The paper itself

Abstract

backgroundWe explore whether the number of null results in large National Heart Lung, and Blood Institute (NHLBI) funded trials has increased over time.

methodsWe identified all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease. Trials were included if direct costs >$500,000/year, participants were adult humans, and the primary outcome was cardiovascular risk, disease or death. The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000, whether they registered in clinicaltrials.gov prior to publication, used active or placebo comparator, and whether or not the trial had industry co-sponsorship. We tabulated whether the study reported a positive, negative, or null result on the primary outcome variable and for total mortality.

results17 of 30 studies (57%) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8%) trials published after 2000 (χ2=12.2,df= 1, p=0.0005). There has been no change in the proportion of trials that compared treatment to placebo versus active comparator. Industry co-sponsorship was unrelated to the probability of reporting a significant benefit. Pre-registration in clinical trials.gov was strongly associated with the trend toward null findings.

conclusionsThe number NHLBI trials reporting positive results declined after the year 2000. Prospective declaration of outcomes in RCTs, and the adoption of transparent reporting standards, as required by clinicaltrials.gov, may have contributed to the trend toward null findings.

Indexed as

Randomized Controlled Trials as TopicCardiovascular DiseasesHumansNational Heart, Lung, and Blood Institute (U.S.)PublishingRegistriesResearch DesignTreatment OutcomeUnited States

Identifiers

PMID26244868
PMCPMC4526697

What OpenQuestion holds

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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.