Evidence map›Paper›PMID 29506561›Full record

Trial reportTrials2018

Improved adherence adjustment in the Coronary Drug Project.

Eleanor J Murray, Miguel A Hernán

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00000482. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing 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.

NCT00000482 phase3completed

Coronary Drug Project

Ran1965Registered outcomes0Posted comparisons0ConditionsCardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial InfarctionArmsclofibrate clofibrate, dextrothyroxine sodium, Estrogen, niacin
Open the trial in the graph
NCT07512401 completednot on this map

Safety of Reduced Methotrexate Lab Monitoring: a Population-based, Target Trial Emulation Study

TypeobservationalSponsorMayo ClinicRan2012 to 2025Enrolled2,414ConditionsRheumatic DiseasesArmsStandard methotrexate lab monitoring, Reduced methotrexate lab monitoring
3 · Its place in the literature

Who cites it

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

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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

2 authors.

Eleanor J MurrayDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Suite 911, Boston, MA, 02115, USA. emurray@mail.harvard.edu.
Miguel A HernánDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Suite 911, Boston, MA, 02115, USA.

Funding

Patient-Centered Outcomes Research Institute ME-1503-28119
6 · The paper itself

Abstract

backgroundThe survival difference between adherers and non-adherers to placebo in the Coronary Drug Project has been used to support the thesis that adherence adjustment in randomized trials is not generally possible and, therefore, that only intention-to-treat analyses should be trusted. We previously demonstrated that adherence adjustment can be validly conducted in the Coronary Drug Project using a simplistic approach. Here, we re-analyze the data using an approach that takes full advantage of recent methodological developments.

methodsWe used inverse-probability weighted hazards models to estimate the 5-year survival and mortality risk when individuals in the placebo arm of the Coronary Drug Project adhere to at least 80% of the drug continuously or never during the 5-year follow-up period.

resultsAdjustment for post-randomization covariates resulted in 5-year mortality risk difference estimates ranging from - 0.7 (95% confidence intervals (CI), - 12.2, 10.7) to 4.5 (95% CI, - 6.3, 15.3) percentage points.

conclusionsOur analysis confirms that appropriate adjustment for post-randomization predictors of adherence largely removes the association between adherence to placebo and mortality originally described in this trial.

trial registrationClinicalTrials.gov, Identifier: NCT00000482 . Registered retrospectively on 27 October 1999.

Indexed as

Medication AdherencePatient SelectionAdultCardiovascular AgentsHumansMaleMiddle AgedMyocardial InfarctionPlacebosTime FactorsTreatment OutcomeCardiovascular AgentsPlacebosAdherenceCoronary Drug ProjectIntention-to-treat effectInverse-probability weightingPer-protocol effect

Identifiers

PMID29506561
PMCPMC5836455

What OpenQuestion holds

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Registered trials

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.