Evidence mapPaperPMID 29966732Full record

SynthesisJournal of clinical epidemiology2018

Patients and investigators prefer measures of absolute risk in subgroups for pragmatic randomized trials.

Eleanor J Murray, Ellen C Caniglia, Sonja A Swanson, Sonia Hernández-Díaz, Miguel A Hernán

Abstract readSystematic Review
In one paragraph

Synthesis in Journal of clinical epidemiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing 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

26 citing papers in PubMed.

  1. Trial
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  8. Why use methods that require proportional hazards?American journal of epidemiology · 2025
    Article
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  13. Observational
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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

5 authors.

Eleanor J MurrayHarvard T. H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, USA. Electronic address: emurray@mail.harvard.edu.
Ellen C CanigliaHarvard T. H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, USA.
Sonja A SwansonHarvard T. H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, USA; Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands.
Sonia Hernández-DíazHarvard T. H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, USA.
Miguel A HernánHarvard T. H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, USA; Harvard-MIT Division of Health Sciences and Technology, Boston, MA 02139, USA.

Funding

PROGRAM FOR AIDS CLINICAL RESEARCH TRAINING (PACRT)T32AI007433 · MASSACHUSETTS GENERAL HOSPITAL · 1992 to 2025
$2.0M
NIAID NIH HHS T32 AI007433
6 · The paper itself

Abstract

objectivesPragmatic randomized trials are important tools for shared decision-making, but no guidance exists on patients' preferences for types of causal information. We aimed to assess preferences of patients and investigators toward causal effects in pragmatic randomized trials. STUDY DESIGN AND

settingWe (a) held three focus groups with patients (n = 23) in Boston, MA; (b) surveyed (n = 12) and interviewed (n = 5) investigators with experience conducting pragmatic trials; and (c) conducted a systematic literature review of pragmatic trials (n = 63).

resultsPatients were distrustful of new-to-market medications unless substantially more effective than existing choices, preferred stratified absolute risks, and valued adherence-adjusted analyses when they expected to adhere. Investigators wanted both intention-to-treat and per-protocol effects but felt methods for estimating per-protocol effects were lacking. When estimating per-protocol effects, many pragmatic trials used inappropriate methods to adjust for adherence and loss to follow-up.

conclusionWe made four recommendations for pragmatic trials to improve patient centeredness: (1) focus on superiority in effectiveness or safety, rather than noninferiority; (2) involve patients in specifying a priori subgroups; (3) report absolute measures of risk; and (4) complement intention-to-treat effect estimates with valid per-protocol effect estimates.

Indexed as

Chronic DiseaseIntention to Treat AnalysisPatient SafetyPragmatic Clinical Trials as TopicAttitude of Health PersonnelFemaleHumansMaleMiddle AgedPatient PreferenceRandomized Controlled Trials as TopicResearcher-Subject RelationsResearch PersonnelRisk AssessmentAdherence adjustmentCausal inferenceHealth communicationIntention to treatPatient preferencesPer protocolPragmatic trial

Identifiers

PMID29966732
PMCPMC6175611

What Socratic 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 Socratic graph.