Evidence map›Paper›PMID 34383228›Full record

ArticleJournal of general internal medicine2022

Patients' Reactions to Letters Communicating Collateral Findings of Pragmatic Clinical Trials: a National Web-Based Survey.

Kevin P Weinfurt, Juli M Bollinger, Elizabeth May, Gail Geller, Debra J H Mathews, Stephanie R Morain, Lorrie Schmid, Diane L Bloom, Jeremy Sugarman

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of general internal medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
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

9 authors.

Kevin P WeinfurtDepartment of Population Health Sciences, Duke University School of Medicine, 215 Morris St, Durham, NC, 27701, USA. kevin.weinfurt@duke.edu.
Juli M BollingerBerman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.
Elizabeth MayBerman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.
Gail GellerBerman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.
Debra J H MathewsBerman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.
Stephanie R MorainCenter for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA.
Lorrie SchmidSocial Science Research Institute, Duke University, Durham, NC, USA.
Diane L BloomDepartment of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Jeremy SugarmanBerman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.

Funding

NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)U24AT009676 · NCCIH · DUKE UNIVERSITY · PI LESLEY H CURTIS, Adrian Hernandez · 2017 to 2026
$21.5M
NCCIH NIH HHS U24 AT009676
6 · The paper itself

Abstract

backgroundCollateral findings in pragmatic clinical trials are findings that may have implications for patients' health but were not generated to address a trial's primary research questions. It is uncertain how best to communicate these collateral findings to patients.

objectivesTo determine how reactions to a letter communicating collateral findings relate to who signed the letter, the type of finding, or whether the letter specified that the finding arose from a pragmatic clinical trial. RESEARCH

designWeb-based survey experiment using a between-subjects design in which respondents were randomly assigned within education strata to view and respond to 1 of 16 hypothetical scenarios. SUBJECTS: Adults recruited from an online panel constructed from a probability sample of US-based postal addresses. MEASURES: The primary outcomes were the action the respondent would take next (i.e., contact a doctor immediately or something else) and the respondent's emotional reactions (i.e., all positive, all negative, mixed, or none).

resultsA total of 4080 respondents had analyzable data. Although some effects were statistically significant (P < .05), none exceeded a prespecified threshold for policy relevance (15 or more percentage points). Ratings of letter clarity and level of understanding were lower for letters that included a description of the clinical trial.

conclusionsSignatory and level of detail about collateral findings did not substantially affect people's intentions to take the recommended action of contacting their doctor. Deciding whether to include a description of the pragmatic clinical trial requires a trade-off between transparency and more difficulty understanding the contents of the letter.

Indexed as

IntentionInternetPragmatic Clinical Trials as TopicAdultHumansSurveys and Questionnairesbioethicsdisclosurepragmatic clinical trials

Identifiers

PMID34383228
PMCPMC8359628

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.