Patients' Reactions to Letters Communicating Collateral Findings of Pragmatic Clinical Trials: a National Web-Based Survey.
J Gen Intern Med
; 37(7): 1658-1664, 2022 05.
Article
em En
| MEDLINE
| ID: mdl-34383228
ABSTRACT
BACKGROUND:
Collateral 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.OBJECTIVES:
To 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. RESEARCHDESIGN:
Web-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).RESULTS:
A 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.CONCLUSIONS:
Signatory 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Internet
/
Intenção
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Limite:
Adult
/
Humans
Idioma:
En
Revista:
J Gen Intern Med
Ano de publicação:
2022
Tipo de documento:
Article