Format

Send to

Choose Destination
See comment in PubMed Commons below
Trials. 2011 Jan 11;12:7. doi: 10.1186/1745-6215-12-7.

Accrual and drop out in a primary prevention randomised controlled trial: qualitative study.

Author information

1
Department of Health Sciences, University of Leicester, UK. hce3@le.ac.uk

Abstract

BACKGROUND:

Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community.

METHODS:

Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA) trial (N = 11), and AAA trial participants who had stopped taking the trial medication (N = 11). A focus group with further participants who had stopped taking the trial medication (N = 6). (Total participants N = 28).

RESULTS:

Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating.Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind.

CONCLUSIONS:

These results indicate that when planning trials (especially in preventive medicine) particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation.

TRIAL REGISTRATION:

ISRCTN66587262.

PMID:
21223551
PMCID:
PMC3024954
DOI:
10.1186/1745-6215-12-7
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for BioMed Central Icon for PubMed Central
    Loading ...
    Support Center