Display Settings:

Format

Send to:

Choose Destination
Stroke. 2006 Jan;37(1):123-8. Epub 2005 Dec 1.

Recruiting subjects for acute stroke trials: a meta-analysis.

Author information

  • 1The University of California, San Francisco, CA 94143, USA.

Abstract

BACKGROUND AND PURPOSE:

Recruitment rate is a major determinant of the duration, cost, and feasibility of acute stroke trials.

METHODS:

We performed a meta-analysis of all randomized, controlled trials of > or =300 subjects that were designed to evaluate the efficacy of a medical intervention for the treatment of acute ischemic stroke. Data about trial recruitment, organization, and inclusion/exclusion criteria were abstracted independently by 2 reviewers who applied predefined criteria. Recruitment efficiency was defined as the number of subjects enrolled per study center per month of recruitment.

RESULTS:

Of 32 trials meeting inclusion criteria, the average recruitment efficiency was 0.79 subjects per center per month (range 0.08 to 3.7). Recruitment efficiency did not vary by geographic region (P=0.36), but trials conducted in 1 country had more efficient recruitment than international studies (P=0.03), and recruitment efficiency declined with each percentage increase in the total number of study centers (P=0.002). The primary study entry criteria that predicted reduced recruitment efficiency were the maximum allowable time from stroke to study enrollment (P=0.002) and the exclusion of mild strokes (P=0.009). Trials with a treatment window >6 hours had approximately double the recruitment rates of trials that used treatment windows < or =6 hours (1.03 versus 0.52 patients per center per month).

CONCLUSIONS:

Recruitment rates for acute stroke trials are influenced by organizational structure and study entry criteria. Characterizing predictors of recruitment may help optimize future trial design.

PMID:
16322489
[PubMed - indexed for MEDLINE]
Free full text
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Icon for HighWire
    Loading ...
    Write to the Help Desk