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Published on: January 8, 2020
A rapid review indicated higher recruitment rates in treatment trials than in prevention trials
Cindy L Cooper1, Daniel Hind1, Rosie Duncan2
1The School of Health and Related Research (ScHARR), Clinical Trials Research Unit, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
Objectives:
To test the hypothesis that the percentage of patients screened that randomize differs between prevention and therapy trials.
Study Design And Setting:
Rapid review of randomized controlled trials (RCTs) identified through published systematic reviews in August 2013. Individually randomized, parallel group controlled RCTs were eligible if they evaluated metformin monotherapy or exercise for the prevention or treatment of type 2 diabetes. Numbers of patients screened and randomized were extracted by a single reviewer. Percentages were calculated for each study for those randomized: as a function of those approached, screened, and eligible. Percentages (95% confidence intervals) from each individual study were weighted according to the denominator and pooled rates calculated. Statistical heterogeneity was assessed using I(2).
Results:
The percentage of those screened who subsequently randomized was 6.2% (6.0%, 6.4%; 3 studies, I(2) = 100.0%) for metformin prevention trials; 50.7% (49.9%, 51.4%; 21 studies, I(2) = 99.6%) for metformin treatment trials; 4.8% (4.7%, 4.8%; 14 studies, I(2) = 99.9%) for exercise prevention trials; and 43.3% (42.6%, 43.9%; 28 studies, I(2) = 99.8%) for exercise treatment trials.
Conclusion:
This study provides qualified support for the hypothesis that prevention trials recruit a smaller proportion of those screened than treatment trials. Statistical heterogeneity associated with pooled estimates and other study limitations is discussed.
Insights
Prevention trials for type 2 diabetes recruit a smaller proportion of screened patients than treatment trials. This finding supports the hypothesis that trial design impacts patient recruitment rates for metformin and exercise interventions.
Area of Science:
- Clinical Trials
- Diabetes Research
- Public Health
Background:
- Recruitment is a critical phase in clinical trials.
- Understanding factors influencing patient randomization is essential for trial efficiency.
- Previous research has not clearly delineated recruitment differences between prevention and treatment trials.
Purpose of the Study:
- To investigate whether the percentage of screened patients who randomize differs between prevention and treatment trials for type 2 diabetes.
- To compare recruitment rates in trials evaluating metformin and exercise interventions.
Main Methods:
- A rapid review of randomized controlled trials (RCTs) was conducted using published systematic reviews.
- Data from 66 RCTs on metformin or exercise for type 2 diabetes prevention or treatment were analyzed.
- The percentage of screened patients who were randomized was calculated and pooled across studies.
Main Results:
- Metformin prevention trials randomized 6.2% of screened patients, while treatment trials randomized 50.7%.
- Exercise prevention trials randomized 4.8% of screened patients, compared to 43.3% in treatment trials.
- Significant statistical heterogeneity was observed in pooled estimates.
Conclusions:
- The study provides evidence that prevention trials recruit a lower proportion of screened individuals than treatment trials.
- These findings suggest that trial objectives (prevention vs. treatment) influence patient recruitment success.
- Limitations including statistical heterogeneity warrant cautious interpretation of the pooled results.
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