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The many faces of recruitment in a randomized controlled trial
Bernardine M Pinto1, Shira I Dunsiger2
1College of Nursing, University of South Carolina, 1601 Greene Street, Rm 302B, Columbia, SC 29208, USA.
Background:
Thoughtful approaches to study recruitment are a critical step in designing and implementing randomized controlled trials. Delays and challenges in recruitment can be costly and can result in smaller than proposed sample sizes which have downstream effects, such as underpowered studies.
Purpose:
The current study evaluated recruitment methods (e.g., targeted mailings, brochures/flyers, social media) and their relationship to eligibility, randomization, participant characteristics and retention at end of a randomized controlled trial of physical activity adoption and maintenance among breast cancer survivors.
Methods:
Screening data from 874 women was analyzed for recruitment method, study eligibility, randomization and retention through end of treatment. Costs per randomized participant were calculated by recruitment method. Baseline participant characteristics were compared across recruitment methods and between randomized and retained participants.
Results:
Rates of participant accrual from eligibility screening through randomization differed statistically significantly depending on recruitment method (p < .05). The highest randomization rates were obtained via targeted mailings (88.2%) and lowest via brochure/flyer (0.4%). Among the randomized sample, there were no differences in demographic characteristics between recruitment methods, however, there were differences within the targeted mailings category (registries vs. organizational recruitment). There were statistically significant differences in costs between recruitment methods (p < .001) with lowest (non-negligible) cost being targeted mailings.
Conclusions:
The current RCT of breast cancer survivors successfully recruited and retained participants, highlighting the need to combine recruitment methods to achieve accrual goals. Recruitment methods differed substantially in their cost and their ability to attract individuals who would ultimately be randomized.
Insights
Targeted mailings were the most effective recruitment method for a physical activity randomized controlled trial in breast cancer survivors, yielding higher randomization rates and lower costs compared to other strategies. Combining recruitment methods is key for achieving trial goals.
Area of Science:
- Clinical Trials
- Public Health
- Cancer Survivorship
Background:
- Effective study recruitment is crucial for the success of randomized controlled trials (RCTs).
- Recruitment challenges can lead to costly delays and underpowered studies due to smaller sample sizes.
- Optimizing recruitment strategies is essential for robust clinical trial design and implementation.
Purpose of the Study:
- To evaluate various recruitment methods (targeted mailings, brochures/flyers, social media) in a physical activity RCT for breast cancer survivors.
- To assess the relationship between recruitment methods and participant eligibility, randomization rates, participant characteristics, and retention.
- To determine the cost-effectiveness of different recruitment strategies per randomized participant.
Main Methods:
- Analysis of screening data from 874 women undergoing an RCT for physical activity adoption and maintenance.
- Calculation of costs per randomized participant for each recruitment method.
- Comparison of baseline demographic characteristics across recruitment methods and between randomized and retained participants.
Main Results:
- Recruitment method significantly impacted participant accrual rates from screening to randomization (p < .05).
- Targeted mailings achieved the highest randomization rate (88.2%), while brochures/flyers had the lowest (0.4%).
- Significant cost differences were observed between methods (p < .001), with targeted mailings being the most cost-effective.
Conclusions:
- The RCT successfully recruited and retained breast cancer survivors, demonstrating the feasibility of physical activity interventions.
- Combining multiple recruitment strategies is recommended to meet accrual targets in clinical trials.
- Recruitment methods vary significantly in cost and effectiveness for attracting participants eligible for randomization.
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