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The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study: Lessons
Krupa K Nathan1, Kristin M Follmer2, Michael G Nash3
1Department of Urology, University of North Carolina, Chapel Hill, North Carolina, USA.
Background:
The growth of patient and public involvement in clinical research highlights the paucity of literature on operational practices that ensure the success of large, patient-centered outcomes trials. The authors' objective was to identify tools launched by the Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study team to determine their effectiveness in maximizing patient enrollment in this observational, pragmatic trial.
Methods:
The primary outcomes for this study were patient screening and enrollment across 36 CISTO study sites. The operational strategies included CISTOquestion email correspondence and All Sites Meetings, specifically poll performance data from meetings, and a nonanonymized feedback survey about the CISTO study's management practices. Effectiveness was measured using correlation analysis with patient cohort data, including screenings, enrollments, post-hoc exclusions, and the post-hoc exclusion rate.
Results:
Average screenings and enrollment rose after the implementation of CISTOquestion in April 2021, with the average number of screenings rising from 7.42 to 26.8 patients per month and enrollment rising from 3.76 to 16 patients per month. Use of CISTOquestion was correlated strongly with increased patient screenings and enrollment across all study sites. Eighty-three percent of sites with above-average post-hoc exclusion rates (≥0.092) sent below the average number of CISTOquestion inquiries. Poll performance and survey data revealed that all survey respondents who used CISTOquestion found that it was a valuable and accessible resource.
Conclusions:
Of the several operational tools implemented within the CISTO study that aimed to improve patient enrollment, CISTOquestion, a centralized email for addressing eligibility questions, was most beneficial to overall patient accrual.
Insights
The CISTOquestion email effectively boosted patient enrollment in a bladder cancer trial by addressing eligibility concerns. This centralized communication tool proved valuable for increasing patient screenings and successful accrual in clinical research.
Area of Science:
- Clinical Research Operations
- Patient-Centered Outcomes Research
- Oncology Clinical Trials
Background:
- Limited literature exists on operational strategies for large, patient-centered outcomes trials.
- Growing patient and public involvement necessitates effective trial management practices.
- The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study aimed to address this gap.
Purpose of the Study:
- To identify and evaluate operational tools used by the CISTO study team.
- To determine the effectiveness of these tools in maximizing patient enrollment.
- To assess strategies for improving patient accrual in pragmatic clinical trials.
Main Methods:
- The study analyzed patient screening and enrollment data across 36 CISTO sites.
- Operational strategies included CISTOquestion (email correspondence) and All Sites Meetings.
- Effectiveness was measured by correlating tool usage with screening, enrollment, and exclusion rates.
Main Results:
- Implementation of CISTOquestion correlated with a significant rise in patient screenings (7.42 to 26.8/month) and enrollment (3.76 to 16/month).
- Sites with higher post-hoc exclusion rates used CISTOquestion less frequently.
- Survey data indicated CISTOquestion was perceived as a valuable and accessible resource by users.
Conclusions:
- CISTOquestion, a centralized email for eligibility questions, was the most effective tool for improving patient accrual in the CISTO study.
- Effective operational tools are crucial for maximizing patient enrollment in large clinical trials.
- Centralized communication channels can enhance the efficiency of clinical research operations.
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