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Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: a
Paul Hilton1, Brian S Buckley2,3, Elaine McColl4
1Faculty of Medical Sciences, Medical School, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK. paul.hilton@newcastle.ac.uk.
Trials
|October 27, 2016
Summary
This study investigated variability in patient eligibility screening for a trial on urinary incontinence treatments. Clearer criteria and training are needed to ensure consistent patient selection for clinical trials.
Area of Science:
- Urology
- Clinical Trial Methodology
- Women's Health
Background:
- The INVESTIGATE-I study aimed to inform a future trial on surgical treatments for stress urinary incontinence.
- A pilot randomized controlled trial screened 771 potential participants across seven sites.
- Screen-positive rates varied significantly (22-79%), with an overall rate of 37%.
Purpose of the Study:
- To explore the reasons for wide variations in 'screen positive' rates among different study sites.
- To identify factors contributing to inconsistent patient eligibility assessment in clinical trials.
Main Methods:
- Eleven trial staff evaluated 20 identical clinical vignettes representing potential patients.
- Vignettes included defined inclusion/exclusion criteria and some ambiguous cases.
- Free-text comments were collected to understand screening decisions.
Main Results:
- Inter-rater reliability was high for clearly eligible (6/20) and ineligible (1/20) vignettes.
- Mixed agreement was observed for the remaining vignettes, indicating areas of uncertainty.
- Free-text comments revealed ambiguities in applying eligibility criteria.
Conclusions:
- Variability in eligibility judgments underscores the need for explicit inclusion/exclusion criteria and standardized assessment strategies.
- Vignettes can be valuable tools for training staff and improving consistency in patient screening during trial planning.
Keywords:
EligibilityEquipoiseRandomised controlled trialRecruitmentScreeningStress urinary incontinenceSurgeryUrodynamic investigationVignetteMore Related Videos
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