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Verifying participant-reported clinical outcomes: challenges and implications.
Suzanne Breeman1, Lynda Constable2, Anne Duncan1
1Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit (HSRU), University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, Scotland.
Trials
|March 6, 2020
Summary
Verifying participant-reported outcomes in clinical trials requires varied methods, as accuracy differs significantly. Case studies show confirmation rates ranging from 6% for knee admissions to 84% for re-operations.
Area of Science:
- Clinical Trials Methodology
- Patient-Reported Outcomes
- Health Services Research
Background:
- Clinical trials frequently depend on participants self-reporting outcomes like fractures or re-operations.
- Limited data exists on the accuracy of participant-reported outcomes, especially within randomized controlled trials (RCTs).
- This study addresses the evidence gap by comparing participant-reported outcomes with clinician reports or medical records in four RCTs.
Purpose of the Study:
- To evaluate the accuracy of participant-reported clinical outcomes in randomized controlled trials (RCTs).
- To compare different verification methods for participant-reported outcomes against clinician-verified data.
- To inform best practices for collecting accurate participant-reported outcomes in clinical research.
Main Methods:
- Four publicly funded RCTs with distinct verification strategies for participant-reported outcomes were analyzed.
- Methods included direct confirmation from surgeons for knee admissions (KAT) and re-operations (REFLUX).
- Fracture verification (RECORD) involved initial checks with research nurses, while urinary tract infection (UTI) confirmation (CATHETER) involved GP contact for antibiotic prescriptions.
Main Results:
- Accuracy varied by outcome: 6% of participant-reported knee admissions (KAT) were relevant, while 84% of reported re-operations (REFLUX) were confirmed.
- Confirmation rates for low-trauma fractures in RECORD were 61%, and for UTIs in CATHETER, 52% were confirmed by GPs.
- These results highlight significant discrepancies between self-reported and verified clinical outcomes across different trial contexts.
Conclusions:
- No single optimal method exists for verifying participant-reported outcomes in clinical trials.
- The choice of verification approach should consider the type of information sought, question phrasing, and the reliability of medical records.
- Balancing the costs and benefits of different verification strategies is crucial for determining the most appropriate method for specific RCTs.
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