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Alignment between patient-reported outcomes and clinician-reported adverse events in gynecologic oncology trials: a
Daniela Krepper1, Ainhoa Madariaga2, Reyes Oliver-Perez3
1Health Outcomes Research Unit, University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria.
Objective:
To evaluate the use and reporting of patient-reported outcomes in randomized trials in gynecologic oncology and to assess whether commonly reported clinician-reported symptomatic adverse events are covered by the patient-reported outcome measures used in these trials.
Methods:
We conducted a scoping review of randomized controlled trials in gynecologic cancers published in PubMed between 2019 and November 2023. Eligible trials randomized at least 50 patients, evaluated biomedical treatments, and reported at least one patient-reported outcome endpoint. Data included trial characteristics, patient-reported outcome measures and reporting, clinician-reported symptomatic adverse events, adverse event reporting approaches, and coverage of common adverse events by European Organisation for Research and Treatment of Cancer patient-reported outcome measures.
Results:
We included 67 trials with 26,455 patients. Ovarian cancer was the most common disease site, represented in 36 trials (53.7%), followed by cervical cancer and endometrial cancer. Patient-reported outcomes were most commonly included as secondary endpoints, and the most frequently used instruments were the European Organisation for Research and Treatment of Cancer measures and Functional Assessment of Chronic Illness Therapy instruments. Clinician-reported adverse event data were reported in 53 trials (79.1%), but the reporting approaches varied. Nausea, asthenia/fatigue, and vomiting were the most frequently reported symptomatic adverse events. Asthenia/fatigue, nausea, and alopecia showed the highest prevalence across experimental treatments. The most common adverse events were covered by the European Organisation for Research and Treatment of Cancer measures. However, several adverse events, including headache, fever, dizziness, and cough, were not captured by the instruments administered in the included studies, despite being reported in up to 33% of the trials.
Conclusion:
Our findings show heterogeneity in both patient-reported outcomes and clinician-reported adverse event reporting in gynecologic oncology trials, highlighting the need for harmonization. Although common symptomatic adverse events appear to be covered by existing patient-reported outcome measures, gaps remain. These findings support complementing existing patient-reported outcome measures with selected items from item libraries to capture emerging toxicities associated with evolving treatment approaches.
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