PATIENT-REPORTED OUTCOMES (PROS) IN BLADDER CANCER
Author(s)
Barsdorf AI1, Pease S2
1Pfizer, Inc, New York, NY, USA, 2Pfizer, New York, NY, USA
Presentation Documents
OBJECTIVES: To assess frequency and type of Patient-Reported Outcomes (PROs) in studies of bladder cancer. METHODS: A search of Citeline’s Trialtrove was conducted using the search criteria “Bladder Cancer” as the disease, drugs tested was “any”, trial phase was II/III, III, and IV, and included planned, ongoing and completed studies. This resulted in 182 trials. Study design included clinical trials (double-blind, open-label) and observational studies. Start dates ranged from 1985-2014. Trials were excluded if disease type was other than bladder cancer. The remaining 138 trials were reviewed to determine prevalence and type of PROs. RESULTS: Only 27 (7.4%) of the studies included PROs as stated in the endpoints section despite bladder cancer being one of the most commonly diagnosed types of cancer in the US, especially among men. For these 27 trials, 9 different PROs were identified, 3 of which were bladder cancer disease specific. A total of 39 PROs were included with a range of 1-2 PROs per study, an average of 1.44 PROs. Thirty-four (87%) of these PROs measured Health-Related Quality of Life (HRQL) and 5 (13%) were symptom-based measures. Within the HRQL measures, 9 (26.5%) were cancer general, 9 (26.5%) were specific to Bladder Cancer, 1 (3%) was generic (e.g., SF-36), and the remaining 15 (44%) were not specified. Among the symptom measures, 3 (60%) were specific to bladder cancer and 2 (40%) were generic. CONCLUSIONS: Results indicate that the prevalence of PROs in bladder cancer trials is low compared to other cancers (e.g., ovarian cancer) and other diseases despite their importance in evaluating impact of disease and treatment benefit. The type of PRO most commonly indicated was a bladder cancer disease-specific measure of HRQL. Findings show the need to highlight the value and relevance of patient-reported data to increase incorporation of PROs in bladder cancer trials.
Conference/Value in Health Info
2015-05, ISPOR 2015, Philadelphia, PA, USA
Value in Health, Vol. 18, No. 3 (May 2015)
Code
PCN121
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology