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Title: Assessment of content validity for patient-reported outcome measures used in patients with non-muscle invasive bladder cancer: a systematic review
Authors: Rutherford C; Patel MI; Tait M; Smith DP; Costa DSJ; King MT
Categories: Cancer Type - Bladder Cancer
Treatment - Resources and Infrastructure
Year: 2018
Journal Title: Support Care in Cancer
Volume: 26
Issue: 4
Page number start: 1061
Page number end: 1076
Abstract: Objective Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring ongoing treatment and endoscopic examinations that are frequent and can be life-long. To ensure the comprehensive assessment of the benefits and harms of treatments for NMIBC, the impact on important and relevant patient-reported outcomes (PROs) should be determined. We systematically reviewed the NMIBC PRO literature to determine the suitability of available PRO measures (PROMs) for use in evaluating patient outcomes in NMIBC research. Methods We searched six electronic databases, reference lists, and key authors. Two reviewers independently applied inclusion and quality criteria and extracted findings. PROM domains, item content, and content coverage and relevance were determined for identified PROMs. Content validity was assessed against an empirically derived NMIBC-specific conceptual framework that includes 11 PRO domains and 19 sub-domains. Results Seventeen studies assessed PROs related to NMIBC and treatment impact. From these studies, 11 PROMs were identified, including three generic, three cancer-specific, and five symptom-specific. None of the PROMs cover all PRO domains important in NMIBC as assessed against our conceptual framework. The EORTC QLQ-C30 plus the NMIBC24 module was best aligned to the conceptual model, but failed to represent six outcomes important to NMIBC patients. Conclusions Currently, some outcomes important in NMIBC are inadequately covered by generic and cancer-specific measures despite similar conceptual models. This review identified gaps in the literature regarding assessment of symptoms and other PROs considered important by NMIBC patients. Careful consideration of PROM item content is required when selecting outcome measures for use in future NMIBC clinical trials to ensure that appropriate measures are used to assess outcomes that matter to patients.
Division: Cancer Research Division
Funding Body: A/Prof Patel was supported by a Cancer Institute NSW Early Career Research Fellowship (10/ECF/2-29). These funds also contributed towards Dr. Rutherford’s salary via Sydney University for her time spent undertaking this research. A/Prof Smith was supported by a Cancer Institute Career Development Fellowship (2015/CDF110).
DOI: 10.1007/s00520-018-4058-8
Appears in Collections:Research Articles

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