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.
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Acknowledgements
We thank Emma Jones, Research Assistant, University of Sydney, for her assistance with data extraction and Yaping Liu, Librarian, Cancer Council NSW, and Ying Zhao, Library Technician, Cancer Council NSW, for their assistance in obtaining PDFs.
Funding
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).
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Rutherford, C., Patel, M.I., Tait, MA. et al. Assessment of content validity for patient-reported outcome measures used in patients with non-muscle invasive bladder cancer: a systematic review. Support Care Cancer 26, 1061–1076 (2018). https://doi.org/10.1007/s00520-018-4058-8
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DOI: https://doi.org/10.1007/s00520-018-4058-8