Journal of patient-reported outcomes · 2025
Development and psychometric evaluation of a patient-reported symptom index for patients with non-muscle invasive bladder cancer: the NMIBC-SI.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Rutherford Claudia, Tait Margaret-Ann, Costa Daniel S J, King Madeleine T, Smith David P, Sengupta Shomik, Ischia Joseph, Mitterdorfer Andrew, Hayne Dickon, Watson Roger, Anderson Paul, Frydenberg Mark, Gilling Peter, Buchan Nicholas, Green Euan, Clarke Noel, Boorjian Stephen A, Konety Badrinath, Holzbeierlein Jeffrey M, Black Peter C, Chalasani Venu, Henseler Jörg, Patel Manish I, NMIBC-SI Study Group
Аннотация
BACKGROUND AND OBJECTIVE: Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring frequent follow-up with endoscopic examinations, tumour resections and intravesical treatments. In this clinical context, patient-reported outcomes (PROs) have enormous potential to inform treatment assessment and recommendations for NMIBC. We aimed to develop and evaluate a patient-reported NMIBC Symptom Index (NMIBC-SI) to facilitate clinical research and enhance care.
METHODS: NMIBC-SI items were developed based on existing literature and qualitative interviews with patients and clinicians, and evaluated in two field tests: item reduction, using NMIBC-SI data from 220 patients on active treatment from nine Australian centres; reliability and validity evaluation of item-reduced version using NMIBC-SI data from 232 patients from five countries.
RESULTS: NMIBC-SI assesses disease and treatment-related symptom burden and two treatment-specific side-effects (cystoscopy, intravesical BCG/Chemotherapy). Composite analysis supported a single composite model including core symptom and cystoscopy index items (Intravesical index items were not tested due to small sample). Test-retest reliability was strong (range 0.894-0.91). As expected, the NMIBC-SI was able to discriminate between no treatment and any treatment groups, and no treatment and chemo/BCG groups, providing evidence towards validity.
CONCLUSIONS AND CLINICAL IMPLICATIONS: NMIBC-SI assesses patients' self-reported symptom burden and can be used to evaluate NMIBC treatments from the perspective of patients. The NMIBC-SI is acceptable to patients and has evidence for reliability and validity. Future validation work with patients with greater symptom burden is warranted.
METHODS: NMIBC-SI items were developed based on existing literature and qualitative interviews with patients and clinicians, and evaluated in two field tests: item reduction, using NMIBC-SI data from 220 patients on active treatment from nine Australian centres; reliability and validity evaluation of item-reduced version using NMIBC-SI data from 232 patients from five countries.
RESULTS: NMIBC-SI assesses disease and treatment-related symptom burden and two treatment-specific side-effects (cystoscopy, intravesical BCG/Chemotherapy). Composite analysis supported a single composite model including core symptom and cystoscopy index items (Intravesical index items were not tested due to small sample). Test-retest reliability was strong (range 0.894-0.91). As expected, the NMIBC-SI was able to discriminate between no treatment and any treatment groups, and no treatment and chemo/BCG groups, providing evidence towards validity.
CONCLUSIONS AND CLINICAL IMPLICATIONS: NMIBC-SI assesses patients' self-reported symptom burden and can be used to evaluate NMIBC treatments from the perspective of patients. The NMIBC-SI is acceptable to patients and has evidence for reliability and validity. Future validation work with patients with greater symptom burden is warranted.