Claudia Rutherford, Margaret-Ann Tait, Daniel S J Costa, Madeleine T King, David P Smith, Shomik Sengupta, Joseph Ischia, Andrew Mitterdorfer, Dickon Hayne, Roger Watson, Paul Anderson, Mark Frydenberg, Peter Gilling, Nicholas Buchan, Euan Green, Noel Clarke, Stephen A Boorjian, Badrinath Konety, Jeffrey M Holzbeierlein, Peter C Black, Venu Chalasani, Jörg Henseler, Manish I Patel
{"title":"Development and psychometric evaluation of a patient-reported symptom index for patients with non-muscle invasive bladder cancer: the NMIBC-SI.","authors":"Claudia Rutherford, Margaret-Ann Tait, Daniel S J Costa, Madeleine T King, David P Smith, Shomik Sengupta, Joseph Ischia, Andrew Mitterdorfer, Dickon Hayne, Roger Watson, Paul Anderson, Mark Frydenberg, Peter Gilling, Nicholas Buchan, Euan Green, Noel Clarke, Stephen A Boorjian, Badrinath Konety, Jeffrey M Holzbeierlein, Peter C Black, Venu Chalasani, Jörg Henseler, Manish I Patel","doi":"10.1186/s41687-025-00864-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and clinical implications: </strong>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.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"36"},"PeriodicalIF":2.4000,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950540/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Patient-Reported Outcomes","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s41687-025-00864-7","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
