Multicenter Study

. 2025 Mar 27;9(1):36.

doi: 10.1186/s41687-025-00864-7.

Development and psychometric evaluation of a patient-reported symptom index for patients with non-muscle invasive bladder cancer: the NMIBC-SI

Claudia Rutherford^{1

2

3}, Margaret-Ann Tait^{4

5}, Daniel S J Costa^{6

7}, Madeleine T King⁶, David P Smith⁵, Shomik Sengupta^{8

9}, Joseph Ischia¹⁰, Andrew Mitterdorfer¹¹, Dickon Hayne^{9

12}, Roger Watson^{9

13}, Paul Anderson^{9

14}, Mark Frydenberg¹⁵, Peter Gilling¹⁶, Nicholas Buchan^{9

17}, Euan Green¹⁸, Noel Clarke¹⁸, Stephen A Boorjian¹⁹, Badrinath Konety²⁰, Jeffrey M Holzbeierlein²¹, Peter C Black²², Venu Chalasani^{9

23}, Jörg Henseler^{24

25}, Manish I Patel^{9

26

27}; NMIBC-SI Study Group

Affiliations

¹ Faculty of Medicine and Health, Susan Wakil School of Nursing and Midwifery, University of Sydney, Sydney, Australia. claudia.rutherford@sydney.edu.au.
² The Daffodil Centre, The University of Sydney, A Joint Venture with Cancer Council New South Wales, Sydney, NSW, Australia. claudia.rutherford@sydney.edu.au.
³ Sydney Quality of Life Office, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia. claudia.rutherford@sydney.edu.au.
⁴ Faculty of Medicine and Health, Susan Wakil School of Nursing and Midwifery, University of Sydney, Sydney, Australia.
⁵ The Daffodil Centre, The University of Sydney, A Joint Venture with Cancer Council New South Wales, Sydney, NSW, Australia.
⁶ Faculty of Science, School of Psychology, University of Sydney, Sydney, NSW, Australia.
⁷ Pain Management Research Institute, Royal North Shore Hospital, St Leonards, NSW, Australia.
⁸ Eastern Health Clinical School, Monash University, Melbourne, VIC, Australia.
⁹ ANZUP Cancer Trials Group, Sydney, NSW, Australia.
¹⁰ Department of Surgery, University of Melbourne, Austin Health, Heidelberg, VIC, Australia.
¹¹ Concord Repatriation General Hospital, Concord, NSW, Australia.
¹² UWA Medical School, University of Western Australia, Perth, WA, Australia.
¹³ Mater Hospital, South Brisbane, QLD, Australia.
¹⁴ Royal Melbourne Hospital, Parkville, VIC, Australia.
¹⁵ Monash Medical Centre, Department of Surgery, Monash University, Melbourne, VIC, Australia.
¹⁶ Tauranga Urology Research, Tauranga, New Zealand.
¹⁷ Canterbury Urology Research Trust, Forte Health, Christchurch, New Zealand.
¹⁸ The Christie and Salford Royal Hospitals, Manchester, UK.
¹⁹ Mayo Clinic, Rochester, MN, USA.
²⁰ University of Minnesota, Minneapolis, MN, USA.
²¹ University of Kansas Health System, Kansas City, KS, USA.
²² University of British Columbia, Vancouver, BC, Canada.
²³ University of Sydney, Northern Clinical School, Sydney, NSW, Australia.
²⁴ University of Twente, Enschede, The Netherlands.
²⁵ Nova Information Management School, Universidade Nova de Lisboa, Lisbon, Portugal.
²⁶ Sydney Medical School, Specialty of Surgery, University of Sydney, Sydney, NSW, Australia.
²⁷ Department of Urology, Westmead Hospital, Westmead, NSW, Australia.

PMID: 40146452
PMCID: PMC11950540
DOI: 10.1186/s41687-025-00864-7

Multicenter Study

Development and psychometric evaluation of a patient-reported symptom index for patients with non-muscle invasive bladder cancer: the NMIBC-SI

Claudia Rutherford et al. J Patient Rep Outcomes. 2025.

. 2025 Mar 27;9(1):36.

doi: 10.1186/s41687-025-00864-7.

Authors

Affiliations

¹ Faculty of Medicine and Health, Susan Wakil School of Nursing and Midwifery, University of Sydney, Sydney, Australia. claudia.rutherford@sydney.edu.au.
² The Daffodil Centre, The University of Sydney, A Joint Venture with Cancer Council New South Wales, Sydney, NSW, Australia. claudia.rutherford@sydney.edu.au.
³ Sydney Quality of Life Office, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia. claudia.rutherford@sydney.edu.au.
⁴ Faculty of Medicine and Health, Susan Wakil School of Nursing and Midwifery, University of Sydney, Sydney, Australia.
⁵ The Daffodil Centre, The University of Sydney, A Joint Venture with Cancer Council New South Wales, Sydney, NSW, Australia.
⁶ Faculty of Science, School of Psychology, University of Sydney, Sydney, NSW, Australia.
⁷ Pain Management Research Institute, Royal North Shore Hospital, St Leonards, NSW, Australia.
⁸ Eastern Health Clinical School, Monash University, Melbourne, VIC, Australia.
⁹ ANZUP Cancer Trials Group, Sydney, NSW, Australia.
¹⁰ Department of Surgery, University of Melbourne, Austin Health, Heidelberg, VIC, Australia.
¹¹ Concord Repatriation General Hospital, Concord, NSW, Australia.
¹² UWA Medical School, University of Western Australia, Perth, WA, Australia.
¹³ Mater Hospital, South Brisbane, QLD, Australia.
¹⁴ Royal Melbourne Hospital, Parkville, VIC, Australia.
¹⁵ Monash Medical Centre, Department of Surgery, Monash University, Melbourne, VIC, Australia.
¹⁶ Tauranga Urology Research, Tauranga, New Zealand.
¹⁷ Canterbury Urology Research Trust, Forte Health, Christchurch, New Zealand.
¹⁸ The Christie and Salford Royal Hospitals, Manchester, UK.
¹⁹ Mayo Clinic, Rochester, MN, USA.
²⁰ University of Minnesota, Minneapolis, MN, USA.
²¹ University of Kansas Health System, Kansas City, KS, USA.
²² University of British Columbia, Vancouver, BC, Canada.
²³ University of Sydney, Northern Clinical School, Sydney, NSW, Australia.
²⁴ University of Twente, Enschede, The Netherlands.
²⁵ Nova Information Management School, Universidade Nova de Lisboa, Lisbon, Portugal.
²⁶ Sydney Medical School, Specialty of Surgery, University of Sydney, Sydney, NSW, Australia.
²⁷ Department of Urology, Westmead Hospital, Westmead, NSW, Australia.

PMID: 40146452
PMCID: PMC11950540
DOI: 10.1186/s41687-025-00864-7

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.

Keywords: Early bladder cancer; Measurement properties; Non-muscle invasive bladder cancer; Patient-reported outcome; Patient-reported outcome measure; Symptom benefit; Symptom burden; Symptom index.

Plain language summary

Patients with NMIBC require long-term monitoring with regular endoscopic examinations and various treatments. This research describes the development of the NMIBC-SI, a patient-completed questionnaire that assesses the impact of those treatments on health outcomes important to patients. The NMIBC-SI can be used in research and in the clinic to improve communication and treatment decisions.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Northern Sydney Local Health District Human Research Ethics Committee on 26 October 2016 (HREC/16/HAWKE/329). Written informed consent was obtained from all individual participants included in the study. Consent included publication of results from this study in the form of anonymised survey data. Consent for publication: Not applicable. Clinical trial registration: ClinicalTrials.gov NCT03091764, 27 March 2017. http://clinicaltrials.gov/ct2/showNCT03091764 . Competing interests: The co-authors have disclosed the following as financial interests, relationships, and affiliations relevant to the subject matter discussed in the manuscript: SAB is a consultant for Ferring, FerGene, Artara, and Prokarium. SS is an unpaid board director of ANZUP trials group. Has been an adviser/speaker for Mundipharma, Ipsen, Abbvie and MSD (with honoraria donated directly into departmental research funds) and a paid adviser to Janssen. NB is an unpaid board director of ANZUP trials group. BK is a consultant for Ferring Pharmaceuticals Inc and Investigator clinical trial, Pacific Edge. MP is an advisor/speaker for Jannsen, MSD, Mundipharma, Astra Zenaca. The remaining authors declare that they have no competing interests.

Figures

**Fig. 1**
Flow of participants through field test 2

**Fig. 2**
NMIBC-Core 23-item response frequency

**Fig. 3**
NMIBC-Intra 10-item response frequency

**Fig. 4**
NMIBC-Cyst 6-item response frequency

See this image and copyright information in PMC

References

1. Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, et al (2024) Global Cancer Observatory: Cancer Today. https://gco.iarc.who.int/today. Accessed 06 March 2024
1. Heney NM (1992) Natural history of superficial bladder cancer. Prognostic features and long-term disease course. Urol Clin North Am 19(3):429–433 - PubMed
1. Miyake M, Kitamura H, Nishimura N, Miyamoto T, Nakahama T, Fujii T, et al (2024) Validation of non-muscle-invasive bladder cancer risk stratification updated in the 2021 European association of urology guidelines. 5(2):269–280. 10.1002/bco2.305 - PMC - PubMed
1. Sylvester RJ, Rodríguez O, Hernández V, Turturica D, Bauerová L, Bruins HM et al (2021) European association of urology (EAU) prognostic factor risk groups for Non–muscle-invasive bladder cancer (NMIBC) incorporating the WHO 2004/2016 and WHO 1973 classification systems for grade: An update from the EAU NMIBC guidelines panel. Eur Urol 79(4):480–488. 10.1016/j.eururo.2020.12.033 - PubMed
1. Anastasiadis A, de Reijke TM (2012) Best practice in the treatment of nonmuscle invasive bladder cancer. Ther Adv Urol 4(1):13–32. 10.1177/1756287211431976 - PMC - PubMed

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Development and psychometric evaluation of a patient-reported symptom index for patients with non-muscle invasive bladder cancer: the NMIBC-SI

Affiliations

Development and psychometric evaluation of a patient-reported symptom index for patients with non-muscle invasive bladder cancer: the NMIBC-SI

Authors

Affiliations

Abstract

Plain language summary

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials

Miscellaneous