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A conceptual framework for patient-reported outcomes in non-muscle invasive bladder cancer

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Abstract

Purpose

Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring repeated treatment and endoscopic examinations that can be life-long. In this context, health-related quality of life (HRQOL) is important to patients and managing clinicians, and integral to treatment recommendations for NMIBC. The aim of this study was to develop a conceptual framework of patient-reported NMIBC symptoms, treatment side effects, and HRQOL impacts from three sources: (1) literature, (2) patients and (3) treating clinicians.

Methods

First, we undertook a scoping literature review for studies reporting patient-reported outcomes associated with NMIBC. Outcomes were extracted and grouped conceptually. Then, we conducted semi-structured interviews with patients with NMIBC and treating clinicians. Patients were asked about symptoms and HRQOL impacts experienced from their NMIBC and treatments. Clinicians were asked about commonly reported outcomes, and outcomes they felt were important to assess clinically. Interviews were audio recorded, transcribed and content analysed.

Results

A total of 125 symptom- and functioning-related expressions from 18 studies, 26 patients and 20 clinicians were coded into three themes and 18 sub-themes. Patients commonly reported blood in urine and frequent urination. Clinicians considered BCG sepsis and flu-like symptoms important outcomes to assess during treatment for NMIBC.

Conclusion

Our empirically derived conceptual framework identifies patient-reported outcomes that are important to people with NMIBC, provides the basis for the development of a new NMIBC-specific symptom index, and guides the design of a comprehensive PRO assessment plan for clinical practice in NMIBC and future clinical trials of treatments for NMIBC.

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Acknowledgements

We thank Ms. Marla Luther, RN, The Urological Cancer Centre, Westmead, and Ms. Julie Ashbourne, Department of Urology, Westmead Hospital, for their assistance with patient recruitment, and Ms. Emma Jones, Research Assistant at the University of Sydney for assistance with data extraction.

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Authors and Affiliations

  1. Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Camperdown, NSW, 2006, Australia

    Claudia Rutherford & Madeleine T King

  2. Royal North Shore Hospital, Pain Management Research Institute, St Leonards, Sydney, NSW, Australia

    Daniel S J Costa

  3. Central Clinical School, Sydney Medical School, University of Sydney, Camperdown, NSW, 2006, Australia

    Daniel S J Costa & Madeleine T King

  4. Cancer Research Division, Cancer Council New South Wales, Kings Cross, NSW, Australia

    David P Smith

  5. Sydney School of Public Health, University of Sydney, Camperdown, NSW, Australia

    David P Smith

  6. Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia

    David P Smith

  7. Discipline of Surgery, Sydney Medical School, Westmead Hospital, University of Sydney and Department of Urology, Sydney, Australia

    Manish I Patel

Authors
  1. Claudia Rutherford
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  2. Daniel S J Costa
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  3. Madeleine T King
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  4. David P Smith
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  5. Manish I Patel
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Corresponding author

Correspondence to Claudia Rutherford.

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Conflict of interest

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. The remaining authors have no conflicts of interest to declare. The authors have full control of all primary data and allow the journal to review the data if requested.

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Rutherford, C., Costa, D.S.J., King, M.T. et al. A conceptual framework for patient-reported outcomes in non-muscle invasive bladder cancer. Support Care Cancer 25, 3095–3102 (2017). https://doi.org/10.1007/s00520-017-3717-5

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  • DOI: https://doi.org/10.1007/s00520-017-3717-5

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