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Supportive Care in Cancer
Published in: Supportive Care in Cancer 10/2017

01-10-2017 | Original Article

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

Authors: Claudia Rutherford, Daniel S J Costa, Madeleine T King, David P Smith, Manish I Patel

Published in: Supportive Care in Cancer | Issue 10/2017

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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.
Literature
1.
Cheluvappa R, Smith DP, Cerimagic S, Patel MI (2014) A comprehensive evaluation of bladder cancer epidemiology and outcomes in Australia. Int Urol Nephrol 46(7):1351–1360CrossRefPubMed
2.
Heney NM (1992) Natural history of superficial bladder cancer. Prognostic features and long-term disease course. Urol Clin North Am 19(3):429–433PubMed
3.
Botteman MF, Pashos CL, Redaelli A, Laskin B, Hauser R (2003) The health economics of bladder cancer: a comprehensive review of the published literature. PharmacoEconomics 21(18):1315–1330CrossRefPubMed
4.
Zlotta AR, van Vooren JP, Huygen K, Drowart A, Decock M, Pirson M et al (2000) What is the optimal regimen for BCG intravesical therapy? Are six weekly instillations necessary? Eur Urol 37(4):470–477CrossRefPubMed
5.
Food and Drug Administration (2009) Patient reported outcome measures: use in medical product development to support labelling claims. US Department of Health & Human Support Food & Drug Administration, MD
6.
Bottomley A, Flechtner H, Efficace F, Vanvoorden V, Coens C, Therasse P et al (2005) Health related quality of life outcomes in cancer clinical trials. Eur J Cancer 41(12):1697–1709CrossRefPubMed
7.
Patrick DL, Burke LB, Powers JH, Scott JA, Rock EP, Dawisha S et al (2007) Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health 10(2):S125–S137CrossRefPubMed
8.
Rothman M, Burke L, Erickson P, Kline Leidy N, Patrick DL, Petrie CD (2009) Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR good research practices for evaluating and documenting content validity for the use of existing instruments and their modification PRO tasck force report. Value Health 12(8):1075–1083CrossRefPubMed
9.
10.
Babjuk M, Oosterlinck W, Sylvester R, Kaasinen E, Bohl RD, Palou Redorta J et al (2011) EAU guidelines on non-muscle invasive urothelial carcinoma of the bladder, the 2011 update. Eur Urol 59(6):997–1008CrossRefPubMed
11.
Johnson C, Aaronson N, Blazeby J, Bottomley A, Fayers P, Koller M et al (2011) EORTC quality of life group: guidelines for developing questionnaire modules, 4th edn. EORTC, Brussels
12.
Charmaz K (2003) Qualitative interviewing and grounded theory analysis. In: Holstein JA, Gubrium JF (eds) Inside interviewing: new lenses, new concerns. Sage, Thousand Oaks, CA, pp 311–330
13.
14.
15.
16.
Glaser BG, Strauss AL (1967) The discovery of grounded theory. Aldine, Chicago, IL
17.
Brenner MH, Curbow B, Legro MW (1995) The proximal-distal continuum of multiple health outcome measures: the case of cataract surgery. Med Care 33(4 Suppl):As236–As244PubMed
18.
19.
Osoba D, Zee B, Pater J, Warr D, Latreille J, Kaizer L (1997) Determinants of postchemotherapy nausea and vomiting in patients with cancer. Quality of life and symptom control committees of the National Cancer Institute of Canada clinical trials group. J Clin Oncol 15(1):116–123. doi:10.​1200/​jco.​1997.​15.​1.​116 CrossRefPubMed
20.
Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM et al (2004) Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 22(4):714–724. doi:10.​1200/​jco.​2004.​06.​078 CrossRefPubMed
21.
Metadata
Title
A conceptual framework for patient-reported outcomes in non-muscle invasive bladder cancer
Authors
Claudia Rutherford
Daniel S J Costa
Madeleine T King
David P Smith
Manish I Patel
Publication date
01-10-2017
Publisher
Springer Berlin Heidelberg
Published in
Supportive Care in Cancer / Issue 10/2017
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-017-3717-5

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