Observational Study

. 2019 Sep;124(3):408-417.

doi: 10.1111/bju.14690. Epub 2019 Mar 4.

Mixed-methods approach to exploring patients' perspectives on the acceptability of a urinary biomarker test in replacing cystoscopy for bladder cancer surveillance

Wei Shen Tan^{1

2}, Chin Hai Teo³, Delcos Chan³, Malgorzata Heinrich⁴, Andrew Feber^{1

5}, Rachael Sarpong⁶, Jennifer Allan¹, Norman Williams⁶, Chris Brew-Graves⁶, Chirk Jenn Ng³, John D Kelly^{1

2}; DETECT II trial collaborators

Collaborators, Affiliations

Collaborators

DETECT II trial collaborators:
P Khetrapal, A Ridhar, H Baker, F Ocampo, N Whotton, K Dent, S Pearson, J Hatton, M Newton, E Heeney, K Green, S Evans, M Rogers, A Dann, J Cook, M Cornwell, R Mills, H Knight, S Maher, A Rane, S Thomas, S Reyner, G Vallejera, P Adeniran, S Masood, S Ridgway, M Coulding, H Savill, J Mccormick, M Clark, G Collins, K Jewers, S Keith, G Bowen, J Hargreaves, K Riley, S Srirangam, R Mistry, J Chadwick, S Cocks, R Hull, A Loftus, L Dawson, H Roberts, C Main, S Jain, C Waymont, J Rogers, A Grant, V Carter, H Heap, C Lomas, P Cooke, Y Baird, S Moore, S Greenslade, J Margalef, I Chadbourn, M Harris, J Hicks, P Clitheroe, S Connolly, S Hodgkinson, H Haydock, A Inclair, E Storr, L Cogley, S Natale, W Lovegrove, S Smith, K Smith, D Hewitt, R Sriram, K Atkinson, L Royle, J Madine, K MacLean, J Walsh, M Guerdette, M Hill, D Payne, A Power, J Cannon, L Devereaux, A Thompson, L Scarratt, T Hodgkiss, D Johnstone, J Johnson, J Allsop, J Rothwell, K Connolly, J Cherian, H Wardle, D Wilson, A Bayles, S Pelluri, J Pati, A Gherman, C Scott, S Madaan, A Taylor, E Edmunds, J Moore, A Rees, S Williams, S Caddy, S Dukes, A Goffe, K Buckhorn, L Nichols, P Acher, K Baillie, K Middleton, C Proctor, J Cresswell, A Chilvers, M Cain, A Vaux, D Watson, S Bradfield, H Gregory, H Mostafid, L Kehoe, S Drakeley, A Davies, L Williamson, R Krishnan, N Lunt, P Hill, H Burns, B Townley, L Wilkinson, H Wassall, J Hunt, B Holbrook, L Stancombe, J Morrison, L Vankoutrik, S Misra, G Fossey, A Richards, K Mcdonald, A Henderson, R Fennelly, M Tribbeck, K Ames, J Borwell, M Kotze, K Beesley, K Rennie, T Porter, A Gipson, L Piper, L Bailey, A Chrisopoulou, K Slevin, F McCartin, H Warburton, S Hathaway-Lees, K Whetton, G Delves, A Day, T Bankole, S Broadhead, S Malde, M Oblak, D Ellis, S Bishara, T Barias-Lara, I Donkov, H Thatcher, M Morris, C Culmsee, H Menzies, C Bartlett, C Cutting, N O'Brien, R Jannapureddy, A Kelkar, J Fitzgerald, S Longhurst, C Worth, M Peracha, S Mzazi, C Poile, L Griffiths, A Cook, N Barber, N Brar, A Lty, B Zelhof, Rosie Blades

Affiliations

¹ Division of Surgery and Interventional Science, University College London, London, UK.
² Department of Urology, University College London Hospital, London, UK.
³ Department of Primary Care Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
⁴ Health Behaviour Research Centre, Department of Epidemiology and Public Health, University College London, London, UK.
⁵ UCL Cancer Institute, London, UK.
⁶ Surgical and Interventional Trials Unit, University College London, London, UK.

PMID: 30694612
PMCID: PMC6767410
DOI: 10.1111/bju.14690

Observational Study

Mixed-methods approach to exploring patients' perspectives on the acceptability of a urinary biomarker test in replacing cystoscopy for bladder cancer surveillance

Wei Shen Tan et al. BJU Int. 2019 Sep.

. 2019 Sep;124(3):408-417.

doi: 10.1111/bju.14690. Epub 2019 Mar 4.

Authors

Collaborators

DETECT II trial collaborators:
P Khetrapal, A Ridhar, H Baker, F Ocampo, N Whotton, K Dent, S Pearson, J Hatton, M Newton, E Heeney, K Green, S Evans, M Rogers, A Dann, J Cook, M Cornwell, R Mills, H Knight, S Maher, A Rane, S Thomas, S Reyner, G Vallejera, P Adeniran, S Masood, S Ridgway, M Coulding, H Savill, J Mccormick, M Clark, G Collins, K Jewers, S Keith, G Bowen, J Hargreaves, K Riley, S Srirangam, R Mistry, J Chadwick, S Cocks, R Hull, A Loftus, L Dawson, H Roberts, C Main, S Jain, C Waymont, J Rogers, A Grant, V Carter, H Heap, C Lomas, P Cooke, Y Baird, S Moore, S Greenslade, J Margalef, I Chadbourn, M Harris, J Hicks, P Clitheroe, S Connolly, S Hodgkinson, H Haydock, A Inclair, E Storr, L Cogley, S Natale, W Lovegrove, S Smith, K Smith, D Hewitt, R Sriram, K Atkinson, L Royle, J Madine, K MacLean, J Walsh, M Guerdette, M Hill, D Payne, A Power, J Cannon, L Devereaux, A Thompson, L Scarratt, T Hodgkiss, D Johnstone, J Johnson, J Allsop, J Rothwell, K Connolly, J Cherian, H Wardle, D Wilson, A Bayles, S Pelluri, J Pati, A Gherman, C Scott, S Madaan, A Taylor, E Edmunds, J Moore, A Rees, S Williams, S Caddy, S Dukes, A Goffe, K Buckhorn, L Nichols, P Acher, K Baillie, K Middleton, C Proctor, J Cresswell, A Chilvers, M Cain, A Vaux, D Watson, S Bradfield, H Gregory, H Mostafid, L Kehoe, S Drakeley, A Davies, L Williamson, R Krishnan, N Lunt, P Hill, H Burns, B Townley, L Wilkinson, H Wassall, J Hunt, B Holbrook, L Stancombe, J Morrison, L Vankoutrik, S Misra, G Fossey, A Richards, K Mcdonald, A Henderson, R Fennelly, M Tribbeck, K Ames, J Borwell, M Kotze, K Beesley, K Rennie, T Porter, A Gipson, L Piper, L Bailey, A Chrisopoulou, K Slevin, F McCartin, H Warburton, S Hathaway-Lees, K Whetton, G Delves, A Day, T Bankole, S Broadhead, S Malde, M Oblak, D Ellis, S Bishara, T Barias-Lara, I Donkov, H Thatcher, M Morris, C Culmsee, H Menzies, C Bartlett, C Cutting, N O'Brien, R Jannapureddy, A Kelkar, J Fitzgerald, S Longhurst, C Worth, M Peracha, S Mzazi, C Poile, L Griffiths, A Cook, N Barber, N Brar, A Lty, B Zelhof, Rosie Blades

Affiliations

¹ Division of Surgery and Interventional Science, University College London, London, UK.
² Department of Urology, University College London Hospital, London, UK.
³ Department of Primary Care Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
⁴ Health Behaviour Research Centre, Department of Epidemiology and Public Health, University College London, London, UK.
⁵ UCL Cancer Institute, London, UK.
⁶ Surgical and Interventional Trials Unit, University College London, London, UK.

PMID: 30694612
PMCID: PMC6767410
DOI: 10.1111/bju.14690

Abstract

Objectives: To determine the minimal accepted sensitivity (MAS) of a urine biomarker that patients are willing to accept to replace cystoscopy and to assess qualitatively their views and reasons.

Patients and methods: Patients were part of a prospective multicentre observational study recruiting people with bladder cancer for a urine biomarker study (DETECT II; ClinicalTrials.gov: NCT02781428). A mixed-methods approach comprising (1) a questionnaire to assess patients' experience with cystoscopy and patients' preference for cystoscopy vs urinary biomarker, and (2) semi-structured interviews to understand patient views, choice and reasons for their preference.

Results: A urine biomarker with an MAS of 90% would be accepted by 75.8% of patients. This was despite a high self-reported prevalence of haematuria (51.0%), dysuria/lower urinary tract symptoms (69.1%) and urinary tract infection requiring antibiotics (25.8%). There was no association between MAS with patient demographics, adverse events experienced, cancer characteristics or distance of patients' home to hospital. The qualitative analysis suggested that patients acknowledge that cystoscopy is invasive, embarrassing and associated with adverse events but are willing to tolerate the procedure because of its high sensitivity. Patients have confidence in cystoscopy and appreciate the visual diagnosis of cancer. Both low- and high-risk patients would consider a biomarker with a reported sensitivity similar to that of cystoscopy.

Conclusion: Patients value the high sensitivity of cystoscopy despite the reported discomfort and adverse events experienced after it. The sensitivity of a urinary biomarker must be close to cystoscopy to gain patients' acceptance.

Keywords: #BladderCancer; #blcsm; biomarker; diagnostic; patient-reported outcome measure; questionnaires; semi-structured interviews.

PubMed Disclaimer

Conflict of interest statement

John D. Kelly and Andrew Feber are involved in the development and validation of a urine biomarker ‘UroMark’ which is the primary objective of the current DETECT II study.

Figures

**Figure 1**
Patient experience after cystoscopy: (A) overall experience, (B) pain during cystoscopy, (C) anxiety preceding cystoscopy. 1 denotes no symptoms/painless/not anxious. 5 denotes severe symptoms/very painful/very anxious.

See this image and copyright information in PMC

Comment in

Editorial Comment.
Tan WS, Kelly JD. Tan WS, et al. J Urol. 2020 Jul;204(1):56-57. doi: 10.1097/JU.0000000000000786.02. Epub 2020 Apr 13. J Urol. 2020. PMID: 32282283 No abstract available.

References

1. Babjuk M, Bohle A, Burger M et al. EAU guidelines on non‐muscle‐invasive urothelial carcinoma of the bladder: update 2016. Eur Urol 2017; 71: 447–61 - PubMed
1. Tan WS, Feber A, Sarpong R et al. Who should be investigated for haematuria? Results of a contemporary prospective observational study of 3556 patients. Eur Urol 2018; 74: 10–4 - PubMed
1. Cambier S, Sylvester RJ, Collette L et al. EORTC nomograms and risk groups for predicting recurrence, progression, and disease‐specific and overall survival in non‐muscle‐invasive stage Ta‐T1 urothelial bladder cancer patients treated with 1‐3 years of maintenance Bacillus Calmette‐Guerin. Eur Urol 2016; 69: 60–9 - PubMed
1. Tan WS, Rodney S, Lamb B, Feneley M, Kelly J. Management of non‐muscle invasive bladder cancer: a comprehensive analysis of guidelines from the United States, Europe and Asia. Cancer Treat Rev 2016; 47: 22–31 - PubMed
1. Svatek RS, Hollenbeck BK, Holmang S et al. The economics of bladder cancer: costs and considerations of caring for this disease. Eur Urol 2014; 66: 253–62 - PubMed

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Mixed-methods approach to exploring patients' perspectives on the acceptability of a urinary biomarker test in replacing cystoscopy for bladder cancer surveillance

Collaborators

Affiliations

Mixed-methods approach to exploring patients' perspectives on the acceptability of a urinary biomarker test in replacing cystoscopy for bladder cancer surveillance

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

Comment in

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical