Photodynamic Diagnosis of Bladder Cancer

Evidence Base

This section has been designed to provide Trusts wishing to progress with implementation of the technology with the evidence base required to agree a Business Case and to ensure that the technology being adopted is safe and complies with relevant clinical governance frameworks locally and nationally.

In this section you will find a short background to national standards, relevant trial reports, and supporting evidence, other useful reference papers and useful websites.

NTAC Project Data

Methods of quantitative and qualitative measurement and evaluation of the clinical utility of implementing the diagnostic technique were developed by project teams from the NTAC project sites (see Contacts and Links). These were used in the determination of the impact of the technology on patient outcomes and support requirements, hospital resource requirements and the clinical utility of adoption the technology.

The evaluation measures and values were subjected to independent analysis undertaken by the NHS Technology Adoption Centre and York Health Economics Consortium. The data was further reviewed by the NHS Information Centre for Health and Social Care.

The following reports were created as part of this project: 

PDD slides shows a summary presentation of the data collected during this project.

PDD Headline Report shows a headline of project data.

PDD Data Analysis Report shows a full breakdown of the data collected.

PDD Economic Report shows a full health economic analysis on this technology.

PDD Costing Model demonstrates a full costing model for this technology.

 

Background to National Standards

Bladder cancer is caused by the uncontrolled growth of the cells lining the bladder wall. If the cancer hasn't grown from the bladder lining into the muscle of the bladder it is called non-muscle invasive bladder cancer - this is the most common type of bladder cancer and can be treated by removing it from the bladder wall. The procedure is called transurethral resection of bladder tumour (TURBT).

The use of photodynamic diagnosis of bladder cancer (PDD) is sign posted by the Map of Medicine, the European Association of Urology, the Scottish Intercollegiate Guidelines Network and the British Association of Urological Surgeons. The availability of PDD which is concurrent with transurethral resection of bladder tumour (TURBT) offers the potential to streamline the number of subsequent surgeries undertaken for primary bladder cancer each year, with length of stay savings of up to 0.24 days per patient (this will vary depending on local protocols). This would equate to a saving of approximately 2,116 bed days in the UK over a five year period and would remove the inefficiencies associated with unnecessary follow-up protocol post-operatively.

The National Institute for Health and Clinical Excellence (NICE) completed a Health Technology Assessment on the PDD technology in January 2010 which found that photodynamic diagnosis has higher sensitivity but lower specificity than white light cystoscopy and cytology, respectively in detecting bladder cancer. Diagnostic strategies involving photodynamic diagnosis provide additional benefits in terms of more complete tumour removal at initial surgery (TURBT) with a subsequent reduction in later cancer recurrence at a cost that society might be willing to pay.

Health Technology Assessment, other Systematic Reviews, and Key Studies

Health Technology Assessment, other Systematic Reviews, and Key Studies

1.

Systematic review of the clinical effectiveness and cost-effectiveness of photodynamic diagnosis and urine biomarkers (FISH, ImmunoCyt, NMP22) and cytology for the detection and follow-up of bladder cancer. Health Technol Assess 2010 Jan; 14(4):1-356.

http://www.urotoday.com/bladder-cancer-1038/137-bladder-cancer-1038/34111-systematic-review-of-the-clinical-effectiveness-and-costeffectiveness-of-photodynamic-diagnosis-and-urine-biomarkers-fish-immunocyt-nmp22-and-cytology-for-the-detection-and-followup-of-bladder-cancer-abstract-2227027.html

2.

HTA Technology Assessment Report. National Institute for Health Research Health Technology Assessment programme. Volume 14, number 4. January 2010.

http://www.hta.ac.uk/project/1713.asp

3.

Hexaminolevulinate-Guided Fluorescence Cystoscopy in the Diagnosis and Follow-Up of Patients with Non-Muscle-Invasive Bladder Cancer: Review of the Evidence and Recommendations.
European Urology. April 2010. Volume 57, Issue 4, pages 607-614.

http://www.ncbi.nlm.nih.gov/pubmed/20116164

4.

Photodynamic Diagnosis in Non-Muscle-Invasive Bladder Cancer: A Systematic Review and Cumulative Analysis of Prospective Studies.
European Urology. April 2010. Volume 57, Issue 4, pages 595-606. 

http://www.ncbi.nlm.nih.gov/pubmed/20004052

5.

The role of hexylaminolaevulinate in the diagnosis and follow-up of non-muscle-invasive bladder cancer.

http://www.ncbi.nlm.nih.gov/pubmed/20089091

6.

Hexaminolevulinate fluorescence cystoscopy and transurethral resection of the bladder in noninvasive bladder tumors.

http://www.ncbi.nlm.nih.gov/pubmed/19473068

7.

Hexylaminolevulinate photodynamic diagnosis for multifocal recurrent nonmuscle invasive bladder cancer.

http://www.ncbi.nlm.nih.gov/pubmed/19441882

8.

The economic benefit of photodynamic diagnosis in non-muscle invasive bladder cancer.

http://www.ncbi.nlm.nih.gov/pubmed/19356647

9.

Fluorescence-guided transurethral resection of bladder cancer using hexaminolevulinate: analysis of health economic impact in Sweden.

http://www.ncbi.nlm.nih.gov/pubmed/19330681

10.

Hexylaminolaevulinate 'blue light' fluorescence cystoscopy in the investigation of clinically unconfirmed positive urine cytology.

http://www.ncbi.nlm.nih.gov/pubmed/19076151

11.

Positive urine cytology but negative white-light cystoscopy: an indication for fluorescence cystoscopy?

http://www.ncbi.nlm.nih.gov/pubmed/18793301

12.

Incorporating fluorescence cystoscopy for the diagnosis of bladder cancer into clinical practice.

http://www.ncbi.nlm.nih.gov/pubmed/18577979

13.

Photodynamic diagnosis in urology: state-of-the-art.

http://www.ncbi.nlm.nih.gov/pubmed/18096307

14.

The role of hexaminolevulinate fluorescence cystoscopy in bladder cancer. 

http://www.ncbi.nlm.nih.gov/pubmed/17921969

15.

A comparison of hexaminolevulinate fluorescence cystoscopy and white light cystoscopy for the detection of carcinoma in situ in patients with bladder cancer: a phase III, multicenter study.

http://www.ncbi.nlm.nih.gov/pubmed/17499291

16.

Improved detection of urothelial carcinoma in situ with hexaminolevulinate fluorescence cystoscopy.

http://www.ncbi.nlm.nih.gov/pubmed/14665861

Other useful reference papers

Department of Health

Cancer Commissioning Guidance, January 2009

Click here to view this guidance

Guide to practice-based commissioners in developing good cancer care services, June 2009.

Click hereto view this guide

Cancer Reform Strategy - 2010

Click hereto view this strategy

Other useful web links

National Cancer Intelligence Network

November 2009: Report and Presentations from the NCIN Co-morbidity Data Collection Workshop.

http://www.ncin.org.uk/data/comorbidity.shtml

Transforming Care for Cancer Inpatients - Spreading the Winning Principles and Good Practice, July 2009

Click here to view this publication


Ensuring Better Treatment: Going Further on Cancer Waits - An Improvement guide for supporting sustainable delivery, February 2009.

Click here to view this guide


Locally Developed CQUIN Schemes 2009/10
http://www.institute.nhs.uk/world_class_commissioning/pct_portal/cquin_schemes.html


Measuring Surgical Outcomes

http://www.rcseng.ac.uk/media/media-background-briefings-and-statistics/measuring-surgical-outcomes

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