identify_overview



The Investigation and DEtection of urological Neoplasia in paTIents reFerred with suspected urinary tract cancer: A multicentre analYsis (IDENTIFY)

Service Evaluation Project

Background
Clinical practice varies considerably across hospitals and countries for the investigation of patients referred with suspected urinary tract cancer. In the UK, NICE recently set new recommended criteria for suspected cancer referral from primary to secondary care. Furthermore many hospitals have a one-stop clinic where all appropriate investigations may be performed in one visit to screen for urothelial cancer. This will normally include a flexible cystoscopy, but many hospitals will differ in their choice of upper tract imaging as well as the use of other investigations such as urine cytology.


Aims and Objectives
Primary aims:
  • Determine the prevalence of urological cancers in patients presenting to secondary care with suspected urinary tract cancer (e.g. in patients presenting with haematuria to urology services).


Secondary aims:
  • To determine the difference in diagnostic practice across hospitals and countries and assess if this has an impact on diagnostic yield
  • Identify an optimal diagnostic strategy that can be personalised to the individual patient


Methods
A multi-centre prospective international service evaluation in at least 5000 patients (largest ever series of this kind), collecting data on patients referred to secondary care with suspected urinary tract cancer, and observing the differences in diagnostic practice between hospitals.


As this is observational only and no there is no intervention the project meets the criteria for a service evaluation project as per the Health Research Authority online tool (see attachment below) and has also been evaluated by the R&D department at Royal Devon and Exeter Hospital. In the UK this means it is exempt from requiring ethics approval. 


This service evaluation will be carried out at a number of hospital sites. It is hoped that by observing variation in practice between sites this may help identify areas for service improvement.  


Local Hospital Trust data management policies will be followed. Only anonymised data will be collected.


How to get involved:
  1. Pre-register by emailing identifystudy@gmail.com with your name, country and institution
  2. Follow @BURSTurology on Twitter for regular updates
  3. Register your site by completing the documents we will send to you and clear the study as a service evaluation / audit
  4. Register for our online database (Redcap) and receive your login details
  5. Start entering data for patients with haematuria (or other presentations) that you investigate at your site
  6. Enter the follow up data on your patients (Imaging/ TURBT/pathology results)


Timeline:
  • September-December 2017: Register centres, allow collaborators to get usernames and local approvals
  • November 2017-January 2018: Start data collection. Patients will usually be identified from haematuria clinics/ cystoscopy lists and data collection will cover demographics, presentation, past medical history and investigation findings.
  • March-May 2018: Collect final investigation results and complete data
  • June 2018: Data analysis and results reporting


Benefits of getting involved:
  • Registration is simple and should avoid formal ethical approvals: In the UK the study will qualify as a “service evaluation” and is exempt from needing ethical approval, although individual centres in other countries will have to follow local governance rules.
  • Taking part is simple: you will be part of what could potential be the largest prospective study of haematuria investigation ever performed
  • Anybody who performs investigations on patients referred with haematuria can quickly and easily enter the data into our user-friendly online secure database.
  • All contributors will receive Pubmed indexed collaborator authorship
  • The highest recruiting individuals will be invited on the writing committee. The more patients recruited the higher up the collaborative list and you will gain preference for presentation of the study findings at conferences.
  • Returns on this will be fast


What you will need
  • Regularly perform, supervise or have access to cystoscopy lists (flexible or rigid) for investigation of haematuria
  • A consultant/attending who is willing to act as the named supervisor
  • Local approvals
  • Detailed instructions will be sent when formal registration opens


To qualify for collaborative authorship:
  • Each centre will be required to collect data for a minimum of 50 patients.
  • You are encouraged to work in teams and up to 2 trainees can be recognised as authors for collection of data for these 50 patients.
  • We will also recognise a supervising consultant on the authorship.
  • If any additional authors want to take part from the same centre this is still possible.
  • For each additional trainee author, a further 25 patients will be required per author to gain authorship.
  • Authors are required to collect data when the patient first presents, when their investigations are complete a few months later and may also be asked to check that their data is accurate towards the end of the study (data validation).
  • We recognise that some high volume centres will be able to enter data for 50 patients in a few weeks whereas others might take 6 weeks or more. For high-volume centres, we recommend that you collect data for more than 50 patients and will reward centres and individuals who enter data for the most patients across the whole study.
  • The more patients that a particular author enters data for, the closer to the start of the collaborative authorship list the author will appear. The highest recruiting individuals and centres will also be invited onto the manuscript writing panel and will be given preference to submit and present the work for the whole study at international conferences with an excellent chance of winning prizes.


Key personnel involved in designing the project
This is a BURST-research collaborative led project. This means that the project lead trainee, BURST committee and BURST advisors have worked together to design this project.

  • Lead trainee - Mr Sinan Khadhouri
  • Key committee members - Mr Matt Jeffries, Mr Taimur Shah, Mr Arjun Nambiar, Mr Kenneth MacKenzie, Mr Kevin Gallagher, Mr Eric Edison, Ms Eleanor Zimmerman, Mr Chuanyu Gao, Ms Lynsey Williams, Mr Sacha Moore.
  • Key project supervisors - Mr John McGrath (BAUS Academic Section President, Consultant Urological Surgeon (Royal Devon and Exeter NHS Trust, Honorary Senior Lecturer (University of Exeter Medical School, Cancer Lead  - SW NHS Genomic Medicine Centre) & Mr Veeru Kasivisvanathan (BURST Co-chair, NIHR Doctoral Fellow and Urology SpR University College London & UCLH, BAUS Academic Section Committee)
  • BURST advisors: Professor Mark Emberton, Professor Hashim Ahmed, Mr Ben Challacombe, Professor Robert Pickard

Further information:

Please join us in this ground-breaking study by emailing identifystudy@gmail.com with your name and site details to register your interest.

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