APCCR- Prostate Cancer Registry

Transcription

1 APCCR- Prostate Cancer Registry Sue Evans 12 June 2014 APCCR 2013: Movember established National Prostate Cancer Registry WA QLD SA/NT PCHORU APCCR VIC NSW/ACT TAS

2 EOI released 31 May 2013 Announcement 22 nd November 2013 Contracts 31 March 2014 Movember A men s health charity that operates in 15 countries and raises >AU$110 million pa globally Prostate cancer is a Movember sstrategic priority In 2011, Movemberdeveloped a set of results statements after widespread stakeholder engagement Movemberhas facilitated a joint state & territory initiative to seek consensus on implementation of a national prostate cancer clinical registry

3 APCCR Objectives Monitor, benchmark and publicly report annually on the outcomes of prostate cancer treatment and care Provide risk-adjusted, evidence-based data to clinicians, hospitals and decision-makers on prostate cancer clinical practice that fosters and evaluates improved quality of treatment and care Foster research leading to improvement in care and survival; ideally enabling comparisons across countries Steps Develop governance structures including Steering Committee Develop national data setincluding QIs to measure achievement Develop operational model including communication plan

4 APCCR Committee membership Committee position Chair David Roder Funder Paul Villanti Elaine Farelly Quality of care expert Epidemiology Consumer Medical Administrator Pathology APCCR Clinician APCCR Custodian Prof David Currow A/Prof David Smith Dr Ian Roos Professor Paddy Phillips TBD Mark Frydenberg Prof John McNeil State representatives Andrew Brooks (NSW) Paolo De Ieso(NT) Peter Heathcote (QLD) Hany Elsalah(ACT) Jeremy Millar (VIC) Marketa Skala(TAS) Kim Moretti(SA) TBD (WA) Steering Committee Strategic development of the registry Monitor registry performance Review and endorse policies, standard operating procedures (SOPs) and terms of reference (TOR) of subcommittees Monitor data quality and compliance with ethical requirements Review and endorse (where appropriate) publications, reports and communications Monitor the budget Receive and act (when appropriate) on reports from subcommittees Registry Steering Committee Data Management Committee Working Groups (specialtyspecific or project-specific)

5 Governance Contracts Two contracts One between Movemberand Monash to operate the APCCR One between Monash and each jurisdiction to provide funds to jurisdictions to operate the state registry A Local Responsibility Agreement was drawn up by MU Solicitors Office

6 Hospital engagement Hospital Agreement Provides boundaries around responsibility of the hospital and the registry Hospital Access to medical records +/-Data collection and data extract EnsureHREC requirements are met Comply with data audit request Act on outliers identified by the registry in amanner not to jeopardise registry involvement by clinicians Registry Develop dataset specifications Provide a workable web-enabled registry Ensure the registry is appropriately governed Adhere to data access policy Provide reports relatingto quality indicators as outlined in the Protocol Clinician engagement Clinician Agreement provides understanding between the registry and the clinician Clinician Access to medical records Providing ctwhen not recorded in medical record Provide advicere TURP patients Registry Registry contacting your patients to invite participation Act in a courteousmanner towards consulting room staff Providinga report on quality indicators to clinicians

7 Recruitment Cancer Registry is notified detailing newly diagnosed prostate cancer case (Pt UR, Last Name, First Name, DOB) Hospital Medical record accessed to retrieve Address Explanatory Statement sent to eligible participants. Period of 2/52 elapses Participants "opt-off by telephoning 1800 no. Participants included in the Registry No further information collected Participants phoned at 12/12 Quality of life and treatment outcomes recorded Clinical data collected for each treatment from Medical Record IT arrangement

8 Ethics Vic PCR approved in 38 hospitals across Victoria APCCR-Monash University as lead HREC (although this might not work as planned) Health Regulation Act form in Queensland lodged (multi-site): under review NSW Health Department HREC (multi-site) lodged: under review Minimum Dataset Cancer Council Demographic information -name, DOB, UR number Pathology Results - Gleason score, TMN stage, date of biopsy Post surgery biopsy results Medical Records Patient s Medicare number, address, phone number, address, preferred language Next of Kin Details PSA levels including before subsequent treatments Clinical TMN staging Treatment details - Provider details - Radiotherapy - Surgery - Androgen Deprivation - Chemotherapy

9 Minimum dataset Prostate Cancer DSS Cancer Australia Andrology Australia Data items and definitions for the DSS for prostate cancer have been finalised Piloting of the data set at three different sites has finished Recommendations from the pilot will be made to the project working group and will be used to update the DSS Movember results statements Result Indicator 2014 Baseline I am satisfied I had access to well-coordinated advice and care with the information, care I made a well-informed treatment decision that I do not regret and treatment I I had access to the treatment of my choice received I am physically well I am mentally well I have fully recovered from any urinary dysfunction that I had I am satisfied with the level of sexual function that I have I have fully recovered from any bowel dysfunction that I had I am effectively managing any pain, fatigue, nausea and other symptoms that I experience I know what to expect during and after treatment, including when and where to seek help if specific issues arise I am able to live a meaningful life in the community of my choice I have accepted and am prepared for the possible consequences and possible outcomes of my cancer and my treatment(s) I am not depressed or anxious

10 Quality indicators Quality indicators developed by Steering Committee based on evidence-based guidelines National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology Prostate Cancer. National Collaborating Centre for Cancer. Prostate Cancer: diagnosis and treatment. Full guideline. London: National Institute for Clinical Excellence (NICE), 2008; NICE clinical guideline Australian Cancer Network Working Party on Management of Localised Prostate Cancer. Clinical practice guidelines: evidence-based information and recommendations for the management of localised prostate cancer. Canberra: Commonwealth of Australia, Thompson I, Thrasher JB, Aus G et al. Guideline for the management of clinically localized prostate cancer: 2007 update. Journal of Urology 2007; 177(6): Risk adjustment CAPRA-UCLA risk assessment tool Age, PSA at diagnosis, Gleason score (primary/secondary), Clinical stage, % positive cassettes D Amico risk assessment tool Clinical stage, PSA at diagnosis, Gleason score (total) Categorises men into High, Intermediate, Low risk of biochemical recurrence, metastases and prostate cancer death

11 Quality indicators All indicators can be assessed by patient risk group (low, int, high) patient age treatment received clinician hospital hospital type (private/public) ICS Follow up Yet to be determined at a national level In Victoria 12 and 24 months post diagnosis (confirmed biopsy result): Latest PSA results Confirmation of cancer treatments Quality of Life questionnaire SF12 Prostate Cancer specific complications

12 International PROMS working group Aims to develop consistent PROMS across UK, Ireland, US (participating sites) and Australia Coordinated by Australia Lit review of available tools undertaken Challenges Legal stuff Keeping momentum going in jurisdictions Staff appointment in other jurisdictions

13 Extra slides Reports

14 PSA at diagnosis-by notifying ICS WCMICSS SMICS NEMICS LMICS BSWRICS No assigned ICS Gippsland RICS PSA_Diag excludes outside values

15 Gleason at diagnosis ICS Gleason 6 Gleason = 7 Gleason 8-10 Metro 34% 44% 22% LMICS 57% 30% 13% BSWRICS 41% 36% 23% GRICS 41% 31% 29% TOTAL 38% 41% 22% P<0.001 Stage of disease at diagnosis No ics GRICS BSWRICS LMICS Very low/low int risk high risk very high NEMICS met SMICS WCMICS 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

16 Expected Outcomes Population based data Treatment complications, Quality of Life Inter-hospital variations public/private, metro/rural Data spine for further research Biomedical research, targeted clinical projects