GLOBAL PROSTATE CANCER OUTCOMES REGISTRY · healthcare, designed to engender “competition”...

P C O R A N D T H E D E L P H I P R O J E C T

GLOBAL PROSTATE CANCER OUTCOMES REGISTRY

• Provide an overview of the registry/timeline

• Describe the dataset development

• Discuss the Delphi consensus quality indicator project

• Outline the next steps

Objectives

P C O R - V I C P C O R - A N Z T R U E N T H G L O B A L P C O R

PCOR-Vic

Prostate Cancer Outcome Registry-Victoria (PCOR-VIC)• Established 2009 to test feasibility of clinician-led registry to monitor quality of care• 6 sites• Extended to two regional areas with additional funding• Currently captures 75% of cases in Victoria

PCOR-Vic

Hospital volumePositive marginsDocumented cTAS for low-risk diseaseHigh-risk disease having RxRisk adjusted CaP-specific survival and recurrencePRO-sexual, bowel and urinary bother and functionIn-hospital death from major complicationsTime from biopsy to treatment for men with pT2 disease

PCOR-Vic

PCOR-Vic

0%

20%

40%

60%

80%

100%

2009 2010 2011 2012 2013% o

f men

met

sel

ecte

d Q

Is

Year

Trend in Quality Care Improvement in Victoria

% positive surgical margins for organ-confined pathological T2disease

% of men with low-risk group who underwent prostate cancertreatment

% of men with high and locally advanced disease group who

0%

20%

40%

60%

80%

100%

2010(n=2428)

2011(n=2422)

2012(n=2496)

2013(n=2186)

2014(n=2147)

2015(n=2221)

To 1/7/2016(n=1033)

Low Intermediate High Very high/mets

Low risk

Intermediate

High risk

Very high risk/ metastatic

Temporal trend- stage at diagnosis

P<0.001

30% to 20%(2011) (2016)

6.1% to 10.5%(2011) (2016)

Low risk

V high/ mets

Temporal trend- Method of diagnosis

0%

20%

40%

60%

80%

100%

2010(n=2428)

2011(n=2422)

2012(n=2496)

2013(n=2186)

2014(n=2147)

2015(n=2221)

To 1/7/2016(n=1033)

TRUS

Transperineal

Clinical/otherTURP

P<0.001

Temporal trend-low risk disease management

0%

20%

40%

60%

80%

100%

2010(n=640)

2011(n=710)

2012(n=660)

2013(n=529)

2014(n=454)

2015 (n=468) To 1/7/2016(n=208)

Surg EBRT Brachy AS/WW

AS/WW

BRACHYEBRT

SURGERY

P<0.001

52% to 75%(2011) (2016)

AS/WW

Surg 35% to 20%(2011) (2016)

Temporal trend-intermediate risk disease management

0%

20%

40%

60%

80%

100%

2010(n=1021)

2011(n=1016)

2012(n=1085)

2013(n=980)

2014(n=961)

2015 (n=984)

To 1/7/2016 (n=463)

Surg AS/WW EBRT Surg+EBRT Brachy Other

AS/WW

EBRT

SURGERY

P<0.001

16% to 11%(2011) (2016)EBRT

13% to 18%(2011) (2016)

AS/WW

Temporal trendHigh risk disease management (n=3245)

0%

20%

40%

60%

80%

100%

2010(n=520)

2011(n=511)

2012(n=526)

2013(n=459)

2014(n=483)

2015 (n=467)

To 1/7/2016 (n=220)

Surg EBRT Surg+EBRT ADT AS/WW

SURGERY

EBRT

AS/WW

ADT

P<0.001

40% to 51%(2011) (2016)Surg

15% to 8%(2011) (2016)

ADT

Very high risk/ metastatic disease (n=1153)

0%

20%

40%

60%

80%

100%

2010(n=174)

2011(n=145)

2012(n=171)

2013(n=157)

2014(n=178)

2015 (n=215)

To 1/7/2016 (n=104)

Surg EBRT Chemo ADT Other

SURGERY

EBRT

CHEMO

ADT

OTHER

3% to 14%(2011) (2016)Chemo

PCOR-ANZ

Prostate Cancer Outcome Registry-Aust and NZ

• Progressively rolled out• National indicators developed through

Delphi panel

Data• Cancer registries

• Mandatory hospital and pathology notifications• Demographic details• Diagnosing clinician/hospital

• Hospital databases• Procedures (electronically where possible)• Pathology (PSA levels)/ histopathology

• Consulting rooms• Treatment• PSA level

• Patients• Treatment confirmation• PROMs• Comorbidities (no ICD complications)

PCOR-ANZ

TrueNTH Global Prostate Cancer Registry

Prostate Cancer Outcome Registry-Global registry

Largest international prostate cancer cohort study to date.

It provides the ability to make a large contribution to our knowledge of how prostate cancer can best be managed to provide the best possible outcomes for men, their partners and their families.


2012: Movember funded first registry effort- PCOR-ANZ

22013: Movember funded IPCOR-

Irish Prostate Cancer initiative2013: ICHOM face-to-face

meeting Harvard Uni, Boston 2013: ICHOM localised prostate cancer minimum dataset released

2015: (July) PCO-CRV project EOI released for global coordination centre

2016: (May) PCO-CRV project protocol v1 for comment

2017: (July) PCO-CRV project data managers meeting

2017: (Jan) PCO-CRV project commencement date

2015: (Dec) PCO-CRV kick off meeting in LA. PCC/DCC led

2016: (Dec) PCO-CRV protocol released for HREC authorisation






2015: (July) PCO-CRV project EOI released

2016: (May) PCO-CRV project protocol v1 for comment



2015: (Dec) PCO-CRV kick off meeting in LA. PCC/DCC led



• Develop consensus standardised minimum dataset

• Facilitate comparative effectiveness research and foster value-based healthcare, designed to engender “competition” between high-quality entities to achieve better outcomes for patients and simultaneously optimize cost of this care

• .

• Facilitate international collaborations to combine data, allow comparisons, insight into high value and high quality features of care, and action to adopt these more widely

• Mechanism to do this was not described

Goals

ICHOM

Study schema

• Develop consensus standardised minimum dataset

• Facilitate comparative effectiveness research and foster value-based healthcare, designed to engender “competition” between high-quality entities to achieve better outcomes for patients and simultaneously optimize cost of this care

• .

• Facilitate international collaborations to combine data, allow comparisons, insight into high value and high quality features of care, and action to adopt these more widely

• Mechanism to do this was not described

Goals

ICHOM

The theory of “positive deviance”

Identify organisations consistently

achieving high performance in area of interest

Study this organisation using qualitative methods

to generate hypotheses about

why this is occurring

Test hypotheses in larger

representative sample

Disseminate evidence about

newly characterised best practice

Timeline





2015: (July) PCO-CRV project EOI released

2016: (May) PCO-CRV project protocol with proposed dataset



2015: (Dec) PCO-CRV kick off meeting in LA. PCC/DCC


Participating Sites contribute to data governance, dataset development and evolution, analysis, dissemination of identified “best practice”, and monitoring change

Data Coordination Centre: • hosts the clinical quality registry providing high security, highly reliable, flexible

controlled storage and data manipulation services • Coordinates activities of the Participating Sites.• Conducting principal data analyses under the guidance of the project Steering

Committee

EOI released mid-2015 for Participating Sites and Data Coordination Centre

Task 1: Identify participating sites and coordination centre

DCC and PCC appointed

DCC

PCC

Data discovery project-DCC

Task 2: is ICHOM data collection feasible?


Not straight away…….

…. Concept of Tier 1 (T1) and Tier 2 (T2) introduced

…. By the PCO-CRV Executive Committee

G-PCOR Governance structure

Global Prostate Cancer

Outcomes Steering Committee

Joint DCC and PCC* (Monash and UCLA)

Leadership team

Executive Committee

PCO-CRV Project

Steering Committee

Australia

Austria

Canada

Germany

Ireland

Italy

Spain

United Kingdom

USA

Switzerland

Czech Republic

Netherlands

New Zealand

* DCC=Global Data Coordination Centre PCC= Global Project coordination Centre

G-PCOR study sites

G-PCOR governance

DCC“we are all about the data and the

database where it is stored”

PCC“we are all about the project

management”

We are your contact for:• Any queries about data export,

transfer and load

• Any issues with the upload

• Any issues with data formatting

• Any technical issues relating to the reports

• Getting access to your research data through Safe Haven

We are your contact for:• Any issues with recruitment

• Any requests to do with research project requests

• Discussion on quality improvement activities

• Distribution and shared of your learnings

• Anything to do with meetings

M O D I F I E D D E L P H I P R O C E S S TO D E V E L O P G L O B A L Q U A L I T Y I N D I C ATO R S

Modified Delphi panel

Select a reasonable number of indicators that can measure thequality of prostate cancer management worldwide.

Refine and reduce the number of quality-of-care indicators thatwere derived from the clinical guideline literature review.

Disclaimer: We acknowledge that there are many important indicators that have not been considered in this panel discussion. Many indicators had to be excluded after the literature review due to the limitations of the PCOR-CRV dataset.

A process for determining consensus on something…It is iterative (one round builds on the next) 3 roundsBegins with an open ended questionnaire to solicit information about a subject Often a large group participate

**The modified Delphi technique is similar to the full Delphi in terms of procedure (i.e., a series of rounds with selected experts) and intent (i.e., to predict future events and to arrive at consensus).

Modified Delphi

What is a Delphi panel?

Delphi Not part of the original Delphi processIt is an iterative process with 3 rounds including a face-to-face meetingBegins with a set of carefully selected items for discussionOnly 9-14 people participateAllows for expert interaction to provide clarification on matters and to present arguments in order to justify their point of viewStudies show it is can be superior to Delphi 3,4

The Delphi panel

1. Literature review2. Feasibility with existing data3. Online survey 14. Analysis of online survey5. Face to face panel meeting6. Online survey 2

The Delphi process

Guidelines

Ref Pub FULL REFERENCE

Alberta HS 2015 Alberta Health Services – Clinical Practice Guidelines for Prostate Cancer

Andrology AUS

2010Andrology Australia - Clinical Practice Guidelines for the Management of Locally Advanced and Metastatic Cancer (Australia)

AUA 2013 American Urological Association - Radiotherapy after Prostatectomy (United States of America)

AUA Cyro-surgery

2008American Urological Association – Best Practice Policy Statement on Cyrosurgery for the Treatment of Localised Prostate Cancer

BAUS 2013 British Association of Urological Surgeons - Section of Oncology (United Kingdom)

Cancer Care Ontario

2014Cancer Care Ontario 2014 – Active Surveillance for the Management of Localized Prostate Cancer (Canada)

Cancer Council

2016 Cancer Council - Prostate Cancer Clinical Guidelines (Australia)

EAU ED 2015 European Association of Urology - Guidelines on Male Sexual Dysfunction

EAU 2017 European Association of Urology - Guidelines on Prostate Cancer (Netherlands)

Guidelines

Ref Year Guideline/ Reference

EAU 2017 European Association of Urology - Guidelines on Prostate Cancer (Netherlands)

ESMO 2015European Society for Medical Oncology - Cancer of the Prostate: ESMO Clinical Practice Guidelines for Diagnosis, Treatment and Follow-Up (Switzerland)

KCE 2014Belgian Health Care Knowledge Centre - National Practice Guideline on the Treatment of Localized Prostate Cancer (Belgium)

NCI 2016 National Cancer Institute - Prostate Cancer Treatment (United States of America)

NCCN 2017National Comprehensive Cancer Network - Clinical Practice Guidelines in Oncology: Prostate Cancer (United States of America)

NCCP 2015 National Cancer Control Programme - Diagnosis, Staging and Treatment of Patients with Prostate Cancer (Ireland)

NCCS 2013 National Cancer Centre Singapore - Guidelines on Management of Prostate Cancer (Singapore)

NICE 2016 National Institute for Health and Care Excellence - Prostate Cancer: Diagnosis and Management (United Kingdom)

NZ PCT 2013 Prostate Cancer Taskforce (New Zealand)

VIC-OCP 2015 Optimal Care Pathway for Men with Prostate Cancer (Victoria, Australia)

ArticlesRef (et al) Year FULL REFERENCE

Ahmadi 2014 Androgen Deprivation Therapy for Prostate Cancer Patient Relat Outcome Meas., 5:63-70

Ahmed 2014Comparison of biochemical failure rates between permanent prostate brachytherapy and radical retropubic prostatectomy as a function of posttherapy PSA nadir plus ‘X’, Radiation Oncology, 9:171

Chin 2015Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation or Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical trial, European Urology, 70:447-455

Loeb 2013 Systematic review of complications of prostate biopsy Eur.Urol., 64 (6), pp. 876–892

Nag 2016 Development of Indicators to Assess Quality of Care for Prostate Cancer. Eur Urol Focus

Punnen 2015Long-Term Health-Related Quality of Life after Primary Treatment for Localized Prostate Cancer: Results from the CaPSURERegistry, European Urology, 68(4):600-608

Ramsay 2015Ablative therapy for People with Localized Prostate Cancer: A Systematic Review and Economic Evaluation - Chapter 4: The Comparative Effectiveness of Cryotherapy, Health Technology Assessment, No. 19.49

Resnick 2013 Long-Term Functional Outcomes after Treatment for Localized Prostate Cancer, N Engl J Med Jan 31;368(5):436-45

Robinson 2009A Randomized Trial of External Beam Radiotherapy versus Cryoblation in Patients with Localized Prostate Cancer Quality of Life Outcomes, Cancer, 115 (20)

Wegner 2014 Laser Ablation as Focal Therapy for Prostate Cancer, Curr Opin Uro, 24(3):236-240

Yap 2016The Effects of Focal Therapy for Prostate Cancer on Sexual Function: A Combined Analysis of Three Prospective Trials, European Urology, 69(5):844-851


The Delphi process

Which indicators to include

1. Those where there is a high level of agreement among the panel that it is a good indicator

• = Median score

2. Those where there is little disagreement (dispersion) among the panel that it is a good indicator

• = Disagreement Index (DI)

The Delphi process

Median score 7-9 and no disagreement (DI<1)

Any disagreement regardless of median score (DI≥1)

Median score 1-6 and no disagreement

Panellist ID #1 #2 #3 #4 #5 #6 #7 #8 #9 #10 #11

Ratinggiven (from 1-9)

1 2 3 5 5 5 5 5 7 8 9

Median: 5Lower IPR: 10th percentile = 2 Upper IPR: 90th percentile = 8IPR: 8 - 2 = 6IPRCP: (2+8) / 2 = 5Asymmetry index: 5 - 5 = 0IPRAS: 2.35 + (1.5 x 0) = 2.35Disagreement Index (DI): 6 / 2.35 = 2.55

The Delphi process

Panellist ID #11 #12 #13 #14 #15 #16 #17 #18 #19 #20 #21


1 1 7 8 9 7 8 9 7 8 9


The Delphi process

Panellist ID #11 #12 #13 #14 #15 #16 #17 #18 #19 #20 #21


3 4 4 5 5 5 5 5 6 6 7


The Delphi process

1. Literature review2. Feasibility with existing data3. Online survey 14. Analysis of online survey5. Face to face meeting6. Online survey 2

The Delphi process

This means that the Median panel score (scale 1-9) was 9 and the Disagreement Index was 0.37

Results from round 1

Arghhh!!!!!


The Delphi process

Vancouver

Rated importance AND feasibility (scale 1-9)

Face to face meeting

The Delphi process

The Delphi process

Quality indicators

# Indicator

DiagInitial investigations of a male with PCa include measurement of

PSA level

DiagT category/stage (DRE or MRI) is documented prior to treatment for

localised PCa

DiagIn men with high risk localised PCa, nodal staging using CT, MRI or

PET/CT is performed

DiagIn men with high risk localised PCa, perform metastatic screening

using a CT/MRI and a bone scan

DiagIn men with intermediate risk localised PCa, a bone scan is not

conducted

# Indicator

Diag In men with low risk PCa, a bone scan is not conducted

Diag In men with low risk localised PCa, a CT is not conducted

Primary Rx Men with high risk localised PCa receive active treatment

Primary Rx Men with high risk localised PCa do not receive AS

Primary Rx PSA is taken within 3 months post RP

Primary Rx For pN0 men undergoing RP, adjuvant ADT is not given

Quality indicators

# Indicator

Primary Rx

Men with localised PCa who are undergoing radical EBRT receive a

minimum dose of 74Gy at standard fractionation or the equivalent of hypo-

fractionation to the prostate

Primary Rx PSA level is taken within 12 months post RT

Primary Rx Men with high risk localised PCa do not receive brachytherapy alone

Primary Rx PSA level is taken within 6 months post focal therapy

Salvage RxMen who have salvage RT post RP receive a salvage RT dose ≥66 Gy at

standard fractionation or the equivalent hypo-fractionated dose

OutcomeEPIC-26 is completed 12 months post diagnosis for men on AS and 12

months post active treatment for men receiving active treatment

Quality indicators

# Indicator

Outcome EPIC-26 is completed at baseline

OutcomeEORTC QLQ-PR25 is completed 12 months post diagnosis for men on AS

and 12 months post active treatment for men receiving active treatment

Outcome

Utilisation of Sexual Medication/Devices is completed 12 months post

diagnosis for men on AS and 12 months post active treatment for men

receiving active treatment

Outcome EORTC QLQ-PR25 is completed at baseline

Outcome Utilisation of Sexual Medication/Devices is completed at baseline

Outcome Death within 30 days of RP

Quality indicators

# Indicator

Outcome Men with low risk PCa who had a positive margin post-RP

Outcome Men with pT2 disease who had a positive margin post-RP

Outcome Men with pT3 disease who had a positive margin post-RP

Outcome Biochemical recurrence at 1 year post RP

OutcomeRadical or systemic treatment at 18 months post focal-gland or

whole-gland ablation therapy

Quality indicators

1. Publish findings2. Build the reports3. Test and refine the indicators 4. Develop reports 5. Distribute reports to LDCs 6. LDCs will distribute reports to participating sites

Next steps…

Building the reports

PCO-CRV Monash/Movember teamFanny SampurnoJeremy MillarJia ZhengEllie JamesAshwini KannonHarvey Goh

Acknowledgement

PCO-CRV UCLA teamSarah ConnorMark LitwinEmily Pearman

Delphi panel

TrueNTH Steering Committee

Contributors to the registry

PCOR-Vic and ANZ teamMelanie EvansGabriella TikellisData collector and follow up team

Funding bodies

Acknowledgement

Endorsing groups

Thank youPCOR-Vic Steering Committee

Contributing clinicians and hospitals

Participating men

PCOR-Vic data collectors and researchers

Questions?

GLOBAL PROSTATE CANCER OUTCOMES REGISTRY · healthcare, designed to engender “competition”...

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