data collection reference guide

LOCALIZED
PROSTATE CANCER
DATA COLLECTION
REFERENCE GUIDE
Revised: May 7, 2014
Measuring
results
that matter
Level of urinary
incontinence
Localized
Prostate Cancer
Contents
1.1
Introducing ICHOM and the reference guide
1.2
2
Working Group Members for Localized Prostate Cancer3
2.1
What are the conditions and treatment approaches covered for Localized Prostate Cancer?
4
3.1
How should the outcomes and risk factors be collected?
5
4.1
What are the Localized Prostate Cancer outcomes and risk factors?
6
5.1
Example follow-up schemes
8
6.1
Definitions: outcomes and risk factors
9
6.1.1
Outcomes
9
6.1.2
Risk Factors
11
7.1
ICHOM Contact Information
14
8.1
Revisions Made to Localized Prostate Cancer Data Collection Reference Guide
15
© 2013 ICHOM. All rights reserved. When using this set of outcomes, or quoting therefrom, in any way, we solely require that you always
make a reference to ICHOM as the source so that this organization can continue its work to define more standard outcome sets.
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1.1
Introducing ICHOM and the reference guide
The International Consortium for Health Outcomes Measurement (ICHOM) brings together patient
representatives, clinician leaders, and registry leaders from all over the world to develop ICHOM Standard Sets:
minimum sets of outcomes and risk factors we recommend all providers track.
Our Standard Sets focus on the results that matter most to patients and provide an internationally-agreed upon
method for measuring each of these outcomes. We do this because we believe that standardized outcomes
measurement will open up new possibilities to compare performance globally, learn from each other, and rapidly
improve the care we provide our patients.
Our Standard Sets also include initial conditions and risk factors to enable meaningful case-mix adjustment
globally, ensuring that comparisons of outcomes will take into account the differences in patient populations
across providers.
This reference guide describes the ICHOM Standard Set for Localized Prostate Cancer and contains the
following:
• The individuals who developed this Standard Set
• The conditions and treatment approaches covered
• The ways that the outcomes and risk factors can be collected
• A summary of the outcomes and risk factors in the Standard Set, along with the recommended collection
time points, patient population, and reporting format
• The definitions of each outcome and risk factor
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1.2
Working Group Members for Localized Prostate Cancer
The following individuals have developed the ICHOM Standard Set for Localized Prostate Cancer in partnership
with ICHOM, under the leadership of Professor Hartwig Huland, Chairman of the Martini Klinik in Hamburg,
Germany.
Australia
Kim Moretti | Urologist, South Australian Prostate Cancer Clinical Outcomes Collaborative (SA-PCCOC); The
Queen Elizabeth Hospital
Mark Frydenberg | Urologist, Prostate Cancer Registry of Victoria; Monash University
Ian Roos | Patient Representative, Melbourne Graduate School of Education, University of Melbourne; Cancer
Action Victoria
Germany
Hartwig Huland | ICHOM Working Group Leader; Urologist, Martini-Klinik at University Medical Center HamburgEppendorf
Markus Graefen | Urologist, Martini-Klinik at University Medical Center Hamburg-Eppendorf
Gunter Feick | Patient Representative, Bundesverband Prostatakrebs Selbsthilfe (BPS); Europa UOMO
Michael Froehner | Urologist, University Hospital Carl Gustav Carus, Technical University of Dresden
Thomas Weigel | Radiation Oncologist, University Hospital Ulm
Ireland
Frank Sullivan | Radiation Oncologist, Galway University Hospital; Prostate Cancer Institute at NUI Galway
John Fitzpatrick | Urologist, Irish Cancer Society
Israel
Jacob Ramon | Urologist, Sheba Medical Center
Italy
Alberto Briganti | Urologist, Vita-Salute San Raffaele University Hospital
Netherlands
Chris Bangma | Urologist, Erasmus Medical Center
Sweden
Anna Bill-Axelson | Urologist, Uppsala University Hospital; National Prostate Cancer Register (NPCR) of Sweden
United Kingdom
Adam Glaser | Outcomes Researcher; Pediatric Oncologist, Leeds Teaching Hospitals NHS Trust
James Catto | Urologist, Academic Urology Unit and Academic Unit of Molecular Oncology, CR-UK/YCR Sheffield
Cancer Research Centre
United States
Steven Jay Frank | Radiation Oncologist, MD Anderson Cancer Center
David Swanson | Urologist, MD Anderson Cancer Center
Michael Blute | Urologist, Massachusetts General Hospital
Howard Sandler | Radiation Oncologist, Cedars-Sinai Medical Center
Nancy Mendenhall | Radiation Oncologist, University of Florida Proton Therapy Institute
Daniel Hamstra | Radiation Oncologist, University of Michigan Health System
Ronald Chen | Radiation Oncologist, University of North Carolina Lineberger Comprehensive Cancer Center
Neil Martin | ICHOM Fellow; Radiation Oncologist, Dana-Farber Cancer Institute; Brigham and Women’s Hospital
Anthony D’Amico | Radiation Oncologist, Dana-Farber Cancer Institute; Brigham and Women’s Hospital
Adam Kibel | Urologist, Dana-Farber Cancer Institute; Brigham and Women’s Hospital
Ashutosh Tewari | Urologist, Icahn School of Medicine at Mount Sinai Hospital
Andrew Vickers | Outcomes Researcher; Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center
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2.1
What are the conditions and treatment approaches covered for Localized Prostate Cancer?
For Localized Prostate Cancer, the following condition and treatment approaches (or interventions) are covered
by our Standard Set of outcomes and risk factors.
Table 1: Conditions and Treatment Approaches Covered.
Conditions Covered
Treatment Approaches
Localized prostate cancer
Active surveillance
Watchful waiting
Radical prostatectomy*
External beam radiation therapy*
Brachytherapy*
Androgen Deprivation Therapy (ADT)*
Focal therapy*
Other*
*These should also be collected as salvage treatments where necessary.
When documenting the treatment plan, record using the categorization below:
At 6 months: Record primary treatment.
• Watchful waiting (clinical observation)
• Active surveillance (with intent of delayed curative treatment)
• Surgery (specify nerve-sparing or non-nerve-sparing)
• External beam radiation as primary treatment or adjuvant following surgery (specify total radiation dose and
dose per fraction)
• Brachytherapy (specify high dose rate or low dose rate)
• Androgen Deprivation Therapy (ADT)
• Focal therapy
• Other
Was ADT part of the primary treatment of this patient? Yes/No
Annually: Record initiation of any salvage therapies and date according to the convention above.
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3.1
How should the outcomes and risk factors be collected?
When using the ICHOM Standard Sets for outcomes and risk factors, there is normally a number of ways that
the data can be collected. The approaches currently used typically vary between countries due to different
infrastructures, different resource constraints, and different cultures. Table 2 shows the data collection terms
used in this guide along with specific examples. Towards the end of this guide the data definitions provide guidance on which mechanisms we recommend
for collecting different data points. For each outcome and risk factor, the method of collection used should
be recorded. Response rates for each outcome should also be recorded to understand what proportion of the
population each measure is capturing.
Table 2: Data collection options.
Data collection category
Examples
Administrative data
Claims data, death registry
Patient-reported data
Patient-reported outcomes (PROMs)
(e.g. Expanded Prostate Cancer Index Composite:
EPIC-26*)
Clinical data
Data abstraction, physician report
* To view a copy of the EPIC-26 and the scoring instructions, please click here: http://www.ichom.org/files/
proms/EPIC-26_and_Scoring_Instructions.pdf
More information on the EPIC-26 can be accessed by visiting their website at: http://www.med.umich.edu/
urology/research/epic.html
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4.1
What are the Localized Prostate Cancer outcomes and risk factors?
The following table highlights the Localized Prostate Cancer outcomes, which are accompanied by the
corresponding patient population and time points at which to measure.
Table 3: Localized Prostate Cancer Outcomes.
Patient population
Outcomes
Timeline
Acute complications of treatment
RP patients
Major surgical
complications
Radiation (or other)
patients
Major radiation
complications
Reporting format
Occurring within 6 months Clinical or patientafter treatment
reported
Survival and disease control
All patients
Overall survival
Cause-specific survival
Metastasis
Biochemical recurrence
Administrative
For life
Clinical or patientreported
Patient-reported health status
All patients
Urinary incontinence
Urinary frequency/
urgency/irritation
Bowel irritation
Sexual dysfunction
Before treatment
6 months after treatment
Annually up to 10 years
Patient-reported
Patients who received ADT Vitality
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Table 4: Localized Prostate Cancer Risk Factors.
Patient population
Risk factors
Patient Factors
Timeline
Administrative or patientreported
Age
All patients
Comorbidities
Baseline patient-reported health
status
Reporting format
Before treatment
Patient-reported
Baseline Tumor Factors
All patients
Date of diagnosis
Clinical or administrative
PSA level
AJCC (American Joint Committee
Before treatment
on Cancer) 7th Clinical Stage
Number of biopsy cores involved
Greatest percentage involvement
Gleason score
Clinical
Pathological Information
RP patients
DATA COLLECTION REFERENCE GUIDE
AJCC 7th Pathologic Stage
Margin status
Gleason score
After surgery
Clinical
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5.1
Example follow-up schemes
The following timelines are examples to illustrate when particular risk factors and outcomes should be collected
for specific patients.
Example 1: Patient diagnosed with localized prostate cancer, treated with radical prostatectomy
Baseline
Surgery
(post-diagnosis,
pre-treatment)
6 months
post-surgery
1 year
2 years
3 years
Example 2: Patient diagnosed with localized prostate cancer,
chooses active surveillance then initiates radiation at later point
Baseline
(post-diagnosis,
pre-treatment)
6 months
post-diagnosis
1 year
Initiates
Radiation
6 months
post-radiation
1 year
post-radiation
2 years
post-radiation
Example 3: Patient diagnosed with localized prostate cancer,
treated with radical prostatectomy and adjuvant radiation
Baseline
Surgery Radiation
(post-diagnosis,
pre-treatment)
6 months
post-radiation
1 year
post-radiation
2 years
3 years
Example 4: Patient diagnosed with localized prostate cancer,
treated with radical prostatectomy then initiates salvage therapy at later point
Baseline
Surgery
(post-diagnosis,
pre-treatment)
6 months
post-surgery
1 year
2 years
Initiates
Salvage
Therapy
6 months
post-salvage
therapy
3 years
Risk Factors
Pathologic risk factors
PROMs
Acute complications of treatment
Survival and disease control outcomes
Tracked ongoing annually for life
Tracked annually for 10 years
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6.1
Definitions: outcomes and risk factors
6.1.1 Outcomes
Acute complications of treatment
Major surgical complications
Data Collection Options:
Clinical or patient-reported data
Definition:
Indicate whether patient experienced a Clavien grade III-V complication within
first 6 months following treatment
Response Options:
Yes/No; record maximal grade
Inclusion/Exclusion Criteria:
Include: patients who undergo surgical interventions
Major radiation complications
Data Collection Options:
Clinical or patient-reported data
Definition:
Indicate whether patient experienced a CTCAE (Common Terminology Criteria
for Adverse Events) v. 4.0 grade III-V complication within first 6 months
following treatment
Response Options:
Yes/No; record maximal grade and domain
Inclusion/Exclusion Criteria:
Include: patients who undergo radiation therapy
Survival and disease control
Overall survival
Data Collection Options:
Administrative data
Definition:
Indicate whether patient has died
Response Options:
Yes/No; If yes, provide date of death (DD/MM/YYYY)
Inclusion/Exclusion Criteria:
Not applicable
Cause-specific survival
Data Collection Options:
Administrative data. Additional data based on physician review according to
local custom can be tracked/reported in addition to death certificate cause of
death, but should be done so as a separate data point
Definition:
If applicable, indicate if death is attributable to prostate cancer
Response Options:
Yes/No
Inclusion/Exclusion Criteria:
Not applicable
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Metastasis
Data Collection Options:
Clinical or patient-reported data
Definition:
Indicate whether patient was diagnosed with metastatic disease
Response Options:
Yes/No; If yes, record date of diagnosis (DD/MM/YYYY)
Inclusion/Exclusion Criteria:
Not applicable
Biochemical recurrence
Data Collection Options:
Clinical or patient-reported data
Definition:
Indicate whether patient has biochemical recurrence, which is defined as:
• Per AUA definition, PSA>0.2 ng/mL after surgery, with a second
confirmatory level of >0.2 ng/ml
• Phoenix criteria (nadir + 2 ng/mL) after radiation
Recommended that PSA is measured at least annually and providers record all
PSA values and dates to accommodate future changes to definitions
Response Options:
Yes/No
Inclusion/Exclusion Criteria:
Not applicable
Patient-reported health status
Urinary Incontinence, Urinary frequency/urgency/irritation, Bowel irritation, and Sexual dysfunction
Data Collection Options:
Patient-reported data
Definition:
Recommend using EPIC-26 domain responses and summary scores, along with
three additional sexual function questions: EORTC QLQ-PR 25 #50, Utilization
of Sexual Medications/Devices #2-3
Response Options:
To view a copy of the EPIC-26 and the scoring instructions, please click here:
http://www.ichom.org/files/proms/EPIC-26_and_Scoring_Instructions.pdf
More information on the EPIC-26 can be accessed by visiting their website at:
http://www.med.umich.edu/urology/research/epic.html
Additional sexual function questions:
EORTC QLQ-PR 25 #50: During the last 4 weeks, to what extent were you
interested in sex? (Not at all, A little, Quite a bit, Very much)
Utilization of Sexual Medications/Devices #2: Have you used any medications
or devices to aid or improve erections? (Yes/No)
Utilization of Sexual Medications/Devices #3: For each of the following
medicines or devices, please indicate whether or not you have tried it or
currently use it to improve your erections (Have not tried it, Tried it but was not
helpful, It helped but I am not using it now, It helped and I use it sometimes, It
helped and I use it always):
• Viagra or other pill (name pill if not Viagra)
• Muse (intra-urethral alprostadil suppository)
• Penile injection therapy (such as caverject)
• Vacuum erection device (such as erect-aid)
• Other (name medication/device if not listed)
Inclusion/Exclusion Criteria:
Exclude: Patients who have initiated salvage treatment
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Vitality (ADT-related outcomes)
Data Collection Options:
Patient-reported data
Definition:
Recommend using EPIC-26 domain responses and summary score
Response Options:
To view a copy of the EPIC-26 and the scoring instructions, please click here:
http://www.ichom.org/files/proms/EPIC-26_and_Scoring_Instructions.pdf
More information on the EPIC-26 can be accessed by visiting their website at:
http://www.med.umich.edu/urology/research/epic.html
Inclusion/Exclusion Criteria:
Include: Patients who received ADT as part of their initial management
Exclude: Patients who have initiated salvage treatment
6.1.2 Risk Factors
Demographic factors
Age
Data Collection Options:
Administrative or patient-reported data
Definition:
Age recorded as the date of birth (DOB)
Response Options:
Date of birth (DD/MM/YYYY)
Inclusion/Exclusion Criteria:
Not applicable
Comorbidities
Data Collection Options:
Patient-reported data
Definition:
Have you been told by a doctor that you have any of the following?
•
•
•
•
•
•
Response Options:
•
•
•
•
•
•
•
Inclusion/Exclusion Criteria:
DATA COLLECTION REFERENCE GUIDE
Heart disease (e.g. angina, heart attack, or heart failure)
High blood pressure
Leg pain when walking due to poor circulation
Lung disease (e.g. asthma, chronic bronchitis, or emphysema)
Diabetes
Kidney disease
Liver disease
Problems caused by stroke
Disease of the nervous system (e.g. Parkinson’s disease or multiple
sclerosis)
Other cancer (within the last 5 years)
Depression
Arthritis
HIV/AIDS
Not applicable
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Baseline patient-reported health status
Data Collection Options:
Patient-reported data
Definition:
Recommend using EPIC-26 domain responses and summary scores at baseline,
along with three additional sexual function questions: EORTC QLQ-PR 25 #50,
Utilization of Sexual Medications/Devices #2-3
Response Options:
To view a copy of the EPIC-26 and the scoring instructions, please click here:
http://www.ichom.org/files/proms/EPIC-26_and_Scoring_Instructions.pdf
More information on the EPIC-26 can be accessed by visiting their website at:
http://www.med.umich.edu/urology/research/epic.html
Additional sexual function questions:
EORTC QLQ-PR 25 #50: During the last 4 weeks, to what extent were you
interested in sex? (Not at all, A little, Quite a bit, Very much)
Utilization of Sexual Medications/Devices #2: Have you used any medications
or devices to aid or improve erections? (Yes/No)
Utilization of Sexual Medications/Devices #3: For each of the following
medicines or devices, please indicate whether or not you have tried it or
currently use it to improve your erections (Have not tried it, Tried it but was not
helpful, It helped but I am not using it now, It helped and I use it sometimes, It
helped and I use it always):
• Viagra or other pill (name pill if not Viagra)
• Muse (intra-urethral alprostadil suppository)
• Penile injection therapy (such as caverject)
• Vacuum erection device (such as erect-aid)
• Other (name medication/device if not listed)
Inclusion/Exclusion Criteria:
Not applicable
Baseline tumor factors
Date of diagnosis
Data Collection Options:
Clinical or administrative data
Definition:
Record initial date of histological diagnosis
Response Options:
DD/MM/YYYY
Inclusion/Exclusion Criteria:
Not applicable
PSA level
Data Collection Options:
Clinical data
Definition:
Indicate most recent PSA value before histological diagnosis
Response Options:
PSA in nm/mL
Inclusion/Exclusion Criteria:
Not applicable
AJCC 7 Clinical Stage
th
Data Collection Options:
Clinical data
Definition:
Indicate the clinical stage (per AJCC 7th )
Response Options:
cT-category, cN-category, and cM-category
Inclusion/Exclusion Criteria:
Not applicable
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Number of biopsy cores involved
Data Collection Options:
Clinical data
Definition:
Indicate the results of the patient’s biopsy
Response Options:
Number of cores taken; number of cores positive
Inclusion/Exclusion Criteria:
Not applicable
Greatest percentage involvement
Data Collection Options:
Clinical data
Definition:
Indicate the greatest percentage involvement from biopsy results
Response Options:
Greatest percentage involvement of any core
Inclusion/Exclusion Criteria:
Not applicable
Gleason score
Data Collection Options:
Clinical data
Definition:
Indicate the Gleason score
Response Options:
Highest primary and highest secondary
Inclusion/Exclusion Criteria:
Not applicable
Pathologic information
AJCC 7th Pathologic Stage
Data Collection Options:
Clinical data
Definition:
Indicate pathologic Stage (per AJCC 7th )
Response Options:
pT-category, pN-category
Inclusion/Exclusion Criteria:
Include: patients who undergo surgical interventions
Margin status
Data Collection Options:
Clinical data
Definition:
Indicate margin status
Response Options:
Negative/Positive (if positive, focal/multi-focal)
Inclusion/Exclusion Criteria:
Include: patients who undergo surgical interventions
Gleason score
Data Collection Options:
Clinical data
Definition:
Indicate the Gleason score
Response Options:
Highest primary and highest secondary
Inclusion/Exclusion Criteria:
Include: patients who undergo surgical interventions
DATA COLLECTION REFERENCE GUIDE
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7.1
ICHOM Contact Information
Website
http://www.ichom.org
Email Address
[email protected]
Business Address
14 Arrow Street, Suite #11
Cambridge, MA 02138
DATA COLLECTION REFERENCE GUIDE
LOCALIZED PROSTATE CANCER | 14
8.1
Revisions Made to the Localized Prostate Cancer Data Collection Reference Guide
Date of content change
Location within document
Content change
December 20, 2013
N/A
Deletion of appendix and sample forms
December 20, 2013
5.1 Example follow-up schemes Added section “Example follow-up schemes”
December 20, 2013
1.2 Working Group Members
December 20, 2013
7.1 ICHOM Contact Information Added section “ICHOM Contact Information”
December 20, 2013
1.1 Introduction to ICHOM
Modified introduction text
December 20, 2013
6.1 Definitions: outcomes and
risk factors
Inserted PROM URLs for patient-reported health
status (6.1.1)
December 20, 2013
6.1 Definitions: outcomes and
risk factors
Inserted PROM URLs for baseline patientreported functional status (6.1.2)
December 20, 2013
3.1 How should the outcomes
and risk factors be collected?
Added reference for EPIC-26 and link to copy of
PROM
December 20, 2013
3.1 How should the outcomes
and risk factors be collected?
Added sentence “Response rates...”
January 8, 2014
6.1 Definitions: outcomes and
risk factors
Modified title of definition to “Major surgical
complications” from “Major Acute Complications
of Surgery” (6.1.1)
January 8, 2014
6.1 Definitions: outcomes and
risk factors
Modified title of definition to “Major radiation
complications” from “Major Acute Complications
of Radiation” (6.1.1)
February 26, 2014
6.1 Definitions: outcomes and
risk factors
Included additional sexual function questions to
patient-reported health status definitions and
response options (6.1.1 and 6.1.2)
February 26, 2014
2.1 What are the conditions and
Modified treatment approaches to account for
treatment approaches covered
salvage therapy
for Localized Prostate Cancer?
February 26, 2014
5.1 Example follow-up schemes
March 5, 2014
4.1 What are the Localized
Prostate Cancer outcomes and
risk factors?
Added section “Working Group Members”
Added example follow-up scheme for patients
who undergo salvage therapy (Example 4)
Deleted asterisk and accompanying text from 6
months after treatment:
(*If patient initiates a new or additional treatment (such
as moving from active surveillance to surgery, or initiating
adjuvant radiation, the time points for measurement should
reset based on the most recent treatment.)
March 5, 2014
5.1 Example follow-up schemes
Added example follow-up scheme for patients
who undergo surgical treatment after active
surveillance (Example 5)
March 18, 2014
4.1 What are the Localized
Prostate Cancer outcomes and
risk factors?
Added “(or other)” to Radiation patient
population (Table 3)
DATA COLLECTION REFERENCE GUIDE
LOCALIZED PROSTATE CANCER | 15
Date of content change
Location within document
Content change
March 18, 2014
3.1 How should the outcomes
and risk factors be collected?
4.1 What are the Localized
Prostate Cancer outcomes and
risk factors?
6.1 Definitions: outcomes and
risk factors
Expanded acronyms for clarity:
3.1 EPIC-26
4.1 AJCC (Table 4)
6.1 CTCAE (6.1.1)
March 18, 2014
4.1 What are the Localized
Prostate Cancer outcomes and
risk factors?
6.1 Definitions: outcomes and
risk factors
Modified “Baseline patient-reported functional
status” to “Baseline patient-reported health
status” (Table 4; 6.1.2)
March 18, 2014
5.1 Example follow-up schemes
Deleted example follow-up scheme for patients
who undergo surgical treatment after active
surveillance (Example 5)
April 9, 2014
Across the document
Replaced “User Manual” with “Reference Guide”
May 7, 2014
7.1 ICHOM Contact Information
Altered ICHOM address to reflect office move to
14 Arrow Street (from 12 Arrow Street)
DATA COLLECTION REFERENCE GUIDE
LOCALIZED PROSTATE CANCER | 16
www.ichom.org
[email protected]
DATA COLLECTION USER
REFERENCE
GUIDE
MANUAL
LOCALIZED
PROSTATE
CANCER | 17
CORONARY
ARTERY DISEASE

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