Understanding the Utilization of Active Surveillance as a … · 2018-09-04 · Jersey...
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Problem and Significance • Prostate cancer affects men worldwide, is the most common non-cutaneous malignancy and 2 nd leading cause of cancer death in men in the U.S. à 9.6% of all new cancer cases. • Prostate cancer is the most common cancer diagnosed among Pennsylvania men and the 3 rd most common cause of cancer-related death among the state’s male residents. Southeast and Northwest regions of Pennsylvania have a significantly higher prostate cancer rate. • Incidence rates from 2009 – 2013: United States: 132.9 per 100,000 / Pennsylvania: 121.8 per 100,000 / Philadelphia: 154.9 per 100,000. • Lack of consensus regarding prostate cancer screening guidelines has created confusion among the Pennsylvania public and the medical community. Some providers champion early screening with Prostate-specific antigen (PSA) testing while others decry PSA testing as an unnecessary and potentially harmful expense. • Routine use of PSA testing: o Overdiagnosis and overtreatment for low risk prostate cancer: estimated overdiagnosis rate is between 87%–94%. o ↓ quality of life: treatment of overdiagnosed prostate cancer manifest to overtreatment, therefore, placing undue burden on the patient and its potential side effects. o ↑ health care costs to medical organization: millions of dollars in health care costs. o U.S. Preventative Task Force recommended against routine PSA screenings for prostate cancer. Purpose and Objectives To understand and characterize the utilization of active surveillance as a treatment option for men with low risk prostate cancer among Pennsylvania Urologic Regional Collaborative (PURC) providers from nine major urology practices from across Southeastern Pennsylvania and New Jersey. 1. Survey urology providers in the PURC cohort regarding the utilization of AS. 2. Determine if there is a difference in the utilization of AS in relation to years of practicing experience. 3. Characterize the utilization of AS among PURC providers using the PURC data registry. Conclusion • AS is a safe treatment option for of men with low risk prostate cancer. • Immediate definitive treatment of men meeting these low risk criteria may result in an unnecessary number of treatments in these selected patients. • Criteria used to identify men with low risk prostate cancer varies but are rather similar. • Confirming AS eligibility and follow up tests for patients on AS also varies. • This study provided the landscape of the current utilization of AS among PURC providers which in turn will facilitate AS initiatives. • Understanding the current utilization of AS as a treatment option for men with low risk prostate cancer is important prior to any intervention implementation. • Addressing barriers to implementing a standardized AS guideline or protocol also must be addressed prior to implementing an intervention. • Educational programs aimed to increase health professional and community awareness of AS can initiate the breakdown of some of these barriers. • Careful and thorough patient monitoring is critical for AS and the responsibility must lie on both the patient and the provider to ensure that appropriate tests are performed at the appropriate time intervals. • Effectiveness of any proposed interventions to improve the utilization and adherence of AS is not only dependent on the intervention but must include an ongoing assessment of the potential progression of the disease. Implications and Recommendations 1. Decision making tool and aids are not frequently used. o Understanding of the entire decision making process between the patient and the provider for AS is needed. o Management of localized prostate cancer, including AS should be made with a standardized guideline in conjunction of an individualized approach after careful risk assessment. o Men should be counseled directly on the need for ongoing surveillance as well as the disease progression that may lead to a recommendation for definitive treatment. 2. Variety of criterion to identify patients for AS and variation in AS follow-up practices. o A multi-institutional, prospective trials comparing criteria may help refine the best selection inclusion criteria for AS. o Assessing and identifying adherence barriers for follow up tests will provide an essential information for understanding the implications of existing variation in the use of AS. o Facilitate evidence-based clinical guidelines or protocols with new research combined with the existing evidence, while collecting information from more long-term studies is needed. 3. Repeat biopsy to confirm AS eligibility is less than optimal. o Assessing and identifying the barriers from both the provider and patients’ perspective. 4. Limited utilization of MRIs and biomarkers. o Premature studies and longer follow-up is warranted. Understanding the Utilization of Active Surveillance as a Treatment Option for Men with Low Risk Prostate Cancer Sitha Dy, MSN RN-BC CNS CCNS Jefferson College of Nursing Active Surveillance • Active surveillance (AS) focuses on the prevention of overtreatment by selecting appropriate patients with low risk prostate cancer characteristics and aggressively monitor them over time with periodic prostate biopsies and serial PSA testing to recognize any potential risk reclassification that would justify deferred definitive treatment, with curative intent if the cancer progresses. • Men with low risk prostate cancer who go on AS, 10-15 years after their diagnosis, have very low rates of their disease spreading or dying of prostate cancer. • Studies shown 50-66% of men during the 10 years after their diagnosis whom stayed on AS do not warrant definitive treatment. • Research has shown a decision not to intervene in a slowly progressing prostate cancer while carefully observing the patient has not increased mortality but positively maintained the patient’s quality of life and saved million in health care costs. • Lessens the morbidities of definitive treatment for men with low risk prostate cancer who will not likely develop cancer related symptoms. • Benefits of AS in most men is the avoidance or delay in having to experience side effects of definitive treatment • Variation in utilization of AS. Methods 1. Population/Sample and Design: – Providers practicing at 1 of the 9 urology practices across the Southeastern Pennsylvania region and New Jersey whom are actively participating in PURC. – Descriptive survey study; 19-item qualitative survey with the following themes: • Identification of AS candidates /Confirming AS eligibility / Following patients on AS 2. Population/Sample and Design: – AS patients whom received care between July 2015 and March 2016 at 1 of the 9 urology practices in the Southeastern Pennsylvania region and New Jersey participating in PURC. – Analysis of AS tests from the PURC ArborMetrix registry for all patients whom obtained care at any of the PURC provider practices. Results Survey Results: 35 of 93 providers responded from 8 of 9 practices Identification of active candidates: • 95% appropriately identify and offer AS. • 86% use predefined eligibility criteria to identify AS candidates. • 53% use a decision making tool. Confirming active surveillance eligibility: • 67% perform repeat biopsy. – 21% within 6 months / 75% within 12 months. • 46% utilize prostate MRI & 30% use genomic testing. Following patients on active surveillance: • 100% perform PSA every 3 to 12 months. – 77% every 6 months. • 82% perform prostate biopsy every 3 to 12 months. – 67% at every 12 months. • 82% perform DRE every 6 to12 months. – 56% at every 6 months. • 64% order Prostate MRI every 6 to 12 months. – 55% at every 12 months. • Cessation of AS à definitive treatment: – 97% for Gleason upgrading on surveillance prostate biopsy. – >50% for concerning PSA kinetics, ↑volume of disease on surveillance biopsy, new nodule on DRE, and new or more lesion on MRI. – <50% for concerning genomic testing results. Statistically significant difference: • Providers with >10 years urology experience report having a patient age below which they would typically not offer AS to compared to providers with <10 years urology experience( χ 2 (1) = 4.212, p = 0.04). • Providers with <10 years urology experience perform Prostate MRI more often during the first two years than providers with >10 years’ practice experience. Those with >10 years (40%) never do this while providers <10 years (69%) of practice do it every 12 months ( χ 2 (3) = 8.476, p = 0.037). PURC Data Registry Results: 240 AS patients (July 2015 – March 2016) Test 0-6 mos. 7-12 mos. 13-18 mos. 19+ mos. Total Rate PSA Test 169 22 3 3 197 82% Only PSA tested Patients 86% 11 % <12 months: 97% Prostate Biopsy 43 48 9 12 114 45% Only Prostate Biopsied Patients 38% 42% <12 months: 80% Prostate MRI 66 18 6 5 95 40% Only MRI’d Patients 69% 19% <12 months: 88%
Transcript of Understanding the Utilization of Active Surveillance as a … · 2018-09-04 · Jersey...
Problem and Significance
• Prostate cancer affects men worldwide, is the most common non-cutaneous malignancy and 2nd leading cause of cancer death in men in the U.S.à 9.6% of all new cancer cases.
• Prostate cancer is the most common cancer diagnosed among Pennsylvania men and the 3rd
most common cause of cancer-related death among the state’s male residents. Southeast and Northwest regions of Pennsylvania have a significantly higher prostate cancer rate.
• Incidence rates from 2009 – 2013: United States: 132.9 per 100,000 / Pennsylvania: 121.8 per 100,000 / Philadelphia: 154.9 per 100,000.
• Lack of consensus regarding prostate cancer screening guidelines has created confusion among the Pennsylvania public and the medical community. Some providers champion early screening with Prostate-specific antigen (PSA) testing while others decry PSA testing as an unnecessary and potentially harmful expense.
• Routine use of PSA testing:o Overdiagnosis and overtreatment for low risk prostate cancer: estimated overdiagnosis
rate is between 87%–94%.o ↓ quality of life: treatment of overdiagnosed prostate cancer manifest to overtreatment,
therefore, placing undue burden on the patient and its potential side effects.o ↑ health care costs to medical organization: millions of dollars in health care costs. o U.S. Preventative Task Force recommended against routine PSA screenings for prostate
cancer.
Purpose and Objectives
To understand and characterize the utilization of active surveillance as a treatment option for men with low risk prostate cancer among Pennsylvania Urologic Regional Collaborative (PURC) providers from nine major urology practices from across Southeastern Pennsylvania and New Jersey.
1. Survey urology providers in the PURC cohort regarding the utilization of AS.2. Determine if there is a difference in the utilization of AS in relation to years of practicing experience.3. Characterize the utilization of AS among PURC providers using the PURC data registry.
Conclusion
• AS is a safe treatment option for of men with low risk prostate cancer. • Immediate definitive treatment of men meeting these low risk criteria may result in an
unnecessary number of treatments in these selected patients. • Criteria used to identify men with low risk prostate cancer varies but are rather similar.• Confirming AS eligibility and follow up tests for patients on AS also varies.• This study provided the landscape of the current utilization of AS among PURC providers
which in turn will facilitate AS initiatives. • Understanding the current utilization of AS as a treatment option for men with low risk
prostate cancer is important prior to any intervention implementation.• Addressing barriers to implementing a standardized AS guideline or protocol also must be
addressed prior to implementing an intervention. • Educational programs aimed to increase health professional and community awareness of
AS can initiate the breakdown of some of these barriers.• Careful and thorough patient monitoring is critical for AS and the responsibility must lie on
both the patient and the provider to ensure that appropriate tests are performed at the appropriate time intervals.
• Effectiveness of any proposed interventions to improve the utilization and adherence of AS is not only dependent on the intervention but must include an ongoing assessment of the potential progression of the disease.
Implications and Recommendations
1. Decision making tool and aids are not frequently used.o Understanding of the entire decision making process between the patient and the provider
for AS is needed.o Management of localized prostate cancer, including AS should be made with a standardized
guideline in conjunction of an individualized approach after careful risk assessment. o Men should be counseled directly on the need for ongoing surveillance as well as the disease
progression that may lead to a recommendation for definitive treatment.2. Variety of criterion to identify patients for AS and variation in AS follow-up practices.
o A multi-institutional, prospective trials comparing criteria may help refine the best selection inclusion criteria for AS.
o Assessing and identifying adherence barriers for follow up tests will provide an essential information for understanding the implications of existing variation in the use of AS.
o Facilitate evidence-based clinical guidelines or protocols with new research combined with the existing evidence, while collecting information from more long-term studies is needed.
3. Repeat biopsy to confirm AS eligibility is less than optimal.o Assessing and identifying the barriers from both the provider and patients’ perspective.
4. Limited utilization of MRIs and biomarkers.o Premature studies and longer follow-up is warranted.
Understanding the Utilization of Active Surveillance as a Treatment Option for Men with Low Risk Prostate Cancer
Sitha Dy, MSN RN-BC CNS CCNSJefferson College of Nursing
Active Surveillance
• Active surveillance (AS) focuses on the prevention of overtreatment by selecting appropriate patients with low risk prostate cancer characteristics and aggressively monitor them over time with periodic prostate biopsies and serial PSA testing to recognize any potential risk reclassification that would justify deferred definitive treatment, with curative intent if the cancer progresses.
• Men with low risk prostate cancer who go on AS, 10-15 years after their diagnosis, have very low rates of their disease spreading or dying of prostate cancer.
• Studies shown 50-66% of men during the 10 years after their diagnosis whom stayed on AS do not warrant definitive treatment.
• Research has shown a decision not to intervene in a slowly progressing prostate cancer while carefully observing the patient has not increased mortality but positively maintained the patient’s quality of life and saved million in health care costs.
• Lessens the morbidities of definitive treatment for men with low risk prostate cancer who will not likely develop cancer related symptoms.
• Benefits of AS in most men is the avoidance or delay in having to experience side effects of definitive treatment
• Variation in utilization of AS.
Methods
1. Population/Sample and Design:– Providers practicing at 1 of the 9 urology practices across the Southeastern Pennsylvania region and New Jersey whom are actively participating in PURC.– Descriptive survey study; 19-item qualitative survey with the following themes:• Identification of AS candidates /Confirming AS eligibility / Following patients on AS
2. Population/Sample and Design:– AS patients whom received care between July 2015 and March 2016 at 1 of the 9 urology practices in the Southeastern Pennsylvania region and New
Jersey participating in PURC.– Analysis of AS tests from the PURC ArborMetrix registry for all patients whom obtained care at any of the PURC provider practices.
Results
Survey Results: 35 of 93 providers responded from 8 of 9 practicesIdentification of active candidates: • 95% appropriately identify and offer AS.• 86% use predefined eligibility criteria to identify AS candidates. • 53% use a decision making tool.Confirming active surveillance eligibility:• 67% perform repeat biopsy.
– 21% within 6 months / 75% within 12 months.• 46% utilize prostate MRI & 30% use genomic testing.Following patients on active surveillance:• 100% perform PSA every 3 to 12 months.
– 77% every 6 months.• 82% perform prostate biopsy every 3 to 12 months.
– 67% at every 12 months.• 82% perform DRE every 6 to12 months.
– 56% at every 6 months.• 64% order Prostate MRI every 6 to 12 months.
– 55% at every 12 months.• Cessation of AS à definitive treatment:
– 97% for Gleason upgrading on surveillance prostate biopsy.– >50% for concerning PSA kinetics, ↑volume of disease on surveillance
biopsy, new nodule on DRE, and new or more lesion on MRI.– <50% for concerning genomic testing results.
Statistically significant difference:• Providers with >10 years urology experience report having a patient age
below which they would typically not offer AS to compared to providers with <10 years urology experience(χ2 (1) = 4.212, p = 0.04).
• Providers with <10 years urology experience perform Prostate MRI more often during the first two years than providers with >10 years’ practice experience. Those with >10 years (40%) never do this while providers <10 years (69%) of practice do it every 12 months (χ2 (3) = 8.476, p = 0.037).
PURC Data Registry Results: 240 AS patients (July 2015 – March 2016)
Test 0-6 mos. 7-12 mos. 13-18 mos. 19+ mos. Total RatePSA Test 169 22 3 3 197 82%Only PSA tested Patients
86% 11 %
<12 months: 97%Prostate Biopsy 43 48 9 12 114 45%Only Prostate Biopsied Patients
38% 42%
<12 months: 80%Prostate MRI 66 18 6 5 95 40%Only MRI’dPatients
69% 19%
<12 months: 88%
Abstract
Understanding the Utilization of Active Surveillance as a Treatment Option for Men with Low Risk Prostate Cancer
Sitha Dy, MSN RN-BC CNS CCNSJefferson College of Nursing
Mary Lou Manning, PhD CRNP CIC FNAP FAAN Thomas Jefferson University
Faculty Committee Chair
Claudette Fonshell, RNHealth Care Improvement Foundation, Director
PURC Program ManagerCommittee Co-Chair
Adam Reese, MDTemple University, Urologist
Active Surveillance Working Group ChairCommittee Co-Chair
Special Thanks to:Bret Marlow
Health Care Improvement FoundationProject Coordinator, Leader of Health Care Data Initiatives
Pamela A. Braun, MSNHealth Care Improvement FoundationClinical Improvement, Vice President
Kate Flynn, FACHEHealth Care Improvement Foundation
President
AcknowledgementsReferences
Purpose/Objectives: To understand and characterize the utilization of active surveillance as a treatment option for men with low risk prostate cancer among providers participating in the Pennsylvania Urologic Regional Collaborative (PURC).
Design: Descriptive survey study.
Methods: An electronic survey of PURC providers and analysis of PURC data registry information.
Findings: Survey respondents utilize active surveillance for men with low risk prostate cancer when appropriate but there is variation of criteria used to identify potential active surveillance candidates. Survey respondents incorporate PSA testing and prostate biopsies to confirm eligibility and to follow patients but the usage of prostate MRI and genomic testing varied. The practice of repeating prostate biopsy to confirm active surveillance eligibility is also suboptimal. There was statistically significant difference between providers with less than 10 years’ of experience and providers with greater than 10 years’ of experience in the utilization of active surveillance in regards to patient’s age and MRI utilization. The data registry revealed practice patterns of PSA tests within 6 months, repeat prostate biopsy and prostate MRI within one year.
Conclusion: Active surveillance is used as a treatment option when appropriate to those with low risk prostate cancer but further investigation is warranted prior to developing standardized criteria to select appropriate men for surveillance and guidelines for following these men while on surveillance.
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