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MOBILE PATIENT-REPORTED OUTCOME (PRO) ASSESSMENT TO DRIVE ADHERENCE Heather Jim, PhD Moffitt Cancer Center [email protected]
There are no conflicts to disclose
LEARNING OBJECTIVES
After reading and reviewing this material, the participant should be able to:
• Describe the benefits of collecting PROs as part of clinical trials and standard care
• Identify electronic methodologies for collecting PROs and other patient-generated data
• Discuss ways in which PROs can contribute to recovery after cystectomy
PATIENT-REPORTED OUTCOMES
“Any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.”
Disease Symptomatology
Treatment Side Effects Quality of Life
Kluetz et al., Clin Cancer Res 2016; 22:1553-8
• Comparison of PROs versus provider ratings of symptom severity in 1,933 patient-provider dyads
PROVIDERS TEND TO UNDERESTIMATE PROS
Pain Fatigue Anorexia Dyspnea Diarrhea Patient 67 71 47 30 14 Provider 47 54 25 16 6
0
20
40
60
80 %
pre
vale
nce
Laugsand et al., Health Qual Life Outcomes 2010; 8:104
• Comparison of PROs versus chart-abstracted CTCAE ratings for common symptoms in 163 patients receiving standard of care chemo
• Examined ratings as predictors of risk of death and ER visits
TOXICITY REPORTS AND OUTCOMES
HR death p HR ER visit p Moderate fatigue Patient 1.46 .23 1.18 .48
Clinician 2.75 <.001 1.87 .004 Moderate pain Patient 1.47 .13 1.44 .09
Clinician 1.56 .08 1.84 .004
Basch et al., J Natl Cancer Inst 2009;101:1624–1632
PROS CAN IMPROVE CLINICAL BENEFIT
• 766 patients starting chemotherapy randomized to clinic-based symptom monitoring (n=441) or standard care (325) § Tablet or kiosk
• Printed report for providers
• Nurse alerts triggered for severe or worsening symptoms
• Followed for 6 months
Basch et al., J Clin Oncol 2016; 34:557-65
PROS CAN IMPROVE CLINICAL BENEFIT
• Improved one-year survival (75% vs. 69%)
• Longer time on treatment (8.2 months vs. 6.3)
• Fewer patients treated at the ER (34% vs. 41%)
-8
-6
-4
-2
0
Intervention Control Basch et al., J Clin Oncol 2016; 34:557-65
Change in QOL
PATIENT-REPORTED OUTCOMES MEASUREMENT SYSTEM (PROMIS)
• Numerous symptoms assessed
• Create web-based surveys through Assessment Center
• Templates available through data management and patient portal software
• Some measures will be available through EMR software
http://www.assessmentcenter.net/ac1/AssessmentCenter_Manual.pdf
PATIENT REPORTED OUTCOMES VERSION OF THE CTCAE (PRO-CTCAE)
https://healthcaredelivery.cancer.gov/pro-ctcae/
SYMPTOM MONITORING: FACILITATED BY TECHNOLOGY
http://www.pewinternet.org/2017/05/17/tech-adoption-climbs-among-older-adults/
Americans Use the Internet
Own a smartphone Own a tablet
≥ 18 years 90% 77% 51% ≥ 65 years 67% 51% 32%
PASSIVE ACTIVITY AND SLEEP MONITORING
Actigraph Link MiniMitter Actiwatches
R03 CA126775 R01 CA164109
Jim et al. Health Psychol 2013; 32: 768-774
Rosenberger et al. Med Sci Sports Exerc 2016; 48: 457-465 http://thewirecutter.com/reviews/best-fitness-tracker/
Passive Activity and Sleep Monitoring
Garmin Vivosmart HR FitBit Charge 2
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RECOVERY AFTER CYSTECTOMY • Poorly controlled symptoms after cystectomy may
indicate complications
• Complications occur in up to 50% of patients
• Primary driver for hospital readmissons
• Patients do not always report symptoms in a timely manner
• Home-based symptom reporting with provider alerts may improve outcomes
Shabsigh et al. Eur Urol 2009;55:164-74
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AIM 1: SELECT RELEVANT ITEMS • Aim: To identify clinically-important symptoms that
warrant home based monitoring
§ Selected symptoms from existing measures, literature, PRO-CTCAE
§ Clinician stakeholders ranked list, added symptoms
§ Collaborated with NCI to adapt PRO-CTCAE items
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AIM 1: SELECT RELEVANT ITEMS • Nausea • Vomiting
• Diarrhea
• Abdominal pain
• Fatigue
• Chills, sweats, feverish
• Bleeding, redness, discharge at surgical site
AIM 2: CREATE INTERFACE
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AIM 3: USABLITY TESTING • Evaluate patient perceptions of length of survey,
content, question comprehension, electronic interface in 10 patients
• Pilot test during 6 week post-surgery period in 15 patients
• Obtain feedback from 12 providers about clinical integration and utility
CONCLUSIONS • Monitoring and managing PROs have the potential to:
§ Improve clinical benefit § More accurately capture toxicity
• New technology can facilitate collection of PROs and other patient-generated data
QUESTIONS?
Scientific American, November 1975