Patient Reported Outcomes After Radical Cystectomy

Transcription

1 Patient Reported Outcomes After Radical Cystectomy Scott M Gilbert, MD, MS, FACS Associate Member GU Oncology & Health Outcomes and Behavior Programs H. Lee Moffitt Cancer Center & Research Institute

2 Disclosures Florida Biomedical Research Program 3BN03 (BCOIS, PI Gilbert) NCI 1-R01CA (BCQOL, PI McMullen) No Industry/Commercial Disclosures

3 What Do We Mean By Success? What defines success? How should we measure it?

4 Some Common Measures of Success Stein et al. J Clin Oncol 2001;19: Grossman et al. N Engl J Med 2003;349: Hu et al. Cancer 2014:120;

5 Usual Suspects Survival (overall, cause-specific) Recurrence Response rate Adverse event/complication Functional outcomes

6 Success Depends On Your Perspective

7 Patient Perspectives and Reports May/Should Dictate Quality Structure Process Outcome How care is organized and where it is provided What is done End results of care

8 Patient Preference Structure Process Outcome How care is organized and where it is provided What is done End results of care Patient Perspective

9 Patient Reported Outcomes (PROs): Definition 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. US Food and Drug Administration definition

10 Patient Reported Outcomes (PROs): An Alternative Measure of Success 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. Example US Food and Drug Administration definition

11 Why/How Are PROs Important Provide an alternative perspective to clinical and clinician-based outcomes Provide more patient-centered information that may be more relevant Reflect health states/conditions that may not be captured by other outcomes (e.g. symptoms, QOL) Provide information warranting additional investigation/research Adaptable as clinical tools/ques that can help guide care

12 Often Correlate With Hard Outcomes Baseline QOL and QOL deficits have been linked to lower survival in lung, colon and pancreatic cancer Baseline QOL deficits also correlate with poor QOL outcomes post-treatment and are associated with complications Early serious (grade 2-4) complications more likely (16% vs. 6%, p=0.023) among colorectal patients with identified preoperative QOL deficit in COST Trial Bingener J et al. J Gastrointest Surg 2015;19:65-71

13 Provide Different View and More Detail Hubble Telescope New Horizons Probe

14 Current State of Knowledge and Use of Patient-Reported Outcomes/Quality of Life in the Managing Bladder Cancer

15 QOL Declines After Diagnosis/Treatment Reeve et al. J Natl Cancer Inst 2009;101:

16 QOL After Cystectomy Somani BK et al. Urology 2009;74(5):

17 Quality of Life After Cystectomy Adjusted mean BCI scores by treatment group - Mean scores varied by treatment type with cystectomy patients experiencing lower scores than native bladder group - Urinary function scores lowest among continent diversion group - Primarily driven by frequent urine leakage and lack of urinary control (continence) - 54% patients reported urinary leakage every night and 48% reported no urine control or frequent leakage at night Gilbert et al. Cancer 2007;109(9):

18 Quality of Life After Cystectomy Hedgepeth et al. Urology 2010;76:671-6

19 Patient Reported Distress Related to Cystectomy Distress Thermometer - Peak Concerns According to Phase of Recovery after Cystectomy Danilla Wittmann, University of Michigan (unpublished)

20 How Might PROs/QOL Could Be Used More Meaningfully or Impact the Future Care of Cystectomy Patients?

21 QOL Outcomes Drove Uptake of Laparoscopic Colonoscopy Weeks JC et al. JAMA 2002;287(3): Stucky CC et al. Ann Surg Oncol 2011;18:

22 Maybe a Primary Outcome Justifying Robotic Cystectomy? Pilot prspetive RCT comapring robot-assisted lap cystectomy to open cystectomy (NCT ) 40 pts randomized in 1:1 allocation QOL assessed with FACT-VCI at 3,6,9 and 12 months postsurgery No QOL differences noted Messer JC et al. BJU Int 2014;114: Khan MS et al Eur Urol 2015; ahead of print

23 PRO Integration into Care Settings Can Help Manage Symptom Distress RCT b/w symptom/qol assessments vs. assessment with targeted education, communication coaching and outcome tracking in 752 cancer patients Lower symptom distress scores after cancer treatment in intervention group (change in SDS from baseline 1.27 in control group (higher distress) vs in intervention group (lower distress)) Berry DL et al. J Clin Oncol 2014;32:

24 Responding to PROs Can Improve Symptom Management RCT tracking 100 lung cancer patients treated with thoracotomy comparing clinical care team notification of patient reported symptoms to no notification during first month after surgery Intervention (symptom reporting with notification to clinical care team) resulted in lower symptom threshold events (19% vs. 8%) and better symptom control Cleeland CS et al. J Clin Oncol 2011;29:

25 Take Home Messages PROs are an important alternative to traditional outcome measures, and capture both the patient perspective and information that only patients can share Can be used to fill in missing details on how patients do during and after treatment, measure quality, and identify what matters to patients PROs could be integrated into clinical information streams and made actionable (the future?)