PROMIS: What is it, Why Use it, and How to Advance the Mission of Integrative Oncology
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1 PROMIS: What is it, Why Use it, and How to Advance the Mission of Integrative Oncology David Cella, PhD Professor and Chair, Dept. of Medical Social Sciences Northwestern University, Feinberg School of Medicine Society for Integrative Oncology 14 th International Conference November 13, 2017
2 A Quick History
3 Cancer Care, Inc The first cancer support program was founded in New York in 1944 A nonprofit organization whose mission is to provide free, professional support services to anyone affected by cancer: people with cancer, caregivers, children, loved ones, and the bereaved. Cancer Care programs (including counseling, education, financial assistance and practical help).
4 Jimmie Holland creates first psychosocial oncology program in New York Simonton s Getting Well Again brings pop psychology to oncology Cella starts graduate school
5 1980 s Support groups slowly transition from research efforts to community programs 1. CancerCare, Inc 2. American Cancer Society 3. Bernie Siegel 4. Simonton program 5. Wellness Community 1989 Spiegel paper, The Lancet
6 The Wellness Community Founded in 1982 by Dr. Harold Benjamin, Santa Monica, CA Cornerstones: Patient Active Concept and free service in community setting Many others followed (5 in Chicago area alone)
7 1980 s Onslaught of self help books and programs Psychosocial Oncology matures with new journals, societies and meetings Alternative Medicine enters the cancer lexicon
8 1990 Cella, D.F. (1990). Health promotion in oncology: A cancer wellness doctrine. Journal of Psychosocial Oncology. 8, 1, 17-31
9 My health is my responsibility I did not cause my disease
10 I will always have hope what I hope for may change over time
11 My doctor and I are partners We both have things to learn
12 Death is not failure Personal dignity and quality of life are better measures of success
13 Cancer provides me with an opportunity I didn t need it; I don t have to be grateful for it
14 I am willing to change the way I deal with stress The past is unimportant unless I make it so
15 Cancer is a family illness My family needs attention too!!
16 I have the power to make a difference in my care I need to look within myself for the proper direction
17 The Needs We Serve Are Expanding SURVIVOR NEEDS ARE GROWING Number of cancer survivors continues to grow Those groups affected by cancer - including family, friends, companies, and institutions - continue to grow as well Need to determine how big the need is and how it s changing
18 1990 s Today Alternative Complementary and Alternative Integrative NIH gets on board Career transition from behavioral medicine to outcomes research FACT, FACIT and PROMIS Back to Integrative Oncology
19 Available Measurement Systems FACT (Functional Assessment of Cancer Therapy) FACIT (Functional Assessment of Chronic Illness Therapy) PROMIS Neuro-QoL NIH Toolbox ASCQ-Me Covered in detail in Post-Conference Workshop, Introduction to PROMIS and NIH Toolbox, Nan Rothrock and Christa Martens, Nov. 14, 1-5pm
20 FACIT Measurement System November, items 100+ questionnaires 70 languages
21 FACIT Searchable Item Library (SIL) 132 Pediatric 643 Adult SEARCH BY PRO-CTCAE Domains Symptoms Function General Health Perceptions Other Key Word Language
22 PROMIS Measurement Aims More widely applicable Variety of settings and with different groups Multiple languages Appropriate across the life span Universal symptoms/function (disease agnostic) More sensitive Psychometrically sound Cover full range of a trait (no floor/ceiling effects) More efficient Brief, easy to use and understand Expressed on a common metric HealthMeasures.net/PROMIS
23 HealthMeasures.net/PROMIS
24 Item Banks Collection of items (questions) All items measure the same underlying thing, each a little differently from all others
25 PROMIS Computer Adaptive Test: Physical Functioning
26 Item Banks Enable Flexible Administration SHORT FORMS Fixed set of 4-10 items All from one item bank Off-the-shelf or custom COMPUTER ADAPTIVE TESTS Individually tailored Next item depends on previous answers Usually 4-12 items from one item bank PROFILES Collection of short forms covering multiple domains (e.g. depression, physical function, pain interference) HealthMeasures.net/PROMIS
27 CAT Provides Coverage of a Wide Range AND Precise Measurement high physical function Question #2 Question #3 Question #1 low physical function Questionnaire with high precision AND a wide range
28 PROMIS T-Score Mean = 50 Standard Deviation = 10 Referenced to the US General Population High scores = more of domain CID = 2-6 points (physical function) 1,2 1 Yost 2011, 2 Hays Yost et al 2011
29 Current list of available measures Data collection tools Scoring instructions/manuals Interpretation guidelines Lists of publications Publicly available datasets Upcoming workshops/events Measurement science basics Interactive forum for Q&A Search & View Measures (PDFs or demo videos)
30 Person-Centered Assessment in Integrative Oncology Measure what is meaningful to the patient Customize assessments without compromising standardization or validity shop and select among item banks and libraries Patient engagement, activation and shared decision making Example applications Symptom monitoring and management Building an evidence base for integrative oncology
31 Symptom Monitoring & Management
32 Northwestern Medicine & Robert H. Lurie Comprehensive Cancer Center Programs Contribute to Meeting the CoC Standards of Care CCSG Cancer Control & Survivorship Research Program Basic measurement, PROs, eheath, cancer care delivery & intervention Science (Penedo, Simon) Supportive Oncology Distress and Practical Concerns Screening & Management (Pearman, Vance, Peal) CoC Standards of Care Cancer Survivorship Institute Specialized Survivorship Care & SCP Delivery (Penedo, Kircher, Garcia)
33 Patient Reported Outcomes (PROs) 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. PROs at Northwestern Medicine Computer Adaptive Assessments integrated with the EMR NMPRO Application Measure quality of care through a patient-centered lens Enhance communication between patient and providers Determine efficacy of treatment and facilitate treatment decision making Patient-reported outcomes: A new era in clinical research; Perspect Clin Res. 2011, 2(4):
34 Distress Screening: Empirical Support First randomized clinical trial to evaluate distress screening outcomes 585 patients with breast cancer and 549 patients with lung cancer randomized to: Minimal screening (DT only) Full screening (DT + Problem Checklist + Personalized Report) Screening plus triage for psychosocial care (Full Screening + Phone Referral) Screening conducted online Triage condition significantly lower distress at 3 months compared to minimal screening. Carlson et al. JCO 2010
35 Single Item Distress Thermometer Quick, easy, but not always sufficient Screening Cut-off = 5 Sensitivity (true +) Specificity (true -) Anxiety Depression Butt et al. JPSM 2007; 35:20-30
36
37 Standard Setting for Clinical Application in Cancer All-day multidisciplinary workshop PROMIS item banks and clinical experts judgment 22 experts in anxiety, depression, pain, fatigue and physical function Expertise: 3 yrs. & > 100 ca pts. with target symptom Sample: 840 oncology patients Completed PROMIS items by domain Vignettes derived from PROMIS items represented full range of severity Experts shown vignettes and asked to rate severity High convergence of clinical judgment with PROMIS scores (Cella et al, 2014)
38 PROMIS T Score Clinical Thresholds Cella et al, Quality of Life Research. 23(10): , 2014
39 HealthMeasures.net/PROMIS
40 Lurie Distress Screening Assessment through NMPRO Question Domains for Cancer Center Physical function Pain Interference Fatigue Depression Anxiety Practical/psychosocial needs Nutritional needs Assessment Criteria Utilized Patient population automatically selected by diagnosis code Assessment sent no more than 1x per month Overall Functionality Patients can take assessment at home via MyChart or in clinic No anticipated disruption to regular clinic workflow Response routing to appropriate providers Real-time access to results and data within EPIC
41 In-Clinic Assessment using ipads
42 Results: GynOnc Psychosocial Concerns 36% assessments generated social work triage 23% assessments generated health education center triage I could use support in the following areas: 13% Managing stress 8% Coping with cancer diagnosis Getting information on support groups 64% 2% 2% 3% 8% Communicating with my medical team Communicating with children about cancer Communicating about my cancer with others (family, friends, employer) No needs at this time 13% requested information on Advance Directives 8% requested information on financial resources (Wagner et al., 2013)
43 Building an Evidence Base: Some examples
44 Expanding PROMIS to measure nonspecific healing factors (C Greco) Full spectrum PROMIS methodology Healing Encounters and Attitudes Lists (HEAL) Patient-Provider Connection (57 items) Healthcare Environment (25 items) Treatment Expectancy (27 items) Positive Outlook (27 items) Spirituality (26 items) Attitudes toward CAM (6-item SF) Greco C et al: Qual Life Res Jul;25(7): doi: /s Epub 2015 Nov 12
45 Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) J Dusek BraveNet PBRN: Whole system IM Protocol Prospective, non-randomized, observational registry 14 sites; 10,000 study participants PROMIS-29, PSS-4, and Patient Activation Measure (PAM) Baseline, 2, 4, 6, 12, 18 and 24 months ClinicalTrials.gov NCT Dusek JA et al: BMC Complement Alt Med 2016 Feb 4;16:53. doi: /s
46 Acupuncture-Related Quality of Life Changes Using PROMIS CATs in a Pragmatic Trial (D Victorson) Pragmatic clinical trial in IM practice H/O prior acupuncture associated with more baseline fatigue, negative affect and sleep disturbance Greater expectation of benefit among those with more pain, fatigue and functional complaints at baseline Acupuncture helped negative affect, pain and sleep No benefit to fatigue or function PROMIS CATs were brief and responsive Victorson D et al: J Altern Complement Med Oct;22(10): Epub 2016 Jul 28
47
48 Conclusion We ve come a long way in 40 years (still a long way to go) Integrative oncology and patient reported outcomes are natural partners Both are manifestations of patient-centeredness Both have become more diverse and flexible over time They can help each other advance in the future As cancer treatments evolve, so also must integrative oncology and outcome measurement
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