1 Lecture #1 Introduction to Outcomes and Effectiveness Research January 5, 2015 (9:00-11:50 am) HPM Broxton Avenue Los Angeles, CA 90024

HPM 214 Schedule 2 01/05/15Introduction to Outcomes and Effectiveness Research, and Patient-Reported Outcomes Fung & Hays (2008); Reeve et al. (2013) 01/12/15HRQOL Profile Measures Hays & Revicki (2005 chapter); Hays & Reeve (2010) 01/19/15MLK Holiday Ganz et al. (2014) 01/26/15HRQOL Preference-Based Measures (Quiz) Feeny (2005, chapter); Kaplan et al. (2011) 02/02/15Designing HRQOL Measures McColl (2005 chapter) 02/09/15 Evaluating HRQOL Measures Hays & Fayers (2005 chapter); Hays & Revicki (2005 chapter) 02/16/15 Presidents’ Day Holiday Improving HRQOL in Dialysis patients nals/CFCs.cfm 02/23/15PROMIS/IRT/Internet Panels Cappelleri et al. (2014); Cella et al. (2010) 03/02/15Responding to reviews of submitted manuscripts; Cognitive Interview questions Example of reviews received, resubmitted article and cover letter 03/09/15Course Review (Cognitive Interview write- ups due) /16/15Final Exam* 9-11:50am

HPM 214 Assignments Class participation (25%) Two class assignments (25%) –Complete the SF-36 v2 survey at 36.org/demos/SF-36v2.htmlhttp:// 36.org/demos/SF-36v2.html –Conduct and summarize 5 cognitive interviews with a self-administered HRQOL survey. Extra credit (2-page critique of published HRQOL article). 3

Final Exam (50% of grade) Which of the following could be a patient-reported measure (PRM)? –Social support –Satisfaction with health care –Income –Adherence to medical recommendations –All of the above 4

U.S. Health Care Issues Access to care –~ 50 million people without health insurance Costs of care –Expenditures ~ $ 2.7 Trillion Effectiveness (quality) of care 5

How Do We Know If Care Is Effective? Effective care maximizes probability of desired health outcomes –Health outcome measures indicate whether care is effective Cost ↓ Effectiveness ↑ 6

What Are Health Outcomes ? Traditional clinical endpoints –Death, disease occurrence, other adverse events –Clinical measures/biological indicators Blood pressure Blood hemoglobin level Symptoms (e.g. fever) Health-Related Quality of Life

8 HRQOL is Multi-Dimensional HRQOL Physical Mental Social

9 Health-Related Quality of Life (HRQOL) How the person FEELs (well-being) Emotional well-being Pain Energy What the person can DO (functioning) Self-care Role Social

10 HRQOL is Not Quality of environment Type of housing Level of income Social Support

People sometimes look to others for companionship, assistance, or other types of support. How often were each of the following kinds of support available to you when you needed it during the past four weeks? –Someone to turn to for help with a personal problem? –Someone to help with daily chores if you were sick? –Someone to love and make you feel wanted? All of the Time Most of the Time Some of the Time A Little of the Time None of the Time

Patient-Reported Outcomes (PROs) “Any report coming from patients about a health condition and its treatment” (U.S. FDA, 2006) Including Health-related quality of life (HRQOL) Satisfaction with treatment Patient reports about care Needs assessment Adherence to treatment

Patient-Reported Outcomes (PROs) “Any report coming from patients about a health condition and its treatment” (U.S. FDA, 2006) Including Health-related quality of life (HRQOL) Satisfaction with treatment Patient reports about care Needs assessment Adherence to treatment

Patient-Reported Measures (PRMs) Background characteristics –Age, education, income Health care experiences –Reports about care (e.g., communication) Behavior –Adherence to physician recommendations Outcomes –Satisfaction with care –HRQOL

15 HRQOL HealthBehaviors(Adherence) Technical Quality Satisfaction With Care Quality of Care Patient Reports About Care Patient Characteristics

Uses of HRQOL Measures

HS 214, Winter 01·11·10

Behavioral Risk Factor Surveillance System (BRFSS) Telephone interview (random digit dialing) of nationwide survey of U.S. adults % reporting poor or fair health about 16%

Greater % of fair or poor health reported by older adults (33% for 75+ vs. 9% for 18-24)

Greater % of fair or poor health reported by females (17%) than males (15%)

Uses of HRQOL Measures

Observational Study Observation of groups (non-random assignment) Outcomes Clinical Complications Survival HRQOL Casemix adjustment needed + Conditions/comorbidity + Severity + Demographics

Observational Studies Process Of Care Outcomes Patient- Reported Clinical ExpertConsensus

Process of Care Expert Consensus –Quality of Care “If, Then” Indicators % of patients with diabetes with one or more HbA1c tests annually Patient reports about communication –In the last 12 months, how often did your doctor explain things in a way that was easy to understand?

Outcomes of Care Clinical –% of patients with diabetes with most recent HbA1c level >9.0% ( poor control) Patient global rating of health –Would you say that in general your health is: Excellent | Very good | Good | Fair | Poor

Uses of HRQOL Measures

Randomized Trial Design Outcomes –Clinical –Complications –Survival –HRQOL Little control for case-mix required Study Population Randomize Intervention Group Control Group

Uses of HRQOL Measures

HRQOL Assessment by Providers May Facilitate patient-physician communication Improve clinician understanding of patients’ problems (particularly those of a psychosocial nature) Detmar SB, Aaronson NK. Quality of life assessment in daily clinical oncology practice: a feasibility study. Eur J Cancer. 1998;34(8): Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. J Am Med Assoc. 2002;288(23): Hess R, Tindle H, Conroy MB, et al. A randomized controlled pilot trial of the Functional Assessment Screening Tablet to engage patients at the point of care. JGIM. 2014; 29(12): Velikova G, Brown JM, Smith AB, Selby PJ. Computer-based quality of life questionnaires may contribute to doctor-patient interactions in oncology. Br J Cancer. 2002;86(1):51-9. Velikova G, Booth L, Smith AB, et al. Measuring quality of life in routine oncologypractice improves communication and patient well-being: a randomized controlled trial. JClin Oncol. 2004;22(4):

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