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Lecture #1 Introduction to Outcomes

and Effectiveness Research

January 5, 2015 (9:00-11:50 am)

HPM 214 http://hpm214.med.ucla.edu/

911 Broxton Avenue

Los Angeles, CA 90024

HPM 214 Schedule

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01/05/15 Introduction to Outcomes and Effectiveness Research, and

Patient-Reported Outcomes

  Fung & Hays (2008); Reeve et al. (2013)

01/12/15 HRQOL Profile Measures   Hays & Revicki (2005 chapter); Hays & Reeve (2010)

01/19/15 MLK Holiday   Ganz et al. (2014)

 

01/26/15 HRQOL Preference-Based Measures (Quiz)

  Feeny (2005, chapter); Kaplan et al. (2011)

02/02/15 Designing 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 inDialysis patients

  http://www.kidney.org/professionals/CFCs.cfm 

02/23/15 PROMIS/IRT/Internet Panels   Cappelleri et al. (2014); Cella et al. (2010)

03/02/15 Responding to reviews of submitted manuscripts;

Cognitive Interview questions

  Example of reviews received, resubmitted article and cover letter

03/09/15 Course Review (Cognitive Interview write-ups due)

 

 

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03/16/15 Final Exam* 9-11:50am   ----------------------------------

HPM 214 Assignments

• Class participation (25%)

• Two class assignments (25%)– Complete the SF-36 v2 survey at

http://www.sf-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).

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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

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U.S. Health Care Issues

• Access to care – ~ 50 million people without health insurance

• Costs of care– Expenditures ~ $ 2.7 Trillion

• Effectiveness (quality) of care5

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 ↑

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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

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HRQOL is Multi-Dimensional

HRQOL

Physical Mental Social

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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

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HRQOL is Not

Quality of environment

Type of housing

Level of income

Social Support

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

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HRQOLHRQOL

HealthHealthBehaviorsBehaviors

(Adherence)(Adherence)

HealthHealthBehaviorsBehaviors

(Adherence)(Adherence)

Technical Technical QualityQuality

Technical Technical QualityQuality

Satisfaction With Care

Satisfaction With Care

Quality of CareQuality of Care

Patient Patient Reports Reports

About CareAbout Care

Patient Patient Reports Reports

About CareAbout Care

Patient Patient CharacteristicsCharacteristics

Patient Patient CharacteristicsCharacteristics

Uses of HRQOL Measures

• Monitoring population (and subgroups)

• Observational studiesObservational studies

• Clinical trials Clinical trials

• Clinical practiceClinical practice

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

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

Greater % of fair or poor health Greater % of fair or poor health reported reported

by females (17%) than males (15%) by females (17%) than males (15%)

Greater % of fair or poor health Greater % of fair or poor health reported reported

by females (17%) than males (15%) by females (17%) than males (15%)

Uses of HRQOL Measures

• Monitoring population (and subgroups)Monitoring population (and subgroups)

• Observational studies

• Clinical trials Clinical trials

• Clinical practiceClinical practice

Observational Study

•Observation of groups •(non-random assignment)

Outcomes

•Clinical•Complications•Survival •HRQOL

Casemix adjustment needed• + Conditions/comorbidity • + Severity• + Demographics•

Observational Studies

ProcessOf CareProcessOf Care

OutcomesOutcomes

Patient-Patient-ReportedReportedPatient-Patient-

ReportedReported ClinicalClinicalClinicalClinical Patient-Patient-ReportedReportedPatient-Patient-

ReportedReportedExpertExpert

ConsensusConsensusExpertExpert

ConsensusConsensus

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

• Monitoring population (and subgroups)Monitoring population (and subgroups)

• Observational studiesObservational studies

• Clinical trialsClinical trials

• Clinical practice Clinical practice

Randomized Trial Design• Outcomes

– Clinical

– Complications

– Survival

– HRQOL

• Little control for case-mix required

StudyPopulation

RandomizeRandomize

Intervention Group

Control Group

Uses of HRQOL Measures

• Monitoring population (and subgroups)Monitoring population (and subgroups)

• Observational studiesObservational studies

• Clinical trials Clinical trials

• Clinical practice

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):1181-6.

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):3027-34.

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):1641-1649.

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):714-24.

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Questions?

Contact Information:drhays@ucla.edu (310-794-2294)

Powerpoint file posted at: http://hpm214.med.ucla.edu/