Patient Reported Outcomes Why的病人报告结果的原因.pptVIP

Patient Reported Outcomes Lowell E. Schnipper, M.D. Berenson Professor of Medicine Harvard Medical School Chief, Hematology-Oncology Beth Israel Deaconess Medical Center Health-Related Quality of Life (HRQOL) Assessment Subjectivity and Objectivity HRQoL is not subjective in the usual sense of the term It can be measured accurately in an individual, and in a group It is “subjective” in that it derives from the human subject of research or clinical practice Patient Reported Outcomes:Why? Cancer often an incurable illness Improvement in patient’s HRQoL is an expectation of appropriate therapy Palliation is often the goal Health Related Quality of Life (HRQoL) Includes a number of domains Physical functioning: ranges from normal to complete impairment Psychological well-being (depression, anxiety, fear of recurrence Social functioning Value to the Clinical Trials Process Provide information about toxicity Symptom relief These often are primary or secondary clinical trial endpoints In the clinical setting HRQoL assessments can have predictive value for survival Definitions Instrument = Questionnaire “Item” = Question “Domain” = Dimension= Area of Behavior or Experience “Cross-Sectional Design”Compares 2 or More Populations at One Point in Time “Longitudinal Design”Assesses Changes in HRQOL Over Time in 1 or More Populations HRQOL Assessment HRQOL Functional Status Functional Status Measure of Functioning Functional Status Measure of Functioning Focus: Generic or Disease-Specific Domain Specific Aggregated Scores Aggregated Scores Sum/Mean to Yield Global Score Aggregated Scores Sum/Mean to Yield Global Score Weights Proportional to Variance Quality of Life Index Quality of Life Index Aggregated Scores Aggregated Scores Empiric Data Used to Assign Weights to Calculate Global Score SF-36 SF-36 Aggregated Scores Aggregated Scores Someone’s Values used to Assign Weights to Calculate Global Score HRQOL Symptoms Symptoms Specific Disease Symptoms Symptoms Frequency S