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Outcomes Research Chapter 5 Cummings 5th ed. Darshni Vira AKA clinical epidemiology Study of the effectiveness of treatment in a nonrandomized, real-world setting (observational data) Outcome measures - survival, costs, physiologic measures, QOL Study Outline Pt presents at baseline with a condition Receives treatment for that condition Experiences a response to treatment Bias and Confounders Bias - “Compared components are not sufficiently similar” Selection bias Treatment bias Confounders – “Variable thought to cause an outcome is actually not responsible because of the unseen effects of another variable age, gender, ethnicity, race, comorbidities Assessment of Baseline Condition Definition of disease Inclusion criteria Disease severity TNM Sinusitis – Lund-Mackay, Harvard, etc ? reproducible results Comorbidity Adult Comorbidity Evaluation 27 (ACE-27) is a validated instrument for evaluating comorbidity in cancer patients Assessment of Treatment Control Groups Assessment of Outcomes Efficacy Health intervention, in a controlled environment, achieves better outcomes than does placebo Effectiveness Retains its value under usual clinical circumstances Study Design Measurement of Clinical Outcomes Psychometric Validation (questionnaires) Reliability Validation Responsiveness Burden Categories of Outcomes Health Status Individual’s physical, emotional, and social capabilities and limitations Function How well an individual is able to perform important roles, tasks, or activities QOL Central focus is on the value that individuals place on their health status and function Examples of Outcome Measures Medical Outcomes Study Short Form-36 (SF-36) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-HN35) Hearing Handicap Inventory in the Elderly (HHIE) Sinonasal Outcome Test (SNOT-20) Child Health Questionnaire (CHQ) Voice Handicap Index Functional Outcomes of Sleep Questionnaire (FOSQ) Interpreting Medical Data Chapter 6 Cum