1. outcome research 1 Introduction weichu@episerv.cph.ntu. edu.tw

2. outcome research 2 Aims: To equip students with basic methodology and skills of clinical and preventive outcome research

3. outcome research 3 Rules –Students: graduate students of the College of Public Health (CPH), NTU –Credit: elective, 2 credits (2 hours/week) –Time: 10:10-12:00am, Tuesday, 1 st semester –Place: Room 205, New Site of CPH –Instructor: Wei-Chu Chie/Kuo-Liong Chien –Language: English/Chinese –Evaluation: class performance 10%, oral presentation 20%, written report 70%

4. outcome research 4 DateTopic 09/16Introduction 09/23*Research design and statistical methods (1) experimental 09/30Research design and statistical methods (2) observational 10/07Sources of data/ethical concerns 10/14Outcomes/instruments selection 10/21Primary endpoint: survival 10/28*Surrogate endpoints 11/04Quality of life/utility 11/11Satisfaction 11/18Outcome evaluation of screening 11/25*Outcome evaluation of drug therapy 12/02*Outcome evaluation of clinical procedures 12/09Outcome evaluation of immunization 12/16Outcome evaluation of health promotion 12/23Application in evidence-based medicine 12/30Students’ presentation 01/06Students’ presentation * Dr. KL Chien

5. outcome research 5 Outcome: importance/rationale Impossible to ask how you grow, ask not what you harvest 只問耕耘不問收 穫 in preventive and clinical medicine Location of outcome –in health care policy management –in clinical epidemiology & evidence- based medicine

6. outcome research 6 Health care policy/management Structure Process Outcome –Donnabedian, 1966

7. outcome research 7 Clinical epidemiology The science of making predictions about individual patients by counting clinical events in similar patients, using strong scientific methods for studies of groups of patients to ensure that the predictions are accurate. –Fletcher, et al. 1996

8. outcome research 8 Clinical epidemiology The study of variation in the outcome of illness and of the reasons for that variation: observation inference –Weiss, 1996

9. outcome research 9 Background of outcome research development Health as basic human right Rising health care cost/movements of cost containment Managed care

10. outcome research 10 Definition of an “ outcome ” The end result of care, or a measurable change in the health status or behavior of patients. –Harris, 1991

11. outcome research 11 Health outcomes in clinical epidemiology Death Disease Discomfort Disability Dissatisfaction –Fletcher et al., 1996

12. outcome research 12 Death A bad outcome if “ untimely ” –Fletcher et al., 1996 The final endpoint –insensitive sometimes –too late in preventive medicine

13. outcome research 13 Disease A set of symptoms, physical signs, and laboratory abnormalities –more objective? –surrogate endpoints –definition of “ normal ”

14. outcome research 14 Discomfort Symptoms such as pain, nausea, itching, and tinnitus –part of health status –part of quality of life –more subjective –usually needs measurement instruments: questionnaires or scales

15. outcome research 15 Disability Impaired ability to go about usual activities at home, work, or recreation –goal of tertiary prevention –specific definition and assessment tools –special domain of health status or quality of life

16. outcome research 16 Dissatisfaction Emotional reaction to disease and its care, such as sadness or anger –more subjective –part of quality of life –part of service satisfaction –more likely to be used in management

17. outcome research 17 Outcomes in outcome management Clinical Functional Financial Perceptual –Hegyvary, 1991

18. outcome research 18 Clinical outcome The patient ’ s response to medical and nursing intervention –wound healing, mobility –weight gain, body temperature –blood pressure, heart rate, blood sugar, peak expiratory flow

19. outcome research 19 Functional outcome The patient ’ s maintenance or improvement of physical functioning –specific: self-catheterization, … –global: overall sense of well-being –independent living skills: ADL, … –part of quality of life: specific and global

20. outcome research 20 Financial outcome Outcome achieved with the most efficient use of resources –direct cost –approximate cost: length of stay, frequency of ER visits –indirect cost –for cost-effectiveness analysis

21. outcome research 21 Perceptual outcome The patient ’ s satisfaction with outcomes, care received, and providers –new attention –more in management

22. outcome research 22 Outcome of health education and health care intervention Health behaviors Self-efficacy Health status Health care utilization –Chronic diseases self-management program –Lorig et al., 1996

23. outcome research 23 Health behaviors –Primary prevention: Exercise, diet, smoking, alcohol, … Stress coping, injury prevention,... Immunization and chemoprophylaxis –Secondary prevention: screening cancer cardiovascular, … –Tertiary prevention compliance, disease management and self-care

24. outcome research 24 Self-efficacy Confidence to perform certain behaviors –health behaviors –disease management –compliance and self-care –community participation

25. outcome research 25 Health status Well-being Disability –physical –mental –social

26. outcome research 26 Health care utilization Visits –regular clinics: physical, mental –emergency –alternative medicine Hospital stays Outpatient surgeries

27. outcome research 27 Multidisciplinary approaches Teamwork –Key caregivers: nurses –Physicians of different clinical specialties –Management specialties –Statisticians –Epidemiologists

28. outcome research 28 Benchmarking Best practice Comparison –between similar organizations or units –between the present outcome and the benchmark Management purposes

29. outcome research 29 Process of outcome management/research –Identifying the patient outcome –building the team –selecting the instrument –measuring the patient outcome –analyzing the data –summarizing the findings –applying the findings to practice –planning future patient outcomes projects

30. outcome research 30 Outline of the course Research design Data source Instrument selection and measurement Different outcomes Different procedures Application to Evidence-based medicine