Clinical Outcomes

1. Clinical Outcomes Mary Haven Research Methodologies in Allied Health

5. Objectives After listening to lecture and participating in class discussion; the student will be able to:

6. Objectives • Name at least four measures of clinical outcomes • Explain the output from a SF-36 assessment • Formulate at least six questions for a patient satisfaction survey • Discuss how the perspective of the evaluator can influence selection of outcome measures

7. Quality and Outcomes “The best measure of quality is not how well or how frequently a medical service is given, but how closely the result approaches the fundamental objectives of prolonging life, relieving distress, restoring function, and preventing disability.” Lembcke, 1952

8. Why go to the Patient? “…achieving and producing health and satisfaction is the ultimate validator of the quality of care.” Donabedian (1986)

9. Outcome Definitions • Changes in health status that can be attributed to care • What comes out after you put something in • Measureable events which occur as a result of the structure and process of health care

10. Group Activities • Identify a chronically ill patient, take the SF-36 from her/his perspective • Design an outcomes research project to convince a hospital administrator that your profession’s expertise is critical for quality patient care • Design an outcomes research project to measure a new intervention in your field

11. Titles of Outcomes Articles • A comparison of physical therapy, chiropractic manipulation and provision of an educational booklet for the treatment of lower back pain • Severity-adjusted mortality and length of stay in teaching and nonteaching hospitals

12. Quality of Life after Knee Replacement • Previous studies focused on • Improvements in joint mechanisms • Post-operative complications • Patient assessments • Pain • Physical function of the knee • Physical function • Satisfaction with result • Context of overall health

13. Types of Outcomes to Measure • Mortality • Morbidity • Physiological/Physical • Patient Satisfaction • Patient Compliance • Health Related Quality of Life • Costs

14. Mortality and Morbidity • The traditional province of the physician • Severity index necessary

15. Physiological/Physical • Often the domain of the allied health professional to be the practitioner who measures these variables • Laboratory values • Functional status • Blood gases, coagulation tests • Radiologic/ultrasound/CT/MRI/nuclear images

16. Patient Satisfaction • Examine a patient satisfaction survey from your institution • Difficult to measure • Demanded of provider groups by contracting entities • Surveys easier than phone or individual interviews

17. Health Related Quality of Life • Patient perceptions are crucial • Ability to engage in activities of daily life • Self-care • Role function • Social function • Perceived well-being • Let’s consider what the patients want

18. Health Related Quality of LifeMeasures • SF-36, http://www.sf-36.org/demos/SF-36v2.html • COOP charts • Duke-UNC Health Profile • Sickness Impact Profile • McMaster Health Index Questionnaire • Nottingham Health Profile • Quality of Well-Being Scale

20. Types of Outcomes to Measure • Costs • From whose perspective? • Patient • Institution • Society

21. Cost-Effectiveness • Dollars/life saved • Dollars/case of disease prevented • Dollars/year-life gained

22. Cost-Benefit Analysis Net social benefit of a program • Radiation Safety Program • $10 million/human life saved • EPA • $7.6 million/human life saved • Childhood immunization • No cost, saves money • Harvard School of Public Health

23. Cost-Utility Measure of effect per quality-adjusted life years (QALY’s) gained Program Reported cost/QAL (1993$) PKU screening <0 Coronary artery bypass $3,500 NICU, 500-999g $6,300 Hemodialysis $54,000

24. Community Acquired Pneumonia Dr. Brent James With guideline Without guideline % patients admitted 39% 29% Average length of stay 6.4 days 4.3 days Time to antibiotic 2.1 hrs 1.5 hrs Average cost/case $2752 $1424

25. Wilson-Cleary Model for Outcomes Research Patient Characteristics Biologic/ Physiologic Variables General Health Perceptions Symptom Status Functional Status Overall QOL Environment Characteristics

26. Strengths of Outcomes Research • Addresses a broad range of questions • Takes into account patient preferences and the social utility of treatment outcomes • More generalizable to community providers, patients, practices • More immediate structural applications

27. Limitations of Outcomes Research • May not be able to prove causation • May not adequately characterize treatments • May not be able to control all biases, confounders and interactions • Findings may be more vulnerable to misinterpretation and abuse

28. Public Release of Medical Outcomes Data in NY • Data on risk adjusted mortality after CABG surgery made public since 1989 • Hospitals and surgeons identified • Data used to stimulate improvement • Statewide risk-adjusted mortality fell 41% in first 4 years (1989-92)

29. Randomized controlled trial of rehabilitation in CRD • Subjects 39 men with dyspnea on exertion • Randomized to treatment and non-treat. • Treatment was rehab 6 wk. • Subjects who received rehab felt better and improved 12 min walking and max. oxygen uptake initially and after 4 mos.

30. Coronary risk factors in Type II diabetes: response to low-intensity aerobic exercise. • Subjects were NIDDM, 9 female, 7 male • Randomly assigned to treatment • VO2 max, ht, wt, BP, pulse, treadmill test, blood glucose, total triglycerides and cholesterol • Increase in VO2 max, decrease in BP, resting pulse, total triglycerides

31. Occupational therapy helps elderly in study, OWH 1997 • Teach elderly people how to keep up their daily activities • Improves physical and mental health • Helps them live independently • Saves money by delaying reliance on expensive nursing home care