Clinical Outcomes

Mary HavenResearch Methodologies in Allied Health

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

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

Why go to the Patient?

“…achieving and producing health and satisfaction is the ultimate validator of the quality of care.”

Donabedian (1986)

Outcome Definitions

• Changes in health status that can be attributed to care

• What comes out after you put something in

• Measurable events which occur as a result of the structure and process of health care

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

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

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

Types of Outcomes to Measure

• Mortality• Morbidity • Physiological/Physical • Patient Satisfaction• Patient Compliance• Health Related Quality of Life• Costs

Mortality and Morbidity

• The traditional province of the physician

• Severity index necessary

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• Radiographs, ultrasound, CT, MRI,

nuclear images

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

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

Health Related Quality of Life Measures

• 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

Types of Outcomes to Measure

Costs

From whose perspective?•Patient•Institution•Society

Cost-Effectiveness

•Dollars/life saved•Dollars/case of disease prevented•Dollars/year-life gained

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 immunizationNo cost, saves money

Harvard School of Public Health

Cost-Utility

Measure of effect per quality-adjusted life years (QALY’s) gained

Program Reported cost/QAL (1993$)

PKU screening <0Coronary artery bypass $3,500NICU, 500-999g $6,300Hemodialysis $54,000

Community Acquired Pneumonia Dr. Brent James

% patients admitted 39% 29%Average length of stay 6.4 days 4.3 daysTime to antibiotic 2.1 hrs 1.5 hrsAverage cost/case $2752 $1424

Without guideline

With guideline

Wilson-Cleary Model for Outcomes Research

PatientCharacteristics

EnvironmentCharacteristics

Biologic/ Physiologic

Variables

SymptomStatus

FunctionalStatus

GeneralHealth

Perceptions

OverallQOL

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

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

• 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)

Public Release of Medical Outcomes Data in NY

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.

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

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

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 filed