HRQOL Flashcards
What is HRQOL?
Health is a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.
Implications of HRQOL Definition
- Personal life events affect health
- Physical status, psychological well-being, social interactions, and economic status affect health
- Intimate relationship between social relationships, beliefs, and health
Why Measure HRQOL
- May differ from clinical outcomes
- Adverse events and their severity
- Increased duration but lower quality of life
- For chronic illness, clinical outcomes alone may not be sufficient
- From societal perspective, HRQOL may be an important gauge of value of a treatment than length of life
- Another measure for comparing treatments which focuses on the impact of disease and its treatment
HRQOL + Health Care + Clinical Trials
- Relevance to patients and society
- Measure of treatment effects beyond clinical measures
- Determine changes in conditions which may not have objective clinical measures
- Identify specific components of HRQOL that are impacted by treatment
Domains in HRQOL
- Physical status and functional abilities
- General health perceptions
- Psychological status and well being
- Social and role functioning
Application of Domains
- Identify which domains most impacted by treatment
- Compare domain measures between patient populations
- Domains may be combined to provide summary measures of physical or mental health
Types of HRQOL Measures
- Generic health status measures
- Disease-specific health status measures - more likely to identify significant changes than generic measures
Generic HRQOL Instruments
- SF-36 and its variants
- WHO-QOL
- Sickness Impact Profile
- PROMIS Health Profiles
Short Form- 36 Versions
- 36: 36 questions with scoring functions, calculate scores on 8 domains, can convert to mental component score/physical component score
- 12: shortened to 12 questions and only scores for mental and physical component scores
- 36 V2: addresses ceiling and floor effects, role physical and role emotional domains
WHO-QOL
- International cross-culturally comparable QoL assessment instrument
- Culture and value systems
- Personal goals, standards, and concerns
WHOQOL-BREF
- 26 item version of original
- Domains: physical, psychological, social, and environment
Sickness Impact Profile
- 68 questions now
- Domains: independence, physical, and emotional
- Uses behavior/activities to estimate HRQOL
- Interviewer or self administered forms
PROMIS-29 Interpretation
- Scoring: Integrated scoring tool available or use Health Measures Scoring Service
- For each domain the total raw with all questions answered is summed
- Raw score converted to T-score
- In general population, each domain has a mean score of 50 and SD of 10
Administering HRQOL
- Frequency: baseline plus regular intervals: 6 months, 1 year, beginning/end of disease-related events
- Data used to track individual changes, group comparisons, and potential data for monitoring during a trial
- Follow guidelines for instrument to assure uniformity/consistency
Interpreting HRQOL Measures
- Compare patient groups or changes within a patient: not for comparing individuals
- Scaling issues: conversion of raw data from an ordinal scale to a interval scale allows parametric stat. analysis
- Improvement from baseline
- Results may not correlate with clinical outcomes
- Compare between study treatment groups
- Mixed effects may occur
- Comparison to other populations/previous research
Disease Specific HRQOL
- Provides domain measures for the disease of interest: more sensitive to changes in a specific disease, more specific information regarding HRQOL of a disease, validity/reliability for specific instruments
- Disadvantage: results are not directly comparable to generic measures of QALYs
- Many options each with their own strengths/weaknesses
Disease Specific HRQOL Examples
- Stroke Specific Quality of Life Scale
- Minnesota Living with Heart Failure Questionnaire
- Diabetes Quality of Life Scale
- Arthritis Impact Measurement Scale
- Beck Depression Inventory
- Hemodialysis QOL
Choosing HRQOL Instruments
- Consider if HRQOL outcomes may differ from clinical outcomes
- Consider disease-specific instruments if they are available
- Consider gold-standards
- How responsive will generic HRQOL instruments be
- Consider which instruments have been used in previous research
- Validity/reliability of instrument
- Should multiple instruments be used
- Will CEA be conducted
- Which results will have the greatest impact
Thoughts on HRQOL Responsiveness
- Statistical significance v.s. clinical significance
- Consider which changes are clinically relevant
- Consider previous research and which instruments were used and what was considered clinically important
- Change of 0.025 QALY considered clinically meaningful by several authors (AKA minimally important difference)