1 health-related quality of life assessment as an indicator of quality of care (hpm 216) ron d. hays...
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Health-Related Quality of Life Assessment as an Indicator of
Quality of Care(HPM 216)
Ron D. Hays
April 11, 2013(8:30-11:30 am)10940 Wilshire Blvd. Suite 700
http://gim.med.ucla.edu/FacultyPages/Hays/
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Key Problems With US Health Care System (ACE)
• Access to care – ~ 50 million people without health insurance
• Costs of care– Expenditures ~ $ 2.7 Trillion
• Effectiveness (quality) of care– Not all care delivered is beneficial
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Access to Care (In the last 12 months …)
• When you phoned this provider’s office to get an appointment for care you needed right away, how often did you get an appointment as soon as you needed?
• When you made an appointment for a check-up or routine care with this provider, how often did you get an appointment as soon as you needed?
• When you phoned this provider’s office during regular office hours, how often did you get an answer to your medical questions that same day?
• When you phoned this provider’s office after regular office hours, how often did you get an answer to your medical question as soon as you needed?
• How often did you see this provider within 15 minutes of your appointment time?
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Cost-Effective Care
Cost ↓
Effectiveness ↑
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How Do We Know If Care Is Effective?
• Effective care maximizes probability of
desired health outcomes
• Outcomes are markers of whether or not
care is effective
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What Are Health Outcomes?
• Traditional clinical endpoints– Death, disease occurrence, other adverse
events
– Clinical measures/biological indicators• Blood pressure• Blood hemoglobin level• Symptoms (e.g. fever)
• Health-Related Quality of Life
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Health-Related Quality of Life is:
How the person FEELs (well-being)• Emotional well-being• Pain• Energy
What the person can DO (functioning)• Self-care • Role • Social
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HRQOL is Not
Quality of environment
Type of housing
Level of income
Social Support
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Patient-Reported Measures (PRMs)
• Patient-reported outcomes (PROs)– HRQOL– Satisfaction with care
• Mediators– Health behaviors (adherence)
• Patient evaluations of care – Reports about care (e.g., communication)
• Needs assessment (preferences for care)
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SF-36 Generic Profile Measure • Physical functioning (10 items)
• Role limitations/physical (4 items)
• Role limitations/emotional (3 items)
• Social functioning (2 items)
• Emotional well-being (5 items)
• Energy/fatigue (4 items)
• Pain (2 items)
• General health perceptions (5 items)
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WeightsSummary scores for SF-36 derived from uncorrelated
(orthogonal) two factor (physical and mental health) solution, producing negative weights in scoring.
PCS-z = (PF-z*.42) + (RP-z*.35) + (BP-z*.32) +
(GH-z*.25) + (EN-z*.03) + (SF-z*-.01) +
(RE-z*-.19) + (MH-z*-.22)
MCS-z = (PF-z*-.23) + (RP-z*-.12) + (BP-z*-.10) +
(GH-z*-.12) + (EN-z*.24) + (SF-z*.27) +
(RE-z*.43) + (MH-z*.48)
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SF-12 Scale
• Items by Scale– General health (1)– Physical functioning (3b, 3d)– Role-Physical (4b, 4c)– Role-Emotional (5b, 5c)– Bodily pain (8)– Emotional well-being (9d, 9f)– Energy/fatigue (9e)– Social functioning (10)
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Targeted HRQOL Measures
• Designed to be relevant to particular group.• Sensitive to small, but clinically-important
changes.• More familiar and actionable for clinicians.• Enhance respondent cooperation.
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Vision-targeted items (Paz et al.)• Color vision
– Match colors of clothes• Distance vision
– See street signs• Near vision
– See things close up during day• Ocular symptoms
– Redness in eyes• Psycho/social
– Frustrated or upset
• Role performance– Limited in how long can do work or activities
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Kidney-Disease Targeted Item
During the last 30 days, to what extent were you bothered by cramps during dialysis?
Not at all bothered
Somewhat bothered
Moderately bothered
Very much bothered
Extremely bothered
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Scoring HRQOL Profile Scales• Average or sum all items in the same scale.
• Transform average or sum to• 0 (worse) to 100 (best) possible range• z-score (mean = 0, SD = 1)• T-score (mean = 50, SD = 10)
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HRQOL for HIV Compared to otherChronic Illnesses and General Population
0 10 20 30 40 50 60
Asymptomatic
Symptomatic
AIDS
General Pop
Epilepsy
GERD
Prostate disease
Depression
Diabetes
ESRD
MSEmot.Phy func
Hays et al. (2000), American Journal of Medicine
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Is New Treatment (X) Better Than Standard Care (O)?
0
10
20
30
40
50
60
70
80
90
100
XX
00XX
00
PhysicalPhysicalHealthHealth
X > 0X > 0
Mental Mental HealthHealth
0 > X0 > X
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Is Medicine Related to Worse HRQOL?
1 No deaddead2 No deaddead
3 No 50 4 No 75 5 No 100 6 Yes 0 7 Yes 25 8 Yes 50 9 Yes 75 10 Yes 100
MedicationPerson Use HRQOL (0-100)
No Medicine 3 75Yes Medicine 5 50
Group n HRQOL
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http://www.ukmi.nhs.uk/Research/pharma_res.asp
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Health state 424421 • Your health limits you a lot in moderate
activities (such as moving a table, pushing a vacuum cleaner, bowling or playing golf)
• You are limited in the kind of work or other activities as a result of your physical health
• Your health limits your social activities (like visiting friends, relatives etc.) most of the time.
• You have pain that interferes with your normal work (both outside the home and housework) moderately
• You feel tense or downhearted and low a little of the time.
• You have a lot of energy all of the time
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Health state 424421 (0.59)• Your health limits you a lot in moderate
activities (such as moving a table, pushing a vacuum cleaner, bowling or playing golf)
• You are limited in the kind of work or other activities as a result of your physical health
• Your health limits your social activities (like visiting friends, relatives etc.) most of the time.
• You have pain that interferes with your normal work (both outside the home and housework) moderately
• You feel tense or downhearted and low a little of the time.
• You have a lot of energy all of the time
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0.0
0.2
0.4
0.6
0.8
1.0
-3.00 -2.00 -1.00 0.00 1.00 2.00 3.00
Posttraumatic Growth
Pro
babilit
y o
f R
esponse
Category Response Curves
Great Change
No Change
Very small
change
No chang
e
Small change
Moderate
change
Great change
Very great change
“Appreciating each day.”
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Variability• Responses fall in each response category
• Distribution approximates bell-shaped “normal” curve (68.2%, 95.4%, and 99.6%)
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Reliability
Reliability is the degree to which the same score is obtained for thing being measured (person, plant or whatever) when that thing hasn’t changed.
– Ratio of signal to noise
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Reliability (0-1) >=0.70 (group comparisons) >=0.90 (individual assessment)
SEM = SD (1- reliability)1/2 95% CI = true score +/- 1.96 x SEM
if z-score = 0, then CI: -.62 to +.62 so width of CI is 1.24 z-score units when reliability = 0.90
z-scores (mean = 0 and SD = 1):– Reliability = 1 – SE2
– So reliability = 0.90 when SE = 0.32T-scores (mean = 50 and SD = 10):
– Reliability = 1 – (SE/10)2
– So reliability = 0.90 when SE = 3.2
T = 50 + (z * 10)
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In the past 7 days …
I was grouchy [1st question]– Never [39]– Rarely [48]– Sometimes [56]– Often [64]– Always [72]
Theta = 56.1 SE = 5.7 (rel. = 0.68)
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In the past 7 days …I felt like I was ready to explode [2nd question]
– Never– Rarely– Sometimes– Often– Always
Theta = 51.9 SE = 4.8 (rel. = 0.77)
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In the past 7 days …
I felt angry [3rd question]– Never– Rarely– Sometimes– Often– Always
Theta = 50.5 SE = 3.9 (rel. = 0.85)
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In the past 7 days …I felt angrier than I thought I should [4th question] - Never
– Rarely– Sometimes– Often– Always
Theta = 48.8 SE = 3.6 (rel. = 0.87)
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In the past 7 days …
I felt annoyed [5th question]– Never– Rarely– Sometimes– Often– Always
Theta = 50.1 SE = 3.2 (rel. = 0.90)
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In the past 7 days …
I made myself angry about something just by thinking about it. [6th question]
– Never– Rarely– Sometimes– Often– Always
Theta = 50.2 SE = 2.8 (rel = 0.92)
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Theta, SEM, and 95% CI
56 and 6 (reliability = .68) W = 2252 and 5 (reliability = .77) W = 1950 and 4 (reliability = .85) W = 1549 and 4 (reliability = .87) W = 1450 and 3 (reliability = .90) W = 1250 and <3 (reliability = .92) W = 11
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Defining a Responder: Reliable Change Index
(RCI)
)( )2(12
SEM
XX
xxbl rSDSEM 1
Note: SDbl = standard deviation at baseline rxx = reliability
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Amount of Change in Observed Score Needed To be Statistically Significant
(1.96) )r - (1)(SD )2( xxbl
Note: SDbl = standard deviation at baseline and rxx = reliability
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Emotional Well-Being and Physical Functioning of 54 Patients at UCLA-Center for East-West
Medicine
EmotionalPhysical
MS = multiple sclerois; ESRD = end-stage renal disease; GERD = gastroesophageal reflux disease.
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Significant Improvement in all but 1 of SF-36 Scales (Change is in T-score metric)
Change t-test prob.
PF-10 1.7 2.38 .0208
RP-4 4.1 3.81 .0004
BP-2 3.6 2.59 .0125
GH-5 2.4 2.86 .0061
EN-4 5.1 4.33 .0001
SF-2 4.7 3.51 .0009
RE-3 1.5 0.96 .3400
EWB-5 4.3 3.20 .0023
PCS 2.8 3.23 .0021
MCS 3.9 2.82 .0067
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Effect Size
(Follow-up – Baseline)/ SDbaseline
Cohen’s Rule of Thumb:
ES = 0.20 Small
ES = 0.50 Medium
ES = 0.80 Large
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Effect Sizes for Changes in SF-36 Scores
0
5
10
15
20
25
30
35
40
45
50
PFI Role-P Pain Gen H Energy Social Role-E EWB PCS MCS
Baseline
Followup
0.13 0.35 0.35 0.21 0.53 0.36 0.11 0.41 0.24 0.30
Effect Size
PFI = Physical Functioning; Role-P = Role-Physical; Pain = Bodily Pain; Gen H=General Health; Energy = Energy/Fatigue; Social = Social Functioning;Role-E = Role-Emotional; EWB = Emotional Well-being; PCS = Physical Component Summary; MCS =Mental Component Summary.
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Amount of Change Needed for Significant Individual
Change 0.67 0.72 1.01 1.13 1.33 1.07 0.71 1.26 0.62 0.73
Effect Size
PFI = Physical Functioning; Role-P = Role-Physical; Pain = Bodily Pain; Gen H=General Health; Energy = Energy/Fatigue; Social = Social Functioning;Role-E = Role-Emotional; EWB = Emotional Well-being; PCS = Physical Component Summary; MCS =Mental Component Summary.
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7-31% of People in Sample Improve Significantly
% Improving % Declining Difference
PF-10 13% 2% + 11%
RP-4 31% 2% + 29%
BP-2 22% 7% + 15%
GH-5 7% 0% + 7%
EN-4 9% 2% + 7%
SF-2 17% 4% + 13%
RE-3 15% 15% 0%
EWB-5 19% 4% + 15%
PCS 24% 7% + 17%
MCS 22% 11% + 11%
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“Implementing patient-reported outcomes assessment in clinical practice: a review of
the options and considerations”
Snyder, C.F., Aaronson, N. K., et al. Quality of Life Research, 21, 1305-1314.
– HRQOL has rarely been collected in a standardized fashion in routine clinical practice.
– Increased interest in using PROs for individual patient management.
– Research shows that use of PROs:• Improves patient-clinician communication• May improve outcomes
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Content Validity
• Does the measure adequately represent the domain?– Do items operationalize concept?– Do items cover all aspects of concept?– Does scale name represent item content?
• Face validity is extent to which measure “appears” to reflect what it is intended to– E.g., by expert judges or by patient focus groups
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Evaluating Construct ValidityScale Age Obesity ESRD Nursing
Home Resident
Physical Functioning
Medium (-). Small (-) Large (-) Large (-)
Depressive Symptoms
? Small (+) ? Small (+)
Cohen effect size rules of thumb (d = 0.2, 0.5, and 0.8):Small correlation = 0.100Medium correlation = 0.243Large correlation = 0.371r = d / [(d2 + 4).5] = 0.8 / [(0.82 + 4).5] = 0.8 / [(0.64 + 4).5] = 0.8 / [( 4.64).5] = 0.8 / 2.154 = 0.371 (Beware r’s of 0.10, 0.30 and 0.50 are often cited as small, medium, and large.)
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Responsiveness to Change and Minimally Important Difference (MID)
• HRQOL measures should be responsive to interventions that changes HRQOL
• Need external indicators of change (Anchors)– mean change in HRQOL scores among people who
have changed (“minimal” change for MID).
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Self-Report Indicator of Change
• Overall has there been any change in your asthma since the beginning of the study?
Much improved Moderately improved Minimally improvedNo changeMinimally worse Moderately worse Much worse
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Raw Score Change on PROMIS Physical Functioning (T-score)
by Change on Anchor
Lot Better
Little Better
Same Little Worse
Lot Worse
(n = 21) (n = 35) (n = 252) (n = 113) (n = 30)
Wave 3 – Wave 1 1.94a 1.63a,b 0.27b -1.68c -3.20d
Wave 3 – Wave 2 3.26a 1.96a,b 0.43b,c -0.82c -3.16d
Wave 3 is 12 months after wave 1. Wave 2 is 6 months after wave 1.
Better = got a lot better or a little better on anchor.Worse = got a lot worse or a little worse on anchor.
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0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
-4 -3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 0.5 1 1.5 2 2.5 3 3.5 4
Trait level
Pro
babi
lity
of "
Yes
" R
espo
nse
Location DIF
Slope DIF
DIF (2-parameter model)
White
AA
AA
White
Location = uniform; Slope = non-uniform
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Person Fit• Large negative ZL values indicate misfit.
– one person who responded to 14 of the PROMIS physical functioning items had a ZL = -3.13
– For 13 items the person could do the activity (including running 5 miles) without any difficulty.
• But this person reported a little difficulty being out of bed for most of the day.
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Final Thoughts
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