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Evaluating the Significance of Health-Related Quality of Life Change in Individual Patients R on Hays [email protected] October 8, 2004 UCLA GIM/HSR Research Seminar Series. Motivation. Interest in knowing how many patients benefit from group intervention

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slide1

Evaluating the Significance of Health-Related Quality of Life Change in Individual PatientsRon [email protected]

October 8, 2004

UCLA GIM/HSR Research Seminar Series

motivation
Motivation
  • Interest in knowing how many patients benefit from group intervention
  • Tracking progress on individual patients
ucla center for east west medicine
UCLA Center for East-West Medicine
  • Staff training in biomedicine and traditional Chinese medicine.
  • Treat chronic pain conditions (e.g., neck and back pain, headaches, fibromyalgia, sports and occupational-related injuries), and cancer-related symptoms.
  • Provide comprehensive care, emphasizing health promotion, disease prevention, treatment and rehabilitation.
  • Patient education, medication adjustments, trigger point injections, acupuncture, acupressure, therapeutic massage, dietary and herbal counseling, and mind-body exercises.
based on submitted paper
Based on Submitted Paper
  • Ron D. Hays, Marc Brodsky, M. Francis Johnston, Karen L. Spritzer, Ka-Kit Hui
  • Evaluating Health-Related Quality of Life Change in Individual Patients
  • Submitted to Evaluation and the Health Professions
methods
Methods
  • 54 patients
  • Average age = 56; 84% white; 58% female
  • Self-administered SF-36 version 2 at baseline and about at end of therapy (about 6 weeks later).
sf 36 version 2
SF-36 Version 2
  • Physical functioning (10 items)
  • Role limitations/physical (4 items)
  • Pain (2 items)
  • General health perceptions (5 items)
  • Social functioning (2 items)
  • Energy/fatigue (4 items)
  • Role limitations/emotional (3 items)
  • Emotional well-being (5 items)
scoring the sf 36
Scoring the SF-36
  • 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)
      • T-score = 50 + (z-score * 10)
internal consistency reliability formula
Internal Consistency Reliability Formula

MSBMS = mean square between, MSEMS = mean square for interaction between respondents and items.

physical health
Physical Health

Physical Health

Physical function

Role function-physical

Pain

General Health

mental health
Mental Health

Mental Health

Emotional Well-Being

Role function-emotional

Energy

Social function

sf 36 version 2 pcs and mcs
SF-36 Version 2 PCS and MCS
  • PCS_z = (PF_z * .42402) + (RP_z * .35119) + (BP_z * .31754) + (GH_z * .24954) + (EF_z * .02877) + (SF_z * -.00753) + (RE_z * -.19206) + (EW_z * -.22069)
  • MCS_z = (PF_z * -.22999) + (RP_z * -.12329) + (BP_z * -.09731) + (GH_z * -.01571) + (EF_z * .23534) + (SF_z * .26876) + (RE_z * .43407) + (EW_z * .48581)
reliability of sf 36 summary scores
Reliability of SF-36 Summary Scores
  • SF-36 PCS = 0.94
  • SF-36 MCS = 0.93
analysis plan
Analysis Plan
  • * Comparison on SF-36 physical functioning and emotional well-being scale scores with other samples
  • * Significance of:
  • - Within group change
  • - Within individual change
t test for within group change
t-test for within group change
  • XD/(SDd/n ½)

XD = is mean difference, SDd = standard deviation of difference

formulas for significance of individual change
Formulas for Significance of Individual Change

SDb = standard deviation at baseline

estimated true score for score of 60
Estimated True Score for Score of 60
  • Mean + reliability (score – mean)
  • 50 + 0.90 (60 – 50) = 59
reliable change index
Reliable Change Index
  • X2 – X1/ SEM * SQRT (2)
slide20

Formulas for Significance of Individual Change

SDb = standard deviation at baseline

minimum delta for individual significance
Minimum Delta for Individual Significance
  • SEM: > 1.96 SEM
  • RCI: > 1.96 * SQRT (2) * SEM
  • SEp-90: > 1.64 SEp; SEp-95: > 1.96 SEp
slide22

Physical Functioning and Emotional Well-Being at Baseline

for 54 Patients at UCLA-Center for East West Medicine

Hays et al. (2000), American Journal of Medicine

change in sf 36 scores over time
Change in SF-36 Scores Over Time

Effect Size

0.13

0.35

0.35

0.21

0.53

0.36

0.11

0.41

0.24

0.30

bibliography
Bibliography
  • Bauer, S., Lambert, M. J., & Nielsen, S. L. (2004). Clinical significance methods: A comparison of statistical techniques. Journal of Personality Assessment, 82, 60-70.
  • Dudek, F. J. (1979). The continuing misinterpretation of the standard error of measurement. Psychological Bulletin, 86, 335-337.
  • Ferguson, R. J., Robinson, A. B., & Splaine, M. (2002). Use of the reliable change index to evaluate clinical significance in SF-36 outcomes. Quality of Life Research, 11, 509-516.
  • Hsu, L. M. (1989). Reliable changes in psychotherapy: Taking into account regression toward the mean. Behavioral Assessment, 11, 459-467.
  • Jacobson, N. S., Follette, W. C., & Revenstorf, D. (1984). Toward a standard definition of clinically significant change. Behavior Therapy, 17, 308-311.
  • Speer, D. C., & Greenbaum, P. E. (1995). Five methods for computing significant individual client change and improvement rates: Support for an individual growth curve approach. Journal of Consulting and Clinical Psychology, 63, 1044-1048.
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