Post on 13-Jun-2020
Minimally Important Difference
MID
Miyazaki.kikuko.4s@kyoto-u.ac.jp
2014 6 21
PRO
1. Minimally Important Difference MID
QOL
2. MID
3. MID
4. MID COSMIN
5. EORTC QLQ-C15-PAL MID
2014/6/21 8 CSP-HOR 2
Donabedian
structure
process
outcome
2014/2/22 QOL/PRO 3
QI
(Donabedian, JAMA, 1988)
Patient-
reported-
outcome
(PRO)
• QOL
QOL
• QOL
2014/2/22 QOL/PRO 4
QOL
• WHO
1948
•
QOL
• QOL
2014/2/22 QOL/PRO 5
Patient-reported outcome(s): PRO(s)
European Medicines Agency EMA (2005)
U. S. Food and Drug Administration (FDA) (2009 )
PRO
•
2014/2/22 QOL/PRO 6
QOL
1.
2.
QOL
3. QOL
4. QOL
5. QOL
2014/2/22 QOL/PRO 7
1. Minimally Important Difference MID
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VAS well-being
10 VAS 0.5
0.5
0.5
Ρ<0.05
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(Jaeschke et al, Control Clin Trials, 1989) 9
QOL MID
QOL/PRO 10
QOL
PROQOL QOL
From Measurement to Understanding
QOL
MID
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MID Minimally Important Difference
QOL
MID
The smallest difference in score in the domain of interest
2014/6/21 8 CSP-HOR QOL/PRO 11
(Jaeschke et al., Control Clin Trials,1989, )
• QOL
• QOL 5
5
• 5
• 5
•
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2014/6/21 8 CSP-HOR 13
2 MID
2014/6/21 8 CSP-HOR QOL/PRO 14
QOL
Distribution-based methods
- QOL
-
Anchor-based methods
-
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Patient subjective view
PS,
Clinical parameter
MID
Distribution-based method Distribution-based method
Anchor-based method
Patient subjective view
PS,
Clinical parameter
Anchor-based method
Clinician perspective
MMMMMMMMMMMMMMIIIIIDDDDDDDDDDDDDMID
MID
QOL
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• Distribution-based method
• Anchor-based method
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17
3. MID
2014/6/21 8 CSP-HOR QOL/PRO 18
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Osoba et al. 1998
246 111
EORTC QLQ-C30 Global rating scale
- 5-10
- 10-20
- 20
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Norman et al. 2003
Systematic review
38 62 effect size
MID 0.5 SD
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Wyrwich et al. 2007
- COPD 2988 610
- CRQ Chronic Respiratory Disease Questionnaire SF36
-
- MID
4. MID COSMIN
2014/6/21 8 CSP-HOR QOL/PRO 22
COSMIN: COnsensus-based Standards for
the selection of health Measurement INstruments
HR-PRO
(http://www.cosmin.nl/)
2014/6/21 8 CSP-HOR 23
COSMIN • 2006 -2007
91 43
•
•
• [Classical Test Theory: CTT]
[Item Response Theory: IRT]
• 4
4 18
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Box J. Interpretability
8. Was the minimal important change (MIC)
or the minimal important difference (MID)
determined?
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5 EORTC QLQ-C15-PAL MID
2014/6/21 8 CSP-HOR QOL/PRO 26
Background Palliative Medicine
• Palliative care is an approach that improves the quality of life (QOL) of patients and their families facing the problem associated with life-threatening illness.
QOL (WHO, 2002, National Cancer Control Programmes
Policies and managerial guideline 2nd edition)
• Outcomes of palliative care can be obtained by measuring patient QOL.
QOL
2014/6/21 27 8 CSP-HOR
Purpose
To estimate MID for EORTC QLQ-C15-PAL scores for the assessment of QOL of palliative care patients.
QOL EORTC QLQ-C15-PAL(European Organisation for Research and Treatment of Cancer Quality of Life Core 15 Palliative) MID
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29
First survey 1 Second survey 2
2w
EORTC QLQ-C15-PAL
Clinical information*
EORTC QLQ-C15-PAL
GRS
Clinical information*
“What do patients themselves think of the
difference between the first and second time
they participated in the QOL survey?”
QOL
Measurement method
2014/6/21 8 CSP-HOR
EORTC QLQ-C15-PAL
• EORTC QLQ-C15-PAL was developed for palliative care patients by taking
the 30-item QLQ-C30 as a base and reducing the number of questions to
15 items.
EORTC QLQ-C15-PAL QLQ-C30
30 15 15
(Groenvold M, et al. Eur J Cancer, 2006)
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Results Flowchart for Patient Selection
Request participation
n=257
Number of patients enrolled in
the 1st QOL survey
1 QOL
n=240
2nd QOL survey and
GRS survey completed
MID analysis subjects 2
n=181
Refusal n=12
Worsened condition n=3
Transfer n=2
Death n=20
Worsened condition n=25 No follow-up due to transfer
n=11
Discontinuation by request
n=2
Unknown n=1
2014/6/21 31 8 CSP-HOR
2nd survey-
response(n=181)
2nd survey-no-
response(n=59)
χ2 test
p-value
Number of
patients
or average
or SD Number of
patients
or average
or SD
Sex Male 92 50.8% 38 64.5% 0.073
Female 89 49.2% 21 35.6%
Age 66.8 12.5 67.3 10.4 0.646
Underlying Lung cancer 31 17.1% 11 18.6% 0.535
disease Colon cancer 24 13.3% 6 10.2%
Brest cancer 21 11.6% 5 8.5%
Prostate cancer 14 7.7% 4 6.8%
Stomach cancer 12 6.6% 5 8.5%
Esophageal cancer 10 5.5% 2 3.4%
Uterine cancer 10 5.6% 3 5.1%
Pancreatic cancer 9 5.5% 6 10.2%
Renal cancer 8 4.4% 0 0.0%
Liver cancer 7 3.9% 7 11.9%
Others* 35 19.3% 10 16.9% 32
*Gallbladder cancer, peritoneal cancer, oral cancer, pharyngeal/laryngeal cancer, bladder cancer, Ewing’s sarcoma, etc.
Characteristics of the patients 2 2
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2nd survey-
response(n=181)
2nd survey-no-
response(n=59)
Number of
patients
Number of
patients
χ2 test
p-value
ECOG PS 0 10 5.5% 2 3.4% 0.014
(1st time) 1 30 16.6% 5 8.5%
2 61 33.7% 12 20.3%
3 67 37.0% 29 49.2%
4 13 7.2% 11 18.6%
ECOG PS 0 10 5.5%
(2nd time) 1 30 16.6%
2 60 33.1%
3 64 35.4%
4 17 9.4%
2014/6/21 33
ECOG PS of patients based on participation in
the second survey 2 2
8 CSP-HOR
Discussion
Examination of MIDs for each domain
• EORTC QLQ-C15-PAL
•
• QOL
2014/6/21 34 8 CSP-HOR
Direction toward improving or worsening
• Anchor-based MID
(Cella, et al. Qual Life Res, 2002)
• QOL MID
Limitation
QOL
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Conclusion
• MID 11.5
• MID 4.5
• QOL
MID
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1. Minimally Important Difference MID
QOL
2. MID Distribution-based methods
Anchor-based methods
3. MID
4. MID COSMIN MID
5. EORTC QLQ-C15-PAL MID
MID
2014/6/21 8 CSP-HOR 37
MID
• MID
• MID
2014/6/21 8 CSP-HOR QOL/PRO 38
2014/6/21 8 CSP-HOR 39
Dr. Wyrwhich