➨㻤ᅇ㻌 㻯㻿㻼㻙㻴㻻㻾ᖺ఍㻌
2014ᖺ6᭶21᪥㻌ᮾி኱Ꮫఀ⸨ㅰᜠ䝩䞊䝹PRO䛾ྛㄽ䛚ヰ䛧䛩䜛ணᐃ
1. Minimally Important Difference䠖MID䛸䛿㻌 㻌 䠄QOLホ౯䛾⮫ᗋ䛻䛚䛡䜛᭱ᑠ㔜せᕪ䠅
2. MID䛾 ᐃ᪉ἲ
3. MID◊✲䛾⤂௓
4. ᑻᗘ㛤Ⓨ䛸MID䠖COSMIN
5. EORTC QLQ-C15-PAL䛾MID

Minimally Important Difference
䠄MID䠅
ᐑᓮ㈗ஂᏊ
ி㒔኱Ꮫ኱Ꮫ㝔་Ꮫ◊✲⛉♫఍೺ᗣ་Ꮫ⣔ᑓᨷ㻌 ೺ᗣ᝟ሗᏛศ㔝
Miyazaki.kikuko.4s@kyoto-u.ac.jp

2014/6/21

Donabedian䛾་⒪ホ౯䝰䝕䝹⫼ᬒ䠖⑌ᝈศᕸ䛾ኚ໬

structure• QOLホ౯䛾⫼ᬒ䛻䛿䚸䛜䜣䚸⢾ᒀ⑓䚸ື⬦◳໬䛺䛹䛾៏ᛶ⑌ᝈ䜔⏕ά⩦័⑓䛜ቑຍ䚹἞⒵䜔ᘏ࿨䛰䛡䛷䛺䛟䚸ᝈ⪅䛾QOL䛾ྥୖ䛜἞⒪䛾┠ᶆ䛸䛥䜜䜛䜘䛖䛻䛺䛳䛯་⒪᪋タ䛾つᶍ䚸タഛ䚸་ᖌ䞉┳ㆤᖌᩘprocess
་⒪ᢏ⾡䞉་⒪䝃䞊䝡䝇䚸QI2㄀8ಲCSP-HORᑈӮ

Patientreportedoutcome(PRO)㻌㻌֝• ᝈ⪅䛾୺ほ䛻ᇶ䛵䛟QOL䜢ᐃ㔞໬䛩䜛䛯䜑䛻䚸⛉Ꮫⓗ䛻ಙ㢗ᛶ䛸ጇᙜᛶ䛜᳨ド䛥䜜䛯ᑻᗘ䛜ᥦ᱌

outcome⨯ᝈ⋡䚸ྜే⑕Ⓨ⑕⋡䚸㔜⑕ᗘ䚸Ṛஸ⋡἞⒵⋡䚸⏕Ꮡᮇ㛫䚸ᝈ⪅❧⬮ᆺ䜰䜴䝖䜹䝮(Donabedian, JAMA, 1988)
2014/2/22

QOL/PRO◊✲఍3

2014/2/22

QOL/PRO◊✲఍

QOL䛾ᵓᡂせ⣲Patient-reported outcome(s): PRO(s)• ᇶᮏⓗ䛺ᵓᡂせ⣲䛿䚸WHO䛾೺ᗣ䛾ᐃ⩏
䠄1948䠅䛻‽ᣐ䛩䜛䛸䛔䛖䝁䞁䝉䞁䝃䝇European Medicines Agency䠄EMA䠅 (2005)• ඲యⓗ೺ᗣ䚸㌟యⓗ⑕≧䚸ᚰ⌮ⓗᶵ⬟䚸♫఍ⓗᶵ⬟䚸ᙺ๭ᶵ⬟䛻ຍ䛘䛶䚸㏆ᖺ䛿QOL䛻䝇䝢䝸䝏䝳䜰䝹䛺䛹䜒ྵ䜎䜜䜛䛸䛔䛖⪃䛘᪉
• QOL䜢 ᐃ䛩䜛┠ⓗ䛻䜘䛳䛶ᚲせ䛺せ⣲䛜␗䛺䜛䛣䛸䛛䜙䚸㻌 э⤫୍ⓗ䛺ᐃ⩏䛿ᐃ䜑䜙䜜䛶䛔䛺䛔PROホ౯ᣦ㔪

2014/2/22

QOL/PRO◊✲఍

4

U. S. Food and Drug Administration (FDA) (2009䠅)5• ⮫ᗋᐙ䛭䛾௚䛾ㄡ䛾ゎ㔘䜒௓䛥䛪䚸ᝈ⪅䛛䜙┤᥋ᚓ䜙䜜䛯䚸ᝈ⪅䛾೺ᗣ≧ែ䛻㛵䛩䜛䛒䜙䜖䜛ሗ࿌䚹

2014/2/22

QOL/PRO◊✲఍6

་⒪䛻䛚䛡䜛QOL ᐃ䛾䝏䜵䝑䜽䝫䜲䞁䝖
1. ఱ䛾䛯䜑䛻 ᐃ䛩䜛䛾䛛䛸䛔䛖┠ⓗ䛿᫂☜䛛䠛
2. 䛭䛾┠ⓗ䛻ྜ⮴䛧䛯ᵓᡂ䛾㉁ၥ㡯┠䛜䛒䜛㻌 㻌 QOL㉁ၥ⚊䛛䠛
3.㻌 䛭䛾QOL㉁ၥ⚊䛿䚸ಙ㢗ᛶ䛸ጇᙜᛶ䛜᳨ド㻌 㻌 䛥䜜䛶䛔䜛䛛䠛
4.㻌 QOL䛿ᇶᮏⓗ䛻䛿ᝈ⪅䛾୺ほⓗᣦᶆ䛷䛒㻌 㻌 䜛䛾䛷䚸ᝈ⪅ᮏே䛻䜘䜛ᅇ⟅䛛䠛
5.㻌 QOL䛾ホ౯䜔ศᯒ䛿⤫ィᏛⓗ᪉ἲ䛻౫ᣐ䛧㻌㻌 㻌 䛶䛔䜛䛛䠛㻌
2014/2/22

QOL/PRO◊✲఍7

1. Minimally Important Difference䠖MID䛸䛿

2014/6/21

㄀8ಲCSP-HORᑈӮ8QOLホ౯ ◊✲䛸MID◊✲䛾ὶ䜜ᝈ⪅䛥䜣䛻VAS䛷well-being䜢⪺䛝䜎䛧䛯QOL◊✲⮫㻌 ᗋ㻌 10䟛䛾VAS䛷䚸๓ᅇ䛸0.5䟛䛾㻌 ኚ໬䛜䛒䜚䜎䛧䛯PRO䛾୍䛴䛸䛧䛶䚸
QOLホ౯⚊䛾㛤Ⓨ㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 0.5䟛䛿䚸㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 ⮫ᗋⓗ䛻ព࿡䛜䛒䜛ᕪ䠛

QOLホ౯䛾⤖ᯝ䜢⮫ᗋ䛷䜒౑⏝䛧䛯䛔䛸䛔䛖せᮃὶ䜜䛾୍䛴䛸䛧䛶䚸㻌 0.5䟛䛷䛿䚸

䇾From
Measurement toUnderstanding䇿䜈㻌 䛒䜎䜚ព࿡䛜䛺䛔䛾䛷䛿䠛㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 Ρ<0.05䛰䛳䛯䜙䚸㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 ⮫ᗋⓗ䛻ព࿡䛜䛒䜛䠛⮫ᗋୖ䛷ព࿡䛜
䛒䜛QOL䝇䝁䜰䛾ᕪ䛸䛿䠛MID䠄᭱ᑠ㔜せᕪ䠅䛾◊✲(Jaeschke et al, Control Clin Trials, 1989)
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9㄀8ಲCSP-HORᑈӮ

2014/6/21

MID䠄Minimally Important Difference䠅㻌 㻌 QOL䝇䝁䜰䛾㻌 㻌 ᭱ᑠ䛾ᕪ䠄್䠅㻌 㻌 䠙䛂⮫ᗋⓗ䛻ព࿡䛜䛒䜛᭱ᑠ㔜せᕪ䠖MID䛃
The smallest difference in score in the domain of interest(Jaeschke et al., Control Clin Trials,1989, )QOL/PRO◊✲఍㻌 11

㄀8ಲCSP-HORᑈӮ• ᝈ⪅䛥䜣䛾どⅬ䛷䚸QOLホ౯䜢䛧䜎䛧䜗䛖䟿• QOL䝇䝁䜰䛷䚸5䝫䜲䞁䝖ୖ䛜䛳䛯䚸㻌 㻌 䛒䜛䛔䛿5䝫䜲䞁䝖ୗ䛜䛳䛯䚹• 䛭䛾5䝫䜲䞁䝖䛿䚸ᝈ⪅䛥䜣䛻䛸䛳䛶㻌 㻌 䛹䛖ឤ䛨䜙䜜䛶䛔䜛䛾䠛• 䛭䛾5䝫䜲䞁䝖䛸䛿䚸ᝈ⪅䛥䜣䛻䛸䛳䛶㻌 㻌 ఱ䜒ឤ䛨䜙䜜䛶䛔䛺䛔䛾䠛• ឤ䛨䜙䜜䛶䛔䜛䛸䛧䛯䜙䚸䛹䛖䛔䛖ព࿡䛷䠛
2014/6/21

䛹䛾⛬ᗘ䛾ᕪ䜢䛂⮫ᗋⓗ䛻᭷ព䛺ᕪ䛃䛸䛩䜛䛛䠛

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13

㄀8ಲCSP-HORᑈӮ

10ᝈ⪅どⅬ䛾་⒪ホ౯㻌 ≉ᐃ㡿ᇦ䛻䛚䛡䜛2014/6/21

QOL/PRO◊✲఍㻌㄀8ಲCSP-HORᑈӮ12

㄀8ಲCSP-HORᑈӮ

2䠊MID䛾

2014/6/21

ᐃ᪉ἲ㄀8ಲCSP-HORᑈӮ

QOL/PRO◊✲఍㻌 14⮫ᗋⓗ䛺ゎ㔘

QOL䝇䝁䜰䛾ᕪ䛾ព࿡䜢ぢฟ䛩䛻䛿䚸MID䛾ㄪᰝ᪉ἲ䠍䠊Distribution-based methods⮫ᗋᐙ䛾ほⅬClinician perspective

Anchor-based method

QOL䝇䝁䜰䛸䚸

㻌 -㻌 QOL䝇䝁䜰䛷ぢ䜙䜜䛯ᕪ䛸
Distribution-based method㻌 㻌 㻌 䝕䞊䝍ศᕸ䜢ẚ㍑
㻌 -㻌 እⓗᇶ‽䛜↓䛔䞉㻱㼒㼒㼑㼏㼠㻌㼟㼕㼦㼑㻌㻔㻱㻿㻕㻌䞉㻿㼠㼍㼚㼐㼍㼞㼐㼕㼦㼑㼐㻌㼞㼑㼟㼜㼛㼚㼟㼕㼢㼑㼚㼑㼟㼟㻌㻌㻌㻌㻌㼙㼑㼍㼚㻌㻾㼑㼟㼜㼛㼚㼟㼕㼢㼑㻌㼟㼠㼍㼠㼕㼟㼠㼕㼏㻌䞉㻼㼍㼕㼞㼑㼐㻌㼠㻙㼟㼠㼍㼠㼕㼟㼠㼕㼏㻌䞉㻿㼠㼍㼚㼐㼍㼞㼐㼕㼦㼑㼐㻌㼑㼞㼞㼛㼞㻌㼛㼒㻌㻌㻌㻌㻌㼙㼑㼍㼟㼡㼞㼑㼙㼑㼚㼠㻌㻔㻿㻱㻹㻕㻌䠎䠊Anchor-based methods㻌 -㻌 ぢ䜙䜜䛯ᕪ䛸እⓗᇶ‽䠄䜰䞁䜹䞊䠅䜢ẚ㍑

MIDMIDᝈ⪅䛾୺ほPatient subjective view䞉㻾㼑㼠㼞㼛㼟㼜㼑㼏㼠㼕㼢㼑㻌㼞㼑㼜㼛㼞㼠㻌㻌䞉㻾㼑㼠㼞㼛㼟㼜㼑㼏㼠㼕㼢㼑㼞㼑㼜㼛㼞㼠㼠㻌㻌㻌㼛㼒㻌㼓㼘㼛㼎㼍㼘㻌㼏㼔㼍㼚㼓㼑㻌㼛㼒 㼓㼘㼛㼎㼍㼘 㼏㼔㼍㼚㼓㼑⤫ィᏛⓗ䛺ゎ㔘PS, ᳨ᰝ್䛺䛹䛾እ㒊ᇶ‽Clinical parameter2014/6/21

㄀8ಲCSP-HORᑈӮ

QOL/PRO◊✲఍㻌 15

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㄀8ಲCSP-HORᑈӮ16• Distribution-based method䠄⤫ィᏛⓗ䠅Ⰻ䛟䛺䛳䛯ᝏ䛟䛺䛳䛯

3. MID◊✲䛾⤂௓• Anchor-based method䠄ᇶ‽䛸ᑐᛂ䠅ᝏ䛟䛺䛳䛯

2014/6/21

୙ኚ

Ⰻ䛟䛺䛳䛯

㄀8ಲCSP-HORᑈӮ17

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㄀8ಲCSP-HORᑈӮ

QOL/PRO◊✲఍㻌 18㻌㻌 㻌 Osoba et al.䠄1998䠅㻌 㻌 ங⒴ᝈ⪅246ே䛸⫵⒴ᝈ⪅111ே䜢ᑐ㇟㻌 㻌 EORTC QLQ-C30䛸ᝈ⪅䛾ሗ࿌䠄Global rating scale䠅䛛䜙䚸㻌 㻌 -㻌 䝇䝁䜰䛾᭱ᑡ䛾ኚ໬䛿5-10
㻌 㻌 -㻌 ୰⛬ᗘ䛾ኚ໬䛿10-20
㻌 㻌 -㻌 ኱䛝䛺ኚ໬䛿20௨ୖ
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㄀8ಲCSP-HORᑈӮ19

㻌 Norman et al.䠄2003䠅㻌 㻌 Systematic review㻌 㻌 38 ᩥ⊩୰䛾 62䛾effect size䜘䜚㻌 㻌 MIDҸ0.5 SD
2014/6/21

㄀8ಲCSP-HORᑈӮ

204. ᑻᗘ㛤Ⓨ䛸MID䠖 COSMIN

㻌 Wyrwich et al.䠄2007䠅-㻌 COPDᝈ⪅䚸2988ே䜢ᑐ㇟䚸610ே䜢䝣䜷䝻䞊- CRQ䠄Chronic Respiratory Disease Questionnaire䠅䛸SF36- ᝈ⪅ᮏே䛾䜲䞁䝍䝡䝳䞊䚸࿧྾ჾᑓ㛛་䚸䝥䝷䜲䝬䝸䜿䜰་ 䛾䚸䠏䛴䛾ពぢ䜢᳨ウ䛧䛯- ᑓ㛛་䛸䝥䝷䜲䝬䝸䜿䜰་䛾MID 䛿䚸ᝈ⪅䜘䜚኱䛝䛛䛳䛯
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㄀8ಲCSP-HORᑈӮ21

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㄀8ಲCSP-HORᑈӮ

QOL/PRO◊✲఍㻌 22COSMIN䝏䜵䝑䜽䝸䝇䝖㻌㻌 COSMIN: COnsensus-based Standards for㻌 the selection of health Measurement INstruments೺ᗣ㛵㐃䛾ᝈ⪅ሗ࿌䜰䜴䝖䜹䝮䠄HR-PRO䠅㻌ᐃᑻᗘసᡂ᫬䛻䛚䛡䜛䝁䞁䝉䞁䝃䝇䛻ᇶ䛵䛔䛯ᇶ‽㻌㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 (http://www.cosmin.nl/)

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㄀8ಲCSP-HORᑈӮ

23• 2006ᖺ-2007ᖺ䛻䚸ᚰ⌮Ꮫ䚸␿Ꮫ䚸⤫ィᏛ䚸་Ꮫ䛾ᑓ㛛ᐙ91ே䛻࿧䜃䛛䛡䜙䜜䚸43ே䛜ཧຍ•ᐃ≉ᛶ䛾⏝ㄒ䛸ᐃ⩏䜢䝕䝹䝣䜯䜲ἲ䛷సᡂ•ᐃᑻᗘ◊✲䛾᪉ἲㄽⓗ䛺㉁䜢䝏䜵䝑䜽䛩䜛ᇶ‽సᡂ• ྂ඾ⓗ䝔䝇䝖⌮ㄽ[Classical Test Theory: CTT]䛸㡯
┠཯ᛂ⌮ㄽ[Item Response Theory: IRT]䛻ᑐᛂ• 䝏䜵䝑䜽᪉ἲ䛿䚸4䝇䝔䝑䝥䜢⤒䛶䚸ヱᙜ䛩䜛䝪䝑
䜽䝇䛾4䛛䜙18䛾㡯┠䜢䝏䜵䝑䜽

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㄀8ಲCSP-HORᑈӮ24

Box J. Interpretability

5䠊EORTC QLQ-C15-PAL䛾MID8. Was the minimal important change (MIC)or the minimal important difference (MID)determined?

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25

㄀8ಲCSP-HORᑈӮ

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QOL/PRO◊✲఍㻌 26

㄀8ಲCSP-HORᑈӮBackground㻌Palliative Medicine㻌 ⦆࿴䜿䜰Purpose• Palliative care is an approach that improves the quality of life (QOL) ofpatients and their families facing the problem associated with lifethreatening illness.

To estimate MID for EORTC QLQ-C15-PAL scores for the assessment of QOL ofpalliative care patients.

㻌 ⦆࿴䜿䜰䛿䚸⏕࿨䛾༴ᶵ䛻┤㠃䛧䛯⑓䛾ᝈ⪅䛸ᐙ᪘䛾㻌㻌 QOL䜢㧗䜑䜛䜰䝥䝻䞊䝏䛷䛒䜛㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 (WHO, 2002, National Cancer Control Programmes䠅
Policies and managerial guideline 2nd edition)• Outcomes of palliative care can be obtained by measuring patient QOL.

⦆࿴䜿䜰ᝈ⪅⏝䛾QOLホ౯⚊䛷䛒䜛EORTC QLQ-C15PAL(European Organisation for Research and Treatmentof Cancer Quality of Life Core 15 Palliative)䛾MID䜢ᥦ♧䛩䜛⦆࿴䜿䜰䛾䜰䜴䝖䜹䝮䛿ᝈ⪅䛾QOL䜢 ᐃ䛩䜛䛣䛸䛷㻌 ᚓ䜙䜜䜛
㻌㻌㻌㻌

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27

㄀8ಲCSP-HORᑈӮ

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EORTC QLQ-C15-PAL

Measurement method
First survey㻌 1ᅇ┠• 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 to15 items.

Second survey㻌 2ᅇ┠EORTC QLQ-C15-PAL

EORTC QLQ-C15-PAL

Clinical information*28

㄀8ಲCSP-HORᑈӮEORTC QLQ-C15-PAL䛿䚸⦆࿴䜿䜰ᝈ⪅⏝䛻QLQ-C30
䛾30㡯┠䛛䜙15㡯┠䜢ῶ䜙䛧䛯15ၥ䛷సᡂ䛥䜜䛯GRS
Clinical information*㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌(Groenvold M, et al. Eur J Cancer, 2006)

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㄀8ಲCSP-HORᑈӮ

2w“What do patients themselves think of thedifference between the first and second timethey participated in the QOL survey?”ᝈ⪅ᮏே䛜๓ᅇ䛻QOL䜢ㄪᰝ䛧䛯᫬䛸ẚ䜉䛶䚸䛹䛾⛬ᗘ䛾㐪䛔䛜䛒䜛䛸ᛮ䛳䛶䛔䜛䛾䛛䠛
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㄀8ಲCSP-HORᑈӮ

29

Characteristics of the patientsResults
Flowchart for Patient Selection
Request participation㻌 ཧຍ༠ຊ䛾䛚㢪䛔㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌
n=257

SexRefusal㻌 ᣄྰn=12
Worsened condition ᝏ໬ n=3Transfer㻌 ㌿㝔㻌 㻌 㻌n=2

1ᅇ┠QOLㄪᰝᐇ᪋⪅㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌n=240㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌Death㻌 Ṛஸ㻌 㻌 㻌 㻌
n=20
Worsened condition㻌 ᝏ໬ n=25
No follow-up due to transfer⤊஢ศᯒᑐ㇟㻌 ㌿㝔ᚋ䝣䜷䝻䞊୙ྍ㻌 㻌 n=11
Discontinuation by request㻌㻌 ୰᩿⏦䛧ฟ㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 n=2
Unknown㻌 ୙᫂㻌 㻌 㻌 㻌 㻌 㻌 n=1㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌n=181
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2nd survey- 2ᅇ┠ᅇ⟅response(n=181)

2nd survey-no- 2ᅇ┠↓ᅇ⟅
response(n=59)

Number ofpatientsor average

Number ofpatientsor average䠂㻌 or㻌 SD

䠂㻌 or SDχ2㻌 testp-value
0.073

Male

92

50.8%

38

64.5%

Female

89

49.2%

21

35.6%

66.8

12.5

67.3

10.4

0.646

Underlying

Lung cancer

31

17.1%

1118.6%0.535

diseaseColon cancer

24

13.3%

610.2%

ཎ⑌ᝈ Brest cancer

Age

Number of patients enrolled in
the 1st QOL survey

2nd QOL survey andGRS survey completed㻌 㻌
MID analysis subjects 2ᅇ┠30

2111.6%

58.5%

Prostate cancer

147.7%

46.8%

Stomach cancer

126.6%

58.5%

Esophageal cancer

105.5%

23.4%

Uterine cancer

105.6%

35.1%

Pancreatic cancer

95.5%

610.2%

Renal cancer

84.4%

00.0%

Liver cancer

73.9%

711.9%

Others*35

19.3%

1016.9%*Gallbladder cancer, peritoneal cancer, oral cancer, pharyngeal/laryngeal cancer, bladder cancer, Ewing’s sarcoma,32etc.
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㄀8ಲCSP-HORᑈӮECOG PS of patients based on participation inthe second survey
2nd survey-2ᅇᅇ⟅
response(n=181)

2nd survey-no-

Number ofpatients䠂㻌

Number ofpatients䠂

χ2㻌 testp-value

23.4%

0.014

response(n=59)2ᅇ┠↓ᅇ⟅

ECOG PS

0105.5%(1st time)

130

16.6%

58.5%

261

33.7%

1220.3%

367

37.0%

2949.2%4137.2%1118.6%ECOG PS

0105.5%(2nd time)

130

16.6%

260

33.1%

364

35.4%

4

179.4%

Discussion
Examination of MIDs for each domain• EORTC QLQ-C15-PAL䛾䛩䜉䛶䛾䝗䝯䜲䞁䛤䛸䛻䚸ᝈ⪅䛾୺ほ䛻䜘䜛ኚ໬䛾⛬ᗘ䜢ㄪ䜉䛯• ⑕≧䛾䝅䞁䜾䝹䜰䜲䝔䝮䛿䚸䛭䛾⑕≧䛜䛒䜛ே䛸䚸䛺䛔ே䛜䛔䜛䛯䜑䛻䚸䜀䜙䛴䛝䛜኱䛝䛛䛳䛯• ⦆࿴䜿䜰䛾ᝈ⪅䛾ከ䛟䛻ඹ㏻䛩䜛䚸඲యⓗQOL䚸㌟యᶵ⬟䚸ᚰ⌮ᶵ⬟䚸೏ᛰឤ䚸⑊③
㻌 䛻䛴䛔䛶᳨ウ䛧䛯

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㄀8ಲCSP-HORᑈӮDirection toward improving or worsening

Conclusion• Anchor-based䛻䜘䜛MID䛿䚸䛂䜘䛟䛺䜛䛃᪉ྥ䛸䛂ᝏ䛟䛺䜛䛃᪉ྥ䛷䛿䚸䛭䛾್䛜㐪䛖䛸ሗ࿌㻌㻌
(Cella, et al. Qual Life Res, 2002)• ⦆࿴䜿䜰䛾QOL䝇䝁䜰䛾MID䛿䚸ᑡ䛧ᝏ䛟䛺䜛ሙྜ䛿䚸ᑡ䛧Ⰻ䛟䛺䜛ሙྜ䛾⣙༙ศ䛾್• 䜘䛟䛺䜛᪉䛾MIDᖹᆒ䛿䚸 11.5
• ᝏ䛟䛺䜛᪉䛾MIDᖹᆒ䛿䚸 4.5• ⦆࿴䜿䜰ᝈ⪅䛷䛿䚸QOL䛜ᑡ䛧䜘䛟䛺䜛ሙྜ䜘䜚䚸ᑡ䛧ᝏ䛟䛺䜛ሙྜ䛾᪉䛜MID䛾್䛜ᑠ䛥䛔ഴྥ䛜☜ㄆ䛷䛝䛯䚹

Limitation䠖㻌㻌 ⦆࿴䜿䜰ᝈ⪅䜢ᑐ㇟䛸䛧䛯䚸ᝈ⪅䛾⮬グᘧ㻌 䛻䜘䜛QOLホ౯䛷䛿䚸Ⓩ㘓᫬䛛䜙⮬グᘧ䛷㻌 ᅇ⟅ྍ⬟䛺≧ែ䛾ᝈ⪅䛛䜙䛰䛡ᅇ⟅䜢ᚓ䛶䛔䜛
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35

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1. Minimally Important Difference䠖MID䛸䛿㻌 㻌 䠄QOLホ౯䛾⮫ᗋ䛻䛚䛡䜛᭱ᑠ㔜せᕪ䠅
2. MID䛾 ᐃ᪉ἲ䛿Distribution-based methods䛸
Anchor-based methods䛜䛒䜛
3. MID◊✲䛾⤂௓
4. ᑻᗘ㛤Ⓨ䛸MID䠖COSMIN䛷䛿MID䜢ᑻᗘసᡂ᫬䛛䜙⪃៖䛩䜛㡯┠䛸䛧䛯
5. EORTC QLQ-C15-PAL䛾MIDㄪᰝ䛛䜙䚸䜘䛟䛺䜛᪉ྥ䛸ᝏ䛟䛺䜛᪉ྥ䛷䛿MID䛜␗䛺䜛㄀8ಲCSP-HORᑈӮ• MID䛿䚸㝈ᐃ䛥䜜䛯᮲௳䛷䚸⮫ᗋุ᩿䛾㻌 䛚䛚䜘䛭䛾䛂ཧ↷್䛃䛻䛺䜚ᚓ䜛• ᑻᗘ㛤Ⓨ䛷䛿䚸MID᥎ᐃ䛿୍⯡ⓗ䛻䛺䜚䛴䛴䛒䜛䚹䛧䛛䛧䚸䛥䜙䛺䜛᳨ウ䛜ᚲせ䛷䛒䜝䛖37䛒䜚䛜䛸䛖䛤䛦䛔䜎䛧䛯䚹㈨ᩱ䜢䛚೉䜚䛧䛯Dr. Wyrwhich䛻䛚♩䜢⏦䛧䜎䛩䚹

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36MID䛾౑⏝䛻䛒䛯䛳䛶䚸䛚ヰ䛧䛧䛯䛣䛸

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㄀8ಲCSP-HORᑈӮQOL/PRO◊✲఍㻌 38