➨㻤ᅇ㻌 㻯㻿㻼㻙㻴㻻㻾ᖺ㻌 2014ᖺ6᭶21᪥㻌 ᮾிᏛఀ⸨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ᏛᏛ㝔་Ꮫ◊✲⛉ ♫ᗣ་Ꮫ⣔ᑓᨷ㻌 ᗣሗᏛศ㔝 [email protected] 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䚸ື⬦◳ 䛺䛹䛾៏ᛶᝈ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┳ㆤᖌᩘ process ་⒪ᢏ⾡䞉་⒪䝃䞊䝡䝇䚸QI 2 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◊✲ Patient-reported outcome(s): PRO(s) QOL䛾ᵓᡂせ⣲ • 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ᙺᶵ⬟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-HORᑈӮ 8 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ᮃ ὶ䜜䛾୍䛴䛸䛧䛶䚸 㻌 0.5䟛䛷䛿䚸 䇾From Measurement to Understanding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) 2014/6/21 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 • • 㻌 • 㻌 • 㻌 • 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 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 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 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 2014/6/21 13 8ಲCSP-HORᑈӮ 10 ᝈ⪅どⅬ䛾་⒪ホ౯ 㻌 ≉ᐃ㡿ᇦ䛻䛚䛡䜛 2014/6/21 QOL/PRO◊✲㻌 8ಲCSP-HORᑈӮ 12 8ಲCSP-HORᑈӮ 2䠊MID䛾 ᐃ᪉ἲ 2014/6/21 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Ⅼ Clinician 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 MID MID ᝈ⪅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 parameter 2014/6/21 8ಲCSP-HORᑈӮ QOL/PRO◊✲㻌 15 2014/6/21 8ಲCSP-HORᑈӮ 16 • 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-HORᑈӮ 17 2014/6/21 8ಲCSP-HORᑈӮ QOL/PRO◊✲㻌 18 㻌 㻌 㻌 Osoba et al.䠄1998䠅 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 ங⒴ᝈ⪅246ே䛸⫵⒴ᝈ⪅111ே䜢ᑐ㇟ EORTC QLQ-C30䛸ᝈ⪅䛾ሗ࿌䠄Global rating scale䠅䛛䜙䚸 -㻌 䝇䝁䜰䛾᭱ᑡ䛾ኚ䛿5-10 -㻌 ୰⛬ᗘ䛾ኚ䛿10-20 -㻌 䛝䛺ኚ䛿20௨ୖ 2014/6/21 8ಲCSP-HORᑈӮ 19 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 20 4. 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 2014/6/21 8ಲCSP-HORᑈӮ 21 2014/6/21 8ಲCSP-HORᑈӮ QOL/PRO◊✲㻌 22 COSMIN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/) 2014/6/21 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 2014/6/21 8ಲCSP-HORᑈӮ 24 Box J. Interpretability 5䠊EORTC QLQ-C15-PAL䛾MID 8. Was the minimal important change (MIC) or the minimal important difference (MID) determined? 2014/6/21 25 8ಲCSP-HORᑈӮ 2014/6/21 QOL/PRO◊✲㻌 26 8ಲCSP-HORᑈӮ Background㻌 Palliative Medicine㻌 ⦆䜿䜰 Purpose • Palliative care is an approach that improves the quality of life (QOL) of patients and their families facing the problem associated with lifethreatening illness. To estimate MID for EORTC QLQ-C15-PAL scores for the assessment of QOL of palliative 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 Treatment of 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 2014/6/21 27 8ಲCSP-HORᑈӮ 2014/6/21 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 to 15 items. Second survey㻌 2ᅇ┠ EORTC QLQ-C15-PAL EORTC QLQ-C15-PAL Clinical information* 28 8ಲCSP-HORᑈӮ EORTC 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) 2014/6/21 8ಲCSP-HORᑈӮ 2w “What do patients themselves think of the difference between the first and second time they 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 2014/6/21 8ಲCSP-HORᑈӮ 29 Characteristics of the patients Results 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 Sex Refusal㻌 ᣄྰ n=12 Worsened condition ᝏ n=3 Transfer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 2014/6/21 31 2nd survey-no- 2ᅇ┠↓ᅇ⟅ response(n=59) Number of patients or average Number of patients or average 䠂㻌 or㻌 SD 䠂㻌 or SD χ2㻌 test p-value 0.073 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% 11 18.6% 0.535 disease Colon cancer 24 13.3% 6 10.2% ཎᝈ 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% 19.3% 10 Others* 8ಲCSP-HORᑈӮ 2nd survey- 2ᅇ┠ᅇ⟅ response(n=181) Male Age Number of patients enrolled in the 1st QOL survey 2nd QOL survey and GRS survey completed㻌 㻌 MID analysis subjects 2ᅇ┠ 30 16.9% *Gallbladder cancer, peritoneal cancer, oral cancer, pharyngeal/laryngeal cancer, bladder cancer, Ewing’s sarcoma,32etc. 2014/6/21 35 8ಲCSP-HORᑈӮ ECOG PS of patients based on participation in the second survey 2nd survey- 2ᅇᅇ⟅ response(n=181) 2nd Number of patients Number of patients 䠂㻌 survey-noresponse(n=59) 2ᅇ┠↓ᅇ⟅ 䠂 χ2㻌 test p-value 2 3.4% 0.014 ECOG PS 0 10 5.5% (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% 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 2014/6/21 8ಲCSP-HORᑈӮ 33 2014/6/21 Conclusion Direction toward improving or worsening • 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䛾್ 34 8ಲCSP-HORᑈӮ • 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 2014/6/21 8ಲCSP-HORᑈӮ 35 2014/6/21 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 2014/6/21 8ಲCSP-HORᑈӮ 36 MID䛾⏝䛻䛒䛯䛳䛶䚸 䛚ヰ䛧䛧䛯䛣䛸 2014/6/21 8ಲCSP-HORᑈӮ 39 2014/6/21 8ಲCSP-HORᑈӮ QOL/PRO◊✲㻌 38
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