QOL I QOL QOL FACT-B 56 13 10 30 2226 2220 1
QOL I QOL QOL FACT-B David F Cella (Evanston Northwestern Healthcare, U.S.A.) Sonya Eremenco (Evanston Northwestern Healthcare, U.S.A.) Neil K Aaronson (Netherlands Cancer Institute, Netherlands) Mirjam A Sprangers (University of Amsterdam, Netherlands) Jane M Blazeby (Bristol Royal Infirmary, U.K.) QOL EBM QOL QOL QOL QOL QOL QOL QOL EORTC QLQ FACT FACT-B 5 128 1, 6, 12 QOL 12 94 FACT HADS FACT 2
3 4 QOL 4 QOL 5 QOL 5 QOL 8 10 QOL 10 FACT-B 12 18 19 19 EORTC, FACT QOL 3
Evidence-Based medicine (EBM) QOL 60 A B A B QOL QOL QOL QOL QOL QOL QOL QOL QOL QOL 4
QOL QOL QOL QOL 20 QOL QOL (Health-Related QOL: HRQOL) QOL HRQOL QOL QOL QOL HRQOL 5
1QOL QOL QOL QOL QOL QOL QOL QOL QOL 0 0.8 0.5 Rating scaletime trade-off (TTO)Standard gamble (SG) 6
1) Rating scale EQ-5D (EuroQol 5-Dimension) 2) HUI (Health Utility Index) 3) EQ-5D QOL [Cost/QALY: Quality-Adjusted Life Year] QOL QOL QOL SF-36 (MOS-Short Form 36) 4) SF-36 EORTC QLQ (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) 5) FACT (Functional Assessment of Cancer Therapy) scale 6) QOL-ACD (QOL Questionnaire for Patients treated with Anticancer Drugs, QOL QOL 7,8) QOL 7
QOL Rating scale TTO, SG EQ-5D, HUI SF-36, SIP, NHP, WHOQOL EORTC QLQ, FACT, QOL-ACD, KD-QOL, AQLQ : : : : : : : : TTO: Time Trade-Off, SG: Standard Gamble, EQ-5D: EuroQol 5-Dimension, HUI: Health Utility Index, SIP: Sickness Impact Profile, NHP: Nottingham Health Profile, EORTC QLQ: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, FACT: Functional Assessment of Cancer Therapy scale, QOL-ACD: Quality of Life Questionnaire for Patients treated with Anticancer Drugs, KD-QOL: Kidney Disease Quality of Life, AQLQ: Asthma Quality of Life Questionnaire 8
QOL QOL QOL 2 0.7-0.8 (Cronbach )0.7 3 a) b) 2 [gold standard] 9
c) 0.4 multitrait scaling analysis 0.4 SE (standard error) d) Performance Status (PS) 0-1 2-4 10
QOL QOL QOL EORTC QLQ FACT QOL-ACD SF-36 QOL QOL Functional equivalence Scale equivalence Operational equivalence Metric equivalence EORTC QLQ, FACT 3 EORTC QLQ FACT EORTC QLQ-BR23 FACT-B FACT-TaxaneTaxane FACT-O FACT-Cx FACT-Sp FACT-ES FACT-GOG-Ntx Appendix 1 EORTC QLQ EORTC QLQ-STO22 FACT FACT-Pal FACT-C QOL 11
QOL Sickness Impact Profile (SIP) Bergner et al Phy, Fnc, Fam, 1981 Emo, Tre, Sex, Soc 136 Yes/No Quality of Life Index (QLI) Spitzer et al 1981 Phy, Fnc, Soc 5 ordered choices, 1 confidence rating Linear Analog Self Assessment (LASA) Psychological Adjustment to Illness Scale (PAIS) Coates et al Derogatis and Lopez 1983 Phy, Emo 5 analog Fnc, Fam, Emo, 1983 Tre, Sex, Soc 46 ordered choices Quality of Life Scale-Cancer Padilla et al Phy, Fnc, Tre, Soc, 30 Likert and 1983 Glo analog C, HN, GYN, BMT Functional Living Index - Cancer (FLIC) Schipper et al Phy, Fnc, Fam, 1984 Emo, Tre, Soc 22 Likert and analog Breast Cancer Chemotherapy Questionnaire (BCQ) Levine et al Phy, Fnc, Fam, 1988 Emo, Sex, Soc 32 Likert B Cancer Rehabilitation Evaluation System (CARES) Schag et al 1989 Phy, Fnc, Fam, 139 Likert and Emo, Tre, Sex, Soc box check The MOS 36-item Short Form Phy, Fnc, Emo, Ware et al 1992 Health Survey (SF-36) Soc, Glo 36 Likert and Yes/No EuropeanOrganization for Research and Treatment of Cancer (EORTC) QLQ-C30 Aaronson et al Phy, Fnc, Fam, 1993 Emo, Soc, Glo 30 Likert B, L, Br, C, HN QOL 1993 (QOL-ACD) Phy, Fnc, Emo, Soc, Glo 22 Likert FunctionalAssessment of Cancer Therapy (FACT) Phy, Fnc, Fam, Cella et al 1993 Emo, Tre, Soc, Sex, Glo 27 Likert B, Br, CNS, C, Cx, L, O, P, HN, E, Bl, Sp, An Ntx, ACT, F, Taxane, BRM, ES, Pal Phy: Fnc: Fam: Emo: Tre: Sex: Soc: Glo: QOL B: Br: CNS: C: Cx: L: O: P: HN: E: Bl: Sp: An: Ntx: ACT: F: Taxane: Taxane BRM: ES: Pal: 12
Step 1Forward translation English Japanese (2 versions) Step 2Reconciliation of forward translations Step 3: Backward translation of reconciled version Japanese English(2 versions) Step 4: Independent reviews by 3-4 bilingual experts Step 5: Spelling and grammatical language verification Step 6: Pilot testing with patients (n=10-15) EORTC QLQ-C30 * EORTC QLQ-BR23 EORTC QLQ-LC13 EORTC QLQ-STO22 FACT-G FACT-B FACT-L FACT-TaxaneTaxane FACT-Sp FACT-An FACT-F FACT-O FACT-Cx FACT-ES FACT-GOG-Ntx FACT-BMT FACT-P FACT-Bl FACT-Pal FACT-C FACT-HN FACT-BRM FAACT 13
FACT-B QOL QOL QOL FACT-B (FACT ) 5 UICC N1 128 (WHOS)-01 HRQOL 1998 12 2001 3 HRQOL Appendix 2 1 12 Cronbach 0.7 6 HRQOL HRQOL FACT-B 4 Hospital Anxiety and Depression Scale (HADS) 9) 14
5 50 <50 49 (38.9) 94 (74.6) 50-59 40 (31.7) - 32 (25.4) 60 37 (29.4) 67 (53.2) 63 (50.0) 56 (44.4) 60 (47.6) 3 ( 2.4) 3 ( 2.4) 5,000,000 51 (40.5) 0 5 ( 4.0) 5,000,000 10,000,000 53 (42.1) I 50 (39.7) 10,000,000 13 (10.3) II 63 (50.0) 9 ( 7.1) IIIA 6 (4.8) IIIB 1 ( 0.8) 78 (61.9) IV 1 ( 0.8) 17 (13.5) 2 ( 1.6) 86 (68.3) 4 ( 3.2) 40 (31.7) 2 ( 1.6) 9 ( 7.1) 95 (75.4) 17 (13.5) 31 (24.6) 15
FACT-B 7 FACT-G / 7 6 FACT-B FACT-TOI 7 9 HADS HADS 7 2FACT-B HADS 16
a) FACT-B HADS 1 98%6 94 12 94 FACT-B 1 40 51 90100 b) FACT-G / FACT-G FACT-B (Treatment Outcome Index: TOI) 0.7 0.48-0.67 FACT-G / 0.73-0.88* (BCS) 0.48-0.67 FACT-G 0.84-0.91* FACT-B (FACT-G + BCS) 0.84-0.92* FACT-TOI BCS0.86-0.88* * >0.7 c) FACT FACT HADS 0.51-0.79 7 FACT Pearson HADS- HADS- 10.79 0.69 FACT- 60.69 0.58 120.61 0.51 17
d) FACT-G 8 1 Kaasa 10) 7 FACT-G 1 / 7 7 6 7 2 1 0 0 4 1 1 0 0.4 2 standard error e) 1 6 PS PS 0 6 9 TOI / 18
16 P (paired t-test) 20.8 21.7 0.06 /20.4 17.5 <0.01* 16.4 16.9 0.25 17.4 20.0 <0.01* 23.2 22.9 0.61 FACT-TOI 61.1 64.2 0.02* FACT-G 74.3 75.8 0.28 FACT-B 97.4 98.5 0.53 * P<0.01 FACT-B FACT-G QOL 1 QOL 6 12 FACT-B 19
QOL QOL QOL information technology (IT) 20
QOL 1. QOL 2001 2. EuroQol Group: EuroQol; A new facility for the measurement of health-related quality of life. Health Policy 16:199-208, 1990 3. Torrance GW, et al: Multi-attribute preference functions; Health utility index. Pharmacoeconomics 9:503-520, 1995 4. Ware JE, et al: The MOS 36-item Short Form Health Survey (SF-36) I. Conceptual framework and item selection. Med Care 30:473-483, 1992 5. Aaronson NK, et al: The European Organization for Research and Treatment of Cancer QLQ-C30; A quality-of-life instrument use in international clinical trials in oncology. J Natl Cancer Inst 85:365-376, 1993 6. Cella DF, et al: The Functional Assessment of Cancer Therapy scale; Development and validation of the general measure. J Clin Oncol 11:570-579, 1993 7. QOL 28:1140-1144, 1993 8. Kurihara M, et al: Development of quality of life questionnaire in Japan: Quality of life assessment of cancer patients receiving chemotherapy. Psycho-oncology 8:355-363, 1999Zigmond AS, et al: The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 67:361-370, 1983 10. Kaasa S, et al: The EORTC core quality of life questionnaire (QLQ-C39): validity and reliability when analyzed with patients treated with palliative radiotherapy. Eur J Cancer 31A:2260-2263, 1995 21
EORTC, FACT
FACT-B Japanese 10/24/1997 1987, 1997 1 3
FACT-B Japanese 10/24/1997 1987, 1997 2 3
FACT-B Japanese 10/24/1997 1987, 1997 3 3
FACIT-Taxane (Version 4A) Japanese 2001/11/02 1987, 1997 1 3
FACIT-Taxane (Version 4A) Japanese 2001/11/02 1987, 1997 2 3
FACIT-Taxane (Version 4A) Japanese 2001/11/02 1987, 1997 3 3
FACT-NTX (Version 4) GP1 GP2 GP3 GP4 GP5 GP6 GP7... 0 1 2 3 4... 0 1 2 3 4 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4 ( ) 0 1 2 3 4... GS1 GS X1 GS2 GS3 GS4 GS5 GS X2 GS6 Q1 GS7... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4.... 0 1 2 3 4 Japanese 2001/10/17 1987, 1997 1 3
FACT-NTX (Version 4) GE 1... 0 1 2 3 4 GE 2... 0 1 2 3 4 GE 3... 0 1 2 3 4 GE 4... 0 1 2 3 4 GE 5... 0 1 2 3 4 GE 6... 0 1 2 3 4 GF1 GF2 GF3 GF4 GF5 GF6 GF7 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 Japanese 2001/10/17 1987, 1997 2 3
FACT-NTX (Version 4) NTX 1 0 1 2 3 4 NTX 2 0 1 2 3 4 NTX 3 0 1 2 3 4 NTX 4 0 1 2 3 4 NTX 5 0 1 2 3 4 HI 12 0 1 2 3 4 NTX 6 0 1 2 3 4 NTX 7 0 1 2 3 4 0 1 2 3 4 8 NTX NTX 9 0 1 2 3 4 0 1 2 3 4 6 An Japanese 2001/10/17 1987, 1997 3 3
Japanese 2/18/1999 1987,1997 Page: 1/3
Japanese 2/18/1999 1987,1997 Page: 2/3
Japanese 2/18/1999 1987,1997 Page: 3/3
FACT-ES (Version 4) GP1 GP2 GP3 GP4 GP5 GP6 GP7... 0 1 2 3 4... 0 1 2 3 4 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4 ( ) 0 1 2 3 4... GS1 GS X1 GS2 GS3 GS4 GS5 GS X2 GS6 Q1 GS7... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4 Japanese 2001/10/17 1987, 1997 1 3
FACT-ES (Version 4) GE1 GE2 GE3 GE4 GE5 GE6... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4... 0 1 2 3 4 GF1 GF2 GF3 GF4 GF5 GF6 GF7 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 Japanese 2001/10/17 1987, 1997 2 3
FACT-ES (Version 4) ES1 ES2 ES3 ES4 ES5 ES6 ES7 ES8 ES9 ES10 An9 O2 C5 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 An 0 1 2 3 4 10 Tax1 0 1 2 3 4 ES11 ES12 ES13 0 1 2 3 4 0 1 2 3 4 0 1 2 3 4 Japanese 2001/10/17 1987, 1997 3 3
Japanese 11/26/97 1987,1997 Page: 1/3
Japanese 11/26/97 1987,1997 Page: 2/3
Japanese 11/26/97 1987,1997 Page: 3/3
Japanese 11/26/97 1987,1997 Page: 1/3
Japanese 11/26/97 1987,1997 Page: 2/3
Japanese 11/26/97 1987,1997 Page: 3/3
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