QOLの正しい評価方法を学ぶ - ganjoho.org

1 14 2014 4 12 1 QOL Kojiro Shimozuma, MD, PhD Div. of Health Services Res., Dpt. of Biomedical Sciences, College of Life Sciences, ritsumeikan 12, 2014 @ Hamamatsu1 14 QOL 2 14 2014 4 12 2 3 QOL 4 14 2014 4 12 3 1. 2. 3. 4. Hastings Center 14 1996 2 1. 2. quality-of-life: QOL Brulde B, Health Care Analysis 9: 1 13, 2001. 5 QOL 6 14 2014 4 12 4 Topics QOL PRO QOL/PRO QOL/PRO QOL/PRO QOL/PRO QOL/PRO 7 How is your quality of lifetoday?

2 QOL 8 Quality of life (QOL) 14 2014 4 12 5 QOL (David Cella) Multidimensionality(Multidomain concept) Subjectivity9 QOL (David Cella) Multidimensionality(Multidomain concept)10 14 2014 4 12 6 QOL 11 QOL(HRQOL) QOL 12 14 2014 4 12 7 QOL WHO 1946 WHO Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. 26 13 QOL QOL 10 Patient-based outcome(s) Patient-derived outcome(s) Patient-reported outcome(s): PRO(s) 14 14 2014 4 12 8 Patient-reported outcome (PRO) EMA (2005) Any outcome evaluated directly by the patient himself and based on patient s perception of a disease and its treatment(s) is called patient-reported outcome (PRO).

3 FDA (2009) A PRO is any report of the status of a patient s health condition that comes directly from the patient, without interpretation of the patient s response by a clinician or anyone else. 15 HRQOL PRO 2005, 7 EMEA) QOL 5 , 2 FDA PRO 39 should 2009, 12 FDA PRO 16 14 2014 4 12 9 PRO QOL 17 QOLPRO spirituality Subjectivity18 QOL (David Cella) 14 2014 4 12 10 19 20 14 2014 4 12 11 2122 14 2014 4 12 121001995 2000 0 QOL 80604020 1002001 2007 080604020 100 080604020 100 080604020 QOL QOL QOL Source: Sonn GA, et al.

4 J Urol. 2013; 189: N-SAS BC 02 (2001-) PI: 14 2014 4 12 13 BaselineCycle 3 Cycle 5 Cycle 77 Months1 YearAC AC AC AC PTX PTX PTX PTX AC AC AC AC DTX DTX DTX DTX PTX PTX PTX PTX PTX PTX PTX PTX DTX DTX DTX DTX DTX DTX DTX DTX ACPACDPTXDTX QOL 25 PNQ*(Patient Neurotoxicity Questionnaire)NCI-CTC (Version )(Neuro-sensory & Neuro-motor)* Hausheer, et al., Semin Oncol 2006, Shimozuma, et al., 2004 SABCS26 14 2014 4 12 1427 PNQ scores distributed between A and E (full range), while NCI-CTC scores mainly distributed between 0 and Shimozuma K, et al, Support Care Cancer 2009 28 Kappa= 14 2014 4 12 15 29 Petersen MA, et al. Eur J Cancer 2006 VariableCorrelationKappaFunctioning scalePhysical (PF) Emotional (EF) Cognitive (CF) Social (SF) Symptom scaleFatigue (FA) Nausea/Vomiting (NV) Pain (PA) Appetite Higher valuelower value30 14 2014 4 12 16 Petersen MA, et al.

5 Eur J Cancer 2006 31 Petersen MA, et al. Eur J Cancer 2006 32 14 2014 4 12 17 467 CTCAE (N Engl J Med. 2010;362(10):865-9) ( ) ( ) 33 ( ) ( ) 34 14 2014 4 12 18 etc. 35 Topics QOL PRO QOL/PRO QOL/PRO QOL/PRO QOL/PRO QOL/PRO 36 14 2014 4 12 19 QOL/PRO Shared-decision making QOL 37 Topics QOL PRO QOL/PRO QOL/PRO QOL/PRO QOL/PRO QOL/PRO 38 14 2014 4 12 20 QOL QOL QOL/PRO Shared-decision making

6 QOL 40 14 2014 4 12 2141 QOL(HRQOL) QOL 42 14 2014 4 12 2243 QOL-ACD 1 FWB1 to 62 PWB7 to 113 EWB12 to 164 SWB17 to 215 QOLGQL22 QOL 44 14 2014 4 12 23 QOL 45 SF-36 Medical Outcome Study (MOS) 36 item Health Survey SF-8 EORTC QLQ, FACT, QOL-ACD KDQOL Asthma-QOL GOHAI, OIDP EORTC QLQ-H&N35, FACT-HN symptom index, symptom checklist QOL 46 14 2014 4 12 24 QOL EORTC QLQ etc.

7 FACT etc. QOL-ACD QOL 47 ScaleItemGlobal health status / QoL Global health status/QoLQL29, 30 Functioning scales Physical functioningPF1 to 5 Role functioningRF6, 7 Emotional functioningEF21 to 24 Cognitive functioningCF20, 25 Social functioningSF26, 27 Symptom scales and/or items FatigueFA10, 12, 18 Nausea and vomitingNV14, 15 PainPA9, 19 DyspnoeaDY8 InsomniaSL11 Appetite lossAP13 ConstipationCO16 DiarrhoeaDI17 Financial difficultiesFI28 EORTC QLQ-C30 48 14 2014 4 12 25 FACT-G ScaleItemPhysical Well-BeingPWB1 to 7 Social/Family Well-BeingSWB8 to 14 Emotional Well-BeingEWB15 to 20 Functional Well-BeingFWB21 to 2749 QOL QOL 14 2014 4 12 26 QOL/PRO Shared-decision making QOL 5152 EQ-5D UK EQ-5D-5L Health Utility Index HUI SF-6D US 14 2014 4 12 27 QOL 53

8 54 14 2014 4 12 28 incremental cost-effectiveness ratio: ICER 55 Quality-adjusted life year: QALY ICER = / QALY56 14 2014 4 12 2957 57 ICER (1903-57) (1902-77) 58 John von NeumannOskar MorgensternJeremy Bentham(1748-1832) 14 2014 4 12 i or i (VAS) (SG) Px / ti t x x (TTO) - -60 EQ-5D UK EQ-5D-5L Health Utility Index HUI SF-6D US 14 2014 4 12 31EQ-5D QOL QOL 2001 p16EQ-5D (Tariff)

9 14 2014 4 12 32 QOL Topics QOL PRO QOL/PRO QOL/PRO QOL/PRO QOL/PRO QOL/PRO 64 14 2014 4 12 33 Psychometric properties Reliability Validity 65 66 14 2014 4 12 34 67 Test-retest 2 1 2 1 Crohnbach N 68 14 2014 4 12 35 Content validity Criterion validity gold standard gold standard QOL FACT HADS Concurrent validity 69 Construct validity Factor validity Convergent validity Discriminant validity multi-trait scaling analysis Known-groups comparison PS 70 14 2014 4 12 36 Responsiveness 71 Feasibility 15 Response rate Ethics 72 14 2014 4 12 37 QOL 73 QOL Functional equivalence Scale equivalence Operational equivalence Metric equivalence Hui C.

10 Triandis HC: Cross Cultural Psychol 16:131-152, 1985 74 14 2014 4 12 38 Topics QOL PRO QOL/PRO QOL/PRO QOL/PRO QOL/PRO QOL/PRO 75 QOL Efficace F, et al J Clin Oncol 21:3502-3511, 2003 Yes NoN/A*Yes No Yes NoYes NoN/A**Yes No Yes NoYes NoYes NoYes No Yes NoYes No* ** 3 76 14 2014 4 12 3977 QOL/PRO FDA PRO QOL/PRO 78 14 2014 4 12 40 (significant change of the scores) minimally important difference (MID) MID QOL 79 (responder definition) (sequential analysis)