± y t 6( FVh !! 19/08/31 WS

•  % •  % •  y % •  ff %

OK •  –  GKEAF •  –  ,+ deVa –  –  –  –  19/08/31 WS

± •  HJG HReZV e JVa ceVU GfeT V% ffi –  w – U.S. Food and Drug Administra:on (FDA). (2009). Guidance for Industry. U.S. Department of Health and Human Services. Pa:ent-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. hRps://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf. . (2014). Patient Health Questionnaire (PHQ-9, PHQ-15) Generalized Anxiety Disorder-7 : up to date. , (7), 35-39.

HJG •  % ± u – u – •  HJG % u •  –u •  – ffi Mercieca-Bebber, R., King, M. T., Calvert, M. J., Stockler, M. R., & Friedlander, M. (2018). The importance of pa:ent- reported outcomes in clinical trials and strategies for future op:miza:on. Pa:ent related outcome measures, 9, 353.

,5 ± 19/08/31 WS •  ,% ffi •  -% ffi •  .% 5 u u u – u u fi ʻ Elbers, R. G., Rietberg, M. B., van Wegen, E. E., Verhoef, J., Kramer, S. F., Terwee, C. B., & Kwakkel, G. (2012). Self-report fatigue questionnaires in multiple sclerosis, Parkinson’s disease and stroke: a systematic review of measurement properties. Quality of life research, 21(6), 925-944.

,5 ± 19/08/31 WS

https://www.cosmin.nl/book-measurement-in-medicine/ http://jabt.umin.ne.jp/j/activities/3-6journal.html ɹCOSMIN͸ɺई౓ಛੑΛݕ౼͢Δ͏͑Ͱɺݚڀऀ͕ཹҙ͢΂͖఺Λ໌֬ʹ ͍ͯ͠Δ (౔԰, 2015) The COnsensus-based Standards for the selection of health MeasurementINstruments (COSMIN) COSMINͷ໨త: ݚڀ΍ྟচ࣮ફͰͷ࣭ͷߴ͍PROͷબ୒Λଅਐ͢Δ͜ͱɻ

GKEAF -++4% COSMIN(2009)

GKEAF -+,3% 19/08/31

GKEAF -+,3% 19/08/31 !!

GKEAF -+,3% •  u-++4 u v 19/08/31 WS https://www.cosmin.nl/tools/guideline-conducting-systematic-review-outcome-measures/

GKEAF -+,3% ± v 19/08/31 WS hRps://cosmin.nl/wp-content/uploads/COSMIN- methodology-for-content-validity-user-manual-v1.pdf ܥ౷ϨϏϡʔͷΨΠυϥΠϯ ίΞΞ΢τΧϜηοτͷΨΠυϥΠϯ

kelk( v ( 1 : 10? 1 2: : 0? 3 - B 1 - 1 1A GKEAF ± ʻ 3VKFGMKOG HPS YTUGNCUKE GWKG T PH :VUEPNG GCTVSGNGOU OTUSVNGOUT 19/08/31 WS

GKEAF Mokkink, L. B., Prinsen, C. A., Patrick, D. L., Alonso, J., Bouter, L. M., de Vet, H. C., & Terwee, C. B. (2018). COSMIN methodology for systematic reviews of Patient-Reported Outcome Measures (PROMs) – user manual. http://www.cosmin.nl/. ϢʔβʔϚχϡΞϧ 10εςοϓ

GKEAF Mokkink, L. B., Prinsen, C. A., Patrick, D. L., Alonso, J., Bouter, L. M., de Vet, H. C., & Terwee, C. B. (2018). COSMIN methodology for systematic reviews of Patient-Reported Outcome Measures (PROMs) – user manual. http://www.cosmin.nl/. 10εςοϓ 8.  9.  10.  A. B. C. PROM 5.  6.  7.  1.  2.  3.  4. 

Lee, J., Lee, E. H., & Moon, S. H. (2019). Systematic review of the measurement properties of the Depression Anxiety Stress Scales–21 by applying updated COSMIN methodology. Quality of Life Research, 1-15.

Lee, J., Lee, E. H., & Moon, S. H. (2019). Systematic review of the measurement properties of the Depression Anxiety Stress Scales–21 by applying updated COSMIN methodology. Quality of Life Research, 1-15. 1. 2. 3. GRADE ࢖ΘΕ͍ͯΔํ๏

-5 Lee, J., Lee, E. H., & Moon, S. H. (2019). Systematic review of the measurement properties of the Depression Anxiety Stress Scales–21 by applying updated COSMIN methodology. Quality of Life Research, 1-15.

19/08/31 WS લεϥΠυͷ࿦จͰ͸ଌఆޡࠩ (measurement error͕ݕ౼͞Ε͓ͯΒͣධՁͰ͖ͣใࠂͳ͠)

fifi – box1: 36 , box2: 31 1. PROMͷ։ൃ (box1) ಺༰తଥ౰ੑͷධՁ 2. ද໘తଥ౰ੑ (box2) ಺తߏ଄ͷධՁ 3. ߏ଄తଥ౰ੑ (box3) 4. ಺త੔߹ੑ (box4) 5. ҟจԽؒଥ౰ੑ (box5) ͦͷଞͷಛੑධՁ 6. ৴པੑ (box6) 7. ଌఆޡࠩ (box7) 8. ج४ؔ࿈ଥ౰ੑ (box8) 9. ߏ੒֓೦ଥ౰ੑ(box9) 10. ൓Ԡੑ (box10) ධՁ͢Δಛੑͷਪ঑ॱং Mokkink, L. B., Prinsen, C. A., Patrick, D. L., Alonso, J., Bouter, L. M., de Vet, H. C., & Terwee, C. B. (2018). COSMIN methodology for systematic reviews of Patient-Reported Outcome Measures (PROMs) – user manual. http://www.cosmin.nl/.

PROMͷ࣭ͷධՁ 1.  ݸʑͷݚڀͷόΠΞε ͷϦεΫͷධՁ 2.  ࢦඪಛੑͷ࣭ΛධՁ 3.  ΤϏσϯεͷ·ͱΊͱ ࣭ͷάϨʔσΟϯά Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J., Stratford, P. W., Knol, D. L., ... & de Vet, H. C. (2010). The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. Journal of clinical epidemiology, 63(7), 737-745. 1. PROMͷ։ൃ (box1) ಺༰తଥ౰ੑͷධՁ 2. ද໘తଥ౰ੑ (box2) ಺తߏ଄ͷධՁ 3. ߏ଄తଥ౰ੑ (box3) 4. ಺త੔߹ੑ (box4) 5. ҟจԽؒଥ౰ੑ (box5) ͦͷଞͷಛੑධՁ 6. ৴པੑ (box6) 7. ଌఆޡࠩ (box7) 8. ج४ؔ࿈ଥ౰ੑ (box8) 9. ߏ੒֓೦ଥ౰ੑ(box9) 10. ൓Ԡੑ (box10) ධՁ͢Δಛੑͷਪ঑ॱং

όΠΞεͷϦεΫ (risk of bias: RoB) ݚڀͷํ๏࿦্ͷ࣭ͷߴ௿ʹΑͬͯɺݚڀ஌ݟͷ֬৴౓ͷ͸࿪Ή (όΠΞε)ͷͰɺݸʑͷݚڀͷ࣭ΛධՁ͠ΤϏσϯεͷ֬৴౓ධՁ ʹՃຯ͢Δɻ hRps://www.cosmin.nl/wp-content/uploads/COSMIN-RoB-checklist-V2-0-v17_rev3.pdf Mokkink, L. B., De Vet, H. C., Prinsen, C. A., Patrick, D. L., Alonso, J., Bouter, L. M., & Terwee, C. B. (2018). COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures. Quality of Life Research, 27(5), 1171-1179. COSMINͰ͸ɺόΠΞεͷϦεΫͷνΣοΫϦετ͕੔උ -  ֤ई౓ಛੑʹෳ਺ͷධՁ߲໨ -  ֤߲໨4݅๏ (very good, adequate, doubtful, inadequate)ͰධՁ

TcZeVcZR W c U VRdfcV V e ac aVcej% Mokkink, L. B., De Vet, H. C., Prinsen, C. A., Patrick, D. L., Alonso, J., Bouter, L. M., & Terwee, C. B. (2018). COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures. Quality of Life Research, 27(5), 1171-1179. COSMINͰ͸ɺࢦඪಛੑ͝ͱʹɺ ྑ͍ई౓ಛੑධՁͷج४͕ ໌֬ʹࣔ͞Ε͍ͯΔɻ + sufficient (े෼) − insufficient (ෆे෼) ? indeterminate (ܾΊΒΕͳ͍) ྫ) ɹ಺త੔߹ੑ: ΫϩϯόοΫͷα ͕ .80Ͱsufficient? ɹߏ଄తଥ౰ੑ: CFI ͕.90ɺRMSEA͕10Ͱsufficient? 3ΧςΰϦධఆ [+ / - / ?]

?J9< •  Z Y E UVcReV D h NVcj h •  –  u •  •  •  % •  % 19/08/31 WS

•  Lee, J., Lee, E. H., & Moon, S. H. (2019). Systematic review of the measurement properties of the Depression Anxiety Stress Scales–21 by applying updated COSMIN methodology. Quality of Life Research, 1-15.

y ffi ffi– de Vries, C. E. E., Kalff, M. C., Prinsen, C. A. C., Coulman, K. D., den Haan, C., Welbourn, R., ... & van Wagensveld, B. A. (2018). Recommenda:ons on the most suitable quality-of-life measurement instruments for bariatric and body contouring surgery: a systema:c review. Obesity reviews, 19(10), 1395-1411.

LR V V EVddR V •  HJG GKEAF •  u •  •  ?J9< •  – u – 19/08/31 WS

GKEAF – Lee, J., Lee, E. H., & Moon, S. H. (2019). Systematic review of the measurement properties of the Depression Anxiety Stress Scales–21 by applying updated COSMIN methodology. Quality of Life Research, 1-15.

:k k – : : 1 :0: :3B 2: - 1 3 1 : 1 - 0 B :2 : GKEAF ± ʻ 3VKFGMKOG HPS YTUGNCUKE GWKG T PH :VUEPNG GCTVSGNGOU OTUSVNGOUT 19/08/31 WS

•  ffi (HJG ffi – i ( ( ( Terwee, C. B., Prinsen, C. A., Chiarotto, A., Westerman, M. J., Patrick, D. L., Alonso, J., ... & Mokkink, L. B. (2018). COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Quality of Life Research, 27(5), 1159-1170.

ؔ࿈ੑ (relevance) 1 ࢦඪʹؚ·Ε߲ͨ໨͸ɺؔ৺ͷ֓೦ʹؔ࿈͍ͯ͠Δ͔ 2 ࢦඪʹؚ·Ε߲ͨ໨͸ɺؔ৺ͷλʔήοτ฼ूஂʹؔ࿈͍ͯ͠Δ͔ 3 ࢦඪʹؚ·Ε߲ͨ໨͸ɺؔ৺ͷར༻จ຺ʹؔ࿈͍ͯ͠Δ͔ 4 ൓Ԡબ୒ࢶ͸ద੾͔ 5 ૝ىظؒ͸ద੾͔ แׅੑ (comprehensiveness) 6 ॏཁͳ֓೦ͷ࿙Ε͕ͳ͍͔ ෼͔Γ΍͢͞ (comprehensibility) 7 ؔ৺ͷ฼ूஂ͕ҙਤͨ͠௨Γʹڭ͕ࣔཧղͰ͖Δ͔ 8 ؔ৺ͷ฼ूஂ͕ҙਤͨ͠௨Γʹ߲໨ͱ൓Ԡબ୒ࢶ͕ཧղͰ͖Δ͔ 9 ߲໨ͷݴޠදݱ͕ద੾͔ 10 ൓Ԡબ୒ࢶ͸࣭໰ͱϚον͍ͯ͠Δ͔ 19/08/31 WS

Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J., Stratford, P. W., Knol, D. L., ... & de Vet, H. C. (2010). The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. Journal of clinical epidemiology, 63(7), 737-745. Step1 •  PROM։ൃͷ࣭ͷධՁ •  (box1: όΠΞεͷϦεΫ) Step2 •  ಺༰తଥ౰ੑݚڀͷ࣭ͷධՁ •  (box2: όΠΞεͷϦεΫ) Step3 •  ݚڀͷ࣭ͷධՁͱྑ͍ଥ౰ੑج४ͷධՁ •  ͷ݁ՌΛ૯߹ධՁ

Step1 (box1). PROM 1a. PROMͷؔ࿈ੑΛ૿ڧ͢ΔPROMઃ ܭͷ࣭ͷධՁج४ શൠతͳઃܭͷཁ੥ ֓೦ੜ੒(ؔ࿈ੑͱแׅੑ) 1b. PROMͷ෼͔Γ΍͢͞ͱแׅੑΛධ Ձ͢ΔͨΊͷɺೝ஌తΠϯλϏϡʔ΍ଞ ͷύΠϩοτݚڀͷ࣭ͷධՁج४ શൠతͳઃܭͷཁ੥ แׅੑ ෼͔Γ΍͢͞ Step2 (box2). ಺༰తଥ౰ੑݚڀͷ࣭ͷධՁ 2a. ؔ࿈ੑ (ױऀ) ߲໨ͷؔ࿈ੑΛױऀʹਘͶ͍ͯΔ 2b. แׅੑ (ױऀ) ߲໨ͷแׅੑΛױऀʹਘͶ͍ͯΔ 2c. ෼͔Γ΍͢͞ (ױऀ) ߲໨ͷ෼͔Γ΍͢͞ΛױऀʹਘͶ͍ͯΔ 2d. ؔ࿈ੑ (ઐ໳Ո) ߲໨ͷؔ࿈Λઐ໳ՈʹਘͶ͍ͯΔ 2e แׅੑ (ઐ໳Ո) ߲໨ͷแׅੑΛઐ໳ՈʹਘͶ͍ͯΔ Terwee, C. B., Prinsen, C. A., Chiarotto, A., de Vet, H. C., Bouter, L. M., Alonso, J., ... & Mokkink, L. B. (2018). COSMIN methodology for assessing the content validity of PROMs–user manual. Amsterdam, Netherlands: VU University Medical Center.

5KL H ,R Terwee, C. B., Prinsen, C. A., Chiarotto, A., de Vet, H. C., Bouter, L. M., Alonso, J., ... & Mokkink, L. B. (2018). COSMIN methodology for assessing the content validity of PROMs–user manual. Amsterdam, Netherlands: VU University Medical Center. શൠతσβΠϯͷཁ੥ ( ߲໨: 1-5) ඪత฼ूஂ͕PROMͷ߲໨ ։ൃʹࢀՃ͍ͯ͠Δ͔(߲໨ 5) PROM։ൃͱͯ͠ෆద੾ ͸͍ ͍͍͑ ߲໨6-13ΛධՁ

5KL H ,R Terwee, C. B., Prinsen, C. A., Chiarotto, A., de Vet, H. C., Bouter, L. M., Alonso, J., ... & Mokkink, L. B. (2018). COSMIN methodology for assessing the content validity of PROMs–user manual. Amsterdam, Netherlands: VU University Medical Center. શൠతσβΠϯͷཁ੥ ( ߲໨: 1-5) ඪత฼ूஂ͕PROMͷ߲໨ ։ൃʹࢀՃ͍ͯ͠Δ͔(߲໨ 5) PROM։ൃͱͯ͠ෆద੾ ͸͍ ͍͍͑ ߲໨6-13ΛධՁ 1 ଌఆର৅ͷ֓೦ʹ͍ͭͯ໌֬ͳهड़͕ͳ͞Ε͍ͯΔ͔ 2 ֓೦ͷഎܠ͸໌͔֬: ཧ࿦ɺ֓೦త࿮૊Έɺ࣬ױϞσϧ͕༻͍ΒΕ͍ͯΔ ଌఆ֓೦ͷఆٛʹؔ͢Δ໌֬Ͱ߹ཧతͳઆ໌͕ͳ͞Ε ͍ͯΔ 3 PROMΛ։ൃ͢Δλʔήοτ฼ूஂ͕໌֬ʹهड़͞Ε͍ͯ Δ 4 PROMΛ࢖༻͢Δจ຺͕໌֬ʹهड़͞Ε͍ͯΔ 5 PROM։ൃݚڀ͕λʔήοτ฼ूஂΛ୅ද͢ΔඪຊͰ࣮ࢪ ͞Ε͍ͯΔ

/(,5 – ( k f g i bicng ma WGSY IPPF PS KOCFGRVCUGk 19/08/31 WS A (very good ra=ng) “ The PROMIS adult Pain Behavior item bank measures self-reported external manifesta:ons of pain: behaviors that typically indicate to others that an individual is experiencing pain. These ac:ons or reac:ons can be verbal or nonverbal, and involuntary or deliberate. They include observable displays (sighing, crying), pain severity behaviors (res:ng, guarding, facial expressions, and asking for help), and verbal reports of pain..” (hRps://www.assessmentcenter.net/documents/PROMIS Pain Behavior Scoring Manual.pdf) B (inadequate ra=ng) The Oswestry Disability Index (ODI) intends to measure disability. “By disability we mean the limita:ons of a pa:ent’s performance compared with that of a fit person” [43]. In this defini:on it is not clear what is considered ‘a pa:ent’s performance’ or ‘a fit person’. It is, for example, not clear whether it refers to physical limita:ons or (also) mental limita:ons. Therefore, it is difficult to rate the comprehensiveness of the PROM or to decide if an item on sleeping problems is relevant for the construct or not.

/(-5 – ) ֓೦ͷഎܠ͸໌͔֬ WGSY IPPF PS FPVDUHVMk 19/08/31 WS A. (very good ra=ng) The Menopause-Specific Quality Of Life (MENQOL) ques:onnaire is a condi:on-specific quality of life ques:onnaire, which was defined as “the extent that the physical, emo:onal and social aspects of an individual’s life are intact and not adversely affected by that condi:on or treatment”. The researchers aRributed each ques:on to one of five domains: physical, vasomotor, psychosocial, sexual and working life. It is unclear why these five domains were chosen and how they relate to the physical, emo:onal and social aspects of an individual’s life, as described in the defini:on of the construct [47]. B. (inadequate ra=ng) The conceptual model for the design of the Adolescent Cancer Suffering Scale was based on the components of the quality of life model in cancer survivors described by Ferrell. “Ferrell defined quality of life from a mul:dimensional perspec:ve including four domains of pa:ent well-being: physical, psychological, social and spiritual. Although dis:nct, each domain is able to influence the others. This model is par:cularly relevant to suffering because it recognizes its mul:dimensional aspect and because suffering could oren derive from a poor quality of life” [46].

/(.5 – λʔήοτ฼ूஂ͕໌֬ʹ WGSY IPPF PS KOCFGRVCUGk 4.จ຺͕໌֬ʹ WGSY IPPF PS FPVDUHVMk The Copenhagen Hip and Groin Outcome Score (HAGOS) was developed for use in “young to middle-aged, physically ac:ve pa:ents with long-standing hip and/or groin pain” [49]. A. The Haemo-QoL Index was developed as a short measure for health-related quality of life assessment in children and adolescents with haemophilia. The instrument was developed to be used as a screening tool in daily clinical rou:ne, to be used in large clinical studies, and for comparing data across ages [50] B. Shapiro et al. developed a ques:onnaire for measuring fa:gue and sleepiness [51]. In the introduc:on of the paper they state: “Although researchers and clinicians have long recognized the importance of these deficit states, psychometrically sound measurement instruments have been lacking un:l recently. The present study was undertaken to develop a psychometrically sound instrument to obtain conceptually dis:nct measures of common facets of the energy deficit states described variously by terms such as fa:gue, sleepiness and :redness.“ It is not stated for which applica:on the PROM is to be developed. Some text in the discussion suggest that the PROM can be used for discrimina:on and evalua:on (“Future studies can contribute usefully by inves:ga:ng whether individuals in treatment for various diagnoses display differen:al responsiveness across subscales in response to alterna:ve treatments (e.g., insomnia vs. narcolepsy vs. chronic fa:gue syndrome). Future research can also contribute importantly by evalua:ng the sensi:vity of the FACES ques:onnaire to change (e.g., in clinical trials))” , but this is not clearly described.

/(/5 – 5. PROM։ൃݚڀ͕λʔήοτ฼ूஂΛ୅ද͢ΔඪຊͰ࣮ࢪ (NVcj U 9UVbfReV < fSeWf A RUVbfReV / ) 19/08/31 WS A. The Haemo-QoL Index was developed as a short measure for health-related quality of life assessment in children and adolescents with haemophilia. The instrument was developed to be used as a screening tool in daily clinical rou:ne, to be used in large clinical studies, and for comparing data across ages [50] B. To iden:fy how thyroid diseases impact the pa:ents’ lives and to select the most relevant quality of life (QoL) issues for a thyroid-specific ques:onnaire pa:ents were selected “by a nonrandom strategic sampling procedure, which aimed at maximizing the pa:ent varia:on as regards diagnoses, treatment, disease dura:on (including both newly diagnosed, untreated pa:ents and treated pa:ents), and age” [53].

5KL H ,R Terwee, C. B., Prinsen, C. A., Chiarotto, A., de Vet, H. C., Bouter, L. M., Alonso, J., ... & Mokkink, L. B. (2018). COSMIN methodology for assessing the content validity of PROMs–user manual. Amsterdam, Netherlands: VU University Medical Center. શൠతσβΠϯͷཁ੥ ( ߲໨: 1-5) ඪత฼ूஂ͕PROMͷ߲໨ ։ൃʹࢀՃ͍ͯ͠Δ͔(߲໨ 5) PROM։ൃͱͯ͠ෆద੾ ͸͍ ͍͍͑ ߲໨6-13ΛධՁ 6 ৽ن։ൃͷPROMͷؔ࿈߲໨Λಛఆ͢ΔͨΊʹద੾ͳ࣭తͳσʔ λऩूํ๏͕༻͍ΒΕ͍ͯΔ͔ 7 ٕज़ͷ͋Δάϧʔϓௐ੔໾΍ΠϯλϏϡΞʔ͕༻͍ΒΕ͍ͯΔ͔? 8 άϧʔϓϛʔςΟϯά΍ΠϯλϏϡʔ͸ద੾ͳτϐοΫ΍Πϯλ ϏϡʔΨΠυʹج͍ͮͯͳ͞Ε͍ͯΔ͔ɻ 9 άϧʔϓϛʔςΟϯά΍ΠϯλϏϡʔ͸ه࿥͞ΕஞޠԽ͞Ε͍ͯ Δ͔ 10 σʔλʹద੾ͳ෼ੳํ๏͕༻͍ΒΕ͍ͯΔ͔ 11 গͳ͘ͱ΋σʔλͷҰ෦ͷίʔσΟϯά͸ಠཱͯ͠ߦΘΕ͍ͯΔ 12 σʔλऩू͕๞࿨(saturation)ʹୡ͢Δ·Ͱଓ͚ΒΕ͍ͯΔ 13 ྔతݚڀ(ௐࠪ)ͷ৔߹: αϯϓϧαΠζ͸ద੾͔

5KL H ,R Terwee, C. B., Prinsen, C. A., Chiarotto, A., de Vet, H. C., Bouter, L. M., Alonso, J., ... & Mokkink, L. B. (2018). COSMIN methodology for assessing the content validity of PROMs–user manual. Amsterdam, Netherlands: VU University Medical Center. 6. HJGE ffi –  ,5 •  •  – u ʼ –  -5 •  –  z Very good Adequate Doubtful Inadequate ౰֘֓೦ͱݚڀର ৅ʹ࣭తͳํ๏ʹ దͨ͠ɺ޿͘·ͨ ͸े෼ʹਖ਼౰Խ͞ Ε࣭ͨతͳํ๏͕ ༻͍ΒΕ͍ͯΔ ౰֘֓೦ͱݚڀର ৅ʹ࣭తͳํ๏ʹ ద࣭ͨ͠తͳํ๏ ͩͱߟ͑ΒΕΔ͕ɺ ໌֬ʹड़΂ΒΕͯ ͍ͳ͍ ྔతํ๏͚ͩ༻͍ ΒΕ͍ͯΔɺ͋Δ ͸౰֘ͷ֓೦ͱू ஂʹదͨ͠ํ๏Ͱ ͋Δ͔ٙΘ͍͠ ౰֘ͷ֓೦ͱूஂ ʹదͨ͠ํ๏Ͱ͸ ͳ͍

5KL H ,R 7. HJGE ffi Very good Adequate Doubtful Inadequate εΩϧͷ͋Δௐ੔໾΍Πϯλ ϏϡΞʔ͕༻͍ΒΕ͍ͯΔ ܦݧ͕ෆ଍͍ͯ͠Δ ܦݧ͕͋Δ͔ෆ໌΋͘͠͸ɺ ܇࿅ͳ͠΍ະܦݧऀ 8. v Very good Adequate Doubtful Inadequate ద੾ͳτϐοΫ΍Πϯλ ϏϡʔΨΠυ͕༻͍ΒΕ ͍ͯΔ ͓ͦΒ͘τϐοΫ΍Πϯ λϏϡʔΨΠυ͸ద੾ͩ ͕໌֬ʹड़΂ΒΕ͍ͯͳ ͍ τϐοΫ΍ΨΠυ͕ͳ͍ɺ τϐοΫ΍ΨΠυΛ༻͍ ͔ͨෆ໌֬ɺτϐοΫΨ Πυͷద੾ੑ͕ٙΘ͍͠ɺ ΨΠυ͕ͳ͍ 9. Very good Adequate Doubtful Inadequate શ͕ͯ࿥ԻɺஞޠԽ͞Ε ͍ͯΔ ͓ͦΒ͘શ͕ͯ࿥Իɺஞ ޠԽ͞Ε͍ͯΔ͕هࡌ͕ ෆ໌֬ શ͕ͯ࿥Իɺஞޠ͞Εͯ ͍Δ͔ෆ໌֬ɺه࿥͞Ε ͯΔ͚ͲஞޠԽ͞Ε͍ͯ ͳ͍ɺϊʔτ͚͕ͩͱΒ Ε͍ͯΔ Կ΋࿥Ի͞Εͯͳ͍͠ ϊʔτʹ΋औΒΕ͍ͯͳ ͍

5KL H ,R •  11. ಺༰෼ੳ (content analysis): ֓೦/୯ޠ/ߦಈͷස౓ूܭ͔Β૊৫Խ ԋ៷෼ੳ (deductive analysis): Ծઆݕূతɺσʔλ಺ʹཧ࿦/ݱ৅/֓೦Λ୳ٻ ࿮૊Έ෼ੳ (framework analysis): த৺ςʔϚɺ֓೦ʹैͬͯσʔλΛ෼ྨɺ૊৫Խ άϥ΢ϯσοτηΦϦʔ (grounded theory): ؼೲతʹσʔλऩूͱ෼ੳΛߦ͏࣭తݚڀ๏ ਪ঑: ࣭తݚڀ๏ͷΤΩεύʔτʹδϟοδΛґཔ Very good Adequate Doubtful Inadequate ޿͘ɺΑ͘ਖ਼౰Խ͞ ΕΔํ๏Λ༻͍͍ͯ Δ ద੾ͳΞϓϩʔνΛ ͓ͦΒ͘༻͍͍ͯΔ ͕هड़͕ෆ໌֬ ͲͷΑ͏ͳΞϓϩʔ νΛ༻͍ͨͷ͔ෆ໌ ֬ɺΞϓϩʔν͕ద ੾͔ٙΘ͍͠ Ξϓϩʔν͕ద੾Ͱ ͸ͳ͍

5KL H ,R •  11. – Very good Adequate Doubtful Inadequate গͳ͘ͱ΋σʔλ ͷ50%͕গͳ͘ͱ ΋2ਓͷಠཱͨ͠ݚ ڀऀʹΑͬͯධՁ ͞Ε͍ͯΔ σʔλͷ11%-49% ͕গͳ͘ͱ΋2ਓͷ ಠཱͨ͠ݚڀऀʹ ΑͬͯධՁ͞Εͯ ͍Δ ೋਓͷݚڀ͕ίʔ σΟϯάʹࢀՃ͠ ͍ͯΔ͔ٙΘ͍͠ɺ 1-10%ͷσʔλ͕ গͳ͘ͱ΋2ਓͷಠ ཱͨ͠ݚڀऀʹ ΑͬͯධՁ͞Εͯ ͍Δ Ұਓͷݚڀऀ͚ͩ ͕ίʔσΟϯάʹ ؔΘ͍ͬͯΔɺ ίʔσΟϯά͕͞ Ε͍ͯͳ͍ •  13. % 5 Very good Adequate Doubtful Inadequate ≥100 50-99 30-49 Not applicable

5KL H ,R •  12. dRefcReZ % Very good Adequate Doubtful Inadequate ๞࿨ʹୡͨ͠Τ Ϗσϯε͕ࣔ͞ Ε͍ͯΔ ͓ͦΒ͘๞࿨ʹ ୡ͍ͯ͠Δ ๞࿨ʹୡ͔ͨ͠ Ͳ͏͔ٙΘ͍͠ ๞࿨ʹୡ͍ͯ͠ ͳ͍ͱΤϏσϯ ε͕͍ࣔͯ͠Δ ๞࿨(saturation): ͜ΕҎ্ΠϯλϏϡʔΛଓ͚ͯ΋৽ͨͳ஌ݟɺ ֓೦ɺΧςΰϦʔ͕ग़ͯ͜ͳ͘ͳΔঢ়ଶ Α͘༻͍ΒΕΔΤϏσϯε. τϥϯεΫϦϓτͷ֤ ηοτͷίʔυΛલͷά ϧʔϓͷίʔυͱൺֱ͠ɺ ๞࿨άϦουΛࣔ͢ 4

5KL H ,S ೝ஌తΠϯλϏϡʔ΍ύΠϩοτςετͷ࣮ࢪ (߲໨14) ױऀ͕แׅੑΛਘͶΒ Ε͍ͯΔ(߲໨ 16) PROM։ൃͱͯ͠ෆద੾ ͸͍ ͍͍͑ ߲໨15ΛධՁ ͸͍ ͍͍͑ ? ױऀ͕෼͔Γ΍͢͞ΛਘͶ ΒΕ͍ͯΔ(߲໨ 26) ͸͍ ͍͍͑ ? ߲໨17-25ΛධՁ ߲໨27-35ΛධՁ PROM։ൃ ͱͯ͠ෆద੾ ࠷ऴతͳධՁΛܾఆ (ϫʔετείΞΛΧ΢ϯτ͢Δ)

ೝ஌తΠϯλϏϡʔ΍ύΠϩοτςετͷ࣮ࢪ (߲໨14) ױऀ͕แׅੑΛਘͶ ΒΕ͍ͯΔ(߲໨ 16) PROM։ൃͱͯ͠ෆద੾ ͸͍ ͍͍͑ ߲໨15ΛධՁ ͸͍ ͍͍ ͑ ? ױऀ͕෼͔Γ΍͢͞Λ ਘͶΒΕ͍ͯΔ(߲໨ 26) ͸͍ ͍͍ ͑ ? ߲໨17-25ΛධՁ ߲໨27-35ΛධՁ PROM։ൃ ͱͯ͠ෆద੾ ࠷ऴతͳධՁΛܾఆ (ϫʔετείΞΛΧ΢ϯτ͢Δ) 5KL H ,S 27 28 PRO (18 ) 29 30 ? 31 32 33 34 35 PROM PRO 17 શͯͷ߲໨͕࠷ऴ൛Ͱݕূ͞Ε͍ͯΔ 18 PROͷڭࣔɺ߲໨ɺ൓Ԡબ୒ࢶɺ૝ىظؒͷ෼͔Γ΍͢ ͞ΛධՁ͢ΔͨΊʹద੾ͳ࣭తํ๏͕༻͍ΒΕ͍ͯΔɻ 19 ద੾ͳױऀͷ਺Ͱ֤߲໨͕ݕূ͞Ε͍ͯΔ ࣭తݚڀͷ৔߹ ྔతݚڀͷ৔߹ 20 ٕज़ͷ͋Δάϧʔϓௐ੔໾΍ΠϯλϏϡΞʔ͕࣋ͪΒΕ ͍ͯΔ͔? 21 άϧʔϓϛʔςΟϯά΍ΠϯλϏϡʔ͸ద੾ͳτϐοΫ ΍ΠϯλϏϡʔΨΠυʹج͍ͮͯͳ͞Ε͍ͯΔ͔ɻ 22 άϧʔϓϛʔςΟϯά΍ΠϯλϏϡʔ͸ه࿥͞ΕஞޠԽ ͞Ε͍ͯΔ͔ 23 σʔλʹద੾ͳ෼ੳํ๏͕༻͍ΒΕ͍ͯΔ͔ 24 গͳ͘ͱ΋ೋਓͷݚڀऀ͕ղੳʹࢀՃ͍ͯ͠Δɻ 25 ͦͷPROMΛױऀʹద༻͢Δ৔߹ʹPROͷڭࣔɺ߲໨ɺ ൓Ԡબ୒ࢶɺ૝ىظؒͷ෼͔Γ΍͢͞ʹؔ͢Δ໰୊͕͋ Δ͔ɻ 20 23 30 33 Step1a 7 10 ( )

5KL H ,S •  17 or 27 Very good Adequate Doubtful Inadequate શͯͷ߲໨͕࠷ऴ൛Ͱς ετ͞ΕͯΔ ͓ͦΒ͘࠷ऴ൛͕ͩ໌֬ ʹهࡌ͞Ε͍ͯͳ͍ ࠷ऴ൛Ͱςετ͔ͨ͠Ͳ ͏͔ෆ໌֬ ࠷ऴ൛Ͱςετ͞Ε͍ͯ ͳ͍ ඍௐ੔͞Εͨޙʹ࠶ςε τ͕ͳ͞Ε͍ͯͳ͍ •  18 or 28.Θ͔Γ΍͢͞΍แׅੑධՁͷͨΊʹద੾ͳํ๏͕༻͍ΒΕ͍ͯ Δ Very good Adequate Doubtful Inadequate ޿͘஌ΒΕɺे෼ʹਖ਼౰ Խ͞Ε͍ͯΔ࣭తݚڀ๏ ͕࣋ͪΒΕ͍ͯΔ ద੾ͳํ๏͕༻͍ΒΕͯ ͍ΔͱࢥΘΕΔ͕ɺ໌֬ ͳهࡌ͕ͳ͍ ྔతͳ(ௐࠪ)ํ๏ͷΈ͕ ༻͍ΒΕ͍ͯΔɺํ๏͕ ద੾͔ٙΘ͍͠ɺױऀ͕ ෼͔Γ΍͢͞΍แׅੑʹ ͍ͭͯਘͶΒΕ͔ͨෆ໌ ֬ɺਘͶΒΕ͍ͯͳ͍ ෆద੾ͳํ๏͕༻͍ΒΕ ͍ͯΔ

5KL H ,S •  19 or 29. Very good Adequate Doubtful Inadequate ࣭తݚڀͷ৔߹ ≥7 ྔతݚڀͷ৔߹ ≥50 ࣭తݚڀͷ৔߹ 4-6 ྔతݚڀͷ৔߹ ≥30 ࣭తݚڀͷ৔߹ <4 or ෆ໌ ྔతݚڀͷ৔߹ <30 or ෆ໌ •  24 or 34. – v Very good Adequate Doubtful Inadequate গͳ͘ͱ΋ೋਓ ͷݚڀऀ͕ղੳ ʹࢀՃ͍ͯ͠Δ গͳ͘ͱ΋ೋਓ ͷݚڀऀ͕ղੳ ʹࢀՃ͍ͯ͠Δ ͱࢥΘΕΔ͕ه ࡌ͕ෆ໌֬ ೋਓࢀՃ͔ͨ͠ ෆ໌ɺͻͱΓͩ ͚ࢀՃ

5KL H ,S •  25 or 35. HJGE HJG u u u ff v Very good Adequate Doubtful Inadequate ໰୊ͳ͠ɺ ໰୊͕໌ࣔ͞Εɺ ௐ੔͞Εɺඞཁ ͳ৔߹ʹ࠶ςε τ͞Ε͍ͯΔ ໰୊ͳ͍Α͏ʹ ࢥΘΕΔ͕ɺ͋ Δ͍͸໰୊͕ద ੾ʹݴٴ͞Εͯ ͍Δ͕ɺهࡌ͕ ෆ໌֬ ໰୊͕͋Δͷ͔ ෆ໌֬ɺ໰୊͕ ͋Δ৔߹ʹ໌ࣔ ͞Ε͍ͯΔ͔ٙ Θ͍͠ɺ໰୊͕ ͋ͬͨ৔߹ʹௐ ੔͕͞Ε͍ͯΔ ͕ɺมߋޙʹ࠶ ςετ͕͞Εͯ ͍ͳ͍ɻ ໰୊͕͖͋Β͔ʹ͋Δ

5KL H - Terwee, C. B., Prinsen, C. A., Chiarotto, A., de Vet, H. C., Bouter, L. M., Alonso, J., ... & Mokkink, L. B. (2018). COSMIN methodology for assessing the content validity of PROMs–user manual. Amsterdam, Netherlands: VU University Medical Center.

5KL H - Terwee, C. B., Prinsen, C. A., Chiarotto, A., de Vet, H. C., Bouter, L. M., Alonso, J., ... & Mokkink, L. B. (2018). COSMIN methodology for assessing the content validity of PROMs–user manual. Amsterdam, Netherlands: VU University Medical Center. Step2a, b, c 1, 8, 15 2, 9, 16 3, 10, 17 ? 4, 11, 18 5, 12, 19 6, 13, 20 7, 14, 21 Step2d,e 22, 27 23, 28 24, 29 25, 30 26, 31 •  ߲໨͸step1ͱڞ௨

5KL H . •  UG C+ ,+ – u HJGE v u HJGE v •  UG D+ u u u u dfrTZV e &% Z dfrTZV e o% Z T dZdeV e p% c Z UVeVc Z ReV 8% •  UG E+ –  KeVa .S •  YZ Y UVcReV h gVcj h •  ffi 19/08/31 WS

KeVa.R5 19/08/31 WS

5 KeVa.R 19/08/31 WS TV EKGOU – HJG % 30 KOTV EKGOU – HJG % 30 , KOFGUGSNKOCUG u ධՁͷࡍʹ͸ɺόΠΞεͷϦεΫͷධՁΛՃຯ ݚڀσβΠϯ͕ෆద੾ͱධՁ͞Εͨ΋ͷ͸ɺ͜ͷධՁΛߦΘͳ͍ (εϥΠυ28,40ͷϑϩʔͰPROͱͯ͠ෆద੾ͱධՁ͞Εͨ΋ͷ)

5 KeVa.R ؔ࿈ੑ (relevance) 1 ࢦඪʹؚ·Ε߲ͨ໨͸ɺؔ৺ͷ֓೦ʹؔ࿈͍ͯ͠Δ͔ 2 ࢦඪʹؚ·Ε߲ͨ໨͸ɺؔ৺ͷλʔήοτ฼ूஂʹؔ࿈͍ͯ͠Δ͔ 3 ࢦඪʹؚ·Ε߲ͨ໨͸ɺؔ৺ͷར༻จ຺ʹؔ࿈͍ͯ͠Δ͔ 4 ൓Ԡબ୒ࢶ͸ద੾͔ 5 ૝ىظؒ͸ద੾͔ ֤߲໨Λ + (sufficient), - (insufficient), ± (indeterminate)ͰධՁ O P 1 : 63 ) ( - ) ( - 5 Step1a Step2

dfrTZV e &% 19/08/31 WS PROM development study Content validity study Reviewers’ rating 1 Very good on Box1.1 and Box1.2 (ଌఆ֓೦ͱͦͷഎܠ͕ΫϦΞ) Not inadequate on box 2d. 22-26 (ؔ࿈ੑ:ઐ໳Ո) গͳ͘ͱ΋߲໨ͷ85%͕ؔ৺ͷ ֓೦Λࢦͯ͠Δ গͳ͘ͱ΋߲໨ͷ85%͕ؔ ৺ͷ֓೦Λࢦͯ͠Δ গͳ͘ͱ΋߲໨ͷ85%͕ؔ ৺ͷ֓೦Λࢦͯ͠ΔͱϨ Ϗϡϫʔ൑அ 2 Box1.3 and very good (ඪతू ஂ͕໌֬) Box1.5 very good or adequate (ඪతूஂ͕߲໨ੜ੒ؔ༩) Box1a 6-13 not inadequate (ؔ ࿈ੑ) ඪతूஂͷ୅දੑ͕ٙΘ͍͠ → ? not inadequate on Box2a1-7 (ױऀධՁͷؔ࿈ੑ) গͳ͘ͱ΋85%ͷ߲໨͕ؔ ࿈ੑ͋Γ গͳ͘ͱ΋߲໨ͷ85%͕ؔ ৺ͷूஂͱؔ࿈ͱϨϏϡ ϫʔ൑அ

dfrTZV e &% T e)% 19/08/31 WS PROM development study Content validity study Reviewers’ rating 3 Box1.4 very good (࢖༻จ ຺͕໌֬) not inadequate on Box2a22-26 (ઐ໳ՈධՁͷؔ ࿈ੑ) গͳ͘ͱ΋85%ͷ߲໨͕ؔ࿈ ੑ͋Γ গͳ͘ͱ΋߲໨ͷ85%͕ؔ৺ ͷจ຺ͱؔ࿈ͱϨϏϡϫʔ൑ அ 4 ൓Ԡબ୒ࢶͷਖ਼౰ੑ͕ࣔ͞ Ε͍ͯΔ Not inadequate on Box2a 1-7 and Box2d 22-26 ױऀͱઐ໳Ո͕൓Ԡબ୒ࢶΛ ద੾ͩͱධՁ গͳ͘ͱ΋85%ͷ൓ԠΦϓ γϣϯ͕ؔ࿈͍ͯ͠Δ গͳ͘ͱ΋൓Ԡબ୒ࢶͷ85% ͕֓೦ɺूஂɺ࢖༻จ຺ͱؔ ࿈͍ͯ͠ΔͱϨϏϡΞʔ൑அ 5 ૝ىظؒͷਖ਼౰ੑ͕ࣔ͞Ε ͍ͯΔ Not inadequate on Box2a 1-7 and Box2d 22-26 ױऀͱઐ໳Ո͕૝ىظؒΛద ੾ͩͱධՁ গͳ͘ͱ΋૝ىظ͕ؒ֓೦ɺ ूஂɺ࢖༻จ຺ͱؔ࿈͍ͯ͠ ΔͱϨϏϡΞʔ൑அ

5 KeVa.R ֤߲໨Λ + (sufficient), - (insufficient), ± (indeterminate)ͰධՁ Step1b Step2 1 5 4 - P M 4 )3 M6 R 4 ? R ( - P M 4 R ( 4 ? 4 ? )3 M6 7 1O? 2 แׅੑ (comprehensiveness) 6 ॏཁͳ֓೦ͷ࿙Ε͕ͳ͍͔

dfrTZV e &% 19/08/31 WS PROM development study Content validity study Reviewers’ rating 6 Not inadequate on box 1a standards 6-13 box 1b standards 26-35 ױऀ͕แׅੑʹ͍ͭͯɺ ֓೦ੜ੒ϑΣʔζ΍ೝ஌ తΠϯλϏϡʔͰਘͶΒ Ε͓ͯΓ ॏཁͳ֓೦ͷ࿙Ε͕ͳ͍ Not inadequate box 2b standards 8-14 box 2e standards 27-31 ױऀͱઐ໳Ո͕แׅੑʹͭ ͍ͯਘͶΒΕ͓ͯΓ धཁͳ֓೦ͷ࿙Ε͕ͳ͍ ϨϏϡΞʔ͸ PRO͕ɺ֓೦ɺ ର৅ɺ࢖༻จ ຺ͱরΒͯ͠ แׅతଥ౰ͱ ߟ͍͑ͯΔ

෼͔Γ΍͢͞ (comprehensibility) 7 ؔ৺ͷ฼ूஂ͕ҙਤͨ͠௨Γʹڭ͕ࣔཧղͰ͖Δ͔ 8 ؔ৺ͷ฼ूஂ͕ҙਤͨ͠௨Γʹ߲໨ͱ൓Ԡબ୒ࢶ͕ཧղͰ͖Δ͔ 9 ߲໨ͷݴޠදݱ͕ద੾͔ 10 ൓Ԡબ୒ࢶ͸࣭໰ͱϚον͍ͯ͠Δ͔ 19/08/31 WS Step1b Step2 1 5 4 - P M 4 )3 M6 R 4 ? R ( - P M 4 R ( 4 ? 4 ? )3 M6 7 1O? 2

dfrTZV e &% 19/08/31 WS PROM development study Content validity study Reviewers’ rating 7 Not inadequate on Box1b.16-25 ױऀ͕ڭࣔͷ෼͔Γқ͞ʹ͍ͭͯ(૝ىظؒΛؚΊ ͯ)ɺ֓೦ੜ੒ϑΣʔζ΍ೝ஌తΠϯλϏϡʔͰਘͶ ΒΕ͓ͯΓ ໰୊͕ద੾ʹ໌ࣔ͞Ε͍ͯΔ Not inadequate on Box2c.15-21 ױऀ͕ڭࣔͷ෼͔Γқ͞ʹ͍ͭͯ(૝ ىظؒΛؚΊͯ)ɺ಺༰తଥ౰ੑݚڀ ͰਘͶΒΕ͓ͯΓ ॏཁͳ໰୊͕ͳ͍ 8 Not inadequate Box1b.16-25 ױऀ͕߲໨ͱ൓Ԡબ୒ࢶͷ෼͔Γқ͞ʹ͍ͭͯ(૝ى ظؒΛؚΊͯ)ɺ֓೦ੜ੒ϑΣʔζ΍ೝ஌తΠϯλ ϏϡʔͰਘͶΒΕ͓ͯΓ ໰୊͕ద੾ʹ໌ࣔ͞Ε͍ͯΔ Not inadequate Box2c.15-21 ױऀ͕߲໨ͱ൓Ԡબ୒ࢶͷ෼͔Γқ ͞ʹ͍ͭͯ(૝ىظؒΛؚΊͯ)ɺ಺༰ తଥ౰ੑݚڀͰਘͶΒΕ͓ͯΓ গͳ͘ͱ΋85%ͷ߲໨ͱ൓Ԡબ୒ࢶ ʹॏཁͳ໰୊͕ͳ͍ ϨϏϡΞʔ͸গͳ͘ͱ ΋߲໨ͷ85%͕ؔ৺ͷ ࢖༻จ຺ͱؔ࿈͍ͯ͠ Δͱߟ͍͑ͯΔ 9 ϨϏϡΞʔ͸গͳ͘ͱ ΋߲໨ͱ൓Ԡબ୒ࢶͷ 85%͕ɺద੾ʹϫʔ σΟϯά͞Ε͍ͯΔͱ ߟ͍͑ͯΔ 10 ϨϏϡΞʔ͸গͳ͘ͱ ΋൓Ԡબ୒ࢶͷ85%͕ɺ ద੾ʹϫʔσΟϯά͞ Ε͍ͯΔͱ࣭໰ͱϚο ν͍ͯ͠Δͱߟ͍͑ͯ Δ

KeVa.S5 19/08/31 WS

KeVa .S5 19/08/31 WS + - ? ± ؔ࿈ੑ গͳ͘ͱ΋ج४1ͱ 2͸(+) AND ଞͷ3ͭͷج४Ͱগ ͳ͘ͱ΋2ͭ(+) 1ͱ2Ҏ֎Ͱͷ(-) ͸ Ұͭ·Ͱڐ༰ (-)͕͍ͭͨ৔߹͸ ±ͷධՁ΋ϨϏϡ ϫʔՄೳ গͳ͘ͱ΋ج४1ͱ2ͷ ͲͪΒ͔ʹ(-) AND ଞͷ3ͭͷج४ͷগͳ ͘ͱ΋2ͭͰ (-) গͳ͘ͱ΋̎ͭ ج४ΛධՁ ͦͷଞͷঢ়گ แׅੑ ج४6ͷධՁ ج४6ͷධՁ ج४6ͷධՁ ج४6ͷධՁ ෼͔Γ΍͢͞: PROM։ൃ ಺༰తଥ౰ੑݚڀ গͳ͘ͱ΋ج४8͕ (+)Ͱج४7͕(–) ͡Όͳ͍ ج४8͕(-) ج४8͕ධՁ͞Ε ͯΔ ج४8͕(+)Ͱج४7 ͕ධՁ͞ΕͯΔ ෼͔Γ΍͢͞ɿ ϨϏϡϫʔධՁ ج४9ͱ10͕(+) ج४9ͱ10͕(-) গͳ͘ͱ΋Ͳͪ Β͔͕ධՁ͞Ε ͯΔ Ұํ͕(+)Ͱ΋͏Ұ ํ͕(-)

KeVa .S5 – p% 19/08/31 WS Ұ؏͠ͳ͍ཧ༝Λݕ౼ɿ ඞཁʹԠͯ͡ɺͦͷཁҼͰαϒάϧʔϓΛߏ੒͠ධՁ ྫ) ΋͠ɺٸੑױऀͱຫੑױऀͰҟͳΔධՁ͕༩͑ ΒΕ͍ͯΔͳΒɺPROͷ಺༰తଥ౰ੑͷ૯߹ධ Ձ͸ɺٸੑױऀͱຫੑױऀͰ෼͚ͯ΍Δɻ ٸੑױऀͰ͸แׅੑͷ૯߹ධՁ͕(+)Ͱ͋Δ͕ɺ ຫੑױऀͰ͸ʢ-)

KeVa.T5 19/08/31 WS

KeVa .T5 •  19/08/31 WS ݚڀσβΠϯ ಺༰తଥ౰ੑݚڀগͳ͘ ͱ΋Ұͭ High όΠΞεͷϦεΫ 1.  Serious 2.  Very serious 3.  Very serious टඌҰ؏ੑ 1.  Serious 2.  Very Serious ඇ௚઀ੑ 1.  Serious 2.  Very Serious ಺༰తଥ౰ੑݚڀͳ͠ Moderate low Very low

KeVa .T5 19/08/31 WS 1 very good adequate 1 doubtul 1 PROM very good or adequate 1 PROM doubtul 1 PROM inadequate -1 -2 -3

KeVa .T5 •  –  – u u – v •  –  u v 19/08/31 WS

LR V Y V VddR V •  – •  ffi u u •  u u u •  u •  19/08/31 WS

: povk vsyq s v : :2 . - 1 GKEAF ± ʻ 3VKFGMKOG HPS YTUGNCUKE GWKG T PH :VUEPNG GCTVSGNGOU OTUSVNGOUT 19/08/31 WS

PROMͷ࣭ͷධՁ 1.  ݸʑͷݚڀͷόΠΞε ͷϦεΫͷධՁ 2.  ࢦඪಛੑͷ࣭ΛධՁ 3.  ΤϏσϯεͷ·ͱΊͱ ࣭ͷάϨʔσΟϯά Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J., Stratford, P. W., Knol, D. L., ... & de Vet, H. C. (2010). The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. Journal of clinical epidemiology, 63(7), 737-745. 1. PROMͷ։ൃ (box1) ಺༰తଥ౰ੑͷධՁ 2. ද໘తଥ౰ੑ (box2) ಺తߏ଄ͷධՁ 3. ߏ଄తଥ౰ੑ (box3) 4. ಺త੔߹ੑ (box4) 5. ҟจԽؒଥ౰ੑ (box5) ͦͷଞͷಛੑධՁ 6. ৴པੑ (box6) 7. ଌఆޡࠩ (box7) 8. ج४ؔ࿈ଥ౰ੑ (box8) 9. ߏ੒֓೦ଥ౰ੑ(box9) 10. ൓Ԡੑ (box10) ධՁ͢Δಛੑͷॱং

•  u GKEAF -++4% •  – v •  GKEAF -++4% v •  u 19/08/31 WS

GKEAF -++4% COSMIN(2009) hRps://www.amazon.co.jp/ %E4%BA%BA%E7%94%9F%E3%81%AB%E3%81%AF%E4%BD%95%E3 %81%B2%E3%81%A8%E3%81%A4%E7%84%A1%E9%A7%84%E3%81 %AA%E3%82%82%E3%81%AE%E3%81%AF%E3%81%AA%E3%81%84- %E6%9C%9D%E6%97%A5%E6%96%87%E5%BA%AB- %E9%81%A0%E8%97%A4-%E5%91%A8%E4%BD%9C/dp/4022614757

•  ffi – – t Terwee, C. B., Prinsen, C. A., Chiarotto, A., Westerman, M. J., Patrick, D. L., Alonso, J., ... & Mokkink, L. B. (2018). COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Quality of Life Research, 27(5), 1159-1170. formative model reflective model :69 78;7 ' &!$ 0 &"$ 20 $ 0 :69 78;7 ' %!$ 0 %"$ 0 %#$ ε ε ε ε formative reflective ⇒ ⇒ CTT, IRT 01,0/ 5)4 0/<,00 * +4-13.( Reflective model͕ධՁର৅

19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 1. ݹయతςετཧ࿦: ୳ࡧత, ݕূతҼࢠ෼ੳ͕࣮ߦ͞Ε͍ͯΔ͔ɻ CFA࣮ࢪ EFA࣮ࢪ ͍ͣΕ΋ͳ͠ 2. IRT/Rash: બ୒ͨ͠Ϟσϧ͕ݚڀٙ໰ʹϑΟοτ͍ͯ͠Δ͔* બ୒ͨ͠Ϟσϧ ͕ϑΟοτͯ͠ Δ ͓ͦΒ͘͸ ϑΟοτͯ͠Δ ϑΟοτͯ͠Δ ͔ٙΘ͍͠ ϑΟοτͯ͠ͳ ͍ϞσϧΛબ୒ ͯ͠Δ 3. ղੳର৅ͷαϯϓϧαΠζ͸ద੾͔ ɻ ৄࡉ͸࣍ͷεϥΠυ 4. ଞͷॏཁͳݚڀσβΠϯ΍౷ܭख๏ͷ͕ܽؕ͋Δ͔ɻ ଞͷॏཁͳܽؕ ͸ͳ͍ ଞͷܰඍͳํ๏ ࿦ͷ͕ܽؕ͋Δ (e.g., ճస๏͕هࡌ͞ Ε͍ͯͳ͍) ଞͷॏཁͳܽؕ ͕͋Δ(e.g.,ෆద੾ ͳճస๏ͷ࢖༻) *ϑΥϩΞοϓσʔλΛՃ͑ͯղੳͯ͠Δ৔߹͸ɺ ϚϧνϨϕϧIRT͕ద੾ͳͷʹద༻ͯ͠ͳ͍ͳͲ

,) 1. ݹయతςετཧ࿦: ୳ࡧత, ݕূతҼࢠ෼ੳ͕࣮ߦ͞Ε͍ͯΔ ͔ɻ 19/08/31 WS item 5 item 6 item 2 item 1 item 3 item 4 f1 f2 EFA CFA CFA item 5 item 6 item 2 item 1 item 3 item 4 f1 f2

LL AJL X5 X6 X2 X1 X3 X4 θi CTT e5 e6 e2 e1 e3 e4 IRT Z5 Z6 Z2 Z1 Z3 Z4 θi CTT IRT Xij : i j ( ) μj j αj j Θi i ej j Zij : i j (2 / ) αj j ( ) βj j Θi i ( ) ej j Z 2 : Rash / 1-PL / 2-PL / 3PL Z : Graded Response Model (GRM)/ Par:al Credit Response Model (PCRM) Xij = μj +αj θi + eij α1 α2 α3 α4 α5 α6 β1 β2 β3 β4 β5 β6 e5 e6 e2 e1 e3 e4 Zij = -αj +βj θi + eij ( )

AJL5 - a j = β j = ߲໨ಛੑۂઢͷ܏͖ ߲໨ಛੑۂઢͷ੾ย IRT Z5 Z6 Z2 Z1 Z3 Z4 θi β1 β2 β3 β4 β5 β6 e5 e6 e2 e1 e3 e4 Zij = -αj +βj θi + eij (item characteris:c curve: ICC)

19/08/31 WS (very good) (adequate) (doubHul) (inadequate) 3. Factor analysis ߲໨਺ͷ7ഒ ≧100Ҏ্ ߲໨਺ͷ5ഒ͔ ͭ≧100 or ߲໨਺ͷ5-7ഒ ͔ͭ<100 ߲໨਺ͷ5ഒ <100ҎԼ ߲໨਺ͷ5ഒҎ Լ Rasch/1PL model 200Ҏ্ 100-199 50-99 <50 2 PL parametric IRT model Mokken scale analysis 1000Ҏ্ 500-999 250-499 <250

•  ffi t https://researchmap.jp/muuex8xf9-1788230/? action=multidatabase_action_main_filedownload&download_flag=1&upload_id=65193&metadata_id=49144

19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 1. ಺త੔߹ੑͷ౷ܭࢦඪ͕୯Ұ࣍ݩई౓·ͨ͸ԼҐई౓͝ͱͰࢉग़͞Εͯ Δ ࢉग़͞ΕͯΔ ई౓શମ͔ԼҐई ౓ͳͷ͔ෆ໌ ࢉग़͞Εͯͳ͍ 2. ࿈ଓείΞͷ৔߹: ΫϩϯόοΫͷα·ͨ͸ϚΫυφϧυͷω͕ࢉग़͞Ε ͯΔ ࢉग़͞Ε͍ͯΔ ITT૬͚ؔͩࢉग़͞ Ε͍ͯΔ ͲͪΒ΋ࢉग़͞Ε ͯͳ͍ 3. ೋ஋είΞͷ৔߹ɿΫϩϯόοΫͷα·ͨ͸KR-20͕ࢉग़͞Ε͍ͯΔ ࢉग़͞Ε͍ͯΔ ITT૬͚ؔͩࢉग़͞ Ε͍ͯΔ ͲͪΒ΋ࢉग़͞Ε ͯͳ͍ 4. IRTʹجͮ͘είΞͷ৔߹ɿೳྗ஋(θ)ͷඪ४ޡࠩ(SE(θ))ͳͲͷજࡏಛੑ ஋ͷ৴པੑ܎਺͕ࢉग़͞Ε͍ͯΔ ࢉग़͞Ε͍ͯΔ ࢉग़͞Ε͍ͯͳ͍

s V R k = ߲໨૯਺ σ2 i = ߲໨iͷ෼ࢄ σ2 test = ߹ܭಘ఺ͷ෼ࢄ ΫϩϯόοΫͷα: Ҽࢠෛՙ͸߲໨ؒͰ౳͍͠ͱ͍͏લఏ͋Γ λ j = ߲໨jͷҼࢠෛՙ (ඪ४Խ) σ2 εi = ߲໨ j ͷޡࠩ෼ࢄ 1 ϚΫυφϧυͷω:Ҽࢠෛՙ͸߲໨ؒͰҟͳ͍ͬͯͯ΋ྑ͍ CFAద༻ͷ৔߹͸ɺω͕ద੾

s CJ(-+ https://researchmap.jp/muuex8xf9-1788230/? action=multidatabase_action_main_filedownload&download_flag=1&upload_id=65193&metadata_id=49144 k = ߲໨૯਺ σ2 i = ߲໨iͷ෼ࢄ σ2 test = ߹ܭಘ఺ͷ෼ࢄ ΫϩϯόοΫͷα: ࿈ଓม਺ͷ৔߹ k = ߲໨૯਺ pi = ͸͍(1)ͱճ౴ͨ͠ਓͷׂ߹ qi = ͍͍͑(0)ͱճ౴ͨ͠ਓͷׂ߹ σ2 test = ߹ܭಘ఺ͷ෼ࢄ KR-20: 2஋ม਺ͷ৔߹

AJL ೳྗ஋ͷඪ४ޡࠩ (SE (θ)) SE(θ) = 1/√ I(θ) I(θ) : ϑΟογϟʔ৘ใྔؔ਺ ೳྗ஋͕౰֘ͷ஋ͰͲΕ͘Β͍ਖ਼͔֬ ςετ৘ใۂઢ

ff ffi https://researchmap.jp/muuex8xf9-1788230/? action=multidatabase_action_main_filedownload&download_flag=1&upload_id=65193&metadata_id=49144 •  ffi 5 ff –  HJG HJG –  ff

ff ffi 19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 1. άϧʔϓԽม਺Λͷ͍ͧͯ܈ؒͷಛ௃͕ྨࣅ͍ͯ͠Δ άϧʔϓԽม਺Λ আ͍ͯ܈͕ྨࣅ͠ ͍ͯΔ͜ͱͷΤϏ σϯε͕ࣔ͞Εͯ ͍Δ ྨࣅ͍ͯ͠Δ͜ͱ ͕ݴٴ͞Ε͍ͯΔ ͕ΤϏσϯε͸ࣔ ͞Ε͍ͯͳ͍ ྨࣅ͍ͯ͠Δͷ͔ ෆ໌֬ ྨࣅ͍ͯ͠ͳ͍ 2. σʔλղੳʹద੾ͳํ๏͕༻͍ΒΕ͍ͯΔ͔ ޿͘஌ΒΕ͍ͯΔɺ ͋Δ͍͸Α͘ਖ਼౰ Խ͞Ε͍ͯΔํ๏ Λ༻͍͍ͯΔ ద੾ͳํ๏ͩͱ૝ ఆ͞ΕΔ͕໌֬ʹ ड़΂ΒΕ͍ͯͳ͍ ద੾͔Ͳ͏͔ෆ໌ ֬ ෆద੾ͳํ๏

ff ffi 19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 3. αϯϓϧαΠζ͸ద੾͔ ճؼ෼ੳ΍ IRT/Rash basedͳ෼ੳ (DIFͷݕग़) ֤܈ 200 ֤܈ 150 ֤܈ 100 ֤܈ < 100 ଟ฼ूஂCFA ߲໨਺ͷ7ഒ ≧100Ҏ্ গͳ͘ͱ΋߲ ໨਺ͷ5ഒ͔ͭ ≧100 or ߲໨਺ͷ5-7ഒ ͔ͭ<100 ߲໨਺ͷ5ഒ <100ҎԼ ߲໨਺ͷ5ഒҎ Լ

AJL SRdVU ff 5 UZqVcV eZR ZeV Wf TeZ % •  – w ffi v hRp://www.jstatsor.org/v39/i08/paper

AJL SRdVU ff Uniform DIF ( ) (or ) non-Uniform DIF ( ) ) ( ) ) ( ) Psychol Sci Q. 2008 ; 50(4): 538. hRp://www.restore.ac.uk/appliedpsychometrics/Tutorial.materials/Measurement.invariance/ DIF%20workshop%202012%20FINAL.pdf α( ) β ( )

AJL SRdVU ff PSFKOCM MPIKTUKE SGISGTTKPO : baseline model non-uniform DIF uniform DIF ( ) DIF : → (χ2) uniform DIFͷݕग़: base model vs uniform DIF non-uniform DIFͷݕग़: uniform DIF vs non-uniform DIF total DIFͷݕग़: base model vs non-uniform DIF pseudo R2 (ٖࣅܾఆ܎਺): ෼ࢄઆ໌཰R2 Δβ: baseline model uniform DIF model β (baseline β - uniform β) / uniform β 10% (prac:cal) (Crane et al. 2004) → pseudo R2, ΔR2 Zumbo (1999) : 0.13 = (negligible) 0.13 0.26 = (moderate) 0.26 = (large)

K E % •  E UV ,5 n fcR Z gRcZR TV –  •  E UV -5 EVecZT Z gRcZR TV –  •  E UV .5 KTR Rc Z gRcZR TV –  •  E UV /5 cVdZUfR Z gRcZR TV –  19/08/31 WS Model1 4 ΔCFI = 0.01 model2

n fcR A gRcZR TV •  ff % ूஂ̍ item 5 item 6 item 2 item 1 item 3 item 4 f1 f2 ूஂ2 item 5 item 6 item 2 item 1 item 3 item 4 f1 f2 ্هͷϞσϧਤͷ৔߹ɺूஂؒͰҼࢠߏ଄͕ҟͳΔ (Configural Invariance͕ຬͨ͞Ε͍ͯͳ͍)

EVecZT A gRcZR TV •  ff ूஂ̍ item 5 item 6 item 2 item 1 item 3 item 4 f1 f2 ूஂ̎ item 5 item 6 item 2 item 1 item 3 item 4 f1 f2 ্هͷϞσϧਤͷ৔߹ɺूஂؒͰҼࢠෛՙ͕ҟͳΔ (Metric invariance͕ຬͨ͞Ε͍ͯͳ͍)

https://researchmap.jp/muuex8xf9-1788230/? action=multidatabase_action_main_filedownload&download_flag=1&upload_id=65193&metadata_id=49144 •  ffi COSMINͰ͸࠶ݕࠪ৴པੑΛࢦ͍ͯ͠Δ

19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 1. ױऀͷଌఆ֓೦͕Ұఆͷظؒ҆ఆ͍ͯ͠Δ 2. ִؒ͸ద੾͔ 3.ςετ৚͕݅ଌఆػձؒͰಉ͔͡

T e)% 19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 4. ࿈ଓई౓ͷ৔߹: ڃ಺૬ؔ܎਺͕ࢉग़͞Ε͍ͯΔ͔ ICC͕ࢉग़͞Εɺ ICCͷ͕ࣜهࡌ ͞Ε͍ͯΔ ICC͕ࢉग़͞Ε ͍ͯΔ͕ɺܭࢉ ࣜ͸ෆ໌·ͨ͸ ෆద੾ ܥ౷తͳมԽ͕ ੜ͍ͯ͡ͳ͍͜ ͱͷΤϏσϯε ͕ࣔ͞ΕΔͱͱ ΋ʹ૬ؔ܎਺Λ ༻͍ͯΔ ܥ౷తͳมԽ͕ ੜ͍ͯ͡ͳ͍͜ ͱͷΤϏσϯε Λࣔͣ͞ɺ૬ؔ ܎਺Λ༻͍ͯΔ ܥ౷తͳมԽ͕ ੜ͍ͯ͡Δ͜ͱ ͷΤϏσϯεΛ ࣔͯ͠૬ؔ܎਺ Λ༻͍͍ͯͳ͍ ICC΋૬ؔ܎਺ ΋ࢉग़͞Ε͍ͯ ͳ͍

T e)% 19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 5. ΧςΰϦΧϧई౓ͷ৔߹: kappa܎਺͕ࢉग़͞Ε͍ͯΔ͔ Kappa܎਺Λࢉ ग़͍ͯ͠Δ ࢉग़͍ͯ͠ͳ͍ 6. ॱংई౓ͷ৔߹ɿॏΈ෇͚kappa͕ࢉग़͞Ε͍ͯΔ͔ ॏΈ෇͚Kappa ܎਺Λࢉग़ͯ͠ ͍Δ ॏΈ෇͚͍ͯͳ ͍Kappa܎਺Λ ࢉग़͍ͯ͠Δ· ͨ͸هࡌ͕ͳ͍ 7. ॱংई౓ͷ৔߹ɿॏΈ෇͚ͷεΩʔϜ͕ड़΂ΒΕ͍ͯΔ͔ ॏΈ෇͚εΩʔ Ϝ͕هࡌ͞Εͯ ͍Δ ॏΈ෇͚εΩʔ Ϝ͕هࡌ͞Εͯ ͍ͳ͍

% https://researchmap.jp/muuex8xf9-1788230/? action=multidatabase_action_main_filedownload&download_flag=1&upload_id=65193&metadata_id=49144

% https://researchmap.jp/muuex8xf9-1788230/? action=multidatabase_action_main_filedownload&download_flag=1&upload_id=65193&metadata_id=49144

ffi https://researchmap.jp/muuex8xf9-1788230/? action=multidatabase_action_main_filedownload&download_flag=1&upload_id=65193&metadata_id=49144 •  ffi

ffi 19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 1. ױऀͷଌఆ֓೦͕Ұఆͷظؒ҆ఆ͍ͯ͠Δ 2. ִؒ͸ద੾͔ 3.ςετ৚͕݅ଌఆػձؒͰಉ͔͡ 1

ffi T e)% 19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 4. ࿈ଓई౓ͷ৔߹: ࢦඪͷඪ४ޡࠩ(SEM), ࠷খݶͷݕग़Մೳ ͳมԽ (SDC), Ұகݶք (LoA)͕ࢉग़͞Ε͍ͯΔ͔ SEM, SDC, or LoA LoA SEM Cronbach alpha SD 5.ΧςΰϦΧϧई౓ͷ৔߹:Ұக཰͕ࢉग़͞Ε͍ͯΔ

ffi K< EA D 9 https://researchmap.jp/muuex8xf9-1788230/? action=multidatabase_action_main_filedownload&download_flag=1&upload_id=65193&metadata_id=49144

ffi K E% K< D 9 •  K< % •  D 9 https://researchmap.jp/muuex8xf9-1788230/? action=multidatabase_action_main_filedownload&download_flag=1&upload_id=65193&metadata_id=49144

https://researchmap.jp/muuex8xf9-1788230/? action=multidatabase_action_main_filedownload&download_flag=1&upload_id=65193&metadata_id=49144 •  ffi J(HJG m ffi l – – ffi– u ff – ffi ffi

19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 1. ࿈ଓई౓ͷ৔߹: ૬ؔɺ͋Δ͍͸ROCۂઢԼ໘ੵ͕ࢉग़͞Ε͍ͯΔ AUC AUC 2.2஋ई౓ͷ৔߹: ײ౓ɾಛҟ౓͕ಛఆ͞Ε͍ͯΔ 3. ଞͷσβΠϯ΍౷ܭ๏্ͷॏཁͳ͕ܽؕ͋Δ͔

ffi 19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 1. ൺֱͱͳΔࢦඪ͕໌֬Ͱ͋Δ͔ 2. ൺֱͱͳΔࢦඪͷಛੑ͸े෼͔ 3. Ծઆݕূʹద੾ͳ౷ܭख๏Ͱ͋Δ͔ 9a) ଞͷΞ΢τΧϜࢦඪͱൺֱ (ऩଋతଥ౰ੑ)

ffi 19/08/31 WS ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 5. αϒάϧʔϓͷॏཁͳಛ௃͕ద੾ʹهड़͞Ε͍ͯΔ͔ 6. Ծઆݕఆͷ౷ܭख๏͕ద੾͔ 9b) αϒάϧʔϓؒͰͷൺֱ (หผత ·ͨ͸know-groups validity)

– hRps://www.slideshare.net/yoshitaket/cosmin-takebayashi-21816803

https://researchmap.jp/muuex8xf9-1788230/? action=multidatabase_action_main_filedownload&download_flag=1&upload_id=65193&metadata_id=49144 •  ffi –  ffi ff •  –  ffi % –  , % –  , %

10a) ج४Ξϓϩʔν (ΰʔϧυελϯμʔυͱͷൺ ֱ) ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 1. ࿈ଓई౓ͷ৔߹: ૬ؔɺ͋Δ͍͸ROCۂઢԼ໘ੵ͕ࢉग़͞Ε͍ͯΔ AUC AUC 2.2஋ई౓ͷ৔߹: ײ౓ɾಛҟ౓͕ಛఆ͞Ε͍ͯΔ

19/08/31 10b) ֓೦Ξϓϩʔν (ଞͷΞ΢τΧϜࢦඪͱͷൺֱ) ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 4. ൺֱͱͳΔࢦඪ͕໌֬Ͱ͋Δ͔ 5. ൺֱͱͳΔࢦඪͷಛੑ͸े෼͔ 6. Ծઆݕূʹద੾ͳ౷ܭख๏Ͱ͋Δ͔ 7. ଞͷσβΠϯ΍౷ܭ๏্ͷॏཁͳ͕ܽؕ͋Δ͔

19/08/31 WS 10c) ֓೦Ξϓϩʔν (αϒάϧʔϓؒͰͷൺֱ) ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 8. αϒάϧʔϓͷॏཁͳಛ௃͕ద੾ʹهड़͞Ε͍ͯΔ͔ 9. Ծઆݕఆͷ౷ܭख๏͕ద੾͔

19/08/31 WS 10d) ֓೦Ξϓϩʔν (հೖલޙ) ͱͯ΋ྑ͍ (very good) ྑ͍ (adequate) ඍົ (doubtful) ෆద੾ (inadequate) 11. ఏڙ͞Εͨհೖʹ͍ͭͯద੾ͳهड़͕ͳ͞Ε͍ͯΔ 12. Ծઆݕఆͷ౷ܭख๏͕ద੾͔

–

LR V Y V VddR V •  u u •  u fi •  19/08/31 WS

k 1 - 2: 3::0 1- ? 1 1 : 1 1 GKEAF ± ʻ 3VKFGMKOG HPS YTUGNCUKE GWKG T PH :VUEPNG GCTVSGNGOU OTUSVNGOUT 19/08/31 WS

% TcZeVcZR W c U VRdfcV V e ac aVcej% Mokkink, L. B., De Vet, H. C., Prinsen, C. A., Patrick, D. L., Alonso, J., Bouter, L. M., & Terwee, C. B. (2018). COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures. Quality of Life Research, 27(5), 1171-1179. COSMINͰ͸ɺࢦඪಛੑ͝ͱʹɺ ྑ͍ई౓ಛੑධՁͷج४͕ ໌֬ʹࣔ͞Ε͍ͯΔɻ + sufficient (े෼) − insufficient (ෆे෼) ? indeterminate (ܾΊΒΕͳ͍) ྫ) ɹ಺త੔߹ੑ: ΫϩϯόοΫͷα ͕ .80Ͱsufficient? ɹߏ଄తଥ౰ੑ: CFI ͕.90ɺRMSEA͕10Ͱsufficient? 3ΧςΰϦධఆ [+ / - / ?]

+ CTT CFI or TLI > 0.95, RMSEA < 0.06, SRMR < 0.08 IRT : CFA: CFI or TLI > 0.95, RMSEA < 0.06, SRMR < 0.08 : < 0.20 or Q3 < 0.37 : or item scalability >0.30 : IRT: χ2 > 0.01 Rasch: infit/outit mean squares ≥ 0.5 and ≤ 1.5 Z- standardized values > -2 and <2 − (+) / ?

− (+) / ? + ICC or Kappa ≥ 0.70 + Cronbach‘s alpha(s) ≥ 0.70 (+) low

ffi •  + SDC or LoA < MIC - SDC or LoA > MIC ? SDC: : LoA: MIC:

EA< ྟচత༗ҙੑ (Clinical Significance/Minimally Important Difference) ྟচత(࣮ફత)ʹҙຯ͕͋Δಘ఺ͷ܈ؒࠩ΍ݸਓ಺ͷมԽ ≠ ౷ܭత༗ҙੑ (Statistical Significance)

K< c D 9 6 EA (2014) MIC SDC ( ) ( ) ( ) MDC: minimally detectable change; MIC: minimally important change MDC: 2 * 1.96 * 2

K< c D 9 7 EA (2014) DC MIC ( ) ( ) ( ) SDC: smallest detectable change ( ); MIC: minimally important change SDC: 2 * 1.96 * 2

EA ffi •  2 •  2 •  Angst, F., Aeschlimann, A., & Angst, J. (2017). The minimal clinically important difference raised the significance of outcome effects above the statistical level, with methodological implications for future studies. Journal of clinical epidemiology, 82, 128-136. SD 0.30-0.50

ff + 0.70 AUC ≥ 0.70 + ( ) + + AUC ≥ 0.70 /

LR V Y V VddR V •  •  ffi EA – 19/08/31 WS

05 Lee, J., Lee, E. H., & Moon, S. H. (2019). Systematic review of the measurement properties of the Depression Anxiety Stress Scales–21 by applying updated COSMIN methodology. Quality of Life Research, 1-15.

05 Lee, J., Lee, E. H., & Moon, S. H. (2019). Systematic review of the measurement properties of the Depression Anxiety Stress Scales–21 by applying updated COSMIN methodology. Quality of Life Research, 1-15.

1 1 -. B 21- . B 1 : 1 0- : GKEAF ± ʻ 3VKFGMKOG HPS YTUGNCUKE GWKG T PH :VUEPNG GCTVSGNGOU OTUSVNGOUT 19/08/31 WS

Z eVcacVeRSZ Zej% •  ffi –  – – ʼ fi –  – fi – v •  EA< u 19/08/31 WS

h k k b –  •  •  u •  u ( ( EZ Z R j A a ceR e YR V EA % ( JVda dV KYZWe JK% ( ( ( ffi 19/08/31 WS

WVRdZSZ Zej •  ffi –  HJG 19/08/31 WS feasibilityͷཁૉ -  ױऀͷΘ͔Γ΍͢͞, ྟচՈͷΘ͔Γ΍͢͞ -  ࣮ࢪͷܗଶͱ༰қ͞, ࢦඪͷ௕͞, ॴ༻࣌ؒ -  ױऀʹඞཁͳਫ਼ਆɺ਎ମతೳྗ, -  ඪ४Խͷ༰қ͞, ࢦඪܭࢉͷ༰қ͞ -  ஶ࡞ݖ, ࢦඪͷίετ -  ඞཁͳ૷ஔ, ҟͳΔηοςΟϯάͰͷೖखՄೳੑ -  ڐՄൃߦௐ੔ػؔ ղऍՄೳੑ΍feasibility͸ɺࢦඪબ୒ͷଆ໘ͱͯ͠ॏཁ ͕ͩɺࢦඪಛੑͰ͸ͳ͍ɻ

•  ffi –  ffi ffi ffff u HJG u fi u – v – – v

•  TYR V aVcd R gR fVd% հೖલ item 5 item 6 item 2 item 1 item 3 item 4 f1 f2 հೖޙ item 5 item 6 item 2 item 1 item 3 item 4 f1 f2

•  cVT decfTeZ % հೖલ item 5 item 6 item 2 item 1 item 3 item 4 f1 f2 հೖޙ item 5 item 6 item 2 item 1 item 3 item 4 f1 f2

•  հೖલ item 5 item 6 item 2 item 1 item 3 item 4 f1 f2 հೖޙ item 5 item 6 item 2 item 1 item 3 item 4 f1 f2 ( ) (uniform recalibra:on) (non-uniform recalibra:on)

•  ffi 19/08/31 WS

19/08/31 WS MIC

High moderate low Very low 19/08/31 WS

High -1 Serious -2 Very serious -3 Extremely serious -1 Serious -2 Very serious ( ) -1 total n=50-100 -2 total n<50 ( ) -1 Serious -2 Very serious moderate low Very low

No adequate very good Serious doubtul adequate Very serious inadequate doubtul Extremely Serious Inadequate 19/08/31 WS

19/08/31 WS

19/08/31 WS

No content

No content

GKEAF 19/08/31 WS A. low OK C. B. A C

LR V Y V VddR V •  u u WVRdZSZ Zeju •  ufi •  19/08/31 WS