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753 1 ~ l s ~ r~h 2 U.S. Food and Drug Administration (FDA). (2009). Guidance for Industry. U.S. Department of Health and Human Services. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf. LMq+. (2014). Patient Health Questionnaire (PHQ-9, PHQ-15) GK€V˜±­ Generalized Anxiety Disorder-7 GK€V: up to date. FU‹‰ ',',ˆv3;Z,cg, (7), 35-39. >tª¯šb³–´?&š:²µ´

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6 3 r a u o 3 European Medicines Agency. Reflection Paper on the use of patient reported outcome 5 (PRO) measures in oncology studies. 2014. Available at: http://www. ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2014/06/ WC500168852.pdf. • d G mYc d c d • in • ind • a MQRMV N • a f

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A • A m l g 4 McKenna, S. P. (2011). Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science. BMC medicine, 9(1), 86. Doward, L. C., Gnanasakthy, A., & Baker, M. G. (2010). Patient reported outcomes: looking beyond the label claim. Health and quality of life outcomes, 8(1), 89.

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A 5 PROªÅºÎ S-O< w# 5X@°]>¸»Ê¿Ð SF-36 [CQ 5X@§‡„¤œ²µ¢ …)° EQ-5D-5L Disease specific W-ª]^°5‘© £•¥ª>tª ADDQoL Population specific W-ªŠ"©˜œ´]>ª  (—¬”i®¢« ’“t) CHIP-CE Dimension specific W-ª_X°_XšRu” e `9”;Z/e ` »¼ÕÍÙºØÁ©8¶ —´f4 BSI Individualized ©WJª‡;°‘ °$ SEIQoL Ruiz, S. P. (2017). Patient-reported outcomes: How useful are they?. Medical Writing, 26, 42-47.

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7 • ~m m h u ~ EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY AMERICAN SOCIETY of CLINICAL ONCOLOGY Mercieca-Bebber, R., King, M. T., Calvert, M. J., Stockler, M. R., & Friedlander, M. (2018). The importance of patient-reported outcomes in clinical trials and strategies for future optimization. Patient related outcome measures, 9, 353.

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~w A m l • myh h y g s ~ r • A m ~ ~ mg y • ~ s m ~ u ~ • s u • u h hm t m h A s h h – u m r h 9 Mercieca-Bebber, R., King, M. T., Calvert, M. J., Stockler, M. R., & Friedlander, M. (2018). The importance of patient- reported outcomes in clinical trials and strategies for future optimization. Patient related outcome measures, 9, 353. Ruiz, S. P. (2017). Patient-reported outcomes: How useful are they?. Medical Writing, 26, 42-47.

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~w A m l • ~ sm A hLPGLFE QS ~ mg 10 Basch, E. (2010). The missing voice of patients in drug-safety reporting. New England Journal of Medicine, 362(10), 865-869.

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A • A m( ). ) c) . ) . c) ( • r y A m A ) c) (. r y • A m ) ( ) • f m 753 A A ~s s g m A m ~ g h A m h mg d 11 Mercieca-Bebber, R., King, M. T., Calvert, M. J., Stockler, M. R., & Friedlander, M. (2018). The importance of patient-reported outcomes in clinical trials and strategies for future optimization. Patient related outcome measures, 9, 353. Gaulin, C., & Osorio, G. (2019). Patient Reported Outcomes in Metastatic Breast Cancer Studies: Evaluating the Impact of the FDA Guidance for Industry. Journal of Scientific Innovation in Medicine, 2(1).

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A • 753 A ) - ) ((1 – 753 i ) )/ ((- A – )/ i .( A m – m / ) (( ) ( 1 – 753 i (. (/) A m – i .. A m 12 Gnanasakthy, A., Mordin, M., Clark, M., DeMuro, C., Fehnel, S., & Copley-Merriman, C. (2012). A review of patient-reported outcome labels in the United States: 2006 to 2010. Value in health, 15(3), 437-442. Gnanasakthy, A., Mordin, M., Evans, E., Doward, L., & DeMuro, C. (2017). A review of patient- reported outcome labeling in the United States (2011–2015). Value in Health, 20(3), 420-429.

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4 : ) 0 16 COSMIN(2009)ªs|”I© (ÏÓØȹ¸¦)2Ÿ¥›®Ÿ¢ http://jabt.umin.ne.jp/j/activities/3-6journal.html

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4 : ) 0 17 COSMIN(2009)ªs|”I© (ÏÓØȹ¸¦)2Ÿ¥›®Ÿ¢ http://jabt.umin.ne.jp/j/activities/3-6journal.html

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4 : ) 0 18 COSMIN(2009)ªs|”I© (ÏÓØȹ¸¦)2Ÿ¥›®Ÿ¢ http://jabt.umin.ne.jp/j/activities/3-6journal.html ¾ÔÃËÕÌÙÃÒت [¶D(Ÿ¨•!!

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4 : ) (/ • n i ) 0 19 https://www.cosmin.nl/tools/guideline-conducting-systematic-review-outcome-measures/

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4 : ) (/ m u i 20 https://cosmin.nl/wp-content/uploads/COSMIN- methodology-for-content-validity-user-manual-v1.pdf

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4 : 23 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/.

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4 : 24 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/. 8. {†u=§.[=ª} 9. D(ª-6 10. kpÖÍÑÙª& A. EYNlª.y B. CQªW=} C. PROMª…B 5. 0`*7=ª} 6. `Pƒª} 7. ¡ªªW=} 1. ÖÍÑÙªa`ª-6 2. o¯µ%Tª-6 3. EYNlª.y 4. zH§Eª…B

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o 25 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.

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28 p sy ~ box1: 36o , box2: 31o : 97 ue B ( k ( : ) k ) lk b + yi + , , - - . o . / / 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/.

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( ) 30 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. : 97 ue B ( k ( : ) k ) lk b + yi + , , - - . o . / / Ža~m«” ž·™²

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h FSL HSLE IQS QQG OHETVSHOHP RSQRHS 31 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. 39 768 t r PR A C c PR A C c 1 C CO ? C p lk b 0 . PR A C 1 k 0 356 / 7 42 PR A C 1 ) 1 Ža~m«” ž·™²

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a 32 R MP PO ) ( gs f d t t https://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. 39 768 t s SCO E ? CNR? C R RI ? CNR? C Ža~m«” ž·™²

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4 : sy 34 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.

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h • u 35 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.

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h s h u 36 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). Recommendations on the most suitable quality-of-life measurement instruments for bariatric and body contouring surgery: a systematic review. Obesity reviews, 19(10), 1395-1411.

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• ~ s i~ nl • A h • r y A i ~ s u • sy h 37 Chiarotto, A., Boers, M., Deyo, R. A., Buchbinder, R., Corbin, T. P., Costa, L. O., ... & Lin, C. W. C. (2018). Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain, 159(3), 481.

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• 38 Lloyd, M., Callander, E., Karahalios, A., Desmond, L., & Karunajeewa, H. (2019). Patient-reported outcome measures in community-acquired pneumonia: a systematic review of application and content validity. BMJ Open Respiratory Research, 6(1), e000398.

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