COSMINアップデート: 全体像の共有

第36回REQUIRE研究会：患者報告式アウトカム尺度の質向上への取り組み: COSMINによる系統的レビューのガイドライン

1. 4 : 1 20/01/18 j36 REQUIREcg
2. 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´
3. 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
4. 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.
5. 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. 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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9. ~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.
10. ~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.
11. 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).
12. 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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23. 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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35. 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.
36. 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.
37. • ~ 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.
38. • 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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