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Sharing Experiences in Selecting Clinical Outcome and Approving Validated Questionnaires : Insights from an Elderly Registry Study

노인등록연구 사례를 통한 임상평가지표 선정 과정 및 검증된 설문도구 승인 경험의 공유

  • Nahyun Cho (Department of Diagnostics, College of Korean Medicine, Wonkwang University) ;
  • Hyungsun Jun (Department of Diagnostics, College of Korean Medicine, Wonkwang University) ;
  • Won-Bae Ha (Department of Korean Medicine Rehabilitation, College of Korean Medicine, Won-Kwang University) ;
  • Junghan Lee (Department of Korean Medicine Rehabilitation, College of Korean Medicine, Won-Kwang University) ;
  • Mi Mi Ko (Korea Medicine Science Research Division, Korea Institute of Oriental Medicine) ;
  • Young-Eun Kim (Korea Medicine Data Research Division, Korea Institute of Oriental Medicine) ;
  • Jeeyoun Jung (Korea Medicine Science Research Division, Korea Institute of Oriental Medicine) ;
  • Jungtae Leem (Department of Diagnostics, College of Korean Medicine, Wonkwang University)
  • 조나현 (원광대학교 한의과대학 진단학교실) ;
  • 전형선 (원광대학교 한의과대학 진단학교실) ;
  • 하원배 (원광대학교 한의과대학 한방재활의학과) ;
  • 이정한 (원광대학교 한의과대학 한방재활의학과) ;
  • 고미미 (한국한의학연구원 한의과학연구부) ;
  • 김영은 (한국한의학연구원 한의약데이터부) ;
  • 정지연 (한국한의학연구원 한의과학연구부) ;
  • 임정태 (원광대학교 한의과대학 진단학교실)
  • Received : 2023.09.27
  • Accepted : 2024.02.16
  • Published : 2024.03.01

Abstract

Objectives: Underpinned by the context of a Korean traditional medicine cohort study on healthy aging, this research primarily aims to guide the selection of Clinical Outcome Assessments (COAs) for elderly healthy aging patient registry research, offering insights into the selection process; and secondly, to streamline the resource-intensive process of obtaining permissions for validated COAs, benefiting future traditional Korean medicine clinical researchers. Methods : In this study, we identified outcomes through a review of previous studies, followed by a process involving expert consultations to select the final outcomes. Subsequently, for the selected outcomes that were Clinical Outcome Assessments (COAs) developed tools, we searched in commercial databases to confirm the availability of Korean versions and the necessity of obtaining permissions. Finally, we obtained permissions for their utilization and, when needed, acquired the original instrument questionnaire through payment. Results: Through a literature review of existing observational studies, a total of 57 outcomes were selected, with 19 of them identified as COA instruments. Upon verifying usage permissions for these 19 instruments, it was found that 17 required author-specific permissions, and among these, 2 needed a purchase as they were commercially available. Conclusion: This study provides a detailed overview of outcome selection and permission acquisition for elderly patient registry research. It underscores the importance of Clinical Outcome Assessment (COA) tools and the rigorous approval process, aiming to enhance research reliability. Continuous verification of COA information is essential, and future research should explore Core Outcome Set (COS) development through consensus-building approaches like Delphi studies.

Keywords

Acknowledgement

본 논문은 한국한의학연구원의 연구비 지원을 받아서 수행되었습니다. (과제번호 KSN2312021). 본 논문은 또한 2024년도 정부(과기정통부)의 재원으로 한국연구재단 세종펠로우쉽사업의 지원을 받아 (NRF-2022R1C1C2008738) 수행된 연구입니다.

References

  1. Briggs, A. M., & Carvalho, I. A. de. (2018). Actions required to implement integrated care for older people in the community using the World Health Organization's ICOPE approach: A global Delphi consensus study. PLOS ONE, 13(10), e0205533. https://doi.org/10.1371/journal.pone.0205533
  2. Kessler, R. C., Davis, R. B., Foster, D. F., Van Rompay, M. I., Walters, E. E., Wilkey, S. A., Kaptchuk, T. J., & Eisenberg, D. M. (2001). Long-term trends in the use of complementary and alternative medical therapies in the United States. Annals of Internal Medicine, 135(4), 262-268. https://doi.org/10.7326/0003-4819-135-4-200108210-00011
  3. Ayele, A. A., Tegegn, H. G., Haile, K. T., Belachew, S. A., Mersha, A. G., & Erku, D. A. (2017). Complementary and alternative medicine use among elderly patients living with chronic diseases in a teaching hospital in Ethiopia. Complementary Therapies in Medicine, 35, 115-119. https://doi.org/10.1016/j.ctim.2017.10.006
  4. Takayama, S., & Iwasaki, K. (2017). Systematic review of traditional Chinese medicine for geriatrics. Geriatrics & Gerontology International, 17(5), 679-688. https://doi.org/10.1111/ggi.12803
  5. Kingston, A., & Jagger, C. (2018). Review of methodologies of cohort studies of older people. Age and Ageing, 47(2), 215-219. https://doi.org/10.1093/ageing/afx183
  6. Walton, M. K., Powers, J. H., Hobart, J., Patrick, D. L., Marquis, P., Vamvakas, S., Isaac, M., Molsen, E., Cano, S. J., & Burke, L. (2015). Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force DOES THIS HAVE TO BE LABLED AS PART 1. Value in Health : The Journal of the International Society for Pharmacoeconomics and Outcomes Research, 18(6), 741-752. https://doi.org/10.1016/j.jval.2015.08.006
  7. Bang, G., Kang, D., & Cho, J. (2022). Current status of routine use of Patient-Reported Outcome in the tertiary hospital clinical setting in Republic of Korea. Korean Journal of Clinical Pharmacy, 32(2), 74-83. https://doi.org/10.24304/kjcp.2022.32.2.74
  8. FDA-NIH Biomarker Working Group. (2016). BEST (Biomarkers, EndpointS, and other Tools) Resource. Food and Drug Administration (US). http://www.ncbi.nlm.nih.gov/books/NBK326791/
  9. Eton, D. T., Bauer, B. A., Sood, A., Yost, K. J., & Sloan, J. A. (2011). Patient-Reported Outcomes in Studies of Complementary and Alternative Medicine: Problems, Solutions, and Future Directions. EXPLORE, 7(5), 314-319. https://doi.org/10.1016/j.explore.2011.06.002
  10. Barnes, P. M., Bloom, B., & Nahin, R. L. (2008). Complementary and alternative medicine use among adults and children: United States, 2007. National Health Statistics Reports, 12, 1-23.
  11. Astin, J. A. (1998). Why Patients Use Alternative MedicineResults of a National Study. JAMA, 279(19), 1548-1553. https://doi.org/10.1001/jama.279.19.1548
  12. Paterson, C., Baarts, C., Launso, L., & Verhoef, M. J. (2009). Evaluating complex health interventions: A critical analysis of the "outcomes" concept. BMC Complementary and Alternative Medicine, 9, 18. https://doi.org/10.1186/1472-6882-9-18
  13. Anfray, C., & Trimoreau, M. (n.d.). Licensing and eCOAs: Lessons learned and pending issues. Mapi Research Trust. Retrieved June 28, 2023, from http://www.mapi-trust.org/news-events/news/licensing-and-ecoas-lesso/
  14. Marcus, A. (2017). Pay up or retract? Drug survey spurs conflict. Science (New York, N.Y.), 357(6356), 1085-1086. https://doi.org/10.1126/science.357.6356.1085
  15. Hays, R. D., Weech-Maldonado, R., Teresi, J. A., Wallace, S. P., & Stewart, A. L. (2018). Commentary: Copyright Restrictions versus Open Access to Survey Instruments. Medical Care, 56(2), 107-110. https://doi.org/10.1097/MLR.0000000000000857
  16. Ongenae, K., Dierckxsens, L., Brochez, L., van Geel, N., & Naeyaert, J. M. (2005). Quality of life and stigmatization profile in a cohort of vitiligo patients and effect of the use of camouflage. Dermatology (Basel, Switzerland), 210(4), 279-285. https://doi.org/10.1159/000084751
  17. Moon, S.-W. (2019). Research Ethics and Laws Related to Survey Research in Clinical Psychology. Korean Journal of Clinical Psychology, 38(1), 112-126. https://doi.org/10.15842/kjcp.2019.38.1.009
  18. Anfray, C., Arnold, B., Martin, M., Eremenco, S., Patrick, D. L., Conway, K., Acquadro, C., & ISOQOL Translation and Cultural Special Interest Group (TCA-SIG). (2018). Reflection paper on copyright, patient-reported outcome instruments and their translations. Health and Quality of Life Outcomes, 16(1), 224. https://doi.org/10.1186/s12955-018-1050-4
  19. About PROQOLID - ePROVIDETM. (n.d.). ePROVIDE - Mapi Research Trust. Retrieved June 28, 2023, from https://eprovide.mapi-trust.org/about/about-proqolid
  20. Ware, J., Kosinski, M., & Keller, S. D. (1996). A 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity. Medical Care, 34(3), 220-233. https://doi.org/10.1097/00005650-199603000-00003
  21. Herdman, M., Gudex, C., Lloyd, A., Janssen, M., Kind, P., Parkin, D., Bonsel, G., & Badia, X. (2011). Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation, 20(10), 1727-1736. https://doi.org/10.1007/s11136-011-9903-x
  22. Nasreddine, Z. S., Phillips, N. A., Bedirian, V., Charbonneau, S., Whitehead, V., Collin, I., Cummings, J. L., & Chertkow, H. (2005). The Montreal Cognitive Assessment, MoCA: A brief screening tool for mild cognitive impairment. Journal of the American Geriatrics Society, 53(4), 695-699. https://doi.org/10.1111/j.1532-5415.2005.53221.x
  23. McKown, S., Acquadro, C., Anfray, C., Arnold, B., Eremenco, S., Giroudet, C., Martin, M., & Weiss, D. (2020). Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures. Journal of Patient-Reported Outcomes, 4(1), 89. https://doi.org/10.1186/s41687-020-00248-z
  24. Won, C. W., Lee, S., Kim, J., Chon, D., Kim, S., Kim, C.-O., Kim, M. K., Cho, B., Choi, K. M., Roh, E., Jang, H. C., Son, S. J., Lee, J.-H., Park, Y. S., Lee, S.-G., Kim, B. J., Kim, H. J., Choi, J., Ga, H., … Kim, M. (2020). Korean frailty and aging cohort study (KFACS): Cohort profile. BMJ Open, 10(4), e035573. https://doi.org/10.1136/bmjopen-2019-035573
  25. Ding, D., Zhao, Q., Guo, Q., Meng, H., Wang, B., Yu, P., Luo, J., Zhou, Y., Yu, L., Zheng, L., Chu, S., Mortimer, J. A., Borenstein, A. R., & Hong, Z. (2014). The Shanghai Aging Study: Study design, baseline characteristics, and prevalence of dementia. Neuroepidemiology, 43(2), 114-122. https://doi.org/10.1159/000366163
  26. Hong, N., Kim, K.-J., Lee, S. J., Kim, C. O., Kim, H. C., Rhee, Y., Youm, Y., Choi, J.-Y., & Park, H.-Y. (2019). Cohort profile: Korean Urban Rural Elderly (KURE) study, a prospective cohort on ageing and health in Korea. BMJ Open, 9(10), e031018. https://doi.org/10.1136/bmjopen-2019-031018
  27. Baek, Y., Seo, B.-N., Jeong, K., Yoo, H., & Lee, S. (2020). Lifestyle, genomic types and non-communicable diseases in Korea: A protocol for the Korean Medicine Daejeon Citizen Cohort study (KDCC). BMJ Open, 10(4), e034499. https://doi.org/10.1136/bmjopen-2019-034499
  28. Dusek, J. A., Abrams, D. I., Roberts, R., Griffin, K. H., Trebesch, D., Dolor, R. J., Wolever, R. Q., McKee, M. D., & Kligler, B. (2016). Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) of the BraveNet practice-based research network: Study protocol. BMC Complementary and Alternative Medicine, 16, 53. https://doi.org/10.1186/s12906-016-1025-0
  29. Kim, S.-H., Jo, M.-W., Ahn, J., Ock, M., Shin, S., & Park, J. (2014). Assessment of psychometric properties of the Korean SF-12 v2 in the general population. BMC Public Health, 14, 1086. https://doi.org/10.1186/1471-2458-14-1086
  30. Yang, S. (1992). Effects of Fluid Intake, Dietary Fiber Supplement and Abdominal Muscle Exercises on Antipsychotic Drug-Induced Constipation in Schizophrenics. Journal of Catholic Medical College, 45(4), 1501-1514.
  31. McMillan, S. C., & Williams, F. A. (1989). Validity and reliability of the Constipation Assessment Scale. Cancer Nursing, 12(3), 183-188. https://doi.org/10.1097/00002820-198906000-00012
  32. KEE, B. S. (1996). A Preliminary Study for the Standardization of Geriatric Depression Scale Short Form-Korea Version. J Korean Neuropsychiatr Assoc, 35(2), 298-306.
  33. Yesavage, J. A., & Sheikh, J. I. (1986). 9/Geriatric Depression Scale (GDS). Clinical Gerontologist, 5(1-2), 165-173. https://doi.org/10.1300/J018v05n01_09
  34. Won, C. W., Yang, K. Y., Rho, Y. G., Kim, S. Y., Lee, E. J., Yoon, J. L., Cho, K. H., Shin, H. C., Cho, B. R., Oh, J. R., Yoon, D. K., Lee, H. S., & Lee, Y. S. (2002). The Development of Korean Activities of Daily Living(K-ADL) and Korean Instrumental Activities of Daily Living(K-IADL) Scale. Journal of the Korean Geriatrics Society, 6(2), 107-120.
  35. Lawton, M. P., & Brody, E. M. (1969). Assessment of older people: Self-maintaining and instrumental activities of daily living. The Gerontologist, 9(3), 179-186. https://doi.org/10.1093/geront/9.3_Part_1.179
  36. Resnick, B., Galik, E., Dorsey, S., Scheve, A., & Gutkin, S. (2011). Reliability and validity testing of the physical resilience measure. The Gerontologist, 51(5), 643-652. https://doi.org/10.1093/geront/gnr016
  37. Park, G., Cho, B., Kwon, I. S., Park, B. J., Kim, T., Cho, K. Y., Park, U. J., & Kim, M. J. (2016). Reliability and Validity of Korean Version of Falls Efficacy Scale-International (KFES-I). Journal of Korean Academy of Rehabilitation Medicine, 34(5), 554-559.
  38. Yardley, L., Beyer, N., Hauer, K., Kempen, G., Piot-Ziegler, C., & Todd, C. (2005). Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age and Ageing, 34(6), 614-619. https://doi.org/10.1093/ageing/afi196
  39. Sohn, S. I., Kim, D. H., Lee, M. Y., & Cho, Y. W. (2012). The reliability and validity of the Korean version of the Pittsburgh Sleep Quality Index. Sleep & Breathing = Schlaf & Atmung, 16(3), 803-812. https://doi.org/10.1007/s11325-011-0579-9
  40. Buysse, D. J., Reynolds, C. F., Monk, T. H., Berman, S. R., & Kupfer, D. J. (1989). The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Research, 28(2), 193-213. https://doi.org/10.1016/0165-1781(89)90047-4
  41. Craig, C. L., Marshall, A. L., Sjostrom, M., Bauman, A. E., Booth, M. L., Ainsworth, B. E., Pratt, M., Ekelund, U., Yngve, A., Sallis, J. F., & Oja, P. (2003). International physical activity questionnaire: 12-country reliability and validity. Medicine and Science in Sports and Exercise, 35(8), 1381-1395. https://doi.org/10.1249/01.MSS.0000078924.61453.FB
  42. Oh, J. Y., Yang, Y. J., Kim, B. S., & Kang, J. H. (2007). Validity and Reliability of Korean Version of International Physical Activity Questionnaire (IPAQ) Short Form. Journal of the Korean Academy of Family Medicine, 28(7), 532-541.
  43. Rubenstein, L. Z., Harker, J. O., Salva, A., Guigoz, Y., & Vellas, B. (2001). Screening for undernutrition in geriatric practice: Developing the short-form mini-nutritional assessment (MNA-SF). The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences, 56(6), M366-372. https://doi.org/10.1093/gerona/56.6.m366
  44. Wilson, M.-M. G., Thomas, D. R., Rubenstein, L. Z., Chibnall, J. T., Anderson, S., Baxi, A., Diebold, M. R., & Morley, J. E. (2005). Appetite assessment: Simple appetite questionnaire predicts weight loss in community-dwelling adults and nursing home residents. The American Journal of Clinical Nutrition, 82(5), 1074-1081. https://doi.org/10.1093/ajcn/82.5.1074
  45. Oh, S. Y., Koh, S.-J., Yeon, B. J., Kwon, K. A., Jeung, H.-C., Lee, K. H., Young-Woong, W., & Lee, H. J. (2019). Validity and Reliability of Korean Version of Simplified Nutritional Appetite Questionnaire in Patients with Advanced Cancer: A Multicenter, Longitudinal Study. Cancer Research and Treatment, 51(4), 1612-1619. https://doi.org/10.4143/crt.2018.505
  46. Frates, B., Tollefson, M., & Comander, A. (n.d.). PAVING the Path to Wellness Workbook. Healthy Learning. Retrieved August 23, 2023, from https://healthylearning.com/paving-the-path-to-wellness-workbook/
  47. Lim, M. K., Kim, M. H., Shin, Y. J., Yoo, W. S., & Yang, B. M. (n.d.). Social Support and Self-rated Health Status in a Low Income Neighborhood of Seoul, Korea. Journal of Preventive Medicine and Public Health, 36(1), 54-62.
  48. Sherbourne, C. D., & Stewart, A. L. (1991). The MOS social support survey. Social Science & Medicine (1982), 32(6), 705-714. https://doi.org/10.1016/0277-9536(91)90150-b
  49. Su, J. E., Yun, Y. G., Ryong, Y. H., Yoo, J.-E., Kim, I. C., Park, J.-Y., & Jung, I. (2017). Preliminary Study to Develop the Instrument of Korean Medical Pattern Identification and Functional Evaluation for Five Organ. Journal of Physiology & Pathology in Korean Medicine, 31(2), 126-137. https://doi.org/10.15188/kjopp.2017.04.31.2.126
  50. Kang, B.-K., Jang, S., Ko, M. M., & Jung, J. (2019). A Study on the Development of a Korean Metabolic Syndrome Questionnaire Using Blood Stasis Clinical Data. Evidence-Based Complementary and Alternative Medicine: eCAM, 2019, 8761417. https://doi.org/10.1155/2019/8761417
  51. Cheong, M. J., Lee, G.-E., Lee, Y., Bae, K.-H., Kang, Y., Kim, J.-H., Lyu, Y.-S., & Kang, H. W. (2019). Validation of the Core Seven-Emotions Inventory-Short form. Integrative Medicine Research, 8(2), 116-119. https://doi.org/10.1016/j.imr.2019.04.003
  52. Lee, J.-Y., Dong Woo Lee, null, Cho, S.-J., Na, D. L., Hong Jin Jeon, null, Kim, S.-K., You Ra Lee, null, Youn, J.-H., Kwon, M., Lee, J.-H., & Maeng Je Cho, null. (2008). Brief screening for mild cognitive impairment in elderly outpatient clinic: Validation of the Korean version of the Montreal Cognitive Assessment. Journal of Geriatric Psychiatry and Neurology, 21(2), 104-110. https://doi.org/10.1177/0891988708316855
  53. Survey contents | KDCA korean National HEalth & Nutrition Examination Survey. (n.d.). Retrieved August 23, 2023, from https://knhanes.kdca.go.kr/knhanes/sub04/sub04_01_02.do?classType=2
  54. Kim, C. O. (n.d.). Geriatric Diseases Prevention and Management Cohort. (2012. December) (1465012630). Retrieved August 23, 2023, from https://scienceon.kisti.re.kr/srch/selectPORSrchReport.do?cn=TRKO201300030794
  55. Guralnik, J. M., Simonsick, E. M., Ferrucci, L., Glynn, R. J., Berkman, L. F., Blazer, D. G., Scherr, P. A., & Wallace, R. B. (1994). A short physical performance battery assessing lower extremity function: Association with self-reported disability and prediction of mortality and nursing home admission. Journal of Gerontology, 49(2), M85-94. https://doi.org/10.1093/geronj/49.2.m85
  56. McGill, S. M., Childs, A., & Liebenson, C. (1999). Endurance times for low back stabilization exercises: Clinical targets for testing and training from a normal database. Archives of Physical Medicine and Rehabilitation, 80(8), 941-944. https://doi.org/10.1016/s0003-9993(99)90087-4
  57. Korea Health Panel Survey. (n.d.). Retrieved August 23, 2023, from https://www.khp.re.kr:444/web/data/board/view.do?bbsid=54&seq=1731
  58. Demers, L., Ska, B., Desrosiers, J., Alix, C., & Wolfson, C. (2004). Development of a conceptual framework for the assessment of geriatric rehabilitation outcomes. Archives of Gerontology and Geriatrics, 38(3), 221-237. https://doi.org/10.1016/j.archger.2003.10.003
  59. Prorok, J. C., Williamson, P. R., Shea, B., Rolfson, D., Manas, L. R., Cesari, M., Kim, P., & Muscedere, J. (2022). An international Delphi consensus process to determine a common data element and core outcome set for frailty: FOCUS (The Frailty Outcomes Consensus Project). BMC Geriatrics, 22(1), 284. https://doi.org/10.1186/s12877-022-02993-w
  60. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, & U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. (2006). Guidance for industry: Patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health and Quality of Life Outcomes, 4(1), 79. https://doi.org/10.1186/1477-7525-4-79
  61. Al Sayah, F., Jin, X., & Johnson, J. A. (2021). Selection of patient-reported outcome measures (PROMs) for use in health systems. Journal of Patient-Reported Outcomes, 5(Suppl 2), 99. https://doi.org/10.1186/s41687-021-00374-2
  62. Revicki, D. A., & Schwartz, C. E. (2009). Intellectual property rights and good research practice. Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation, 18(10), 1279-1280. https://doi.org/10.1007/s11136-009-9551-6
  63. center for reserach ethics information. (2021). CRE Research Ethics Questions and Answers (Vol. 1). https://www.cre.or.kr/bbs/BoardDetail.do?nttId=568&bbsId=BBSMSTR_000000000041&pageIndex=1
  64. Williamson, P. R., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E., & Tugwell, P. (2012). Developing core outcome sets for clinical trials: Issues to consider. Trials, 13(1), 132. https://doi.org/10.1186/1745-6215-13-132
  65. Webbe, J., Sinha, I., & Gale, C. (2018). Core Outcome Sets. Archives of Disease in Childhood. Education and Practice Edition, 103(3), 163-166. https://doi.org/10.1136/archdischild-2016-312117
  66. Williamson, P. R., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E., & Tugwell, P. (2012). Developing core outcome sets for clinical trials: Issues to consider. Trials, 13, 132. https://doi.org/10.1186/1745-6215-13-132