Correspondence to: Jungtae Leem, College of Korean Medicine, Wonkwang University, 460 Iksandae-ro, Iksan, 54538, Republic of Korea, Tel: +82-63-850-6914, Fax: +82-63-850-7324, E-mail: julcho@naver.com

Correspondence to: Jeeyoun Jung, Korea Medicine Science Research Division, Korea Institute of Oriental Medicine,, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea, Tel: +82-42-868-9272, Fax: +82-42-868-9299, E-mail: jjy0918@kiom.re.kr

Received 2023 September 27; Revised 2023 October 26; Accepted 2024 February 16.

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: Outcome Assessment; Health Care; Healthy Aging; Data Collection/methods*; Medicine; Korean Traditional; Copyright; Surveys and Questionnaires*

Fig. 1

Flow diagram of the process of Selecting Clinical Outcome and Approving Validated Questionnaires

Table 1

Overview of Prior Research

Table 2

Process of Outcome Revision

Table 3

Final Outcomes and Classification According to FDA⁸⁾

Table 4

Permission to Use of Clinical Outcome Assessment Instruments

Supplementary Information

jkm-45-1-17-Supplementary-table-1.pdf

jkm-45-1-17-Supplementary-table-2.pdf

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Article information Continued

Fig. 1

Flow diagram of the process of Selecting Clinical Outcome and Approving Validated Questionnaires

Table 1

Overview of Prior Research

Author, Year	Country	Starting Year	Study Period (year)	Plans for Follow-up Period (month)	Study Name	Study Population	No. of Subjects	Study Design
Baek Y, 2020	Korea, Daejeon-si	2017	9	2 year	KDCC(Korean Medicine Daejeon Citizen Cohort Study)	men and women aged 30–55 years ; residents of Daejeon ; individuals who provided informed consent	2000	prospective cohort study, multi-center, protocol
Won CW, 2020	Korea	2016	10	2 year	KFACS (Korean Frailty and Aging Cohort Study)	men and women aged 70–84 years ; currently living in the community ; having no plans to move out in the next 2 years ; having no problems with communication and no prior dementia diagnosis.	3014	multicenter longitudinal cohort study
Ding D,2014	China, Shanghai	2010	ongoing	baseline and 4 year	Shanghai Aging Study	(1) registered residents in Jingansi community; (2) ≥ 60 years; (3) without schizophrenia or mental retardation based on their medical records; or (4) able to communicate and accept physical and cognitive examinations	3141	a prospective cohort, protocol
Hong N,2019	Korea	2012	10	2 year†	The Korean Urban Rural Elderly (KURE) Cohort	age ≥65 years; residence in the study area; ability to communicate with the research team; and provision of written informed consent	3517	prospective cohort study, multi-center
Jeffery A D,2022	US (14 member sites)	2013	10	baseline, 2, 4, 6, 12, 18 and 24months*	Patients Receiving Integrative MedicineEffectiveness Registry (PRIMIER)	outpatient aged 18 or over who was seen by an IM provider at any of the clinical sites in the 8weeks preceding their enrollment ; must be willing and able to provide informed consent, to participate, and to be contacted in the future by study personnel.	2374	A prospective, longitudinal,observational evaluation

Tobacco and alcohol use are asked at baseline, 12, and 24 months, and medical record data are pulled at baseline and every 6 months

^†

the first and second follow-up performed every 4 years

Table 2

Process of Outcome Revision

Domain	Classification	Reasons for Exclusions and Changes	Excluded Instruments
Health Status	Pregnancy	1st : Excluded from selection because age range on inclusion criteria
Health Status	Breast-feeding	1st : Excluded from selection because age range on inclusion criteria
Health Assessment / Vital Signs	Body Mass Index; Body temperature	1st : Additional selections
Health Status	Family history	1st : Exclude because it’s in the medical history 2nd : Reselected to evaluate family history separately.
	Health Related Quality of Life (HRQOL)	1st : Selected (1) SF-12v2, but changed to (2) SF-36v2 with more detailed questions 2nd : Re-selected (1) SF-12v2 as the shortened version to save patient interview time.	(2) SF-36v2 Korean
	Comorbidity	1st : Select three objective comorbidity measures (1) CCI, (2) ECM, (3) SCQ 2nd : Selected CCI as the most commonly used of the three metrics, and excluded SCQ because it was not possible to calculate a final score.	(3) SCQ (2) ECM
	Polypharmacy	1st : Selection of two “inappropriate medication prescribing criteria” to assess polypharmacy ((1)AGS Beers criteria, (2) STOPP Citeria) 2nd : Decided not to use criteria, but to collect through history taking of medication history. Excluded from selection	(1) AGS Beers criteria (2) STOPP criteria
	Dietary supplement	1st : Further refine dietary supplement categorization by nutrient and function
	Constipation	1st : Select 3 most commonly used constipation endpoints in Korea (1) CAS, (2) PAC-SYM, (3) PAC-QOL 2nd : (1) CAS was selected as the most commonly used of the three metrics, (2) PAC-SYM, and (3) PAC-QOL were excluded because they require a paid purchase or have a complicated registration process.	(2) PAC-SYM (3) PAC-QOL
	Geriatric depression	1st : (1) GDS (2) GDS-SF 2nd : Decide to utilize the shortened form (2) GDS-SF, to save time on patient interviews	(1) GDS
	Instrumental activities of daily living	1st : Select two Korean adaptations of instrumental activities of daily living (IADLs). (1) Jang Won Won Development - 10 questions (2) Kang Soo Jin Development - 11 questions 2nd : Decided to use (1) Jang Won Won Development - 10 questions, because it’s easier to get the author’s contact information for the translation	(2) Korean IADL (Kang Soo Jin Development - 11 questions)
	Activities of daily living	1st : (1) Excluded K-ADLs due to lack of sensitivity when surveying the elderly.	(1) ADL
	Physical resilience	1st : Additional selections
	Fall scale	1st : Four assessment tools were selected for fall risk prediction (1)MFS (2)Huhn’s Fall Risk Assessment Tool (3)JHFRAT (4)FAS-K 2nd : Decided to assess fractures and falls comprehensively through (1) MFS. 3rd : Korean translations were selected to the extent possible. As kFES-I is more researched among fall-related assessment scales in Korean subjects, we decided to evaluate kFES-I except for (1) MFS.	(1) MFS (2) Huhn’s Fall Risk Assessment Tool (3) JHFRAT (4) FAS-k
	Recent injury	1st : Select questions using the Fracture Assessment Questions as a guide 2nd : Decided to assess fractures and falls comprehensively through (1) MFS.
	Fear of falling	1st : Select 2 fear of falling scales (1)kFES-I (Korean Version of Falls Efficacy Scale-International ) (2)ABC-scale 2nd : Decided to assess fractures and falls comprehensively through (1) MFS. 3rd : Korean translations were selected to the extent possible. As kFES-I is more researched among fall-related assessment scales in Korean subjects, we decided to evaluate kFES-I except for (1) MFS.	(2) ABC-scale
	Oral health	1st : Five oral health assessment items were selected: (1) whether to brush daily yesterday; (2) when to brush yesterday; (3) whether to have an oral examination in the past year; (4) mastication discomfort; and (5) pronunciation discomfort.
	Urine-hCG	1st : Add blood test items for pregnancy and lactation. 2nd : Decide not to collect because patients screened for cohort are not likely to be of childbearing potential. Delete this entry
Health Behavior	Eating behavior	1st : Select 3 assessment tools for dietary habits (1) National Health and Nutrition Examination Survey_Dietary Habits Survey (2) DEBQ, (3) TFEQ 2nd : (2) DEBQ and (3) TFEQ were not selected because they do not have Korean translations and the license purchase process is complicated.	(2) DEBQ, (3) TFEQ
	Food security	1st : Selection of two assessment tools for food safety items (1) National Health and Nutrition Examination Survey_Food Security Survey (2) U.S. Household food security survey module 2nd : Eliminated all due to lack of clinical significance of food security when evaluating geriatric populations	(1) National Health and Nutrition Examination Survey_Food Security Survey (2) U.S. Household food security survey module
	Paving Wheel Questionnaire	2nd : No validation studies have been done on the translations, so we requested and obtained appropriate translations from the journal.
	Social network	1st : Select 2 additional social network questionnaire assessment tools (1) MOS-SSS (2) Lubben-6 2nd : (2) Lubben-18 tool was not selected because no information could be found about purchasing licenses and permissions.	(2) Lubben-18
Healthcare	Unmet needs	1st : Use survey items provided by the Korean Medical Panel
Healthcare	Long-term care services	2nd : The service is offered to people 65 and older, so it does not meet the cohort selection criteria and was not selected.
Cognitive-Psychiatric Function	Cognitive function - MMSE2, MMSE	1st : Select 2 tools (1) MMSE, (2) MMSE-2 3rd : Excluded (1) MMSE and (2) MMSE-2 due to the high number of overlapping questions with the MoCA instrument and the difficulty of purchasing a research license for both.	(1) MMSE (2) MMSE-2
Cognitive-Psychiatric Function	Cognitive function - CDT scoring	1st : For the Clock Drawing item of MoCA-K, we decided to use a separately developed scoring system, (1) the CDT Scoring Table. 3rd : Decided to utilize only MoCA-k, and excluded (1) the CDT Scoring Table..	(1) the CDT Scoring Table.
Physical Function	TUG test, FRT	1st : Select (1) TUG and (2) FRT, which are common physical performance tests with SPPB. 2nd : Eliminated (1) TUG and (2) FRT because we believe SPPB is sufficient to assess physical performance.	(1) TUG (2) FRT
	Knee MMT	2nd : Knee MMT excluded from selection, as it is replaced by knee ROM test
	Knee, lumbar spine X ray	2nd : Decide not to order knee and hip X-rays and replace them with a bone density test to save time with the patient.
	Core muscle assessment	1st : Decided to use ultrasound to assess abdominal, rectus femoris, and core muscle thickness. 2nd : Decided to eliminate it due to inefficiency of patient interview time and instead use McGil’s core endurance test to assess abdominal core muscle function.
	Availability of squat tests	2nd : Decide to run a simple squat test to assess physical function and strength 3rd : Decided to use McGil’s endurance test to comprehensively assess strength measures. The squat test was excluded
	Hearing, vision test	1st : Hearing loss and vision loss are common symptoms of the elderly, so select vision loss as an additional category.
	EEG; HRV test; Biological age measurement; PFT	3rd : Access to equipment at healthcare organizations conducting clinical research. Added to leverage rich evaluation metrics
Body Composition	Inbody - assessment of Sarcopenia	3rd : Decided to evaluate muscle mass through inbody testing. We decide to further evaluate for sarcopenia.
Korean Medicine Questionnaire	BSQ-MS	3rd : The existing questionnaire is full of Korean medicine terminology, which makes it difficult to conduct interviews in the field, so we changed it to a simplified questionnaire that is easy, clear, and shortened.	(1) BSQ-MS

Sf-12v2; 12-item Short Form Survey, Sf-36v2; 36-item Short Form Survey, CCI; Charlson comorbidity index, ECM; Elixhauser et al. comorbidity measure, SCQ; Self-Administered Comorbidity Questionnaire, AGS; American Geriatrics Society, STOPP; Screening Tool of Older Persons’ Prescriptions, CAS; Constipation Assessment Scale, PAC-SYM; Psychometric validation of a constipation symptom assessment questionnaire, PAC-QOL; Patient Assessment of Constipation Quality of Life questionnaire, GDS; Geriatric Depression Scale, GDS-SF: Geriatric Depression Scale-Short Form, IADL; Instrumental Activities of Daily Living, ADL; Activities of Daily Living, MFS; Morse Fall Scale, JHFRAT; The Johns Hopkins Fall Risk Assessment Tool, FAS-K; Adult Fall Assessment Scale Korean version, kFES-I; Korean Version of Falls Efficacy Scale-International, ABC-scale; Activities-specific Balance Confidence scale, DEBQ; Dutch Behavior Questionnaire, TFEQ; Three-Factor Eating Questionnaire, MOS-SSS; Medical Outcomes Study Social Support Survey, MMSE; Mini-mental State Examination, MMSE-2; Mini-mental State Examination 2^nd edition, CDT; Clock Drawing Test, TUG; Timed Up and Go, FRT; Functional Reach Test, MMT; Manual Muscle Test, ROM; Range of Motion, EEG; electroencephalography, HRV; heart rate variability, PFT; Pulmonary function test, BSQ-MS; Blood Stasis Questionnaires on metabolic

Table 3

Final Outcomes and Classification According to FDA⁸⁾

Outcome Domain	Individual Clinical Outcome Variable	Clinical Outcome Assessments/Biomarkers/Other Outcomes (Classification According to FDA)
Demographics	Sex	Other outcomes
	Date of birth; age	Other outcomes
	Education attainment	Other outcomes
	Family relationship	Other outcomes

Anthropometry	Body weight; Height; Body Mass Index	Biomarker

Health Assessment Vital Signs	Blood Pressure : Systolic blood pressure; Diastolic blood pressure	Biomarker
	Pulse rate	Biomarker
	Body temperature	Biomarker

Health Status	Medical history; Surgical history; Drug history(polypharmacy); Family history	PRO

Health Behavior	Korean 12-item Short Form Survey	PROs instrument
	Comorbidity as Charlson comorbidity index	PRO
	Dietary supplement	PRO
	Constipation - Constipation Assessment Scale	PROs instrument
	Quality of life - EQ-5D-5L, EQ-5D-5L visual Analogue	PROs instrument
	Geriatric Depression Scale Short Form Korea Version	PROs instrument
	Korean instrumental activities of daily living scale.	PROs instrument
	Physical resilience scale	PROs instrument
	Fear of falling - Korean Version of Falls Efficacy Scale-International	PROs instrument
	Oral health	PRO
	Women’s health	PRO
	Smoking; drinking	PRO
	Sleep - Korean version of the Pittsburgh Sleep Quality Index	PROs instrument
	Physical activity - Korean Version of International Physical Activity Questionnaire Short Form	PROs instrument
	Nutritional risk - short form	PROs instrument
	Eating behavior	PRO
	Korean Version of Simplified Nutritional Appetite Questionnaire	PROs instrument
	Paving Wheel Questionnaire	PROs instrument
	Social network - Korean translation of the Medical Outcomes Study Social Support Survey scale	PROs instrument

Healthcare	Unmet needs	Other outcomes
Healthcare	Healthcare costs	Other outcomes

Cognitive Function	Korean Version of the Montreal Cognitive Assessment	PerfO instrument

Physical Function	Hand-grip	PerfO
	SPPB score	PerfO
	Range Of Motion (knee; lumbar)	ClinRO
	Hearing, vision test	ClinRO
	Electroencephalography(EEG)	ClinRO
	Heart Rate Variability test (pulse wave test)	ClinRO
	McGil’s core endurance test	PerfO
	Biological age measurement	ClinRO
	Pulmonary function test	PerfO

Body Composition	DEXA	ClinRO
Body Composition	Inbody ; assessment of Sarcopenia	ClinRO

Korean Medicine Questionnaire	Instrument of Korean Medical Pattern Identification and Functional Evaluation for Five Organ	PROs instrument
	Blood Stasis Questionnaires on metabolic syndrome	PROs instrument
	Kidney deficiency pattern screening assessment questionnaire	PROs instrument
	Core Seven-Emotions Inventory - short form	PROs instrument

Clinical Laboratory Tests		Biomarker

Biochemistry	Albumin, aspartate aminotransferase, Total Protein, Total bilirubin, Calcium, Chlorine, Phosphorus, Sodium, Alkaline phosphatase isoenzymes, Amylase, creatine kinase, Aspartate Aminotransferase, Lactate dehydrogenase, γ-Gamma-glutamyl transpeptidase, Blood Urea Nitrogen, Creatinine, Uric Acid, Total cholesterol, High-density lipoprotein cholesterol, Triglyceride, Ferritin, total iron binding capacity, C-Reactive Protein, Low-density lipoprotein cholesterol

Immunology	25-OH Vitamin D-Osteocalcin, Cortisol, Free Thyroxine 4, Thyroid Stimulating Hormone, Dehydroepiandrosterone-sulfate - Vitamin B12, Insulin

Male Hormone	Testosterone, prostate-specific antigen

Female Hormone	Follicle stimulating hormone, Luteinizing Hormone, Estradiol

Hematology, HbA1c	White Blood Cell, Red Blood Cell, Hemoglobin, hematocrit, Platelet, Mean corpuscular volume, Mean Corpuscular Hemoglobin, Mean Corpuscular Hemoglobin Concentration, White Blood Cell differential (Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil), Hemoglobin A1c

Glucose	Glucose

Urinalysis	Urine White Blood Cell, Specific gravity, pH, Protein, Glucose, Occult blood, Ketones, Urobilinogen, Bilirubin, Nitrite, Urine Sediment (White Blood Cell, Red Blood Cell, Epithelial cell, Bacteria, Casts, Crystal, Others)

Omics analysis	Metabolomic metrics, Plasma proteomics

EQ-5D-5L; EuroQOL 5-Dimension 5-level, PRO; Patient-reported outcomes, PerfO; performance outcome, SPPB; Short Physical Performance Battery, ClinRO; clinician-reported outcome, DEXA; Dual-energy X-ray absorptiometry

Table 4

Permission to Use of Clinical Outcome Assessment Instruments

	Clinical Outcome Assessment Instruments	Concept of Interest	Population Intended to Use	Response Option	Number of Items	Range of Score	PROQOLID Database Availability	Authorization Required for Use of Original Work	Requires Purchase of Original Work	Questionnaire Acquisition Methods: Availability of Original Author Contacts/Platform Link	[Korean] PROQOLID Database Korean Version Availability	[Korean] Authorization Required for Use of Translation Author	[Korean] Questionnaire Acquisition Methods: Availability of Translation Author Contacts/Platform Link
Health Status	Korean version of 12-item Short Form Survey 20,29)	Health-Related Quality of Life - HRQL (incl. health status)	Adult	Yes/No 5 to 6-point Likert Scale	12	0–100	O	O	O	https://www.qualitymetric.com/contact-info/?	O	O	O https://www.qualitymetric.com/contact-info/?
Health Status	Constipation Assessment Scale30,31)	Signs and symptoms	Adult	3-point Likert scale	8	0–16	O	X	X	NA	O	O	X
Health Status	EuroQOL 5-Dimension 5-level21)	Utility, Health-Related Quality of Life - HRQL (incl. health status)	Adolescent Adult Pediatrics	5-point Likert/Likert-type Scale	5	−0.59 ~ 1.00	O	O	X	https://customer.euroqol.org/users/sign_in	O	X	https://customer.euroqol.org/users/sign_in
Health Status	EuroQOL 5-Dimension 5-level Visual Analogue21)	Utility, Health-Related Quality of Life - HRQL (incl. health status)	Adolescent Adult Pediatrics	Visual Analog Scale(VAS)	1 VAS (20 cm)	0~100	O	O	X	https://customer.euroqol.org/users/sign_in	O	X	https://customer.euroqol.org/users/sign_in
Health Status	Geriatric Depression Scale Short Form Korea Version32,33)	NA	NA	Yes/no	15	N/A	O	X	X	NA	X	O	X
Health Status	Korean instrumental activities of daily living scale34,35)	Physical functioning	Geriatrics	3-, 4-point Likert scale	10	10–37	O	O	O	O	O	O	O
Health Status	Physical resilience scale 36)	Psychological functioning (incl. coping)	NA	2-point Likert scale	17 + 1 subjective question	0–17	X	O	X	O	X	X	X
Health Status	Korean Version of Falls Efficacy Scale-Internation al37,38)	Physical functioning	NA	4-point Likert Scale	16	16–64	O	O	X	O	O	O	O
Health Behavior	Paving Wheel Questionnaire46)	Psychological functioning (incl. coping), Social functioning (incl. work)	NA	5-point Likert scale	60	60–300	X	O	O	O	X	O	X
Health Behavior	Korean version of the Pittsburgh Sleep Quality Index42,43)	Signs and symptoms	Adult Caregivers	4-point Likert Scale	19 (+ 5 items rated by the bedpartner or roommate for clinical information only/not scored)	0–21	O	X	X	NA	O	O	O
Health Behavior	Korean Version of International Physical Activity Questionnaire Short Form41,42)	Physical functioning	Youth 15 years of age and older	Other: Number of minutes per week within each activity category Open-ended questions surrounding individuals’ last 7-day recall of physical activity	7	N/A	O	X	X	NA https://sites.google.com/view/ipaq	O	O	X
Health Behavior	Nutritional risk - short form43)	Other_ Nutritional status	Geriatrics	2-,3-,4-point Likert-type Scale	6+1	0–14	O	X	X	https://www.mna-elderly.com/	O	X	https://www.mna-elderly.com/sites/default/files/2021-10/mna-mini-korean.pdf
Health Behavior	Simplified nutritional appetite questionnaire 44,45)	Signs and symptoms	Adult Geriatrics	5-point Likert/Likert-type Scale	4	4–20	O	X	X	NA https://www.medlineuniversity.com/viewdocument/skintegrity-snaq-simplified-nutrit?CommunityKey=d15198e2-e041-4be7-be2b-1cc2c8291f86&tab=librarydocuments	O	O	O
Health Behavior	Medical outcomes study-social support survey 47,48)	Psychological functioning (incl. coping), Social functioning (incl. work)	Adult	5-point Likert scale	19	19–95	O	X	X	NA https://www.rand.org/health-care/surveys_tools/mos/social-support.html	O	O	X
Cognitive Function	Korean Version of the Montreal Cognitive Assessment22,52)	Psychological functioning (incl. coping)	Validated for 55 to 85 years	Other: drawing, multiple choices, pictorial, analogy, open-ended question, counting	28	0–30	O	X	X	NA https://mocacognition.com/paper/	O	X	https://mocacognition.com/paper/
Korean Medicine Questionnaire	Instrument of Korean Medical Pattern Identification and Functional Evaluation for Five Organ49)	Signs and symptoms	NA	5-point Likert scale	48	48–240	X	O	X	O		.	.
Korean Medicine Questionnaire	Blood Stasis Questionnaires on metabolic syndrome50)	Signs and symptoms	NA	5-point Likert scale Yes/No	15	0–32	X	O	X	O		.	.
Korean Medicine Questionnaire	Core Seven-Emotions Inventory - short form51)	Psychological functioning	NA	5-point Likert scale	28	28–140	X	O	X	O		.	.
Korean Medicine Questionnaire	Kidney deficiency pattern screening assessment questionnaire	Signs and symptoms	Adult Geriatrics	5-point Likert scale	20		X	O	O	O		.	.