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JKM > Volume 45(1); 2024 > Article
Cho, Jun, Ha, Lee, Ko, Kim, Jung, and Leem: Sharing Experiences in Selecting Clinical Outcome and Approving Validated Questionnaires : Insights from an Elderly Registry Study

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.

Fig. 1
Flow diagram of the process of Selecting Clinical Outcome and Approving Validated Questionnaires
jkm-45-1-17f1.gif
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
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
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 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 2nd 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 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
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 . .

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