Development and Validation of the Facial Line Distress Scale for Lateral Canthal Lines: FINE-LCL.

Background: Currently available patient-reported outcome measures (PROM) have limited ability to assess unique issues related to lateral canthal lines (LCL). This study aimed to develop a PROM to assess the severity and psychosocial impact of LCL in afflicted patients. Methods: We conducted a cross-sectional survey at a tertiary hospital and two local clinics in Korea. Exploratory factor analysis was conducted to identify the underlying factor structure of the Facial Line Distress Scale for LCL (FINE-LCL), and the internal consistency and test-retest reliability were also examined. Results: We developed a questionnaire comprising 20 items in four domains. Coefficient alphas ranged from 0.94 to 0.97 for subdomains and 0.97 for the total questionnaire. The test-retest intraclass correlation coefficient ranged from 0.77 to 0.90. The FINE-LCL was moderately correlated with the appearance appraisal score and body image. Analysis of the accuracy of the FINE-LCL score in predicting severe LCL was characterized by an area under the curve of 0.79. Conclusions: FINE-LCL is a reliable, valid, and comprehensive PROM for the assessment of the severity of LCL and their associated distress.

Development and Validation of Facial Line Distress Scale for Forehead Lines: FINE-FL.

BACKGROUND: Forehead lines (FL) are one of the main signs of aging. Traditional tools to measure FL have limited ability to evaluate the multidimensional impact of these lines on appearance, confidence, and psychological and social relationships. OBJECTIVES: We developed and validated the Facial Line Distress Scale-Forehead Lines (FINE-FL) to evaluate the severity and psychosocial distress associated with FL. METHODS: We conducted a cross-sectional survey for FINE-FL psychometric validation at a tertiary hospital and 2 local clinics in Korea. First, a preliminary item pool for the FINE-FL was developed through a qualitative interview based on literature reviews and expert consultations. Second, cognitive interviews and a pilot test were conducted to evaluate comprehension, ease of response, acceptability of terminology, phrasing, and response options. FINE-FL consisted of 26 items. In this study, exploratory factor analysis was conducted to identify the underlying factor structure of the FINE-FL, and internal consistency and test-retest reliability were also examined. RESULTS: We found 21 items in 4 domains. The model fit was good. Coefficient αs ranged from 0.89 to 0.95 for subdomains and 0.96 for the total. The FINE-FL was moderately correlated with the appearance appraisal score. On the test-retest, the range of the intraclass correlation coefficient was 0.65 to 0.79. CONCLUSIONS: FINE-FL is a reliable, valid, and comprehensive patient-reported outcome measure for assessing FL severity and distress. This will be helpful in determining a patient's eligibility for inclusion in a study and measuring primary or secondary effectiveness endpoints for forehead line treatment.

Efficacy of the PRO-CTCAE mobile application for improving patient participation in symptom management during cancer treatment: a randomized controlled trial.

PURPOSE: Although mobile-based symptom monitoring is expected to improve patient participation in symptom management during anticancer therapy, previous trials have not evaluated its effectiveness. Therefore, this study aims to evaluate the impact of a symptom monitoring mobile application on improving patient participation in symptom management during anticancer therapy. METHODS: We conducted a single-center, open-label, randomized controlled trial that enrolled patients with breast, lung, head and neck, esophageal, or gynecologic cancer who were scheduled to receive anticancer therapy (oral or intravenous) between October 2020 and March 2021. We excluded patients with physical or psychological problems. The intervention group received a symptom monitoring application for 8 weeks, and the control group received the usual clinical practice. At 8 weeks, the improvement in patient participation in symptom management was assessed, and additionally quality of life and unplanned clinical visits were assessed. RESULTS: A total of 222 patients were included in the analysis, of whom 142 were randomly assigned to the intervention group and 71 to the control group. The intervention group reported better outcome in patient participation in symptom management than the control group at 8 weeks (mean scores of 8.5 vs. 8.0; P = 0.01). There were no significant differences between the groups in Quality of life (P = 0.88) and unplanned clinical visits (P = 0.39-0.76). CONCLUSIONS: This study is meaningful in figuring out that the mobile-based symptom monitoring made them more engaged in their management. Future research should continue to evaluate the effects of patient participation as mediators of clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04568278.

Validation of the Korean Version of the Patient-Reported Outcomes Measurement Information System 29 Profile V2.1 among Cancer Survivors.

PURPOSE: The purpose of the study was to validate the Korean version of Patient-Reported Outcomes Measurement Information System 29 Profile v2.1 (K-PROMIS-29 V2.1) among cancer survivors. MATERIALS AND METHODS: Participants were recruited from outpatient clinics of the Comprehensive Cancer Center at the Samsung Medical Center in Seoul, South Korea, from September to October 2018. Participants completed a survey questionnaire that included the K-PROMIS-29 V2.1 and the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). Principal component analysis and confirmatory factor analysis (CFA) and Pearson's correlations were used to evaluate the reliability and validity of the K-PROMIS-29 V2.1. RESULTS: The mean age of the study participants was 54.4 years, the mean time since diagnosis was 1.2 (±2.4) years, and 349 (87.3%) completed the entire questionnaire. The Cronbach's alpha coefficients of the seven domains in the K-PROMIS-29 V2.1 ranged from 0.81 to 0.96, indicating satisfactory internal consistency. In the CFA, the goodness-of-fit indices for the K-PROMIS-29 V2.1 were high (comparative fit index, 0.91 and standardized root-mean-squared residual, 0.06). High to moderate correlations were found between comparable subscales of the K-PROMIS-29 V2.1 and subscales of the EORTC QLQ-C30 (r=0.52-0.73). CONCLUSION: The K-PROMIS-29 V2.1 is a reliable and valid measure for assessing the health-related quality of life domains in a cancer population, thus supporting their use in studies and oncology trials.

Psychometric validation of the Korean version of PROMIS 29 Profile V2.1 among patients with lower extremity problems.

BACKGROUND: Patients with lower extremity problems (LEP) commonly experience functional loss, pain, decreased range of motion, inadequacy in daily living activities, and structural change in radiographic evaluations. However, the traditional patient-reported outcome measurement which focused on symptoms, had a limited scope of applicability. This study aimed to validate the psychometric properties of the Korean version of PROMIS-29 Profile v2.1 (K-PROMIS-29 V2.1), a multi-dimensional measure for assessing generic profile health-related quality-of-life (HRQoL) in a sample of patients with lower extremity problems (LEP). METHODS: Participants were recruited from the orthopedic outpatient clinics at the Samsung Medical Center in Seoul, South Korea from September to October 2018. Participants completed a survey questionnaire that included the K-PROMIS-29 V2.1 and the SF-36v2. Principal component analysis (PCA) and confirmatory factor analysis (CFA) and Pearson's correlations were used to evaluate the reliability and validity of the K-PROMIS-29 V2.1. RESULTS: A total of 299 participants were enrolled in the study and 258 (86%) completed the study questionnaire. The mean age (SD) of the participants was 56.6 (14.5) and 32.3%, 29.8, and 25.2% of the study participants visited outpatient clinics for foot, knee, and hip problems respectively. The Cronbach's alpha coefficients of 7 sub-domains in K-PROMIS-29 V2.1 ranged from 0.80 to 0.95, indicating satisfactory internal consistency. In CFA, the goodness-of-fit indices were high (CFI = 0.937 and SRMR = 0.061). High to moderate correlations were found between comparable subscales of the K-PROMIS-29 V2.1 and subscales of the SF-36v2 (r = 0.55-0.70). CONCLUSIONS: The K-PROMIS-29 V2.1 is a reliable and valid measure for assessing a broad range of health-related quality-of-life domains in patients with LEP. It would reflect the real-life symptoms experienced by patients with LEP.

Psychometric validation of the Korean Patient-Reported Outcome Measurement Information System (PROMIS)-29 Profile V2.1 among patients with chronic pulmonary diseases.

BACKGROUND: This study aimed to validate the Korean version of the Patient-Reported Outcome Measurement Information System 29 Profile V2.1 (K-PROMIS-29 V2.1) in a sample of patients with chronic pulmonary diseases (CPDs). METHODS: Participants were recruited from the respiratory disease outpatient clinics of Samsung Medical Center in Seoul, South Korea, from September to October 2018. Participants completed a survey questionnaire, including the K-PROMIS-29 V2.1 and Short Form Health Survey version-2.0 (SF-36v2). Modified Medical Research Council (mMRC) and chronic obstructive pulmonary disease (COPD) Assessment Test (CAT) scores were obtained these scores from electronic medical records (EMRs). Exploratory and confirmatory factor analyses (CFA) and Pearson's correlations were used to evaluate the reliability and validity of the K-PROMIS-29 V2.1. RESULTS: The mean age [standard deviation (SD)] was 62.8 (12.0) years, and 19.2% had less than middle-school education. Disease types included bronchiectasis (n=46, 24.5%), COPD (n=45, 23.9%), nontuberculous mycobacterial lung disease (n=25, 13.3%), interstitial lung disease (n=22, 11.7%), and others (n=50, 26.6%). Cronbach's alpha coefficients of the 7 subdomains in the K-PROMIS-29 V2.1 ranged from 0.77 to 0.96, indicating satisfactory internal consistency. In CFA, the goodness-of-fit indices were high (comparative fit index =0.90, standardised root mean residual =0.06). Moderate correlations were observed between comparable subscales of the K-PROMIS-29 V2.1 and those of the SF-36v2 (r=0.55-0.70) and CAT (r=-0.80 to 0.70). CONCLUSIONS: The findings of this study suggest that the K-PROMIS-29 V2.1 is a reliable and valid measure for assessing a broad range of health-related quality-of-life domains in patients with CPDs.