Psychometric validation of the Functional Assessment of Cancer Therapy-Endometrial among endometrial cancer patients.

OBJECTIVE: To evaluate a psychometric validation of the endometrial cancer subscales (EnCS) in the Functional Assessment of Cancer Therapy-Endometrial (FACT-EN) among patients with endometrial cancer. METHODS: This cross-sectional study was conducted at a tertiary university-based hospital in South Korea between April and October 2022. Participants completed a survey questionnaire that included the FACT-EN. Exploratory and confirmatory factor analyses (EFA, CFA) and the reliability were measured using the intraclass correlation coefficient (ICC) under a two-way mixed model. Pearson's correlations were used to evaluate the validity. We also tested known-group validity. RESULTS: In total, 240 patients with endometrial cancer participated in the survey. In EFA, we found EnCS included four domains. In CFA, four-factor solution model was good: CFI = 0.659; SRMR = 0.066, and RMSEA = 0.073. The mean (SD) of total score of FACT-EN was 122.84 (23.58). The floor and ceiling effects were 0.4% and 0.4%, respectively. Cronbach's α coefficients for the five scales of the EnCS ranged from 0.78 to 0.91. The ICC of EnCS was 0.76. The convergent and discriminant validity of EnCS was acceptable. In the group analysis, older age and lower ECOG performance scores were associated with higher EnCS scores. The stomach and vaginal domains in EnCS were higher in patients who had completed treatment for more than 1 year compared to those who were still undergoing treatment. CONCLUSIONS: FACT-EN has demonstrated its validity as an assessment tool with significant implications for capturing various symptoms in patients with endometrial cancer.

Development and validation of the Pediatric-Youth Hyperphagia Assessment for Prader-Willi syndrome.

OBJECTIVES: Hyperphagia is a highly stressful, life-threatening feature of Prader-Willi syndrome (PWS). It is important to assess this complex behavior accurately over time. This study aimed to develop and validate the Pediatric-Youth Hyperphagia Assessment for Prader-Willi syndrome (PYHAP) as a tool targeting children and adolescents. METHODS: After an extensive literature review and qualitative interviews, the final version of the PYHAP with 14 questions in 3 domains (verbal [5], behavior [4], and social [5]) was developed and tested at Samsung Medical Center in Seoul, Korea from July 2018 to September 2019. Exploratory factor analysis and confirmatory factor analysis (CFA) were performed to confirm construct validity. The correlations between the PYHAP and the Korean Children's Eating Behavior Questionnaire (K-CEBQ) were calculated to evaluate convergent and discriminant validity. Criterion validity and the validity of the response categories were also tested. RESULTS: Cronbach's alpha coefficient of the PYHAP was 0.91. The fit indices for CFA were good (comparative fit index, 0.87; standardized root mean squared residual, 0.08). The domains of the PYHAP were closely correlated with the relevant domains of the K-CEBQ. The accuracy of the PYHAP score for predicting uncontrolled hyperphagia was good (area under the curve, 0.75; 95% confidence interval, 0.65 to 0.85). CONCLUSIONS: The PYHAP was confirmed to be a reliable and valid tool to evaluate hyperphagia in children and adolescents with PWS via caregivers' assessments. It is recommended to use the PYHAP to communicate with parents or caregivers about patients' hyperphagia or to monitor and manage extreme behaviors in children with PWS.

Linguistic Validation of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Korean.

PURPOSE: The aim of this study was to translate and linguistically validate a Korean-language version of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). METHODS: All 124 PRO-CTCAE items were translated into Korean (PRO-CTCAE-Korean) using International Society for Pharmacoeconomics and Outcomes Research best practices and linguistically validated in a diverse sample of patients undergoing cancer treatment (n = 120) to determine whether the Korean translation captured the original concepts. During the cognitive interviews, participants first completed approximately 60 PRO-CTCAE-Korean questions and were then interviewed to evaluate the conceptual equivalence of the translation to the original PRO-CTCAE English-language source. Interview probes addressed comprehension, clarity, and ease of judgement. Three rounds of interviews were conducted. Items that met the a priori threshold of 10% or more of respondents with comprehension difficulties were considered for rephrasing and retesting. RESULTS: A majority of PRO-CTCAE-Korean items were well comprehended in round 1; 14 items posed comprehension difficulties for at least 10% of respondents in round 1. Four symptom terms (mouth and throat sores, feeling like nothing could cheer you up, frequent urination, and pain, swelling, redness at drug injection or intravenous insertion site) were revised and retested in rounds 2 and 3. For the other 10 symptom terms, no suitable alternative phrasing was identified, and the terms were retested in rounds 2 and 3. After rounds 2 and 3, no item presented difficulties in 20% or more of participants. CONCLUSION: PRO-CTCAE-Korean has been linguistically validated for use in Korean-speaking populations. Quantitative evaluation of this new measure to establish its measurement properties and responsiveness in Korean speakers undergoing cancer treatment is in progress.