RESUMO
BACKGROUND AND AIM: The Patient-Generated Subjective Global Assessment (PG-SGA©) is a globally used malnutrition screening, assessment, triage and monitoring tool. The aim of this study was to perform a linguistic and content validation of the translated and culturally adapted version of the PG-SGA for the Danish setting. METHOD: The study was conducted according to the International Society of Pharmaeconomics and Outcomes Research (ISPOR) Principles of Good Practice for the Translational and Cultural Adaptation Process for Patient-Reported Outcomes Measures. Cancer patients (n = 121) and healthcare professionals (HCPs, n = 80) participated in the cognitive debriefing. A questionnaire was used in the cognitive debriefing in which comprehensibility, difficulty, and content validity (relevance) were quantified by a 4-point scale. Item and scale indices were calculated using the average item ratings divided by the number of respondents for content validity (Item-CVI, Scale-CVI), comprehensibility (Item-CI, Scale-CI) and difficulty (Item-DI, Scale-DI). As pre-defined, item indices <0.78 required further analysis of the item, and scale indices ≥0.90 were defined as excellent and 0.80-0.89 as acceptable. RESULTS: The patient component of the PG-SGA was rated as excellent content validity (Scale-CVI = 0.95) by HCPs and easy to comprehend (Scale-CI = 0.97) and use (Scale-DI = 0.92) by patients. The professional component of the PG-SGA was rated as acceptable content validity (Scale-CVI = 0.80), but below acceptable for comprehension (Scale-CI = 0.71) and difficulty (Scale-DI = 0.69). The physical exam was rated the least comprehensible Item-CI = 0.51-0.70) and most difficult (Item-DI = 0.33-0.063). CONCLUSION: The PG-SGA was successfully translated and culturally adapted to the Danish setting. Patients found it easy to understand and to complete. Except for the physical exam, HCPs rated the PG-SGA as relevant, comprehensive, and easy to use. Training of HCPs is recommended before implementing the tool into clinical practise.