Study protocol of translation into Spanish and cross-cultural adaptation and validation of the problem areas in diabetes-Pediatric version (PAID-Peds) survey.

AIM: The metabolic and psychological management of paediatric type 1 diabetes mellitus (T1DM) can be challenging over time given that T1DM may cause a negative emotional burden and, consequently, result in poor metabolic control of the disease. The objectives of this study are to translate the Problem Area in Diabetes Survey-Pediatric version (PAID-Peds) into Spanish, adapt it culturally and validate it. DESIGN: Multicenter cross sectional study. METHODS: 636 patients aged 8-17 years, diagnosed with T1DM, under treatment with insulin and follow-up at the Miguel Servet University Hospital in Zaragoza (Aragón, Spain), the Ramón y Cajal University Clinical Hospital in Madrid (Spain) and at the Sant Joan de Déu Hospital in Barcelona (Catalonia, Spain) between 1 January 2023 and 31 December 2024 will be included. This study will consist of two phases: (1) Translation and cultural adaptation of the original PAID-Peds® survey into Spanish following eight steps; (2) Validation of the Spanish version of the PAIS-Peds® survey. The statistical analysis will be performed using Jamovi® 2.1.23. The reliability or internal consistency will be calculated using Cronbach's alpha index (considering an index higher than 0.8 to be good) and the test-retest will be evaluated using the intraclass correlation coefficient. For validity, confirmatory factor analysis will be calculated. This study has been approved by the ethics and research committees at each centre. RESULTS: The translation and validation into Spanish language of the Problem Area in Diabetes Survey-Pediatric version will be feasible, valid and reliable to detecting the youth-perceived burden of T1DM. Therapeutic education in diabetes-recommended by the WHO and the Diabetes Education Study Group-has shown encouraging results in glycaemia and psychosocial and behavioural factors in T1DM.

Translation and psychometric evaluation of the Spanish version of the problem areas in diabetes-pediatric version (PAID-Peds) survey.

BACKGROUND: Metabolic control and psychological management of paediatric type 1 diabetes mellitus (T1DM) can be challenging over time. Development of an instrument to assess the youth-reported burden could aid in preventing T1DM-associated diseases. METHODS: The aim of this study was to translate and validate the Spanish version of the Problem Area in Diabetes Survey-Pediatric version (PAID-Peds). A multicentre, cross-sectional translation and linguistic validation study was performed on a sample of 30 participants aged 8-17 years with a minimum 1-year history of T1DM diagnosed at the Miguel Servet University Hospital in Zaragoza (Aragon, Spain), Ramón y Cajal University Clinical Hospital in Madrid (Spain), and Sant Joan de Déu Hospital in Barcelona (Catalonia, Spain). The qualitative validation consisted of translation into Spanish and back-translation into English of the Paid-Peds survey and subsequent administration to the sample population. Data were gathered on parameters related to sociodemographic characteristics and metabolic control. Validity, feasibility, and test-retest reliability were evaluated. Internal consistency was determined using Cronbach's alpha coefficient, test-retest reliability by means of interclass correlation, and paired samples using the Wilcoxon W-test. The study was approved by the ethics and research committees at each participating centre. RESULTS: The study assessed 30 children (46.7% female) with an average age of 13.33 ± 2.98 years; mean age at onset was 5.70 ± 3.62 years, and the mean disease duration was 7.63 ± 4.36 years. The mean score on the PAID-Peds survey was 42.88 ± 17.85. Cronbach's alpha coefficient was 0.90. Test-retest reliability measured by interclass correlation coefficient was 0.8 (95% CI: 0.63-0.90). No significant differences in total scores were found between test and retest (Wilcoxon W-test: 289; p = 0.051). CONCLUSIONS: The Spanish version of the PAID-Peds survey is a feasible, valid, and reliable instrument to assess the youth-perceived burden of T1DM.