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.

Responsabilidades de autocuidado acordes a la edad en población pediátrica con diabetes tratada con ISCI / Age-appropriate self-care responsibilities in the pediatric population with diabetes treated with CSII

Objetivo: Determinar en población infantil con Diabetes tipo 1 (DT1) en tratamiento con infusión subcutánea continua de insulina (ISCI), si asumir responsabilidades de autocuidado tras recibir un programa estructurado de educación terapéutica (PEET) se relaciona con el control metabólico y la calidad de vida (CV). Métodos: Estudio observacional, transversal. Se realizó un sub-análisis retrospectivo. Se incluyeron sujetos con DT1 (edad 9-17 años) en terapia ISCI (>1año) que habían recibido el mismo PEET al inicio de ISCI. Se registraron: grado en que asumían responsabilidades de autocuidado acordes a su edad, control metabólico, CV, nivel de conocimientos sobre diabetes y uso de funciones específicas del dispositivo. Resultados: Se incluyeron 44 pacientes. Los niños que asumieron responsabilidades de autocuidado acordes a su edad presentaron valores de hemoglobina glicada (HbA1c) significativamente menores que los niños que no las asumieron (8,0±0,7% vs. 9,2±1,1%, respectivamente, p<0,001), así como una mayor puntuación en los cuestionarios de CV y de conocimientos (CV 84,3±9,3 vs. 79,4±10,6, p<0,01; conocimientos 27,9±4,2 vs. 26,5±4,3, respectivamente, n.s). El uso de las funciones específicas de la bomba se observó principalmente en aquellos que asumieron esas responsabilidades de autocuidado presentando valores más bajos de HbA1c que aquellos niños que no las utilizaron (7,9±1,0% vs. 8,4±0,8%, p<0,05). Conclusiones: Los pacientes con DT1 en tratamiento con ISCI que asumieron responsabilidades de autocuidado de su diabetes acorde a su edad, mostraron mejor control de HbA1c y mejor CV que aquellos que no lo hicieron. Se necesitan más estudios para profundizar en el conocimiento de estos aspectos. (AU)

Objective: The aim of this study was to determine if children and adolescents with type 1 diabetes (DT1) managed with continuous subcutaneous insulin infusion (ISCI) who assume self-care responsibilities tailored to the age after a specific structured education program (PEET), present better metabolic control and quality of life (CV). Methods: A observational, cross-sectional study was conducted. A retrospective sub-analysis was performed. Subjects with DT1 (aged 9-17 years) who have been using ISCI (>1year) were included. All patients received the same structured PEET when initiating ISCI treatment. The degree of self-care age-appropriate responsibilities assumed by children was registered. Data related to metabolic control, diabetes knowledge, use of different pump features, and quality of life were also collected. Results: Forty-four patients were included. Children assuming age-appropriate self-care responsibilities had a significantly lower glycated hemoglobin (HbA1c) value compared to those children who did not take on these responsibilities (8,0±0,7% vs. 9,2±1,1%, p<0,001). as well as higher scores in the CV and knowledge questionnaires (84,3±9,3 vs. 79,4±10,6 respectively, p<0,01; knowledge 27,9±4,2 vs. 26,5±4,3, respectively, n.s). The use of specific pump features was mainly observed in those who assumed age-appropriate self-care responsibilities and showed lower HbA1c values than those children who did not take on these responsibilities (7,9±1,0% vs. 8,4±0,8%, p<0,05). Conclusion: Patients with DT1 managed with ISCI, who assumed age-appropriate responsibilities on disease self- management, showed better HbAc1 and better CV than those who did not. More studies are needed to deepen the knowledge of these topics. (AU)

Psychometric analysis of the cross-cultural Spanish version of the diabetes management questionnaire.

Evaluation of the degree of adherence to self-care among Spanish type 1 diabetes (T1DM) pediatric population lacks of a validated tool. PURPOSE: To cross-culturally adapt and determine the psychometric properties of the Spanish version of the Diabetes Management Questionnaire to assess the degree of adherence to self-care among children with T1DM. METHODS: Translation, back-translation, and patient suggestions, were considered to obtain the Spanish version (DMQ-Sp). A cross-sectional study was conducted with 323 children (aged 8-18 years) with T1DM and their parents to determine internal reliability, structural validity, and external validity. Responsiveness to change was analyzed through a prospective longitudinal study involving 102 newly diagnosed T1DM patients. Psychometrics were evaluated for the entire sample and stratified by age (8-12 and 13-18 years). RESULTS: A total of 323 children with T1DM [49.8% female; age 13.3 ± 2.8 years; 155 aged 8-12; glycated hemoglobin (HbA1c) value 7.7 ± 1.0%] answered the Spanish final version. The internal consistency Cronbach's alpha was 0.76 and intraclass correlation coefficient 0.84. Test-retest reliability was r = 0.84 (p < 0.001). Fit index of structural validity was >0.7. External validity correlated inversely with HbA1c (r = -0.39; p < 0.001). The DMQ-Sp score increased significantly after 6 months of receiving the full therapeutic education program (TEP) (baseline 57.07 ± 10.81 vs. 6 months 78.80 ± 10.31; p < 0.001). CONCLUSION: The DMQ-Sp is reliable, valid, and sensitive to change in a large sample of children (aged 8-18 years) with T1DM and their parents. PRACTICE IMPLICATIONS: DMQ-Sp can be a useful tool for diabetes teams to identify adherence to different tasks and to evaluate TEPs.