The aim of this study was to validate the Spanish version of the PAID-Peds survey through a qualitative validation phase and analysis of the psychometric properties of the instrument.
Design and setting of the study
Procedures and stages: qualitative validation
The PAID-Peds survey, originally developed in English by Markowitz et al., is a specific instrument to measure youth-reported burden related to T1DM management [12]. The survey begins with an instructions section followed by 20 items to assess burden over the previous month. There are 5 response options scored on a 0–4 Likert scale (agree to disagree). When applying the questionnaire in the present study, the sample was divided into 2 age groups: 8–12 and 13–18 years.
The study authors contacted Markowitz et al. and the Pediatric, Adolescent and Young Adult Section at the Joslin Diabetes Center (Department of Psychiatry, Harvard Medical School, Boston, MA), who authorised the translation of the instrument into Spanish and subsequent validation.
The aim of this stage was to evaluate the face validity and feasibility of the Spanish version. We used an eight-step structured method in accordance with the principles of good practice of the International Society for Pharmacoeconomics and Outcomes Research Task Force for Translation and Cultural Adaptation [16]:
Step 1: Forward translation. Two native Spanish-speaking professional translators independently translated the questionnaire into Spanish; Step 2: Reconciliation and synthesis. Five multidisciplinary specialists in diabetes and endocrinology disorders compared and merged the two translations into one single translation; Step 3: Back-translation. Working independently, 2 native English-speaking professional translators translated the questionnaire into English; Step 4: Comparison and harmonisation of the back translations with the original; Step 5: Cognitive debriefing. Multicentre pilot study of 30 young patients with T1DM selected by consecutive sampling to evaluate the Spanish version of the PAID-Peds survey; Step 6: Review of the cognitive debriefing; Step 7: Proofreading, spelling, and grammar revision; Step 8: Final report (Fig. 1).
Stages of translation into Spanish, cultural adaptation, and validation of the PAID-Peds® survey
Characteristics of participants
Psychometric properties
Setting and sampling
An observational, multicentre, cross-sectional validation study.
Inclusion criteria: a sample of 30 subjects aged 8–17 years diagnosed with T1DM for more than one year according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) criteria [5] under treatment with insulin therapy (multiple doses or continuous subcutaneous infusion pump) and under follow-up at the Miguel Servet University Hospital in Zaragoza (Aragón, Spain), the Ramón y Cajal University Clinical Hospital in Madrid (Spain), and the Sant Joan de Déu Hospital in Barcelona (Catalonia, Spain).
Exclusion criteria: Patients diagnosed with disorders associated with intellectual diversity (chromosopathies, autism, cerebral palsy, etc.) and language difficulties.
In addition, the authors of manuscript, as a future line of research, propose a multicentre cross sectional study of 636 population (CI 95% in the same participants’ hospitals).
Study variables
Sociodemographic and clinical characteristics were collected for the study. The sociodemographic variables were sex, age, and type of family. The clinical variables were weight; SD weight; height; SD height; body mass index; systolic and diastolic blood pressure; chronic complications; HbA1c (%) at 3, 6, 9, and 12 months prior to the study; glucose management indicator; glucose time in range; year of disease onset; insulin administration type; number of hospitalisations due to ketoacidosis in the previous year; number of episodes of hyperglycaemia treated in the emergency department; history of hypoglycaemia with and without loss of consciousness; hypoglycaemia with loss of consciousness and administration of glucagon; hypoglycaemia without loss of consciousness requiring immediate medical attention; hypoglycaemia without loss of consciousness and with hospitalisation; and other autoimmune disorders.
All patients completed the Spanish version of the PAID-Peds survey. The time required to complete the survey was recorded.
The study was approved by the Ethics and Research Committee of the Autonomous Community of Aragon and the Ramón y Cajal University Hospital of Madrid (C.P.-C.I. P21/425) and the Fundació Sant Joan de Déu (C.I. PIC-33-22). Informed consent for all participants was obtained and patients with age less 16, informed consent was obtained from their respective parent(s)/guardian. All methods were carried out in accordance with relevant guidelines and regulations and Declaration of Helsinki was followed.
Score and time to complete the questionnaire
Each question was scored on a five-point Likert scale (0: strongly agree; 1: agree; 2: unsure; 3: disagree; 4: strongly disagree). The total score was obtained by reversing the scores of each item and calculating the mean of all non-missing items and multiplying this value by 25 to normalize the total score to a 100-point scale [12]. Patients scoring 41 or higher may be at the level of “emotional burnout” [17].
Internal consistency
The internal consistency of each question was determined using Cronbach’s alpha index [18], with values of 0.7 or higher considered as acceptable [19].
Test-retest reliability
The PAID-Peds survey was administered a second time 3 weeks after the first one in the same study population. The test-retest reliability was evaluated using the interclass correlation coefficient and Wilcoxon W-test for paired samples and there were not any losses.
The statistical calculations were performed with Jamovi® statistical software, version 2.3.13. The level of statistical significance was established at a p value of < 0.05.
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