ALSATION

The translation and cultural adaptation of the questionnaires will be done applying the methodology described by HSRI (Human Services Research Institute, USA) [11] and following the methodology recommended by Sousa and Rojjanasrirat [12]. Table 1 summarizes the steps that apply to each instrument. The procedures that will be followed are presented in Table 2.

Table 1. ALSATION study: steps and description.
Step 1: Translating the tool from En to Ro (2 experienced researchers from academia with different backgrounds). The first translator must have knowledge of medical terminology and tool construction, and the second translator must be familiar with colloquial phrases, slang, and jargon regarding digital literacy, idiomatic expressions, and emotional terms. The approach will generate two translated versions containing words and sentences that cover both medical language and ordinary spoken language with its cultural nuances.
Step 2: Evaluation of the translation by a bilingual researcher independent of the two researchers who made the initial translation. At this stage, ambiguities and discrepancies of words, sentences, and meanings are evaluated. The identified discrepancies are discussed and resolved by a group consisting of the two researchers who made the initial translation, the third researcher, and at least two other members of the research team. This group must reach a consensus and will report the preliminary Ro versions.
Step 3: Translate the preliminary version of the tool from Ro to En. Use different two researchers/translators with the characteristics described in step 1.
Step 4: Apply the approach presented in step 2 for comparing the translated versions from Ro to En relative to the original version of the tool. At this stage, the similarity of the instructions, elements, and response format is assessed in terms of wording, item structure, meaning, and relevance. Repeat steps 1 to 4 as many times as necessary to solve all ambiguities and discrepancies. Alternatively, only elements that do not retain their original meaning are retranslated and translated back.
Step 5: Evaluate the translation of the tool in an expert group (targeted number is 10). We will evaluate the clarity of instructions, items, and response possibilities. The experts will be invited to assess each element of the instrument in terms of content relevance (1 = not relevant; 2 = somewhat relevant; 3 = relevant but requires minor changes; 4 = very relevant. Items classified as 1 or 2 will be revised [13]); sharpness (1 = blurry; 2 = item needs review; and 3 = very clear); and necessity (1 = non-essential; 2 = useful but not essential; and 3 = essential). The content validity index will be calculated at the element level (I-CVI, CVI=content validity) and at the S-CVA/Ave scale level (mean calculation method) [14]. The items with 0.70 ≤ I-CVI (relevance of items) ≤ 0.79 will be reviewed [15], and those with I-CVI < 0.70 will be removed [16]; S-CVA/Ave ≥ 0.90 shows excellent content validity [15]. The process will continue until acceptable indices of validity are obtained or eliminated. The final version will be analyzed in terms of content (internal validity) by calculating the kappa coefficient [17], the minimum acceptable coefficient to be considered a good tool being 0.60, excellent above 0.74.
Step 6: Pilot testing on a sample of the target population (targeted sample size: 10-40 participants). At this stage, each participant evaluates the instructions and elements of the instrument using a dichotomous scale (clear or unclear). For evaluations in the “blurry” category, participants are asked to provide suggestions on how to rewrite to make the language clearer. We will reassess items and elements of the instrument that at least 20% of the sample consider unclear [18].
Step 7: Full psychometric testing of the version resulting from step 6 (targeted sample size: minimum 10 subjects per instrument scale item). What do we evaluate? At least one of the following: (1) reliability of internal consistency; (2) stability reliability (test-retest reliability); (3) the validity of the construction (convergent and/or divergent, discriminatory validity).

Table 2. ALSATION study: main procedures.
Step 1: Criteria for identifying potential participants for translation: Language skills En (minimum level C1) and Ro (mother tongue); Experience in the field (medicine, sociology, public health, applied informatics in medicine or related fields); Previous experience in questionnaire translation or questionnaire-based research: if possible, previous translation experience (questionnaires or other research materials) in the previously listed areas. Participants must give their consent. Benefits (fees or other benefits – e.g., inclusion in the research team) and delivery times are established.
Step 2: Two researchers (other than those in step 1) will be invited to take part in the activities of this step. Eligibility criteria: Language skills En (minimum level C1) and Ro (mother tongue), and Experience in questionnaire research.
Step 3: The criteria for translators are those described in Step 1. The people involved in Step 1 cannot be involved in this step.
Step 4: Identical as the procedure described in Step 2.
Step 5: Eligibility criteria for the Expert Group participants: Experience in the field (medicine, sociology, public health, applied informatics in medicine or related fields); Previous experience in questionnaire-based research; Availability of active participation.
Step 6: Eligibility criteria: It is part of the target group, represented by the general population; The mother tongue is Romanian; Has the ability to understand what reads in Romanian; Preferably, has the necessary skills to use online tools. To capture all demographic and socio-cultural groups, at least two trained researchers will help the potential participants in this process. How to identify participants: Individual invitations of research team members – convenient snowball – those who participate are asked to invite 1-2 more acquaintances/colleagues/family members/neighbors; Groups – social media platforms (e.g., Facebook, etc.); Invitations – Professional social media platforms/patient groups/patients, etc.
Step 7: Eligibility criteria: It is part of the target group, represented by the general population; The mother tongue is Romanian; She/He can understand what he reads in Romanian; She/He has the necessary skills to use online tools. How to identify participants: Students: regardless of field of study, form of schooling, sex, or other criteria (reliability of stability); Participants in activities intended for the general population: leisure, health (cross-country, health education), screening, etc.; Support groups and patient associations; General population.

The ethical approval has been received from the Ethics Committee of the Iuliu Hațieganu University of Medicine and Pharmacy Cluj-Napoca (approval number AVZ152/29 July 2024) and the signed informed consent was waived.