Process of translating and cross - cultural adapting two instruments to evaluate medication adherence and inhaler technique in Macedonian

Background Patient-Reported Outcome (PRO) measures are essential tools to assess medication adherence and inhaler technique in asthma patients. In North Macedonia, no validated instruments existed in the local language, limiting clinical assessment and research. This study aimed to translate and cross-culturally adapt two internationally recognized PRO questionnaires - the Medication Intake Survey for Asthma (MIS-A) and the Inhaler Technique Questionnaire (InTeQ) - into Macedonian. Methods Following ISPOR guidelines for translation and cultural adaptation, we conducted forward and backward translations, reconciliation by an expert panel, and cognitive debriefing interviews with patients with asthma. Linguistic and conceptual equivalence, clarity, and cultural relevance were evaluated. Cognitive interviews assessed patient comprehension, item relevance, and instrument usability. Results The Macedonian versions of MIS-A and InTeQ were successfully developed. Minor wording adjustments were made to ensure conceptual equivalence, such as replacing “fully” with “completely” in InTeQ and clarifying the term “inhalations/puffs” in MIS-A. Cognitive debriefing conducted with 13–15 patients for each instrument demonstrated that the items were clear, easily understood, and culturally appropriate. Participants reported that both questionnaires were easy to understand, and no major linguistic, conceptual, or cultural difficulties were identified. Conclusions This study provides a comprehensive report of the linguistic translation and cross-cultural adaptation of the MIS-A and InTeQ into Macedonian. These PRO tools are suitable for use in clinical practice and research, enabling systematic assessment of medication adherence and inhaler technique. The work demonstrates a rigorous approach to translation and linguistic validation, addressing linguistic challenges and ensuring accuracy and consistency for a non-English-speaking population. Future studies will focus on psychometric validation to further establish reliability and validity.