Background/Purpose: Systemic sclerosis-associated Raynaud’s phenomenon (SSc-RP) significantly impacts patients’ quality of life, yet validated tools to assess this condition in Spanish-speaking populations are lacking. The Assessment of Systemic Sclerosis-associated Raynaud’s Phenomenon (ASRAP) is a new patient-reported outcome measure originally developed in English. This study aims to adapt the ASRAP into Spanish using a rigorous cross-cultural methodology.

Methods: We designed a prospective, qualitative, observational, and multicenter study to ensure cultural and linguistic equivalence of the ASRAP in Spanish. The adaptation process followed established international guidelines and included the following steps: (1) forward translation by two independent native Spanish-speaking healthcare professionals; (2) reconciliation to create a consensus version; (3) back-translation by a native English speaker unfamiliar with the questionnaire; (4) review of the back-translation to identify discrepancies; (5) harmonization through expert panel input involving bilingual SSc specialists from Spain and Latin America; (6) cognitive debriefing with iterative testing in 11 Spanish-speaking SSc-RP patients using semi-structured interviews and a 5-point rating scale to assess comprehension and relevance; (7) two rounds of professional proofreading; and (8) generation of the final Spanish version of the ASRAP.

Results: The four initial steps of the translation process were completed without complications. During the harmonization phase with the expert panel, some discrepancies emerged, particularly in wording choices. After discussion, the term “Medianamente” was replaced with “Algo”, and “Episodios” was revised to “Ataques” to better reflect common usage among Spanish-speaking patients with RP. The pre-final Spanish version of the ASRAP was field-tested in 11 patients with SSc-RP (6 from Chile and 5 from Mexico). The mean age was 58.5 ± 13.0 years, and 10 participants were female. The mean disease duration since RP onset was 11.3 ± 14.4 years, and 10.9 ± 13.7 years since the first non-RP symptom. Six participants (54%) had completed higher education. Overall, patients found the questionnaire clear and easy to understand. A minor revision was suggested during cognitive debriefing, specifically for item 27. Based on patient feedback, the phrase “Un cambio en mi rutina normal ha hecho que me preocupe sobre un posible empeoramiento de mis síntomas de Raynaud” was revised to “Un cambio en mi rutina normal hizo que me preocupara sobre un posible empeoramiento de mis síntomas de Raynaud”. As an initial validation step, the short-form ASRAP (ASRAP-SF, 10 items) was administered to 37 consecutive patients with SSc-RP (25 from Mexico and 12 from Chile), yielding a broad distribution of scores (mean ± SD: 50.5 ± 9.8; range: 31.32–67.07).

Conclusion: This collaborative cross-cultural adaptation process ensures that the Spanish version of the ASRAP is conceptually and culturally equivalent to the original, linguistically neutral, and relevant, clear, and comprehensible for Spanish-speaking patients with SSc-RP. Ongoing validation will further establish its utility across Spanish-speaking populations.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/translation-to-spanish-and-linguistic-validation-of-the-assessment-of-systemic-sclerosis-associated-raynauds-phenomenon-asrap/