Language translation, development, and usability testing of a Spanish contraception decision tool: protocol for a mixed methods pilot study (Preprint)
Year: 2026
Type: preprint
Study design: Study Protocol
Abstract: BACKGROUND Contraceptive care is complex, especially for individuals with health conditions (e.g., diabetes, depression, cardiovascular disease), who must consider how and to what extent their condition may be affected by contraception or vice versa. My Health, My Choice (MHMC), is a novel web-based contraceptive decision tool designed for patients with health conditions to promote shared decision-making, and is currently being tested in a cluster randomized clinical trial (RCT). However, to date, MHMC is not available in Spanish, creating linguistic and cultural barriers for trial participation for those who prefer to read and learn in Spanish. OBJECTIVE This protocol describes a robust and innovative language translation process and the development and usability testing of Mi salud, mi decisión, the Spanish version of MHMC for use by Spanish-speaking individuals. METHODS The pilot study combines an iterative convergent mixed methods design with user design (UX) methodology to test an innovative translation process and tool usability. First, a highly trained team of native Spanish speakers and professional translators will use a rigorous 7-step evidence-based translation process to develop a culturally and linguistically acceptable tool. The process involves: 1) resource and team preparation; 2) forward translations; 3) synthesis of translations; 4) back translation; 5) consensus (harmonizing) of translations; 6) review and proofreading; and 7) pretest/pilot of the translated adaptation. Our non-probability sampling strategy seeks to recruit a sample of 10-25 Spanish-speaking individuals (aged 18-49, can get pregnant, and want contraceptive decision support) with variations in reading level and Spanish dialect through tailored recruitment messages via local community groups, an academic research website, and social media. Quantitative usability data will be collected via electronic survey, using an adapted version of the Spanish System Usability Scale (SUS). Simultaneously, qualitative data will be collected via “think aloud” cognitive interviews in Spanish with trained Spanish-speaking qualitative researchers while participants navigate the tool and answer various questions about the tool’s usability and linguistic acceptability. A rapid qualitative analysis will be used to iteratively incorporate appropriate adjustments (e.g., translation inconsistencies, syntax) to the tool. Testing will be considered complete when data is no longer yielding substantive linguistic or cultural feedback. RESULTS We anticipate enrollment and data collection to begin in May 2026 and for study completion in 12 months. CONCLUSIONS This protocol describes the language translation, development, and usability testing of a novel web-based contraceptive decision tool in Spanish. Upon completion of this project, Mi salud, mi decisión will be ready for efficacy testing in a cluster RCT.
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W7162768637