Association of treated neovascular AMD with disability and mood disorders: A longitudinal nationwide study.

In the United States (US), low literacy can be defined as reading proficiency at or below the sixth-grade level, as this limits the ability to understand written health information and complete written questionnaires independently [–]. It is estimated that between one-fifth and almost half of all adults have low levels of English literacy [, ]. Low literacy is independently associated with poor health status [], and rates of low literacy are disproportionately higher among cohorts with challenges in social determinants of health (SDOH), often including racial and ethnic minority populations [, , ]. Although measuring patient-reported outcomes (PROs) has become a critical component of understanding and improving care and health status, administration of patient-reported outcomes measures (PROMs) in low literacy patient populations remains a major challenge []. This aligns with recent studies that have shown that PROM completion rates are influenced by SDOH [, ]. Almost all existing PROMs rely on text to convey meaning []. This precludes an accurate measurement of outcomes for low literacy populations, prevents providers from comprehensively evaluating these vulnerable populations at the point of care, and limits their inclusion in research. Although interviewer administration of PROMs is an option when self-administration is not feasible, it can be labor intensive and expensive, making it impractical and cost prohibitive as PROs become widely used []. Interviewer administration also introduces the potential for interviewer bias [] and patient embarrassment [], important considerations for patients with low literacy who may hide the inability to read due to shame [, ]. Growing reliance on PROs to understand outcomes facilitates the provision of patient-centered care, and measure quality can result in these tools contributing to the perpetuation and exacerbation of health disparities unless PROMs are designed for inclusive and equitable implementation []. We developed the Multimedia Adaptation Protocol (MAP) to guide translation of text-only PROMs to multimedia PROMs (mPROMs) with audio and video components that can be self-administered by patients of all literacy levels (not to be confused with mHealth (mobile health) technologies) []. The MAP takes a human-centered design (HCD) approach and has four stages: (1) forward adaptation, (2) back adaptation, (3) qualitative evaluation, and (4) psychometric validation (Fig. ) []. For the first development of a mPROM, we focused on the hand and upper extremity population because we expected variation in physical function to be easier to convey in multimedia elements than variation in mental or social health. We used (1) forward adaptation to adapt the Patient-Reported Outcomes Measurement Information System Short Form v2.0 Upper Extremity 7a (PROMIS-UE) to a multimedia prototype (multimedia PROMIS-UE) []. We selected PROMIS-UE because PROMIS instruments are among those that the National Institutes of Health encourages investigators to use [] and because the PROMIS-UE item bank affords us flexibility to create a customized short form if needed [–]. Additionally, although PROMIS development standards specify that items should be written at a sixth grade reading level or lower [], we calculated that the PROMIS-UE Short Form v2.0 Upper Extremity 7a including the instructions has a SMOG (Simple Measure of Gobbledygook) reading level of the seventh grade. The goal of this study was to refine the multimedia PROMIS-UE via (2) back adaptation and (3) qualitative evaluation to produce a conceptually-equivalent, user-tested multimedia PROMIS-UE ready to undergo (4) psychometric validation.