Med Care

Background Many research participants are misinformed about research terms, procedures and goals, however no validated instruments exist to assess individual’s comprehension of health-related research information. We propose research literacy as a concept that incorporates understanding about the purpose and nature of research. Objectives We developed the Research and Knowledge Scale (RaKS) to measure research literacy in a culturally, literacy-sensitive manner. We describe its development and psychometric properties. Research Design Qualitative methods were used to assess perspectives of research participants and researchers. Literature and informed consent reviews were conducted to develop initial items. These data were used to develop initial domains and items of the RaKS, and expert panel reviews and cognitive pre-testing were done to refine the scale. We conducted psychometric analyses to evaluate the scale. Subjects The cross-sectional survey was administered to a purposive community-based sample (n=430) using a web-based data collection system and paper. Measures We did classical theory testing on individual items and assessed test- retest reliability and Kuder Richardson-20 (KR-20) for internal consistency. We conducted exploratory factor analysis and analysis of variance to assess differences in mean research literacy scores in socio-demographic subgroups. Results The RaKS is comprised of 16 items, with a KR-20 estimate of 0.81 and test-retest reliability 0.84. There were differences in mean scale scores by race/ethnicity, age, education, income, and health literacy (all p<0.01). Conclusions This study provides preliminary evidence for the reliability and validity of the RaKS. This scale can be used to measure research participants’ understanding about health-related research processes and identify areas to improve informed decision-making about research participation.

27579914

PMC5233643

CDC Public Access