Objectives: Many scales have been developed to assess health literacy. These scales have
been developed extensively in clinical populations in developed countries. Our study
describes the process of development and validation of the Health Literacy Questionnaire
to measure health literacy in the general Iranian population. Methods: We followed the
scale development process outlined by Schwab in 1980. After a comprehensive review of
the research published on Nutbeam's definition of health literacy and its measurement,
two focus groups were considered to generate a pool of items. We then assessed the face
validity and content validity of the items. The final version of the questionnaire was subject
to independent exploratory and confirmatory factor analysis. The internal consistency of
the questionnaire was evaluated using Cronbach's alpha. Finally, construct validity was
assessed using bivariate analysis between the total scores on the scale and theoretically
relevant variables. Results: The results of exploratory factor analysis revealed a three factor 14-item structure for the scale. Confirmatory factor analysis provided a good
statistical and conceptual fit for the data. The analysis of the internal consistency of the
scale was satisfactory (α = 0.798). Further, health literacy was significantly associated with
participants' age, educational level, self-rated household income, smoking history, self-rated
health, and self-rated health literacy. Conclusions: The results we obtained indicate that
this newly constructed health literacy tool is highly valid and reliable. Prospective studies
are required to evaluate the predictive validity of the scale with regard to health outcomes.