OBJECTIVE To develop a valid, reliable instrument to measure the functional health literacy of patients. DESIGN The Test of Functional Health Literacy in Adults (TOFHLA) was developed using actual hospital materials. The TOFHLA consists of a 50-item reading comprehension and 17-item numerical ability test, taking up to 22 minutes to administer. The TOFHLA, the Wide Range Achievement Test--Revised (WRAT-R), and the Rapid Estimate of Adult Literacy in Medicine (REALM) were administered for comparison. A Spanish version was also developed (TOFHLA-S). SETTING Outpatient settings in two public teaching hospitals. PATIENTS 256 English- and 249 Spanish-speaking patients were approached. 78% of the English- and 82% of the Spanish-speaking patients gave informed consent, completed a demographic survey, and took the TOFHLA or TOFHLA-S. RESULTS The TOFHLA showed good correlation with the WRAT-R and the REALM (correlation coefficients 0.74 and 0.84, respectively). Only 52% of the English speakers completed more than 80% of the questions correctly. 15% of the patients could not read and interpret a prescription bottle with instructions to take one pill by mouth four times daily, 37% did not understand instructions to take a medication on an empty stomach, and 48% could not determine whether they were eligible for free care. CONCLUSIONS The TOFHLA is a valid, reliable indicator of patient ability to read health-related materials. Data suggest that a high proportion of patients cannot perform basic reading tasks. Additional work is needed to determine the prevalence of functional health illiteracy and its effect on the health care experience.
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