Ruth M. Parker

Development of a brief test to measure functional health literacy

We describe the development of an abbreviated version of the Test of Functional Health Literacy in Adults (TOFHLA) to measure patients ability to read and understand health-related materials. The TOFHLA was reduced from 17 Numeracy items and 3 prose passages to 4 Numeracy items and 2 prose passages (S-TOFHLA). The maximum time for administration was reduced from 22 minutes to 12. In a group of 211 patients given the S-TOFHLA, Cronbachs alpha was 0.68 for the 4 Numeracy items and 0.97 for the 36 items in the 2 prose passages. The correlation (Spearman) between the S-TOFHLA and the Rapid Estimate of Adult Literacy in Medicine (REALM) was 0.80, although there were important disagreements between the two tests. The S-TOFHLA is a practical measure of functional health literacy with good reliability and validity that can be used by health educators to identify individuals who require special assistance to achieve learning goals.

The Prevalence of Limited Health Literacy

AbstractOBJECTIVE: To systematically review U.S. studies examining the prevalence of limited health literacy and to synthesize these findings by evaluating demographic associations in pooled analyses.n DESIGN: We searched the literature for the period 1963 through January 2004 and identified 2,132 references related to a set of specified search terms. Of the 134 articles and published abstracts retrieved, 85 met inclusion criteria, which were 1) conducted in the United States with ≥25 adults, 2) addressed a hypothesis related to health care, 3) identified a measurement instrument, and 4) presented primary data. The authors extracted data to compare studies by population, methods, and results.n MAIN RESULTS: The 85 studies reviewed include data on 31,129 subjects, and report a prevalence of low health literacy between 0% and 68%. Pooled analyses of these data reveal that the weighted prevalence of low health literacy was 26% (95% confidence interval [CI], 22% to 29%) and of marginal health literacy was 20% (95% CI, 16% to 23%). Most studies used either the Rapid Estimate of Adult Literacy in Medicine (REALM) or versions of the Test of Functional Health Literacy in Adults (TOFHLA). The prevalence of low health literacy was not associated with gender (P=.38) or measurement instrument (P=.23) but was associated with level of education (P=.02), ethnicity (P=.0003), and age (P=.004).n CONCLUSIONS: A pooled analysis of published reports on health literacy cannot provide a nationally representative prevalence estimate. This systematic review exhibits that limited health literacy, as depicted in the medical literature, is prevalent and is consistently associated with education, ethnicity, and age. It is essential to simplify health services and improve health education. Such changes have the potential to improve the health of Americans and address the health disparities that exist today.

Functional Health Literacy and the Risk of Hospital Admission Among Medicare Managed Care Enrollees

OBJECTIVESnThis study analyzed whether inadequate functional health literacy is an independent risk factor for hospital admission.nnnMETHODSnWe studied a prospective cohort of 3260 Medicare managed care enrollees.nnnRESULTSnOf the participants, 29.5% were hospitalized. The crude relative risk (RR) of hospitalization was higher for individuals with inadequate literacy (n = 800; RR = 1.43; 95% confidence interval [CI] = 1.24, 1.65) and marginal literacy (n = 366; RR = 1.33; 95% CI = 1.09, 1.61) than for those with adequate literacy (n = 2094). In multivariate analysis, the adjusted relative risk of hospital admission was 1.29 (95% CI = 1.07, 1.55) for individuals with inadequate literacy and 1.21 (95% CI = 0.97, 1.50) for those with marginal literacy.nnnCONCLUSIONSnInadequate literacy was an independent risk factor for hospital admission among elderly managed care enrollees.

Health Literacy and the Risk of Hospital Admission

OBJECTIVE: To determine the association between patient literacy and hospitalization.DESIGN: Prospective cohort study.SETTING: Urban public hospital.PATIENTS: A total of 979 emergency department patients who participated in the Literacy in Health Care study and had completed an intake interview and literacy testing with the Test of Functional Health Literacy in Adults were eligible for this study. Of these, 958 (97.8%) had an electronic medical record available for 1994 and 1995.MEASUREMENTS AND MAIN RESULTS: Hospital admissions to Grady Memorial Hospital during 1994 and 1995 were determined by the hospital information system. We used multivariate logistic regression to determine the independent association between inadequate functional health literacy and hospital admission. Patients with inadequate literacy were twice as likely as patients with adequate literacy to be hospitalized during 1994 and 1995 (31.5% vs 14.9%, p<.001). After adjusting for age, gender, race, self-reported health, socioeconomic status, and health insurance, patients with inadequate literacy were more likely to be hospitalized than patients with adequate literacy (adjusted odds ratio [OR] 1.69; 95% confidence interval [CI] 1.13, 2.53). The association between inadequate literacy and hospital admission was strongest among patients who had been hospitalized in the year before study entry (OR 3.15; 95% CI 1.45, 6.85).CONCLUSIONS: In this study population, patients with inadequate functional health literacy had an increased risk of hospital admission.

The relationship of patient reading ability to self-reported health and use of health services.

OBJECTIVESnThis study examined the relationship of functional health literacy to self-reported health and use of health services.nnnMETHODSnPatients presenting to two large, urban public hospitals in Atlanta, Ga, and Torrance, Calif, were administered a health literacy test about their overall health and use of health care services during the 3 months preceding their visit.nnnRESULTSnPatients with inadequate functional health literacy were more likely than patients with adequate literacy to report their health as poor. Number of years of school completed was less strongly associated with self-reported health. Literacy was not related to regular source of care or physician visits, but patients in Atlanta with inadequate literacy were more likely than patients with adequate literacy to report a hospitalization in the previous year.nnnCONCLUSIONSnLow literacy is strongly associated with self-reported poor health and is more closely associated with self-reported health than number of years of school completed.

Literacy and misunderstanding prescription drug labels.

Context Low literacy contributes to medical and drug nonadherence. Contribution The authors tested patients in indigent communities to see how well they understood pill bottle labels. Patients with lower literacy levels and those taking a greater number of medications were less able to understand the meaning of the labels. Even among patients who understood the labels, only a minority could correctly demonstrate how to take the pills. Cautions Patients actual drug-taking behaviors were not observed, so the authors could not demonstrate a link between misunderstanding and medication errors. Implications Lower literacy and a greater number of medications being taken were associated with patient misunderstanding of pill bottle labels. The Editors Reducing adverse events associated with medication errors in the ambulatory care setting remains an important patient safety objective for physicians and for the health care community at large (17). Although much attention has been directed to medication-related errors attributed to physician or system failure (1, 810), patient-initiated errors in medication use have received less recognition. As the focus on health care delivery continues to shift from inpatient to outpatient settings, the practice of quality control over medication use is becoming more the responsibility of the patient and less the responsibility of the provider. Yet, patients do not always take medications as prescribed, and as a result, outpatient adverse drug events are common (46). Previous studies have found that many patients are not receiving oral or written instructions from their physicians and pharmacists on how to appropriately manage prescription medications (11, 12). As a result, instructions on the prescription container label assume greater importance. The Institute of Medicine (13) estimates that 90 million adults in the United States may have trouble understanding and acting on health information. Medication container labels, in particular, may be confusing and difficult to comprehend for many patients (1418). The incidence of patient medication errors is likely to increase, because Americans are taking more prescription medications annually (19). The physician and the pharmacist may assume that their patients can read, understand, and act on brief instructions found on prescription medication labels, but this may not be the case (1113). The purpose of this study was to examine whether adult primary care patients were able to read and correctly state how they would take various medicines after reviewing label instructions on actual pill bottles. We hypothesized that low literacy would be associated with higher rates of misunderstanding and incorrect demonstration. Methods Participants Study participants were adult patients who attended 1 of 3 outpatient primary care clinics that predominantly serve indigent community populations in 3 distinct cities and states (Shreveport, Louisiana; Jackson, Michigan; and Chicago, Illinois). Participant recruitment took place in Shreveport, Louisiana, during July 2003 and at the remaining 2 sites during July 2004. In Shreveport, the primary care clinic was situated within a public hospital, whereas the clinics in Chicago and Jackson are both federally qualified health centers that provide care to medically underserved neighborhoods. Patients were considered eligible for the study if they were 18 years of age or older and were considered ineligible if the clinic nurse or study research assistant (during the course of the interview) identified a patient as having 1 or more of the following conditions: 1) severely impaired vision, 2) hearing problems, 3) illness too severe to participate, and 4) inability to speak English. The institutional review boards at all locations approved the study. All participants provided informed consent. A total of 458 patients were approached in the order they arrived at the clinics and before the medical encounter; 446 consented to participate in the study. Seventeen patients were excluded on the basis of self-reported impairments in hearing (n= 5) or vision (n= 12). Nine patients were excluded because they spoke English as a second language, and 25 additional patients were excluded on the basis of incomplete information. In all, 395 patients participated in the study. A response rate was determined following the American Association for Public Opinion Research standards (20), which estimated that 91.6% of approached eligible patients participated in the study. Structured Interview and Literacy Assessment A structured cognitive interview protocol was developed to assess patients understanding the instructions of 5 common prescription medication container labels. Interviews were conducted with 6 primary care physicians and 1 hospital pharmacist to identify common medication prescriptions for acute and chronic health conditions. Through these interviews, a consensus was reached and 5 medications were identified for the study, including 2 antibiotics (amoxicillin [for pediatric use] and trimethoprim); an expectorant (guaifenesin); an antihypertensive, channel-blocking agent (felodipine); and a diuretic (furosemide). After patients consented to participate in the study, a trained research assistant administered the structured interview that included self-report of sociodemographic information (age, sex, race and ethnicity, education, source of payment for medications, and number of prescription medications currently taken daily). Actual prescription pill bottle containers with labels were then shown in the same order to all of the patients for review. Once the patient provided his or her interpretation of all of the labels, the research assistant administered a brief literacy assessment, which concluded the interview. Understanding Medication Container Label Instructions To assess patient understanding of the instructions on each of the 5 prescription medication labels, the research assistant asked, How would you take this medicine? The patients verbatim response was then documented on a separate form. All patient responses (n= 1975) to the instructions for each of the 5 medications were then independently rated as either correct or incorrect by 3 general internal medicine attending physicians from 3 academic medical centers. Each physician-rater was blinded to all patient information and was trained to follow stringent coding guidelines previously agreed on by the research team. Specifically, correct scores were to be given only if the patients response included all aspects of the labels instruction, including dosage; timing; and if applicable, duration. Responses were given an incorrect score if they were inaccurate or if they did not contain all aspects of the instructions. Interrater reliability was high among the 3 physicians who coded the patient responses (= 0.85). The 147 responses (7.4%) that received discordant ratings among the 3 reviewers were sent to an expert panel for further review. This panel included 3 primary care physicians and 2 behavioral scientists with expertise in health literacy. Each panel member, also blinded to patient information, independently reviewed and coded the responses as correct or incorrect. For 76.2% (n= 112) of the 147 responses, a consensus ruling was achieved among the 5-member panel for a final ruling on the coding of those responses. For the remaining 35 patient responses, a majority rule was imposed and the rating by a minimum of 3 panel members was used to determine the scores. In a final review, responses that were coded as incorrect were qualitatively reviewed by 3 research assistants, who were trained by the expert panel members to code the responses according to the nature of the misunderstanding (incorrect dosage, incorrect frequency, incomplete response, navigation difficulty as defined by stating information on the container other than the primary label instruction, and no attempt because of self-reported reading difficulties). Interrater agreement was high among the research assistants (= 0.82). Attendance to Auxiliary Label Instructions We also investigated the patients attentiveness to the auxiliary or secondary warning labels on the pill bottles. These labels provide supplementary instructions, such as Take with food or Do not chew or crush, swallow whole, which support the safe administration of the medications. Research assistants were instructed to document whether patients attempted to interpret the auxiliary label along with the primary label, or whether they physically turned the bottle to inspect the color stickers on which these warning messages are placed. Patient attendance to the auxiliary label was coded as yes if his or her response or behavior was noted by the reviewer and no if the label was disregarded. Our research team has previously investigated patients understandings of these auxiliary labels (21). Understanding versus Demonstration A substudy was conducted among all patients to test whether those who could accurately read and state the instructions for guaifenesin (Take two tablets by mouth twice daily) could correctly demonstrate how many pills were to be taken daily. After patients answered the first question, How would you take this medicine? they were asked, Show me how many pills you would take [of this medicine] in one day. The medication container was filled with candy pills for patients to dispense and count out the correct amount. Responses were coded as correct if their answer was 4 and incorrect if any other response was provided. Literacy Assessment Patient literacy was assessed by using the Rapid Estimate of Adult Literacy in Medicine (REALM), a reading recognition test comprising 66 health-related words (2224). This is the most commonly used test of patient literacy in medical settings (24). Raw scores can be converted into 1 of 3 reading levels: sixth grade or less (score, 046), seventh to eighth grade (score, 4560), and nin

Low Literacy Impairs Comprehension of Prescription Drug Warning Labels

AbstractBACKGROUND: Adverse events resulting from medication error are a serious concern. Patients’ literacy and their ability to understand medication information are increasingly seen as a safety issue.n OBJECTIVE: To examine whether adult patients receiving primary care services at a public hospital clinic were able to correctly interpret commonly used prescription medication warning labels.n DESIGN: In-person structured interviews with literacy assessment.n SETTING: Public hospital, primary care clinic.n PARTICIPANTS: A total of 251 adult patients waiting for an appointment at the Louisiana State University Health Sciences Center in Shreveport (LSUHSC-S) Primary Care Clinic.n MEASUREMENTS: Correct interpretation, as determined by expert panel review of patients’ verbatim responses, for each of 8 commonly used prescription medication warning labels.n RESULTS: Approximately one-third of patients (n=74) were reading at or below the 6th-grade level (low literacy). Patient comprehension of warning labels was associated with one’s literacy level. Multistep instructions proved difficult for patients across all literacy levels. After controlling for relevant potential confounding variables, patients with low literacy were 3.4 times less likely to interpret prescription medication warning labels correctly (95% confidence interval: 2.3 to 4.9).n CONCLUSIONS: Patients with low literacy had difficulty understanding prescription medication warning labels. Patients of all literacy levels had better understanding of warning labels that contained single-step versus multiple-step instructions. Warning labels should be developed with consumer participation, especially with lower literate populations, to ensure comprehension of short, concise messages created with familiar words and recognizable icons.

Health Literacy and Use of Outpatient Physician Services by Medicare Managed Care Enrollees

AbstractOBJECTIVE: To determine whether inadequate functional health literacy adversely affects use of physician outpatient services.n DESIGN: Cohort study.n SETTING: Community.n PARTICIPANTS: New Medicare managed care enrollees age 65 or older in 4 U.S. cities (N=3,260).n MEASUREMENTS AND MAIN RESULTS: We measured functional health literacy using the Short Test of Functional Health Literacy in Adults. Administrative data were used to determine the time to first physician visit and the total number of visits during the 12 months after enrollment. The time until first visit, the proportion without any visit, and adjusted mean visits during the year after enrollment were unrelated to health literacy in crude and multivariate analyses. Participants with inadequate and marginal health literacy were more likely to have an emergency department (ED) visit than those with adequate health literacy (30.4%, 27.6%, and 21.8%, respectively; P=.01 and P<.001, respectively). In multivariate analysis, the adjusted relative risk of having 2 or more ED visits was 1.44 (95% confidence interval, 1.01 to 2.02) for enrollees with marginal health literacy and 1.34 (1.00 to 1.79) for those with inadequate health literacy compared to participants with adequate health literacy.n CONCLUSIONS: Inadequate health literacy was not independently associated with the mean number of visits or the time to a first visit. This suggests that inadequate literacy is not a major barrier to accessing outpatient health care. Nevertheless, the higher rates of ED use by persons with low literacy may be caused by real or perceived barriers to using their usual source of outpatient care.

Patients' Shame and Attitudes Toward Discussing the Results of Literacy Screening

We investigated patients willingness to have their reading ability documented in their medical records and the degree of shame and embarrassment associated with such disclosure. Structured interviews were conducted among a consecutive sample of 283 primary care patients at an urban public hospital. Patients literacy was measured using the Rapid Estimate of Adult Literacy in Medicine (REALM). Self-report of degree of shame and embarrassment related to literacy skills was measured using an orally administered questionnaire. Fifty-one percent of patients had low literacy skills (≤sixth grade) and 27.9% were assessed as having marginal literacy (seventh–eighth grade). Half (47.6%) of patients reading at or below the third-grade level admitted feeling ashamed or embarrassed about their difficulties reading, compared with 19.2% of those reading at the fourth–sixth-grade level and 6.5% of those reading at the seventh–eighth-grade level (p < 0.001). More than 90% of patients with low or marginal literacy reported it would be helpful for the doctor or nurse to know they did not understand some medical words. Patients with limited literacy were more likely to report feelings of shame as a result of disclosure (p < 0.05). Health care providers must recognize the potential shame patients might experience as a result of literacy screening.

Health Literacy: A Second Decade of Distinction for Americans

Efforts to describe health literacy in the last decade have helped us define the issue and recognize that our publics skills and abilities are not adequate for successfully navigating the growing demands and complexity of healthcare. There have been significant developments in health literacy over the last decade, with milestones of progress. Much of the work done in the 1990s focused on defining health literacy, initially measuring its prevalence and subsequently looking at its associations. Since then, health literacy has grown from an issue of an under-recognized “silent epidemic” to an issue of health policy and reform. Ideas and objectives proposed have actually been adopted in recent years, with significant policy developments. This article recognizes many achievements and milestones while developing recommendations for implementation in the decade ahead.