Stacy Cooper Bailey

University of North Carolina at Chapel Hill, North Carolina, United States

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Publications (41)124.55 Total impact

  • Stacy Cooper Bailey · Lauren A McCormack · Michael K Paasche-Orlow ·

    Journal of Health Communication 10/2015; 20(sup2):1-3. DOI:10.1080/10810730.2015.1083637 · 1.61 Impact Factor
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    ABSTRACT: Objective: Problematic prescription drug labeling has been cited as a root cause of patient misunderstanding, medication errors, and nonadherence. Although numerous studies have recently been conducted to identify and test labeling best practices, the last systematic review on this topic was conducted a decade ago. The objective of this review was, therefore, to examine, summarize, and update best practices for conveying written prescription medication information and instructions to patients. Data sources: English-language articles published from June 2005 to June 2015 were identified in MEDLINE and CINAHL by searching the following text words: 'medication OR prescription OR drug' AND 'label OR leaflet OR brochure OR pamphlet OR medication guide OR medication insert OR drug insert OR medication information OR drug information OR instructions' AND 'patient OR consumer.' Reference mining and secondary searches were also performed. Study selection and data extraction: A total of 31 articles providing evidence on how to improve written, prescription drug labeling for patient use were selected. Two reviewers independently screened articles, rated their quality, and abstracted data. Data synthesis: Identified best practices included the use of plain language, improved formatting and organization, and more explicit instructions to improve patient comprehension. The use of icons had conflicting findings, and few studies tested whether practices improved knowledge or behaviors with patients' actual prescribed regimens. Conclusions: Future studies are needed to determine how specific modifications and improvements in drug labeling can enhance patient knowledge and behavior in actual use. Synthesizing best practices across all patient materials will create a more useful, coordinated system of prescription information.
    Annals of Pharmacotherapy 09/2015; 49(11). DOI:10.1177/1060028015602272 · 2.06 Impact Factor
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    ABSTRACT: Current adherence scales often fail to assess the full spectrum of behaviors associated with safe and appropriate drug use and may be unsuitable for patients with limited health literacy. We sought to develop and evaluate a comprehensive yet brief Measure of Drug Self-Management (MeDS) for use in research and clinical settings among diverse patient groups. Expert opinion, literature reviews, and interviews with patients and providers were utilized to create and revise potential items. Item performance testing was then conducted among 193 adult English-speaking patients with hypertension and diabetes. Factor analysis was used to inform item selection. Reliability was assessed via calculations of internal consistency. To assess construct and predictive validity, MeDS scores were compared with scores from the 8-item Morisky Medication Adherence Scale and relevant clinical measures (HbA1c, blood pressure, and low-density lipoprotein cholesterol). The MeDS demonstrated adequate internal consistency with a Cronbach's α of 0.72. The MeDS was significantly correlated with the Morisky Medication Adherence Scale (r= -0.62; P<0.001). The MeDS was also associated with clinical measures, with statistically significant correlations found between MeDS scores and low-density lipoprotein cholesterol (r= -0.27, P≤0.001) and diastolic blood pressure (r= -0.18, P=0.01). The MeDS seems to be a valid and reliable tool that can be used to assess medication self-management skills among diverse patients, including those with limited literacy skills. Future studies are needed to test the tool in actual use and explore clinical applications.
    Patient Preference and Adherence 07/2015; 9:1101-8. DOI:10.2147/PPA.S85411 · 1.68 Impact Factor
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    ABSTRACT: Objective To assess the validity of a predictive model of health literacy, and to examine the relationship between derived health literacy estimates and 30-day hospital readmissions for acute myocardial infarction (AMI). Design Retrospective cohort study. Setting and participants A National Institute of Aging (NIA) study cohort of 696 adult, English-speaking primary care patients, aged 55–74 years, was used to assess the validity of derived health literacy estimates. Claims from 7733 Medicare beneficiaries hospitalised for AMI in 2008 in North Carolina and Illinois were used to investigate the association between health literacy estimates and 30-day hospital readmissions. Measures The NIA cohort was administered 3 common health literacy assessments (Newest Vital Sign, Test of Functional Health Literacy in Adults, and Rapid Estimate of Adult Literacy in Medicine). Health literacy estimates at the census block group level were derived via a predictive model. 30-day readmissions were measured from Medicare claims data using a validated algorithm. Results Fair agreement was found between derived estimates and in-person literacy assessments (Pearson Correlation coefficients: 0.38–0.51; κ scores: 0.38–0.40). Medicare enrollees with above basic literacy according to derived health literacy estimates had an 18% lower risk of a 30-day readmission (RR=0.82, 95% CI 0.73 to 0.92) and 21% lower incidence rate of 30-day readmission (IRR=0.79, 95% CI 0.68 to 0.87) than patients with basic or below basic literacy. After adjusting for demographic and clinical characteristics, the risk of 30-day readmission was 12% lower (p=0.03), and the incidence rate 16% lower (p<0.01) for patients with above basic literacy. Conclusions Health literacy, as measured by a predictive model, was found to be a significant, independent predictor of 30-day readmissions. As a modifiable risk factor with evidence-based solutions, health literacy should be considered in readmission reduction efforts.
    BMJ Open 06/2015; 5(6):e006975-e006975. DOI:10.1136/bmjopen-2014-006975 · 2.27 Impact Factor
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    ABSTRACT: Health literacy (HL) and numeracy are measured by one of two methods: performance on objective tests or self-report of one's skills. Whether results from these methods differ in their relationship to health outcomes or use of health services is unknown. We performed a systematic review to identify and evaluate articles that measured both performance-based and self-reported HL or numeracy and examined their relationship to health outcomes or health service use. To identify studies, we started with an AHRQ-funded systematic review of HL and health outcomes. We then looked for newer studies by searching MEDLINE from 1 February 2010 to 9 December 2014. We included English language studies meeting pre-specified criteria. Two reviewers independently assessed abstracts and studies for inclusion and graded study quality. One reviewer abstracted information from included studies while a second checked content for accuracy. We identified four "fair" quality studies that met inclusion criteria for our review. Two studies measuring HL found no differences between performance-based and self-reported HL for association with self-reported outcomes (including diabetes, stroke, hypertension) or a physician-completed rheumatoid arthritis disease activity score. However, HL measures were differentially related to a patient-completed health assessment questionnaire and to a patient's ability to interpret their prescription medication name and dose from a medication bottle. Only one study measured numeracy and found no difference between performance-based and self-reported measures of numeracy and colorectal cancer (CRC) screening utilization. However, in a moderator analysis from the same study, performance-based and self-reported numeracy were differentially related to CRC screening utilization when stratified by certain patient-provider communication behaviors (e.g., the chance to always ask questions and get the support that is needed). Most studies found no difference in the relationship between results of performance-based and self-reported measures and outcomes. However, we identified few studies using multiple instruments and/or objective outcomes.
    Journal of General Internal Medicine 04/2015; 30(10). DOI:10.1007/s11606-015-3288-4 · 3.42 Impact Factor
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    ABSTRACT: Background The Northwestern University Center for Education and Research on Therapeutics (CERT), funded by the Agency for Healthcare Research and Quality, is one of seven such centers in the USA. The thematic focus of the Northwestern CERT is `Tools for Optimizing Medication Safety.¿ Ensuring drug safety is essential, as many adults struggle to take medications, with estimates indicating that only half of adults take drugs as prescribed. This report describes the methods and rationale for one innovative project within the CERT: the `Primary Care, Electronic Health Record-Based Strategy to Promote Safe and Appropriate Drug Use.¿Methods/DesignThe overall objective of this 5-year study is to evaluate a health literacy-informed, electronic health record-based strategy for promoting safe and effective prescription medication use in a primary care setting. A total of 600 English and Spanish-speaking patients with diabetes will be consecutively recruited to participate in the study. Patients will be randomized to receive either usual care or the intervention; those in the intervention arm will receive a set of print materials designed to support medication use and prompt provider counseling and medication reconciliation. Participants will be interviewed in person after their index clinic visit and again one month later. Process outcomes related to intervention delivery will be recorded. A medical chart review will be performed at 6 months. Patient outcome measures include medication understanding, adherence and clinical measures (hemoglobin A1c, blood pressure, and cholesterol; exploratory outcomes only).DiscussionThrough this study, we will be able to examine the impact of a health literacy-informed, electronic health record-based strategy on medication understanding and adherence among diabetic primary care patients. The measurement of process outcomes will help inform how the strategy might ultimately be refined and disseminated to other sites. Strategies such as these are needed to address the multifaceted challenges related to medication self-management among patients with chronic conditions.Trial NCT01669473.
    Trials 01/2015; 16(1):17. DOI:10.1186/s13063-014-0524-x · 1.73 Impact Factor
  • Christine Oramasionwu · Stacy Cooper Bailey · Terence L Johnson · Lu Mao ·
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    ABSTRACT: Abstract Prior studies that have assessed engagement within the various stages of care for persons living with HIV (PLWH) studied patients receiving care in HIV medical care facilities. These data are not representative of care received throughout the United States, as not all PLWH receive care in HIV clinics. This study evaluated engagement in outpatient care and healthcare utilization for PLWH, beyond facilities that specialize in HIV. Cross-sectional data were from the 2009-2010 National Hospital Ambulatory Medical Care Survey. Levels of care included receiving any care, receiving HIV-related care, established in care, engaged in care, and prescribed antiretroviral therapy (ARV). Factors associated with ARV prescription were determined by logistic regression. We analyzed data for ∼2.6 million outpatient clinic visits for PLWH. Of these, 90% were receiving HIV-related care, 86% were established in care, 75% were engaged in care, and 65% were prescribed ARV. In stratified analysis, the proportion of PWLH who were engaged in care varied by race/ethnicity (p<0.001) and ARV prescription varied significantly across the three age groups (p=0.004). Clinic visits within the past year did not differ for those prescribed ARV vs. not prescribed ARV [median, IQR=3.3 visits (1.8-5.6) vs. 3.6 visits (1.3-5.9); p=0.7]. Seeing a physician was associated with ARV prescription (OR=0.27, 95% CI=0.15-0.51), whereas routine engagement in care was not associated with ARV prescription (OR=0.99, 95% CI=0.96-1.03). Given that non-ARV-treated PLWH utilized outpatient care services at rates similar to ARV-treated PLWH, these routine clinic visits are missed opportunities for increasing ARV prescription in untreated patients.
    AIDS Research and Human Retroviruses 11/2014; 31(2). DOI:10.1089/aid.2014.0049 · 2.33 Impact Factor
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    Stacy Cooper Bailey · Lauren A McCormack · Steven R Rush · Michael K Paasche-Orlow ·

    Journal of Health Communication 10/2014; 19 Suppl 2(sup2):5-9. DOI:10.1080/10810730.2014.946116 · 1.61 Impact Factor
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    ABSTRACT: Patients on warfarin therapy need to achieve and maintain anticoagulation control in order to experience the benefits of treatment while minimizing bleeding risk. Low health literacy skills may hinder patients' ability to use and adhere to warfarin in a safe and effective manner. The authors conducted this study to evaluate the relationship between health literacy and anticoagulation control among patients on chronic warfarin therapy. Participants were recruited from 2 diverse anticoagulation clinics in North Carolina. Time in therapeutic range (TTR) for warfarin therapy was used as a measure of anticoagulation control. Health literacy was assessed using the short form of the Test of Functional Health Literacy in Adults (S-TOFHLA). Of the 198 study participants, 51% had limited health literacy (S-TOFHLA score of 0-90) and 33% had poor anticoagulation control (TTR <50%). Participants with limited health literacy were less likely to correctly answer warfarin-related knowledge questions. Limited health literacy was significantly associated with TTR <50% (adjusted odds ratio = 2.34, 95% CI [1.01, 5.46]). Findings indicate that limited health literacy is associated with poor anticoagulation control for patients on warfarin therapy. Lack of medication understanding may hinder the safe and effective use of this narrow therapeutic index drug.
    Journal of Health Communication 10/2014; 19 Suppl 2(sup2):19-28. DOI:10.1080/10810730.2014.934934 · 1.61 Impact Factor
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    ABSTRACT: Objective The aim of this study was to determine the frequency and nature of physician, nurse, and pharmacist verbal counseling at the time of a new prescription for an opioid-acetaminophen containing medication as recalled by patients.DesignA mixed methods approach with data from cross sectional, structured interviews was used.SettingThe settings were one academic emergency department in Chicago, IL and one outpatient pharmacy at a public hospital in Atlanta, GA.PatientsOne hundred forty-nine patients receiving a new prescription for an opioid-acetaminophen medication were enrolled.Methods Interviews assessed patient recall of counseling they received from their physician, nurse, and pharmacist upon receiving the new prescription. Their responses were unitized and assigned to categories.ResultsOne hundred forty-nine patients were enrolled; 61.1% African American and 58.4% female. Seven major categories of responses were noted; frequencies of patient recall for counseling in these categories were reported. Four categories related to the content of the counseling discussion were 1) details of administration (patient recall counseling from: physician/nurse only 44.3%, pharmacist only 5.4%, both providers 12.8%); 2) activities to avoid and side effects (36.2%, 4.7%, 8.7%); 3) medication indication (32.9%, 4%, 4%); and 4) addictive potential (9.3%, 1.3%, 0%). Three categories describe patients' recall of the interaction in broad terms: 5) being referred to print informational material accompanying the prescription (MD/RN only 7.4%, pharmacist only 20.1%, both providers 2.7%); 6) having questions solicited (0%, 11.4%, 0%); 7) having no interaction relating to medication counseling (3.4%, 32.2%, 1.3%).Conclusions Patients infrequently recall counseling from providers on topics that are important to prevent harm from opioid-acetaminophen prescriptions. Future patient-centered clinical research should target identifying optimal strategies to convey these critical messages.
    Pain Medicine 08/2014; 15(10). DOI:10.1111/pme.12499 · 2.30 Impact Factor
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    ABSTRACT: Purpose: Inadequate literacy is common among patients with diabetes and may lead to adverse outcomes. The authors reviewed the relationship between literacy and health outcomes in patients with diabetes and potential interventions to improve outcomes. Methods: We reviewed 79 articles covering 3 key domains: (1) evaluation of screening tools to identify inadequate literacy and numeracy, (2) the relationships of a range of diabetes-related health outcomes with literacy and numeracy, and (3) interventions to reduce literacy-related differences in health outcomes. Results: Several screening tools are available to assess patients' print literacy and numeracy skills, some specifically addressing diabetes. Literacy and numeracy are consistently associated with diabetes-related knowledge. Some studies suggest literacy and numeracy are associated with intermediate outcomes, including self-efficacy, communication, and self-care (including adherence), but the relationship between literacy and glycemic control is mixed. Few studies have assessed more distal health outcomes, including diabetes-related complications, health care utilization, safety, or quality of life, but available studies suggest low literacy may be associated with increased risk of complications, including hypoglycemia. Several interventions appear to be effective in improving diabetes-related outcomes regardless of literacy status, but it is unclear if these interventions can reduce literacy-related differences in outcomes. Conclusions: Low literacy is associated with less diabetes-related knowledge and may be related to other important health outcomes. Further studies are needed to better elucidate pathways by which literacy skills affect health outcomes. Promising interventions are available to improve diabetes outcomes for patients with low literacy; more research is needed to determine their effectiveness outside of research settings.
    The Diabetes Educator 06/2014; 40(5). DOI:10.1177/0145721714540220 · 1.79 Impact Factor
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    ABSTRACT: To determine whether an interactive computer program could improve patient knowledge regarding genetic screening and diagnostic concepts. In this randomized trial, women 6-26 weeks' gestation were assigned to standard care with provider-based counseling or to augmented counseling with an interactive computer program. The computer-based tool conveyed information about genetic testing options. Women were administered a 23-item test of content knowledge immediately and 2-4 weeks after exposure. Test scores were compared between groups at both points using T-tests. 150 women were randomized equally between groups. Groups were similar with regard to demographic characteristics. Women randomized to the interactive tool correctly answered a significantly greater proportion of questions than those who received standard counseling (69.4% ±14.2% vs. 46.0% ± 15.2%, p < .001) on the immediate questionnaire. One hundred and twenty-three (82%) participants participated in the follow-up test. Women randomized to the tool continued to correctly answer a significantly greater proportion of questions (60.6% ± 16% vs. 49.7% ± 18.9%, p = .001). Education, health literacy, electronic health literacy, and other discussions with providers were not associated with a differential benefit from the educational intervention. A patient-directed interactive computer program may help providers to convey relevant information about genetic screening and diagnostic concepts. This article is protected by copyright. All rights reserved.
    Prenatal Diagnosis 06/2014; 69(9). DOI:10.1002/pd.4347 · 3.27 Impact Factor
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    ABSTRACT: Improved drug labelling for chronic pill-form medications has been shown to promote patient comprehension, adherence and safety. We extended health literacy principles and included patients' perspectives to improve instructions for: (1) non-pill form, (2) short term, (3) 'as needed,' (4) tapered and (5) escalating dose medications. Participants were recruited via convenience sampling from primary care clinics in Chicago, Illinois and San Francisco, California, USA. 40 adult, English-speaking participants who reported taking at least one prescription drug in the past 12 months were enrolled in the study. Participant opinions, preferences and comprehension of standard and improved medication instructions were assessed during four iterative waves of discussion groups. Brief interviews preceding the discussion groups measured individuals' literacy skills, sociodemographic and health characteristics. On average, participants were 46 years old, took four medications and reported two chronic health conditions. Patients varied sociodemographically; 40% were men and 33% had limited literacy skills. Patients agreed on the need for simpler terminology and specificity in instructions. Discussions addressed optimal ways of presenting numeric information, indication and duration of use information to promote comprehension and safe medication use. Consensus was reached on how to improve most of the instructions. Through this patient-centred approach, we developed a set of health literacy-informed instructions for more challenging medications. Findings can inform current drug labelling initiatives and promote safe and appropriate medication use.
    BMJ Open 01/2014; 4(1):e003699. DOI:10.1136/bmjopen-2013-003699 · 2.27 Impact Factor
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    ABSTRACT: To systematically review mobile applications currently available to patients to support outpatient medication self-management. Three online stores were searched in March 2013 using nine distinct search terms. Applications were selected if they supported general outpatient medication self-management for adults; they were excluded if they focused on only one medication or condition, provided only a medication list or reference, only ordered refills, were written in a non-English language, or were for local pharmacy/hospital patients only. A multi-step review process was utilized by two independent reviewers to identify eligible applications. A standardized form was used to abstract data. User reviews were compiled from a subsample of applications and qualitatively coded to identify common criticisms. 14 893 applications were initially identified. After the multi-step review process, 424 applications were deemed eligible for inclusion by reviewers (κ=0.85). On average, applications were rated 2.8 stars (out of 5) from 107 reviews. Almost all provided medication reminders (91.0%), half enabled patients to create a medication history or log (51.5%), and 22% could email the log to a third party. Few helped patients organize their regimen (6.2%), check for drug interactions (2.8%), or identify pills (4.0%). User reviews (N=1091) from the subsample of 26 applications revealed common criticisms, including technical malfunctions, poor compatibility with certain medications, and absence of desired features. Hundreds of applications exist in the marketplace to support medication self-management. However, their quality, content, and functionality are highly variable. Research is needed to determine optimal capabilities, evaluate utility, and determine clinical benefit.
    Journal of the American Medical Informatics Association 10/2013; 21(3). DOI:10.1136/amiajnl-2013-002232 · 3.50 Impact Factor
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    ABSTRACT: To contrast barriers to colon cancer (CRC) screening and Fecal Occult Blood Test (FOBT) completion between rural and urban safety-net patients. Interviews were administered to 972 patients who were not up-to-date with screening. Rural patients were more likely to believe it was helpful to find CRC early (89.7% vs 66.1%, p < .0001), yet were less likely to have received a screening recommendation (36.4% vs. 45.8%, p = .03) or FOBT information (14.5% vs 32.3%, p < .0001) or to have completed an FOBT (22.0% vs 45.8%, p < .0001). Interventions are needed to increase screening recommendation, education and completion, particularly in rural areas.
    American journal of health behavior 05/2013; 37(3):289-98. DOI:10.5993/AJHB.37.3.1 · 1.31 Impact Factor
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    ABSTRACT: This article examines the relationship between literacy and colorectal cancer (CRC) screening knowledge, beliefs, and experiences, with a focus on fecal occult blood tests (FOBTs). Participants were 975 patients in 8 Louisiana federally qualified health centers. Participants were 50 years of age or older and not up to date with CRC screening; approximately half (52%) had low literacy (less than a 9th-grade level). Participants with low literacy were less likely than were those with adequate literacy to be aware of advertisements promoting CRC screening (58.7% vs. 76.3%, p < .0001) or to believe it was very helpful to find CRC early (74.5% vs. 91.9%, p < .0001). The majority of participants had positive beliefs about the benefits of CRC screening using FOBTs. Participants with low literacy had more perceived barriers to FOBT completion and were more likely to strongly agree or agree that FOBTs would be confusing, embarrassing, or a lot of trouble; however, none of these remained significant in multivariate analyses controlling for relevant covariates. Confidence in being able to obtain an FOBT kit was high among those with low and adequate literacy (89.8% vs. 93.1%, respectively, p = .20); yet multivariate analyses revealed a significant difference in regard to literacy (p = .04) with low-literacy participants indicating less confidence. There was no significant difference by literacy in ever receiving a physician recommendation for CRC screening (38.4% low vs. 39.0% adequate, p = .79); however, multivariate analyses revealed significant differences in FOBT completion by literacy (p = .036). Overall, findings suggest that literacy is a factor in patients' CRC knowledge, beliefs, and confidence in obtaining a FOBT.
    Journal of Health Communication 10/2012; 17 Suppl 3(Suppl. 3):252-64. DOI:10.1080/10810730.2012.713441 · 1.61 Impact Factor
  • Stacy Cooper Bailey · Lauren A McCormack · Steven R Rush · Michael K Paasche-Orlow ·
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    ABSTRACT: We are pleased to present this special issue on health literacy of the Journal of Health Communication. The journal continues to demonstrate a deep commitment to this important topic, offering a venue to exhibit leading health literacy research for the third year in a row. We hope that this special issue helps guide the overall direction of the field and serves as a springboard for lively discussion, innovative research, and practice initiatives.
    Journal of Health Communication 10/2012; 17 Suppl 3:2-6. DOI:10.1080/10810730.2012.717816 · 1.61 Impact Factor
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    ABSTRACT: Evaluate the evidence regarding the relative effectiveness of multimedia and print as modes of dissemination for patient education materials; examine whether development of these materials addressed health literacy. A structured literature review utilizing Medline, PsycInfo, and the Cumulative Index to the Nursing and Allied Health Literature (CINAHL), supplemented by reference mining. Of 738 studies screened, 30 effectively compared multimedia and print materials. Studies offered 56 opportunities for assessing the effect of medium on various outcomes (e.g., knowledge). In 30 instances (54%), no difference was noted between multimedia and print in terms of patient outcomes. Multimedia led to better outcomes vs. print in 21 (38%) comparisons vs. 5 (9%) instances for print. Regarding material development, 12 studies (40%) assessed readability and 5 (17%) involved patients in tool development. Multimedia appears to be a promising medium for patient education; however, the majority of studies found that print and multimedia performed equally well in practice. Few studies involved patients in material development, and less than half assessed the readability of materials. Future research should focus on comparing message-equivalent tools and assessing their effect on behavioral outcomes. Material development should include explicit attention to readability and patient input.
    Patient Education and Counseling 07/2012; 89(1):7-14. DOI:10.1016/j.pec.2012.06.007 · 2.20 Impact Factor
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    ABSTRACT: BACKGROUND: There is increasing concern over the risk of consumer unintentional misuse of non-prescription (a.k.a. 'over-the-counter') medications containing acetaminophen, which could lead to acute liver failure. OBJECTIVE: To determine the prevalence of potential misuse and overdose of over-the-counter medications containing acetaminophen, either alone or in combination. DESIGN: Cross-sectional, structured interviews with literacy assessment. SETTING: One academic and one community-based general internal medicine practice in Chicago, IL, and one academic general internal medicine practice and a public hospital clinic in Atlanta, GA. PATIENTS: Five hundred adults seeking primary care, ages 18-80. MEASUREMENT: Demonstration of how and when patients would take over-the-counter medications containing acetaminophen, alone or in combination with one another, over a 24-hour period. RESULTS: Overall, 23.8 % of participants demonstrated they would overdose on a single over-the-counter acetaminophen product by exceeding a dose of four grams in a 24-hour period; 5.2 % made serious errors by dosing out more than six grams. In addition, 45.6 % of adults demonstrated they would overdose by 'double-dipping' with two acetaminophen-containing products. In multivariable analyses, limited literacy (Relative Risk Ratio (RR) 1.65, 95 % Confidence Interval (CI) 1.03-2.66) and heavy acetaminophen use in the past six months (RR 1.70, 95 % CI 1.10-2.64) were independently associated with overdosing over-the-counter products. CONCLUSION: Misunderstanding of the active ingredient and proper instructions for over-the-counter medications containing acetaminophen is common. The potential for errors and adverse events associated with unintentional misuse of these products is substantial, particularly among heavy users of acetaminophen and those with limited literacy.
    Journal of General Internal Medicine 05/2012; 27(12). DOI:10.1007/s11606-012-2096-3 · 3.42 Impact Factor
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    ABSTRACT: BACKGROUND: Medication guides are required documents to be distributed to patients in order to convey serious risks associated with certain prescribed medicines. Little is known about the effectiveness of this information to adequately inform patients on safe use. OBJECTIVE: To examine the readability, suitability, and comprehensibility of medication guides, particularly for those with limited literacy. DESIGN: Assessments of suitability and readability of 185 medication guides, and a sub-study examining change in suitability and readability from 2006 to 2010 among 32 of the medication guides (Study 1); 'open book' comprehension assessment of medication guides (Study 2). SETTING: Two general internal medicine clinics in Chicago, IL. PATIENTS: Four hundred and forty-nine adults seeking primary care services, ages 18-85. MEASUREMENTS: For Study 1, the Suitability Assessment of Materials (SAM) and Lexile score for readability. For Study 2, a tailored comprehension assessment of content found in three representative medication guides. RESULTS: The 185 analyzed medication guides were on average 1923 words (SD = 1022), with a mean reading level of 10-11th grade. Only one medication guide was deemed suitable in SAM analyses. None provided summaries or reviews, or framed the context first, while very few were rated as having made the purpose evident (8 %), or limited the scope of content (22 %). For Study 2, participants' comprehension of medication guides was poor (M = 52.7 % correct responses, SD = 22.6). In multivariable analysis, low and marginal literacy were independently associated with poorer understanding (β = -14.3, 95 % CI -18.0 - -10.6, p < 0.001; low: β = -23.7, 95 % CI -28.3 - -19.0, p < 0.001). CONCLUSION: Current medication guides are of little value to patients, as they are too complex and difficult to understand especially for individuals with limited literacy. Explicit guidance is offered for improving these print materials.
    Journal of General Internal Medicine 05/2012; 27(12). DOI:10.1007/s11606-012-2068-7 · 3.42 Impact Factor

Publication Stats

430 Citations
124.55 Total Impact Points


  • 2013-2015
    • University of North Carolina at Chapel Hill
      • Division of Pharmaceutical Outcomes and Policy
      North Carolina, United States
  • 2007-2014
    • Northwestern University
      • Division of General Internal Medicine and Geriatrics
      Evanston, Illinois, United States
  • 2011
    • Vanderbilt University
      • Department of Medicine
      Nashville, MI, United States
    • Northeastern University
      Boston, Massachusetts, United States