Readability and Content Characteristics of Powdered Infant Formula Instructions in the United States.

OBJECTIVES: This study aimed to assess readability characteristics and layout features, including reading grade level, text point size, dimensions (length and width), diagrams, key directions (warnings, proper hygiene, preparation and use, and storage), and compliance to International Code provisions of English-language instructions affixed to a representative sample of brand-name and generic powdered, infant formula containers currently available for purchase in the US. METHODS: During June 2014, comprehensive Internet searches were conducted to identify brand-name powdered infant formulas currently available for purchase in the US (n = 10). The English-language instruction section affixed to each formula container was evaluated for readability characteristics and layout features, including reading grade level, text point size, dimensions (length and width), diagrams, key directions (warnings, proper hygiene, preparation and use, and storage), and compliance to International Code. RESULTS: Overall, containers were similar in circumference (50.8 ± 7.3 cm) and height (14.0 ± 0.0 cm) and held an average of 656.0 ± 12.3 g (range 629-663 g) of powdered infant formula. Both Directions for Preparation and Use and Storage Instructions sections had average reading difficulty scores at the college level. Step-by-Step Preparation Directions and Warnings and Safe Handling sections had reading difficulty between the 8th and 9th grade level. All container labels contained three diagrams depicting step-by-step preparation instructions and a feeding chart. Overall, infant formula containers reviewed in our study adhered to compliance to International Code provisions. CONCLUSIONS: As negative health outcomes are associated with inappropriately prepared infant formula feedings, healthcare providers should routinely query infant caregivers regarding their formula preparation and administration practices.

Brief screening items to identify spanish-speaking adults with limited health literacy and numeracy skills.

BACKGROUND: Limited health literacy (HL) and numeracy have been shown to be associated with a wide array of poor health-related outcomes, knowledge, and behaviors. The purpose of this study was to evaluate the clinical utility of brief HL and numeracy screening items in identifying Spanish-speaking adults' HL and numeracy skills. METHODS: We studied convenience samples of native Spanish-speaking adults in Columbus, Ohio. A trained research assistant administered sociodemographic items, HL and numeracy screening items, Short Assessment of Health Literacy (SAHL), and Newest Vital Sign (NVS) to participants in Spanish. RESULTS: Participants (n = 151) averaged 36.8 ± 11.0 years of age and 54.7% were female. Average SAHL score was 15.7 ± 2.8 (range = 4 to 18), while the average NVS score was 1.7 ± 1.5 (range = 0 to 6). "How confident are you filling out medical forms by yourself?" performed best in detecting limited NVS scores (AUROC = 0.66; 95% confidence interval [CI] = 0.57-0.75), limited/marginal NVS scores (AUROC = 0.75; 95% CI = 0.65-0.84), and inadequate SAHL scores (AUROC = 0.69; 95% CI = 0.58-0.79). CONCLUSION: A single HL screening item is useful for quickly estimating HL and numeracy skills in native Spanish-speaking adults.

Predictors of children's health insurance coverage discontinuity in 1998 versus 2009: parental coverage continuity plays a major role.

To identify predictors of coverage continuity for United States children and assess how they have changed in the first 12 years since implementation of the Children's Health Insurance Program in 1997. Using data from the nationally-representative Medical Expenditure Panel Survey, we used logistic regression to identify predictors of discontinuity in 1998 and 2009 and compared differences between the 2 years. Having parents without continuous coverage was the greatest predictor of a child's coverage gap in both 1998 and 2009. Compared to children with at least one parent continuously covered, children whose parents did not have continuous coverage had a significantly higher relative risk (RR) of a coverage gap [RR 17.96, 95 % confidence interval (CI) 14.48-22.29 in 1998; RR 12.88, 95 % CI 10.41-15.93 in 2009]. In adjusted models, parental continuous coverage was the only significant predictor of discontinuous coverage for children (with one exception in 2009). The magnitude of the pattern was higher for privately-insured children [adjusted relative risk (aRR) 29.17, 95 % CI 20.99-40.53 in 1998; aRR 25.54, 95 % CI 19.41-33.61 in 2009] than publicly-insured children (aRR 5.72, 95 % CI 4.06-8.06 in 1998; aRR 4.53, 95 % CI 3.40-6.04 in 2009). Parental coverage continuity has a major influence on children's coverage continuity; this association remained even after public health insurance expansions for children. The Affordable Care Act will increase coverage for many adults; however, 'churning' on and off programs due to income fluctuations could result in coverage discontinuities for parents. If parental coverage instability persists, these discontinuities may continue to have a negative impact on children's coverage stability as well.

Recent health insurance trends for US families: children gain while parents lose.

In the past decade, political and economic changes in the United States (US) have affected health insurance coverage for children and their parents. Most likely these policies have differentially affected coverage patterns for children (versus parents) and for low-income (versus high-income) families. We aimed to examine--qualitatively and quantitatively--the impact of changing health insurance coverage on US families. Primary data from interviews with Oregon families (2008-2010) were analyzed using an iterative process. Qualitative findings guided quantitative analyses of secondary data from the nationally-representative Medical Expenditure Panel Survey (MEPS) (1998-2009); we used Joinpoint Regression to assess average annual percent changes (AAPC) in health insurance trends, examining child and parent status and type of coverage stratified by income. Interviewees reported that although children gained coverage, parents lost coverage. MEPS analyses confirmed this trend; the percentage of children uninsured all year decreased from 9.6 % in 1998 to 6.1 % in 2009; AAPC = -3.1 % (95 % confidence interval [CI] from -5.1 to -1.0), while the percentage of parents uninsured all year rose from 13.6 % in 1998 to 17.1 % in 2009, AAPC = 2.7 % (95 % CI 1.8-3.7). Low-income families experienced the most significant changes in coverage. Between 1998 and 2009, as US children gained health insurance, their parents lost coverage. Children's health is adversely affected when parents are uninsured. Investigation beyond children's coverage rates is needed to understand how health insurance policies and changing health insurance coverage trends are impacting children's health.

Terminology matters: patient understanding of "opioids" and "narcotics".

BACKGROUND: The terms "opioid" and "narcotic" are often used interchangeably by healthcare providers. The purpose of this study was to compare understanding "narcotics" vs. "opioids." METHODS: A convenience sample of English-speaking women (n = 188), aged 21-45 years, seeking care at a primary care clinic were asked (1) "What is an opioid/narcotic?" (2) "Give an example of an opioid/narcotic?" (3) "Why does someone take an opioid/narcotic?" and (4) "What happens when someone takes an opioid/narcotic for a long time?" Responses were recorded verbatim by a research assistant and then coded independently by two investigators. RESULTS: More than half of respondents (55.9%) responded "don't know" to all 4 opioid questions, while just 3.2% responded "don't know" to all 4 narcotic questions (P < 0.01). Most women were unfamiliar with the term opioid (76.3%) and did not know why someone would take an opioid (68.8%). About two-thirds of respondents were able to give an example of a narcotic (64.2%) and knew the consequences of long-term narcotic use (63.2%). CONCLUSIONS: While more women were more familiar with narcotic, many identified negative connotations with this term. Future research should explore how to improve patient understanding and attitudes regarding both the terms opioids and narcotics.

Tennessee emergency medicine workforce, 2009.

OBJECTIVE: Describe the characteristics of the Tennessee (TN) Emergency Medicine (EM) workforce. METHODS: A cross-sectional mail survey of all non-government emergency departments (EDs) in TN was performed between January and April 2009. Data collected included: number and residency training of physicians, ED volume, employment and type of mid-level providers. Survey datawere compared to recent national EM workforce data. Subgroup analysis of rural EDs using Rural-Urban Commuting Area Code (RUCA) criteria was conducted. RESULTS: We received responses from 50 of the 100 emergency departments surveyed. Roughly half (53 percent) were rural, based on RUCA criteria. Mid-level providers worked with physicians in 31 departments, with physician assistants(PAs) being employed more commonly than nurse practitioners(NPs). Paramedics and emergency medical technicians (EMTs) were employed less frequently. Most EM residency trained physicians in Tennessee are working in EDs with approximately 39,000 annual visits per year or greater. Subspecialty physicians such as neurosurgeons, gastroenterologists and otorhinolaryngologists are generally not available to rural EDs, except by patient transfer, illustrating the marked differences in the work environments. CONCLUSION: While there is clearly a need for more emergency medicine residency training programs in Tennessee, the need to continue to provide advanced training for family medicine residency trained physicians is also clear. Family medicine doctors provide most of the rural emergency medicine in Tennessee.

Do pediatric oral suspension acetaminophen and ibuprofen product labeling and online resources facilitate intended use?

Background: Caregivers often have difficulty administering pediatric medications which frequently results in increased dosing error risk. Objective: We examined health literacy characteristics of pediatric over-the-counter (OTC) oral suspension acetaminophen and ibuprofen instructional materials and dosing instruments. Methods: We conducted a descriptive analysis of dosing instructions, measuring syringe characteristics, and internet-based resources among a sample of OTC pediatric oral suspension acetaminophen and ibuprofen products (n = 14). Results: All products included Drug Facts Panels, employed consistent abbreviation use, and stated measuring dosage with syringe provided. However, oral syringe dosing increment markings did not match box or bottle dosing charts. Most products had supplemental English-language internet-based content resources available. Conclusions: While OTC pediatric oral suspension acetaminophen and ibuprofen products labeling included key drug fact elements, there were inconsistencies between medication dosing chart labeling guidelines and oral syringe dosing increments/markings. It is vital that oral dosing syringes are clearly marked to match product dosing chart labeling s as a means of potentially reducing caregiver dosing errors.

Is health insurance enough? A usual source of care may be more important to ensure a child receives preventive health counseling.

Despite the promise of expanded health insurance coverage for children in the United States, a usual source of care (USC) may have a bigger impact on a child's receipt of preventive health counseling. We examined the effects of insurance versus USC on receipt of education and counseling regarding prevention of childhood injuries and disease. We conducted secondary analyses of 2002-2006 data from a nationally-representative sample of child participants (≤17 years) in the Medical Expenditure Panel Survey (n = 49,947). Children with both insurance and a USC had the lowest rates of missed counseling, and children with neither one had the highest rates. Children with only insurance were more likely than those with only a USC to have never received preventive health counseling from a health care provider regarding healthy eating (aRR 1.21, 95% CI 1.12-1.31); regular exercise (aRR 1.06, 95% CI 1.01-1.12), use of car safety devices (aRR 1.10, 95% CI 1.03-1.17), use of bicycle helmets (aRR 1.11, 95% CI 1.05-1.18), and risks of second hand smoke exposure (aRR 1.12, 95% CI 1.04-1.20). A USC may play an equally or more important role than insurance in improving access to health education and counseling for children. To better meet preventive counseling needs of children, a robust primary care workforce and improved delivery of care in medical homes must accompany expansions in insurance coverage.

A longitudinal descriptive assessment of US college COVID-19 dashboards.

BACKGROUND: The purposes of this study were to (1) longitudinally examine US college and university COVID-19 dashboard content and (2) explore county-level population health and COVID-19 community indicators where colleges with large undergraduate enrollments were located. METHODS: We identified 10 colleges with the largest undergraduate enrollments. Next, we located all public and private two- and four-year nonprofit colleges (n = 58) in each respective county. We assessed active COVID-19 dashboards using established criteria from We Rate COVID Dashboards in March 2021 and February 2022. RESULTS: In 2021 and 2022, two-thirds (n = 38/58) of colleges had an active COVID-19 dashboard. While most COVID-19 dashboards were easy to read, they were less likely to include updated daily infection rates and testing frequency details. CONCLUSION: Overall quality, content, and features of COVID-19 dashboards varied greatly across colleges. Future COVID-19 dashboard designs should focus on providing evidence-based information with the goal of promoting and supporting informed decision making.

Health literacy characteristics of over-the-counter rapid antigen COVID-19 test materials.

BACKGROUND: The United States Food & Drug Administration's emergency authorized use, in December 2020, of over-the-counter (OTC) rapid antigen COVID-19 tests was a pandemic control milestone. OBJECTIVE: To assess health literacy-related characteristics of OTC rapid antigen COVID-19 test materials. METHODS: Between September-December 2021, we identified eleven (n = 11) OTC rapid antigen COVID-19 tests available for purchase in the US. We assessed readability (Flesch Reading Ease and Fernández-Huerta), formatting and layout features of English- and Spanish-language step-by-step OTC rapid antigen COVID-19 test package insert instructions. Video-based step-by-step OTC rapid antigen COVID-19 test instructions were evaluated for understandability and actionability (Patient Education Materials Assessment Tool for Audiovisual Materials [PEMAT-A/V]), overall quality (Global Quality Scale [GQS]) and cultural diversity and inclusiveness. Descriptive analyses were performed using IBM® Statistical Package for the Social Sciences. RESULTS: Nine (81.8%) OTC rapid antigen COVID-19 tests included English-language (≈8th-9th reading grade level) step-by-step instructions, while 4 included Spanish-language (≈10th-12th reading grade level) instructions. On average, instructions were printed on a tabloid sized piece of paper, with text size ranging from 4 to 12 point and including nearly 20 illustrations. English-language step-by-step OTC rapid antigen COVID-19 test video-based instructions (n = 6) ranged from 1:04 to 5:41 min with PEMAT-A/V scores ranging from 80% to 100%. As indicated by GQS scores, English-language videos were of high quality (5 videos scored 5/5; 1 video scored 4/5). One COVID-19 test product manufacturing website included Spanish-language video-based instructions (time = 4:59 min; PEMAT-A/V = 100%; GQS = 5). CONCLUSIONS: OTC COVID-19 test step-by-step instructions-both package inserts and video-based-included features shown to foster patient understanding and facilitate proper use. Moving forward, greater attention needs to be placed on expanding both Spanish-language and video-based OTC COVID-19 test material availability to improve accessibility across diverse populations.

Comparing types of health insurance for children: a public option versus a private option.

BACKGROUND: Many states have expanded public health insurance programs for children, and further expansions were proposed in recent national reform initiatives; yet the expansion of public insurance plans and the inclusion of a public option in state insurance exchange programs sparked controversies and raised new questions with regard to the quality and adequacy of various insurance types. OBJECTIVES: We aimed to examine the comparative effectiveness of public versus private coverage on parental-reported children's access to health care in low-income and middle-income families. METHODS/PARTICIPANTS/MEASURES: We conducted secondary data analyses of the nationally representative Medical Expenditure Panel Survey, pooling years 2002 to 2006. We assessed univariate and multivariate associations between child's full-year insurance type and parental-reported unmet health care and preventive counseling needs among children in low-income (n=28,338) and middle-income families (n=13,160). RESULTS: Among children in families earning <200% of the federal poverty level, those with public insurance were significantly less likely to have no usual source of care compared with privately insured children (adjusted relative risk, 0.79; 95% confidence interval, 0.63-0.99). This was the only significant difference in 50 logistic regression models comparing unmet health care and preventive counseling needs among low-income and middle-income children with public versus private coverage. CONCLUSIONS: The striking similarities in reported rates of unmet needs among children with public versus private coverage in both low-income and middle-income groups suggest that a public children's insurance option may be equivalent to a private option in guaranteeing access to necessary health care services for all children.

The case for synergy between a usual source of care and health insurance coverage.

BACKGROUND: In 2010, the United States (US) passed health insurance reforms aimed at expanding coverage to the uninsured. Yet, disparities persist in access to health care services, even among the insured. OBJECTIVE: To examine the separate and combined association between having health insurance and/or a usual source of care (USC) and self-reported receipt of health care services. DESIGN/SETTING: Two-tailed, chi-square analyses and logistic regression models were used to analyze nationally representative pooled 2002-2007 data from the Medical Expenditure Panel Survey (MEPS). PARTICIPANTS: US adults (≥18 years of age) in the MEPS population who had at least one health care visit and who needed any care, tests, or treatment in the past year (n = 62,067). MAIN OUTCOME MEASURES: We assessed the likelihood of an adult reporting unmet medical needs; unmet prescription needs; a problem getting care, tests, or treatment; and delayed care based on whether each individual had health insurance, a USC, both, or neither one. KEY RESULTS: Among adults who reported a doctor visit and a need for services in the past year, having both health insurance and a USC was associated with the lowest percentage of unmet medical needs, problems and delays in getting care while having neither one was associated with the highest unmet medical needs, problems and delays in care. After adjusting for potentially confounding covariates (age, race, ethnicity, employment, geographic residence, education, household income as a percent of federal poverty level, health status, and marital status), compared with insured adults who also had a USC, insured adults without a USC were more likely to have problems getting care, tests or treatment (adjusted relative risk [aRR] 1.27; 95% confidence interval [CI] 1.18-1.37); and also had a higher likelihood of experiencing a delay in urgent care (aRR 1.12; 95% CI 1.05-1.20). CONCLUSIONS: Amidst ongoing health care reform, these findings suggest the important role that both health insurance coverage and a usual source of care may play in facilitating individuals' access to care.

Parent and child usual source of care and children's receipt of health care services.

PURPOSE In the United States, children who have a usual source of care (USC) have better access to health care than those who do not, but little is known about how parental USC affects children's access. We examined the association between child and parent USC patterns and children's access to health care services. METHODS We undertook a secondary analysis of nationally representative, cross-sectional data from children participating in the 2002-2007 Medical Expenditure Panel Survey (n = 56,302). We assessed 10 outcome measures: insurance coverage gaps, no doctor visits in the past year, less than yearly dental visits, unmet medical and prescription needs, delayed care, problems getting care, and unmet preventive counseling needs regarding healthy eating, regular exercise, car safety devices, and bicycle helmets. RESULTS Among children, 78.6% had a USC and at least 1 parent with a USC, whereas 12.4% had a USC but no parent USC. Children with a USC but no parent USC had a higher likelihood of several unmet needs, including an insurance coverage gap (adjusted risk ratio [aRR] 1.33; 95% confidence interval [CI], 1.21-1.47), an unmet medical or prescription need (aRR 1.70; 95% CI 1.09-2.65), and no yearly dental visits (aRR 1.12; 95% CI 1.06-1.18), compared with children with a USC whose parent(s) had a USC. CONCLUSIONS Among children with a USC, having no parent USC was associated with a higher likelihood of reporting unmet needs when compared with children whose parent(s) had a USC. Policy reforms should ensure access to a USC for all family members.

Insurance coverage gaps among US children with insured parents: are middle income children more likely to have longer gaps?

Millions of US children have unstable health insurance coverage. Some of these uninsured children have parents with stable coverage. We examined whether household income was associated with longer coverage gaps among US children with at least one insured parent. A secondary data analysis of the nationally-representative 2004 Medical Expenditure Panel Survey, this study uses logistic regression models to examine the association between income and children's insurance gaps. We focused on children with at least one parent insured all year (n = 6,151; estimated weighted N = 53.5 million). In multivariate models, children from families earning between 125 and 400% of the federal poverty level (FPL) had twice the odds of experiencing coverage gaps >6 months, as compared to those from high income families. Children in the poorest income groups (<125% FPL) did not have significantly greater odds of a gap >6 months. However, the odds of a gap ≤6 months were significantly greater for all income groups below 400% FPL, when compared to the highest income group. Among children with continuously insured parents, those from lower middle income families were most vulnerable to experiencing coverage gaps >6 months, as compared to those from the lowest and highest income families. These findings are likely due to middle class earnings being too high to qualify for public insurance but not high enough to afford private coverage. This study highlights the need for new US health care financing models that give everyone in the family the best chance to obtain stable coverage. It also provides valuable information to other countries with employer-sponsored insurance models or those considering privatization of insurance payment systems and how this might disproportionately impact the middle class.

Evaluation of limitation-of-medical-treatment forms used in emergency medicine residency programs in the United States.

BACKGROUND: Patients are encouraged to complete limitation-of-medical-treatment forms (LMTFs), sometimes referred to as code status forms or do-not-resuscitate forms, before admission to hospitals or other health care facilities in the United States. OBJECTIVE: The purpose of this study was to review, evaluate, and to assess the LMTFs currently used in emergency medicine residency training programs throughout the United States. METHODS: In February 2009, researchers sent letters to all allopathic and osteopathic emergency medicine residency program directors (n = 193) requesting a copy of the LMTF used in their hospital. These forms were evaluated for content, consistency, and readability. RESULTS: Sixty-five responses were received (corrected response rate = 34%); 45 LMTFs were reviewed. Nineteen LMTFs required the signature of the patient, or the patient's appointed durable power of attorney for health care. The readability ranged from 11th to 17th grade (mean ± SD = 13.16 ± 1.77), greatly exceeding the average Americans' 8(th)-grade reading level. CONCLUSIONS: Our findings demonstrate that there is no standardization across LMTFs currently used in hospitals throughout the United States, and these forms are written above the literacy level of the average American adult. Therefore, there is a need to develop and disseminate an LMTF that is both consistent and better understood by the average American adult.

Setting the stage: Surgery patients' expectations for greetings during routine office visits.

BACKGROUND: The need for surgeons to exhibit adequate communication skills is paramount to providing exemplary patient care. The manner in which patients are greeted by their surgeon sets the stage for the remainder of the clinical encounter. This study examined patients' expectations for greetings upon meeting a surgeon for the first time. MATERIALS AND METHODS: A convenience sample of 152 English-speaking patients (> or =21 y of age) attending a university-based vascular surgery clinic were recruited to participate in this study. Eligible patients were interviewed prior to their consultation using valid and reliable questionnaires to obtain data about sociodemographic characteristics and expectations for greetings upon meeting a surgeon for the first time. RESULTS: Patients' mean age was 61.4 +/- 14.6 approximately half (n = 81;54.3%) were male, and most were Caucasian (n = 148; 97.4%). Most (n = 132; 86.8%) patients wanted the surgeon to shake their hand, 113 (74.3%) wanted their first name to be used when a surgeon greets them, and 86 (56.6%) wanted a surgeon to introduce him/herself using his/her last name. Patients also desired for surgeons to be attentive/calm and make patient feel like a priority, adjust vocabulary and/or explain better, and be friendly, personable, polite, respectful, and/or courteous. CONCLUSIONS: Surgeons should shake hands, use patients' first names, and introduce themselves using their last names when greeting patients for the first time. They should also be pleasant, personable, and make the patient feel like a priority. Additionally, surgeons should be cognizant of the way in which they present information to patients and verify understanding.

Children's receipt of health care services and family health insurance patterns.

PURPOSE: Insured children in the United States have better access to health care services; less is known about how parental coverage affects children's access to care. We examined the association between parent-child health insurance coverage patterns and children's access to health care and preventive counseling services. METHODS: We conducted secondary analyses of nationally representative, cross-sectional, pooled 2002-2006 data from children (n = 43,509), aged 2 to 17 years, in households responding to the Medical Expenditure Panel Survey (MEPS). We assessed 9 outcome measures pertaining to children's unmet health care and preventive counseling needs. RESULTS: Cross-sectionally, among US children (aged 2 to 17 years) living with at least 1 parent, 73.6% were insured with insured parents, 8.0% were uninsured with uninsured parents, and the remaining 18.4% had discordant family insurance coverage patterns. In multivariable analyses, insured children with uninsured parents had higher odds of an insurance coverage gap (odds ratio [OR] = 2.45; 95% confidence interval [CI], 2.02-2.97), no usual source of care (OR = 1.31; 95% CI, 1.10-1.56), unmet health care needs (OR = 1.11; 95% CI, 1.01-1.22), and having never received at least 1 preventive counseling service (OR = 1.20; 95% CI, 1.04-1.39) when compared with insured children with insured parents. Insured children with mixed parental insurance coverage had similar vulnerabilities. CONCLUSIONS: Uninsured children had the highest rates of unmet needs overall, with fewer differences based on parental insurance status. For insured children, having uninsured parents was associated with higher odds of going without necessary services when compared with having insured parents.

Do medication samples jeopardize patient safety?

BACKGROUND: Medication samples are commonly dispensed by prescribers. Written consumer medication information (CMI) provided with sample packaging is an important source of patient information. Although one-third of Americans have health literacy deficiencies, previous studies have found that CMI is often too complex for many patients to understand. This may prevent patients from using these medications appropriately. OBJECTIVE: To evaluate readability and formatting characteristics of CMI included with nonsolid (ie, topical cream/lotion, inhalation, transdermal) drug samples. METHODS: We collected a convenience sample of nonsolid dosage sample medications (N = 55) from several different private and university-affiliated primary care and specialty physician practices at a large academic medical center in the southeastern US. We noted whether CMI was present and, if it was, we assessed it for instruction presentation, reading level, text size, format/layout, and comprehensibility. RESULTS: Most (43 of 55) products included CMI, either as a separate leaflet or directly on the packaging. Reading level of CMI leaflets ranged from the 6th- to 14th-grade level, with just 4 (16.0%) written at the recommended 6th-grade level. Text font point size was 9.48 +/- 2.14 (mean +/- SD; range 5-12). Text printed directly on sample packaging averaged 6.61 point +/- 2.62 (4-11) font size. Ninety-two percent of CMI leaflets included a combination of text and pictures; only 11.1% of CMI printed directly on the packaging used pictorial aids. CONCLUSIONS: Most CMI accompanying nonsolid medication samples is written at a reading level that exceeds that of many consumers and does not meet recommended standards for readability and comprehensibility of patient education material.

Development and validation of the Rapid Estimate of Adult Literacy in Vascular Surgery (REAL_VS).

The purposes of this study were to develop and validate the (1) Rapid Estimate of Adult Literacy in Vascular Surgery (REAL_VS) for researchers studying the impact of literacy skills as related to vascular surgery-related knowledge and outcomes and (2) short version of the REAL_VS (REAL_VSs) to allow clinicians to gauge their patients' familiarity with vascular surgery-related terms. A three-phase process was used to identify potential words for inclusion in the REAL_VS, including reviewing Internet-based patient education material content and listening to a random sample of 50 archived audiorecordings of vascular surgeon-patient encounters. The REAL_VS was composed of 75 terms (e.g., stent, gangrene, invasive, aneurysm) of varying pronunciation difficulty. One hundred fifty-two English-speaking patients (>or=18 years of age) attending a university-based vascular surgery clinic were recruited to participate in this study (mean age = 61.4 +/- 14.6 years). During face-to-face interviews, patients' sociodemographic information was collected, and patients were administered the widely used Rapid Estimate of Adult Literacy in Medicine (REALM) and REAL_VS. Mean scores on the REALM (56.9 +/- 14.0) and REAL_VS (63.3 +/- 15.6) were highly correlated (Spearmans rank correlation [rho] = 0.91; p < 0.00). Internal consistency of the REAL_VS (Cronbachs alpha = 0.98) was excellent. Mean scores on the REAL_VSs (4.1 +/- 2.7) were highly correlated with both the REALM (rho = 0.82; p < 0.00) and REAL_VS (rho = 0.94; p < 0.00). Internal consistency, measured using Cronbachs alpha, of the REAL_VSs was 0.86. This study demonstrates that both the REAL_VS and REAL_VSs are both promising tools for use in vascular surgery research and clinical practice, respectively.