Search

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., Competing Interests: Declaration of competing interest Authors declare no known conflicts of interest., (Copyright © 2022. Published by Elsevier Inc.)

Objective: To examine trends in health insurance type among US children and their parents., Methods: Using the Medical Expenditure Panel Survey (1998-2011), we linked each child (n = 120,521; weighted n ≈ 70 million) with his or her parent or parents and assessed patterns of full-year health insurance type, stratified by income. We examined longitudinal insurance trends using joinpoint regression and further explored these trends with adjusted regression models., Results: When comparing 1998 to 2011, the percentage of low-income families with both child and parent or parents privately insured decreased from 29.2% to 19.1%, with an estimated decline of -0.86 (95% confidence interval, -1.10, -0.63) unadjusted percentage points per year; middle-income families experienced a drop from 74.5% to 66.3%, a yearly unadjusted percentage point decrease of -0.73 (95% confidence interval, -0.98, -0.48). The discordant pattern of publicly insured children with uninsured parents increased from 10.4% to 27.2% among low-income families and from 1.4% to 6.7% among middle-income families. Results from adjusted models were similar to joinpoint regression findings., Conclusions: During the past decade, low- and middle-income US families experienced a decrease in the percentage of child-parent pairs with private health insurance and pairs without insurance. Concurrently, there was a rise in discordant coverage patterns-mainly publicly insured children with uninsured parents., (Copyright © 2016 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Background: Oral contraceptives (OCs) are the most widely used contraceptive method among women of reproductive age in the United States (US). Routine download and use of health-related smartphone applications (apps) continues to increase., Objective: The purpose of this study was to evaluate the utility of English-language, smartphone-platform OC reminder apps currently available for download in the US., Methods: During June-July 2013, official Internet-based, mobile app platforms for the two major smartphone operating systems in the US-Android (Google Play Store) and iPhone (iTunes)-were searched. "Birth control," "the pill," and "contraception" were entered into the search-bar of each Smartphone store. Apps were assessed for the following: cost, health care professionals' involvement in app development, reminder mechanisms, and functionality., Results: Of the 39 unique OC reminder apps meeting inclusion criteria, 7 (18%) did not operate as intended when downloaded. Most apps functioned without an Internet connection (97%) and included pop-up notifications (84%)., Conclusions: Certain app features overcome common causes of missing an alarm, and hypothetically, may minimize likelihood of an OC user missing a daily pill. Health care providers should inform users of potential pitfalls and advise them that an OC reminder app should be not be used as a sole reminder method., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: The purpose of this study was to explore average monthly cost of commonly prescribed oral and transvaginal contraceptives, across ZIP code income groups, in Florida., Study Design: In March, 2011, the MyFloridarx.com database was searched to assess monthly prices of seven commonly prescribed contraceptives charged by Florida pharmacies., Results: With the exception of TNRG/EE 35 (χ(2)[4, N=401]=18.72, p=.00), monthly costs of contraceptives did not vary significantly across Florida ZIP code median income quintile groups., Conclusion: Overall, while there was little variability in retail pharmacy prices in Florida for seven commonly prescribed contraceptives, monthly costs of individual contraceptives varied widely., Implications: This report found little variability, across ZIP codes, in retail pharmacy prices in Florida for seven commonly prescribed contraceptives, but the monthly costs of individual contraceptives varied widely. It is paramount that clinicians consider costs when discussing contraceptive options with their patients., (© 2013.)

Background: Many American adults struggle to use and interpret medical-related instructions. Plain language materials have been shown to improve patient understanding and adherence., Objective: The study objective was to compare the effectiveness of a "standard" Patient Instructions for Use (PIFU-standard) with a "plain language" Patient Instructions for Use (PIFU-PL) by testing user comprehension and ability to administer a biologic agent with an auto-injector ("pen")., Methods: A trained research assistant administered sociodemographic items and the Rapid Estimate of Adult Literacy in Medicine to study participants (n = 50). Next, using a priori random assignment, participants received either PIFU-PL or PIFU-standard. Participants' knowledge of preparation (6 steps) and pre-injection (3 steps) procedures, and demonstrated correctness of self-administration (15 steps) were then evaluated., Results: Participants receiving the PIFU-PL were more likely to correctly describe a greater number of both preparation (4.5 ± 1.3 versus 3.1 ± 1.5, P = 0.01) and pre-injection steps (2.4 ± 0.8 versus 1.6 ± 0.6, P = 0.01), and demonstrated more correct self-injection steps (13.1 ± 2.1 versus 10.8 ± 4.4, P = 0.05) as compared to participants receiving the PIFU-standard., Conclusion: Participants given "plain language" instructions had a significantly better understanding of how to prepare for and self-administer medication with a pen and were consistently more accurate in demonstrating how to self-inject., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Both chronic kidney disease (CKD) and end-stage renal disease (ESRD) have tremendous impacts on health care expenditures. Several CKD knowledge-related instruments are available; however, most tools include content focusing on measuring pre-dialysis or dialysis options of patients with CKD and kidney transplant recipients., Objective: To develop a clinically useful, low-literacy Chronic Kidney Disease Self-Management Knowledge Tool (CKD-SMKT) with the guidance of a panel of content experts., Methods: Initially, the authors generated a list of potential items to include in the CKD-SMKT. Sixteen content experts reviewed two drafts of the CKD-SMKT and provided qualitative and quantitative assessments. The Lexile(®) Framework for Reading was used to assess reading grade level of the CKD-SMKT., Results: Eleven items were rated as "essential" (content validity ratio > 0.49, P < .05) by content experts and composed the final CKD-SMKT. The final version of the CKD-SMKT had an overall Lexile score of 470, equivalent to a ≈3rd grade reading level., Conclusion: The CKD-SMKT is a content valid instrument designed to assess kidney disease patients' knowledge of various key self-management behaviors, which upon subsequent field testing will be suitable for use in the clinic setting. Its conciseness and suitability for administration to all kidney disease patients, including those with low literacy makes it an attractive tool for the busy clinician., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Because generic medications are less expensive than brand-name medications, government and private insurers have encouraged and/or mandated the use of generics., Objective: This study aimed at evaluating perceptions about generic medications among English-speaking women of childbearing age currently enrolled in U.S. TennCare (Medicaid)., Methods: We recruited a convenience sample of patients from the waiting room of a primary care/gynecology health clinic, with 80% recruitment rate among those approached. We orally administered a 25-item questionnaire to gather sociodemographic information and to assess beliefs regarding the efficacy, safety, cost, and preferences for personal use of generic medications., Results: The average age of the women (n=172) was 28.8 ± 6.4 years, and most were white (82.0%) and currently married (58.1%). Nearly one-fifth (19.2%) had not completed high school. Most women believed that generic medications were less expensive (97.6%) and better value (60.5%) than brand-name medications, but only 45.3% preferred to take generics themselves. About a quarter (23.3%) believed that brand-name medications were more effective than generics, whereas 13.4% believed that generics caused more side effects. Few women reported that their doctor (29.7%) and/or pharmacist (35.5%) had ever talked to them about taking generics., Conclusion: Awareness of the benefits of generics did not equal preferences for personal use of generics among this sample of women enrolled in U.S. TennCare. Furthermore, women reported that providers-both physicians and pharmacists-infrequently discussed generic substitution with them., (Copyright © 2012 Elsevier Inc. All rights reserved.)

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., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Time constraints often limit the amount of instruction pharmacists can provide to patients regarding accurate prescription medication use., Objectives: To assess the content, text point size, and reading difficulty of medication container labels and auxiliary warning labels (stickers) of 2 commonly prescribed children's medications (prednisolone and amoxicillin) dispensed by 20 US pharmacies. Secondly, to examine variability of pharmacy interpretations of electronically generated physician instructions (signatures [sigs])., Methods: All medication container labels were evaluated on the following: presence and rank order of 7 Food and Drug Administration (FDA)-required label items, presence of additional label content (eg, fill date), and whether each label content item was emphasized in some way (eg, highlighting). Presence, placement, content, and color of auxiliary warning labels (stickers) were also assessed. Text point size of pharmacy name, instructions, medication name, and instructional/warning stickers was measured to the nearest centimeter. Reading grade level (RGL) of medication label instructions and auxiliary warning labels was estimated using the Lexile Analyzer (available via the Internet [http://www.lexile.com]). Amount and timing of medication administration of pharmacy interpretations of sigs were examined., Results: All containers included the 7 FDA-required label items. Text point sizes varied widely (pharmacy name [mean ± standard deviation [SD] = 12.0 ± 3.9] versus auxiliary warning labels [mean ± SD = 6.8 ± 1.1]). Four (10%) containers did not include any additional type of warnings related to the medication, beyond the dosage amount and administration frequency. Mean Lexile score of warning stickers was 488.3 ± 316.3 (approximately third to fourth RGL), whereas that of pharmacy-generated instructions was 648.3 ± 215.9 (approximately fifth to sixth RGL). Prednisolone sig instructions were presented in 14 distinct ways by the pharmacies, whereas amoxicillin sig instructions were interpreted in 16 different ways., Conclusions: Although all prescriptions reviewed met the minimum FDA-required labeling standards, pharmacy characteristics were more likely to be prominently emphasized on the labels than were medication instructions and patient information. Systematic initiatives to standardize and call attention to key medication instructions and warnings should be considered., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to develop a content valid, understandable, readable, and reliable Chronic Obstructive Pulmonary Disease knowledge Questionnaire (COPD-Q)., Methods: Twenty-one questions were generated as potential items to include in the COPD-Q. Twenty-two content experts provided both qualitative and quantitative assessments of two COPD-Q drafts. Ten patient volunteers completed a field test to assess clarity of individual COPD-Q items. An additional 24 patient volunteers completed a pilot test to determine internal consistency and test-retest reliability of the COPD-Q. The Flesch Reading Ease (FRE) was used to assess reading grade level of the COPD-Q., Results: Thirteen items were rated as "essential" (content validity ratio= p <0.05) by content experts and composed the final COPD-Q. Internal consistency, using Cronbach's alpha, was 0.72. Test-retest reliability, using intraclass correlation coefficient, was 0.90. The FRE score of the COPD-Q was 74.7 (equivalent to a 5th grade reading level)., Conclusion: The COPD-Q is a valid, readable and reliable knowledge assessment instrument for assessing COPD knowledge in patients who may have low health literacy skills., Practice Implications: Health care providers can use the COPD-Q to tailor counseling efforts according to individual patient needs, and to assess the effectiveness of their educational interventions., ((c) 2009 Elsevier Ireland Ltd. All rights reserved.)

Objectives: The aim of this study was to assess supplementary materials accompanying 2 commonly prescribed pediatric medications, including the following: 1) readability and layout characteristics of pharmacy-generated consumer medical information(CMI); and 2) types and features of oral liquid measuring devices(OLMDs) provided., Methods: We filled the same two prescriptions (prednisolone and amoxicillin) at 20 pharmacies (national grocery store chain [n = 1], regional grocery store chains [n = 4], national pharmacy chains [n = 3], national superstore chains [n = 3], and independently owned [n = 9]) across three states (Colorado,Georgia, and Tennessee). We evaluated readability, using both the Flesch-Kincaid (FK) formula and McLaughlin's Simplified Measure of Gobbledygook (SMOG), and text point size of pharmacy-generated CMI. We also assessed whether an OLMD(oral syringe, dropper, or cylindrical spoon) was included with each prescription and recorded the largest marked dose (in mL)., Results: Three pharmacies did not provide any type of CMI for either medication. Therefore, CMI was reviewed for 34 prescriptions. Reading grade levels of CMI averaged 9.6 1.9 (range, 5.3-11.7) using the FK and 11.2 2.6 (range, 6-14) based on the SMOG. Average text font size of CMI was 9.8 1.9 (range, 6-12). Although 32 (80%) prescriptions included an OLMD (oral syringe [n = 20], cylindrical spoon [n = 7], and dropper [n = 5]), close to one third (31.3%) would require multiple measurements to attain prescribed dosages., Conclusions: Many of the supplemental materials accompanying the prescriptions filled in this study were suboptimal;CMI was written at reading levels exceeding that of many parents,and the largest marked dose on each OLMD varied substantially. Physicians should be cognizant of the shortcomings of supplemental materials included with many medications, whereas pharmacies should strive to provide understandable CMI (ie, written at or below sixth-grade reading level) and suitable OLMDs (ie,requiring only one measurement of medication) to promote proper medication use.

The purposes of this study were to develop and validate the (1) Rapid Estimate of Adult Literacy in Vascular Surgery (REAL&#95;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&#95;VS (REAL&#95;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&#95;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&#95;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&#95;VS. Mean scores on the REALM (56.9 +/- 14.0) and REAL&#95;VS (63.3 +/- 15.6) were highly correlated (Spearmans rank correlation [rho] = 0.91; p < 0.00). Internal consistency of the REAL&#95;VS (Cronbachs alpha = 0.98) was excellent. Mean scores on the REAL&#95;VSs (4.1 +/- 2.7) were highly correlated with both the REALM (rho = 0.82; p < 0.00) and REAL&#95;VS (rho = 0.94; p < 0.00). Internal consistency, measured using Cronbachs alpha, of the REAL&#95;VSs was 0.86. This study demonstrates that both the REAL&#95;VS and REAL&#95;VSs are both promising tools for use in vascular surgery research and clinical practice, respectively.

Background: This study was conducted to estimate the readability and related features of English-language over-the-counter (OTC) pre-coital female contraceptive (PFC) instructions., Study Design: We identified and purchased all currently available OTC PFCs (n=8), including Encare (Contraceptive Gel and Insert), F.C. Female Condom, Ortho Options (Conceptrol, Delfen and Gyncol II Jelly), Today Sponge and VCF Vaginal Film. Reading grade level was calculated using the Simple Measure of Gobbledygook. Text point size was measured and total number of graphics was tallied. Graphic dimensions were also measured. We also assessed OTC PFC instructions on four main criteria--derived from the "User-Friendliness Tool (UFT)"--including layout features, graphic characteristics, presence of a clear message and presentation of manageable information., Results: Reading level ranged from 8th to 12th grade (mean+/-SD=10.0+/-1.2). Mean page length was 24.4+/-7.0 cm (9.6+/-2.76 in.), while average page width was 20.3+/-13.8 cm (7.99+/-5.43 in.). Average text point size was 7.9+/-2.3 (range=6-12). Illustrations, predominantly line drawings, were used throughout (range=3-11), and most were similar in size to a matchbox. None of the "How to Use" sections scored high in all criteria on the UFT., Conclusions: "How to Use" sections of OTC PFC instructions should be revised to be easier to read and more user friendly. Ideally, the gap between "typical" and "perfect" contraceptive efficacy could potentially be narrowed if instructions were developed that the large majority of women could easily understand.

We examined the association of place of residence--urban versus non-urban--with patients' perceptions regarding communication and interactions with healthcare providers. Respondents' perceptions of their healthcare providers' communication skills were assessed by responses to six items from the 2002 Medical Expenditure Panel Survey, a nationally representative survey of the civilian, non-institutionalized US population. After controlling for several covariates, respondents in urban areas reported poorer communication by their healthcare providers than non-urban respondents. Differences in perceived quality of communication could contribute to reduce use of preventive healthcare and indicates a need to improve healthcare provider-patient communication in the urban setting.

Objective: To examine readability and formatting characteristics of consumer medication information (CMI) accompanying prescription medication samples., Methods: We collected the most commonly used prescription medication samples (n=100) from four out-patient clinics at a large teaching hospital in the Southeastern US. Seventeen percent of samples were not pills/tablets and of such diverse nature (e.g., injections, drops, and creams) that there were not enough in any category to draw conclusions. Therefore, our analyses were limited to 83pill/tablet samples, belonging to 11 drug classes (e.g., cardiovascular, and psychiatric). We noted if CMI was present, and if so we assessed it for how instructions were presented, reading level, text size, format/layout, and comprehensibility., Results: No CMI was present in 39 (46.9%) samples. In 19 (22.9%), CMI was contained in a package insert and in 25 (30.2%) it was printed on the medication package. Average reading difficulty of CMI was at the 10th grade level (range=6-15) using the Fry formula, and text point size was small (mean 9.9+/-2.2 on package inserts and 9.4+/-2.6 when printed on packages)., Conclusions: Almost half of samples did not include any type of CMI. For those that had CMI, it was often written at a reading difficulty level higher than the average reading skills of American adults, and the format of most CMI was not optimal for comprehensibility. It is likely that many patients do not understand the instructions accompanying medication samples they receive from clinicians., Practice Implications: Clinicians should be cognizant of the shortcomings of CMI accompanying medication samples and thereby, distribute them to patients with caution. Manufacturers too should consider revising CMI to comply with low-literacy guidelines.

Background: We sought to describe the development and validation of the Postpartum Tubal Sterilization Knowledge Questionnaire (PTSK-Q), a survey designed to assess Medicaid recipients' understanding of the postpartum tubal sterilization process., Study Design: Initially, the investigators generated a list of 17 potential items to include in the PTSK-Q. Eleven content experts reviewed two drafts of the PTSK-Q and provided qualitative and quantitative assessments. Eight women completed a field test to determine suitability and clarity of individual PTSK-Q items, while 26 women completed a pilot test to determine internal consistency and test-retest reliability of the PTSK-Q. The Flesch Reading Ease (FRE) was used to assess reading grade level of the PTSK-Q., Results: Seven items were rated as "essential" (content validity ratio=p<.05) by content experts and composed the final PTSK-Q. Internal consistency, using Kuder Richardson-20, was 0.68. Test-retest reliability, using intraclass correlation coefficient, was 0.93. The FRE score of the PTSK-Q was 85.14 (sixth reading grade level)., Conclusions: The PTSK-Q is a valid, readable and reliable knowledge assessment instrument for assessing understanding of postpartum sterilization and Medicaid sterilization consent requirements.

Introduction: We sought to assess readability and comprehension characteristics of the Consent to Sterilization section of the Medicaid-Title XIX form (Title XIX-SCF) in order to determine if it was likely providing informed consent to the Medicaid population., Materials and Methods: The current Title XIX-SCF was evaluated using the Readability and Processability Form (RPF). The RPF, designed to assess the format of informed consent documents, assigns points to each of 20 areas of comprehension analysis according to established scoring criteria. Finally, a modified Title XIX-SCF was developed and evaluated using the RPF., Results: The overall RPF score for the current Title XIX-SCF was in the "poor" range (total=37), while the Fry reading level was at the ninth grade. The modified Title XIX-SCF scored in the "excellent" range (total=92), while the Fry reading level was at the sixth grade., Conclusions: The readability and comprehension demands of the current Title XIX-SCF exceed recommended guidelines for patient education and informed consent materials. The current Title XIX-SCF should be revised to ensure that women understand, desire and consent to permanent sterilization.