Search

Objective: The Institute for Safe Medication Practices (ISMP) and the United States Food and Drug Administration (FDA) disseminated widely used lists of drug name pairs involved in wrong-drug errors, for which they recommended tall-man lettering (TML). Linguistic similarity is believed responsible for confusion of these drugs. This study aims to quantify linguistic similarity and other linguistic properties of these generic-generic name pairs. Methods: The FDA's Phonetic and Orthographic Computer Analysis (POCA) software was used to generate numerical similarity scores for the generic-generic name pairs on these lists and to identify conflicts between these names and the names of other marketed products. Within each pair, differences in name length and the number of identical prefix (initial) letters and suffix (final) letters were determined. Results: The selected pairs shared a mean of 2.5 (± 1.8) identical prefix letters and 3.2 (± 2.9) identical suffix letters. The mean POCA score 69.5 (± 9.7), indicated moderate-to-high similarity. POCA scores for individual pairs ranged from 90 (most similar) to 46 (least similar). Individual names averaged 11.2 (± 9.1) high-similarity conflicts with names of other marketed drugs. Conclusions: POCA analysis could be a valuable tool in determining whether linguistic similarity contributes to specific wrong-drug errors. The finding of 11.2 (± 9.1) high-similarity conflicts with names of other marketed drugs is more than for candidate names USAN accepts and suggests the names on the FDA and ISMP lists are linguistically problematic. [ABSTRACT FROM AUTHOR]

Background: A medication guide (MG) is a form of FDA-approved labeling that provides patients with information about certain prescribed drugs so that patients can use these drugs safely and effectively. Given ongoing efforts by FDA and industry to continuously improve MG content and format, we hypothesized that more recently approved MGs for new molecular entities (NMEs) would be shorter and more readable compared to NME MGs approved earlier. Methods: We analyzed 53 NME MGs that were either approved in 2011 (n = 16), 2013 (n = 9), 2015 (n = 12), or 2017 (n = 16) to determine whether MG page length, word count, and readability scores differed by year. Readability was estimated by Flesch Reading Ease, Flesch–Kincaid Grade Level (FKGL), Fry graph (FRY), and Gunning's Fog Index (FOG) scores. Results: Mean page length was significantly lower in 2017 than in 2011 and 2013 (ps <.0001). Mean FKGL scores reflected sentences and words found in 8th grade textbooks, but mean FOG and FRY scores were consistent with sentences and words found in 10th and 11th grade textbooks. Conclusions: Although more recent NME MGs were shorter than older NME MGs, additional research is warranted to determine whether shorter MGs lead to improved readability. Developers choosing to estimate MG readability with equations should consider using multiple readability formulas and weigh the strengths and weaknesses of this approach. Using validated tools to more comprehensively assess MG readability should also be considered. [ABSTRACT FROM AUTHOR]

Purpose: A discussion forum was hosted by the Association for Applied Human Pharmacology (AGAH e.V.) to critically debate how to interpret and optimise the Investigator's Brochure (IB) for meaningful risk assessment of early clinical trials. Materials and Methods: Four topics were specifically discussed: deficiencies/uncertainties in IBs, guidance for the investigator, reference safety information, and potential risks for human subjects associated with inadequate non-clinical safety assessment in the IB. In each case, 43 participants took part in a real-time online survey with pre-defined questions to capture the audience's opinion. Results: The 'Summary of Data and Guidance for the Investigator' was considered as the section of the IB with the highest need for improvement with emphasis on readability, comprehensibility, timeliness of data, and appropriateness for risk assessment. It was suggested that the IB should at least be signed by the sponsor's scientist responsible for the content on pharmacology and toxicology. It was agreed that sponsors should consider thoroughly whether changes to an IB constitute a substantial amendment, and that the IB should include a section on the change history. Non-clinical pharmacology studies with negative outcomes should be reported in the IB in order to avoid assessment bias. The reference safety information for expectedness assessment of suspected serious adverse reactions should be provided as a stand-alone section of the IB. Conclusion: The overall consensus was that an optimised presentation of data will ensure the best possible understanding of a compound's characteristics and an optimal benefit-risk assessment which will safeguard the participants in clinical trials. [ABSTRACT FROM AUTHOR]

Background: Informed consent is an important aspect of ethical medical practice. In legal terms, making an intervention without informed consent may mean negligence or malpractice and may lead to legal action, maltreatment, and even attack against the doctor. This study aims to evaluate the readability of informed consent forms (ICFs) used for elective (urology and general surgery) and emergency procedures (emergency medicine and intensive care) by comparing through readability formulas. Method: Elective and emergency ICFs were accessed through the web sites of national health care associations. A total of 387 consent forms were evaluated and the same forms were included only once. A total of 35 consent forms were evaluated for emergency procedures, while a total of 55 consent forms were evaluated for elective procedures. Ateşman and Bezirci-Yılmaz formulas defined for determining the readability level of Turkish texts and Gunning fog and Flesch Kincaid formulas measuring the general readability level were used for calculating the readability level of consent forms. Results: Even though elective ICFs are more readable compared to those of emergency procedures according to Bezirci-Yılmaz formulas, this was statistically insignificant ( P =. 54 \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$P=.54$$\end{document}). The readability of elective consent forms was found to be at a significantly more difficult level to read compared to Ateşman, Gunning fog, and Flesch Kincaid formulas ( P =. 002 \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$P=.002$$\end{document} , P <. 001 \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$P <.001$$\end{document} , P <. 001 \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$P <.001$$\end{document} , respectively). Conclusion: Even though the procedure is emergency or elective, a difficult readability level may cause problems for the doctor in legal phases. Readable and understandable consent forms should be available to be able to explain morbidity and mortality and improve prognosis. Education level of our country should also be considered while preparing these consent forms. [ABSTRACT FROM AUTHOR]

Background: More patients are now taking high-risk medicines such as non–vitamin K oral anticoagulants (NOACs). Hence, patient education materials need to be in an understandable format so that they can be empowered to act on their knowledge. Factors such as health literacy and the design of the medicine information material may influence the patient's ability to understand and act on key information. Method: The PRISMA checklist was used to inform the study design. A structured search was conducted to obtain all freely accessible online educational resources designed for patients about the non–vitamin K antagonists (NOACs) during August 2018. Three search engines were used: Google, Yahoo! and Bing, using the search terms "NOAC" and "anticoagulant" combined with "patient/consumer information and patient/consumer resources."We applied the Patient Education Materials Assessment Tool (PEMAT) to evaluate web-based patient education materials in terms of understandability and actionability for patients taking NOACs. Results: Of the 35 materials included, the majority of the materials (n = 32, 91%) were rated as highly understandable (PEMAT score ≥ \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$\ge $$\end{document} 70%), and more than three-quarters of all the materials (n = 29, 83%) were rated as poorly actionable (PEMAT score <70%). For understandability, the majority of materials neither provided a summary of the key points nor used visual aids for several items such as simple tables, illustrations, and photographs. For actionability, few materials provided a tangible tool, such as a checklist, to prompt the user into action (n = 4). Few used visual aids such as nonverbal cues to the written instructions (n = 4). Conclusion: To improve the understandability and actionability of most of the NOAC patient education materials, there is a need to include more summaries of information, visual aids, and tangible tools such as checklists. Further research is warranted where patients are involved in providing feedback on the design of medicine information materials for NOACs. [ABSTRACT FROM AUTHOR]

Background: The volunteers approached for participation in a clinical trial should be given detailed and understandable information about the study through an informed consent form (ICF) before enrollment. In this study, we evaluated clinical trial files submitted to the Turkish Medicines and Medical Devices Agency (TITCK) to investigate the compliance to legal legislation and readability of ICFs as well as the factors affecting them. Methods: This is a descriptive, cross-sectional study. We evaluated 160 ICFs in the phase II-IV clinical trial files submitted to TITCK in 2016 to determine their compliance to legislation (n = 160) and to assess their readability (n = 152) using Atesman formula. Overall compliance score was calculated. ICFs were also evaluated in terms of written format (font size, line spacing, section headings) and page count. Statistical analysis was performed with chi-square, Student's t test, analysis of variance, Mann-Whitney U, and Kruskal Wallis analysis. Results: Compliance to legislation and suitability of written format of international trial ICFs were significantly higher than those of national trial ICFs. Most of the national trials were investigator initiated. Readability was low in both national and international trial ICFs where the text was longer in the latter. Conclusion: Results showed that researchers need easy-to-read ICF writing training that fits legal regulations. [ABSTRACT FROM AUTHOR]

Objective: To apply "user testing" to maximize readability and acceptability of a Clinical Trial Results Laypersons Summary--a new European requirement. Methods: "User testing" (using questionnaire and semistructured interview) assessed whether people could find and understand key points. Findings were used to improve content and design, prior to retesting. Participants had a range of levels of health literacy and there was a higher education group. Participants accessed the summary on screen. In round 1 we tested 12 points of information. In round 2 a revised summary addressing round 1 findings was tested, leading to a third final version. Results: In round 1, 2 of 12 points of information did not reach the target and interviews raised further format and content issues (some distracting technical explanations and inability to find or understand the 2 main study purposes). These findings informed revisions for the version tested in round 2, with 2 different points not reaching the target (inclusion criteria relating to duration of seasonal allergies and how researchers found out about participants' symptoms). Identified problems in both rounds were addressed and reflected in the final version. Despite improvements, participants did not consistently understand that summaries were intended for the public, or to only interpret results of single trials in the context of additional trials. All readers, including those with higher education, found the clear and straightforward language acceptable. Conclusions: Applying "user testing" resulted in a largely health-literate summary suitable for people across a range of backgrounds. [ABSTRACT FROM AUTHOR]

Background: Organizations presenting reports to independent data monitoring committees (IDMCs) should present data in a way that facilitates the ability of the IDMC to make informed judgments about the trial. Methods: This paper reviews reports to IDMCs and suggests approaches an independent statistical reporting group (ISRG) might take to prepare clear, complete, and comprehensible reports. Results: Sensible reporting by an ISRG and informed decision making by an IDMC require a productive partnership between the quantitative and clinical disciplines involved in a clinical trial. IDMC reports differ in structure and purpose from clinical study reports that summarize data at the end of a trial. The ISRG must have intellectual independence, recognizing that although the sponsor may be paying the bills, the ISRG is responsible to the IDMC. Ideally, it should have access to all data from the trial and should be capable of responding to requests from the IDMC without the sponsor's specific permission. The ISRG and sponsor must understand the differences between clean data at the end of the trial and data collected during the trial. To perform its role most effectively, the ISRG must collaborate with sponsor and IDMC clinicians to become conversant with the disease area, the product's mechanism of action, and the clinical relevance of important outcome measures. Conclusions: An IDMC is best served by an independent ISRG that will prepare clear, complete, and comprehensible reports. Given the complexities of interim data and IDMC requirements, the ISRG must be an active and informed participant in the monitoring process. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to develop a one-page (1-page) prescription drug information leaflet (PILs) and assess their impact on the information processing variables, across 2 levels of patient involvement. Methods: One-page PILs were developed using cognitive principles to lower mental effort and improve comprehension. An experimental, 3 × 2 repeated measures study was conducted to determine the impact of cognitive effort, manipulated using leaflet type on comprehension across 2 levels (high/low) of patient involvement. Adults (≥18 years) in a university setting in Houston were recruited for the study. Each participant was exposed to 3 different types of prescription drug information leaflet (the current practice, preexisting 1-page text-only, and 1-page PILs) for the 3 drugs (Celebrex, Ventolin HFA, Prezista) for a given involvement scenario. A prevalidated survey instrument was used to measure product knowledge, attitude toward leaflet, and intention to read. Results: Multivariate analysis of variance indicated significant positive effect of cognitive effort, involvement, and their interaction effect across all measured variables. Mean scores for product knowledge, attitude toward leaflet, and intention to read were highest for PILs (P < .001), indicating that PILs exerted lowest cognitive effort. Univariate and post hoc analysis indicate that product knowledge significantly increases with high involvement. Conclusion: Patients reading PILs have higher comprehension compared with the current practice and text-only prototype leaflets evaluated. Higher levels of involvement further improve participant knowledge about the drug, increase their intention to read the leaflet, and change their attitude toward the leaflet. Implementation of PILs would improve information processing for consumers by reducing their cognitive effort. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to determine how well patients could correctly recognize and comprehend the various information items in over-the-counter (OTC) medications package leaflets in Saudi Arabia. Methods: Leaflets from 20 most commonly sold OTC medications were examined by experts to evaluate the leaflet layout, language, and content. The same leaflets were also evaluated by patients who had their medicines dispensed at 2 hospitals and 8 community pharmacies in Al Kharj, Saudi Arabia. A questionnaire was used for the patients' examination. Results: A total of 479 questionnaires were included in the study. Each package leaflet was examined by at least 20 participants. The results indicate poor comprehensibility, for many items, particularly items regarding "drug interactions" and "contraindications." Conclusion: The participants had some difficulty recognizing and comprehending certain information items in the package leaflets that are supplied with OTC medications in Saudi Arabia. [ABSTRACT FROM AUTHOR]

Background: In the European Union (EU), all medicines are mandated to be provided with a patient information leaflet (PIL). Many patients express concerns about the length and complexity of some PILs, and this can be a disincentive for patients to read the PILS. In order to address this, the UK’s regulatory body (Medicine and Healthcare products Regulatory Agency [MHRA]) suggested leaflets might include a headline section—information presented prominently at the beginning of a leaflet that summarizes key safety messages about a drug. Objective: To explore the extent to which readers used a headline section in a PIL, using a form of diagnostic testing called user-testing, which examines how readers find and understand key information. Methods: The study used a cross-sectional design to user-test a PIL with a headline section in a target sample of 20 participants. Participants were provided with an exemplar PIL, and the performance of the PIL was evaluated by a questionnaire and semistructured interview. Results: The results showed that a headline section was used just over one-third of the time (39%); 90% of participants used the headline section to find information when they initially began the user-test. The qualitative findings suggested that the participants valued the presence of the headline section. Conclusion: The research suggests there does not appear to be any negative impact from including a headline section in a PIL, and it is a technique that is highly valued by the consumers of medicines information. [ABSTRACT FROM AUTHOR]