Best-practices for the design and development of prescription medication information: A systematic review.

OBJECTIVE: To present evidence supporting best-practices for prescription drug labeling and educational materials. METHODS: Articles were selected from three online databases (PubMed, Embase, CINAHL). Eligible manuscripts were: 1) English-language, 2) randomized, controlled trials, and 3) focused on improving prescription drug labeling practices. RESULTS: Forty-nine articles were reviewed, and included both regulated label materials and pharmacy or health systems-generated tools. Best-practices included use of plain language principles, typographic cues, quantitative descriptors, and standardized formats, when applicable. Common outcomes included preference and comprehension, while few studies examined actual medication use (e.g. adherence, harms) or clinical health outcomes. Approximately half of studies directly engaged patients' perspectives in intervention development, which may have helped increase tool effectiveness. CONCLUSIONS: Several best practices were apparent in the literature, particularly for written materials and pharmacy-generated container labeling. Design principles for supplemental instructions and multimedia tools were less cohesive, albeit less researched. The impact of patient involvement in tool design is promising, though requiring further study. PRACTICE IMPLICATIONS: Definitive studies to inform practice standards on how to best communicate medication information to consumers are needed, especially as communication modalities continue to evolve. Increased research on if and how to incorporate patient-centered decision-making into the development process should be considered.

The future of safety science is happening now: The modernization of the benefit-risk paradigm.

The future of safety science is happening now and has the potential to improve patient outcomes through an evolving approach to benefit-risk assessment. Three building blocks for the future of safety science, cognitive and behavioral systems, medical assessment, and data science, individually and collaboratively advance and modernize the benefit-risk paradigm. Incorporating the patient perspective and patient experiences will help identify tools that are useful in real-world practice. Medical assessment teams will bring together the study of toxicity and toxicogenomics, biomarkers, and special populations to personalize the benefit-risk profile. Personalized benefit-risk profiles for patients will help improve outcomes. Data science and related quantitative sciences such as safety statistics, database integration, technology, and epidemiology will provide new approaches and tools for analysis of safety data as well as more rapid access to insights that benefit patients.

Usability of FDA-approved medication guides.

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 (ß = -14.3, 95 % CI -18.0 - -10.6, p < 0.001; low: ß = -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.

A review of histological outcomes from peri-menopausal and post-menopausal women with a cytological report of possible high grade abnormality: an alternative management strategy for these women.

AIM: To investigate the histological outcomes of women with cytological reports of possible high grade abnormality and to determine if patient age may be a clinically significant factor in determining the presence of high grade disease for this cytological category. METHODS: Using annual quality reports supplied by the Queensland Pap Test Register, the histological outcomes for 2054 women with possible high grade cytological reports over a 4 year period were investigated to determine the clinical significance of this category in older aged women. Women in the total study group were aged between 16 and 84 years and outcomes were divided into women aged under 40 years and 40 years and over as well as those aged under 50 years and 50 years and over. Cytomorphological features were compared to determine if there were any significant differences between the outcome groups. RESULTS: The histological confirmation rate for high grade disease for all women was 53.1%. The incidence of histologically confirmed high grade disease was significantly higher in women aged under 40 years (59.7%) compared to women aged 40 years and over (40.3%) (p = 0.001). This was also true for women aged under 50 years compared to those aged 50 years and over (55.8% versus 37.5%) (p = 0.001). When the smears from these women were reviewed, a predominance of mature intermediate and superficial cells was evident in the background of the majority of slides in all histological outcome categories. Many of the smears in the negative outcome group showed reactive, reparative or inflammatory changes. CONCLUSIONS: The currently mandated Australian management guideline for women with a cytology report of possible high grade disease is referral for colposcopic and histological examination. Since the incidence of high risk human papillomavirus (HPV) decreases with age, a less invasive strategy may be to test women in these older age groups for high risk HPV before proceeding to colposcopy.