The Drug Facts Box: Improving the Communication of Prescription Drug Information

Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label—the Food and Drug Administration\u27s (FDA) mechanism to get physicians information needed for appropriate prescribing—may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit ben

Know Your Chances: Understanding Health Statistics Book Discussion Final Report

The Know Your Chances: Understanding Health Statistics Book Discussion Project evolved from a webinar held by the National Network of Libraries of Medicine New England Region’s (NN/LM NER) on March 4, 2014. Following the webinar, Margot Malachowski, NER’s Healthy Communities COI (Community of Interest) Leader, shared a vision for a book discussion group project. In June 2014, the NN/LM NER Healthy Communities, Community of Interest (COI) invited network members to apply to participate in a health statistics book discussion project. The nine libraries and organizations selected to participate were required to: host and lead a book discussion at least once; attend planning teleconferences, and provide a brief post-project report to share their experiences. Participants were asked to select an audience for a book discussion, ideally public libraries, high school students, health professions students, caregivers, teachers, support groups or patient educators. Project participants lead book discussions that helped consumers learn how to calculate risk, put risk in perspective, and develop a healthy skepticism. Know Your Chances is a quick read and is freely available online on the PubMed Health bookshelf at: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0050876

Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick

To get a sense of how the media works in the context of a major disease promotion effort, the authors examined news coverage of restless leg syndrome

Influence of medical journal press releases on the quality of associated newspaper coverage: retrospective cohort study

Objective To determine whether the quality of press releases issued by medical journals can influence the quality of associated newspaper stories

Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review

Objective To study how composite outcomes, which have combined several components into a single measure, are defined, reported, and interpreted

Communication of survival data in US Food and Drug Administration-approved labeling of cancer drugs

This cross-sectional study examines how information on overall survival benefits of novel cancer drug indications is communicated in labeling

Disclosure of study funding and author conflicts of interest in press releases and the news: A retrospective content analysis with two cohorts

Objectives To examine how often study funding and author conflicts of interest are stated in science and health press releases and in corresponding news; and whether disclosure in press releases is associated with disclosure in news. Second, to specifically examine disclosure rates in industry-funded studies. Design Retrospective content analysis with two cohorts. Setting Press releases about health, psychology or neuroscience research from research universities and journals from 2011 (n=996) and 2015 (n=254) and their associated news stories (n=1250 and 578). Primary outcome measure Mention of study funding and author conflicts of interest. Results In our 2011 cohort, funding was reported in 94% (934/996) of journal articles, 29% (284/996) of press releases and 9% (112/1250) of news. The corresponding figures for 2015 were: 84% (214/254), 52% (131/254) and 10% (58/578). A similar pattern was seen for the industry funding subset. If the press release reported study funding, news was more likely to: 22% if in the press release versus 7% if not in the press release (2011), relative risk (RR) 3.1 (95% CI 2.1 to 4.3); for 2015, corresponding figures were 16% versus 2%, RR 6.8 (95% CI 2.2 to 17). In journal articles, 27% and 22% reported a conflict of interest, while less than 2% of press releases or news ever mentioned these. Conclusions Press releases and associated news did not frequently state funding sources or conflicts of interest. Funding information in press releases was associated with such information in news. Given converging evidence that news draws on press release content, including statements of funding and conflicts of interest in press releases may lead to increased reporting in news

Presenting quantitative information about decision outcomes: a risk communication primer for patient decision aid developers

Abstract Background Making evidence-based decisions often requires comparison of two or more options. Research-based evidence may exist which quantifies how likely the outcomes are for each option. Understanding these numeric estimates improves patients’ risk perception and leads to better informed decision making. This paper summarises current “best practices” in communication of evidence-based numeric outcomes for developers of patient decision aids (PtDAs) and other health communication tools. Method An expert consensus group of fourteen researchers from North America, Europe, and Australasia identified eleven main issues in risk communication. Two experts for each issue wrote a “state of the art” summary of best evidence, drawing on the PtDA, health, psychological, and broader scientific literature. In addition, commonly used terms were defined and a set of guiding principles and key messages derived from the results. Results The eleven key components of risk communication were: 1) Presenting the chance an event will occur; 2) Presenting changes in numeric outcomes; 3) Outcome estimates for test and screening decisions; 4) Numeric estimates in context and with evaluative labels; 5) Conveying uncertainty; 6) Visual formats; 7) Tailoring estimates; 8) Formats for understanding outcomes over time; 9) Narrative methods for conveying the chance of an event; 10) Important skills for understanding numerical estimates; and 11) Interactive web-based formats. Guiding principles from the evidence summaries advise that risk communication formats should reflect the task required of the user, should always define a relevant reference class (i.e., denominator) over time, should aim to use a consistent format throughout documents, should avoid “1 in x” formats and variable denominators, consider the magnitude of numbers used and the possibility of format bias, and should take into account the numeracy and graph literacy of the audience. Conclusion A substantial and rapidly expanding evidence base exists for risk communication. Developers of tools to facilitate evidence-based decision making should apply these principles to improve the quality of risk communication in practice.http://deepblue.lib.umich.edu/bitstream/2027.42/116070/1/12911_2013_Article_751.pd

Estimating the Impact of Adding C-Reactive Protein as a Criterion for Lipid Lowering Treatment in the United States

BACKGROUND: There is growing interest in using C-reactive protein (CRP) levels to help select patients for lipid lowering therapy—although this practice is not yet supported by evidence of benefit in a randomized trial. OBJECTIVE: To estimate the number of Americans potentially affected if a CRP criteria were adopted as an additional indication for lipid lowering therapy. To provide context, we also determined how well current lipid lowering guidelines are being implemented. METHODS: We analyzed nationally representative data to determine how many Americans age 35 and older meet current National Cholesterol Education Program (NCEP) treatment criteria (a combination of risk factors and their Framingham risk score). We then determined how many of the remaining individuals would meet criteria for treatment using 2 different CRP-based strategies: (1) narrow: treat individuals at intermediate risk (i.e., 2 or more risk factors and an estimated 10–20% risk of coronary artery disease over the next 10 years) with CRP > 3 mg/L and (2) broad: treat all individuals with CRP > 3 mg/L. DATA SOURCE: Analyses are based on the 2,778 individuals participating in the 1999–2002 National Health and Nutrition Examination Survey with complete data on cardiac risk factors, fasting lipid levels, CRP, and use of lipid lowering agents. MAIN MEASURES: The estimated number and proportion of American adults meeting NCEP criteria who take lipid-lowering drugs, and the additional number who would be eligible based on CRP testing. RESULTS: About 53 of the 153 million Americans aged 35 and older meet current NCEP criteria (that do not involve CRP) for lipid-lowering treatment. Sixty-five percent, however, are not currently being treated, even among those at highest risk (i.e., patients with established heart disease or its risk equivalent)—62% are untreated. Adopting the narrow and broad CRP strategies would make an additional 2.1 and 25.3 million Americans eligible for treatment, respectively. The latter strategy would make over half the adults age 35 and older eligible for lipid-lowering therapy, with most of the additionally eligible (57%) coming from the lowest NCEP heart risk category (i.e., 0–1 risk factors). CONCLUSION: There is substantial underuse of lipid lowering therapy for American adults at high risk for coronary disease. Rather than adopting CRP-based strategies, which would make millions more lower risk patients eligible for treatment (and for whom treatment benefit has not yet been demonstrated in a randomized trial), we should ensure the treatment of currently defined high-risk patients for whom the benefit of therapy is established