Drug Fact Sheet Review
At the Barcelona AIDS Conference, an international network of treatment advocates met to begin laying groundwork for a treatment preparedness project for resource-poor settings. The goal of treatment preparedness is to increase awareness of the promise and realities of antiretroviral therapy in anticipation of their availability and to educate and mobilize well-informed local advocates. A preliminary stage of this project has begun to collect and evaluate existing educational materials that can be used as written, or as a model for locally produced materials. Several sources of drug fact sheets and treatment information resources are reviewed here.
Methods: An Internet search was made during the week of September 16, 2002, to identify HIV drug fact sheets and other HIV drug information resources. Information about the nucleoside analog 3TC (Epivir, lamivudine) was selected and copied into a text document. This material was evaluated for its discussion of the drug's action and of its side effects. The texts were graded on the criteria of accuracy, currency and clarity. The reading level of each resource's entire 3TC entry was assessed using the Flesch-Kincaid Reading Level utility internal to Microsoft Word. After the specific sections were evaluated, each criterion was graded and an overall score was assigned. Finally, a brief assessment of the source's additional resources was noted.
Results: Treatment information resources available on the Internet can be divided into two categories based on the mode used to address the reader, on the format used to discuss serious side effects and upon the Flesch-Kincaid reading level.
Simple Fact Sheets: Simple language fact sheets tend to address the reader directly (i.e., "You should know ..."). Simple fact sheets also tend to list the most common side effects before warning about rare potential adverse events. The reading level of simple fact sheets ranged from 7.4 to 10.0. These fact sheets are designed to be used by clients who may be learning about HIV treatment for the first time.
Treatment Information Resources: Treatment information resources tend to discuss information objectively and reference clinical trial evidence. Serious side effects are usually listed first as is typical of information presented to health care professionals. Reading levels are at the top end of the scale (11.0-12.0) These resources can be used by educated or motivated readers, or as a "wholesale" source of information that is ultimately retailed to clients through treatment educators.
Simple Fact Sheets
The tone of this material is non-judgmental and unfailingly polite: "3TC does not kill the virus or cure AIDS. It also does not prevent the transmission of HIV, so please remember to always take precautions if you are having sex (e.g., use latex condoms) or using drugs (e.g., use clean syringes)."
The producers of these fact sheets seem comfortable with a harm minimization approach to treatment education, advising, for example, not to skip a dose just because you want to have a drink. But this fact sheet takes harm reduction a little further: "3TC liquid contains sugar, you should clean your teeth regularly after taking the medication to prevent tooth decay."
Treatment Information in Asian Languages is available as text or in a PDF format as a two-page handout. The design is simple and does not rely on graphics or color. This fact sheet is rivaled by New Mexico AIDS INFOnet for its simple reading-level score but runs about a third longer and packs in more concepts with grace. Top honors.
One problem with the freshness of InfoNET fact sheets is that they are widely distributed by third parties that may not have the latest version on line. For example, the 3TC fact sheet found on AIDS.org is dated February 7, 2002, and lacks news of the approval of once-a-day dosing found on the main InfoNET site.
The fact sheets are organized by category and reference related fact sheets by number. However, the Web site itself is cluttered and it can sometimes be difficult to locate what you want. All of AIDS InfoNET's many fact sheets are translated into Spanish and can be downloaded in a format ready for the Xerox machine.
Positive Words offers an abundance of brief, easy to read articles about a wide array of HIV-related topics. If you can manage to navigate the confusing site, you can find some basic drug fact sheets that balance readability with accuracy and brevity.
The reading level is fairly high and terms such as inhibit, abdominal and gastrointestinal are not defined within the text. Certain medical terms, such as neutropenia and pancreatitis are explained. The materials were written by a pharmacist (which may explain the tone of authority) and the site is sponsored by several major pharmaceutical makers. The colorful, illustrated fact sheets are preformatted and ready to print. The drugs are pictured in color photographs and there are spaces provided to note a persons's dosage and contact phone numbers.
It was interesting to compare the 3TC entry to that for a more recently approved drug, tenofovir. The writing style and format is completely different and the obsessive warnings are mostly absent. For the newer drug, efficacy is discussed and the evidence is referenced. Despite some spelling errors, it delivers a far more useful plate of information. This is a commercial site and affects an active magazine-like design that is visually busy and sometimes overwhelming. AIDSmeds.com is a great resource for someone with time to browse everything that is offered and has a 24-hour hotline to a physician.
These fact sheets are written in a conversational style, but that does not mean they are simple to read and understand. The discussion of side effects is poorly organized, with the risk of rash mentioned first, followed by common, mild effects, then back to liver side effects, which can also be life threatening -- a fact not made clear here. The statement, "Viramune ... has been known to cause hepatitis ..." could easily cause confusion: does Viramune cause hepatitis C? For a drug with potentially far more serious toxicities than 3TC, this lack of clarity is unacceptable. GMHC says a new series of fact sheets is due out soon.
Treatment Information Resources
AIDSmap is unique in that it is scalable: the overview can expand into a review of virtually every clinical trial result ever published. Users of this site can go as deep as they like into what is known about 3TC. The site is also optimized for international treatment preparedness workers with the trade names of Indian generic versions of 3TC (Lamivir) listed along with Glaxo's. Best of the bunch.
Technical ViewFact sheets for Ph.D.s. A scholarly review of what is known about 3TC right down to the drug's molecular weight and melting point (160°-162° C). Absorb this information and write your own fact sheet.
Non-Technical ViewACTIS (thankfully) boils down all the information contained in the Technical View into a simple one-page summary.
Although this is the non-technical version, the 3TC summary is written at a relatively high reading level, with many clauses and semicolons lengthening the sentences. Side effects are clearly described without jargon, and the less serious effects are put in context of when they are likely to occur. The term enzyme is defined but not necessarily in a way that will be meaningful for understanding its role HIV replication. The discussion of side effects makes the useful point that drugs have effects on the body -- some desirable, some not. It may be that the cost of maintaining accuracy and clarity is the loss of simplicity. Overall, a great source of reliable information.
This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.