EVALUATION OF MEDICAL LITERATURE AND JOURNAL CLUBS

Lindsay Davison, PharmD, and Jean Cunningham, PharmD, BCPS

CASE

H.G. is a pharmacy student on an internal medicine APPE rotation. At the end of the month, all students on the rotation are required to participate in the pharmacy’s journal club. H.G. remembers presenting a handful of journal clubs during pharmacy school, but he has never presented to a roomful of pharmacists before.

WHY IT’S ESSENTIAL

Discussions about journal clubs and medical literature evaluation have been known to cause rapid heart rate, increased blood pressure, and a host of other unfortunate adverse events in otherwise healthy final-year student pharmacists (please note: these data were derived from observational N of 1 studies). Alas, have no fear! This chapter is here to save you. You may wonder why medical literature evaluation and journal clubs are considered part of The Essentials. Medical literature is what creates the treatment guidelines we rely on as clinicians, and its evaluation is how we can be confident (or not so confident) in a publication’s findings. Just as you would not drive a car through an intersection with your eyes shut while the passenger concluded that the coast was clear, you should not accept the author’s conclusions of a trial without evaluating the literature. Understandably, you may now be wondering how in the world pharmacists can find the time to evaluate all of the medical literature that impacts their practice. The answer is that they do not. This is where journal clubs come in. A journal club is typically comprised of practitioners who meet to critique and discuss recently published medical literature, distributing among a number of practitioners the difficult task of keeping up. While you are on your APPE rotations, you will most likely be asked to become a part of a journal club by reviewing an article and leading the critique—a discussion of the article’s strengths, weaknesses, and potential impact on pharmacy practice.

“Though literature evaluation can be a difficult skill to master, your rotations offer the perfect environment to put your abilities to the test and build a strong foundation for the rest of your career. Use your preceptors to find and fix any areas in need of improvement and start getting into good habits.”—Preceptor

DOES THIS STUDY MATTER TO ME?

The process of designing a journal club presentation begins with identifying an appropriate article to present. The age-old question “Does this study matter to me?” is probably the most important one you can ask yourself when surveying the medical literature for an article to present on rotation. If a trial is conducted using a therapy not available to your patients or includes a patient population completely unlike the patients you treat, then reading about it will most likely be a waste of your time. The results of that trial may matter a great deal to other pharmacists but mean nothing to you.

Lesson #1: Do not waste your time. Choosing appropriate journal articles will give you more time to accomplish other tasks and also make your preceptors appreciative that you are providing them with a journal club that they are actually interested in! Interpretations of what matters to a practice site can vary, so do not hesitate to ask your preceptors for guidance when choosing an article. On occasion, a preceptor will direct you toward articles in a certain therapeutic area or within a certain class of drugs. Take this advice and run with it! Use PubMed’s medical subject headings (MeSH) terms and limits to your advantage to limit the scope of your search results to match your preceptor’s guidance (see Chapter 5 for a review of PubMed searches). Skim over the two to three articles that seem to be the best fit, and if they seem like good options, provide your preceptor with copies. Typically, your preceptor will be more than happy to review your short list of articles and tell you if one stands out as most interesting or impactful on his or her practice.

Finally, if this route is not effective, search the lay press. A general Internet search can help determine if an article you are considering sparked media attention that may have patients making inquiries to your preceptor. For example, if a trial was published in a major medical journal and the nightly news ran a story about how a commonly prescribed drug may reduce cancer risk, the story is definitely going to generate patient interest. Whenever new information is touted to the masses, it represents an opportunity to be one step ahead of the questions that will be coming up in patient encounters.

CASE QUESTION

H.G. is having trouble picking an article to present for his journal club. Where can he turn to get some ideas?

BACKGROUND AND INTRODUCTION

Now that you have chosen an article, your evaluation begins before you read a single word of the article. First, the audience at your journal club will expect you to be well versed in the current standards of care for the condition treated in the article and where the investigational agent fits in. Next, you will need to assess the journal that published the article along with its title and authors. Reviewing this information before you dive in to the trial’s methods and results will build a strong foundation of knowledge and improve your overall journal club presentation.

Study Context

Before you begin to evaluate your article in detail, you should perform an appropriate literature search to find supplemental materials for the selected article. The introduction section of your presentation, which includes the relevant background information and previous studies, should be about 15% of the total presentation time. This will allow you to put your article into context and describe relevant background data (guidelines, reviews, existing studies on similar agents, etc.). It will also be imperative to find recent publications preceding this article or that have been published since the article was released.

In addition to searching the literature to see what else has been published, make sure you are able to describe the current standard of care in detail. If your article is discussing weight loss therapies, it is expected that you know the lifestyle and drug therapies currently available (including mechanism of action [MOA], efficacy, side effects, monitoring parameters, and cost), the acceptable outcomes, and what the investigational agent may bring to the table. A great place to find this information would be in the guidelines released by relevant organizations. If you are not sure of what guidelines are available, try searching one of the various drug information databases. See Chapter 5 for a discussion on drug information sources.

QUICK TIP

Keep in mind that you will want to cite the original source of all introductory information appropriately. Do not simply cite a drug database or your class notes. Find and cite the primary article.

Finally, you should describe the rationale of the study. Answer the most important question for any presentation, “Why do we care?” Keep your audience in mind. If they are pharmacists, tell them why they should care about this study. The easiest answer is if you are evaluating a study on a new drug. Pharmacists would care because they want to know if the new drug should replace or be added to the current standard of care. You need to put the study into context first and familiarize yourself with the current standards of care, and then you will be able to determine for yourself and your audience why you should care that this study was performed.

The Journal

Although high-quality articles can be published in smaller journals (and vice versa), understanding the peer-review process and relative importance of the journal can give you an idea about the process your article has gone through before reaching you. The best journals will be peer reviewed and targeted toward a specific audience. Each journal has an impact factor that can be used as a surrogate measure for its relevance. In short, the impact factor is one quantitative measure of how often a journal’s articles are cited by others, but it does not directly reflect the quality of the articles published. Although some practitioners rely on impact factor to evaluate a journal, others feel this measure of journal exposure can be manipulated and does not reflect quality. Most pharmacy journals have an impact factor of three or less (similar to most practice-specific journals). The “big” journals (e.g., New England Journal of Medicine, Journal of the American Medical Association, and The Lancet) have impact factors above 25. A more thorough evaluation of overall journal quality would look at the diversity of the editorial board, training of the peer reviewers, and number of retracted articles. Unfortunately, this measure does not yet exist, so you are on your own to look up and evaluate this information. Most journals have this information readily available on their websites.

QUICK TIP

Peer review is not a replacement for literature evaluation. Plenty of flawed articles have been published in peer-reviewed journals. You should always perform an evaluation and come to your own conclusions.

The Title

The title of an article is its first impression. It should be unbiased and avoid misleading statements in favor of neutrality. For example, if an article is titled “Reduction in the Risk of Prostate Cancer by 10% with New Diabetes Treatment: The Results of a Randomized, Double-Blind, Placebo-Controlled Clinical Trial,” you would automatically think, without even reading another sentence, that this trial would present you with data supporting a drug that reduces the risk of prostate cancer. You are already biased by the title, alone, to think this drug is effective! A more appropriate title would be “An Evaluation of the Efficacy of a New Diabetes Treatment in Reducing the Risk of Prostate Cancer.” Now you would need to read on without bias to see whether the treatment was effective. Ideally, the article’s title should also avoid using brand names for medications.

The Authors

Next, you will want to look into the authors of the study. Specifically, find out what degrees the authors have, where they practice, and if it makes sense for them to be writing on the topic. If you see a gastroenterologist writing about autism and vaccines, it should make you wonder about the author’s expertise. Another helpful step is to search PubMed to identify the author’s other publications. This will help you clarify the author’s expertise in the topic area. It is recommended that you search at least the first three authors in PubMed. If authored by a study group, find out what else the group has worked on.

STUDY DESIGN AND METHODS

The methods section of any article concisely describes the study’s plan. The information provided in this section is the backbone on which the trial is built and usually comprises a large percentage of a journal club presentation.

Common Study Designs

Common study designs include case reports and case series, case-control studies, cohort studies, randomized control trials (RCTs), and meta analyses and systematic reviews. In this chapter, we will focus on the common study designs and provide you with a basic survival guide to noninferiority trials. See Table 4-1 for a summary of common study designs.

Case Reports and Case Series

These types of studies are typically published to document and communicate clinicians’ experiences with particular patients, to share ideas on a subject, or to describe unusual treatments or events, such as a case series or case report of a possible adverse reaction to a drug and how it was treated or resolved. Case reports tell the story of an individual patient’s experience, whereas a case series tells the story of multiple patients. These types of publications do not establish causality and are published as food for thought. Case series and case reports need to be analyzed to determine if enough information was given for the reader to re-evaluate the case. Do you know enough about the patient being reported to determine how similar or different your patients may be? These publications can be useful in determining if following the same course of action could be beneficial for your patients. They are often not good choices for a journal club because they are brief, do not provide any methodology or statistical analysis, and do not provide information that can be generalized to a larger patient population.

TABLE 4-1. COMMON STUDY DESIGNS

Case-Control Studies

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