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In five steps you can develop a stellar evidence-based medicine program
Come up with best answer each time
Hospital pharmacists need to think like research investigators before recommending medication changes to hospital formularies or prescribing best practices. Each answer to a clinical question should be based on the strongest possible evidence, an expert says.
"Pharmacists need to get involved more with evidence-based medicine," says Patrick J. Bryant, PharmD, FSCIP, director of the drug information center and a clinical professor in the division of pharmacy practice and administration in the school of pharmacy at the University of Missouri-Kansas City. Bryant is the primary editor of a book, titled, The Pharmacist's Guide to Evidence-Based Medicine for Clinical Decision Making, which was published in paperback in 2008.
Bryant worked in the pharmaceutical industry for 15 years, and has been in academia for 12 years. It was while teaching a drug information course that he realized that this needs to be expanded and broadened for health system pharmacy practice.
The result is a five-step process for making the best decisions based on existing evidence in the literature. Here is how the process works:
1. Define the clinical question.
Unpublished data show that 85% of the time hospitals in seeking an answer to a question end up with an answer to a different question, Bryant says.
"It justifies the time you spend on finding an answer if you make sure you're asking the correct clinical question," he says. "It also assists you in staying focused as you go through this process."
The key is to clarify objectives and reconcile these with what it will be possible to discover in the literature. And it might be that the original question is abandoned and a better one is posed.
2. Retrieve pertinent information.
"Use database searching strategies and bibliography searching," Bryant advises. "In the papers you do find, look at their cited references in the back of the article and see if there are any other questions there that might relate to your question."
These could be something a pharmacist has overlooked in the initial search.
Once a pharmacist has collected a pile of studies, it'd be a good strategy to sort these according to which are randomized clinical trials, which tend to be a higher quality of evidence, Bryant says.
Sometimes, there might be little high-quality evidence, and a pharmacist will have to settle for studies lower on the strength scale, such as observational trials, followed by testimonials and case studies, he adds.
"Having an understanding of the strength of the studies will help you decide where to start," Bryant says.
3. Evaluate the literature.
"A lot of people will use a multi-item checklist for this," Bryant says. "This could have 20-40 different items related to specific questions you'd ask yourself about an article or study."
The simple questions would be as follows:
Bryant recommends using 10 major considerations when evaluating the literature.
"We boiled these down to 10 specific attributes or considerations that you should look at and use to determine whether each of those is a strength or limitation," Bryant says. "Any of these being a limitation can have a devastating effect on the results of the trial, and it's your job to determine how devastating that would be."
4. Categorize the quality of the evidence.
"Once you identify what the limitations are and whether you think these have affected the results, then you need to categorize the quality of evidence," Bryant says.
This is difficult to do, so Bryant and colleagues came up with a five-point scale, with level one being the highest level of evidence and five being the lowest.
In the top levels, pharmacists will place the well-designed randomized, controlled clinical trials. The studies rated a three or four would include observational studies, and level five would be the case studies, case theories, testimonials, and case reports.
The next step is to put together a table of evidence called the summary table of evidence that lists the name of the study, the author, and whether it was a level one through five, Bryant suggests.
"What was the outcome? Was the drug better than another agent?" he says. "The fourth column would show major limitations, which come from the 10 literature review considerations."
If the answers to the 10 considerations show all strengths, then this is a very high quality study. If there are a few limitations, it would be less so. But a study with major limitations in most or all categories would be a real problem.
"When you're looking at this table, it allows you to look at everything you have at one time," Bryant says.
5. Reach a conclusion and make a recommendation.
This is the easiest of the five steps because with all of the thinking and work put into the other four steps, a pharmacist should be able to say with confidence, "We believe, based on our research of the evidence-based medicine, that this is the conclusion."
The formulation of the recommendation is based on the quality of the evidence, logical reasoning, and clinical judgment.
"We teach our students that if they're making a population-based decision, like a formulary decision where you'll affect a lot of different patients and they don't have very much detail on any of those patients, then they'll have to make a more conservative recommendation," Bryant says. "But if this is an individual patient decision where you know a lot about that patient through his medical chart, then you can be less conservative and make a decision based on less quality of evidence."