Building evidence-based medicine skills in gynecology
Deciphering the evidence, and emerging with the best management approach, requires knowing the basics of study design and interpretation as well as the intricacies of patient interaction. Here, a primer.
In thIS article
- RCTs: The good, the bad, and the ugly
- Systematic reviews: What, why, and how?
- Assessing harms
- Applying the evidence and your expertise to your patient
As a result, these studies typically lack information on subjective harms, such as impaired sexual function. The reporting of treatment harms suffers from inconsistent and imprecise terminology, making it hard to reliably gather all reports of similar adverse events. Adverse event reporting in clinical trials is often driven by regulatory definitions and requirements instead of patient-centered definitions. In fact, there has been little work to date that assesses which adverse events or complications may be most relevant or important from the patient perspective.
Taken together, it is clear that the medical literature tends to emphasize treatment benefits (with robust methodologies and data to detect these benefits) but does not reliably or adequately assess harms. For rare events, risk estimates always will be imprecise. Nonetheless, better systematic reviews and today’s larger comparative effectiveness reviews strive to gather harms data from the multiple available sources described above.
Applying the evidence and your expertise to your patient
Now that you have identified the best valid and important evidence to support or refute a clinical decision (TABLE15), and have coupled this with your own expert knowledge and judgment in shared decision making with your patient, you must communicate to her the personalized information about outcomes, probabilities, and scientific uncertainties of her available treatment options.15 Patients, in turn, should be allowed to communicate their values and the relative importance they place on benefits and harms.16 This conversation, of course, is built on the foundation of a sound physician–patient relationship and is a part of every informed consent process.
Is this evidence applicable to my patient? A decision guide.15
- Is my patient so different from those in the study that the trial results cannot be applied?
- Is the treatment feasible in my setting?
- What are my patient’s likely benefits and harms from the therapy?
- How will my patient’s values influence the final treatment decision?
Decision tools
Increasingly, decision-aid tools are being developed to support this process. These aids must express the helpful and harmful effects of a treatment, including alternative options, in statements that are valid and concise. Furthermore, they must be intelligible to both the clinician and patient and modifiable to the patient’s values and wishes.17 Two examples of counseling aids are the Gail model of breast cancer risk prediction18 and the Framingham Coronary Heart Disease Prediction Score.19 Web-based decision aids that can be accessed in real-time in busy clinical settings also are being developed for gynecology.20
Never stop re-evaluating
The final piece of EBM is to “close the loop”—meaning to evaluate the effectiveness of applying the evidence in clinical practice. To do this, watch for clinical practice guidelines that are based on systematic reviews and the EBM approach and stay abreast of ACOG’s and other professional societies’ guideline statements. Ultimately, guidelines beget performance measures. Organizations such as the National Quality Forum are working to define these standards of performance measurement and seek feedback from individual clinicians to ensure measures are meaningful and accurate. By 2017, 9% of all Medicare payments are scheduled to be performance based.21
Conclusion
During the course of reading medical literature, stay attuned to comparative effectiveness research and recognize studies with active comparators that examine clinical questions that could impact your day-to-day practice and that can be applied to your patient population. While there is no such thing as a perfect research study, and it is rare that one trial can address any one clinician’s specific patients precisely, increasingly we are seeing better systematic reviews and meta-analyses. It is these studies that provide the high quality data for you to couple with your clinical expertise and your patients’ values and preferences to truly deliver evidence-based medicine.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.