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It is obvious that maximal societal benefit from something new in anesthesiology will come if the learning curve is minimal (intuitively obvious material and quickly mastered) and or is steep (meaning that it doesnt take long to master the new knowledge no matter how complex). A maximal learning curve consists of very difficult material that takes a long time to master. It is of interest and importance to determine the characteristics (shape) of the learning curves of anesthesiology innovations, that is, to measure whether these innovations in our practice have minimal or maximal learning curves. In this issue, Joshi et al. (1) describe the learning curve associated with the new opioid, remifentanil. Because this is a relatively new opioid with unique pharmacokinetic characteristics, the authors ask a practical question, "Is there a learning curve associated with the use of remifentanil?" If one sets out to describe a learning curve, there are some essential features required to properly describe the curve. The most important is to decide what knowledge is to be learned. In the case of a new opioid in the practice of anesthesia, one would focus learning on the safety, efficacy, methods of administration, and side effects of the drug. It is vital to document how quickly the anesthesiologist can learn to safely use the drug to accomplish the therapeutic goals. Importantly, it is critical to design the study to span a time sufficiently long enough to actually measure the learning. Obviously, it is impractical to measure at the beginning and again after infinite experience, but it is crucial that the study time be sufficiently long to encompass a significant portion of the learning. Another factor in study design is to have an adequate sample size to extrapolate the results to a larger universe of clinicians. Finally, as with any study design, the fewer the confounding variables the better. For example, if one is studying the use of a new opioid, and multiple other drugs known to influence analgesia, as well as side effects of the drug, are also concurrently used, then the information about the opioid alone will be less valid. However, the modern practice of anesthesia involves the use of multiple drugs and any study that included only a single drug would be almost meaningless within the context of usual clinical practice: Thus, some confounding from other drugs is expected and desirable. The study by Joshi et al. (1) unfortunately has many limitations in describing the true nature of the remifentanil learning curve. Some relate to study design, some to data available to the investigators, and some to interpretation of the data. The first difficulty is in the selection of endpoints of learning. A number of these outcome variables chosen were for the most part controlled by the remifentanil use protocol. Thus, nothing is learned because the anesthesiologists were told exactly how and how much remifentanil to give. It is not surprising that wake-up times, remifentanil doses, and use of other drugs did not change over the study time: they were prescribed by protocol. One key outcome that was omitted was the degree of subjective pain experienced by the patients. One of the domains in which learning was demonstrated was in the use of adjuvant analgesics, and the crucial question regarding this outcome is did postoperative analgesia per se change over time in the patients. Another fundamental problem in the study is that the learning curve consisted of a data set taken from the initial 3 and final 3 patients in a series of only 10 patients in the experience of 190 clinicians. It would have been more instructive to describe the learning curve by sampling the first 3 uses and 3 subsequent uses separated in a series of perhaps 10, 25, and 100 consecutive patients. To sample multiple times over a longer experience without a strict protocol would describe the shape of the learning curve best. The investigators could only use data available to them. It is unfortunate that, to demonstrate the value of the five hours of education, half the physicians had been randomly given the full five hours of education and the other half a brief 15- to 30-minute instruction. This methodology would allow us to determine whether the intensive education led to the learning or whether the results were a product of either the drug characteristics (easy to learn to use) or the strict adherence to the protocol (learning was controlled by protocol). Despite these deficiencies, we can draw valid conclusions. First, using a strict protocol and five hours of education with a new, unique drug permits very rapid adaptation and relatively uniform clinical results. The fact that fewer total adverse events occurred in the last three patients compared to the first three probably means that some subtle learning was taking place early in the use of remifentanil. The investigators document change in the outpatient use of adjuvant analgesics and this shows that learning about postoperative analgesia was occurring. What we learn best, however, is that in future studies a better understanding of how to describe a learning curve must contain measuring the important knowledge domains of learning, sampling over a long enough time to adequately describe the curve, and ideally, sampling multiple times to accurately fit a curve. With properly designed studies, we can determine just how close to ideal the learning curve of an anesthesia innovation is, a fact that will influence its safe, effective, and timely adoption. References
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