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• W2945551317 abstract "Where Are We Now? Ryan and colleagues [10] have eloquently summarized the current dilemmas facing clinicians when choosing a single- or multiple-dose antibiotic prophylaxis strategy for orthopaedic procedures that use implants. Most notable in this debate is that large health policy organizations, such as the Centers for Diseases Control and Prevention (CDC) and the World Health Organization (WHO), have released strong recommendations against the use of postoperative antibiotic prophylaxis [1, 12]. The data supporting these guidelines primarily comes from other surgical specialties, which have substantially different implant burdens and baseline surgical site infections (SSI) risks. Even so, it is important to acknowledge that the evidence suggesting the absence of benefit from postoperative prophylaxis has been relatively consistent in meta-analyses across surgical disciplines, including orthopaedics [9, 11]. One must recognize several benefits to using only a single preoperative antibiotic dose. First, it is easy for hospitals and accreditation agencies to understand, implement, and monitor; this helps ensure standardization of processes, which is suggested to improve quality in many areas of medicine. Second, it can facilitate earlier hospital discharge for short-stay surgery patients, and mitigate any medicolegal concerns associated with not providing prophylaxis. Third, fewer doses of antibiotics results in a direct pharmacy cost savings for healthcare systems. Finally, decreased prophylaxis administration is consistent with the principles of good antibiotic stewardship, which seek minimize the emergence of antibiotic-resistant organisms and Clostridium difficile colitis, which is more common and deadly than many realize [2, 5]. Where Do We Need To Go? While the benefits of a single-dose policy are apparent, we must still question if it is correct. What if a multiple-dose prophylaxis strategy is more effective than a single preoperative dose? The simple answer: It does not matter for most patients. This public health approach becomes more defensible when considering the incidence of SSIs after clean or clean-contaminated orthopaedic surgery is typically 3%; even with a 25% risk reduction from a multiple-dose prophylaxis strategy, > 99% of treated patients would not experience a treatment benefit. As clinicians, how do we balance the dilemma that acknowledges the benefits of a single-dose policy versus the uncertainty that a small portion of our patients might benefit from a prolonged duration of antibiotic prophylaxis? The question is even more challenging in healthcare systems with punitive reimbursement policies for readmissions and SSI. Regardless, we must strive to protect each patient against a preventable SSI. As broader guidelines are developed, we must seize upon all opportunities to provide personalized recommendations to each individual patient whenever possible. While we often lack the necessary data to provide individualized recommendations with confidence, individual treatment decisions are the basis of good medical practice, and so should also be our goal during research and policy development. How Do We Get There? A large, multicenter randomized clinical trial (RCT) tends to be our default reaction whenever high-quality evidence is necessary; however, traditional RCT designs are unlikely to solve our current knowledge gap. The limitations of a traditional RCT to help determine which patients will benefit from multiple perioperative antibiotic prophylaxis doses are highlighted by the challenges of obtaining adequate power to detect relatively small effect sizes with a low baseline SSI risk. Similarly, traditional RCT designs and analyses are inefficient for performing subgroup analyses that capture the complex interplay of multiple differing variables among patients. Finally, even if one were to create a large enough trial to provide adequate power for the primary and subgroup effects, other important questions such as, “How many postoperative doses should be used?” or “Which antibiotics or doses should we use?” will remain unanswered. Given that these decisions are unlikely to be answered in a definitive trial, it becomes apparent that other large observational designs should be considered. While observational data is often fraught with selection bias and unidentifiable confounding, this is not necessarily true for all research questions. Propensity score methods have made substantial advances for causal inferences from observational data [3]. These techniques attempt to account for the decisions, or propensity, to receive the study treatment [3]. If the factors determining the treatment decision are known and measured, then appropriate statistical adjustments can be made to compare the efficacy of the single- and multiple-dose strategies. This study design is best suited for the existing registries in joint arthroplasty in which the current data collection might provide the necessary information. Once we obtain more robust data on the effectiveness of differing prophylaxis strategies, further efforts to explore heterogeneity of treatment effects will be needed. This has traditionally been done with one-variable-at-a-time subgroup analyses. While testing for differential treatment efficacy of the multiple-dose approach based on the type of surgery or presence of comorbidity sounds appropriate, this conventional subgroup method does not capture the interplay of multiple relevant variables that describe a single patient. Kent and colleagues [4] recently outlined the limitations of these traditional approaches and the authors present alternative predictive modeling approaches that could allow clinicians to move closer to using population data to derive better individual patient estimates. Essentially, risk calculators incorporating several patient characteristics could be developed to guide our prophylaxis decisions at the individual level. Finally, if larger clinical trials are to be performed, there are several innovative trial designs that could improve the likelihood of completing a study capable of answering many of our prophylaxis questions. For example, Bayesian adaptive trial [6] designs could be used to implement a trial that would start with more than one type of antibiotic or multiple different durations of perioperative dosing. As the trial progresses, the probability of each treatment arm being the ideal dosing strategy is updated and stopping rules for individual arms are established so that the study design removes treatment arms as it goes along when those treatments prove unlikely to demonstrate clinical benefit—shifting future study participants into the remaining study arms that still show clinical promise [7]. Alternatively, a cluster-crossover randomized trial is a novel pragmatic clinical trial design that can improve patient recruitment and minimize recruitment bias. Unlike a traditional cluster trial in which a hospital will be randomized to use one specific antibiotic prophylaxis strategy for all of its eligible patients, the cluster-crossover design ensures that each participating hospital will eventually crossover and deliver the other study treatment(s) in order to act as an internal control to balance unmeasured confounders at the cluster-level [8]. Our group is currently using this study design to compare the efficacy of common preoperative iodophor and chlorhexidine antiseptic skin solutions in more than 10,000 fracture patients (NCT# 03385304 and 03523962). For many clinicians and hospital policymakers, the decision to use a single-dose of perioperative antibiotic prophylaxis will be simple—just follow the latest guidelines or new hospital policy. For the clear majority of our patients, this is likely the correct decision; however, the discerning surgeon must also recognize that a one-size-fits-all approach will always have limitations. Ryan and colleagues [10] have provided the readers with a synthesis of the best-available evidence for our patients, and yet uncertainty surrounding a simple prophylactic decision persists. The final responsibility will always remain with each clinician to consider the best evidence, the current guidelines, and the individual patient’s risk for each procedure in order to avoid preventable SSIs." @default.
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• W2945551317 title "CORR Insights®: Is There a Difference in Infection Risk Between Single and Multiple Doses of Prophylactic Antibiotics? A Meta-analysis" @default.
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