JAMA surgery
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The Fragility Index (FI) is the minimum number of participants in a randomized clinical trial (RCT) whose status would have to change from a nonevent (not experiencing the primary end point) to an event (experiencing the primary end point) required to turn a statistically significant result to a nonsignificant result. The FI measures the robustness (or fragility) of the results of an RCT and is an important aid to the clinician's interpretation of RCT results. It has now been recognized that RCTs, which provide the foundation for treatment guideline recommendations, may not be robust. ⋯ The provision of high-quality, evidence-based clinical care in surgery for optimal patient outcomes requires a foundation of robust clinical research evidence, and knowledge of the FI will assist in future surgical RCT design. We strongly recommend the routine reporting of FI scores for all future trauma and surgical RCTs to assist in appropriate and optimal decision making in the care of patients who have experienced trauma and/or need surgery. We also recommend the routine inclusion of the FI score in the development of clinical guidelines to assist the clinician in ascertaining whether guideline recommendations are robust. Surgeons should be aware to particularly exercise caution when considering a potential change in clinical practice based on RCTs with a low FI score.
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Observational Study
Association of the Use of a Mandatory Prescription Drug Monitoring Program With Prescribing Practices for Patients Undergoing Elective Surgery.
Most states have adopted the routine use of a prescription drug monitoring program (PDMP) to curb overprescribing of opioids. The American College of Surgeons promotes the use of these programs as a "guiding principle to curb the opioid epidemic." However, there is a paucity of data on the effects of the use of these programs for surgical patient populations. ⋯ A mandatory PDMP query requirement was not significantly associated with the overall rate of opioid prescribing or the mean number of pills prescribed for patients undergoing general surgical procedures. In no cases was a high-risk patient identified, leading to avoidance of an opioid prescription. A PDMP can be a useful adjunct in certain settings, but this study found that it did not have the intended effect in a population undergoing elective surgical procedures. Legislative efforts to mandate PDMP use should be targeted to populations in which benefit can be demonstrated.
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In 2014, the US Drug Enforcement Administration moved hydrocodone-containing analgesics from schedule III to the more restrictive schedule II to limit prescribing and decrease nonmedical opioid use. The association of this policy change with postoperative prescribing is not well understood. ⋯ Changing hydrocodone from schedule III to schedule II was associated with an increase in the amount of opioids filled in the initial prescription following surgery. Opioid-related policies require close follow-up to identify and address early unintended effects given the multitude of competing factors that influence health care professional prescribing behaviors.
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Randomized Controlled Trial
Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial.
Preserving functional capacity is a key element in the care continuum for patients with esophagogastric cancer. Prehabilitation, a preoperative conditioning intervention aiming to optimize physical status, has not been tested in upper gastrointestinal surgery to date. ⋯ Prehabilitation improves perioperative functional capacity in esophagogastric surgery. Keeping patients from physical and nutritional status decline could have a significant effect on the cancer care continuum.
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Breast cancer surgery, the most common cancer operation performed in nursing home residents, is viewed as a low-risk surgical intervention. However, outcomes in patients with high functional dependence and limited life expectancy are poorly understood. ⋯ For female nursing home residents who underwent breast cancer surgery, 30-day mortality and survival as well as 1-year mortality and functional decline were high. The 1-year survivors had significant functional decline. This study's findings suggest that this information should be incorporated into collaborative surgical decision-making processes.