Objective: We aimed to study the contributing factors and costs of malpractice claims involving the surgical management of benign biliary disease given the emotional, physical, and financial toll of these claims on patients, providers, and the healthcare system. Summary Background Data: Cholecystectomy complications carry significant morbidity and rank among the leading sources of surgical malpractice claims. Methods: Using the CRICO Strategies’ Comparative Benchmarking System database, representing approximately 30% of all paid and unpaid malpractice claims in the United States, 4081 closed claims filed against general surgeons from 1995 to 2015 were reviewed to isolate 745 cholecystectomy-related claims. A multivariable model was used to determine factors associated with claim outcome. Results: The most common associated complications included bile duct injury (n = 397), bowel perforation (n = 96), and hemorrhage (n = 78). Bile duct injuries were recognized intraoperatively only 19% of the time and required biliary reconstruction surgery 77% of the time. The total cost for all claims over the study period was over $128 M and the median time from event to case close was over 3 years. 40% of claims resulted in patient payout; of these, most claims were settled out of court and the median cost per claim was $264,650. For the 60% of claims not resulting in patient payout, most cases were denied, dropped, or dismissed, yet still averaged over $15,000 per claim in legal and administrative fees. On multivariable analysis, bile duct injury, bowel perforation, and high clinical severity were associated with patient payout, while a resident or fellow being named in a claim was negatively associated with patient payout ( P < 0.05). Conclusion: Cholecystectomy-related claims are costly and time-consuming. Strategies that reduce the risk and aid in recognition of cholecystectomy complications, as well as advance support of patients and families after poor outcomes, may improve clinical care and reduce claim burden.
Patients with pancreatic and periampullary cancers may experience significant reduction in their quality of life and often rely on family and unpaid caregivers for assistance after surgery. However, as caregivers are not systematically identified, little is known about the nature, difficulty, and personal demands of assistance they provide. We aim to assess the frequency and difficulty of specific assistance caregivers provide and identify potential interventions that could alleviate the caregiving demands.
This news section offers Cancer readers timely information on events, public policy analysis, topical issues, and personalities.This edition looks at ways researchers are using nanotechnology to diagnose and treat cancer, and the results of a new study that show how aspirin may lower the risk of colorectal cancer in specific cases.
As we strive to improve the quality and safety of the surgical care we deliver, a large body of research has focused on identifying characteristics of both hospitals and individual surgeons that function as a proxy for high-quality care. Many studies, notably the work of John Birkmeyer,1,2 have validated a volume-outcome relationship in which numerous patient outcome measures improve when surgical procedures are performed at high-volume centers and by surgeons who perform a larger number of the procedure. Last year, these findings were translated into policy as 3 major academic hospital systems announced a “Take the Volume Pledge,”3,4 which sets a minimum volume threshold for hospitals and surgeons performing 10 different complex surgical procedures. There is no doubt that the motivation behind this pledge, to improve patient outcomes, is sound. However, volume, although undeniably correlated with improved care, is an imperfect stand-alone measure of quality. Notably, a surgeon's years of past experience or advanced training are discounted in a simplified threshold of number of cases performed per year. Proponents of the policy argue that waiting for further research before effecting these changes would represent an unnecessary delay. However, in this article, we would argue that implementing policy based on incomplete analysis will lead to more harm than good for the patients. CONSEQUENCES OF RUSHED POLICY-MAKING Setting large-scale policy, even with good intentions, based on an imperfect metric can lead to long-term negative effects that are often not considered until it is too late. A recent example is “No Child Left Behind”, the act passed by Congress in 2001 aimed at improving public education by setting measurable standards to evaluate school quality.5 The act intensely focused on standardized testing as an outcome measure, with schools that failed to meet yearly improvement standards either being supplemented with additional tutoring services, penalized by offering students the opportunity to transfer to higher performing schools, or in the most severe cases, permanently closed. Initially, education advocates applauded the law as a concrete step to address failing schools. However, the consequences of using an incomplete quality metric soon became clear. Because standardized testing was used as a singular marker of excellence and a benchmark for resource distribution, even the most creative teachers were forced to bend their teaching to fit test content. Students did not take advantage of tutoring services, and failure rates remained unchanged. Most interestingly, only a tiny percentage of eligible students agreed to transfer from their local school to a higher performing one, even with the offer of free transportation.6 Students and parents preferred their local school even once it had been defined as in need of improvement. As these issues became clear, the education community and policymakers turned against the law. On December 2, 2015, Congress passed sweeping revisions amending national testing standards, and allowing states and local school districts to set their own measures of quality with remediation plans for underperformers.7 Passed with strong bipartisan support, these revisions were a recognition that the attempt to define quality with a single outcome measure failed to account for a number of serious adverse downstream effects. POTENTIAL UNINTENDED EFFECTS OF MANDATORY VOLUME THRESHOLDS Before making the same mistakes in writing national healthcare policy, we should carefully consider the negative implications of setting a volume threshold for performance of surgical procedures. Significant impact of this change will be felt at the patient, family, hospital, and societal levels. At the patient level, an obvious impact is the increased travel burden they will face as care becomes regionalized. Patients will be forced to spend more time in traveling, not only for the index procedure, but also for every preoperative and postoperative appointment. More time in transit means more missed days of work, increased need for childcare coverage, and higher cost. Although some of this access issue could be ameliorated through a military-like system of transport to regional centers, an outside entity would need to pay for the service to avoid saddling patients with this financial hardship. Taxpayers currently fund emergency medical services and transport for transplantable organs, but paying for similar transportation for elective surgical patients would represent a huge additional cost. High-volume centers, which would benefit from this policy, could contribute, but would be unlikely to do so voluntarily. An obligatory policy centralizing complex surgery has social and economic consequences for patients’ families as well. When an elderly or pediatric patient is hospitalized, a family member often wants, or needs, to visit daily to provide social support and advocate for patient needs. Health insurance companies do not cover the cost of travel or accommodations for family members. Furthermore, a family member's spending multiple nights, or even weeks, away from home to be with a hospitalized loved one carries a high social cost. Not only must family members miss work, but this situation also leaves a single spouse home to take care of siblings and other domestic responsibilities. Hospitals will also be significantly affected by this national policy. One important issue is that using procedure volume as a solitary outcome metric fails to capture the relevant support systems within a hospital that not only bolster surgical quality, but also contribute to ability to rescue when complications arise. These components include intensive care capability, presence of experienced nurses, as well as 24-hour access to subspecialty surgeons, interventional radiology, and advanced gastroenterology. A policy that focuses narrowly on procedural volume may disincentivize these other system-level investments that can ultimately prove crucial in patient care. These components could likely be improved upon at community centers, limiting the need for regionalization. There is also the practical concern that many regional centers are already operating at, or above, capacity the majority of the time. With emergency rooms overflowing, inpatient and intensive care beds full, and operating room schedules booked out for months, there is limited capability to absorb additional patients. Forcing more volume into overloaded academic centers will inevitably increase wait times for procedures. This capacity problem will be exacerbated by the fact that surgeons tend to have a higher threshold for discharging patients who have traveled a long distance for care. Patients must be not only medically ready for discharge, but also sufficiently recovered to tolerate increased travel time home and confident that they will remain well until their scheduled follow-up. Escalating lengths of stay will only further contribute to hospital census overload. Furthermore, the societal impact of compulsory regionalization must be recognized. Although the initial “Volume Pledge” only applies to 10 different complex surgical procedures, a trend of defining a minimum number of cases per surgeon for all major procedures cannot be far behind. Community surgeons will find it difficult to meet these numbers, and slowly the scope of their practice will become limited, no matter how technically talented or well trained they are.3 These restrictions will not only make community surgery less satisfying intellectually and more financially tenuous, but will also starve small hospitals into economic disaster or even closure.8 Patients residing in more rural areas will then have limited access to care, even for smaller procedures. In this way, an initiative intended to improve patient outcomes actually negatively affects the quality of care delivered outside of major academic centers. A final issue with imposing volume standards as a proxy for quality is that it will essentially create a quota system. Surgeons nearing the end of the year without having performed a sufficient number of a given procedure may be tempted to offer an operation to a patient who does not truly need one, simply to meet their volume requirement. Although nonoperative management is often the superior therapeutic option for patients, surgical appropriateness would potentially be compromised under the new system. A policy that introduces any incentive other than medical necessity into patient care decisions is dangerous. Fundamentally, volume metrics ignore the importance of surgical judgment in cases where patients are best served by not offering them an operation. FUTURE DIRECTIONS There is no argument about the fact that the outcomes of elective complex surgery are improved when performed by surgeons and at centers with higher volume. However, before rushing to make national policy using this singular imperfect measure as a threshold, we need to have a real debate about potential unintended consequences. The urge to act now instead of waiting for more in-depth research is strong, especially when the motivation is to improve patient outcomes. However, we should keep in mind the old adage that “for every complex problem, there is an answer that is clear, simple, and wrong.”9 Our experience with “No Child Left Behind” taught us that flawed policy created with the best of intentions has unforeseen costs and ultimately needs substantial revision. The goal of engaging in further discussion is not to inhibit progress, but rather to avoid creating our own “No Patient Left Behind” act. We must take the time to develop a more comprehensive policy that defines quality using multiple metrics and, most importantly, includes solutions to address the negative consequences of the changes proposed.
In Gram-negative bacteria, lipid asymmetry is critical for the function of the outer membrane (OM) as a selective permeability barrier, but how it is established and maintained is poorly understood. Here, we characterize a non-canonical ATP-binding cassette (ABC) transporter in Escherichia coli that provides energy for maintaining OM lipid asymmetry via the transport of aberrantly localized phospholipids (PLs) from the OM to the inner membrane (IM). We establish that the transporter comprises canonical components, MlaF and MlaE, and auxiliary proteins, MlaD and MlaB, of previously unknown functions. We further demonstrate that MlaD forms extremely stable hexamers within the complex, functions in substrate binding with strong affinity for PLs, and modulates ATP hydrolytic activity. In addition, MlaB plays critical roles in both the assembly and activity of the transporter. Our work provides mechanistic insights into how the MlaFEDB complex participates in ensuring active retrograde PL transport to maintain OM lipid asymmetry.
Wound infections after pancreaticoduodenectomy (PD) are common. The standard antibiotic prophylaxis given to prevent the infections is often a cephalosporin. However, this decision is rarely guided by microbiology data pertinent to PD, particularly in patients with biliary stents.To analyze the microbiology of post-PD wound infection cultures and the effectiveness of institution-based perioperative antibiotic protocols.The pancreatic resection databases of 3 institutions (designated as institutions A, B, or C) were queried on patients undergoing PD from June 1, 2008, to June 1, 2013, and a total of 1623 patients were identified. Perioperative variables as well as microbiology data for intraoperative bile and postoperative wound cultures were analyzed from June 1, 2008, to June 1, 2013.Perioperative antibiotic administration.Wound infection microbiology analysis and resistance patterns.Of the 1623 patients who underwent PD, 133 with wound infections (8.2%) were identified. The wound infection rate did not differ significantly across the 3 institutions. The predominant perioperative antibiotics used at institutions A, B, and C were cefoxitin sodium, cefazolin sodium with metronidazole, and ampicillin sodium-sulbactam sodium, respectively. Of the 133 wound infections, 89 (67.1%) were deep-tissue infection, occurring at a median of 8 (range, 1-57) days after PD. A total of 53 (40.0%) of the wound infections required home visiting nurse services on discharge, and 73 (29.1%) of all PD readmissions were attributed to wound infection. Preoperative biliary stenting was the strongest predictor of postoperative wound infection (odds ratio, 2.5; 95% CI, 1.58-3.88; P = .03). There was marked institutional variation in the type of microorganisms cultured from both the intraoperative bile and wound infection cultures (Streptococcus pneumoniae, 114 cultures [47.9%] in institution A vs 3 [4.5%] in institution B; P = .001) and wound infection cultures (predominant microorganism in institution A: Enterococcus faecalis, 18 cultures [51.4%]; institution B: Staphylococcus aureus, 8 [43.9%]; and institution C: Escherichia coli, 17 [36.2%], P = .001). Similarly, antibiotic resistance patterns varied (resistance pattern in institution A: cefoxitin, 29 cultures [53.1%]; institution B: ampicillin-sulbactam, 9 [69.2%]; and institution C: penicillin, 32 [72.7%], P < .001). Microorganisms isolated in intraoperative bile cultures were similar to those identified in wound cultures in patients with post-PD wound infections.The findings of this large-scale, multi-institutional study indicate that intraoperative bile cultures should be routinely obtained in patients who underwent preoperative endoscopic retrograde cholangiopancreatography since the isolated microorganisms closely correlate with those identified on postoperative wound cultures. Institution-specific internal reviews should amend current protocols for antibiotic prophylaxis to reduce the incidence of wound infections following PD.
