Considering Usual Medical Care in Clinical Trial Design

Liza Dawson and colleagues discuss the scientific and ethical issues associated with choosing clinical trial designs when there is no consensus on what constitutes usual care

ACS-NSQIP has the potential to create an HPB-NSQIP option

AbstractBackgroundThe American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) was started in 2004. Presently, 58% of the 198 hospitals participating in ACS-NSQIP are academic or teaching hospitals. In 2008, ACS-NSQIP initiated a number of changes and made risk-adjusted data available for use by participating hospitals. This analysis explores the ACS-NSQIP database for utility in developing hepato-pancreato-biliary (HPB) surgery-specific outcomes (HPB-NSQIP).MethodsThe ACS-NSQIP Participant Use File was queried for patient demographics and outcomes for 49 HPB operations from 1 January 2005 through 31 December 2007. The procedures included six hepatic, 16 pancreatic and 23 complex biliary operations. Four laparoscopic or open cholecystectomy operations were also studied. Risk-adjusted probabilities for morbidity and mortality were compared with observed rates for each operation.ResultsDuring this 36-month period, data were accumulated on 9723 patients who underwent major HPB surgery, as well as on 44189 who received cholecystectomies. The major HPB operations included 2847 hepatic (29%), 5074 pancreatic (52%) and 1802 complex biliary (19%) procedures. Patients undergoing hepatic resections were more likely to have metastatic disease (42%) and recent chemotherapy (7%), whereas those undergoing complex biliary procedures were more likely to have significant weight loss (20%), diabetes (13%) and ascites (5%). Morbidity was high for hepatic, pancreatic and complex biliary operations (20.1%, 32.4% and 21.2%, respectively), whereas mortality was low (2.3%, 2.7% and 2.7%, respectively). Compared with laparoscopic cholecystectomy, the open operation was associated with higher rates of morbidity (19.2% vs. 6.0%) and mortality (2.5% vs. 0.3%). The ratios between observed and expected morbidity and mortality rates were <1.0 for hepatic, pancreatic and biliary operations.ConclusionsThese data suggest that HPB operations performed at ACS-NSQIP hospitals have acceptable outcomes. However, the creation of an HPB-NSQIP has the potential to improve quality, provide risk-adjusted registries with HPB-specific data and facilitate multi-institutional clinical trials

Assessment of Complications After Pancreatic Surgery: A Novel Grading System Applied to 633 Patients Undergoing Pancreaticoduodenectomy

OBJECTIVE: To define a simple and reproducible classification of complications following pancreaticoduodenectomy (PD) based on a therapy-oriented severity grading system. BACKGROUND: While mortality is rare after PD, morbidity rates remain high. The lack of standardization in evaluating morbidity after PD has severely hampered meaningful comparisons over time and among centers. We adapted a novel classification of complication to stratify morbidity by severity after PD, to test whether the incidence of pancreatic fistula has changed over time, and to identify risk factors in a single North American center. METHODS: The classification was applied to a consecutive series of 633 patients undergoing PD between February 2003 and August 2005. Another series of 141 patients treated between 1987 and 1990 was also analyzed to identify changes in the incidence and severity of fistula. Univariate and multivariate analyses were performed to link respective complications with preoperative and intraoperative parameters, length of hospital stay, and long-term survival. RESULTS: A total of 263 (41.5%) patients did not develop any complication, while 370 (58.5%) had at least one complication; 62 (10.0%) patients had only grade I complications (no need for specific intervention), 192 patients (30.0%) had grade II (need for drug therapy such as antibiotics), 85 patients (13.5%) had grade III (need for invasive therapy), and 19 patients (3.0%) had grade IV complications (organ dysfunction with ICU stay). Grade V (death) occurred in 12 patients (2.0%). A total of 57 patients (9.0%) developed pancreatic fistula, of which 33 (58.0%) were classified as grade II, 17 (30.0%) as grade III, 5 (9.0%) as grade IV, and 2 (3.5%) as grade V. Delayed gastric emptying was documented in 80 patients (12.7%); half of them were scored as grade II and the other half as grade III. A significant decrease in the incidence of fistula was observed between the 2 periods analyzed (14.0% vs. 9.0%, P < 0.001), mostly due to a decrease in grade II fistula. Cardiovascular disease was a risk factor for overall morbidity and complication severity, while texture of the gland and cardiovascular disease were risk factors for pancreatic fistula. CONCLUSION: This study demonstrates the applicability and utility of a new classification in grading complications following pancreatic surgery. This novel approach may provide a standardized, objective, and reproducible assessment of pancreas surgery enabling meaningful comparison among centers and over time

The case against preoperative biliary drainage with pancreatic resection1

The majority of patients with periampullary malignancies currently undergo biliary drainage before pancreaticoduodenectomy. Placement of an endoprosthesis reliably ameliorates jaundice and pruritus. However, preoperative biliary drainage leads to bile colonization and increases the risk of postoperative wound infection after pancreatic resection. Preoperative biliary drainage does not appear to lower postoperative morbidity or mortality following pancreatic resection and does not lower but probably increases costs associated with pancreatic resection. Preoperative biliary drainage is frequently used with little clinical benefit and its utilization should be limited to specific clinical indications, i.e. patients receiving neoadjuvant therapy, patients waiting several weeks or more for surgical evaluation and resection, patients with cholangitis

Improvement in Pediatric Cardiac Surgical Outcomes Through Interhospital&nbsp;Collaboration

BackgroundPatients undergoing complex pediatric cardiac surgery remain at considerable risk of mortality and morbidity, and variation in outcomes exists across hospitals. The Pediatric Cardiac Critical Care Consortium (PC4) was formed to improve the quality of care for these patients through transparent data sharing and collaborative learning between participants.ObjectivesThe purpose of this study was to determine whether outcomes improved over time within PC4.MethodsThe study analyzed 19,600 hospitalizations (18 hospitals) in the PC4 clinical registry that included cardiovascular surgery from August 2014 to June 2018. The primary exposure was 2 years of PC4 participation; this provided adequate time for hospitals to accrue data and engage in collaborative learning. Aggregate case mix-adjusted outcomes were compared between the first 2 years of participation (baseline) and all months post-exposure. We also evaluated outcomes from the same era in a cohort of similar, non-PC4 hospitals.ResultsDuring the baseline period, there was no evidence of improvement. We observed significant improvement in the post-exposure period versus baseline for post-operative intensive care unit mortality (2.1% vs. 2.7%; 22% relative reduction [RR]; p&nbsp;=&nbsp;0.001), in-hospital mortality (2.5% vs. 3.3%; 24% RR; p&nbsp;=&nbsp;0.001), major complications (10.1% vs. 11.5%; 12% RR; p&nbsp;&lt;&nbsp;0.001), intensive care unit length of stay (7.3&nbsp;days vs. 7.7&nbsp;days; 5% RR; p&nbsp;&lt;&nbsp;0.001), and duration of ventilation (61.3&nbsp;h vs. 70.6 h; 13% RR; p&nbsp;=&nbsp;0.01). Non-PC4 hospitals showed no significant improvement in mortality, complications, or hospital length of stay.ConclusionsThis analysis demonstrates improving cardiac surgical outcomes at children's hospitals participating in PC4. This change appears unrelated to secular improvement trends, and likely reflects PC4's commitment to transparency and collaboration