Prospective Creation and Validation of the PREVENTT (Prediction and Enaction of Prevention Treatments Trigger) Scale for Surgical Site Infections (SSIs) in Patients With Diverticulitis.

OBJECTIVE: Create and validate diverticulitis surgical site infection prediction scale. BACKGROUND: Surgical site infections cause significant morbidity after colorectal surgery. An infection prediction scale could target infection prevention bundles to high-risk patients. METHODS: Prospectively collected National Surgical Quality Improvement Program and electronic medical record data obtained on diverticulitis colectomy patients across a Healthcare Network-wide Colorectal Surgery Collaborative (5 hospitals). Patients with and without surgical site infections were compared. Predictive variables were identified using logistic regression model; model estimates obtained through 1000 bootstrap replications for scale validation. RESULTS: A total of 1737 colectomies were performed (2010-2016): mean age 59.9 years (SD 12.7), 56.4% female; 93.4% Caucasian; smokers 16.3%, diabetics 7.7%, steroid use 6.0%. Two hundred thirty-one (13.3%) were presented to operating room emergently and 138 (7.9%) with abscess at time of disease admission. Two hundred ninety-six patients underwent Hartman procedures, and 113 (6.5%) received diverted primary anastomosis. Average length of stay was 6.9 days (standard deviation 7.01), 30-day mortality was 1.5%, anastomotic leak rate was 3.1%. Twenty-one percent of patients (n = 366) developed a surgical site infection. Several predictors for infection were identified: obesity (body mass index >30), advanced age (>70 years), diabetes mellitus, preoperative abscess, open surgery, emergent operations, and prolonged operations (>3 h). Creation of protected anastomosis in emergent settings was associated with increased infection rates. Presence of more than 5 risk factors was associated with infection rates of 45.8% (c = 0.69). CONCLUSIONS: Patients with diverticulitis have high surgical site infection rates due to nonmodifiable risk factors. Our Prediction and Enaction of Prevention Treatments Trigger scale can risk stratify patients for targeting surgical site infection prevention bundles and outcomes risk adjustments.

Truth in Reporting: How Data Capture Methods Obfuscate Actual Surgical Site Infection Rates within a Health Care Network System.

BACKGROUND: Two systems measure surgical site infection rates following colorectal surgeries: the American College of Surgeons National Surgical Quality Improvement Program and the Centers for Disease Control and Prevention National Healthcare Safety Network. The Centers for Medicare & Medicaid Services pay-for-performance initiatives use National Healthcare Safety Network data for hospital comparisons. OBJECTIVE: This study aimed to compare database concordance. DESIGN: This is a multi-institution cohort study of systemwide Colorectal Surgery Collaborative. The National Surgical Quality Improvement Program requires rigorous, standardized data capture techniques; National Healthcare Safety Network allows 5 data capture techniques. Standardized surgical site infection rates were compared between databases. The Cohen κ-coefficient was calculated. SETTING: This study was conducted at Boston-area hospitals. PATIENTS: National Healthcare Safety Network or National Surgical Quality Improvement Program patients undergoing colorectal surgery were included. MAIN OUTCOME MEASURES: Standardized surgical site infection rates were the primary outcomes of interest. RESULTS: Thirty-day surgical site infection rates of 3547 (National Surgical Quality Improvement Program) vs 5179 (National Healthcare Safety Network) colorectal procedures (2012-2014). Discrepancies appeared: National Surgical Quality Improvement Program database of hospital 1 (N = 1480 patients) routinely found surgical site infection rates of approximately 10%, routinely deemed rate "exemplary" or "as expected" (100%). National Healthcare Safety Network data from the same hospital and time period (N = 1881) revealed a similar overall surgical site infection rate (10%), but standardized rates were deemed "worse than national average" 80% of the time. Overall, hospitals using less rigorous capture methods had improved surgical site infection rates for National Healthcare Safety Network compared with standardized National Surgical Quality Improvement Program reports. The correlation coefficient between standardized infection rates was 0.03 (p = 0.88). During 25 site-time period observations, National Surgical Quality Improvement Program and National Healthcare Safety Network data matched for 52% of observations (13/25). κ = 0.10 (95% CI, -0.1366 to 0.3402; p = 0.403), indicating poor agreement. LIMITATIONS: This study investigated hospitals located in the Northeastern United States only. CONCLUSIONS: Variation in Centers for Medicare & Medicaid Services-mandated National Healthcare Safety Network infection surveillance methodology leads to unreliable results, which is apparent when these results are compared with standardized data. High-quality data would improve care quality and compare outcomes among institutions.

Ten Rules for Conducting Retrospective Pharmacoepidemiological Analyses: Example COVID-19 Study.

Since the beginning of the COVID-19 pandemic, pharmaceutical treatment hypotheses have abounded, each requiring careful evaluation. A randomized controlled trial generally provides the most credible evaluation of a treatment, but the efficiency and effectiveness of the trial depend on the existing evidence supporting the treatment. The researcher must therefore compile a body of evidence justifying the use of time and resources to further investigate a treatment hypothesis in a trial. An observational study can provide this evidence, but the lack of randomized exposure and the researcher's inability to control treatment administration and data collection introduce significant challenges. A proper analysis of observational health care data thus requires contributions from experts in a diverse set of topics ranging from epidemiology and causal analysis to relevant medical specialties and data sources. Here we summarize these contributions as 10 rules that serve as an end-to-end introduction to retrospective pharmacoepidemiological analyses of observational health care data using a running example of a hypothetical COVID-19 study. A detailed supplement presents a practical how-to guide for following each rule. When carefully designed and properly executed, a retrospective pharmacoepidemiological analysis framed around these rules will inform the decisions of whether and how to investigate a treatment hypothesis in a randomized controlled trial. This work has important implications for any future pandemic by prescribing what we can and should do while the world waits for global vaccine distribution.

Resource utilisation among patients transferred for intracerebral haemorrhage.

Background: Patients with intracerebral haemorrhage (ICH) are frequently transferred between hospitals for higher level of care. We aimed to identify factors associated with resource utilisation among patients with ICH admitted to a single academic hospital. Methods: We used a prospectively collected registry of consecutive patients with primary ICH at an urban academic hospital between 1 January 2005 and 31 December 2015. The primary outcome was use of either intensive care unit (ICU) admission or surgical intervention. Logistic regression examined factors associated with the outcome, controlling for age, sex, Glasgow coma score (GCS) and ICH score. Results: Of the 2008 patients included, 887 (44.2%) received ICU stay or surgical intervention. These patients were younger (71 vs 74 years, p<0.001), less often white (83.9% vs 89.3%, p<0.001), had lower baseline GCS (12 vs 14, p<0.001) and more frequently had intraventricular haemorrhage (58.6% vs 43.4%, p<0.001). Factors independently associated with ICU stay or surgical intervention were age >65 years (OR 0.38, 95% CI 0.21 to 0.69), GCS <15 (1.23, 95% CI 1.01 to 1.52) and ICH score >0 (OR 2.23, 95% CI 1.70 to 2.91). Conclusion: Among this cohort of primary patients with ICH, GCS of 15 and ICH score of 0 were associated with less frequent use of ICU or intervention. These results should be validated in a larger sample but may be valuable for hospitals considering which patients with ICH could safely remain at the referring facility.

Novel fast-track recovery protocol for alternative access transcatheter aortic valve replacement: application to non-femoral approaches.

OBJECTIVES: Although the transfemoral approach for transcatheter aortic valve replacement is the preferred choice, alternative access remains indicated for inadequate iliofemoral vessels. We report the successful implementation of a novel fast-track (FT) protocol for patients undergoing alternative access transcatheter aortic valve replacement compared with conventional controls. METHODS: Between September 2014 and January 2017, 31 and 23 patients underwent alternative access transcatheter aortic valve replacement under FT and pre-fast-track (p-FT) protocols, respectively. Comparisons of outcomes (in terms of mortality, complications, readmissions and resource utilization) were made before and after the implantation of the FT protocol in September 2015. RESULTS: Overall, mean age was 78.7 years in FT and 79.6 years in p-FT patients (P = 0.71). There were no significant differences in procedural (3.2% vs 13.0%, P = 0.301) or 90-day mortality (3.2% vs 17.4%, P = 0.151) between the FT and p-FT groups, respectively. Compared with p-FT patients, FT patients had significantly shorter intensive care unit stays (12 h vs 27 h, P = 0.006) and a trend towards more discharges within 3 days (41.9% vs 17.4%, P = 0.081). Resource utilization analyses projected a 56% and 17% reduction in the mean intensive care unit time (hours) per 100 patients and the total length of stay (days) per 100 patients, respectively, with respect to the FT approach. CONCLUSIONS: This pilot study demonstrates the feasibility and safety of the novel FT protocol for alternative access transcatheter aortic valve replacement, resulting in shorter intensive care unit stays, without increasing procedural complications or readmissions. With the expected increase in transcatheter aortic valve replacement utilization, FT protocols should be integrated with a multidisciplinary heart team approach to enhance patient recovery and optimize resource utilization.

Incidence and predictors of incomplete revascularization in a contemporary cohort.

OBJECTIVES: Complete coronary revascularization has been associated with improved mortality among patients undergoing surgical bypass grafting. A similar evaluation among patients undergoing percutaneous coronary intervention (PCI) for multivessel disease has produced largely concordant results, although complete percutaneous revascularization is often not achieved in this population. The present study sought to evaluate the clinical and anatomic limitations to complete revascularization among contemporary patients undergoing percutaneous revascularization for multivessel coronary artery disease. METHODS: All patients undergoing nonemergent PCI for unprotected left main or multivessel coronary artery disease were identified at two academic medical centers from 2009 to 2012. Complete revascularization was determined through a review of the electronic medical records and corresponding coronary angiograms. The underlying reasons that precluded complete revascularization were then derived from a review of the clinical and angiographic findings. RESULTS: Among 978 patients with multivessel coronary artery disease, 267 (27%) underwent complete percutaneous coronary revascularization. Factors that prevented complete revascularization included chronic total occlusions (54%), treatment limited to the culprit lesion (24%), or persistent disease in small nondominant vessels (24%). After multivariable adjustment, the presence of a chronic total occlusion was associated with significantly reduced odds of receiving complete revascularization (adjusted odds ratio: 0.18, 95% confidence interval: 0.12-0.27). CONCLUSION: Complete percutaneous revascularization is uncommon and is hindered by the presence of chronic total occlusions or isolated treatment of an angiographic culprit lesion. Evolving interventional techniques enabling treatment of chronic total occlusions may increase the prevalence of complete percutaneous revascularization in the future.

Use of Chronic Oral Anticoagulation and Associated Outcomes Among Patients Undergoing Percutaneous Coronary Intervention.

BACKGROUND: Contemporary rates of oral anticoagulant (OAC) therapy and associated outcomes among patients undergoing percutaneous coronary intervention (PCI) have been poorly described. METHODS AND RESULTS: Using data from an integrated health care system from 2009 to 2014, we identified patients on OACs within 30 days of PCI. Outcomes included in-hospital bleeding and mortality. Of 9566 PCIs, 837 patients (8.8%) were on OACs, and of these, 7.9% used non-vitamin K antagonist agents. OAC use remained stable during the study (8.1% in 2009, 9.0% in 2014; P=0.11), whereas use of non-vitamin K antagonist agents in those on OACs increased (0% in 2009, 16% in 2014; P<0.01). Following PCI, OAC-treated patients had higher crude rates of major bleeding (11% versus 6.5%; P<0.01), access-site bleeding (2.3% versus 1.3%; P=0.017), and non-access-site bleeding (8.2% versus 5.2%; P<0.01) but similar crude rates of in-hospital stent thrombosis (0.4% versus 0.3%; P=0.85), myocardial infarction (2.5% versus 3.0%; P=0.40), and stroke (0.48% versus 0.52%; P=0.88). In addition, prior to adjustment, OAC-treated patients had longer hospitalizations (3.9±5.5 versus 2.8±4.6 days; P<0.01), more transfusions (7.2% versus 4.2%; P<0.01), and higher 90-day readmission rates (22.1% versus 13.1%; P<0.01). In adjusted models, OAC use was associated with increased risks of in-hospital bleeding (odds ratio 1.50; P<0.01), 90-day readmission (odds ratio 1.40; P<0.01), and long-term mortality (hazard ratio 1.36; P<0.01). CONCLUSIONS: Chronic OAC therapy is frequent among contemporary patients undergoing PCI. After adjustment for potential confounders, OAC-treated patients experienced greater in-hospital bleeding, more readmissions, and decreased long-term survival following PCI. Efforts are needed to reduce the occurrence of adverse events in this population.