Validation of a Screening Risk Index for Serious Prescription Opioid-Induced Respiratory Depression or Overdose in a US Commercial Health Plan Claims Database.

Objective: To validate a risk index that estimates the likelihood of overdose or serious opioid-induced respiratory depression (OIRD) among medical users of prescription opioids. Subjects and Methods: A case-control analysis of 18,365,497 patients with an opioid prescription from 2009 to 2013 in the IMS PharMetrics Plus commercially insured health plan claims database (CIP). An OIRD event occurred in 7,234 cases. Four controls were selected per case. Validity of the Risk Index for Overdose or Serious Opioid-induced Respiratory Depression (RIOSORD), developed previously using Veterans Health Administration (VHA) patient data, was assessed. Multivariable logistic regression was used within the CIP study population to develop a slightly refined RIOSORD. The composition and performance of the CIP-based RIOSORD was evaluated and compared with VHA-based RIOSORD. Results: VHA-RIOSORD performed well in discriminating OIRD events in CIP (C-statistic = 0.85). Additionally, re-estimation of logistic model coefficients in CIP yielded a 0.90 C-statistic. The resulting comorbidity and pharmacotherapy variables most highly associated with OIRD and retained in the CIP-RIOSORD were largely concordant with VHA-RIOSORD. These variables included neuropsychiatric and cardiopulmonary disorders, impaired drug excretion, opioid characteristics, and concurrent psychoactive medications. The average predicted probability of OIRD ranged from 2% to 83%, with excellent agreement between predicted and observed incidence across risk classes. Conclusions: RIOSORD had excellent predictive accuracy in a large population of US medical users of prescription opioids, similar to its performance in VHA. This practical risk index is designed to support clinical decision-making for safer opioid prescribing, and its clinical utility should be evaluated prospectively.

Development of a Risk Index for Serious Prescription Opioid-Induced Respiratory Depression or Overdose in Veterans' Health Administration Patients.

OBJECTIVE: Develop a risk index to estimate the likelihood of life-threatening respiratory depression or overdose among medical users of prescription opioids. SUBJECTS, DESIGN, AND METHODS: A case-control analysis of administrative health care data from the Veterans' Health Administration identified 1,877,841 patients with a pharmacy record for an opioid prescription between October 1, 2010 and September 30, 2012. Overdose or serious opioid-induced respiratory depression (OSORD) occurred in 817. Ten controls were selected per case (n = 8,170). Items for an OSORD risk index (RIOSORD) were selected through logistic regression modeling, with point values assigned to each predictor. Modeling of risk index scores produced predicted probabilities of OSORD; risk classes were defined by the predicted probability distribution. RESULTS: Fifteen variables most highly associated with OSORD were retained as items, including mental health disorders and pharmacotherapy; impaired drug metabolism or excretion; pulmonary disorders; specific opioid characteristics; and recent hospital visits. The average predicted probability of experiencing OSORD ranged from 3% in the lowest risk decile to 94% in the highest, with excellent agreement between predicted and observed incidence across risk classes. The model's C-statistic was 0.88 and Hosmer-Lemeshow goodness-of-fit statistic 10.8 (P > 0.05). CONCLUSION: RIOSORD performed well in identifying medical users of prescription opioids within the Veterans' Health Administration at elevated risk of overdose or life-threatening respiratory depression, those most likely to benefit from preventive interventions. This novel, clinically practical, risk index is intended to provide clinical decision support for safer pain management. It should be assessed, and refined as necessary, in a more generalizable population, and prospectively evaluated.

Risk factors for serious prescription opioid-related toxicity or overdose among Veterans Health Administration patients.

OBJECTIVE: Prescription opioid use and deaths related to serious toxicity, including overdose, have increased dramatically in the United States since 1999. However, factors associated with serious opioid-related respiratory or central nervous system (CNS) depression or overdose in medical users are not well characterized. The objective of this study was to examine the factors associated with serious toxicity in medical users of prescription opioids. DESIGN: Retrospective, nested, case-control analysis of Veterans Health Administration (VHA) medical, pharmacy, and health care resource utilization administrative data. SUBJECTS: Patients dispensed an opioid by VHA between October 1, 2010 and September 30, 2012 (N=8,987). METHODS: Cases (N=817) experienced life-threatening opioid-related respiratory/CNS depression or overdose. Ten controls were randomly assigned to each case (N=8,170). Logistic regression was used to examine associations with the outcome. RESULTS: The strongest associations were maximum prescribed daily morphine equivalent dose (MED)≥ 100 mg (odds ratio [OR]=4.1, 95% confidence interval [CI], 2.6-6.5), history of opioid dependence (OR=3.9, 95% CI, 2.6-5.8), and hospitalization during the 6 months before the serious toxicity or overdose event (OR=2.9, 95% CI, 2.3-3.6). Liver disease, extended-release or long-acting opioids, and daily MED of 20 mg or more were also significantly associated. CONCLUSIONS: Substantial risk for serious opioid-related toxicity and overdose exists at even relatively low maximum prescribed daily MED, especially in patients already vulnerable due to underlying demographic factors, comorbid conditions, and concomitant use of CNS depressant medications or substances. Screening patients for risk, providing education, and coprescribing naloxone for those at elevated risk may be effective at reducing serious opioid-related respiratory/CNS depression and overdose in medical users of prescription opioids.

Preoperative oral antibiotics reduce surgical site infection following elective colorectal resections.

BACKGROUND: Surgical site infection is a major cause of morbidity after colorectal resections. Despite evidence that preoperative oral antibiotics with mechanical bowel preparation reduce surgical site infection rates, the use of oral antibiotics is decreasing. Currently, the administration of oral antibiotics is controversial and considered ineffective without mechanical bowel preparation. OBJECTIVE: The aim of this study is to examine the use of mechanical bowel preparation and oral antibiotics and their relationship to surgical site infection rates in a colorectal Surgical Care Improvement Project cohort. DESIGN: This retrospective study used Veterans Affairs Surgical Quality Improvement Program preoperative risk and surgical site infection outcome data linked to Veterans Affairs Surgical Care Improvement Project and Pharmacy Benefits Management data. Univariate and multivariable models were performed to identify factors associated with surgical site infection within 30 days of surgery. SETTINGS: This study was conducted in 112 Veterans Affairs hospitals. PATIENTS: Included were 9940 patients who underwent elective colorectal resections from 2005 to 2009. MAIN OUTCOME MEASURE: The primary outcome measured was the incidence of surgical site infection. RESULTS: Patients receiving oral antibiotics had significantly lower surgical site infection rates. Those receiving no bowel preparation had similar surgical site infection rates to those who had mechanical bowel preparation only (18.1% vs 20%). Those receiving oral antibiotics alone had an surgical site infection rate of 8.3%, and those receiving oral antibiotics plus mechanical bowel preparation had a rate of 9.2%. In adjusted analysis, the use of oral antibiotics alone was associated with a 67% decrease in surgical site infection occurrence (OR=0.33, 95% CI 0.21-0.50). Oral antibiotics plus mechanical bowel preparation was associated with a 57% decrease in surgical site infection occurrence (OR=0.43, 95% CI 0.34-0.55). Timely administration of parenteral antibiotics (Surgical Care Improvement Project-1) had a modest protective effect, with no effect observed for other Surgical Care Improvement Project measures. Hospitals with higher rates of oral antibiotics use had lower surgical site infection rates (R = 0.274, p < 0.0001). LIMITATIONS: Determination of the use of oral antibiotics and mechanical bowel preparation is based on retrospective prescription data, and timing of actual administration cannot be determined. CONCLUSIONS: Use and type of preoperative bowel preparation varied widely. These results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections. The role of oral antibiotics independent of mechanical bowel preparation should be examined in a prospective randomized trial.

Surgical site infection prevention: time to move beyond the surgical care improvement program.

OBJECTIVES: The objective of this study was to evaluate whether the Surgical Care Improvement Project (SCIP) improved surgical site infection (SSI) rates using national data at the patient level for both SCIP adherence and SSI occurrence. BACKGROUND: The SCIP was established in 2006 with the goal of reducing surgical complications by 25% in 2010. METHODS: National Veterans' Affairs (VA) data from 2005 to 2009 on adherence to 5 SCIP SSI prevention measures were linked to Veterans' Affairs Surgical Quality Improvement Program SSI outcome data. Effect of SCIP adherence and year of surgery on SSI outcome were assessed with logistic regression using generalized estimating equations, adjusting for procedure type and variables known to predict SSI. Correlation between hospital SCIP adherence and SSI rate was assessed using linear regression. RESULTS: There were 60,853 surgeries at 112 VA hospitals analyzed. SCIP adherence ranged from 75% for normothermia to 99% for hair removal and all significantly improved over the study period (P < 0.001). Surgical site infection occurred after 6.2% of surgeries (1.6% for orthopedic surgeries to 11.3% for colorectal surgeries). None of the 5 SCIP measures were significantly associated with lower odds of SSI after adjusting for variables known to predict SSI and procedure type. Year was not associated with SSI (P = 0.71). Hospital SCIP performance was not correlated with hospital SSI rates (r = -0.06, P = 0.54). CONCLUSIONS: Adherence to SCIP measures improved whereas risk-adjusted SSI rates remained stable. SCIP adherence was neither associated with a lower SSI rate at the patient level, nor associated with hospital SSI rates. Policies regarding continued SCIP measurement and reporting should be reassessed.

Characterization of Device-Related Malfunction, Injury, and Death Associated with Using Elastomeric Pumps for Delivery of Local Anesthetics in the US Food and Drug Administration MAUDE Database.

PURPOSE: To characterize medical device reports about elastomeric pumps delivering local anesthesia made to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. PATIENTS AND METHODS: We conducted a retrospective review of medical device reports submitted to MAUDE from January 2010 to July 2018. A systematic, computerized algorithm was used to identify records pertaining to elastomeric pumps using local anesthesia. Included records indicated the use of local anesthesia or were determined to involve the use of local anesthetics (if they did not contain specific information on drug use). Reports were analyzed within the MAUDE event type categories of malfunction, injury, death, other, and missing. Possible cases of liver injury or surgical site infection were also identified. Manual review of narratives provided in MAUDE was performed by 2 reviewers to identify possible or probable cases of local anesthetic system toxicity (LAST). RESULTS: From a pool of 384,285 reports about elastomeric pumps from the MAUDE database, 4093 met inclusion criteria for involving elastomeric pumps to deliver local anesthetics, with the peak number of reports occurring in 2014. Of these identified reports, 3624 (88.5%) were categorized as malfunctions, 292 (7.1%) as injuries, and 8 (0.2%) as involving death. We identified 13 cases (0.3%) of possible liver injury and 51 cases (1.2%) of possible surgical site infection; 139 reports (3.4%) were determined to be probably (n=53) or possibly (n=86) associated with LAST. CONCLUSION: Malfunction of elastomeric pumps delivering local anesthetics leaves patients vulnerable to injury or death. Our study indicates that reports of malfunction, injury, and death have been reported to the MAUDE database. These reports likely reflect an underrepresentation of cases in the real-world population, emphasizing the need for more comprehensive medical device reporting.

Umbilical herniorrhapy in cirrhosis: improved outcomes with elective repair.

OBJECTIVE: This study was undertaken to examine the effect of cirrhosis on elective and emergent umbilical herniorrhapy outcomes. METHODS: Procedures were identified from the Veterans' Affairs National Surgical Quality Improvement Program at 16 hospitals. Medical records and operative reports were physician abstracted to obtain preoperative and intraoperative variables. RESULTS: Of the 1,421 cases reviewed, 127 (8.9%) had cirrhosis. Cirrhotics were more likely to undergo emergent repair (26.0% vs. 4.8%, p < 0.0001), concomitant bowel resection (8.7% vs. 0.8%, p < 0.0001), return to operating room (7.9% vs. 2.5%, p = 0.0006), and increased postoperative length of stay (4.0 vs. 2.0 days, p = 0.01). Best-fit regression models found cirrhosis was not a significant predictor of postoperative complications. Significant predictors of complications were emergent case (OR 5.4; 95% CI 3.1-9.4), diabetes (OR 2.1; 95% CI 1.2-3.8), congestive heart failure (OR 4.0; 95% CI 1.4-11.4), and chronic obstructive pulmonary disease (OR 2.0; 95% CI 1.1-3.6). Among emergent repairs, cirrhosis (OR 4.4; 95% CI 1.3-14.3) was strongly associated with postoperative complications. CONCLUSION: Elective repair in cirrhotics is associated with similar outcomes as in patients without cirrhosis. Emergent repair in cirrhotics is associated with worse outcomes. Early elective repair may improve the overall outcomes for patients with cirrhosis.

A comparison of approaches to identify possible cases of local anesthetic systemic toxicity in the FDA Adverse Event Reporting System (FAERS) database.

BACKGROUND: Local anesthetic systemic toxicity (LAST) is a rare but potentially serious adverse event . METHODS: Data from the US Food and Drug Administration Adverse Event Reporting System were examined for liposomal bupivacaine (LB), bupivacaine, or other injectable local anesthetics. Possible LAST cases were identified based on MedDRA system organ classes (Approach 1), a recent publication (Approach 2), and a novel approach based on LAST literature (Approach 3). Disproportionality analyses compared possible LAST cases for LB and bupivacaine with other injectable local anesthetics. RESULTS: Approaches 1, 2, and 3 identified 75, 42, and 29 possible LAST cases associated with LB, respectively, compared with 9,595, 3,422, and 549 for other injectable local anesthetics. The proportional reporting ratios (95% CI) for LB versus other injectable local anesthetics for the 3 approaches were 1.9 (1.6-2.3), 2.9 (2.2-3.9), and 1.6 (1.1-2.2), respectively. Based on sales data, the estimated incidence of possible LAST with LB was 0.1 per 10,000 uses; literature estimates for LAST with other injectable local anesthetics were 0 to 18 per 10,000 uses. CONCLUSIONS: Our findings suggest the estimated incidence of possible LAST cases with LB is similar to, or less than, the reported incidence with other injectable local anesthetics.

Fibroblast-derived MT1-MMP promotes tumor progression in vitro and in vivo.

BACKGROUND: Identification of fibroblast derived factors in tumor progression has the potential to provide novel molecular targets for modulating tumor cell growth and metastasis. Multiple matrix metalloproteases (MMPs) are expressed by both mesenchymal and epithelial cells within head and neck squamous cell carcinomas (HNSCCs), but the relative importance of these enzymes and the cell source is the subject of controversy. METHODS: The invasive potential of HNSCC tumor cells were assessed in vitro atop type I collagen gels in coculture with wild-type (WT), MMP-2 null, MMP-9 null or MT1-MMP null fibroblasts. A floor of mouth mouse model of HNSCC was used to assess in vivo growth after co-injection of FaDu tumor cells with MMP null fibroblasts. RESULTS: Here we report changes in tumor phenotype when FaDu HNSCCs cells are cocultured with WT, MMP-2 null, MMP-9 null or MT1-MMP null fibroblasts in vitro and in vivo. WT, MMP-2 null and MMP-9 null fibroblasts, but not MT1-MMP null fibroblasts, spontaneously invaded into type I collagen gels. WT fibroblasts stimulated FaDu tumor cell invasion in coculture. This invasive phenotype was unaffected by combination with MMP-9 null fibroblasts, reduced with MMP-2 null fibroblasts (50%) and abrogated in MT1-MMP null fibroblasts. Co-injection of FaDu tumor cells with fibroblasts in an orthotopic oral cavity SCID mouse model demonstrated a reduction of tumor volume using MMP-9 and MMP-2 null fibroblasts (48% and 49%, respectively) compared to WT fibroblasts. Consistent with in vitro studies, MT1-MMP null fibroblasts when co-injected with FaDu cells resulted in a 90% reduction in tumor volume compared to FaDu cells injected with WT fibroblasts. CONCLUSION: These data suggest a role for fibroblast-derived MMP-2 and MT1-MMP in HNSCC tumor invasion in vitro and tumor growth in vivo.

Timely administration of prophylactic antibiotics for major surgical procedures.

BACKGROUND: Prophylactic antibiotics (PA) given within 60 minutes before surgical incision decrease risk of subsequent surgical site infection. Nationwide quality improvement initiatives have focused on improving the proportion of patients who receive timely prophylactic antibiotics. STUDY DESIGN: This is a cohort study of major surgical procedures performed in 108 Veterans Affairs hospitals between January and December 2005. Using data from the External Peer Review Program and the National Surgical Quality Improvement Program, we examined factors associated with timely PA administration. Univariate and multivariable analyses were performed. RESULTS: There were 8,137 major surgical procedures: cardiac (2,664), hip and knee arthroplasty (3,603), colon (1,142), arterial vascular (606), and hysterectomy (122). Timely PA occurred in 76.2% of patients, 18.2% received them too early, and 5.4% received them too late. Early administration accounted for 79% of untimely PA. Differences in timeliness were seen by procedure type (68% to 87%; p < 0.0001), admission status (67% to 80%; p < 0.0001), and antibiotic class (65% to 89%; p < 0.0001). PA administration occurred in the operating room for 63.5% of patients. When PA administration occurred in the operating room, they were timely in 89% of patients, compared with 54% of patients where administration was outside the operating room (odds ratio, 7.74; 95% CI = 6.49 to 9.22). CONCLUSIONS: Early PA administration accounted for the majority of inappropriately timed PA. Efforts to improve performance on this measure should focus on administering antibiotics in the operating room.

Predictors of wound infection in ventral hernia repair.

BACKGROUND: Postoperative wound infection is a significant risk factor for recurrence after ventral hernia repair (VHR). The current study examines patient- and procedure-specific variables associated with wound infection. METHODS: A cohort of subjects undergoing VHR from 13 regional Veterans Health Administration (VHA) sites was identified. Patient-specific risk variables were obtained from National Surgical Quality Improvement Program (NSQIP) data. Operative variables were obtained from physician-abstracted operative notes. Univariate and multivariable logistic regression analysis was used to model predictors of postoperative wound infection. RESULTS: A total of 1505 VHR cases were used for analysis; wound infection occurred in 5% (n = 74). Best-fit logistic regression models demonstrated that steroid use, smoking, prolonged operative time, and use of absorbable mesh, acting as a surrogate marker for a more complex procedure, were significant independent predictors of wound infection. CONCLUSION: Permanent mesh placement was not associated with postoperative wound infection. Smoking was the only modifiable risk factor and preoperative smoking cessation may improve surgical outcomes in VHR.

Variation in Institutional Review processes for a multisite observational study.

BACKGROUND: The Veterans Administration is an ideal setting for multisite studies; however, individual VA Institutional Review Board (IRB) approval is necessary. This study examines the burden of multisite IRB approval on a Health Services Research and Development (HSRD) ventral hernia outcomes observational study. METHODS: Data gathered on the IRB process per site included time required for application completion, staff training and compliance, IRB affiliation (VA or university), approval status, and time to IRB approval. Wilcoxon rank sum tests were used to determine differences in median times for application completion and approval. Financial and temporal expenses were calculated. RESULTS: Significant differences were found in median time to complete applications by IRB affiliation (P < .01) and median time to approval by changes required to the consent letter (P < .05). CONCLUSIONS: The IRB process for a multisite observational study is expensive in both time and money. A VA national IRB for multisite studies would significantly decrease the financial and temporal burden for observational studies.

Surgical Site Infection After Arthroplasty: Comparative Effectiveness of Prophylactic Antibiotics: Do Surgical Care Improvement Project Guidelines Need to Be Updated?

BACKGROUND: Prophylactic antibiotics decrease surgical site infection (SSI) rates, and their timing, choice, and discontinuation are measured and reported as part of the Surgical Care Improvement Project (SCIP). The aim of this study was to assess the comparative effectiveness of the SCIP-approved antibiotics for SSI prevention. METHODS: This retrospective cohort study utilized national Veterans Affairs (VA) data on patients undergoing elective hip or knee arthroplasty from 2005 to 2009. Data on prophylactic antibiotics were merged with VA Surgical Quality Improvement Program data to identify patient and procedure-related risk factors for SSI. Patients were stratified by documented penicillin allergy. Chi-square and Wilcoxon rank-sum tests were used to compare SSI rates among patients receiving SCIP-approved prophylactic antibiotics. RESULTS: A total of 18,830 elective primary arthroplasties (12,823 knee and 6007 hip) were included. Most patients received prophylactic cefazolin as the sole agent (81.9%), followed by vancomycin as the sole agent (8.0%), vancomycin plus cefazolin (5.6%), and clindamycin (4.5%). Documented penicillin allergy accounted for 54.1% of cases involving vancomycin administration compared with 94.6% of cases involving clindamycin. The overall thirty-day SSI rate was 1.4%, and the unadjusted rate was 2.3% with vancomycin only, 1.5% with vancomycin plus cefazolin, 1.3% with cefazolin only, and 1.1% with clindamycin. Unadjusted analysis of penicillin-allergic patients revealed an SSI rate of 2.0% with vancomycin only compared with 1.0% with clindamycin (p = 0.18). For patients without penicillin allergy, the SSI rate was 2.6% with vancomycin only compared with 1.6% with vancomycin plus cefazolin (p = 0.17) and 1.3% with cefazolin only (p < 0.01). CONCLUSIONS: Current SCIP guidelines address antibiotic timing but not antibiotic dosage. (The generally accepted recommendation for vancomycin is 15 mg/kg.) Although vancomycin is a narrower-spectrum antibiotic than either cefazolin or clindamycin, our finding of higher SSI rates following prophylaxis with vancomycin only may suggest a failure to use an appropriate dosage rather than an inequality of antibiotic effectiveness. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Choice of intravenous antibiotic prophylaxis for colorectal surgery does matter.

BACKGROUND: The Surgical Care Improvement Program endorses mandatory compliance with approved intravenous prophylactic antibiotics; however, oral antibiotics are optional. We hypothesized that surgical site infection (SSI) rates may vary depending on the choice of antibiotic prophylaxis. STUDY DESIGN: A retrospective cohort study of elective colorectal procedures using Veterans Affairs Surgical Quality Improvement Program (VASQIP) and SSI outcomes data was linked to the Office of Informatics and Analytics (OIA) and Pharmacy Benefits Management (PBM) antibiotic data from 2005 to 2009. Surgical site infection rates by type of IV antibiotic agent alone (IV) or in combination with oral antibiotic (IV + OA) were determined. Generalized estimating equations were used to examine the association between type of antibiotic prophylaxis and SSI for the entire cohort and stratified by use of oral antibiotics. RESULTS: After 5,750 elective colorectal procedures, 709 SSIs (12.3%) developed within 30 days. Oral antibiotic + IV (n = 2,426) had a lower SSI rate than IV alone (n = 3,324) (6.3% vs 16.7%, p < 0.0001). There was a significant difference in the SSI rate based on type of preoperative IV antibiotic given (p ≤ 0.0001). Generalized estimating equations adjusting for significant covariates of age, body mass index, procedure work relative value units, and operation duration demonstrated an independent protective effect of oral antibiotics (odds ratio [OR] 0.37, 95% CI 0.29 to 0.46), as well as increased rates of SSI associated with ampicillin/sulbactam (OR 2.21, 95% CI 1.37 to 3.56) and second generation cephalosporins (cefoxitin, OR 2.50, 95% CI 1.83 to 3.42; cefotetan, OR 2.70, 95% CI 1.72 to 4.22) when compared with first generation cephalosporin/metronidazole. CONCLUSIONS: The choice of IV antibiotic was related to the SSI rate; however, oral antibiotics were associated with reduced SSI rate for every antibiotic class.

Timing of surgical antibiotic prophylaxis and the risk of surgical site infection.

IMPORTANCE: Timing of prophylactic antibiotic administration for surgical procedures is a nationally mandated and publicly reported quality metric sponsored by the Centers for Medicare and Medicaid Services Surgical Care Improvement Project. Numerous studies have failed to demonstrate that adherence to the Surgical Care Improvement Project prophylactic antibiotic timely administration measure is associated with decreased surgical site infection (SSI). OBJECTIVE; To determine whether prophylactic antibiotic timing is associated with SSI occurrence. DESIGN: Retrospective cohort study using national Veterans Affairs patient-level data on prophylactic antibiotic timing for orthopedic, colorectal, vascular, and gynecologic procedures from 2005 through 2009. SETTING: National Veterans Affairs Surgical Care Improvement Project data from 112 Veterans Affairs hospitals and matched Veterans Affairs Surgical Quality Improvement Program data. PATIENTS: Patients undergoing hip or knee arthroplasty, colorectal surgical procedures, arterial vascular surgical procedures, and hysterectomy. INTERVENTION: Timing of prophylactic antibiotic administration with respect to surgical incision time. MAIN OUTCOMES AND MEASURES: Data for prophylactic antibiotic agent, prophylactic antibiotic timing with respect to surgical incision, and patient and procedure risk variables were assessed for their relationship with the occurrence of a composite superficial or deep incisional SSI within 30 days after the procedure. Nonlinear generalized additive models were used to examine the association between antibiotic timing and SSI. RESULTS: Of the 32,459 operations, prophylactic antibiotics were administered at a median of 28 minutes (interquartile range, 17-39 minutes) prior to surgical incision, and 1497 cases (4.6%) developed an SSI. Compared with procedures with antibiotic administration within 60 minutes prior to incision, higher SSI rates were observed for timing more than 60 minutes prior to incision (unadjusted odds ratio [OR] = 1.34; 95% CI, 1.08-1.66) but not after incision (unadjusted OR = 1.26; 95% CI, 0.92-1.72). In unadjusted generalized additive models, we observed a significant nonlinear relationship between prophylactic antibiotic timing and SSI when considering timing as a continuous variable (P = .01). In generalized additive models adjusted for patient, procedure, and antibiotic variables, no significant association between prophylactic antibiotic timing and SSI was observed. Vancomycin hydrochloride was associated with higher SSI occurrence for orthopedic procedures (adjusted OR = 1.75; 95% CI, 1.16-2.65). Cefazolin sodium and quinolone in combination with an anaerobic agent were associated with fewer SSI events (cefazolin: adjusted OR = 0.49; 95% CI, 0.34-0.71; quinolone: adjusted OR = 0.55; 95% CI, 0.35-0.87) for colorectal procedures. CONCLUSIONS AND RELEVANCE: The SSI risk varies by patient and procedure factors as well as antibiotic properties but is not significantly associated with prophylactic antibiotic timing. While adherence to the timely prophylactic antibiotic measure is not bad care, there is little evidence to suggest that it is better care.

Outcomes for incisional hernia repair in patients undergoing concomitant surgical procedures.

The safety and efficacy of performing concomitant surgical procedures with an incisional hernia repair (IHR) is not well understood. There are conflicting reports on the outcomes for permanent mesh implantation in the setting of clean-contaminated procedures. The purpose of this study was to review the effect of concomitant surgical procedures on IHR outcomes. This is a retrospective multisite cohort of patients undergoing elective IHR at 16 Veterans Affairs hospitals from 1998 to 2002. Concomitant procedure status, hernia characteristics, and operative details were determined using physician-abstracted operative notes. Hernia outcomes of recurrence and mesh explantation were determined from the medical chart. χ(2) tests, Kaplan-Meier curves, and Cox regression were used to evaluate the effects of concomitant status on hernia outcomes. Of the 1495 elective IHRs, 75 (4.8%) were same site and 56 (3.8%) different site concomitant procedures. At median follow-up of 69.3 months (range 19.1-98.3), 33.6 per cent of patients had a recurrence, mesh explantation, or both. Permanent mesh placement was less likely among concomitant procedures as compared with nonconcomitant procedures (P < 0.0001). Adjusted Cox proportional hazards models of hernia outcomes resulted in an increased hazard for recurrence among same site clean procedures (Hazard Ratio (HR) = 1.8, P = 0.03) and an increased hazard for mesh explantation among same site clean-contaminated procedures (HR = 8.4, P = 0.002). Concomitant same site procedures are significantly associated with adverse hernia outcomes as compared with isolated IHR or IHR with other site concomitant procedures. The high failure rate of hernia repairs among same site concomitant procedures should be taken into account during the surgical decision-making process.

Factors influencing emergency department preference for access to healthcare.

INTRODUCTION: African-Americans are more likely than Caucasians to access healthcare through the emergency department (ED); however, the reasons behind this pattern are unclear. The objective is to investigate the effect of race, insurance, socioeconomic status, and perceived health on the preference for ED use. METHODS: This is a prospective study at a tertiary care ED from June to July 2009. Patients were surveyed to capture demographics, healthcare utilization, and baseline health status. The primary outcome of interest was patient-reported routine place of healthcare. Other outcomes included frequency of ED visits in the previous 6 months, barriers to primary care and patient perception of health using select questions from the Medical Outcomes Study Short Form 36 (SF-36). RESULTS: Two hundred and ninety-two patients completed the survey of whom 58% were African-American and 44% were uninsured. African-Americans were equally likely to report 3 or more visits to the ED, but more likely to state a preference for the ED for their usual place of care (24% vs. 13%, p < 0.01). No significant differences between groups were found for barriers to primary care, including insurance. African-Americans less often reported comorbidities or hospitalization within the previous 6 months (23% vs. 34%, p = 0.04). On logistic regression modeling, African-Americans were more than 2 times as likely to select the ED as their usual place of healthcare (OR 2.24, 95% CI 1.22 - 4.08). CONCLUSION: African-Americans, independent of health insurance, are more likely than Caucasians to designate the ED as their routine place of healthcare.

Association between Surgical Care Improvement Program venous thromboembolism measures and postoperative events.

BACKGROUND: In 2006, the Surgical Care Improvement Program (SCIP) implemented measures to reduce venous thromboembolism (VTE). There are little data on whether these measures reduce VTE rates. This study proposed to examine associations between SCIP-VTE adherence and VTE rates. METHODS: SCIP-VTE adherence for 30,531 surgeries from 2006 to 2009 was linked with VA Surgical Quality Improvement Program data. Patient demographics, comorbidities, and surgical characteristics associated with VTE were summarized. VTE rates were compared by SCIP-VTE adherence. Multivariable logistic regression was used to model VTE by adherence, adjusting for multiple associated factors. RESULTS: Of 30,531 surgeries, 89.9% adhered to SCIP-VTE; 1.4% experienced VTE. Logistic regression identified obesity, smoking, functional status, weight loss, emergent status, age older than 64 years, and surgical time as associated with VTE. SCIP-VTE was not associated with VTE (1.4% vs 1.33%; P = .3), even after adjustment. CONCLUSIONS: This study identified several important risk factors for VTE but found no association with SCIP-VTE adherence.

Predictors of mesh explantation after incisional hernia repair.

BACKGROUND: Prosthetic mesh used for incisional hernia repair (IHR) reduces hernia recurrence. Mesh infection results in significant morbidity and challenges for subsequent abdominal wall reconstruction. The risk factors that lead to mesh explantation are not well known. METHODS: This is a multisite cohort study of patients undergoing IHR at 16 Veterans Affairs hospitals from 1998 to 2002. RESULTS: Of the 1,071 mesh repairs, 55 (5.1%) had subsequent mesh explantation at a median of 7.3 months (interquartile range 1.4-22.2) after IHR with permanent mesh prosthesis. Infection was the most common reason for explantation (69%). No differences were observed by the type of repair. Adjusting for covariates, same-site concomitant surgery (hazard ratio [HR] = 6.3) and postoperative surgical site infection (HR = 6.5) were associated with mesh explantation. CONCLUSIONS: Patients undergoing IHR with concomitant intra-abdominal procedures have a greater than 6-fold increased hazard of subsequent mesh explantation. Permanent prosthetic mesh should be used with caution in this setting.

Agreement between patient survey and medical chart: Pitfalls in measurement strategies for hernia recurrence.

BACKGROUND: Little information is available on agreement between patient-reported outcomes and data collected from medical chart abstraction (MCA) for recurring events. Recurring conditions pose a risk of misclassification, especially when events occur relatively close together in time. We examined agreement, predictors of agreement, and relative accuracy of patient survey and MCA for assessment of outcomes of incisional hernia repair (IHR). METHODS: Surveys to assess hernia outcomes were mailed to 1,124 living patients who underwent ≥ 1 IHR during 1998-2002 at 16 Veteran's Affairs Medical Center study sites. Patients were asked if they developed a recurrence or an infection at their hernia site. Physician-abstracted data from the medical chart were compared with patient response. Chi-square tests were used to assess significance. RESULTS: Of 487 (43.3%) individuals responding to the survey, 33 (6.8%) with >1 re-repair during 1998-2002 and 98 (20.5%) with a repair before the 1998-2002 period were excluded from the analysis. Although recurrence rates derived from self-reported data and data abstracted from the medical chart were similar (29.3% and 26.1%, respectively), overall concordance was low. Only 49% (n = 54) of self-reported recurrences were confirmed by data abstracted from the medical chart. In addition, 16 (8.3%) recurrences abstracted from the medical chart were not reported by the patient. Factors associated with discordance were high reported pain intensity (P = .02), poorer general health (P = .03), and poorer perceived repair results (P < .0001). CONCLUSION: Multiple recurrences and subsequent operations across the study period complicate the interpretation of both patient response and data abstracted from the medical chart when referring to a hernia repair. Further study on how best to assess treatment outcomes for recurring conditions is warranted.