Health Care Resource Utilization and Exacerbation Rates in Patients with COPD Stratified by Disease Severity in a Commercially Insured Population.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality and is associated with substantial economic burden. There is a lack of data regarding COPD outcomes and costs in a real-world setting, particularly by Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity. OBJECTIVES: To (a) characterize a commercially insured U.S. population with COPD and (b) assess prevalence of exacerbations, health care resource utilization (HCRU), costs, and treatment patterns in a cohort of patients with confirmed COPD, overall and stratified by GOLD stage. METHODS: This retrospective observational cohort study used administrative claims data from the HealthCore Integrated Research Database to identify patients with ≥ 1 inpatient, emergency room (ER), or office visit claim for COPD between January 1, 2012, and November 30, 2013, and continuous enrollment for 1 year before and 2 years after the first COPD diagnosis date. Patients with a spirometry claim within 12 months were eligible for medical record abstraction to confirm COPD diagnosis (forced expiratory volume in 1 second [FEV1]/forced vital capacity ratio < 0.7) and GOLD 1-4 classification (based on postbronchodilator FEV1 percent predicted). HCRU, costs, treatment patterns, and rate of moderate/severe exacerbation were identified from diagnosis up to 24 months. Outcomes were analyzed by univariate analysis stratified by GOLD classification. Multivariable analysis was conducted to assess associations between GOLD classification and outcomes of interest. RESULTS: 53,484 patients newly diagnosed with COPD were identified who met initial inclusion criteria: 14,293 (27%) had a qualifying spirometry claim, and 1,505 had confirmed COPD (GOLD 1, 333 [22%]; GOLD 2, 823 [55%]; GOLD 3, 317 [21%]; GOLD 4, 32 [2%]). Patients with greater disease severity had higher rates of moderate/severe COPD exacerbations (GOLD 1 and 2, 40.4 and 48.9 per 100 person-years, respectively; GOLD 3 and 4, 83.6 and 89.1 per 100 person-years, respectively). All-cause and COPD-related inpatient admissions, COPD-related office visits, and COPD-related ER visits were more prevalent with more severe GOLD classification. Mean annual COPD-related medical costs increased with GOLD classification ($5,945 for GOLD 1 patients, $18,070 for GOLD 4). COPD maintenance medication was filled by 42%, 56%, 73%, and 75% of patients in GOLD 1-4 (57% overall), respectively; combination corticosteroid/long-acting beta2-agonist inhalers were the most commonly used medication, regardless of GOLD classification. Patients with more severe disease had greater adherence (range 44%-68% of days covered for GOLD 1-4) and persistence (range 107-209 days for GOLD 1-4). CONCLUSIONS: Trends toward increases in exacerbations, HCRU, and costs were observed as airflow limitation worsened. Adherence and persistence with COPD maintenance therapy was suboptimal even with severe disease. DISCLOSURES: This study was supported by Boehringer Ingelheim Pharmaceuticals (Ridgefield, CT), which was given the opportunity to review the manuscript for medical and scientific accuracy, as well as intellectual property considerations. Willey and Singer are employees of HealthCore (parent company Anthem), which received funding from Boehringer Ingelheim to complete this study. Wallace and Shinde were employed by HealthCore at the time of this study. Wallace and Singer report stock ownership in Anthem. Napier is an employee of Anthem. Kaila, Bayer, and Shaikh are employees of Boehringer Ingelheim Pharmaceuticsls. Portions of this research were presented at the following conferences: (a) A. Wallace, S. Kaila, V. Zubek, A. Shaikh, M. Shinde, V. Willey, M. Napier, and J. Singer, Healthcare resource utilization, costs, and exacerbation rates in patients with COPD stratified by GOLD airflow limitation classification in a US commercially insured population, presented at AMCP Nexus 2017; October 16-19, 2017; Dallas, TX; and (b) A.E. Wallace, V. Zubek, S. Kaila, A. Shaikh, M. Shinde, V. Willey, M.B. Napier, and J.R. Singer, Real-world treatment patterns among newly diagnosed COPD patients according to GOLD airflow limitation severity classification in a U.S. commercially insured/Medicare Advantage population, presented at CHEST 2017 Annual Meeting; October 28-November 1, 2017; Toronto, Ontario, Canada.

Prevalence and Predictors of Postdischarge Antibiotic Use Following Mastectomy.

OBJECTIVE Survey results suggest that prolonged administration of prophylactic antibiotics is common after mastectomy with reconstruction. We determined utilization, predictors, and outcomes of postdischarge prophylactic antibiotics after mastectomy with or without immediate breast reconstruction. DESIGN Retrospective cohort. PATIENTS Commercially insured women aged 18-64 years coded for mastectomy from January 2004 to December 2011 were included in the study. Women with a preexisting wound complication or septicemia were excluded. METHODS Predictors of prophylactic antibiotics within 5 days after discharge were identified in women with 1 year of prior insurance enrollment; relative risks (RR) were calculated using generalized estimating equations. RESULTS Overall, 12,501 mastectomy procedures were identified; immediate reconstruction was performed in 7,912 of these procedures (63.3%). Postdischarge prophylactic antibiotics were used in 4,439 procedures (56.1%) with immediate reconstruction and 1,053 procedures (22.9%) without immediate reconstruction (P.05). CONCLUSIONS Prophylactic postdischarge antibiotics are commonly prescribed after mastectomy; immediate reconstruction is the strongest predictor. Stewardship efforts in this population to limit continuation of prophylactic antibiotics after discharge are needed to limit antimicrobial resistance. Infect Control Hosp Epidemiol 2017;38:1048-1054.

Comparison of Wound Complications After Immediate, Delayed, and Secondary Breast Reconstruction Procedures.

IMPORTANCE: Few data are available concerning surgical site infection (SSI) and noninfectious wound complications (NIWCs) after delayed (DR) and secondary reconstruction (SR) compared with immediate reconstruction (IR) procedures in the breast. OBJECTIVE: To compare the incidence of SSI and NIWCs after implant and autologous IR, DR, and SR breast procedures after mastectomy. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included women aged 18 to 64 years undergoing mastectomy from January 1, 2004, through December 31, 2011. Data were abstracted from a commercial insurer claims database in 12 states and analyzed from January 1, 2015, through February 7, 2017. EXPOSURES: Reconstruction within 7 days of mastectomy was considered immediate. Reconstruction more than 7 days after mastectomy was considered delayed if the mastectomy did not include IR or secondary if the mastectomy included IR. MAIN OUTCOMES AND MEASURES: International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes for SSI and NIWCs. RESULTS: Mastectomy was performed in 17 293 women (mean [SD] age, 50.4 [8.5] years); 61.4% of women had IR or DR. Among patients undergoing implant reconstruction, the incidence of SSI was 8.9% (685 of 7655 women) for IR, 5.7% (21 of 369) for DR, and 3.2% (167 of 5150) for SR. Similar results were found for NIWCs. In contrast, the incidence of SSI was similar after autologous IR (9.8% [177 of 1799]), DR (13.9% [19 of 137]), and SR (11.6% [11 of 95]) procedures. Compared with women without an SSI after implant IR, women with an SSI after implant IR were significantly more likely to have another SSI (47 of 412 [11.4%] vs 131 of 4791 [2.7%]) and an NIWC (24 of 412 [5.8%] vs 120 of 4791 [2.5%]) after SR. The incidence of SSI (24 of 379 [6.3%] vs 152 of 5286 [2.9%]) and NIWC (22 of 379 [5.8%] vs 129 of 5286 [2.4%]) after implant SR was higher in women who had received adjuvant radiotherapy. Wound complications after IR were associated with significantly more breast surgical procedures (mean of 1.92 procedures [range, 0-9] after implant IR and 1.11 [range, 0-6] after autologous IR) compared with women who did not have a complication (mean of 1.37 procedures [range, 0-8] after implant IR and 0.87 [range, 0-6] after autologous IR). CONCLUSIONS AND RELEVANCE: The incidence of SSI and NIWCs was slightly higher for implant IR compared with delayed or secondary implant reconstruction. Women who had an SSI or NIWC after implant IR had a higher risk for subsequent complications after SR and more breast operations. The risk for complications should be carefully balanced with the psychosocial and technical benefits of IR. Select high-risk patients may benefit from consideration of delayed rather than immediate implant reconstruction to decrease breast complications after mastectomy.

Risk Factors for Surgical Site Infection After Cholecystectomy.

BACKGROUND: There are limited data on risk factors for surgical site infection (SSI) after open or laparoscopic cholecystectomy. METHODS: A retrospective cohort of commercially insured persons aged 18-64 years was assembled using International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) procedure or Current Procedural Terminology, 4th edition codes for cholecystectomy from December 31, 2004 to December 31, 2010. Complex procedures and patients (eg, cancer, end-stage renal disease) and procedures with pre-existing infection were excluded. Surgical site infections within 90 days after cholecystectomy were identified by ICD-9-CM diagnosis codes. A Cox proportional hazards model was used to identify independent risk factors for SSI. RESULTS: Surgical site infections were identified after 472 of 66566 (0.71%) cholecystectomies; incidence was higher after open (n = 51, 4.93%) versus laparoscopic procedures (n = 421, 0.64%; P < .001). Independent risk factors for SSI included male gender, preoperative chronic anemia, diabetes, drug abuse, malnutrition/weight loss, obesity, smoking-related diseases, previous Staphylococcus aureus infection, laparoscopic approach with acute cholecystitis/obstruction (hazards ratio [HR], 1.58; 95% confidence interval [CI], 1.27-1.96), open approach with (HR, 4.29; 95% CI, 2.45-7.52) or without acute cholecystitis/obstruction (HR, 4.04; 95% CI, 1.96-8.34), conversion to open approach with (HR, 4.71; 95% CI, 2.74-8.10) or without acute cholecystitis/obstruction (HR, 7.11; 95% CI, 3.87-13.08), bile duct exploration, postoperative chronic anemia, and postoperative pneumonia or urinary tract infection. CONCLUSIONS: Acute cholecystitis or obstruction was associated with significantly increased risk of SSI with laparoscopic but not open cholecystectomy. The risk of SSI was similar for planned open and converted procedures. These findings suggest that stratification by operative factors is important when comparing SSI rates between facilities.

Use of Quantile Regression to Determine the Impact on Total Health Care Costs of Surgical Site Infections Following Common Ambulatory Procedures.

OBJECTIVE: To determine the impact of surgical site infections (SSIs) on health care costs following common ambulatory surgical procedures throughout the cost distribution. BACKGROUND: Data on costs of SSIs following ambulatory surgery are sparse, particularly variation beyond just mean costs. METHODS: We performed a retrospective cohort study of persons undergoing cholecystectomy, breast-conserving surgery, anterior cruciate ligament reconstruction, and hernia repair from December 31, 2004 to December 31, 2010 using commercial insurer claims data. SSIs within 90 days post-procedure were identified; infections during a hospitalization or requiring surgery were considered serious. We used quantile regression, controlling for patient, operative, and postoperative factors to examine the impact of SSIs on 180-day health care costs throughout the cost distribution. RESULTS: The incidence of serious and nonserious SSIs was 0.8% and 0.2%, respectively, after 21,062 anterior cruciate ligament reconstruction, 0.5% and 0.3% after 57,750 cholecystectomy, 0.6% and 0.5% after 60,681 hernia, and 0.8% and 0.8% after 42,489 breast-conserving surgery procedures. Serious SSIs were associated with significantly higher costs than nonserious SSIs for all 4 procedures throughout the cost distribution. The attributable cost of serious SSIs increased for both cholecystectomy and hernia repair as the quantile of total costs increased ($38,410 for cholecystectomy with serious SSI vs no SSI at the 70th percentile of costs, up to $89,371 at the 90th percentile). CONCLUSIONS: SSIs, particularly serious infections resulting in hospitalization or surgical treatment, were associated with significantly increased health care costs after 4 common surgical procedures. Quantile regression illustrated the differential effect of serious SSIs on health care costs at the upper end of the cost distribution.

Validation of ICD-9-CM Diagnosis Codes for Surgical Site Infection and Noninfectious Wound Complications After Mastectomy.

BACKGROUND Few studies have validated ICD-9-CM diagnosis codes for surgical site infection (SSI), and none have validated coding for noninfectious wound complications after mastectomy. OBJECTIVES To determine the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes in health insurer claims data to identify SSI and noninfectious wound complications, including hematoma, seroma, fat and tissue necrosis, and dehiscence, after mastectomy. METHODS We reviewed medical records for 275 randomly selected women who were coded in the claims data for mastectomy with or without immediate breast reconstruction and had an ICD-9-CM diagnosis code for a wound complication within 180 days after surgery. We calculated the positive predictive value (PPV) to evaluate the accuracy of diagnosis codes in identifying specific wound complications and the PPV to determine the accuracy of coding for the breast surgical procedure. RESULTS The PPV for SSI was 57.5%, or 68.9% if cellulitis-alone was considered an SSI, while the PPV for cellulitis was 82.2%. The PPVs of individual noninfectious wound complications ranged from 47.8% for fat necrosis to 94.9% for seroma and 96.6% for hematoma. The PPVs for mastectomy, implant, and autologous flap reconstruction were uniformly high (97.5%-99.2%). CONCLUSIONS Our results suggest that claims data can be used to compare rates of infectious and noninfectious wound complications after mastectomy across facilities, even though PPVs vary by specific type of postoperative complication. The accuracy of coding was highest for cellulitis, hematoma, and seroma, and a composite group of noninfectious complications (fat necrosis, tissue necrosis, or dehiscence). Infect Control Hosp Epidemiol 2017;38:334-339.

Modification of claims-based measures improves identification of comorbidities in non-elderly women undergoing mastectomy for breast cancer: a retrospective cohort study.

BACKGROUND: Accurate identification of underlying health conditions is important to fully adjust for confounders in studies using insurer claims data. Our objective was to evaluate the ability of four modifications to a standard claims-based measure to estimate the prevalence of select comorbid conditions compared with national prevalence estimates. METHODS: In a cohort of 11,973 privately insured women aged 18-64 years with mastectomy from 1/04-12/11 in the HealthCore Integrated Research Database, we identified diabetes, hypertension, deficiency anemia, smoking, and obesity from inpatient and outpatient claims for the year prior to surgery using four different algorithms. The standard comorbidity measure was compared to revised algorithms which included outpatient medications for diabetes, hypertension and smoking; an expanded timeframe encompassing the mastectomy admission; and an adjusted time interval and number of required outpatient claims. A χ2 test of proportions was used to compare prevalence estimates for 5 conditions in the mastectomy population to national health survey datasets (Behavioral Risk Factor Surveillance System and the National Health and Nutrition Examination Survey). Medical record review was conducted for a sample of women to validate the identification of smoking and obesity. RESULTS: Compared to the standard claims algorithm, use of the modified algorithms increased prevalence from 4.79 to 6.79 % for diabetes, 14.75 to 24.87 % for hypertension, 4.23 to 6.65 % for deficiency anemia, 1.78 to 12.87 % for smoking, and 1.14 to 6.31 % for obesity. The revised estimates were more similar, but not statistically equivalent, to nationally reported prevalence estimates. Medical record review revealed low sensitivity (17.86 %) to capture obesity in the claims, moderate negative predictive value (NPV, 71.78 %) and high specificity (99.15 %) and positive predictive value (PPV, 90.91 %); the claims algorithm for current smoking had relatively low sensitivity (62.50 %) and PPV (50.00 %), but high specificity (92.19 %) and NPV (95.16 %). CONCLUSIONS: Modifications to a standard comorbidity measure resulted in prevalence estimates that were closer to expected estimates for non-elderly women than the standard measure. Adjustment of the standard claims algorithm to identify underlying comorbid conditions should be considered depending on the specific conditions and the patient population studied.

Patients With Hepatocellular Carcinoma Have Highest Rates of Wait-listing for Liver Transplantation Among Patients With End-Stage Liver Disease.

BACKGROUND & AIMS: Despite recent attention to differences in access to livers for transplantation, research has focused on patients already on the wait list. We analyzed data from a large administrative database that represents the entire US population, and state Medicaid data, to identify factors associated with differences in access to wait lists for liver transplantation. METHODS: We performed a retrospective cohort study of transplant-eligible patients with end-stage liver disease using the HealthCore Integrated Research Database (2006-2014; n = 16,824) and Medicaid data from 5 states (2002-2009; California, Florida, New York, Ohio, and Pennsylvania; n = 67,706). Transplant-eligible patients had decompensated cirrhosis, hepatocellular carcinoma (HCC), and/or liver synthetic dysfunction, based on validated International Classification of Diseases, Ninth Revision-based algorithms and data from laboratory studies. Placement on the wait list was determined through linkage with the Organ Procurement and Transplantation Network database. RESULTS: In an unadjusted analysis of the HealthCore database, we found that 29% of patients with HCC were placed on the 2-year wait list (95% confidence interval [CI], 25.4%-33.0%) compared with 11.9% of patients with stage 4 cirrhosis (ascites) (95% CI, 11.0%-12.9%) and 12.6% of patients with stage 5 cirrhosis (ascites and variceal bleeding) (95% CI, 9.4%-15.2%). Among patients with each stage of cirrhosis, those with HCC were significantly more likely to be placed on the wait list; adjusted subhazard ratios ranged from 1.7 (for patients with stage 5 cirrhosis and HCC vs those without HCC) to 5.8 (for patients with stage 1 cirrhosis with HCC vs those without HCC). Medicaid beneficiaries with HCC were also more likely to be placed on the transplant wait list, compared with patients with decompensated cirrhosis, with a subhazard ratio of 2.34 (95% CI, 2.20-2.49). Local organ supply and wait list level demand were not associated with placement on the wait list. CONCLUSIONS: In an analysis of US healthcare databases, we found patients with HCC to be more likely to be placed on liver transplant wait lists than patients with decompensated cirrhosis. Previously reported reductions in access to transplant care for wait-listed patients with decompensated cirrhosis underestimate the magnitude of this difference.

Effect of Noninfectious Wound Complications after Mastectomy on Subsequent Surgical Procedures and Early Implant Loss.

BACKGROUND: Noninfectious wound complications (NIWCs) after mastectomy are not routinely tracked and data are generally limited to single-center studies. Our objective was to determine the rates of NIWCs among women undergoing mastectomy and assess the impact of immediate reconstruction (IR). STUDY DESIGN: We established a retrospective cohort using commercial claims data of women aged 18 to 64 years with procedure codes for mastectomy from January 2004 through December 2011. Noninfectious wound complications within 180 days after operation were identified by ICD-9-CM diagnosis codes and rates were compared among mastectomy with and without autologous flap and/or implant IR. RESULTS: There were 18,696 procedures (10,836 [58%] with IR) among 18,085 women identified. The overall NIWC rate was 9.2% (1,714 of 18,696); 56% required surgical treatment. The NIWC rates were 5.8% (455 of 7,860) after mastectomy only, 10.3% (843 of 8,217) after mastectomy plus implant, 17.4% (337 of 1,942) after mastectomy plus flap, and 11.7% (79 of 677) after mastectomy plus flap and implant (p < 0.001). Rates of individual NIWCs varied by specific complication and procedure type, ranging from 0.5% for fat necrosis after mastectomy only, to 7.2% for dehiscence after mastectomy plus flap. The percentage of NIWCs resulting in surgical wound care varied from 50% (210 of 416) for mastectomy plus flap, to 60% (507 of 843) for mastectomy plus implant. Early implant removal within 60 days occurred after 6.2% of mastectomy plus implant; 66% of the early implant removals were due to NIWCs and/or surgical site infection. CONCLUSIONS: The rate of NIWC was approximately 2-fold higher after mastectomy with IR than after mastectomy only. Noninfectious wound complications were associated with additional surgical treatment, particularly in women with implant reconstruction, and with early implant loss.

Development of a Risk Prediction Model to Individualize Risk Factors for Surgical Site Infection After Mastectomy.

BACKGROUND: Little data are available regarding individual patients' risk of surgical site infection (SSI) following mastectomy with or without immediate reconstruction. Our objective was to develop a risk prediction model for mastectomy-related SSI. METHODS: Using commercial claims data, we established a cohort of women <65 years of age who underwent a mastectomy from 1 January 2004-31 December 2011. International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes were used to identify SSI within 180 days after surgery. SSI risk factors were determined with multivariable logistic regression using derivation data from 2004-2008 and validated with 2009-2011 data using discrimination and calibration measures. RESULTS: In the derivation cohort, 595 SSIs were identified in 7607 (7.8 %) women, and 396 SSIs were coded in 4366 (9.1 %) women in the validation cohort. Independent risk factors for SSIs included rural residence, rheumatologic disease, depression, diabetes, hypertension, liver disease, obesity, pre-existing pneumonia or urinary tract infection, tobacco use disorder, smoking-related diseases, bilateral mastectomy, and immediate reconstruction. Receipt of home healthcare was associated with lower risk. The model performed equally in the validation cohort per discrimination (C-statistics 0.657 and 0.649) and calibration (Hosmer-Lemeshow p = 0.091 and 0.462 for derivation and validation, respectively). Three risk strata were created based on predicted SSI risk, which demonstrated good correlation with the proportion of observed infections in the strata. CONCLUSIONS: We developed and internally validated an SSI risk prediction model that can be used to counsel women with regard to their individual risk of SSI post-mastectomy. Immediate reconstruction, diabetes, and smoking-related diseases were important risk factors for SSI in this non-elderly population of women undergoing mastectomy.

Bayesian estimation of the accuracy of ICD-9-CM- and CPT-4-based algorithms to identify cholecystectomy procedures in administrative data without a reference standard.

PURPOSE: To estimate the accuracy of two algorithms to identify cholecystectomy procedures using International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM) and Current Procedural Terminology (CPT-4) codes in administrative data. METHODS: Private insurer medical claims for 30 853 patients 18-64 years with an inpatient hospitalization between 2006 and 2010, as indicated by providers/facilities place of service in addition to room and board charges, were cross-classified according to the presence of codes for cholecystectomy. The accuracy of ICD-9-CM- and CPT-4-based algorithms was estimated using a Bayesian latent class model. RESULTS: The sensitivity and specificity were 0.92 [probability interval (PI): 0.92, 0.92] and 0.99 (PI: 0.97, 0.99) for ICD-9-CM-, and 0.93 (PI: 0.92, 0.93) and 0.99 (PI: 0.97, 0.99) for CPT-4-based algorithms, respectively. The parallel-joint scheme, where positivity of either algorithm was considered a positive outcome, yielded a sensitivity and specificity of 0.99 (PI: 0.99, 0.99) and 0.97 (PI: 0.95, 0.99), respectively. CONCLUSIONS: Both ICD-9-CM- and CPT-4-based algorithms had high sensitivity to identify cholecystectomy procedures in administrative data when used individually and especially in a parallel-joint approach.

Incidence of Surgical Site Infection Following Mastectomy With and Without Immediate Reconstruction Using Private Insurer Claims Data.

OBJECTIVE: The National Healthcare Safety Network classifies breast operations as clean procedures with an expected 1%-2% surgical site infection (SSI) incidence. We assessed differences in SSI incidence following mastectomy with and without immediate reconstruction in a large, geographically diverse population. DESIGN: Retrospective cohort study. PATIENTS: Commercially insured women aged 18-64 years with ICD-9-CM procedure or CPT-4 codes for mastectomy from January 1, 2004 through December 31, 2011 METHODS: Incident SSIs within 180 days after surgery were identified by ICD-9-CM diagnosis codes. The incidences of SSI after mastectomy with and without immediate reconstruction were compared using the χ2 test. RESULTS: From 2004 to 2011, 18,696 mastectomy procedures among 18,085 women were identified, with immediate reconstruction in 10,836 procedures (58%). The incidence of SSI within 180 days following mastectomy with or without reconstruction was 8.1% (1,520 of 18,696). In total, 49% of SSIs were identified within 30 days post-mastectomy, 24.5% were identified 31-60 days post-mastectomy, 10.5% were identified 61-90 days post-mastectomy, and 15.7% were identified 91-180 days post-mastectomy. The incidences of SSI were 5.0% (395 of 7,860) after mastectomy only, 10.3% (848 of 8,217) after mastectomy plus implant, 10.7% (207 of 1,942) after mastectomy plus flap, and 10.3% (70 of 677) after mastectomy plus flap and implant (P<.001). The SSI risk was higher after bilateral compared with unilateral mastectomy with immediate reconstruction (11.4% vs 9.4%, P=.001) than without (6.1% vs 4.7%, P=.021) immediate reconstruction. CONCLUSIONS: SSI incidence was twice that after mastectomy with immediate reconstruction than after mastectomy alone. Only 49% of SSIs were coded within 30 days after operation. Our results suggest that stratification by procedure type facilitates comparison of SSI rates after breast operations between facilities.

Stratification of surgical site infection by operative factors and comparison of infection rates after hernia repair.

OBJECTIVE: To investigate whether operative factors are associated with risk of surgical site infection (SSI) after hernia repair. DESIGN: Retrospective cohort study. Patients Commercially insured enrollees aged 6 months-64 years with International Classification of Diseases, Ninth Revision, Clinical Modification procedure or Current Procedural Terminology, fourth edition, codes for inguinal/femoral, umbilical, and incisional/ventral hernia repair procedures from January 1, 2004, through December 31, 2010. METHODS: SSIs within 90 days after hernia repair were identified by diagnosis codes. The χ2 and Fisher exact tests were used to compare SSI incidence by operative factors. RESULTS: A total of 119,973 hernia repair procedures were analyzed. The incidence of SSI differed significantly by anatomic site, with rates of 0.45% (352/77,666) for inguinal/femoral, 1.16% (288/24,917) for umbilical, and 4.11% (715/17,390) for incisional/ventral hernia repair. Within anatomic sites, the incidence of SSI was significantly higher for open versus laparoscopic inguinal/femoral (0.48% [295/61,142] vs 0.34% [57/16,524], P=.020) and incisional/ventral (4.20% [701/16,699] vs 2.03% [14/691], P=.005) hernia repairs. The rate of SSI was higher following procedures with bowel obstruction/necrosis than procedures without obstruction/necrosis for open inguinal/femoral (0.89% [48/5,422] vs 0.44% [247/55,720], P<.001) and umbilical (1.57% [131/8,355] vs 0.95% [157/16,562], P<.001), but not incisional/ventral hernia repair (4.01% [224/5,585] vs 4.16% [491/11,805], P=.645). CONCLUSIONS: The incidence of SSI was highest after open procedures, incisional/ventral repairs, and hernia repairs with bowel obstruction/necrosis. Stratification of hernia repair SSI rates by some operative factors may facilitate accurate comparison of SSI rates between facilities.

Increased Risk of Surgical Site Infection Among Breast-Conserving Surgery Re-excisions.

PURPOSE: The aim of this study was to determine the risk of surgical site infection (SSI) after primary breast-conserving surgery (BCS) versus re-excision among women with carcinoma in situ or invasive breast cancer. METHODS: We established a retrospective cohort of women aged 18-64 years with International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure or Current Procedural Terminology, 4th edition (CPT-4) codes for BCS from 29 June 2004 to 31 December 2010. Prior insurance plan enrollment of at least 180 days was required to establish the index BCS; subsequent re-excisions within 180 days were identified. SSIs occurring 2-90 days after BCS were identified by ICD-9-CM diagnosis codes. The attributable surgery was defined based on SSI onset compared with the BCS date(s). A χ (2) test and generalized estimating equations model were used to compare the incidence of SSI after index and re-excision BCS procedures. RESULTS: Overall, 23,001 women with 28,827 BCSs were identified; 23.2 % of women had more than one BCS. The incidence of SSI was 1.82 % (418/23,001) for the index BCS and 2.44 % (142/5,826) for re-excision BCS (p = 0.002). The risk of SSI after re-excision remained significantly higher after accounting for multiple procedures within a woman (odds ratio 1.34, 95 % confidence interval 1.07-1.68). CONCLUSIONS: Surgeons need to be aware of the increased risk of SSI after re-excision BCS compared with the initial procedure. Our results suggest that risk adjustment of SSI rates for re-excision would allow for better comparison of BCS SSI rates between institutions.

Can additional information be obtained from claims data to support surgical site infection diagnosis codes?

OBJECTIVE: International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes are increasingly used to identify healthcare-associated infections, often with insufficient evidence demonstrating validity of the codes used. Absent medical record verification, we sought to confirm a claims algorithm to identify surgical site infections (SSIs) by examining the presence of clinically expected SSI treatment. METHODS: We performed a retrospective cohort study, using private insurer claims data from persons less than 65 years old with ICD-9-CM procedure or Current Procedure Terminology (CPT-4) codes for anterior cruciate ligament (ACL) reconstruction from January 2004 through December 2010. SSIs occurring within 90 days after ACL reconstruction were identified by ICD-9-CM diagnosis codes. Antibiotic utilization, surgical treatment, and microbiology culture claims within 14 days of SSI codes were used as evidence to support the SSI diagnosis. RESULTS: Of 40,702 procedures, 401 (1.0%) were complicated by SSI, 172 (0.4%) of which were specifically identified as septic arthritis. Most SSIs were associated with an inpatient admission (232/401 [58%]), and/or surgical procedure(s) for treatment (250/401 [62%]). Temporally associated antibiotics, surgical treatment procedures, and cultures were present for 84% (338/401), 61% (246/401), and 59% (238/401), respectively. Only 5.7% (23/401) of procedures coded for SSI after the procedure had no antibiotics, surgical treatments, or cultures within 14 days of the SSI claims. CONCLUSIONS: More than 94% of patients identified by our claims algorithm as having an SSI received clinically expected treatment for infection, including antibiotics, surgical treatment, and culture, suggesting that this algorithm has very good positive predictive value. This method may facilitate retrospective SSI surveillance and comparison of SSI rates across facilities and providers.

Immune globulins and thrombotic adverse events as recorded in a large administrative database in 2008 through 2010.

BACKGROUND: Thrombotic events (TEs) are rare but often serious adverse events that could occur after administration of immune globulin (IG) products. Our study objective was to assess occurrence of recorded TEs after administration of different US-licensed IG products and investigate potential risk factors using a large administrative database. STUDY DESIGN AND METHODS: This is a retrospective claims-based cohort study of individuals exposed to IG products from January 1, 2008, through September 30, 2010, using HealthCore's Integrated Research Database, a longitudinal health care database. IG products were identified by recorded Healthcare Common Procedure Coding System codes. TEs were ascertained via International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. Logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for same-day TEs by IG product, while controlling for confounders. RESULTS: Of 11,785 individuals exposed to IG products in the study period, 122 (1%) had TE(s) recorded on the same day as IG administration. TE rates per 1000 persons exposed ranged from 6.1 to 20.5 for different IG product groups. Vivaglobin users had an increased same-day TE risk compared to reference Gammagard Liquid users (OR, 3.56; 95% CI, 1.54-8.23). An increased TE risk was also found with older age (≥ 45 years), prior TE(s), and hypercoagulable state(s). CONCLUSION: The study suggests potentially elevated TE rates for different IG products, including subcutaneous. It also identifies important recipient TE risk factors and suggests that risk-benefit profiles should be weighed before IG administration. The observed differences may be due to various factors such as dosage, administration rates, and product manufacturing processes that warrant further evaluation.

Obstetric and parental psychiatric variables as potential predictors of autism severity.

Associations between obstetric and parental psychiatric variables and subjects' Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS) domain scores were examined using linear mixed effects models. Data for the 228 families studied were provided by the Autism Genetic Resource Exchange. Hypertension (P = 0.002), preeclampsia (P = 0.021) and generalized edema (P = 0.011) were associated with higher ADI-R communication scores. Hypertension (P = 0.011), albuminuria (P = 0.039) and generalized edema (P = 0.009) were associated with higher ADI-R repetitive behaviors scores. Parent depression was associated with higher ADI-R repetitive behaviors scores (P = 0.005), and parent anxiety with lower ADOS social/communication composite scores (P = 0.025). The associations between hypertension-related obstetric conditions and autistic severity warrant further investigation and raise intriguing questions regarding potential causal and modifying factors in autism.