Meaningful Patient-centered Outcomes 1 Year Following Cardiac Surgery.

OBJECTIVE: To evaluate meaningful, patient-centered outcomes including alive-at-home status and patient-reported quality of life 1 year after cardiac surgery. BACKGROUND: Long-term patient-reported quality of life after cardiac surgery is not well understood. Current operative risk models and quality metrics focus on short-term outcomes. METHODS: In this combined retrospective/prospective study, cardiac surgery patients at an academic institution (2014-2015) were followed to obtain vital status, living location, and patient-reported outcomes (PROs) at 1 year using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS). We assessed the impact of cardiac surgery, discharge location, and Society of Thoracic Surgeons perioperative predicted risk of morbidity or mortality on 1-year outcomes. RESULTS: A total of 782 patients were enrolled; 84.1% (658/782) were alive-at-home at 1 year. One-year PROMIS scores were global physical health (GPH) = 48.8 ±â€Š10.2, global mental health (GMH) = 51.2 ±â€Š9.6, and physical functioning (PF) = 45.5 ±â€Š10.2 (general population reference = 50 ±â€Š10). All 3 PROMIS domains at 1 year were significantly higher compared with preoperative scores (GPH: 41.7 ±â€Š8.5, GMH: 46.9 ±â€Š7.9, PF: 39.6 ±â€Š9.0; all P < 0.001). Eighty-two percent of patients discharged to a facility were alive-at-home at 1 year. These patients, however, had significantly lower 1-year scores (difference: GPH = -5.1, GMH = -5.1, PF = -7.9; all P < 0.001). Higher Society of Thoracic Surgeons perioperative predicted risk was associated with significantly lower PRO at 1 year (P < 0.001). CONCLUSIONS: Cardiac surgery results in improved PROMIS scores at 1 year, whereas discharge to a facility and increasing perioperative risk correlate with worse long-term PRO. One-year alive-at-home status and 1-year PRO are meaningful, patient-centered metrics that help define long-term quality and the benefit of cardiac surgery.

Liver transplant candidates have impaired quality of life across health domains as assessed by computerized testing.

INTRODUCTION AND OBJECTIVES: Liver transplantation candidates are among the most comorbid patients awaiting lifesaving intervention. Health related quality of life (HRQOL) measured by instruments that incorporate dynamic computerized adaptive testing, could improve their assessment. We aimed to determine the feasibility of administration of the Patient-Reported Outcomes Measurement Information System (PROMIS-CAT) in liver transplant candidates. MATERIALS AND METHODS: Liver transplantation candidates were prospectively enrolled following a review of their available medical history. Subjects were given a tablet computer (iPad) to access the pre-loaded PROMIS CAT. RESULTS: 109 candidates with mean age 55.6±8.6 years were enrolled in this pilot study. Mean MELD-Na score was 16.3±6.3; 92.6% had decompensated liver disease. Leading etiologies of cirrhosis included hepatitis C (34.8%), nonalcoholic steatohepatitis (25.7%) and alcohol (21.1%). Subjects with MELD-Na score>20 had the most significant impairment in HRQOL (anxiety/fear+5.9±2.7, p=0.0289, depression+5.1±2.5, p=0.0428, fatigue+4.3±2.6, p=0.0973) and physical impairment (-7.8±2.5, p=0.0022). Stage of cirrhosis and decompensated liver disease were predictive of impaired HRQOL but Child-Pugh Turcotte score was not. Hepatic encephalopathy was the strongest independent predictor of impaired HRQOL, with significant impairment across all domains of health. CONCLUSIONS: Liver transplant candidates have significantly impaired HRQOL across multiple domains of health as measured by PROMIS-CAT. HRQOL impairment parallels disease severity. Future study is needed to determine how best HRQOL could be systematically included in liver transplantation listing policy, especially in those candidates with hepatic encephalopathy.

More Frequent Surveillance Following Lung Cancer Resection Is Not Associated With Improved Survival: A Nationally Representative Cohort Study.

OBJECTIVE: To evaluate whether an association exists between the intensity of surveillance following surgical resection for non-small cell lung cancer (NSCLC) and survival. BACKGROUND: Surveillance guidelines following surgical resection of NSCLC vary widely and are based on expert opinion and limited evidence. METHODS: A Special Study of the National Cancer Database randomly selected stage I to III NSCLC patients for data reabstraction. For patients diagnosed between 2006 and 2007 and followed for 5 years through 2012, registrars documented all postsurgical imaging with indication (routine surveillance, new symptoms), recurrence, new primary cancers, and survival, with 5-year follow-up. Patients were placed into surveillance groups according to existing guidelines (3-month, 6-month, annual). Overall survival and survival after recurrence were analyzed using Cox Proportional Hazards Models. RESULTS: A total of 4463 patients were surveilled with computed tomography scans; these patients were grouped based on time from surgery to first surveillance. Groups were similar with respect to age, sex, comorbidities, surgical procedure, and histology. Higher-stage patients received more surveillance. More frequent surveillance was not associated with longer risk-adjusted overall survival [hazard ratio for 6-month: 1.16 (0.99, 1.36) and annual: 1.06 (0.86-1.31) vs 3-month; P value 0.14]. More frequent imaging was also not associated with postrecurrence survival [hazard ratio: 1.02/month since imaging (0.99-1.04); P value 0.43]. CONCLUSIONS: These nationally representative data provide evidence that more frequent postsurgical surveillance is not associated with improved survival. As the number of lung cancer survivors increases over the next decade, surveillance is an increasingly important major health care concern and expenditure.

Geographic variation in liver transplantation persists despite implementation of Share35.

AIM: Geographic disparities persist in the USA despite locoregional organ sharing policies. The impact of national organ sharing policies on waiting-list mortality on a regional basis remains unknown. METHODS: Data on all adult liver transplants between 1 February 2002 and 31 March 2015 were obtained from the United Network for Organ Sharing/Organ and Transplantation Network. Multivariable Cox proportional hazards models were constructed in a time-to-event analysis to estimate waiting-list mortality for the pre- and post-Share35 eras. RESULTS: In the analyzed time period, 134 247 patients were listed for transplantation and 54 510 received organs (42.8%). Listing volume increased following the introduction of the Share35 organ sharing policy (15 976 candidates pre- vs. 18 375 post) without significant regional changes as did the number of transplants (7210 pre- vs. 8224 post). Waiting-list mortality improved from 12.2% to 8.1% (P < 0.001). Adjusted waiting-list mortality ratios remained geographically disparate. Region 10 and region 11 had lower hazard ratios (HR) but still had increased mortality (1.46, 95% confidence interval [CI] 1.34-1.60, P < 0.001; and HR 1.49, 95% CI 1.37-1.62, P < 0.001, respectively). Regions 3 and 6 had increased HR with persistently elevated waiting-list mortality (1.79, 95% CI 1.66-1.93, P < 0.001; and HR 1.29, 95% CI 1.16-1.45, P < 0.001, respectively). Model for End-state Liver Disease (MELD) exception continued to propagate a survival benefit (HR 0.65, 95% CI 0.63-0.68, P < 0.001). CONCLUSIONS: Although overall waiting-list mortality has decreased, geographic disparities persist, but appear reduced despite broader sharing policies enacted by Share35. The advantage afforded by MELD exception, while still present, was diminished by Share35 as organs are being shifted to MELD >35 candidates. The disparities highlighted by our findings imply a need to review current allocation policies to best balance local, regional, and national transplant environments.

Early Palliative Care Reduces End-of-Life Intensive Care Unit (ICU) Use but Not ICU Course in Patients with Advanced Cancer.

BACKGROUND: Early palliative care for advanced cancer patients improves quality of life and survival, but less is known about its effect on intensive care unit (ICU) use at the end of life. This analysis assessed the effect of a comprehensive early palliative care program on ICU use and other outcomes among patients with advanced cancer. PATIENTS AND METHODS: A retrospective cohort of patients with advanced cancer enrolled in an early palliative care program (n = 275) was compared with a concurrent control group of patients receiving standard care (n = 195) during the same time period by using multivariable logistic regression analysis. The multidisciplinary outpatient palliative care program used early end-of-life care planning, weekly interdisciplinary meetings to discuss patient status, and patient-reported outcomes assessment integrated within the electronic health record. RESULTS: Patients in the control group had statistically significantly higher likelihood of ICU admission at the end of life (odds ratios [ORs]: last 6 months, 3.07; last month, 3.59; terminal admission, 4.69), higher likelihood of death in the hospital (OR, 4.14) or ICU (OR, 5.57), and lower likelihood of hospice enrollment (OR, 0.13). Use of chemotherapy or radiation did not significantly differ between groups, nor did length of ICU stay, code status, ICU procedures (other than cardiopulmonary resuscitation), disposition location, and outcomes after ICU admission. CONCLUSION: Early palliative care significantly reduced ICU use at the end of life but did not change ICU events. This study supports early initiation of palliative care for advanced cancer patients before hospitalizations and intensive care. The Oncologist 2017;22:318-323 IMPLICATIONS FOR PRACTICE: Palliative care has shown clear benefit in quality of life and survival in advanced cancer patients, but less is known about its effect on intensive care. This retrospective cohort study at a university hospital showed that in the last 6 months of life, palliative care significantly reduced intensive care unit (ICU) and hospital admissions, reduced deaths in the hospital, and increased hospice enrollment. It did not, however, change patients' experiences within the ICU, such as number of procedures, code status, length of stay, or disposition. The findings further support that palliative care exerts its benefit before, rather than during, the ICU setting.

A pilot study of patient-centered outcome assessment using PROMIS for patients undergoing colorectal surgery.

PURPOSE: Few studies have assessed patient-reported outcomes following colorectal surgery. The absence of this information makes it difficult to inform patients about the near-term effects of surgery, beyond outcomes assessed by traditional clinical measures. This study was designed to provide information about the effects of colorectal surgery on physical, mental, and social well-being outcomes. METHODS: The NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Assessment Center was used to collect patient responses prior to surgery and at their routine postoperative visit. Four domains were selected based on patient consultation and clinical experience: depression, pain interference, ability to participate in social roles and activities, and interest in sexual activity. Multilevel random coefficient models were used to assess the change in scores during the follow-up period and to assess the statistical significance of differences in trends over time associated with key clinical measures. RESULTS: In total, 142 patients were consented, with 107 patients completing pre- and postoperative assessments (75%). Preoperative assessments were typically completed 1 month prior to surgery (mean 29.5 days before, SD = 19.7) and postoperative assessments 1 month after surgery (mean 30.7 days after, SD = 9.2), with a mean of 60.3 days between assessment dates. Patients demonstrated no statistically significant changes in scores for pain interference (-0.18 points, p = 0.80) or the ability to participate in social roles and activities (0.44 points, p = 0.55), but had significant decreases in depression scores between pre- and postoperative assessments (-1.6 points, p = 0.03) and near significant increases in scores for interest in sex (1.5 points, p = 0.06). Pain interference scores for patients with neoadjuvant chemotherapy significantly increased (3.5 points, p = 0.03). Scores for the interest in sex domain decreased (worsened) for patients with oncologic etiology (-3.7 points, p = 0.03). No other differences in score trends by patient characteristics were large enough to be statistically significant at the p < 0.05 threshold. CONCLUSION: These data suggest that the majority of patients quickly return to baseline physical, mental, and social function following colorectal surgery. This information can be used preoperatively to counsel patients about the typical impact of colorectal surgery on quality of life.

Affordable Care Act Qualified Health Plan Coverage: Association With Improved HIV Viral Suppression for AIDS Drug Assistance Program Clients in a Medicaid Nonexpansion State.

BACKGROUND: With the Patient Protection and Affordable Care Act, many state AIDS Drug Assistance Programs (ADAPs) shifted their healthcare delivery model from direct medication provision to purchasing qualified health plans (QHPs). The objective of this study was to characterize the demographic and healthcare delivery factors associated with Virginia ADAP clients' QHP enrollment and to assess the relationship between QHP coverage and human immunodeficiency virus (HIV) viral suppression. METHODS: The cohort included persons living with HIV who were enrolled in the Virginia ADAP (n = 3933). Data were collected from 1 January 2013 through 31 December 2014. Multivariable binary logistic regression was conducted to assess for associations with QHP enrollment and between QHP coverage and viral load (VL) suppression. RESULTS: In the cohort, 47.1% enrolled in QHPs, and enrollment varied significantly based on demographic and healthcare delivery factors. In multivariable binary logistic regression, controlling for time, age, sex, race/ethnicity, and region, factors significantly associated with achieving HIV viral suppression included QHP coverage (adjusted odds ratio, 1.346; 95% confidence interval, 1.041-1.740; P = .02), an initially undetectable VL (2.809; 2.174-3.636; P < .001), HIV rather than AIDS disease status (1.377; 1.049-1.808; P = .02), and HIV clinic (P < .001). CONCLUSIONS: QHP coverage was associated with viral suppression, an essential outcome for individuals and for public health. Promoting QHP coverage in clinics that provide care to persons living with HIV may offer a new opportunity to increase rates of viral suppression.

Comparative Effectiveness of Esophagectomy Versus Endoscopic Treatment for Esophageal High-grade Dysplasia.

OBJECTIVE: The purpose of this study is to determine the comparative effectiveness of esophagectomy versus endoscopic mucosal resection followed by radiofrequency ablation (EMR-RFA) for the treatment of Barrett esophagus with high-grade dysplasia (HGD). BACKGROUND: HGD of the esophagus may be managed by surgical resection or EMR-RFA. National guidelines suggest that EMR-RFA is effective at eradicating HGD. The comparative effectiveness and cost-effectiveness of EMR-RFA versus esophagectomy for HGD remains unclear. METHODS: A decision-analysis model was constructed to represent 3 management strategies for HGD: (1) esophagectomy, (2) EMR-RFA, and (3) endoscopic surveillance. Estimates for model variables were obtained from literature review, and costs were estimated from Medicare fee schedules. Costs and utilities were discounted at an annual rate of 3%. The baseline model was adjusted for alternative age groups and high-risk dysplastic variants. One-way and multivariable probabilistic sensitivity analyses were conducted. RESULTS: For a 65-year-old patient, compared to esophagectomy, EMR-RFA yields equivalent utility (11.5 vs 11.4 discounted quality-adjusted life years) with lower total cost ($52.5K vs $74.3K) over the first 20 years. Dominance of EMR-RFA over esophagectomy persists for all age groups. Patients with diffuse or ulcerated HGD are more effectively treated with esophagectomy. Model outcomes are sensitive to estimated rates of disease progression and postintervention utility parameters. CONCLUSIONS: Existing evidence supports EMR-RFA over esophagectomy for the treatment of esophageal HGD. Long-term outcomes and more definitive quality-of-life studies for both interventions are crucial to better inform decision-making.

Screening individuals with intracranial aneurysms for abdominal aortic aneurysms is cost-effective based on estimated coprevalence.

OBJECTIVE: Aneurysm rupture is a major cause of morbidity and mortality, and evidence suggests shared risk for both abdominal aortic aneurysms (AAAs) and intracranial aneurysms (IAs). We hypothesized that screening for AAA in patients with known IA is cost-effective. METHODS: We used a decision tree model to compare costs and outcomes of AAA screening vs no screening in a hypothetical cohort of patients with IA. We measured expected outcomes using quality-adjusted life-years (QALYs) and the incremental cost-effectiveness ratio (ICER). We performed a Monte Carlo simulation and additional sensitivity analyses to assess the effects of ranging base case variables on model outcomes and identified thresholds where a decision alternative dominated the model (both less expensive and more effective than the alternative). RESULTS: In our base case analysis, screening for AAA provided an additional 0.17 QALY (2.5-97.5 percentile: 0.11-0.27 QALY) at a saving of $201 (2.5-97.5 percentile: $-127 to $896). This yielded an ICER of $-1150/QALY (2.5-97.5 percentile: $-4299 to $6374/QALY), that is, screening saves $1150 per QALY gained. CONCLUSIONS: Based on this model, screening for AAA in individuals with IA is cost-effective at an ICER of $1150/QALY, well below accepted societal thresholds estimated at $60,000/QALY. Cost-effectiveness of cross-screening in these populations is sensitive to aneurysm coprevalence and risk of rupture. Further prospective study is warranted to validate this finding.

Blood transfusion is an independent predictor of morbidity and mortality after hepatectomy.

BACKGROUND: Previous studies have indicated that blood transfusion is associated with increased risk of worse outcomes among patients selected for hepatectomy. However, the independent effect of transfusion has not been confirmed. We hypothesize that blood transfusion is an independent factor that affects outcomes in patients undergoing hepatectomy. MATERIALS AND METHODS: Patients at tertiary care center who underwent hepatectomy between 2006 and 2013 were identified and linked with the American College of Surgeons National Surgical Quality Improvement Program PUF data set. Multivariable logistic regression analysis was used to estimate the effect of blood transfusion on 30-d mortality and morbidity, adjusted for differences in extent of resection and estimated probabilities of morbidity and mortality. RESULTS: Among 522 patients in the study, 48 (9.2%) patients required perioperative blood transfusion within 72 h of resection, and 172 (33%) underwent major hepatectomy. Indications for hepatectomy included metastatic neoplasm (n = 229, 44%), primary hepatic neoplasm (n = 108, 21%), primary extra-hepatic biliary neoplasm (n = 23, 4%), and nonmalignant indications (n = 162, 31%). Eighty-eight (17%) patients had a postoperative morbidity. Blood transfusion was significantly associated with postoperative morbidity (odds ratio [OR] = 4.18, 95% CI = 2.18-8.02, P = 0.0001) and mortality (OR = 14.5, 95% CI = 3.08-67.8, P = 001), after adjustment for the concurrent effect of National Surgical Quality Improvement Program estimated probability of morbidity (OR = 1.15, 95% CI = 0.11-12.2, P = 0.042). The extent of resection was not significantly associated with morbidity (OR = 1.30, 95% CI, 0.74-2.28, P = 0.366) or mortality (OR = 1.14, 95% CI = 0.24-5.50, P = 0.870). CONCLUSIONS: Blood transfusion is a highly statistically significant independent predictor of morbidity and mortality after hepatectomy. Judicious use of perioperative transfusion is indicated in patients with benign and malignant indications for liver resection.

Longitudinal patterns of cancer patient reported outcomes in end of life care predict survival.

PURPOSE: Patients with advanced cancer typically demonstrate sharp deterioration in physical function and psychological status during the last months of life. This study evaluates the relationship between survival in patients with advanced cancer and longitudinal assessment of anxiety, depression, fatigue, pain interference, and/or physical function using the US National Institute of Health Patient Reported Outcomes Information System. METHODS: Mixed-effects models were used to evaluate patient-reported outcome trajectories over time among patients with advanced loco-regional or metastatic cancer receiving care in a hospital-based palliative care clinic. Cox regression analysis was used to assess the statistical significance of differences in the probability of survival associated with patient-reported outcome scores. RESULTS: A total of 472 patients completed 1992 assessments during the 18-month study period. Longitudinal scores for fatigue, pain interference, and physical function demonstrated statistically significant non-linear trajectories. Scores for depression, fatigue, pain interference, and physical function were highly statistically significant predictors of survival (p < 0.01). Clinically meaningful differences in the probability of survival were demonstrated between patients with scores at the 25th vs. 75th percentiles, with absolute differences in survival at 6 and 12 months after assessment from 10 to 18 percentage points. CONCLUSIONS: Patient-reported outcomes can be used to reliably estimate where patients are along the trajectory of deteriorating health status leading toward the end of life, and for identifying patients with declining symptoms in need of referral to palliative care or more aggressive symptom management.

Defining Surgical Site Infection in Colorectal Surgery: An Objective Analysis Using Serial Photographic Documentation.

BACKGROUND: Surgical site infection is common following colorectal surgery, yet the incidence varies widely. CDC criteria include "diagnosis by attending physician," which can be subjective. Alternatively, the ASEPSIS score is an objective scoring system based on the presence of clinical findings. OBJECTIVE: The aim of this study is to compare the interrater reliability of the ASEPSIS score vs CDC definitions in identifying surgical site infection. DESIGN: This 24-month prospective study used serial photography of the wound. Three attending surgeons independently reviewed blinded photographic/clinical data. SETTINGS: This study was conducted at an academic institution. PATIENTS: Patients undergoing elective colorectal surgery were selected. INTERVENTIONS: Surgeons assigned an ASEPSIS score and identified surgical site infection by using CDC definitions. The interrater reliability of ASEPSIS and the CDC criteria were compared by using the κ statistic. These data were also compared with the institutional National Surgical Quality Improvement Program database. RESULTS: One hundred seventy-one patients were included. Four surgical site infections (2.4%) were identified by the National Surgical Quality Improvement Program. Data from the surgeons demonstrated significantly higher yet discrepant rates of infection by the CDC criteria, at 6.2%, 7.4%, and 14.1% with a κ of 0.55 indicating modest interrater agreement. Alternatively, the ASEPSIS assessments demonstrated excellent interrater agreement between surgeons with 96% agreement (2.4%, 2.4%, and 3.6%) and a κ of 0.83. LIMITATIONS: This was a single-institution study. CONCLUSIONS: This study demonstrates the relatively poor reliability of CDC definitions for surgical site infections in comparison with an objective scoring system. These findings could explain the wide variability in the literature and raise concern for the comparison of institutional surgical site infection rates as a quality indicator. Alternatively, an objective scoring system, like the ASEPSIS score, may yield more reliable measures for comparison.

Utility of sentinel lymph node biopsy for solitary dermal melanomas.

BACKGROUND AND OBJECTIVES: Solitary dermal melanoma (SDM) is melanoma confined to subcutaneous and/or dermal layers in the absence of a known primary cutaneous lesion. We hypothesized that sentinel node biopsy is an effective staging strategy for this rare disease. METHODS: A Markov decision model was constructed to represent two management strategies for SDM: wide local excision followed by observation, and wide local excision followed by sentinel node biopsy. Utilities, likelihood of positive sentinel node biopsy, and cancer progression rates during a five year time horizon were assigned based on institutional data and a review of existing literature. Estimated costs were derived using Medicare reimbursements. RESULTS: Excision followed by sentinel node biopsy provides greater utility, yielding 3.85 discounted quality-adjusted life years (dQALY) compared to 3.66 for excision alone. The incremental cost-effectiveness ratio for sentinel node biopsy is $19,102 per dQALY. Sensitivity analyzes demonstrated that observation is more cost-effective if greater than 23% of sentinel node biopsies are positive (16% reported), or if 5-year survival for observed patients is greater than 76% (69% reported). CONCLUSIONS: Based on existing clinical evidence, sentinel node biopsy yields greater utility than excision alone and is cost-effective for patients presenting with solitary dermal melanoma.

Improving treatment and survival: a population-based study of current outcomes after a hepatic resection in patients with metastatic colorectal cancer.

BACKGROUND: Population-based studies historically report underutilization of a resection in patients with colorectal metastases to the liver. Recent data suggest limitations of the methods in the historical analysis. The present study examines trends in a hepatic resection and survival among Medicare recipients with hepatic metastases. METHODS: Medicare recipients with incident colorectal cancer diagnosed between 1991 and 2009 were identified in the SEER(Surveillance, Epidemiology and End Results)-Medicare dataset. Patients were stratified into historical (1991-2001) and current (2002-2009) cohorts. Analyses compared treatment, peri-operative outcomes and survival. RESULTS: Of 31.574 patients with metastatic colorectal cancer to the liver, 14,859 were in the current cohort treated after 2002 and 16,715 comprised the historical control group. The overall proportion treated with a hepatic resection increased significantly during the study period (P < 0.001) with pre/post change from 6.5% pre-2002 to 7.5% currently (P < 0.001). Over time, haemorrhagic and infectious complications declined (both P ≤ 0.047), but 30-day mortality was similar (3.5% versus 3.9%, P = 0.660). After adjusting for predictors of survival, the use of a hepatic resection [hazard ratio (HR) = 0.40, 95% confidence interval (CI): 0.38-0.42, P < 0.001] and treatment after 2002 (HR = 0.88, 95% CI: 0.86-0.90, P < 0.001) were associated with a reduced risk of death. CONCLUSIONS: Case identification using International Classification of Diseases, 9th Revision (ICD-9) codes is imperfect; however, comparison of trends over time suggests an improvement in multimodality therapy and survival in patients with colorectal metastases to the liver.

Use of prophylactic postoperative antibiotics during surgical drain presence following mastectomy.

BACKGROUND: National guidelines recommend one dose of perioperative antibiotics for breast surgery and discourage postoperative continuation. However, reported skin and soft tissue infection (SSI) rates after mastectomy range from 1-26 %, higher than expected for clean cases. Utility of routine or selective postoperative antibiotic use for duration of drain presence following mastectomy remains uncertain. METHODS: This study included all female patients who underwent mastectomy without reconstruction at our institution between 2005 and 2012. SSI was defined using CDC criteria or clinical diagnosis of cellulitis. Information on risk factors for infection (age, body mass index [BMI], smoking status, diabetes, steroid use), prior breast cancer treatment, drain duration, and antibiotic use was abstracted from medical records. Multivariable logistic regression was used to assess the association between postoperative antibiotic use and the occurrence of SSI, adjusting for concurrent risk factors. RESULTS: Among 480 patients undergoing mastectomy without reconstruction, 425 had sufficient documentation for analysis. Of these, 268 were prescribed antibiotics (63 %) at hospital discharge. An overall SSI rate of 7.3 % was observed, with 14 % of patients without postoperative antibiotics developing SSI compared with 3.4 % with antibiotics (p < 0.0001). Factors independently associated with SSI were smoking and advancing age. Diabetes, steroid use, BMI, prior breast surgery, neoadjuvant chemotherapy, prior radiation, concomitant axillary surgery, and drain duration were not associated with increased SSI rates. CONCLUSIONS: SSI rates among patients who did and did not receive postoperative antibiotics after mastectomy were significantly different, particularly among smokers and women of advanced age. These patient subgroups may warrant special consideration for postoperative antibiotics.

Primary payer status is associated with mortality and resource utilization for coronary artery bypass grafting.

BACKGROUND: Medicaid and uninsured populations are a significant focus of current healthcare reform. We hypothesized that outcomes after coronary artery bypass grafting (CABG) in the United States is dependent on primary payer status. METHODS AND RESULTS: From 2003 to 2007, 1,250,619 isolated CABG operations were evaluated using the Nationwide Inpatient Sample (NIS) database. Patients were stratified by primary payer status: Medicare, Medicaid, uninsured, and private insurance. Hierarchical multiple regression models were applied to assess the effect of primary payer status on postoperative outcomes. Unadjusted mortality for Medicare (3.3%), Medicaid (2.4%), and uninsured (1.9%) patients were higher compared with private insurance patients (1.1%, P<0.001). Unadjusted length of stay was longest for Medicaid patients (10.9 ± 0.04 days) and shortest for private insurance patients (8.0 ± 0.01 days, P<0.001). Medicaid patients accrued the highest unadjusted total costs ($113 380 ± 386, P<0.001). Importantly, after controlling for patient risk factors, income, hospital features, and operative volume, Medicaid (odds ratio, 1.82; P<0.001) and uninsured (odds ratio, 1.62; P<0.001) payer status independently conferred the highest adjusted odds of in-hospital mortality. In addition, Medicaid payer status was associated with the longest adjusted length of stay and highest adjusted total costs (P<0.001). CONCLUSIONS: Medicaid and uninsured payer status confers increased risk adjusted in-hospital mortality for patients undergoing coronary artery bypass grafting operations. Medicaid was further associated with the greatest adjusted length of stay and total costs despite risk factors. Possible explanations include delays in access to care or disparate differences in health maintenance.

A method for estimating the risk of surgical site infection in patients with abdominal colorectal procedures.

BACKGROUND: Surgical site infection is one of the most common and significant morbidities following colon and rectal surgery, representing a marker of institutional quality. Various measures have been implemented to lower its incidence. However, the level of incidence remains unacceptable in many reports. OBJECTIVE: This study addresses whether surgical site infections can be accurately predicted in an outpatient clinical setting among patients undergoing elective colon and rectal surgery. DESIGN: This investigation was designed as a retrospective cohort study with the use of logistic regression modeling. SETTINGS: Data for this study were extracted from the American College of Surgeons National Surgical Quality Improvement Program Participant user data file. PATIENTS: Patients undergoing elective intraabdominal colorectal surgery during 2009 were included. MAIN OUTCOME MEASURES: The primary outcome measured was the probability of 30-day surgical site infection (superficial and deep incisional). RESULTS: A total of 18,403 records for patients with colorectal surgery were identified. Superficial incisional surgical site infections were identified in 1447 records (7.86%). Deep incisional surgical site infections were identified in 278 records (1.51%). Body mass index, preoperative hematocrit, open approach, ASA classification level, smoking, alcohol use, functional status before surgery, and age more than 75 years were identified as likely independent predictors of deep and superficial surgical site infections. Multivariable logistic regression analysis was used to develop a series of predictive models. Reduced versions of the models were then developed that included only highly statistically significant predictors of infection in the corresponding full models (age, alcohol abuse, ASA classification, stoma closure, open approach, BMI, and hematocrit). Nomograms representing the final reduced model equations are presented. LIMITATIONS: This study was limited by the use of an administrative database and its retrospective design. CONCLUSIONS: Surgical site infection is common morbidity following colon and rectal surgery. Nomograms using key patient characteristics can be used to accurately calculate a patients' risk of surgical site infection. This tool could be applied in the clinical setting to prospectively identify patients at highest risk of surgical site infection.

Administration of rescue surfactant by laryngeal mask airway: lessons from a pilot trial.

OBJECTIVES: To determine if surfactant can be effectively administered to larger preterm babies by laryngeal mask airway (LMA), reducing the need for supplemental oxygen. STUDY DESIGN: Enrollment criteria: birth weight > 1200 g, < 72 hours old, treated with nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome, with fraction of inspired oxygen (Fio2) requirement between 0.30 and 0.60. Subjects were randomized either to receive 3 mL/kg calfactant by LMA (experimental) followed by LMA removal back to CPAP, or continued on nCPAP (control). After intervention, both groups remained on nCPAP with Fio2 adjusted to maintain O2 saturations at 88 to 95%. RESULTS: A total of 26 patients (13 per group) were randomized, and 24 completed the study (11 experimental, 13 control). Groups were similar with respect to gender, mode of delivery, estimated gestational age, birth weight, and oxygen and pressure requirements at enrollment. Infants enrolled in the treatment group had an abrupt and sustained decrease in oxygen requirement after LMA surfactant therapy. CONCLUSION: This pilot study demonstrates that surfactant can be delivered by LMA, which leads to a significant decrease in supplemental oxygen requirement. Larger controlled trials in low-resource settings may show this technique to be valuable in clinical situations where direct laryngoscopy and intubation are difficult or where resources for mechanical ventilation are limited.

Hospital procedure volume should not be used as a measure of surgical quality.

INTRODUCTION: The Agency for Healthcare Research and Quality and the Leapfrog Group use hospital procedure volume as a quality measure for pancreatic resection (PR), abdominal aortic aneurysm (AAA) repair, esophageal resection (ER), and coronary artery bypass grafting (CABG). However, controversy exists regarding the strength and validity of the evidence for the volume-outcome association. The purpose of this study was to reevaluate the volume-outcome relationship for these procedures. METHODS: Discharge data for 261,412 patients were extracted from the 2008 Nationwide Inpatient Sample. The relationship between hospital procedure volume and mortality was rigorously assessed using hierarchical general linear modeling with restricted cubic splines, adjusted for patient demographics, comorbid disease, and elective procedure status. RESULTS: Unadjusted mortality rates were PR (4.7%), AAA (12.7%), ER (5.8%), and CABG (2.2%), and the majority of operations were elective. Hospital procedure volume was not a statistically significant predictor of in-hospital mortality for any of the 4 procedures. Strong predictors of mortality included age, elective procedure status, renal failure, and malnutrition (P < 0.001). Each of the models demonstrated excellent performance in estimating the probability of death. CONCLUSIONS: Hospital procedure volume is not a significant predictor of mortality for the performance of pancreatectomy, AAA repair, esophagectomy, or CABG. Procedure volume by itself should not be used as a proxy measure for surgical quality. Patient mortality risk is primarily attributable to patient-level characteristics such as age and comorbidity.

Transcatheter arterial revascularization outcomes at vascular and general surgery teaching hospitals and nonteaching hospitals are comparable.

BACKGROUND: Outcomes following transcatheter interventions at vascular and general surgery teaching hospitals (STH) are unknown. We examine whether surgery training programs influence clinically relevant outcomes after commonly performed endovascular procedures. METHODS: Using an all-payer inpatient care database from 2008, we selected adults who underwent either endovascular carotid stenting, endografting of descending thoracic aortic aneurysm, endovascular abdominal aortic aneurysm repair, or peripheral arterial revascularization. Patients were stratified by procedures completed at Surgery Teaching (Participate in Accreditation Council for Graduate Medical Education [ACGME]-accredited vascular and general surgery programs), STH, or nonteaching hospitals (NTH). Hierarchical regression models assessed adverse outcomes and in-hospital mortality among groups. RESULTS: Of the 175,698 records, 44% of the patients were treated at STH, while 56% underwent procedures at NTH. The adjusted odds ratio of any complication or mortality at STH and NTH were similar. Transfers, weekend admissions, and nonelective cases were higher at STH (P < .001, respectively). Paradoxically, STH treated fewer patients with more than three comorbidities compared with NTH (STH: 47% vs NTH: 53%; P < .001). Surgical teaching status did not lower the adjusted odds of mortality for any procedure. Moreover, the occurrence of any complication (adjusted odds ratios, 0.9; 95% confidence interval, .82-1.14; P = .69) and mortality (adjusted odds ratios, 0.9; 95% confidence interval, .74-1.22; P = .67) were equivalent between vascular and general STH. CONCLUSIONS: Following commonly performed transcatheter vascular procedures, and despite more transfers, weekend admissions, and nonelective procedures completed at STH, complications, and mortality were comparable across centers.