Showing papers in "JAMA Surgery in 2018"

Understanding Costs of Care in the Operating Room.

Abstract: Importance Increasing value requires improving quality or decreasing costs. In surgery, estimates for the cost of 1 minute of operating room (OR) time vary widely. No benchmark exists for the cost of OR time, nor has there been a comprehensive assessment of what contributes to OR cost. Objectives To calculate the cost of 1 minute of OR time, assess cost by setting and facility characteristics, and ascertain the proportion of costs that are direct and indirect. Design, Setting, and Participants This cross-sectional and longitudinal analysis examined annual financial disclosure documents from all comparable short-term general and specialty care hospitals in California from fiscal year (FY) 2005 to FY2014 (N = 3044; FY2014, n = 302). The analysis focused on 2 revenue centers: (1) surgery and recovery and (2) ambulatory surgery. Main Outcomes and Measures Mean cost of 1 minute of OR time, stratified by setting (inpatient vs ambulatory), teaching status, and hospital ownership. The proportion of cost attributable to indirect and direct expenses was identified; direct expenses were further divided into salary, benefits, supplies, and other direct expenses. Results In FY2014, a total of 175 of 302 facilities (57.9%) were not for profit, 78 (25.8%) were for profit, and 49 (16.2%) were government owned. Thirty facilities (9.9%) were teaching hospitals. The mean (SD) cost for 1 minute of OR time across California hospitals was $37.45 ($16.04) in the inpatient setting and $36.14 ($19.53) in the ambulatory setting (P = .65). There were no differences in mean expenditures when stratifying by ownership or teaching status except that teaching hospitals had lower mean (SD) expenditures than nonteaching hospitals in the inpatient setting ($29.88 [$9.06] vs $38.29 [$16.43];P = .006). Direct expenses accounted for 54.6% of total expenses ($20.40 of $37.37) in the inpatient setting and 59.1% of total expenses ($20.90 of $35.39) in the ambulatory setting. Wages and benefits accounted for approximately two-thirds of direct expenses (inpatient, $14.00 of $20.40; ambulatory, $14.35 of $20.90), with nonbillable supplies accounting for less than 10% of total expenses (inpatient, $2.55 of $37.37; ambulatory, $3.33 of $35.39). From FY2005 to FY2014, expenses in the OR have increased faster than the consumer price index and medical consumer price index. Teaching hospitals had slower growth in costs than nonteaching hospitals. Over time, the proportion of expenses dedicated to indirect costs has increased, while the proportion attributable to salary and supplies has decreased. Conclusions and Relevance The mean cost of OR time is $36 to $37 per minute, using financial data from California’s short-term general and specialty hospitals in FY2014. These statewide data provide a generalizable benchmark for the value of OR time. Furthermore, understanding the composition of costs will allow those interested in value improvement to identify high-yield targets.

Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction.

Abstract: Importance Previous outcome studies comparing implant and autologous breast reconstruction techniques have been limited by short-term follow-up, single-center design, and a lack of rigorous patient-reported outcome data. An understanding of the expected satisfaction and breast-related quality of life associated with each type of procedure is central to the decision-making process. Objective To determine outcomes reported by patients undergoing postmastectomy breast reconstruction using implant or autologous techniques 2 years after surgery. Design, Setting, and Participants Patients were recruited from 11 centers (57 plastic surgeons) across North America for the Mastectomy Reconstruction Outcomes Consortium study, a prospective, multicenter trial, from February 1, 2012, to July 31, 2015. Women undergoing immediate breast reconstruction using implant or autologous tissue reconstruction after mastectomy for cancer treatment or prophylaxis were eligible. Overall, 2013 women (1490 implant and 523 autologous tissue reconstruction) met the inclusion criteria. All patients included in this analysis had 2 years of follow-up. Exposures Procedure type (ie, implant vs autologous tissue reconstruction). Main Outcomes and Measures The primary outcomes of interest were scores on the BREAST-Q, a validated, condition-specific, patient-reported outcome instrument, which were collected prior to and at 2 years after surgery. The following 4 domains of the BREAST-Q reconstruction module were evaluated: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. Responses from each scale were summed and transformed on a 0 to 100 scale, with higher numbers representing greater satisfaction or quality of life. Results Of the 2013 women in the study (mean [SD] age, 48.1 [10.5] years for the group that underwent implant-based reconstruction and 51.6 [8.7] years for the group that underwent autologous reconstruction), 1217 (60.5%) completed questionnaires at 2 years after reconstruction. After controlling for baseline patient characteristics, patients who underwent autologous reconstruction had greater satisfaction with their breasts (difference, 7.94; 95% CI, 5.68-10.20;P Conclusions and Relevance At 2 years, patients who underwent autologous reconstruction were more satisfied with their breasts and had greater psychosocial well-being and sexual well-being than did those who underwent implant reconstruction. These findings can inform patients and their clinicians about expected satisfaction and quality of life outcomes of autologous vs implant-based procedures and further support the adoption of shared decision making in clinical practice.

Temporal Trends in Gender-Affirming Surgery Among Transgender Patients in the United States.

Abstract: Importance Little is known about the incidence of gender-affirming surgical procedures for transgender patients in the United States. Objectives To investigate the incidence and trends over time of gender-affirming surgical procedures and to analyze characteristics and payer status of transgender patients seeking these operations. Design, Setting, and Participants In this descriptive observational study from 2000 to 2014, data were analyzed from the National Inpatient Sample, a representative pool of inpatient visits across the United States. The initial analyses were done from June to August 2015. Patients of interest were identified byInternational Classification of Diseases,Ninth Revision, diagnosis codes for transsexualism or gender identity disorder. Subanalysis focused on patients with procedure codes for surgery related to gender affirmation. Main Outcomes and Measures Demographics, health insurance plan, and type of surgery for patients who sought gender-affirming surgery were compared between 2000-2005 and 2006-2011, as well as annually from 2012 to 2014. Results This study included 37 827 encounters (median [interquartile range] patient age, 38 [26-49] years) identified by a diagnosis code of transsexualism or gender identity disorder. Of all encounters, 4118 (10.9%) involved gender-affirming surgery. The incidence of genital surgery increased over time: in 2000-2005, 72.0% of patients who underwent gender-affirming procedures had genital surgery; in 2006-2011, 83.9% of patients who underwent gender-affirming procedures had genital surgery. Most patients (2319 of 4118 [56.3%]) undergoing these procedures were not covered by any health insurance plan. The number of patients seeking these procedures who were covered by Medicare or Medicaid increased by 3-fold in 2014 (to 70) compared with 2012-2013 (from 25). No patients who underwent inpatient gender-affirming surgery died in the hospital. Conclusions and Relevance Most transgender patients in this national sample undergoing inpatient gender-affirming surgery were classified as self-pay; however, an increasing number of transgender patients are being covered by private insurance, Medicare, or Medicaid. As coverage for these procedures increases, likely so will demand for qualified surgeons to perform them.

Practical Guide to Surgical Data Sets: Surveillance, Epidemiology, and End Results (SEER) Database.

Abstract: Introduction The Surveillance, Epidemiology, and End Results (SEER) database is a publicly available, federally funded cancer reporting system that represents a collaboration between the US Centers for Disease Control and Prevention, the National Cancer Institute, and regional and state cancer registr ies. 1 SEER data are national, with information from 18 states that represent all regions of the country. In contrast to other commonly used data sets (eg, the National Cancer Data Base), SEER is population-based, because local registries report information for all cancer cases within a specific region and/or defined racial/ethnic population. Given that SEER data is both a cancer reporting system and a research tool, we aim to present salient aspects of these data, strengths and limitations for analyses, and important statistical considerations.

Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial

Abstract: Importance Preserving functional capacity is a key element in the care continuum for patients with esophagogastric cancer Prehabilitation, a preoperative conditioning intervention aiming to optimize physical status, has not been tested in upper gastrointestinal surgery to date Objective To investigate whether prehabilitation is effective in improving functional status in patients undergoing esophagogastric cancer resection Design, Setting, and Participants A randomized clinical trial (available-case analysis based on completed assessments) was conducted at McGill University Health Centre (Montreal, Quebec, Canada) comparing prehabilitation with a control group Intervention consisted of preoperative exercise and nutrition optimization Participants were adults awaiting elective esophagogastric resection for cancer The study dates were February 13, 2013, to February 10, 2017 Main Outcomes and Measures The primary outcome was change in functional capacity, measured with absolute change in 6-minute walk distance (6MWD) Preoperative (end of the prehabilitation period) and postoperative (from 4 to 8 weeks after surgery) data were compared between groups Results Sixty-eight patients were randomized, and 51 were included in the primary analysis The control group were a mean (SD) age, 680 (116) years and 20 (80%) men Patients in the prehabilitation group were a mean (SD) age, 673 (74) years and 18 (69%) men Compared with the control group, the prehabilitation group had improved functional capacity both before surgery (mean [SD] 6MWD change, 369 [514] vs −228 [525] m;P Conclusions and Relevance Prehabilitation improves perioperative functional capacity in esophagogastric surgery Keeping patients from physical and nutritional status decline could have a significant effect on the cancer care continuum Trial Registration ClinicalTrialsgov Identifier:NCT01666158

Pregnancy and Motherhood During Surgical Training.

Abstract: Importance Although family priorities influence specialty selection and resident attrition, few studies describe resident perspectives on pregnancy during surgical training. Objective To directly assess the resident experience of childbearing during training. Design, Setting, and Participants A self-administered 74-question survey was electronically distributed in January 2017 to members of the Association of Women Surgeons, to members of the Association of Program Directors in Surgery listserv, and through targeted social media platforms. Surgeons who had 1 or more pregnancies during an Accreditation Council for Graduate Medical Education–accredited US general surgery residency program and completed training in 2007 or later were included. Important themes were identified using focus groups of surgeons who had undergone pregnancy during training in the past 7 years. Additional topics were identified through MEDLINE searches performed from January 2000 to July 2016 combining the keywordspregnancy,resident,attrition, andparentingin any specialty. Main Outcomes and Measures Descriptive data on perceptions of work schedule during pregnancy, maternity leave policies, lactation and childcare support, and career satisfaction after childbirth. Results This study included 347 female surgeons (mean [SD] age, 30.5 [2.7] years) with 452 pregnancies. A total of 297 women (85.6%) worked an unmodified schedule until birth, and 220 (63.6%) were concerned that their work schedule adversely affected their health or the health of their unborn child. Residency program maternity leave policies were reported by 121 participants (34.9%). A total of 251 women (78.4%) received maternity leave of 6 weeks or less, and 250 (72.0%) perceived the duration of leave to be inadequate. The American Board of Surgery leave policy was cited as a major barrier to the desired length of leave by 268 of 326 respondents (82.2%). Breastfeeding was important to 329 (95.6%), but 200 (58.1%) stopped earlier than they wished because of poor access to lactation facilities and challenges leaving the operating room to express milk. Sixty-four women (18.4%) had institutional support for childcare, and 231 (66.8%) reported a desire for greater mentorship on integrating a surgical career with motherhood and pregnancy. A total of 135 (39.0%) strongly considered leaving surgical residency, and 102 (29.5%) would discourage female medical students from a surgical career, specifically because of the difficulties of balancing pregnancy and motherhood with training. Conclusions and Relevance The challenges of having children during surgical residency may have significant workforce implications. A deeper understanding is critical to prevent attrition and to continue recruiting talented students. This survey characterizes these issues to help design interventions to support childbearing residents.

Performance of a Genomic Sequencing Classifier for the Preoperative Diagnosis of Cytologically Indeterminate Thyroid Nodules

Abstract: Importance Use of next-generation sequencing of RNA and machine learning algorithms can classify the risk of malignancy in cytologically indeterminate thyroid nodules to limit unnecessary diagnostic surgery. Objective To measure the performance of a genomic sequencing classifier for cytologically indeterminate thyroid nodules. Design, Setting, and Participants A blinded validation study was conducted on a set of cytologically indeterminate thyroid nodules collected by fine-needle aspiration biopsy between June 2009 and December 2010 from 49 academic and community centers in the United States. All patients underwent surgery without genomic information and were assigned a histopathology diagnosis by an expert panel blinded to all genomic information. There were 210 potentially eligible thyroid biopsy samples with Bethesda III or IV indeterminate cytopathology that constituted a cohort previously used to validate the gene expression classifier. Of these, 191 samples (91.0%) had adequate residual RNA for validation of the genomic sequencing classifier. Algorithm development and independent validation occurred between August 2016 and May 2017. Exposures Thyroid nodule surgical histopathology diagnosis by an expert panel blinded to all genomic data. Main Outcomes and Measures The primary end point was measurement of genomic sequencing classifier sensitivity, specificity, and negative and positive predictive values in biopsies from Bethesda III and IV nodules. The secondary end point was measurement of classifier performance in biopsies from Bethesda II, V, and VI nodules. Results Of the 183 included patients, 142 (77.6%) were women, and the mean (range) age was 51.7 (22.0-85.0) years. The genomic sequencing classifier had a sensitivity of 91% (95% CI, 79-98) and a specificity of 68% (95% CI, 60-76). At 24% cancer prevalence, the negative predictive value was 96% (95% CI, 90-99) and the positive predictive value was 47% (95% CI, 36-58). Conclusions and Relevance The genomic sequencing classifier demonstrates high sensitivity and accuracy for identifying benign nodules. Its 36% increase in specificity compared with the gene expression classifier potentially increases the number of patients with benign nodules who can safely avoid unnecessary diagnostic surgery.

International Validation of the Eighth Edition of the American Joint Committee on Cancer (AJCC) TNM Staging System in Patients With Resected Pancreatic Cancer.

Abstract: Importance: The recently released eighth edition of the American Joint Committee on Cancer TNM staging system for pancreatic cancer seeks to improve prognostic accuracy but lacks international validation. Objective: To validate the eighth edition of the American Joint Committee on Cancer TNM staging system in an international cohort of patients with resected pancreatic ductal adenocarcinoma. Design, Setting, and Participants: This international multicenter cohort study took place in 5 tertiary centers in Europe and the United States from 2000 to 2015. Patients who underwent pancreatoduodenectomy for nonmetastatic pancreatic ductal adenocarcinoma were eligible. Data analysis took place from December 2017 to April 2018. Exposures: Patients were retrospectively staged according to the seventh and eighth editions of the TNM staging system. Main Outcomes and Measures: Prognostic accuracy on survival rates, assessed by Kaplan-Meier and multivariate Cox proportional hazards analyses and concordance statistics. Results: A total of 1525 consecutive patients were included (median [IQR] age, 66 (58-72) years; 802 (52.6%) male). Distribution among stages via the seventh edition was stage IA in 41 patients (2.7%), stage IB in 42 (2.8%), stage IIA in 200 (13.1%), stage IIB in 1229 (80.6%), and stage III in 12 (0.8%); this changed with use of the eighth edition to stage IA in 118 patients (7.7%), stage IB in 144 (9.4%), stage IIA in 22 (1.4%), stage IIB in 643 (42.2%), and stage III in 598 (39.2%). With the eighth edition, 774 patients (50.8%) migrated to a different stage; 183 (12.0%) were reclassified to a lower stage and 591 (38.8%) to a higher stage. Median overall survival for the entire cohort was 24.4 months (95% CI, 23.4-26.2 months). On Kaplan-Meier analysis, 5-year survival rates changed from 38.2% for patients in stage IA, 34.7% in IB, 35.3% in IIA, 16.5% in IIB, and 0% in stage III (log-rank P <.001) via classification with the seventh edition to 39.2% for patients in stage IA, 33.9% in IB, 27.6% in IIA, 21.0% in IIB, and 10.8% in stage III (log-rank P <.001) with the eighth edition. For patients who were node negative, the T stage was not associated with prognostication of survival in either edition. In the eighth edition, the N stage was associated with 5-year survival rates of 35.6% in N0, 20.8% in N1, and 10.9% in N2 (log-rank P <.001). The C statistic improved from 0.55 (95% CI, 0.53-0.57) for the seventh edition to 0.57 (95% CI, 0.55-0.60) for the eighth edition. Conclusions and Relevance: The eighth edition of the TNM staging system demonstrated a more equal distribution among stages and a modestly increased prognostic accuracy in patients with resected pancreatic ductal adenocarcinoma compared with the seventh edition. The revised T stage remains poorly associated with survival, whereas the revised N stage is highly prognostic.

Comparison of 2-Year Complication Rates Among Common Techniques for Postmastectomy Breast Reconstruction.

Abstract: Importance In breast reconstruction, it is critical for patients and surgeons to have comprehensive information on the relative risks of the available options. However, previous studies that evaluated complications were limited by single-center designs, inadequate follow-up, and confounding. Objective To assess 2-year complication rates across common techniques for postmastectomy reconstruction in a multicenter patient population. Design, Setting, and Participants This longitudinal, multicenter, prospective cohort study conducted from February 1, 2012, through July 31, 2015, took place at the 11 study sites associated with the Mastectomy Reconstruction Outcomes Consortium study. Eligible patients included women 18 years and older presenting for first-time breast reconstruction with at least 2 years of follow-up. Procedures evaluated included direct-to-implant (DTI) technique, expander-implant (EI) technique, latissimus dorsi (LD) flap, pedicled transverse rectus abdominis myocutaneous (pTRAM) flap, free transverse rectus abdominis myocutaneous (fTRAM) flap, deep inferior epigastric perforator (DIEP) flap, and superficial inferior epigastric artery (SIEA) flap. Interventions Postmastectomy breast reconstruction. Main Outcomes and Measures Development of complications, reoperative complications, and wound infections during 2-year follow-up. Mixed-effects logistic regression analysis controlled for variability among centers and for demographic and clinical variables. Results A total of 2343 patients (mean [SD] age, 49.5 [10.1] years; mean [SD] body mass index, 26.6 [5.7]) met the inclusion criteria. A total of 1525 patients (65.1%) underwent EI reconstruction, with 112 (4.8%) receiving DTI reconstruction, 85 (3.6%) pTRAM flaps, 95 (4.1%) fTRAM flaps, 390 (16.6%) DIEP flaps, 71 (3.0%) LD flaps, and 65 (2.8%) SIEA flaps. Overall, complications were noted in 771 (32.9%), with reoperative complications in 453 (19.3%) and wound infections in 230 (9.8%). Two years postoperatively, patients undergoing any autologous reconstruction type had significantly higher odds of developing any complication compared with those undergoing EI reconstruction (pTRAM flap: odds ratio [OR], 1.91; 95% CI, 1.10-3.31; P = .02; fTRAM flap: OR, 2.05; 95% CI, 1.24-3.40; P = .005; DIEP flap: OR, 1.97; 95% CI, 1.41-2.76; P < .001; LD flaps: OR, 1.87; 95% CI, 1.03-3.40; P = .04; SIEA flap: OR, 4.71; 95% CI, 2.32-9.54; P < .001). With the exception of LD flap reconstructions, all flap procedures were associated with higher odds of reoperative complications (pTRAM flap: OR, 2.48; 95% CI, 1.33-4.64; P = .005; fTRAM flap: OR, 3.02; 95% CI, 1.73-5.29; P < .001; DIEP flap: OR, 2.76; 95% CI, 1.87-4.07; P < .001; SIEA flap: OR, 2.62; 95% CI, 1.24-5.53; P = .01) compared with EI techniques. Of the autologous reconstructions, only patients undergoing DIEP flaps had significantly lower odds of infection compared with those undergoing EI procedures (OR, 0.45; 95% CI, 0.25-0.29; P = .006). However, DTI and EI procedures had higher failure rates (EI and DTI techniques, 7.1%; pTRAM flap, 1.2%; fTRAM flap, 2.1%; DIEP flap, 1.3%; LD flap, 2.8%; and SIEA flap, 0%; P < .001). Conclusions and Relevance Significant differences were noted across reconstructive procedure types for overall and reoperative complications, which is critically important information for women and surgeons making breast reconstruction decisions.

Prevalence of Preoperative Opioid Use and Characteristics Associated With Opioid Use Among Patients Presenting for Surgery.

Abstract: Importance Patterns of preoperative opioid use are not well characterized across different surgical services, and studies in this patient population have lacked important self-reported data of pain and affect Objectives To assess the prevalence of preoperative opioid use and the characteristics of these patients in a broadly representative surgical cohort Design, Setting, and Participants Cross-sectional, observational study of patients undergoing surgery at a tertiary care academic medical center Data were collected as a part of large prospective institutional research registries from March 1, 2010, through April 30, 2016 Exposures Preoperative patient and procedural characteristics, including prospectively assessed self-reported pain and functional measures Main Outcomes and Measures Patient-reported opioid use before surgery Results Of the total 34 186 patients recruited (542% women; mean [SD] age, 531 [161] years), preoperative opioid use was reported in 7894 (231%) The most common opioids used were hydrocodone bitartrate (4685 [594%]), tramadol hydrochloride (1677 [212%]), and oxycodone hydrochloride (1442 [183%]) Age of 31 to 40 years (adjusted odds ratio [aOR], 126; 95% CI, 110-145), tobacco use (former use aOR, 132 [95% CI, 122-142]; current use aOR, 162 [95% CI, 148-178]), illicit drug use (aOR, 174; 95% CI, 116-260), higher pain severity (aOR, 133; 95% CI, 131-135), depression (aOR, 122; 95% CI, 112-133), higher Fibromyalgia Survey scores (aOR, 106, 95% CI, 105-107), lower life satisfaction (aOR, 095, 95% CI, 093-096), and more medical comorbidities (American Society of Anesthesiology score aOR, 147 [95% CI, 137-158]; Charlson Comorbidity Index aOR, 129 [95% CI, 118-141]) were all independently associated with preoperative opioid use Preoperative opioid use was most commonly reported by patients undergoing orthopedic (226 [651%]) and neurosurgical spinal (596 [551%]) procedures and least common among patients undergoing thoracic procedures (244 [157%]) After adjusting for patient characteristics, the patients undergoing lower extremity procedures were most likely to report preoperative opioid use (aOR, 361; 95% CI, 281-464), as well as those undergoing pelvic (excluding hip) (aOR, 309; 95% CI, 188-508), upper extremity (aOR, 307; 95% CI, 212-445), and spinal or spinal cord (aOR, 268; 95% CI, 215-332) procedures, with the group undergoing intrathoracic surgery as the reference group Conclusions and Relevance In this large study of preoperative opioid use that includes patient-reported outcome measures, more than 1 in 4 patients presenting for surgery reported opioid use These data provide important insights into this complicated patient population that would appear to help guide future preoperative optimization and perioperative opioid-weaning interventions

Practical Guide to Surgical Data Sets: National Cancer Database (NCDB).

Abstract: Introduction The National Cancer Database (NCDB) is a joint program of the American College of Surgeons Commission on Cancer (CoC) and the American Cancer Society (Box).1 The NCDB is a hospital-based clinical cancer registry established in 1989 that collects data from more than 1500 hospitals in the United States, capturing more than 70% of all newly diagnosed cancers. In2013,theAmericanCollegeofSurgeonsCoCbegantomakeavailable the Participant User File (PUF) to CoC member facilities. This led to an exponential growth in the number and breadth of publications using the NCDB. With the continued expansion and access to NCDB, it is expected that the number of publications will continue to increase. Given the power of the NCDB, it is of primary importance to ensure that appropriate methods are used during data analysis and reporting. Like all secondary data sets, there are unique nuances and challenges that may introduce significant confounding and bias into study results. Our objectives are to present an overview of unique data elements in the NCDB and provide an analytic framework when using the data set for the purposes of research.

Association of BRAF Mutations With Survival and Recurrence in Surgically Treated Patients With Metastatic Colorectal Liver Cancer

Abstract: Importance BRAF mutations are reportedly associated with aggressive tumor biology. However, in contrast with primary colorectal cancer, the association of V600E and non-V600E BRAF mutations with survival and recurrence after resection of colorectal liver metastases (CRLM) has not been well studied. Objective To investigate the prognostic association of BRAF mutations with survival and recurrence independently and compared with other prognostic determinants, such as KRAS mutations. Design, setting, and participants In this cohort study, all patients who underwent resection for CRLM with curative intent from January 1, 2000, through December 31, 2016, at the institutions participating in the International Genetic Consortium for Colorectal Liver Metastasis and had data on BRAF and KRAS mutational status were retrospectively identified. Multivariate Cox proportional hazards regression models were used to assess long-term outcomes. Interventions Hepatectomy in patients with CRLM. Main outcomes and measures The association of V600E and non-V600E BRAF mutations with disease-free survival (DFS) and overall survival (OS). Results Of 853 patients who met inclusion criteria (510 men [59.8%] and 343 women [40.2%]; mean [SD] age, 60.2 [12.4] years), 849 were included in the study analyses. Forty-three (5.1%) had a mutated (mut) BRAF/wild-type (wt) KRAS (V600E and non-V600E) genotype; 480 (56.5%), a wtBRAF/wtKRAS genotype; and 326 (38.4%), a wtBRAF/mutKRAS genotype. Compared with the wtBRAF/wtKRAS genotype group, patients with a mutBRAF/wtKRAS genotype more frequently were female (27 [62.8%] vs 169 [35.2%]) and 65 years or older (22 [51.2%] vs 176 [36.9%]), had right-sided primary tumors (27 [62.8%] vs 83 [17.4%]), and presented with a metachronous liver metastasis (28 [64.3%] vs 229 [46.8%]). On multivariable analysis, V600E but not non-V600E BRAF mutation was associated with worse OS (hazard ratio [HR], 2.76; 95% CI, 1.74-4.37; P Conclusions and relevance The presence of the V600E BRAF mutation was associated with worse prognosis and increased risk of recurrence. The V600E mutation was not only a stronger prognostic factor than KRAS but also was the strongest prognostic determinant in the overall cohort.

Association of Opioid-Related Adverse Drug Events With Clinical and Cost Outcomes Among Surgical Patients in a Large Integrated Health Care Delivery System.

Abstract: Importance Opioids are commonly used for pain control during and after invasive procedures. However, opioid-related adverse drug events (ORADEs) are common and have been associated with worse patient outcomes. Objectives To examine the incidence of ORADEs in patients undergoing hospital-based surgical and endoscopic procedures and to evaluate the association of ORADEs with clinical and cost outcomes. Design, Setting, and Participants In this retrospective study of clinical and administrative data, ORADEs were identified using International Classification of Diseases , Ninth Revision diagnosis codes for known adverse effects of opioids or by opioid antagonist use. Multivariable regression analysis was used to measure the association of ORADEs with outcomes after adjusting for potential confounding factors. The setting was 21 acute care hospitals in a large integrated health care delivery system. Participants were 135 379 patients (aged ≥18 years, admitted from January 1, 2013, to September 30, 2015) who underwent surgical and endoscopic procedures and were given opioids. Exposure Opioid use, reported as morphine milligram equivalent doses. Main Outcomes and Measures Opioid-related adverse drug events and their association with inpatient mortality, discharge to another care facility, length of stay, cost of hospitalization, and 30-day readmission. Results Among 135 379 adult patients in this study (67.5% female), 14 386 (10.6%) experienced at least one ORADE. Patients with ORADEs were more likely to be older, of white race/ethnicity, and male and have more comorbidities. Patients with ORADEs received a higher total dose of opioids (median morphine milligram equivalent dose, 46.8 vs 30.0 mg; P P Conclusions and Relevance Opioid-related adverse drug events were common among patients undergoing hospital-based invasive procedures and were associated with significantly worse clinical and cost outcomes. Hospital-acquired harm from ORADEs in the surgical patient population is an important opportunity for health systems to improve patient safety and reduce cost.

Development and Validation of a Prediction Model for Pain and Functional Outcomes After Lumbar Spine Surgery.

Abstract: Importance Functional impairment and pain are common indications for the initiation of lumbar spine surgery, but information about expected improvement in these patient-reported outcome (PRO) domains is not readily available to most patients and clinicians considering this type of surgery. Objective To assess population-level PRO response after lumbar spine surgery, and develop/validate a prediction tool for PRO improvement. Design, Setting, and Participants This statewide multicenter cohort was based at 15 Washington state hospitals representing approximately 75% of the state’s spine fusion procedures. The Spine Surgical Care and Outcomes Assessment Program and the survey center at the Comparative Effectiveness Translational Network prospectively collected clinical and PRO data from adult candidates for lumbar surgery, preoperatively and postoperatively, between 2012 and 2016. Prediction models were derived for PRO improvement 1 year after lumbar fusion surgeries on a random sample of 85% of the data and were validated in the remaining 15%. Surgical candidates from 2012 through 2015 were included; follow-up surveying continued until December 31, 2016, and data analysis was completed from July 2016 to April 2017. Main Outcomes and Measures Functional improvement, defined as a reduction in Oswestry Disability Index score of 15 points or more; and back pain and leg pain improvement, defined a reduction in Numeric Rating Scale score of 2 points or more. Results A total of 1965 adult lumbar surgical candidates (mean [SD] age, 61.3 [12.5] years; 944 [59.6%] female) completed baseline surveys before surgery and at least 1 postoperative follow-up survey within 3 years. Of these, 1583 (80.6%) underwent elective lumbar fusion procedures; 1223 (77.3%) had stenosis, and 1033 (65.3%) had spondylolisthesis. Twelve-month follow-up participation rates for each outcome were between 66% and 70%. Improvements were reported in function, back pain, and leg pain at 12 months by 306 of 528 surgical patients (58.0%), 616 of 899 patients (68.5%), and 355 of 464 patients (76.5%), respectively, whose baseline scores indicated moderate to severe symptoms. Among nonoperative patients, 35 (43.8%), 47 (53.4%), and 53 (63.9%) reported improvements in function, back pain, and leg pain, respectively. Demographic and clinical characteristics included in the final prediction models were age, sex, race, insurance status, American Society of Anesthesiologists score, smoking status, diagnoses, prior surgery, prescription opioid use, asthma, and baseline PRO scores. The models had good predictive performance in the validation cohort (concordance statistic, 0.66-0.79) and were incorporated into a patient-facing, web-based interactive tool (https://becertain.shinyapps.io/lumbar_fusion_calculator). Conclusions and Relevance The PRO response prediction tool, informed by population-level data, explained most of the variability in pain reduction and functional improvement after surgery. Giving patients accurate information about their likelihood of outcomes may be a helpful component in surgery decision making.

Association of Perioperative Red Blood Cell Transfusions With Venous Thromboembolism in a North American Registry.

Abstract: Importance Increasing evidence supports the role of red blood cells (RBCs) in physiological hemostasis and pathologic thrombosis. Red blood cells are commonly transfused in the perioperative period; however, their association with postoperative thrombotic events remains unclear. Objective To examine the association between perioperative RBC transfusions and postoperative venous thromboembolism (VTE) within 30 days of surgery. Design, Setting, and Participants This analysis used prospectively collected registry data from the American College of Surgery National Surgical Quality Improvement Program (ACS-NSQIP) database, a validated registry of 525 teaching and nonteaching hospitals in North America. Participants included patients in the ACS-NSQIP registry who underwent a surgical procedure from January 1 through December 31, 2014. Data were analyzed from July 1, 2016, through March 15, 2018. Main Outcomes and Measures Risk-adjusted odds ratios (aORs) were estimated using multivariable logistic regression. The primary outcome was the development of postoperative VTE (deep venous thrombosis [DVT] and pulmonary embolism [PE]) within 30 days of surgery that warranted therapeutic intervention; DVT and PE were also examined separately as secondary outcomes. Subgroup analyses were performed by surgical subtypes. Propensity score matching was performed for sensitivity analyses. Results Of 750 937 patients (56.8% women; median age, 58 years; interquartile range, 44-69 years), 47 410 (6.3%) received at least 1 perioperative RBC transfusion. Postoperative VTE occurred in 6309 patients (0.8%) (DVT in 4336 [0.6%]; PE in 2514 [0.3%]; both DVT and PE in 541 [0.1%]). Perioperative RBC transfusion was associated with higher odds of VTE (aOR, 2.1; 95% CI, 2.0-2.3), DVT (aOR, 2.2; 95% CI, 2.1-2.4), and PE (aOR, 1.9; 95% CI, 1.7-2.1), independent of various putative risk factors. A significant dose-response effect was observed with increased odds of VTE as the number of intraoperative and/or postoperative RBC transfusion events increased (aOR, 2.1 [95% CI, 2.0-2.3] for 1 event; 3.1 [95% CI, 1.7-5.7] for 2 events; and 4.5 [95% CI, 1.0-19.4] for ≥3 events vs no intraoperative or postoperative RBC transfusion;P Conclusions and Relevance The results of this study suggest that perioperative RBC transfusions may be significantly associated with the development of new or progressive postoperative VTE, independent of several putative confounders. These findings, if validated, should reinforce the importance of rigorous perioperative management of blood transfusion practices.

Association of Lowering Default Pill Counts in Electronic Medical Record Systems With Postoperative Opioid Prescribing.

Abstract: Importance Reliance on prescription opioids for postprocedural analgesia has contributed to the opioid epidemic. With the implementation of electronic medical record (EMR) systems, there has been increasing use of computerized order entry systems for medication prescriptions, which is now more common than handwritten prescriptions. The EMR can autopopulate a default number of pills prescribed, and 1 potential method to alter prescriber behavior is to change the default number presented via the EMR system. Objective To investigate the association of lowering the default number of pills presented when prescribing opioids in an EMR system with the amount of opioid prescribed after procedures. Design, Setting, and Participants A prepost intervention study was conducted to compare postprocedural prescribing patterns during the 3 months before the default change (February 18 to May 17, 2017) with the 3 months after the default change (May 18 to August 18, 2017). The setting was a multihospital health care system that uses Epic EMR (Hyperspace 2015 IU2; Epic Systems Corporation). Participants were all patients in the study period undergoing 1 of the 10 most common operations and discharged by postoperative day 1. Intervention The default number of opioid pills autopopulated in the EMR when prescribing discharge analgesia was lowered from 30 to 12. Main Outcomes and Measures Linear regression estimating the change in the median number of opioid pills and the total dose of opioid prescribed was performed. Opioid doses were converted into morphine milligram equivalents (MME) for comparison. The frequency of patients requiring analgesic prescription refills was also evaluated. Results There were 1447 procedures (mean [SD] age, 54.4 [17.3] years; 66.9% female) before the default change and 1463 procedures (mean [SD] age, 54.5 [16.4] years; 67.0% female) after the default change. After the default change, the median number of opioid pills prescribed decreased from 30 (interquartile range, 15-30) to 20 (interquartile range, 12-30) per prescription ( P P P P = .41). Conclusions and Relevance Lowering the default number of opioid pills prescribed in an EMR system is a simple, effective, cheap, and potentially scalable intervention to change prescriber behavior and decrease the amount of opioid medication prescribed after procedures.

Practical Guide to Surgical Data Sets: National Surgical Quality Improvement Program (NSQIP) and Pediatric NSQIP.

Abstract: Introduction For more than 100 years, the American College of Surgeons (ACS) has set the standard for the delivery of high-quality medical and surgical care. Based on programs originally created at the Department of Veterans Affairs, the ACS developed and implemented the National Surgical Quality Improvement Program (NSQIP) in 2004.1 Since its inception, the NSQIP has spread to nearly 700 hospitals and captures more than 1 million incident cases annually. A major strength of the ACS NSQIP program is the means that it provides to report national, clinically abstracted, highly reliable, risk-adjusted, and case-mix–adjusted surgical data that facilitates validated peer-comparison. As such, the ACS NSQIP is widely recognized as the premier surgical quality and outcomes assessment program (Box). Via the ACS NSQIP, hospitals and clinicians have access to granular, actionable data that have led to improvements in morbidity and mortality, cost savings from prevention of complications, and a platform for disease-specific, procedure-specific, or regional or system-based collaboratives. In parallel, the ACS NSQIP Pediatric (NSQIP-P) program was piloted in 2008 to address surgical quality improvement for children undergoing surgery.2 The ACS NSQIP-P now includes more than 100 sites and captures more than 150 000 pediatric cases annually.

Association of Frailty With Failure to Rescue After Low-Risk and High-Risk Inpatient Surgery

Abstract: Importance Failure to rescue (FTR), or death after a potentially preventable complication, is a nationally endorsed, publicly reported quality measure. However, little is known about the impact of frailty on FTR, in particular after low-risk surgical procedures. Objective To assess the association of frailty with FTR in patients undergoing inpatient surgery. Design, Setting, and Participants This study assessed a cohort of 984 550 patients undergoing inpatient general, vascular, thoracic, cardiac, and orthopedic surgery in the National Surgical Quality Improvement Program between January 1, 2005, and December 31, 2012. Frailty was assessed using the Risk Analysis Index (RAI), and patients were stratified into 5 groups (RAI score, ≤10, 11-20, 21-30, 31-40, and >40). Procedures were categorized as low mortality risk (≤1%) or high mortality risk (>1%). The association between RAI scores, the number of postoperative complications (0, 1, 2, or 3 or more), and FTR was evaluated using hierarchical modeling. Main Outcomes and Measures The number of postoperative complications and inpatient FTR. Results A total of 984 550 patients were included, with a mean (SD) age of 58.2 (17.1) years; women were 549 281 (55.8%) of the cohort. For patients with RAI scores of 10 or less, major complication rates after low-risk surgery were 3.2%; rates of those with RAI scores of 11 to 20, 21 to 30, 31 to 40, and more than 40 were 8.6%, 13.5%, 23.8%, and 36.4%, respectively. After high-risk surgery, these rates were 13.5% for those with scores of 10 or less, 23.7% for those with scores of 11 to 20, 31.1% for those with scores of 21 to 30, 42.5% for those with scores of 31 to 40, and 54.4% for those with scores of more than 40. Stratifying by the number of complications, significant increases in FTR were observed across RAI categories after both low-risk and high-risk procedures. After a low-risk procedure, odds of FTR after 1 major complication for patients with RAI scores of 11 to 20 increased 5-fold over those with RAI scores of 10 or less (odds ratio [OR], 5.3; 95% CI, 3.9-7.1). Odds ratios were 8.1 (95% CI, 5.6-11.7) for patients with RAI scores of 21 to 30; 22.3 (95% CI, 13.9-35.6) for patients with scores of 31 to 40; and 43.9 (95% CI, 19-101.1) for patients with scores of more than 40. For patients undergoing a high-risk procedure, the corresponding ORs were likewise consistently elevated (RAI score 11-20: OR, 2.5; 95% CI, 2.3-2.7; vs RAI score 21-30: 5.1; 95% CI, 4.6-5.5; vs RAI score 31-40: 8.9; 95% CI, 8.1-9.9; vs RAI score >40: 18.4; 95% CI, 15.7-21.4). Conclusions and Relevance Frailty has a dose-response association with complications and FTR, which is apparent after low-risk and high-risk inpatient surgery. Systematic assessment of frailty in preoperative patients may help refine estimates of surgical risk that could identify patients who might benefit from perioperative interventions designed to enhance physiologic reserve and potentially mitigate aspects of procedural risk, and would provide a framework for shared decision-making regarding the value of a given surgical procedure.

Association of Integrated Care Coordination With Postsurgical Outcomes in High-Risk Older Adults: The Perioperative Optimization of Senior Health (POSH) Initiative.

Abstract: Importance Older adults undergoing elective surgery experience higher rates of preventable postoperative complications than younger patients. Objective To assess clinical outcomes for older adults undergoing elective abdominal surgery via a collaborative intervention by surgery, geriatrics, and anesthesia focused on perioperative health optimization. Design, Setting, and Participants Perioperative Optimization of Senior Health (POSH) is a quality improvement initiative with prospective data collection. Participants in an existing geriatrics-based clinic within a single-site academic health center were included if they were at high risk for complications (ie, older than 85 years or older than 65 years with cognitive impairment, recent weight loss, multimorbidity, or polypharmacy) undergoing elective abdominal surgery. Outcomes were compared with a control group of patients older than 65 years who underwent similar surgeries by the same group of general surgeons immediately before implementation of POSH. Main Outcomes and Measures Primary outcomes included length of stay, 7- and 30-day readmissions, and level of care at discharge. Secondary outcomes were delirium and other major postoperative complications. Outcomes data were derived from institutional databases linked with electronic health records and billing data sets. Results One hundred eighty-three POSH patients were compared with 143 patients in the control group. On average, patients in the POSH group were older compared with those in the control group (75.6 vs 71.9 years;P Conclusions and Relevance Despite higher mean age and morbidity burden, older adults who participated in an interdisciplinary perioperative care intervention had fewer complications, shorter hospitalizations, more frequent discharge to home, and fewer readmissions than a comparison group.

Practical Guide to Surgical Data Sets: National Trauma Data Bank (NTDB)

Abstract: Introduction Trauma remains a leading cause of death and disability and accounts for a substantial portion of health care expenditures.1 Therefore, research to improve trauma care is a leading public health priority. Spearheading this effort, the American College of Surgeons Committee on Trauma coordinated a landmark multi-institutional endeavor, the Major Trauma Outcomes Study.2 On its completion in 1989, the American College of Surgeons Committee on Trauma recognized the importance of national trauma data aggregation to inform quality improvement. In 1997, it formed a subcommittee to develop the National Trauma Data Bank (NTDB), a standardized collection of national trauma data (Box). Today, to our knowledge, the NTDB is the world’s largest trauma data repository, with more than 7.5 million electronic records from more than 900 trauma centers.

Factors Associated With Residency and Career Dissatisfaction in Childbearing Surgical Residents.

Abstract: Importance Previous work shows women who have children during surgical residency face difficulty balancing childbearing with training, which negatively affects residency and career satisfaction. Little is known about the factors that drive professional discontent. Objective To determine factors associated with professional dissatisfaction for childbearing residents. Design, Setting, and Participants Self-administered survey questionnaire electronically distributed through the Association of Program Directors in Surgery, the Association of Women Surgeons, and targeted Twitter and Facebook platforms. The survey was distributed in January 2017 to surgeons who delivered at least 1 child during a US general surgery residency and was available online for 4 weeks. Main Outcomes and Measures Respondents were reported to be dissatisfied with their residency if they indicated agreement that they considered leaving residency owing to challenges surrounding childbearing (considered leaving). Respondents were reported to be unhappy with their career if they indicated agreement with statements that (1) given an opportunity to revisit their job choice, they would choose a nonsurgical career more accommodating of motherhood (revisit career choice) or (2) they would advise a female medical student against a surgical career owing to difficulties balancing motherhood with the profession (advise against surgery). Logistic regression was used to determine predictors of agreement with each of the 3 statements of professional dissatisfaction. Results In total, 347 women responded to the survey and reported 452 pregnancies, and the mean (SD) age was 30.5 (2.7) years. One hundred seventy-nine respondents (51.6%) agreed with at least 1 statement of residency or career dissatisfaction. Lack of a formal maternity leave policy was associated with “considered leaving” (odds ratio [OR], 1.83; 95% CI, 1.07-3.10). Perception of stigma during pregnancy was associated with “revisit career choice” (OR, 1.79; 95% CI, 1.01-3.19). Changing fellowship plans owing to perceived difficulty balancing motherhood with the originally chosen subspecialty was associated with all 3 markers of residency and career dissatisfaction (“considered leaving” OR, 2.68; 95% CI, 1.30-5.56; “revisit career choice” OR, 2.23; 95% CI, 1.13-4.43; and “advise against surgery” OR, 2.44; 95% CI, 1.23-4.84). Conclusions and Relevance Surgery residents who perceived stigma during pregnancy, did not have a formal institutional maternity leave policy, or altered their fellowship training plans because of challenges of childbearing expressed greater professional dissatisfaction. Mentorship in subspecialty selection and work-life integration, interventions to reduce workplace bias, and identification of obstacles to establishment of maternity leave policies are needed to enhance professional fulfillment for childbearing residents.

Effect of Depth of Sedation in Older Patients Undergoing Hip Fracture Repair on Postoperative Delirium: The STRIDE Randomized Clinical Trial

Abstract: Importance Postoperative delirium is the most common complication following major surgery in older patients. Intraoperative sedation levels are a possible modifiable risk factor for postoperative delirium. Objective To determine whether limiting sedation levels during spinal anesthesia reduces incident delirium overall. Design, Setting, and Participants This double-blind randomized clinical trial (A Strategy to Reduce the Incidence of Postoperative Delirum in Elderly Patients [STRIDE]) was conducted from November 18, 2011, to May 19, 2016, at a single academic medical center and included a consecutive sample of older patients (≥65 years) who were undergoing nonelective hip fracture repair with spinal anesthesia and propofol sedation. Patients were excluded for preoperative delirium or severe dementia. Of 538 hip fractures screened, 225 patients (41.8%) were eligible, 10 (1.9%) declined participation, 15 (2.8%) became ineligible between the time of consent and surgery, and 200 (37.2%) were randomized. The follow-up included postoperative days 1 to 5 or until hospital discharge. Interventions Heavier (modified observer’s assessment of sedation score of 0-2) or lighter (observer’s assessment of sedation score of 3-5) propofol sedation levels intraoperatively. Main Outcomes and Measures Delirium on postoperative days 1 to 5 or until hospital discharge determined via consensus panel using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) criteria. The incidence of delirium was compared between intervention groups with and without stratification by the Charlson comorbidity index (CCI). Results Of 200 participants, the mean (SD) age was 82 (8) years, 146 (73%) were women, 194 (97%) were white, and the mean (SD) CCI was 1.5 (1.8). One hundred participants each were randomized to receive lighter sedation levels or heavier sedation levels. A good separation of intraoperative sedation levels was confirmed by multiple indices. The overall incident delirium risk was 36.5% (n = 73) and 39% (n = 39) vs 34% (n = 34) in heavier and lighter sedation groups, respectively ( P = .46). Intention-to-treat analyses indicated no statistically significant difference between groups in the risk of incident delirium (log-rank test χ 2 , 0.46; P = .46). However, in a prespecified subgroup analysis, when stratified by CCI, sedation levels did effect the delirium risk ( P for interaction = .04); in low comorbid states (CCI = 0), heavier vs lighter sedation levels doubled the risk of delirium (hazard ratio, 2.3; 95% CI, 1.1- 4.9). The level of sedation did not affect delirium risk with a CCI of more than 0. Conclusions and Relevance In the primary analysis, limiting the level of sedation provided no significant benefit in reducing incident delirium. However, in a prespecified subgroup analysis, lighter sedation levels benefitted reducing postoperative delirium for persons with a CCI of 0. Trial Registration clinicaltrials.gov Identifier:NCT00590707

Negative Pressure Wound Therapy for Closed Laparotomy Incisions in General and Colorectal Surgery: A Systematic Review and Meta-analysis.

Abstract: Importance Surgical site infections (SSIs) are common after laparotomy wounds and are associated with a significant economic burden. The use of negative pressure wound therapy (NPWT) has recently been broadened to closed surgical incisions. Objective To evaluate the association of prophylactic NPWT with SSI rates in closed laparotomy incisions performed for general and colorectal surgery in elective and emergency settings. Data Sources The PubMed, Embase, Cochrane Central Register of Controlled Trials, and Google Scholar databases were searched without language restrictions for relevant articles from inception until December 2017. The latest search was performed on December 31, 2017. The bibliographies of retrieved studies were further screened for potential additional studies. Study Selection Randomized clinical trials and nonrandomized studies were included. Unpublished reports were excluded, as were studies that examined NPWT (or standard nonpressure) dressings only without a comparator group. Studies that evaluated the use of NPWT in open abdominal incisions were also excluded. Disagreement was resolved by discussion, and if the question remained unsettled, the opinion of the senior author was sought. A total of 198 citations were identified, and 189 were excluded. Data Extraction and Synthesis This meta-analysis was conducted according to PRISMA guidelines. Data were independently extracted by 2 authors. A random-effects model was used for statistical analysis. Main Outcomes and Measures The primary outcome measure was SSI, and secondary outcomes included seroma and wound dehiscence rates. These outcomes were chosen before data collection. Results Nine unique studies (3 randomized trials and 2 prospective and 4 retrospective studies) capturing 1266 unique patients were included. Of these, 1187 patients with 1189 incisions were included in the final analysis (52.3% male among 7 studies reporting data on sex; mean [SD] age, 52 [15] years among 8 studies reporting data on age). Significant clinical and methodologic heterogeneity existed among studies. On random-effects analysis, NPWT was associated with a significantly lower rate of SSI compared with standard dressings (pooled odds ratio [OR], 0.25; 95% CI, 0.12-0.52;P Conclusions and Relevance Application of NPWT on closed laparotomy wounds in general and colorectal surgery is associated with reduced SSI rates but similar rates of seroma and wound dehiscence compared with conventional nonpressure dressings.

Association Between Changes in Body Composition and Neoadjuvant Treatment for Pancreatic Cancer.

Abstract: Importance Sarcopenia and sarcopenic obesity have been associated with poor outcomes in unresectable pancreatic cancer (PC). Neoadjuvant treatment (NT) is used increasingly to improve resectability; however, its effects on fat and muscle body composition have not been characterized. Objectives To evaluate whether NT affects muscle mass and adipose tissue in patients with borderline resectable PC (BRPC) and locally advanced PC (LAPC) and determine whether there were potential differences between patients who ultimately underwent resection and those who did not. Design, Setting, and Participants In this retrospective cohort study conducted at 4 academic medical centers, 193 patients with BRPC and LAPC undergoing surgical exploration after NT who had available computed tomographic scans (both at diagnosis and preoperatively) and confirmed pancreatic ductal adenocarcinoma were evaluated. The study was conducted from January 2013 to December 2015. Data analysis was performed from September 2016 to May 2017. Measurement of body compartments was evaluated with volume assessment software before and after NT. A radiologist blinded to the patient outcome assessed the areas of skeletal muscle, total adipose tissue, and visceral adipose tissue through a standardized protocol. Exposures Receipt of NT. Main Outcomes and Measures Achievement of pancreatic resection at surgical exploration after the receipt of NT. Results Of the 193 patients with complete radiologic imaging available after NT, 96 (49.7%) were women; mean (SD) age at diagnosis was 64 (11) years. Most patients received combined therapy with fluorouracil, irinotecan, oxaliplatin, leucovorin, and folic acid (124 [64.2%]) and 86 (44.6%) received chemoradiotherapy as well. The median interval between pre-NT and post-NT imaging was 6 months (interquartile range [IQR], 4-7 months). All body compartments significantly changed. The adipose compound decreased (median total adipose tissue area from 284.0 cm2; IQR, 171.0-414.0 to 250.0 cm2; IQR, 139.0-363.0;P Conclusions and Relevance Patients with PC experience a significant loss of adipose tissue during neoadjuvant chemotherapy, but no muscle wasting. An increase in muscle tissue during NT is associated with resectability.

Race/Ethnicity and Age Distribution of Breast Cancer Diagnosis in the United States.

Abstract: This study assesses the age distribution of breast cancer diagnosis across race/ethnicity in US female patients using the Surveillance, Epidemiology, and End Results Program database.

Association of Low Nodal Positivity Rate Among Patients With ERBB2-Positive or Triple-Negative Breast Cancer and Breast Pathologic Complete Response to Neoadjuvant Chemotherapy.

Abstract: Importance A recent publication reported that of 527 patients with clinically node-negative (cN0) cT1/cT2 triple-negative breast cancer (TNBC) orERBB2-positive disease treated with neoadjuvant chemotherapy (NAC), 100% of those who achieved a breast pathologic complete response (pCR) had pathologic node negativity (pN0). Eliminating axillary surgery in these patients has been suggested as safe based on these results. Objective To evaluate nodal positivity rates in patients with cT1/cT2 N0ERBB2-positive disease and TNBC with a breast pCR after NAC using the National Cancer Database (NCDB), which included academic and community settings. Design, Setting, and Participants This retrospective study reviewed data from the NCDB from January 1, 2010, through December 31, 2015. Participants included patients with cN0/cN1 cT1/cT2 breast cancer who received NAC followed by surgery. Pathologic nodal positivity rates by breast pCR were compared in cN0 and cN1 disease, within each tumor subtype (ERBB2-positive, TNBC, and hormone receptor–positive/ERBB2-negative). Data were analyzed from September 13, 2017, through January 30, 2018. Exposures Neoadjuvant chemotherapy followed by surgery. Main Outcomes and Measures The pathologic nodal positivity rate after NAC (ypN) specifically in patients with cT1/cT2 cN0ERBB2-positive disease or TNBC who achieve a breast pCR after NAC. Results A total of 30 821 patients with cT1/cT2 cN0/cN1 breast cancer treated with NAC and surgical resection (99.6% female; mean [SD] age, 52.0 [11.5] years) were identified. Of 6802 patients with cN0ERBB2-positive disease, 3062 (45.0%) achieved breast pCR and of those, 49 (1.6%; 95% CI, 1.2%-2.1%) were ypN positive. In 6222 patients with cN0 TNBC, 2315 (37.2%) achieved breast pCR, and of those, 36 (1.6%; 95% CI, 1.1%-2.1%) were pathologic node positive after NAC. Rates of ypN positivity were higher in patients with cN0 and residual disease in the breast; 632 of 3740 (16.9%) withERBB2-positive disease and 492 of 3907 (12.6%) with TNBC with residual disease in the breast were node positive (P Conclusions and Relevance In this study, the highest rates of breast pCR were seen inERBB2-positive disease and TNBC. In patients with cN0ERBB2-positive disease or TNBC with breast pCR, the nodal positivity rate was less than 2%, which supports consideration of omission of axillary surgery in this subset of patients.

Comparison of Efficacy and Safety of 4 Combinations of Laparoscopic and Intraoperative Techniques for Management of Gallstone Disease With Biliary Duct Calculi: A Systematic Review and Network Meta-analysis.

Abstract: Importance Several techniques are used for surgical treatment of gallstone disease with biliary duct calculi, but the safety and efficacy of these approaches have not been compared. Objectives To compare the efficacy and safety of 4 surgical approaches to gallstone disease with biliary duct calculi. Data Sources MEDLINE, Scopus, and ISI-Web of Science databases, articles published between 1950 and 2017 and searched from August 12, 2017, to September 14, 2017. Search terms used wereLCBDE,LC,preoperative,ERCP,postoperative,period,cholangiopancreatography,endoscopic,retrograde,rendezvous,intraoperative,one-stage,two-stage,single-stage,gallstone,gallstones,calculi,stone,therapy,treatment,therapeutics,surgery,surgical,procedures,clinical trialsas topic,random, andallocationin several logical combinations. Study Selection Randomized clinical trials comparing at least 2 of the following strategies: preoperative endoscopic retrograde cholangiopancreatography (PreERCP) plus laparoscopic cholecystectomy (LC); LC with laparoscopic common bile duct exploration (LCDBE); LC plus intraoperative endoscopic retrograde cholangiopancreatography (IntraERCP); and LC plus postoperative ERCP (PostERCP). Data Extraction and Synthesis A frequentist random-effects network meta-analysis was performed. The surface under the cumulative ranking curve (SUCRA) was used to show the probability that each approach would be the best for each outcome. Main Outcomes and Measures Primary outcomes were the safety to efficacy ratio using overall mortality and morbidity rates as the main indicators of safety and the success rate as an indicator of efficacy. Secondary outcomes were acute pancreatitis, biliary leak, overall bleeding, operative time, length of hospital stay, total cost, and readmission rate. Results The 20 trials comprised 2489 patients (and 2489 procedures). Laparoscopic cholecystectomy plus IntraERCP had the highest probability of being the most successful (SUCRA, 87.2%) and safest (SUCRA, 69.7%) with respect to morbidity. All approaches had similar results regarding overall mortality. Laparoscopic cholecystectomy plus LCBDE was the most successful for avoiding overall bleeding (SUCRA, 83.3%) and for the shortest operative time (SUCRA, 90.2%) and least total cost (SUCRA, 98.9%). Laparoscopic cholecystectomy plus IntraERCP was the best approach for length of hospital stay (SUCRA, 92.7%). Inconsistency was found in operative time (indirect estimate, 19.05; 95% CI, 2.44-35.66;P = .02) and total cost (indirect estimate, 17.06; 95% CI, 3.56-107.21;P = .04). Heterogeneity was observed for success rate (τ, 0.8), operative time (τ, >1), length of stay (τ, >1), and total cost (τ, >1). Conclusions and Relevance The combined LC and IntraERCP approach had the greatest odds to be the safest and appears to be the most successful. Laparoscopic cholecystectomy plus LBCDE appears to reduce the risk of acute pancreatitis but may be associated with a higher risk of biliary leak.

Association of the Affordable Care Act Medicaid Expansion With Access to and Quality of Care for Surgical Conditions.

Abstract: Importance Lack of insurance coverage has been associated with delays in seeking care, more complicated diseases at the time of diagnosis, and decreased likelihood of receiving optimal surgical care The Patient Protection and Affordable Care Act’s (ACA) Medicaid expansion has increased coverage among millions of low-income Americans, but its effect on care for common surgical conditions remains unknown Objective To evaluate the association of the ACA’s Medicaid expansion with access to timely and recommended care for common and serious surgical conditions Design, Setting, and Participants This quasi-experimental, difference-in-differences study used hospital administrative data to compare patient-level outcomes in expansion vs nonexpansion states before (2010-2013) vs after (2014-2015) expansion A total of 293 529 patients aged 18 to 64 years with appendicitis, cholecystitis, diverticulitis, peripheral artery disease (PAD), or aortic aneurysm admitted to an academic medical center or affiliated hospital in 27 Medicaid expansion states and 15 nonexpansion states from January 1, 2010, through September 31, 2015, were included in the study Data analysis was performed from November 1, 2016, to March 3, 2017 Exposures State adoption of Medicaid expansion Main Outcomes and Measures Presentation with early uncomplicated disease (diverticulitis without abscess, fistula, or sepsis; nonruptured aortic aneurysm at time of repair; and PAD without ulcerations or gangrene) and receipt of optimal management (cholecystectomy for acute cholecystitis, laparoscopic approach for cholecystectomy or appendectomy, and limb salvage for PAD) Results Of the 293 529 study patients (128 392 [437%] female and 165 137 [563%] male), 225 572 had admissions in Medicaid expansion states and 67 957 had admissions in nonexpansion states Medicaid expansion was associated with a 75–percentage point decreased probability of patients being uninsured (95% CI, −122 to −29; P = 002) and an 86–percentage point increased probability of having Medicaid (95% CI, 61-111; P P = 001) and a 26–percentage point increase in the probability of receiving optimal management (95% CI, 08-44; P = 006) Conclusions and Relevance The ACA’s Medicaid expansion was associated with increased insurance coverage and improved receipt of timely care for 5 common surgical conditions Health care systems and policymakers should be aware of the influence of insurance coverage expansion (or its repeal) on presentation with and management of surgical disease