The evolution of emergency general surgery: its time for a dedicated program manager.

BACKGROUND: Emergency general surgery (EGS) is emerging as a distinct sub-specialty of acute care surgery but continues to exist without essential processes that drive modern trauma programs. An EGS-specific quality program was created with service-based Advanced Practice Provider (SB APP) administrative oversight, thus validating the need for a dedicated EGS program manager. METHODS: In 2017, a quality structure was formalized with primary focus on scheduled quality meetings, peer review and outcomes review. All admission, service-specific dashboards, and readmission data were manually audited by SB APPs to confirm accuracy and identify opportunities for process improvement. RESULTS: Surgical quality metrics including patient volume, mortality, complications, readmission and infection prevention indicators, were reviewed by SBAPPs. Annual EMR data for all EGS patients was compared to data collected via manual review with a novel registry logic. Comparison of EMR generated data versus EGS registry data identified under-representation of total admissions: in 2016, the EMR identified 130 admissions with registry logic identifying 625 actual EGS admissions. The EMR identified 515 admissions in 2017 and 485 admission in 2018 with registry logic identifying 777 and 712, respectively. Review of readmission data revealed an error of 14 patients in 2017 and 11 patients in 2018. CONCLUSIONS: The quest to improve quality of care for the EGS patient requires timely review of high-quality, accurate data by dedicated and trained personnel. Our process revealed the vital functions of an EGS PM are crucial in the evolution of the EGS specialty. LEVEL OF EVIDENCE: Level IV economic and value-based evaluations.

Does routine postoperative contrast radiography improve outcomes for patients with perforated peptic ulcer? A multicenter retrospective cohort study.

BACKGROUND: Perforated peptic ulcer is a morbid emergency general surgery condition. Best practices for postoperative care remain undefined. Surgical dogma preaches practices such as peritoneal drain placement, prolonged nil per os, and routine postoperative enteral contrast imaging despite a lack of evidence. We aimed to evaluate the role of postoperative enteral contrast imaging in postoperative perforated peptic ulcer care. Our primary objective was to assess effects of routine postoperative enteral contrast imaging on early detection of clinically significant leaks. METHODS: We conducted a multicenter retrospective cohort study of patients who underwent repair of perforated peptic ulcer between July 2016 and June 2018. We compared outcomes between those who underwent routine postoperative enteral contrast imaging and those who did not. RESULTS: Our analysis included 95 patients who underwent primary/omental patch repair. The mean age was 60 years, and 54% were male. Thirteen (14%) had a leak. Eighty percent of patients had a drain placed. Nine patients had leaks diagnosed based on bilious drain output without routine postoperative enteral contrast imaging. Use of routine postoperative enteral contrast imaging varied significantly between institutions (30%-87%). Two late leaks after initial normal postoperative enteral contrast imaging were confirmed by imaging after a clinical change triggered the second study. Two patients had contained leaks identified by routine postoperative enteral contrast imaging but remained clinically well. Duration of hospital stay was longer in those who received routine postoperative enteral contrast imaging (12 vs 6 days, median; P = .000). CONCLUSION: Routine postoperative enteral contrast imaging after perforated peptic ulcer repair likely does not improve the detection of clinically significant leaks and is associated with increased duration of hospital stay.

Empiric antifungals do not decrease the risk for organ space infection in patients with perforated peptic ulcer.

INTRODUCTION: Infection control in patients with perforated peptic ulcers (PPU) commonly includes empiric antifungals (AF). We investigated the variation in the use of empiric AF and explored the association between their use and the subsequent development of organ space infection (OSI). METHODS: This was a secondary analysis of a multicenter, case-control study of patients treated for PPU at nine institutions between 2011 and 2018. Microbiology and utilization of empiric AF, defined as AF administered within 24 hours from the index surgery, were recorded. Patients who received empiric AF were compared with those who did not. The primary outcome was OSI and secondary outcome was OSI with growth of Candida spp. A logistic regression was used to adjust for differences between the two cohorts. RESULTS: A total of 554 patients underwent a surgical procedure for PPU and had available timing of AF administration. The median age was 57 years and 61% were male. Laparoscopy was used in 24% and omental patch was the most common procedure performed (78%). Overall, 239 (43%) received empiric AF. There was a large variation in the use of empiric AF among participating centers, ranging from 25% to 68%. The overall incidence of OSI was 14% (77/554) and was similar for patients who did or did not receive empiric AF. The adjusted OR for development of OSI for patients who received empiric AF was 1.04 (95% CI 0.64 to 1.70), adjusted p=0.86. The overall incidence of OSI with growth of Candida spp was 5% and was similar for both groups (adjusted OR 1.29, 95% CI 0.59 to 2.84, adjusted p=0.53). CONCLUSION: For patients undergoing surgery for PPU, the use of empiric AF did not yield any significant clinical advantage in preventing OSI, even those due to Candida spp. Use of empiric AF in this setting is unnecessary. STUDY TYPE: Original article, case series. LEVEL OF EVIDENCE: III.

Surgical Faculty Perception of Service-Based Advanced Practice Provider Impact: A Southwestern Surgical Congress Multicenter Survey.

BACKGROUND: A previous single-center survey of trauma and general surgery faculty demonstrated perceived positive impact of trauma and surgical subspecialty service-based advanced practice providers (SB APPs). The aim of this multicenter survey was to further validate these findings. METHODS: Faculty surgeons on teams that employ SB APPs at 8 academic centers completed an electronic survey querying perception about advanced practice provider (APP) competency and impact. RESULTS: Respondents agreed that SB APPs decrease workload (88%), length of stay (72%), contribute to continuity (92%), facilitate care coordination (87%), enhance patient satisfaction (88%), and contribute to best practice/safe patient care (83%). Fewer agreed that APPs contribute to resident education (50%) and quality improvement (QI)/research (36%). Although 93% acknowledged variability in the APP level of function, 91% reported trusting their clinical judgment. CONCLUSION: This study supports the perception that SB APPs have a positive impact on patient care and quality indicators. Areas for potential improvement include APP contribution to resident education and research/QI initiatives.

Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection.

The COVID-19 pandemic caused by the new SARS-CoV-2 coronavirus has imposed severe challenges on laboratories in their effort to achieve sufficient diagnostic testing capability for identifying infected individuals. In this study, we report the analytical and clinical performance characteristics of a new, high-throughput, fully automated nucleic acid amplification test system for the detection of SARS-CoV-2. The assay utilizes target capture, transcription-mediated amplification, and acridinium ester-labeled probe chemistry on the automated Panther system to directly amplify and detect two separate target sequences in the open reading frame 1ab (ORF1ab) region of the SARS-CoV-2 RNA genome. The probit 95% limit of detection of the assay was determined to be 0.004 50% tissue culture infective dose (TCID50)/ml using inactivated virus and 25 copies/ml (c/ml) using synthetic in vitro transcript RNA targets. Analytical sensitivity (100% detection) was confirmed to be 83 to 194 c/ml using three commercially available SARS-CoV-2 nucleic acid controls. No cross-reactivity or interference was observed with testing of six related human coronaviruses, as well as 24 other viral, fungal, and bacterial pathogens, at high titers. Clinical nasopharyngeal swab specimen testing (n = 140) showed 100%, 98.7%, and 99.3% positive, negative, and overall agreement, respectively, with a validated reverse transcription-PCR nucleic acid amplification test (NAAT) for SARS-CoV-2 RNA. These results provide validation evidence for a sensitive and specific method for pandemic-scale automated molecular diagnostic testing for SARS-CoV-2.

Evaluation of a water-soluble contrast protocol for small bowel obstruction: A southwestern surgical congress multicenter trial.

Differentiation between SBO that will resolve with supportive measures and those requiring surgery remains challenging. WSC administration may be diagnostic and therapeutic. The purpose of this study was to evaluate use of a SBO protocol using WSC challenge. A protocol was implemented at five tertiary care centers. Demographics, prior surgical history, time to operation, complications, and LOS were analyzed. 283 patients were admitted with SBO; 13% underwent immediate laparotomy; these patients had a median LOS of 7.5 days. The remaining 245 were candidates for WSC challenge. Of those, 80% received contrast. 139 (71%) had contrast passage to the colon. LOS in these patients was 4 days. Sixty-five patients (29%) failed contrast passage within 24 h and underwent surgery. LOS was 9 days. 8% of patients in whom contrast passage was observed at 24 h nevertheless subsequently underwent surgery. 4% of patients who failed WSC challenge did not proceed to surgery. Our multicenter trial revealed that implementation of a WSC protocol may facilitate early recognition of partial from complete obstruction.

Laparoscopic omental patch for perforated peptic ulcer disease reduces length of stay and complications, compared to open surgery: A SWSC multicenter study.

RCTs showed benefits in Lap repair of perforated peptic ulcer (PPU). The SWSC Multi-Center Trials Group sought to evaluate whether Lap omental patch repairs compared to Open improved outcomes in PPU in general practice. Data was collected from 9 SWSC Trial Group centers. Demographics, operative time, 30-day complications, length of stay and mortality were included. 461 PATIENTS: Open in 311(67%) patients, Lap in 132(28%) with 20(5%) patients converted from Lap to Open. Groups were similar at baseline. Significant variability was found between centers in their utilization of Lap (0-67%). Complications at 30 days were lower in Lap (18.5% vs. 27.5%, p < 0.05) as was unplanned re-operation (4.7% vs 14%, p < 0.05). Lap reduced LOS (6 vs 8 days, p < 0.001). Ileus was more in Lap (42% vs 18 p < 0.001) operative time was 14 min higher in Lap(p < 0.01) and admission to OR time was 4 h higher in Lap(<0.05). No significant difference readmission or mortality. Our results suggest Lap should be considered a first-line option in suitable PPU patients requiring omental patch repair in centers that have the capacity and resources 24/7.

Service-Based Advanced Practice Providers: The Surgeon's Perspective.

The ACGME work hour restrictions facilitated increased utilization of service-based advanced practice providers (APPs) to offset reduced general surgery resident work hours. Information regarding attending surgeon perceptions of APP impact is limited. The aim of this survey was to gauge these perceptions with respect to workload, length of stay (LOS), safety, best practice, level of function, and clinical judgment. Attending surgeons on surgical teams that employ service-based APPs at an urban tertiary referral center responded to a survey at the completion of academic year 2016. Perceptions regarding APP impact on workload, LOS, safety, best practice, level of function, and clinical judgment were examined. Twenty-two attending surgeons (40%) responded. Respondents agreed that APPs always/usually decrease their workload (77%), decrease LOS (64%), improve safety (68%), contribute to best practice (82%), and decrease near misses (71%). They also agreed that APPs decrease resident workload (87%), but fewer agreed that APPs contribute to resident education (68%). The majority perceived APPs function at the PGY1/2 (43%) or PGY3 (39%) level and always/usually trust their clinical judgment (72%), and felt there was variability in level of function among APPs (56%). This single-center study illustrates that attending surgeons perceive a positive impact on patient care by service-based APPs.

High-Risk Human Papillomavirus Detection in Urine Samples From a Referral Population With Cervical Biopsy-Proven High-Grade Lesions.

The aim of the study was to evaluate the performance of the HPV-HR test to detect high-risk human papillomavirus (HPV) in urine samples in comparison with a commercial molecular HPV test. MATERIALS AND METHODS: This is a prospective study, in which 350 patients diagnosed previously with cervical intraepithelial neoplasia (CIN) grade 2 or higher were enrolled. Urine and cervical specimens were collected. Urine was tested with the HPV-HR test and cervical specimens were tested with the Cobas. RESULTS: Of the 336 evaluable patients, there were 271 cases of CIN 2+, of which 202 were CIN 3+ and the remaining 65 patients were less than CIN 2. Positivity was 77.1% (95% confidence interval [CI] = 72.5-81.5) for the urine samples and 83.6% (95% CI = 79.6-87.6) for the cervical samples. Agreement between cervical and urine samples for HPV detection was 79.8% (κ = 0.363; 95% CI = 0.243-0.484). Sensitivity for CIN 2+ was 83.4% (95% CI = 78.4-87.6) for urine and 90.8% (95% CI = 86.7-92.9) for cervical samples. The sensitivity for CIN 3+ was 85.6% (95% CI = 80.0-90.2) for urine and 92.6% (95% CI = 88.0-95.8) for cervical samples. Specificity for worse than CIN 2 was 50.8% (95% CI = 33.7-59.0) and 46.2% (95% CI = 33.7-59.0) for urine and cervical samples, respectively. CONCLUSIONS: Although these results demonstrated slightly higher detection rates for HR-HPV and clinical sensitivity in cervical samples than in urine, when compared with histological diagnoses, urine sampling is a viable alternative to access women who do not participate in routine screening programs.

Acute care surgery and emergency general surgery: Addition by subtraction.

INTRODUCTION: The formation of Acute Care Surgery services leads to decreased time to treatment and improved outcomes for emergency general surgery (EGS) patients. However, minimal work has focused on the ideal care delivery system and team structure. We hypothesize that the implementation of a dedicated EGS team (separate from trauma and surgical critical care), with EGS-specific protocols and dedicated operating room (OR) time, will increase productivity and improve mortality. METHODS: This is a retrospective review of financial and EGS registry data from fiscal year (FY) 12 to FY15. Data are from an academic, university-based EGS team composed of two acute care surgery attending surgeons, advanced practitioners (APs), residents, and a fellow. In FY12, processes were implemented to standardize paging of consults, patient sign-out with attending surgeons' and APs' participation, clinical/billing protocols, OR availability, and quality improvement. Outcomes included relative value units (RVUs), surgical case volume, charges/payments, and number of patient encounters. The secondary outcome was mortality. The χ test was used to compare mortality, and p < 0.05 was considered significant. RESULTS: Total patient encounters increased from 6,723 in FY 12 to 9,238 in FY 15 (+37%). Relative value units increased from 18,422 in FY 12 to 25,314 in FY 15 (+37%). Charges increased by 76% and payments increased by 60% from FY 12 to FY 15. Charges per encounter increased from $461 in FY 12 to $591 in FY 15 (+28%) Additionally, both inpatient and surgical case loads increased. Mortality remained stable throughout the study period (FY 12, 4.5%; FY 13, 5.2%; FY 14, 5.3%; FY 15, 3.2%: p = 0.177). CONCLUSIONS: Implementation of dedicated OR time, defined EGS team structure, practice protocols, and active attending surgeons'/APs' participation was temporally related to increased case volume, patients seen, and revenue, while mortality remained unchanged. Further study is necessary to establish the translatability of these data to other systems. LEVEL OF EVIDENCE: Economic/decision, level III.

Comparison of human papillomavirus detection by Aptima HPV and cobas HPV tests in a population of women referred for colposcopy following detection of atypical squamous cells of undetermined significance by Pap cytology.

Few studies have compared the cobas HPV test to the Aptima HPV assay (AHPV) and the Aptima HPV 16 18/45 genotype assay (AHPV GT) for high-risk human papillomavirus (hrHPV) detection, clinical performance in detecting cervical intraepithelial neoplasia grade 2 (CIN2) or more severe (CIN2+) diagnoses, and risk stratification by partial HPV genotyping. The cobas HPV test is a DNA test that separately and concurrently detects HPV16, HPV18, and a pool of 12 other hrHPV types. AHPV is an RNA test for a pool of 14 hrHPV genotypes, and AHPV GT is an RNA test run on AHPV-positive results to detect HPV16 separately from HPV18 and HPV45, which are detected together. In a population of patients (n=988) referred for colposcopy because of a cervical Pap cytology result of atypical squamous cells of undetermined significance (ASC-US), a cervical scrape specimen was taken, placed into a ThinPrep Pap test vial containing PreservCyt liquid cytology medium, and tested in a blinded fashion with cobas and AHPV and with AHPV GT for AHPV-positive results. The final diagnoses were based on a consensus panel review of the biopsy specimen histology. AHPV and cobas were equally sensitive for CIN2+ diagnoses (89.4% each; P=1.000), and AHPV was more specific than cobas (63.1% versus 59.3%; P≤0.001). The percent total agreement, percent positive agreement, and kappa value were 90.9%, 81.1%, and 0.815, respectively. Risk stratification using partial HPV genotyping was similar for the two assays. AHPV and AHPV GT had similar sensitivity and risk stratification to cobas HPV, but they were more specific than cobas HPV.

Analytical characterization of the APTIMA HPV Assay.

BACKGROUND: Human papillomavirus (HPV) testing has improved the sensitivity for the detection of cervical pre-cancer and cancer as compared to Pap testing. Several HPV tests are commercially available and most target the DNA from 13 or 14 high-risk HPV types. The APTIMA HPV Assay however, detects HPV E6/E7 mRNA from 14 high-risk types of HPV: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. OBJECTIVE: To determine the analytical performance characteristics of the APTIMA HPV Assay. STUDY DESIGN: Analytical sensitivity, analytical specificity, reproducibility, and the effect of potentially interfering substances was determined for the APTIMA HPV Assay on both the DTS (semi-automated) and TIGRIS DTS (fully automated) systems. RESULTS: The 95% detection limit for both systems was between 17 and 488 copies/reaction, depending on the HPV type. The assay did not cross-react with normal flora and opportunistic organisms that may be found in cervical samples, or low-risk HPV types. Spermicides, anti-fungal and anti-itch medications, whole blood, glacial acetic acid, and most lubricants did not interfere with assay performance. Those lubricants containing polyquaternium 15 did interfere with assay performance. Inter-instrument, inter-operator, inter-lot, and inter-run signal variability were <10% for >99% of the data. Intra-run variability was <15%, except for those samples with concentrations at or below the 95% detection limit of the assay. CONCLUSIONS: Based upon the analytical sensitivity, analytical specificity, and low variability, the APTIMA HPV Assay showed excellent performance and robustness.

The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial.

BACKGROUND: Carbamazepine is widely accepted as a drug of first choice for patients with partial onset seizures. Several newer drugs possess efficacy against these seizure types but previous randomised controlled trials have failed to inform a choice between these drugs. We aimed to assess efficacy with regards to longer-term outcomes, quality of life, and health economic outcomes. METHODS: SANAD was an unblinded randomised controlled trial in hospital-based outpatient clinics in the UK. Arm A recruited 1721 patients for whom carbamazepine was deemed to be standard treatment, and they were randomly assigned to receive carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate. Primary outcomes were time to treatment failure, and time to 12-months remission, and assessment was by both intention to treat and per protocol. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN38354748. FINDINGS: For time to treatment failure, lamotrigine was significantly better than carbamazepine (hazard ratio [HR] 0.78 [95% CI 0.63-0.97]), gabapentin (0.65 [0.52-0.80]), and topiramate (0.64 [0.52-0.79]), and had a non-significant advantage compared with oxcarbazepine (1.15 [0.86-1.54]). For time to 12-month remission carbamazepine was significantly better than gabapentin (0.75 [0.63-0.90]), and estimates suggest a non-significant advantage for carbamazepine against lamotrigine (0.91 [0.77-1.09]), topiramate (0.86 [0.72-1.03]), and oxcarbazepine (0.92 [0.73-1.18]). In a per-protocol analysis, at 2 and 4 years the difference (95% CI) in the proportion achieving a 12-month remission (lamotrigine-carbamazepine) is 0 (-8 to 7) and 5 (-3 to 12), suggesting non-inferiority of lamotrigine compared with carbamazepine. INTERPRETATION: Lamotrigine is clinically better than carbamazepine, the standard drug treatment, for time to treatment failure outcomes and is therefore a cost-effective alternative for patients diagnosed with partial onset seizures.

The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial.

BACKGROUND: Valproate is widely accepted as a drug of first choice for patients with generalised onset seizures, and its broad spectrum of efficacy means it is recommended for patients with seizures that are difficult to classify. Lamotrigine and topiramate are also thought to possess broad spectrum activity. The SANAD study aimed to compare the longer-term effects of these drugs in patients with generalised onset seizures or seizures that are difficult to classify. METHODS: SANAD was an unblinded randomised controlled trial in hospital-based outpatient clinics in the UK. Arm B of the study recruited 716 patients for whom valproate was considered to be standard treatment. Patients were randomly assigned to valproate, lamotrigine, or topiramate between Jan 12, 1999, and Aug 31, 2004, and follow-up data were obtained up to Jan 13, 2006. Primary outcomes were time to treatment failure, and time to 1-year remission, and analysis was by both intention to treat and per protocol. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN38354748. FINDINGS: For time to treatment failure, valproate was significantly better than topiramate (hazard ratio 1.57 [95% CI 1.19-2.08]), but there was no significant difference between valproate and lamotrigine (1.25 [0.94-1.68]). For patients with an idiopathic generalised epilepsy, valproate was significantly better than both lamotrigine (1.55 [1.07-2.24] and topiramate (1.89 [1.32-2.70]). For time to 12-month remission valproate was significantly better than lamotrigine overall (0.76 [0.62-0.94]), and for the subgroup with an idiopathic generalised epilepsy 0.68 (0.53-0.89). But there was no significant difference between valproate and topiramate in either the analysis overall or for the subgroup with an idiopathic generalised epilepsy. INTERPRETATION: Valproate is better tolerated than topiramate and more efficacious than lamotrigine, and should remain the drug of first choice for many patients with generalised and unclassified epilepsies. However, because of known potential adverse effects of valproate during pregnancy, the benefits for seizure control in women of childbearing years should be considered.