Multisite Implementation of an American College of Surgeons Geriatric Surgery Quality Improvement Initiative.

BACKGROUND: The American College of Surgeons (ACS) Coalition for Quality in Geriatric Surgery (CQGS) identified standards of surgical care for the growing, vulnerable population of aging adults in the US. The aims of this study were to determine implementation feasibility for 30 selected standards, identify barriers and best practices in their implementation, and further refine these geriatric standards and verification process. STUDY DESIGN: The CQGS requested participation from hospitals involved in the ACS NSQIP Geriatric Surgery Pilot Project, previous CQGS feasibility analyses, and hospitals affiliated with a core development team member. Thirty standards were selected for implementation. After implementation, site visits were conducted, and postvisit surveys were distributed. RESULTS: Eight hospitals were chosen to participate. Program management (55%), immediate preoperative and intraoperative clinical care (62.5%), and postoperative clinical care (58%) had the highest mean percentage of "fully compliant" standards. Goals and decision-making (30%), preoperative optimization (28%), and transitions of care (12.5%) had the lowest mean percentage of fully compliant standards. Best practices and barriers to implementation were identified across 13 of the 30 standards. More than 80% of the institutions reported that participation changed the surgical care provided for older adults. CONCLUSIONS: This study represents the first national implementation assessment undertaken by the ACS for one of its quality programs. The CQGS pilot testing was able to demonstrate implementation feasibility for 30 standards, identify challenges and best practices, and further inform dissemination of the ACS Geriatric Surgery Verification Program.

Stakeholder Engagement Significantly Decreased Colorectal Surgical Site Infections.

Background: Patients and care providers raised concerns about the increased incidence of colorectal surgical site infection (SSI) at a community hospital in Baltimore compared with peer institutions. Patients and Methods: A preliminary analysis was performed that identified several modifiable targets for interventions to reduce SSIs in this patient population. The intervention focused on wide engagement of all stakeholder groups across the spectrum of care including physicians, pharmacists, nurses, administrators, and patients. The engagement process involved hospital-wide educational sessions, adoption and implementation of the best clinical guidelines, and utilization of the electronic medical record system to reinforce compliance and ensure quality control. Data for SSIs in colorectal surgical procedures were collected prior to the intervention (January 1, 2017 to March 31, 2018) and after implementation (April 1, 2018 to October 31, 2018). Results: A total of 355 cases (229 pre-intervention group, 126 post-intervention group) met the inclusion criteria; the two groups were comparable with respect to all the key parameters except the procedure type and use of endoscopy. Multivariable logistic regression modeling was utilized to evaluate the effects of the stakeholder engagement intervention while adjusting for potential confounders. The incidence of colorectal SSIs was substantially lower after the intervention (2.78% vs. 8.73%, p = 0.02). This reduction was robust to adjustment for covariates in regression modeling (p = 0.04). Conclusions: Informed stakeholder engagement helped bring cohesion to the inherently fragmented elements of the care delivery model and was associated with decreased incidence of colorectal SSIs.

Preoperative Nutritional Status Predicts Major Morbidity After Primary Rectal Cancer Resection.

BACKGROUND: Malnutrition has been associated with adverse surgical outcomes, but data regarding its impact specifically in rectal cancer are sparse. The goal of this study was to use national data to determine the effects of malnutrition on surgical outcomes in rectal cancer resection. METHODS: Data were obtained from the American College of Surgeons National Surgical Quality Initiative Program from the years 2012-2015. Patients were included on the basis of International Classification of Disease 9/10 and Current Procedural Terminology codes for rectal cancer and proctectomy. Malnutrition was defined as body mass index <18.5 kg/m2, weight loss >10% in 6 mo, or preoperative albumin <3.5 mg/dL. Associations between malnutrition and postoperative outcomes were assessed by the Student t-test and chi-square test. Multivariate regression models were constructed to adjust for potential confounders of the association between malnutrition and surgical outcomes. RESULTS: Of the 9289 patients with primary rectal cancer who underwent resection, 1425 (15%) were in a state of malnutrition at the time of surgery. Patients with malnutrition had longer mean length of stay (LOS), and higher rates of 30-d mortality, wound infection, organ-space infection, sepsis, reoperation, prolonged LOS (>30 d), failure to wean off ventilator, renal failure, and cardiac arrest. With the exception of LOS, renal failure, and organ-space infection, malnutrition was still significantly associated with higher rates of these adverse outcomes after adjustment for confounders in multivariate regression models. CONCLUSIONS: Malnutrition is a practical marker associated with a variety of adverse outcomes after rectal cancer surgery, and it represents a potential target for nutritional therapies to improve surgical outcomes.

A Mucinous Cystic Neoplasm Originating from the Gallbladder: A Case Report and Literature Review.

INTRODUCTION: Mucinous cystic neoplasms of the gallbladder are extremely rare, benign, unilocular or multilocular cystic tumors that contain septations. Mucinous cystadenoma, a subtype of mucinous cystic neoplasm, is defined as epithelial cystic proliferations composed of cells that contain intracytoplasmic mucin. CASE PRESENTATION: A 70-year-old African American woman was admitted to the hospital because of progressive lower back pain and inability to walk. She was scheduled for a kyphoplasty. However, the day before surgery, she reported severe abdominal pain radiating to her right shoulder. On further workup, results of abdominal ultrasonography revealed a cystic mass in the lumen of the gallbladder. The kyphoplasty was postponed and a laparoscopic cholecystectomy was performed. Pathologic evaluation of the gallbladder revealed a multiloculated mucinous cystic neoplasm. DISCUSSION: Mucinous cystadenoma of the gallbladder account for 0.02% of the total number of cases in the hepatobiliary system. They are more frequently seen in middle-age women with a mean age at presentation of 45 years. Symptoms vary depending on the location of the tumor, but it typically presents as acute or chronic right upper quadrant pain, epigastric pain, and nausea and vomiting. The multilocular form is more common than unilocular. The cystic lesions can be filled with serous, hemorrhagic, mucinous, or mixed fluids. Clinicians should be suspicious of mucinous cystadenoma of the gallbladder when common gallbladder disease is excluded because malignant features can be present in the lesion.

Optimizing the Feasibility and Scalability of a Geriatric Surgery Quality Improvement Initiative.

BACKGROUND: The American College of Surgeons Coalition for Quality in Geriatric Surgery is a multidisciplinary stakeholder group that aims to systematically improve the surgical care of older adults by establishing a verifiable quality improvement program with standards based on best evidence. Prior work confirmed the validity of a preliminary set of 308 standards to improve the quality of geriatric surgery, but concerns exist as to whether the standards are feasible for hospitals to implement. OBJECTIVE: Our aim was to utilize data gained from a multi-institutional survey and interview to improve the scalability and generalizability of a geriatric quality improvement program. METHODS: Using a survey followed by a targeted debrief interview, 15 hospitals gathered an interdisciplinary panel to answer whether each standard was already in place at their institution, and if not, the perceived difficulty of implementation according to a five-point Likert scale (from 1 [very easy] to 5 [very difficult]). The standards were then placed into categories according to the hospital responses. Standards were designated "duplicative" if 11 or more hospitals reported baseline implementation, "prohibitively difficult" if 6 or more hospitals rated the standard as such, and "high potential" if they were neither duplicative nor difficult. A targeted debrief interview was then conducted with each participating hospital. RESULTS: Fifteen participating hospitals evaluated the feasibility of 108 standards and found 28 (26%) duplicative, 35 (32%) too difficult, and 45 (42%) high potential. Of the 108 standards, 49 (45%) were selected for the next iteration of standards, and 59 were removed. Among the standards that were removed, the majority (64%) were rated duplicative and/or difficult. CONCLUSION: A multi-institutional survey and interview successfully identified care standards that were redundant or too difficult to implement on the hospital level. These data will help improve the generalizability and scalability of the program while maintaining the overall goal of improving care. J Am Geriatr Soc 67:1074-1078, 2019.

Operative Mortality Prediction for Primary Rectal Cancer: Age Matters.

BACKGROUND: The risk of colorectal cancer increases with age, and the number of older adults requiring operations has increased. The purpose of this study was to determine whether a current risk calculator can accurately predict operative mortality for rectal cancer and whether the predictive accuracy varied with age. METHODS: The American College of Surgeons NSQIP database using ICD-9/10 codes for rectal cancer and CPT codes for proctectomy was accessed (2012 to 2015). The prognostic value of the risk calculator was evaluated using the predicted mortality variable code. Age categories were 18 to 64 years, 65 to 79 years, and 80 to 89 years. Analysis of variance was performed to assess differences between age categories in predicted and actual mortality and Pearson correlation coefficients were computed. Logistic regression models were constructed to evaluate associations adjusted for key covariates. RESULTS: There were 9,289 patients included, with age distribution as follows: 18 to 64 years (n = 5,674), 65 to 79 years (n = 2,899), and 80 to 89 years (n = 716). Both predicted and actual mortality increased with age, adjusting for functional status, comorbidity, and other covariates (p < 0.0001). The overall correlation between predicted and actual mortality was low (r = 0.20). The correlation was weakest from 18 to 64 years (r = 0.07), strongest from 65 to 79 years (r = 0.25), and in between from 80 to 89 years (r = 0.13). Predicted mortality was overestimated in the 18 to 64 years and underestimated in both the 65 to 79 years and 80 to 89 years age groups. Predicted mortality by age category interaction terms was also significantly associated with actual mortality in covariate-adjusted logistic regression models, providing additional evidence that the accuracy of predicted mortality varies by age. CONCLUSIONS: The American College of Surgeons NSQIP mortality risk estimates appear to be poorly associated with actual mortality and the accuracy might differ between younger and older patients with primary rectal cancer. Goals of care discussion with the older patient about outcomes are indicated, as there is an almost twice predicted mortality.

Sinai Abbreviated Geriatric Evaluation: Development and Validation of a Practical Test.

OBJECTIVE: To develop and validate a simple geriatric screening tool that performs as well as more complex assessments BACKGROUND:: Many tools that predict treatment risk in older adults are impractical for routine clinical use. METHODS: We prospectively conducted comprehensive preoperative evaluations on 1025 patients age ≥75 years who presented to Sinai Hospital of Baltimore for major elective surgery, then retrospectively reviewed patients' medical records for occurrence of postoperative outcomes. Using logistic regression modeling and receiver operating characteristic curve analysis we selected the best combination of simple tests, labeling this the Sinai Abbreviated Geriatric Evaluation (SAGE). The performance of the SAGE was then compared with 3 standard tools in its power to predict postoperative outcomes. RESULTS: The SAGE is a statistically significant predictor of postoperative outcomes. Each unit decrease in SAGE score was significantly associated with a 51% (95% CI 1.30-1.77) increase in odds of a complication, a 2-fold increase in odds of postoperative delirium (95% CI 1.65-2.66), a 27% increase in odds of length of hospital stay >2 days (95% CI 1.10-1.47), a 54% increase in odds of a hospital readmission within 30 days (95% CI 1.25-2.88), and a 38% increase in odds of an unanticipated discharge to higher-level care (95% CI 1.18-1.61). We estimated the receiver operating characteristic curve area under the curve (AUC) for the SAGE of 0.69, 0.77, 0.73, 0.66, and 0.78 for the above outcomes, respectively. The SAGE performed as well in predicting postoperative outcomes as Fried's frailty phenotype, Charlson Comorbidity Index, and American Society of Anesthesiologists Physical Status Class (ASA). CONCLUSION: The SAGE performs as well as other geriatric evaluations that require equipment or memorization.

An Interview with Dr. John L. Cameron, the Hall of Famer of Pancreatic Cancer.

The Society of Surgical Alimentary Tract (SSAT) Resident Education Committee aim is to facilitate resident participation in the annual meeting and foster the education of the next generation of gastrointestinal. The SSAT "Residents Corner" was developed as a video-blog highlighting areas of interest for surgical trainees looking to focus on a career in gastrointestinal surgery. The topics covered are to make surgical education more accessible, one way is to highlight leaders in the field who discuss their journey. A 10-min video of a surgical mentor is recorded and archived on the SSAT site under a video series called "Mentor of the Month." A synopsis of a video published online February 2018 featuring Dr. John Cameron interviewed by one of his trainee, Dr. Vanita Ahuja. Dr. Cameron shares his thoughts on his accomplishments, challenges, and advice for young surgeons and the future of pancreatic surgery. The interview offers an insight into the mind of one of the greatest leaders of surgery of our time.

Application of the RAND-UCLA Appropriateness Methodology to a Large Multidisciplinary Stakeholder Group Evaluating the Validity and Feasibility of Patient-Centered Standards in Geriatric Surgery.

OBJECTIVES: To explore (1) differences in validity and feasibility ratings for geriatric surgical standards across a diverse stakeholder group (surgeons vs. nonsurgeons, health care providers vs. nonproviders, including patient-family, advocacy, and regulatory agencies); (2) whether three multidisciplinary discussion subgroups would reach similar conclusions. DATA SOURCE/STUDY SETTING: Primary data (ratings) were reported from 58 stakeholder organizations. STUDY DESIGN: An adaptation of the RAND-UCLA Appropriateness Methodology (RAM) process was conducted in May 2016. DATA COLLECTION/EXTRACTION METHODS: Stakeholders self-administered ratings on paper, returned via mail (Round 1) and in-person (Round 2). PRINCIPAL FINDINGS: In Round 1, surgeons rated standards more critically (91.2 percent valid; 64.9 percent feasible) than nonsurgeons (100 percent valid; 87.0 percent feasible) but increased ratings in Round 2 (98.7 percent valid; 90.6 percent feasible), aligning with nonsurgeons (99.7 percent valid; 96.1 percent feasible). Three parallel subgroups rated validity at 96.8 percent (group 1), 100 percent (group 2), and 97.4 percent (group 3). Feasibility ratings were 76.9 percent (group 1), 96.1 percent (group 2), and 92.2 percent (group 3). CONCLUSIONS: There are differences in validity and feasibility ratings by health professions, with surgeons rating standards more critically than nonsurgeons. However, three separate discussion subgroups rated a high proportion (96-100 percent) of standards as valid, indicating the RAM can be successfully applied to a large stakeholder group.

Hospital Standards to Promote Optimal Surgical Care of the Older Adult: A Report From the Coalition for Quality in Geriatric Surgery.

OBJECTIVE: The aim of this study was to establish high-quality, valid standards to improve surgical care of the older adult. BACKGROUND: The aging population increases demand for high-quality surgical care. Building upon prior guidelines, quality indicators, and pilot projects, the Coalition for Quality in Geriatric Surgery (CQGS) includes 58 diverse stakeholder organizations committed to improving geriatric surgery. METHODS: Using a modified RAND-UCLA Appropriateness Methodology, 44 of 58 CQGS Stakeholders twice rated validity (primary outcome) and feasibility for 308 standards, ranging from goals and decision-making, pre-operative assessment and optimization, perioperative and postoperative care, to transitions of care beyond the acute care hospital. RESULTS: Three hundred six of 308 (99%) standards were rated as valid to improve quality of geriatric surgery. There were 4 sections. Section 1 included 157 (57%) standards and focused on goals and decision-making, preoperative optimization, and transitions into and out of the hospital. Section 2 included 84 (27.3%) standards focused on in-hospital care, across the immediate preoperative, intraoperative, and postoperative phases. Section 3 included 59 (19.1%) standards about program management, including personnel and committee structure, credentialing, and education. Section 4 included 8 (2.6%) standards establishing overarching concepts for data collection and patient follow-up. Two hundred ninety of 308 standards (94.2%) were rated as feasible; 18 (5.8%) were rated as uncertain in feasibility. CONCLUSIONS: CQGS Stakeholders rated the vast majority of standards of care as highly valid (99%) and feasible (94%) for improving the quality of surgical care provided to older adults. Future work will focus on a pilot phase to better understand and address challenges to implementation of the standards.

Wartime toxin exposure: recognising the silent killer.

Wartime toxin exposures have been implicated in the genesis of malignancy in war veterans. Agent Orange, one toxin among many, has been linked to malignancy and the subcomponent phenoxyacetic acid has been associated with soft tissue sarcomas (STSs). This case demonstrates the association between a wartime toxin exposure (Agent Orange) and subsequent cancer development. Ultimately, we aim to highlight the importance of simple, specific questions in the patient history to account for previous wartime toxin exposures.

Optimal Preoperative Evaluation and Perioperative Care of the Geriatric Patient: A Surgeon's Perspective.

The elderly preoperative patient benefits from an assessment that includes more than a routine physical examination and electrocardiogram. Such an assessment includes domains likely to affect the elderly: cognition, functionality, frailty, polypharmacy, nutrition, and social support. This fosters decisions based on functional age rather than chronologic age and on each patient as an individual. One such assessment is that promulgated by the American College of Surgeons National Surgery Quality Improvement Program/American Geriatrics Society Best Practice Guidelines. We should not miss any opportunity to improve results in this growing population of surgical patients.

Old War Scar Revisited.

In 1828, Jean Nicholas Marjolin, a French surgeon, first described the findings of a neoplastic development arising from a burn scar, now more commonly referred to as a Marjolin's ulcer. A Marjolin's ulcer describes malignant degeneration in any chronic wound. The majority of cases arises in burn scars and are often latent for decades. Marjolin ulcers have been widely identified in post-war time injuries. These ulcers may arise in almost any anatomical location. We report a case of an 82-year-old male that presented with a painful fluctuating mass on the right arm localized to the site of an old grenade blast injury he sustained many years earlier. While the presentation of these cases may be variable, the significance of proper management of the wounds is essential to optimal patient outcomes. An aggressive course and poor prognosis is associated with Marjolin's ulcers that degenerate into squamous cell carcinoma. Early detection and aggressive treatment/management with wide local excision and prompt coverage yield the best results when treating patients with Marjolin's ulcers.

Single-dose replication-defective VSV-based Nipah virus vaccines provide protection from lethal challenge in Syrian hamsters.

Nipah virus (NiV) continues to cause outbreaks of fatal human encephalitis due to spillover from its bat reservoir. We determined that a single dose of replication-defective vesicular stomatitis virus (VSV)-based vaccine vectors expressing either the NiV fusion (F) or attachment (G) glycoproteins protected hamsters from over 1000 times LD50 NiV challenge. This highly effective single-dose protection coupled with an enhanced safety profile makes these candidates ideal for potential use in livestock and humans.

Variability in P-glycoprotein inhibitory potency (IC50) using various in vitro experimental systems: implications for universal digoxin drug-drug interaction risk assessment decision criteria.

A P-glycoprotein (P-gp) IC50 working group was established with 23 participating pharmaceutical and contract research laboratories and one academic institution to assess interlaboratory variability in P-gp IC50 determinations. Each laboratory followed its in-house protocol to determine in vitro IC50 values for 16 inhibitors using four different test systems: human colon adenocarcinoma cells (Caco-2; eleven laboratories), Madin-Darby canine kidney cells transfected with MDR1 cDNA (MDCKII-MDR1; six laboratories), and Lilly Laboratories Cells--Porcine Kidney Nr. 1 cells transfected with MDR1 cDNA (LLC-PK1-MDR1; four laboratories), and membrane vesicles containing human P-glycoprotein (P-gp; five laboratories). For cell models, various equations to calculate remaining transport activity (e.g., efflux ratio, unidirectional flux, net-secretory-flux) were also evaluated. The difference in IC50 values for each of the inhibitors across all test systems and equations ranged from a minimum of 20- and 24-fold between lowest and highest IC50 values for sertraline and isradipine, to a maximum of 407- and 796-fold for telmisartan and verapamil, respectively. For telmisartan and verapamil, variability was greatly influenced by data from one laboratory in each case. Excluding these two data sets brings the range in IC50 values for telmisartan and verapamil down to 69- and 159-fold. The efflux ratio-based equation generally resulted in severalfold lower IC50 values compared with unidirectional or net-secretory-flux equations. Statistical analysis indicated that variability in IC50 values was mainly due to interlaboratory variability, rather than an implicit systematic difference between test systems. Potential reasons for variability are discussed and the simplest, most robust experimental design for P-gp IC50 determination proposed. The impact of these findings on drug-drug interaction risk assessment is discussed in the companion article (Ellens et al., 2013) and recommendations are provided.

Application of receiver operating characteristic analysis to refine the prediction of potential digoxin drug interactions.

In the 2012 Food and Drug Administration (FDA) draft guidance on drug-drug interactions (DDIs), a new molecular entity that inhibits P-glycoprotein (P-gp) may need a clinical DDI study with a P-gp substrate such as digoxin when the maximum concentration of inhibitor at steady state divided by IC50 ([I1]/IC50) is ≥0.1 or concentration of inhibitor based on highest approved dose dissolved in 250 ml divide by IC50 ([I2]/IC50) is ≥10. In this article, refined criteria are presented, determined by receiver operating characteristic analysis, using IC50 values generated by 23 laboratories. P-gp probe substrates were digoxin for polarized cell-lines and N-methyl quinidine or vinblastine for P-gp overexpressed vesicles. Inhibition of probe substrate transport was evaluated using 15 known P-gp inhibitors. Importantly, the criteria derived in this article take into account variability in IC50 values. Moreover, they are statistically derived based on the highest degree of accuracy in predicting true positive and true negative digoxin DDI results. The refined criteria of [I1]/IC50 ≥ 0.03 and [I2]/IC50 ≥ 45 and FDA criteria were applied to a test set of 101 in vitro-in vivo digoxin DDI pairs collated from the literature. The number of false negatives (none predicted but DDI observed) were similar, 10 and 12%, whereas the number of false positives (DDI predicted but not observed) substantially decreased from 51 to 40%, relative to the FDA criteria. On the basis of estimated overall variability in IC50 values, a theoretical 95% confidence interval calculation was developed for single laboratory IC50 values, translating into a range of [I1]/IC50 and [I2]/IC50 values. The extent by which this range falls above the criteria is a measure of risk associated with the decision, attributable to variability in IC50 values.