Faculty Bibliography

The design of randomized controlled clinical studies can greatly benefit from iterative assessments of population representativeness of eligibility criteria. We propose a multi-trait metric - GIST 2.0 that can compute the a priori generalizability based on the population representativeness of a clinical study by explicitly modeling the dependencies among all eligibility criteria. We evaluate this metric on twenty clinical studies of two diseases and analyze how a study's eligibility criteria affect its generalizability (collectively and individually). We statistically analyze the effects of trial setting, trait selection and trait summarizing technique on GIST 2.0. Finally we provide theoretical as well as empirical validations for the expected properties of GIST 2.0.

CONTEXT: Ventricular assist devices (VADs) have been shown to improve survival and overall quality of life, but there are limited data on pain control and functional status in this patient population. OBJECTIVES: This study examined changes in pain, functional status, and quality of life over time in VAD patients. METHODS: Patients were enrolled in this prospective cohort study before or as early after VAD implant as possible and then followed for up to 48 weeks. The Brief Pain Inventory was used to assess pain. The Katz Independent Activities of Daily Living questionnaire was used to assess functional status. The Kansas City Cardiomyopathy Questionnaire, a 23-item questionnaire covering five domains (physical function, symptoms, social function, self-efficacy, and quality of life), was used to assess quality of life and health status. RESULTS: Eighty-seven patients were enrolled at four medical centers. The median Brief Pain Inventory severity score was 2.8 (interquartile range 0.5-5.0) before implantation and 0.0 (interquartile range 0.0-5.3) 48 weeks after implantation (P = 0.0009). Katz Independent Activities of Daily Living summary scores also demonstrated significant improvement over time (P < 0.0001). Kansas City Cardiomyopathy Questionnaire summary scales demonstrated significant improvement with time (P < 0.0016). CONCLUSION: This study demonstrated that patients with VADs experienced improved pain, functional status, and quality of life over time. These data may be useful to help patients make decisions when they are considering undergoing VAD implantation.

This article reviewed a program evaluation conducted among correctional health care staff in New York City (NYC) using a 68-question electronic survey to assess satisfaction, attitudes, and beliefs in relation to ethics and burnout of health care employees in NYC jails. Descriptive statistics were tabulated and reviewed, and further assessment of burnout and ethics was performed through group sessions with participants. This evaluation has led to changes in agency policies and procedures and an emphasis on the human rights issue of the dual loyalty challenges that the security setting places on the overall mission to care for patients.

Background: Interactions of resident intestinal microbes with the luminal contents and the mucosal surface play important roles in normal intestinal development, nutrition and immunity. Long-standing infections such as gastric H. pylori modify the gastric microbiota and might modify fecal microbiota composition. Objective: To evaluate the fecal microbiota of mother-child pairs and its relation to H. pylori status. Methods: Consecutive mothers and their newborns were recruited in the maternity unit, immediately after delivery. After signing informed consent, we took one stool sample of the mother before hospital discharge and one stool sample of the newborns at home (15 days old). Maternal H. pylori status was evaluated by H. pylori antigen detection (Platinum HpSA, Meridian Diagnostics, Ohio, USA). Collected samples were stored at-80degreeC until processing. The V4 region of the 16S rRNA gene was sequenced using Illumina MiSeq platform. Sequences were analyzed using the QIIME pipeline. Results: 22 mother-child pairs were recruited and 11 of them have positive maternal H. pylori status (50%). Thirteen babies were vaginally delivered and 9 were born by Caesarean section. All babies were fully breastfed. H. pylori was not detected in the feces of newborns. The analyses showed that there were differences in the structure of the microbiota by maternal H. pylori status only in infant feces born vaginally (PERMANOVA, p=0.01). Although with similar bacterial alpha diversity level, infants born vaginally to H. pylori-infected mothers had higher abundance of Enterobacteriaceae and Veilonella (LEfSe analysis, LDA > 3.0-fold). Conclusions: Maternal H. pylori status affects the fecal microbiota composition in babies born by vaginal delivery, but not in babies born by Caesarean section. The results suggest that the effect of the maternal H. pylori on the infant fecal microbiota is mediated by the acquired vaginal microbiota at birth

INTRODUCTION: Hospitalization is a unique opportunity for smoking cessation, but prior interventions have measured efficacy with narrowly defined populations. The objective of this study was to enroll smokers admitted to two "safety net" hospitals and compare the effectiveness of two post-discharge cessation interventions. DESIGN: A randomized comparative effectiveness trial was conducted. SETTING/PARTICIPANTS: At two New York City public hospitals, every hospitalized patient identified as a smoker (based on admission records) was approached. Inclusion criteria were: smoked cigarettes in the past 30 days; spoke English, Spanish, or Mandarin; had a U.S. phone number; not discharged to an institution where follow-up or smoking was limited; and not pregnant/breastfeeding. Of 18,797 patients identified as current smokers between July 2011 and April 2014, a total of 3,047 (16%) were discharged before being approached, 3,273 (17%) were not current smokers, 4,026 (21%) had no U.S. phone number, 2,831 (15%) were ineligible for other reasons, and 3,983 (21%) refused participation. In total, 1,618 (9%) participants enrolled in the study. During follow-up, 69% of participants were reached at 2 months and 68% at 6 months. INTERVENTION: At discharge, participants were randomized to multisession telephone counseling from study staff (n=804) or referral to the state quitline for proactive outreach and counseling (n=814). MAIN OUTCOME MEASURES: Self-reported abstinence at 6 months was measured. Analyses were conducted in late 2015. RESULTS: One quarter of participants were homeless or in unstable housing, 60% had a history of substance abuse, 43% reported current hazardous drinking, and half had a psychiatric diagnosis other than substance abuse. At follow-up, the rate of abstinence (30-day point prevalence) was higher in the intensive counseling arm than the quitline arm at 2 months (29.0% vs 20.7%; relative risk=1.40; 95% CI=1.13, 1.73) and 6 months (37.4% vs 31.5%; relative risk=1.19; 95% CI=1.01, 1.40). CONCLUSIONS: Intensive counseling was more effective than referral to the state quitline. Long-term abstinence was excellent in both groups. Many patients were not eligible for enrollment despite minimal exclusion criteria. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01363245.

BACKGROUND: Mesenteric venous thrombosis (MVT) is a relatively uncommon but potentially lethal condition associated with bowel ischemia and infarction. The natural history and long-term outcomes are poorly understood and under-reported. METHODS: A single-institution retrospective review of noncirrhotic patients diagnosed with MVT from 1999 to 2015 was performed using International Classification of Diseases, Ninth Revision and radiology codes. Patients were excluded if no radiographic imaging was available for review. Eighty patients were identified for analysis. Demographic, clinical, and radiographic data on presentation and at long-term follow-up were collected. Long-term sequelae of portal venous hypertension were defined as esophageal varices, portal vein cavernous transformation, splenomegaly, or hepatic atrophy, as seen on follow-up imaging. RESULTS: There were 80 patients (57.5% male; mean age, 57.9 +/- 15.6 years) identified; 83.3% were symptomatic, and 80% presented with abdominal pain. Median follow-up was 480 days (range, 1-6183 days). Follow-up radiographic and clinical data were available for 50 patients (62.5%). The underlying causes of MVT included cancer (41.5%), an inflammatory process (25.9%), the postoperative state (20.7%), and idiopathic cases (18.8%). Pancreatic cancer was the most common associated malignant neoplasm (53%), followed by colon cancer (15%). Twenty patients (26%) had prior or concurrent lower extremity deep venous thromboses. Most patients (68.4%) were treated with anticoagulation; the rest were treated expectantly. Ten (12.5%) had bleeding complications related to anticoagulation, including one death from intracranial hemorrhage. Four patients underwent intervention (three pharmacomechanical thrombolysis and one thrombectomy). One patient died of intestinal ischemia. Two patients had recurrent MVT, both on discontinuing anticoagulation. Long-term imaging sequelae of portal hypertension were noted in 25 of 50 patients (50%) who had follow-up imaging available. Patients with long-term sequelae had lower recanalization rates (36.8% vs 65%; P = .079) and significantly higher rates of complete as opposed to partial thrombosis at the initial event (73% vs 43.3%; P < .005). Long-term sequelae were unrelated to the initial cause or treatment with anticoagulation (P = NS). CONCLUSIONS: Most cases of MVT are associated with malignant disease or an inflammatory process, such as pancreatitis. A diagnosis of malignant disease in the setting of MVT has poor prognosis, with a 5-year survival of only 25%. MVT can be effectively treated with anticoagulation in the majority of cases. Operative or endovascular intervention is rarely needed but important to consider in patients with signs of severe ischemia or impending bowel infarction. There is a significant incidence of radiographically noted long-term sequelae from MVT related to portal venous hypertension, especially in cases of initial complete thrombosis of the mesenteric vein.

The Patient Protection and Affordable Care Act will have a dramatic impact on Academic Medical Centers (AMC) across many fronts. The expansion of Medicaid and creation of healthcare exchanges to compete with existing commercial payers will alter the current payer-mix seen at AMC's. While prior studies have analyzed this impact at a hospital level, we evaluated these changes in payer-mix on three distinct internal medicine service lines by modeling out their effect on overall contribution margin (CM) for each service line using actual hospital data collected from a tertiary-care, urban AMC. We performed a sensitivity analysis to account for varying rates of participation in the newly created exchanges using 33, 50, and 100% take-up rates to simulate the unknown migration of current commercial patients to exchanges in addition to a threshold analysis. We found that despite an increase in CM from Medicaid expansion, the negative impact on CM from commercial patients migrating to exchange plans at all three take-up rates caused an overall loss in CM across all three service lines ranging from $215 020 to $1 482 597. Threshold points ranged from 19 to 37% across service lines. Our results reveal that the key drivers to determining the impact on CM is ultimately driven by what exchange rates will be set at as well as how many current commercial patients transition to the newly created exchanges

BACKGROUND:Limb lengthening with external fixation is performed to treat patients with leg length discrepancy or short stature. Although the procedure has a high rate of success, one potential drawback from limb lengthening is the amount of time spent in the fixation device while regenerate bone consolidates. Although some studies have assessed different treatment modalities, there has not been a study that has systematically evaluated whether low intensity pulsed ultrasound (LIPUS) or pulsed electromagnetic fields (PEMF) have significant effects on regenerate bone growth. The purpose of this study was to evaluate these two non-pharmacological treatment options to stimulate regenerate bone, and to assess whether they affect the treatment time in limb lengthening. METHODS:Utilizing the electronic databases Medline, Embase and Ovid, we performed a literature search for studies describing the application of LIPUS or PEMF following limb lengthening. With the aid of a statistical software package, Forest-Plots were generated to compare the differences in bone healing index with and without the use of regenerate bone stimulation. RESULTS:A total of 7 studies assessed these two bone stimulation modalities in a cohort of 153 patients. Overall, the mean healing index was 11.7 days/cm faster when using bone stimulation that in the comparison cohorts (33.7 vs 45.4 day, standardized mean difference of 1.16; p = 0.003). CONCLUSION/CONCLUSIONS:Amongst the drawbacks from limb lengthening is the relatively high rate of non- and delayed-union. Several methods, both pharmacological and non-pharmacological, have been investigated for their potential to stimulate the growth of regenerate bone. After systematically evaluating the limited and heterogeneous current literature, we found that LIPUS and PEMF both decreased the time for bone healing (healing index in days/cm) of the newly formed regenerate bone in an adequately selected cohort of patients that underwent limb lengthening. However, a high number of complications should be noted, which could be attributed to the lengthening procedure or to the additional bone stimulation. PROSPERO REGISTRATION NUMBER/UNASSIGNED:CRD42016039024.

Sanguis draconis, a resin known to improve blood circulation, relieve pain, stimulate tissue regeneration, and heal wounds, is widely used in clinical practice. In this study, we prepared an ethanol extract of sanguis draconis (EESD) containing 75.08 mg/g of dracorhodin. The experiment was carried out on 20 rats that were divided into two groups, a control group (n = 10) and an EESD group (n = 10). All the rats underwent a perforator flap surgery, after which post-operative abdominal compressions of EESD were given to the EESD group for seven days, while the control group received saline. Flap survival percentages were determined after seven days, and were found to be significantly higher in the EESD group than in the control group. Results of laser Doppler flowmetry (LDF) showed that perforator flaps in the EESD group had higher perfusion values than those of the control group. The flap tissues were stained with hematoxylin and eosin, followed by immunohistochemical evaluation. Superoxide dismutase (SOD) expression and micro-vessel development markedly increased in the EESD group, while malondialdehyde (MDA) levels decreased. This is the first study to investigate the effect of sanguis draconis on perforator flap survival. Our results demonstrate that sanguis draconis can improve perforator flap survival in rats by promoting microvessel regeneration and blood perfusion.