[IMPACT OF CLINICAL PHARMACIST CONSULTATIONS ON RATE OF COMPLICATIONS, RE-HOSPITALIZATIONS AND MORTALITY IN PATIENTS UNDERGOING BARIATRIC SURGERY].

BACKGROUND: Patients undergoing bariatric surgery are prone to changes in absorption, improvement in their chronic diseases and other pharmacokinetic/pharmacodynamic alteration which can affect continuation and the required doses of their chronic medications. OBJECTIVES: To examine the effect of a clinical pharmacist's consultation on the rate of complications, re-hospitalizations and mortality among patients who underwent bariatric surgery. METHODS: In this retrospective cohort study, results of bariatric patients who were consulted by a clinical pharmacist between the years 2013-2019 were compared with the results of a wider group of bariatric patients with chronic diseases who were recorded in the Israeli General Bariatric Registry during the same years. The intervention cohort included bariatric patients members of Clalit Health Services, who were treated at the Herzliya Medical Center and who were identified by the treating staff as complex cases requiring drug counseling. The primary outcomes measured in the study included: rates of surgical complications, re-hospitalizations, and death up to one year after surgery. RESULTS: The intervention group included 165 patients; the 12 month rate of re-hospitalization in the intervention group was 10.9% vs. 19.5% in the comparison group (p=0.005). The rate of documented postoperative complications was 2.7% vs. 3.9% (p=0.462) and mortality was null vs. 0.16%. CONCLUSIONS: Although the intervention population was identified in advance as more complex in terms of age and background morbidity, the rate of re-hospitalization and mortality was significantly lower in the intervention group than in the general bariatric surgery population in Israel. These results demonstrate the importance of referring to a specialized clinical pharmacist around bariatric surgery for improving patient safety, especially in complex patients.

An immune-protein score combining TRAIL, IP-10 and CRP for predicting severe COVID-19 disease.

COVID-19 patients are oftentimes over- or under-treated due to a deficit in predictive management tools. This study reports derivation of an algorithm that integrates the host levels of TRAIL, IP-10, and CRP into a single numeric score that is an early indicator of severe outcome for COVID-19 patients and can identify patients at-risk to deteriorate. 394 COVID-19 patients were eligible; 29% meeting a severe outcome (intensive care unit admission/non-invasive or invasive ventilation/death). The score's area under the receiver operating characteristic curve (AUC) was 0.86, superior to IL-6 (AUC 0.77; p = 0.033) and CRP (AUC 0.78; p < 0.001). Likelihood of severe outcome increased significantly (p < 0.001) with higher scores. The score differentiated severe patients who further deteriorated from those who improved (p = 0.004) and projected 14-day survival probabilities (p < 0.001). The score accurately predicted COVID-19 patients at-risk for severe outcome, and therefore has potential to facilitate timely care escalation and de-escalation and appropriate resource allocation.

Observational cohort study of IP-10's potential as a biomarker to aid in inflammation regulation within a clinical decision support protocol for patients with severe COVID-19.

BACKGROUND: Treatment of severely ill COVID-19 patients requires simultaneous management of oxygenation and inflammation without compromising viral clearance. While multiple tools are available to aid oxygenation, data supporting immune biomarkers for monitoring the host-pathogen interaction across disease stages and for titrating immunomodulatory therapy is lacking. METHODS: In this single-center cohort study, we used an immunoassay platform that enables rapid and quantitative measurement of interferon γ-induced protein 10 (IP-10), a host protein involved in lung injury from virus-induced hyperinflammation. A dynamic clinical decision support protocol was followed to manage patients infected with severe acute respiratory syndrome coronavirus 2 and examine the potential utility of timely and serial measurements of IP-10 as tool in regulating inflammation. RESULTS: Overall, 502 IP-10 measurements were performed on 52 patients between 7 April and 10 May 2020, with 12 patients admitted to the intensive care unit. IP-10 levels correlated with COVID-19 severity scores and admission to the intensive care unit. Among patients in the intensive care unit, the number of days with IP-10 levels exceeding 1,000 pg/mL was associated with mortality. Administration of corticosteroid immunomodulatory therapy decreased IP-10 levels significantly. Only two patients presented with subsequent IP-10 flare-ups exceeding 1,000 pg/mL and died of COVID-19-related complications. CONCLUSIONS: Serial and readily available IP-10 measurements potentially represent an actionable aid in managing inflammation in COVID-19 patients and therapeutic decision-making. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04389645, retrospectively registered on May 15, 2020.

The Israel National Bariatric Surgery Registry: the inception process.

BACKGROUND: Obesity rates in Israel are increasing, and so is the popularity of bariatric surgeries, which reached in 2017 a prevalence rate of 1428.7 surgeries per million citizens. However, data regarding patient characteristics and surgery outcomes, including complications, are limited and the procedure requires monitoring. OBJECTIVES: To establish a national bariatric surgery registry with high reliability and validity. SETTING: All private and public medical centers performing bariatric surgeries in the state of Israel. METHODS: The Israeli Bariatric Surgery Registry (IBSR) was established in June 2013 by the Israel Center for Disease Control in the Ministry of Health, in collaboration with the Israel Bariatric Surgery Society. An official directive of the Director General of the Ministry of Health as of 2013 made reporting of all bariatric surgeries carried out in Israel mandatory. The bariatric surgery centers relay clinical and surgical information to the IBSR. Presurgery and follow-up outcome information was retrieved from all 4 health maintenance organizations. RESULTS: All 32 certified bariatric units report to the national IBSR. National reporting rates increased from 46.3% in 2013 to 98.7% in 2017. Adherence to bariatric surgery guidelines also increased from 72.8% in 2013 to 98.7% in 2017, and fewer patients not fulfilling the guidelines underwent bariatric surgeries in 2017. Importantly, the considerable annual preregistry increase in surgical procedures has been halted. Registry data regarding obesity-related co-morbidities were validated against hospital files with high Cohen's kappa coefficients for hypertension (r = .8), diabetes (r = .8), and sleep apnea (r = .7). CONCLUSIONS: The national IBSR is an identified, validated, mandatory database with access to other national databases, which enables quality assurance of bariatric surgeries in Israel and short- and long-term postoperative follow-up.

Impact of gastric banding on plasma adiponectin levels.

BACKGROUND: Several endocrine abnormalities are reported in obesity. In an earlier study, we found that the changes in BMI following laparoscopic adjustable gastric banding (LAGB) were associated with changes in hormone profiles such as insulin and proinsulin. In the current study, we explored the changes in plasma adiponectin levels in morbidly obese subjects who lost abundant weight following LAGB. METHODS: 23 adult morbidly obese patients (15 females), aged 21-56 years, were studied. Blood samples were collected before, and 6 and 14 months after LAGB. The plasma adiponectin levels were determined by commercial kit (B-Bridge International, Inc). Statistical analysis was based on one-way repeated measures ANOVA, followed by Student-Newman-Keuls post-hoc test. Regression model was used to look for predictors of adiponectin change after LAGB. RESULTS: Mean BMI before surgery was 46.04+/-4.44 kg/m2, and decreased significantly by 18% 6 months after surgery to 37.67+/-4.47 kg/m2. BMI further decreased by 32% 14 months after surgery to a mean of 31.30+/-4.65 kg/m2 (P=.000). The mean adiponectin level before surgery was 3997+/-1766 microg/ml, and increased significantly by 16% to 4763+/-1776 microg/ml 6 months after surgery, and to 6336+/-3292 microg/ml (37%) 14 months after surgery. Although BMI persistently decreased, while adiponectin persistently increased, BMI did not correlate with adiponectin. CONCLUSION: In morbidly obese patients who underwent LAGB, adiponectin levels persistently increased, probably due to the reduction of visceral fat mass. Adiponectin plasma increase was correlated with proinsulin levels prior to the surgery. The interaction between adiponectin, proinsulin and BMI change in morbid obesity merits further investigation.

Impact of gastric banding on plasma ghrelin, growth hormone, cortisol, DHEA and DHEA-S levels.

BACKGROUND: Several endocrine abnormalities are reported in obesity. Some are considered as causative factors, whereas others are considered to be secondary effects of obesity. In the current study, we explored the changes in cortisol, growth hormone (GH), DHEA, DHEA-S and GH releasing hormone (ghrelin) plasma levels in morbidly obese subjects who lost abundant weight following laparoscopic adjustable gastric banding (LAGB). METHODS: 12 morbidly obese adult patients (15 females), age 21-56 years with BMI 46.0+/-4.4 kg/cm(2), were studied. Blood samples were collected before, 6 and 14 months after LAGB. The levels of DHEA, DHEA-S, cortisol, GH, and ghrelin were determined by commercial kits. Statistical analysis was based on one-way repeated measures ANOVA, followed by Student-Newman-Keuls post-hoc test. RESULTS: Mean BMI reduced significantly along the study course (P=.000). Cortisol plasma levels significantly decreased 6 months after surgery (from 541.4+/-242.4 nM to 382.4+/-142.1 nM, P=.004), but did not change further after 14 months (460.2+/-244.9 nM), despite further reduction in BMI (P=.050). GH constantly increased throughout the study from 0.076+/-0.149 ng/ml, to 0.410+/-0.509 ng/ml at 6 months (NS), to 1.224+/-1.738 ng/ml at 14 months after surgery (P=.001). DHEA, DHEA-S and ghrelin plasma levels remained stable throughout the study. CONCLUSIONS: GH levels showed a persistent increase during the 14 months following LAGB in association with the weight loss, while a transient decrease in cortisol levels occurred at the 6-months time-point. In contrast, ghrelin, DHEA and DHEA-S were not altered after surgery. The association between GH and cortisol secretion and surgical- and nonsurgical-induced weight reduction merits further investigation.