Best practice considerations on the assessment of robotic assisted surgical systems: results from an international consensus expert panel.

BACKGROUND: Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. METHODS: A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. RESULTS: A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. CONCLUSIONS: Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.

Behavior of trifloxystrobin and propineb as combination product in tomato (Solanum lycopersicum) and their risk assessment for human health.

Fungicides have their own unique characteristics and modes of action; a combination formulation [combination product (combi product)] of trifloxystrobin and propineb was applied to tomatoes for their dissipation kinetics and to ensure consumer safety. The combi product was applied at a 10-day interval with standard (61.25 + 1072.75 g a.i. ha-1 ) and double (122.5 + 2145.50 g a.i. ha-1 ) doses. The efficient analytical method was established using the quick, easy, cheap, effective, rugged, and safe (QuEChERS) approach followed by LC-MS. The maximum residue levels of 0.15 and 0.35 mg kg-1 of trifloxystrobin were detected in tomato fruits immediately after application at standard and double doses, respectively. The corresponding levels of propineb as carbon disulfide were 0.47 and 0.90 mg kg-1 , respectively. Considering trifloxystrobin (0.7 mg kg-1 ) codex maximum residue limit and propineb as dithiocarbamate (3.0 mg kg-1 ) European Commission maximum residue limit in tomato, a pre-harvest interval of 1 day can be proposed. The anticipated residue contributions of both fungicides were far less than the acceptable daily intake. The targeted hazard quotient and hazard index were also less than 1 for both fungicides. Furthermore, the theoretical maximum residue contribution was less than its maximum permissible intake, which indicates that the consumption of tomatoes containing the measured value of each fungicide residue could not pose any health risks.

Method validation, dissipation and residue status of fluopicolide and fosetyl-aluminium in citrus using a rapid extraction method coupled with ultra-performance liquid chromatography-tandem mass spectrometry.

The dissipation and residue status of a combination of fluopicolide and fosetyl-aluminium (fosetyl-Al) in citrus were evaluated in an experimental field. An efficient and sensitive liquid chromatography-tandem mass spectrometry, with rapid extraction, was carried out according to the SANTE guidelines. During the method validation, the recovery was within the range of 106.1-117.5, 94.4-115 and 85.4-109.5%, for fluopicolide, its metabolite 2,6-dichlorobenzamide and fosetyl-Al, respectively, with a relative standard deviation (RSD) of 0.3-10.6%. As a result, accuracy and precision at the spiking concentrations of 0.01, 0.05 and 0.10 mg/kg in citrus were within the acceptable range of 70-120% with an RSD of 20%. The amount of the deposits of fluopicolide, 2,6-dichlorobenzamide and fosetyl-Al was less than the limit of quantification (LOQ) at 0.01 mg/kg at 0 day, adhering to the application in standard [1.77 + 2.66 g of active ingredient (a.i.)/L] and double (3.54 + 5.32 g a.i./L) doses. The present study proposes that the utilisation of fluopicolide and fosetyl-Al in citrus and the soil may not pose a health or environmental hazard provided that good agricultural practices are followed.

Elective paraesophageal hernia repair in elderly patients: an analysis of ACS-NSQIP database for contemporary morbidity and mortality.

BACKGROUND: Elective paraesophageal hernia (PEH) repair in asymptomatic or minimally symptomatic patients ≥ 65 years of age remains controversial. The widely cited Markov Monte Carlo decision analytic model recommends watchful waiting in this group, unless the mortality rate for elective repair was to reach ≤ 0.5%; at which point, surgery would become the optimal treatment. We hypothesized that with advances in minimally invasive surgery, perioperative care, and practice specialization, that mortality threshold has been reached in the contemporary era. However, the safety net would decrease as age increases, particularly in octogenarians. METHODS: We identified 12,422 patients from the 2015-2017 ACS-NSQIP database, who underwent elective minimally invasive PEH repair, of whom 5476 (44.1%) were with age ≥ 65. Primary outcome was 30-day mortality. Secondary outcomes were length of stay (LOS), operative time, pneumonia, pulmonary embolism, unplanned intubation, sepsis, bleeding requiring transfusion, readmission, and return to OR. RESULTS: Patients age ≥ 65 had a higher 30-day mortality (0.5% vs 0.2%; p < 0.001). Subset analysis of patients age 65-80 and > 80 showed a 30-day mortality of 0.4% vs. 1.8%, respectively (p < 0.001). Independent predictors of mortality in patients ≥ 65 years were age > 80 (OR 5.23, p < 0.001) and COPD (OR 2.59, p = 0.04). Patients ≥ 65 had a slightly higher incidence of pneumonia (2% vs 1.2%; p < 0.001), unplanned intubation (0.8% vs 0.5%; p < 0.05), pulmonary embolism (0.7% vs 0.3%; p = 0.001), bleeding requiring transfusion (1% vs 0.5%; p < 0.05), and LOS (2.38 vs 1.86 days, p < 0.001) with no difference in sepsis, return to OR or readmission. CONCLUSION: This is the largest series evaluating elective PEH repair in the recent era. While morbidity and mortality do increase with age, the mortality remains below 0.5% until age 80. Our results support consideration for a paradigm shift in the management of patients < 80 years toward elective repair of PEH.

Impact of type of minimally invasive approach on open conversions across ten common procedures in different specialties.

BACKGROUND: Conversion rates during minimally invasive surgery are generally examined in the limited scope of a particular procedure. However, for a hospital or payor, the cumulative impact of conversions during commonly performed procedures could have a much larger negative effect than what is appreciated by individual surgeons. The aim of this study is to assess open conversion rates during minimally invasive surgery (MIS) across common procedures using laparoscopic/thoracoscopic (LAP/VATS) and robotic-assisted (RAS) approaches. STUDY DESIGN: Retrospective cohort study using the Premier Database on patients who underwent common operations (hysterectomy, lobectomy, right colectomy, benign sigmoidectomy, low anterior resection, inguinal and ventral hernia repair, and partial nephrectomy) between January 2013 and September 2015. ICD-9 and CPT codes were used to define procedures, modality, and conversion. Propensity scores were calculated using patient, hospital, and surgeon characteristics. Propensity-score matched analysis was used to compare conversions between LAP/VATS and RAS for each procedure. RESULTS: A total of 278,520 patients had MIS approaches of the ten operations. Conversion occurred in 5% of patients and was associated with a 1.77 day incremental increase in length of stay and $3441 incremental increase in cost. RAS was associated with a 58.5% lower rate of conversion to open surgery compared to LAP/VATS. CONCLUSION: At a health system or payer level, conversion to open is detrimental not just for the patient and surgeon but also puts a significant strain on hospital resources. Use of RAS was associated with less than half of the conversion rate observed for LAP/VATS.

Development, validation and evaluation of matrix effect of a QuEChERS-based multiresidue method with low temperature dispersive clean-up for analysis of 104 pesticides in cumin (Cuminum cyminum) by LC-MS/MS.

BACKGROUND: Until now, there is no method available for analysis of pesticide residues in complex matrices like spices. Therefore, there is an urgent need to develop and validate a QuEChERS-based method for the estimation of 104 pesticides in cumin seed. RESULTS: Samples were spiked for 109 pesticides at concentrations of 0.1, 0.5 and 1.0 mg kg-1 . Of these 104 pesticides were recovered. At 0.1, 0.5 and 0.1 mg kg-1 , recoveries ranged from 71% to 108% when compared with matrix matched standards. Seventeen pesticides showed higher or lower recoveries than acceptable range (70-120%) when quantified using solvent standards showing significant matrix effect (ME) (≥ ±20%) even after 20× dilution. However, for the other pesticides ME was significantly eliminated on dilution. The recovery percentage improved for all pesticides on quantitation with matrix matched standards when compared with solvent standards. For pesticides with lower European Union (EU) maximum residue limits (MRLs), an experiment at lower spiking concentrations of 0.01 and 0.05 mg kg-1 with lower dilutions (8×) reveals that almost all pesticides with lower EU MRLs (0.02 and 0.05 mg kg-1 ) showed recoveries in the range 74-124% and relative standard deviation (RSD) less than 20%. CONCLUSION: Theoretical limit of quantitation (LOQ) is proposed which ranged from 0.01 to 0.18 mg kg-1 for matrix matched standards. An LOQ of 0.01 mg kg-1 was easily achieved for the pesticides with lower EU MRLs with lower dilutions (8×) with exception of fipronil for which this can be achieved without dilution provided matrix matched standards are used. The method can be extended to other spices. © 2021 Society of Chemical Industry.

International Delphi Expert Consensus on Safe Return to Surgical and Endoscopic Practice: From the Coronavirus Global Surgical Collaborative.

OBJECTIVE: The aim of this work is to formulate recommendations based on global expert consensus to guide the surgical community on the safe resumption of surgical and endoscopic activities. BACKGROUND: The COVID-19 pandemic has caused marked disruptions in the delivery of surgical care worldwide. A thoughtful, structured approach to resuming surgical services is necessary as the impact of COVID-19 becomes better controlled. The Coronavirus Global Surgical Collaborative sought to formulate, through rigorous scientific methodology, consensus-based recommendations in collaboration with a multidisciplinary group of international experts and policymakers. METHODS: Recommendations were developed following a Delphi process. Domain topics were formulated and subsequently subdivided into questions pertinent to different aspects of surgical care in the COVID-19 crisis. Forty-four experts from 15 countries across 4 continents drafted statements based on the specific questions. Anonymous Delphi voting on the statements was performed in 2 rounds, as well as in a telepresence meeting. RESULTS: One hundred statements were formulated across 10 domains. The statements addressed terminology, impact on procedural services, patient/staff safety, managing a backlog of surgeries, methods to restart and sustain surgical services, education, and research. Eighty-three of the statements were approved during the first round of Delphi voting, and 11 during the second round. A final telepresence meeting and discussion yielded acceptance of 5 other statements. CONCLUSIONS: The Delphi process resulted in 99 recommendations. These consensus statements provide expert guidance, based on scientific methodology, for the safe resumption of surgical activities during the COVID-19 pandemic.

Hyperlipasemia in absence of acute pancreatitis is associated with elevated D-dimer and adverse outcomes in COVID 19 disease.

BACKGROUND: Coronavirus SARS-CoV-2 affects multiple organs. Studies have reported mild elevations of lipase levels of unclear significance. Our study aims to determine the outcomes in patients with COVID-19 and hyperlipasemia, and whether correlation with D-dimer levels explains the effect on outcomes. METHODS: Case-control study from two large tertiary care health systems, of patients with COVID-19 disease admitted between March 1 and May 1, 2020 who had lipase levels recorded. Data analyzed to study primary outcomes of mortality, length of stay (LOS) and intensive care utilization in hyperlipasemia patients, and correlation with D-dimer and outcomes. RESULTS: 992 out of 5597 COVID-19 patients had lipase levels, of which 429 (43%) had hyperlipasemia. 152 (15%) patients had a lipase > 3x ULN, with clinical pancreatitis in 2 patients. Hyperlipasemia had a higher mortality than normal lipase patients (32% vs. 23%, OR = 1.6,95%CI = 1.2-2.1, P = 0.002). In subgroup analysis, hyperlipasemia patients had significantly worse LOS (11vs.15 days, P = 0.01), ICU admission rates (44% vs. 66%,OR = 2.5,95%CI = 1.3-5.0,P = 0.008), ICU LOS (12vs.19 days,P = 0.01), mechanical ventilation rates (34% vs. 55%,OR = 2.4,95%CI = 1.3-4.8,P = 0.01), and durations of mechanical ventilation (14 vs. 21 days, P = 0.008). Hyperlipasemia patients were more likely to have a D-dimer value in the highest two quartiles, and had increased mortality (59% vs. 15%,OR = 7.2,95%CI = 4.5-11,P < 0.001) and LOS (10vs.7 days,P < 0.001) compared to those with normal lipase and lower D-dimer levels. CONCLUSION: There is high prevalence of hyperlipasemia without clinical pancreatitis in COVID-19 disease. Hyperlipasemia was associated with higher mortality and ICU utilization, possibly explained by elevated D-dimer.

Seroprevalence and incidence of primary dengue infections among children in a rural region of Maharashtra, Western India.

BACKGROUND: Dengue infections have become a huge threat to public health systems in developing countries. Data on seroprevalence and incidence of dengue infections are lacking from rural regions of India. The objective of present study was to investigate the seroprevalence and incidence of dengue infection utilizing repeated serosurveys from a rural region of Maharashtra, Western India. METHODS: In the present study, 819 children between ages 5 to 15 years from 21 villages in Pune District of Maharashtra, India were sampled in 2014 and 2016. The sera were tested for the presence of dengue specific IgG using an indirect IgG ELISA kit. RESULTS: Overall seroprevalence of dengue was 15.3% (95% confidence intervals (CI) 12.9-17.8%) in 2014 and 20.5% (95% CI 17.8-23.4%) in 2016. Among the 694 children who were seronegative at baseline (2014), 78 seroconverted. Overall incidence rate of primary dengue was 54.2 infections/1000 children years (95% CI 43.0-67.3). Incidence of primary dengue infection was higher in children from urbanized villages compared to rural villages (Incidence rate ratio (IRR) 2.6 (95% CI 1.3-5.2)). In rural villages, incidence of primary dengue infection was higher in children aged 10 years or above as compared to those aged below 10 years (IRR 9.75 (95% CI 1.21-77.9). CONCLUSIONS: The study provides the incidence rates of primary dengue infections from a rural region of India. More multi centric studies investigating the incidence of dengue will provide accurate estimate of incidence of dengue and help formulate well directed policies. The results also suggest that urbanization and transitions in demographic settings might favour dengue outbreaks in rural regions and these regions need to be targeted for vector control measures.

Development and validation of multiresidue analytical method in cotton and groundnut oil for 87 pesticides using low temperature and dispersive cleanup on gas chromatography and liquid chromatography-tandem mass spectrometry.

A method was developed and validated for the analysis of 87 pesticides in cotton and groundnut oil by GC with ECD and FPD detectors and LC-MS/MS. The extraction procedure based on QuEChERS followed by low-temperature freezing and dispersive cleanup steps was validated in two oil matrices for 87 pesticides of different classes. Linearity, expressed as coefficient of variation, was within the acceptable range. Of those tested, 77-83 and 77-89% pesticides showed recoveries within the acceptable range of 70-120% on LC-MS/MS in cottonseed oil and groundnut oil, respectively, at different spiking levels. In case of GC analysis, 63-65 and 53-82% pesticides showed recoveries within the acceptable range of 70-120% on GC in cottonseed oil and groundnut oil, respectively, at different spiking levels. The exceptions to these recoveries were the few organochlorines which consistently gave lower recoveries. Recovery factors can be employed while analysing these pesticides by this method as the results obtained were consistent in both oils. RSD was less than 20% for most of the pesticides. The calculated limit of quantitation (LOQ) for most of the pesticides satisfies the maximum residue level (MRL) requirements as per European Union (EU) guidelines and Food Safety and Standards Authority of India (FSSAI).

Closing the gap between the laparoscopic and open approaches to abdominal wall hernia repair: a trend and outcomes analysis of the ACS-NSQIP database.

OBJECTIVE: To assess trends in utilization and perioperative outcomes of laparoscopic and open abdominal wall hernia repair. METHODS: Using the ACS-NSQIP database between 2009 and 2012, patients were identified as having an ICD-9 diagnosis of an umbilical, ventral, or incisional hernia as well as a CPT code for a laparoscopic or open abdominal wall hernia repair. A coarsened exact matching procedure was utilized to create a matched cohort to mitigate selection bias. Thirty-day outcomes analysis was done for the aggregate and matched cohorts. Subcategory analysis was performed for inpatient/outpatient status, strangulated/incarcerated hernias, initial/recurrent repairs, and hernia type (umbilical, ventral, incisional). Chi-square analysis was performed to determine the statistical significance of each comparison. RESULTS: In total, 112,074 qualifying patients were identified, 86,566 (77.24 %) open and 25,508 (22.76 %) laparoscopic. Patients undergoing laparoscopic repair were more likely to have preexisting comorbidities, but less likely to experience any postoperative morbidity (11.74 vs. 7.25 %, P < 0.0001), serious morbidity (4.55 vs. 3.02 %, P < 0.0001), or mortality (0.36 vs. 0.24 %, P = 0.0030). Creation of the matched cohort produced 17,394 patients in both the laparoscopic and open groups and resulted in a loss of advantage for the laparoscopic approach in terms of morbidity associated with umbilical hernia repairs (P = 0.0082 vs. P = 0.3172). Patients undergoing laparoscopic repair were still less likely to experience any postoperative (9.57 vs. 4.92 %, P < 0.0001) or serious morbidity (3.37 vs. 1.70 %, P < 0.0001). Hospital length of stay in the matched cohort supported initial primary repairs done by an open approach. CONCLUSION: The laparoscopic approach is used in a minority of abdominal wall hernia repairs, though utilization increased by 40 % from 2009 to 2012. The laparoscopic approach continues to be safer on many fronts, but not all, and is arguably not better for umbilical or primary hernia repairs on the basis of overall morbidity and length of stay.

Validation of a QuEChERS-based gas chromatographic method for analysis of pesticide residues in Cassia angustifolia (senna).

A simple multi-residue method based on modified QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) approach was established for the determination of 17 organochlorine (OC), 15 organophosphorous (OP) and 7 synthetic pyrethroid (SP) pesticides in an economically important medicinal plant of India, Senna (Cassia angustifolia), by gas chromatography coupled to electron capture and flame thermionic detectors (GC/ECD/FTD) and confirmation of residues was done on gas chromatograph coupled with mass spectrometry (GC-MS). The developed method was validated by testing the following parameters: linearity, limit of detection (LOD), limit of quantification (LOQ), matrix effect, accuracy-precision and measurement uncertainty; the validation study clearly demonstrated the suitability of the method for its intended application. All pesticides showed good linearity in the range 0.01-1.0 µg mL(-1) for OCs and OPs and 0.05-2.5 µg mL(-1) for SPs with correlation coefficients higher than 0.98. The method gave good recoveries for most of the pesticides (70-120%) with intra-day and inter-day precision < 20% in most of the cases. The limits of detection varied from 0.003 to 0.03 mg kg(-1), and the LOQs were determined as 0.01-0.049 mg kg(-1). The expanded uncertainties were <30%, which was distinctively less than a maximum default value of ±50%. The proposed method was successfully applied to determine pesticide residues in 12 commercial market samples obtained from different locations in India.

Multilocation field trials for risk assessment of a combination fungicide Fluopicolide + Propamocarb in tomato.

Dissipation kinetics of two systemic fungicides, namely fluopicolide and propamocarb used as a combination formulation (Infinito 68.75 SC), were studied on tomato at four different locations by the All India Network Project on Pesticide Residues to recommend their pre-harvest interval (PHI) and to propose the maximum residue limits (MRL) for the two fungicides based on chronic hazard exposure assessment. The combination fungicide was sprayed thrice at the recommended dosage of 93.75 g a.i./ha fluopicolide and 937.50 g a.i./ha propamocarb as well as at double the recommended dosage of 187.50 g a.i./ha fluopicolide and 1875.0 g a.i./ha propamocarb on tomato crops and the residues were monitored periodically by GC-MS. The fungicides dissipated to below the limit of quantification (LOQ) within 10 to 15 days, with a half-life of 2-4 days for fluopicolide and 1-2 days for propamocarb. Taking into consideration the MRLs of codex and calculations made using the method of MRL fixation of the Food Safety and Standard Authority of India (FSSAI) as well as the Organization for Economic Co-operation and Development (OECD) calculator, MRL of 5 mg/kg is proposed for fluopicolide and 15 mg/kg for propamocarb, following critical exposure of the commodity considering PHI of 1 day.

Higher levels of dengue-virus-specific IgG and IgA during pre-defervescence associated with primary dengue hemorrhagic fever.

Dengue hemorrhagic fever (DHF), although predominantly associated with secondary infections, has also been reported in primary infections. An enhanced immune response including antibodies and cytokines is implicated in the pathogenesis of secondary DHF. However, the factors operating in primary DHF are poorly understood. To understand the role of the antibody response, the relative levels of different antibody isotypes during the acute phase of infection in primary and secondary dengue infections were determined. Levels of DENV-specific IgM, IgG, IgA and IgE were measured in the serum samples of 200 dengue patients and 20 dengue-naïve individuals. Samples were collected within 15 days of onset of illness. The DENV-specific IgM levels were significantly higher in DF cases compared to DHF, which was more evident in secondary infections and in post-defervescence samples. The levels of IgG, IgA and IgE were higher in DHF cases, with greater significance in primary infections. A higher level of IgG in DHF cases was evident in pre-defervescence samples, whilst the IgE level was higher in pre- and post-defervescence samples. There was a significant correlation of IgG titres with platelet counts, with higher titres associated with lower platelet counts. It is speculated that IgG, IgA and IgE produced in response to primary infections may contribute to pathogenesis, whilst IgM produced in response to secondary infections may protect against progression to severe disease.

A comprehensive process for disclosing and managing conflicts of interest on perceived bias at the SAGES annual meeting.

INTRODUCTION: The relationship between the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and its industry partners has been longstanding, productive technologically, and beneficial to patient care and education. In order to both maintain this important relationship to honor its responsibility to society for increasing transparency, SAGES established a Conflict of Interest Task Force (CITF) and charged it with identifying and managing potential conflicts of interest (COI) and limiting bias at the SAGES Annual Scientific Meetings. The CITF developed and implemented a comprehensive process for reporting, evaluating, and managing COI in accordance with (and exceeding) Accreditation Council for Continuing Medical Education guidelines. METHODS: From 2011 to 2013, all presenters, moderators, and session chairs received proactive and progressively increasing levels of education regarding the CITF rationale and processes and were required to disclose all relationships with commercial interests. Disclosures were reviewed and discussed by multiple layers of reviewers, including moderators, chairs, and CITF committee members with tiered, prescribed actions in a standardized, uniform fashion. Meeting attendees were surveyed anonymously after the annual meeting regarding perceived bias. The CITF database was then analyzed and compared to the reports of perceived bias to determine whether the implementation of this comprehensive process had been effective. RESULTS: In 2011, 68 of 484 presenters (14 %) disclosed relationships with commercial interests. In 2012, 173 of 523 presenters (33.5 %) disclosed relationships, with 49 having prior review (9.4 %), and eight required alteration. In 2013, 190 of 454 presenters disclosed relationships (41.9 %), with 93 presentations receiving prior review (20.4 %), and 20 presentations were altered. From 2008 to 2010, the perceived bias among attendees surveyed was 4.7, 6.2, and 4.4 %; and in 2011-2013, was 2.2, 1.2, and 1.5 %. CONCLUSION: It is possible to have a surgical meeting that includes participation of speakers that have industry relationships, and minimize perceived bias.

Carcinoid abdominal crisis: a case report.

Over the past 40 years, the incidence of neuroendocrine tumors (NETs) has been increasing. Distal small bowel (i.e., midgut) NETs most often cause carcinoid syndrome manifested as cutaneous flushing, diarrhea, bronchial constriction, and cardiac involvement. Carcinoid abdominal crisis occurs when submucosal tumors impede the vascular supply to the gut leading to mesenteric ischemia and worsening abdominal pain. Here, we report the case of a young woman with progressively worsening abdominal pain.

Response to glucose tolerance testing and solid high carbohydrate challenge: comparison between Roux-en-Y gastric bypass, vertical sleeve gastrectomy, and duodenal switch.

BACKGROUND: Hyperinsulinemic hypoglycemia is common after Roux-en-Y gastric bypass (RYGB) and may result in weight regain. The purpose of our investigation was to compare the effect of RYGB, vertical sleeve gastrectomy (VSG), and duodenal switch (DS) on insulin and glucose response to carbohydrate challenge. METHODS: Patients meeting National Institutes of Health criteria for bariatric surgery selected their bariatric procedure after evaluation and education in this prospective nonrandomized study. Preoperatively and at 6, 9, and 12 months' follow-up, patients underwent blood draw to determine levels of fasting glucose, fasting insulin, glycated hemoglobin (HbA1c), C-peptide, and 2-h oral glucose challenge test. Homoeostatic Model Assessment (HOMA)-IR, fasting to 1-h and 1- to 2-h ratios of glucose and insulin, were calculated. Statistical analysis was performed using ANOVA and Student's paired t test. All procedures were performed via a laparoscopic technique at a single institution. RESULTS: Data from a total of 38 patients (13 RYGB, 12 VSG, 13 DS) were available for analysis. At baseline, all groups were similar; the only statistically significant difference was that DS patients had a higher preoperative weight and body mass index (BMI). All operations caused weight loss (BMI 47.7 ± 10-30.7 ± 6.4 kg/m(2) in RYGB; 45.7 ± 8.5-31.1 ± 5.5 kg/m(2) in VSG; 55.9 ± 11.4-27.5 ± 5.6 kg/m(2) in DS), reduction of fasting glucose, and improved insulin sensitivity. RYGB patients had a rapid rise in glucose with an accompanying rise in 1-h insulin to a level that exceeded preoperative levels. This was followed by a rapid decrease in glucose level. In comparison, DS patients had a lower increase in glucose and 1-h insulin, and the lowest HbA1c. These differences were statistically significant at various data points. For VSG, the results were intermediary. CONCLUSIONS: Compared to gastric bypass, DS results in greater weight loss and improves insulin sensitivity and glucose homeostasis without causing a hyperinsulinemic response. Because the response to challenge after VSG is intermediary, pyloric preservation alone cannot account for this difference.

Persistence and risk assessment of spiromesifen on tomato in India: a multilocational study.

Supervised field trials were conducted at four different agro-climatic locations of India to evaluate the dissipation pattern and risk assessment of spiromesifen on tomato. Spiromesifen 240 SC was sprayed on tomato at 150 and 300 g a.i. ha(-1). Samples of tomato fruits were drawn at 0, 1, 3, 5, 7, 10 and 15 days after treatment and soil at 15 days after treatment. Quantification of residues was done on gas chromatograph-mass spectrophotometer in selective ion monitoring mode in the mass range of 271-274 (m/z). The limit of quantification of the method was found to be 0.05 mg kg(-1), while the limit of determination was 0.015 mg kg(-1). Residues were found below the LOQ of 0.05 mg kg(-1) in 10 days at both the doses of application at all the locations. Spiromesifen dissipated with a half-life of 0.93-1.38 days at the recommended rate of application and 1.04-1.34 days at the double the rate of application. Residues of spiromesifen in soil were detectable level (<0.05 mg kg(-1)) after 15 days of treatment. A preharvest interval (PHI) of 1 day has been recommended on tomato on the basis of data generated under All India Network Project on Pesticide Residues. Spiromesifen 240 SC has been registered for its use on tomato by Central Insecticide Board and Registration Committee, Ministry of Agriculture, Government of India. The maximum residue limit (MRL) of spiromesifen on tomato has been fixed by Food Safety Standard Authority of India, Ministry of Health and Family Welfare, Government of India as 0.3 µg/g after its risk assessment.

Severe disease during both primary and secondary dengue virus infections in pediatric populations.

Dengue is a global epidemic causing over 100 million cases annually. The clinical symptoms range from mild fever to severe hemorrhage and shock, including some fatalities. The current paradigm is that these severe dengue cases occur mostly during secondary infections due to antibody-dependent enhancement after infection with a different dengue virus serotype. India has the highest dengue burden worldwide, but little is known about disease severity and its association with primary and secondary dengue infections. To address this issue, we examined 619 children with febrile dengue-confirmed infection from three hospitals in different regions of India. We classified primary and secondary infections based on IgM:IgG ratios using a dengue-specific enzyme-linked immunosorbent assay according to the World Health Organization guidelines. We found that primary dengue infections accounted for more than half of total clinical cases (344 of 619), severe dengue cases (112 of 202) and fatalities (5 of 7). Consistent with the classification based on binding antibody data, dengue neutralizing antibody titers were also significantly lower in primary infections compared to secondary infections (P ≤ 0.0001). Our findings question the currently widely held belief that severe dengue is associated predominantly with secondary infections and emphasizes the importance of developing vaccines or treatments to protect dengue-naive populations.