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EClinicalMedicine
Number of Followers: 0  

  This is an Open Access Journal Open Access journal
ISSN (Online) 2589-5370
Published by Elsevier Homepage  [3158 journals]
  • Epilepsy in Africa: Can we end suffering and financial hardship due to
           lack of access to effective and affordable care'

    • Abstract: Publication date: Available online 3 April 2019Source: EClinicalMedicineAuthor(s): Marcia R. Weaver, Elizabeth A. Cromwell
       
  • HIV Drug Resistance in Resource-limited Countries: Threat for HIV
           Elimination

    • Abstract: Publication date: Available online 1 April 2019Source: EClinicalMedicineAuthor(s): Nicole Ngo-Giang-Huong, Avelin F. Aghokeng
       
  • HIV Incidence and Risk Behaviours of People Who Inject Drugs in Bangkok,
           1995–2012

    • Abstract: Publication date: Available online 1 April 2019Source: EClinicalMedicineAuthor(s): Michael Martin, Suphak Vanichseni, Udomsak Sangkum, Philip A. Mock, Manoj Leethochawalit, Sithisat Chiamwongpaet, Punnee Pitisuttithum, Jaranit Kaewkungwal, Frits van Griensven, Janet M. McNicholl, Jordan W. Tappero, Timothy D. Mastro, Somyot Kittimunkong, Kachit Choopanya BackgroundThree consecutive prospective studies were conducted among people who inject drugs (PWID) from May 1995 through June 2012 in Bangkok, Thailand. We examined data from these studies to evaluate HIV incidence and explore trends in risk behaviours.MethodsWe used data from a 1995–1998 cohort study, a 1999–2004 HIV vaccine trial, and a 2005–2012 HIV pre-exposure prophylaxis (PrEP) study to examine per-quarter trends in HIV incidence, using a restricted cubic spline function for time in a Poisson regression. We also examined temporal trends in HIV-associated risk behaviours.FindingsHIV incidence declined from 5.7 per 100 person-years during the cohort study, to 2.7 per 100 person-years in the vaccine trial, to 0.7 per 100 person-years among PrEP study placebo recipients. Incidence peaked at 12.1 per 100 person-years in 1996 and declined to
       
  • Safely combining trabectedin with radiotherapy to treat myxoid liposarcoma

    • Abstract: Publication date: Available online 31 March 2019Source: EClinicalMedicineAuthor(s): Mark Chen, David G. Kirsch
       
  • Cord Blood Haptoglobin, Cerebral Palsy and Death in Infants of Women at
           Risk for Preterm Birth: A Secondary Analysis of a Randomised Controlled
           Trial

    • Abstract: Publication date: Available online 22 March 2019Source: EClinicalMedicineAuthor(s): Catalin S. Buhimschi, Kathleen A. Jablonski, Dwight J. Rouse, Michael W. Varner, Uma M. Reddy, Brian M. Mercer, Kenneth J. Leveno, Ronald J. Wapner, Yoram Sorokin, John M. Thorp, Susan M. Ramin, Fergal D. Malone, Marshall W. Carpenter, Mary J. O'Sullivan, Alan M. Peaceman, George R. Saade, Donald Dudley, Steve N. Caritis, Irina A. Buhimschi, Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network BackgroundAntenatal exposure to intra-uterine inflammation results in precocious Haptoglobin (Hp) expression (switch-on status). We investigated the relationships between foetal Hp expression at birth with newborn and childhood outcomes.MethodsWe evaluated cord blood samples from 921 newborns of women at imminent risk for preterm delivery randomised to either placebo (n = 471, birth gestational age (GA) median [min-max]: 31 [24–41] weeks) or magnesium sulphate (n = 450, GA 31 [24–42] weeks]). Primary outcome was infant death by 1 year and/or cerebral palsy (CP) ≥ 2 years of corrected age. Adjusted odd ratios (aOR) for neonatal and childhood outcomes were calculated controlling for GA, birth weight, sex, and magnesium exposure.FindingsPrimary outcome occurred in 2.8% of offspring. Newborns were classified in three pre-defined categorisation groups by cord blood Hp switch status and IL-6 levels: inflammation-nonexposed (Category 1, n = 432, 47%), inflammation-exposed haptoglobinemic (Category 2, n = 449, 49%), and inflammation-exposed anhaptoglobinemic or hypohaptoglobinemic (Category 3, n = 40, 4%). Newborns, found anhaptoglobinemic or hypohaptoglobinemic (Category 3) had increased OR for intraventricular haemorrhage (IVH) and/or death (aOR: 7.0; 95% CI: 1.4–34.6, p = 0.02) and for CP and/or death (aOR: 6.27; 95% CI: 1.7–23.5, p = 0.006) compared with Category 2. Foetal ability to respond to inflammation by haptoglobinemia resulted in aOR similar to inflammation-nonexposed newborns. Hp1-2 or Hp2-2 phenotypes protected against retinopathy of prematurity (aOR = 0.66; 95% CI 0.48–0.91, p = 0.01).InterpretationFoetal ability to switch-on Hp expression in response to inflammation was associated with reduction of IVH and/or death, and CP and/or death. Foetuses unable to mount such a response had an increased risk of adverse outcomes.Trial Registration: clinicaltrials.gov Identifier: NCT00014989
       
  • From Development to Application: Bridging the Translational Gap of
           Artificial Intelligence-based Diagnostics for Childhood Cataract

    • Abstract: Publication date: Available online 9 March 2019Source: EClinicalMedicineAuthor(s): Ameenat Lola Solebo
       
  • Multi-centre Randomised Controlled Trial of a Smartphone-based Event
           Recorder Alongside Standard Care Versus Standard Care for Patients
           Presenting to the Emergency Department with Palpitations and Pre-syncope:
           The IPED (Investigation of Palpitations in the ED) study

    • Abstract: Publication date: February 2019Source: EClinicalMedicine, Volume 8Author(s): Matthew J. Reed, Neil R. Grubb, Christopher C. Lang, Rachel O'Brien, Kirsty Simpson, Mia Padarenga, Alison Grant, Sharon Tuck, Liza Keating, Frank Coffey, Lucy Jones, Tim Harris, Gavin Lloyd, James Gagg, Jason E. Smith, Tim Coats BackgroundPatients with palpitations and pre-syncope commonly present to Emergency Departments (EDs) but underlying rhythm diagnosis is often not possible during the initial presentation. This trial compares the symptomatic rhythm detection rate of a smartphone-based event recorder (AliveCor) alongside standard care versus standard care alone, for participants presenting to the ED with palpitations and pre-syncope with no obvious cause evident at initial consultation.MethodsMulti-centre open label, randomised controlled trial. Participants ≥ 16 years old presenting to 10 UK hospital EDs were included. Participants were randomised to either (a) intervention group; standard care plus the use of a smartphone-based event recorder or (b) control group; standard care alone. Primary endpoint was symptomatic rhythm detection rate at 90 days. Trial registration number NCT02783898 (ClinicalTrials.gov).FindingsTwo hundred forty-three participants were recruited over an 18-month period. A symptomatic rhythm was detected at 90 days in 69 (n = 124; 55.6%; 95% CI 46.9–64.4%) participants in the intervention group versus 11 (n = 116; 9.5%; 95% CI 4.2–14.8) in the control group (RR 5.9, 95% CI 3.3–10.5; p 
       
  • Association of Community Factors with Hospital-onset Clostridioides
           (Clostridium) difficile Infection: A Population Based U.S.-wide Study

    • Abstract: Publication date: February 2019Source: EClinicalMedicine, Volume 8Author(s): Ioannis M. Zacharioudakis, Fainareti N. Zervou, Fadi Shehadeh, Evangelia K. Mylona, Eleftherios Mylonakis BackgroundClostridioides (Clostridium) difficile ranks first among the pathogens of hospital-acquired infections with hospital-based preventive strategies being only partially successful in containing its spread.MethodsWe performed a spatial statistical analysis to examine the association between population characteristics and parameters of community healthcare practice and delivery with hospital-onset Clostridioides (Clostridium) difficile infection (HO-CDI), using data from the Medicare Hospital Compare, Medicare Provider Utilization Part D, and other databases. Among the areas with the highest HO-CDI rates (“hot spots”), we conducted a geographically weighted regression (GWR) to quantify the effect of the decrease in the modifiable risk factors on the HO-CDI rate.FindingsPercentage of population > 85 years old, community claims of antimicrobial agents and acid suppressants, and density of hospitals and nursing homes within the hospital service areas (HSAs) had a statistically significant association with the HO-CDI incidence (p 
       
  • Microbiome transplantation and modulation of immune related adverse events

    • Abstract: Publication date: February 2019Source: EClinicalMedicine, Volume 8Author(s): Olivia C. Smibert, Christina W. Guo, Chloe Khoo, K.A. Thursky, Shahneen Sandhu, Monica A. Slavin
       
  • The Democratization of Diagnosis: Bringing the Power of Medical Diagnosis
           to the Masses

    • Abstract: Publication date: February 2019Source: EClinicalMedicine, Volume 8Author(s): Rupan Bose, Leslie A. Saxon
       
  • Pertussis: Point-of-Care Testing in the Making

    • Abstract: Publication date: February 2019Source: EClinicalMedicine, Volume 8Author(s): Carl Heinz Wirsing von Koenig
       
  • Reduced Risk of Intracerebral Haemorrhage from Statins: Added-Value of
           Large Healthcare Data

    • Abstract: Publication date: February 2019Source: EClinicalMedicine, Volume 8Author(s): Craig S. Anderson
       
  • Waking up to the health implications of poor sleep habits

    • Abstract: Publication date: February 2019Source: EClinicalMedicine, Volume 8Author(s):
       
  • Statins and Risk of Intracerebral Haemorrhage in a Stroke-Free Population:
           A Nationwide Danish Propensity Score Matched Cohort Study

    • Abstract: Publication date: February 2019Source: EClinicalMedicine, Volume 8Author(s): Anette Riisgaard Ribe, Claus Høstrup Vestergaard, Mogens Vestergaard, Morten Fenger-Grøn, Henrik Schou Pedersen, Lone Winther Lietzen, Peter Krogh Brynningsen BackgroundStatins may increase the risk of intracerebral haemorrhage (ICH) in individuals with previous stroke. It remains unclear whether this applies to individuals with no history of stroke. This study is the first to explore the statin-associated risk of ICH in stroke-free individuals while considering the timing of statin initiation.MethodsWe conducted a population-based, propensity score matched cohort study using information from five Danish national registers. We included all stroke-free individuals initiating statins in 2004–2013 and a propensity score matched group of non-users. Adjusted hazard ratios (aHRs) for ICH risk among statin users compared to non-users were calculated as a function of time since statin initiation.Findings519,894 stroke-free individuals initiating statins and their 1:5 matched stroke-free reference subjects were included and followed for up to ten years. During this period, 1409 ICHs occurred in statin users. Statin users had an overall aHR of 0.85 (95% confidence interval: 0.80–0.90) compared to non-users, but this risk was modified by time since statin initiation. Statin users and non-users had similar ICH risk during the first six months after statin initiation. Hereafter, statin users had a 22–35% lower risk throughout the study period.InterpretationStatin users had lower ICH risk than non-users from six months after statin initiation. This finding could not be explained by healthy initiator bias or differences between users and non-users in terms of sociodemographic characteristics, comorbidity, or parallel treatment regimens. Our study suggests that statin use in stroke-free populations is associated with reduced ICH risk.FundingThe Novo Nordisk Foundation.
       
  • Meta-analytic Evidence for the Plurality of Mechanisms in Transdiagnostic
           Structural MRI Studies of Hallucination Status

    • Abstract: Publication date: February 2019Source: EClinicalMedicine, Volume 8Author(s): Colleen P.E. Rollins, Jane R. Garrison, Jon S. Simons, James B. Rowe, Claire O'Callaghan, Graham K. Murray, John Suckling BackgroundHallucinations are transmodal and transdiagnostic phenomena, occurring across sensory modalities and presenting in psychiatric, neurodegenerative, neurological, and non-clinical populations. Despite their cross-category occurrence, little empirical work has directly compared between-group neural correlates of hallucinations.MethodsWe performed whole-brain voxelwise meta-analyses of hallucination status across diagnoses using anisotropic effect-size seed-based d mapping (AES-SDM), and conducted a comprehensive systematic review in PubMed and Web of Science until May 2018 on other structural correlates of hallucinations, including cortical thickness and gyrification.Findings3214 abstracts were identified. Patients with psychiatric disorders and hallucinations (eight studies) exhibited reduced gray matter (GM) in the left insula, right inferior frontal gyrus, left anterior cingulate/paracingulate gyrus, left middle temporal gyrus, and increased in the bilateral fusiform gyrus, while patients with neurodegenerative disorders with hallucinations (eight studies) showed GM decreases in the left lingual gyrus, right supramarginal gyrus/parietal operculum, left parahippocampal gyrus, left fusiform gyrus, right thalamus, and right lateral occipital gyrus. Group differences between psychiatric and neurodegenerative hallucination meta-analyses were formally confirmed using Monte Carlo randomizations to determine statistical significance, and a jackknife sensitivity analysis established the reproducibility of results across nearly all study combinations. For other structural measures (28 studies), the most consistent findings associated with hallucination status were reduced cortical thickness in temporal gyri in schizophrenia and altered hippocampal volume in Parkinson's disease and dementia. Additionally, increased severity of hallucinations in schizophrenia correlated with GM reductions within the left superior temporal gyrus, right middle temporal gyrus, bilateral supramarginal and angular gyri.InterpretationDistinct patterns of neuroanatomical alteration characterize hallucination status in patients with psychiatric and neurodegenerative diseases, suggesting a plurality of anatomical signatures. This approach has implications for treatment, theoretical frameworks, and generates refutable predictions for hallucinations in other diseases and their occurrence within the general population.FundingNone.
       
  • Rapid and Accurate Diagnosis of the Respiratory Disease Pertussis on a
           Point-of-Care Biochip

    • Abstract: Publication date: February 2019Source: EClinicalMedicine, Volume 8Author(s): Maowei Dou, Natalie Macias, Feng Shen, Jennifer Dien Bard, Delfina C. Domínguez, XiuJun Li BackgroundPertussis is a highly contagious respiratory disease caused by the bacterium Bordetella pertussis (B. pertussis). The infection is difficult to diagnose especially in underserved or resource-limited areas. We developed a low-cost and instrument-free diagnostic method for rapid and accurate detection of B. pertussis on a point-of-care (POC) testing device.MethodsWe developed a paper/polymer hybrid microfluidic biochip integrated with loop-mediated isothermal amplification (LAMP) method for the rapid and accurate detection of B. pertussis. This microfluidic approach was validated by testing 100 de-identified remnant clinical nasopharyngeal swabs and aspirates, which were confirmed to be either positive or negative for B. pertussis by a validated real-time PCR assay at the Children's Hospital Los Angeles.FindingsThe instrument-free detection results could be successfully read by the naked eye within 45 min with a limit of detection (LOD) of 5 DNA copies per well. Our optimized bacterial lysis protocol allowed the direct testing of clinical samples without any complicated sample processing/preparation (i.e. DNA extraction) or the use of any equipment (e.g. centrifuges). The validation of the microfluidic approach was accomplished by testing 100 clinical samples. High sensitivity (100%) and specificity (96%) with respect to real-time PCR were achieved.InterpretationThis microfluidic biochip shows great potential for point-of-care disease diagnosis in various venues including schools and physician's offices, especially in low-resource settings in developing nations.FundingNIH/NIAID under award number R21AI107415, NIH RCMI Pilot Grant, the Philadelphia Foundation, the Medical Center of the Americas Foundation.
       
  • Congo Red Dot Paper Test for Antenatal Triage and Rapid Identification of
           Preeclampsia

    • Abstract: Publication date: February 2019Source: EClinicalMedicine, Volume 8Author(s): Kara M. Rood, Catalin S. Buhimschi, Theresa Dible, Shaylyn Webster, Guomao Zhao, Philip Samuels, Irina A. Buhimschi BackgroundProteins in the urine of women with preeclampsia (PE) bind Congo Red dye (urine congophilia). We sought to determine the diagnostic performance of a paper-based point-of-care test detecting urine congophilia for rapid triage and diagnosis of PE.MethodsProspective cohort study conducted in 346 consecutive pregnant women evaluated for PE in the Labour and Delivery triage unit at our institution. The Congo Red Dot (CRD) Paper Test (index test) was performed on fresh urine samples. The CRD Paper Test results were compared to an expert adjudicated diagnosis in each case. The accuracy of the CRD Paper Test was also compared to urine and serum analytes (placental growth factor and soluble fms-like tyrosine kinase-1) previously proposed as diagnostic aids for PE.FindingsDuring the first triage visit, 32% (112/346) of women received a clinical diagnosis of PE. Yet, 63% (217/346) were admitted for in-patient diagnostic work-up or delivery. The CRD Paper Test was positive in 25% (86/346) of the cases. Adjudication confirmed PE in 28% (96/346) of all cases. The CRD Paper Test outperformed measured serum and urine markers (80·2% sensitivity, 89·2% specificity, 92·1% negative predictive value, 86·7% accuracy). The pre-test, positive and negative post-test probabilities were 27·7%, 74·0%, and 8·0%, respectively. Of women who were discharged undelivered, 38% (133/346) had at least one additional triage visit and the interval between the last negative and first positive CRD Paper Test was 12 (interquartile range, [5–34]) days.InterpretationThe CRD Paper Test is a simple, non-invasive, “sample-in/answer-out” point-of-care clinical tool for rapid identification of PE.FundingSaving Lives at Birth Program and NICHD.
       
  • Marijuana Smoking in Men with HIV Infection: A Cause for Concern

    • Abstract: Publication date: January 2019Source: EClinicalMedicine, Volume 7Author(s): David S. Wenger, Kristina Crothers
       
  • Now Is the Time to Implement Whole Genome Sequencing in the Global
           Antimicrobial Resistance Surveillance for Neisseria gonorrhoeae'

    • Abstract: Publication date: January 2019Source: EClinicalMedicine, Volume 7Author(s): Daniel Golparian, Magnus Unemo
       
  • Sexual Harassment in Medicine: Toward Legal Clarity and Institutional
           Accountability

    • Abstract: Publication date: January 2019Source: EClinicalMedicine, Volume 7Author(s): Julie K. Silver, Michael S. Sinha
       
  • Celebrating diversity, tolerance and inclusion in STEM

    • Abstract: Publication date: January 2019Source: EClinicalMedicine, Volume 7Author(s):
       
  • A Clinical Staging Model for Obsessive–Compulsive Disorder: Is It
           Ready for Prime Time'

    • Abstract: Publication date: January 2019Source: EClinicalMedicine, Volume 7Author(s): Leonardo F. Fontenelle, Murat Yücel Recent changes to the diagnostic classification of obsessive–compulsive disorder (OCD), including its removal from the anxiety/neurotic, stress-related and somatoform disorders chapters of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and International Classification of Diseases 11th Revision (ICD-11), are based on growing evidence of unique pathogenic signatures and linked diagnostic and treatment approaches. In this review, we build on these recent developments and propose a ‘clinical staging model’ of OCD that integrates the severity of symptoms and phase of illness for personalised case management. A clinical staging model is especially relevant for the early identification and management of subthreshold OCD - a substantial and largely neglected portion of the population who, despite having milder symptoms, experience harms that may impact personal relationships, work-related functioning and productivity. Research on the pathogenesis, classification and management of such cases is needed, including the development of new outcomes measures that prove sensitive to changes in future clinical trials. Early intervention strategies in OCD are likely to yield better long-term outcomes.
       
  • A Whole-genome Sequencing Analysis of Neisseria gonorrhoeae Isolates in
           China: An Observational Study

    • Abstract: Publication date: January 2019Source: EClinicalMedicine, Volume 7Author(s): Jun-Ping Peng, Yue-Ping Yin, Shao-Chun Chen, Jian Yang, Xiu-Qin Dai, He-Ping Zheng, Wei-Ming Gu, Bang-Yong Zhu, Gang Yong, Na Zhong, Li-Hua Hu, Wen-Ling Cao, Zhong-Jie Zheng, Feng Wang, Qi Zhi, Chi Zhang, Le-Shan Xiu, Bo Liu, Jie Dong, Li-Lian Sun BackgroundTracking the spread of the Neisseria gonorrhoeae strains with decreased susceptibility or resistance to cephalosporins is a major priority for global surveillance programmes. Whole-genome sequencing (WGS) has been widely used by increasing countries in North America, Europe, and Pacific to determine the decreased susceptible or resistance determinants of Neisseria gonorrhoeae, track the spread of these determinants throughout the gonococcal population at national or regional level. However, no studies to date have examined the genomic epidemiology of gonorrhea in Asia where the antimicrobial resistant strains of Neisseria gonorrhoeae appears to have emerged before disseminating the strains globally.MethodsWe obtained clinical isolates and data from the China Gonococcal Resistance Surveillance Programme (China-GRSP) from 2012 to 2013. We sequenced the genomes of 435 clinical isolates of Neisseria gonorrhoeae, including 112 (25.6%) isolates with decreased susceptibility to ceftriaxone (Cfx-DS). We assessed the association between antimicrobial resistance genotype and phenotype. We also compared our data with the whole genome data of the isolates from the USA and the UK in the GenBank.FindingsThe most prevalent MLST STs in our gonococcal population were MLST ST7827 (n = 74), followed by ST7365 (n = 58), ST1600 (n = 38), ST7367 (n = 35), and ST7363 (n = 29). MLST ST1901 which was reported as the predominant ST in the US was not found in our population. A total of 2512 strains, including additional 2077 published NG strains, were further included for phylogenetic analysis. It generated two distinct lineages - lineage 1 and lineage 2. Analysis of MLST ST1901 in the database indicate that most of MLST ST1901 isolates in the lineage2.6 were Cfx-DS isolates while all isolates in the lineage 2.1 were sensitive to ceftriaxone (77/110 vs. 0/13; p 
       
  • Are Neuroanatomical Abnormalities Underlying Hallucinations
           Modality-specific'

    • Abstract: Publication date: Available online 2 February 2019Source: EClinicalMedicineAuthor(s): Judith M. Ford, Holly K. Hamilton
       
  • Cell and Gene Therapy Trials: Are We Facing an ‘Evidence
           Crisis’'

    • Abstract: Publication date: Available online 2 February 2019Source: EClinicalMedicineAuthor(s): Mohamed Abou-El-Enein, Spencer Phillips Hey
       
  • Who's Afraid of the Big Bad Wolf' Safety of Beta-Blockers in COPD

    • Abstract: Publication date: Available online 29 January 2019Source: EClinicalMedicineAuthor(s): Giuseppe Ambrosio, Sergio Harari, Iosief Abraha
       
  • Sustained Effect of Immunotherapy for Food Allergy: Breaking Up is Hard to
           Do

    • Abstract: Publication date: Available online 29 January 2019Source: EClinicalMedicineAuthor(s): Lars K. Poulsen
       
  • A Phase 2 Randomized Controlled Multisite Study Using
           Omalizumab-facilitated Rapid Desensitization to Test Continued vs
           Discontinued Dosing in Multifood Allergic Individuals

    • Abstract: Publication date: Available online 21 January 2019Source: EClinicalMedicineAuthor(s): Sandra Andorf, Natasha Purington, Divya Kumar, Andrew Long, Katherine L. O'Laughlin, Scott Sicherer, Hugh Sampson, Antonella Cianferoni, Terri Brown Whitehorn, Daniel Petroni, Melanie Makhija, Rachel G. Robison, Michelle Lierl, Stephanie Logsdon, Manisha Desai, Stephen J. Galli, Efren Rael, Amal Assa'ad, Sharon Chinthrajah, Jacqueline Pongracic BackgroundAs there is limited data on the sustainability of desensitization of multifood-oral immunotherapy (multifood-OIT), we conducted a multisite multifood-OIT study to compare the efficacy of successful desensitization with sustained dosing vs discontinued dosing after multifood-OIT.MethodsWe enrolled 70 participants, aged 5–22 years with multiple food allergies confirmed by double-blind placebo-controlled food challenges (DBPCFCs). In the open-label phase of the study, all participants received omalizumab (weeks 1–16) and multi-OIT (2–5 allergens; weeks 8–30) and eligible participants (on maintenance dose of each allergen by weeks 28–29) were randomized 1:1:1 to 1 g, 300 mg, or 0 mg arms (blinded, weeks 30–36) and then tested by food challenge at week 36. Success was defined as passing 2 g food challenge to at least 2 foods in week 36.FindingsMost participants were able to reach a dose of 2 g or higher of each of 2, 3, 4, and 5 food allergens (as applicable to the participant's food allergens in OIT) in week 36 food challenges. Using an intent-to-treat analysis, we did not find evidence that a 300 mg dose was effectively different than a 1 g dose in maintaining desensitization, and both together were more effective than OIT discontinuation (0 mg dose) (85% vs 55%, P = 0.03). Fifty-five percent of the intent-to-treat participants and 69% of per protocol participants randomized to the 0 mg arm showed no objective reactivity after 6 weeks of discontinuation. Cross-desensitization was found between cashew/pistachio and walnut/pecan when only one of the foods was part of OIT. No statistically significant safety differences were found between the three arms.InterpretationThese results suggest that sustained desensitization after omalizumab-facilitated multi-OIT best occurs through continued maintenance OIT dosing of either 300 mg or 1 g of each food allergen as opposed to discontinuation of multi-OIT.FundingSean N. Parker Center for Allergy and Asthma Research at Stanford University, Jeff and MacKenzie Bezos, NIAID AADCRC U19AI104209.Trial Registration NumberClinicalTrials.gov number, NCT02626611.
       
 
 
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