scholarly journals Cognitive Aid for Anesthetic Preparation in An Emergency Situation: A Simulation-Based Study

Healthcare ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1646
Author(s):  
Emmanuel Rineau ◽  
Anna Collard ◽  
Lorine Jean ◽  
Sarah Guérin ◽  
Louise Maunoury ◽  
...  
Keyword(s):  
Phase 1 ◽  
Emergency Situation ◽  
Control Group ◽  
Phase 2 ◽  
Validation Rate ◽  
Simulation Based ◽  
Simulation Session ◽  
To Receive ◽  
Later Phase ◽  
Anesthesia Residents

When anesthesia checklists and preparations are performed urgently, omissions may occur and be deleterious to the patient. The aim of this study was to evaluate in simulation the interest of a cognitive aid to effectively prepare an anesthetic room for an emergency. In a prospective single-center simulation-based study, 32 anesthesia residents had to prepare an anesthetic room in an emergency scenario, without cognitive aid in the first phase. Three months later (phase 2), they were randomly assigned to receive a cognitive aid (aid group) or no additional aid (control) and were involved in the same scenario. The primary outcome was the validation rate of each essential item in the first 5 min in phase 2. Eight items were significantly more frequently completed in the first 5 min in the aid group in phase 2 (vs. phase 1), compared with two only in the control group. However, there were no significant differences in the overall number of completed items between the two groups, as both groups completed significantly more items in phase 2, either in the first 5 min (19 (14–23) vs. 13 (9–15) in phase 1 for all residents, p < 0.001) or without time limit. Preparation times were reduced in phase 2 in both groups. In conclusion, the use of a cognitive aid allowed anesthesia residents to complete some safety items of a simulated urgent anesthesia preparation more frequently. In addition, despite daily clinical experience, a single simulation session improved anesthesia preparation and reduced the preparation time with or without cognitive aid.

Relocation does not have a significant effect on the growth rate of Bos indicus cross steers

2008 ◽  
Vol 48 (5) ◽  
pp. 608 ◽  
Author(s):  
R. G. Holroyd ◽  
V. J. Doogan ◽  
M. R. Jeffery ◽  
J. A. Lindsay ◽  
B. K. Venus ◽  
...  
Keyword(s):  
Growth Rate ◽  
Phase 1 ◽  
Bos Indicus ◽  
Poor Performance ◽  
The Other ◽  
Control Group ◽  
Phase 2 ◽  
Treatment Groups ◽  
Normal Ranges ◽  
Native Pastures

This experiment tested the hypothesis that relocating cattle is detrimental to their growth. The study examined the effect of having relocated cattle mixed with, or segregated from, the local acclimatised cattle at the destination property. Bos indicus cross steers (120) were allocated to three groups and were relocated, in two separate cohorts, 980 km from northern Queensland to improved pastures in central Queensland. At the start of Phase 1, the control group (C) was moved 3 months before the other two groups. The remaining two groups grazed native pastures; one group was supplemented (SR) to increase growth rate similar to that expected from improved pasture in central Queensland and the other was not supplemented (R). At the end of Phase 1, C was significantly (P < 0.05) heavier than SR, which was significantly (P < 0.05) heavier than R. At the start of Phase 2, the SR and R groups were relocated and after transportation the R and SR groups lost 12 kg or 4.4% of liveweight and 18 kg or 5.7% of liveweight, respectively; this weight loss was recovered after 5 days. All steers were reallocated to segregated (SEG) or mixed (MIX) treatment groups forming six treatments (SEG.C, SEG.R and SEG.SR and MIX.C, MIX.R and MIX.SR). There were no significant differences in liveweights within the SEG treatments by 57 days or within the MIX treatments by 106 days after relocation. There were few if any significant differences in the plasma constituents and differential leucocyte counts of the steers and most results were within physiologically normal ranges. We conclude on the basis of these results and of other experiments that the anecdotal poor performance of cattle after relocation appears to be unfounded.

Rearing Dairy Heifers on Pastures Fertilized at Moderate Levels With or Without Supplemental Concentrates at Different Stages.

1969 ◽  
pp. 143-154
Author(s):  
Paul F. Randel ◽  
Jaime Vélez-Santiago
Keyword(s):  
Crude Protein ◽  
Phase 1 ◽  
Protein Concentrate ◽  
Phase 2 ◽  
Phase 3 ◽  
Concentrate Supplementation ◽  
Dairy Heifers ◽  
To Receive ◽  
Stocking Rates ◽  
Total Gain

The experiment involved 3 successive phases in rearing Holstein heifers at Corozal on pastures of mixed grasses, fertilized annually with 168, 56 and 112 kg/ha of N, P2O5 and K20, respectively, in 3 applications. Mean initial age was 9 months and liveweight (LW) 167 kg. In phase 1 (91 days), 39 control animals stocked at 5/ha and not supplemented gained 0.41 kg daily, inferior (P < 0.01) to the gain of a like number supplemented with 2 kg daily of 14% crude protein concentrate (0.64 kg), 8.6 kg of concentrate per kg of extra gain over the control. In phase 2 (182 days), 32 animals stocked at 4/ha gained less (P = 0.01) per head than 24 stocked at 3/ha (0.53 vs. 0.59 kg daily), but total gain per ha was 16.4% greater for the former. During 259 days of phase 3, while 3 groups of 19 each remained intact, grazing at 3.75 animals/ha without supplementation (treatment 1) resulted in lower (P = 0.01) gain than treatments 2 and 3, involving concentrate supplementation at 2.5 or 4 kg daily beginning 200 or 125 days before expected parturition (0.57 vs. 0.64 and 0.62 kg, respectively), but supplementation increased gains over the control very inefficiently. Mean LW increased from 318 kg in all 3 groups to 485, 513 and 497 kg in treatments 1, 2 and 3, respectively. Only heifers of the latter 2 groups continued to receive concentrates after returning to their home farms in Cayey and Manatí until first calving. All animals received usual herd management postpartum. Mean 305-day first lactation milk production was 4292 kg in 18 control animals of phase 3, surpassing (not significantly, P = 0.05) productions of 3,771 and 3,869 kg by 16 and 17 former treatment 2 and treatment 3 animals, respectively. Stocking rates employed at each stage seemed suited to available pastures, and concentrate supplementation was unnecessary for rearing dairy heifers under these conditions.

Oral weekly MLN9708, an investigational proteasome inhibitor, in combination with lenalidomide and dexamethasone in patients (pts) with previously untreated multiple myeloma (MM): A phase I/II study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8033-8033 ◽  
Author(s):  
Paul Gerard Guy Richardson ◽  
Jesus G. Berdeja ◽  
Ruben Niesvizky ◽  
Sagar Lonial ◽  
Vivek Roy ◽  
...  
Keyword(s):  
Proteasome Inhibitor ◽  
Phase 1 ◽  
Fixed Dose ◽  
Hematologic Toxicity ◽  
Phase 2 ◽  
Nonhematologic Toxicity ◽  
Immunomodulatory Drug ◽  
Grade 3 ◽  
To Receive

8033 Background: MLN9708 is an oral, reversible 20S proteasome inhibitor. The feasibility of combining a proteasome inhibitor with an immunomodulatory drug and a steroid in previously untreated MM has been demonstrated with the RVD regimen. This is the first study of MLN9708 in combination with lenalidomide and dexamethasone (NCT01217957). Here we report the phase (Ph) 1 MTD and preliminary Ph 2 results. Methods: Pts with previously untreated MM, aged ≥18 yrs with measurable disease received oral MLN9708 (phase 1: 1.68–3.95 mg/m2) days 1, 8, and 15, lenalidomide 25 mg days 1–21, and dexamethasone 40 mg days 1, 8, 15, and 22, for up to twelve 28-day cycles. Primary objectives were determination of safety, MTD, and recommended phase 2 dose (RP2D) (Ph 1), and CR+VGPR rate (Ph 2). Results: At data cut-off (Dec 1, 2011), 29 pts had been enrolled (15 Ph 1, 14 Ph 2). Median age was 64 yrs (range 40–82); 69% ISS stage II/III. In Ph 1, the MLN9708 MTD was determined as 2.97 mg/m2 and the RP2D as 2.23 mg/m2; for Ph 2, the RP2D was converted to a 4.0 mg fixed dose based on population PK results. Ph 1 pts have received a median of 6 treatment cycles (range 1–11), 8 received ≥6 cycles; 6 stopped to receive ASCT, 7 are ongoing. Ph 2 pts received a median of 1 (range 1–2), all are ongoing. Grade ≥3 hematologic toxicity was reversible and included anemia (n=2) and thrombocytopenia (n=1). Grade ≥3 nonhematologic toxicity included erythematous rash, syncope, and vomiting (2 pts each). All-grade drug-related peripheral neuropathy was seen in 6 pts (21%), including grade 2 with pain in 2 (both Ph 1 at doses above the MTD). Two pts discontinued due to AE; there were 5 pts who had serious drug-related AE (all Ph 1). Of 19 response-evaluable pts (Ph 1 + Ph 2), all achieved ≥PR, including 5 CR (1 sCR), 4 VGPR, and 10 PR; all remain in response with duration of confirmed response of up to 9.5 months. Of 4 response-evaluable Ph 2 pts, 1 has achieved VGPR and 3 PR to date. Conclusions: Oral MLN9708 plus lenalidomide and dexamethasone appears well tolerated with manageable toxicity. These data show antitumor activity at the RP2D in pts with previously untreated MM, with ≥PR in all pts to date.

Randomized Clinical Trial of Balance-Based Torso Weighting for Improving Upright Mobility in People with Multiple Sclerosis

2009 ◽  
Vol 23 (8) ◽  
pp. 784-791 ◽  
Author(s):  
Gail L. Widener ◽  
Diane D. Allen ◽  
Cynthia Gibson-Horn
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Body Weight ◽  
Randomized Clinical Trial ◽  
Phase 1 ◽  
Gait Velocity ◽  
Control Group ◽  
Phase 2 ◽  
Timed Up And Go ◽  
Standard Weight

Background. Torso weighting has sometimes been effective for improving upright mobility in people with multiple sclerosis, but parameters for weighting have been inconsistent. Objective. To determine whether balance-based torso weighting (BBTW) has immediate effects on upright mobility in people with multiple sclerosis. Methods. This was a 2-phase randomized clinical trial. In phase 1, 36 participants were randomly assigned to experimental and control groups. In phase 2, the control group was subsequently randomized into 2 groups with alternate weight-placement. Tests of upright mobility included: timed up and go (TUG), sharpened Romberg, 360-degree turns, 25-foot walk, and computerized platform posturography. Participants were tested at baseline and again with weights placed according to group membership. In both phases, a physical therapist assessed balance for the BBTW group and then placed weights to decrease balance loss. In phase 1, the control group had no weights placed. In phase 2, the alternate treatment group received standard weight placement of 1.5% body weight. Results. People with BBTW showed a significant improvement in the 25-foot walk ( P = .01) over those with no weight, and the TUG ( P = .01) over those with standard weight placement. BBTW participants received an average of 0.5 kg, less than 1.5% of any participant’s body weight. Conclusion. BBTW can have immediate advantages over a nonweighted condition for gait velocity and over a standardized weighted condition for a functional activity in people with multiple sclerosis (MS) who are ambulatory but have balance and mobility abnormalities.

scholarly journals Enhancing Organizational Memory Through Virtual Memoryscapes: Does It Work?

2021 ◽  
Vol 12 ◽  
Author(s):  
Antonio Mastrogiorgio ◽  
Francesca Zaninotto ◽  
Francesca Maggi ◽  
Emiliano Ricciardi ◽  
Nicola Lattanzi ◽  
...  
Keyword(s):  
Ecological Validity ◽  
Phase 1 ◽  
Memory Task ◽  
Organizational Memory ◽  
Phase 2 ◽  
Group Memory ◽  
Organizational Settings ◽  
Immersive Virtual Environment ◽  
Method Of Loci ◽  
Later Phase

Enhancing cognitive memory through virtual reality represents an issue, that has never been investigated in organizational settings. Here, we compared a virtual memoryscape (treatment) – an immersive virtual environment used by subjects as a shared memory tool based on spatial navigation – with respect to the traditional individual-specific mnemonic tool based on the “method of loci” (control). A memory task characterized by high ecological validity was administered to 82 subjects employed by large banking group. Memory recall was measured, for both groups, immediately after the task (Phase 1) and one week later (Phase 2). Results show that (i) in Phase 1, the method of loci was more efficient in terms of recalling information than the to the virtual memoryscape; (ii) in Phase 2, there was no difference. Compared to the method of loci, the virtual memoryscape presents the advantages – relevant for organizations – of being collective, controllable, dynamic, and non-manipulable.

scholarly journals 8 Positive Distraction Entertainment System (PDES) in Paediatric Population Undergoing Day Surgery

2020 ◽  
Vol 25 (Supplement_2) ◽  
pp. e3-e3
Author(s):  
Michael Chang ◽  
Alicia Fernandes ◽  
Alexandra Frankel
Keyword(s):  
Virtual Reality ◽  
Separation Anxiety ◽  
Pediatric Population ◽  
Phase 1 ◽  
Paediatric Population ◽  
Day Surgery ◽  
Control Group ◽  
Phase 2 ◽  
Before And After ◽  
Experience Survey

Abstract Background Patients undergoing procedures at hospitals may experience anxiety and such anxiety can be heightened in pediatric populations. Anxiety can invoke a physical and mental stress response leading to poorer health outcomes and in children these outcomes include: resistance to treatment, nightmares, longer recovery periods, lowered pain thresholds and separation anxiety (Biddis, 2014; Manyande 2015; Aydın 2017). Objectives This study aimed to test whether a virtual reality intervention is feasible, beneficial and effective in reducing anxiety prior to surgery in the pediatric population of Scarborough Health Network. Design/Methods Virtual Reality (VR) is a computer technology that simulates a user’s physical presence in a virtual or imaginary environment. ‘Bubble Bloom’, an underwater fishing game where participants launch bubbles to catch colourful fish, is the VR game that the children are administered in a two phased research design to explore whether the VR intervention was a beneficial tool in reducing anxiety in our pediatric population. Phase 1 was a trial phase in which participants (n=20) were administered the condensed version of the State Trait Anxiety Scale before and after the intervention to determine if anxiety levels had been reduced. Participants were also administered an experience survey to explore patient satisfaction, headset comfort, and virtual reality satisfaction. Phase 2, randomized control trial, is currently ongoing with the same measures and VR intervention being administered. In Phase 2, participants are randomized to the control group (regular play activities) or intervention (virtual reality game). Results In Phase 1, all participants indicated they enjoyed the experience of the virtual reality intervention. Sixteen of the 20 participants had pre scores that were in the mild to moderate anxiety range (80%). Of these 16 participants, 10 participants’ post scores decreased to the normal or no anxiety range (63%). Additionally, 80% of participants demonstrated a reduction in anxiety post-virtual reality intervention. Conclusion Phase 1 results were encouraging with 80% of participants experiencing a reduction in anxiety and all participants enjoying the virtual reality experience.

SPEARHEAD-1: A phase II trial of ADP-A2M4 SPEAR T cells in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS11569-TPS11569
Author(s):  
Dejka M. Araujo ◽  
Mihaela Druta ◽  
Mark Agulnik ◽  
Sandra P. D'Angelo ◽  
Jean-Yves Blay ◽  
...  
Keyword(s):  
T Cells ◽  
Synovial Sarcoma ◽  
Phase 1 ◽  
Antigen Expression ◽  
Genetically Engineered ◽  
Phase 2 ◽  
Round Cell ◽  
Open Label ◽  
Human Pathology ◽  
To Receive

TPS11569 Background: ADP-A2M4 specific peptide enhanced affinity receptor (SPEAR) T-cells are genetically engineered to target MAGE-A4+ tumors in the context of HLA-A*02. MAGE-A4 has been described as having high expression in synovial sarcoma (SS) and myxoid/round cell liposarcoma (MRCLS) [1, 2]. This Phase 2 trial was initiated based on the favorable benefit:risk profile of ADP-A2M4 observed in a Phase 1 trial (NCT03132922) of ADP-A2M4 which demonstrated compelling clinical responses in patients with SS. Methods: This Phase 2, open-label trial (SPEARHEAD-1; NCT04044768) is designed to evaluate the efficacy, safety and tolerability of ADP-A2M4 in patients with advanced/metastatic SS or MRCLS who are HLA-A*02 positive and whose tumors express the MAGE-A4 protein. Enrolled patients are to undergo apheresis, and their isolated T-cells are then transduced with the MAGE-A4c1032 TCR, and expanded. Prior to ADP-A2M4 infusion, patients are to receive lymphodepleting chemotherapy consisting of fludarabine (30 mg/m2/day x 4 days) and cyclophosphamide (600 mg/m2/day x 3 days). Patients are to receive 1 – 10 × 109 transduced T-cells. An independent Data Safety Monitoring Board will review ongoing safety and benefit:risk during the interventional phase of the study. Disease will be assessed by independent review per RECIST v1.1 by CT/MRI at weeks 4, 8, 12, 16, 24, and every 2 months thereafter until confirmed disease progression. As of 24 Jan 2020, there were 17 clinical sites open in the US, one in Canada, and two in Spain. References: 1. Iura K, et al. Cancer-testis antigen expression in synovial sarcoma: NY-ESO-1, PRAME, MAGEA4, and MAGEA1. Human Pathology 2017; 61:130-139. 2. Iura K, et al. MAGEA4 expression in bone and soft tissue tumors: its utility as a target for immunotherapy and diagnostic marker combined with NY-ESO-1. Virchows Archiv 2017;471:383–392. Clinical trial information: NCT04044768 .

Indomethacin Treatment for Symptomatic Patent Ductus Arteriosus: A Double-Blind Control Study

PEDIATRICS ◽  
1981 ◽  
Vol 67 (5) ◽  
pp. 647-652
Author(s):  
Ruth M. Yanagi ◽  
Allen Wilson ◽  
Edgar A. Newfeld ◽  
Kalim U. Aziz ◽  
Carl E. Hunt
Keyword(s):  
Patent Ductus Arteriosus ◽  
Phase 1 ◽  
Ductus Arteriosus ◽  
Control Group ◽  
Phase 2 ◽  
Closure Rate ◽  
Double Blind ◽  
Double Blind Control Study ◽  
Patent Ductus ◽  
Indomethacin Treatment

A double-blind control study was designed to determine the efficacy and safety of indomethacin treatment of patients with symptomatic patent ductus arteriosus. Infants with severe respiratory distress syndrome and symptomatic patent ductus arteriosus were eligible for this prospective study if the ratio of left atrial/aortic root diameter remained ≥ 1.3:1 following a 24-hour period of medical management. Thirty-nine eligible infants were randomly assigned to the control or indomethacin group and given 0.2 mg/kg of enteral indomethacin or placebo in a double-blind manner. Second and third doses were administered at 24-hour intervals in phase 1 (17 patients), and at eight-hour intervals in phase 2 (22 patients). The 75% patent ductus arteriosus closure rate with indomethacin treatment in phase 1 was not statistically significant due to a 44% spontaneous closure rate in the control group. In phase 2, however, 85% of the indomethacin group demonstrated patent ductus arteriosus closure vs only 11% in the matched control group (P .01). Although no indomethacin side effects occurred in phase 1, in phase 2 indomethacin administration was associated with minimal, but statistically significant, transient impaired renal function and, in three infants (23%), mild upper gastrointestinal bleeding. In summary, enteral administration of three 0.2 mg/kg indomethacin doses at eight-hour intervals thus appears to be a safe and effective alternative to surgical closure.

Capsaicin pretreatment attenuates monocrotaline-induced ventilatory dysfunction and pulmonary hypertension

1993 ◽  
Vol 75 (6) ◽  
pp. 2781-2788 ◽  
Author(s):  
K. R. Zhou ◽  
Y. L. Lai
Keyword(s):  
Pulmonary Hypertension ◽  
Substance P ◽  
Tissue Injury ◽  
Phase 1 ◽  
Weight Ratio ◽  
Functional Study ◽  
Control Group ◽  
Neurokinin A ◽  
Phase 2 ◽  
Phase 3

In view of bronchoconstrictor and proliferative effects of tachykinins (TKs; mainly substance P and neurokinin A), as well as increased TK release during tissue injury, we hypothesized that monocrotaline (MCT)-induced ventilatory dysfunction and pulmonary hypertension may be mediated via TKs. In phase 1 of the study (n = 19 rats), we tested and found that elevated lung substance P level and suppressed neutral endopeptidase activity occurred 1–2 wk post-MCT (60 mg/kg sc). Both phase 2 (n = 32) and phase 3 (n = 32) young Sprague-Dawley rats were divided into five groups: control, sham, capsaicin, MCT, and capsaicin + MCT. Rats in the control group received no treatment. Each sham rat received the vehicles. Chronic capsaicin treatment was used to deplete neuropeptides. Each MCT rat received a single injection of MCT 1 wk (phase 2) or 3 wk (phase 3) before the functional study. Each capsaicin + MCT rat received the MCT administration 3 days after the completion of capsaicin pretreatment. In the MCT group, there were significant decreases in dynamic compliance, quasi-static compliance, and the maximal expiratory flow rate at 50% total lung capacity in phase 2, which was accompanied by significant increases in pulmonary arterial pressure, the weight ratio of right ventricle/(left ventricle + septum), and the arterial medial wall thickness in phase 3. In the capsaicin + MCT group, however, all the above MCT-induced changes were significantly attenuated or abolished. All values from the sham and capsaicin groups were not significantly different from those of the control group. These data demonstrate that MCT induces pneumotoxicity, accompanied by elevated levels of substance P in the lung.(ABSTRACT TRUNCATED AT 250 WORDS)

scholarly journals Study of induction of Tolerance to Oral Peanut: a randomised controlled trial of desensitisation using peanut oral immunotherapy in children (STOP II)

2014 ◽  
Vol 1 (4) ◽  
pp. 1-56 ◽  
Author(s):  
Katherine Anagnostou ◽  
Sabita Islam ◽  
Yvonne King ◽  
Loraine Foley ◽  
Laura Pasea ◽  
...  
Keyword(s):  
Peanut Allergy ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Phase 1 ◽  
Oral Immunotherapy ◽  
Peanut Protein ◽  
Control Group ◽  
Phase 2 ◽  
Daily Ingestion ◽  
Randomised Controlled

BackgroundPeanut allergy is a common disease that causes severe and fatal food allergic reactions. Currently, the best treatment is avoidance as repeated reactions can occur. Quality of life (QoL) is reduced by fear of severe reactions and social limitations. Oral immunotherapy (OIT) is a novel treatment that may be an effective treatment for peanut allergy.ObjectivesTo determine the efficacy of peanut OIT in children.DesignA phase 2 randomised, controlled, crossover trial (open label).SettingSingle UK centre study.ParticipantsChildren aged 7–15 years with peanut allergy diagnosed by double-blind, placebo-controlled food challenge (DBPCFC). No children were excluded because of anaphylaxis or asthma.InterventionsDaily immunotherapy (2 mg, 5 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg of peanut protein) was administered as peanut flour (containing 50% peanut protein). Doses were increased at 2-weekly intervals to a maintenance dose of 800 mg of protein. The control group underwent peanut avoidance for 6 months during phase 1.Main outcome measureA peanut DBPCFC up to 1400 mg of peanut protein was performed in both groups at 6 months. The highest amount of peanut tolerated was the main outcome measure.RandomisationRandomised by online audited system to active or control group (1 : 1).BlindingThe intervention arm allocation was not blinded.MethodsWe assigned 99 participants aged 7–16 years with peanut allergy of all severities to active OIT or control (peanut avoidance/current standard of care). The primary outcome was desensitisation, defined as negative peanut challenge (1400 mg of protein DBPCFC) at 6 months (phase 1). Control participants underwent OIT during phase 2, followed by DBPCFC. Immunological parameters and disease-specific QoL scores were measured.ResultsThe primary outcome, desensitisation, was observed in 62% (24/39) of the active group and none (0/46) of the control group after phase 1 [95% confidence interval (CI) 45% to 78% vs. 0% to 9%;p < 0.001]; 84% (95% CI 70% to 93%) of the active group tolerated daily ingestion of 800 mg of protein (≈ five peanuts). Median increase in peanut threshold after OIT was 1345 mg (range 45–1400 mg;p < 0.001) or 2.5-fold (range 1.82–280-fold;p < 0.001). After phase 2, 54% (95% CI 35% to 72%) tolerated a 1400-mg challenge (≈ 10 peanuts) and 91% (95% CI 79% to 98%) tolerated a daily ingestion of 800 mg of protein. QoL scores improved (decreased) after OIT (median change –1.61;p < 0.001). Side effects were mostly mild with gastrointestinal symptoms being the most common: oral pruritus occurred after 6.3% of doses, wheeze occurred after 0.41% of doses (one-fifth of participants) and intramuscular epinephrine was required after 0.01% of doses (one participant).ConclusionIn children with peanut allergy of any severity, OIT successfully induced desensitisation in the majority, with a clinically meaningful increase in peanut threshold. QoL improved after intervention and there was a good safety profile. Immunological changes reflected clinical desensitisation. Peanut OIT should not be undertaken in non-specialist settings. Future work will include a phase 3 confirmatory study and studies of long-term tolerance; similar studies of other allergens are also required.Trial registrationCurrent Controlled Trials ISRCTN62416244.FundingThis project was awarded by the Efficacy and Mechanism Evaluation programme and is funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC–NIHR partnership, and jointly sponsored by the University of Cambridge and Addenbrooke’s Hospital [Cambridge University Hospital Foundation Trust (RD authorisation A091686)]. The project will be published in full inEfficacy and Mechanism Evaluation; Vol. 1, No. 4. See the NIHR Journals Library website for further project information.

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