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Background | diaphragmatic dysfunction | Few specific methods are available to reduce the risk of diaphragmatic dysfunction for patients under mechanical ventilation. The number of studies involving transcutaneous electrical stimulation of the diaphragm (TEDS) is increasing but none report results for diaphragmatic measurements, and they lack power. We hypoth... | PMC10469422 | |
Methods | diaphragm dysfunction, extubation failure, cough | We conducted a controlled trial to assess the impact of daily active electrical stimulation versus sham stimulation on the prevention of diaphragm dysfunction during the weaning process from mechanical ventilation. The evaluation was based on ultrasound measurements of diaphragm thickening fraction during spontaneous b... | PMC10469422 | |
Results | DIAPHRAGM | Sixty-six patients were included and randomised using a 1:1 ratio. The mean number of days of mechanical ventilation was 10 ± 6.8. Diaphragm thickening fraction was > 30% at the SBT for 67% of participants in the TEDS group and 54% of the Sham group (OR1.55, 95% CI 0.47–5.1; | PMC10469422 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s13054-023-04597-1. | PMC10469422 | ||
Keywords | PMC10469422 | |||
Background | muscle weakness, involuntary muscle contractions | MUSCLE WEAKNESS | Inspiratory muscle weakness is caused by the suppression of respiratory muscle activity by sedative agents and mechanical ventilation, as well as other inflammatory mechanisms [Neuromuscular electrical stimulation can be used to maintain muscle thickness and strength and has the advantage of not requiring cooperation s... | PMC10469422 |
Method | PMC10469422 | |||
Design and recruitment | cutaneous lesion | MUSCLE WEAKNESS, PATHOLOGY | We conducted a single centre, double-blind randomised controlled trial with intention to treat analysis in our 18 bed ICU at Le Havre Hospital in France. We recruited consecutive individuals with a diagnosis that did not involve covid-19, who were admitted to our ICU between December 2019 and July 2022. The inclusion c... | PMC10469422 |
Procedure | muscle contractions, CM | CONTRACTION, BLIND | The medical, paramedical and physiotherapist teams involved in the care and decision to wean the patient from mechanical ventilation were not aware of the participant’s group allocation. Each morning, after the daily assessment for contraindications to transcutaneous electrical stimulation and diaphragm thickness measu... | PMC10469422 |
Measures | PMC10469422 | |||
Primary aim | diaphragmatic dysfunction | DYSFUNCTION | Every morning, between 10 and 11 a.m., we used the Philips CX 50 ultrasound machine with a linear probe (5–12 MHz) to measure diaphragm thickness. The probe was placed perpendicular to the skin in the zone of apposition between the mid-axillary or antero-axillary line, in the 8th to 11th intercostal spaces. We measured... | PMC10469422 |
Secondary aims | PMC10469422 | |||
Respiratory muscle evaluation | cough, CM, ® | BLIND | The blind assessors (CM and YC) monitored daily changes in end-tidal thickness of the right hemidiaphragm from the day of inclusion until extubation using a high frequency (13 MHz) linear transducer over the apposition zone to monitor diaphragm thickness. Maximum inspiratory pressure (MIP) and cough peak expiratory flo... | PMC10469422 |
Characteristics and clinical outcomes | death, SBT failure, illness, extubation failure | EVENTS | At admission, we collected demographic data, comorbidities, primary cause of admission and severity of illness by Simplified Acute Physiology Score (SAPS 2) and Sequential Organ Failure Assessment (SOFA). Each day we collected ventilator setting, administration of neuromuscular blockers or sedative drugs and Ramsay sed... | PMC10469422 |
Statistical analysis | REGRESSION | Based on the results of the studies with the most robust methodology [Baseline data for both groups were summarised using means and standard deviations for continuous variables and absolute and relative frequencies for categorical data. We performed a chained equation multiple imputation with 20 imputed datasets for mi... | PMC10469422 | |
Discussion | diaphragm dysfunction, cough | ADVERSE EFFECTS | This study is the first to compare the use of transcutaneous electrical stimulation of the diaphragm with a sham intervention on diaphragm function in intubated and ventilated patients in the ICU. We found that: (1) TEDS did not significantly decrease the risk of diaphragm dysfunction; (2) both groups had similar decre... | PMC10469422 |
Conclusion | diaphragm dysfunction, critically ill | CRITICALLY ILL, MUSCLE ATROPHY | This study is the first to investigate the effect of TEDS on diaphragm function in ventilated critically ill patients and to compare it with a sham intervention. TEDS did not prevent diaphragm dysfunction or muscle atrophy. Clinically important outcomes were not better with TEDS. Further studies are warranted to addres... | PMC10469422 |
Acknowledgements | The authors thank Johanna Robertson for translation and critical review. | PMC10469422 | ||
Take home message | diaphragm dysfunction | Transcutaneous electrical stimulation of the diaphragm in mechanically ventilated patients in ICU did not significantly decrease the risk of diaphragm dysfunction or optimise weaning from mechanical ventilation and extubation success rate. | PMC10469422 | |
Author contributions | MC, GP and YC designed the study. MC, MM, GP and YC collected data. All authors performed the analysis and interpretation of data. MC, MM, GP and YC wrote the main manuscript. All authors critically revised the manuscript for important intellectual content. RH performed the statistical analysis. | PMC10469422 | ||
Funding | Not applicable. | PMC10469422 | ||
Availability of data and materials | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10469422 | ||
Declarations | PMC10469422 | |||
Ethics approval and consent to participate | Ethical approval was granted by the French Comité de Protection des Personnes Ile de France X (38-19). All participants or their relatives provided written informed consent for participation. | PMC10469422 | ||
Consent for publication | Not applicable. | PMC10469422 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10469422 | ||
References | PMC10469422 | |||
Taher Abofol | cognitive asymmetries | received his PhD in cognitive science from the Faculty of Data and Decision Sciences at the Technion. His research interests revolve around decision-making, learning, and behavioral economics. His main contributions are in the study of cognitive asymmetries arising from different incentive structures and individual dif... | PMC10543786 | |
Ido Erev | EVENTS | is the Women’s Division – ATS Academic Chair in the Faculty of Data and Decision Sciences at the Technion. His research highlights a robust description-experience gap: people exhibit oversensitivity to rare events when they decide based on a description of the incentive structure, but experience reverses this bias and ... | PMC10543786 | |
Raanan Sulitzeanu-Kenan | human behavior | is an associate professor of political science and public policy in the Federmann School of Public Policy at Hebrew University. His studies address human behavior in the contexts of public organizations, politics, and law; he has published articles in the This research provides evidence regarding the causal effect of g... | PMC10543786 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s12110-023-09454-2. | PMC10543786 | ||
Keywords | ROTH | What is the causal effect of conformity on the performance and adaptability of groups? Despite the number of studies devoted to conformity since Asch’s (Although these theoretical predictions have received some support from empirical studies, they provide only tentative and partial support for their key propositions. T... | PMC10543786 | |
Experimental Design | ROTH | We utilize an experience-based decision-making task (Erev & Roth, To test our hypotheses, we employ one of the games used by Lejarraga et al. (Two hundred and forty university students participated in the study. Participants were randomly assigned to the The temporal change in the environment was simulated by implement... | PMC10543786 | |
Procedure | Participants assigned to the individual condition were provided with asocial information only in the form of their payoff for each decision round. In the two group conditions, participants were provided with both asocial information (decision payoff) and implicit social information. They inferred the latter from whethe... | PMC10543786 | ||
Statistical Analysis | To identify the effect of conformity on performance in a temporally varying environment, we estimate the interaction effect of change and conformity on performance. Equation 1 presents this relationship:
where | PMC10543786 | ||
Results | PMC10543786 | |||
Assessing the Validity and Efficacy of the Conformity Treatment | We begin by assessing the validity and efficacy of our conformity treatment. To assess the efficacy of the conformity treatment at the group level, we compare the propensity for minority opinions within group decisions in the LoConf group and HiConf group conditions. The proportion of group decisions involving the mino... | PMC10543786 | ||
Descriptive Results | Figure
The probability of choosing the maximizing choice before and after the change (round = 61) and across conditions (blue: individual; red: LoConf group; green: HiConf group). The vertical dashed red line indicates the point of change in the gameTable
Average probabilities of correct choice | PMC10543786 | ||
Generalized Estimating Equation Results | To formally estimate the varying effect of environmental change on performance across group conformity levels, we conducted a set of generalized estimating equation (GEE) analyses, reported in Table
Generalized estimation equation (GEE) analyses of group performanceCoefficients represent logit estimates. Group cluster... | PMC10543786 | ||
Individual Level Within-Group Mechanism | EVENT | In order to obtain a better understanding of the group-level results, we conducted a set of (within-group) individual-level analyses, to estimate the role of social information—holding a minority opinion—in determining the decisions of group members: namely, whether they change their choice in the subsequent round. Fol... | PMC10543786 | |
Discussion | This research provides evidence regarding the causal effect of conformity on group performance in stable and variable environments. Drawing on studies in the evolution of culture and the social transmission of information (Boyd & Richerson, Our experimental design builds on the works of Rakow and Miler (The results do ... | PMC10543786 | ||
Acknowledgements | We are grateful to Reut Blaywais, Yuval Berger, Itamar Faran, Micha Mandel, Sarah Roost, and Omer Yair for helpful suggestions and comments on previous versions of this article. | PMC10543786 | ||
Declarations | PMC10543786 | |||
Conflict of Interest | The authors declare that they have no conflict of interest. | PMC10543786 | ||
References | PMC10543786 | |||
Subject terms | autism | Early supports to enhance social development in children with autism are widely promoted. While oxytocin has a crucial role in mammalian social development, its potential role as a medication to enhance social development in humans remains unclear. We investigated the efficacy, tolerability, and safety of intranasal ox... | PMC9607840 | |
Introduction | lifelong social behavior, impairments in social communication, Autism spectrum disorder, repetitive behaviors, autism | RECRUITMENT | Autism spectrum disorder (autism) is a neurodevelopmental condition characterized in the DSM-V by impairments in social communication and interaction, and the presence of stereotypical and repetitive behaviors [Oxytocin is a crucial regulatory hormone to both early life social learning and lifelong social behavior [Thi... | PMC9607840 |
Materials and methods | PMC9607840 | |||
Study design | RECRUITMENT, BRAIN | Patients were enrolled in a double-blind, randomized controlled, placebo lead-in, multi-site trial of oxytocin nasal spray and an identical placebo across four assessment time points (wk 0 baseline, wk 3 post-placebo lead in, wk 15 post randomized treatment, wk 27 follow-up assessment). The study was conducted at the B... | PMC9607840 | |
Participants | Autism, Autism Spectrum Disorder, DSM-5, autism | Children aged between 3 and 12 years of age who met DSM-5 criteria for Autism Spectrum Disorder were recruited. Children aged between 3–12 were recruited to the BMC, while children aged 3–6 were recruited to TKI. This decision was based on available funding provided to each site. Participants were recruited through adv... | PMC9607840 | |
Medication | Pfeiffer | PFEIFFER | Oxytocin nasal spray consisted of 8IU each spray per nostril morning and night; 32IU per day). The placebo spray included all of the same ingredients except oxytocin. All sprays contained sorbitol (2%), glycerol (2%), benzyl alcohol as preservative, and distilled water, within an amber 8 ml glass nasal spray with meter... | PMC9607840 |
Assessment schedule | A schedule of assessments conducted at each visit is provided in Supplementary Table | PMC9607840 | ||
Medication schedule and adverse event reporting | ADVERSE EVENTS | Instructions were provided to caregivers on site during drug allocation visits (Wk 0 and 3) consistent with our previous published guidelines [Monitoring of potential adverse events was by telephone during mid-intervention for the treatment phase (i.e., wk 9) and at treatment completion (wk 15). Caregivers (and the chi... | PMC9607840 | |
Primary and secondary outcome measures | PMC9607840 | |||
Primary outcomes | The first primary outcome measure was the caregiver-completed Social Responsiveness Scale, Second Edition (SRS-2) [ | PMC9607840 | ||
Secondary outcomes | Repetitive Behavior Scale-Revised | Secondary caregiver-completed outcomes measures included the Repetitive Behavior Scale-Revised (RBS-R) [ | PMC9607840 | |
Statistical analyses | SECONDARY, SENSITIVITY | Data were managed using REDCap [Within the participants who were included in the modified intention-to-treat analysis (Analysis of primary and secondary outcomes were conducted on the modified intention-to-treat population and were based on a 2 (Drug; Oxytocin, Placebo) x 4 (Time; baseline wk 0, post-placebo lead in wk... | PMC9607840 | |
Results | PMC9607840 | |||
Participants | Participants were recruited to each site between April 2017 and February 2020. Caregivers of 331 children expressed interest in this trial. Due to logistical reasons and restraints, the time period for being enrolled in this trial was limited, which impacted on our ability to assess large numbers of participants for el... | PMC9607840 | ||
Primary outcomes | PMC9607840 | |||
Primary outcome 1 – social responsiveness scale (SRS-2) total score | For SRS-2 Total scores, there was no main effect of treatment condition ( | PMC9607840 | ||
Plotting mean scores on the primary outcome measure (Social Responsiveness Scale-2) separately for younger and older children. | Error bars represent 95% confidence intervals.To further break down this interaction, we used individual repeated measures ANOVAs to look at differences between visits (V1 and V3, V1 and V4) between the oxytocin and placebo conditions separately for each age group. Considering first the 3–5 year age group, there was a ... | PMC9607840 | ||
Primary outcome 2 – clinician global impression–improvement | Considering the second primary outcome, the CGI, there were no significant main effects for time or treatment condition on overall improvement (There was no significant three-way interaction between time, treatment condition and age group on the CGI for overall improvement ( | PMC9607840 | ||
Secondary outcomes | SECONDARY | Overall, there were no significant effects of treatment condition, or interactions between treatment condition, time and age group across the duration of the trial for any total scores of secondary outcomes. | PMC9607840 | |
Clinical data | Figure | PMC9607840 | ||
SRS-2 Total scores at Visit 1 (Baseline) and Visit 3 (Post-treatment). | The solid diagonal line represents ‘line of no change’ and the dotted lines represent upper and lower Reliable Change Index (RCI) confidence limits. Test-retest reliability = 0.84; s.d. for baseline = 25.47.Inspection of the figure shows that, within the younger age group, 94.4% (17/18) of participants fell at or on th... | PMC9607840 | ||
Treatment guess | At Visit 3 (post-treatment) caregivers were asked to guess whether their child had received oxytocin or placebo for the duration of the treatment (see Table Treatment Guesses in whole sample ( | PMC9607840 | ||
Discussion | autistic, autism | ADVERSE EVENTS | The results of this study showed there was no overall benefit of oxytocin treatment for children with autism. Despite this, there was some evidence to suggest that younger children showed greater improvements on social responsiveness at the end of oxytocin treatment, in comparison to placebo. There was no evidence of a... | PMC9607840 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41380-022-01845-8. | PMC9607840 | ||
Acknowledgements | We would like to thank the staff and students who assisted in the collection of data and the children and families who gave their time to the completion of this research. We thank statistician Caro Badcock for the independent statistical plans, data monitoring, and review of all conducted analysis. We also thank the da... | PMC9607840 | ||
Author contributions | Authors AJG, AJOW, IBH, and SGG were involved in the conception and the design of the study, authors AJG, AJOW, YJS, SGG, and IBH were involved in the development of the initial protocol and ethics submission, authors AJG, AJOW YJS, RT, IP, JG, MMD, ZA, JW, EET, and IBH collected trial data, authors AJG and KAB analyse... | PMC9607840 | ||
Funding | This study was supported by the National Health and Medical Research Council (1043664) and the Bupa Health Foundation independent research grants program. Open Access funding enabled and organized by CAUL and its Member Institutions. | PMC9607840 | ||
Competing interests | depression, Psychosis, anxiety | BRAIN | Author AJG has received contracted funding for his team to conduct sponsored clinical trials. He has not received personal financial benefits from this contracted work. Professor Ian Hickie was an inaugural Commissioner on Australia’s National Mental Health Commission (2012-18). He is the Co-Director, Health and Policy... | PMC9607840 |
References | PMC9607840 | |||
Introduction: | deaths | ACUTE PANCREATITIS, DISEASE, ACUTE PANCREATITIS, COMPLICATIONS | Acute pancreatitis is a high-incidence benign disease. In 2009, it was the second highest cause of total hospital stays, the largest contributor to aggregate costs (approximately US$ 7000.00 per hospitalization), and the fifth leading cause of in-hospital deaths in the United States. Although almost 80% of acute pancre... | PMC10194650 |
Methods: | ACUTE PANCREATITIS | This will be a multicenter open-label randomized (1:1) controlled clinical trial to assess the efficacy and safety of home monitoring compared to in-hospital care for mild acute pancreatitis. All patients coming to the emergency department with suspected acute pancreatitis will be screened for enrollment. The main vari... | PMC10194650 | |
Discussion: | ACUTE PANCREATITIS, DISEASE, ACUTE PANCREATITIS | Acute pancreatitis implies a high economic burden in healthcare systems worldwide. Recent evidence suggests that mild disease can be safely and effectively treated with home monitoring. This approach may produce considerable cost savings and positively impact patients’ quality of life. We expect the results to show tha... | PMC10194650 | |
1. Introduction | PMC10194650 | |||
1.1. Background | nonalcoholic | ACUTE PANCREATITIS, DISEASE, ACUTE PANCREATITIS, COMPLICATIONS | Acute pancreatitis (AP) is a high-incidence benign disease. In the United States, the estimated annual incidence ranges from 110 to 140 cases/100,000 peopleSevere AP can be quite challenging, usually requiring long-term hospitalizations, intensive care, and/or surgical treatment. Fortunately, almost 80% of APs are mild... | PMC10194650 |
1.2. Working hypotheses and objectives | AP-related complications | SECONDARY | The current study protocol has 2 working hypotheses:home monitoring is effective and safe for managing mild AP.home monitoring is not inferior to hospitalization for managing mild AP.Our main objective is to assess the efficacy of home monitoring compared to in-hospital care for mild AP.Our secondary objectives are:To ... | PMC10194650 |
2. Methods | PMC10194650 | |||
2.1. Study design | nausea or, pain, vomits, abdominal pain | ACUTE PANCREATITIS | This will be a multicenter open-label pilot randomized controlled clinical trial to assess the safety, efficacy, and non-inferiority of home monitoring compared to in-hospital care for mild AP. Patients will be randomly assigned (1:1) to either the home monitoring (experimental) group or the in-hospital (control) group... | PMC10194650 |
2.2. Settings | This multicenter study will be carried out at the following medical centers:Hospital Univeritari de Bellvitge;Consorci Corporació Sanitària Parc Taulí de Sabadell;Hospital Sant Joan Despí Moises Broggi—Consorci Sanitari Integral;Hospital de Viladecans;Hospital Hospital de Igualada - Consorci Sanitari de l’Anoia;Hospita... | PMC10194650 | ||
2.3. Eligibility criteria | Patients who meet all inclusion criteria and none of the exclusion criteria will be included in the RHINO-trial. | PMC10194650 | ||
2.3.1. Inclusion criteria. | vomiting, AP-related complications, pain | SYSTEMIC INFLAMMATORY RESPONSE, BLOOD | Adult patients (≥18 and ≤80 years of age);Both sexes;Diagnosed with mild AP by at least 2 of the following 3 criteria:Abdominal pain;Plasma/urine amylase or lipase levels ≥ 3× upper limit of normal;Imaging tests (Abdominal ultrasound/ computerized tomography scan) showing signs of AP.Lack of potential severity criteria... | PMC10194650 |
2.3.2. Exclusion criteria. | chronic pulmonary disease, cirrhosis, chronic kidney disease, pancreatic disease | ACUTE MYOCARDIAL INFARCTION, HYPERBILIRUBINEMIA, CIRRHOSIS, PANCREATIC DISEASE, CHRONIC PULMONARY DISEASE | Past medical history of pancreatic disease such as:Known or Recurrent AP (>3 flare-ups/year).Previous AP flare-up within 1 month.AP after endoscopic retrograde cholangiopancreatography.Hyperbilirubinemia > 3× upper limit of normal.Past medical history of acute myocardial infarction, cirrhosis, chronic kidney disease, a... | PMC10194650 |
2.4. Interventions and criteria for discontinuing allocated interventions | PMC10194650 | |||
2.4.1. Home monitoring group. | COMPLICATIONS | Patients randomized to this group will be discharged and monitored through homecare. They will be prescribed an easy-digestion diet plan and oral analgesics. A face-to-face visit will be performed for all patients 24 hours after randomization (Time 3) by both a nurse and a physician from the Homecare Department. If the... | PMC10194650 | |
2.4.2. In-hospital group. | a lithiasic pancreatitis | Patients randomized to this group will be admitted under the care of physicians from the Digestive and General Surgery Department or the Gastroenterology Department. Patients will be visited daily during admission and will be discharged according to their clinical evolution; however, they will remain at in-hospital car... | PMC10194650 | |
2.4.3. Criteria for discontinuing allocated interventions. | Patients allocated to the home monitoring group will be discontinued if their clinical status worsens and they require further admission. We will also discontinue patients who request to be withdrawn from the study and those who fail to comply with study-related procedures. | PMC10194650 | ||
2.7. Sample size | ADVERSE EVENTS | Previously published dataAn interim analysis (for safety purposes) will be performed when half the estimated sample size is included. A detailed report of all recorded adverse events will be provided to the Data Safety Monitoring Committee (DSMC). | PMC10194650 | |
2.8. Recruitment | Patients coming to the ER with suspected AP will be screened for enrollment. A study team member will evaluate them in the ER following the steps detailed in Figure | PMC10194650 | ||
2.9. Allocation (sequence generation, concealment, implementation) and blinding | Patients will be randomly allocated to either the experimental or the control group following a parallel group design and a 1:1 allocation ratio. A total of 308 opaque envelopes (154 for the experimental group and 154 for the control group) will be prepared prior to the study start. The envelopes will be stored in a se... | PMC10194650 | ||
2.10. Data collection plan | pain, illness, anxiety/depression, Comorbidity | Patients’ data will be gathered through clinical interview, clinical examination, and by reviewing the electronic medical records and the Participant Diary (provided to each participant after randomization).We will gather information on:Baseline characteristics: age, sex, recruiting hospital, body mass index, and the A... | PMC10194650 | |
2.11. Plans to promote participant retention and complete follow-up | EVENT | Follow-up will be performed either at homecare or during hospital admission. Notably, patients will be required to attend to the outpatient clinic 5 to 7 days after being discharged from the emergency department (as a safety measure); however, we do not think this will imply a considerable extra-effort that would preve... | PMC10194650 | |
2.12. Data management | An electronic case report form (eCRF), based on REDCap platform (REDCap Consortium), will be created Before closing the database for analysis, the data manager and the principal investigator will check the completeness and accuracy of the recorded data. | PMC10194650 | ||
2.13. Statistical methods | Considering this is a pilot study, analyses will be primarily performed in the per protocol population; however, we will also perform intention-to-treat analyses whenever feasible. We will perform a general descriptive analysis of all study variables. The results will be expressed as means (standard deviation [SD]) or ... | PMC10194650 | ||
2.14. Data monitoring, description of any interim analyses and stopping guideline | A DSMC will be created As mentioned before, an interim analysis (for safety purposes) will be performed when half the estimated sample size is included. | PMC10194650 | ||
2.15. Harms | ADVERSE EVENTS, ADVERSE EVENT | Adverse events recorded during the study will be coded according to the latest available version of the MedDRA dictionary and will be described using absolute and relative frequencies by study group, according to severity and its causal relation with treatment.Serious adverse events will be described by study group and... | PMC10194650 | |
2.16. Auditing | The Investigator shall allow direct access to trial data and documents for monitoring, audits and/or inspections by competent regulatory or health authorities. As such, eCRFs, source records and other trial-related documentation must be kept current, complete, and accurate at all times. | PMC10194650 |
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