The Evolution of the Use of Extracorporeal Membrane Oxygenation in Respiratory Failure

Extracorporeal membrane oxygenation (ECMO) has been used with increasing frequency to support patients with acute respiratory failure, most commonly, and severe forms of acute respiratory distress syndrome (ARDS). The marked increase in the global use of ECMO followed the publication of a large randomized trial in 2009 and the experience garnered during the 2009 influenza A (H1N1) pandemic, and has been further supported by the release of a large, randomized clinical trial in 2018, confirming a benefit from using ECMO in patients with severe ARDS. Despite a rapid expansion of ECMO-related publications, optimal management of patients receiving ECMO, in terms of patient selection, ventilator management, anticoagulation, and transfusion strategies, is evolving. Most recently, ECMO is being utilized for an expanding variety of conditions, including for cases of severe pulmonary or cardiac failure from coronavirus disease 2019 (COVID-19). This review evaluates modern evidence for ECMO for respiratory failure and the current challenges in the field.

Using infographics to improve trust in science: a randomized pilot test

Objective This study describes the iterative process of selecting an infographic for use in a large, randomized trial related to trust in science, COVID-19 misinformation, and behavioral intentions for non-pharmaceutical prevenive behaviors. Five separate concepts were developed based on underlying subcomponents of ‘trust in science and scientists’ and were turned into infographics by media experts and digital artists. Study participants (n = 100) were recruited from Amazon’s Mechanical Turk and randomized to five different arms. Each arm viewed a different infographic and provided both quantitative (narrative believability scale and trust in science and scientists inventory) and qualitative data to assist the research team in identifying the infographic most likely to be successful in a larger study. Results Data indicated that all infographics were perceived to be believable, with means ranging from 5.27 to 5.97 on a scale from one to seven. No iatrogenic outcomes were observed for within-group changes in trust in science. Given equivocal believability outcomes, and after examining confidence intervals for data on trust in science and then the qualitative responses, we selected infographic 3, which addressed issues of credibility and consensus by illustrating changing narratives on butter and margarine, as the best candidate for use in the full study.

Hyperbaric Oxygen Therapy for Carbon Monoxide-Induced Delayed Neuropsychiatric Sequelae: Case Report of Two Cases and Relevant Literature Review

We herein report two cases with carbon monoxide- (CO-) induced delayed neuropsychiatric sequelae (DNS) successfully treated with hyperbaric oxygen therapy (HBOT) in attempt suicide by charcoal burning. The two patients with CO-induced DNS were successfully treated with a total of more than 100 sessions of HBOT. Frontal assessment battery (FAB) was useful to examine the effectiveness of HBOT objectively. In the future study, a large-randomized trial is required to establish the efficacy of HBOT for the treatment of DNS.

Implementation Monitoring of a Promotora-Led, Home-Based Obesity Prevention Pilot Study With Latino Preschool Children and Their Mothers

Background Latino preschool children have higher rates of obesity than children from other racial/ethnic backgrounds. Few effective, culturally-tailored obesity prevention interventions exist that have focused on Latino preschool children, and even fewer have published results of the process evaluation. The purpose of this paper was to monitor reach, fidelity, and completeness of implementation to determine whether ANDALE, a promising promotora-led, home-based pilot study to prevent obesity in Latino preschool children, was implemented as planned. Methods Guided by a logic model, we assessed reach, implementation fidelity and completeness through descriptive analyses of multiple data sources. Reach was assessed through attendance records. Fidelity was assessed via observation checklist and completeness was assessed via survey with both parents and promotoras in a subsample of 12 families. Results Promotoras recruited participants primarily through their own social networks and delivered the intervention to 50 families (mother-child dyads); the majority were of Mexican-origin, low-acculturation, dual-parent households. Nearly all (98%) families completed the whole 10-week intervention. Results demonstrated completeness and fidelity of implementation were acceptable in a subsample of 12 families. In sum, 75% of families in the subsample met the criteria (≥75%) for overall implementation of essential program elements (i.e., reach, completeness, and fidelity). Conclusion Evidence suggests that ANDALE was delivered with high levels of completeness and fidelity in this sample of Latino families with preschool-aged children. These results support implementation of ANDALE in a large, randomized trial.

Investigating modifications to participant information materials to improve recruitment into a large randomized trial

Background Large randomized trials are the best method to test the efficacy and safety of treatments expected to have moderate effects. We observed a significant decline in potential participants’ response to mailed invitations to participate in such trials over a 10-year period and investigated possible reasons behind this and potential modifications to the invitation process to mitigate it. Methods Participants who declined to participate in the HPS2-THRIVE trial were asked to give a reason. Formal focus groups were conducted to explore the reasons that potential participants might have for not participating. In addition, two embedded randomized comparisons around the timing of provision of the full participant information leaflet (PIL) and its style were conducted during recruitment into this large randomized trial. HPS2-THRIVE is registered at ClinicalTrials.gov (NCT00461630). Results The commonest reason given for declining invitations related to mobility and transportation (despite the offer of travel expenses). Both the focus groups and potential participants who declined their invitation indicated concern about side-effects of the treatment (as presented in the PIL) as a reason for declining the invitation. Neither delaying provision of the full PIL until the potential participant attended the trial clinic, nor modifying the style of the PIL improved the proportion of potential participants entering the trial: odds ratio (OR) 1.05 (95% confidence interval (CI) 0.94–1.17) and 1.10 (95% CI 0.94–1.28), respectively. However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03–1.33). Conclusions Many reasons given for not participating in trials are not tractable to individual trials. However, modification of the PIL does show potential to modestly improve participation. If further trials could identify similar simple interventions that were beneficial, their net effects could substantially improve trial participation and facilitate recruitment into large trials.

Digoxin–mortality: randomized vs. observational comparison in the DIG trial

Aims The Digitalis Investigation Group (DIG) trial, the only large randomized trial of digoxin in heart failure, reported a neutral effect on mortality and a significant reduction in heart failure hospitalizations. Recent observational studies reported increased mortality with digoxin treatment. We present further analyses of the DIG trial displaying the inability to control bias in observational treatment comparisons despite extensive statistical adjustments. Methods and results Forty-four percent of the 6800 patients in the DIG trial had been treated with digoxin before randomization, and half of them were randomly withdrawn from digoxin treatment. We contrast the main randomization-based result of the DIG trial with the observational non-randomized comparison of patients pre-treated or not pre-treated with digoxin. Mortality [hazard ratio (HR) 1.22, 95% confidence interval (CI) 1.12–1.34; P < 0.001] and heart failure hospitalizations (HR 1.47, 95% CI 1.33–1.61; P < 0.001) were significantly higher in patients pre-treated with digoxin even after adjustment for baseline population differences. The higher risks for both outcomes in those who had previously received digoxin persisted even if they received placebo during the trial (HR 1.24, 95% CI 1.10–1.40; P < 0.001). This sharply contradicts the neutral effect on mortality and the significant reduction in heart failure hospitalizations observed in the randomized comparison. Conclusion Prescription of digoxin is an indicator of disease severity and worse prognosis, which cannot be fully accounted for by covariate adjustments in the DIG trial where patients were well-characterized. It is unlikely that weaker research approaches (observational studies of administrative data or registries) can provide more reliable estimates of the effects of cardiac glycosides.

Classroom Pivotal Response Teaching: Teacher Training Outcomes of a Community Efficacy Trial

Classroom Pivotal Response Teaching (CPRT) is a naturalistic behavioral intervention for students with autism spectrum disorder (ASD) that was systematically adapted for teacher use. In this study, the authors evaluate outcomes of a large randomized trial training teachers ( n = 126) to use CPRT. Training involved 12 hours of small group sessions and additional 1:1 coaching in each teacher’s classroom. Overall, CPRT fidelity was significantly higher at the end of the training year relative to the observation year ( B = 0.24, p = .001) and teachers report using CPRT an average of 47 minutes per day. Moderator analyses indicate that training, teacher, and classroom- and school-level characteristics affected CPRT fidelity. Teachers report high overall satisfaction ( M = 4.37, SD = 0.45; 1-5 Likert-type scale) and confidence in their ability to use CPRT with their students ( M = 4.2, SD = 0.57). In this study, the authors indicate the acceptability and feasibility of the CPRT training protocol and adds to the limited number of school-based randomized controlled trials (RCTs) evaluating interventions for students with ASD.