Group-randomized Controlled Trial Research Articles

Association Between Single-Dose and Longer Term Clinical Response to Stimulants in Attention-Deficit/Hyperactivity Disorder: A Systematic Review of Randomized Controlled Trials.

Objectives: Stimulants, such as methylphenidate (MPH) and amphetamines, represent the first-line pharmacological option for attention-deficit/hyperactivity disorder (ADHD). Randomized controlled trials (RCTs) have demonstrated beneficial effects at a group level but could not identify characteristics consistently associated with varying individual response. Thus, more individualized approaches are needed. Experimental studies have suggested that the neurobiological response to a single dose is indicative of longer term response. It is unclear whether this also applies to clinical measures. Methods: We carried out a systematic review of RCTs testing the association between the clinical response to a single dose of stimulants and longer term improvement. Potentially suitable single-dose RCTs were identified from the MED-ADHD data set, the European ADHD Guidelines Group RCT Data set (https://med-adhd.org/), as updated on February 1, 2024. Quality assessment was carried out using the Cochrane Risk of Bias (RoB) 2.0 tool. Results: A total of 63 single-dose RCTs (94% testing MPH, 85% in children) were identified. Among these, only a secondary analysis of an RCT tested the association between acute and longer term clinical response. This showed that the clinical improvement after a single dose of MPH was significantly associated with symptom improvement after a 4-week MPH treatment in 46 children (89% males) with ADHD. The risk of bias was rated as moderate. A further RCT used near-infrared spectroscopy, thus did not meet the inclusion criteria, and reported an association between brain changes under a single-dose and longer term clinical response in 22 children (82% males) with ADHD. The remaining RCTs only reported single-dose effects on neuropsychological, neuroimaging, or neurophysiological measures. Conclusion: This systematic review highlighted an important gap in the current knowledge. Investigating how acute and long-term response may be related can foster our understanding of stimulant mechanism of action and help develop stratification approaches for more tailored treatment strategies. Future studies need to investigate potential age- and sex-related differences.

Effects of Custom, Molded Foot Orthoses on Balance, Gait Speed, and Pain in Postmenopausal Osteoporotic Women: A Prospective Experimental Study

ABSTRACT Introduction Osteoporotic changes displace the center of pressure (COP) closer to the limits of stability, causing balance impairment and alteration of gait characteristics. Bone architecture destruction hinders the weight-bearing capacity of lower extremities, causing foot pain, redness, and swelling. Foot orthoses increase somatosensory input and shock absorption, thus improving balance, gait speed, and pain. Objectives The aim of this study was to evaluate and quantify the effects of custom-molded insoles on the balance, gait speed, and foot pain of postmenopausal osteoporotic women. Study Design This study is a parallel group randomized control trial. Methods A total of 44 postmenopausal osteoporotic women were recruited and randomized into two groups: experimental (EG) (n = 22) and control (CG) (n = 22). EG completed a 2-week intervention period with custom-molded insoles, whereas CG did not receive any intervention. Balance, gait speed, and foot pain were measured at baseline and after 2 weeks for both groups. Results The comparison of preintervention and postintervention outcomes for both groups highlighted that they were similar at baseline; however, EG showed significant improvement in all outcome measures after 2 weeks. Conclusions This study provides preliminary evidence that custom-molded insoles had a positive effect on the proprioceptive feedback of the lower limb, thus enhancing balance. The inclusion of a heel cup in the orthoses minimized the abnormal movement of the ankle that affected the mechanical stability of the lower limbs. Additionally, they increased the surface of contact, thus reducing the load per unit of surface, minimizing foot pain and discomfort. Clinical Relevance Osteoporotic falls and fractures have severe consequences and are a major public health concern; therefore, developing effective fall prevention strategies is crucial. Custom-molded insoles could help improve balance, gait speed, and pain, potentially reducing falls while also improving the quality of life for postmenopausal osteoporotic women.

Planning for the forgotten fourth trimester of pregnancy: A parallel group randomized control trial to test a postpartum planning intervention vs. standard prenatal care

BackgroundBlack and brown birthing people experience persistent disparities in adverse maternal health outcomes, partially due to inadequate perinatal care. The goal of this study is to design and evaluate a patient-centered intervention for obstetric patients with one or more cardiometabolic risk factors for severe maternal morbidity [gestational diabetes, diabetes mellitus, hypertensive disorders of pregnancy (chronic hypertension, preeclampsia, eclampsia, or gestational hypertension), or preconception obesity (BMI > 30)] to promote postpartum visit attendance. MethodsTo address identified unmet needs for postpartum support and barriers to postpartum care, we developed 20 thematic postpartum planning modules, each with corresponding patient educational materials, community resources, care coordination protocols, and clinician support tools (decision aids, electronic medical record prompts and fields). During prenatal care encounters, a research coordinator delivers the educational content (in English or Spanish), facilitates the participant's planning and shared decision-making, provides the participant with resources, and documents decisions in the electronic medical record. We will randomize 320 eligible patients with a 1:1 ratio to the intervention or standard prenatal care and evaluate the impact on postpartum visit attendance at 4–12 weeks and secondary outcomes (postpartum mental health, perceived future maternal and cardiometabolic risk, contraceptive use, primary care use, readmission, and patient satisfaction with care). DiscussionThrough engagement with patients and community stakeholders, we developed a guideline-based, locally tailored intervention to address drivers of engagement with postpartum care for high-risk obstetric patients. If demonstrated to be effective, the educational materials and electronic medical record based-tool can be adapted to other settings. Trial registrationThis trial was registered on ClinicalTrials.gov (NCT05430815) on June 23, 2022.

Feasibility, acceptability, and initial efficacy of a wheelchair exercise training program in persons with multiple sclerosis: study protocol for a parallel group randomized controlled trial

Purpose: This study is a randomized controlled trial (RCT) that examines the feasibility, acceptability, and initial efficacy of a home-based, remotely supported and supervised exercise training program that was developed using a three-step community engaged research process for persons with multiple sclerosis (MS) who are wheelchair users.Materials and Methods: The study design is a parallel group RCT (NCT05888727). We aim to enroll 24 wheelchair users with MS who will be randomly assigned using REDCap randomization module into exercise training or attention/contact wellness control conditions. The conditions will be delivered remotely over 16 weeks and supported using online, one-onone behavioral coaching. The feasibility outcomes of interest include recruitment and retention rates, and safety outcomes collected throughout the study period. The acceptability outcomes include participant satisfaction and perceptions measured using formative surveys and interviews following the 16-week period. Efficacy outcomes include metabolic health, MS symptoms, and exercise behavior measured before and after the 16-week period. The data analysis will follow intent-to-treat principles using 2 group by 2 time mixed factor ANOVA with estimation of Cohen’s d values as effect sizes.Conclusions: The results will guide future research targeting health outcomes using exercise training among wheelchair users with MS who have largely been absent from health promotion research.

A Suprapatellar approach, when compared to an Infrapatellar approach, yields less Anterior Knee Pain and better patellofemoral joint Function, for intramedullary nailing of diaphyseal tibial fractures. Results of a Randomised Controlled Trial.

To assess if a suprapatellar (SP) approach, when compared to an infrapatellar (IP) approach, yielded less patient reported anterior knee pain and higher patellofemoral joint function at 6 weeks and 12 months post operatively, when treating tibial fractures with intramedullary nailing. Prospective, parallel group randomized control trial. Tertiary level one trauma care centre, Brisbane, Australia. Skeletally mature patients with an acute diaphyseal tibial fracture (AO/OTA 41A2/3, 42 A1- 43A3) amenable to an IMN were included. Exclusion criteria were peri-prosthetic fractures, nonunions, and presence of a contralateral injury that would restrict weightbearing. Anterior knee pain, through the visual analogue scale (VAS) and patellofemoral function using the Kujala scale at 6-weeks and 12-months were compared between those treated with a SP and IP approach. 95 tibia fractures were included in the randomized trial, with complete follow-up data for 44 and 46 tibia fractures in the SP and IP groups, respectively. The SP cohort exhibited better patella-femoral knee function at both 6 weeks post operatively (Kajula 53.0 for SP vs 43.2 for IP, p<0.01)) and 12 months (Kujala 92.0 for SP vs 81.3 for IP (p<0.01)), and a reduction in anterior knee pain at 12-months post-operatively (VAS 0.7 SP vs 2.9 IP, p<0.01). This randomized trial demonstrated clinically meaningful differences in patellofemoral function, for a suprapatellar versus infrapatellar approach, with a greater than 10 point discrepancy in Kujala score at both 6 weeks and 12 months. Additionally, there was a clinically important difference in VAS knee pain scores for patients at 12 months, but not at 6 weeks, post operatively. These results contribute to the growing body of evidence demonstrating the functional and clinical benefits of the suprapatellar approach.

Mobile health biometrics to prescribe immediate remote physical activity for enhancing uptake to cardiac rehabilitation (MOTIVATE-CR+): protocol for a randomised controlled feasibility trial

IntroductionCardiac rehabilitation (CR) can reduce cardiovascular mortality and improve health-related quality of life. In the United Kingdom, patient uptake of CR remains low (52%), falling well short of the target...

Train to sustain: a randomised controlled trial evaluation of a vitality training employing behaviour-change techniques.

This paper reports on the effects of a 9-week vitality training that employed behaviour-change techniques and was evaluated using a randomised controlled trial (RCT) in three large companies based in the Netherlands. A total of 84 adult employees from three participating organisations in the Netherlands were enrolled in the study. A parallel group RCT design was employed and participants were assigned using individual random assignment to either an intervention (n = 38) or a waitlist control group (n = 46). The intervention consisted of a 9-week vitality training employing the behaviour-change techniques of self-persuasion, implementation intentions, and self-efficacy, which was delivered in-house over five fortnightly 2-hour sessions. Primary outcomes (i.e., reported energy and stress) and secondary outcomes (i.e., reported daily life satisfaction and work capacity) were assessed prior to, immediately after, and 3 months following the intervention. A mixed MANOVA revealed a significant interaction effect between treatment group and time period for the combination of reported energy, stress, daily life satisfaction, and work capacity. Subsequent univariate ANOVAs revealed significant interactions between treatment group and time period for reported energy, stress, and daily life satisfaction; however, not for reported work capacity. Improvements in outcomes were observed for both groups following their completion of the vitality training; however, not all improvements reached statistical significance. Reported self-efficacy regarding managing work-life balance was found to mediate the relationship between the effects of the intervention and reported energy; however, such an effect was not found for stress. An intervention drawing upon evidence-based behaviour-change techniques shows promise for improving indicators associated with burnout; although, it is recommended that in future research a larger-scale evaluation be conducted over a longer time period with an active control group to establish effectiveness.Clinical trial registration: https://www.anzctr.org.au/, ACTRN12622001268730.

The Fulfillment Center Intervention Study: Protocol for a group-randomized control trial of a participatory workplace intervention.

Warehousing and storage is an economically vital industry, with 1.2 million workers in 2020. The Fulfillment Center Intervention Study focuses on workers in fulfillment centers in the e-commerce segment of this industry. Fulfillment centers are a growing yet understudied work environment which provides a unique setting to further examine how working conditions and worker voice influence health. The Study involves a group-randomized controlled trial comparing participants in worksites randomized to launch the participatory intervention (Health and Well-Being Committees, or HaWCs) with participants working for the same firm in control sites. HaWCs serve as a new formal voice channel where a small group of frontline workers and supervisors solicit workers' concerns and ideas about safety (e.g., physical hazards), the psychosocial environment (e.g., how workers feel about their treatment at work), and work organization (e.g., workflow, training opportunities, scheduling) and then develop and implement improvement projects in response. The primary objectives of the study are to evaluate the efficacy of the HaWC intervention and its effect on mental health outcomes and changes in the conditions of work within fulfillment centers, and to conduct a process evaluation of key contextual factors that support effective intervention implementation and sustained engagement. To our knowledge, this will be the first trial of a participatory intervention within a fulfillment center setting. Anticipated challenges include competing demands and company initiatives that may limit management support and high turnover. Should the intervention be shown to be feasible, the outcomes from this study will inform future randomized controlled trials of participatory interventions. Trial registration: This trial is registered with the ClinicalTrials.gov registry (NCT05199415) and approved by the Institutional Review Board (IRB) at the Massachusetts Institute of Technology (Protocol: 200800024).

Study Protocol: Role of Intermittent Fasting on Disease Severity and Quality of Life in Psoriasis and Psoriatic Arthritis: A Single-Blind Parallel Group Randomized Control Trial

BACKGROUND Psoriasis and psoriatic arthritis (PsA) have a strong association with obesity and metabolic syndrome. Despite patient interest in non-pharmacologic methods to treat psoriasis and manage overall health, there is insufficient data available to guide dietary counseling. OBJECTIVE This study aims to identify the role of a popular anti-inflammatory diet known as intermittent fasting (IF) in psoriasis and psoriatic arthritis (PsA). METHODS A single-blind parallel group randomized control trial will be performed in 60 patients who have been diagnosed with psoriasis or PsA. Patients will be assigned 1:1 to either the IF group or control group. Patients assigned to the IF group will follow a 16:8 fasting IF method for the first 12 weeks, followed by the resumption of their routine diet. Patients assigned to the control group will follow their routine diet for 24 weeks. RESULTS A total of 24 patients have been enrolled in our study, with a final enrollment goal of 60 patients. The final visit is foreseen for July 2023. CONCLUSIONS This study aims to identify the role of a popular anti-inflammatory diet known as intermittent fasting (IF) in the management of psoriasis and PsA. Publishing this data will allow all dermatologists and the National Psoriasis Foundation to provide a consistent, evidence-based recommendation for IF as a potential non-pharmacologic intervention for patients with psoriasis and psoriatic arthritis (PsA).

O-033 A randomised control trial of an online decision-aid for women considering elective egg-freezing

Abstract Study question Does a Decision-Aid for those considering elective egg-freezing impact decisional conflict, the decision-making process, and quality of the decision made, compared to existing information? Summary answer The Decision-Aid significantly reduced decisional conflict and improved preparedness for decision-making. What is known already Elective egg-freezing offers women the potential to extend their reproductive years. The decision to freeze eggs is complex, and our previous data shows that 78% of women had high decisional conflict (uncertainty) when they considered elective egg-freezing. Decision-Aids are the gold-standard for supporting complex health-related decisions. They have been shown to reduce decisional conflict and improve knowledge, risk perception, and decision alignment with personal values, when compared to standard care alone across a range of health conditions. We developed an online Decision-Aid to support women considering elective egg-freezing. Study design, size, duration A single-blinded, two-arm parallel group Randomised Control Trial. Participants were recruited September 2020-March 2021 (target n = 286). Randomisation was 1:1 to the intervention (Decision-Aid plus existing information) or control (existing information only) group, stratified by Australian state/territory and prior consultation with an IVF specialist about elective egg-freezing. Existing information was the Victorian Assisted Reproductive Treatment Authority website. Online surveys were completed at recruitment (baseline), 6, and 12-months. Participants/materials, setting, methods Australian women aged ≥18 years, considering elective egg-freezing, proficient in English, and with internet access were recruited using various methods including social media, Google advertising, newsletters, and clinic referrals. Participants completing the baseline survey were randomised (intervention n = 150, control n = 156) and emailed their allocated resources. Subsequent surveys were emailed 6 and 12-months post-randomisation. Surveys covered decisional conflict (primary outcome), distress, egg-freezing and fertility knowledge, decision made/not made, preparedness for decision-making, informed choice, and decisional regret. Main results and the role of chance Of 306 participants (mean age=30 years, SD: 5.2), 50% were single and 65% worked in professional occupations. At 6-months, the intervention group was substantially more prepared for decision-making than the control (Preparation for Decision-Making Scale; mean score difference: 9.22 [95% CI: 2.35, 16.08], p = 0.009). Overall, 77% of participants completed the primary outcome at 12-months (intervention n = 113, control n = 124). Between baseline and 12-months, the mean reduction in Decisional Conflict Scale (DCS) scores was greater for the intervention group than the control (mean score difference: -6.99 [95% CI: -12.96, -1.02], p = 0.022), whilst there were no group differences in distress (Depression Anxiety and Stress Scale; mean score difference: 0.61 [95% CI: -3.72, 4.93], p = 0.783), knowledge (study-specific scale; mean score difference: 0.23 [95% CI: -0.21, 0.66], p = 0.309) and whether a decision had been made about egg-freezing (odds ratio: 1.95 (95% CI: 0.67, 5.69), p = 0.221). No differences were observed between groups in informed choice (Multi-Dimensional Measure of Informed Choice; relative risk: 1.00 [95% CI: 0.81, 1.25]) or decision regret (Decisional Regret Scale; median score difference: -5.00 [95% CI: -15.30, 5.30]) for participants who had made their decision about egg-freezing at 12-months (intervention n = 48, control n = 45). Limitations, reasons for caution The total eligible population reached cannot be calculated due to the broad recruitment methods used. Adaption of some scales to improve relevancy may impact validity. Biases from self-selection and the use of self-reported data are possible, and some results had small sample sizes limiting the inferences made. Wider implications of the findings This is the first study to evaluate the effectiveness of a Decision-Aid for women considering elective egg-freezing. It demonstrates the benefit of a Decision-Aid in supporting women’s decision-making. Given these results, the Decision-Aid will be made publicly available. There is also potential to adapt the tool for international relevancy. Trial registration number ACTRN12620001032943

Critical Care Cycling to Improve Lower Extremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients

IntroductionIn-bed leg cycling with critically ill patients is a promising intervention aimed at minimising immobility, thus improving physical function following intensive care unit (ICU) discharge. We previously completed a pilot...

The Effects of Cognitively Challenging Physical Activity Games versus Health-Related Fitness Activities on Students' Executive Functions and Situational Interest in Physical Education: A Group-Randomized Controlled Trial.

This study compared cognitively challenging physical activity games and health-related fitness activities in terms of their effects on students' executive functions and situational interest in physical education. A total of 102 fourth- and fifth-grade students (56 boys, 46 girls) participated in this study. A group-randomized controlled trial design involving an acute experiment was used. Two intact classes of students (one fourth-grade and one fifth-grade) were randomly assigned to each one of the three groups. Students in Group 1 participated in cognitively challenging physical activity games, students in Group 2 participated in activities for developing their health-related fitness, and Group 3 students were the control group without physical education. Executive functions were measured pre- and post-intervention with the design fluency test, whereas situational interest was only measured post-intervention with the situational interest scale. Group 1 students who played cognitively challenging physical activity games had increased their executive functions' scores more than the Group 2 students involved in health-related fitness activities. Students of both these groups outperformed control group students. Moreover, Group 1 students reported higher levels of instant enjoyment and total interest than Group 2 students. The results of this study suggest that cognitively challenging physical activity games can be an effective means for enhancing executive functions, and motivate students to be involved in interesting and enjoyable forms of physical activity.

Mobile-assisted medication adherence support intervention among tuberculosis patients: a parallel group randomized control trial

Mobile-assisted medication adherence support intervention among tuberculosis patients: a parallel group randomized control trial

Primary results of a phase-III, randomized controlled trial of the Behavioral Intervention for increasing Physical Activity in Multiple Sclerosis project

Background We undertook a phase-III, randomized controlled trial (RCT) that examined the effectiveness of a behavioral intervention based on social cognitive theory (SCT) and delivered through the Internet using e-learning approaches for immediate and sustained increases in physical activity among persons with multiple sclerosis (MS). Method The study followed a parallel group RCT design. Persons with MS (N = 318) were randomized into either behavioral intervention (n = 159) or attention/social contact control (n = 159) conditions. The conditions were administered over a 6-month period by persons who were uninvolved in screening, recruitment, random assignment, and outcome assessment. There was a 6-month follow-up period without access of conditions. We collected outcome data every 6 months over the 12-month period. The primary outcome was device-measured minutes/day of moderate-to-vigorous physical activity (MVPA). The data analysis involved a modified intent-to-treat approach (i.e. those who received the allocated conditions) using a linear mixed model. Results There was a significant group by time interaction on the primary outcome of device-measured minutes/day of MVPA (p < 0.005). MVPA was increased immediately after the 6-month period in the behavioral intervention compared with control, and this difference was sustained over the 6-month follow-up. Conclusion This study provides evidence for the effectiveness of a widely scalable approach for increasing MVPA in persons with MS.

Targeted exercise for African-Americans with multiple sclerosis: Project TEAAMS

BackgroundWe propose a randomized controlled trial (RCT) that examines the effects of a remotely-delivered, cultrally-tailored exercise training program for immediate and sustained improvements in patient-reported outcomes (PROs) of walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans with multiple sclerosis (MS). Methods/designThe study will be conducted using a parallel group RCT design. The RCT examines the effects of a remotely-delivered, culturally-tailored exercise training program compared with an active control condition among 100 African-Americans with MS. The primary PROs focus on walking dysfunction. The secondary PROs include symptoms of fatigue, depression, anxiety, and HRQOL. The tertiary PROs include exercise behavior and mediator variables based on social cognitive theory. Participants will be randomly assigned into one of two conditions, intervention (Aerobic and Resistance Exercise Training) or active control (Stretching and Flexibility), using a random numbers sequence with concealed allocation. The conditions will be administered over four months by a trained behavioral coach who will be uninvolved in recruitment, screening, random assignment, and outcome assessment. We will monitor the outcomes of interest before and after the 4-month intervention period, and then again 4 months after intervention cessation for capturing stability of intervention effects. The data analysis will follow intent-to-treat principles with a linear mixed model. DiscussionIf successful, this RCT will provide initial evidence for the uptake and implementation of the program in clinics/environments providing healthcare for African-Americans with MS.

Inconsistencies in Adolescent Self-Reported Sexual Behavior: Experience from Four Randomized Controlled Trials.

To examine the degree, correlates, and implications of inconsistent self-report data on sexual risk behaviors of adolescents. We analyzed data from four longitudinal group-randomized controlled trials of evidence-based HIV/STI/pregnancy prevention programs in Texas and California from 2000 to 2010. Across- and within-time logical inconsistencies in sexual behavior survey responses were analyzed using multilevel logistic regression. Rates of any inconsistencies ranged from 12 to 18% across the four trials. In all trials, rates were higher in males than in females. Age, normative beliefs, and race/ethnicity were most strongly associated with inconsistencies. We found substantial rates of inconsistencies in adolescents' self-reports of their sexual behavior, which did not occur at random. Studies should routinely report observed rates of inconsistencies and methods used to adjust for them so that any biases in the population to which the study generalizes are understood by public health practitioners and policy-makers looking to adopt programs for their particular population.

Group Randomized Trial of Healthy Eating and Gardening Intervention in Navajo Elementary Schools (Yéego!)

Few healthy eating, school-based interventions have been rigorously evaluated in American Indian communities. Gardening and healthy eating are priorities in the Navajo Nation. Collaborations between researchers and local partners supported the design and implementation of this project. The Yéego! Healthy Eating and Gardening Study was a group-randomized controlled trial to evaluate a school-based healthy eating and gardening intervention in 6 schools in the Navajo Nation. Schools were randomized 1:2 to intervention or comparison. The Shiprock and Tsaile/Chinle areas in the Navajo Nation were selected. Elementary schools were screened for eligibility. All students in third and fourth grades were invited to participate in the assessments. Delivered during 1 school year in the intervention schools, the intervention included a culturally relevant nutrition and gardening curriculum and a school garden. Student self-efficacy for eating fruits and vegetables, student self-efficacy for gardening, and student healthy foods score from a modified Alternative Healthy Eating Index were assessed in third and fourth graders at the beginning and end of a school year affected by the COVID-19 pandemic. Primary analyses used repeated measures linear mixed models accounting for students nested within schools to estimate the intervention effect and 95% CIs. Students in the intervention schools had self-efficacy scores for eating fruits and vegetables that were 0.22 points greater (95% CI=0.04, 0.41) than those in the comparison schools, although the student healthy foods score increased in the intervention schools by 2.0 (95% CI=0.4, 3.6); the differential change was modest at 1.7 (95% CI=-0.3, 3.7). The self-efficacy to grow fruits and vegetables in the school garden increased among those in the intervention schools (OR=1.92; 95% CI=1.02, 3.63) but not significantly more than it increased in the comparison schools (OR=1.29; 95% CI=0.60, 2.81). The intervention was efficacious in improving self-efficacy for eating fruits and vegetables among third- and fourth-grade students over a school year. The findings warrant further evaluation of the intervention in larger-group randomized trials with schools in Navajo communities. This study is registered at clinicaltrials.gov NCT03778021.

Promoting Children's Psychomotor Development with Multi-Teaching Didactics.

This group randomized control trial examined the dose-response effect of varied combinations of linear and nonlinear pedagogy (enriched physical education with specific program led by specialist vs. conventional physical education led by generalist) for improving first-grade children’s motor creativity, executive functions, self-efficacy, and learning enjoyment. We led three physical education classes per group through 12 weeks of combined instruction, based on linear and nonlinear pedagogy: mostly linear (ML; 80% linear, 20% nonlinear; n = 62); mostly nonlinear (MNL; 20% linear, 80% nonlinear; n = 61); and control (C; conventional teaching from generalists; n = 60). MNL improved in (a) motor creativity ability (DMA; 48.7%, 76.5%, and 47.6% for locomotor, stability, and manipulative tasks, respectively); (b) executive functions (working memory and inhibitory control) for RNG task (14.7%) and task errors (70.8%); (c) self-efficacy (5.9%); and (d) enjoyment (8.3%). In ML, DMA improved by 18.0% in locomotor and 60.9% in manipulative tasks. C improved of 10.5% in enjoyment, and RNG task worsened by 22.6%. MNL improvements in DMA tasks, executive functions, and self-efficacy were significantly better than those in C. ML was better than C in DMA task and in executive functions’ task errors. Overall, ML and MNL approaches were more effective than conventional generalist teaching (C), and the MNL combination of 80% nonlinear and 20% linear pedagogy was optimal. We recommend that educators favor the MNL approach.

Protocol for a Randomized Multiple Center Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children (Oxy-PICU): Oxygen in Pediatric Intensive Care.

OBJECTIVES:Oxygen administration is a fundamental part of pediatric critical care, with supplemental oxygen offered to nearly every acutely unwell child. However, optimal targets for systemic oxygenation are unknown. Oxy-PICU aims to evaluate the clinical effectiveness and cost-effectiveness of a conservative peripheral oxygen saturation (Spo2) target of 88–92% compared with a liberal target of more than 94%.DESIGN:Pragmatic, open, multiple-center, parallel group randomized control trial with integrated economic evaluation.SETTING:Fifteen PICUs across England, Wales, and Scotland.PATIENTS:Infants and children age more than 38 week-corrected gestational age to 16 years who are accepted to a participating PICU as an unplanned admission and receiving invasive mechanical ventilation with supplemental oxygen for abnormal gas exchange.INTERVENTION:Adjustment of ventilation and inspired oxygen settings to achieve an Spo2 target of 88–92% during invasive mechanical ventilation.MEASUREMENTS and MAIN RESULTS:Randomization is 1:1 to a liberal Spo2 target of more than 94% or a conservative Spo2 target of 88–92% (inclusive), using minimization with a random component. Minimization will be performed on: age, site, primary reason for admission, and severity of abnormality of gas exchange. Due to the emergency nature of the treatment, approaching patients for written informed consent will be deferred to after randomization. The primary clinical outcome is a composite of death and days of organ support at 30 days. Baseline demographics and clinical status will be recorded as well as daily measures of oxygenation and organ support, and discharge outcomes. This trial received Health Research Authority approval on December 23, 2019 (reference: 272768), including a favorable ethical opinion from the East of England—Cambridge South Research Ethics Committee (reference number: 19/EE/0362). Trial findings will be disseminated in national and international conferences and peer-reviewed journals.

Web-based intervention to reduce psychological barriers to insulin therapy among adults with non-insulin-treated type 2 diabetes: study protocol for a two-armed randomised controlled trial of ‘Is insulin right for me?’

IntroductionPsychological barriers to insulin therapy are associated with the delay of clinically indicated treatment intensification for people with type 2 diabetes (T2D), yet few evidence-based interventions exist to address these...