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20,188 result(s) for "Randomized control trial"
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Can Solar Lanterns Improve Youth Academic Performance? Experimental Evidence from Bangladesh
We conducted an experimental intervention in unelectrified areas of northern Bangladesh to investigate the effectiveness of solar products in improving children’s educational achievement. We found that treated households substituted solar lanterns for kerosene-based lighting products, helping to decrease total household expenditure. Solar lanterns increased the children’s home-study hours, particularly at night and before exams. The solar lanterns initially led to an increase in school attendance, but this effect diminished over time. However, the increased study hours and initial improvement in school attendance did not translate into improved academic performance. Varying the number of solar products within the treated households did not alter these results. Analyses that exploited the school grade treatment intensity also provided no evidence suggesting that spillover effects explained the “no academic performance effects.” These findings suggest that improving the home-study environment solely through the provision of solar products may have a limited impact on children’s educational achievement.
Dorsolateral Prefrontal Cortex Activity during a Brain Training Game Predicts Cognitive Improvements after Four Weeks’ Brain Training Game Intervention: Evidence from a Randomized Controlled Trial
Background: Recent studies have demonstrated that brain activities using NIRS (near-infrared spectroscopy) at baseline during cognitive tasks (e.g., N-back task) can predict the cognitive benefits of a cognitive training. In this study, we investigated whether brain activities during brain training game (BT) at baseline would predict benefits to cognitive functions after the intervention period. Methods: In a four-week double-blinded randomized control trial (RCT) 72 young adults were randomly assigned to one of the two groups: participants in the BT group played specific game, called the Brain Age. Participants in an active control group (ACT) played the puzzle game Tetris. We measured brain activity during the training games using two channel NIRS before the intervention period. Cognitive functions were tested before and after the four-week intervention period. Results: The BT showed significant improvements in inhibition, processing speed, and working memory performance compared to ACT. The left and right DLPFC (dorsolateral prefrontal cortex) brain activities during the BT at baseline were associated with improvements in inhibition and processing speed. Discussion: This randomized control trial first provides scientific evidence that DLPFC activities during BT at baseline can predict cognitive improvements after a four-week intervention period.
Distress improves after mindfulness training for progressive MS: A pilot randomised trial
Background: Mindfulness-based interventions have been shown to effectively reduce anxiety, depression and pain in patients with chronic physical illnesses. Objectives: We assessed the potential effectiveness and cost-effectiveness of a specially adapted Skype distant-delivered mindfulness intervention, designed to reduce distress for people affected by primary and secondary progressive MS. Methods Forty participants were randomly assigned to the eight-week intervention (n = 19) or a waiting-list control group (n = 21). Participants completed standardised questionnaires to measure mood, impact of MS and symptom severity, quality of life and service costs at baseline, post-intervention and three-month follow-up. Results: Distress scores were lower in the intervention group compared with the control group at post-intervention and follow-up (p < 0.05), effect size −0.67 post-intervention and −0.97 at follow-up. Mean scores for pain, fatigue, anxiety, depression and impact of MS were reduced for the mindfulness group compared with control group at post-therapy and follow-up; effect sizes ranged from −0.27 to −0.99 post-intervention and −0.29 to −1.12 at follow-up. There were no differences in quality-adjusted life years, but an 87.4% probability that the intervention saves on service costs and improves outcome. Conclusions: A mindfulness intervention delivered through Skype video conferences appears accessible, feasible and potentially effective and cost-effective for people with progressive MS.
Alzheimer's disease drug development in an evolving therapeutic landscape
The Alzheimer's disease (AD) research field has entered a new era, where our fundamental understanding of the pathophysiology of AD and advances in biomarkers have not only allowed for earlier, timely, and accurate detection and diagnosis of the disease, but that amyloid removal has been shown to be associated with signals of slowing cognitive and functional decline. Although recent FDA‐approved amyloid plaque‐lowering monoclonal antibody therapies have shifted the trajectory of AD, additional treatment options will be key to further slowing clinical decline or stopping disease progression. Thus, new and emerging therapies for AD have created an evolving therapeutic landscape. The Alzheimer's Association Research Roundtable (AARR) Spring meeting held on May 23–34, 2023, brought together a broad array of scientific leaders from the AARR membership, academia, industry, and government and regulatory agencies to discuss the future of clinical trials in an era of regulator‐approved amyloid‐targeting therapies. Participants discussed lessons learned from other neurological diseases where disease‐modifying treatments were first approved and key considerations for future clinical trials, for example, trial population real‐world representativeness, duration, biomarker screening, efficacy endpoints, combination therapy, as well as overall trial design and the ethical and equity concerns that clinicians, patients, and their families face when considering clinical trial participation. Highlights The Alzheimer's Association Research Roundtable (AARR) convened leaders from industry and academia, as well as patients, clinicians, and government and regulatory agency scientists to discuss the topic, “Alzheimer's Disease Drug Development in an Evolving Therapeutic Landscape.” While recently approved amyloid‐targeting therapies show great promise in providing clinically meaningful outcomes for patients and families, additional treatments, and a better understanding of dosing and administration of these approved treatments, are needed to further slow and eventually prevent clinical decline in AD. Approved therapies will impact many aspects of clinical trial design including the use of placebo‐controls, participant re‐enrollment, safety monitoring, as well as biomarker selection. This exciting new era in AD research represents a hopeful future for clinicians, patients, and their care partners.
Face-to-Face Exercises Performed by Instructors to Improve the Mental Health of Japanese in the Community—A Randomized Control Trial
Background and objectives: The purpose of this study is to clarify the effects on the mental health of face-to-face exercise performed by an instructor (lesson-style Group: Group L) and exercise using machines (program-style Group: Group P) by randomized control trial. Materials and Methods: Among 120 subjects, 117 subjects were allocated to two groups with stratified randomization by sex (Group P: 58 subjects; Group L: 59 subjects). A 60-min health exercise class was held once per week for 12 consecutive weeks. The measurement items were mental health as a primary evaluation item and self-efficacy as a secondary evaluation item. Physical fitness was also measured using a new physical fitness test used in Japan. The 12-item general health questionnaire (GHQ-12) was used to measure mental health and the general self-efficacy scale (GSES) was used to measure self-efficacy. Results: After the intervention, 102 subjects were analyzed. The changes in mental health evaluated by GHQ-12 scores were significantly lower in Group L −0.7 (95% CI, −1.2 to −0.3) than Group P −0.1 (95% CI, −0.4 to 0.2) (p = 0.03). The changes in self-efficacy evaluated by GSES scores were significantly higher in Group P 5.3 (95% CI, 3.1 to 7.5) than Group L 1.3 (95% CI, −0.4 to 3.1) (p < 0.01). Conclusions: Compared with program exercises mainly using machines, face-to-face exercises performed by instructors improved mental health.
Can Solar Lanterns Improve Youth Academic Performance? Experimental Evidence from Bangladesh
We conducted an experimental intervention in unelectrified areas of northern Bangladesh to investigate the effectiveness of solar products in improving children’s educational achievement. We found that treated households substituted solar lanterns for kerosene-based lighting products, helping to decrease total household expenditure. Solar lanterns increased the children’s home-study hours, particularly at night and before exams. The solar lanterns initially led to an increase in school attendance, but this effect diminished over time. However, the increased study hours and initial improvement in school attendance did not translate into improved academic performance. Varying the number of solar products within the treated households did not alter these results. Analyses that exploited the school grade treatment intensity also provided no evidence suggesting that spillover effects explained the “no academic performance effects.” These findings suggest that improving the home-study environment solely through the provision of solar products may have a limited impact on children’s educational achievement.
The impact of a poverty reduction intervention on infant brain activity
Early childhood poverty is a risk factor for lower school achievement, reduced earnings, and poorer health, and has been associated with differences in brain structure and function. Whether poverty causes differences in neurodevelopment, or is merely associated with factors that cause such differences, remains unclear. Here, we report estimates of the causal impact of a poverty reduction intervention on brain activity in the first year of life. We draw data from a subsample of the Baby’s First Years study, which recruited 1,000 diverse low-income mother–infant dyads. Shortly after giving birth, mothers were randomized to receive either a large or nominal monthly unconditional cash gift. Infant brain activity was assessed at approximately 1 y of age in the child’s home, using resting electroencephalography (EEG; n = 435). We hypothesized that infants in the high-cash gift group would have greater EEG power in the mid- to high-frequency bands and reduced power in a low-frequency band compared with infants in the low-cash gift group. Indeed, infants in the high-cash gift group showed more power in high-frequency bands. Effect sizes were similar in magnitude to many scalable education interventions, although the significance of estimates varied with the analytic specification. In sum, using a rigorous randomized design, we provide evidence that giving monthly unconditional cash transfers to mothers experiencing poverty in the first year of their children’s lives may change infant brain activity. Such changes reflect neuroplasticity and environmental adaptation and display a pattern that has been associated with the development of subsequent cognitive skills.
A Scientific Approach to Entrepreneurial Decision Making: Evidence from a Randomized Control Trial
A classical approach to collecting and elaborating information to make entrepreneurial decisions combines search heuristics, such as trial and error, effectuation, and confirmatory search. This paper develops a framework for exploring the implications of a more scientific approach to entrepreneurial decision making. The panel sample of our randomized control trial includes 116 Italian startups and 16 data points over a period of about one year. Both the treatment and control groups receive 10 sessions of general training on how to obtain feedback from the market and gauge the feasibility of their idea. We teach the treated startups to develop frameworks for predicting the performance of their idea and conduct rigorous tests of their hypotheses, very much as scientists do in their research. We let the firms in the control group instead follow their intuitions about how to assess their idea, which has typically produced fairly standard search heuristics. We find that entrepreneurs who behave like scientists perform better, are more likely to pivot to a different idea, and are not more likely to drop out than the control group in the early stages of the startup. These results are consistent with the main prediction of our theory: a scientific approach improves precision—it reduces the odds of pursuing projects with false positive returns and increases the odds of pursuing projects with false negative returns. This paper was accepted by Marie Thursby, entrepreneurship and innovation.
POS0830 BARICITINIB VERSUS TNF-INHIBITORS IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO CSDMARDS: 12 WEEKS RESULTS OF A PRAGMATIC, MULTICENTER, OPEN LABEL, NONINFERIORITY TRIAL
The EULAR guidelines for RA recommend that treatment should be aimed at reaching a predefined disease activity target (T2T). If this treatment target is not achieved with csDMARD, adding a TNFi or a JAK-inhibitor are advised options in patients with poor prognostic factor, obviously considering contraindications. While randomized clinical trials have provided relevant data on the relative efficacy and safety of TNFi and JAKi under ideal conditions, the extent to which such results can be generalized to real-life clinical practice conditions remains unclear. To demonstrate non-inferiority (NI) and, in case NI could be shown, subsequent superiority of a T2T strategy in which csDMARDs refractory RA patients are subsequently treated with baricitinib versus TNFi. Biologic or targeted synthetic DMARD-naïve RA patients failing to respond to csDMARDs were eligible if they were pretreated according to T2T principles, had a disease duration <5 years and no contraindications to b/tsDMARD. All included patients were treated open label at the discretion of their attending rheumatologist with either TNFi (any type) or baricitinib. Patients were seen at baseline and 12-weekly until final follow-up (48 weeks). Full clinical assessment was performed at each visit. Self-report questionnaires, including PROMs, were collected as well. The primary endpoint was defined as NI of baricitinib versus TNFi in the proportion of patients achieving ACR50 response at week 12, with subsequent superiority testing in case non-inferiority was shown. For the primary efficacy analysis, the proportion of patients achieving ACR50 response were compared, using 95% confidence intervals calculated using the Wilson score method. The non-inferiority margin for baricitinib was set at -12%. 199 patients who received a first dose of either TNFi (102) or baricitinib (97) were included. Baseline characteristics were comparable between both groups (see Table 1). At 12 weeks, the lower bound of the 95% confidence interval for the difference in proportions of patients meeting the ACR50 response is to the right of zero in both the per-protocol and intention-to-treat analysis (see Figure 1). Hence, baricitinib was found to be non-inferior and statistically superior to TNFi in the analysis of the primary endpoint. Moreover, DAS28 remission (DAS28-CRP <0.6) was achieved in 74% of baricitinib patients compared with 46% of TNFi patients (p<0.001) at 12 weeks. Baricitinib was found to be non-inferior and superior to TNFi in terms of ACR50 response at 12 weeks in real-world csDMARD refractory RA patients. Analysis of secondary endpoints, disease activity across other measurement points, PROMs, radiology, safety and costs is currently ongoing. NIL. NIL. Martjin Oude Voshaar: None declared, Peter ten Klooster: None declared, Danyta Tedjo: None declared, Celine van de Laar: None declared, Mart van de Laar Speakers bureau: Eli Lilly and Company, Grant/research support from: Eli Lilly and Company. [Display omitted] Table 1Baseline characteristicsTNFiBaricitinibpN=102N=97Age55.2 (13.4)54.8 (12.0)0.833Gender0.796F68 (66.7%)62 (63.9%)M34 (33.3%)35 (36.1%)Smoking0.963never38 (37.3%)37 (38.9%)Stopped39 (38.2%)36 (37.9%)Yes25 (24.5%)22 (23.2%)BMI27.5 (4.91)26.5 (5.03)0.178Disease duration (years)2.00 [1.00;3.00]2.00 [1.00;3.00]0.766Erosions0.537No71 (69.6%)74 (76.3%)Unknown12 (11.8%)10 (10.3%)Yes19 (18.6%)13 (13.4%)CV0.432No74 (72.5%)76 (78.4%)Yes28 (27.5%)21 (21.6%)RF0.576Neg33 (32.4%)27 (27.8%)Pos67 (65.7%)66 (68.0%)Unknown2 (1.96%)4 (4.12%)ACCP0.262Neg37 (36.3%)27 (27.8%)Pos65 (63.7%)70 (72.2%)MTX1No31 (30.4%)30 (30.9%)Yes71 (69.6%)67 (69.1%)DAS28ESR4.41 (1.06)4.43 (1.14)0.919DAS28CRP4.17 (1.02)4.12 (1.07)0.741TJC284.00 [2.00;7.00]4.00 [2.00;7.00]0.662SJC283.00 [1.00;5.00]3.00 [2.00;4.00]0.805BSE24.0 (19.7)25.0 (22.1)0.738CRP13.7 (19.1)12.8 (17.6)0.728HAQ12.2 (5.66)10.9 (6.35)0.13SDAI21.2 (8.97)21.1 (9.00)0.933
Efficacy of PRIME, a Mobile App Intervention Designed to Improve Motivation in Young People With Schizophrenia
Abstract The onset of schizophrenia occurs during a period critical for development of social relationships and functional independence. As such, interventions that target the early course of illness have the potential to stave off functional decline and restore functioning to pre-illness levels. In this entirely remote study, people with recent-onset schizophrenia spectrum disorders (SSDs) participated in a 12-week randomized controlled trial to determine the efficacy of PRIME (personalized real-time intervention for motivational enhancement), a mobile-based digital health intervention designed to improve motivation and quality of life. Participants were randomized into the PRIME (n = 22) or treatment-as-usual/waitlist (TAU/WL) condition (n = 21) and completed assessments at baseline, post-trial (12 wk), and for people in the PRIME condition, 3 months after the end of the trial. After 12-weeks, WL participants received PRIME, resulting in a total sample of 38 participants completing PRIME. In PRIME, participants worked towards self-identified goals with the support of a virtual community of age-matched peers with schizophrenia-spectrum disorders as well as motivation coaches. Compared to the WL condition, people in the PRIME condition had significantly greater improvements in self-reported depression, defeatist beliefs, self-efficacy, and a trend towards motivation/pleasure negative symptoms post-trial, and these improvements were maintained 3 months after the end of trial. We also found that people in the PRIME condition had significantly greater improvements in components of social motivation post-trial (anticipated pleasure and effort expenditure). Our results suggest that PRIME has the potential to be an effective mobile-based intervention for improving aspects of mood and motivation in young people with SSDs.