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.

Collaborative model of care between orthopaedics and allied healthcare professionals (CONNACT) in knee osteoarthritis: Effectiveness-implementation hybrid randomized controlled trial of a community-based, multidisciplinary, stratified intervention.

OBJECTIVE: To compare the clinical and cost effectiveness of the Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT), a community-based, stratified, multidisciplinary intervention consisting of exercise, education, psychological and nutrition delivered through a chronic care model to usual hospital care in adults with knee osteoarthritis (OA). METHODS: Pragmatic, parallel-arm, single-blinded superiority RCT trial. Community-dwelling, ambulant adults with knee OA (Kellgren-Lawrence grade > 1; Knee Injury and OA Outcome Score (KOOS4) ≤75) were enrolled. Primary outcome was KOOS4 at 12-months; secondary outcomes included: quality of life, physical performance measures, symptom satisfaction, psychological outcomes, dietary habits, and global perceived effect. Intention-to-treat analysis using generalized linear model (GLM) and regression modeling were conducted. Economic evaluation through a societal approach was embedded. RESULTS: 110 participants (55 control, 55 intervention) were randomized. No between-group difference found for the primary outcome (MD [95%CI]: -1.86 [-9.11. 5.38]), although both groups demonstrated within-group improvement over 12-months. Among the secondary outcomes, the CONNACT group demonstrated superior dietary change (12 months) and physical performance measures (3 months), and global perceived effect (6 months). While there was no between-group difference in total cost, significant productivity gains (reduced indirect cost) were seen in the CONNACT group. CONCLUSION: CONNACT was not superior to usual care at 1 year. Further efforts are needed to understand the underlying contextual and implementation factors in order to further improve and refine such community-based, stratified care models moving forward. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03809975. Registered January 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03809975.

The Effect of Iron Supplements on the Gut Microbiome of Females of Reproductive Age: A Randomized Controlled Trial.

BACKGROUND: Iron deficiency is the most common nutritional deficiency worldwide, particularly for young children and females of reproductive age. Although oral iron supplements are routinely recommended and generally considered safe, iron supplementation has been shown to alter the fecal microbiota in low-income countries. Little is known about the effect of iron supplementation on the fecal microbiota in high-income settings. OBJECTIVES: To assess the effect of oral iron supplementation compared with placebo on the gut microbiome in nonpregnant females of reproductive age in a high-income country. METHODS: A 21-d prospective parallel design double-blind, randomized control trial conducted in South Australia, Australia. Females (18-45 y) were randomly assigned to either iron (65.7 mg ferrous fumarate) or placebo. Fecal samples were collected prior to commencing supplements and after 21 d of supplementation. The primary outcome was microbiota ß-diversity (paired-sample weighted unique fraction metric dissimilarity) between treatment and placebo groups after 21 d of supplementation. Exploratory outcomes included changes in the relative abundance of bacterial taxa. RESULTS: Of 82 females randomly assigned, 80 completed the trial. There was no significant difference between the groups for weighted unique fraction metric dissimilarity (mean difference: 0.003; 95% confidence interval: -0.007, 0.014; P = 0.52) or relative abundance of common bacterial taxa or Escherichia-Shigella (q > 0.05). CONCLUSIONS: Iron supplementation did not affect the microbiome of nonpregnant females of reproductive age in Australia. This trial was registered at clinicaltrials.gov as NCT05033483.

Remote monitoring of automated peritoneal dialysis reduces mortality, adverse events, and hospitalizations: a cluster randomized controlled trial.

BACKGROUND AND HYPOTHESIS: Remote monitoring (RM) of patients on automated peritoneal dialysis (APD) prevent complications and improve treatment quality. We analyzed the effect of RM-APD on mortality and complications related to cardiovascular disease (VD), fluid overload and insufficient dialysis efficiency. METHODS: In a cluster-randomized, open-label, controlled trial, 21 hospitals with APD programs were assigned to use either RM-APD (10 hospitals; 403 patients) or conventional APD (11 hospitals; 398 patients) for the treatment of adult patients starting PD. Primary outcomes were time to first event of: 1) Composite Index-1 comprising all-cause mortality, first adverse events and hospitalizations of any cause, and 2) Composite Index-2 comprising cardiovascular mortality, first adverse event and hospitalizations related to CVD, fluid overload and insufficient dialysis efficiency. Secondary outcomes were time to first event of individual components of the two composite indices, and rates of adverse events, hospitalizations, unplanned visits, and transfer to hemodialysis. Patients were followed for a median of 9.5 months. Primary outcomes were evaluated by competing-risk analysis and restricted mean survival time (RMST) analysis. RESULTS: While time to reach Composite Index-1 did not differ between the groups, Composite Index-2 was reached earlier (ΔRMST: -0.85 months; p=0.02), and all-cause mortality (55 vs. 33 deaths, p=0.01; sHR 1.69 (95%CI 1.39-2.05), p<0.001) and hospitalizations of any cause were higher in APD group than in RM-APD as were cardiovascular deaths (24 vs. 13 deaths, p=0.05; sHR 2.44 (95%CI 1.72 - 3.45), p<0.001) and rates of adverse events and hospitalizations related to CVD, fluid overload or insufficient dialysis efficiency. Dropouts were more common in the APD group (131 vs. 110, p=0.048). CONCLUSIONS: This randomized controlled trial shows that remote monitoring may add significant advantages to APD, including improved survival and reduced rate of adverse events and hospitalizations, which can favorably impact the acceptance and adoption of the therapy.

Adaptive designs were primarily used but inadequately reported in early phase drug trials.

BACKGROUND: Faced with the high cost and limited efficiency of classical randomized controlled trials, researchers are increasingly applying adaptive designs to speed up the development of new drugs. However, the application of adaptive design to drug randomized controlled trials (RCTs) and whether the reporting is adequate are unclear. Thus, this study aimed to summarize the epidemiological characteristics of the relevant trials and assess their reporting quality by the Adaptive designs CONSORT Extension (ACE) checklist. METHODS: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov from inception to January 2020. We included drug RCTs that explicitly claimed to be adaptive trials or used any type of adaptative design. We extracted the epidemiological characteristics of included studies to summarize their adaptive design application. We assessed the reporting quality of the trials by Adaptive designs CONSORT Extension (ACE) checklist. Univariable and multivariable linear regression models were used to the association of four prespecified factors with the quality of reporting. RESULTS: Our survey included 108 adaptive trials. We found that adaptive design has been increasingly applied over the years, and was commonly used in phase II trials (n = 45, 41.7%). The primary reasons for using adaptive design were to speed the trial and facilitate decision-making (n = 24, 22.2%), maximize the benefit of participants (n = 21, 19.4%), and reduce the total sample size (n = 15, 13.9%). Group sequential design (n = 63, 58.3%) was the most frequently applied method, followed by adaptive randomization design (n = 26, 24.1%), and adaptive dose-finding design (n = 24, 22.2%). The proportion of adherence to the ACE checklist of 26 topics ranged from 7.4 to 99.1%, with eight topics being adequately reported (i.e., level of adherence ≥ 80%), and eight others being poorly reported (i.e., level of adherence ≤ 30%). In addition, among the seven items specific for adaptive trials, three were poorly reported: accessibility to statistical analysis plan (n = 8, 7.4%), measures for confidentiality (n = 14, 13.0%), and assessments of similarity between interim stages (n = 25, 23.1%). The mean score of the ACE checklist was 13.9 (standard deviation [SD], 3.5) out of 26. According to our multivariable regression analysis, later published trials (estimated ß = 0.14, p < 0.01) and the multicenter trials (estimated ß = 2.22, p < 0.01) were associated with better reporting. CONCLUSION: Adaptive design has shown an increasing use over the years, and was primarily applied to early phase drug trials. However, the reporting quality of adaptive trials is suboptimal, and substantial efforts are needed to improve the reporting.

The effect of 20-minute mindful breathing exercise on psychological well-being in epilepsy: A pilot randomized controlled trial.

INTRODUCTION: Depression and anxiety are prevalent in epilepsy patients, but psychiatric or psychological services may not be accessible to all patients. This study aimed to determine the effectiveness of the 20-minute mindful breathing on the psychological well-being of PWE using an instructional video. METHOD: This was a pilot, assessor-blinded, randomized controlled trial. The intervention group received a guided video and was briefed to perform the exercise twice a week for two weeks while the waitlist control group only received the video upon completion of the study. The subjects were assessed at three-time points (T0: Baseline, T1: 2 weeks after the intervention, T2: 4 weeks after intervention), using the Neurological Disorders Depression Index (NDDI-E), General Anxiety Disorder (GAD-7), Quality of Life in Epilepsy Inventory (QOLIE-31) and Mindfulness Attention Awareness Scale (MAAS). RESULTS: Twenty patients were recruited, with 10 in the intervention and waitlist-control groups. Compared with the waitlist-control group, participants in the intervention group showed significant improvement in NDDI-E at T1 (p = 0.022) but not at T2 (p = 0.056) and greater improvement in GAD-7 at T1 and T2 but not statistically significant. The QOLIE-31 overall score in the intervention group has significantly improved at T1 (p = 0.036) and T2 (p = 0.031) compared to the waitlist-control group. For MAAS, the intervention group also had an increased score at T2 (p = 0.025). CONCLUSION: The 20-minute mindfulness breathing exercise has an immediate effect in improving depression and quality of life among people with epilepsy.

Effect of a chimney-fitted improved stove on pregnancy outcomes in Northwest Ethiopia: a randomized controlled trial.

BACKGROUND: Exposure to household air pollution during pregnancy has been linked to adverse pregnancy outcomes. Improved stove was implemented in Ethiopia to reduce this exposure and related health problems. However, the effects of improved stove interventions on pregnancy outcomes remains uncertain. METHOD: Individually randomized stove replacement trial was conducted among 422 households in six low-income rural kebeles of Northwestern Ethiopia. Pregnant women without known health conditions were recruited at ≤ 24 weeks gestation and randomized to an intervention or control group with a 1:1 ratio. A baseline survey was collected and a balance test was done. Two-sided independent samples t-test for continuous outcomes and chi-square for categorical variables were used to compare the effect of the intervention between the groups. Mean differences with 95% CIs were calculated and a p-value of < 0.05 was considered statistically significant. RESULT: In this study, the mean birth weight was 3065 g (SD = 453) among the intervention group and not statistically different from 2995 g (SD = 541) of control group. After adjusting for covariates, infants born from intervention group weighed 55 g more [95% CI: - 43 to 170) than infants born from the control group, but the difference was not statistically significant (P = 0.274). The respective percentages for low birth weight were 8% and 10.3% for intervention and control groups respectively (P = 0.346). However, the average gestational age at delivery was higher among improved stove users (38 weeks (SD = 8.2) compared to control groups 36.5 weeks (SD = 9.6) with statistically significant difference at 0.91 weeks (95% CI: 0.52 to 1.30 weeks, p < 0.001). The corresponding difference in risk ratio for preterm birth is 0.94 (95% CI:0.92 to 0.97; p < 0.001). The percentages for maternal complications, stillbirth, and miscarriage in the intervention group were not statistically different from the control group. CONCLUSIONS: While the increase in average birth weight among babies born to mothers using improved stoves was not statistically significant, babies had a longer gestational age on average, offering valuable health benefits. However, the study didn't find a significant impact on other pregnancy outcomes like stillbirth, miscarriage, or maternal complications. TRIAL REGISTRATION: The study was registered at the Pan African Clinical Trial Registry website under the code PACTR202111534227089, ( https://pactr.samrc.ac.za/ (Identifier). The first trial registration date was (11/11/2021).

Effect of WhatsApp-based BETTER model sexual counselling on sexual function and sexual quality of life in breast cancer survivors: a randomized control trial.

OBJECTIVE: The aim of the study was to determine the effect of WhatsApp-based BETTER sex counselling on sexual function and sexual quality of life in breast cancer survivors in a randomized control trial. METHODS: This is a randomized controlled trial in which a total of 90 breast cancer survivors were recruited using convenience sampling and then randomly assigned to two groups of WhatsApp-based BETTER model counselling and routine care. Data collection tools consisted of a demographic questionnaire, the Sexual Quality of Life-Female (SQOL-F) and the Sexual Function Index (FSFI-BC). Participants in the intervention group were given access to the 6-week program. The program consisted of six consultation and assignment packages covering all six steps of the BETTER model. Data were analyzed using SPSS software version 20. Chi-square test, independent samples t-test and repeated measures analysis of variance were used. The significance level (p-value) was considered to be less than 0.05. RESULTS: In the control group, the mean score of SQL scale changed from 35.16 ± 10.71 to 35.16 ± 12.97 (P > 0.05) and in the intervention group, it significantly increased from 34.76 ± 10.13 to 68.20 ± 20.48 (P < 0.001). Similarly, the comparison of mean of FSF in the control group showed a none-significant change from 58.13 ± 7.11 to 58.35 ± 6.11 (P > 0.05), and in the intervention group, it significantly improved from 59.49 ± 6.10 to 120.73 ± 25.54 (P < 0.001). The results of rANOVA indicated that there was a significant difference in the mean scores of the SQL and SFS between the two groups from pre- to post-intervention, and then over the 1-month follow-up period in the intervention group (p < 0.001). Considering partial eta squared, the effect of the intervention had the highest interaction effect on both variables of the sexual function index (η2 = 0.73) and sexual quality of life (η2 = 0.41). CONCLUSIONS: The intervention program was a successful model for improving female sexual quality of life and female sexual function in breast cancer survivors. TRIAL REGISTRATION: IRCT20210926052601N1, 7-11-2021.

Effects of timing of oral calcium administration on milk production in high-producing early-lactation Holstein cows.

Supplementation of oral Ca via blanket administration of an oral Ca bolus at 0 and 24 h after calving has shown limited success in increasing production and minimizing adverse health events. Recent evidence that reductions in blood Ca at 4 d in milk (DIM) are more closely associated with negative outcomes than hypocalcemia at 0 to 24 h postpartum might explain this lack of Ca bolus efficacy. Therefore, our primary objective was to explore the effect of delayed oral Ca bolus supplementation on milk production, with secondary objectives of exploring the effects on disease incidence and postpartum blood Ca dynamics. We conducted a randomized controlled trial on multiparous Holstein cows (n = 998) from 4 herds in New York. At calving, cows were randomly assigned to 1 of 3 treatment groups: (1) control, no supplemental Ca at or around parturition (CON; n = 343); (2) conventional bolus, an oral Ca bolus containing 43 g of Ca at calving and 24 h later (BOL-C; n = 330); or (3) delayed bolus, an oral Ca bolus containing 43 g of Ca at 48 and 72 h after calving (BOL-D; n = 325). We created generalized linear mixed models to analyze differences in milk yield for the first 10 wk of lactation and serum total Ca (tCa) at 1 and 4 DIM between treatment groups; multivariable Poisson regression models were used to analyze adverse event outcomes (metritis, displaced abomasum, herd removal, or a combination of one or more of the 3) in the first 30 DIM. Milk yield increased by week and was not affected by treatment. However, a treatment by parity group interaction for milk yield showed that BOL-D cows in the third parity produced more milk than third-parity BOL-C or CON cows (BOL-D = 52.0 kg/d, 95% confidence interval [50.6, 53.4] kg/d, BOL-C = 47.9 [46.3, 49.5] kg/d, CON = 49.8 [48.2, 51.2] kg/d). The incidence of adverse health events was similar between treatments (BOL-D = 3.7%, BOL-C = 3.7%, CON = 3.6%). Serum tCa was lower at 1 than 4 DIM, and we detected no difference in tCa between treatment groups. Our findings suggest that delaying oral Ca bolus supplementation has limited influence on blood Ca concentrations but may be beneficial to cohorts of cows as a targeted prophylactic supplement to support milk production.

Mixed-Method, Multilevel Clustered-Randomized Control Trial for Menstrual Health Disparities.

Menstrual cycle characteristics are largely considered unmodifiable reproductive factors, a framing that prevents exploration of the ways structural factors interfere with menstrual health. Given the role of structural factors like healthy food and healthcare access on reproductive health and the grave need for structural interventions to known reproductive health disparities that disproportionately target cisgender women racialized as Black, it is imperative that science begin to examine how structural factors influence menstrual health. To explore such research, we employ critical race theory and intersectionality to illustrate what a structural intervention to improve menstrual cycle health could look like. Centering those with the greatest need, persons racialized as Black and/or LatinX living in food and healthcare deserts in Northern Manhattan, our illustrative sample includes four groups of persons who menstruate (e.g., cisgender girls and women) that are pre-menarche, pre-parous, postpartum, or perimenopausal. We describe a hypothetical, multilevel clustered-randomized control trial (cRCT) that provides psychoeducation on racism-related trauma and free delivered groceries to both treatment and control groups, while randomizing 30 clusters of housing associations to receive either sexual health clinics at their housing association or free vouchers for healthcare. We embed mixed methods (diaries, interviews, surveys, mobile apps, observation) into the design to evaluate the effectiveness of the 1-year intervention, in addition to determining the impact on participants through their perspectives. Through this illustration, we provide a novel example of how structural interventions can apply mixed methods to evaluate effectiveness while delivering services to populations impacted by multiple structural factors. We demonstrate how qualitative and quantitative approaches can be paired in clustered RCTs and how a living logic model can empirically incorporate the population perspective into more effective interventions. Lastly, we reveal how sensitive menstrual health is to structural factors and how upstream improvements will trickle down to potentially reduce health disparities in reproductive health.

Japan-Multimodal Intervention Trial for the Prevention of Dementia: A randomized controlled trial.

INTRODUCTION: We examined the efficacy of a multidomain intervention in preventing cognitive decline among Japanese older adults with mild cognitive impairment (MCI). METHODS: Participants aged 65-85 years with MCI were randomized into intervention (management of vascular risk factors, exercise, nutritional counseling, and cognitive training) and control groups. The primary outcome was changes in the cognitive composite score over a period of 18 months. RESULTS: Of 531 participants, 406 completed the trial. The between-group difference in composite score changes was 0.047 (95% CI: -0.029 to 0.124). Secondary analyses indicated positive impacts of interventions on several secondary health outcomes. The interventions appeared to be particularly effective for individuals with high attendance during exercise sessions and those with the apolipoprotein E ε4 allele and elevated plasma glial fibrillary acidic protein levels. DISCUSSION: The multidomain intervention showed no efficacy in preventing cognitive decline. Further research on more efficient strategies and suitable target populations is required. HIGHLIGHTS: This trial evaluated the efficacy of multidomain intervention in individuals with MCI. The trial did not show a significant difference in preplanned cognitive outcomes. Interventions had positive effects on a wide range of secondary health outcomes. Those with adequate adherence or high risk of dementia benefited from interventions.

Practice-based research in dentistry: Exploring methodologies, benefits, and challenges.

BACKGROUND: Practice-Based Research Network (PBRN) studies typically assess the effectiveness of clinical interventions in settings that match real-world conditions. Dental PBRNs have the capacity to amass, identify, and analyze vast amounts of data from patient populations that include diverse racial, ethnic, socio-economic, and geographic backgrounds. These dental studies encompass a broad spectrum of healthcare aspects, including prevention, diagnosis, symptom and disease treatment, quality enhancement, and care coordination. METHODS: An extensive range of research methodologies can be employed within dental PBRNs to investigate these topics, including randomized controlled trials. Dental PBRNs have evolved from primarily focusing on case observations to leveraging advanced network infrastructure and collaborating across multiple regional and national sites. In addition to producing numerous high-impact peer-reviewed publications, study results have led to improved clinical care. However, PBRNs encounter challenges, such as the sustainability of research capacity (relying heavily on ongoing support from funding agencies), diverse research cultures, and an imperative to design studies that are both feasible and relevant to everyday clinical practice. Recognizing the pivotal role of real-world evidence, it is important to have sustained investment in dental PBRN infrastructure and feasible opportunities for practitioners to participate in network activities nationwide. CONCLUSION: Practice-Based Research Network studies capitalize on an important research context within which to investigate a range of clinical topics that can employ multiple research methodologies. However, sustaining productive networks requires strategic effort, ongoing financial support, and customized organizational skills.

Can a multicomponent positive psychological intervention promote well-being in parents of young children? A randomized controlled trial study in Hong Kong.

The present research examined the effects of an Early Advancement in Social-Emotional Health and Positivity (EASP) multicomponent positive psychological intervention on parents' well-being in Hong Kong. Participants were parents of young children (N = 120; Mage = 37.19 years, SD = 4.71, range = 24-53; female = 95.00%) who participated in the one-month randomized control trial. Participants were randomly assigned into the intervention (n = 50) and waitlist control groups (n = 70). Parents in the intervention group received two online workshops and an evidence-based smartphone application that targeted four positive psychological skills: (1) mindful parenting, (2) hope, (3) positive reappraisal, and (4) growth mindset. The results of the multivariate regression analysis revealed that the intervention significantly improved various dimensions of participants' positive psychological skills, subjective well-being, and psychological well-being immediately at the conclusion of the program. The findings of this study underscore the importance of the well-being payoffs linked to cultivating positive psychological skills among parents of young children.

Mentorship for young gay men in Hong Kong: A pilot mixed-methods randomized controlled trial.

This study examined whether mentorship could promote young gay men's identities and well-being, and whether a mentor's sexual orientation matters. A randomized control trial compared outcomes across three conditions: Arm A (a mentee matched with a sexual minority mentor), Arm B (a mentee matched with a heterosexual mentor), and a control arm receiving psychoeducation only. A community sample of 60 mentees aged 18-25 years was randomly allocated to the three arms and completed questionnaires at baseline, 3 months into the intervention, and at the end of the 6-month program. Fifteen mentees recounted their mentoring experiences through in-depth interviews. Linear mixed effects models showed that for both intervention and control conditions, internalized homonegativity declined while resilience, loneliness, and body acceptance improved over time. No time and group interactions were found. Meanwhile, a mentor's sexual orientation did not drive differential quality and outcomes of mentorship. Interviewees cited various benefits of mentorship, including providing companionship, enriching connection with lesbian, gay, bisexual (LGB) communities, and adding knowledge and perspectives of LGB lives and identities. Although quantitative data did not support any exclusive benefits of mentorship, most mentees recognized mentorship as a vital source of affirmation and companionship. Implications for research and mentoring programs are discussed.

A survey of statistical methods utilized for analysis of randomized controlled trials of behavioral interventions.

OBJECTIVES: Given the many statistical analysis options used for randomized controlled trials (RCTs) of behavioral interventions and the lack of clear guidance for analysis selection, the present study aimed to characterize the predominate statistical analyses utilized in RCTs in palliative care and behavioral research and to highlight the relative strengths and weaknesses of each of these methods as guidance for future researchers and reform. METHODS: All RCTs published between 2015 and 2021 were systematically extracted from 4 behavioral medicine journals and analyzed based on prespecified inclusion criteria. Two independent raters classified each of the manuscripts into 1 of 5 RCT analysis strategies. RESULTS: There was wide variation in the methods used. The 2 most prevalent analyses for RCTs were longitudinal modeling and analysis of covariance. Application of method varied significantly by sample size. SIGNIFICANCE OF RESULTS: Each statistical analysis presents its own unique strengths and weaknesses. The information resulting from this research may prove helpful for researchers in palliative care and behavioral medicine in navigating the variety of statistical methods available. Future discussion around best practices in RCT analyses is warranted to compare the relative impact of interventions in a more standardized way.

Effectiveness of blended happy age education program (B-HAEP) on active aging promotion among pre-disable community dwelling older adults in Pakistan.

BACKGROUND: Addressing aging related functional declines in older adults has become a top priority for countries around the world. The aim of this study was to investigate the effectiveness of a blended happy age education program in promoting active aging among community-based pre-disable older adults. METHODS: We conducted a two-arm trial study in Khyber Pakhtunkhwa, Pakistan. Participants were randomly assigned into two groups using a computer-generated random sequence of 150 participants. RESULTS: Blended Happy Age Education Program (BHAEP) reduced time for 3 m walk (Estimated mean 19.5 ± 3.4 to 13.7 ± 1.3, effect size ηp² = 0.98, (P < 0.001). The current level of happiness improved in B-HAEP group from 4.7 ± 1.05 scores to 7.8 ± 1.6, P < 0.001, effect size (ηp² = 0.540). Healthy lifestyle significantly improved (P < 0.001, ηp² = 0.4). CONCLUSIONS: B-HAEP can be an effective intervention strategy to promote active aging in older adults with risk for immobility.

Increasing Production Diversity and Diet Quality: Evidence from Bangladesh.

In the context of rural Bangladesh, we assess whether agriculture training alone, nutrition Behavior Communication Change (BCC) alone, combined agriculture training and nutrition BCC, or agriculture training and nutrition BCC combined with gender sensitization improve: (a) production diversity, either on household fields or through crop, livestock or aquaculture activities carried out near the family homestead and (b) diet diversity and the quality of household diets. All treatment arms were implemented by government employees. Implementation quality was high. No treatment increased production diversification of crops grown on fields. Treatment arms with agricultural training did increase the number of different crops grown in homestead gardens and the likelihood of any egg, dairy, or fish production but the magnitudes of these effect sizes were small. All agricultural treatment arms had, in percentage terms, large effects on measures of levels of homestead production. However, because baseline levels of production were low, the magnitude of these changes in absolute terms was modest. Nearly all treatment arms improved measures of food consumption and diet with the largest effects found when nutrition and agriculture training were combined. Relative to treatments combining agriculture and nutrition training, we find no significant impact of adding the gender sensitization on our measures of production diversity or diet quality. Interventions that combine agricultural training and nutrition BCC can improve both production diversity and diet quality, but they are not a panacea. They can, however, contribute towards better diets of rural households.

Stir-up Regimen After General Anesthesia in the Postanesthesia Care Unit: A Nurse Led Stepped Wedge Cluster Randomized Control Trial.

PURPOSE: To implement a standardized Stir-up Regimen (deep breathing, coughing, repositioning, mobilization [moving arms/legs], assessing and managing pain and nausea) within the first 30 minutes of arrival in the postanesthesia care unit (PACU), with a goal of decreasing recovery time in the immediate postanesthesia period (Phase I). DESIGN: A pragmatic stepped wedge cluster randomized control trial. Initially, data were collected on time in Phase I in three PACUs (control). Subsequently, the same three units were randomized to sequentially transition to the Stir-up Regimen (intervention). METHODS: A stepped wedge cluster randomized control trial design was used to implement a standardized Stir-up Regimen in three PACUs in an academic hospital for adult patients who received at least 30 minutes of general anesthesia. The measured outcome was the PACU time in minutes from patient arrival to when the patient met Phase I discharge criteria. Differences between intervention and control groups were evaluated using a generalized mixed-effects model. Nurses were educated about the Stir-up Regimen in team huddles, in-services, video demonstrations, email notifications and reminders, and immediate feedback at the bedside. Implementation science principles were used to assess the adoption of the Stir-up Regimen through a presurvey, postsurvey and spot-check observations in all three PACUs. FINDINGS: A total of 5,809 PACU adult patient admissions were included: control group (n = 2,860); intervention group (n = 2,949); males (n = 2,602), and females (n = 3,206). The intervention was associated with a reduction in overall mean Phase I recovery time of 4.9 minutes (95% CI: -8.4 to -1.4, P = .007). One PACU decreased time by 9.6 minutes (95% CI: -15.3 to -4.0, P < .001). The other units also reduced Phase I recovery time, but this did not reach statistical significance. The spot-check observations confirmed the intervention was adopted by the nurses, as most interventions were nurse-initiated versus patient-initiated during the first 30 minutes in PACU. CONCLUSIONS: Standardization of a Stir-up Regimen within 30 minutes of patient PACU arrival resulted in decreased Phase I recovery time.

Comparison of a Pure Plug-Based Versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial.

BACKGROUND: Transcatheter aortic valve replacement is an established treatment option for patients with severe symptomatic aortic stenosis and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce. METHODS: The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure during Transfemoral Transcatheter Aortic Valve Implantation) is an investigator-initiated, multicenter study, in which patients undergoing transfemoral transcatheter aortic valve replacement were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular) potentially complemented by a small plug. The primary end point consisted of access site- or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary end points included the rate of access site- or access-related bleeding, VCD failure, and time to hemostasis. RESULTS: A total of 516 patients were included and randomly assigned. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary end point occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk, 1.61 [95% CI, 1.07-2.44], P=0.029). Access site- or access-related bleeding occurred in 11.6% versus 7.4% (relative risk, 1.58 [95%CI: 0.91-2.73], P=0.133) and device failure in 4.7% versus 5.4% (relative risk, 0.86, [95% CI, 0.40-1.82], P=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32-180] versus 240 [174-316] seconds, P<0.001). CONCLUSIONS: Among patients treated with transfemoral transcatheter aortic valve replacement, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access site- or access-related vascular complications but a shorter time to hemostasis compared with a primary suture-based technique using the ProGlide VCD. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04459208.

Three-Week Versus 4-Week Schedule of nab-Paclitaxel in Patients With Metastatic Breast Cancer: A Randomized Phase II Study.

BACKGROUND: This head-to-head study compared a 3-week versus 4-week schedule of nab-paclitaxel in patients with metastatic breast cancer (mBC). METHODS: Patients with HER2-negative mBC were enrolled and randomly assigned (1:1) to receive nab-paclitaxel for a 3-week schedule (125 mg/m2 on days 1 and 8) or a 4-week schedule (same dose on days 1, 8, and 15) until disease progression or treatment intolerance. Patients with intolerable toxicities were allowed to receive a maintenance regimen after benefiting from nab-paclitaxel. The primary endpoint was progression-free survival (PFS). RESULTS: Ninety-four patients were included in the analysis (n = 47 in each arm). A longer median PFS (mPFS) was observed in the 3-week versus the 4-week schedule in the overall population (not reached vs. 6.8 months; hazard ratio [HR] = 0.44; P = .029). Patients in the 2 arms had a similar overall survival (28.0 vs. 25.8 months), objective response rate (51.1% vs. 48.9%), and disease control rate (93.6% vs. 80.9%). The 3-week schedule was associated with a lower rate of toxicity-related treatment discontinuation (8.5% vs. 29.8%) and dose delays (6.4% vs. 23.4%). CONCLUSION: This study demonstrated the better antitumor activity and safety profile of a 3-week over 4-week nab-paclitaxel schedule in HER2-negative mBC, suggesting that a 3-week schedule may be a better treatment regimen in clinical practice (ClinicalTrials.gov Identifier: NCT04192331).