Cluster-randomized Trial Research Articles

Symptom prevalence in patients with advanced heart failure and its association with quality of life and activities of daily living.

Quality of life (QOL) and functional status are two key outcomes for patients with advanced heart failure (HF). We examined the association of eleven symptoms with QOL and functional status impairment in patients with advanced HF. This was a retrospective analysis of baseline data from a multi-center, cluster-randomized controlled trial (NCT01459744) which enrolled patients with an implanted cardioverter-defibrillator and advanced HF at high-risk for mortality. Study instruments included the Condensed Memorial Symptom Assessment Scale, the Kansas City Cardiomyopathy Questionnaire QOL subscale, and the number of activities of daily living (ADL) patients had difficulties with. The study included 413 subjects. In generalized linear models which were adjusted for baseline characteristics, the total number of symptoms was significantly associated with worse QOL, as was the presence of each individual symptom, except constipation. Lack of energy demonstrated the strongest negative association with QOL. Similarly, the total number of symptoms was associated with a higher number of ADL difficulties (i.e., worse functional status). The presence of pain, lack of energy and drowsiness was individually associated with more ADL difficulties. Among patients with advanced HF, a higher number of symptoms and specific individual symptoms were associated with worse QOL and functional status.

Hemagglutination-Inhibition Antibodies and Protection against Influenza Elicited by Inactivated and Live Attenuated Vaccines in Children.

Hemagglutinin (HA)-inhibiting antibodies contribute to the immune defense against influenza infection. However, there are insufficient data on the extent of correlation between vaccine-elicited HA antibodies and protection in children against different influenza strains, particularly when comparing live attenuated influenza vaccines (LAIV) versus inactivated influenza vaccines (IIV). We measured postvaccination hemagglutination-inhibition (HAI) titers in 3-15-year-old participants of a cluster-randomized controlled trial of trivalent LAIV(3) versus IIV(3) in Canadian Hutterite colonies. We assessed HAI titers as predictors of symptomatic, reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza over 3 influenza seasons using Cox proportional hazards regression models with vaccine type as a covariate. For each log2 unit increase in postvaccination HAI against A/H1N1 in 2013-2014, A/H3N2 2014-2015, and B/Yamagata in 2013-2014 (each the predominant circulating strain for the respective influenza season), the reduction in the risk of confirmed influenza was equal to 29.6% (95% confidence interval [CI], 17.1%-39.5%), 34.8% (95% CI, 17.2%-47.9%), and 31.8% (95% CI, 23.8%-38.5%), respectively. No reduction in the risk of influenza was observed with B/Yamagata-specific HAI titers in 2012-2013, which was dominated by a mixture of Yamagata and Victoria strains. Despite the overall lower HAI titers in the LAIV3 group, both H1N1 and H3N2 HAI titers were associated with protection against subtype matched influenza. Both LAIV3- and IIV3-elicited HA antibodies are associated with protection against influenza infection in seasons when the vaccine strains match the circulating influenza strain subtypes, supporting the use of HAI as a correlate of protection for both vaccine types in children.

Estimating an adjusted risk difference in a cluster randomized trial with individual-level analyses.

In cluster randomized trials (CRTs) with a binary outcome, intervention effects are usually reported as odds ratios, but the CONSORT statement advocates reporting both a relative and an absolute intervention effect. With a simulation study, we assessed several methods to estimate a risk difference (RD) in the framework of a CRT with adjustment on both individual- and cluster-level covariates. We considered both a conditional approach (with the generalized linear mixed model [GLMM]) and a marginal approach (with the generalized estimating equation [GEE]). For both approaches, we considered the Gaussian, binomial, and Poisson distributions. When considering the binomial or Poisson distribution, we used the g-computation method to estimate the RD. Convergence problems were observed with the GEE approach, especially with low intra-cluster coefficient correlation values, small number of clusters, small mean cluster size, high number of covariates, and prevalences close to 0. All methods reported no bias. The Gaussian distribution with both approaches and binomial and Poisson distributions with the GEE approach had satisfactory results in estimating the standard error. Results for type I error and coverage rates were better with the GEE than GLMM approach. We recommend using the Gaussian distribution because of its ease of use (the RD is estimated in one step only). The GEE approach should be preferred and replaced with the GLMM approach in cases of convergence problems.

Long-term clinical outcomes and healthcare resource utilization in male and female patients following hospitalization for heart failure.

Heart failure (HF) is a leading cause of hospitalization, and sex differences in care have been described. We assessed sex-specific clinical outcomes and healthcare resource utilization following hospitalization for HF. This was an exploratory analysis of patients hospitalized for HF across 10 Canadian hospitals in the Patient-Centered Care Transitions in HF (PACT-HF) cluster-randomized trial. The primary outcome was all-cause mortality. Secondary outcomes included all-cause readmissions, HF readmissions, emergency department (ED) visits, and healthcare resource utilization. Outcomes were obtained via linkages with administrative datasets. Among 4441 patients discharged alive, 50.7% were female. By 5 years, 63.6% and 65.5% of male and female patients, respectively, had died (p = 0.19); 85.4% and 84.4%, respectively, were readmitted (p = 0.35); and 72.2% and 70.9%, respectively, received ED care without hospitalization (p = 0.34). There were no sex differences in mean [SD] number of all-cause readmissions (males, 2.8 [7.8] and females, 3.0 [8.4], p = 0.54), HF readmissions (males, 0.9 [3.6] and females, 0.9 [4.5], p = 0.80), or ED visits (males, 1.8 [11.3] and females, 1.5 [6.0], p = 0.24) per person. There were no sex differences in mean [SD] annual direct healthcare cost per patient (males, $80 334 [116 762] versus females, $81 010 [112 625], p = 0.90), but males received more specialist, multidisciplinary HF clinic, haemodialysis, and day surgical care, and females received more home visits, continuing/convalescent care, and long-term care. Annualized clinical events were highest in first year following index discharge in both males and females. Among people discharged alive after hospitalization for HF, there were no sex differences in total and annual deaths, readmissions, and ED visits, or in total direct healthcare costs. Despite similar risk profiles, males received relatively more specialist care and day surgical procedures, and females received more supportive care. ClinicalTrials.gov NCT02112227.

Implementation of a Mobile Health Approach to a Long-Lasting Insecticidal Net Uptake Intervention for Malaria Prevention Among Pregnant Women in Tanzania: Process Evaluation of the Hati Salama (HASA) Randomized Controlled Trial Study.

Malaria infection is associated with many adverse outcomes for pregnant women and neonates, yet pregnant women in East and Southern Africa remain frequently exposed to malaria. Long-lasting insecticidal nets (LLINs) can help prevent malarial infections and the associated adverse events. The Hati Salama (HASA) study was a cluster-randomized controlled trial implemented in 100 antenatal health facilities in urban and rural settings of Tanzania that provided pregnant women in both intervention and control groups with e-vouchers to redeem for LLINs for malaria prevention. The intervention group received behavior change communication mobile messages across a 14-day period while the e-voucher was active, and no significant difference between the rates of e-voucher redemption was found across the two groups. This study was a process evaluation of the HASA randomized controlled trial to determine barriers and facilitators to e-voucher reception and LLIN acquisition for pregnant women enrolled in the trial, as well as challenges and lessons learned by nurses who worked at the antenatal health facilities supporting the trial. Following the e-voucher's expiration at 14 days, voluntary phone follow-up surveys were conducted for nurses who supported the trial, as well as participants in both intervention and control groups of the trial who did not redeem their e-vouchers. Survey questions asked nurses about workflow, training sessions, network connectivity, proxy phone use, and more. Surveys asked participants about reasons for not redeeming e-vouchers. Both surveys provided lists of preset answers to questions, as well as the option to provide open-ended responses. Nurses and trial participants were contacted between January and June 2016 on up to three occasions. While nurses who supported the HASA trial seemed to recognize the value of the program in their communities, some barriers identified by nurses included network connectivity, workload increase, inadequate training and on-the-ground support, and difficulty following the workflow. Several barriers identified by trial participants included personal obligations preventing them from redeeming the e-voucher on time, network connectivity issues, losing the e-voucher number, no stock of LLINs at retailers when attended, inadequate explanation of where or how to redeem the e-voucher, or not receiving an SMS text message with the e-voucher number promptly or at all. Large-scale e-voucher platforms for health-related commodity interventions, such as LLIN distribution in sub-Saharan Africa, are feasible, but challenges, including network connectivity, must be addressed. Nurses identified issues to be considered in a future scale-up, such that the number of nurses trained should be increased and the e-voucher issuance workflow should be simplified. To address some of the key barriers impacting e-voucher redemption for trial participants, the network of retailers could be expanded and the e-voucher expiration period should be extended. ClinicalTrials.gov NCT02561624; https://clinicaltrials.gov/ct2/show/NCT02561624.

The effectiveness of a problem-solving intervention with workplace involvement on self-reported sick leave, psychological symptoms and work ability: a cluster randomised clinical trial.

Problem-solving interventions with workplace involvement (PSI-WPI) have been shown to reduce sick leave and increase return to work in an occupational health services context. However, many employees struggle with reduced work functioning, anxiety-, and depressive symptoms up to 12months after a sick leave episode, and it is unclear if the intervention affects outcomes other than sick leave. The aim of this study is to investigate if a PSI-WPI added to care as usual (CAU) is superior to CAU with respect to self-reported sick leave, psychological symptoms, work ability, work performance, and health after RTW when provided in primary care. Employed individuals aged 18-59years on sick leave (2 to 12weeks) diagnosed by a physician at a primary care center with mild to moderate depression, anxiety, or adjustment disorder were enrolled in a two-armed cluster-randomised trial evaluating the effectiveness of a PSI-WPI. Multiple outcomes were recorded at baseline, six months, 12months, and every fourth week during the study period. Outcomes were categorised into psychological symptoms, health, work ability, work performance, and self-reported sick leave. Data were analysed using MANOVA, GEE (Generalized Estimating Equations), and cox regression. One hundred ninety-nine individuals responded to the invitation to participate; one participant withdrew, one was excluded as the employment ended, nine did not answer the baseline survey, and three were removed from the analysis due to missing data. The analysis included 81 subjects who received the intervention and 104 subjects who received the control. Baseline characteristics were similar across both groups. No differences between the groups were found among either variables except one. There was a significant difference between the groups in self-rated health (EQ5D) in favour of the CAU group from baseline to six-month follow-up, with a mean difference of -8.44 (-14.84, -2.04). A problem-solving intervention with workplace involvement added to CAU did not result in statistically significant reductions in outcomes. Further research is needed to understand why problem-solving interventions appear to have an effect on sick leave in an occupational health services context and not in a primary care context. NCT3346395, registration date 2017-11-17.

Predictors of HIV seroconversion in Botswana: machine learning analysis in a representative, population-based HIV incidence cohort.

To identify predictors of HIV acquisition in Botswana. We applied machine learning approaches to identify HIV risk predictors using existing data from a large, well-characterized HIV incidence cohort. We applied machine learning (randomForestSRC) to analyze data from a large population-based HIV incidence cohort enrolled in a cluster-randomized HIV prevention trial in 30 communities across Botswana. We sought to identify the most important risk factors for HIV acquisition, starting with 110 potential predictors. During a median 29-month follow-up of 8,551 HIV-negative adults, 147 (1.7%) acquired HIV. Our machine learning analysis found that for females, the most important variables for predicting HIV acquisition were the use of injectable hormonal contraception, frequency of sex in the prior 3 months with the most recent partner and residing in a community with HIV prevalence of 29% or higher. For the small proportion (0.3%) of females who had all three risk factors, their estimated probability of acquiring HIV during 29 months of follow-up was 34% (approximate annual incidence of 14%). For males, non-long-term relationships with the most recent partner and community HIV prevalence of 34% or higher were the most important HIV risk predictors. The 6% of males who had both risk factors had a 5.1% probability of acquiring HIV during the follow-up period (approximate annual incidence of 2.1%). Machine learning approaches allowed us to analyze a large number of variables to efficiently identify key factors strongly predictive of HIV risk. These factors could help target HIV prevention interventions in Botswana. NCT01965470.

The Clinical Interpretation of Cluster Trials.

Cluster-randomized trials randomize entire groups of participants, instead of individual participants, to different treatment arms. For certain interventions (eg, institutional policies, processes of care, treatment algorithms), these designs protect against contamination between study arms. However, cluster trials are logistically complex to implement and have unique vulnerabilities that must be evaluated for accurate interpretation. Here, we provide a general overview of the design and statistical issues in cluster trials to facilitate their interpretation by clinicians.

Improvement of Care Cascade for Hypertension and Diabetes in Rural China: Protocol for an Implementation Study.

The management of hypertension and diabetes poses significant challenges to China's healthcare system, necessitating seamless patient progression through screening, diagnosis, management, and control. Utilizing the care cascade model, this study aims to systematically identify patient drop-offs and devise strategies to address healthcare delivery bottlenecks for hypertension and diabetes in rural China. This study consists of three phases. In Phase 1, qualitative interviews are conducted to explore healthcare experiences and identify determinants across the care cascade. Phase 2 involves systematically assessing barriers identified in Phase 1 and collaborating with local stakeholders using intervention mapping and co-design to generate interventions and implementation strategies. Phase 3 is a cluster randomized controlled trial involving 48 villages, randomly assigned in a 1:1 ratio, to compare changes in hypertension and diabetes care. Intervention villages will implement interventions developed in Phase 2 for 1 year, while control villages will continue with usual care. Primary outcomes include between-group differences in achieving blood pressure and glycemic targets, along with service and implementation outcomes. This study aims to identify the stage with the largest patient retention gap in the care cascade and develop intervention strategies through participatory co-design with practitioners, emphasizing feasible, low-cost approaches. The pragmatic cluster RCT will assess strategy effectiveness, offering valuable insights for practical interventions to enhance hypertension and diabetes care in rural settings, potentially shaping impactful programs and improving healthcare outcomes. Trial Registration: ClinicalTrials.gov. identifier: NCT06141278.

School Poverty Level Moderates the Effectiveness of a Physical Activity Intervention.

To explore whether school poverty level and funding modified the effectiveness of an evidence-based Comprehensive School Physical Activity Program called Health Empowers You! implemented in elementary schools in Georgia. Secondary data analysis of a multi-level, cluster-randomized controlled trial. 40 elementary schools in Georgia in 2018-2019. 4th grade students in Georgia. Intervention schools implemented the Health Empowers You! program to increase school-day physical activity. The outcome was average daily moderate-to-vigorous physical activity, school free-reduced price lunch (FRPL) percentage and per pupil expenditures were effect modifiers. Separate linear mixed regression models estimated the effect of the intervention on average daily moderate-to-vigorous physical activity, with interaction terms between intervention status and (1) school FRPL percentage or (2) per pupil expenditures. The effect of the intervention was significantly higher in schools with higher FRPL percentage (intervention*school % FRPL β (95% CI): .06 (.01, .12)), and was modestly, but not statistically significantly, higher in schools with lower per pupil expenditures. Findings support the use of the Health Empowers You! intervention, which was effective in lower income schools, and may potentially reduce disparities in students' physical activity levels.

Estimating the effect of intervention compliance on long-term outcome trajectories: Application of the latent adherence growth curve model in a cluster-randomized trial of the good behavior game.

Estimating the effect of intervention compliance on long-term outcome trajectories: Application of the latent adherence growth curve model in a cluster-randomized trial of the good behavior game.

Effects of active breaks on educational achievement in children with and without ADHD: study protocol and rationale of the Break4Brain project

The Break4Brain project aims to elucidate the effects of both acute and chronic physical activity (PA) on educational achievement in children with and without Attention Deficit Hyperactivity Disorder (ADHD). This study will be conducted in two phases: a cross-over design followed by a hybrid type 1 implementation-effectiveness trial, which includes both a cluster randomized controlled trial (RCT) and a qualitative study. In phase I, 60 children aged 10–12, with 30 each from ADHD and non-ADHD groups, will participate in a laboratory-based study over 4 days within 1 month. They will participate in three counterbalanced experimental conditions: (i) PA with cognitive engagement, (ii) PA without cognitive engagement, and (iii) a cognitively engaging control. This phase will assess acute changes in brain function, academic performance, working memory, inhibitory control, and sustained attention. Phase II will involve 600 children aged 10–12, randomly assigned to either a video-based PA program or a control group (300 children per group) in an 8-week cluster RCT. This phase will also incorporate a qualitative approach to explore the implementation context through pre- and post-intervention semi-structured interviews with teachers and school staff, and questionnaires for students. The outcomes of interest in this phase will include working memory, cognitive flexibility, selective attention, and academic performance. For the cross-over study, we hypothesize that PA conditions will enhance the studied outcomes compared to the control condition. In the RCT, we anticipate that the 8-week active breaks program will result in significant improvements in the selected outcomes compared to the control group. This study is expected to make pioneering contributions by including novel variables and focusing on the ADHD population. Furthermore, if the cluster RCT proves effective, it could offer a practical and cost-effective resource for integrating active breaks into daily school routines.

Strategies to Limit Benzodiazepine Use in Anesthesia for Older Adults

Despite guidelines recommending avoidance of benzodiazepine administration to older patients, many of them now receive benzodiazepines as a part of anesthesia care. The effectiveness of clinician- and patient-facing interventions to discourage such use remains insufficiently characterized. To evaluate the effect of clinician peer comparison, patient informational mail, or a combination of these interventions compared with usual care on the rate of perioperative benzodiazepine administration to older patients. This 2 × 2 factorial, stepped-wedge, cluster randomized clinical trial of a corporate quality improvement initiative was conducted between August 8, 2022, and May 28, 2023, across 415 hospitals, surgery centers, and physician offices in 8 US states served by anesthesia clinicians from a national anesthesia practice. Participants were adults aged 65 years or older who underwent an elective surgical or endoscopic procedure with general anesthesia. Data analyses followed the intention-to-treat principle. Patients were randomly assigned to 1 of 4 groups-clinician peer comparison (wherein clinicians received feedback regarding their performance compared with other clinicians in the practice), patient informational mail (wherein patients received an informational letter encouraging them to have a discussion regarding medication selection with their clinician on the day of surgery), both interventions, or usual care (no intervention). Rate of benzodiazepine administration during anesthesia care and patient satisfaction with anesthesia care (measured by the Anesthesia Patient Satisfaction Questionnaire, version 2). Among the 509 269 enrolled participants (255 871 females [50.2%]; mean [SD] age, 74 [7] years), 81 363 (16.0%) were assigned to clinician peer comparison, 98 520 (19.3%) to patient informational mail, 169 712 (33.3%) to both interventions, and 159 674 (31.4%) to usual care. Among patients who received benzodiazepine during anesthesia care, 24.5% were in the usual care group compared with 19.7% in the clinician peer comparison group, 20.0% in the patient informational mail group, and 19.7% in the combination group. After adjustment for time, none of the study interventions were associated with lower odds of benzodiazepine administration compared with usual care (odds ratio [OR], 1.02 [95% CI, 0.98-1.07]; P = .35 for clinician peer comparison; OR, 1.01 [95% CI, 0.96-1.05]; P = .81 for patient informational mail; and OR, 1.11 [95% CI, 1.05-1.16]; P < .001 for combined interventions). Satisfaction scores were high in all groups and did not vary by treatment assignment. This randomized clinical trial found that clinician peer comparison, patient informational mail, or a combination of both interventions did not reduce benzodiazepine administration to older patients compared with usual care; patient satisfaction remained high throughout the study. Overall, the findings suggest a need to explore other patient-targeted interventions to improve anesthesia care. Clinicaltrials.gov Identifier: NCT05436392.

A Virtual Breakthrough Series Collaborative for Missed Test Results

Missed test results, defined as test results not followed up within an appropriate time frame, are common and lead to delays in diagnosis and treatment. To evaluate the effect of a quality improvement collaborative, the Virtual Breakthrough Series (VBTS), on the follow-up rate of 2 types of test results prone to being missed: chest imaging suspicious for lung cancer and laboratory findings suggestive of colorectal cancer. This stepped-wedge cluster-randomized clinical trial was conducted between February 2020 and March 2022 at 12 Department of Veterans Affairs (VA) medical centers, with a predefined 3-cohort roll-out. Each cohort was exposed to 3 phases: preintervention, action, and continuous improvement. Follow-up ranged from 0 to 12 months, depending on cohort. Teams at each site were led by a project leader and included diverse interdisciplinary representation, with a mix of clinical and technical experts, senior leaders, nursing champions, and other interdisciplinary team members. Analysis was conducted per protocol, and data were analyzed from April 2022 to March 2024. All teams participated in a VBTS, which included instruction on reducing rates of missed test results at their site. The primary outcome was changes in the percentage of abnormal test result follow-up, comparing the preintervention phase with the action phase. Secondary outcomes were effects across cohorts and the intervention's effect on sites with the highest and lowest preintervention follow-up rates. Previously validated electronic algorithms measured abnormal imaging and laboratory test result follow-up rates. A total of 11 teams completed the VBTS and implemented 47 (mean, 4 per team; range, 3-8 per team; mode, 3 per team) unique interventions to improve missed test results. A total of 40 027 colorectal cancer-related tests were performed, with 5130 abnormal results, of which 1286 results were flagged by the electronic trigger (e-trigger) algorithm as being missed. For lung cancer-related studies, 376 765 tests were performed, with 7314 abnormal results and 2436 flagged by the e-trigger as being missed. There was no significant difference in the percentage of abnormal test results followed up by study phase, consistent across all 3 cohorts. The estimated mean difference between the preintervention and action phases was -0.78 (95% CI, -6.88 to 5.31) percentage points for the colorectal e-trigger and 0.36 (95% CI, -5.19 to 5.9) percentage points for the lung e-trigger. However, there was a significant effect of the intervention by site, with the site with the lowest follow-up rate at baseline increasing its follow-up rate from 27.8% in the preintervention phase to 55.6% in the action phase. In this cluster-randomized clinical trial of the VBTS intervention, there was no improvement in the percentage of test results receiving follow-up. However, the VBTS may offer benefits for sites with low baseline performance. ClinicalTrials.gov Identifier: NCT04166240.

Effects of the informed health choices secondary school intervention after 1 year: a prospective meta-analysis using individual participant data

BackgroundCritical thinking about health choices is essential to avoid being misled by unreliable information and to use reliable information appropriately. The aim of this prospective meta-analysis was to synthesize the results of 1-year follow-up data from three cluster-randomized trials of an intervention designed to teach lower secondary school students to think critically about health choices. Only one other randomized trial has evaluated a school-based intervention to teach adolescents to think critically about health choices. That trial compared two teaching strategies to teach statistical reasoning. It did not assess long-term learning-retention.MethodsWe conducted the trials in Kenya, Rwanda, and Uganda. The intervention included providing a 2–3-day teacher training workshop and digital resources for ten lessons. The intervention focused on nine key concepts. We did not intervene in control schools. The primary outcome was a passing score on a test (≥ 9 of 18 multiple-choice questions answered correctly). We performed random effects meta-analyses to estimate the overall intervention effects. We calculated learning retention as the test results in the intervention schools after 1 year relative to just after the intervention, adjusted for chance.ResultsAltogether, 244 schools (11,344 students) took part in the three trials. Follow-up data was collected for 8298 students (73%). The overall odds ratio for the primary outcome after 1 year was 3.6 (95% CI: 1.9–7.1; p = 0.0001) in favor of the intervention, whereas it was 5.5 (95% CI: 3.0–10.2) just after the intervention. This corresponds to 25.6% (95% CI: 21.1–30.0%) more students in the intervention schools passing the test after 1 year versus 33.3% (95% CI: 28.7–37.8%) just after the intervention. Overall, 2273 (52.6%) of 4324 students in intervention schools had a passing score after 1 year compared to 3397 (58.1%) of 5846 students just after the intervention, indicating 88.3% learning retention.ConclusionsOne year after the intervention, we still found a positive effect on the ability of students to think critically about health choices, but 5.5% fewer students in the intervention schools had a passing score. The certainty of the evidence was also lower due to 27% of students being lost to follow-up.Trial registrationThe protocol for this prospective meta-analysis was registered with PROSPERO May 31, 2022, ID 336580. The three randomized trials were registered in the Pan African Clinical Trial Registry February 15, 2022, PACTR202203880375077; April 5, 2022, PACTR20220488391731; and April 14, 2022, PACTR202204861458660.

Credentialed pharmacist-led home medicines reviews targeting treatable traits and their impact on health outcomes in people with chronic obstructive pulmonary disease: a pre- and post-intervention study.

Patients with chronic obstructive pulmonary disease (COPD) should engage in self-management strategies targeting behavioural traits and lifestyle risk-factors for optimal outcomes. To evaluate the impact of credentialed pharmacist-led home medicines review (HMR) targeting treatable traits (TTs) on health outcomes in COPD in primary care. A pre- and post-intervention study was nested within a cluster-randomised controlled trial. A total of 81 participants with COPD from 21 Australian general practices received an HMR with a credentialed pharmacist targeting TTs. Changes in health outcomes at 6 and 12months from baseline were assessed. Ten TTs were assessed and targeted during the HMR. At baseline, no-one had a written action plan for managing exacerbations, and medication adherence was sub-optimal in 85% of patients. Additionally, 53% of participants demonstrated inadequate inhaler device technique, while 52% were current smokers. At 6-months follow-up, significant improvements were observed in health-related quality of life (St. George's Respiratory Questionnaire score = 34.6 versus 39.1 at baseline, p = 0.006), health status (COPD Assessment Test score = 12 versus 16, p = 0.002), anxiety (Hospital Anxiety and Depression Scale (HADS)-Anxiety score = 2.0 versus 5.0, p < 0.001), depression (HADS-Depression score = 1.0 versus 5.0, p < 0.001), self-reported smoking (47% versus 51.9%, p = 0.031) and treatment adherence (Tool for Adherence Behaviour Screening score = 12.5 versus 10.0, p = 0.002). At 12-months: health status, anxiety, depression, smoking abstinence and adherence to treatment, continued to show statistically significant improvements compared to baseline measurements. HMRs targeting TTs improved health outcomes in people with COPD. Credentialed pharmacists in primary care can work alongside general practitioners to optimise COPD management.

Estimated lifetime impact of a school-based intervention for mental health: A microsimulation study

Abstract Background The prevalence of childhood mental health problems is increasing. School-based interventions have the potential to reduce poor mental health and mental health inequalities. Our aim was to estimate the long-term costs and benefits of the Incredible Years Teacher® Classroom Management (IY-TCM) intervention in primary schools compared to no intervention. Methods LifeSim, an existing microsimulation model, was used to estimate the lifetime costs and benefits of IY-TCM by linking short-term changes in SDQ based on a previous trial in primary schools (Cluster RCT: 2075 children aged 4-9 years with a 30-month follow-up) to long-term health, social, economic and wellbeing outcomes. Benefits were measured in quality adjusted life years and wellbeing adjusted life years. We examined subgroup based on deprivation, conduct scores and parental depression. Results Microsimulation modelling estimated small gains in lifetime outcomes including reduced conduct disorder in adolescence and depression in adulthood. Estimates indicate IY-TCM could be cost-effective with a large amount of uncertainty (Net monetary benefit (NMB)=£21, Estimated CI = -£195, £240). IY-TCM was estimated to be more cost-effective for those with high deprivation (NMB = £231, Estimation CI - -£99, £231) and high conduct problem scores (NMB=£315, Estimated CI = £45, £483). Total net social benefit for a typical year size group was estimated to be £111m. Conclusions IY-TCM could be cost-effective compared to no intervention with a large estimated social benefit supporting wider implementation of IY-TCM, but results indicate a large amount of uncertainty. Greater benefits and higher certainty of cost-effectiveness for children with conduct problems and those living in a deprived area suggest IY-TCM has the potential to reduce mental health inequalities and may be more cost-effective for schools with higher deprivation and/or a high prevalence of conduct problems. Key messages • The Incredible Years Teacher Classroom Management intervention for mental health in primary schools could be considered cost-effective but there is a large amount of uncertainty. • Greater benefits for children with conduct problems and those living in a deprived area indicates the intervention has the potential to reduce mental health inequalities.

Representativeness of disadvantaged pupils in a trial to improve beverage consumption in Belgium

Abstract Background The cluster-randomized controlled trial DRINK was implemented in 2021 to evaluate the effect of interventions aimed at reducing sweetened beverages and increasing tap water consumption among children in French-speaking primary schools in Belgium. Multiple participation issues related to the implementation in the school setting were encountered. Our aim was to describe the individual characteristics of pupils at baseline and their participation in the data collection. Methods In 2021, out of a sample of 168 schools stratified by region and socioeconomic index (SEI), 46 were included. Children in grades 3 to 5 were asked to complete a 4-day diary to record all beverages consumed. Questionnaires were completed by children and parents, from which individual characteristics were summarised, such as the Family Affluence Scale (FAS; in three groups). Results School participation (overall: 29.0%) was higher in Wallonia (33.0%) than in Brussels (22.0%), and in schools with an intermediate SEI (33.0%). At baseline, a total of 3,631 children participated in the data collection, either through the 4-day diary, the child questionnaire, or the parent questionnaire; 2,013 completed all three instruments. Participating children were more likely to be girls, to have an intermediate FAS, to be born in Belgium, and to have two working parents. The proportion of children attending schools in the Brussels region was 27.9% of the total participating children and dropped to 11.5% for those who returned three valid questionnaires. The proportions of low FAS (14.4% to 11.8%), birth outside Belgium (11.8% to 8.7%), and low parents’ schooling (35.3% to 33.8%) were lower among children who completed the three instruments. Conclusions The low participation of Brussels schools, possibly exacerbated by the Covid-19 impact, may explain why disadvantaged children were less represented in the baseline sample. Such knowledge is valuable for interpreting the findings of such a trial. Key messages • Participation issues may have affected the representativeness of less advantaged children. • Documenting such disparities is key to understanding the context in which interventions were implemented.

The impact of a block-based visual programming curriculum: Untangling coding skills and computational thinking

Backgroundand Context: Computer programming is increasingly being taught to young children worldwide. Quality programming curricula are needed to enable students to explore computer science concepts and develop a positive attitude towards programming. However, few studies have been conducted on the available curricula for young learners. ObjectiveThis study aims to provide an evidence-based, public, and free computer science curriculum for early childhood education by investigating the efficacy of the CAL-ScratchJr curriculum, among second graders. MethodA cluster-randomized controlled trial involving 11 schools and 21 second-grade classrooms was conducted to examine the impact of the 24-lesson curriculum on students’ coding proficiency and computational thinking. FindingsThe results indicated that the CAL-ScratchJr curriculum intervention had a medium positive effect on second graders’ coding skills, but no significant impact on computational thinking. ImplicationsResults caution against incorporating disconnected abstract computational thinking practices in education. The features of the curriculum were discussed.

Sex-specific clinical outcomes and healthcare resource utilization in the 5 years following hospitalization for heart failure

Abstract Background Heart failure (HF) a leading cause of hospitalization, and sex differences in care have been described. Purpose We assessed sex-specific clinical outcomes and healthcare resource utilization following hospitalization for HF. Methods This was an exploratory analysis of patients hospitalized for HF across 10 Canadian hospitals enrolled in the Patient-Centred Care Transitions in HF pragmatic cluster-randomized trial. Primary outcome was all-cause mortality. Secondary outcomes included all-cause readmissions, HF readmissions, emergency department (ED) visits, and healthcare resource utilization. Outcomes were obtained via linkages with administrative datasets. Results The 4441 patients (50.7% female) had high event rates. At 5 years of follow-up, 63.6% male and 65.5% of male and female patients, respectively, had died (p=0.19); 85.4% and 84.4% of male and female patients, respectively, were readmitted with no sex differences in mean [SD] all-cause readmissions (males, 2.8 [7.8] and females, 3.0 [8.4], p=0.54) or HF readmissions (males, 0.9 [3.6] and females, 0.9 [4.5], p=0.80) per person. The mean (SD) annual total healthcare costs per patient was $80334 (116762) for males and $81010 (112625) for females, with no sex difference (p=0.90); however, there were sex differences in cost breakdown: males incurred greater costs from specialist, hemodialysis, and day surgical care, and females incurred greater costs from home visits and long-term care. Conclusions Males and females were at similarly high risk of mortality and readmissions, and had similar total healthcare costs following hospitalized for HF. Notwithstanding similar risks, males received relatively more specialist and invasive care, and females received relatively more supportive care.