Cluster-randomized Trial Research Articles

A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: statistical analysis plan for a pragmatic cluster randomised controlled trial

BackgroundGlobally, violence against children poses substantial health and economic challenges, with estimated costs nearing USD 7 trillion. This prompts the urgent call for effective evidence-based interventions in preventing and mitigating violence against children. ParentApp is a mobile, open-source application designed to offer a remote version of the Parenting for Lifelong Health (PLH) programme. ParentApp is the first digital parenting intervention for caregivers of adolescents aged 10–17 years to be tested in low- and middle-income settings.MethodsThis study is a pragmatic, two-arm, cluster-randomised trial in Mwanza, Tanzania’s urban and peri-urban areas. Assessments are set for baseline, 1 month post-intervention, and 12 months post-intervention. We randomised 80 clusters, each with about 30 caregiver-adolescent dyads, with a 1:1 ratio stratified by urban or peri-urban location. Both arms receive an entry-level smartphone preloaded with Kiswahili apps—ParentApp for intervention and WashApp control.The primary method of analysis will be generalised linear mixed-effects models with adjustment for person-level characteristics and multiple imputation. In three-level models, measurement waves are nested within a person, nested within a sub-ward. Regressions will constrain groups to be equal at baseline and include covariates for stratification, percentage of male caregivers, and individual-level characteristics.DiscussionsPreparations for the trial began in December 2022, including community mobilisation and sensitisation. Rolling recruitment, baseline data collection, and implementation onboarding took place between April and September 2023. One-month post-test data collection began in August 2023 and thus far achieved 97% and 94% retention rates for caregivers and adolescents respectively. Final post-test data collection will begin in September 2024, anticipated to run until April 2025. This SAP was submitted to the journal before the interim analysis to preserve scientific integrity under a superiority hypothesis testing framework.Trial registrationThe trial was registered on the Open Science Framework on 14 March 2023: https://doi.org/10.17605/OSF.IO/T9FXZ.The trial protocol was published in Trials 25, 119 (2024): Baerecke, L., Ornellas, A., Wamoyi, J. et al. A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial. Trials 25, 119 (2024). https://doi.org/10.1186/s13063-023-07893-x.

Effects of a staff-led multicomponent physical activity intervention on preschooler's fundamental motor skills and physical fitness: The ACTNOW cluster-randomized controlled trial

BackgroundFundamental motor skills (FMS) and physical fitness (FIT) play important roles in child development and provide a foundation for lifelong participation in physical activity (PA). Unfortunately, many children have suboptimal levels of PA, FMS, and FIT. The Active Learning Norwegian Preschool(er)s (ACTNOW) study investigated the effects of a staff-led PA intervention on FMS, FIT, and PA in 3–5-year-old children.MethodsPreschools in Western Norway having ≥ six 3–4-year-old children were invited (n = 56). Of these, 46 agreed to participate and were cluster-randomized into an intervention (n = 23 preschools [381 children, 3.8 yrs., 55% boys]) or a control group (n = 23 [438, 3.7 yrs., 52% boys]). Intervention preschools participated in an 18-month PA intervention involving a 7-month staff professional development between 2019 and 2022, amounting to 50 h, including face-to-face seminars, webinars, and digital lectures. Primary outcomes in ACTNOW were cognition variables, whereas this study investigated effects on secondary outcomes. FMS was measured through 9 items covering locomotor, object control, and balance skills. FIT was assessed as motor fitness (4 × 10 shuttle-run test) and upper and lower muscular strength (handgrip and standing long jump). PA was measured with accelerometers (ActiGraph GT3X +). All measures took place at baseline, 7-, and 18-month follow-up. Effects were analysed using a repeated measures linear mixed model with child and preschool as random effects and with adjustment for baseline scores.ResultsParticipants in the intervention preschools showed positive, significant effects for object control skills at 7 months (standardized effect size (ES) = 0.17) and locomotor skills at 18 months (ES = 0.21) relative to controls. A negative effect was found for handgrip strength (ES = -0.16) at 7 months. No effects were found for balance skills, standing long jump, or motor fitness. During preschool hours, sedentary time decreased (ES = -0.18), and light (ES = 0.14) and moderate-to-vigorous PA (ES = 0.16) increased at 7 months, whereas light PA decreased at 18 months (ES = -0.15), for intervention vs control. No effects were found for other intensities or full day PA.ConclusionsThe ACTNOW intervention improved some FMS outcomes and increased PA short-term. Further research is needed to investigate how to improve effectiveness of staff-led PA interventions and achieve sustainable improvements in children’s PA, FMS, and FIT.Trial registrationClinicaltrials.gov, identifier NCT04048967, registered August 7, 2019.FundingACTNOW was supported by the Research Council of Norway (grant number 287903), the County Governor of Sogn og Fjordane, the Sparebanken Sogn og Fjordane Foundation, and the Western Norway University of Applied Sciences.

Understanding modifiable caregiver factors contributing to child development among young children in rural Malawi.

This study examined modifiable caregiver factors influencing child development in Malawi using baseline data from 1,021 mothers and their children <2 years of age participating in a cluster-randomized controlled trial implemented in rural Malawi (2022-2025). We fit an evidence-based theoretical model using structural equation modelling examining four caregiver factors: (1) diet diversity (sum of food groups consumed in the past 24 h), (2) empowerment (assessed using the project-level Women's Empowerment in Agriculture Index), (3) mental health (assessed using the Self-Reported Questionnaire, SRQ-20), and (4) stimulation (number of stimulation activities the mother engaged in the past 3 days). Child development was assessed using the Malawi Development Assessment Tool (norm-referenced aggregate Z-score). The model controlled for child, caregiver, and household socioeconomic characteristics. Results showed that caregiver dietary diversity was directly associated with higher child development scores (standardized coefficient 0.091 [95% CI 0.027, 0.153]) and lower SRQ-20 scores -0.058 (-0.111, -0.006). Empowerment was directly associated with higher child development scores (0.071 [0.007, 0.133]), higher stimulation score (0.074 [0.013, 0.140]), higher dietary diversity (0.085 [0.016, 0.145]), and lower SRQ-20 scores (-0.068 [-0.137, -0.002]). Further, higher empowerment was indirectly associated with improved child development through enhancement of caregiver dietary diversity, with an indirect effect of 0.008 (0.002, 0.018). These findings highlight the important role that caregiver diet and empowerment play in directly influencing child development and other aspects of caregiver well-being. Interventions aimed at enhancing child development should consider these factors as potential targets to improve outcomes for children and caregivers.

Effect of Primary Arthroplasty on Post Treatment Results among Elderly with Pertrochanteric Femur Fracture

Abstract Background With an increasing global incidence of hip fractures, designing ppropriate treatment strategies for hip fractures is fundamentally important to healthcare professionals. Evaluation of the role of 1ry arthroplasty in the setting of trauma for the acute treatment of hip fractures will be fulfilled. Aim of the Work to review the literature to know the best arthroplastic option for elderly people with pertrochantric fracture and compare between them as regard post-operative complications (infections, bed sores, pneumonia and other chest infections, dislocations), post-operative functional outcome, post-operative dislocation, rate of revision surgrey. Patients and Methods The included studies were randomized controlled trials, including cluster RCTs, controlled (non-randomized) clinical trials or cluster trials, prospective and retrospective comparative cohort studies, and case-control or nested case-control studies. The excluded studies were cross-sectional studies, case series, case reports and literature not in English. Results after extraction of non-compatible studies as regard our priciples, we setteled on 18 studies that compare different types of primary arthroplasty and their post operative outcome among elderly with pertrochanteric femur fracture. We found some heterogenty in the results of some studies but we overcome this problem by using other methods for comparison.Another problem is lack of studies that compare among interventios in some comparative points. Among these studies We found that, as regard postoperative functional outcome and harris hip scoring (HHS), dual mobility arthroplasty(DMA) is higher than Total Hip Arthroplasty (THA). Total hip arthroplasty (THA) is also higher than (BHA) in the score. Conclusion As the general population is getting older while staying active, faster and more complete rehabilitation as well as decreased complication rate must be achieved for these patients.

Total Hip Arthroplasty versus Hemiarthroplasty for the Treatment of Displaced Femoral Neck Fracture in Elderly

Abstract Background Displaced intracapsular hip fractures are most commonly treated using either total hip arthroplasty (THA) or hemiarthroplasty. Aim of the Work To review systematically studies about the use of Total hip arthroplasty Versus hemiarthoplasty in management of displaced femoral neck fracture in elderly. Patients and Methods We included randomized controlled trials, including cluster RCTs, controlled (non-randomized) clinical trials or cluster trials, prospective and retrospective comparative cohort studies, and case-control or nested case-control studies. We excluded cross-sectional studies, case series, and case reports. Search results were uploaded to systematic review management software and manually screened for eligibility to be included. PRISMA flowchart were produced based on the search results and the inclusion/exclusion criteria. Results In our study there was statistically significant increase in the incidence of Reoperation in total hip arthroplasty (3.5%) than hemiarthroplasty (2.3%) with p-value &amp;lt; 0.001. Regarding Dislocation, there was statistically significant increase in the incidence of Dislocation in total hip arthroplasty (3.2%) than hemiarthroplasty (1.7%) with p-value &amp;lt; 0.001. Regarding Infection there was statistically significant increase in the incidence of Infection in total hip arthroplasty (4.5%) than hemiarthroplasty (3.4%) with p- value &amp;lt; 0.001. Regarding General Complications including: (Pneumonia – DVT- Pulmonary embolism- Myocardial infarct- Cerebral vascular lesion- Acute kidney failure- life threatening complications there was statistically no significant difference in the incidence of General complications in hemiarthroplasty (5.5%) and total hip arthroplasty (5.4%) with p-value = 0.608. Conclusions The authors concluded that DMTHA offered a better functional outcome than BA with no significant complications or mortality, and there was no significant difference between DMTHA and BA in the rate of dislocation.

Treatment of Acute Acromioclavicular Joint Dislocation Using Hook Plate: A Systematic Review and Meta-Analysis and Update of Current Literature

Abstract Background the hook plate metallic device showed early promise as an alternative implant to treat unstable acromioclavicular joint dislocation injuries. The hook plate can be used to provide an indirect reduction of a distal clavicle fracture. This indirect reduction technique is useful for comminuted fractures or fractures with very small distal fragments in which conventional reduction and fixation is difficult. Aim of the Work to evaluate the treatment of acute acromioclavicular joint dislocation and radiographic outcomes. Materials and Methods Studies were considered eligible if they expressed treatment of acromioclavicular joint dislocation using the hook plate and described the patient's clinical and functional outcomes; intra-operative, post-operative complications, full-text articles were available, randomized controlled trials, including cluster RCTs, controlled (non-randomized) clinical trials or cluster trials, prospective and retrospective comparative cohort studies, and case-control or nested case-control studies. We will exclude cross-sectional studies, case series, case reports and literature not in English. All items that didn't match the above criteria were excluded. Results The total studies included 270 patients with average mean age 35.5 years and mean follow up 25.33 months. The Constant Murely score average 84 points (The CMS was developed for the evaluation of shoulder function with subjective and objective components) and the p value &amp;lt;.05 that means all patients had significant improvement. Full range of motion could be achieved in the patients. Patients with restrictions of range of motion mainly showed limitations in abduction and external rotation. These limitations are most probably caused by the post-operative immobilization, which is necessary after implantation of hook plates to ensure healing of the ligament structures and avoid damage of the acromion by the hook itself. Other studies also showed restrictions of range of motion for abduction and external rotation after hook plate implantation. Conclusion it has a good to excellent Constant Murely score (full range of motion) that enables quick return to activities. It is useful for (Rockwood III-VI). So good clinical results can be achieved with hook plate.

A cluster-randomized trial of client and provider directed financial interventions to align incentives with appropriate case management in private medicine retailers: Results of the TESTsmART trial in Lagos, Nigeria.

Malaria remains a major health priority in Nigeria. Among children with fever who seek care, less than a quarter gets tested for malaria, leading to inappropriate use of the recommended treatment for malaria; Artemisinin-based Combination Therapy (ACT). Here we test an innovative strategy to target ACT subsidies to clients seeking care in Nigeria's private retail health sector who have a confirmed malaria diagnosis. We supported point-of-care malaria testing (mRDTs) in 48 Private Medicine Retailers (PMRs) in the city of Lagos, Nigeria and randomized them to two study arms; a control arm offering subsidized mRDT testing for USD $0.66, and an intervention arm where, in addition to access to subsidized testing as in the control arm, clients who received a positive mRDT at the PMR were eligible for a free (fully subsidized) first-line ACT and PMRs received USD $0.2 for every mRDT performed. Our primary outcome was the proportion of ACTs dispensed to individuals with a positive diagnostic test. Secondary outcomes included proportion of clients who were tested at the PMR and adherence to diagnostic test results. Overall, 23% of clients chose to test at the PMR. Test results seemed to inform treatment decisions and resulted in enhanced targeting of ACTs to confirmed malaria cases with only 26% of test-negative clients purchasing an ACT compared to 58% of untested clients. However, the intervention did not offer further improvements, compared to the control arm, in testing rates or dispensing of ACTs to test-positive clients. We found that ACT subsidies were not passed on to clients testing positive in the intervention arm. We conclude that mRDTs could reduce ACT overconsumption in Nigeria's private retail health sector, but PMR-oriented incentive structures are difficult to implement and may need to be complemented with interventions targeting clients of PMRs to increase test uptake and adherence. Trials registration: Clinical Trials Registration Number: NCT04428307. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816435/ Correction: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9476591/.

Changes in risk behaviour following a network peer education intervention for HIV prevention among male Tajik migrants who inject drugs in Moscow: a cluster-randomized controlled trial.

The "Migrants' Approached Self-Learning Intervention in HIV/AIDS for Tajiks" (MASLIHAT) recruits and trains Tajik labour migrants who inject drugs as peer educators (PEs) in delivering HIV prevention information and encouragement to adopt risk-reduction norms and practices within their diaspora social networks while reducing their own HIV risk. The MASLIHAT intervention was tested in Moscow in a cluster-randomized controlled trial with 12 recruitment sites assigned to either the MASLIHAT intervention or an equal-time peer-educator training focused on other health conditions (TANSIHAT). From October 2021 to April 2022, 140 male Tajik migrants who inject drugs were recruited as PEs to attend the 5-session MASLIHAT training or the TANSIHAT non-HIV comparison condition. Each participant in both groups recruited two network members (NMs) who inject drugs with the intent to share with them the information and positive strategies for change they had learned (n = 280). All PEs and NMs (n = 420) participated in baseline and follow-up interviews at 3-month intervals for 1 year. All received HIV counselling and testing. Modified mixed effects Poisson regressions tested for group differences in injection practices, sexual risk behaviours and heavy alcohol use over time. At baseline, across both groups, 75% of participants reported receptive syringe sharing (RSS), 42% reported condomless sex and 20% reported binge drinking at least once a month. In contrast to TANSIHAT where HIV risk behaviours remained the same, significant intervention effects that were sustained over the 12 months were observed for receptive syringe and ancillary equipment sharing among both MASLIHAT PEs and NMs (p < 0.0001). Significant declines in the prevalence of sexual risk behaviours were also associated with the MASLIHAT intervention (p < 0.01), but not the comparison condition. Binge alcohol use was not affected in either condition; the MASLIHAT intervention had a transitory effect on drinking frequency that dissipated after 9 months. The MASLIHAT peer-education intervention proved highly effective in reducing HIV-related injection risk behaviour, and moderately effective in reducing sexual risk behaviour among both PEs and NMs. Network-based peer education is an important tool for HIV prevention among people who inject drugs, especially in environments that are not amenable to community-based harm reduction.

The Effect of Two Health Education Packages on Nutritional Knowledge, Practices, and Physical Activity Levels Among School-Going Adolescents in Rishikesh: A Cluster Randomized Trial.

Introduction Adolescence is a critical period known for presenting specific challenges in disease treatment and health promotion. Studies have highlighted that increased nutritional awareness is associated with healthier eating habits, while regular physical activity aids in controlling and preventing non-communicable diseases. Equipping adolescents with health education in schools prepares them to adopt and maintain healthy lifestyles throughout their lives. To assess and compare the efficacy of health education packages targeting nutrition knowledge, practices, and physical activity levels, a cluster-randomized trial was conducted among school-going adolescents. Methodology Two distinct health education packages were developed for the two intervention groups. In group 1, a health talk supported by a flip chart was delivered, followed by pamphlet distribution. In contrast, in group 2, only information pamphlets were distributed. The study was conducted in government schools in Rishikesh, with four schools selected. Two schools were randomly allocated to each intervention arm. In each school, a questionnaire was administered to assess the students' nutrition knowledge, practicesand physical activity levels. This was followed by the intervention, and the students were reassessed for the same parameters after two weeks. Result The pre-intervention and post-intervention comparisons within the same group- the mean scores for nutrition knowledge, food practice, sleep duration, and recreational screen time were comparable in the intervention group 1 (p>0.05). There was a decrease in the mean physical activity score and screen time for studies in intervention group 1, and these differences were statistically significant (p<0.05). The mean scores for nutrition knowledge, physical activity, sleep duration, and screen time for studies were comparable in the intervention group 2 (p>0.05). There was an increase in the mean food practice score and a decrease in recreational screen time in intervention group 2, and these differences were statistically significant (p<0.05). On comparing the groups with each other, it was found thatGroup 2 exhibited a significantly higher mean food practice score compared to group 1 post-intervention. While there was a statistically significant decrease in the mean physical activity score in intervention group 1, this group still had higher physical activity levels than group 2.Post-intervention, group 2 exhibited a higher screen time for studies compared to group 1. Both groups had comparable sleep durations at baseline and post-intervention, with intervention group 1's mean sleep duration falling within the recommended range set by the American Academy of Sleep Medicine. Regression analysis provided valuable insights into the relationship between baseline values of various variables and their post-intervention values, aiding in understanding the impact of the health education packages. Conclusion The findings emphasize the significance of incorporating nutrition and physical activity education into the curriculum of students.

Conquering hypertension in Vietnam: 12- month follow up results from a cluster-randomised controlled trial

BackgroundApproximately 20% of adults in Vietnam have hypertension, and management of this chronic condition remains challenging. This study aimed to assess the effectiveness of a multicomponent intervention in reducing blood pressure (BP) in adults with uncontrolled hypertension. MethodsThis cluster randomised controlled trial was conducted in sixteen communities (8 intervention and 8 comparison) in a rural setting in Vietnam (2017-2022). Consenting adults (aged≥18 years) with uncontrolled hypertension were enrolled. Sixteen communities were equally randomised to an intervention or comparison group stratified by district. Consenting adults were assigned to study groups by community. The comparison arm received training sessions about hypertension prevention and management for health workers, and patient education materials. The intervention arm received training sessions about hypertension prevention and management for health workers, and patient education materials and three enhancement components including a storytelling intervention, home BP self-monitoring, and expanded community health worker services. The primary outcome was the difference in changes in patient’s levels of systolic BP between the study groups over a 12-month follow-up period. Patients and outcome assessors were masked. FindingsA total of 671 patients (340: intervention, 331: comparison) were enrolled in the trial. The mean age was 66 years and 45% were men. At the 12-month follow-up, the mean systolic BP declined by 18.4 mmHg in the intervention group and 3.7 mmHg in the control group (differential decline of 14.7 mmHg [95% CI: 11.8 – 17.6]). The intervention group also achieved better BP control and medication adherence than the control group. There were no serious adverse events related to study participation. InterpretationThe results of this trial demonstrate that a multicomponent intervention can effectively reduce elevated BP in individuals with uncontrolled hypertension in Vietnam. Trial registrationThis trial was registered at ClinicalTrials.gov, NCT03590691. FundingNational Heart, Lung, and Blood Institute

The ESSAG-trial protocol: A randomized controlled trial evaluating the efficacy of offering a self-sampling kit by the GP to reach women underscreened in the routine cervical cancer screening program

BackgroundIn Flanders (Belgium), women not screened for cervical cancer (CC) within the last three years receive an invitation letter from the regional screening organization, the Centre for Cancer Detection (CCD), encouraging them to have a cervical specimen taken by their general practitioner (GP) or gynecologist. However, the coverage for CC screening remains suboptimal (63%). The offer of a self-sampling kit (SSK, for HPV testing) by a GP may trigger participation among women who do not attend regular screening. MethodsThe ESSAG-trial is a cluster-randomized controlled trial with three arms, each including 1125 women aged 31–64 years, who were not screened for CC in the last 6 years. In arm A, GPs offer a SSK when eligible women consult for any reason. In arm B, women receive a personal GP signed invitation letter including an SSK at their home address. In the control arm, women receive the standard invitation letter from the CCD. The primary outcome is the response rate at three months after inclusion. Secondary outcomes are: screen test positivity; compliance with foreseen follow-up among screen-positives; costs per invited and per screened women; as well as contrasts between trial arms and between socio-demographic categories. ConclusionThe ESSAG-trial will assess the effect of GP-based interventions using SSKs on CC screening participation among hard-to-reach populations. Findings will inform policymakers about feasible strategies on increasing CC screening that may be rolled-out throughout the whole region. Trial registrationClinicalTrials.gov: NCT05656976

Perinatal Morbidity Among Women With a Previous Cesarean Delivery (PRISMA Trial): A Cluster-Randomized Trial

(Abstracted from Lancet 2024;403:44–54) Women who have delivered a baby via cesarean section have a difficult choice when it comes to delivering a second child: delivery via a second cesarean or attempting vaginal delivery, both of which are associated with some risks to both mother and baby. Recent studies have shown evidence that provider support for decision-making is vital in minimizing risk.

Unit costs and cost-effectiveness of a device to improve TB treatment adherence in China.

Adherence to TB drugs is crucial for improving treatment outcomes. Digital adherence technologies can improve adherence; however, there is a lack of evidence on cost-effectiveness. This study aimed to explore the cost-effectiveness of medication event reminder monitors (MERM) in China compared with the standard of care, using results from a pragmatic, cluster-randomised superiority trial of an electronic MERM in China. We collected primary unit cost data from the societal perspective, both at and above the health facility level. We estimated the incremental cost-effectiveness of MERM using a Markov model with a 20-year time horizon; a 3% discount rate was applied to costs and outcomes. We explored uncertainty through a series of sensitivity and scenario analyses. The incremental cost of MERM was $27.22 per patient. Probabilistic sensitivity analysis showed significant uncertainty about the intervention's cost-effectiveness. Changing assumptions around key parameters substantially affected our estimated incremental cost-effectiveness ratio. Although the incremental cost of the MERM box was low, current evidence does not indicate that the intervention would be cost-effective. However, the intervention's cost-effectiveness could improve if implemented as part of a broader strategy, including enhanced patient management.

Two-Year Outcomes of Umbilical Cord Milking in Nonvigorous Infants

Compared with early cord clamping (ECC), umbilical cord milking (UCM) reduces delivery room cardiorespiratory support, hypoxic-ischemic encephalopathy, and therapeutic hypothermia in nonvigorous near-term and full-term infants. However, UCM postdischarge outcomes are not known. To determine the 2-year outcomes of children randomized to UCM or ECC at birth in the Milking in Nonvigorous Infants (MINVI) trial. A secondary analysis to evaluate longer-term outcomes of a cluster-randomized crossover trial was conducted from January 9, 2021, to September 25, 2023. The primary trial took place in 10 medical centers in the US, Canada, and Poland from January 5, 2019, to June 1, 2021, and hypothesized that UCM would reduce admission to the neonatal intensive care unit compared with ECC; follow-up concluded September 26, 2023. The population included near-term and full-term infants aged 35 to 42 weeks' gestation at birth who were nonvigorous; families provided consent to complete developmental screening questionnaires through age 2 years. UCM and ECC. Ages and Stages Questionnaire, 3rd Edition (ASQ-3) and Modified Checklist for Autism in Toddlers, Revised/Follow-Up (M-CHAT-R/F) questionnaires at ages 22 to 26 months. Intention-to-treat analysis and per-protocol analyses were used. Among 1730 newborns from the primary trial, long-term outcomes were evaluated in 971 children (81%) who had ASQ-3 scores available at 2 years or died before age 2 years and 927 children (77%) who had M-CHAT-R/F scores or died before age 2 years. Maternal and neonatal characteristics by treatment group were similar, with median birth gestational age of 39 (IQR, 38-40) weeks in both groups; 224 infants (45%) in the UCM group and 201 (43%) in the ECC group were female. The median ASQ-3 total scores were similar (UCM: 255 [IQR, 225-280] vs ECC: 255 [IQR, 230-280]; P = .87), with no significant differences in the ASQ-3 subdomains. Medium- to high-risk M-CHAT-R/F scores were also similar (UCM, 9% [45 of 486] vs ECC, 8% [37 of 441]; P = .86). In this secondary analysis of a randomized clinical trial among late near-term and full-term infants who were nonvigorous at birth, ASQ-3 scores at age 2 years were not significantly different between the UCM and ECC groups. Combined with previously reported important short-term benefits, this follow-up study suggests UCM is a feasible, no-cost intervention without longer-term neurodevelopmental risks of cord milking in nonvigorous near-term and term newborns. ClinicalTrials.gov Identifier: NCT03631940.

Redisplacement of reduced distal radius fractures in adults: does the type of casting play a role? The CAST study, a multicentre cluster randomized controlled trial.

It is not clear which type of casting provides the best initial treatment in adults with a distal radial fracture. Given that between 32% and 64% of adequately reduced fractures redisplace during immobilization in a cast, preventing redisplacement and a disabling malunion or secondary surgery is an aim of treatment. In this study, we investigated whether circumferential casting leads to fewer the redisplacement of fewer fractures and better one-year outcomes compared with plaster splinting. In a pragmatic, open-label, multicentre, two-period cluster-randomized superiority trial, we compared these two types of casting. Recruitment took place in ten hospitals. Eligible patients aged ≥ 18 years with a displaced distal radial fracture, which was acceptably aligned after closed reduction, were included. The primary outcome measure was the rate of redisplacement within five weeks of immobilization. Secondary outcomes were the rate of complaints relating to the cast, clinical outcomes at three months, patient-reported outcome measures (PROMs) (using the numerical rating scale (NRS), the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and Patient-Rated Wrist/Hand Evaluation (PRWHE) scores), and adverse events such as the development of compartment syndrome during one year of follow-up. We used multivariable mixed-effects logistic regression for the analysis of the primary outcome measure. The study included 420 patients. There was no significant difference between the rate of redisplacement of the fracture between the groups: 47% (n = 88) for those treated with a plaster splint and 49% (n = 90) for those treated with a circumferential cast (odds ratio 1.05 (95% confidence interval (CI) 0.65 to 1.70); p = 0.854). Patients treated in a plaster splint reported significantly more pain than those treated with a circumferential cast, during the first week of treatment (estimated mean NRS 4.7 (95% CI 4.3 to 5.1) vs 4.1 (95% CI 3.7 to 4.4); p = 0.014). The rate of complaints relating to the cast, clinical outcomes and PROMs did not differ significantly between the groups (p > 0.05). Compartment syndrome did not occur. Circumferential casting did not result in a significantly different rate of redisplacement of the fracture compared with the use of a plaster splint. There were comparable outcomes in both groups.

RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial: Study rationale and design

Out-of-hospital cardiac arrest (OHCA) occurs in nearly 350,000 people each year in the United States (US). Despite advances in pre- and in-hospital care, OHCA survival remains low and is highly variable across systems and regions. The critical barrier to improving cardiac arrest outcomes is not a lack of knowledge about effective interventions, but rather the widespread lack of systems of care to deliver interventions known to be successful. The RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial is a 7-year pragmatic, cluster-randomized trial of 60 counties (57 clusters) in North Carolina using an established registry and is testing whether implementation of a customized set of strategically targeted community-based interventions improves survival to hospital discharge with good neurologic function in OHCA relative to control/standard care. The multi-faceted intervention comprises rapid cardiac arrest recognition and systematic bystander CPR instructions by 9-1-1 telecommunicators, comprehensive community CPR training and enhanced early automated external defibrillator (AED) use prior to emergency medical systems (EMS) arrival. Approximately 20,000 patients are expected to be enrolled in the RACE CARS Trial over 4 years of the assessment period. The primary endpoint is survival to hospital discharge with good neurologic outcome defined as a cerebral performance category (CPC) of 1 or 2. Secondary outcomes include the rate of bystander CPR, defibrillation prior to arrival of EMS, and quality of life. We aim to identify successful community- and systems-based strategies to improve outcomes of OHCA using a cluster randomized-controlled trial design that aims to provide a high level of evidence for future application.

App-Based Addiction Prevention at German Vocational Schools: Implementation and Reach for a Cluster-Randomized Controlled Trial

This article examines the implementation, participation rates, and potential determinants of participation in the digital addiction prevention program “ready4life.” A two-arm cluster-randomized trial recruited German vocational students via class-based strategies. Intervention group received 16 weeks of in-app coaching; the control group received health behavior information, with coaching offered after 12 months. Potential determinants of participation were analyzed based on class and individual characteristics. Out of 525 contacted schools, 35 participated, enrolling 376 classes. Implementation during the pandemic required flexible adjustments, with 49.7% of introductions conducted in person, 43.1% digitally via online streaming, and 7.2% received a video link via email. Despite challenges, 72.3% of the vocational students downloaded the app, and 46.7% gave informed consent. Participation rates were highest among (associate) professionals, vocational grammar school classes, classes introduced by females, younger individuals, members of the project team, and classes introduced face-to-face. Female gender, lower social competencies, lifetime cannabis use, higher problematic internet use, and higher perceived stress were associated with higher individual participation. The study highlights the importance of proactive outreach and personalized interventions for addiction prevention programs in vocational schools. While reached students aligned with the aims of the app, tailored recruitment strategies could enhance engagement among under-represented groups. The trial was registered in the German Clinical Trials Register (DRKS): DRKS00022328; registration date 09.10.2020.

Using FRAME to characterize provider-identified adaptations to a stepped care intervention for adolescents and youth living with HIV in Kenya: a mixed methods approach.

The Data-informed Stepped Care (DiSC) study is a cluster-randomized trial implemented in 24 HIV care clinics in Kenya, aimed at improving retention in care for adolescents and youth living with HIV (AYLHIV). DiSC is a multi-component intervention that assigns AYLHIV to different intensity (steps) of services according to risk. We used the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) to characterize provider-identified adaptations to the implementation of DiSC to optimize uptake and delivery, and determine the influence on implementation outcomes. Between May and December 2022, we conducted continuous quality improvement (CQI) meetings with providers to optimize DiSC implementation at 12 intervention sites. The meetings were guided by plan-do-study-act processes to identify challenges during early phase implementation and propose targeted adaptations. Meetings were audio-recorded and analysed using FRAME to categorize the level, context and content of planned adaptations and determine if adaptations were fidelity consistent. Providers completed surveys to quantify perceptions of DiSC acceptability, appropriateness and feasibility. Mixed effects linear regression models were used to evaluate these implementation outcomes over time. Providers participated in eight CQI meetings per facility over a 6-month period. A total of 65 adaptations were included in the analysis. The majority focused on optimizing the integration of DiSC within the clinic (83%, n = 54), and consisted of improving documentation, addressing scheduling challenges and improving clinic workflow. Primary reasons for adaptation were to align delivery with AYLHIV needs and preferences and to increase reach among AYLHIV: with reminder calls to AYLHIV, collaborating with schools to ensure AYLHIV attended clinic appointments and addressing transportation challenges. All adaptations to optimize DiSC implementation were fidelity-consistent. Provider perceptions of implementation were consistently high throughout the process, and on average, slightly improved each month for intervention acceptability (β = 0.011, 95% CI: 0.002, 0.020, p = 0.016), appropriateness (β = 0.012, 95% CI: 0.007, 0.027, p<0.001) and feasibility (β = 0.013, 95% CI: 0.004, 0.022, p = 0.005). Provider-identified adaptations targeted improved integration into routine clinic practices and aimed to reduce barriers to service access unique to AYLHIV. Characterizing types of adaptations and adaptation rationale may enrich our understanding of the implementation context and improve abilities to tailor implementation strategies when scaling to new settings.

Use of digital patient decision-support tools for atrial fibrillation treatments: a systematic review and meta-analysis

ObjectivesTo assess the effects of digital patient decision-support tools for atrial fibrillation (AF) treatment decisions in adults with AF.Study designSystematic review and meta-analysis.Eligibility criteriaEligible randomised controlled trials (RCTs) evaluated digital...

Design and deployment of the STEEER-AF trial to evaluate and improve guideline adherence: a cluster-randomized trial by the European Society of Cardiology and European Heart Rhythm Association.

The aim is to describe the rationale, design, delivery, and baseline characteristics of the Stroke prevention and rhythm control Treatment: Evaluation of an Educational programme of the European society of cardiology in a cluster-Randomized trial in patients with Atrial Fibrillation (STEEER-AF) trial. STEEER-AF is a pragmatic trial designed to objectively and robustly determine whether guidelines are adhered to in routine practice and evaluate a targeted educational programme for healthcare professionals. Seventy centres were randomized in six countries (France, Germany, Italy, Poland, Spain, and UK; 2022-23). The STEEER-AF centres recruited 1732 patients with a diagnosis of atrial fibrillation (AF), with a mean age of 68.9 years (SD 11.7), CHA2DS2-VASc score of 3.2 (SD 1.8), and 647 (37%) women. Eight hundred and forty-three patients (49%) were in AF at enrolment and 760 (44%) in sinus rhythm. Oral anticoagulant therapy was prescribed in 1543 patients (89%), with the majority receiving direct oral anticoagulants (1378; 89%). Previous cardioversion, antiarrhythmic drug therapy, or ablation was recorded in 836 patients (48.3%). Five hundred fifty-one patients (31.8%) were currently receiving an antiarrhythmic drug, and 446 (25.8%) were scheduled to receive a future cardioversion or ablation. The educational programme engaged 195 healthcare professionals across centres randomized to the intervention group, consisting of bespoke interactive online learning and reinforcement activities, supported by national expert trainers. The STEEER-AF trial was successfully deployed across six European countries to investigate guideline adherence in real-world practice and evaluate if a structured educational programme for healthcare professionals can improve patient-level care. Clinicaltrials.gov, NCT04396418.