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The growing number of people living with dementia will result in increased costs of dementia worldwide. The e-Health intervention 'Exergaming' may improve health and quality of life of people with dementia, but the cost-effectiveness is unknown. We assessed the cost-effectiveness of exergaming compared to regular activities from a societal perspective in day-care centres (DCC) for people with dementia and their informal caregivers (IC) alongside a cluster randomised controlled trial. We included 112 dyads (person with dementia and IC) from 20 psychogeriatric DCCs (11 exergaming, 9 control) across the Netherlands. Exergaming consisted of interactive cycling at least twice a week for 6 months. Measurements were conducted at baseline (T0), after 3 (T1) and 6 (T2) months. Primary outcomes were minutes of physical activity, mobility of the participants with dementia (Short Physical Performances Battery, SPPB), and Quality-Adjusted Life-Years (QALYs) of participants with dementia and ICs. ICs filled out cost diaries to measure healthcare and informal care utilisation during the study. There were no statistically significant differences in outcomes or costs between the groups at the level of participants with dementia, the ICs or the dyad. With regard to QALYs and SPPB, the probability that exergaming is cost-effective compared to control was low for all possible willingness-to-pay (WTP) thresholds. However, for physical activity at WTP thresholds of 0, 50 and 250 Euros per additional minute of physical activity, the probability of cost-effectiveness is 0.46, 0.84 and 0.87, respectively. Exergaming in DCC was not cost-effective compared to usual activities. However, considering the small sample size and the large number of missing observations, findings should be interpreted with caution. Future studies with larger samples are recommended to obtain definitive answers on the cost-effectiveness of exergaming. This trial was registered in the Netherlands Trial Register (NTR5537/NL5420).

Background Pediatric postoperative pain is still undertreated. Aims To assess whether educational intervention increases nurses’ knowledge and improves pediatric postoperative pain management. Design Cluster randomized controlled trial with three measurement points (baseline T1, 1 month after intervention T2, and 6 months after intervention T3). Participants/Subjects The study was conducted in postanesthesia care units at six hospitals in Norway. Nurses working with children in the included units and children who were undergoing surgery were invited to participate in this study. Methods Nurses were cluster randomized by units to an intervention (n = 129) or a control group (n = 129). This allocation was blinded for participants at baseline. Data were collected using “The Pediatric Nurses’ Knowledge and Attitudes Survey Regarding Pain: Norwegian Version” (primary outcome), observations of nurses’ clinical practice, and interviews with children. The intervention included an educational day, clinical supervision, and reminders. Results At baseline 193 nurses completed the survey (75% response rate), 143 responded at T2, and 107 at T3. Observations of nurses’ (n = 138) clinical practice included 588 children, and 38 children were interviewed. The knowledge level increased from T1 to T3 in both groups, but there was no statistically significant difference between the groups. In the intervention group, there was an improvement between T1 and T2 in the total PNKAS-N score (70% vs. 83%), observed increase use of pain assessment tools (17% vs. 39%), and children experienced less moderate-to-severe pain. Conclusions No significant difference was observed between the groups after intervention, but a positive change in knowledge and practice was revealed in both groups. Additional studies are needed to explore the most potent variables to strengthen pediatric postoperative pain management.

Background The rising number of nursing home (NH) residents and their increasingly complex treatment needs pose a challenge to the German health care system. In Germany, there is no specialized geriatric medical care for NH residents. Nursing staff and general practitioners (GPs) in particular have to compensate for the additional demand, which is compounded by organizational and structural hurdles. As a result, avoidable emergency calls and hospital admissions occur. In the SaarPHIR project (Saarländische PflegeHeimversorgung Integriert Regelhaft), a complex intervention focusing on a medical care concept was developed in a participatory practice-based approach involving NH representatives and GPs. The complex intervention addresses the collaboration between nurses and GPs and aims to help restructure and optimize the existing daily care routine. It is expected to improve the medical care of geriatric patients in NHs and reduce stressful, costly hospital admissions. The intervention was pilot-tested during the first 12 months of the project. In the present study, its effectiveness, cost-effectiveness, and safety will be evaluated. Methods The study is a cluster-randomized controlled trial, comparing an intervention group with a control group. The intervention includes a concept of interprofessional collaboration, in which GPs group into regional cooperating teams. Teams are encouraged to cooperate more closely with NH staff and to provide on-call schedules, pre-weekend visits, joint team meetings, joint documentation, and improved medication safety. At least 32 NHs in Saarland, Germany (with at least 50 residents each) will be included and monitored for 12 months. The primary endpoint is hospitalization. Secondary endpoints are quality of life, quality of care, and medication safety. The control group receives treatment as usual. Process evaluation and health economic evaluation accompany the study. The data set contains claims data from German statutory health insurance companies as well as primary data. Analysis will be conducted using a generalized linear mixed model. Conclusion A reduction in hospital admissions of NH residents and relevant changes in secondary endpoints are expected. In turn, these will have a positive impact on the economic assessment. Trial registration German Clinical Trials Register: DRKS00017129. Registered on 23 April 2019. https://www.drks.de/drks_web/setLocale_EN.do.

Handwashing is key to preventing the transmission of various infectious diseases of which school-aged children are particularly susceptible. Traditional, information-messaging campaigns may increase handwashing awareness but have had limited success in promoting behavior change. Behavioral economics “nudges,” which explicitly target the knowledge-behavior gap, is a promising alternative. We evaluate the impact of school-based nudges in the first fully powered cluster randomized controlled trial in the Philippines. Out of our sample of 132 eligible schools, we randomly assigned half to receive nudges, including contextual cues (painted footpath from toilet to handwashing station) and visible reminders (posters and eye sticker), and half to the control group. Four months after implementation, we measured handwashing with soap (HWWS) after toilet use among grades 1–6 students using direct observation and compared this outcome between treatment and control schools. We also assessed whether nudges increased soap availability. The intervention increased HWWS rates by 17.3% points (pp), [95% CI: 4.2, 30.4] in treatment schools from the control group mean of 11.7%. The effect size was comparable across gender and age groups. Access to functioning handwashing facilities with soap increased by 36% (+20.2 pp, 95% CI: 10.9, 29.4). Mediation analysis suggests the program simultaneously nudged students to wash hands with soap in classrooms that already had soap, and nudged teachers to provide soap where it was not already available. These findings demonstrate that behavioral nudges costing less than $70 per school can lead to significant increases in HWWS among students 4 months post-intervention.

Background Coronary heart disease (CHD) mortality among young men is very high and the prevention methods usable in family practice (FP) settings are limited (1,2). The objectives of this study were to investigate the cardiovascular risk profile among young males (18–50) visiting their family doctor (FD) and to find out if using an interactive computer-based decision aid (DA) has advantages in reducing cardiovascular risk factors compared to usual counselling at the FD’s office. Methods The study was a cluster-randomized controlled trial including hypertensive male patients aged 18–50 recruited by their FD in 2015–2016. Patients with cardiovascular complications were not included. FDs were randomly divided into intervention groups (n = 9) and control groups (n = 11). Altogether, FDs recruited 130 patients, 77 into the intervention group (IG) and 53 into the control group (CG). IG patients were counselled about cardiovascular risk factors using a computer-based DA. CG patients received usual counselling by their FD. Data was collected with questionnaires, clinical examinations and laboratory analyses at the baseline and at the follow-up visit three months later. We compared the cardiovascular risk factors of the IG and CG patients. Results Baseline characteristics of the IG and CG patients were comparable. Of the whole study group, 51.5% (n = 67) of the patients had hypertension grade 1, 45.4% (n = 59) had grade 2 and 3.1% (n = 4) had grade 3. Twenty-seven per cent (n = 21) of the IG and 42% (n = 22) of the CG patients were smokers. We found that shared decision making with the DA was more effective in smoking reduction compared to usual FD counselling: 21 smoking patients in the IG reduced the number of cigarettes per day which is significantly more than the 22 smoking patients in the CG (− 3.82 ± 1.32 (SE Mean) versus + 2.32 ± 1.29; p = 0.001). Systolic blood pressure (SBP), diastolic blood pressure (DBP) and the number of cigarettes per day, all showed a statistically significant reduction among patients who were using the DA. Male patients with hypertension grade 2 had a significantly greater reduction in their SBP (− 6.003 ± 2.59 (SE Mean) versus + 1.86 ± 2.58; p = 0.038) grade 1. Reduction of DBP, cigarettes per day and CVD risk in general were nearly significant in the IG whereas the CG showed an increase in all of these parameters. Conclusion Using interactive DAs at FD’s offices for counselling of young hypertensive male patients is one possibility to help patients understand their risk factors and make changes in their treatment choices. DAs can be more effective in achieving behavioural changes like reducing smoking or blood pressure compared to normal counselling.

Objectives Interventions to prevent postpartum common mental disorders (PCMD) among unselected populations of women have had limited success. The aim was to determine whether What Were We Thinking (WWWT) a gender-informed, psychoeducational programme for couples and babies can prevent PCMD among primiparous women 6 months postpartum. Design Cluster-randomised controlled trial. Setting 48 Maternal and Child Health Centres (MCHCs) from 6 Local Government Areas in Melbourne, Australia were allocated randomly to usual care (24) or usual care plus WWWT (24). Participants English-speaking primiparous women receiving primary care at trial MCHCs were recruited to the intervention (204) and control (196) conditions. Of these, 187 (91.7%) and 177 (90.3%) provided complete data. Intervention WWWT is a manualised programme comprising primary care from a trained nurse, print materials and a face-to-face seminar. Main outcome measures Data sources were standardised and study-specific measures collected in blinded computer-assisted telephone interviews at 6 and 26 weeks postpartum. The primary outcome was PCMD assessed by Composite International Diagnostic Interviews and Patient Health Questionnaire (PHQ) Depression and Generalised Anxiety Disorder modules. Results In intention-to-treat analyses the adjusted OR (AOR) of PCMD in the intervention compared to the usual care group was 0.78 (95% CI 0.38 to 1.63, ns), but mild to moderate anxiety symptoms (AOR 0.58, 95% CI 0.35 to 0.97) and poor self-rated health (AOR 0.46, 95% CI 0.22 to 0.97) were significantly lower. In a per protocol analysis, comparing the full (three component) intervention and usual care groups, the AOR of PCMD was 0.36, (95% CI 0.14 to 0.95). The WWWT seminar was appraised as salient, comprehensible and useful by >85% participants. No harms were detected. Conclusions WWWT is readily integrated into primary care, enables inclusion of fathers and addresses modifiable risks for PCMD directly. The full intervention appears a promising programme for preventing PCMD, optimising family functioning, and as the first component of a stepped approach to mental healthcare. Trial registration number ACTRN12613000506796; Results.

The present study investigated how intervention might alter the relationship between perpetrating violence and later drug use. A cluster-randomized controlled trial design involving 72 schools (38 intervention, 34 control) and 6390 students attending grades 7 and 8 was employed in Brazil. Drug use and violence were assessed at three points. A random-intercept cross-lagged panel model examined the reciprocal association between drug use and school violence domains across the three data collection waves. For both groups, we found that the cross-lagged effect of perpetration on further drug use in adolescents was stronger than the reverse, but the interrelationship was not statistically significant between #Tamojunto and control schools. The carry-over effects of drug use and violence were also not significantly different between groups. There is a lack of evidence showing that #Tamojunto can modify the dynamics between drug use and school violence across the 21-month period. The direction of the causal effect (i.e., the more perpetration behavior, the more subsequent drug use behavior) is present, but weak in both groups. The trial registration protocol at the national Brazilian Register of Clinical Trials (REBEC) is #RBR-4mnv5g.

Objective The main objective of the economic evaluation was to determine the cost-effectiveness of a weaning-food safety and hygiene programme in reducing rates of diarrhoea compared to the control in rural Gambia. Methods The public health intervention, using critical control points and motivational drivers, was evaluated in a cluster randomised controlled trial at 6- and 32-month follow-up. An economic evaluation was undertaken alongside the RCT with data collected prospectively from a societal perspective. Decision-analytical modelling was used to explore cost-effectiveness over a longer time period (4 years). Results Direct out-of-pocket healthcare expenditure for households due to diarrhoea was large. The intervention significantly reduced reported childhood diarrhoeal episodes after six months (incident risk ratio =0.40, 95%CI 0.33, 0.49) and two years after the intervention (incident risk ratio = 0.68, 95%CI 0.46, 1.02). The within-trial analysis found that the intervention led to total savings of 8064 dalasi six months after the intervention, and 4224 dalasi two years after the intervention. Based on the model results, if the intervention is successful in maintaining the reduction in the risk of diarrhea, the ICER is US$ 814 per DALY avoided over 4 years. This is cost effective. Conclusions This study suggests that there are substantial household costs associated with diarrhoeal episodes in children. The within-trial analysis and model results suggest that the community-based approach to improving weaning food hygiene and safety is likely to be cost-effective compared to control.

This article discusses optimal allocation of experimental units in a control versus intervention cluster randomized trial for binary responses. Optimal allocations are based on a well known Ds− opt...

This article presents the findings of an exploratory randomised controlled trial of the PAX Good Behaviour Game (PAX GBG) in Northern Ireland. The PAX GBG is an evidence‐based universal prevention programme designed to improve mental health by increasing self‐regulation, academic engagement, and decreasing disruptive behaviour in children. The study was designed in line with the Medical Research Council guidance on the development of complex interventions and is based on the Medical Research Council framework, more specifically within a Phase 2 exploratory trial. The study used a cluster randomised controlled trial design with a total of 15 schools (19 classes) randomised to intervention and control. This article reports specifically on the outcome of self‐regulation with 355 elementary school pupils in year 3 (age M = 7.40, SD = 0.30). Participating schools in the trial were located in areas of socio‐economic disadvantage. The teachers in the intervention group received training in the delivery of the PAX GBG and implemented the PAX GBG intervention for 12 weeks. A range of pre‐ and post‐test measures, including child reported behaviours, were undertaken. After the 12 weeks of implementation, this exploratory trial provided some evidence that the PAX GBG may help improve self‐regulation (d = .42) in participating pupils, while the findings suggest that it may offer a feasible mental health prevention and early intervention approach for Northern Ireland classrooms. However, a larger definitive trial would be needed to verify the findings in this study.

Background Venous thromboembolism (VTE) is one of the most common causes of preventable harm for patients in hospitals. Nearly half of all VTE events was estimated to occur after surgical procedure. The Caprini risk score is the most extensively used risk assessment tool in predicting postoperative VTE, which is too complicate for surgeons to use properly in their clinical practice. Methods The CHAT-3 trial will be a prospective, multicenter, randomized, parallel-group trial, which is designed to identify patients at moderate or high risk of VTE after inguinal hernia surgery using the previously established three-factor model, and to use low molecular weight heparin (LMWH) for VTE prevention, in comparison to the current routine assessment and practice used in those patients. Totally, 1,008 patients planned to undergo inguinal hernia surgery will be enrolled, with cluster randomization at 1:1 ratio into intervention arm and control arm. The primary outcomes are the accordance of perioperative VTE prophylaxis based on current guidelines and the rate of pharmacological prophylaxis for VTE. The secondary outcomes are the occurrences of perioperative VTE, major bleeding, mortality of patients after inguinal hernia surgery, and trend of D-dimer during the follow-up period. Discussion This study will create evidence that whether the administration based on a simple model is of efficacy and safety for VTE prophylaxis among Chinese patients underwent inguinal hernia surgery. Trial registration The CHAT-3 trial (Trial registration number: ChiCTR2000033769).

Background A quality improvement (QI) collaborative approach to enhancing integrated HIV-Tuberculosis (TB) services may be effective in scaling up and improving the quality of service delivery. Little is known of the role of organizational contextual factors (OCFs) in influencing the success of QI collaboratives. This study aims to determine which OCFs were associated with improvement in a QI collaborative intervention to enhance integrated HIV-TB services delivery. Methods This is a nested sub-study embedded in a cluster-randomized controlled trial. Sixteen nurse supervisors (clusters) overseeing 40 clinics were randomized (1:1) to receive QI training and mentorship, or standard of care support (SOC). In the QI arm, eight nurse supervisors and 20 clinics formed a “collaborative” which aimed to improve HIV-TB process indicators, namely HIV testing, TB screening, isoniazid preventive therapy (IPT) initiations, viral load testing, and antiretroviral therapy for TB patients. OCFs measured at baseline were physical infrastructure, key staff, flexibility of clinic hours, monitoring data for improvement (MDI), and leadership support. Surveys were administered to clinic staff at baseline and month 12 to assess perceptions of supportiveness of contexts for change, and clinic organization for delivering integrated HIV-TB services. Linear mixed modelling was used to test for associations between OCFs and HIV-TB process indicators. Results A total of 209 clinic staff participated in the study; 97 (46.4%) and 112 (53.6%) from QI and SOC arms, respectively. There were no differences between the QI and SOC arms scores achieved for physical infrastructure (78.9% vs 64.7%; p = 0.058), key staff (95.8 vs 92; p = 0.270), clinic hours (66.9 vs 65.5; p = 0.900), MDI (63.3 vs 65; p = 0.875, leadership support (46.0 vs 57.4; p = 0.265), and perceptions of supportiveness of contexts for change (76.2 vs 79.7; p = 0.128 and clinic organization for delivering integrated HIV-TB services (74.1 vs 80.1; p = 0.916). IPT initiation was the only indicator that was significantly improved in the parent study. MDI was a significantly associated with increasing IPT initiation rates [beta coefficient (β) = 0.004; p = 0.004]. Discussion MDI is a practice that should be fostered in public health facilities to increase the likelihood of success of future QI collaboratives to improve HIV-TB service delivery. Trial registration Clinicaltrials.gov, NCT02654613. Registered 01 June 2015.

Background Women delivering in health facilities in sub-Saharan Africa and their newborns do not always receive proven interventions needed to prevent and/or adequately manage severe complications. The gaps in quality of care are increasingly pointed out as major contributing factor to the high and slow declining perinatal mortality rates. The World Health Organization Safe Childbirth Checklist (WHO-SCC), as a quality improvement strategy, targets low cost and easy to perform interventions and suits well with the context of limited resource settings. In this matched-pair cluster randomized controlled trial, we assess the effectiveness of the WHO-SCC in improving healthcare providers’ adherence to best practices and ultimately improving childbirth outcomes. Methods This is a multi-country study. In each country we will carry out a matched-pair cluster randomized controlled trial whereby four pairs of regional hospitals will be randomized on a 1:1 basis to either the intervention or control group. A context specific WHO-SCC will be implemented in the intervention facilities along with trainings of healthcare providers on best childbirth practices and ongoing supportive supervisions. The standard of care will prevail in the control group. The primary outcome is a summary composite metric that combine the following poor childbirth outcomes: stillbirths, maternal deaths, early neonatal deaths, severe postpartum hemorrhage, maternal infections, early neonatal infections, prolonged obstructed labor, severe pre-eclampsia, uterine rupture in the health facility, eclampsia and maternal near miss. The occurrence of these outcomes will be ascertained in a sample of 2530 childbirth events in each country using data extraction. A secondary outcome of interest is the adherence of healthcare providers to evidence best practices. This will be measured through direct observations of a sample of 620 childbirth events in each country. Discussion Our study has the potential to provide strong evidence on the effectiveness of the WHO-SCC, a low cost and easy to implement intervention that can be easily scaled up if found effective. Trial registration The trial was registered in the Pan-African Clinical Trials Registry on 21st January 2020 under the following number: PACTR202001484669907. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9662

Background Reducing sugar-sweetened beverage (SSB) consumption is a promising dietary target for childhood obesity prevention. This paper describes the design and methods of a cluster randomized trial of H2GO!, a youth empowerment intervention to prevent childhood obesity through reducing SSB consumption among a low-income, ethnically diverse sample of youth. Methods This cluster randomized controlled trial is an academic-community partnership with the Massachusetts Alliance of Boys and Girls Clubs (BGC). Ten BGC sites will be randomly assigned to the H2GO! intervention or a wait-list, usual care control. Eligible study participants will be N = 450 parent-child pairs (youth ages 9–12 years and their parents/caregivers) recruited from participating BGCs. The 6-week in-person H2GO! intervention consists of 12 group-based sessions delivered by BGC staff and youth-led activities. An innovative feature of the intervention is the development of youth-produced narratives as a strategy to facilitate youth empowerment and parental engagement. Child outcomes include measured body mass index z scores (zBMI), beverage intake, and youth empowerment. Parent outcomes include beverage intake and availability of SSBs at home. Outcomes will be measured at baseline and at 2, 6, and 12 months. With a 75% retention rate, the study is powered to detect a minimum group difference of 0.1 zBMI units over 12 months. Discussion Empowering youth may be a promising intervention approach to prevent childhood obesity through reducing SSB consumption. This intervention was designed to be delivered through BGCs and is hypothesized to be efficacious, relevant, and acceptable for the target population of low-income and ethnically diverse youth. Trial registration ClinicalTrials.gov NCT04265794. Registered 11 February 2020.

AIMS We assessed the effect of transitional care on patient-reported outcomes (PROs) in women and men hospitalized for heart failure. METHODS AND RESULTS In this sex-specific analysis of a stepped wedge cluster randomized trial in Canada, the effect of a patient-centered transitional care model was tested on pre-specified PROs of discharge preparedness (B-PREPARED score, range 0-22), quality of transition [Care Transitions Measure-3 (CTM-3) score, range 0-100], and health-related quality of life (HRQOL) (EQ-5D-5L, range 0-1). Among 986 patients (47.4% women), B-PREPARED at 6 weeks was greater with the intervention than usual care [mean difference (MD) 4.01 (95% confidence interval-CI 2.90-5.12); P

Randomized clinical trials are the gold standard for the development of new drugs. Clinical trials have become increasingly complex, in particular in the field of inflammatory bowel diseases. For this reason, a new study design called ‘cluster randomized trial’ has been introduced. Cluster randomized trials randomly assign groups of individuals within a population of interest, such as people in a particular research site, clinic or hospital, and measure the effects of an intervention at the individual level. In contrast to individual randomization, cluster randomization permits the evaluation of a cluster-level intervention, may be logistically simpler and less expensive than a conventional randomized trial, and can help reduce the effect of treatment contamination. An important aspect requiring particular attention in cluster randomized trials is the risk for imbalance of covariates at baseline which decreases the statistical power and precision of the results, and reduces face validity and credibility of the trial results. A variety of restricted randomization methods have been proposed to minimize risk of imbalance. Our aim here is to clarify the advantages and drawbacks of cluster randomized trials in order to properly interpret study results and to identify their role in upcoming inflammatory bowel disease trials.

Background: Antenatal care (ANC) is low in developing countries, with an estimated 20% of Indonesian women not initiating ANC during the first trimester. The present study sought to determine the impact of a mentoring program on the timing of the first ANC visit. Methods: This cluster randomized controlled trial was conducted in 3 subdistricts of the Bantul District, divided into 61 clusters per treatment arm, with a final sample size of 205 confirmed pregnant women. The mentoring program consisted of (1) health education, (2) monitoring, and (3) text-message reminders. The primary outcome was the timing of first ANC visit. A multilevel mixed-effect logistic regression model was used to measure the effect of the program on the likelihood of having an earlier first ANC visit, with statistical significance at α=0.05. Results: At the individual-level, the intervention group had a mean time of first ANC visit±2 days earlier than the control group (P

Background Care home residents are mainly inactive, leading to increased dependency and low mood. Although exercise classes may increase activity, a more sustainable model is to engage staff and residents in increasing routine activity. Objectives The objectives were to develop and preliminarily test strategies to enhance the routine physical activity of care home residents to improve their physical, psychological and social well-being through five overlapping workstreams. Design This trial had a mixed-methods research design to develop and test the feasibility of undertaking an evaluative study consisting of gaining an understanding of the opportunities for and barriers to enhancing physical activity in care homes (workstream 1); testing physical activity assessment instruments (workstream 2); developing an intervention through a process of intervention mapping (workstream 3); refining the provisional intervention in the care home setting and clarifying outcome measurement (workstream 4); and undertaking a cluster randomised feasibility trial of the intervention [introduced via three facilitated workshops at baseline (with physiotherapist input), 2 weeks (with artist input) and 2 months], with embedded process and health economic evaluations (workstream 5). Setting The trial was set in 12 residential care homes differing in size, location, ownership and provision in Yorkshire, UK. Participants The participants were elderly residents, carers, managers and staff of care homes. Intervention The intervention was MoveMore, designed for the whole home, to encourage and support the movement of residents in their daily routines. Main outcome measures The main outcome measures related to the feasibility and acceptability of implementing a full-scale trial in terms of recruitment and retention of care homes and residents, intervention delivery, completion and reporting of baseline data and outcomes (including hours of accelerometer wear, hours of sedentary behaviour and hours and type of physical activity), and safety and cost data (workstream 5). Results Workstream 1 – through a detailed understanding of life in a care home, a needs assessment was produced, and barriers to and facilitators of activity were identified. Key factors included ethos of care; organisation, management and delivery of care; use of space; and the residents’ daily routines. Workstream 2 – 22 (73.3%) out of 30 residents who wore a hip accelerometer had valid data (≥ 8 hours on ≥ 4 days of the week). Workstream 3 – practical mechanisms for increasing physical activity were developed, informed by an advisory group of stakeholders and outputs from workstreams 1 and 2, framed by the process of intervention mapping. Workstream 4 – action groups were convened in four care homes to refine the intervention, leading to further development of implementation strategies. The intervention, MoveMore, is a whole-home intervention involving engagement with a stakeholder group to implement a cyclical process of change to encourage and support the movement of residents in their daily routines. Workstream 5 – 12 care homes and 153 residents were recruited to the cluster randomised feasibility trial. Recruitment in the care homes varied (40–89%). Five care homes were randomised to the intervention and seven were randomised to usual care. Predetermined progression criteria were recruitment of care homes and residents (green); intervention delivery (amber); and data collection and follow-up – 52% of residents provided usable accelerometer data at 9 months (red), > 75% of residents had reported outcomes at 9 months (green, but self-reported resident outcomes were red), 26% loss of residents to follow-up at 9 months [just missing green criterion (no greater than 25%)] and safety concerns (green). Limitations Observations of residents’ movements were not conducted in private spaces. Working with care home residents to identify appropriate outcome measures was challenging. Take-up of the intervention was suboptimal in some sites. It was not possible to make a reliably informed decision on the most appropriate physical activity end point(s) for future use in a definitive trial. Conclusions A whole-home intervention was developed that was owned and delivered by staff and was informed by residents and staff. The feasibility of conducting a cluster randomised controlled trial was successfully tested: the target numbers of care homes and residents were recruited, demonstrating that it is possible to recruit care home residents to a cluster randomised trial, although this process was time-consuming and resource heavy. A large data set was collected, which provided a comprehensive picture of the environment, residents and staff in care homes. Extensive quantitative and qualitative work comprehensively explored a neglected area of health and social care research. Completion of ethnographic work in a range of settings enabled the production of an in-depth picture of life in care homes that will be helpful for other researchers considering organisational change in this setting. Future work The content and delivery of the intervention requires optimisation and the outcome measurement requires further refinement prior to undertaking a full trial evaluation. Consideration could be given to a recommended, simplified, core outcome set, which would facilitate data collection in this population. Trial registration Current Controlled Trials ISRCTN16076575. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grant for Applied Research programme and will be published in full in Programme Grant for Applied Research; Vol. 9, No. 9. See the NIHR Journals Library website for further project information.

Summary Background There is limited access to eye health services in many low-income and middle-income populations. We aimed to assess the effectiveness in increasing service utilisation of the Peek Community Eye Health (Peek CEH) system, a smartphone-based referral system comprising decision support algorithms (Peek Community Screening app), SMS reminders, and real-time reporting. Methods In this cluster-randomised controlled trial of eye health in Kenya, community unit clusters were defined as one health centre and its catchment population. Clusters were randomly allocated (1:1) to receive Peek CEH and referral (intervention group) or standard care via periodic health centre-based outreach clinics and onward referral (control group). Individuals in the intervention group were assessed at home by screeners and those referred were asked to present for triage assessment in a central location. They received regular SMS reminders. In both groups, community sensitisation was done followed by a triage clinic at the cluster health centre 4 weeks after sensitisation. During triage, individuals in both groups were assessed and treated and, if necessary, referred to a specific hospital. Individuals in the intervention group received further SMS reminders. The primary outcome was the mean attendance rate (the number of people per 10 000 population) at triage of those with confirmed eye conditions, as assessed at 4 weeks after sensitisation in the intention-to-treat population. We estimated the intervention effect using a Student's t-test on cluster-level rates. This trial is registered with Pan African Clinical Trial Registry, number 201807329096632. Findings Between Nov 26, 2018, and June 7, 2019, of the 85 community units in Trans Nzoia County, Kenya, 49 were excluded. We randomly allocated 18 community units each to the intervention group (68 348 individuals) and the control group (60 243 individuals). 9387 individuals from the intervention group and 3070 from the control group attended triage assessment. The mean attendance rate at triage by individuals with eye problems was 1429 (92% CI 1228–1629) in the intervention group and 522 (418–625) in the control group (rate difference 906 per 10 000 [95% CI 689–1124; p Interpretation The Peek CEH system increased primary care attendance by people with eye problems compared with standard approaches, indicating the potential of this mobile health package to increase service uptake and guide appropriate task sharing. Funding The Queen Elizabeth Diamond Jubilee Trust and Wellcome Trust.

Youth who witness parental intimate partner violence (IPV) are at increased risk of teen dating violence (DV). This analysis of secondary data investigated whether a bystander intervention program, Green Dot, was effective at reducing physical and psychological DV victimization and perpetration among youth who had and had not previously witnessed parental IPV. The parent RCT assigned 13 schools to control and 13 schools to the Green Dot intervention. Responses from 71,797 individual surveys that were completed by high school students were analyzed across three phases of a 5-year cluster randomized control trial. Multigroup path analyses revealed that students in intervention schools who witnessed parental IPV had a reduction in psychological (p p p p p p p Green Dot is an effective program at reducing DV victimization and perpetration among the high-risk group of youth who previously witnessed parental IPV, largely operating through violence acceptance norms. This underscores the bystander intervention approach as both a targeted and universal prevention program.

Background We implemented an opt-out clinic-based intervention pairing syphilis tests with routine human immunodeficiency virus (HIV) viral load testing. The primary objective was to determine the degree to which this intervention increased the detection of early syphilis. Methods The Enhanced Syphilis Screening Among HIV-Positive Men (ESSAHM) Trial was a stepped wedge cluster-randomized controlled trial involving 4 urban HIV clinics in Ontario, Canada, from 2015 to 2017. The population was HIV-positive adult males. The intervention was standing orders for syphilis serological testing with viral loads, and control was usual practice. We obtained test results via linkage with the centralized provincial laboratory and defined cases using a standardized clinical worksheet and medical record review. We employed a generalized linear mixed model with a logit link to estimate odds ratios (ORs) and 95% confidence intervals (CIs) of the intervention. Results A total of 3895 men were followed over 7471 person-years. The mean number of syphilis tests increased from 0.53 to 2.02 tests per person per year. There were 217 new diagnoses of syphilis (control, 81; intervention, 136), for which 147 (68%) were cases of early syphilis (control, 61 [75%]; intervention, 86 [63%]). The annualized proportion with newly detected early syphilis increased from 0.009 to 0.032 with implementation of the intervention; the corresponding time-adjusted OR was 1.25 (95% CI, .71–2.20). Conclusions The implementation of standing orders for syphilis testing with HIV viral loads was feasible and increased testing, yet produced less-than-expected increases in case detection compared to past uncontrolled pre–post trials. Clinical Trials Registration NCT02019043.

International audience; Objectives: To estimate the prevalence of time-to-event (TTE) outcomes in cluster randomized trials (CRTs) and to examine their statistical management. Study design and setting: We searched PubMed to identify primary reports of CRTs published in six major general medical journals (2013-2018). Nature of outcomes and, for TTE outcomes, statistical methods for sample size, analysis, and measures of intracluster correlation were extracted.Results: A TTE analysis was used in 17% of the CRTs (32/184) either as a primary or secondary outcome analysis, or in a sensitivity analysis. Among the five CRTs with a TTE primary outcome, two accounted for both intracluster correlation and the TTE nature of the outcome in sample size calculation; one reported a measure of intracluster correlation in the analysis. Among the 32 CRTs with a least one TTE analysis, 44% (14/32) accounted for clustering in all TTE analyses. We identified 12 additional CRTs in which there was at least one outcome not analyzed as TTE for which a TTE analysis might have been preferred.Conclusion: TTE outcomes are not uncommon in CRTs but appropriate statistical methods are infrequently used. Our results suggest that further methodological development and explicit recommendations for TTE outcomes in CRTs are needed.

In a cross-sectional stepped wedge cluster randomized trial (SWT), clusters are randomized to crossover from control to intervention at different time periods and outcomes are assessed for a different set of individuals in each cluster-period. Randomization-based inference is an attractive analysis strategy for SWTs because it does not require full parametric specification of the outcome distribution or correlation structure and its validity does not rely on having a large number of clusters. Existing randomization-based approaches for SWTs, however, either focus on hypothesis testing and omit technical details on confidence interval (CI) calculation with noncontinuous outcomes, or employ weighted cluster-period summary statistics for p-value and CI calculation, which can result in suboptimal efficiency if weights do not incorporate information on varying cluster-period sizes. In this article, we propose a framework for calculating randomization-based p-values and CIs for a marginal treatment effect in SWTs by using test statistics derived from individual-level generalized linear models. We also investigate how study design features, such as stratified randomization, subsequently impact various SWT analysis methods including the proposed approach. Data from the XpertMTB/RIF tuberculosis trial are reanalyzed to illustrate our method and compare it to alternatives.

Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p p p Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.

BACKGROUND To determine if a school-based physical activity (PA) intervention that supported primary school teachers to schedule PA during school hours impacted their own PA. METHODS A 2x2 factorial group cluster-randomised controlled trial was undertaken in 12 Australian primary schools. The nine-month intervention supported classroom teachers to increase scheduled weekly PA for their class via physical education, sport, Energisers and integrated lessons. Teachers' PA (n = 76) was measured at follow-up only using accelerometers (Actigraph GT3X or GT9X). Linear mixed models were used to estimate between-group differences in teachers' mean minutes of sedentary, light, moderate-to-vigorous-intensity physical activity (MVPA) across the school day and during class-time. RESULTS At follow-up, there were non-significant between-group differences favouring intervention teachers, compared to controls, for light PA (4.9 minutes, 95% CI: -6.3, 16.0; P = .33) and MVPA (0.4 minutes, 95% CI: -10.9, 11.6; P = .94) across the school day; although not favouring the intervention for sedentary behaviour (5.1 minutes, 95% CI: -11.4, 21.7; P = .48). Similar patterns were seen during class-time for light PA and sedentary time, but not for MVPA. CONCLUSIONS Supporting teachers with the scheduling of PA for their class may impact on their own PA. Fully powered studies are needed to better understand the impact of the intervention on teachers' PA. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12616001228471 (http://www.anzctr.org.au/).

Background Rates of depression among Pakistani mothers are high, leading to poor developmental outcomes in their children. This study tested the effectiveness of a manualized integrated parenting program; Learning through Play Plus (LTP+) for maternal depression in Karachi, Pakistan. Methods A cluster randomized control trial conducted from January 2014 to December 2015 across 120 villages in Karachi. A total of 774 depressed mothers aged 18-44 years with children aged 0-30 months old, were included. Villages were randomized to receive LTP+ added to treatment as usual (TAU) or TAU alone. Primary outcomes were severity of maternal depression at 3 and 6 months measured by the Edinburgh Postnatal Depression Scale and child socio-emotional development at 6 months measured by the Ages and Stages Questionnaire (ASQ). Secondary outcomes included maternal anxiety, quality of life, social support, parenting competence, and knowledge about child development. Results Mothers in the LTP+ group reported significantly lower depression scores compared to those in the TAU group (6.6 vs. 13.8, effect size [ES]: -7.2; 95% confidence interval [CI]: -8.2, -6.1) at 3 and 6 months (7.2 vs. 12.00; ES: -4.6; 95% CI: -5.9, -3.4). Child socio-emotional development at 6 months was significantly better in the LTP+ group on all domains of the ASQ. There were also statistically significant improvements on all secondary outcomes at 3- and 6-month follow-up. Conclusion In low-resource settings like Pakistan, low-cost integrated parenting interventions delivered by lay health workers can provide effective treatment for depressed mothers, leading to improvements in child development.

Background Finding effective, accessible treatment options such as professional-delivered cognitive behavioral therapy (CBT) for medically complex individuals is challenging in rural communities. Purpose We examined whether a CBT-based program intended to increase physical activity despite chronic pain in patients with diabetes delivered by community members trained as peer coaches also improved depressive symptoms and perceived stress. Methods Participants in a cluster-randomized controlled trial received a 3-month telephonic lifestyle modification program with integrated CBT elements. Peer coaches assisted participants in developing skills related to adaptive coping, diabetes self-management goal-setting, stress reduction, and cognitive restructuring. Attention controls received general health advice with an equal number of contacts but no CBT elements. Depressive symptoms and stress were assessed using the Centers for Epidemiologic Studies Depression and Perceived Stress scales. Assessments occurred at baseline, 3 months, and 1 year. Results Of 177 participants with follow-up data, 96% were African Americans, 79% women, and 74% reported annual income Conclusions This peer-delivered CBT-based program improved depressive symptoms and stress in individuals with diabetes and chronic pain. Training community members may be a feasible strategy for offering CBT-based interventions in rural and under-resourced communities. Clinical Trial Registration NCT02538055.

Background Syphilis is a common sexually transmitted infection (STI) among men who have sex with men (MSM). Increasing syphilis testing is important to syphilis control. However, in low- and middle-income countries like China, syphilis testing rates remain low among MSM. We describe a randomized controlled trial protocol to examine the effectiveness of social network distribution approaches of syphilis self-testing among MSM in China. Methods We will recruit index and alter MSM. Indexes will be eligible if they: are born biologically male; aged 18 years or above; ever had sex with another man; are willing to distribute syphilis testing packages or referral links to their alters; and willing to provide personal contact information for future follow-up. Three hundred MSM will be recruited and randomly assigned in a 1:1:1 ratio into three arms: standard of care (control arm); standard syphilis self-testing (SST) delivery arm; and referral link SST delivery arm. Indexes will distribute SST packages or referral links to encourage alters to receive syphilis testing. All indexes will complete a baseline survey and a 3-month follow-up survey. Syphilis self-test results will be determined by photo verification via a digital platform. The primary outcome is the mean number of alters who returned verified syphilis testing results per index in each arm. Discussion The trial findings will provide practical implications in strengthening syphilis self-testing distribution and increasing syphilis testing uptake among MSM in China. This study also empowers MSM community in expanding syphilis testing by using their own social network. Trial registration Chinese Clinical Trial Registry, ChiCTR2000036988. Registered 26 August 2020 - Retrospectively registered.

Objective:To evaluate the effectiveness of a multicomponent intervention (MCI) on children’s dietary diversity and its impact pathway components of children’s food knowledge and healthy food preferences.Design:A 6-week cluster randomised controlled trial with a MCI consisting of child nutrition education plus family engagement through parental nutrition education, meal preparation and tasting was compared with two groups: single component intervention (SCI) of child nutrition education, and control, conducted during February to July 2018. Preschool centres were randomly assigned to one of the three arms. Children’s food knowledge, healthy food preferences and dietary diversity scores were collected. Intervention effects were analysed using a pre-post analysis and a difference-in-difference model.Setting:Fourteen preschool centres in an urban area of Kurunegala, Sri Lanka.Participants:Child–parent dyads of children aged 4–6 years. Final analyses included 306 (for food knowledge and preferences) and 258 (for dietary diversity) dyads.Results:MCI significantly influenced the impact pathways to children’s dietary diversity by increasing children’s food knowledge and healthy food preferences scores by 3·76 and 2·79 (P < 0·001), respectively, but not the dietary diversity score (P = 0·603), compared with the control arm. Relative to SCI, MCI significantly improved children’s food knowledge score by 1·10 (P < 0·001), but no significant effects were noted for other outcome variables.Conclusions:Improved food knowledge and preferences require a positive food environment and time to develop into healthy eating behaviours. Research into dietary diversity should broaden to incorporate the contextual roles of the home and general food environments to more completely understand food choices of children.

Background Moderate to severe pain has been frequently reported in hospitalized older adults. Pain in hospitalized persons with dementia within the context of other common symptoms, functional decline, delirium, and behavioral and psychological symptoms of dementia (BPSD), has received little attention. Aims Describe the incidence of pain, the pharmacologic management of pain, and the association of pain with physical function, delirium, and BPSD in hospitalized persons with dementia. Design Descriptive, cross-sectional study. Setting Six medical units in three hospitals. Participants Baseline data from 299 hospitalized persons with dementia enrolled in the Family-centered Function-focused Care (Fam-FFC) cluster randomized trial. Methods Descriptive analyses of pain used the Pain Assessment in Advanced Dementia (PAINAD) scale and the use of medication for pain management. Linear regression analyses tested relationships between pain and:1) physical function (Barthel Index), 2) delirium severity (Confusion Assessment Method Severity Short Form) and 3) BPSD severity (Neuropsychiatric Inventory- Questionnaire). Results The majority of the sample was female (61.9%), non-Hispanic (98%), and Black (53.2%), with a mean age of 81.58 (SD=8.54).Of the 299 patients, 166 (56%) received pain medication. Of the 108 individuals who demonstrated pain, 40% (n=43) did not receive pain medication. When controlling for age, gender, cognition, and comorbidities, pain was significantly associated with function, delirium severity, and BPSD severity. Conclusions Results suggest that pain may be undertreated in hospitalized persons with dementia, and should be considered upon admission to optimize function, decrease delirium, and prevent or decrease BPSD.

To determine the effects of Chinese medicine (CM) involving triple rehabilitation therapy (中医三联康复疗法) on the progression of knee osteoarthritis (KOA). A total of 722 patients recruited from 38 community health service centers located in China from March 2013 to March 2017 were randomly divided into treatment and control groups equally, using a cluster randomization design. Health education combined with CM involving triple rehabilitation therapy for KOA (electro-acupuncture, Chinese medicinal herb fumigating-washing, and traditional exercises) was administered in the treatment group while conventional rehabilitation therapy (physical factor therapy, joint movement training, and muscle strength training) was administered in the control group. Patients with a visual analog scale (VAS) scores ≽4 were treated with dispersible meloxicam tablets (7.5 mg, once daily). The Lequesne index scores, VAS scores, range of motion (ROM), lower limb muscle strength, knee joint circumference, quantitative scores of KOA symptoms, and the short-form 36 item health survey questionnaire (SF-36) scores were measured for each patient at 5 checkpoints (before treatment, at the 2nd week and the 4th week during the 4-week treatment period, at 1 month and 3 months after end of treatment), and adverse reactions were observed also. A total of 696 patients completed the entire process, with 351 in the treatment group and 345 in the control group. At all treatment checkpoints, the treatment group demonstrated better outcomes than the control group with regard to the total Lequesne index scores, effective rate and improvement rate of the total Lequesne index scores, VAS scores, lower limb muscle strength, knee circumference, quantitative scores of KOA symptoms, and SF-36 scores as well (P

Justice-involved youth are at a higher risk of negative outcomes from sexual activity and alcohol use relative to their non-justice involved peers. In the current study, we tested the extent to which variability in neurocognitive response (i.e., activation in the right superior parietal lobule; rSPL) during a risky decision-making task moderated the success of a sexual risk reduction intervention. In a cluster randomized trial blocked by gender, justice-involved adolescents (N = 269) first completed a risky decision-making task during a magnetic resonance imaging (MRI) session, then were assigned to an information-only control (GINFO) or sexual risk reduction intervention incorporating alcohol risk reduction content (GPI + GMET) and then re-contacted every three months for one year. Youth in the GPI + GMET intervention reported less sexual risk behavior 12 months after intervention than those in the control. Although neurocognitive activation was associated with sexual risk behavior, it did not moderate intervention outcomes. This risk-reduction intervention appears to work equally well across a range of neurocognitive responses.

Background It is reported that the longer-term outcomes for stroke survivors are poor, with a range of unmet needs identified. Objectives The aims were to develop and test a longer-term stroke care strategy focused on improving the quality of life of stroke survivors and their carers by addressing unmet needs, and maintenance and enhancement of participation (i.e. involvement in life situations). Design Five overlapping workstreams were undertaken – (1) refinement of content by semistructured interviews with stroke survivors and their carers and by a review of the literature to inform content and delivery of the care strategy; (2) exploration of service models by national survey and focus groups with purposely selected services; (3) intervention development by interaction with a reference group of stroke survivors, carers, and health and social care professionals; (4) refinement and pilot implementation of the developed intervention in three stroke services (case studies); and (5) a cluster randomised controlled feasibility trial in 10 stroke services across England and Wales. Setting The intervention development work and feasibility trial were in stroke services (inclusive of primary, secondary, community and social care provision) across England and Wales. Participants Participants were stroke survivors resident in the community and their carers, and health and social care professionals in the included stroke services. Data sources Interviews with 28 stroke survivors and their carers at least 9 months post stroke ascertained their needs and the barriers to and facilitators of addressing those needs. Additional literature reviews identified 23 needs. No evidence-based interventions to address these needs were reported; self-management was highlighted as a possible delivery mechanism. In workstream 2, a national survey revealed that the most common model of stroke service provision was care up to 12 months post stroke, reported by 46 (40%) services. Thirty-five (30%) services provided care up to 6 months post stroke and 35 (30%) provided care beyond 12 months, thus identifying 6 months post stroke as an appropriate delivery point for a new intervention. Through focus groups in a range of services, stroke survivors’ perceived unmet needs and the barriers to and enablers of service provision were identified. Intervention Using information obtained in workstreams 1 and 2 and working closely with a stakeholder reference group, we developed an intervention based on the unmet needs prioritised by stroke survivors and their carers (workstream 3). In workstream 4, action groups (clinicians, stroke survivors and researchers) were established in three stroke services that led implementation in their service and contributed to the iterative refinement of the intervention, associated training programme and implementation materials. The intervention (called New Start) was delivered at 6 months post stroke. Key components were problem-solving self-management with survivors and carers, help with obtaining usable information, and helping survivors and their carers build sustainable, flexible support networks. Results A cluster randomised feasibility trial (workstream 5) was successfully implemented in 10 stroke services across England and Wales, with associated process and health economic evaluations. Five services were randomised to provide New Start, while five continued with usual care; 269 participants were recruited. Progression criteria – in terms of our pre-determined (red, amber, green) criteria for progress to a full trial: target stroke survivor recruitment rates were achieved, on average, across sites (24.1 per site over 6 months, green); 216 (80.3%) registered stroke survivors returned follow-up questionnaires at 9 months (84.1% in the intervention arm and 75.8% in the usual care arm, green); according to data reported by sites, overall, 95.2% of registered stroke survivors were offered at least one session of the intervention (green); all five intervention sites had at least two facilitators deemed competent, delivered the New Start intervention and provided it to stroke survivors (green). However, at some sites, there were concerns regarding the number of stroke survivors being offered, accepting and receiving the intervention. Only small differences in outcomes and costs were observed between the New Start and usual care groups, and considerable uncertainty around the cost-effectiveness remains. Conclusions We report a complex programme of work that has described the longer-term needs of stroke survivors and highlighted evidence and service gaps. Working closely with stroke survivors, an intervention was developed that has been refined in three services and feasibility tested in a cluster randomised controlled trial. Further refinement of the target population and optimisation of the intervention materials is required prior to a full randomised controlled trial evaluation. Future work Optimisation of the intervention, and clearer specification of recipients, are required prior to a full trial evaluation. Trial registration Current Controlled Trials ISRCTN38920246. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 3. See the NIHR Journals Library website for further project information.

This study evaluated the effectiveness of an educational board game aimed at increasing knowledge of appearance-related issues, positive body image, media literacy, and acceptance of appearance diversity with British school children. Two hundred and fifty-nine children, aged 9–11 (Mage = 10.26), from three primary schools in South-West England participated in a two-arm matched cluster randomised controlled trial. Outcome measures were collected pre-, post- and at two-week follow-up. Knowledge of appearance-related issues significantly increased in the intervention group, compared to the control group post-intervention, but was not maintained at follow-up. There were no significant differences between groups for body appreciation, media literacy or acceptance of visible difference. Of the intervention arm, 78 % (n=117) they would like to play again and 85.3 % (n=128) thought other children would like to play. Qualitative data suggests participants learned the key messages of the game. The findings suggest ‘Everybody’s Different: The Appearance Game’ is an enjoyable way to increase knowledge of appearance-related issues. In future, researchers should consider how to increase body appreciation, media literacy and acceptance of appearance diversity, for example by increasing the dosage of the game or using it in conjunction with discussions and lessons surrounding appearance diversity and appearance-altering conditions.

Background Around 1 in 7 people in India are impacted by mental illness. The treatment gap for people with mental disorders is as high as 75–95%. Health care systems, especially in rural regions in India, face substantial challenges to address these gaps in care, and innovative strategies are needed. Methods We hypothesise that an intervention involving an anti-stigma campaign and a mobile-technology-based electronic decision support system will result in reduced stigma and improved mental health for adults at high risk of common mental disorders. It will be implemented as a parallel-group cluster randomised, controlled trial in 44 primary health centre clusters servicing 133 villages in rural Andhra Pradesh and Haryana. Adults aged ≥ 18 years will be screened for depression, anxiety and suicide based on Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorders (GAD-7) scores. Two evaluation cohorts will be derived—a high-risk cohort with elevated PHQ-9, GAD-7 or suicide risk and a non-high-risk cohort comprising an equal number of people not at elevated risk based on these scores. Outcome analyses will be conducted blinded to intervention allocation. Expected outcomes The primary study outcome is the difference in mean behaviour scores at 12 months in the combined ‘high-risk’ and ‘non-high-risk’ cohort and the mean difference in PHQ-9 scores at 12 months in the ‘high-risk’ cohort. Secondary outcomes include depression and anxiety remission rates in the high-risk cohort at 6 and 12 months, the proportion of high-risk individuals who have visited a doctor at least once in the previous 12 months, and change from baseline in mean stigma, mental health knowledge and attitude scores in the combined non-high-risk and high-risk cohort. Trial outcomes will be accompanied by detailed economic and process evaluations. Significance The findings are likely to inform policy on a low-cost scalable solution to destigmatise common mental disorders and reduce the treatment gap for under-served populations in low-and middle-income country settings. Trial registration Clinical Trial Registry India CTRI/2018/08/015355. Registered on 16 August 2018.

BackgroundPost-exposure prophylaxis (PEP) is a well-established strategy for the prevention of infectious diseases, in which recently exposed people take a short course of medication to prevent infection. The primary objective of the COVID-19 Ring-based Prevention Trial with lopinavir/ritonavir (CORIPREV-LR) is to evaluate the efficacy of a 14-day course of oral lopinavir/ritonavir as PEP against COVID-19 among individuals with a high-risk exposure to a confirmed case.MethodsThis is an open-label, multicenter, 1:1 cluster-randomized trial of LPV/r 800/200 mg twice daily for 14 days (intervention arm) versus no intervention (control arm), using an adaptive approach to sample size calculation. Participants will be individuals aged > 6 months with a high-risk exposure to a confirmed COVID-19 case within the past 7 days. A combination of remote and in-person study visits at days 1, 7, 14, 35, and 90 includes comprehensive epidemiological, clinical, microbiologic, and serologic sampling. The primary outcome is microbiologically confirmed COVID-19 infection within 14 days after exposure, defined as a positive respiratory tract specimen for SARS-CoV-2 by polymerase chain reaction. Secondary outcomes include safety, symptomatic COVID-19, seropositivity, hospitalization, respiratory failure requiring ventilator support, mortality, psychological impact, and health-related quality of life. Additional analyses will examine the impact of LPV/r on these outcomes in the subset of participants who test positive for SARS-CoV-2 at baseline. To detect a relative risk reduction of 40% with 80% power atα = 0.05, assuming the secondary attack rate in ring members (p0) = 15%, 5 contacts per case and intra-class correlation coefficient (ICC) = 0.05, we require 110 clusters per arm, or 220 clusters overall and approximately 1220 enrollees after accounting for 10% loss-to-follow-up. We will modify the sample size target after 60 clusters, based on preliminary estimates ofp0, ICC, and cluster size and consider switching to an alternative drug after interim analyses and as new data emerges. The primary analysis will be a generalized linear mixed model with logit link to estimate the effect of LPV/r on the probability of infection. Participants who test positive at baseline will be excluded from the primary analysis but will be maintained for additional analyses to examine the impact of LPV/r on early treatment.DiscussionHarnessing safe, existing drugs such as LPV/r as PEP could provide an important tool for control of the COVID-19 pandemic. Novel aspects of our design include the ring-based prevention approach, and the incorporation of remote strategies for conducting study visits and biospecimen collection.Trial registrationThis trial was registered atwww.ClinicalTrials.gov(NCT04321174) on March 25, 2020.

Introduction Acute kidney injury (AKI) is associated with increased health care utilization and higher costs. The Tackling AKI study was a multicenter, pragmatic, stepped-wedge cluster randomized trial that demonstrated a reduced hospital length of stay after implementation of a multifaceted AKI intervention (e-alerts, care bundle, and an education program). We tested whether this would result in cost savings. Methods A decision-analytic tree model from the payer perspective (National Health Service in the United Kingdom) was generated on which cost-effectiveness analyses were performed using a probabilistic sensitivity analysis, accounting only for direct medical costs. Clinical data from the Tackling AKI study were used as inputs and economic and utility data derived from relevant published literature. Results A total of 24,059 AKI episodes occurred during the study period, and in 18,887 admissions the patient was discharged alive. When all AKI stages were considered together, the cost per AKI admission was £5065 in the control arm and £4333 in the intervention arm, representing an incremental cost saving of £732 per admission with the intervention. Similar results were obtained when AKI stages were included as separate variables. Costs per quality-adjusted life year were £61,194 in the control group and £51,161 in the intervention group. At a willingness to pay threshold of £20,000 per quality-adjusted life year, the probability of the intervention being cost-effective compared with standard care was 90%. Conclusion An organizational level approach to improve standards of AKI care reduces the cost of hospital admissions and is cost effective within the National Health Service in the United Kingdom., Graphical abstract

This study reports the impact of the HiFive program, a 6-week handwashing campaign that targets social and emotional motivators to improve student handwashing in primary schools in the Philippines. We designed a clustered randomized trial to evaluate the impact of HiFive on student handwashing behavior, motivation, and access. Of the sample of 196 primary schools located in two districts, half were randomly assigned to receive the program in the 2017–2018 school year. Survey and observation data were collected 3 months after the conclusion of the campaign. In control schools, only 2.5% of students were observed washing their hands with soap and water, our primary outcome and 14.8% were observed washing their hands with at least water. HiFive led to a 3.7 percentage point (p.p.) increase (P < 0.01) in the rate of handwashing with soap and water and a 5.6 p.p. increase (P = 0.03) in handwashing with at least water after toilet use. HiFive also led to a 10.8 p.p. (P < 0.01) increase in the number of handwashing facilities stocked with soap. The program had limited impact on the motivators targeted by the program, suggesting that the small improvements in handwashing may have been driven by increases in the availability of soap. More research is needed to understand how interventions can effectively trigger social motivators to improve handwashing behavior among schoolchildren, and whether the effectiveness of these programs can be augmented with “nudge”-based interventions from the behavioral sciences.

Background Long-lasting insecticidal nets (LLINs) are currently the primary method of malaria control in sub-Saharan Africa and have contributed to a significant reduction in malaria burden over the past 15 years. However, this progress is threatened by the wide-scale selection of insecticide-resistant malaria vectors. It is, therefore, important to accelerate the generation of evidence for new classes of LLINs. Methods This protocol presents a three-arm superiority, single-blinded, cluster randomized controlled trial to evaluate the impact of 2 novel dual-active ingredient LLINs on epidemiological and entomological outcomes in Benin, a malaria-endemic area with highly pyrethroid-resistant vector populations. The study arms consist of (i) Royal Guard® LLIN, a net combining a pyrethroid (alpha-cypermethrin) plus an insect growth regulator (pyriproxyfen), which in the adult female is known to disrupt reproduction and egg fertility; (ii) Interceptor G2® LLIN, a net incorporating two adulticides (alpha-cypermethrin and chlorfenapyr) with different modes of action; and (iii) the control arm, Interceptor® LLIN, a pyrethroid (alpha-cypermethrin) only LLIN. In all arms, one net for every 2 people will be distributed to each household. Sixty clusters were identified and randomised 1:1:1 to each study arm. The primary outcome is malaria case incidence measured over 24 months through active case detection in a cohort of 25 children aged 6 months to 10 years, randomly selected from each cluster. Secondary outcomes include 1) malaria infection prevalence (all ages) and prevalence of moderate to severe anaemia in children under 5 years old, measured at 6 and 18 months post-intervention; 2) entomological indices measured every 3 months using human landing catches over 24 months. Insecticide resistance intensity will also be monitored over the study period. Discussion This study is the second cluster randomised controlled trial to evaluate the efficacy of these next-generation LLINs to control malaria transmitted by insecticide-resistant mosquitoes. The results of this study will form part of the WHO evidence-based review to support potential public health recommendations of these nets and shape malaria control strategies of sub-Saharan Africa for the next decade. Trial registration ClinicalTrials.gov, NCT03931473, registered on 30 April 2019.

Objectives: To examine the effects of web-based SUpport PRogram (SUPR) for communication partners (CPs) of persons with hearing loss (PHLs) in a HA dispensing setting. Design: Cluster randomised controlled trial (cRCT) with two arms (SUPR: Booklet, online videos; care as usual: no support) plus process evaluation. Measurements: baseline, and immediately-, six, and 12 months post-intervention. Outcomes: Significant Other Scale for Hearing Disability (SOS-HEAR), International Outcome Inventory for HAs/Alternative Interventions for Significant Others (IOI-HA/AI-SO). Process evaluation: dose-received, satisfaction, and benefit. Study sample: The cRCT included 73 (SUPR) and 57 (care as usual) CPs. In the process evaluation study, 41 CPs (SUPR) participated. Results: There were no significant effects of SUPR for third-party disability (SOS-HEAR), the proxy report (IOI-HA-SO item “use”), and third-party disability (IOI-HA-SO items “satisfaction”, and “quality of life”). SUPR-videos were watched by 15-22% of the CPs. SUPR materials were rated as moderately beneficial and useful. Conclusions: Low baseline disability (floor effect) and low intervention dose-received may explain the findings. Directly targeting CPs rather than via their PHLs and providing intervention materials specifically for CPs may improve their engagement and contribute to SUPR’s value supplementary to standard HA care.

We thank the China Medical Board, which financially supported our study. Objective To investigate if a Family-Clinician Shared Decision-Making (FCSDM) intervention benefits patients, families and intensive care units (ICUs) clinicians. Methods Six ICUs in China were allocated to intervention or usual care. 548 patients with critical illness, 548 family members and 387 ICU clinicians were included into the study. Structured FCSDM family meetings were held in the intervention group. Scales of SSDM, HADS, QoL2 and CSACD were used to assess families’ satisfaction and distress, patients’ quality of life, and clinicians’ collaboration respectively. Results Comparing the intervention group with the control group at post-intervention, there were significant differences in the families’ satisfaction (P =0.0001), depression level (P =0.005), and patients’ quality of life (P =0.0007). The clinicians’ mean CSCAD score was more positive in the intervention group than controls (P < 0.05). There was no significant between-group differences on ICU daily medical cost, but the intervention group demonstrated shorter number of days’ stay in ICU (P=0.0004). Conclusion The FCSDM intervention improved families’ satisfaction and depression, shortened patients’ duration of ICU stay, and enhanced ICU clinicians’ collaboration. Practice implications Further improvement and promotion of the FCSDM model are needed to provide more evidence to this field in China. Publisher PDF

Background Since the advent of COVID-19, accelerated adoption of systems that reduce face-to-face encounters has outpaced training and best practices. Electronic consultations (eConsults), structured communications between PCPs and specialists regarding a case, have been effective in reducing face-to-face specialist encounters. As the health system rapidly adapts to multiple new practices and communication tools, new mechanisms to measure and improve performance in this context are needed. Objective To test whether feedback comparing physicians to top performing peers using co-specialists’ ratings improves performance. Design Cluster-randomized controlled trial Participants Eighty facility-specialty clusters and 214 clinicians Intervention Providers in the feedback arms were sent messages that announced their membership in an elite group of “Top Performers” or provided actionable recommendations with feedback for providers that were “Not Top Performers.” Main Measures The primary outcomes were changes in peer ratings in the following performance dimensions after feedback was received: (1) elicitation of information from primary care practitioners; (2) adherence to institutional clinical guidelines; (3) agreement with peer’s medical decision-making; (4) educational value; (5) relationship building. Key Results Specialists showed significant improvements on 3 of the 5 consultation performance dimensions: medical decision-making (odds ratio 1.52, 95% confidence interval 1.08–2.14, p

The COVID-19 pandemic has highlighted the challenges of evidence-based health policymaking, as critical precautionary decisions, such as school closures, had to be made urgently on the basis of little evidence. As primary and secondary schools once again close in the face of surging infections, there is an opportunity to rigorously study their reopening. School-aged children appear to be less affected by COVID-19 than adults, yet schools may drive community transmission of the virus. Given the impact of school closures on both education and the economy, schools cannot remain closed indefinitely. But when and how can they be reopened safely? We argue that a cluster randomized trial is a rigorous and ethical way to resolve these uncertainties. We discuss key scientific, ethical, and resource considerations both to inform trial design of school reopenings and to prompt discussion of the merits and feasibility of conducting such a trial.

Background Patients with firearm injuries are at high risk of subsequent arrest and injury following hospital discharge. We sought to evaluate the effect of a 6-month joint hospital- and community-based low-intensity intervention on risk of arrest and injury among patients with firearm injuries. Methods We conducted a cluster randomized controlled trial, enrolling patients with firearm injuries who received treatment at Harborview Medical Center, the Level 1 trauma center in Seattle, Washington, were 18 years or older at the time of injury, spoke English, were able to provide consent and a method of contact, and lived in one of the five study counties. The intervention consisted of hospital-based motivational interviewing, followed by a 6-month community-based intervention, and multiagency support. The primary outcome was the risk of subsequent arrest. The main secondary outcome was the risk of death or subsequent injury requiring treatment in the emergency department or hospitalization. Results Neither assignment to, or engagement with, the intervention, defined as having at least 1 contact point with the Support Specialist, was associated with risk of arrest at 2 years post hospital discharge (Relative Risk for intervention assignment = 1.15; 95% CI: 0.90, 1.48; Relative Risk for intervention engagement = 1.07; 95% CI: 0.74, 2.19). There was similarly no association observed for subsequent injury. Conclusions This study represents one of the first randomized controlled trials of a joint hospital- and community-based intervention delivered exclusively among patients with firearm injuries. The intervention was not associated with changes in risk of arrest or injury, a finding most likely due to the low intensity of the program. Level of evidence Care Management, level II.RegistrationRegistered at clinicaltrials.gov NCT02630225.

Despite multiple studies demonstrating the effectiveness of household water treatment with chlorine in disinfecting water and preventing diarrhea, social marketing of this intervention in low- and middle-income countries has resulted in only modest uptake. In a cluster randomized trial in Vihiga district, western Kenya, we compared uptake of household water treatment with chlorine among six villages served by community vendors trained in standard social marketing plus education through listening (ETL), an innovative behavior change method, and six villages served by community vendors trained in standard social marketing only. Water treatment uptake, water quality, and childhood diarrhea were measured over 6 months and compared between the two groups of villages. During the 6-month period, we found no association between ETL exposure and reported and confirmed household water treatment with chlorine. In both groups (ETL and comparison), reported use of water treatment was low and did not change during our 6-month follow-up. However, persons confirmed to have chlorinated water had improved bacteriologic water quality. Study findings suggest that ETL implementation was suboptimal, which, along with unexpected changes in the supply and price of chlorine, may have prevented an accurate assessment of the potential impact of ETL on water treatment behavior. Taken together, these observations exemplify the complexities of habits, practices, attitudes, and external factors that can create challenging conditions for implementing behavioral interventions. As a consequence, in this trial, ETL had no measurable impact on water treatment behavior.

Background The need to develop new products and novel approaches for malaria vector control is recognized as a global health priority. One approach to meeting this need has been the development of new products for indoor residual spraying (IRS) with novel active ingredients for public health. While initial results showing the impact of several of these next-generation IRS products have been encouraging, questions remain about how to best deploy them for maximum impact. To help address these questions, a 2-year cluster-randomized controlled trial to measure the impact of IRS with a microencapsulated formulation of pirimiphos-methyl (PM) in an area with high ownership of long-lasting insecticidal nets (LLINs) was conducted in a high-transmission district of central Mozambique with pyrethroid resistant vectors. Presented here are the results of the vector surveillance component of the trial. Methods The 2 year, two-armed trial was conducted in Mopeia District, Zambezia Province, Mozambique. In ten sentinel villages, five that received IRS with PM in October–November 2016 and again in October–November 2017 and five that received no IRS, indoor light trap collections and paired indoor-outdoor human landing collections catches (HLCs) were conducted monthly from September 2016 through October 2018. A universal coverage campaign in June 2017, just prior to the second spray round, distributed 131,540 standard alpha-cypermethrin LLINs across all study villages and increased overall net usage rates in children under 5 years old to over 90%. Results The primary malaria vector during the trial was Anopheles funestus sensu lato (s.l.), and standard World Health Organization (WHO) tube tests with this population indicated variable but increasing resistance to pyrethroids (including alpha-cypermethrin, from > 85% mortality in 2017 to 7% mortality in 2018) and uniform susceptibility to PM (100% mortality in both years). Over the entire duration of the study, IRS reduced An. funestus s.l. densities by 48% (CI95 33–59%; p 95 38–90%; p = 0.010) during indoor and outdoor HLC, though in each study year reductions in vector density were consistently greatest in those months immediately following the IRS campaigns and waned over time. Overall there was no strong preference for An. funestus to feed indoors or outdoors, and these biting behaviours did not differ significantly across study arms: observed indoor-outdoor biting ratios were 1.10 (CI95 1.00–1.21) in no-IRS villages and 0.88 (CI95 0.67–1.15) in IRS villages. The impact of IRS was consistent in reducing HLC exposures both indoors (75% reduction: CI95 47–88%; p = 0. 95 22–87%; p = 0.012). While substantially fewer Anopheles gambiae s.l. were collected during the study, trends show a similar impact of IRS on this key vector group as well, with a 33% (CI95 7–53%; p = 0.019) reduction in mosquitoes collected in light traps and a non-statistically significant 39% reduction (p = 0.249) in HLC landing rates. Conclusion IRS with PM used in addition to pyrethroid-only LLINs substantially reduced human exposures to malaria vectors during both years of the cluster-randomized controlled trial in Mopeia—a high-burden district where the primary vector, An. funestus s.l., was equally likely to feed indoors or outdoors and demonstrated increasing resistance to pyrethroids. Findings suggest that IRS with PM can provide effective vector control, including in some settings where pyrethroid-only ITNs are widely used. Trial registrationclinicaltrials.gov, NCT02910934. Registered 22 September 2016, https://www.clinicaltrials.gov/ct2/show/NCT02910934.

Aim Optimal airway management during out-of-hospital cardiac arrest (OHCA) is uncertain. Complications from tracheal intubation (TI) may be avoided with supraglottic airway (SGA) devices. The AIRWAYS-2 cluster randomised controlled trial (ISRCTN08256118) compared the i-gel SGA with TI as the initial advanced airway management (AAM) strategy by paramedics treating adults with non-traumatic OHCA. This paper reports the trial cost-effectiveness analysis. Methods A within-trial cost-effectiveness analysis of the i-gel compared with TI was conducted, with a 6-month time horizon, from the perspective of the UK National Health Service (NHS) and personal social services. The primary outcome measure was quality-adjusted life years (QALYs), estimated using the EQ-5D-5L questionnaire. Multilevel linear regression modelling was used to account for clustering by paramedic when combining costs and outcomes. Results 9,296 eligible patients were attended by 1,382 trial paramedics and enrolled in the AIRWAYS-2 trial (4410 TI, 4886 i-gel). Mean QALYs to 6 months were 0.03 in both groups (i-gel minus TI difference -0.0015, 95% CI –0.0059 to 0.0028). Total costs per participant up to 6 months post-OHCA were £3,570 and £3,413 in the i-gel and TI groups respectively (mean difference £157, 95% CI –£270 to £583). Based on mean difference point estimates, TI was more effective and less costly than i-gel; however differences were small and there was great uncertainty around these results. Conclusion The small differences between groups in QALYs and costs shows no difference in the cost-effectiveness of the i-gel and TI when used as the initial AAM strategy in adults with non-traumatic OHCA.

To compare the rate of orthodontic space closure with and without systemic administration of probiotics. Cluster randomised controlled trial, an invivo RCT study. Forty-eight male patients undergoing orthodontic fixed appliance treatment were recruited based on purposive sampling technique and randomly allocated to group A (control) and group B (experimental). During retraction, the patients in the experimental group were given 90 probiotic capsules each and instructed to take one capsule per day along with breakfast for 90 days. The distance between the canine and 2nd premolar on the maxillary arch in both groups were measured using a digital vernier calliper. The measurements were taken before starting the retraction, after 30 days, after 60 days and after 90 days of retraction. The collected data was calculated and tabulated for statistical analysis. Independent t-test revealed that pre retraction, there was no statistically significant difference (p>0.05) between the control and experimental. Post retraction, there was significant (p

This study examined the efficacy of a classroom-based positive education program, Flourishing Students, on early adolescents’ positive and negative affect using a cluster randomized control trial (RCT) design. In total, 140 students (aged 10–12) participated in the study: 72 students participated in 32 well-being lessons during one school year, and 68 students followed the standard curriculum. Positive and negative affect (PANAS questionnaire), and daily positive and negative affect (experience sampling method, ESM) were gathered at baseline and post-intervention. PANAS data was also gathered at a follow-up 5 months after the intervention. Student questionnaire and ESM data indicated that the intervention had a beneficial impact on students’ positive affect and daily negative affect from baseline to post-intervention. No effect was seen in parental reports. Both qualitative data from focus group interviews with students and questionnaires for teachers supported the view that the students benefited from the program. Overall, these results demonstrate a positive effect of the positive education program on increasing positive affect and well-being among early adolescents.