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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 inSCALE cluster randomised controlled trial evaluated two interventions, mHealth and Village Health Clubs (VHCs) which aimed to improve Community Health Worker (CHW) treatment for malaria, diarrhoea, and pneumonia within the Integrated Community Case Management programme. Methods: In a cluster randomised trial, 39 sub-counties in Midwest Uganda, covering 3167 CHWs, were randomly allocated to mHealth; VHC or usual care (control) arms. Household surveys captured parent-reported child illness, care seeking and treatment practices. Intention-to-treat analysis estimated the proportion of appropriately treated children with malaria, diarrhoea and pneumonia according to WHO informed national guidelines. Registration: ClinicalTrials.gov (NCT01972321). ResultsBetween April-June 2014, 7679 households were surveyed; 2806 children were found with malaria, diarrhoea or pneumonia symptoms in the last one month. Appropriate treatment was 11% higher in the mHealth compared to the control arm (risk ratio [RR] 1·11, 95% CI 1·02, 1·21; p=0·018). The largest effect was on appropriate treatment for diarrhoea (RR 1·39; 95% CI 0·90, 2·15; p=0·134). The VHC intervention increased appropriate treatment by 9% (RR 1·09; 95% CI 1·01, 1·18; p=0·059), again with largest effect on treatment of diarrhoea (RR 1·56, 95% CI 1·04, 2·34, p=0·030). CHWs provided the highest levels of appropriate treatment compared to other providers. However, differences in appropriate treatment were at health facilities and pharmacies, with CHW appropriate treatment the same across the arms. The rate of CHW attrition in both intervention arms was less than half that of the control arm; adjusted risk difference mHealth arm -4·42% (95% CI -8·54, -0·29, p=0·037) and VHC arm -4·75% (95% CI -8·74, -0·76, p=0·021). Interpretation: Appropriate treatment by CHWs was encouragingly high across arms. The inSCALE mHealth and VHC interventions have the potential to reduce CHW attrition and improve the treatment of sick children, but not through the hypothesised mechanisms of improved CHW utilization and treatment. Trial Registration: ClinicalTrials.gov (NCT01972321). Funding: Bill & Melinda Gates Foundation and UK DFID Declaration of Interest: We declare no competing interests Ethical Approval: The inSCALE trial, registered as NCT01972321, was approved by Makerere University Institutional Review Board, the Uganda National Council of Science and Technology (ref. HS 958), and London School of Hygiene & Tropical Medicine Ethics Committee in the UK (ref. 5762). Oral consent for the random allocation of districts to intervention or control groups was obtained from the sub-county leadership. Individual written informed consent was obtained from the caregiver for baseline and follow up data collection after explaining the purpose of the interview. Participants were free to decline the interview at any time.

BACKGROUND: Child care settings significantly influence children's physical activity (PA) and screen time (ST) behaviors, yet less research has been conducted in family child care homes (FCCHs) than in child care centers. While a few studies have measured family child care providers' (FCCPs’) PA practices, none have used observation to assess which specific evidence-based, best practice guidelines FCCPs met or did not meet, and no previous studies have included Latinx providers. This article examines FCCPs' adherence to PA and ST best practice guidelines using primarily observational methods with diverse FCCPs (including Latinx). METHODS: We examined baseline data from a cluster randomized trial including surveys and observational data collected at the FCCH to assess whether providers met specific PA and ST best practices from the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) and the American Academy of Pediatrics. RESULTS: Providers completed a telephone survey and participated in two full-day observations (n = 127; 72% Hispanic). Overall, only 4 of 14 PA and ST best practices were met by >50% of providers including: leading a planned PA class more than once a week; no ST during meal or snack; not modeling sedentary behavior; and providing families with information about children's ST. Best practices least likely to be met (60 minutes of outdoor play daily; providing children with >45 minutes of adult-led PA each day; participating in outdoor PA with children; participating in indoor PA with children; prompting and praising children for being active; and talking with children informally about the importance of PA. CONCLUSIONS: : While FCCPs engage in some positive PA and ST practices, many providers do not meet best practice guidelines. There is a need for more research about how to overcome providers' personal and environmental barriers for meeting these guidelines as well as interventions and supports to overcome these barriers. Clinical Trial Registration Number NCT0245645.

Background Little is known whether patients with lower health literacy could retain the practice and knowledge of home blood pressure monitoring (HBPM) after an educational programme. Methods A cluster randomised controlled trial in five primary care clinics recruited participants with uncontrolled hypertension. Clinics were randomised either to a HBPM group education (Risk Assessment and Management Programme (RAMP-group), or individual counselling of self-management (RAMP-individual). Health literacy was assessed by the Chinese Health Literacy Scale for Chronic Care. Practice and knowledge of HBPM were surveyed by a 10-item HBPM knowledge checklist and patient record review 6 months after interventions. Predictors for regular HBPM and good HBPM knowledge were assessed by multivariate logistic regression models. Results 287 participants (RAMP-group: 151; RAMP-individual: 136) were follow-up for 6 months. 272 participants completed the knowledge questionnaires (response rate 94.8%). 67.8% of the participants performed HBPM regularly, and there was no statistical difference between both interventions. Age more than 65 (adjusted odds ratios (aOR) 2.58, 95% CI 1.37 to 4.86, p=0.003), not working (aOR 2.34, 95% CI 1.10 to 4.97, p=0.027)and adequate health literacy (aOR 2.25, 95% CI 1.28 to 3.95, p=0.005) predicted regular HBPM. Participants in RAMP-group demonstrated a significant lower body weight than those in RAMP-individual (−0.3±2.0 kg vs +0.7 ±1.7 kg, p Conclusion Patients could retain HBPM knowledge better after RAMP-group than RAMP-individual. Older, retired and patients with adequate health literacy were more likely to continue weekly HBPM 6 months after education. Trial registration number NCT02551393.

Background In the context of the Coronavirus Disease (COVID-19) pandemic, adherence to suggested precautionary measures has been highlighted to be extremely important in preventing and curtailing the spread of COVID-19. However, strict adherence to precautionary measures could be very demanding. Materials and Method This cluster randomized controlled trial done among 1517 undergraduate dental students tested the effectiveness of ‘Dissonance Induction’(DI) and ‘Assessment Reactivity’(AR) in improving adherence to WHO suggested COVID-19 precautionary measures as compared to a control group. At baseline, participants in the DI group were tested for their knowledge on COVID-19 precautionary measures, immediately followed by assessment of their adherence to these precautionary measures. This methodology was adapted so as to systematically reveal to the participants the poor adherence to their self-held cognitions, should there be any. The magnitude of dissonance was measured as the proportion of such dissonant cognitions held by an individual. In the AR group, at baseline, participants were inquired about their attitudes alone towards COVID-19 precautionary measures. The control group was neither assessed for knowledge and adherence nor for attitudes towards the precautionary measures at baseline. Two weeks after the administration of the aforementioned interventions in the DI and AR groups, the three study groups were assessed for adherence to COVID-19 precautionary measures. Results The follow-up adherence scores in the DI group were found to be significantly higher (15.11±4.1) compared to the AR (13.13±2.01) and control (12.87±2.97) groups as analyzed by Kruskal-Wallis ANOVA (H=243.5; P

Purpose The aim of this study is to test the effects of an electronic screening and feedback tool and training for primary care clinicians on care and adolescent health behaviors. Methods We conducted a stepped-wedge cluster randomized trial with six clinics randomly assigned to sequential crossover from control to intervention periods with clinician training between periods. Adolescents (ages 13–18) with a well visit during the control periods (n = 135) received usual care, while adolescents during the intervention periods (n = 167) received the electronic screening and feedback tool prior to their well visit, with results sent to their clinicians. Adolescents completed surveys at baseline, 1 day, 3 months, 6 months, and 12 months. Linear mixed effects models were used to examine associations between outcomes and treatment, controlling for time as a fixed effect and clinic as a random effect. All analyses employed intent-to-treat analyses and utilized multiple imputations for missing data. Results Adolescents who received the intervention had a higher rate of counseling for their endorsed risk behaviors during the well visit (45% vs. 33%, Wald’s T = 2.29, p = .02). There were no significant intervention effects on adolescent satisfaction with the clinician or perception of patient centeredness. The intervention was associated with a small but statistically significant reduction in overall risk score relative to control at 3 months (−.63, 95% confidence interval [−1.07, −.19], Cohen’s d = .21), but not at 6 or 12 months. Conclusions The results suggest that electronic screening and feedback may be associated with small reductions in risk behaviors at 3 months but that changes do not persist at longer term follow-up.

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.

ObjectivesTo improve teen contraceptive use, the SpeakOut intervention combines structured counseling, online resources, and text reminders to encourage teens to share their experiences using intrauterine contraception (IUC) or an implant with peers.Study designTo evaluate the effectiveness of remote delivery of the SpeakOut intervention in increasing teen contraceptive use, we conducted a cluster randomized trial involving female adolescents who were recruited online. Primary participants (n=520) were randomly assigned to receive SpeakOut or an attention control; each primary participant recruited a cluster of up to 5 female peers as secondary participants (n=581). We assessed contraceptive communication, knowledge, and use, at baseline, 3 and 9 months after participants enrolled. We examined differences between study groups, controlling for clustering by primary participant and baseline characteristics.ResultsThe trial's primary outcome, contraceptive use by secondary participants, was similar between groups at both 3 and 9 months postintervention. Compared to controls, primary participants receiving SpeakOut tended to be less likely to discontinue contraception within 9 months (4.8% vs 7.8%, p=0.11 for IUC; 7.8% vs 9.8%, p=0.45 for implants), but this did not reach statistical significance. SpeakOut failed to increase contraceptive communication; regardless of study group, most secondary participants reported peer communication about contraception (86% vs 88%, p=0.57). Most secondary participants were aware of the hormonal IUC (91.4% vs 90.4%, p=0.72), copper IUC (92.9% vs 88.6%, p=0.13), and implant (96.5% vs 96.1%, p=0.83) 3 months after enrolling, regardless of the intervention their primary participant received. However, contraceptive knowledge remained incomplete in all study groups.ConclusionRemote delivery of the SpeakOutintervention did not improve contraceptive communication, knowledge or use among participating teens or their peers.ImplicationsEfforts to support teen-to-teen contraceptive communication and ensure that teens have accurate information about the full range of contraceptive methods, including highly effective reversible contraceptives, require refinement.

Background Child mortality remains unacceptably high, with Northern Nigeria reporting some of the highest rates globally (e.g. 192/1000 live births in Jigawa State). Coverage of key protect and prevent interventions, such as vaccination and clean cooking fuel use, is low. Additionally, knowledge, care-seeking and health system factors are poor. Therefore, a whole systems approach is needed for sustainable reductions in child mortality. Methods This is a cluster randomised controlled trial, with integrated process and economic evaluations, conducted from January 2021 to September 2022. The trial will be conducted in Kiyawa Local Government Area, Jigawa State, Nigeria, with an estimated population of 230,000. Clusters are defined as primary government health facility catchment areas (n = 33). The 33 clusters will be randomly allocated (1:1) in a public ceremony, and 32 clusters included in the impact evaluation. The trial will evaluate a locally adapted ‘whole systems strengthening’ package of three evidence-based methods: community men’s and women’s groups, Partnership Defined Quality Scorecard and healthcare worker training, mentorship and provision of basic essential equipment and commodities. The primary outcome is mortality of children aged 7 days to 59 months. Mortality will be recorded prospectively using a cohort design, and secondary outcomes measured through baseline and endline cross-sectional surveys. Assuming the following, we will have a minimum detectable effect size of 30%: (a) baseline mortality of 100 per 1000 livebirths, (b) 4480 compounds with 3 eligible children per compound, (c) 80% power, (d) 5% significance, (e) intra-cluster correlation of 0.007 and (f) coefficient of variance of cluster size of 0.74. Analysis will be by intention-to-treat, comparing intervention and control clusters, adjusting for compound and trial clustering. Discussion This study will provide robust evidence of the effectiveness and cost-effectiveness of community-based participatory learning and action, with integrated health system strengthening and accountability mechanisms, to reduce child mortality. The ethnographic process evaluation will allow for a rich understanding of how the intervention works in this context. However, we encountered a key challenge in calculating the sample size, given the lack of timely and reliable mortality data and the uncertain impacts of the COVID-19 pandemic. Trial registration ISRCTN 39213655. Registered on 11 December 2019

Thailand has a rapidly aging population yet lacks evidence for effective and scalable evidence-based psychosocial interventions to support persons living with dementia and their family caregivers. In this study of a culturally adapted and evidence-based clinical program (Reducing Disabilities in Alzheimer's Disease [RDAD]), designed to reduce behavioral and psychological symptoms of dementia in older adults, the authors test the hypothesis that an implementation support strategy, Getting To Outcomes (GTO), would produce better implementation and clinical outcomes compared with usual implementation of RDAD in Thailand.The study uses a hybrid type III cluster-randomized design to compare eight geographical districts that receive training on both implementing the RDAD clinical intervention and on GTO implementation support strategies (intervention arm) with eight other districts that receive the same RDAD training but without training in GTO implementation support strategies (control arm). GTO is an evidence-based intervention designed to support implementers to better plan, implement, and evaluate innovative intervention programs in a novel setting. Primary outcomes, including implementation and clinical outcomes, will be assessed at baseline, month 3 (posttreatment), and month 6 (3-month follow-up).The research team anticipates that there will be significantly more improvements in the delivery of the RDAD intervention program in the experimental group than in the control group.If clinical trial findings are positive, the authors plan to replicate and scale up the proposed implementation science approach across Thailand to enhance and expand mental health services for older adults with dementia.

Highlights • Iron folic acid consumption can reduce anemia, but compliance remains low. • Interventions can promote interpersonal communication for behavior change. • Topic-specific and general interpersonal communication modalities appear effective. • Interpersonal communication mediated the intervention effect on iron supplement use., Objective More than half of Indian women of reproductive age are anemic. Regular iron folic acid uptake can prevent and treat anemia. This study investigated the effect of interpersonal communication on improving IFA use among women of reproductive age. Methods The Reduction in Anemia through Normative Innovations (RANI) Project is a cluster randomized trial that collected longitudinal data from control (n = 1896) and intervention (n = 1898) communities in Odisha, India at Time 1 and six months later at Time 2. Structural equation models assessed the effect of the intervention on iron folic acid use via multiple interpersonal communication pathways. Results Compared to the control arm, iron folic acid use significantly increased in the intervention arm. Both, general health interpersonal communication and anemia-specific interpersonal communication were augmented in the intervention communities. The impact of the intervention on iron folic acid use was mediated through anemia-specific interpersonal communication. Conclusion The RANI Project increased interpersonal communication among participants, resulting in increased iron folic acid use for anemia reduction. Practice implications Strategic use of targeted interpersonal communication to promote behavior change appears to be a viable strategy to increase iron folic acid use to reduce anemia.

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.

OBJECTIVES The management of early childhood caries is challenging and the impacts of its treatment on child oral health-related quality of life (COHRQoL) and dental anxiety among Australian Aboriginal children is relatively unknown. The aim of the study was to compare the impact on COHRQoL and dental anxiety after approximately 12 months among Aboriginal children treated for early childhood caries (ECC) using the Atraumatic Restorative Treatment and the Hall Technique (ART/HT: test) or standard care (control). METHODS Consenting Aboriginal communities in the North-West of Western Australia were randomized into early (test) or delayed (control) intervention for the management of ECC. Children and parents/carers completed a questionnaire at baseline and at follow-up. The questionnaire sought information on COHRQoL using the proxy-reported Early Childhood Oral Health Impact Scale (ECOHIS) and the self-reported Caries Impacts and Experiences Questionnaire for Children (CARIES-QC). The test group was provided with the ART/HT care at baseline while the control group was advised to seek care through the usual care options available within the community. At follow-up, both groups were offered care using the ART/HT approach. Changes in the mean scores from baseline to follow-up within groups were evaluated using appropriate paired (t-test, Wilcoxon paired test), and between groups with unpaired tests (t-test). Multivariate regression analysis after multiple imputations of missing data used generalized estimating equation (GEE) controlling for clustering within communities. RESULTS Twenty-five communities and 338 children (mean age = 3.6 years, sd 1.7) participated in the study (test = 177). One child was excluded from the analysis because of a missing questionnaire and clinical data at baseline and follow-up. At baseline, test group children were older (test = 3.8 years, 95% CI 3.6-4.1;control = 3.3 years, 95% CI 3.1-3.6) and had higher caries experience (test dmft = 4.4, 95% CI 3.8-5.0;control dmft = 3.1, 95% CI 2.5-3.7), but there was no significant difference in COHRQoL or anxiety levels between the groups. At follow-up, parents in the delayed intervention reported worsening of COHRQoL (70% worsening of the family impact section of the ECOHIS and 37% worsening of the total ECOHIS scale), and there was an 8% reduction in child dental anxiety among the early treatment group. CONCLUSIONS The application of the ART/HT approaches was feasible, effective, and impacted positively on child oral health-related quality of life and child dental anxiety among Aboriginal children in remote communities. The model of care as tested in this study should be further developed for inclusion in main-stream service delivery programmes.

Development during the early stage of life i.e. in the first 1000 d is crucial in determining the psychosocial productivity of a child in the future. Frontline workers (FLWs) are not trained to detect of developmental delays (DDs) in children under the national programme of Rashtriya Bal Swasthya Karyakram (RBSK) in India. To train the FLWs and assess the effectiveness of a training strategy in detection of DDs in children less than 6 y of age using a cluster-randomized trial approach. A community-based interventional study was conducted in Khurdha district of Odisha. Training was imparted to FLWs in intervention arm using a training module developed in regional language. Knowledge level of FLWs was assessed before and after the training in both study arms using a structured questionnaire, and data were analyzed in IBM SPSS 22. Outcomes were compared using chi square, Student t (both paired and unpaired) and Man–Whitney U test. After 3 mo of intervention, the investigator examined a sample of children (intervention arm: 870, control arm: 847) for DDs using the Denver Developmental Screening Test II. The mean difference in knowledge scores of FLWs was found to be 7.26 (8.8 to 5.7) and 1.11 (1.38 to 0.84) in intervention and control arm, respectively. Case detection rate by FLWs in intervention and control arm was 61.5% and 9.09%, respectively. Capacity building of the FLWs should be considered by the government for integrating them in the Rashtriya Bal Swasthya Karyakram (RBSK) programme for screening children.

To assess whether improvements in social norms related to iron and folic acid consumption are associated with increased iron and folic acid consumption.In a cluster randomized trial in Odisha, India, we implemented an intervention to improve descriptive norms (people's perceptions about how many other people take iron and folic acid), injunctive norms (social pressures people feel to take iron and folic acid) and collective norms (actual levels of iron and folic acid consumption). We assessed changes in these norms and self-reported iron and folic acid consumption in control and intervention arms after 6 months (September 2019-February 2020). We collected data from control (At follow-up, mean scores in self-reported iron and folic acid consumption in the control arm had decreased from 0.39 to 0.31 (21% decrease; not significant). In the intervention arm, mean scores increased from 0.39 to 1.62 (315% increase;Our results show that social norms can be improved and that these improvements are associated with positive behavioural changes. A social norms-based approach may help promote iron and folic acid consumption in India.Déterminer si l'évolution des normes sociales en matière de consommation de fer et d'acide folique a permis d'accroître cette consommation.Dans le cadre d'un essai randomisé en grappes dans l'Odisha, en Inde, nous avons mené une intervention visant à améliorer les normes descriptives (perception des gens vis-à-vis du nombre de personnes prenant du fer et de l'acide folique), injonctives (pression sociale ressentie par les gens, les incitant à prendre du fer et de l'acide folique) et collectives (niveaux de consommation réels pour le fer et l'acide folique). Nous avons évalué les changements affectant ces normes, ainsi que la consommation déclarée de fer et d'acide folique dans les groupes d'intervention et de contrôle après 6 mois (septembre 2019 – février 2020). Nous avons récolté des données dans les groupes de contrôle (Lors du suivi, les scores moyens en termes de consommation déclarée de fer et d'acide folique au sein du groupe de contrôle ont diminué de 0,39 à 0,31 (baisse de 21%; non significative). Au sein du groupe d'intervention, les scores moyens sont passés de 0,39 à 1,62 (hausse de 315%;Nos résultats montrent que les normes sociales peuvent évoluer, et qu'une telle évolution est liée à des modifications comportementales positives. L'adoption d'une approche fondée sur ces normes pourrait contribuer à promouvoir la consommation de fer et d'acide folique en Inde.Evaluar si las mejoras en las normas sociales relacionadas con el consumo de hierro y ácido fólico se asocian a un mayor consumo de hierro y ácido fólico.En un ensayo aleatorizado por grupos en Odisha, India, se implementó una intervención para mejorar las normas descriptivas (las percepciones de las personas sobre cuántas otras personas consumen hierro y ácido fólico), las normas por mandato (las presiones sociales que las personas sienten para que tomen hierro y ácido fólico) y las normas colectivas (los niveles reales de consumo de hierro y ácido fólico). Se evaluaron los cambios en estas normas y el consumo de hierro y ácido fólico informado por los participantes en los grupos de control y de intervención después de 6 meses (septiembre de 2019 a febrero de 2020). Se recopilaron datos de los grupos de control (En el seguimiento, las puntuaciones medias en el consumo de hierro y ácido fólico informado por los participantes en el grupo de control disminuyeron de 0,39 a 0,31 (disminución del 21 %; no significativa). En el grupo de intervención, las puntuaciones medias aumentaron de 0,39 a 1,62 (315 % de aumento;Los resultados de este ensayo demuestran que las normas sociales se pueden mejorar y que estas mejoras se asocian a cambios positivos del comportamiento. Un enfoque basado en las normas sociales puede ayudar a promover el consumo de hierro y de ácido fólico en la India.تقييم ما إذا كانت التحسينات في الثوابت الاجتماعية المتعلقة باستهلاك الحديد وحمض الفوليك مرتبطة بزيادة استهلاك الحديد وحمض الفوليك. اأثناء المتابعة، انخفض متوسط الدرجات في استهلاك الحديد وحمض الفوليك الذي أبلغ عنه الأشخاص ذاتيًا في ذراع التحكم من 0.39 إلى 0.31 (انخفاض بنسبة 21%؛ ليس ملموسًا). في ذراع التدخل، زاد متوسط الدرجات من 0.39 إلى 1.62 (زيادة بنسبة 315%؛ نسبة الاحتمال أقل من 0.001). كان الفرق بين الذراعين ذي دلالة إحصائية (نسبة الاحتمال أقل من 0.001). تحسن كل من الثوابت الثلاثة أيضًا بمعدلات أعلى بشكل ملموس في ذراع التدخل عنه في ذراع التحكم (نسبة الاحتمال أقل من 0.001 لكل من الثوابت). ارتبطت التغييرات في الثوابت الوصفية والجماعية (ولكن ليس الثوابت التحذيرية) بالتغيرات في استهلاك الحديد وحمض الفوليك الذي أبلغ عنه الأشخاص ذاتيًا (نسبة الاحتمال أقل من 0.001 لكلا الثابتين).تظهر نتائجنا أنه يمكن تحسين الثوابت الاجتماعية، وأن هذه التحسينات مرتبطة بالتغيرات السلوكية الإيجابية. قد يساعد الأسلوب القائم على الثوابت الاجتماعية في الارتقاء باستهلاك الحديد وحمض الفوليك في الهند.旨在评估与铁和叶酸消耗相关的社会规范的改善是否与铁和叶酸消耗量的增加有关。.在印度奥里萨邦的一项集群随机试验中，我们实施了一项干预措施以改善描述性规范（人们对有多少人服用铁和叶酸的看法）、指令性规范（人们对服用铁和叶酸感受到的社会压力）和群体性规范（铁和叶酸消耗的实际水平）。我们对这些规范的变化进行了评估，并对 6 个月后（2019 年 9 月至 2020 年 2 月）对照组和干预组中铁和叶酸的消耗量进行了自我报告。我们从对照组（n = 2048）和干预组（n = 2060）收集了基线数据和后续数据（分别为 n = 1966 和 n = 1987）。.在后续跟踪中，自我报告显示对照组中铁和叶酸消耗量的平均分值从 0.39 下降到 0.31（下降了 21%；不显著）。干预组中的平均分值从 0.39 增加到 1.63（增加了 315%；我们的结果表明社会规范可以得到改善，并且这些改善与积极的行为改变有关。基于社会规范采取的方法可能有助于促进印度地区铁和叶酸的消耗量。.Оценить, связаны ли улучшения социальных норм, относящихся к потреблению железа и фолиевой кислоты, с увеличением потребления железа и фолиевой кислоты.В кластерном рандомизированном исследовании, проводимом в штате Одиша, Индия, авторы осуществили мероприятие, направленное на улучшение дескриптивных норм (представления людей о том, какое количество человек принимают железо и фолиевую кислоту), предписательных норм (социальное давление, которое люди испытывают, чтобы принимать железо и фолиевую кислоту) и коллективных норм (фактические уровни потребления железа и фолиевой кислоты). Была проведена оценка изменения этих норм и самоотчетности о потреблении железа и фолиевой кислоты в группе контроля и экспериментальной группе после 6 месяцев (сентябрь 2019 г. — февраль 2020 г.). Авторы собрали данные группы контроля (В период последующего наблюдения средний балл по самоотчетности о потреблении железа и фолиевой кислоты в группе контроля снизился с 0,39 до 0,31 (снижение на 21%; несущественное). В экспериментальной группе средний балл увеличился с 0,39 до 1,62 (увеличение на 315%;Наши результаты показывают, что социальные нормы можно улучшить и что эти улучшения связаны с положительными изменениями поведения. Подход, основанный на социальных нормах, может способствовать увеличению потребления железа и фолиевой кислоты в Индии.

Background Clinical pathways (CPs) can improve health outcomes, but to be sustainable, must be deemed acceptable and appropriate by staff. A CP for screening and management of anxiety and depression in cancer patients (the ADAPT CP) was implemented in 12 Australian oncology services for 12 months, within a cluster randomised controlled trial of core versus enhanced implementation strategies. This paper compares staff-perceived acceptability and appropriateness of the ADAPT CP across study arms. Methods Multi-disciplinary lead teams at each service tailored, planned, championed and implemented the CP. Staff at participating services, purposively selected for diversity, completed a survey and participated in an interview prior to implementation (T0), and at midpoint (6 months: T1) and end (12 months: T2) of implementation. Interviews were recorded, transcribed and thematically analysed. Results Seven metropolitan and 5 regional services participated. Questionnaires were completed by 106, 58 and 57 staff at T0, T1 and T2 respectively. Eighty-eight staff consented to be interviewed at T0, with 89 and 76 at T1 and T2 (response rates 70%, 66% and 57%, respectively). Acceptability/appropriateness, on the quantitative measure, was high at T0 (mean of 31/35) and remained at that level throughout the study, with no differences between staff from core versus enhanced services. Perceived burden was relatively low (mean of 11/20) with no change over time. Lowest scores and greatest variability pertained to perceived impact on workload, time and cost. Four major themes were identified: 1) Mental health is an important issue which ADAPT addresses; 2) ADAPT helps staff deliver best care, and reduces staff stress; 3) ADAPT is fit for purpose, for both cancer care services and patients; 4) ADAPT: a catalyst for change. Opposing viewpoints are outlined. Conclusions This study demonstrated high staff-perceived acceptability and appropriateness of the ADAPT CP with regards to its focus, evidence-base, utility to staff and patients, and ability to create change. However, concerns remained regarding burden on staff and time commitment. Strategies from a policy and managerial level will likely be required to overcome the latter issues. Trial registration The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347. https://www.anzctr.org.au/.

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.

BACKGROUND: We conducted this study to examine the effect of taking versus holding BP medications before hemodialysis on intradialytic hypotension (IDH). METHODS: In this cluster randomized trial, each dialysis unit was randomly designated as TAKE or HOLD units. Participants within a TAKE unit were instructed to take all BP medications as prescribed, whereas participants within a HOLD unit were instructed to hold medications dosed more than once daily before hemodialysis. The intervention lasted for 4 weeks. We hypothesized that TAKE would be noninferior to HOLD on the primary outcome of asymptomatic IDH, defined as ≥30% of sessions with nadir systolic BP 160 mm Hg), failure to achieve dry weight, and shortened dialysis sessions. RESULTS: We randomized 10 dialysis units in a 1:1 ratio to TAKE or HOLD, which included 65 participants in TAKE and 66 participants in HOLD. We did not show that TAKE was noninferior to HOLD for the primary IDH outcome (mean unadjusted difference of 8%; 95% CI, −3% to 19%). TAKE was superior to HOLD for the outcome of uncontrolled hypertension (mean unadjusted difference of −15%, 95% CI, −28% to −1%). TAKE was noninferior to HOLD for the outcomes of failure to achieve dry weight and shortened dialysis sessions. CONCLUSIONS: In this cluster randomized trial that randomized patients to either taking or holding BP medications before hemodialysis, a strategy of taking BP medications dosed more than once daily was not noninferior to holding BP medications for the primary outcome of IDH, but did reduce the occurrence of uncontrolled hypertension. Whether any potential benefit of holding BP medications on reducing IDH is offset by any potential harm related to higher predialysis BP remains to be seen.

Background The quality of the home learning environment has a significant influence on children’s language and communication skills during the early years with children from disadvantaged families disproportionately affected. This paper describes the protocol and participant baseline characteristics of a community-based effectiveness study. It evaluates the effects of ‘smalltalk’, a brief group parenting intervention (with or without home coaching) on the quality of the early childhood home learning environment. Methods/design The study comprises two cluster randomised controlled superiority trials (one for infants and one for toddlers) designed and conducted in parallel. In 20 local government areas (LGAs) in Victoria, Australia, six locations (clusters) were randomised to one of three conditions: standard care (control); smalltalk group-only program; or smalltalk plus (group program plus home coaching). Programs were delivered to parents experiencing socioeconomic disadvantage through two existing age-based services, the maternal and child health service (infant program, ages 6–12 months), and facilitated playgroups (toddler program, ages 12–36 months). Outcomes were assessed by parent report and direct observation at baseline (0 weeks), post-intervention (12 weeks) and follow-up (32 weeks). Primary outcomes were parent verbal responsivity and home activities with child at 32 weeks. Secondary outcomes included parenting confidence, parent wellbeing and children’s communication, socio-emotional and general development skills. Analyses will use intention-to-treat random effects (“multilevel”) models to account for clustering. Recruitment and baseline data Across the 20 LGAs, 986 parents of infants and 1200 parents of toddlers enrolled and completed baseline measures. Eighty four percent of families demonstrated one or more of the targeted risk factors for poor child development (low income; receives government benefits; single, socially isolated or young parent; culturally or linguistically diverse background). Discussion This study will provide unique data on the effectiveness of a brief group parenting intervention for enhancing the early home learning environment of young children from disadvantaged families. It will also provide evidence of the extent to which additional one-on-one support is required to achieve change and whether there are greater benefits when delivered in the 1st year of life or later. The program has been designed for scale-up across existing early childhood services if proven effective. Trial registration 8 September 2011; ACTRN12611000965909.

Introduction The increased use of long-acting reversible contraceptives (LARCs), such as intrauterine devices and hormonal implants, has the potential to reduce unintended pregnancy and abortion rates. However, use of LARCs in Australia is very low, despite clinical practice guidance and statements by national and international peak bodies advocating their increased use. This protocol paper describes the Australian Contraceptive ChOice pRojet (ACCORd), a cluster randomised control trial that aims to test whether an educational intervention targeting general practitioners (GPs) and establishing a rapid referral service are a cost-effective means of increasing LARC uptake. Methods and analysis The ACCORd intervention is adapted from the successful US Contraceptive CHOICE study and involves training GPs to provide ‘LARC First’ structured contraceptive counselling to women seeking contraception, and implementing rapid referral pathways for LARC insertion. Letters of invitation will be sent to 600 GPs in South-Eastern Melbourne. Using randomisation stratified by whether the GP inserts LARCs or not, a total of 54 groups will be allocated to the intervention (online ‘LARC First’ training and rapid referral pathways) or control arm (usual care). We aim to recruit 729 women from each arm. The primary outcome will be the number of LARCs inserted; secondary outcomes include the women's choice of contraceptive method and quality of life (Short Form Health Survey, SF-36). The costs and outcomes of the intervention and control will be compared in a cost-effectiveness analysis. Ethics and dissemination The ACCORd study has been approved by the Monash University Human Research Ethics Committee: CF14/3990-2014002066 and CF16/188-2016000080. Any protocol modifications will be communicated to Ethics Committee and Trial Registration registry. The authors plan to disseminate trial outcomes through formal academic pathways comprising journal articles, nation and international conferences and reports, as well as using more ‘popular’ strategies including seminars, workshops and media engagements. Trial registration number ACTRN12615001346561.

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.

Palliative care (PC) benefits patients with serious illness including end-stage liver disease (ESLD). As part of a cluster randomized trial, hepatologists were trained to deliver primary palliative care to patients with ESLD using an online course, Palliative Care Always: Hepatology (PCA:Hep). Here we present a multimethod formative evaluation (feasibility, knowledge acquisition, self-efficacy, and practice patterns) of PCA:Hep. Feasibility was measured by completion of coursework and achieving a course grade of >80%. Knowledge acquisition was measured through assessments before and throughout the course. Pre/post-course surveys were conducted to determine self-efficacy and practice patterns. The hepatologists (n = 39) enrolled in a 12-week online course and spent 1-3 hours on the course weekly. The course was determined to be feasible as 97% successfully completed the course and 100% passed. The course was acceptable to participants; 91.7 % reported a positive course experience and satisfaction with knowledge gained (91.6%). The pre/post knowledge assessment showed an improvement of 6.0% (pre 85.9% to post 91.9%, 95% CI [2.8, 9.2], P = 0.001). Self-efficacy increased significantly (P < 0.001) in psychological symptom management, hospice, and psychosocial support. A year after training, over 80% of the hepatologists reported integrating a variety of PC skills into routine patient care. Conclusion: PCA:Hep is feasible, acceptable, and improves learner knowledge and confidence in palliative care skills. This is a viable method to teach primary PC skills to specialists caring for patients with ESLD.

INTRODUCTION: The aim of this analysis is to present initial contraceptive choices of women offered postpartum contraception in rural Guatemala. METHODS: We trained community nurses participating in the delivery of a home-based antepartum and postpartum care program in rural Guatemala in contraceptive implant placement and had them offer condoms, pills, an injection, or an implant at women’s home-based 40-day postpartum visit in intervention clusters of a non-blinded, cluster-randomized trial. Women who had already started postpartum contraception or were over the age of 35 were excluded from participation. The primary outcome of the trial was contraceptive use at 3 months postpartum, so this initial analysis describes immediate preferences in the population. RESULTS: Of 208 women enrolled in the study, 108 were in intervention clusters and 100 lived in control clusters. In the intervention group, 32 women declined contraception, 36 women received the injectable, 30 women had an implant placed, 5 women started pills, 2 women chose condoms, and data on 3 women were missing. In the control clusters, 43 women were planning on the injectable, 11 planned on the implant, 10 did not want to start a method, 5 planned on sterilization, 2 aimed for natural family planning, 2 wanted a copper IUD, 1 woman wanted condoms, 18 did not know, and data on 8 women were missing. DISCUSSION: The contraceptive implant, which was not previously available in this community, had high uptake at 27.8% in the intervention group. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04005391; Retrospectively Registered 7/2/2019, https://clinicaltrials.gov/ct2/show/NCT04005391 PROTOCOL: https://doi.org/10.1186/s13063-019-3735-3

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.

BACKGROUND AND AIMS There is a higher prevalence of unhealthy alcohol use among Indigenous populations, but there have been few studies of the effectiveness of screening and treatment in primary health care. Over 24 months, we tested whether a model of service-wide support could increase screening and any alcohol treatment. DESIGN Cluster-randomized trial with 24-month implementation (12 months active, 12 months maintenance). SETTING Australian Aboriginal Community Controlled primary care services. PARTICIPANTS Twenty-two services (83 032 clients) that use Communicare practice software and see at least 1000 clients annually, randomized to the treatment arm or control arm. INTERVENTION AND COMPARATOR Multi-faceted early support model versus a comparator of waiting-list control (11 services). MEASUREMENTS A record (presence = 1, absence = 0) of: (i) Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screening (primary outcome), (ii) any-treatment and (iii) brief intervention. We received routinely collected practice data bimonthly over 3 years (1-year baseline, 1-year implementation, 1-year maintenance). Multi-level logistic modelling was used to compare the odds of each outcome before and after implementation. FINDINGS The odds of being screened within any 2-month reference period increased in both arms post-implementation, but the increase was nearly eight times greater in early-support services [odds ratio (OR) = 7.95, 95% confidence interval (CI) = 4.04-15.63, P

Objective To test an implementation strategy, the Systems Analysis and Improvement Approach (SAIA), to increase rates of HIV testing and counseling (HTC) in family planning (FP) clinics in Mombasa, Kenya. Design Cluster randomized trial. Methods Twenty-four FP clinics were randomized 1:1 to implementing SAIA versus usual procedures. Study staff implemented monthly SAIA cycles with FP clinic staff for 12 months. SAIA has five steps. Step 1 uses a "cascade analysis" tool to quantify the number of individuals who complete each step of a process. Step 2 involves sequential process flow mapping to identify modifiable bottlenecks in the system. Step 3 develops and implements workflow modifications to address bottlenecks. Step 4 assesses impact of the modification by recalculating the cascade analysis. Step 5 repeats the cycle. The primary outcome was the proportion of new FP clients tested for HIV during the last quarter of the trial. Results During the last three months of the trial, 85% (740/868) of new FP clients were counseled for HIV in intervention clinics compared to 67% (1036/1542) in control clinics (prevalence rate ratio [PRR] 1.27, 95% confidence interval [CI] 1.15-1.30). Forty-two percent (364/859) of FP clients were tested for HIV at intervention clinics compared to 32% (485/1521) at control clinics (PRR 1.33, 95%CI 1.16-1.52). Conclusion SAIA led to a significant increase in HIV testing in FP clinics in Mombasa. Integrating routine HTC into FP clinics is a promising strategy to achieve the UNAIDS goal of 95% of people living with HIV being aware of their status.

This study aimed to evaluate the feasibility of a peer support intervention to encourage adoption and maintenance of a Mediterranean diet (MD) in established community groups where existing social support may assist the behaviour change process. Four established community groups with members at increased Cardiovascular Disease (CVD) risk and homogenous in gender were recruited and randomised to receive either a 12-month Peer Support (PS) intervention (PSG) (n 2) or a Minimal Support intervention (educational materials only) (MSG) (n 2). The feasibility of the intervention was assessed using recruitment and retention rates, assessing the variability of outcome measures (primary outcome: adoption of an MD at 6 months (using a Mediterranean Diet Score (MDS)) and process evaluation measures including qualitative interviews. Recruitment rates for community groups (n 4/8), participants (n 31/51) and peer supporters (n 6/14) were 50 %, 61 % and 43 %, respectively. The recruitment strategy faced several challenges with recruitment and retention of participants, leading to a smaller sample than intended. At 12 months, a 65 % and 76·5 % retention rate for PSG and MSG participants was observed, respectively. A > 2-point increase in MDS was observed in both the PSG and the MSG at 6 months, maintained at 12 months. An increase in MD adherence was evident in both groups during follow-up; however, the challenges faced in recruitment and retention suggest a definitive study of the peer support intervention using current methods is not feasible and refinement based on the current feasibility study should be incorporated. Lessons learned during the implementation of this intervention will help inform future interventions in this area.

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 Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and health services. This study will evaluate the effectiveness of a team-based motivational engagement intervention, the Early Youth Engagement (EYE-2) intervention. Methods and design The EYE-2 trial is a cluster randomised controlled trial comparing the EYE-2 intervention plus standardised EIP service to standardised EIP service alone, with randomisation at the clinical team (cluster) level. The study aimed to enrol 950 young people (aged 14–35 years) with first episode psychosis in 10 teams per arm. Results The primary outcome is time to disengagement: days from the date of allocation to care coordinator to date of the last contact following either refusal to engage with an EIP team or lack of response to EIP contact for 3 consecutive months which will be analysed using a shared frailty model. Secondary outcomes are Health of the Nation Outcome Scale (HoNOS), Process of Recovery Questionnaire (QPR), DIALOG (a service user-reported measure of quality of life and treatment satisfaction) and service use outcomes which will be analysed using mixed effects regression models. Discussion This paper is the detailed statistical analysis plan for the EYE-2 trial. Any changes to, or deviations from, this plan will be described and justified in the final trial report. Trial registration ISRCTN 51629746. Prospectively registered on 7 May 2019. Date assigned 10 May 2019.

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 Upwards of one in seven individuals experience perinatal depression and many individuals cannot access treatment. In response, perinatal depression is increasingly being managed in the obstetric setting. This study aimed to characterize the experiences of clinicians and clinician assistants to inform the extent to which clinician assistants can help address depression in obstetric settings. METHODS This cross-sectional analysis used data from an ongoing cluster randomized control trial: The PRogram In Support of Moms (PRISM). Participants included clinicians (physicians, certified nurse midwives, nurse practitioners) and clinician assistants (medical assistants, nursing assistants). Baseline data regarding practices and attitudes of clinicians and clinician assistants toward addressing depression in the obstetric setting were described. Logistic regressions were used to examine the association of clinician time to complete work and depression management. RESULTS Clinician assistants experienced significantly fewer time constraints than did clinicians. However, having adequate time to complete work was not significantly associated with increased depression management in clinicians. Clinician assistants reported feeling that addressing depression is an important part of their job, despite variation in doing so. CONCLUSION Clinician assistants are interacting with perinatal women extensively and are a vital part of obstetric care workflows. Clinician assistants report that they want to address depression and have time to do so. Thus, clinician assistants may be poised to help address the mental health needs of perinatal individuals.

AIM: This study aimed to determine whether targeted interventions, proven to be effective at improving evidence-based bronchiolitis management, changed factors previously found to influence variation in bronchiolitis management. METHODS: This survey assessed change in factors influencing clinicians' (nurses and doctors) bronchiolitis management at baseline and post-intervention in a cluster randomised controlled trial of targeted, theory-informed interventions aiming to de-implement non-evidence-based bronchiolitis management (no use of chest X-ray, salbutamol, antibiotics, glucocorticoids and adrenaline). Survey questions addressed previously identified factors influencing bronchiolitis management from six Theoretical Domains Framework domains (knowledge; skills; beliefs about consequences; social/professional role and identity; environmental context and resources; social influences). Data analysis was descriptive. RESULTS: A total of 1958 surveys (baseline = 996; post-intervention = 962) were completed by clinicians from the emergency department and paediatric inpatient units from 26 hospitals (intervention = 13; control = 13). Targeted bronchiolitis interventions significantly increased knowledge of the Australasian Bronchiolitis Guideline (intervention clinicians = 74%, control = 39%, difference = 34.7%, 95% confidence interval (CI) = 25.6-43.8%), improved skills in diagnosing (intervention doctors = 89%, control = 76%, difference = 12.6%, 95% CI = 6.2-19%) and managing bronchiolitis (intervention doctors = 87%, control = 76%, difference = 9.9%, 95% CI = 3.7-16.1%), positively influenced both beliefs about consequences regarding salbutamol use (intervention clinicians = 49%, control = 29%, difference = 20.3%, 95% CI = 13.2-27.4%) and nurses questioning non-evidence-based bronchiolitis management (chest X-ray: intervention = 71%, control = 51%, difference = 20.8%, 95% CI = 11.4-30.2%; glucocorticoids: intervention = 64%, control = 40%, difference = 21.9%, 95% CI = 10.4-33.5%) (social/professional role and identity). A 14% improvement in evidence-based bronchiolitis management favouring intervention hospitals was demonstrated in the cluster randomised controlled trial. CONCLUSION: Targeted interventions positively changed factors influencing bronchiolitis management resulting in improved evidence-based bronchiolitis care. This study has important implications for improving bronchiolitis management and future development of interventions to de-implement low-value care.

Background Valid and reliable measures such as London Measure of Unplanned Pregnancy (LMUP) are imperative for understanding fertility-related behaviors and estimating unintended pregnancy. The aim of this study was to validate the LMUP in the Hindi language for a wider reach in India. Methods An interviewer administered version of the LMUP was translated and pretested in Hindi. The LMUP was field tested with married women in the reproductive age group across forty informal settlements in Mumbai in the post intervention census of a cluster randomized control trial to improve the health of women and children. Analyses involved the full sample and sub-groups according to time-from-conception. Reliability (internal consistency) was assessed using Cronbach’s alpha, inter-item correlations, and item-rest correlations. Construct validity was assessed by hypothesis testing and confirmatory factor analysis. Results 4991 women were included in the study (1180 were pregnant, 2126 in their first- and 1685 in their second postnatal year). LMUP item completion rates were 100 % and the full range of LMUP scores was captured. Reliability: the scale was internally consistent (Cronbach’s α = 0.84), inter-item correlations were positive, and item-rest correlations were above 0.2 for all items except item six (0.07). Construct validity: hypotheses were met, and confirmatory factor analysis showed that a one-factor model was a good fit for the data, confirming unidimensional measurement. The sub-group analysis (by pregnant, first-, and second postnatal year) showed that the psychometric properties of the LMUP were similar across the groups. In terms of LMUP scores, the women in the postnatal groups were very slightly, but significantly, more likely to have an LMUP score of 10 + compared to pregnant women; the difference between the first and second postnatal year was not significant. Conclusions The Hindi LMUP is valid and reliable measure of pregnancy intention that may be used in India. Trial Registration This study is registered with ISRCTN, number ISRCTN56183183, and Clinical Trials Registry of India, number CTRI/2012/09/003004.

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: The benefit of specialist palliative care for cancer inpatients is established, but the best method to deliver specialist palliative care is unknown. Aim: To compare a consult model versus a co-rounding model; both provide the same content of specialist palliative care to individual patients but differ in the level of integration between palliative care and oncology clinicians. Design: An open-label, cluster-randomized trial with stepped-wedge design. The primary outcome was hospital length of stay; secondary outcomes were 30-day readmissions and access to specialist palliative care. ClinicalTrials.gov number NCT03330509. Setting/participants: Cancer patients admitted to the oncology inpatient service of an acute hospital in Singapore. Results: A total of 5681 admissions from December 2017 to July 2019 were included, of which 5295 involved stage 3-4 cancer and 1221 received specialist palliative care review. Admissions in the co-rounding model had a shorter hospital length of stay than those in the consult model by 0.70 days (95%CI −0.04 to 1.45, p = 0.065) for all admissions. In the sub-group of stage 3-4 cancer patients, the length of stay was 0.85 days shorter (95%CI 0.05–1.65, p = 0.038). In the sub-group of admissions that received specialist palliative care review, the length of stay was 2.62 days shorter (95%CI 0.63–4.61, p = 0.010). Hospital readmission within 30 days (OR1.03, 95%CI 0.79–1.35, p = 0.822) and access to specialist palliative care (OR1.19, 95%CI 0.90–1.58, p = 0.215) were similar between the consult and co-rounding models. Conclusions: The co-rounding model was associated with a shorter hospital length of stay. Readmissions within 30 days and access to specialist palliative care were similar.

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.

BACKGROUND AND OBJECTIVE: Prophylactic antibiotics are routinely given at the time of catheter removal post radical prostatectomy (RP). The low rate of infectious complications entails that large sample sizes are required for randomized controlled trials (RCTs), a challenge given the cost of standard RCTs. We evaluated infectious complications associated with 1 vs 3 days of prophylactic antibiotics at the time of catheter removal post RP using a novel, clinically-integrated trial with randomization at the surgeon level. METHODS: Surgeons were cluster randomized for periods of 3 months to prescribe 1-day versus 3-day regimen of prophylactic antibiotics at the time of catheter removal. The primary endpoint was an infectious complication as routinely captured by nursing phone call within 10 days of catheter removal and defined as: positive urine cultures (≥10(5) CFU) and at least 1 of the following symptoms: fever (>38C), urgency, frequency, dysuria or suprapubic tenderness. RESULTS: A total of 824 patients were consented and underwent RP, with respectively, 389 and 435 allocated to 1-and 3-day antibiotics, predominately ciprofloxacin. Accrual was achieved within 3 years: 95% and 88% of patients received the allocated 3-day or 1-day antibiotic regimen, respectively. There was 0 UTI (0%) in the 1-day regimen and 3 UTIs (0.7%) in the 3-day regimen, meeting our prespecified criterion for declaring the 1-day regimen to be non-inferior. CONCLUSION: A clinically integrated trial using cluster randomization accrued rapidly with no important logistical problems and negligible burden on surgeons. If surgeons choose to prescribe empiric prophylactic antibiotics after catheter removal following RP, then the duration should not exceed 1 day.

Aim and objective The objective of this study was to evaluate the AccuVeinAV400® viewing device for peripheral venous catheter insertion in children on the first try. Background Inserting a peripheral venous catheter is the most frequent invasive procedure carried out by healthcare professionals in hospitalised children. Several attempts are sometimes necessary, and veins can be damaged. Design A quasi-experimental cluster randomised controlled trial based on the CONSORT 2010 guidelines. Methods This randomised study comparing standard practice to the use of AccuVein400® was carried out on children who were less than 3 years old, with difficult intravenous access (DIVA Score), hospitalised in three paediatric units and who needed cannulation. Result A total of 304 children were included (156 in the AccuVein arm and 148 in the standard arm). There was no significant difference between AccuVein and standard groups in age (respectively, 2.5 ± 0.9 years vs. 2.5 ± 0.8), or mean DIVA score (respectively 5.9 ± 1.3 vs. 5.5 ± 1.2). The success of cannulation on the first attempt was 40.38% in the AccuVein arm vs. 41.2% in the standard arm (p = .6). The caregiver's assessment of pain on the Face Legs Activity Cry Consolability scale was 4.8 ± 0.2 in the AccuVein arm vs. 5.0 ± 0.2 (p = .4). Conclusions The use of AccuVein400® did not lead to greater success in intravenous insertion at the first attempt in children under 3 years of age with difficult intravenous access. Relevance to clinical practice This device can therefore be used according to the healthcare professionals' situation and needs. It is widely used in paediatric wards, and our study shows that it offers a support tool that reassures healthcare professionals and helps validate their choice of vein easiest to catheterise.

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.

Chronic spinal pain poses complex challenges for health care around the world and is in need of effective interventions. Pain neuroscience education (PNE) is a promising intervention hypothesized to improve pain and disability by changing individuals' beliefs, perceptions, and expectations about pain. Pain neuroscience education has shown promise in small, controlled trials when implemented in tightly controlled situations. Exploration of promising interventions through more pragmatic methodologies is a crucial but understudied step towards improving outcomes in routine clinical care. The purpose was to examine the impact of pragmatic PNE training on clinical outcomes in patients with chronic spine pain. The cluster-randomized clinical trial took place in 45 outpatient physical therapist (PT) clinics. Participants included 108 physical therapists (45 clinics and 16 clusters) and 319 patients. Clusters of PT clinics were randomly assigned to either receive training in PNE or no intervention and continue with usual care (UC). We found no significant differences between groups for our primary outcome at 12 weeks, Patient-Reported Outcomes Measurement Information System Physical Function computer adaptive test {mean difference = 1.05 (95% confidence interval [CI]: -0.73 to 2.83), P = 0.25}. The PNE group demonstrated significant greater improvements in pain self-efficacy at 12 and 2 weeks compared with no intervention (mean difference = 3.65 [95% CI: 0.00-7.29], P = 0.049 and = 3.08 [95% CI: 0.07 to -6.09], P = 0.045, respectively). However, a similar percentage of participants in both control (41.1%) and treatment (44.4%) groups reported having received the treatment per fidelity question (yes or no to pain discussed as a perceived threat) at 2 weeks. Pragmatic PT PNE training and delivery failed to produce significant functional changes in patients with chronic spinal pain but did produce significant improvement in pain self-efficacy over UC PT.

Background and objectives Women’s ability to negotiate condom use helps prevent sexually transmissible infections (STIs) and unintended pregnancies. The aim of this study was to assess the relationship between substance use, risk perception and the certainty of using condoms in several hypothetical situations. Methods This is a secondary analysis from the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial. Descriptive statistics and logistic regression were used for the analysis. Results At baseline, contraceptive questions were answered by 698 women attending 57 general practices in Melbourne, Australia. Condom use was reported by 47%. Of those using condoms as the sole form of contraception (n = 137), 20% used them inconsistently. Dual protection was used by 58% of women (188/325). Condoms and the pill were more frequently used than condoms and longer-acting contraceptives. Women were less likely to be confident negotiating condom use when using substances. Discussion Substance use and the concurrent use of other forms of contraception impact use of condoms. Even when condoms are the sole form of contraception with willing partners, use is inconsistent, leaving women at risk of pregnancy and STI.

BackgroundThe Sustainable Development Goals (SDGs) highlight the importance of investments in early childhood care and education (ECCE) for young children and youth development. Given Pakistan’s large young population, and gender and urban-rural inequalities in access to education, training and employment, such investments offer opportunities. LEAPS is a youth-led ECCE program that trains female youth, 18-24 years, as Community Youth Leaders (CYLs) to deliver high-quality ECCE for children, 3.5-5.5 years, in rural Sindh, Pakistan.MethodsWe use a stepped-wedge cluster randomized trial to evaluate implementation of LEAPS. Ninety-nine clusters will be randomized to receive the intervention in one of three seven-month steps (33 clusters/step). Primary outcomes are children’s school readiness (measured with the International Development and Early Learning Assessment) and executive functions. Secondary outcomes are youth personal and professional development, depressive symptoms, and executive functions. Data is collected in cross-sectional surveys of 1,089 children (11 children/cluster from 99 clusters) aged 4.5-5.5 years at four time points (baseline and at the end of each step). We will enroll three youth participant open cohorts, one per step (33 CYLs: 66 comparison youth per cohort; 99:198 in total). Youth cohorts will be assessed at enrollment and every six to seven months thereafter (i.e., once per consecutive Step). A school cohort of 330 LEAPS students (10 students/cluster from 33 clusters) will be enrolled and assessed during Step 1 after intervention rollout and at endline. The quality of the learning environment will be assessed in each LEAPS ECCE center and in a comparison center at two time points midway following rollout and at endline. A concurrent mixed-methods implementation evaluation will assess program fidelity and quality, as well as the extent to which a technical support strategy is successful in strengthening systems for program expansion. A cost evaluation will assess cost-per-beneficiary. Data collection for implementation and cost evaluations will occur in Step 3.DiscussionYouth-led models for ECCE offer a promising approach to support young children and youth; however, there is little empirical evidence on real-world implementation. This study will contribute to the evidence as a means to promote sustainable human development across multiple SDG targets.Trial RegistrationClinicalTrials.gov:NCT03764436. Registered December 5th, 2018,https://clinicaltrials.gov/ct2/show/NCT03764436.

Objective This study aimed to examine the effects of a six-month group-based low-intensity resistance exercise program on depression and the cognitive function of hemodialysis patients. Method We conducted a quasi-cluster randomized, open-label controlled study from October 2017 to December 2018. Forty-two patients undergoing hemodialysis completed the trial over six months; half participated in the resistance exercise group (n = 21, mean = 74.90 years of age, SD = 2.23, 66.67% female) and the other half were in a stretching control group (n = 21, mean = 72.57 years of age, SD = 2.26, 28.57% female). Depressive symptoms and cognitive function were the primary outcome measures. Behavioral and psychological problems associated with cognitive decline (NPI-Q), subjective insomnia, and exercise self-efficacy were secondary outcomes. Outcomes were measured at baseline, three-month (mid-intervention), six-month (end of intervention), and 12-month (six months after intervention) follow-ups. Linear mixed model analyses were used to determine short-term (immediately after intervention) and long-term (six months after intervention) effects. Results In depression, cognitive function, and the NPI-Q, there were no significant effects. In subjective insomnia, a short-term group-by-time interaction in the intervention group compared to the control group was found (ES = .43). However, the effect had disappeared by the 12-month follow-up. In exercise self-efficacy, short- and long-term group-by-time interactions were found. A significant short-term increase in the resistance exercise and a significant decrease in the stretching control was observed (ES = -.83). However, the effect was weakened in the long term (ES = -.38). Conclusion The results showed that low-intensity group resistance exercise would reduce subjective insomnia and improve exercise self-efficacy, but the effect was not maintained by six months after the program. Trial registration: This study was registered on the University Hospital Medical Information Network Clinical Trials Registry (UMIN000029372). Trial registration: UMIN Japan identifier: UMIN000029372.