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Background Mental health policies outline the need for codesign of services and quality improvement in partnership with service users and staff (and sometimes carers), and yet, evidence of systematic implementation and the impacts on healthcare outcomes is limited. Objective The aim of this study was to test whether an adapted mental health experience codesign intervention to improve recovery‐orientation of services led to greater psychosocial recovery outcomes for service users. Design A stepped wedge cluster randomized‐controlled trial was conducted. Setting and Participants Four Mental Health Community Support Services providers, 287 people living with severe mental illnesses, 61 carers and 120 staff were recruited across Victoria, Australia. Main Outcome Measures The 24‐item Revised Recovery Assessment Scale (RAS‐R) measured individual psychosocial recovery. Results A total of 841 observations were completed with 287 service users. The intention‐to‐treat analysis found RAS‐R scores to be similar between the intervention (mean = 84.7, SD= 15.6) and control (mean = 86.5, SD= 15.3) phases; the adjusted estimated difference in the mean RAS‐R score was −1.70 (95% confidence interval: −3.81 to 0.40; p = .11). Discussion This first trial of an adapted mental health experience codesign intervention for psychosocial recovery outcomes found no difference between the intervention and control arms. Conclusions More attention to the conditions that are required for eight essential mechanisms of change to support codesign processes and implementation is needed. Patient and Public Involvement The State consumer (Victorian Mental Illness Awareness Council) and carer peak bodies (Tandem representing mental health carers) codeveloped the intervention. The adapted intervention was facilitated by coinvestigators with lived‐experiences who were coauthors for the trial and process evaluation protocols, the engagement model and explanatory model of change for the trial.

Schools provide a relevant and equitable environment to influence students towards increased vegetable consumption. This study aimed to evaluate the effectiveness of a Vegetable Education Resource To Increase Children’s Acceptance and Liking (VERTICAL) for Australian primary schools (curriculum aligned and based on a framework of food preference development and sensory experiential learning) on positively influencing factors predisposing children towards increased vegetable consumption. The secondary aim was to evaluate two levels of teacher training intensity on intervention effectiveness. A cluster-RCT amongst schools with three conditions was conducted: 1 = teaching VERTICAL preceded by online teacher training; 2 = as per 1 with additional face-to-face teacher training; 3 = Control. Pre-test, post-test and 3-month follow-up measures (knowledge, verbalization ability, vegetable acceptance, behavioural intentions, willing to taste, new vegetables consumed) were collected from students (n = 1639 from 25 schools in Sydney/Adelaide, Australia). Data were analyzed using mixed model analysis. No difference in intervention effectiveness was found between the two training methods. Compared to the Control, VERTICAL positively affected all outcome measures after intervention (p < 0.01) with knowledge sustained at 3-month follow-up (p < 0.001). In conclusion, VERTICAL was effective in achieving change amongst students in mediating factors known to be positively associated with vegetable consumption.

Large epidemiological impacts resulting from disease vector control interventions are typically associated with significant disruption of vector populations. While vector density is a frequently measured response, impacts on demography and connectivity are suspected but rarely quantified. We analysed low‐coverage whole‐genome sequence data of 893 Anopheles gambiae mosquitoes collected between 2014 and 2015 during a cluster‐randomized control trial (cRCT) in Burkina Faso to compare a pyrethroid‐only net (ITN) with a pyrethroid‐pyriproxyfen (ITN‐PPF) net. Despite reductions of clinical malaria by 12% and vector density by 22% in the ITN‐PPF arm, we found no significant changes in An. gambiae population genetic structure or diversity. We found remarkably low population differentiation and a lack of discernible clustering by treatment, time, or space. Nucleotide diversity and inbreeding coefficient remained stable between treatments, and genome‐wide scans showed no putative signatures of selection between trial arms. These results show that ITN‐PPF did not alter An. gambiae genetic structure, possibly due to large, vagile populations in West Africa. More widely, this is the first evidence that epidemiologically meaningful reductions in vector density may not impact genetic diversity or connectivity and challenges what constitutes adequate vector control in large populations.

Complementary foods in Africa are often poor sources of bioavailable iron. We assessed the efficacy of iron‐fortified wheat‐based infant cereal (IC) to reduce the risk of iron deficiency anemia in children aged 18–59 months in Cameroon. A 6‐month double‐blind, cluster‐randomized controlled trial was conducted in 2017 among anemic (hemoglobin 7–11 g/dl) but otherwise healthy children. In conjunction with usual diet, children received two 50 g servings/day of a standard, micronutrient‐fortified IC (providing 3.75 mg iron/serving; n = 106) or the same IC without iron fortification (n = 99). Anthropometric measurements, blood sampling, and systematic deworming were performed in all children at baseline (pre‐intervention), 3, and 6 months. Mean hemoglobin, ferritin adjusted for C‐reactive protein (CRP), serum iron, transferrin saturation, prevalence of anemia, iron deficiency, and iron deficiency anemia as well as anthropometrics were compared between the groups at baseline, 3, and 6 months. Compared to the control group, children consuming the iron‐fortified IC had significantly higher baseline‐adjusted mean hemoglobin (10.0 ± 1.8 vs. 9.7 ± 1.4 g/dl, respectively; p = .023), ferritin adjusted for CRP (16.1 ± 8.3 vs. 9.5 ± 7.5 μg/L, p < .001), serum iron (14.5 ± 3.9 vs. 11.2 ± 4.4 μg/dl; p < .001), and transferrin saturation (19.0 ± 17.4 vs. 10.7 ± 12.5%; p ˂ .001) at 6 months. The prevalence of anemia, iron deficiency, and iron deficiency anemia at 6 months decreased by a larger extent in the iron‐fortified group versus controls (all p < .01). In addition, at 6 months, children in the iron‐fortified group demonstrated higher weight‐for‐age z‐scores (p = .016) compared to the control group. Wheat‐based IC fortified with 7.5 mg ferrous fumarate administered daily for 6 months improved iron and nutritional status and decreased the prevalence of iron deficiency anemia in children aged 18–59 months in Salapoumbé, Cameroon. Consumption of micronutrient‐fortified wheat‐based infant cereal providing 7.5 mg/day of iron fumarate for 6 months improved iron status and decreased the prevalence of iron deficiency anemia in children aged 18–59 months.

Background Despite considerable progress in reduction of both under-five and maternal mortality in recent decades, Bangladesh is still one of the low and middle income countries with high burden of maternal and neonatal mortality. The primary objective of the current study is to measure the impact of a comprehensive package of interventions on maternal and neonatal mortality. In addition, changes in coverage, quality and utilization of maternal and newborn health (MNH) services, social capital, and cost effectiveness of the interventions will be measured. Methods A community-based, cluster randomized controlled trial design will be adopted and implemented in 30 unions of three sub-districts of Chandpur district of Bangladesh. Every union, the lowest administrative unit of the local government with population of around 20,000–30,000, will be considered a cluster. Based on the baseline estimates, 15 clusters will be paired for random assignment as intervention and comparison clusters. The primary outcome measure is neonatal mortality, and secondary outcomes are coverage of key interventions like ANC, PNC, facility and skilled provider delivery. Baseline, midterm and endline household survey will be conducted to assess the key coverage of interventions. Health facility assessment surveys will be conducted periodically to assess facility readiness and utilization of MNH services in the participating health facilities. Discussion The current study is expected to provide essential strong evidences on the impact of a comprehensive package of interventions to the Bangladesh government, and other developmental partners. The study results may help in prioritizing, planning, and scaling-up of Safe Motherhood Promotional interventions in other geographical areas of Bangladesh as well as to inform other developing countries of similar settings. Trial registration NCT03032276 .

Background To achieve higher effectiveness in population-based SARS-CoV-2 surveillance and to reliably predict the course of an outbreak, screening, and monitoring of infected individuals without major symptoms (about 40% of the population) will be necessary. While current testing capacities are also used to identify such asymptomatic cases, this rather passive approach is not suitable in generating reliable population-based estimates of the prevalence of asymptomatic carriers to allow any dependable predictions on the course of the pandemic. Methods This trial implements a two-factorial, randomized, controlled, multi-arm, prospective, interventional, single-blinded design with cluster sampling and four study arms, each representing a different SARS-CoV-2 testing and surveillance strategy based on individuals’ self-collection of saliva samples which are then sent to and analyzed by a laboratory. The targeted sample size for the trial is 10,000 saliva samples equally allocated to the four study arms (2500 participants per arm). Strategies differ with respect to tested population groups (individuals vs. all household members) and testing approach (without vs. with pre-screening survey). The trial is complemented by an economic evaluation and qualitative assessment of user experiences. Primary outcomes include costs per completely screened person, costs per positive case, positive detection rate, and precision of positive detection rate. Discussion Systems for active surveillance of the general population will gain more importance in the context of pandemics and related disease prevention efforts. The pandemic parameters derived from such active surveillance with routine population monitoring therefore not only enable a prospective assessment of the short-term course of a pandemic, but also a more targeted and thus more effective use of local and short-term countermeasures. Trial registration ClinicalTrials.gov DRKS00023271 . Registered November 30, 2020, with the German Clinical Trials Register (Deutsches Register Klinischer Studien)

To describe the application of the stepped wedge cluster randomized controlled trial (CRCT) design. Systematic review. We searched Medline, Embase, PsycINFO, HMIC, CINAHL, Cochrane Library, Web of Knowledge, and Current Controlled Trials Register for articles published up to January 2010. Stepped wedge CRCTs from all fields of research were included. Two authors independently reviewed and extracted data from the studies. Twenty-five studies were included in the review. Motivations for using the design included ethical, logistical, financial, social, and political acceptability and methodological reasons. Most studies were evaluating an intervention during routine implementation. For most of the included studies, there was also a belief or empirical evidence suggesting that the intervention would do more good than harm. There was variation in data analysis methods and insufficient quality of reporting. The stepped wedge CRCT design has been mainly used for evaluating interventions during routine implementation, particularly for interventions that have been shown to be effective in more controlled research settings, or where there is lack of evidence of effectiveness but there is a strong belief that they will do more good than harm. There is need for consistent data analysis and reporting.

Background The German guideline on psychosocial interventions for people with severe mental disorders recommends a broad spectrum of evidence-based treatments. Structured implementation of the associated patient version of the guideline is missing to date. The study aims to assess whether structured implementation of a patient guideline improves the empowerment of patients with severe mental disorders, as well as knowledge, attitudes and experiences regarding psychosocial interventions, service use, treatment satisfaction, treatment needs, quality of life and burden of care. Methods The study is a multicentre, cluster-randomised, controlled study with two parallel groups. Inpatients and day hospital patients (all sexes; 18–65 years) with severe mental disorders will be included. Additionally, relatives of patients with mental disorders (all sexes; ≥ 18 years) will be included. In the experimental group, the patient guideline will be implemented using a multimodal strategy. Participants in the control group will receive treatment as usual but will be made aware of the patient guideline. The primary outcome is the change of empowerment, assessed by using the ‘empowerment in the process of psychiatric treatment of patients with affective and schizophrenia disorders’ (EPAS) scale. In addition, knowledge, attitudes and experiences regarding psychosocial interventions will be assessed as secondary outcomes, as well as service use, satisfaction with care, patient need and quality of life and participation and social inclusion. For relatives, the perceived burden of care also will be recorded. Results will be analysed using hierarchical linear models. For the health economic evaluation, the incremental cost-utility ratios will be computed using the differences in total costs of illness and the differences in quality-adjusted life years (QALY) between study groups. Discussion The study will be the first to assess the effects of a structured implementation of the patient version of a psychiatric treatment guideline. The study has some limitations regarding the transferability of the results to other patients and other regions. Furthermore, problems with the recruitment of patients and relatives and with the implementation of intervention could occur during the study. Trial registration The study is registered in the German Clinical Trials Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00017577 (Date of registration: 23 October 2019.

Background The stepped wedge (SW) cluster randomized controlled trial (CRCT) design is being used with increasing frequency. However, there is limited published research on the quality of reporting of SW-CRCTs. We address this issue by conducting a literature review. Methods Medline, Ovid, Web of Knowledge, the Cochrane Library, PsycINFO, the ISRCTN registry, and ClinicalTrials.gov were searched to identify investigations employing the SW-CRCT design up to February 2015. For each included completed study, information was extracted on a selection of criteria, based on the CONSORT extension to CRCTs, to assess the quality of reporting. Results A total of 123 studies were included in our review, of which 39 were completed trial reports. The standard of reporting of SW-CRCTs varied in quality. The percentage of trials reporting each criterion varied to as low as 15.4%, with a median of 66.7%. Conclusions There is much room for improvement in the quality of reporting of SW-CRCTs. This is consistent with recent findings for CRCTs. A CONSORT extension for SW-CRCTs is warranted to standardize the reporting of SW-CRCTs.

Variability in treatment effects is common in intervention studies using cluster randomized controlled trial (C-RCT) designs. Such variability is often examined in multilevel modeling (MLM) to understand how treatment effects (TRT) differ based on the level of a covariate (COV), called TRT × COV. In detecting TRT × COV effects using MLM, relationships between covariates and outcomes are assumed to vary across clusters linearly. However, this linearity assumption may not hold in all applications and an incorrect assumption may lead to biased statistical inference about TRT × COV effects. In this study, we present generalized additive mixed model (GAMM) specifications in which cluster-specific functional relationships between covariates and outcomes can be modeled using by-variable smooth functions. In addition, the implementation for GAMM specifications is explained using the mgcv R package (Wood, 2021 ). The usefulness of the GAMM specifications is illustrated using intervention data from a C-RCT. Results of simulation studies showed that parameters and by-variable smooth functions were recovered well in various multilevel designs and the misspecification of the relationship between covariates and outcomes led to biased estimates of TRT × COV effects. Furthermore, this study evaluated the extent to which the GAMM can be treated as an alternative model to MLM in the presence of a linear relationship.