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Background: Ethiopia has high rates of maternal and neonatal mortality. In 2019 and 2020, the maternal and newborn mortality rates were estimated at 412 per 1,000,000 births and 30 per 10,000 births, respectively. While mobile health interventions to improve maternal and neonatal health management have shown promising results, there are still insufficient scientific studies to assess the effectiveness of mobile phone messaging-based message framing for maternal and newborn health., Objective: This research aims to examine the effectiveness of mobile phone messaging-based message framing for improving the use of maternal and newborn health services in the Jimma Zone, Ethiopia., Methods: A 3-arm cluster-randomized trial design was used to evaluate the effects of mobile phone-based intervention on maternal and newborn health service usage. The trial arms were (1) gain-framed messages (2) loss-framed messages, and (3) usual care. A total of 21 health posts were randomized, and 588 pregnant women who had a gestational age of 16-20 weeks, irrespective of their antenatal care status, were randomly assigned to the trial arms. The intervention consisted of a series of messages dispatched from the date of enrolment until 6-8 months. The control group received existing care without messages. The primary outcomes were maternal health service usage and newborn care practice, while knowledge, attitude, self-efficacy, iron supplementation, and neonatal and maternal morbidity were secondary outcomes. The outcomes will be analyzed using a generalized linear mixed model and the findings will be reported according to the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement for randomized controlled trials., Results: Recruitment of participants was conducted and the baseline survey was administered in March 2023. The intervention was rolled out from May 2023 till December 2023. The end-line assessment was conducted in February 2024., Conclusions: This trial was carried out to understand how mobile phone-based messaging can improve maternal and newborn health service usage. It provides evidence for policy guidelines around mobile health strategies to improve maternal and newborn health., Trial Registration: Pan African Clinical Trials Registry PACTR202201753436676; https://tinyurl.com/ykhnpc49., International Registered Report Identifier (irrid): DERR1-10.2196/52395., (©Gebeyehu Bulcha, Hordofa Gutema Abdissa, Josef Noll, Demisew Amenu Sori, Zewdie Birhanu Koricha. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.07.2024.)

Objectives: In this study, we conducted a cluster randomized control trial to verify the effectiveness of a treatment work balance support (TWBS) program promoted by occupational health nurses (OHNs) in small and medium-sized enterprises (SMEs) using a web meeting system., Methods: We analyzed data from 64 managers (32 each in the control and intervention groups) and 541 workers (246 and 295 in the control and intervention groups, respectively) from 22 SMEs (11 in each group) with less than 200 workers. The TWBS program comprised online consultations for managers and seminars for workers by an OHN. TWBS leaflets were distributed among both groups. The "Recognition and Attitude Scale toward TWBS" was administered and workplace climate, psychological safety (PS), and work engagement (WE) scores were measured at baseline and endpoint. The increase in scores of each group was analyzed using a linear mixed-effects model., Results: Increases in managers' scores on all three recognition and attitude subscales were significantly greater in the intervention than in the control group (P = .048, .003, and .032, respectively). Workers' score increases were significantly higher on two subscales-recognition of workplace initiatives and understanding of professionals' roles-in the intervention than in the control group (P = .043 and .001, respectively). There was no difference between the two groups in the amount of increase in PS and WE, as perceived by managers and workers., Conclusions: The TWBS program by OHNs increased recognition and attitude among SME managers and workers, indicating the usability of promoting TWBS in SMEs., (© 2023 The Authors. Journal of Occupational Health published by John Wiley & Sons Australia, Ltd on behalf of The Japan Society for Occupational Health.)

Background: Regular physical activity (PA) contributes to positive health outcomes, but a minority of US adults meet minimum guidelines for moderate-to-vigorous PA (MVPA) and muscle-strengthening, and Latinos are less likely than whites to meet these guidelines. Public parks can be leveraged for community PA but tend to be underutilized, while churches have reach within Latino communities and can influence parishioners' health., Methods: We are conducting a cluster randomized controlled trial to examine the impact of a multilevel, faith-based intervention linking Catholic parishes (n = 14) to their local parks on adult Latino parishioners' (n = 1204) MVPA and health-related outcomes. Our approach targets multiple levels (individual, group, church, and neighborhood-park) to promote health-enhancing PA through park-based exercise classes led by kinesiology students, peer leader-led walking groups, park-based church events, church-based PA support activities, and environmental advocacy. Data are collected at churches by trained bilingual/bicultural research assistants using accelerometry, surveys, and biometric procedures. We will implement a set of hierarchical repeated-measure linear models to examine effects on the primary outcome (MVPA) and secondary outcomes (self-reported PA, heart rate/fitness, waist circumference, waist-to-hip ratio, body fat, mental health, and perceived social support for PA). We will also conduct a process evaluation., Conclusion: To our knowledge, this will be the first study examining efficacy of an integrated church and park-based intervention on Latino adults' PA and represents a scalable model of PA programming for low-income communities. The intervention makes use of innovative partnerships within and across sectors - faith-based, local parks/city government, and local universities - further facilitating sustainability., Clinicaltrials: govID: NCT03858868., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Cluster randomized controlled trials (cluster RCTs), also known as parallel-arm group-randomized trials, are trials in which the randomized units are groups of participants, as opposed to individual participants. These trials have largely been implemented to address broad public health issues, but with the growing interest in use of real-world data in the regulatory setting, this design may be increasingly considered for industry trials. The key difference between cluster RCTs and traditional RCTs is the intraclass correlation coefficient (ICC) that needs to be considered in cluster RCTs. In this article, we discuss some key practical considerations that are related to ICC in the design, conduct, analysis, and report stages of a cluster RCT. These key considerations related to ICC can lead to improvement in how we translate research findings from cluster RCTs into practices in the biopharmaceutical industry.

Background: Prospective review and feedback (PRF) of antibiotic prescriptions and compulsory computerized decision support system (CDSS) are 2 strategies of antimicrobial stewardship. There are limited studies investigating their combined effects. We hypothesized that the use of on-demand (voluntary) CDSS would achieve similar patient outcomes compared with automatically triggered (compulsory) CDSS whenever broad-spectrum antibiotics are ordered., Methods: A parallel-group, 1:1 block cluster randomized crossover study was conducted in 32 medical and surgical wards from March to August 2017. CDSS use for piperacillin-tazobactam or carbapenem in the intervention clusters was at the demand of the doctor, while in the control clusters CDSS use was compulsory. PRF was continued for both arms. The primary outcome was 30-day mortality., Results: Six hundred forty-one and 616 patients were randomized to voluntary and compulsory CDSS, respectively. There were no differences in 30-day mortality (hazard ratio [HR], 0.87; 95% CI, 0.67-1.12), re-infection and re-admission rates, antibiotic duration, length of stay, or hospitalization cost. The proportion of patients receiving PRF recommendations was not significantly lower in the voluntary CDSS arm (62 [10%] vs 81 [13%]; P = .05). Appropriate indication of antibiotics was high in both arms (351/448 [78%] vs 330/433 [74%]; P = .18). However, in geriatric medicine patients where antibiotic appropriateness was <50%, prescription via compulsory CDSS resulted in a shorter length of stay and lower hospitalization cost., Conclusions: Voluntary broad-spectrum antibiotics with PRF via CDSS did not result in differing clinical outcomes, antibiotic duration, or length of stay. However, in the setting of low antibiotic appropriateness, compulsory CDSS may be beneficial., (© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Objectives: To assess markers of selection bias risk in a sample of recently published cluster randomized controlled trials compared with individually randomized trials., Study Design and Setting: We used OVID Medline and the online archives of the Journal of the American Medical Association to search for cluster randomized trials published between January 2015 and June 2017 from four high-impact journals and compared them to a matched sample of individually randomized trials., Results: We identified 23 cluster trials: 57% (n = 13) described a robust allocation method and 17% (n = 4) recruited all participants before randomization. Four (17%), eight (35%), and 11 (48%) were classified as at low, medium, and high bias risk, respectively. Meta-analysis showed significant age imbalance (-0.05, 95% CI = -0.057 to -0.043, I 2  = 93.2%) in cluster trials, while the matched individually randomized trials showed no imbalance (0.005, 95% CI = -0.026 to 0.035, I 2  = 0%). Cluster trials finding a statistically significant outcome in their primary measure showed a larger age imbalance (0.082, 95% CI = -0.091 to -0.073, I 2  = 87%) than trials finding a nonstatistically significant outcome (0.022, 95% CI = 0.008 to 0.035, I 2  = 83%)., Conclusions: There is strong evidence in this sample of an effect of selection bias seen in an imbalance in baseline participant age, something not seen in a comparable sample of individually randomized trials., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Exclusive breastfeeding (EBF) improves infant health and survival. We tested the effectiveness of a home-based intervention using Community Health Workers (CHWs) on EBF for six months in urban poor settings in Kenya., Methods: We conducted a cluster-randomized controlled trial in Korogocho and Viwandani slums in Nairobi. We recruited pregnant women and followed them until the infant's first birthday. Fourteen community clusters were randomized to intervention or control arm. The intervention arm received home-based nutritional counselling during scheduled visits by CHWs trained to provide specific maternal infant and young child nutrition (MIYCN) messages and standard care. The control arm was visited by CHWs who were not trained in MIYCN and they provided standard care (which included aspects of ante-natal and post-natal care, family planning, water, sanitation and hygiene, delivery with skilled attendance, immunization and community nutrition). CHWs in both groups distributed similar information materials on MIYCN. Differences in EBF by intervention status were tested using chi square and logistic regression, employing intention-to-treat analysis., Results: A total of 1110 mother-child pairs were involved, about half in each arm. At baseline, demographic and socioeconomic factors were similar between the two arms. The rates of EBF for 6 months increased from 2% pre-intervention to 55.2% (95% CI 50.4-59.9) in the intervention group and 54.6% (95% CI 50.0-59.1) in the control group. The adjusted odds of EBF (after adjusting for baseline characteristics) were slightly higher in the intervention arm compared to the control arm but not significantly different: for 0-2 months (OR 1.27, 95% CI 0.55 to 2.96; p = 0.550); 0-4 months (OR 1.15; 95% CI 0.54 to 2.42; p = 0.696), and 0-6 months (OR 1.11, 95% CI 0.61 to 2.02; p = 0.718)., Conclusions: EBF for six months significantly increased in both arms indicating potential effectiveness of using CHWs to provide home-based counselling to mothers. The lack of any difference in EBF rates in the two groups suggests potential contamination of the control arm by information reserved for the intervention arm. Nevertheless, this study indicates a great potential for use of CHWs when they are incentivized and monitored as an effective model of promotion of EBF, particularly in urban poor settings. Given the equivalence of the results in both arms, the study suggests that the basic nutritional training given to CHWs in the basic primary health care training, and/or provision of information materials may be adequate in improving EBF rates in communities. However, further investigations on this may be needed. One contribution of these findings to implementation science is the difficulty in finding an appropriate counterfactual for community-based educational interventions., Trial Registration: ISRCTN ISRCTN83692672 . Registered 11 November 2012. Retrospectively registered.

Growing use of cluster randomized control trials (RCTs) in health care research requires careful attention to study designs, with implications for the development of an evidence base for practice. The objective of this study is to investigate the characteristics, quality, and reporting of cluster RCTs evaluating occupational therapy interventions to inform future research design. An extensive search of cluster RCTs evaluating occupational therapy was conducted in several databases. Fourteen studies met our inclusion criteria; four were protocols. Eleven (79%) justified the use of a cluster RCT and accounted for clustering in the sample size and analysis. All full studies reported the number of clusters randomized, and five reported intercluster correlation coefficients (50%): Protocols had higher compliance. Risk of bias was most evident in unblinding of participants. Statistician involvement was associated with improved trial quality and reporting. Quality of cluster RCTs of occupational therapy interventions is comparable with those from other areas of health research and needs improvement., (© The Author(s) 2015.)

In a cluster randomized controlled trial (RCT), the number of randomized units is typically considerably smaller than in trials where the unit of randomization is the patient. If the number of randomized clusters is small, there is a reasonable chance of baseline imbalance between the experimental and control groups. This imbalance threatens the validity of inferences regarding post-treatment intervention effects unless an appropriate statistical adjustment is used. Here, we consider application of the propensity score adjustment for cluster RCTs. For the purpose of illustration, we apply the propensity adjustment to a cluster RCT that evaluated an intervention to reduce suicidal ideation and depression. This approach to adjusting imbalance had considerable bearing on the interpretation of results. A simulation study demonstrates that the propensity adjustment reduced well over 90% of the bias seen in unadjusted models for the specifications examined., (Copyright © 2013 John Wiley & Sons, Ltd.)