scholarly journals Biomass-fuelled improved cookstove intervention to prevent household air pollution in Northwest Ethiopia: a cluster randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Mesafint Molla Adane ◽  
Getu Degu Alene ◽  
Seid Tiku Mereta
Keyword(s):  
Risk Factors ◽  
Air Pollution ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Household Air Pollution ◽  
Randomized Controlled ◽  
Link Type ◽  
Improved Cookstove ◽  
Cluster Randomized

Abstract Background Household air pollution from biomass fuels burning in traditional cookstoves currently appeared as one of the most serious threats to public health with a recent burden estimate of 2.6 million premature deaths every year worldwide, ranking highest among environmental risk factors and one of the major risk factors of any type globally. Improved cookstove interventions have been widely practiced as potential solutions. However, studies on the effect of improved cookstove interventions are limited and heterogeneous which suggested the need for further research. Methods A cluster randomized controlled trial study was conducted to assess the effect of biomass-fuelled improved cookstove intervention on the concentration of household air pollution compared with the continuation of an open burning traditional cookstove. A total of 36 clusters were randomly allocated to both arms at a 1:1 ratio, and improved cookstove intervention was delivered to all households allocated into the treatment arm. All households in the included clusters were biomass fuel users and relatively homogenous in terms of basic socio-demographic and cooking-related characteristics. Household air pollution was determined by measuring the concentration of indoor fine particulate, and the effect of the intervention was estimated using the Generalized Estimating Equation. Results A total of 2031 household was enrolled in the study across 36 randomly selected clusters in both arms, among which data were obtained from a total of 1977 households for at least one follow-up visit which establishes the intention-to-treat population dataset for analysis. The improved cookstove intervention significantly reduces the concentration of household air pollution by about 343 μg/m3 (Ḃ = − 343, 95% CI − 350, − 336) compared to the traditional cookstove method. The overall reduction was found to be about 46% from the baseline value of 859 (95% CI 837–881) to 465 (95% CI 458–472) in the intervention arm compared to only about 5% reduction from 850 (95% CI 828–872) to 805 (95% CI 794–817) in the control arm. Conclusions The biomass-fuelled improved cookstove intervention significantly reduces the concentration of household air pollution compared to the traditional method. This suggests that the implementation of these cookstove technologies may be necessary to achieve household air pollution exposure reductions. Trial registration The trial project was retrospectively registered on August 2, 2018, at the clinical trials.gov registry database (https://clinicaltrials.gov/) with the NCT03612362 registration identifier number.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

scholarly journals Cluster Randomized Controlled Trial of a Patient and General Practitioner Intervention to Improve the Management of Multiple Risk Factors After Stroke

Stroke ◽  
2010 ◽  
Vol 41 (11) ◽  
pp. 2470-2476 ◽  
Author(s):  
Charles David Alexander Wolfe ◽  
Judith Redfern ◽  
Anthony George Rudd ◽  
Andrew Peter Grieve ◽  
Peter Ulrich Heuschmann ◽  
...  
Keyword(s):  
Risk Factors ◽  
Randomized Controlled Trial ◽  
General Practitioner ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Multiple Risk Factors ◽  
Randomized Controlled ◽  
Multiple Risk ◽  
Cluster Randomized

scholarly journals Statistical Analysis Plan for the Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN): a study protocol for a stepped-wedge cluster randomized controlled trial

2021 ◽  
Author(s):  
Yaseen M Arabi ◽  
Ramesh Kumar Vishwakarma ◽  
Hasan M Al-Dorzi ◽  
Eman Al Qasim ◽  
Sheryl Ann Abdukahil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Hospital Mortality ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Cluster Randomized Controlled Trial ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized

Abstract Background It is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes. The objective of the Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) is to examine the effect of electronic screening for sepsis compared to no screening among hospitalized ward patients on all-cause 90-day hospital mortality. Methods This study is designed as a stepped-wedge cluster randomized controlled trial. A sepsis e-alert was developed in the electronic medical record (EMR), with the feature of being active (visible to treating team) or masked (inactive in EMR frontend for the treating team but active in the backend of the EMR). Forty-five hospital wards in 5 hospitals are randomized to active sepsis e-alert versus masked sepsis e-alert on 2-month sequences, with 5 wards in each sequence totaling 10 sequences. The primary endpoint is in-hospital mortality by 90 days. All data are extracted from EMR. Discussion The SCREEN trial provides an opportunity for a novel trial design and analysis of routinely collected and entered data to evaluate the effectiveness of an intervention (sepsis alert) for a common medical problem (sepsis in ward patients). In this statistical analysis plan, we outline details of the planned analyses in advance of trial completion. Prior specification of the statistical methods and outcomes analysis will facilitate unbiased analyses of these important clinical data. Trial registration ClinicalTrials.gov NCT04078594. Registered on September 6, 2019, https://clinicaltrials.gov/ct2/show/NCT04078594 Keywords Sepsis, Alert, Screening, qSOFA, mortality, electronic medical records 

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