The Impact of Covariates on Statistical Power in Cluster Randomized Designs: Which Level Matters More?

2012 ◽  
Vol 47 (3) ◽  
pp. 392-420 ◽  
Author(s):  
Spyros Konstantopoulos
2016 ◽  
Vol 41 (6) ◽  
pp. 605-627 ◽  
Author(s):  
Jessaca Spybrook ◽  
Benjamin Kelcey ◽  
Nianbo Dong

Recently, there has been an increase in the number of cluster randomized trials (CRTs) to evaluate the impact of educational programs and interventions. These studies are often powered for the main effect of treatment to address the “what works” question. However, program effects may vary by individual characteristics or by context, making it important to also consider power to detect moderator effects. This article presents a framework for calculating statistical power for moderator effects at all levels for two- and three-level CRTs. Annotated R code is included to make the calculations accessible to researchers and increase the regularity in which a priori power analyses for moderator effects in CRTs are conducted.


2019 ◽  
Author(s):  
Curtis David Von Gunten ◽  
Bruce D Bartholow

A primary psychometric concern with laboratory-based inhibition tasks has been their reliability. However, a reliable measure may not be necessary or sufficient for reliably detecting effects (statistical power). The current study used a bootstrap sampling approach to systematically examine how the number of participants, the number of trials, the magnitude of an effect, and study design (between- vs. within-subject) jointly contribute to power in five commonly used inhibition tasks. The results demonstrate the shortcomings of relying solely on measurement reliability when determining the number of trials to use in an inhibition task: high internal reliability can be accompanied with low power and low reliability can be accompanied with high power. For instance, adding additional trials once sufficient reliability has been reached can result in large gains in power. The dissociation between reliability and power was particularly apparent in between-subject designs where the number of participants contributed greatly to power but little to reliability, and where the number of trials contributed greatly to reliability but only modestly (depending on the task) to power. For between-subject designs, the probability of detecting small-to-medium-sized effects with 150 participants (total) was generally less than 55%. However, effect size was positively associated with number of trials. Thus, researchers have some control over effect size and this needs to be considered when conducting power analyses using analytic methods that take such effect sizes as an argument. Results are discussed in the context of recent claims regarding the role of inhibition tasks in experimental and individual difference designs.


2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Joseph M. Wagman ◽  
Kenyssony Varela ◽  
Rose Zulliger ◽  
Abuchahama Saifodine ◽  
Rodaly Muthoni ◽  
...  

Abstract Background The need to develop new products and novel approaches for malaria vector control is recognized as a global health priority. One approach to meeting this need has been the development of new products for indoor residual spraying (IRS) with novel active ingredients for public health. While initial results showing the impact of several of these next-generation IRS products have been encouraging, questions remain about how to best deploy them for maximum impact. To help address these questions, a 2-year cluster-randomized controlled trial to measure the impact of IRS with a microencapsulated formulation of pirimiphos-methyl (PM) in an area with high ownership of long-lasting insecticidal nets (LLINs) was conducted in a high-transmission district of central Mozambique with pyrethroid resistant vectors. Presented here are the results of the vector surveillance component of the trial. Methods The 2 year, two-armed trial was conducted in Mopeia District, Zambezia Province, Mozambique. In ten sentinel villages, five that received IRS with PM in October–November 2016 and again in October–November 2017 and five that received no IRS, indoor light trap collections and paired indoor-outdoor human landing collections catches (HLCs) were conducted monthly from September 2016 through October 2018. A universal coverage campaign in June 2017, just prior to the second spray round, distributed 131,540 standard alpha-cypermethrin LLINs across all study villages and increased overall net usage rates in children under 5 years old to over 90%. Results The primary malaria vector during the trial was Anopheles funestus sensu lato (s.l.), and standard World Health Organization (WHO) tube tests with this population indicated variable but increasing resistance to pyrethroids (including alpha-cypermethrin, from > 85% mortality in 2017 to 7% mortality in 2018) and uniform susceptibility to PM (100% mortality in both years). Over the entire duration of the study, IRS reduced An. funestus s.l. densities by 48% (CI95 33–59%; p < 0.001) in indoor light traps and by 74% (CI95 38–90%; p = 0.010) during indoor and outdoor HLC, though in each study year reductions in vector density were consistently greatest in those months immediately following the IRS campaigns and waned over time. Overall there was no strong preference for An. funestus to feed indoors or outdoors, and these biting behaviours did not differ significantly across study arms: observed indoor-outdoor biting ratios were 1.10 (CI95 1.00–1.21) in no-IRS villages and 0.88 (CI95 0.67–1.15) in IRS villages. The impact of IRS was consistent in reducing HLC exposures both indoors (75% reduction: CI95 47–88%; p = 0. < 0.001) and outdoors (68% reduction: CI95 22–87%; p = 0.012). While substantially fewer Anopheles gambiae s.l. were collected during the study, trends show a similar impact of IRS on this key vector group as well, with a 33% (CI95 7–53%; p = 0.019) reduction in mosquitoes collected in light traps and a non-statistically significant 39% reduction (p = 0.249) in HLC landing rates. Conclusion IRS with PM used in addition to pyrethroid-only LLINs substantially reduced human exposures to malaria vectors during both years of the cluster-randomized controlled trial in Mopeia—a high-burden district where the primary vector, An. funestus s.l., was equally likely to feed indoors or outdoors and demonstrated increasing resistance to pyrethroids. Findings suggest that IRS with PM can provide effective vector control, including in some settings where pyrethroid-only ITNs are widely used. Trial registrationclinicaltrials.gov, NCT02910934. Registered 22 September 2016, https://www.clinicaltrials.gov/ct2/show/NCT02910934.


BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  

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.


2021 ◽  
pp. 174077452098486
Author(s):  
Charles Weijer ◽  
Karla Hemming ◽  
Spencer Phillips Hey ◽  
Holly Fernandez Lynch

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


2020 ◽  
Vol 41 (S1) ◽  
pp. s38-s39
Author(s):  
Jerome Leis ◽  
Jeff Powis ◽  
Allison McGeer ◽  
Daniel Ricciuto ◽  
Tanya Agnihotri ◽  
...  

Background: The current approach to measuring hand hygiene (HH) relies on human auditors who capture <1% of HH opportunities and rapidly become recognized by staff, resulting in inflation in performance. Our goal was to assess the impact of group electronic monitoring coupled with unit-led quality improvement on HH performance and prevention of healthcare-associated transmission and infection. Methods: A stepped-wedge cluster randomized quality improvement study was undertaken across 5 acute-care hospitals in Ontario, Canada. Overall, 746 inpatient beds were electronically monitored across 26 inpatient medical and surgical units. Daily HH performance as measured by group electronic monitoring was reported to inpatient units who discussed results to guide unit-led improvement strategies. The primary outcome was monthly HH adherence (%) between baseline and intervention. Secondary outcomes included transmission of antibiotic resistant organisms such as methicillin resistant Staphylococcus aureus (MRSA) and other healthcare-associated infections. Results: After adjusting for the correlation within inpatient units, there was a significant overall improvement in HH adherence associated with the intervention (IRR, 1.73; 95% CI, 1.47–1.99; P < .0001). Monthly HH adherence relative to the intervention increased from 29% (1,395,450 of 4,544,144) to 37% (598,035 of 1,536,643) within 1 month, followed by consecutive incremental increases up to 53% (804,108 of 1,515,537) by 10 months (P < .0001). We identified a trend toward reduced healthcare-associated transmission of MRSA (0.74; 95% CI, 0.53–1.04; P = .08). Conclusions: The introduction of a system for group electronic monitoring led to rapid, significant, and sustained improvements in HH performance within a 2-year period.Funding: NoneDisclosures: None


BMJ ◽  
2015 ◽  
Vol 350 (mar04 8) ◽  
pp. h1019-h1019 ◽  
Author(s):  
E. K. Ansah ◽  
S. Narh-Bana ◽  
H. Affran-Bonful ◽  
C. Bart-Plange ◽  
B. Cundill ◽  
...  

2016 ◽  
Vol 40 (4) ◽  
pp. 450-482 ◽  
Author(s):  
Kendra M. Lewis ◽  
David L. DuBois ◽  
Peter Ji ◽  
Joseph Day ◽  
Naida Silverthorn ◽  
...  

We describe challenges in the 6-year longitudinal cluster randomized controlled trial (CRCT) of Positive Action (PA), a social–emotional and character development (SECD) program, conducted in 14 low-income, urban Chicago Public Schools. Challenges pertained to logistics of study planning (school recruitment, retention of schools during the trial, consent rates, assessment of student outcomes, and confidentiality), study design (randomization of a small number of schools), fidelity (implementation of PA and control condition activities), and evaluation (restricted range of outcomes, measurement invariance, statistical power, student mobility, and moderators of program effects). Strategies used to address the challenges within each of these areas are discussed. Incorporation of lessons learned from this study may help to improve future evaluations of longitudinal CRCTs, especially those that involve evaluation of school-based interventions for minority populations and urban areas.


2002 ◽  
Vol 181 (1) ◽  
pp. 17-21 ◽  
Author(s):  
S. J. Ziguras ◽  
G. W. Stuart ◽  
A. C. Jackson

BackgroundEvidence on the impact of case management is contradictory.AimsTo discuss two different systematic reviews (one conducted by the authors and one conducted through the Cochrane collaboration) that came to contradictory conclusions about the impact of case management in mental health services.MethodWe summarised the findings of the two reviews with respect to case management effectiveness, examined key methodological differences between the two approaches and discuss the impact of these on the validity of the results.ResultsThe differences in conclusions between the two reviews result from the differences in inclusion criteria, namely non-randomised trials, data from unpublished scales and data from variables with skewed distributions. The theoretical and empirical effects of these are discussed.ConclusionsSystematic reviewers may face a trade-off between the application of strict criteria for the inclusion of studies and the amount of data available for analysis and hence statistical power. The available research suggests that case management is generally effective.


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