Comparison of Statistical Models For Estimating Intervention Effects Based On Time-To-Recurrent-Event In Stepped Wedge Cluster Randomized Trial Using Open Cohort Design

2021 ◽  
Author(s):  
Shunsuke Oyamada ◽  
Shih-Wei Chiu ◽  
Takuhiro Yamaguchi
Keyword(s):  
Monte Carlo ◽  
Monte Carlo Simulations ◽  
Statistical Models ◽  
Randomised Trial ◽  
Recurrent Event ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Intervention Effects ◽  
Cohort Design

Abstract Background: There are currently no methodological studies on the performance of the statistical models for estimating intervention effects based on the time-to-recurrent-event (TTRE) in stepped wedge cluster randomised trial (SWCRT) using an open cohort design. This study aims to address this by evaluating the performance of these statistical models using an open cohort design with the Monte Carlo simulation in various settings and their application using an actual example.Methods: Using Monte Carlo simulations, we evaluated the performance of the existing extended Cox proportional hazard models, i.e., the Andersen-Gill (AG), Prentice-Williams-Peterson Total-Time (PWP-TT), and Prentice-Williams-Peterson Gap-time (PWP-GT) models, using the settings of several event generation models and true intervention effects, with and without stratification by clusters. Unidirectional switching in SWCRT was represented using time-dependent covariates.Results: Using Monte Carlo simulations with the various described settings, the PWP-GT model with stratification by clusters showed the best performance in most settings and reasonable performance in the others. The only situation in which the performance of the PWP-TT model with stratification by clusters was not inferior to that of the PWP-GT model with stratification by clusters was when there was a certain amount of follow-up period, and the timing of the trial entry was random within the trial period, including the follow-up period. The AG model performed well only in a specific setting. By analysing actual examples, it was found that almost all the statistical models suggested that the risk of events during the intervention condition may be somewhat higher than in the control, although the difference was not statistically significant.Conclusions: The PWP-GT model with stratification by clusters had the most reasonable performance when estimating intervention effects based on the TTRE in SWCRT in various settings using an open cohort design.

Precommitting to choose wisely about low-value services: a stepped wedge cluster randomised trial

2017 ◽  
Vol 27 (5) ◽  
pp. 355-364 ◽  
Author(s):  
Jeffrey Todd Kullgren ◽  
Erin Krupka ◽  
Abigail Schachter ◽  
Ariel Linden ◽  
Jacquelyn Miller ◽  
...  
Keyword(s):  
Primary Care ◽  
Low Back Pain ◽  
Randomised Trial ◽  
Choosing Wisely ◽  
Cluster Randomised Trial ◽  
Low Back ◽  
Stepped Wedge ◽  
Intervention Period ◽  
Cluster Randomised

BackgroundLittle is known about how to discourage clinicians from ordering low-value services. Our objective was to test whether clinicians committing their future selves (ie, precommitting) to follow Choosing Wisely recommendations with decision supports could decrease potentially low-value orders.MethodsWe conducted a 12-month stepped wedge cluster randomised trial among 45 primary care physicians and advanced practice providers in six adult primary care clinics of a US community group practice.Clinicians were invited to precommit to Choosing Wisely recommendations against imaging for uncomplicated low back pain, imaging for uncomplicated headaches and unnecessary antibiotics for acute sinusitis. Clinicians who precommitted received 1–6 months of point-of-care precommitment reminders as well as patient education handouts and weekly emails with resources to support communication about low-value services.The primary outcome was the difference between control and intervention period percentages of visits with potentially low-value orders. Secondary outcomes were differences between control and intervention period percentages of visits with possible alternate orders, and differences between control and 3-month postintervention follow-up period percentages of visits with potentially low-value orders.ResultsThe intervention was not associated with a change in the percentage of visits with potentially low-value orders overall, for headaches or for acute sinusitis, but was associated with a 1.7% overall increase in alternate orders (p=0.01). For low back pain, the intervention was associated with a 1.2% decrease in the percentage of visits with potentially low-value orders (p=0.001) and a 1.9% increase in the percentage of visits with alternate orders (p=0.007). No changes were sustained in follow-up.ConclusionClinician precommitment to follow Choosing Wisely recommendations was associated with a small, unsustained decrease in potentially low-value orders for only one of three targeted conditions and may have increased alternate orders.Trial registration numberNCT02247050; Pre-results.

scholarly journals PREPARE: protocol for a stepped wedge trial to evaluate whether a risk stratification model can reduce preterm deliveries among women with suspected or confirmed preterm pre-eclampsia

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Marcos Augusto Bastos Dias ◽  
◽  
Leandro De Oliveira ◽  
Arundhanthi Jeyabalan ◽  
Beth Payne ◽  
...  
Keyword(s):  
Knowledge Transfer ◽  
Adverse Events ◽  
Risk Stratification ◽  
Risk Reduction ◽  
Randomised Trial ◽  
Adverse Outcomes ◽  
Cluster Randomised Trial ◽  
Care Providers ◽  
Stepped Wedge ◽  
Number Of Patients

Abstract Background Preeclampsia (PE) is a major cause of short and long-term morbidity for affected infants, including consequences of fetal growth restriction and iatrogenic prematurity. In Brazil, this is a special problem as PE accounts for 18% of preterm births (PTB). In the PREPARE (Prematurity REduction by Pre-eclampsia cARE) study, we will test a novel system of integrated care based on risk stratification and knowledge transfer, to safely reduce PTB. Methods This is a stepped wedge cluster randomised trial that will include women with suspected or confirmed PE between 20 + 0 and 36 + 6 gestational weeks. All pregnant women presenting with these findings at seven tertiary centres in geographically dispersed sites, throughout Brazil, will be considered eligible and evaluated in terms of risk stratification at admission. At randomly allocated time points, sites will transition to risk stratification performed according to sFlt-1/PlGF (Roche Diagnostics) measurement and fullPIERS score with both results will be revealed to care providers. The healthcare providers of women stratified as low risk for adverse outcomes (sFlt-1/PlGF ≤38 AND fullPIERS< 10% risk) will receive the recommendation to defer delivery. sFlt-1/PlGF will be repeated once and fullPIERS score twice a week. Rates of prematurity due to preeclampsia before and after the intervention will be compared. Additionally, providers will receive an active program of knowledge transfer about WHO recommendations for preeclampsia, including recommendations regarding antenatal corticosteroids for foetal benefits, antihypertensive therapy and magnesium sulphate for seizure prophylaxis. This study will have 90% power to detect a reduction in PTB associated with PE from a population estimate of 1.5 to 1.0%, representing a 33% risk reduction, and 80% power to detect a reduction from 2.0 to 1.5% (25% risk reduction). The necessary number of patients recruited to achieve these results is 750. Adverse events, serious adverse events, both anticipated and unanticipated will be recorded. Discussion The PREPARE intervention expects to reduce PTB and improve care of women with PE without significant adverse side effects. If successful, this novel pathway of care is designed for rapid translation to healthcare throughout Brazil and may be transferrable to other low and middle income countries. Trial registration ClinicalTrials.gov: NCT03073317.

scholarly journals Correction: Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial

PLoS Medicine ◽  
2019 ◽  
Vol 16 (12) ◽  
pp. e1002993
Author(s):  
Nina Østerås ◽  
Tuva Moseng ◽  
Leti van Bodegom-Vos ◽  
Krysia Dziedzic ◽  
Ibrahim Mdala ◽  
...  
Keyword(s):  
Primary Healthcare ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Structured Model ◽  
Cluster Randomised

scholarly journals Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial

PLoS Medicine ◽  
2016 ◽  
Vol 13 (11) ◽  
pp. e1002175 ◽  
Author(s):  
Badara Cissé ◽  
El Hadj Ba ◽  
Cheikh Sokhna ◽  
Jean Louis NDiaye ◽  
Jules F. Gomis ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Cluster Randomised ◽  
Seasonal Malaria Chemoprevention

scholarly journals Improving quality of care during childbirth in primary health centres: a stepped-wedge cluster-randomised trial in India

2018 ◽  
Vol 3 (5) ◽  
pp. e000907 ◽  
Author(s):  
Ramesh Agarwal ◽  
Deepak Chawla ◽  
Minakshi Sharma ◽  
Shyama Nagaranjan ◽  
Suresh K Dalpath ◽  
...  
Keyword(s):  
Quality Of Care ◽  
Management Strategy ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Primary Health ◽  
Cluster Randomised ◽  
Primary Health Centres ◽  
Health Centres

BackgroundLow/middle-income countries need a large-scale improvement in the quality of care (QoC) around the time of childbirth in order to reduce high maternal, fetal and neonatal mortality. However, there is a paucity of scalable models.MethodsWe conducted a stepped-wedge cluster-randomised trial in 15 primary health centres (PHC) of the state of Haryana in India to test the effectiveness of a multipronged quality management strategy comprising capacity building of providers, periodic assessments of the PHCs to identify quality gaps and undertaking improvement activities for closure of the gaps. The 21-month duration of the study was divided into seven periods (steps) of 3  months each. Starting from the second period, a set of randomly selected three PHCs (cluster) crossed over to the intervention arm for rest of the period of the study. The primary outcomes included the number of women approaching the PHCs for childbirth and 12 directly observed essential practices related to the childbirth. Outcomes were adjusted with random effect for cluster (PHC) and fixed effect for ‘months of intervention’.ResultsThe intervention strategy led to increase in the number of women approaching PHCs for childbirth (26 vs 21 women per PHC-month, adjusted incidence rate ratio: 1.22; 95% CI 1.17 to 1.28). Of the 12 practices, 6 improved modestly, 2 remained near universal during both intervention and control periods, 3 did not change and 1 worsened. There was no evidence of change in mortality with a majority of deaths occurring either during referral transport or at the referral facilities.ConclusionA multipronged quality management strategy enhanced utilisation of services and modestly improved key practices around the time of childbirth in PHCs in India.Trial registration numberCTRI/2016/05/006963.

scholarly journals Secular trend, seasonality and effects of a community-based intervention on neonatal mortality: follow-up of a cluster-randomised trial in Quang Ninh province, Vietnam

2018 ◽  
Vol 72 (9) ◽  
pp. 776-782
Author(s):  
Leif Eriksson ◽  
Nguyen T Nga ◽  
Dinh T Phuong Hoa ◽  
Duong M Duc ◽  
Anna Bergström ◽  
...  
Keyword(s):  
Time Series ◽  
Neonatal Mortality ◽  
Secular Trend ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Neonatal Deaths ◽  
Live Births ◽  
Cluster Randomised ◽  
Quang Ninh

BackgroundLittle is know about whether the effects of community engagement interventions for child survival in low-income and middle-income settings are sustained. Seasonal variation and secular trend may blur the data. Neonatal mortality was reduced in a cluster-randomised trial in Vietnam where laywomen facilitated groups composed of local stakeholders employing a problem-solving approach for 3 years. In this analysis, we aim at disentangling the secular trend, the seasonal variation and the effect of the intervention on neonatal mortality during and after the trial.MethodsIn Quang Ninh province, 44 communes were allocated to intervention and 46 to control. Births and neonatal deaths were assessed in a baseline survey in 2005, monitored during the trial in 2008–2011 and followed up by a survey in 2014. Time series analyses were performed on monthly neonatal mortality data.ResultsThere were 30 187 live births and 480 neonatal deaths. The intervention reduced the neonatal mortality from 19.1 to 11.6 per 1000 live births. The reduction was sustained 3 years after the trial. The control areas reached a similar level at the time of follow-up. Time series decomposition analysis revealed a downward trend in the intervention areas during the trial that was not found in the control areas. Neonatal mortality peaked in the hot and wet summers.ConclusionsA community engagement intervention resulted in a lower neonatal mortality rate that was sustained but not further reduced after the end of the trial. When decomposing time series of neonatal mortality, a clear downward trend was demonstrated in intervention but not in control areas.Trial registration numberISRCTN44599712, Post-results.

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