Article
Multidisciplinary Sciences
Ivan Baldassari, Andreina Oliverio, Vittorio Krogh, Eleonora Bruno, Giuliana Gargano, Mauro Cortellini, Alice Casagrande, Maria G. Di Mauro, Elisabetta Venturelli, Daniela Del Sette Cerulli, Bellegotti Manuela, Franco Berrino, Patrizia Pasanisi
Summary: This article reports on the recruitment experience and results of the MeMeMe trial. It suggests that the passive recruitment method was more effective than the active one.
Article
Mathematical & Computational Biology
Xiangmei Ma, Paul Milligan, Kwok Fai Lam, Yin Bun Cheung
Summary: Our study investigates five estimators of intervention effects on event rates, each with different precision and power depending on the conditions, and proposes a set of unbiased estimators to control bias in studies with few clusters. The unbiased estimators perform well in simulations and are practically unbiased, while the asymptotically unbiased estimators show good performance with a larger number of clusters. Despite its simplicity, one estimator performs comparably with others in trials with a realistic number of clusters, and two estimators offer higher power in certain conditions.
STATISTICS IN MEDICINE
(2022)
Review
Cardiac & Cardiovascular Systems
Robert P. Murphy, Martin J. O'Donnell, Aoife Nolan, Emer McGrath, Aengus O'Conghaile, John Ferguson, Alberto Alvarez-Iglesias, Maria Costello, Elaine Loughlin, Catriona Reddin, Sarah Ruttledge, Sarah Gorey, Diarmaid Hughes, Andrew Smyth, Michelle Canavan, Conor Judge
Summary: This meta-analysis found that the use of a run-in period does not significantly affect the magnitude of treatment effects in cardiovascular prevention trials.
JOURNAL OF THE AMERICAN HEART ASSOCIATION
(2022)
Article
Mathematical & Computational Biology
Philipp Mildenberger, Jochem Koenig
Summary: Stepped wedge cluster randomized trials (SWCRT) are increasingly used in health services research, but the unbalanced allocation over time periods and uncertainty about cluster-level correlation structures pose challenges in their design and analysis. To better estimate treatment effects, we discuss two measures of cell influence and propose a new, more general and computationally efficient formula for information content (IC).
BIOMETRICAL JOURNAL
(2023)
Article
Public, Environmental & Occupational Health
Brennan C. Kahan, Fan Li, Andrew J. Copas, Michael O. Harhay
Summary: This article discusses the different estimands targeted in cluster-randomized trials (CRTs) and how the choice of analytic approach can impact the interpretation of results. The study findings highlight the potential bias introduced by common estimators when cluster size is informative, and propose alternative estimators that provide unbiased estimates even in the presence of informative cluster size.
INTERNATIONAL JOURNAL OF EPIDEMIOLOGY
(2022)
Review
Gastroenterology & Hepatology
Benedicte Caron, Ferdinando D'Amico, Silvio Danese, Laurent Peyrin-Biroulet
Summary: Randomized clinical trials are essential for drug development, and cluster randomized trials offer a new study design for evaluating intervention effects at the cluster level. However, the risk of imbalance in covariates at baseline should be carefully considered to ensure the credibility of the results.
JOURNAL OF CROHNS & COLITIS
(2022)
Article
Psychology, Mathematical
Mirjam Moerbeek
Summary: This paper investigates the impact of missing data on design efficiency in multi-period trials, finding that efficiency increases with the number of subjects per day and number of weeks, but decreases due to missing data and dropout, especially when there are few subjects per day and many weeks.
BEHAVIOR RESEARCH METHODS
(2021)
Article
Health Care Sciences & Services
Halil Kilicoglu, Lan Jiang, Linh Hoang, Evan Mayo-Wilson, Christiaan H. Vinkers, Willem M. Otte
Summary: This study provides large-scale quantitative support for the hypothesis that RCT methodology reporting has improved over time. While there has been an increase in the reporting of some method information, there is still room for improvement. The differences in the proportion of items reported between disciplines are small.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2023)
Article
Medicine, Research & Experimental
Jonathan C. C. Moyer, Patrick J. J. Heagerty, David M. M. Murray
Summary: This study compared the effectiveness of using RC models and RM-ANOVA models to analyze multiple-period parallel GRTs. The results showed that both RC and saturated analytic models maintained the nominal type I error rate in all data sets, while RM-ANOVA models with unstructured covariance exhibited inflation in type I error rates when applied to cohort data. In addition, analytic models that omitted time-varying group random effects were prone to substantial type I error inflation unless the residual error variance was high relative to the time x group variance.
Article
Emergency Medicine
Steven L. Bernstein, Patrick M. Carter, William Meurer, Maureen A. Walton, Kelly M. Kidwell, Rebecca M. Cunningham, James Dziura, Linda M. Collins
Summary: The classical two-arm randomized clinical trial (RCT) is limited in providing information for intervention development, while the Multiphase Optimization Strategy (MOST) is a new framework that allows for the development, optimization, and evaluation of interventions. MOST includes an optimization phase before the RCT, and the experimental design is strategically selected based on the type of intervention.
AMERICAN JOURNAL OF EMERGENCY MEDICINE
(2022)
Article
Immunology
Alex Allard-Gray, Isaac Boakye, Alioune Camara, Lisa Eisenbeis, Eleny Guimaraes-Teixeira, Oumou Sow, David Zielinski, Jonathon R. Campbell, Dick Menzies
Summary: This study assessed the association between participant behaviors early in tuberculosis preventive treatment (TPT) and subsequent discontinuation. The researchers found that four behavioral predictors recorded early in therapy were more strongly associated with discontinuation than participant characteristics, particularly when multiple predictors were recorded.
CLINICAL INFECTIOUS DISEASES
(2023)
Article
Social Sciences, Mathematical Methods
Xiangmei Ma, Yin Bun Cheung
Summary: The study describes five asymptotically unbiased estimators of intervention effects on event rates in nonmatched and matched-pair cluster randomized trials. It also presents a bias-corrected version of the estimators for use when the number of clusters is small. These estimators can be used to estimate the total effect and the direct effect.
Review
Biochemistry & Molecular Biology
Sergio Davinelli, Sawan Ali, Vincenzo Solfrizzi, Giovanni Scapagnini, Graziamaria Corbi
Summary: Recent evidence suggests that diet can modify the risk of future cognitive impairment and dementia. Carotenoid interventions have shown significant effects on cognitive outcomes and may help reduce the risk of cognitive impairment and dementia.
Review
Orthopedics
Lauren K. King, Nicolas S. Bodmer, Pakeezah Saadat, Pavlos Bobos, Gillian A. Hawker, Bruno R. da Costa
Summary: This study reviewed 20 cluster randomized controlled trials (RCTs) in osteoarthritis (OA) and found that only 25% of trials reported the observed intracluster correlation coefficient (ICC), with one trial being underpowered due to a larger ICC value than used for sample size calculation. This highlights the need for more attention and reporting on the importance of ICCs in cluster RCTs.
OSTEOARTHRITIS AND CARTILAGE
(2023)
Article
Nutrition & Dietetics
Alice H. Lichtenstein, Kristina Petersen, Kathryn Barger, Karen E. Hansen, Cheryl A. M. Anderson, David J. Baer, Johanna W. Lampe, Helen Rasmussen, Nirupa R. Matthan
Summary: RCTs are considered the gold standard in establishing causal relations in human nutrition, and decisions made during the design and conduct of these trials impact the utility and generalizability of the study results. The goal is to maximize generalizability while producing high-quality data within limited resources.
ADVANCES IN NUTRITION
(2021)