Stepped wedge trials are increasingly adopted because practical constraints necessitate staggered roll-out. While a complete design requires clusters to collect data in all periods, resource and patient-centered considerations may call for an incomplete stepped wedge design to minimize data collection burden. To study incomplete designs, we expand the metric of information content to discrete outcomes. We operate under a marginal model with general link and variance functions, and derive information content expressions when data elements (cells, sequences, periods) are omitted. We show that the centrosymmetric patterns of information content can hold for discrete outcomes with the variance-stabilizing link function. We perform numerical studies under the canonical link function, and find that while the patterns of information content for cells are approximately centrosymmetric for all examined underlying secular trends, the patterns of information content for sequences or periods are more sensitive to the secular trend, and may be far from centrosymmetric.
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http://dx.doi.org/10.1111/sjos.12615 | DOI Listing |
AIDS Behav
January 2025
Department of Medicine, University of Alabama at Birmingham, 845 19th Street South, Bevill Biomedical Research Building, Room 256D, Birmingham, AL, 35294-2170, USA.
Antiretroviral therapy (ART) use and HIV suppression among people living with HIV (PLHIV) are critical for HIV control and prevention. Extreme restrictions on movement early during the COVID-19 pandemic in Uganda may have impeded the ability to initiate and sustain access to and use of ART. From our stepped-wedge cluster-randomized trial of an integrated PrEP and ART intervention for HIV-serodifferent couples at 12 ART clinics in Uganda, we identified participants who enrolled and had a 6-month post-ART initiation viral load measured before the beginning of the first COVID-19 lockdown (Period 1), participants whose enrollment and 6-month viral load measurement straddled pre-COVID and COVID lockdown times (Period 2), and participants whose enrollment and 6-month viral load were quantified entirely during COVID-19 (Period 3).
View Article and Find Full Text PDFAlzheimers Dement
December 2024
National Ageing Research Institute, Melbourne, VIC, Australia.
Background: The Promoting Independence Through quality Care at Home (PITCH) project aimed to improve outcomes for people with dementia and their carers via a co-designed training intervention for home care workers (HCWs). The results of the primary efficacy analysis of the successful stepped-wedge cluster RCT (n = 172 HCWs in 18 clusters in 7 Australian service providers) were presented at AAIC 2023.
Method: This presentation goes beyond efficacy and discusses the implementation science (process evaluation and behavioural change) and health economic analysis of the intervention.
Can Commun Dis Rep
January 2025
Data, Surveillance and Foresight Branch, Public Health Agency of Canada, Ottawa, ON.
Background: Antimicrobial resistance (AMR) is associated with significant human and financial costs, particularly among vulnerable populations like older adults living in long-term care homes (LTCHs). Urinary tract infection (UTI) is the leading indication for antibiotic use in this population, with some estimates suggesting that up to 70% of these prescriptions may be avoidable.
Objective: The purpose of this study is to develop and test novel behavioural science-informed antimicrobial stewardship (AMS) quality improvement strategies in Canadian LTCHs, which aim to decrease unnecessary testing and treatment for residents who lack the minimum clinical signs and symptoms of UTI.
Background: Ambient artificial intelligence offers promise for improving documentation efficiency and reducing provider burden through clinical note generation. However, challenges persist in workflow integration, compliance, and widespread adoption. This study leveraged a Learning Health System (LHS) framework to align research and operations using a hybrid effectiveness-implementation protocol, embedded as pragmatic trial operations within the electronic health record (EHR).
View Article and Find Full Text PDFBMJ
January 2025
Biostatistics Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
This article presents the CONSORT (consolidated standards of reporting trials) extension for cluster randomised crossover trials. A cluster randomised crossover trial involves randomisation of groups of individuals (known as clusters) to different sequences of interventions over time. The design has gained popularity in settings where cluster randomisation is required because it can largely overcome the loss in power due to clustering in parallel cluster trials.
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