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A multilevel framework for recruitment and retention in implementation trials: An illustrative example.
Clin Trials
January 2025
Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Background: Implementation and hybrid effectiveness-implementation trials aspire to speed the translation of science into practice by generating crucial evidence for improving the uptake of effective health interventions. By design, they pose unique recruitment and retention challenges due to their aims, units of analysis, and sampling plans, which typically require many clinical sites (i.e.
View Article and Find Full Text PDFApplying Normalisation Process Theory to a peer-delivered complex health intervention for people experiencing homelessness and problem substance use.
Commun Med (Lond)
January 2025
Salvation Army Centre for Addiction Services and Research, Faculty of Social Sciences, Colin Bell Building, University of Stirling, Stirling, Scotland, UK.
Background: The Supporting Harm Reduction through Peer Support (SHARPS) study involved designing and implementing a peer-delivered, harm reduction intervention for people experiencing homelessness and problem substance use. Normalisation Process Theory (NPT) provided a framework for the study.
Methods: Four Peer Navigators (individuals with personal experience of problem substance use and/or homelessness) were recruited and hosted in six third sector (not-for-profit) homelessness services in Scotland and England (United Kingdom).
Safety, bactericidal activity, and pharmacokinetics of the antituberculosis drug candidate BTZ-043 in South Africa (PanACEA-BTZ-043-02): an open-label, dose-expansion, randomised, controlled, phase 1b/2a trial.
Lancet Microbe
December 2024
Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Germany; German Center for Infection Research, Munich Partner Site, Munich, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology, Infection, and Pandemic Research, Munich, Germany; Unit Global Health, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany. Electronic address:
Background: The broad use of bedaquiline and pretomanid as the mainstay of new regimens to combat tuberculosis is a risk due to increasing bedaquiline resistance. We aimed to assess the safety, bactericidal activity, and pharmacokinetics of BTZ-043, a first-in-class DprE1 inhibitor with strong bactericidal activity in murine models.
Methods: This open-label, dose-expansion, randomised, controlled, phase 1b/2a trial was conducted in two specialised tuberculosis sites in Cape Town, South Africa.
Design and implementation of an action plan for justice, equity, diversity, and inclusion within the Clinical Genome Resource.
Am J Hum Genet
January 2025
National Human Genome Research Institute, National Institutes of Health (NIH), Bethesda, MD, USA.
How might members of a large, multi-institutional research and resource consortium foster justice, equity, diversity, and inclusion as central to its mission, goals, governance, and culture? These four principles, often referred to as JEDI, can be aspirational-but to be operationalized, they must be supported by concrete actions, investments, and a persistent long-term commitment to the principles themselves, which often requires self-reflection and course correction. We present here the iterative design process implemented across the Clinical Genome Resource (ClinGen) that led to the development of an action plan to operationalize JEDI principles across three major domains, with specific deliverables and commitments dedicated to each. Active involvement of consortium leadership, buy-in from its members at all levels, and support from NIH program staff at pivotal stages were essential to the success of this effort.
View Article and Find Full Text PDFKnowing is Half the Battle: The Factors Leading to Efficient Recruitment of Representative Samples in Schizophrenia Research.
Pharmaceut Med
January 2025
New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032, USA.
Background And Objectives: Drug development in schizophrenia is limited by the differential scaling of the active treatment and placebo arms of a study, such that, as the number of sites increases, the magnitude of placebo response disproportionately increases. The objective of this article was to identify factors conducive to efficient recruitment as a step towards trial designs allowing recruitment of more participants per site, leading to reduced variability, and potentially a smaller placebo effect.
Patients And Methods: Using the information of 554 individuals, we calculated the percentage of individuals who were screened, consented, and retained in our research, along with rationale for nonconsent.
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