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Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials
Pragmatism in clinical trials is focused on increasing the generalizability of research findings for routine clinical care settings. Hybridism in...
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PRECIS-2 analysis of pragmatic acupuncture trials: a systematic review
BackgroundPragmatic acupuncture trials (PATs) are a research tool for assessing the effectiveness of acupuncture treatments in a real-world setting....
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Optimizing clinical nutrition research: the role of adaptive and pragmatic trials
Evidence-based nutritional recommendations address the health impact of suboptimal nutritional status. Efficacy randomized controlled trials (RCTs)...
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Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9—Pragmatic Research and Innovation through Multinational Experimentation
In an era focused on value-based healthcare, the quality of healthcare and resource allocation should be underpinned by empirical evidence. Pragmatic...
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Modifications of the readiness assessment for pragmatic trials tool for appropriate use with Indigenous populations
BackgroundInequities in health access and outcomes exist between Indigenous and non-Indigenous populations. Embedded pragmatic randomized, controlled...
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Analysis of the characteristics and the degree of pragmatism exhibited by pragmatic-labelled trials of antineoplastic treatments
BackgroundPragmatic clinical trials (PCTs) are designed to reflect how an investigational treatment would be applied in clinical practice. As such,...
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Heterogeneity in pragmatic randomised trials: sources and management
BackgroundPragmatic trials aim to generate evidence to directly inform patient, caregiver and health-system manager policies and decisions....
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Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies
BackgroundWith recent growth in the conduct of pragmatic clinical trials, the reliance on frontline staff to contribute to trial-related activities...
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Approaches to multiplicity in publicly funded pragmatic randomised controlled trials: a survey of clinical trials units and a rapid review of published trials
BackgroundOpinions and practices vary around the issue of performing multiple statistical tests in randomised controlled trials (RCTs). We carried...
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Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis
BackgroundOver the past two decades, pragmatic and implementation science clinical trial research methods have advanced substantially. Pragmatic and...
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Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology review
BackgroundPragmatic trials evaluating complex health interventions often compare them to usual care. This comparator should resemble care as provided...
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Pragmatic trials can address diagnostic controversies: recent lessons from gestational diabetes
ObjectiveThe aim of the paper is to discuss how a pragmatic definition could change our conception of diagnosis, using gestational diabetes mellitus...
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The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory
BackgroundThe COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research....
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Strengths, challenges, and strategies for implementing pragmatic multicenter randomized controlled trials (RCTs): example of the Personalized Citizen Assistance for Social Participation (APIC) trial
BackgroundRandomized controlled trials (RCTs) are rigorous scientific research designs for evaluating intervention effectiveness. However,...
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Group sequential designs for pragmatic clinical trials with early outcomes: methods and guidance for planning and implementation
BackgroundGroup sequential designs are one of the most widely used methodologies for adaptive design in randomized clinical trials. In settings where...
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Group sequential designs in pragmatic trials: feasibility and assessment of utility using data from a number of recent surgical RCTs
BackgroundAssessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant...
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Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya
BackgroundSelf-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring...
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Clinical reasoning in pragmatic trial randomization: a qualitative interview study
BackgroundPragmatic trials, because they study widely used treatments in settings of routine practice, require intensive participation from...
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Health professional’s perception of a smoking cessation intervention among disadvantaged patients participating in a pragmatic randomized trial
IntroductionIndividuals who have a low socio-economic position (SEP) are more likely to smoke and face greater barriers to quitting tobacco. However,...