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  1. 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...

    John C. Fortney, Geoffrey M. Curran, ... David R. Flum in Journal of General Internal Medicine
    Article 16 April 2024
  2. PRECIS-2 analysis of pragmatic acupuncture trials: a systematic review

    Background

    Pragmatic acupuncture trials (PATs) are a research tool for assessing the effectiveness of acupuncture treatments in a real-world setting....

    **woong Lim, Hyeonhoon Lee, Yong-Suk Kim in BMC Complementary Medicine and Therapies
    Article Open access 03 May 2024
  3. 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)...

    Camila E. Orsso, Katherine L. Ford, ... Carla M. Prado in European Journal of Clinical Nutrition
    Article 15 September 2023
  4. 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...

    Elmir Omerovic, Mark Petrie, ... Torsten Doenst in Trials
    Article Open access 23 January 2024
  5. Modifications of the readiness assessment for pragmatic trials tool for appropriate use with Indigenous populations

    Background

    Inequities in health access and outcomes exist between Indigenous and non-Indigenous populations. Embedded pragmatic randomized, controlled...

    Joanna Hikaka, Ellen M. McCreedy, ... Rosa R. Baier in BMC Medical Research Methodology
    Article Open access 31 May 2024
  6. Analysis of the characteristics and the degree of pragmatism exhibited by pragmatic-labelled trials of antineoplastic treatments

    Background

    Pragmatic clinical trials (PCTs) are designed to reflect how an investigational treatment would be applied in clinical practice. As such,...

    Robbe Saesen, Kevin Depreytere, ... Isabelle Huys in BMC Medical Research Methodology
    Article Open access 24 June 2023
  7. Heterogeneity in pragmatic randomised trials: sources and management

    Background

    Pragmatic trials aim to generate evidence to directly inform patient, caregiver and health-system manager policies and decisions....

    Bruno Giraudeau, Agnès Caille, ... Monica Taljaard in BMC Medicine
    Article Open access 28 October 2022
  8. Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies

    Background

    With recent growth in the conduct of pragmatic clinical trials, the reliance on frontline staff to contribute to trial-related activities...

    Lisa A. Juckett, Kimberly P. Bernard, Kali S. Thomas in Trials
    Article Open access 17 November 2023
  9. Approaches to multiplicity in publicly funded pragmatic randomised controlled trials: a survey of clinical trials units and a rapid review of published trials

    Background

    Opinions and practices vary around the issue of performing multiple statistical tests in randomised controlled trials (RCTs). We carried...

    Katie Pike, Barnaby C. Reeves, Chris A. Rogers in BMC Medical Research Methodology
    Article Open access 06 February 2022
  10. Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis

    Background

    Over the past two decades, pragmatic and implementation science clinical trial research methods have advanced substantially. Pragmatic and...

    Douglas Zatzick, Lawrence Palinkas, ... Eileen Bulger in Trials
    Article Open access 21 April 2023
  11. ORCHARD: a model for conducting pragmatic randomised trials in pregnancy

    Priscilla Smith, Kathryn Dalrymple, ... Kate Bramham in Journal of Nephrology
    Article 17 May 2024
  12. Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology review

    Background

    Pragmatic trials evaluating complex health interventions often compare them to usual care. This comparator should resemble care as provided...

    Katrina M. Turner, Alyson Huntley, ... Shoba Dawson in Trials
    Article Open access 12 February 2024
  13. Pragmatic trials can address diagnostic controversies: recent lessons from gestational diabetes

    Objective

    The aim of the paper is to discuss how a pragmatic definition could change our conception of diagnosis, using gestational diabetes mellitus...

    Jean Raymond, Hélène Long, Tim Darsaut in Trials
    Article Open access 01 April 2022
  14. The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory

    Background

    The COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research....

    Emily C. O’Brien, Jeremy Sugarman, ... Lesley H. Curtis in Trials
    Article Open access 21 May 2022
  15. Strengths, challenges, and strategies for implementing pragmatic multicenter randomized controlled trials (RCTs): example of the Personalized Citizen Assistance for Social Participation (APIC) trial

    Background

    Randomized controlled trials (RCTs) are rigorous scientific research designs for evaluating intervention effectiveness. However,...

    Mélanie Levasseur, Agathe Chaintré-Prieur, ... Helen-Maria Vassiliadis in Trials
    Article Open access 27 June 2024
  16. Group sequential designs for pragmatic clinical trials with early outcomes: methods and guidance for planning and implementation

    Background

    Group sequential designs are one of the most widely used methodologies for adaptive design in randomized clinical trials. In settings where...

    Nick R. Parsons, Joydeep Basu, Nigel Stallard in BMC Medical Research Methodology
    Article Open access 16 February 2024
  17. Group sequential designs in pragmatic trials: feasibility and assessment of utility using data from a number of recent surgical RCTs

    Background

    Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant...

    Nick R. Parsons, Nigel Stallard, ... Andrew Metcalfe in BMC Medical Research Methodology
    Article Open access 01 October 2022
  18. 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

    Background

    Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring...

    Elena Marbán-Castro, Lorrein Muhwava, ... Sonjelle Shilton in Trials
    Article Open access 21 May 2024
  19. Clinical reasoning in pragmatic trial randomization: a qualitative interview study

    Background

    Pragmatic trials, because they study widely used treatments in settings of routine practice, require intensive participation from...

    Justin T. Clapp, Cassandra Dinh, ... Mark D. Neuman in Trials
    Article Open access 27 June 2023
  20. Health professional’s perception of a smoking cessation intervention among disadvantaged patients participating in a pragmatic randomized trial

    Introduction

    Individuals who have a low socio-economic position (SEP) are more likely to smoke and face greater barriers to quitting tobacco. However,...

    Aurélia Manns, Sarah Mahdjoub, ... Fabienne El-Khoury in BMC Health Services Research
    Article Open access 14 September 2023
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