Author Archive: coprhcon

Recent Developments in Statistical Methods for Pragmatic, Stepped Wedge Cluster Randomized Trials

Posted on by

DESCRIPTION

The stepped wedge cluster randomized design has received increasing attention in pragmatic trials and implementation science research. The key feature of the design is the unidirectional crossover of clusters from the control to intervention conditions on a staggered schedule, which induces confounding of the intervention effect by time. While such designs first appeared in the 1980s, the associated statistical methods were not formally introduced until 2007. Since then, a variety of novel methods have been introduced for improving the design, analysis and conduct of these trials. In this talk, we explore these new methods under a unified perspective. We describe essential ingredients in analytical models for stepped wedge designs and discuss their implications for study planning, data analyses and reporting. Recent trial examples, challenges and opportunities are also discussed throughout this talk.

LEARNING OBJECTIVES

  1. To describe common variants of stepped wedge design and when such designs are appropriate choices
  2. To describe essential ingredients in analytical models for stepped wedge designs, and to understand key concepts and steps for determining the sample sizes
  3. To recognize challenges and opportunities in using stepped wedge designs for pragmatic trials

PRESENTER(S)

Stakeholder Engagement in Complex Environments

Posted on by

DESCRIPTION

The use of pragmatic trials and calls for stakeholder engagement during trial implementation have common goals: increase diversity of views and contributions, co-creation during the implementation process, and sustainment of evidence-based practices in real-world clinical and community settings. Early calls for the value of pragmatic trials can be traced back to 1967 with Schwarts and Lelouch’si call for ‘pragmatic attitudes’ during clinical trials. The younger field of implementation science with an emphasis on contexts and faster translation of evidence into routine practices in real-world settings can greatly contribute to the achievement of pragmatic trial goals. I will first provide an overview of the concept of implementation strategies and their role in pragmatic trials, as well as an overview of the state of the literature. Then, I will discuss stakeholder engagement using the 7 P’s Stakeholder Matrix by highlighting the role of context on shaping engagement within and across stakeholder categories. Last, I will advocate for the inclusion of engagement strategies that can foster co-creation, and social justice and inclusion, as promising avenues to increase health equity in the United States. My overall goal is that this discussion will enable a shift, from linear and formulaic approaches to engagement with diverse communities, to a contex-dependent and health equity approach.

LEARNING OBJECTIVES

  1. Learn the concept of implementation strategies and its role in pragmatic trials
  2. Identify state of the literature on approaches to stakeholder engagement in
    pragmatic trials, limitations, and future research
  3. Analyze stakeholder engagement taxonomies (7 P’S Stakeholder Matrix) as context
    dependent
  4. Learn various ways to incorporate stakeholder engagement in grant applications and
    scientific publications
  5. Advocate for concrete ways to co-create and incorporate a lens of social justice and
    inclusion in stakeholder engagement efforts

PRESENTER(S)

An Introduction to Pragmatic Trials: A View into the Rationale and Process of Real-Life interventions

Posted on by

DESCRIPTION

Pragmatic trials are intended to help typical clinicians and typical patients make difficult decisions in typical clinical care settings by maximizing the chance that the trial results will apply to patients that are usually seen in practice (external validity). – Sox 2016

 

LEARNING OBJECTIVES

  1. Describe the evolution of the efficacy trial to the pragmatic.

  2. Use systematic approaches to design and evaluate pragmatic trials.

  3. Describe practical approaches and resources to ensure administrative, clinical and patient preferences in design.

PRESENTER(S)