Using the Smiley Faces task to teach the fundamentals for good clinical trials

Helen Mcaneney,Mike Clarke,Lisa Maguire

doi:10.15694/mep.2018.000005.1

Abstract

This article was migrated. The article was not marked as recommended. Background: Many factors need to be considered when designing a clinical trial. Although structures such as PICOT (Population, Intervention, Comparator, Outcome, Timeline) are helpful, people with little or no prior knowledge can find designing and implementing a trial to be overly complicated. We developed a simple exercise to illustrate key features of trials: the Smiley Faces task. Aim: We describe how the Smiley Faces task can demonstrate the importance of good planning of trials and highlight pitfalls. Method and Results: The Smiley Faces task is centred on the simple, intuitive task to "draw a smiley face". It requires no existing knowledge about trials or research generally, but can be used to highlight key features of a trial; such as formulating the research question; planning for coding, collection and analysis of data; handling of missing data and drawing of conclusions. We present insights from conducting the exercise dozens of times and collecting hundreds of smiley face drawings in a range of educational settings. Conclusion: The simplicity and accessibility of the task makes it relatively easy to demonstrate key points for careful planning of clinical trials. The approach is generalizable and applicable to researchers and teachers in a variety of medical settings.

Highlights

Many factors need to be considered when designing a clinical trial
As Young et al state; "It is been recommended that evidenced based health care (EBHC) becomes a core component of the curriculum for all healthcare professional, since learning the fundamentals of research and how to apply an evidence-based approach are essential in the implementation of EBHC and subsequently improvement in the quality of health care."(Young et al, 2014)
It is known that the best options for improving EBHC knowledge, skills and attitudes, is by clinically integrating teaching and learning, the method of delivery can vary from lecture-based to online teaching, interactive online courses to workshops, with varying degrees of success (Young et al, 2015; Young et al, 2014)

Summary

Introduction

Many factors need to be considered when designing a clinical trial. structures such as PICOT (Population, Intervention, Comparator, Outcome, Timeline) are helpful, people with little or no prior knowledge can find designing and implementing a trial to be overly complicated. Metaphors and analogies are a valuable pedagogical tool to enhance the learning experience (Harrison and Treagust, 2006). This is especially true within medical education where ideas are often complex and multi-faceted. Innovative ways to embrace the process of clinical trials need to be proposed, to allow students to critically reason through the essential steps of evidence-based medicine on the processes of clinical trials. This will allow them to understand the consequences and relevance of the decision-making process on the conduct of a trial. We propose just one such innovative method, the Smiley Faces task

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Discussion

Conclusion