Elsevier

Injury

Volume 41, Supplement 1, July 2010, Pages S3-S6
Injury

Asking good clinical research questions and choosing the right study design

https://doi.org/10.1016/j.injury.2010.04.016Get rights and content

Abstract

Clinicians and researchers seek answers to clinical research questions, primarily by accessing the results of clinical research studies. This paper moves the focus of research enquiry from getting answers to developing good clinical research questions. Using worked examples, the steps involved in refining questions drawn from various sources to create ‘answerable’ clinical research questions using the ‘PICO’ principle are described. Issues to consider in prioritising clinical research questions are also identified.

Theoretical and practical considerations involved in choosing the right study design for a clinical research question are then discussed using the worked examples. These include:

  • Categorisation of questions according to their central clinical issues;

  • Use of preliminary literature searching to identify existing research and further refine questions;

  • Identifying whether a quantitative or qualitative research paradigm is best suited to a research question;

  • Hierarchies of evidence that rank study designs and how they vary according to central clinical issues;

  • Other factors influencing study design selection.

Introduction

“Judge of a man by his questions rather than by his answers”

(Voltaire, French author, humanist, rationalist, & satirist; 1694–1778).4

Users of medical research, especially clinical practitioners, focus primarily on accessing results of clinical studies to answer clinical questions, most frequently “Does this intervention work?” Comparatively little attention is paid to the questions themselves. Yet failure to think carefully about the meaning, structure and intention of research questions can have adverse effects on every subsequent step of the research process, potentially compromising the answers. The fundamental purpose of asking good questions is to match these to an appropriate and feasible study design.

This paper outlines principles and strategies for asking good clinical research questions and identifying appropriate research paradigms and designs.

Section snippets

Sources and examples of questions

Clinicians and researchers encounter a range of external and self-generated questions on a daily basis. As outlined in Table 1, the focus and nature of these questions varies according to the perspective of the stakeholder. Patients focus on issues of most relevance to their specific situation, such as relief of symptoms; the clinician or researcher considers broader issues, for example choosing from a range of intervention options; colleagues and funders seek justification of interventions and

What is the question about?

The development of an answerable clinical research question using the ‘PICO’ principles facilitates the important process of categorising the question according to its central clinical issue,6 as illustrated in Table 3. This table shows that therapeutic interventions are only one of a number of clinical issues that can be addressed by clinical research questions. There are many other categories in addition to those identified in Table 3, including aetiology, prevention and differential

Conclusion

This paper has examined the issue of question development by considering two key principles: asking good questions and choosing the right study design. Identification and consideration of these principles is a critical first step in the research process. Giving careful thought to these issues can substantially focus emerging questions and aid in the determination of how they may be best addressed in research terms.

However, the nature of human enquiry, combined with the complexity of medicine,

Disclosure statement

The author has no conflicts of interest to declare in relation to this paper.

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