Clinical trial recruitment – a complex intervention?

Authors

  • Ralph Tramm RN, MAppSc, PhD Scholar,

    Research Associate, Corresponding author
    1. Australian Catholic University, Melbourne, Australia
    • Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
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  • Karen Daws RN, MSN,

    Research Fellow
    1. St Vincent's/ACU Centre for Nursing Research, Australian Catholic University, Melbourne, Australia
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  • Verena Schadewaldt RN, MHSc, PhD Candidate

    1. Faculty of Health Sciences, Australian Catholic University, Melbourne, Australia
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Correspondence: Ralph Tramm, PhD Scholar, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Australian and New Zealand Intensive Care Research Centre, Monash University, The Alfred Centre, Level 6, 99 Commercial Road, Melbourne, Vic. 3004, Australia. Telephone: +61 (03) 990 30932.

E-mail: ralph.tramm@monash.edu.au

Abstract

Aims and objectives

To discuss the evidence of poor recruitment rates in randomised clinical trials and relate this to existing recruitment methodology before a novel approach to recruitment is suggested.

Background

Recruitment is crucial to the success of research projects. Effective recruitment leads to effective retention, an increased pool of data and in-time completion of projects. Robust evidence indicates that recruitment remains a challenge in many clinical trials.

Design

Discursive article.

Methods

The complexity of recruitment is mandated based on the findings from a literature review that summarises common threats to successful recruitment. Nursing theories and models that incorporate recruitment are critically reviewed before recruiting, and its planning is related to existing complex intervention methodology.

Conclusion

Threats to sufficient recruitment are inherent in the planning of studies, the recruiting process and triadic relationships between institutions, recruiter and participants. Existing nursing theories and models address important recruitment issues but do not account for all aspects that jeopardise sufficient recruitment. Hence, available frameworks for complex intervention planning and evaluation are useful to guide recruitment and its planning as an umbrella methodology.

Relevance to clinical practice

Using complex intervention methodology for recruitment and its planning enhances a nurse researcher's awareness of the challenges and pitfalls recruitment poses and may translate to improved recruitment rates and overall success of clinical trials.

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