A new simple six-step model to promote recruitment to RCTs was developed and successfully implemented.

Journal of Clinical Epidemiology
Alba RealpeJenny L Donovan

Abstract

How a randomized controlled trial (RCT) is explained to patients is a key determinant of recruitment to that trial. This study developed and implemented a simple six-step model to fully inform patients and to support them in deciding whether to take part or not. Ninety-two consultations with 60 new patients were recorded and analyzed during a pilot RCT comparing surgical and nonsurgical interventions for hip impingement. Recordings were analyzed using techniques of thematic analysis and focused conversation analysis. Early findings supported the development of a simple six-step model to provide a framework for good recruitment practice. Model steps are as follows: (1) explain the condition, (2) reassure patients about receiving treatment, (3) establish uncertainty, (4) explain the study purpose, (5) give a balanced view of treatments, and (6) Explain study procedures. There are also two elements throughout the consultation: (1) responding to patients' concerns and (2) showing confidence. The pilot study was successful, with 70% (n = 60) of patients approached across nine centers agreeing to take part in the RCT, so that the full-scale trial was funded. The six-step model provides a promising framework for successful recruitment...Continue Reading

References

Oct 30, 1998·Health Technology Assessment : HTA·A BrittonC Bain
Jun 18, 2002·BMJ : British Medical Journal·Peter McCullochDamian Griffin
Apr 24, 2003·Health Technology Assessment : HTA·J DonovanUNKNOWN ProtecT Study Group
Nov 15, 2007·Health Technology Assessment : HTA·M K CampbellUNKNOWN STEPS group
May 16, 2008·Contemporary Clinical Trials·Isabel de SalisJenny Donovan
Jul 16, 2008·Journal of Clinical Epidemiology·Jenny L DonovanUNKNOWN ProtecT Study Group
Sep 29, 2009·Lancet·Patrick L ErginaJan Vandenbroucke
Apr 12, 2011·Journal of Clinical Epidemiology·Nicola MillsJ Athene Lane

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Citations

Aug 9, 2016·Journal of Clinical Epidemiology·Matthias BrielStefan Schandelmaier
Sep 29, 2018·Health Technology Assessment : HTA·Freddie C HamdyTom A Leslie
May 16, 2019·BMC Health Services Research·Charissa Fritzen-PediciniUNKNOWN CDC Prevention Epicenter Program
Dec 20, 2018·International Wound Journal·Victoria Team, Carolina D Weller

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Clinical Trials Mentioned

ISRCTN09754699

Software Mentioned

ProtecT

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