Abstract

Background Use of discussion and questioning is an effective supplement to written information provision during trial recruitment. Current evaluations of recruitment consultations monitor information delivered by recruiters, ignoring evidence of patient understanding/misunderstanding. This study a) developed a method of evaluating the quality of information provision and understanding during informed consent consultations for RCT recruitment (QUICC-RCT) that took patient responses into account and b) investigated the feasibility of applying it as a tool to evaluate informed consent (IC) in recruitment consultations.

Highlights

  • Open AccessEvaluating best practice in informed consent discussions: a new method of evaluating information provision and patient understanding during trial recruitment consultations

  • Use of discussion and questioning is an effective supplement to written information provision during trial recruitment

  • Current evaluations of recruitment consultations monitor information delivered by recruiters, ignoring evidence of patient understanding/misunderstanding

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Summary

Open Access

Evaluating best practice in informed consent discussions: a new method of evaluating information provision and patient understanding during trial recruitment consultations. Julia Wade1*, Jenny Donovan, Sangeetha Paramasivan, Athene Lane, David Neal, Freddie Hamdy. From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. 18-19 November 2013

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