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A randomised controlled trial evaluating the utility of a patient Decision Aid to improve clinical trial (RAVES 08.03) related decision-making

Radiotherapy & Oncology Sep 05, 2017

Sundaresan P, et al. – The utility of a Decision Aid (DA) in reducing RCT–related decisional conflict, and improving randomised controlled trial (RCT) knowledge and recruitment, was gauged. DA was found to be beneficial in reducing decisional conflict and improving trial knowledge in men with cancer who were making decisions regarding RCT participation.

Methods

  • Invitation was sent to potential participants for a radiotherapy RCT to participate in the current study.
  • The clinicians randomised participants to receive the RCT’s participant information sheet with or without a DA.
  • They administered questionnaires at baseline, one and six months.
  • Decisional conflict was the primary outcome measure, and secondary outcome measures included knowledge regarding and recruitment to the RCT.

Results

  • In this study, 129 men were randomised to the DA (63) and control (66) arms.
  • Results reported significantly lower decisional conflict over 6-months (p=0.048) in the DA arm.
  • They observed significantly higher knowledge regarding the RCT at 6 months (p=0.033) in the DA arm.
  • Moreover, 20.6% of the DA arm (13 of 63) and 9% of the control arm (6 of 66) entered the RCT.

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