Puma Sundaresan1, Brittany Ager2, Sandra Turner3, Dan Costa4, Andrew Kneebone5, Maria Pearse6, Henry Woo7, Stephanie Tesson2, Ilona Juraskova8, Phyllis Butow8. 1. Sydney Medical School, University of Sydney, Australia; Radiation Oncology Network, Westmead Hospital, NSW, Australia. Electronic address: psun8480@sydney.edu.au. 2. Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Australia. 3. Sydney Medical School, University of Sydney, Australia; Radiation Oncology Network, Westmead Hospital, NSW, Australia. 4. Sydney Medical School, University of Sydney, Australia; Pain Management Research Institute, Royal North Shore Hospital, Australia. 5. Sydney Medical School, University of Sydney, Australia; Northern Sydney Cancer Centre, Australia. 6. Department of Radiation Oncology, Auckland City Hospital, New Zealand. 7. Sydney Medical School, University of Sydney, Australia. 8. Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Australia; Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, The University of Sydney, Australia.
Abstract
BACKGROUND AND PURPOSE: Randomised controlled trials (RCTs) are considered the 'gold-standard' for evaluating medical treatments. However, patients and clinicians report difficulties with informed consent and recruitment. We evaluated the utility of a Decision Aid (DA) in reducing RCT-related decisional conflict, and improving RCT knowledge and recruitment. MATERIALS AND METHODS: Potential participants for a radiotherapy RCT were invited to participate in the current study. Participants were randomised to receive the RCT's participant information sheet with or without a DA. Questionnaires were administered at baseline, one and six months. The primary outcome measure was decisional conflict. Secondary outcome measures included knowledge regarding and recruitment to the RCT. RESULTS:129 men were randomised to the DA (63) and control (66) arms. Decisional conflict was significantly lower over 6-months (p=0.048) in the DA arm. Knowledge regarding the RCT was significantly higher at 6months (p=0.033) in the DA arm. 20.6% of the DA arm (13 of 63) and 9% of the control arm (6 of 66) entered the RCT. CONCLUSIONS: This study demonstrates the utility of a DA in reducing decisional conflict and improving trial knowledge in men with cancer who are making decisions regarding RCT participation. Crown
RCT Entities:
BACKGROUND AND PURPOSE: Randomised controlled trials (RCTs) are considered the 'gold-standard' for evaluating medical treatments. However, patients and clinicians report difficulties with informed consent and recruitment. We evaluated the utility of a Decision Aid (DA) in reducing RCT-related decisional conflict, and improving RCT knowledge and recruitment. MATERIALS AND METHODS: Potential participants for a radiotherapy RCT were invited to participate in the current study. Participants were randomised to receive the RCT's participant information sheet with or without a DA. Questionnaires were administered at baseline, one and six months. The primary outcome measure was decisional conflict. Secondary outcome measures included knowledge regarding and recruitment to the RCT. RESULTS: 129 men were randomised to the DA (63) and control (66) arms. Decisional conflict was significantly lower over 6-months (p=0.048) in the DA arm. Knowledge regarding the RCT was significantly higher at 6months (p=0.033) in the DA arm. 20.6% of the DA arm (13 of 63) and 9% of the control arm (6 of 66) entered the RCT. CONCLUSIONS: This study demonstrates the utility of a DA in reducing decisional conflict and improving trial knowledge in men with cancer who are making decisions regarding RCT participation. Crown
Authors: Rubee Dev; Nancy F Woods; Jennifer A Unger; John Kinuthia; Daniel Matemo; Shiza Farid; Emily R Begnel; Pamela Kohler; Alison L Drake Journal: Reprod Health Date: 2019-07-08 Impact factor: 3.223