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We looked at trial discussions in a variety of consultations, not just in those in which randomisation decisions were imminent.
This study compared how trial discussions looked to an observer and how they felt to the parents of the children being recruited.
Research and specialist breast care nurses had a primary role in many of these trial discussions reflecting common practice in the United Kingdom.
As part of an intervention to facilitate effective multidisciplinary team communication about RCTs, cancer patients completed two study-specific questionnaires following trial discussions.
In addition, the HCPs involved in trial discussions were all participating in a study to improve communication about trials with both patients and members of their team.
The trial discussions were embedded within the consultations and introduced at a time that seemed to link the trial with the child's clinical management.
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Both questionnaires were given to patients by the research nurse in clinic following the trial discussion.
Consultation with the clinical team may help practitioners establish appropriate timing for a trial discussion.
The present study is a sub-study of the MoodSwings 2.0 3-arm randomised controlled trial (discussion board only (arm 1), discussion board plus psychoeducation (arm 2), discussion board, psychoeducation plus cognitive behavioural therapy-based tools (arm 3)).
Extra comments about the HCP's trial discussion were recorded by 112 patients, and were categorised into six themes: trust in the doctor, wanting to help others and self, randomisation, explanation of trial; time burdens and other comments.
Breast was chosen as the reference tumour group as these patients had the highest rate of trial discussion, and therefore the group against which we wished to contrast other tumour groups.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com