Disclosing information about randomised controlled trials in oncology: training concept and evaluation of an individualised communication skills training for physicians COM-ON-rct

Abstract

When physicians disclose information about randomised controlled trials, they have to balance the requirements of conducting high standard research and the respect for patients' rights. Physicians need training in this difficult matter. An individualised communication skills training (CST) about randomised controlled trials for oncologists has been developed. The aim of this publication is to describe the concept of our CST and present data of evaluation by the participants: First, a theoretical introduction about a communication model and important ethical and legal issues was presented. Individual learning goals of participants were then derived through video assessment with actor-patients. The learning goals were the basis for practicing in role play. Individual coaching helped physicians to transfer the made experience into their daily work. Forty physicians have been trained. The acceptance of the training concept was assessed by a questionnaire consisting of 14 items and using a 6-point scale from 1 (very best) to 6 (very bad): the individualised CST was highly accepted (mean = 1.33). Practicing with actor-patients (mean = 1.4), providing constructive feedback (mean = 1.3) and assessing individual learning goals (mean = 1.85) were seen as helpful. Our CST trains physicians to realise best research standards and incorporate patients' rights.

What do our patients understand about their trial participation? Assessing patients' understanding of their informed consent consultation about randomised clinical trials

“…Different sources were used to create the half-standardised interview guideline (see box 1) such as literature about manual construction,14 quality of IC,9 15 16 and included aspects from a current communication workshop about clinical trials from the authors 16. The interview covered different aspects of the IC and started with open questions so that patients had the opportunity to give free answers.…”

Training Programs for Improving Communication about Medical Research and Clinical Trials: A Systematic Review

“…Authors reported assessing participants' performance on how to offer the opportunity to participate in clinical trials (with the exception of [40], which does not explicitly mention it). Only six studies instructed participants how to address possible benefits and side effects associated with clinical trials participation [11,29,35,37,45,46]. Generally, authors did not recommend different communication strategies for different phases of clinical trials.…”

“…Six studies [10,13,29,38,42,46], reported training participants on the importance of assessing the eligibility of patients for the clinical trials. Authors reported assessing participants' performance on how to offer the opportunity to participate in clinical trials (with the exception of [40], which does not explicitly mention it).…”

“…Other topics specifically addressed by the training programs included how to explain the aims of clinical trials [10,13,29,30,39,41], the importance of informing patients about the voluntariness of their potential enrollment [10,11,29,30,33], or the importance of avoiding coercive behaviors and/or the importance of adopting a shared decision making process [34,35,37]. In some training, participants were instructed on strategies for clarifying key terms such as "randomization" and "placebo," which tend to be difficult for a large proportion of patients to understand or accept [10,13,30,36,39,41,42,45,46,48]. Few studies explicitly addressed concerns and strategies to successfully deal with potential participants' struggle to manage uncertainty [29,30,36,37,42].…”

“…Duration of the trainings varied across studies, ranging from a minimum of 3 hours, to a maximum of three days. Some trainings were spread over 2 days [29][30][31] or 3 days [46]. In the majority of the studies, participants selfselected into the training programs.…”