Table 1.

Items of the COM-ON-rct-checklist

Content-specific items: Disclose information about clinical trails

Did the participant:

• Explore the patient’s perception of the situation?

• Set an agenda for the discussion?

• Maintain sequences of treatment options (first standard then trials)?a

• Introduce and explain treatment options?

• Explain the set up and process of the research project?

• Provide an appropriate explanation of randomisation?

• Explain the reason for randomisation?

• Explain possible risks and side-effects?

• Explain that unknown effects may occur?

• Explain that participation is voluntary?

• Close the discussion in an appropriate manner?

General Communication Skills-related Items

Did the participant:

• Achieve an appropriate beginning?

• Use appropriate language?

• Employ adequate nonverbal communication?

• Take pauses?

• Show empathy to the patient?

• Encourage the patient to ask questions?

• Employ an adequate way to check the patient’s understanding?

• Structure the discussion?

Overall Evaluation Item

• What is your overall evaluation of the participant’s communication competence?

^aBinary item (yes/no) not integrated in the Mixed Model analysis utilized in the evaluation