A Short Communication Course for Physicians Improves the Quality of Patient Information in a Clinical Trial

Posted: Oct 24, 2011
Acta Oncol. 46. 1. 42-8.
KEYWORDS: Knowledge/Attitudes/Beliefs, Attitudes, International, Consent, Women, Cancer


Brief communications course that includes role-playing for docs and nurses may improve the quality of informed consent.

Why this item may be useful

This article addresses the question of how to improve the informed consent process. The investigators tested a one-day communications course for physicians and research nurses that included lecture and role-play approaches for its ability to improve the quality of informed consent and the satisfaction of patients who enrolled in a randomized clinical trial of adjuvant treatment for breast cancer. Based on their findings, they concluded that although the course needs some improvement, this kind of training should be included in the clinical trial planning. Of note, the authors point out that some research results suggest that patient satisfaction with study information is associated with clinical trial participation.


  • Prior to introducing the clinical trial to the patients, physicians and nurses in the intervention group at three participating Finnish hospitals attended a one-day communications skills course that focused on disclosing information about clinical trials to improve the quality of informed consent.
  • Three months after randomization, 320 participants of a breast cancer clinical trial were given a questionnaire addressing the quality of information given about the trial and the communication skills of the physicians who had presented the trial to them.
  • Compared to the patients of the matched control group of physicians (i.e., who did not take the course), the intervention group patients: o Were more satisfied with the information provided and time given for making decisions; o Were more likely to recall that the physician offered other therapeutic options; o Were more likely to understand the main aim of the trial; o Were equally likely to have some misconceptions about patient safety and probability of improved efficacy.
  • The training course did not affect patients’ understanding of randomized treatment allocation, satisfaction with the amount of information received, or perception of reaching a decision independently, nor resolve their misconceptions about patient safety and probability of improved efficacy.