Shortcomings of Written Informed Consent Forms

Relatively simple improvements could increase patient satisfaction and potentially improve the important process of imparting patient information during enrollment of cancer patients into clinical trials, according to a study published in BMC Health Services Research.

Since enrollment into clinical trials is vital to the process of developing, evaluating, and implementing new cancer treatments, efforts must be made to improve the consent process, particularly the written forms, concluded study authors, Pia Dellson and colleagues at the Institute of Clinical Sciences at Lund University, Sweden. They note that written consent materials should be complete, but at the same time not so complex that it may be questioned if fully informed consent is even possible to provide.

Their study explored patient representatives’ views and perceptions of written consent information used in 4 colorectal cancer clinical trials through the use of focus groups. Fourteen patients enrolled in randomized and nonrandomized phase I, II, and III trials that evaluated chemotherapy/targeted therapy were involved in the focus groups. Each had been diagnosed with colorectal cancer 1 to 8 years prior to the study.

The authors explain that oral clinical trial information is provided to patients by physicians and research nurses, but that written informed consent forms are typically developed by study sponsors who may represent academic researchers or commercial companies. The written information is typically extensive, providing a full and comprehensive picture of potential risks and benefits.

Though patients are generally satisfied with the consent process, studies have shown that their understanding of study aims, treatment risks and benefits, and randomization and research aspects are suboptimal.

Two major themes emerged from the focus groups, which researchers classified as emotional responses (including individual preferences and perceptions of effects) and cognitive responses (including comprehensibility and layout). Based on their findings, patient representatives suggested improvements in written consent materials. The suggested improvements were simple, and entailed the use of simplified and plain language, and structured text and illustrations to create more attractive informed consent forms.

The study authors suggest that future written consent information be developed with the aid of professional writers, illustrators, and patient representatives.