The Importance of Informed Consent

An ongoing study by University of Michigan researchers has indicated that women diagnosed in the early stages of breast cancer are not being fully informed of all the treatment options available to them.

"In the earliest stages of breast cancer, it's broadly endorsed that lumpectomy is the most appropriate treatment," says the lead researcher Dr. Steven Katz. "Yet mastectomy remains a commonly used procedure for women with this early cancer, and that has raised concerns among some clinicians and policy makers. Are we being too aggressive?"

Katz says there is very little information about how these treatment decisions are made, who makes them, or whether the information given to patients about the advantages and disadvantages of the different treatment options is being effectively communicated.

The survey involved 183 women in the Detroit area who had been recently diagnosed with non-metastatic breast cancer. All had surgery within the previous three months.

The researchers found a substantial portion of the women-up to a third-did not perceive that they were given a choice between lumpectomy with radiation or mastectomy.

"We think that the likely reason is that a diagnosis of cancer is a real shock," said Katz. "It's a stressful time and digesting a lot of treatment information quickly is very difficult. We believe surgeons and other clinicians are making a good faith effort, but we all need to try even harder."

Results from the pilot study were presented at the national scientific meeting of the Society of General Medicine. The results are scheduled to be published in the September 2001 issue of the Journal of Women's Health and Gender-Based Medicine.

Overall, 52 percent of the women surveyed had received a mastectomy. However, many of the women said they did not have accurate knowledge about the respective risks and benefits of lumpectomy versus mastectomy. Only a quarter of the women knew that, because of the early stage of their disease, their chance of survival was the same regardless of which procedure they chose.

The results of the study raise an important concern, said Katz. "Many women may be undergoing treatments for breast cancer without a sense of full participation with clinicians," he said, "and without accurate knowledge about the tradeoffs of different treatment options."

To date, 19 states have passed legislation that requires surgeons to document that they have informed patients of all the available surgical treatments. "Several studies suggest that these laws may not be the answer to this problem," Katz warns. He called on clinicians to "develop new strategies to improve communication with women during a very difficult time in their lives."

SOURCES:
University of Michigan Medical Center (http://www.umich.edu)
Society of General Medicine, National Scientific Meeting, May 2001

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