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Monday, May 23, 2011

Sterilization form leaves some badly misinformed

Sterilization form leaves some badly misinformed
Confusion about surgery is common, study finds
Dr. Nikki B. Zite

A new study involving TennCare patients reveals women often don’t understand what they’re signing when they give consent to undergo surgical sterilization.

The federally required form is written at a reading level that is difficult for women with low literacy skills to comprehend. The form poses problems for women who want the surgery as well as those who don’t, the study showed.

The form requires written consent 30 days inadvance of the surgery. Dr. Nikki B. Zite, an author of the study in this month’s issue ofObstetrics & Gynecology, became interested in the subject when she was a medical resident in Memphis.

“Women who had nine babies would be crying to me, ‘I want my tubes tied,’ but I could not tie their tubes because they didn’t have these papers signed,” Zite said.

The surgery can be done at the same time as a cesarean section.
Improving comprehension

Zite, now an associate professor at the University of TennesseeGraduate School of Medicine in Knoxville, evaluated the comprehension level of two groups of TennCare patients.

Two hundred women participated. Half were given the standard form, which is written at a high school reading level, while the other half got a modified version written at a sixth-grade level. Women who filled out the modified version were much more likely to give correct answers on a followup questionnaire.

The biggest gap concerned understanding the time frame for the consent form. More than half of the women given the modified form correctly answered that the permission expired in six months, but only 1 in 5 got the answer right after reading the standard form.

Ninty-three percent of the women given the modified form understood the 30-day requirement before surgery, compared with just under 70 percent for the group using the standard form.

But the most disturbing difference showed that the form often failed at its intended purpose. More than a third of the women — 34.3 percent — who were given the standard form incorrectly agreed that “In a few years, if I change my mind, doctors can easily fix my tubes so I can have another baby.” Fewer than 19 percent of the women given the modified form had this misconception.

The modified form spelled out the consequences in simple language: “If I decided to have my tubes tied, I know that I will NOT be able to have a baby now or later on.” The relevant phrase in the standard form is longer with bigger words.
Barriers to change

Federal regulations require all state Medicaid programs, including TennCare, to use the standard form.

“The text of that form is included in our federal rules, so changes to that form would have to be made at the federal level,” said Kelly Gunderson, director of communications for TennCare.

At this point, the Centers for Medicare & Medicaid Services is not considering any changes to the wording, said Lee Millman, a spokeswoman for the federal agency.

“CMS would like to make clear that, while states should not be amending the consent form, nothing prohibits states from issuing separate forms that clarify these requirements in language the state believes to be more understandable,” Millman said.

The federal government began requiring the consent form in the 1970s after the Southern Poverty Law Center filed suit on behalf of two mentally disabled girls, aged 14 and 12, who were surgically sterilized in Ala. Their mother, who could not read, signed a consent form with an X and testified she thought they would be given birth control shots. The lawsuit contended that tens of thousands of poor, black women in the South were being coerced into surgical sterilization.

Zite believes there’s still a problem.

“People who don’t understand are getting sterilized,” she said. “But there are also women who are very appropriate for sterilization. They have had five or six babies and they want the sterilization, but they don’t make it to that one prenatal care visit where you would sign your papers.”

Women who failed to sign the consent form in advance of a cesarean section are unlikely to come back for another surgical procedure, she said.

“These papers were created with good intentions, but now they act as barriers for numerous reasons,” Zite said.

Asked if CMS or the U.S. Department of Health and Human Services had conducted research on how well women comprehend the form, Millman made an inquiry.

“We are not aware of any such research,” she said. “However, CMS would be interested in reviewing research gathered from other stakeholders.”

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