More older women avoid research participation
July 1, 2006 5 minutes read
More older women avoid research participation
But, once they've participated, they'd do it again
As IRBs work to ensure that women are fairly represented in clinical research, results from a new survey provide a disquieting message: More older women are uninterested in research and don't believe in participating.
The survey, released by the Society for Women's Health Research, a Washington, DC, advocacy group, also had some good news for the research community. More than 60% of older women who had previously participated in a medical study would be willing to do so again.
But getting them to agree to that first-time participation in a study is the key, says Sherry Marts, PhD, vice president for scientific affairs for the society.
In the study, 1,014 U.S. women age 50 and older were surveyed in April and asked about their attitudes regarding research. Their answers were compared to a similar survey conducted for the society among 1,017 women in 2003. A little more than 10% of respondents reported in 2006 that they had previously participated in a medical research study, down from nearly 12% in 2003.
Of the 2006 group who had been in a study before, 61.6% would be willing to do it again.
When asked what might make women hesitate to participate in a study, the most frequently chosen response was: "Just not interested in it/don't believe in it." In 2006, 15.9% of respondents chose that answer, compared to only 9.1% in 2003.
The second most common answer was "Too risky/dangerous/side effects," with 15.8% of respondents choosing this answer, up from 14.9% in 2003.
Why the large increase in disinterest in research? Marts says she thinks it's not so much a response to particular concerns about clinical research, as it is a general distrust of science that has taken hold in recent years.
Reports about the removal of drugs such as Vioxx from the market after patient deaths, controversy over stem cell research and the Plan B emergency contraceptive, even debates over global warming can lead to an environment in which people don't believe that research make a difference, she says.
Marts says the current climate in Washington these days is almost anti-science, and she believes that attitude trickles down the public at large.
"Science and medicine are things that people think of as hard — 'It's difficult, I didn't like it in school, I just don't even want to think about it anymore,'" she says.
"You couple that with the kind of publicity that the Vioxx situation has gotten — you couple it with the Plan B situation where disinformation about how the medication works has been the basis for objecting to having it approved. I just think there is this generalized, anti-research atmosphere that we're trying to function in, those of us who are research advocates and researchers, that just makes this doubly challenging," Marts says.
She notes that coverage of the Women's Health Initiative is informative in seeing why women might be discouraged from even entering a study. The long-term national health study focuses on preventing heart disease, cancer and fractures in post-menopausal women.
Recent results showed from the study showed that taking calcium supplements led to improved bone density, but to a less-than-expected decrease in bone fractures. Other recent results from the study showed that a lower total fat intake did not provide expected preventative benefits against breast cancer, colorectal cancer, heart disease or stroke.
Marts says that in each case, results were complex and nuanced, but the general public message that got out was not.
Exclusion issues
In the past, she says, her organization has had to convince researchers that it's important to focus on women as research subjects — that their biology is different from that of men, and so drugs and other interventions work differently in the female body.
Marts says she's seen improvement in that area. "There's a truism in the not-for-profit world that people don't volunteer it they don't feel asked," she says. "Part of our campaign was to make the 'ask.' Now what we're up against is not so much the ask — I think women do feel asked. I think it's 'What good is it going to do anyway?'"
While IRBs may not be able to do much to improve women's public perception of research, Marts, who herself has previously managed an IRB, says there are issues raised by the survey that IRBs can address as they review studies.
Two of the reasons chosen by respondents regarding reluctance to participate in research: "Health problems/not healthy enough" (9.9% in 2006, up from 8.3% in 2003) and "Age/too old" (9.4% in 2006, up from 6.6% in 2003) go directly to issues of how studies include or exclude potential participants.
Marts notes that it's harder to design studies around people with existing health problems, who may be taking a number of concomitant medications, but that such studies would more accurately reflect a drug's use in the real world.
Likewise, approving a study for cardiovascular treatment that sets a cutoff age of 65 would miss many women, who tend to develop cardiovascular disease later in life than men, Marts says.
She says there's current debate in the research community as to whether separate studies should be conducted of a drug's effects in older patients, which could lead to interesting questions about their use in women. "Does a drug behave differently pre- or post-menopause?" she asks. "They don't ask that question."
IRBs can ensure that the informed consent process is as easy to understand as possible, and doesn't scare away potential recruits.
And Marts says IRBs can continue to do look at local issues that may prevent women from being able to participate in a study. Examples of this may include lack of child care or concerns about personal safety at the research site.
"How far away is the parking lot? How safe is it to get to the clinic at night? We've had folks who've simply had an escort to walk women to and from the parking lot," Marts says.
The Society for Women's Health Research created a web site several years ago to help encourage women to participate in research as part of a campaign called "Some Things Only a Woman Can Do."
Marts says her group plans to update information on the site, www.womancando.org, which includes focus-group tested descriptions of clinical studies that can be used as text in informed consent documents.
There are also brochures and information kits in English, Spanish and a large-print edition that can be distributed to women.
Marts says one of the society's goals is to let women know more about clinical studies before they're ever diagnosed with a disease.
"We felt that even if getting the brochure didn't immediately lead them to participate in the study, at some point down the road it might be useful for them to already have this in the back of their head," she says.
She notes that work with focus groups revealed that many members didn't realize that they could participate in studies even if they weren't sick.
"They were surprised to learn about epidemiological studies or observational studies or prevention studies," she says. "It was really rewarding doing the focus groups because the women were hungry for the information."
As IRBs work to ensure that women are fairly represented in clinical research, results from a new survey provide a disquieting message: More older women are uninterested in research and don't believe in participating.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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