This interview is the second in a series between CFAH President and Founder Jessie Gruman and patient and consumer group leaders about their experiences with and attitudes toward comparative effectiveness research (CER).
Gruman: Can you remember a time when you looked for comparative effectiveness research (CER) to help you make a personal health decision?
Judy Norsigian: Before I gave birth to my daughter at home in 1982, I sought out available research about hospital-based births, trying to figure out what were the trade-offs of home births vs. a hospital delivery.' I was particularly interested in what I could learn about avoiding the risky but routine interventions in the hospital. The research available even then had an influence on me, although it wasn't great.
The evidence gathered about this question has gotten so much stronger since then. There is now serious CER that helps women with decisions about pregnancy and birth. I would like to think that our work with Our Bodies Ourselves has been an influence on both increasing the amount and improving the quality of women's health research'?¦.and most critically, more public access to health information.
Gruman: Tell me about your role in the Our Bodies Ourselves organization.
Judy Norsigian: I am a co-author of the book Our Bodies, Our Selves (OBOS) -- first published in 1970 as a newsprint booklet titled 'Women and Their Bodies'-- and one of the co-founders of the Boston Women's Health Book Collective, Inc. (still our legal name though we now go by the organizational title Our Bodies Ourselves).' Our efforts grew out of frustration among women about medicine (particularly obstetrics and gynecology) as practiced by primarily male physicians and the realization of our profound ignorance about our own bodies. Our early emphasis was often on the demystification of what was going on in our bodies.
Gruman: What did you use as resources to 'demystify' women's health?
Judy Norsigian: We drew heavily from medical literature and textbooks ' or at least we tried to. Then we realized that most physicians weren't being taught about nutrition and sexuality, for example. Over the years we joined together with public health professionals to better understand how the safety and efficacy of the drugs and procedures routinely used in women's health could be better evaluated. Fairly quickly, we realized that we had a dearth of good evidence, and that most gynecologists were following 'convention' without much of an evidence base.' Remember, Archie Cochrane, the father of the Cochrane Collaboration awarded the first booby prize ' a wooden spoon, I think ' to obstetrics and gynecology for being the least evidence-based of all fields of medicine.
Gruman: You've been active in raising the visibility of new research and the need for comparative effectiveness research (CER) for some time now.' Why is CER important to OBOS and where does it fit in the effort to improve the effectiveness of health care?
Judy Norsigian: We believe women deserve the best information available about their health care. We have been struck by how little good comparative information there is to help women make good choices about their reproductive health. We've watched the FDA issue rulings based on comparisons of drugs or devices that really don't shed light on the questions that women are asking. The comparison of Yaz and Yasmin (drospirenone-containing oral contraceptives) with pregnancy rather than with oral contraceptives containing alternative progestins is just one example. Doing the former gives women no information about which oral contraceptive formulations might be safest.
Gruman: Do you distinguish CER from patient-centered outcomes research (PCOR)?
Judy Norsigian: I believe that good CER includes PCOR. We've always argued that CER should include patient stakeholders in the design of studies and in the review of proposals, for example.
Gruman: Some professionals believe that patients are opposed to comparative effectiveness research.' Do you think this accurately represents the views of the public in the US?
Judy Norsigian: I don't have a good sense of what people know about comparative effectiveness research. When we talk about it in the context of an issue, people resonate; they agree that we need the right evidence -- evidence that can help them weigh their choices among drugs or procedures.' We don't ask if they understand what CER is.
Gruman: How do you see the increased attention to CER/PCOR affecting the care you will receive in the future?
Judy Norsigian: I can only see it having an impact in positive ways. More accurate information gives us a better handle on what we can do. People often want access to a treatment that they view as offering any hope at all, but if such unfettered access interferes with our ability to conduct CER, then maybe unfettered choice isn't such a good thing. If you take a systems perspective and want to have the best treatments available, it may be that some of our choices will have to be limited at times. In balance, I think more people benefit with this research.
Gruman: Can you give me an example of how this plays out for one of OBOS's concerns?
Judy Norsigian: Sure.' We don't have good data on the long-term risks of GnRH (gonadatropin-releasing hormone) drugs that are often used to suppress ovarian function during the process of harvesting eggs for in vitro fertilization (IVF) procedures. Although I have met women undergoing such egg extraction for their own IVF procedures ' women who still want to forge ahead even when they are aware of this lack of good data ' I think it is unacceptable that we have not gathered such data after so many years.' And as more and more younger women take these drugs and undergo egg extraction for other women (in large part because the fees offered are an attractive way to generate income), it becomes even more unacceptable that this information is not yet available.
Because there are more data on the effects of other drugs used as part of egg extraction ' the so-called super-ovulating drugs that can produce the rare complication known as ovarian hyper-stimulation syndrome (OHSS) ' there is often the illusion that reasonable informed choice is taking place. But this is not really the case. Plus, many women seeking to do IVF are probably invested in viewing the whole egg extraction process as beyond any experimental stage.
It would be expensive to conduct prospective clinical trials, but we do already have in place a voluntary registry created with an NIH-funded grant.' This registry- the Infertility Family Research Registry (www.ifrr-registry.org), based at the Dartmouth-Hitchcock Medical Center in Hanover, NH ' is at least one good mechanism for collecting meaningful data, but so far most fertility centers are not participating. (Participation is simple: just inform patients about its existence with signs and brochures in the waiting areas.) OBOS has found college interns to help this registry reach out multiple times to several hundred clinics that should be participating, but the number is still shy of 100.
Gruman: How do you see the future of comparative effectiveness research?
Judy Norsigian: Right now I see doctors frustrated with limitations on how much time they can spend with their patients.' Comparative effectiveness research sometimes finds unequivocally that 'This drug is much better than that one.' But far more often, the results are complicated and raise questions of risks and benefits that require doctors to spend more time explaining and discussing the evidence with their patients in order to help personalize their choices and their care. With less time for such discussions, CER may be less likely to find its way into these critically important conversations. When that is the case, it is even more important that patients can find a way to access such information on the Internet.
More CER Interviews by Jessie Gruman