The image above reflects a contraceptive counseling session. "You can have a big impact in a woman's life if you are able to identify that she has a need for more contraceptive counseling." – Sheila Mody, MD
UC-ReX Employed for Research Data
March 2, 2015 | Patti Wieser
With support from the University of California Office of the President (UCOP), the family planning fellowship-trained specialists at the five UC medical campuses – led by Sheila Mody, MD, at UC San Diego – have established a UC-wide complex contraception registry.
"We are looking at how women with medical conditions access family planning specialists for contraception and how they make contraceptive decisions," said Mody, the first family planning specialist at UC San Diego. Last summer the Complex Contraception Registry–UC Family Planning Collaborative Study began recruiting patients with medical conditions such as diabetes, cardiovascular disease, epilepsy, migraines, cancer and organ transplants. Presently 75 participants are enrolled in the registry, which is on ClinicalTrials.gov, a service of the NIH. The registry contains demographics, diagnoses and contraceptive method.
Many women with complex medical conditions who do not wish to become pregnant are not receiving in-depth contraception counseling from their primary or subspecialty care clinicians, and often they are not using contraception, Mody said. Several, she added, have conditions that could worsen with pregnancy or for whom pregnancy could be complicated by the medical condition.
"You can have a big impact in a woman's life if you are able to identify that she has a need for more contraceptive counseling. If the recommendation is for a patient to prevent pregnancy at this point in her life, we want to help her achieve that," said Mody. She is supported through an institutional NIH K12 award and mentored by UC San Diego Clinical and Translational Research Institute (CTRI) Executive Committee member Christina Chambers, PhD, MPH.
"The work Dr. Mody is doing is groundbreaking in terms of preventing 'preventable' birth defects," said Chambers, a professor of pediatrics at UC San Diego. "When we are prescribing medications known to have the potential to cause birth defects, it is essential to couple this with effective contraception counseling."
A family planning fellowship-trained specialist can also recommend contraceptive methods that won't interfere with therapy. For example, if a patient is taking medication for epilepsy and is concerned about drug-drug interactions, the specialist might recommend an intrauterine device rather than an oral contraceptive.
Mody said bringing the five medical campuses together with inter-institutional support and resources has a greater impact on patient health. The collaborative partners include UC's Davis, Irvine, Los Angeles, San Diego and San Francisco.
"In order to progress the research knowledge about family planning with these medical conditions, it is helpful to have the UCs work together so we can improve patient care," Mody said. The UC partnership is also important for tackling state-specific research questions and policy issues.
The collaborative employed University of California Research eXchange (UC ReX), an initiative of UC Biomedical Research Acceleration, Integration, and Development (UC BRAID), a consortium of the five UC medical campuses. The UC ReX Data Explorer is a secure online system that enables cross-institution queries of clinical aggregate data from 13.6 million de-identified records. The collaborative then used the UC system-wide IRB Reliance Registry to streamline its administrative processes. IRB Reliance is a regulatory initiative that enables UC campuses to rely on the Institutional Review Board (IRB) approval received by another UC campus.
"We began by using UC ReX. We wanted to get numbers of potential participants with different diagnoses. UC ReX enables us to search by age, gender, medical condition or diagnosis, and we were able to get rough estimates," Mody said.
Through CTRI, the researchers also used Research Electronic Data Capture (REDCap) for data entry. REDCap is a secure web application for building and managing online surveys and databases. "All of these tools have definitely helped us launch this project," said Mody.
UCOP and each medical campus provided funding for the study. "We received a generous grant to do our first research together and develop the collaborative as a whole," Mody said. The effort included combining its family planning journal clubs and salary support for research assistants at five study sites.
"Seeing the concept come to life has been very fulfilling. Everyone's hard work, dedication and vision for the study's potential have really contributed to its success," she said. "The key is not to work in silos."