The Illinois Women’s Health Registry: advancing women’s health research and education in Illinois, USA

Abstract

To achieve the goal of personalized medicine, we must first improve our understanding of the differences in health and illness between men and women. The purpose of the Illinois Women’s Health Registry (USA) is to provide a research and education tool that advances scientific knowledge of sex- and gender-based differences in health and disease. Specifically, the Registry is a confidential 30-min health and lifestyle survey for female residents of Illinois over the age of 18 years. The survey includes questions regarding health, environment, health-related behaviors, symptoms and illnesses or conditions that a participant may have now or has had in the past. By enrolling in the Registry, women throughout the state are provided with information and access to clinical research studies that they may be eligible for, based on their self-reported health information. The Registry not only serves as a platform for recruitment into pivotal research studies, but also represents the beginning of a state-wide database that enables researchers to examine the collective de-identified health information provided by women living in Illinois. Ultimately, a cross-sectional and longitudinal analysis of these data will help to clarify the issues that women themselves identify as their main health concerns. In response to these concerns, specific research studies can be designed and launched, allowing us to eventually deliver tailored treatment and prevention options to women. Finally, by creating a reliable state-focused research tool, developed by staff that are trained in women’s health research, we can compare health issues across the state and apply strategies for improvement where it is needed most. This article will provide examples of sex differences in disease, the lack of federal enforcement for inclusion of women in studies, researcher-perceived burdens and sex-based reasons as to why recruitment of women is considered to be more challenging. In addition, this article will discuss what a women’s health registry is and why we need one in Illinois, how we have recruited women and our successes and challenges. Our goal is to inform the reader about the utility of a state-based tool and to provide a discussion regarding the lessons learned in order to aid other states in implementing this kind of program.

Traditionally, women’s health is discussed in the context of the reproductive system; however, it is increasingly apparent that we lack knowledge regarding the role of sex in all aspects of human biology and medical intervention. In the past, the research community assumed that, beyond the reproductive system, differences between the genders simply did not exist or were not relevant [1]. The debatable justifications as to why researchers have preferred male subjects have been a sense of having to protect vulnerable women and/or a potential fetus, uniformity, avoiding the ‘complications’ of the menstrual cycle, perceived complexity of recruitment and cutting costs of duplication. Sex- and gender-based approaches to research and medicine frame questions concerning the differences and similarities in men’s and women’s normal biological, behavioral and social function, in combination with their experience of the same diseases [2]. If we create a mechanism to help the research community transform their practices into a system that highly values gender as an important research variable, we will eventually fill the existing knowledge gap. In turn, this transformation will translate into optimal care for both men and women. The Illinois Women’s Health Registry (USA) [101] provides a friendly gateway between the community and researchers by offering motivated individuals a chance to participate in sex- and gender-based research studies. In so doing, we are able to take the recruitment burden off researchers while simultaneously providing women with authoritative health information and evidence surrounding the importance of research participation. The goal of the Registry is to provide two-way communication that will ultimately facilitate a better understanding of how and why illnesses develop differently or similarly in men and women, how best to treat diseases in women and what women can specifically do to prevent illness.

How we analyze the differences in the basic cellular biochemistry of males and females and study sex as a variable in health at all stages of the life cycle is crucial to the advancement of medicine. Numerous reports indicate that males and females display different symptoms of similar illnesses and have discordant incidence of disease prevalence, onset, severity and susceptibility; for example, since 1984, the number of cardiovascular disease deaths for females has exceeded those for males, but survey results suggest that women are only now becoming more aware of the ‘atypical’ signs and symptoms of heart disease that are specific to their gender [3,102]. In addition, autoimmune disorders (e.g., lupus, rheumatoid arthritis and multiple sclerosis); obesity, which often leads to diabetes; lung cancer; infectious disease (e.g., HIV); and mental health disorders (e.g., depression) more commonly affect women than men [4-8]. Areas that are starting to generate attention are sex differences in drug dosing and metabolism, pain perception and sleep, depending on hormone fluctuations of the menstrual cycle [9-13]. Male and female biology is not duplicated in all health indices and should be characterized at the most fundamental molecular and cellular level.

Sex-based analyses of research results cannot be carried out if adequate representations of both sexes are not recruited into clinical studies. Failure of many investigators to conduct sex-based analyses stems not only from poor study design that leads to a lack of recruitment, but also from a lack of enforcement. While the NIH emphasized the importance of the inclusion of women in federally funded clinical trials, set by the NIH Revitalization Act of 1993, the literature documents instances of noncompliance. Moreover, the majority of drug trials (~80%) sponsored by pharmaceutical companies and regulated by the US FDA often fail to recruit adequate numbers of women or fail to assess for differences in drug effects that are attributable to gender, even though guidelines were issued in 1993 [14,103]. A stumbling block in advancing our knowledge regarding the sex and gender basis of health and disease is that the effect of sex as a modifier on cellular and molecular function is under-represented in the NIH research portfolio and in the clinical trial literature. Specifically, from 2000 to 2003, the average yearly percentage of grants awarded for the study of sex/gender differences was 0.6, 1.3 and 0.6% from the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHBLI) and the National Institute of Allergy and Infectious Diseases (NIAID), respectively. These institutions have the largest research budgets, and the proportion awarded for sex/gender-specific research falls well below the total NIH average of 3% [1]. Examples of the invisibility of women in clinical research continue to be published in high-impact medical journals. Carnes et al. recently summarized an analysis of findings from randomized controlled trials published in nine influential medical journals in 2004 that indicated women were generally under-represented, comprising on average 37% of the sample and only 24% of participants in drug trials [15,16]. Furthermore, 87% of the studies did not report any outcomes by sex or include sex as a covariate in modeling, illustrating inadequate compliance with the NIH guidelines [16,17]. Until the NIH and FDA have attained the goals of implementing the requirement of sex-specific analysis and reporting of sex-specific results from each federally or FDA-funded protocol, the ability to provide accurate sex-based medical information will continue to be a systemic problem in medical research.

The evidence that since the early 1990s women have been participating in clinical trials in increasing numbers is often misleading. In fact, since 1993, there have been more women than men enrolled in NIH-sponsored Phase III clinical trials [18]. However, this is largely owing to single-sex cancer trials (i.e., breast [>98% in females], cervical or uterine), the Women’s Health Study and the Women’s Health Initiative [19,20]. Owing to researcher-perceived burdens of inclusion or ineffective recruitment strategies, women are still under-represented in studies of diseases or conditions that can affect both men’s and women’s health across the lifespan. To solve this recurrent problem, we must understand the sex-based reasons as to why recruitment of women is considered more challenging. Some of these reasons include: women are traditionally the caretakers of others and may find that these responsibilities make it difficult to participate in research; compared with men, women are more likely to work part-time leaving them with no health insurance or paid time off in order to participate in studies; women show more distrust of medical researchers; women perceive a greater risk of harm from participation; and women are less aware of the benefits of participation in clinical trials [21-24]. We are finding that an approach through Registry involvement may help ease traditional concerns and remedy investigator struggles with recruitment. This includes key processes for building and maintaining trust, providing authoritative educational information, maintaining consistent but not overbearing contact and creating a comfortable and easy connection to researchers. By asking for female involvement while healthy, and stressing the importance of prevention, we can start the education process early, increase awareness of sex differences in disease and empower women to be their own healthcare advocates.

Profound health issues for women living in Illinois

Unfortunately, women’s health status in Illinois is poor according to the 2007 edition of “Making the grade on women’s health: a national and state-by-state report card” [104]. Illinois was ranked 33rd, indicating that, on a national basis, Illinois ranks low and is not meeting the health needs of women. Specifically, one benchmark of women’s health status that was analyzed and given a failing grade was the percentage of obese women; 26.3% of women living in Illinois were found to be obese. This troubling percentage has increased since 2004 and obesity often leads to other serious health consequences, such as diabetes, high blood pressure and cardiovascular disease. Owing to the overall poor health status of women in Illinois, the Institute for Women’s Health Research began to investigate tangible ways to advance women’s health. One notion was to develop a program that would simultaneously educate women about the importance of clinical research while providing a means to engage women from the community in research studies. We hypothesized that if women were provided with information and access to health, wellness and prevention studies, which are often not widely known about among general practitioners, women would enroll. These efforts led the Institute for Women’s Health Research to the concept and development of a statewide women’s health registry [25]. With guidance from the University of Kentucky’s Center for the Advancement of Women’s Health, it became apparent that we could build a database of patient-reported outcomes reflective of women’s health in each state by mimicking what had begun in Kentucky after being pioneered at the University of Michigan [25].

Developing a valuable research tool

We researched the Michigan and Kentucky models, and replicated most aspects here in Illinois. This included hiring a program development manager (and eventually an outreach coordinator), obtaining Institutional Review Board (IRB) approval, finding the appropriate systems analysts for database programming and obtaining statistical assistance. In addition to the costs of employing these key personnel, there was a need to budget for marketing, printing and postage. To date, the Institute for Women’s Health Research has not been successful in obtaining external funding; we have supported this effort solely on Institute start-up funds from the Feinberg School of Medicine (IL, USA) and Northwestern Memorial Hospital (IL, USA), as well as a generous donation from the Friends of Prentice. In March of 2008, the Institute for Women’s Health Research launched the IRB-approved Illinois Women’s Health Registry with the ambitious goal of enrolling 3000 women per year and using this tool to serve community women and researchers throughout the state. Our community-oriented objectives are to educate women about the importance of clinical research participation while also becoming a source of authoritative health and wellness information that women can trust and continually refer back to. At the same time, we aim to coordinate efforts to help researchers overcome the barriers to the recruitment of women for clinical investigation. The Registry provides women in the state of Illinois with the opportunity to annually contribute their self-reported health information to a research participant database that has been structured to achieve two purposes: to help researchers recruit female participants for their sex- and gender-based studies and to collect general health-trend data to help identify community health priorities and accelerate new treatments to the public. By enrolling in this database, women throughout the state become part of an important community of research-aware participants who are provided with information and access to research studies that match their profiles.

Women choose to either fill out the survey online or otherwise they request a paper version. The consent form is identical, in that women agree to fill out the survey with their self-reported health information and we then contact them when their health profile matches a study that they are qualified for. Once we make contact regarding a study, they must opt out if they do not want their contact information released to a study investigator. Women who participate online accept the terms and conditions of the consent form electronically and have the ability to print out a copy for their records. Those who take the paper version need to sign a consent form and send it back to us with their Registry survey. Upon receipt, the outreach coordinator creates an account for those who take the paper version and then enters the data into the system. All information is kept strictly confidential and paper versions are destroyed once the information is entered into the database. Each year, women are reminded of their renewal date (via letters, e-mail and phone calls) and are asked to fill out the new survey and sign the consent form once again.

Registry technology

We diverged from the Kentucky Women’s Health Registry slightly and decided to launch the online version of the survey first as opposed to supplying the paper version only. From the outset, we had the capacity to build a very robust online tool and wanted to decrease the labor and costs associated with paper versions. Therefore, the initial focus was a dedicated effort in Registry programming, consisting of building a useful, multiyear data capture tool. The Registry is a secure, web-based tool that has been built using Agile methods using Ruby on Rails^® [101]. The tool has been built by informaticists in the Northwestern University Biomedical Informatics Center (NUBIC) and has involved a team of people including a project manager, a systems architect and two talented web developers. The project has been broken into many short iterations, each resulting in highly tested, production-quality code. The team follows a test-driven development philosophy, with the tests for each iteration being written before the code, resulting in a near 100% code coverage in tests. The Ruby on Rails server is running on an Ubuntu™ (Canonical Ltd, UK) virtual machine and the data are housed in a separate Ubuntu virtual machine in PostgreSQL. All servers are located behind the NUBIC firewall and only secure web connections (via secure sockets layer) are allowed.

Participant profile & successful connections

Since we launched the Registry initiative, we have recruited over 3700 women into the program. This strong beginning suggests that women are willing, ready to help and want to get involved. We have summarized demographic information for our Registry participant pool using complete data from year 1 and partial data from year 2 (survey years run from March to March). Figure 1 depicts the age distribution of our participants. These data not only mirror the Michigan data [25], but also demonstrate that research participation, particularly in cancer research trials, tends to be higher in those groups under the age of 65 years [26]. Moreover, this distribution is somewhat expected owing to our marketing campaigns and the greater accessibility to these groups through electronic and online media. Participants in the 71–90 years of age group are more likely to request paper versions of the survey and are a group for when we will need to develop a separate targeted marketing strategy for. A profile of the racial breakdown of participants is described in Figure 2. The Registry population is also compared with the population of women living in Illinois in Figure 2. Given the small sample size of the Registry responses (n = 2799), we believe the racial distribution of the Registry participants is a reasonably accurate representation of the Illinois population. Unfortunately, we do lack adequate representations of Hispanic and Latina ethnic groups since most of our participants are neither Hispanic nor Latina. We continue to search for outreach opportunities in various communities that include minorities. We also plan to publish our Registry survey and promotional materials in other languages, including Spanish, so that we might reach non-English speaking residents. Additional socioeconomic factors have been summarized for year 1 participants only in Table 1. While our Registry population is racially diverse (Figure 2), as a group, we have recruited professional, highly educated and privately insured women in very good or excellent health. We aim to diversify our outreach over the next several years in order to obtain a population that fully represents women living in Illinois.

Figure 1. Illinois Women’s Health Registry participant age distribution.

Women in the state of Illinois between 18 and 90 years of age are encouraged to enroll in the Registry. The category with the greatest number of participants is the group aged 31–50 years, followed closely by the group aged 18–30 years.

Figure 2. Racial demographics of Illinois Women’s Health Registry participants.

A summary of participants based on race and a comparison of the Registry statistics (dark purple) with the Illinois state percentages (light purple). The state percentages are based on census data from 2004 to 2007 with an n-value of 4,900,000. Registry participants are always given the option of ‘choose not to answer’ for any question; therefore, the total number of responses differs between survey questions.

Table 1.

Demographic profile of Illinois Women’s Health Registry participants from March 2008 to March 2009.

Demographic attribute	Number of responses (total participants = 1983)	Percentage of total
Type of employment†
Professional	1197	47.11
Clerical	460	18.10
Retail	262	10.31
Factory work	24	0.94
Farming	9	0.35
Mining	0	0.00
Never employed outside of home	6	0.24
Other	384	15.11
No response	199	7.83
Where participants live
House	834	42.06
Apartment	517	26.07
Condominium	428	21.58
Trailer/mobile home	2	0.10
Shelter/group home	5	0.25
No permanent home	3	0.15
No response	194	9.78
Education
Less than high school	1	0.05
Some high school	3	0.15
High school diploma	34	1.71
General Educational Development	1	0.05
Some college	225	11.35
Vacation or technical certificate or degree	41	2.07
Associates degree	71	3.58
Bachelor degree	634	31.97
Postgraduate degree	720	36.31
Other	55	2.77
No response	198	9.98
Health insurance†
Private insurance/HMO/PPO	1590	76.48
Medicaid	36	1.73
Medicare	145	6.97
Veterans Affairs	4	0.19
Do not have insurance	90	4.33
Do not know	14	0.67
No response	200	9.62
Self-reported health status
Excellent	464	23.40
Very good	748	37.72
Good	433	21.84
Fair	115	5.80
Poor	16	0.81
No response	207	10.44

^†Participants may record more than one response for type of employment and for health insurance; thus, the total number of responses may exceed the total number of participants.

HMO: Health maintenance organization; PPO: Preferred provider organization.

In January 2009, we began to query the database with parameters set by a small set of investigators willing to test this resource as a recruitment tool. Investigator access is granted based on the exact provisions set by the University of Michigan [25]. Researchers submit a detailed application to the program development manager. The investigator includes their inclusion and exclusion criteria, and the informaticists run the query to find women who match. For the women who match, contact information only (not entire survey information) is downloaded to a secure depot site that the program development manager is able to access. From here, Registry staff can create study-specific letters and begin the process of informing women that they have matched a particular study. Ultimately, investigators are only provided with contact information for the women who match and who did not actively decline. Specifically, Northwestern University-affiliated researchers interested in enrolling women have applied to recruit for studies involving knee osteoarthritis, hearing, postpartum depression, the economics of fertility preservation, the impact of maternal obesity on a child’s future risk for obesity, guidelines for discussing fertility impairment with breast cancer patients and women’s perception of fertility and aging.

The first investigator to use the Registry applied to obtain women for an IRB-approved knee osteoarthritis study. We queried our database and found 238 women with the initial qualifying characteristics and, under our IRB, we were able to call these women and summarize the 2-year observational study. There were 220 women who were interested, and we released the contact information of these women to the study coordinator. The study coordinator was astonished that she had all the potential recruits needed for a 5-year NIH study in one afternoon. The study coordinator is currently following-up with all of these women to gain their consent and enroll them into that study. Our second investigator required a more racially diverse population for a smaller survey-based study for which she had previously struggled to recruit. Our Registry identified 56 qualified candidates who were then contacted; 14 were transferred to and finished the study. These connections are examples of how this tool can leapfrog the current methods by which studies are ordinarily conducted. Over 900 women have been prescreened for participation in clinical research, equaling 24% of our participant pool. By all measures, our first experiences with mining the Registry data have been a success; however, we have also met various challenges that are described in the next two sections.

Query challenges

With regard to interacting with investigators, we have found the need to develop standard operating procedures for researcher access and for us to implement policies that we did not anticipate. For instance, when women in our database are notified that they match a study, the majority of them are interested in finding out additional details. Once contact information is released by the Registry, prompt follow-up with these interested women needs to occur. If women have to wait several months to be screened further or to consent this may result in a lack of interest, a loss of eagerness and, ultimately, a low yield of subjects. We are developing a plan to cut down the time between releasing contact information to investigators and the time it takes the study coordinator to make contact with the interested women. This step is critical and, in the future, we will be implementing a 4-month recruitment period. Similar to the process that the University of Michigan has adopted, we will require investigators to provide us with monthly updates on the progress of contact and potential participant enrollment [25]. Women who have been contacted but are not eligible will be replaced into the pool of available research subjects. Any women not contacted during this 4-month period will be relinquished by the investigator and added back to the Registry pool.

In some instances, study coordinators cannot handle the influx of recruits because they do not have sufficient resources to respond to the high volume of follow-up calls that need to be made. For certain studies, we may need to do a slow release of contact information, whereby we perform a query every few months and pull 50 women at a time. Furthermore, study coordinators are multitasking, working concurrently on recruiting participants at health fairs or clinics, screening potential participants and seeking consent from patients after the initial recruitment, as well as running the study. In general, researchers are not marketers; thus, devising ways to recruit is a very inefficient use of their time. If the Registry can serve to remove the recruitment burden, study coordinators can focus their efforts on consenting those who are already willing to participate.

Outreach challenges

In order to successfully enroll women in the Registry, it is critical that we work towards solutions for the sex-based reasons as to why women do not participate in research. It is important that we build a trusting, not overbearing, relationship with women in various communities by establishing ourselves as a reliable source of information with helpful connections. Continued communication with current Registry members through newsletters and periodic renewal reminder mailings allows us to strengthen our relationship with the women already in the Registry. These women represent our link to their communities, and through them, we hope to build strong relationships. Providing health information through our newsletter and online blog [105] will establish the Institute for Women’s Health Research as a valuable resource. This effort will take time to develop and will progress as the Registry database grows, but is essential for striving towards two-way communication.

The Registry asks questions of a personal nature, which many women may feel uncomfortable in providing to an unfamiliar entity. Not only do the participants provide health history information, but they are also required to include full names, addresses, dates of birth and phone numbers. The security of information in an online medium is a significant source of uncertainty in a woman’s decision to enroll in the Registry. We must be prepared to address these concerns openly by assuring women of the security and confidentiality measures in place. If our goal is to obtain trust and respect from women and their respective communities, we need to strive to break down the barriers of research distrust and the perception that participation poses a risk of harm to women.

Since its inception in March 2008, we have attempted several different approaches for marketing the Registry. Through our Google™ Analytics web-tracking account, we are able to determine the relative success of our campaigns based on website traffic. However, since we do not have unique uniform resource locators assigned for each marketing campaign, and because women’s reporting of where they heard about the Registry may be unspecific, it is difficult for us to identify which marketing efforts recruit which women. Consequently, we are not able to estimate the cost per registrant of each campaign. Our participation rate as of November 2009, based on county of residence, is illustrated in Figure 3. Our outreach coordinator is making an impact, but we realize our statewide audience is large and several different marketing tactics need to be tested. The addition of a marketing manager to our staff would be helpful for coordinating marketing efforts and in generating detailed reports in order to determine the economic efficiency of different campaigns. Nevertheless, we have observed that virtual marketing and social networking with tools such as online advertisements, listserv announcements, networking website announcements (e.g., Facebook) and blog postings are among the highest yielding marketing strategies. For instance, since July 2008, we have periodically posted an advertisement message on the popular online classified advertising website, Craigslist (US$25 per post). Our most consistently successful promotional tool thus far, the Craigslist posting, generated an average of 123 website visits in the first week following listing. Moreover, the traffic generated from the Craigslist site represented an average of 44% of all traffic to the Registry during the first week of posting. Of the Craigslist postings, the advertisement on 5 May 2009 was the most successful. On the day of the posting, there were a total of 207 visits to the Registry website and 63 new participants registered (Figure 4A). Over the next several days, we experienced considerably more traffic and registrations compared with usual. The design of Craigslist is such that each new advertisement appears at the top of the page, so that as time passes the listing becomes less visible to users. Because of this, we often see the greatest traffic within the first few days of listing the Registry. We believe that virtual advertising is an effective technique because of the ease of moving from the advertisement to the Registry website, where further information and the ability to register are available immediately. Unfortunately, this technique is likely to attract only a specific cohort of women who are comfortable with computer technology and who have access to online resources.

Figure 3. County of residence of Illinois Women’s Health Registry participants.

A graphic representation of where our participants reside based on county. Northwestern University is located in Cook County, the darkest purple shade in the Northeast corner of the state. The greatest participation exists in Cook, DuPage, Kane, Will and Lake counties, which surround the Chicago area, and in Champaign County, where another large academic medical center exists. We continue to search for local contacts and organizations in the counties where we have the least participation so that we may engage women in those areas to participate as well.

Figure 4. Marketing campaign results.

The rise in website traffic and participation corresponding to two different marketing initiatives. (A) Website traffic and participation 3 days prior and 4 days following the first Craigslist campaign on 5 May 2009. (B) Website traffic and participation 4 days prior and 6 days following the Chicago Tribune article on 29 April 2008. Both events yielded over 150 website visits and over 60 new participants.

Thus far, more traditional marketing strategies, such as billboards, newspaper advertisements and newsletter announcements, have proved less effective. The nature of the Registry and what we are asking women to do makes it difficult to represent in a visual advertisement. In August 2008, the Institute for Women’s Health Research worked with the Chicago Transit Authority (CTA) to create a billboard advertisement for display on Chicago’s high-traffic public transportation elevated train and bus lines (US$6000 total cost). Although not considered full saturation of public transportation lines, the Registry had significant representation with interior bus or rail cards in 139 elevated train cars on the Eastern lakefront North/South train line and in 100 Northern Chicago and suburban buses. During the campaign, the Registry website experienced no significant change in direct traffic. Similar visual advertisements in community newsletters and resource books have also generated little traffic. However, a news article published 29 April 2008 in the Chicago Tribune did generate significant website traffic (Figure 4B). The detailed article introduced the issue of gender gaps in medical research and highlighted the Registry as a tool to help fill those gaps. The educational and motivational information contained in the article, and its appearance in a trusted news source, are probably responsible for the 457 visits to the Registry website page that week, a 451% increase from the previous week. Of these visits, 61% were from direct traffic, meaning that users were entering the Registry’s uniform resource locator into the address bar of their web browser. Another 12% came to the website from a search engine where they typed in keywords related to the Illinois Women’s Health Registry. In general, Figure 4 indicates that when we generate enough publicity, there is interest and people visit the website. We believe that as the Registry continues to grow and becomes a trusted, authoritative resource, our enrollment numbers will start to reflect our website traffic more consistently.

In February 2009, the Institute for Women’s Health Research partnered with Direct Impact, a national marketing firm, in order to assemble a comprehensive marketing plan. The first phase of the plan was initiated in March and used a direct marketing technique through Direct Impact’s 44-station Communications Center located in Washington, DC, USA. The Communications Center contacted 300 community-based organizations in counties throughout the state of Illinois via telephone outreach (US$10,000 total cost). Many of these organizations were located in Northeastern and Central Illinois, with somewhat less representation in Southern Illinois. Of those organizations, 104 agreed to participate in our campaign. Participation meant that the organization agreed to distribute brochures, display posters, distribute a web link to the Registry website or to host a Registry staff member for a speaking engagement. A total of 10,465 brochures and 248 posters were then distributed among these organizations. Unfortunately, the Registry website did not experience an increase in traffic or participation during this period. Failure of this campaign is difficult to decipher, but we believe that much of our outreach success depends upon follow-up from specific contacts in various regions. Ultimately, we hope to support a larger staff of coordinators who will each focus on outreach in a specific region of Illinois. Having dedicated regional outreach coordinators would allow us to ensure that we have equal representation throughout the state, so that research studies might be conducted that encompass the true population and allow for comparison between subpopulations.

Lastly, we have learned that speaking engagements where we have a focused discussion with women have been more successful than brief personal contact at health fairs, community events or symposia. If we are able to capture women’s attention by talking about different kinds of clinical research, the history of women in research and its consequences for women’s health today, as well as how the Registry can fill those gaps, women are far more motivated and are more likely to complete the survey when they go home. Health fairs or similar events where a representative speaks for 1–2 min with each woman have been less productive. For this reason, we often send an e-mail reminder to follow-up with women who are willing to leave their contact information. This is helpful in some cases, but we do not experience the same increase in numbers from these types of interactions as we do from a lengthier, focused discussion to a small group of women.

Overall, these distinct marketing efforts have suggested that face-to-face personal contact is more effective than visual advertising or telecommunication, particularly when we are able to present to small groups of women as opposed to health fairs that, despite having a huge draw, tend to result in little participation. Online marketing and social networking have proven to be more successful than we had originally anticipated; however, this strategy tends to recruit a narrow group of women. We have also learned that it is essential that information comes from a trusted source, such as a local newspaper, a community group leader or a friend or family member (Figure 5A). With this in mind, we recently sent an e-mail announcement via a listserv management tool to all members of the Registry, asking women to help recruit new members to the Registry. In the e-mail, we included a link to our website and a message asking participants to forward the e-mail to at least two other Illinois women. From a marketing perspective, this has been our most successful initiative (Figure 5B). The Registry website received 408 visits on the day of the e-mail, with 80 women joining the Registry on that day and 50 women joining the following day. 1 week after the initial e-mail blast, we were still receiving high traffic-volume and enrollment. We believe that the response we attained is largely attributable to the fact that information about the Registry was transmitted through communication with friends and family members. For this reason, the Institute for Women’s Health Research strives to become a familiar and trusted authority on women’s health, willing to forsake the methods of traditional recruitment marketing to try new avenues. We anticipate that other states that may wish to implement this type of tool can learn from these various marketing experiences.

Figure 5. How did participants hear of the Illinois Women’s Health Registry?

(A) Visual representation of how women heard about the Registry. Responses in the ‘Other’ category include work, email, Institute for Women’s Health Research meeting or a speaking engagement. Responses for ‘Advertisement’ include the Chicago Tribune, the Chicago Transit Authority or a brochure in a doctor’s office. The large proportion of women who heard about the Registry from the internet or from a friend or family member indicates to us that online advertising and word-of-mouth marketing are likely to help increase our participation. (B) Results of an e-mail campaign sent to all Registry members asking for their coordinated help in recruiting friends and family members.

Conclusion & future perspective

The recruitment of women into clinical research studies is a challenge faced by all clinical investigators [27]. Most studies are slow to recruit participants, and all clinical research studies duplicate the monotonous effort of finding people who are interested and willing to participate. In the last several decades, numerous publications have been written that focus on recruitment strategies that take into account ethical, social and cultural challenges. These strategies include utilizing community workers, engaging physicians to recruit their patients, providing financial incentives and putting placards on buses in urban environments. Despite these efforts, we continue to accrue low numbers in many clinical trials. Interventions have focused on patient factors, such as inadequate information, organizational obstacles and barriers related to physicians and healthcare systems, rather than devising versatile, dynamic and multidisciplinary approaches that ultimately link women with investigators [3]. Over the next decade, we aim to reduce these obstacles by continuing to build the Registry bridge between the community and the researcher through education, identifying motivated women, assembling important health information, collecting prospective informed consent to be contacted by researchers and facilitating comfortable and convenient initial contact. This innovative approach addresses the unmet needs of researchers struggling with the recruitment of women for women’s health research studies, thus having the potential to impact more than half the population in a positive and necessary way.

We have a substantial task ahead of us in building state-wide partnerships and in connecting with researchers that perceive value in the Registry not only as a great recruitment tool, but also as a source of patient-reported health outcomes. With any type of self-report data, there is the uncertainty of unreliability; for example, veracity of the data can be a concern in terms of women accurately reporting their family history of disease or recollection of past illnesses. However, researchers who are interested in obtaining data regarding patient perspectives of their health and wellness, in addition to geographic, cultural and social impacts on health, can acquire this from the Registry. As we increase our volume, we will be able to test our pool with state-wide demographics and therefore address reliability and validity more robustly. To date, we have helped 12 local researchers with their recruitment needs; consequently, we are hopeful that, going forward, we will entice researchers from all over the state to allow us to assist with recruiting in their communities and, ultimately, into their specific studies. Once recruitment has closed for these 12 studies, we will be able to obtain data on how well our query process has matched women to the final study requirements. These data may indicate how accurately the women are reporting their health information on the survey. Currently, we do not compare any survey information with medical records, but in the future, it may be interesting to compare how a woman responds to certain questions on the survey with what is actually in her medical record. The reality that many survey questions asked via the Registry might never be included in a medical record or history, and may subsequently better contribute to an improved understanding of the sex differences in health and disease, is worthy of note.

Executive summary.

The Illinois Women’s Health Registry

• The Illinois Women’s Health Registry is a research database comprised of self-reported health information designed in order to achieve two purposes: to help researchers recruit female participants for their sex- and gender-based studies and to collect general health-trend data in order to help identify community health priorities and accelerate new treatments to the public.

• The Registry consists of a comprehensive health and lifestyle survey that asks basic screening questions regarding health, environment, health-related behaviors, symptoms, family history of diseases and illnesses or conditions a participant may have now or has had in the past.

Differences between male & female health & presentation of disease

• Males and females display different symptoms for similar illnesses and have a discordant incidence of disease prevalence, onset, severity and susceptibility.

• Protocol designs have historically addressed disease as it manifests in adult males, but an emerging body of evidence clearly indicates that differential treatment and intervention are necessary to provide the best care for all people.

• Women need to be included in all clinical research phases and study outcomes need to analyze sex and gender as variables.

Obstacles to recruitment

• There are sex-based reasons as to why recruitment of women is considered more challenging; it is our mission to change this paradigm by building and maintaining trust, providing authoritative educational information, maintaining consistent contact and creating a comfortable and easy connection to researchers.

• Study coordinators often do not have the marketing experience or budget required to meet study recruitment needs; however, the Registry tool can leapfrog current practices by prescreening potential subjects in a more efficient manner.

Challenges

• Face-to-face personal contact is more effective than visual advertising or telecommunication and it is essential that information comes from a trusted source, such as a local newspaper, a community group leader or a friend or family member.

• When study coordinators decide to use the Registry tool, they need to be prepared for prompt follow-up with interested women. If women have to wait several months to be screened further or for investigators to seek consent, this may result in a lack of interest, a loss of eagerness and a low yield of subjects.

Future perspective

• The recruitment of women into clinical research studies is a challenge faced by all clinical investigators.

• The Registry aims to reduce recruitment obstacles by continuing to build a bridge between the community and the researcher through education, identifying motivated women, assembling important health information, collecting prospective informed consent to be contacted by researchers and facilitating comfortable and convenient initial contact.