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Social media and online networking proved to be a valuable tool for recruiting participants to a pilot study on a rare heart disease last summer at the Mayo Clinic.
Through patient-run websites dedicated to heart conditions and women's heart health, a team of Mayo Clinic cardiologists led by Sharonne Hayes, MD, reached out to survivors of spontaneous coronary artery dissection, also known as SCAD, a poorly understood heart condition that affects just a few thousand Americans every year.
A SCAD survivor inspired the pilot study. The woman approached Dr. Hayes asking how she could spur more research into the unusual condition. Dr. Hayes' research team then asked the survivor to help recruit participants through an online support community on the website for WomenHeart: The National Coalition for Women with Heart Disease, www.womenheart.org. The SCAD survivor and Dr. Hayes already were affiliated with the site.
Much discussion among researchers has taken place about how study recruitment through social media and online networks could help assemble large and demographically diverse patient groups more quickly and inexpensively than they could using traditional outreach methods, but just how and how well it would work has raised many questions.
The Mayo Clinic patient-initiative research has supplied lots of answers in the September issue of the Mayo Clinic Proceedings. Their report posted online (and quoted at length in this article) generously details the pilot study’s processes, successes, and limitations.
"Patients with rare diseases tend to find one another and connect because they are searching for information and support," says co-author Marysia Tweet, M.D. "Studies of rare diseases often are underfunded, and people with these conditions are quite motivated."
SCAD is a traumatic cardiac event that often induces heart attack, but physicians have no clinical studies on which to base treatment plans, says Dr. Hayes, lead author of the study and founder of Mayo's Women's Heart Clinic.
"This is a completely different research model than the Mayo Clinic is used to," Dr. Hayes says. "Investigators here typically rely on the stores of patient information from the clinic. This was truly patient-initiated research."
The study landed 18 participants in less than a week, six more than could participate in this pilot of 12 patients. The remaining volunteers are eligible to participate in a new, larger study based on the initial study's success.
The new research sought patients through conventional and social media outlets and aims to build a virtual registry and DNA biobank of up to 400 SCAD survivors and their relatives. The database will help physicians conduct more detailed analyses of treatment strategies and factors that affect prognosis and better understand the possible genetic basis of some SCAD cases.
Through its Office of Rare Diseases Research, the National Institutes of Health tracks 6,000 to 7,800 rare diseases such as SCAD that affect fewer than 200,000 Americans. NIH experts can only estimate the number of rare diseases because there's not enough data to know how many patients have them, let alone how to study or treat them.
"Patient leadership in this is huge," says study co-author Lee Aase, director of Mayo Clinic's Center for Social Media. "Designing research protocols to study rare diseases and then recruiting enough patients to participate is extremely difficult for busy physicians, but patients with rare diseases are highly motivated to see research happen."
The report goes on to detail the pilot study setup: “After being approached by several members of an international disease-specific support group on a social networking site, we used it to identify patients who had been diagnosed as having at least one episode of spontaneous coronary artery dissection and recruited them to participate in a clinical investigation of their condition. Medical records were collected and reviewed, the original diagnosis was independently confirmed by review of imaging studies, and health status (both interval and current) was assessed via specially designed questionnaires and validated assessment tools.
“Recruitment of all 12 participants was complete within one week of institutional review board approval (March 18, 2010). Data collection was completed November 18, 2010. All participants completed the study questionnaires and provided the required medical records and coronary angiograms and ancillary imaging data. Identifying and recruiting study participants with rare conditions such as SCAD can be a formidable challenge because no single medical center has adequate experience and/or patient volume. A formal multicenter registry will ultimately be necessary to recruit patients early in the acute phase of their condition, and subsequently randomized clinical trials may become feasible. Until it is created, however, this unique model involving self-organized patients with SCAD provides an excellent option for a virtual multicenter registry. The rapid enrollment of participants in this pilot study through a social networking platform suggests a way to harness patient enthusiasm and organize studies that have been heretofore impractical.
“Data that could be collected in this manner include clinically relevant information about demographics, natural history in survivors, and treatment patterns. We found the personal narrative prepared by participants about their disease and health care experiences to be extremely helpful in filling in gaps in medical history, clarifying time lines and generally complementing the medical records in a manner similar to obtaining a face-to-face clinical history. As in other registries, findings can generate hypotheses and future inquiry. Our report serves as a proof of concept, and extending enrollment to the almost 100 women with SCAD currently on Inspire.com will produce the largest SCAD registry to date and allow development of an imaging and DNA database to complement the retrospective assessment. Moreover, in the future this process could be extended via online surveys and development of electronic centralized data repositories with direct health record data transfer, assuming data security and Health Insurance Portability and Accountability Act compliance could be ensured.
“Obtaining complete medical records is crucial for this type of review. Our participants were highly motivated to provide all requested records. We were impressed with the successful collection of original diagnostic coronary artery imaging for review in all of our pilot participants despite their geographic diversity, the challenges of our medical record retrieval system, and the lack of participants' preexisting clinical relationship with the investigators. Several participants asked their personal physicians to contact us to confirm our data needs, and three potential study participants' physicians contacted an investigator (S.N.H.) at the patients' request to ensure that our study was “legitimate.”
Given the possibility of Internet scams and the fact that the patients had not yet received communication directly from the Mayo Clinic study team, the physicians’ reactions reflected appropriate caution.
“In future studies, posting key information available on Mayo Clinic's Web site for institutional clinical trials before the notice goes “viral” on the patients' social networking site will be important,” says the team.
In-person support groups for conditions as rare as SCAD have proven to be impractical if not impossible. Only a few dozen SCAD survivors are likely to reside in even a large metropolitan area. “An online site with no geographic limitations is more likely to reach critical mass,” cited the report.
Social networking tools have had important health and humanitarian effects ranging from crowd-sourced epidemiology studies to earthquake relief. Projects such as Ushahidi have enabled populations affected by a mass incident to easily pool and organize their knowledge. New York University professor Clay Shirky calls platforms like these mechanisms for harnessing society's “cognitive surplus.”
The Mayo Clinic pilot study points out that their approach differed from those projects in that it applied social tools not in “headline-grabbing localized events such as pandemics and earthquakes, but rather to an unusual condition unnoticed by the broader population because those affected are widely dispersed.”
Building patient registries has traditionally been costly, particularly for rare conditions in which multiple centers are needed to achieve sufficient size. “This pilot study strongly suggests that social networking tools can catalyze community action and that the energy and commitment of affected patients can overcome inertia and reduce registry costs,” says the report.
Women, younger patients, and patients with uncommon medical conditions for which no consensus exists on etiology, treatment, and prognosis might be expected to search more broadly for answers to their questions on the Internet or through other less conventional sources of medical information compared with men, older patients, and those with more common disorders. But the study team found that after the study was underway, they were contacted by a number of persons with SCAD or their family members about clinical and research questions.
The interested parties were not members or were aware of the original Internet networking group, which led the team to believe that they had heard of the SCAD research from a variety of sources, including specific Internet search activity, personal blogs, Facebook, “word of mouth” through other SCAD patients, and Mayo Clinic Web sites. “This suggests that the inherent interconnectivity of the Internet, combined with a strong drive to acquire hard-to-find health information, can be leveraged even more extensively in the future,” says the report.
Lessons from the Mayo study are prompting the team to expand and “to recruit eligible participants via standard methods as well as through communication with this and other heart disease-based social networking sites.
“Ultimately, we aim to provide a higher-powered, descriptive database including prospective biospecimen and DNA collection, physical and mental well-being assessment of participants, and comparisons with age- and sex-matched controls. With collaborating centers, we plan to develop a prospective trial to further guide short- and long-term treatment because, as demonstrated by our cohort and others, significant variability exists in the short- and long-term management of SCAD.”