“Leveling the Research Field Through Social Media” (In the News, October 2011) seems to support the use of Web sites such as PatientsLikeMe, where patients can give and receive medical advice, donate to research, and enroll as research subjects.
PatientsLikeMe is funded in part by drug companies. Some patients on the site say they've been diagnosed with bipolar I, autism, social anxiety, and other psychiatric disorders. If they enroll in research studies, these patients are considered “vulnerable” and require a heightened level of protection, according to the U.S. Department of Health and Human Services’ Code of Federal Regulations (Title 45, Part 46). What safety measures are in place for these patients if they experience psychological trauma as a result of answering questions online?
The Health Literacy of America's Adults, a 2003 report by the National Center for Education Statistics (a part of the Department of Education), revealed that 53% of adults had intermediate skill levels, whereas 22% had basic and 14% had below basic health literacy. Do participants even understand what they're enrolling in?
This article doesn't mention the validity or reliability of online research instruments or any means of protecting subjects who participate.
I suggest we disseminate information to nurses that helps them steer patients away from Web sites such as PatientsLikeMe until programs and processes are in place to better protect the public we've pledged to serve.
Debra Palmer, MS, RN
South Portland, ME
Writer Joy Jacobson responds: The question of whether people with mental illness are competent to consent to participate in research has been discussed for years.1 I asked PatientsLikeMe about its safeguards. Researchers Paul Wicks, Sally Okun, and James Heywood said by e-mail that they welcome the scrutiny “to ensure we are meeting the ethical standards one would expect for our patients. We believe our established processes and procedures are consistent with these expectations and our work is certainly known to Jerry Menikoff, director of the Office for Human Research Protections.”
They have measured the validity of research methods involving online communities of subjects and published their findings in peer-reviewed journals.2, 3 As to the literacy level of the information the site provides, Wicks and colleagues said that using the Test of Functional Health Literacy in Adults (TOFHLA), they found that almost all of their users “scored at ceiling level of TOFHLA, with 50% getting a perfect score.”
The opportunities social media are giving patients and researchers, as Wicks and colleagues conceded to me, are “challenging, if not downright controversial.” PatientsLikeMe's policy of transparency is one step in overcoming such challenges. Nurses can do much to ensure that this new model serves patients and researchers alike. Reading the “e-patient's white paper” (http://e-patients.net/e-Patients_White_Paper.pdf) is a good place to start.
I will explore these topics in a post on AJN’s blog, http://ajnoffthecharts.com, in early March.
2. Wicks P, et al. Use of an online community to develop patient-reported outcome instruments: the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) J Med Internet Res. 2011;13(1):e12
3. Wicks P, et al. Measuring function in advanced ALS: validation of ALSFRS-EX extension items Eur J Neurol. 2009;16(3):353–9