Heightened Attention to Medical Privacy: Challenges for Unbiased Sample Recruitment and a Possible Solution

Abstract

Subject recruitment for epidemiologic studies is associated with major challenges due to privacy laws now common in many countries. Privacy policies regarding recruitment methods vary tremendously across institutions, partly because of a paucity of information about what methods are acceptable to potential subjects. The authors report the utility of an opt-out method without prior physician notification for recruiting community-dwelling US women aged 65 years or older with incident breast cancer in 2003. Participants (n = 3,083) and possibly eligible nonparticipants (n = 2,664) were compared using characteristics derived from billing claims. Participation for persons with traceable contact information was 70% initially (2005-2006) and remained over 90% for 3 follow-up surveys (2006-2008). Older subjects and those living in New York State were less likely to participate, but participation did not differ on the basis of socioeconomic status, race/ethnicity, underlying health, or type of cancer treatment. Few privacy concerns were raised by potential subjects, and no complaints were lodged. Using opt-out methods without prior physician notification, a population-based cohort of older breast cancer subjects was successfully recruited. This strategy may be applicable to population-based studies of other diseases and is relevant to privacy boards making decisions about recruitment strategies acceptable to the public.

History of the Rochester Epidemiology Project: Half a Century of Medical Records Linkage in a US Population

“…34 However, these efforts are struggling with equally strong trends toward strict confidentiality of medical record information. 48 Even if these national databases become available to investigators in the US, they may lack historical depth or may be limited to specific age groups (eg, Medicare generally covers only patients aged Ն65 years). In contrast, the REP system covers a complete population of approximately 500,000 persons of all ages residing in a well-defined geographic region (Olmsted County), has existed for almost half a century, and includes electronic indices for diagnostic codes, surgical procedures, and drug prescriptions.…”

Using administrative health care system records to recruit a community-based sample for population research

“…In addition, the relatively recent privacy laws that now limit access to electronic health records would have made this challenging as well. The Health Insurance Portability and Accountability Act, which is a law that aims to protect the privacy of health system patients and the confidentiality of their data, often (real or perceived) prevents epidemiologists from accessing health system records for use as sample frames [36]. Given unfortunate violations, it is perhaps understandable that restrictions can be severe when actual medical record data (i.e., private health information) are sought.…”

Patterns and trends in quality of response rate reporting in case-control studies of cancer

“…[15] Further, in the context of case-control studies of cancer where the sampling frame usually differs between case and control series, poorly or incorrectly defined eligibility criteria for cases and controls could cause an unpredictable level of selection bias even when reported response rates are high.…”