Pediatric Informatics: Computer Applications in Child Health (Health ...

444 H.P. Lehmann et al.
eligible candidates, such as children with “orphan disease,” recruitment through
patient communities of practice and interest, such as the Children’s Oncology
Group 24 may be possible and attractive to both researchers and subject populations.
Such recruitment approaches may be useful in large organized communities (such
as the Interactive Autism Network (IAN) 25 (see Case Study) ) to raise awareness
of current research trends. Enrollment, registration, and group assignments may
be managed through a combination of telephone and Web site forms linked to a
central database.
The Health Insurance Portability and Accountability Act of 1996 26 has impacted
research in general 27 and pediatric research in particular. 28 A simulation study with
eligible recruits suggests that inclusion of HIPAA-compliant language in informed
consent may reduce participation by over 30% in African Americans. 29 The need
for including protected health information (PHI) in informed consent has formalized
recruitment and retention of research subjects. 30 The development of methods to
recruit subjects without violating HIPAA conditions while creating usable datasets
that are de-identified from at least the 18 defined items of PHI has been challenging. 31
Other challenges in de-identification include genomic data, which is currently not
“protected,” but which is specific to individuals. 32 A concise and informative examination
of HIPAA, security, and research for academic institutions has been created. 33
Pediatrics has a tradition of ambulatory-based research. Office-based, multisite
research efforts have been facilitated through efforts of organizations such as the
American Academy of Pediatrics Pediatric Research in Office Settings Network
(PROS Net) 34,35 or the Slone Center 36,37 Large, simple randomized “studies,” where
patients are recruited without inclusion/exclusion or stratification criteria of traditional
studies have been implemented using phone and fax, and are easier with the
Internet. 38 Information technology has eased the ability of practices to join, either
through facilitating registration or making data collection and participation simpler.
34.2.5.2 Data Collection and Recording
IT tools can facilitate data collection, storage, and transfer using secure wireless
technology or well-designed personal digital assistant (PDA) applications. Such
technologies work in locations as diverse as clinical offices, community settings and
developing countries. One of the authors of this chapter (PL) has been very successful
in incorporating PDA-based data collection in the Congo for the delivery of routine
health information from disparate health stations to regional and then national
offices. As useful as these device may be, they have their own vulnerabilities to
errors: failures in uploading or downloading data and or manual entry errors. 39
Researchers who reuse data from electronic patient records (EPR) for research
studies must consider:
Administrative privileges, including institutional review and HIPAA-related
issues regarding the data collection process in the context of the study.
The appropriateness of algorithms used to identify properly the numerators and
denominators in the context of the question being asked and the population
being studied.