Epidemiology can be defined as the study of the distribution and determinants of disease in human populations;54
epistemology, as mentioned previously, is the study of the nature, sources, and validity of knowledge. As noted above, the use of EMRs for epidemiological studies presents epistemological challenges. Should van der Lei’s first law of medical informatics – “Data shall only be used for the purpose for which they were collected” – preclude researchers from using EMR data, collected for the purposes of clinical care and billing, to generate new knowledge about the distribution and determinants of disease? Clearly, the answer is “No,” but van der Lei’s warning should be taken to heart. While the potential for efficiently generating new knowledge from the large numbers of clinical encounters documented in EMRs certainly exists, the epistemological issues should be recognized and addressed. Data not gathered specifically for research purposes may
be incomplete and unreliable. This does not make those data unusable, but it does constrain the uses to which the data can be put and the inferences that can be drawn from them. Less-than-complete data of less-than-certain accuracy are not uncommon in clinical research. With care, data quality checks can be combined with selected epidemiological and statistical tools to address many of the problems presented by such data.
A better long term strategy, however, might be to undertake the important work of improving the validity and reliability of clinical EMR data in order to make them more useful for research. Ideally, our goal should be to shape at least some of the data elements so that research is, with a nod to van der Lei, one of the purposes for which the data were collected. Improving the quality of EMR data for research purposes is likely to impose a burden on practicing pediatricians, because research quality data demands structured data entry, which is often more time consuming. For this reason, this can be accomplished only with the input of the clinicians themselves, according to a few basic principles. First, we should focus (and perhaps limit) attention to areas of the EMR that present the biggest opportunities for generating new knowledge or improving care. Thus, we might choose not to devote efforts to portions of the EMR that deal with acute and self-limited clinical problems (although these too offer interesting opportunities for study), but instead to aspects of the EMR that deal with high-prevalence chronic conditions or with preventive efforts that apply to large portions of the population. Second, we should create dialogues with clinicians about why certain kinds of information should or need to be entered consistently and completely, so that agreement can be reached as to why it is in clinicians’ and patients’ bests interests to do so. Clinicians can be motivated to make changes that they view as beneficial. Third, we must engage clinicians in the design and testing of new structured formats for data entry. There should be no attempt to impose structure on EMR data that clinicians feel can only be effectively documented through narrative. In adhering to this principle, the new structured formats will work better, and clinicians will also feel that they “own” newly designed formats. Fourth, we must agree not to increase the amount of time it takes for pediatric clinicians to document care for the purposes of research, unless the clinicians come to that conclusion themselves. Increasing the work needed to take excellent care of patients is not in anyone’s interest. Finally, we must report the results of the research derived from EMR data back to the clinicians as quickly as possible. Doing so will demonstrate the value of the partnership between clinicians, informaticians, and researchers that is necessary to reap maximum research benefit from EMR data.
Where can we turn to see working partnerships between clinicians, informaticians, and researchers? With their powerful blend of research expertise and informed clinician input, pediatric clinical research networks,55
and especially practice-based research networks,56
provide pediatricians with the best opportunity to collaborate with informaticians to improve the validity and reliability of clinical EMR data to make them more useful for research. An especially innovative group in this regard is the Pediatric Research Consortium (PeRC)57
of the Children’s Hospital of Philadelphia. Established in 2002, this group of researchers and clinicians from 30+ primary care practices benefits from using a single application of a single EMR product for clinical care. PeRC is able to bring practicing pediatricians together with epidemiologists, clinical informaticians, and administrators to, when necessary, shape the EMR in such a way as to facilitate clinical research projects. Such a process is iterative and must take place over time and with sufficient resources. Nevertheless, the PeRC example shows that working partnerships between clinicians, informaticians, and researchers can be realized successfully.
More recently, several national pediatric clinical research networks recently have begun projects aimed at improving EMR data extraction for comparative effectiveness research. Pediatric Research in Office Settings (PROS), the practice-based research network of the American Academy of Pediatrics, was awarded a cooperative agreement by the Health Resources and Services Administration Maternal and Child Health Bureau (HRSA-MCHB) to establish an EMR-based subnetwork among its member practices to conduct comparative effectiveness research on ADHD stimulant medication treatment.58
The Pediatric Emergency Care Applied Research Network (PECARN) also has been awarded a cooperative agreement by HRSA-MCHB to use EMRs at several children’s hospitals to conduct comparative effectiveness research on traumatic brain injury.59
In the subspecialty world, the Improve Care Now inflammatory bowel disease network has received a grant from the Agency for Healthcare Research and Quality to build enhanced registries linked to hospital EMRs to conduct quality improvement and comparative effectiveness research.60
In each of these examples, pediatric clinicians will work hand-in-hand with informaticians to make the clinical data entered in the EMR useful for research purposes. The successes achieved by research networks will provide a roadmap for future efforts.
In summary, although EMRs are primarily a tool for clinical documentation, the routinely collected data within them offer researchers a superb platform from which to enhance future pediatric clinical research. The clinical data provided by EMRs represent a substantial step up from administrative claims, but for the reasons described above, present their own methodological challenges. The full potential of EMR data for pediatric clinical research will only be achieved when research becomes one of the explicit purposes for which pediatricians document patient encounters. Thus the technological advance of the EMR promises to put the pediatric clinician back at the center of twenty-first century pediatric clinical research.