The library of clinical data on common conditions and diseases and their management has led to the development of diagnosis and treatment guidelines and recommendations for nearly every disease category from asthma to various cancers.1,2 Approval of these algorithms by national and international regulatory and professional bodies provide healthcare professionals with the validation needed to incorporate their use into practice. This integration into clinical practice is evidence-based medicine.
Supporting the need for such tools, healthcare professionals continue to show interest in and appreciate tools to help them with their practice.3 These practice tools can range from educational diagrams and models, to treatment algorithms, to dosing calculators and schedulers. The advent of digital tools, especially those used at the point of care and accessed through handheld devices, has allowed these practice tools to take on even greater utility: access to libraries of information and recommended treatment options are now at the HCP’s fingertips. Gone are the days of paging through the Physician’s Desk Reference.
However, has the creation of tools in digital formats eliminated the analog judgment that is the “art of medicine?” For example, and this is a much simplified example considering the space constraints here, the American Diabetes Association designates a diagnostic cut point for diabetes mellitus as =126 mg/dL for fasting plasma glucose.4 A simplified digital tool may determine a patient with an FPG = 127 mg/dL as a candidate for pharmacologic therapy based on the ADA criteria. Can a tool be designed that considers all of the factors a clinician may take into account when determining treatment?
While a clear line of distinction for diagnosis suits the logic of the digital tool well, does this type of black and white recommendation fit the practice of medicine? Further, would this simplified tool potentially take the clinical analysis and decision making out of the hands of the healthcare provider? Can a digital tool ever take all of the subtle clinical cues an HCP considers into account? By limiting the potential options that a clinician can choose, or that may be delivered, is the tool (and the sponsoring company by proxy) actually providing medical advice? And the final question relevant to our role in the pharmaceutical marketing industry is: to what level of regulation must our digital tools adhere?
A digital tool, by definition, is just that: digital. It evaluates multiple factors within a defined logic to deliver a recommendation. Evidence-based medicine has more precisely defined that logic, and we are on the precipice of a world in which digital tools may recreate the analog experience that is the practice of medicine.
We at LBi Health understand the growing need for ease of access to the ever expanding library of medical information. We are continuously evaluating the ability for digital tools to deliver that information in a clear and time-appropriate fashion. However, we also consider 2 important factors in the development of such tools: 1) the ultimate treatment decision must remain in the hands of the clinician, and 2) the scope of such tools in assisting with diagnoses and treatment recommendations will define their oversight by FDA and other regulatory bodies, and thereby inform the likelihood for their approved use.
1. National Asthma Education and Prevention Program, National Heart, Lung, and Blood Institute. “Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma.” Department of Health and Human Services. August 28, 2007. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. Accessed, May 1, 2011.
2. NCCN Clinical Practice Guidelines in Oncology
3. Manhattan Research. “Taking the Pulse® v10.0” April, 2010.
4. American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. January, 2011. 34 Suppl1:S62-S69.