re: Health IT's Next Big Challenge: Comparative Effectiveness Research
Editor's Note: The following comment was written by Richard Tannen, MD
Having spent more than a decade rigorously assessing whether an Electronic Medical Record Database can provide reliable information about healthcare, I was delighted to see someone champion its use for "Comparative Effectiveness" research.
However, while our research efforts have demonstrated the feasibility of this strategy, I would caution that the obstacles that need to be overcome to put it into practice are considerable. They have not been addressed by the various sources quoted in your article, that describe what they or others have done.
Our group using the large (approximately 8.0 Million patient records EMR) United Kingdom General Practice Research Database, has shown that reliable answers can be obtained to determine the effectiveness of treatments1. BUT it only occurs when a properly-constructed, sufficiently-large database is used, and EQUALLY IMPORTANTLY when the vexing problem of "unrecognized confounding" can be overcome (a major advance made by our group)1,2.
To my knowledge no database in the US has been tested to determine whether it can yield reliable results for such studies, and there are huge issues to surmount in order to develop a database with the important characteristics of the UK database. This is because the organized socialized health care system in the UK lends itself to establishing a properly structured EHR database, whereas the unstructured nature of healthcare in the US poses a major challenge to achieve this goal.
The challenges to surmount this issue are beginning to be addressed in the US, and hopefully the effort will be successful. In my judgment a properly constructed, validated DATABASE of 50+ million patient records can transform healthcare by addressing Comparative Effectiveness research and other related questions. In addition, more methods to address "unrecognized confounding" need to be developed. It will take adequate funding and a coordinated effort by many in the healthcare field as well as the government to make this happen. BUT if successful it can usher in a new, dramatically improved era of healthcare.
Richard Tannen, MD
1. 1. Tannen RL, Weiner MG, Xie D. Use of primary care electronic medical record database in drug efficacy research on cardiovascular outcomes: comparison of database and randomized controlled trial findings. BMJ 2009, 338; b81 [doi:10.1136/bmj.b81]
2. Yu M, Xie D, Wang X, Weiner MG, Tannen RL. Prior event rate ratio adjustment: numerical studies of a statistical method to address unrecognized confounding in observational studies. Pharmacoepidemiology and Drug Safety 2012, 21(S2): 60-68.
3. Tannen RL, Xie D, Wang X, Yu M, Weiner MG. A New "Comparative Effectiveness" Assessment Strategy using the THIN Database: Comparison of the Cardiac Complications of Pioglitazone and Rosiglitazone.