Tuesday, September 12, 2006

Were Late Stent Thromboses Really So Unexpected? Why depend on device companies and others to find out?

In "Were Late Stent Thromboses Really So Unexpected?" Roy Poses concludes that:
The lessons, again (see previous post), are that physicians must be very, very skeptical about the results of research sponsored by those with vested interests in the research turning out a certain way, and/or by research done by investigators with financial interests in organizations with such vested interests.

I have a more active solution than mere skepticism: building information systems of, by and for the clinicians to give a degree of independence from clinical trials that might be influenced or tainted by vendors or others with conflicts of interest.

An example of this type of endeavor is the Invasive Cardiology Clinical Database (ICCD) project I re-engineered at a 1,000+ bed medical center as Director of Medical Informatics, along with its executive sponsor, now Executive Director of Cardiology Services at a large healthcare system in the western U.S. The project, ineptly led by IT, was failing - to say the least. I took over at the request of the powerful Sr. VP for Medical Affairs, who apparently managed to outmaneuver internal opposition and got me hired.

I led a data model, application design and clinical implementation remediation process. The goal was an information system that met the needs of the clinicians regarding the way they practiced invasive cardiology (6,000 procedures/year), and that was also compliant with ACC and other standards for national reporting so the data could be shared via national registries.

This ICCD system enabled results reporting, outcomes and best practices analysis, and internal and external benchmarking. It contained items facilitating research such as definitive interventional procedure per lesion, catheter and stent performance and issues, great detail regarding lesion morphology and location, and followup data, all recorded at a high level of precision (several hundred well-defined data points in all). The dataset was developed in true collaboration with the clinician domain experts to meet their needs. This information system had the capability to provide independent confirmation of the performance of the new modalities in cardiology, on an ongoing basis.

An article by the executive sponsor and myself on this initiative is here.

Or, I should say, the "politically correct" version is at that URL. The less politically correct version is here ("MIS inadequacies in tough clinical environments: an invasive cardiology example.")

The major issue in this story is the performance of hospital's IT department, turning the clinicians' desire for such an information system into a clinical and political nightmare over a period of several years, as well as interference and obstructionism by the IT department and its CIO and COO (who IT reported to) in the remediation efforts I then led after my hire as Director of Informatics. The IT department and some excutives acted as an active enemy to this project, in large part due to turf and ego issues, as well as executive fears of "empowering the doctors" with respect to administration.

I recall frequent attempts to impede progress of our remediation initiative. I quite literally had to use strong-arm tactics I'd learned early in my career as Medical Programs Manager and Medical Review Officer (drug testing) in a large municipal transit authority's medical department in order to move this project to success.

It is my recommendation that every invasive cardiology/cardiac surgery center performing a good number of cases acquire or build this type of information system and do their own research on outcomes, and provide the data to specialty societies for pooling so as to maximize independence from those with pecuniary or other incentives to hide bad data.

However, strangely and regrettably, clinicians should be aware that doing so may entail potential warfare with those whose interests are in preserving their own healthcare "territory." That this is so is absolutely crazy, considering the stakes, but occurs nonetheless. The difference in ideology between clinicians and non-clinicians was never more clear to me than during this project. If I'd had firing authority, a house cleaning of that IT department would have been my first priority.

I should also note that the COO in question is now CEO of a major municipal hospital system. I can only hope that person has learned something about clinical informatics since the time of the aforementioned project.

-- SS