The federal Office for Human Research Protections has ruled that it is perfectly fine for hospitals to use checklists to remind doctors and nurses to wash their hands and follow other sanitary procedures — provided the goal is to improve the quality of care given to patients. But if those hospitals want to analyze what impact the checklists might have in reducing infections, that counts as research and they must first seek approval from institutional review boards.
So if no checklists are used that is okay. Or if checklists are always used that is okay. But don't dare try to run a comparison between using and not using checklists with data collected to compare the results. That's experimentation and that isn't allowed without going thru a bureaucratic process.
Japanese manufacturers made huge strides in quality by making lots of changes in their processes aimed at eliminating sources of error and defects. This philosophy of continuous improvement works best when the obstacles to changes are few and where the consequences of changes can be measured. A deep embrace of this approach would do wonders for improving the quality of medical care - quality improvements that are sorely needed both for patient health and to control costs.
By Randall Parker at 2008 January 27 07:00 PM Policy Medical | TrackBackWhat are the top medical tourism destinations?
Maybe we can get India to embrace Deming just like the Japanese did.
If a handful of hospitals end up with measurably lower death rates due to complications and due to doctor caused injury, they could end up charging a premium even after the travel expenses.
Sixty-seven hospitals participated, and no one raised the question of whether the patients should give informed consent? Sure, getting IRB approval would have slowed this research down, but what kind of Kool-Aid were all these people drinking that no one thought to check? Not all "community based" research is so innocuous or beneficial on its face, and it's a clear violation of modern medical research ethics to conduct ANY kind of formal research on patients without their consent. Yes, it sounds ridiculous in this case, but no more ridiculous than a policeman reading a suspect his right to counsel.
This is very disappointing, since the Michigan catheterization protocols have already been shown to be enormously effective, and are taught as a model for cost-effective improvements in hospitals. Say it isn't so, Joe.
Mike,
If existing procedures are not uniform (e.g. not every hospital uses a particular checklist) then either they should all step up and use it if the benefits are not controversial or they should compare. If they compare you can call that an experiment and demand oversight. But if they didn't bother to compare and used different procedures in each hospital that appears to be ethically acceptable. There's something wrong here. Does measurement make something medically unethical? Is there a Heisenberg effect here?
Randall,
It's an unfortunate consequence of current FDA regulations that sensible things that a single physician or hospital can do without permission or oversight are tightly regulated when done in the format of a clinical trial. And you're right that had the hospitals independently applied catheterization protocols and later had the results compared in a retrospective study, there probably would have been no complaint.
I agree there's something wrong here; it appears that the IRB process may be too risk averse. Let's hope the FDA and some medical ethicists find a lesson to be learned here...and learn it.
Hah, that is exactly what I thought as a response, "heisenburg uncertainty".
This is just one of the reasons why I cannot be a public school teacher. That really says it all, but for it to be happening in a life and death situation is even worse.
Mike is correct, this is exactly analagous to the rules of criminal procedure. Sure its terrible when a criminal gets off because a cop didn't get a warrant before a search, but it really does benefit us all when authorities play by the rules. And just as its the rare judge that denies the police a legitimate search warrant request, seriously, how likely is it that any IRB would reject approving a research project that has such a high chance of improving public health with such a low risk of negative outcome?
Granted this particular experiment ended well but its the experiments that aren't publicized one has to worry about. Wasn't there a recent story about drug companies burying antidepressant clinical trials that didn't show positive outcomes? Medical research detrimental to patients isn't reported in the NY Times until years after that fact, if ever. The only independent watchdog that is monitoring a research project from the beginning is the IRB system.
I know I know, its a new age. If we don't cut corners, the terrorists win.