Bondsman:

Gzuckier,

You said,

"don't know about large scale study, but as new laparascopic surgeries get innovated for various procedures, starting with gall bladder surgery and moving up, hospitals certainly do serious comparative studies to see if the rate of negative outcomes is worse for the new surgery than the old. studies which are both statistically and medically sound. i know because that's how i made my living for a couple of years."

I have a confession to make. Before posting earlier I ran a quick search on LRP vs. RP and couldn't find anything big - less than 100 people per arm is all I came up with. I figured I'd look like more of a tool than usual if there were a bunch of 5000 person studies sitting around readily available. There still may be, I didn't spend a lot of time looking, but I don't think so.

Also, I agree with your old doc, if some new technique does NOT show a significant increase in survival, why not let someone else's patients take the initial risk? Same thing with new meds, if you can wait a few years before getting on the bandwagon, you have a lot less explaining to do.

yeah, when i said the hospitals were doing comparative studies, i meant on their normal patient flow (with the additional proviso that the subjects weren't randomly assigned or anything; the doctor decided on whichever method he/she preferred), the study was restricted to looking at the results of whatever last quarter/year's surgeries were. it wasn't intended to be publishable research, just quality control. in fact, the local hospitals pooled their data so we could get some reasonably sized numbers. we actually did find one hospital that was doing pretty badly one year on one of their laparascopic procedures; it turned out they weren't doing as much imaging before the process as everybody else. (that's what i mean by medically valid; the surgeons had input on what variables should be collected, not necessarily for the study itself, but for later interpretation). they seemed surprised firstly to find out that they were doing badly on outcomes, then to find out that they weren't doing the imaging. no resistance or defensiveness, just "thanks for letting us know" and fixing the problem.

on the other hand we found another hospital that had bad outcomes one year and they ended up pulling all the relevant charts and doing a chart review; it turned out that the "victims" were all residents of a local nursing home which was presumably doing inadequate postoperative care, not the hospital's fault. (we've been having periodic nursing home scandals here, like a lot of places).

i guess the bottom line is that there are such large-scale variables which affect short-term outcomes and aren't always things that get included in the study a priori that the subtle effects attributable to the nature of the procedure itself that you really want to study get masked. and as you say, long term effects aren't known at all until large longterm studies get done, so don't be the first on your block to try something.