Kasia

Tue, 19 Jun 2007 00:00:25 -0800

And now for some legitimate statistical thoughts... The Hebert Research telephone survey mentioned in Matt Potter's piece seems to have violated a number of the basic tenets of survey and sample design--including providing respondents with unbiased contextual information and formulating questions that mean the same thing to the interviewer and respondent. This seems in line with more recent work Herbert Research has done for Harborview. In particular, the complete "Exception to Informed Consent Research" not only cleverly samples people living in King County, but only OUTSIDE of Seattle (thereby avoiding any annoying heterogeneity that might come out of directly interviewing a higher proportion of minorities and low-income households--but masking it with proportional weighting), but somehow produces a survey script and questionnaire that any self-respecting freshman social science student would be ashamed to turn in. Not surprisingly, their results reflect every inadequacy of their survey design. The respondents that were paying better attention to the introductory "context" provided by Hebert manage to confidently parrot back both its reasoning and conclusions nearly verbatim--generating a large proportion of "best interest of the patient and the community" responses. The respondents who would not consent to the experimental research (whether noting the absence of consent or not) largely gave "Other" responses, as they were not as immediately aware of the lingo of disagreement necessary here--since the surveyor had not recently read it to them. And then there was the incongruity between the language used in questions--including asking, "Why not?" in response to negative responses, while asking, "Why do you feel that it is all right to do this study without patient consent?" of positive respondents...all in all, a survey no-no. But perhaps the most sorry side of this survey is that the survey design fails to adequately inform respondents of what it is asking. Comments listed verbatim indicate that a number of respondents thought that it was either "safe" experimental treatment or death. Relatively few indicate that they understood how the study would work. It's a pity survey design used to support these studies is not even required to meet the same stringent federal requirements that the waiver of consent asks researchers to satisfy.

James Meinken

Fri, 15 Jun 2007 16:11:55 -0800

Emergency medical treatment without informed consent is performed all the time at this hospital and all others that receive trauma patients that are unconscious or in other dire straits. Just because PolyHeme was administered instead of the usual saline solution doesn't mean a thing. Does an unconscious trauma patient give informed consent to a saline solution? No, of course not. Maybe it was the bad luck of the draw that more patients died having been given PolyHeme instead of a saline solution. Maybe these people would have died anyway all else being equal. The jury is still out on PolyHeme because you'll never know the outcome of the study if all the patients had had their treatments reversed. Perhaps the outcome would have been reversed as well. I find it amazing that this PolyHeme works as well as it does. For a trauma patient to receive an oxygenated fluid vs a saline solution, someone needing that oxygen is going to fare better than with saline. But how do you know if someone needs that oxygenated fluid or not? You simply don't know. At this time, beating up on PolyHeme is a fool's errand.

Seattlest: UW Medical Struggles to Wag the Dog

Kasia

James Meinken