Double blinds are not the gold standard for science. They are not even the gold standard for medicine, although for drug studies in particular they have great utility. They actually have quite limited applicability outside of a particular set of circumstances.
The double blind study is a special construct created to deal with the confounding effect of placebos, which really isn’t a thing outside of medicine.
Medicine has so much trouble with “good science” due to ethics. Random selection and assignment with controls are obvious techniques of science but it means not giving people medicine we suspect is interesting, or randomly assigning potentially bad effects to people.
Double blind means the doctors and nurses who administer protocol won’t even know or care about your medical history or context, let alone whether or not they’re even giving you any medicine at all.
So even clinical, experimental studies which start strong tend to compromise themselves after an initial impression of results.
Yes, there are, which honestly makes this entire article premise a bit bizarre. Double blind and all that is an ideal, not a requirement. It can't be a requirement, because whether we can run double-blind or any other kind of study is not always a matter of how good we are or how much effort we are willing to put in, but a characteristic of the thing we want to study, as it is here. It's hardly the only drug where the participants can have a pretty good guess whether they're on a placebo or not. As just an example off the top of my head, I doubt there were a whole lot of chemotherapy testers who thought they were vomiting for days and losing their hair due to a placebo.
Contrary to frequently-expressed opinion online, we are not in fact constrained to running only super-massive-sample-size triple-blind preregistered peer-reviewed gold-plated scientific studies and only permitted to say we might have an opinion if a metanalysis of multiple of those concurs. It's nice when we can do that, but the universe is not always so accommodating.
Standard double blind trial protocol: you sign up for the trial. You might get the actual drug or you might get placebo. It's double blind because not even the doctor knows who gets what.
"Double-blind placebo-controlled randomized controlled trials" are a TOTAL REQUIREMENT to assess the effectiveness of incremental drugs, i.e. drugs that claim to be better than some other existing drug. In the case of the parachute, there is no such other: apply common sense. If any society has managed to enforce by law the Double-blind ... etc assay, then that society will rightly get what it deserves for its bureaucratically administered shortsightedness.
To be honest, I think a randomised clinical trial is more of a starting point than an endpoint in terms of 'knowing' that an effect is genuine. The 'gold standard' moniker overdoes the authority of the RCT a
It would be damn near impossible to conclude anything from such research without a control. “Randomized double-blind, placebo-controlled trial” is the critical sentence - at best you’d get a correlation which probably has been influenced by the availability of research. Finding truth is freaking hard.
Right. But I would (edit: not) say that is a flaw with this study. Just something else we can try and rule out.
That is, if you did manage to "double blind" it and got no difference in treatments, that means we don't understand the mechanism in this study. It does not, necessarily, mean that there are no results in this study. RIght?
> Consequently, a result is significant or not because of all the parameters of the study, for example measurement characteristics, number of samples, etc, but not its results.
This is true, but sadly in most reports it jst mean p>0.05 in spite they should use a smaller value due to the look elsewhere effect and other stuff.
> A DBRCT'd mean you'd have to refuse care, which is not possible.
No, double blind means that both arms must receive the same visible treatment. It can be a new drug vs sugar pills, or a new drug vs an old drug. If there is some standard treatment, in most cases the control group receives the it.
> Moreover, the medicine was experimental, you can't double blind, as the doctors in charge of the patient must be able to react quickly, and those might not be the clinicians in charge of the study.
What type of reaction is possible if the doctors know in which group each person is?
I agree that in some cases a double blind experiment is impossible or very difficult, but looking at many of the proposed miracle drugs against covid-19, one of the patterns is that most studies have a "control group" that is not a real control group.
You don't actually need a controlled double-blind study to notice a medical effect, IF the effect is sufficiently strong and consistent. Traditional "controlled double-blind studies" are nice to have, but are much too likely to accidentally reject good medicines and medical treatments of the sort that might be discovered and confirmed via this sort of personal experimentation. (Yes, false positives are bad, but false negatives are bad too!)
The era of personalized medicine is just beginning and these sort of devices seem unusually well-suited for that sort of approach.
Looks promising. While it may seem obvious, I would spell out what double-blind means, the problem it solves, and how it is used elsewhere. That then sets you up to point out how doctors use these study types, adding credibility.
In our world, it's considered malpractice if you have the option to include double blinding in your study design, but opt not to for convenience.
In some alternate universe, it is considered malpractice for those who design the study to be the same group that runs the study.
I don't think we can get there from here, but if we had a core track of theorists who designed studies, and a second equally prestigious track of practitioners, who independently tested and ran studies, experimental science would be much more rigorous.
Your prestige should be tied to your ability to identify novel experiments to try, or in rigorous testing procedures, never tied to your ability to shape data to make your claims appear grand.
Unfortunately you have a fundamental misunderstanding of health experimental design. Double-blind means that neither the participants nor the experimenters know which participant is allocated to which group. It doesn't say anything about how many groups there are or what is done to each group. I haven't heard of Dr Bredesen, but they could certainly run a double-blind study to validate their treatment regime. Treatments that haven't been validated in this way have a high risk of being ineffective but appearing effective due to experimenter error, placebo effect, demand characteristics, etc. Requiring convincing evidence in the form of a double-blind trial isn't purism, it's sensible caution based on experience.
edit: you're also on shaky ground statistically. There's a rule of thumb that if interactions between several variables are present in a treatment effect, 70% of that effect will show up on the individual variables (as main effects). It's very unlikely that there exists a treatment where all the effect is on a 35-variable interaction and none of the effect is visible when looking at each variable singly.
The double blind study is a special construct created to deal with the confounding effect of placebos, which really isn’t a thing outside of medicine.
reply