CCSVI double-blinded clinical trial-how?

[redwin]

Hi all,

 

I was just reading about the new development in CCSVI clinical trials last month, and the premiere of Saskatchewan was saying that 86 MS patients will be sent to Albany, NY for a randomized, double-blinded clinical trial.

In double-blinded clinical trial, I can see how the patient might be "blinded". They are anesthetized, have the catheter inserted but the balloon for the angioplasty not inflated to account for the placebo effect, but I was wondering how would the surgeon performing the surgery also be "blinded" to the fact whether he performed the angioplasty or not..? Or maybe the surgeons aren't the ones dealing with the patients primarily (other doctors would) so the surgeon's aren't contributing to experimenter's bias? Any insights on this would be appreciated. Thanks!

 

redwin

[japlanet]

Hi all,

 

I was just reading about the new development in CCSVI clinical trials last month, and the premiere of Saskatchewan was saying that 86 MS patients will be sent to Albany, NY for a randomized, double-blinded clinical trial.

In double-blinded clinical trial, I can see how the patient might be "blinded". They are anesthetized, have the catheter inserted but the balloon for the angioplasty not inflated to account for the placebo effect, but I was wondering how would the surgeon performing the surgery also be "blinded" to the fact whether he performed the angioplasty or not..? Or maybe the surgeons aren't the ones dealing with the patients primarily (other doctors would) so the surgeon's aren't contributing to experimenter's bias? Any insights on this would be appreciated. Thanks!

 

redwin

 

Well, either the surgeons aren't the treating/following physicians, and/or they are blinded to the patient's identity (patient is covered/draped before surgeon enters). Easy.

[redwin]

Well, either the surgeons aren't the treating/following physicians, and/or they are blinded to the patient's identity (patient is covered/draped before surgeon enters). Easy.

 

That's a good point. Thanks!

[A-Stark]

Well, either the surgeons aren't the treating/following physicians, and/or they are blinded to the patient's identity (patient is covered/draped before surgeon enters). Easy.

 

I imagine they'd be blinded to the outcome... though I wonder how that occurs when patients report symptom improvements instantly on the OR table. In any case, it would be unethical for an operator to be blinded to the patient's identity! I don't see how we can throw out OR timeouts and basic things like patient ID for the sake of research.

[mavrik13]

It's a lot easier to blind the provider in this case (simply, the neurologist who is going to be assessing the outcomes won't know if the patient had the treatment or not) than it is the patient. It's not practical (or ethical) to anaesthetize patients to blind them to whether or not they had the procedure.