> parallel pilot randomized open label, double-masked clinical trial.
Dumb questions: What is a parallel pilot | what is open label? And Is double-masked the same as double-blind?
Dumb questions: What is a parallel pilot | what is open label? And Is double-masked the same as double-blind?
"Open-label" generally means "not blind at all." Basically, the patient knows what treatment is being administered.
"Double-masked" is usually synonymous with "double-blind," because "masking" sounds less violent than "blinding."
What did they actually do in the study? Well, §2.2.1 says the following:
> 2.2.1. Randomization and Masking
>
> An electronically generated randomization 2:1 list was prepared by
> independent statisticians. The list was accessible only to nonmasked
> specialists in the study in an attempt to minimize observation bias.
> The patients' data were recorded in the hospital's electronic
> medical record, with blind access by the technical data collectors
> and the statistician who carried out the study.
It sounds like those who analyzed the data didn't know which group was which, but in the case of unequal 2:1 group allocation it is typical for the larger group to be the treatment group. Why was unequal assignment used in the first place?
The descriptor "open-label" suggests that someone knew which patients were in which groups: was it the people who administered the treatment, or the patients, or both? Unclear.
The authors themselves write: "This pilot study has several limitations as it is not double-blind placebo controlled."
This is literally the first time I've heard of "double-blind" being interpreted this way.
- https://link.springer.com/referenceworkentry/10.1007%2F978-3...
- https://az.research.umich.edu/medschool/glossary/double-mask...
- https://aidsinfo.nih.gov/understanding-hiv-aids/glossary/211...