4 ms·

> 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 s

> 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?

legerdemain 6y ago
"Parallel" generally means that different groups of patients receive different treatments. The opposite is a within-patient study, where all patients get all treatments over time (possibly varying the order to prevent order effects). "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. My takeaway is that... the authors don't do a great job of describing who had access to what information. 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."
- gruez 6y ago
  >"Double-masked" is usually synonymous with "double-blind," because "masking" sounds less violent than "blinding." This is literally the first time I've heard of "double-blind" being interpreted this way.
  - legerdemain 6y ago
    I think it's a common euphemism, similar to referring to "subjects" as "participants" and so on. - https://link.springer.com/referenceworkentry/10.1007%2F978-3-540-68706-1_1425 https://link.springer.com/referenceworkentry/10.1007%2F978-3... - https://az.research.umich.edu/medschool/glossary/double-masked-design https://az.research.umich.edu/medschool/glossary/double-mask... - https://aidsinfo.nih.gov/understanding-hiv-aids/glossary/211/double-blind-study https://aidsinfo.nih.gov/understanding-hiv-aids/glossary/211...
  - deleted 6y ago
    [deleted]
jacquesm 6y ago
These are not dumb questions at all. The really dumb questions are the ones that aren't asked.

> 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?

legerdemain 6y ago

"Parallel" generally means that different groups of patients receive different treatments. The opposite is a within-patient study, where all patients get all treatments over time (possibly varying the order to prevent order effects). "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. My takeaway is that... the authors don't do a great job of describing who had access to what information. 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."

gruez 6y ago
>"Double-masked" is usually synonymous with "double-blind," because "masking" sounds less violent than "blinding." This is literally the first time I've heard of "double-blind" being interpreted this way.
- legerdemain 6y ago
  I think it's a common euphemism, similar to referring to "subjects" as "participants" and so on. - https://link.springer.com/referenceworkentry/10.1007%2F978-3-540-68706-1_1425 https://link.springer.com/referenceworkentry/10.1007%2F978-3... - https://az.research.umich.edu/medschool/glossary/double-masked-design https://az.research.umich.edu/medschool/glossary/double-mask... - https://aidsinfo.nih.gov/understanding-hiv-aids/glossary/211/double-blind-study https://aidsinfo.nih.gov/understanding-hiv-aids/glossary/211...
- deleted 6y ago
  [deleted]

jacquesm 6y ago

These are not dumb questions at all. The really dumb questions are the ones that aren't asked.