Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.
Acupuncture
Research Electronic Data Capture
blinding
clinical translational science
double-blind sham acupuncture
randomization
randomized controlled trial
vulvodynia
Journal
Clinical trials (London, England)
ISSN: 1740-7753
Titre abrégé: Clin Trials
Pays: England
ID NLM: 101197451
Informations de publication
Date de publication:
10 2020
10 2020
Historique:
pubmed:
12
7
2020
medline:
14
1
2021
entrez:
12
7
2020
Statut:
ppublish
Résumé
Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia. Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding. At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments. Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.
Sections du résumé
BACKGROUND
Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia.
METHODS
Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding.
RESULTS
At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments.
DISCUSSION
Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.
Identifiants
pubmed: 32650673
doi: 10.1177/1740774520934910
pmc: PMC7529889
mid: NIHMS1598987
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
545-551Subventions
Organisme : NICHD NIH HHS
ID : R01 HD091210
Pays : United States
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