Design and Methodological Issues of Within-Person (Split-Body) Randomized Controlled Trials Evaluating a Topical Treatment: A Systematic Review.
Intra-individual comparison
Randomized clinical trial
Split-body design
Topical treatment
Within-person design
Journal
Dermatology (Basel, Switzerland)
ISSN: 1421-9832
Titre abrégé: Dermatology
Pays: Switzerland
ID NLM: 9203244
Informations de publication
Date de publication:
2023
2023
Historique:
received:
14
12
2022
accepted:
06
03
2023
medline:
12
10
2023
pubmed:
30
3
2023
entrez:
29
3
2023
Statut:
ppublish
Résumé
Topical drugs are often used as first-line treatment for dermatological conditions. A within-person design may then be well adapted: it consists of randomizing lesions/body sites rather than patients, which are then concomitantly treated by the different drugs compared, reducing inter-group variability and therefore requiring fewer patients than the classical parallel-group trial. The aim of this review was to provide a methodological overview of within-person randomized trials (WP-RCTs) in dermatology. We searched for eligible trials published between 2017 and 2021 in MEDLINE, Embase, and Central in dermatology journals and the 6 highest-impact-factor general medical journals. Two authors selected publications and extracted data independently. From 1,034 articles identified, we included 54 WP-RCTs, mainly for acne vulgaris, psoriasis, actinic keratosis, and atopic dermatitis. In most of the trials, patients had only 2 lesions/body sites. In none of the trials, did we detect a potential carry-across effect (known to be the major methodological problem in WP-RCTs). Twelve studies reported a care provider applying the treatment, and in 26 studies, the patients themselves applied the treatment. Finally, we also highlight statistical issues for the statistical analysis: overall, 14 (26.9%) studies used a test for independent observations, thus ignoring the between-lesion correlation. Our systematic review highlights that despite the publication of the CONSORT checklist extension for WP-RCTs in 2017, this design is rarely used, and when it is, there are methodological and reporting concerns.
Sections du résumé
BACKGROUND
BACKGROUND
Topical drugs are often used as first-line treatment for dermatological conditions. A within-person design may then be well adapted: it consists of randomizing lesions/body sites rather than patients, which are then concomitantly treated by the different drugs compared, reducing inter-group variability and therefore requiring fewer patients than the classical parallel-group trial.
OBJECTIVES
OBJECTIVE
The aim of this review was to provide a methodological overview of within-person randomized trials (WP-RCTs) in dermatology.
METHODS
METHODS
We searched for eligible trials published between 2017 and 2021 in MEDLINE, Embase, and Central in dermatology journals and the 6 highest-impact-factor general medical journals. Two authors selected publications and extracted data independently.
RESULTS
RESULTS
From 1,034 articles identified, we included 54 WP-RCTs, mainly for acne vulgaris, psoriasis, actinic keratosis, and atopic dermatitis. In most of the trials, patients had only 2 lesions/body sites. In none of the trials, did we detect a potential carry-across effect (known to be the major methodological problem in WP-RCTs). Twelve studies reported a care provider applying the treatment, and in 26 studies, the patients themselves applied the treatment. Finally, we also highlight statistical issues for the statistical analysis: overall, 14 (26.9%) studies used a test for independent observations, thus ignoring the between-lesion correlation.
CONCLUSION
CONCLUSIONS
Our systematic review highlights that despite the publication of the CONSORT checklist extension for WP-RCTs in 2017, this design is rarely used, and when it is, there are methodological and reporting concerns.
Identifiants
pubmed: 36990057
pii: 000530149
doi: 10.1159/000530149
doi:
Types de publication
Systematic Review
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
720-731Informations de copyright
© 2023 S. Karger AG, Basel.