Statistical fragility of outcomes in acellular dermal matrix literature: A systematic review of randomized controlled trials.
J Plast Reconstr Aesthet Surg
; 91: 284-292, 2024 Apr.
Article
em En
| MEDLINE
| ID: mdl-38432086
ABSTRACT
BACKGROUND:
Acellular dermal matrix (ADM) is commonly used in plastic and reconstructive surgery. With the abundance of randomized controlled trials (RCTs) reporting P-values for ADM outcomes, this study used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate the statistical stability of the outcomes in ADM RCTs.METHODS:
PubMed, Embase, SCOPUS, Medline, and Cochrane databases were reviewed for ADM RCTs (2003-present) reporting a dichotomous, categorical outcome. FI and rFI (event reversals influencing outcome significance) and FQ (standardized fragility) were calculated and reported as median. Subgroup analysis was performed based on intervention types.RESULTS:
Among the 127 studies screened, 56 RCTs with 579 outcomes were included. The median FI stood at 4 (3-5) and FQ was 0.04 (0.03-0.07). Only 101 outcomes were statistically significant with a median FI of 3 (1-6) and FQ of 0.04 (0.02-0.08). The nonsignificant outcomes had a median FI of 4 (3-5) and FQ of 0.04 (0.03-0.07). Notably, 26% of the outcomes had several patients lost to follow up equal to or surpassing the FI. Based on the intervention type, the median FIs showed minor fluctuations but remained low.CONCLUSIONS:
Outcomes from ADM-related RCTs were statistically fragile. Slight outcome reversals or maintenance of patient follow-up can alter the significance of results. Therefore, future researchers are recommended to jointly report FI, FQ, and P-values to offer a comprehensive view of the robustness in ADM literature.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Derme Acelular
Limite:
Humans
Idioma:
En
Revista:
J Plast Reconstr Aesthet Surg
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Estados Unidos