Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta-analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation.
MDR
audit
integrity
meta-analysis
pessary
singletons
twins
Journal
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics
ISSN: 1879-3479
Titre abrégé: Int J Gynaecol Obstet
Pays: United States
ID NLM: 0210174
Informations de publication
Date de publication:
13 Oct 2023
13 Oct 2023
Historique:
revised:
28
07
2023
received:
09
06
2023
accepted:
18
09
2023
medline:
13
10
2023
pubmed:
13
10
2023
entrez:
13
10
2023
Statut:
aheadofprint
Résumé
Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent. Our hypothesis suggests that adhering to the European Medical Device Regulation (MDR) and following the instructions for use are essential prerequisites for successful therapy. Conversely, the non-adherence to these guidelines will probably contribute to its failure. Based on validated criteria from integrity assessments we performed a systematic review identifying 14 RCTs evaluating the effect of cervical pessaries. We analyzed the implications of 14 criteria each accounting for 0-2 points of a score reflecting the clinical evaluation plan (CEP) as proposed by the MDR to evaluate the risk-benefit ratio of medical devices. Seven RCTs in each singleton and twin pregnancies (5193 "cases") were included, detecting a high heterogeneity within control groups (I Non-audited RCTs and meta-analyses mixing studies of different clinical quality as pre-defined by a CEP and the MDR pose the risk for erroneous conclusions.
Sections du résumé
BACKGROUND
BACKGROUND
Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent.
OBJECTIVES
OBJECTIVE
Our hypothesis suggests that adhering to the European Medical Device Regulation (MDR) and following the instructions for use are essential prerequisites for successful therapy. Conversely, the non-adherence to these guidelines will probably contribute to its failure.
SEARCH STRATEGY AND SELECTION CRITERIA
METHODS
Based on validated criteria from integrity assessments we performed a systematic review identifying 14 RCTs evaluating the effect of cervical pessaries.
DATA COLLECTION AND ANALYSIS
METHODS
We analyzed the implications of 14 criteria each accounting for 0-2 points of a score reflecting the clinical evaluation plan (CEP) as proposed by the MDR to evaluate the risk-benefit ratio of medical devices.
MAIN RESULTS
RESULTS
Seven RCTs in each singleton and twin pregnancies (5193 "cases") were included, detecting a high heterogeneity within control groups (I
CONCLUSION
CONCLUSIONS
Non-audited RCTs and meta-analyses mixing studies of different clinical quality as pre-defined by a CEP and the MDR pose the risk for erroneous conclusions.
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023 International Federation of Gynecology and Obstetrics.
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