Variation in outcome reporting in randomized controlled trials of interventions for prevention and treatment of fetal growth restriction.

Data Accuracy Female Fetal Growth Retardation / prevention & control Humans Pregnancy Randomized Controlled Trials as Topic / standards Research Design / standards
aspirin core outcome set fetal growth restriction randomized controlled trial research waste

Journal

Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology
ISSN: 1469-0705
Titre abrégé: Ultrasound Obstet Gynecol
Pays: England
ID NLM: 9108340

Informations de publication

Date de publication:
May 2019
Historique:
received: 31 07 2018
revised: 13 11 2018
accepted: 22 11 2018
pubmed: 14 12 2018
medline: 25 12 2019
entrez: 8 12 2018
Statut: ppublish

Résumé

Although fetal growth restriction (FGR) is well known to be associated with adverse outcomes for the mother and offspring, effective interventions for the management of FGR are yet to be established. Trials reporting interventions for the prevention and treatment of FGR may be limited by heterogeneity in the underlying pathophysiology. The aim of this study was to conduct a systematic review of outcomes reported in randomized controlled trials (RCTs) assessing interventions for the prevention or treatment of FGR, in order to identify and categorize the variation in outcome reporting. MEDLINE, EMBASE and The Cochrane Library were searched from inception until August 2018 for RCTs investigating therapies for the prevention and treatment of FGR. Studies were assessed systematically and data on outcomes that were reported in the included studies were extracted and categorized. The methodological quality of the included studies was assessed using the Jadad score. The search identified 2609 citations, of which 153 were selected for full-text review and 72 studies (68 trials) were included in the final analysis. There were 44 trials relating to the prevention of FGR and 24 trials investigating interventions for the treatment of FGR. The mean Jadad score of all studies was 3.07, and only nine of them received a score of 5. We identified 238 outcomes across the included studies. The most commonly reported were birth weight (88.2%), gestational age at birth (72.1%) and small-for-gestational age (67.6%). Few studies reported on any measure of neonatal morbidity (27.9%), while adverse effects of the interventions were reported in only 17.6% of trials. There is significant variation in outcome reporting across RCTs of therapies for the prevention and treatment of FGR. The clinical applicability of future research would be enhanced by the development of a core outcome set for use in future trials. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

Identifiants

DOI: 10.1002/uog.20189 PMID: 30523658
pubmed: 30523658
doi: 10.1002/uog.20189
doi:

Types de publication

Journal Article Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

598-608

Subventions

Organisme : Health Research Board Mother and Baby Clinical Trials Network Ireland
ID : (HRB-M&B-CTNI)

Informations de copyright

Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

Auteurs

R Townsend (R)

Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, London, UK.
Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK.
ORCID: 0000-0002-3438-7069

F Sileo (F)

Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, London, UK.
ORCID: 0000-0001-7380-0576

L Stocker (L)

Women and Children Division, University Hospital Southampton NHS Foundation Trust, Princess Anne Hospital, Southampton, UK.

H Kumbay (H)

GKT School of Medicine, King's College, London, UK.

P Healy (P)

Health Research Board - Trials Methodology Research Network, Galway, Ireland.
School of Nursing and Midwifery, NUI Galway, Galway, Ireland.

S Gordijn (S)

Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

W Ganzevoort (W)

Department of Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
ORCID: 0000-0002-7243-2115

I Beune (I)

Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

A Baschat (A)

Johns Hopkins Center for Fetal Therapy, Baltimore, MD, USA.
ORCID: 0000-0003-1927-2084

L Kenny (L)

The Irish Centre for Fetal and Neonatal Translational Research (INFANT), University College Cork, Cork, Ireland.

F Bloomfield (F)

Liggins Institute, University of Auckland, Auckland, New Zealand.

M Daly (M)

Advocacy and Policymaking, Irish Neonatal Health Alliance, Wicklow, Ireland.

D Devane (D)

Health Research Board - Trials Methodology Research Network, Galway, Ireland.
School of Nursing and Midwifery, NUI Galway, Galway, Ireland.

A Papageorghiou (A)

Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, London, UK.
Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK.
Nuffield Department of Women's & Reproductive Health, University of Oxford, John Radcliffe Hospital Women's Centre, Oxford, UK.
ORCID: 0000-0001-8143-2232

A Khalil (A)

Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, London, UK.
Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK.
ORCID: 0000-0003-2802-7670

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Classifications MeSH

questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Exactitude des données › Variation in outcome reporting in randomized...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Troubles de la croissance › Retard de croissance intra-utérin › Variation in outcome reporting in randomized...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Variation in outcome reporting in randomized...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Reproduction › Grossesse › Variation in outcome reporting in randomized...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Variation in outcome reporting in randomized...
questionsmedicales.fr › Disciplines des sciences naturelles › Science › Recherche › Plan de recherche › Variation in outcome reporting in randomized...