Variation in outcome reporting in randomised controlled trials of interventions for the prevention and treatment of fetal growth restriction
Variation in outcome reporting in randomised controlled trials of interventions for the prevention and treatment of fetal growth restriction
Objective
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.
Methods
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.
Results
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.
Conclusions
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.
598-608
Townsend, Rosemary
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Sileo, Filomena
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Stocker, Linden
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Kumbay, Hafsah
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Healy, Patricia
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Gordijn, Sanne
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Ganzevoort, Wessel
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Beune, Irene
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Baschat, Ahmet
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Kenny, Louise
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Bloomfield, Frank
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Daly, Mandy
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Devane, Declan
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Papageorghiou, Aris T.
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Khalil, Asma
6954aa6c-ddd6-4205-976e-fe834c6a860d
May 2019
Townsend, Rosemary
25b2db46-b259-46d5-92d3-2b2cef02f021
Sileo, Filomena
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Stocker, Linden
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Kumbay, Hafsah
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Healy, Patricia
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Gordijn, Sanne
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Ganzevoort, Wessel
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Beune, Irene
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Baschat, Ahmet
cd6499c4-65c2-4253-b507-45599186b48f
Kenny, Louise
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Bloomfield, Frank
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Daly, Mandy
da2d9c34-9251-4c49-8e09-03a23ce246c9
Devane, Declan
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Papageorghiou, Aris T.
48974657-d399-4f7f-8b8b-5b9174b8fefa
Khalil, Asma
6954aa6c-ddd6-4205-976e-fe834c6a860d
Townsend, Rosemary, Sileo, Filomena, Stocker, Linden, Kumbay, Hafsah, Healy, Patricia, Gordijn, Sanne, Ganzevoort, Wessel, Beune, Irene, Baschat, Ahmet, Kenny, Louise, Bloomfield, Frank, Daly, Mandy, Devane, Declan, Papageorghiou, Aris T. and Khalil, Asma
(2019)
Variation in outcome reporting in randomised controlled trials of interventions for the prevention and treatment of fetal growth restriction.
Ultrasound in Obstetrics & Gynecology, 53 (5), .
(doi:10.1002/uog.20189).
Abstract
Objective
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.
Methods
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.
Results
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.
Conclusions
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.
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More information
Accepted/In Press date: 22 November 2018
e-pub ahead of print date: 6 December 2018
Published date: May 2019
Identifiers
Local EPrints ID: 428001
URI: http://eprints.soton.ac.uk/id/eprint/428001
ISSN: 0960-7692
PURE UUID: 506b10fc-8d12-4f54-aab2-b3a4cd5ba870
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Date deposited: 06 Feb 2019 17:30
Last modified: 16 Mar 2024 07:32
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Contributors
Author:
Rosemary Townsend
Author:
Filomena Sileo
Author:
Linden Stocker
Author:
Hafsah Kumbay
Author:
Patricia Healy
Author:
Sanne Gordijn
Author:
Wessel Ganzevoort
Author:
Irene Beune
Author:
Ahmet Baschat
Author:
Louise Kenny
Author:
Frank Bloomfield
Author:
Mandy Daly
Author:
Declan Devane
Author:
Aris T. Papageorghiou
Author:
Asma Khalil
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