Outcome reporting across randomized trials and observational studies evaluating treatments for twin-twin transfusion syndrome: systematic review

H Perry; J M N Duffy; O Umadia; A Khalil; International Collaboration to Harmonise Outcomes for Twin-Twin Transfusion Syndrome (CHOOSE)

doi:10.1002/uog.19068

Outcome reporting across randomized trials and observational studies evaluating treatments for twin-twin transfusion syndrome: systematic review

Ultrasound Obstet Gynecol. 2018 Nov;52(5):577-585. doi: 10.1002/uog.19068. Epub 2018 Sep 24.

Authors

H Perry^{1

2}, J M N Duffy^{3

4}, O Umadia², A Khalil^{1

2}; International Collaboration to Harmonise Outcomes for Twin-Twin Transfusion Syndrome (CHOOSE)

Affiliations

¹ Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK.
² Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, University of London, London, UK.
³ Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.
⁴ Balliol College, University of Oxford, Oxford, UK.

PMID: 29607558
DOI: 10.1002/uog.19068

Abstract

Objective: Twin-twin transfusion syndrome (TTTS) is associated with significant mortality and morbidity. Potential treatments for the condition require robust evaluation. The aim of this study was to evaluate outcome reporting across observational studies and randomized controlled trials assessing treatments for TTTS.

Methods: Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE were searched from inception to August 2016. Observational studies and randomized controlled trials reporting outcome following treatment for TTTS in monochorionic-diamniotic twin pregnancy and monochorionic-triamniotic or dichorionic-triamniotic triplet pregnancy were included. Outcome reporting was systematically extracted and categorized.

Results: Six randomized trials and 94 observational studies were included, reporting data from 20 071 maternal participants and 3199 children. Six different treatments were evaluated. Included studies reported 62 different outcomes, including six fetal, seven offspring mortality, 25 neonatal, six early childhood and 18 maternal/operative outcomes. Outcomes were reported inconsistently across trials. For example, when considering offspring mortality, 31 (31%) studies reported live birth, 31 (31%) reported intrauterine death, 49 (49%) reported neonatal mortality and 17 (17%) reported perinatal mortality. Four (4%) studies reported respiratory distress syndrome. Only 19 (19%) studies were designed for long-term follow-up and 11 (11%) of these reported cerebral palsy.

Conclusions: Studies evaluating treatments for TTTS have often neglected to report clinically important outcomes, especially neonatal morbidity outcomes, and most are not designed for long-term follow-up. The development of a core outcome set could help standardize outcome collection and reporting in TTTS studies. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

Keywords: core outcome set; outcome reporting bias; systematic review; twin-twin transfusion syndrome.

Publication types

Systematic Review

MeSH terms

Female
Fetofetal Transfusion / mortality
Fetofetal Transfusion / therapy*
Humans
Observational Studies as Topic
Outcome Assessment, Health Care*
Perinatal Care / standards*
Pregnancy
Pregnancy Outcome
Pregnancy, Twin
Randomized Controlled Trials as Topic