Core Outcome Measures in Effectiveness Trials

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

General Information

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

Authors:
Perry, H. Duffy, J. M. N. Umadia, O. Khalil, A. on behalf of the International Collaboration to Harmonise Outcomes for Twin-Twin Transfusion, Syndrome

Publication

Journal:
Ultrasound in Obstetrics and Gynecology
Volume:
Issue:
Pages:
-
Year:
2018
DOI:
Further Study Information

Date:
- August 2016
Funding source(s):
None reported

Health Area

Disease Category
Pregnancy & childbirth

Disease Name
Feto-fetal transfusion
Twin-Twin Transfusion Syndrome

Target Population

Age Range
0 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Systematic review

Stakeholders Involved

None

Study Type

Systematic review of outcomes measured in trials

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