Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Jul 14;18(1):325.
doi: 10.1186/s13063-017-2042-0.

Twin-Twin Transfusion Syndrome: Study Protocol for Developing, Disseminating, and Implementing a Core Outcome Set

Affiliations
Free PMC article

Twin-Twin Transfusion Syndrome: Study Protocol for Developing, Disseminating, and Implementing a Core Outcome Set

Asma Khalil et al. Trials. .
Free PMC article

Abstract

Background: Twin-Twin Transfusion Syndrome (TTTS) is associated with an increased risk of perinatal mortality and morbidity. Several treatment interventions have been described for TTTS, including fetoscopic laser surgery, amnioreduction, septostomy, expectant management, and pregnancy termination. Over the last decade, fetoscopic laser surgery has become the primary treatment. The literature to date reports on many different outcomes, making it difficult to compare results or combine data from individual studies, limiting the value of research to guide clinical practice. With the advent and ongoing development of new therapeutic techniques, this is more important than ever. The development and use of a core outcome set has been proposed to address these issues, prioritising outcomes important to the key stakeholders, including patients. We aim to produce, disseminate, and implement a core outcome set for TTTS.

Methods: An international steering group has been established to oversee the development of this core outcome set. This group includes healthcare professionals, researchers and patients. A systematic review is planned to identify previously reported outcomes following treatment for TTTS. Following completion, the identified outcomes will be evaluated by stakeholders using an international, multi-perspective online modified Delphi method to build consensus on core outcomes. This method encourages the participants towards consensus 'core' outcomes. All key stakeholders will be invited to participate. The steering group will then hold a consensus meeting to discuss results and form a core outcome set to be introduced and measured. Once core outcomes have been agreed, the next step will be to determine how they should be measured, disseminated, and implemented within an international context.

Discussion: The development, dissemination, and implementation of a core outcome set in TTTS will enable its use in future clinical trials, systematic reviews and clinical practice guidelines. This is likely to advance the quality of research studies and their effective use in order to guide clinical practice and improve patient care, maternal, short-term perinatal outcomes and long-term neurodevelopmental outcomes.

Trial registration: Core Outcome Measures in Effectiveness Trials (COMET), 921 Registered on July 2016. International Prospective Register of Systematic Reviews (PROSPERO), CRD42016043999 . Registered on 2 August 2016.

Keywords: Core outcome set; Modified Delphi method; Twin–Twin Transfusion Syndrome.

Conflict of interest statement

Ethics approval and consent to participate

Not required.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Stages of developing a core outcome set for Twin–Twin Transfusion Syndrome

Similar articles

See all similar articles

Cited by 3 articles

References

    1. Quintero RA, Morales WJ, Allen MH, Bornick PW, Johnson PK, Kruger M. Staging of twin-twin transfusion syndrome. J Perinatol. 1999;19:550–5. doi: 10.1038/sj.jp.7200292. - DOI - PubMed
    1. Roberts D, Gates S, Kilby M, Neilson JP. Interventions for twin–twin transfusion syndrome: a Cochrane review. Ultrasound Obstet Gynecol. 2008;3:701–11. doi: 10.1002/uog.5328. - DOI - PubMed
    1. Roberts D, Neilson JP, Kilby MD, Gates S. Interventions for the treatment of twin–twin transfusion syndrome. Cochrane Database Syst Rev. 2014,Issue 1. Art. No.: CD002073. - PubMed
    1. Karatza AA, Wolfenden JL, Taylor MJO, Wee L, Fisk NM, Gardiner HM. Influence of twin-twin transfusion syndrome on fetal cardiovascular structure and function: prospective case–control study of 136 monochorionic twin pregnancies. Heart. 2002;88:271–7. doi: 10.1136/heart.88.3.271. - DOI - PMC - PubMed
    1. Herberg U, Gross W, Bartmann P, Banek CS, Hecher K, Breuer J. Long term cardiac follow up of severe twin to twin transfusion syndrome after intrauterine laser coagulation. Heart. 2006;92:95–100. doi: 10.1136/hrt.2004.057497. - DOI - PMC - PubMed

Publication types

Feedback