Standardizing Abortion Research Outcomes (STAR): a protocol for developing, disseminating, and implementing a core outcome set for medical and surgical abortion

<h4>Background</h4> <p>Abortion is one of the most common events in women’s healthcare worldwide. Currently there is no standardization for the selection and reporting of outcomes in abortion clinical trials. This heterogeneity in clinical trials can make it difficult to draw mean...

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Main Authors: Duffy, J, Whitehouse, K, Kim, C, Ganatra, B, Blum, J, Brahmi, D, Creinin, M, DePiñeres, T, Gemzell-Danielsson, K, Grossman, D, Winikoff, B, Gülmezoglu, A
Format: Journal article
Published: Elsevier 2017
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author Duffy, J
Whitehouse, K
Kim, C
Ganatra, B
Blum, J
Brahmi, D
Creinin, M
DePiñeres, T
Gemzell-Danielsson, K
Grossman, D
Winikoff, B
Gülmezoglu, A
author_facet Duffy, J
Whitehouse, K
Kim, C
Ganatra, B
Blum, J
Brahmi, D
Creinin, M
DePiñeres, T
Gemzell-Danielsson, K
Grossman, D
Winikoff, B
Gülmezoglu, A
author_sort Duffy, J
collection OXFORD
description <h4>Background</h4> <p>Abortion is one of the most common events in women’s healthcare worldwide. Currently there is no standardization for the selection and reporting of outcomes in abortion clinical trials. This heterogeneity in clinical trials can make it difficult to draw meaningful conclusions across studies.</p> <h4>Objective</h4> <p>We aim to develop, disseminate, and implement a core outcome set (COS) for medical and surgical abortion trials.</p> <h4>Materials and Methods</h4> <p>To guide this project, we have assembled a local study management team and an international advisory group including abortion providers, researchers, methodologists, and abortion clients. A preliminary list of potential outcomes will be developed by undertaking a systematic review of abortion trials. A qualitative review will determine outcomes that are meaningful to women with experience of abortion. The modified Delphi method will use iterative group consensus to reduce the long list of outcomes. Participants in the modified Delphi method will include service-providers, researchers, clients, client advocates, and leaders of relevant medical journals and professional societies. Consensus on the COS will be reached via Delphi and a consensus meeting. Outcome measurements will be designated for each core outcome. Dissemination will be widespread including journals and professional societies. </p> <h4>Discussion</h4> <p>Results of this project will guide the development of future trials, advise trial reporting in collaborating journals, improve the strength of literature reviews and subsequent guidelines, and promote work in the field of COS development. Development and adoption of a COS in abortion would assist researchers in planning future trials, performing reviews, and creating guidelines or recommendations.</p>
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spelling oxford-uuid:ac651e3e-74a3-4462-a01c-245f0f10fcdf2022-03-27T03:28:43ZStandardizing Abortion Research Outcomes (STAR): a protocol for developing, disseminating, and implementing a core outcome set for medical and surgical abortionJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:ac651e3e-74a3-4462-a01c-245f0f10fcdfSymplectic Elements at OxfordElsevier2017Duffy, JWhitehouse, KKim, CGanatra, BBlum, JBrahmi, DCreinin, MDePiñeres, TGemzell-Danielsson, KGrossman, DWinikoff, BGülmezoglu, A <h4>Background</h4> <p>Abortion is one of the most common events in women’s healthcare worldwide. Currently there is no standardization for the selection and reporting of outcomes in abortion clinical trials. This heterogeneity in clinical trials can make it difficult to draw meaningful conclusions across studies.</p> <h4>Objective</h4> <p>We aim to develop, disseminate, and implement a core outcome set (COS) for medical and surgical abortion trials.</p> <h4>Materials and Methods</h4> <p>To guide this project, we have assembled a local study management team and an international advisory group including abortion providers, researchers, methodologists, and abortion clients. A preliminary list of potential outcomes will be developed by undertaking a systematic review of abortion trials. A qualitative review will determine outcomes that are meaningful to women with experience of abortion. The modified Delphi method will use iterative group consensus to reduce the long list of outcomes. Participants in the modified Delphi method will include service-providers, researchers, clients, client advocates, and leaders of relevant medical journals and professional societies. Consensus on the COS will be reached via Delphi and a consensus meeting. Outcome measurements will be designated for each core outcome. Dissemination will be widespread including journals and professional societies. </p> <h4>Discussion</h4> <p>Results of this project will guide the development of future trials, advise trial reporting in collaborating journals, improve the strength of literature reviews and subsequent guidelines, and promote work in the field of COS development. Development and adoption of a COS in abortion would assist researchers in planning future trials, performing reviews, and creating guidelines or recommendations.</p>
spellingShingle Duffy, J
Whitehouse, K
Kim, C
Ganatra, B
Blum, J
Brahmi, D
Creinin, M
DePiñeres, T
Gemzell-Danielsson, K
Grossman, D
Winikoff, B
Gülmezoglu, A
Standardizing Abortion Research Outcomes (STAR): a protocol for developing, disseminating, and implementing a core outcome set for medical and surgical abortion
title Standardizing Abortion Research Outcomes (STAR): a protocol for developing, disseminating, and implementing a core outcome set for medical and surgical abortion
title_full Standardizing Abortion Research Outcomes (STAR): a protocol for developing, disseminating, and implementing a core outcome set for medical and surgical abortion
title_fullStr Standardizing Abortion Research Outcomes (STAR): a protocol for developing, disseminating, and implementing a core outcome set for medical and surgical abortion
title_full_unstemmed Standardizing Abortion Research Outcomes (STAR): a protocol for developing, disseminating, and implementing a core outcome set for medical and surgical abortion
title_short Standardizing Abortion Research Outcomes (STAR): a protocol for developing, disseminating, and implementing a core outcome set for medical and surgical abortion
title_sort standardizing abortion research outcomes star a protocol for developing disseminating and implementing a core outcome set for medical and surgical abortion
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