Methodological decisions influence the identification of potential core outcomes in studies related to pre-eclampsia: an analysis informing the development of recommendations for future core outcome set developers

International Collaboration to Harmonise Outcomes in Pre-eclampsia (iHOPE)

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13 Citations (Scopus)

Abstract

Objective: To quantify the effect of different methodological decisions on the identification of potential core outcomes to inform the development of recommendations for future core coutcome set developers. Design: Mixed methods study. Setting: A core outcome set for pre-eclampsia was used as an exemplar. Sample: A long list of potential core outcomes was developed by undertaking a systematic review of pre-eclampsia trials and performing a thematic analysis of in-depth patient interviews. Methods: Specific methods used to generate long lists of potential core outcomes were evaluated. Results: Different methodological decisions had a substantial impact on the identification of potential core outcomes. Extracting outcomes from published pre-eclampsia trials was an effective way of identifying 48 maternal, eight fetal, 25 neonatal outcomes, and eight patient-reported outcomes. Limiting the extraction of outcomes to primary outcomes or outcomes commonly reported in pre-eclampsia trials reduced the number and diversity of potential core outcomes identified. Thematic analysis of in-depth patient interviews ensured an additional five patient reported outcomes and six outcomes related to future child health were identified. Conclusions: Future core outcome set developers should use quantitative and qualitative methods when developing a long list of potential core outcomes. Tweetable abstract: @OfficialNIHR research published in @BJOGtweets informs new recommendations for future @coreoutcomes developers.

Original languageEnglish
Pages (from-to)1482-1490
Number of pages9
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume126
Issue number12
Early online date5 Sept 2019
DOIs
Publication statusPublished - 1 Nov 2019

Bibliographical note

Funding
This report is independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research. The National Institute for Health Research had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Acknowledgements
This report is independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research. Prof. Richard McManus was supported by a National Institute for Health Research Professorship and receives support from the National Institute for Health Research Oxford Collaborations for Leadership in Applied Health Research and Care. Prof. Richard McManus and Prof. Sue Ziebland are supported by National Institute for Health Research Senior Investigator awards. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research, or the Department of Health.

We would like to thank colleagues at the Women's Health Research Unit, Queen Mary, University of London including Khalid Khan, Tracy Holtham and Rehan Khan for administrative, technical support, and subject specific expertise. We would like to thank David J. Mills for administrative and material support.

Data Availability Statement

No data availability statement.

Keywords

  • Core outcome sets
  • outcomes
  • pre-eclampsia
  • qualitative interviews
  • systematic review

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