TY - JOUR
T1 - A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia
AU - Duffy, James M.N.
AU - van ‘t Hooft, Janneke
AU - Gale, Chris
AU - Brown, Mark
AU - Grobman, William
AU - Fitzpatrick, Ray
AU - Karumanchi, S. Ananth
AU - Lucas, Nuala
AU - Magee, Laura
AU - Mol, Ben
AU - Stark, Michael
AU - Thangaratinam, Shakila
AU - Wilson, Mathew
AU - von Dadelszen, Peter
AU - Williamson, Paula
AU - Khan, Khalid S.
AU - Ziebland, Sue
AU - McManus, Richard J.
N1 - Funding Information:
This report is independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research (NIHR). 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.
Publisher Copyright:
© 2016 International Society for the Study of Hypertension in Pregnancy
PY - 2016/10/1
Y1 - 2016/10/1
N2 - Background Pre-eclampsia is a serious complication of pregnancy and contributes to maternal and offspring mortality and morbidity. Randomised controlled trials evaluating therapeutic interventions for pre-eclampsia have reported many different outcomes and outcome measures. Such variation contributes to an inability to compare, contrast, and combine individual studies, limiting the usefulness of research to inform clinical practice. The development and use of a core outcome set would help to address these issues ensuring outcomes important to all stakeholders, including patients, will be collected and reported in a standardised fashion. Methods An international steering group including healthcare professionals, researchers, and patients, has been formed to guide the development of this core outcome set. Potential outcomes will be identified through a comprehensive literature review and semi-structured interviews with patients. Potential core outcomes will be entered into an international, multi-perspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and patients will be invited to participate. The modified Delphi method encourages whole and stakeholder group convergence towards consensus ‘core’ outcomes. Once core outcomes have been agreed upon it is important to determine how they should be measured. The truth, discrimination, and feasibility assessment framework will assess the quality of potential outcome measures. High quality outcome measures will be associated with core outcomes. Mechanisms exist to disseminate and implement the resulting core outcome set within an international context. Discussion Embedding the core outcome set within future clinical trials, systematic reviews, and clinical practice guidelines could make a profound contribution to advancing the usefulness of research to inform clinical practice, enhance patient care, and improve maternal and offspring outcomes. The infrastructure created by developing a core outcome set for pre-eclampsia could be leveraged in other settings, for example selecting research priorities and clinical practice guideline development. Prospective registration [1] Core Outcome Measures in Effectiveness Trials (COMET) registration number: 588. [2] International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42015015529.
AB - Background Pre-eclampsia is a serious complication of pregnancy and contributes to maternal and offspring mortality and morbidity. Randomised controlled trials evaluating therapeutic interventions for pre-eclampsia have reported many different outcomes and outcome measures. Such variation contributes to an inability to compare, contrast, and combine individual studies, limiting the usefulness of research to inform clinical practice. The development and use of a core outcome set would help to address these issues ensuring outcomes important to all stakeholders, including patients, will be collected and reported in a standardised fashion. Methods An international steering group including healthcare professionals, researchers, and patients, has been formed to guide the development of this core outcome set. Potential outcomes will be identified through a comprehensive literature review and semi-structured interviews with patients. Potential core outcomes will be entered into an international, multi-perspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and patients will be invited to participate. The modified Delphi method encourages whole and stakeholder group convergence towards consensus ‘core’ outcomes. Once core outcomes have been agreed upon it is important to determine how they should be measured. The truth, discrimination, and feasibility assessment framework will assess the quality of potential outcome measures. High quality outcome measures will be associated with core outcomes. Mechanisms exist to disseminate and implement the resulting core outcome set within an international context. Discussion Embedding the core outcome set within future clinical trials, systematic reviews, and clinical practice guidelines could make a profound contribution to advancing the usefulness of research to inform clinical practice, enhance patient care, and improve maternal and offspring outcomes. The infrastructure created by developing a core outcome set for pre-eclampsia could be leveraged in other settings, for example selecting research priorities and clinical practice guideline development. Prospective registration [1] Core Outcome Measures in Effectiveness Trials (COMET) registration number: 588. [2] International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42015015529.
KW - Core outcome set
KW - Modified Delphi method
KW - Pre-eclampsia
KW - Semi-structured interviews
KW - Systematic review
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U2 - 10.1016/j.preghy.2016.04.008
DO - 10.1016/j.preghy.2016.04.008
M3 - Article
C2 - 27939467
AN - SCOPUS:84971280210
SN - 2210-7789
VL - 6
SP - 274
EP - 278
JO - Pregnancy Hypertension
JF - Pregnancy Hypertension
IS - 4
ER -