• BMJ open · Nov 2017

    Core Outcome Sets in Miscarriage Trials (COSMisT) study: a study protocol.

    • Paul Smith, Natalie Cooper, Rima Dhillon-Smith, Emily O'Toole, T Justin Clark, and Arri Coomarasamy.
    • Academic Department, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham Women's Hospital, Birmingham, West Midlands, UK.
    • BMJ Open. 2017 Nov 16; 7 (11): e018535.

    Introduction'Core outcome sets' are an agreed, standardised set of outcomes based on what key stakeholders (clinicians, patients, their partners, researchers, service developers, funding organisations and so on) consider the important outcomes in the management or prevention of a condition. This paper describes the rationale and design for the development of Core Outcome Sets for Miscarriage Trials.Methods And AnalysisSystematic reviews, interviews and focus groups with patients and their partners will be conducted to identify potential core outcomes that will be introduced into a modified Delphi survey. To ensure all key stakeholders are included, patients, partners, clinicians, charities and researchers will be invited to take part in the modified Delphi survey. There will be three rounds of scoring and rescoring during the Delphi survey to reach consensus regarding outcomes to be included in the core set, which will be subsequently refined through face-to-face consensus discussions.Ethics And DisseminationThe use of core outcome sets allows results from different studies to be compared and combined, thereby reducing inconsistency and aiding interpretation of study findings. It also means research is more likely to report relevant outcomes and so can reduce reporting bias. Understanding which outcomes are important to patients has the potential to act as a driver to improve both the quality and cost-effectiveness of miscarriage services.© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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