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

Abstract

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.

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“…In conclusion, this review adds to current evidence, suggesting women with vitamin D deficiency are at increased risk of miscarriage in addition to other serious reproductive and pregnancy outcomes (6,7,60). While our findings strongly endorse future large, well-powered prospective vitamin D supplementation studies, we recommend that these use a predefined and consistent set of clinically meaningful definitions and outcomes agreed internationally to specifically target miscarriage prevention (61). We anticipate that whether preconception vitamin D status differentially affects the first and second trimester loss outcomes individually for women with RM and spontaneous loss is likely an important clinical question that remains unanswered.…”

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“…We encountered a high degree of varied outcome reporting which significantly hindered effective evidence synthesis. Future studies should adopt standardized reporting of core outcomes as per published core sets for miscarriage, fertility and pregnancy to enable more efficient evidence synthesis and reduce research wastage ( Smith et al , 2017 ; Duffy et al , 2020b , 2020a ).…”

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“…The next challenge is to address poor outcome reporting by developing a core outcome set for planned mode of birth. By selecting key outcomes from a core outcome set and using appropriate outcome measures, future studies can reduce inconsistency for outcome reporting, and can thereby improve clinical usefulness of studies 8 . Core outcome sets may be developed with use of the modified Delphi survey where key stakeholders including patients are involved in selecting important reporting outcomes, followed by consensus discussions 8,23 .…”

“…By selecting key outcomes from a core outcome set and using appropriate outcome measures, future studies can reduce inconsistency for outcome reporting, and can thereby improve clinical usefulness of studies 8 . Core outcome sets may be developed with use of the modified Delphi survey where key stakeholders including patients are involved in selecting important reporting outcomes, followed by consensus discussions 8,23 . The Core Outcome Measures in Effectiveness Trials (COMET) initiative advocate for patient and public involvement in the development of core outcome sets because their contribution towards the understanding of important outcomes is essential in the development of patient-centred core outcome sets 9 .…”

“…Core outcome sets capture the key outcomes based on what key stakeholders (clinicians, patients, their partners, researchers, service developers, funding organisations) consider important in the management or prevention of a condition 8,9 . Ideally, the primary outcome and other outcomes of a trial will be selected from a core outcome set if available, but researchers may continue to explore other outcomes and are not restricted to the outcomes in the core outcome set 9 .The RCOG and Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) has formed the Core Outcomes in Women's and Newborn's Health (CROWN) initiative, which is supported by 80 journals, to tackle unwarranted variation in outcome reporting by encouraging the publication of studies reporting outcomes from a core outcome set where available 10,11 .…”