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Core Outcome Set for trials into Miscarriage Prevention (COSMisTPrevention)  – an international collaboration

Miscarriage is generally defined as the loss of a pregnancy before viability (around 22-24weeks gestation). An estimated 23million miscarriages occur every year worldwide. The physical, psychological and financial consequences of miscarriage can be devastating. Although miscarriages are common, they remain poorly understood and there is a great deal of research focused on improving prevention, treatment and services for this condition.

Clinical trials, systematic reviews and guidelines have compared various interventions for the prevention and management of miscarriage. However, studies on miscarriage often do not address the same outcomes, making it difficult to draw conclusions when the evidence is synthesised. Thus, a standardised collection of relevant outcomes is needed to aid the interpretation of study findings and improve miscarriage care and services. This can be achieved through the development of a ‘core outcome set’.

 

What is a core outcome set and why is it needed?

Core outcome sets are an agreed, standardised set of outcomes based on what key stakeholders (clinicians, patients, their partners, researchers, service developers and so on) consider the important outcomes in the management or prevention of a condition. Outcomes can include a wide range of effects like quality of life, side-effects from medications, days off work, bleeding, pain etc. Core outcomes are disease-specific and take into account both the potential benefits and harms of interventions. The use of core outcome sets reduces inconsistencies, allowing results from different studies to be compared and combined. It also means research is more likely to report relevant outcomes and reporting bias may be minimised.

This survey is aimed at creating an internationally applicable set of core outcomes in miscarriage prevention to guide and standardise all future research, subsequently improving miscarriage care globally.

 

How can I contribute?

We are inviting you to participate in three rounds of surveys in which you will be asked to rank which outcomes you consider most important. Each survey will take approximately 15 minutes. In the first-round survey you will be invited to suggest additional outcomes which you feel should be considered. Any additional outcomes will be considered and potentially included for review in round two. In round two, you will be asked to reflect upon any similarities or differences between your scores and your relevant stakeholder group score, and then score each outcome again. A final consensus panel consisting of international experts will review the results and aim to develop a final core outcome set for miscarriage prevention trials.

Please be aware that within this survey there are terms and phrases that may be upsetting reminders, it is important to seek support if needed. It is also particularly important to take part in all three rounds of the study.

Thank you for your participation in this study. Your contribution will be crucial to any future research in miscarriage prevention.

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All DelphiManager data is stored on a secure server in the University of Liverpool data centre. For more information please contact delphimg@liverpool.ac.uk