Core outcomes in women’s health, a road map to better research

By Bassel H. Al Wattar
Edited by Ewelina Rogozińska

The last two decades have witnessed a major shift towards evidence-based medicine in clinical practice. Aiming to benefit patients and improve health outcomes, our investment in clinical research and its applicability grew larger. Despite this, the movement of Evidence-Based Medicine (EBM) faces serious challenges. The limitations to combine, contrast, and synthesis available evidence due to the large variations in reported outcomes are hindering meaningful evidence synthesis and reducing research’s impact on everyday practice. This is where core outcome sets (COS) are greatly needed.

The challenge in women’s health, in particular, is great. Unlike other speciality, the provision of care to women is lifelong (from menarche to menopause), predictable (sexual health and reproductive medicine) and impact the whole society (extending to offspring and families). Care for women is often shared between multiple specialists (gynaecologists, GPs, physicians, etc.) in a various health setting (primary, secondary and tertiary). All these factors contribute to further variation increasing the need for harmonising and standardising the reporting of research findings.

Developing COS is still in its early days. Championed by many pioneer initiatives (such as COMET and CROWN), many challenges still lie ahead. Standardising COS generation methods, harmonising reporting tools and active integration are but a few. Furthermore, revision of available COS given new developments in medicine (such as new treatments) is an unavoidable future task.

Integrating COS into research is a hard task. Recently our collaborative working on the EMPIRE trial (Antiepileptic drug management in pregnancy: an evaluation of effectiveness, cost-effectiveness, and acceptability of dose adjustment strategies) have realised the need for a multi-stakeholder COS to report its findings on the management of epilepsy in pregnancy. Care for pregnant women with epilepsy is shared among many health specialists such as obstetricians, neurologists, neonatologists and specialist epilepsy nurses. As a chronic condition, the impact of epilepsy on the women’s quality of life is significant and often under investigated in research studies.

This prompted our efforts to develop a COS incorporating the input of all stakeholders involved in caring for pregnant women with epilepsy. Our recently developed COS (Al Wattar et al 2016 BJOG) has identified 31 core outcomes as important and will be used to report the findings of the EMPIRE trial.

Reducing research wastage and improving transferability is a massive endeavour; still, the journey of a thousand miles starts with one COS at a time!

Posted in Core Outcome Set, Epilepsy in pregnancy, Researcher Perspective