Getting and keeping your stakeholders on board – tips from the “battle” ground

By Ewelina Rogozińska

You passed the first stage, you have your protocol in place, you’ve gone through publications, extracted numerous outcomes and you are almost ready to send your polished survey around to all relevant stakeholders. But how to find them? Where and how to recruit them? And last but not least, how to retain them in your survey?

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Posted in Researcher Perspective

A winding road to funding – story of a core outcome set for endometriosis trials

By Dr Martin Hirsch

I was fresh faced and green behind the ears when I first heard about core outcome sets in 2013. Fast forward three years and I have been on a journey getting this, the first core outcome set in benign gynaecology, to the launch of its Delphi survey (Click to register). A shameless plug I know. Endometriosis is a special disease. It is believed to affect up to 10% of reproductive-aged women with associated pelvic pain and subfertility, yet we know so little about it. Our poor understanding of this enigmatic disease has resulted in multi-directional research in the quest for novel treatments. This gold hunt for clinical improvements has resulted in outcome reporting variation which prohibits evidence synthesis and guideline formation hindering advances of patient care.

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Posted in Core Outcome Set, Endometriosis, Gynaecology, Researcher Perspective

CROWN initiative – 2016 in review and what is ahead?

By Ewelina Rogozińska

December tends to be a month of annual reviews and planning for the New Year ahead. I felt it would be good to reflect on the passing year to see how far the initiative has progressed and, foremost, where we are heading.

The CROWN Initiative had its official launch in November 2014 at the COMET IVth meeting. Nevertheless, it wasn’t until late 2015 that it could properly spread its wings thanks to the grant from the British Medical Association that included funding for the administrative support. The BMA grant allowed promotion of the CROWN activities, to raise awareness about ongoing core outcome set projects, and disseminate the core outcome set for prematurity trials (van ‘t Hooft et al 2016) developed with the involvement of the CROWN journal editors.

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Posted in Uncategorized

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

Harmonized safety monitoring of immunisation in pregnancy: the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project

By Linda Eckert and Sonali Kochar
Edited by Ewelina Rogozińska

Maternal immunisation (MI) is a rapidly evolving field. The safety of vaccines in pregnancy is a key consideration for pregnant women, healthcare providers, vaccine manufacturers, regulators and ethics committees. There is a need for a globally concerted approach to harmonise and actively monitor the safety of vaccines and global immunisation programs.gaia_final-logo

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Posted in Global Initiatives, Immunisation, Standardised definitions

CROWN & EPHect to promote and improve standards in endometriosis research

By Ewelina Rogozińska and Krina Zondervan

On 8th September, as a CROWN Coordinator, I had a pleasure to talk about the initiative during the 4th meeting of the UK Endometriosis Network. This annual event aims to bring together researchers in the UK involved in endometriosis research ranging from basic medical science to clinical trials. This year, the event was organised by the Oxford-based team led by Prof Christian Becker, Dr Katy Vincent and Prof Krina Zondervan.


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Posted in Endometriosis, Global Initiatives

CROWN & Cochrane Gynaecology and Fertility Group – a core outcome sets the way to reduce research waste

By James MN Duffy

Edited by Ewelina Rogozińska

The Cochrane Fertility and Gynaecology Group brings together researchers undertaking clinical trials and observational studies in the field of reproductive medicine and gynaecology from around the world.

The issue of establishing core outcome sets is of foremost concern to the Cochrane Gynaecology and Fertility Group, and this was clearly visible during the symposium. Prof Andy Vail, University of Manchester, discussed the challenges of outcome reporting bias in Cochrane reviews. Jack Wilkinson, University of Manchester described his work relating to the reporting and misuse of outcomes reported by fertility centres. Malou Herman, Maxima Medical Centre, the Netherlands, presented her systematic review mapping outcome reporting across heavy menstrual bleeding trials (Herman et al. 2016 BJOG). Prof Ben Mol, University of Adelaide, discussed the CROWN initiative as one of the future opportunities for the Cochrane group to secure its 2020 vision, and Prof Siladitya Bhattacharya, University of Aberdeen, described the importance of standardising outcomes and outcome measures in his filling the evidence gaps in reproductive medicine presentation. This is a great momentum we should build on.

Despite the escalation in research activity and an exponential rise in published papers, many of the fundamental questions in subfertility and benign gynaecology remain. One of the key reasons for this is research waste due to unwarranted variation in outcome collection and reporting. A global effort is urgently needed to link evidence synthesis with primary evaluative research which should deliver research which improves the quality of health care.

Posted in event brief

Why I got involved in a core outcome set project? – researcher’s perspective

By Janneke van’t Hooft

Edited by Ewelina Rogozińska

Some questions require such large sample sizes that they cannot be answered unless primary data from multiple studies are combined. One example of such a situation is the use of preventive treatment of preterm birth like progesterone, cerclage or pessary.

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Posted in Core Outcome Set, preterm birth, Researcher Perspective

Breakfast with The CROWN Initiative at RCOG Congress 2016 in Birmingham

by Ewelina Rogozińska

Despite the early hour, we had an impressive turnout! The session was a triple act of Prof Khan, Prof Chescheir and Dr Duffy. Dr Duffy opened the meeting with a brief introduction and a short ice-breaker activity. The first presentation by Prof Khan gave an insight into CROWN Initiative origins and a vision for the future with core outcome sets (COS) to become a vital element of the research landscape in Women’s Health by 2030.

2030 Vision

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Posted in event brief Tagged with: , ,

First steps towards core outcomes in obstetrics

by Janneke van’t Hooft

There is a widespread, unwarranted variation in reporting of outcomes in evaluation research.(1) As heterogeneity in outcomes and their measurements slows down the process of evidence synthesis and uptake, there  now seems to be a mounting interest in recent years, reflected by several publications in high impact journals, emphasising the need for standardising outcome sets as a potential solution.(2-3) In this blog, I will provide a broad overview on the movement of Core Outcome sets in the obstetrical field.

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Posted in Core Outcome Set, preterm birth

Updates from CROWN

by Janneke van’t Hooft and Zinah Sorefan

CROWN postcard updated













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Posted in Core Outcome Set, Get Involved, preterm birth