A systematic review of core outcome sets in women’s and newborn health

By Louisa Waite

BJOG  has recently published a systematic review, which evaluates the progress of the CROWN initiative and the development of core outcome sets for women’s and newborn health. It found that 49 core outcome sets have been registered, 50% of which are funded. Four core outcome sets have been published, along with 7 protocols and 20 systematic reviews.

Find out more in the following video abstract and podcast.

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Posted in Core Outcome Set, Uncategorized

First steps in development of core outcome set – ethical approval

By Natalie Cooper

A key element of a core outcome set (COS) is patient and public involvement; after all, it is patients and their families who struggle and suffer from an illness, so who better to help us identify which outcomes are most important. To this end, we need to ensure that we are protecting our patient and public participants by obtaining appropriate ethical approvals.

It has been debated whether patients and the public involved in COS development are part of a survey or part of a research project. It is now accepted that patients or public who give their opinions about which outcomes are most important are contributing ‘results’ to the project- and should be considered as research participants. COMET has produced a document which discusses ethical approval and what you might need to do (Research ethics considerations for core outcome set studies with patients). There clearly are aspects of COS development where patients need to be protected, for example, in patient workshops, we are expecting them to discuss what could be a very serious or sensitive condition. There is a risk that we might provoke upset or anxiety and although patients may have signed up to help they might not have considered these possible effects. We may be expecting these participants to voice their opinions in front of health professionals or experts in the field which could be an intimidating situation where we need to ensure that they are appropriately supported.

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Posted in Core Outcome Set, Gynaecology, Researcher Perspective

Tips on how to promote your core outcome set

By Louisa Waite

The hard work seems to be over. You’ve spent numerous hours planning, conducting and writing up your research. You’ve submitted to a journal, done the necessary revisions, and received the elusive acceptance email. You must be done right? Wrong.

Ensure your work makes a splash (Pexels CC0 license)

Core outcome sets are incredibly important to the progress of women’s health research. But only if they are read by other researchers and (most of all!) implemented into the future study design. And as every researcher knows, the scholarly publishing landscape is remarkably busy.

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Posted in Uncategorized

Core Outcome Set for Hirschsprung’s Disease – The NETS1HD Study

By Benjamin Allin

Edited by Ewelina Rogozińska

Hirschsprung’s disease affects approximately 300-350 children in the UK each year and is caused by the failure of development of the nerves within the intestines. Affected children require an operation to remove part of the bowel early in infancy, and there are several different ways of performing this operation. At the moment, when comparing treatments, researchers usually report on short-term markers of success such as operative time, as opposed to longer term, patient-centered outcomes such as fecal incontinence. There is also a great variation in the outcomes reported by individual studies (Allin et al. 2016). Both of these factors have made it impossible to reliably identify which operation has the best outcomes.

Developing and implementing a core outcome set (COS) will increase the ability of researchers to identify whether there are differences in outcome between the operations, thereby allowing development of evidence-based management guidelines. Ultimately this will help to improve the care offered to children with the condition and lead to better health outcomes.

The aim of the NETS1HD study was to develop a core outcome set that would address these issues, and increase the likelihood of researchers being able to identify a gold standard treatment for children with Hirschsprung’s disease.

This is the first pediatric surgical core outcome set that has been developed, and as a result, the biggest challenge we faced was in gaining initial ‘buy in’ from the clinical community. Engaging with groups such as the British Association of Paediatric Surgeons and the UK Paediatric Colorectal Group helped to overcome initial skepticism, and we hope that upcoming presentations of the study, along with its planned used in a UK-wide cohort study, will help to demonstrate the utility of core outcome sets to the wider clinical community.  

The key to achieving a useful COS is ensuring that participants fully understand the factors that should be considered when deciding how important each outcome is. Throughout the process, we have honed the language that we use to explain the different concepts that people should consider, particularly when balancing frequency of an outcome against the severity of the outcome. Throughout the NETS1HD study we used written material to explain the scoring process to participants, but after undertaking a review of the process have decided that it would be beneficial to present this material using video clips embedded within the Delphi process.

The NETS1HD core outcome set is a completed project and its results will be published in due course. 

 

 

Mr Benjamin Allin is a National Institute for Health Research Doctoral Research Fellow and Paediatric Surgical Registrar based at National Perinatal Epidemiology Unit, Nuffield Department of Population Health and Nuffield Department of Surgical Sciences, University of Oxford

Web: www.npeu.ox.ac.uk/nets
Twitter: @NPEU_NETS
Email: Benjamin.allin@npeu.ox.ac.uk.

 

Posted in Core Outcome Set, Researcher Perspective

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?

Image source: https://clipartfest.com

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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.

ephect-and-crownv2

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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.

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