Open Access

The CROWN Initiative: journal editors invite researchers to develop core outcomes in women’s health

BMC Women's Health201414:75

DOI: 10.1186/1472-6874-14-75

Received: 29 May 2014

Accepted: 10 June 2014

Published: 3 July 2014

Abstract

Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole. This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention, which found that among 103 randomised trials, no fewer than 72 different outcomes were reported. There is a growing recognition among clinical researchers that this variability undermines consistent synthesis of the evidence, and that what is needed is an agreed standardised collection of outcomes - a “core outcomes set” - for all trials in a specific clinical area. Recognising that the current inconsistency is a serious hindrance to progress in our specialty, the editors of over 50 journals related to women’s health have come together to support The CROWN (CoRe Outcomes in WomeN’s health) Initiative.

Keywords

Research design/standards Treatment outcome Endpoint determination/standards Clinical trials Systematic reviews Guidelines Bias (Epidemiology) Evidence-based medicine Consensus
Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole [1]. This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention, which found that among 103 randomised trials, no fewer than 72 different outcomes were reported [2]. There is a growing recognition among clinical researchers that this variability undermines consistent synthesis of the evidence, and that what is needed is an agreed standardised collection of outcomes – a “core outcomes set” – for all trials in a specific clinical area [1]. Recognising that the current inconsistency is a serious hindrance to progress in our specialty, the editors of over 50 journals related to women’s health have come together to support The CROWN (CoRe Outcomes in WomeN’s health) Initiative (Figure 1).
https://static-content.springer.com/image/art%3A10.1186%2F1472-6874-14-75/MediaObjects/12905_2014_Article_434_Fig1_HTML.jpg
Figure 1

Aims of the CROWN initiative.

Development of consensus is required around a set of well-defined, relevant and feasible outcomes for all trials concerning particular obstetric and gynaecologic health conditions, such as preterm birth, incontinence, infertility and menstrual problems. With so many subspecialties involved, this is no easy task. Duplication of effort can be avoided by working with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative, which is working towards core data sets for all medical specialties [3]. Production of trustworthy core outcome sets will require engagement with patients, healthcare professionals, researchers, industry and regulators, and the employment of scientifically robust consensus methods [1]. The data for these core outcome sets, once agreed upon, should be collected in trials and reported in publications as standard practice in the future.

Journal editors now invite researchers to take the lead in beginning this work. What will we do as editors to support them and their colleagues? First, we are drawing wide attention to The CROWN Initiative by publishing this editorial in the journals listed below. We shall ensure that the global research community, which includes our many reviewers, is aware of the need for core outcome sets. Submissions which describe development of core outcome sets, if deemed acceptable after peer review, will be effectively disseminated.

Our collaboration is not for enforcing harmony at the expense of innovation. To quote from the COMET home page (http://www.comet-initiative.org): “The existence or use of a core outcome set does not imply that outcomes in a particular trial should be restricted to those in the relevant core outcome set. Rather, there is an expectation that the core outcomes will be collected and reported, making it easier for the results of trials to be compared, contrasted and combined as appropriate; while researchers continue to explore other outcomes as well.” We also expect that as new or superior ways of capturing outcomes emerge, core outcome sets will themselves need updating.

Producing, disseminating and implementing core outcome sets will ensure that critical and important outcomes with good measurement properties are incorporated and reported. We believe this is the next important step in advancing the usefulness of research, in informing readers, including guideline and policy developers, who are involved in decision-making, and in improving evidence-based practice.

Authors’ information

On behalf of Chief Editors of Journals participating in The CROWN Initiative.

The CROWN Initiative includes the following journals, in alphabetical order (correct on 13th May 2014, up to date list available at http://www.crown-initiative.org):
  1. 1.

    Acta Obstetricia et Gynecologica Scandinavica

     
  2. 2.

    American Journal of Obstetrics & Gynecology

     
  3. 3.

    American Journal of Perinatology

     
  4. 4.

    Archives of Gynecology and Obstetrics

     
  5. 5.

    Australian and New Zealand Journal of Obstetrics and Gynaecology

     
  6. 6.

    Best Practice & Research: Clinical Obstetrics & Gynaecology

     
  7. 7.

    Birth: Issues in Perinatal Care

     
  8. 8.

    BJOG: An International Journal of Obstetrics and Gynaecology

     
  9. 9.

    BMC Pregnancy and Childbirth

     
  10. 10.

    BMC Women’s Health

     
  11. 11.

    Climacteric

     
  12. 12.

    Clinical Obstetrics and Gynecology

     
  13. 13.

    Clinics in Perinatology

     
  14. 14.

    Cochrane Menstrual Disorders and Subfertility Group

     
  15. 15.

    Cochrane Pregnancy and Childbirth Group

     
  16. 16.

    Contraception

     
  17. 17.

    Current Opinion in Obstetrics and Gynecology

     
  18. 18.

    European Journal of Obstetrics & Gynecology and Reproductive Biology

     
  19. 19.

    Fertility and Sterility

     
  20. 20.

    Fetal Diagnosis and Therapy

     
  21. 21.

    Ginekologia Polska

     
  22. 22.

    Gynecological Surgery

     
  23. 23.

    Gynecologic Oncology

     
  24. 24.

    Gynecologic Oncology Reports

     
  25. 25.

    Human Fertility

     
  26. 26.

    Human Reproduction

     
  27. 27.

    Human Reproduction Update

     
  28. 28.

    Hypertension in Pregnancy

     
  29. 29.

    International Journal of Fertility and Sterility

     
  30. 30.

    International Breastfeeding Journal

     
  31. 31.

    International Journal of Gynecology & Obstetrics

     
  32. 32.

    International Urogynecology Journal

     
  33. 33.

    Journal of Family Planning and Reproductive Health Care

     
  34. 34.

    Journal of Gynecologic Oncology

     
  35. 35.

    Journal of Lower Genital Tract Disease

     
  36. 36.

    Journal of Midwifery & Women’s Health

     
  37. 37.

    Journal of Obstetrics & Gynaecology

     
  38. 38.

    Journal of Obstetrics and Gynaecology Canada

     
  39. 39.

    Journal of Obstetric, Gynecologic & Neonatal Nursing

     
  40. 40.

    Journal of Perinatal & Neonatal Nursing

     
  41. 41.

    Journal of Perinatal Medicine

     
  42. 42.

    Maturitas

     
  43. 43.

    MCN The American Journal of Maternal Child Nursing

     
  44. 44.

    Menopause Review (Przegląd Menopauzalny)

     
  45. 45.

    Menopause: The Journal of The North American Menopause Society

     
  46. 46.

    Neurourology and Urodynamics

     
  47. 47.

    Obstetrics & Gynecology

     
  48. 48.

    Paediatric and Perinatal Epidemiology

     
  49. 49.

    Placenta

     
  50. 50.

    Prenatal Diagnosis

     
  51. 51.

    Reproductive Health

     
  52. 52.

    The Breast Journal

     
  53. 53.

    The European Journal of Contraception and Reproductive Health Care

     
  54. 54.

    The Obstetrician & Gynaecologist (TOG)

     
  55. 55.

    Twin Research and Human Genetics

     
  56. 56.

    Ultrasound in Obstetrics & Gynecology

     

Declarations

Acknowledgements

The CROWN Initiative is grateful to James Duffy (Trainee Scientific Editor, BJOG) and Louisa Waite (Assistant Editor, BJOG) for the drafting, revision and coordination required for the preparation of this article.

Note

Reproduced from The Core Outcomes in Women’s Health (CROWN) Initiative with permission from the Royal College of Obstetricians and Gynaecologists and John Wiley & Sons Ltd.

Authors’ Affiliations

(1)
BJOG: An International Journal of Obstetrics and Gynaecology
(2)
BMC Series

References

  1. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Tugwell P: Developing core outcome sets for clinical trials: issues to consider. Trials. 2012, 13: 132.View ArticlePubMedPubMed CentralGoogle Scholar
  2. Meher S, Alfirevic Z: Choice of primary outcomes in randomised trials and systematic reviews evaluating interventions for preterm birth prevention: a systematic review. BJOG. 2014, doi:10.1111/1471-0528Google Scholar
  3. Williamson PR, Altman DG, Blazeby JM, Clarke M, Gargon E: The COMET (Core Outcome Measures in Effectiveness Trials) Initiative. Trials. 2011, 12 (Suppl 1): A70.View ArticlePubMed CentralGoogle Scholar
  4. Pre-publication history

    1. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6874/14/75/prepub

Copyright

© Khan and O'Donovan; licensee BioMed Central Ltd. 2014

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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