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

  • Khalid Khan1,

    Affiliated with

    • Peter O’Donovan2Email author and

      Affiliated with

      • On behalf of Chief Editors of Journals participating in The CROWN Initiative listed at the end of this article

        Affiliated with

        BMC Pregnancy and Childbirth201414:199

        DOI: 10.1186/1471-2393-14-199

        Received: 29 May 2014

        Accepted: 10 June 2014

        Published: 23 June 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).
        http://static-content.springer.com/image/art%3A10.1186%2F1471-2393-14-199/MediaObjects/12884_2014_1077_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.

        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.

        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. Acta Obstetricia et Gynecologica Scandinavica

        2. American Journal of Obstetrics & Gynecology

        3. American Journal of Perinatology

        4. Archives of Gynecology and Obstetrics

        5. Australian and New Zealand Journal of Obstetrics and Gynaecology

        6. Best Practice & Research: Clinical Obstetrics & Gynaecology

        7. Birth: Issues in Perinatal Care

        8. BJOG: An International Journal of Obstetrics and Gynaecology

        9. BMC Pregnancy and Childbirth

        10. BMC Women's Health

        11. Climacteric

        12. Clinical Obstetrics and Gynecology

        13. Clinics in Perinatology

        14. Cochrane Menstrual Disorders and Subfertility Group

        15. Cochrane Pregnancy and Childbirth Group

        16. Contraception

        17. Current Opinion in Obstetrics and Gynecology

        18. European Journal of Obstetrics & Gynecology and Reproductive Biology

        19. Fertility and Sterility

        20. Fetal Diagnosis and Therapy

        21. Ginekologia Polska

        22. Gynecological Surgery

        23. Gynecologic Oncology

        24. Gynecologic Oncology Reports

        25. Human Fertility

        26. Human Reproduction

        27. Human Reproduction Update

        28. Hypertension in Pregnancy

        29. International Journal of Fertility and Sterility

        30. International Breastfeeding Journal

        31. International Journal of Gynecology & Obstetrics

        32. International Urogynecology Journal

        33. Journal of Family Planning and Reproductive Health Care

        34. Journal of Gynecologic Oncology

        35. Journal of Lower Genital Tract Disease

        36. Journal of Midwifery & Women's Health

        37. Journal of Obstetrics & Gynaecology

        38. Journal of Obstetrics and Gynaecology Canada

        39. Journal of Obstetric, Gynecologic & Neonatal Nursing

        40. Journal of Perinatal & Neonatal Nursing

        41. Journal of Perinatal Medicine

        42. Maturitas

        43. MCN The American Journal of Maternal Child Nursing

        44. Menopause Review (Przegląd Menopauzalny)

        45. Menopause: The Journal of The North American Menopause Society

        46. Neurourology and Urodynamics

        47. Obstetrics & Gynecology

        48. Paediatric and Perinatal Epidemiology

        49. Placenta

        50. Prenatal Diagnosis

        51. Reproductive Health

        52. The Breast Journal

        53. The European Journal of Contraception and Reproductive Health Care

        54. The Obstetrician & Gynaecologist (TOG)

        55. Twin Research and Human Genetics

        56. Ultrasound in Obstetrics & Gynecology

        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.PubMed CentralPubMedView Article
        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:10.1111/1471–0528View Article
        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.PubMed CentralView Article
        4. Pre-publication history

          1. The pre-publication history for this paper can be accessed here: http://​www.​biomedcentral.​com/​1471-2393/​14/​199/​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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