Amer J Perinatol 2014; 31(09): 727-728
DOI: 10.1055/s-0034-1384408
Editorial
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

The CROWN Initiative: Journal Editors Invite Researchers to Develop Core Outcomes in Women's Health

Khalid Khan
1  Editor-in-Chief, BJOG: An International Journal of Obstetrics and Gynaecology
*  On behalf of Chief Editors of Journals participating in The CROWN Initiative (Appendix 1)
› Author Affiliations
Further Information

Address for correspondence

George R. Saade, MD
Professor, Department of Obstetrics and Gynecology
Division of Maternal-Fetal Medicine, The University of Texas Medical Branch, 301 University Blvd., Galveston
TX 77555-1062   

Publication History

Publication Date:
21 June 2014 (eFirst)

 

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 randomized 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 standardized collection of outcomes—a “core outcomes set”—for all trials in a specific clinical area.[1] Recognizing 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 ([Table 1]).

Table 1

Aims of The CROWN Initiative

1. Form a consortium among all gynecology-obstetrics and related journals to promote core outcome sets in all areas of our specialty

2. Encourage researchers to develop core outcome sets using robust consensus methodology involving multiple stakeholders, including patients

3. Strongly encourage the reporting of results for core outcome sets

4. Organize robust peer-review and effective dissemination of manuscripts describing core outcome sets

5. Facilitate embedding of core outcome sets in research practice, working closely with researchers, reviewers, funders, and guideline makers (www.crown-initiative.org)

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 toward core datasets 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 (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.

Appendix 1

The CROWN Initiative includes the following journals, in alphabetical order (correct on May 13, 2014; up-to-date list available at 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 Gynecology

  6. Best Practice & Research: Clinical Obstetrics & Gynecology

  7. Birth: Issues in Perinatal Care

  8. BJOG: An International Journal of Obstetrics and Gynecology

  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 & Gynecology

  38. Journal of Obstetrics and Gynecology 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. Pediatric 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


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Disclosure of interests

None

Acknowledgments

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.



Address for correspondence

George R. Saade, MD
Professor, Department of Obstetrics and Gynecology
Division of Maternal-Fetal Medicine, The University of Texas Medical Branch, 301 University Blvd., Galveston
TX 77555-1062