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The CROWN Initiative: journal editors invite researchers todevelop core outcomes in women’s healthKhalid S. Khan, MBBS, FCPS, MSc; Roberto Romero, MD, DMedSci; on behalf of Chief Editors of Journals participatingin The CROWN Initiative

linical trials, systematic reviews and guidelines compare

C beneficial and non-beneficial outcomes following in-terventions. Often, however, various studies on a particulartopic do not address the same outcomes, making it difficult todraw clinically useful conclusions when a group of studies islooked at as a whole.1 This problem was recently thrown intosharp focus by a systematic review of interventions for pre-term birth prevention, which found that among 103 ran-domized trials, no fewer than 72 different outcomes werereported.2 There is a growing recognition among clinical re-searchers that this variability undermines consistent synthesisof the evidence, and that what is needed is an agreed stan-dardized collection of outcomesea “core outcomes set”eforall trials in a specific clinical area.1 Recognizing that thecurrent inconsistency is a serious hindrance to progress inour specialty, the editors of over 50 journals related towomen’s health have come together to support The CoReOutcomes in WomeN’s health (CROWN) Initiative (Figure).

Development of consensus is required around a set ofwell-defined, relevant and feasible outcomes for all trials

FIGUREAims of The CROWN Initiative

Khan. The CROWN Initiative. Am J Obstet Gynecol 2014.

Journals participating in The CROWN Initiative are listed in the Appendix.The author reports no conflict of interest.

Corresponding author: Roberto Romero, MD, DMedSci. rr.ajoged@gmail.c

0002-9378/freeª2014 Reproduced from The Core Outcomes in Women’s Health (CROWN) Initiative bGynaecologists and John Wiley & Sons Ltd.http://dx.doi.org/10.1016/j.ajog.2014.09.015

concerning particular obstetric and gynecologic healthconditions, such as preterm birth, incontinence, infertilityand menstrual problems. With so many subspecialtiesinvolved, this is no easy task. Duplication of effort can beavoided by working with the Core Outcome Measures inEffectiveness Trials (COMET) Initiative, which is workingtowards core data sets for all medical specialties.3 Productionof trustworthy core outcome sets will require engagementwith patients, health care professionals, researchers, industryand regulators, and the employment of scientifically robustconsensus methods.1 The data for these core outcome sets,once agreed upon, should be collected in trials and reportedin publications as standard practice in the future.

Journal editors now invite researchers to take the lead inbeginning this work. What will we do as editors to supportthem and their colleagues? First, we are drawing wide atten-tion to The CROWN Initiative by publishing this editorial inthe journals listed below. We shall ensure that the globalresearch community, which includes our many reviewers,is aware of the need for core outcome sets. Submissions

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y Professor Khalid Khan with permission from the Royal College of Obstetricians and

DECEMBER 2014 American Journal of Obstetrics & Gynecology 575

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which describe development of core outcome sets, if deemedacceptable after peer review, will be effectively disseminated.

Our collaboration is not for enforcing harmony at theexpense of innovation. To quote from the COMET homepage (www.comet-initiative.org): “The existence or use of acore outcome set does not imply that outcomes in a particulartrial should be restricted to those in the relevant coreoutcome set. Rather, there is an expectation that the coreoutcomes will be collected and reported, making it easier forthe results of trials to be compared, contrasted and combinedas appropriate; while researchers continue to explore otheroutcomes as well.” We also expect that as new or superiorways of capturing outcomes emerge, core outcome sets willthemselves need updating.

Producing, disseminating and implementing core outcomesets will ensure that critical and important outcomes withgood measurement properties are incorporated and reported.We believe this is the next important step in advancingthe usefulness of research, in informing readers, includingguideline and policy developers, who are involved in decision-making, and in improving evidence-based practice. -

ACKNOWLEDGMENTS

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

REFERENCES

1. Williamson PR, Altman DG, Blazeby JM, et al. Developing coreoutcome sets for clinical trials: issues to consider. Trials 2012;13:132.2. Meher S, Alfirevic Z. Choice of primary outcomes in randomised trialsand systematic reviews evaluating interventions for preterm birth pre-vention: a systematic review. BJOG 2014;121:1188-96.3. Williamson PR, Altman DG, Blazeby JM, Clarke M, Gargon E. TheCOMET (Core Outcome Measures in Effectiveness Trials) Initiative. Trials2011;12(Suppl 1):A70.

APPENDIX

The CROWN Initiative includes the following journals, inalphabetical order (correct on May 13, 2014, up to date listavailable at www.crown-initiative.org):

1. Acta Obstetricia et Gynecologica Scandinavica2. American Journal of Obstetrics & Gynecology3. American Journal of Perinatology4. Archives of Gynecology and Obstetrics5. Australian and New Zealand Journal of Obstetrics and

Gynaecology6. Best Practice & Research: Clinical Obstetrics & Gynaecology7. Birth: Issues in Perinatal Care8. BJOG: An International Journal of Obstetrics and

Gynaecology

576 American Journal of Obstetrics & Gynecology DECEMBER 2014

9. BMC Pregnancy and Childbirth10. BMC Women’s Health11. Climacteric12. Clinical Obstetrics and Gynecology13. Clinics in Perinatology14. Cochrane Menstrual Disorders and Subfertility Group15. Cochrane Pregnancy and Childbirth Group16. Contraception17. Current Opinion in Obstetrics and Gynecology18. European Journal of Obstetrics & Gynecology and

Reproductive Biology19. Fertility and Sterility20. Fetal Diagnosis and Therapy21. Ginekologia Polska22. Gynecological Surgery23. Gynecologic Oncology24. Gynecologic Oncology Reports25. Human Fertility26. Human Reproduction27. Human Reproduction Update28. Hypertension in Pregnancy29. International Journal of Fertility and Sterility30. International Breastfeeding Journal31. International Journal of Gynecology & Obstetrics32. International Urogynecology Journal33. Journal of Family Planning and Reproductive Health Care34. Journal of Gynecologic Oncology35. Journal of Lower Genital Tract Disease36. Journal of Midwifery & Women’s Health37. Journal of Obstetrics & Gynaecology38. Journal of Obstetrics and Gynaecology Canada39. Journal of Obstetric, Gynecologic & Neonatal Nursing40. Journal of Perinatal & Neonatal Nursing41. Journal of Perinatal Medicine42. Maturitas43. MCN The American Journal of Maternal Child Nursing44. Menopause Review (Przeglad Menopauzalny)45. Menopause: The Journal of The North American

Menopause Society46. Neurourology and Urodynamics47. Obstetrics & Gynecology48. Paediatric and Perinatal Epidemiology49. Placenta50. Prenatal Diagnosis51. Reproductive Health52. The Breast Journal53. The European Journal of Contraception and Reproduc-

tive Health Care54. The Obstetrician & Gynaecologist (TOG)55. Twin Research and Human Genetics56. Ultrasound in Obstetrics & Gynecology