The CROWN Initiative: journal editors invite researchers to develop core outcomes in women’s health
© The Author(s). 2016
Received: 11 February 2015
Accepted: 9 March 2016
Published: 13 September 2016
KeywordsResearch design/standards Treatment outcome Endpoint determination/standards Clinical trials Systematic reviews Guidelines Bias (Epidemiology) Evidence-based medicine Consensus
Aims of the CROWN initiative
Form a consortium among all gynaecology-obstetrics and related journals to promote core outcome sets in all areas of our specialty.
Encourage researchers to develop core outcome sets using robust consensus methodology involving multiple stakeholders, including patients.
Strongly encourage the reporting of results for core outcome sets.
Organise robust peer-review and effective dissemination of manuscripts describing core outcome sets.
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 towards core data sets for all medical specialties . 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 . 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.
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 14th June 2016, 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 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
12. Clinical Obstetrics and Gynecology
13. Clinics in Perinatology
14. Cochrane Menstrual Disorders and Subfertility Group
15. Cochrane Fertility Regulation Group
16. Cochrane Pregnancy and Childbirth Group
18. Contraception & Reproductive Medicine
19. Current Opinion in Obstetrics and Gynecology
20. European Journal of Obstetrics & Gynecology and Reproductive Biology
21. Fertility and Sterility
22. Fertility Research and Practice
23. Female Pelvic Medicine and Reconstructive Surgery
24. Fetal Diagnosis and Therapy
25. Geburtshilfe & Frauenhelikunde
26. Ginekologia Polska
27. Gynecological Surgery
28. Gynecologic and Obstetric Investigation
29. Gynecologic Oncology
30. Gynecologic Oncology Reports
31. Human Fertility
32. Human Reproduction
33. Human Reproduction Update
34. Hypertension in Pregnancy
35. International Journal of Childbirth
36. International Journal of Fertility and Sterility
37. International Breastfeeding Journal
38. International Journal of Gynecological Cancer
39. International Journal of Gynecology & Obstetrics
40. International Urogynecology Journal
41. Journal de Gynecologie Obstétrique et Biologie de la Reproduction
42. Journal of Family Planning and Reproductive Health Care
43. Journal of Gynecologic Oncology
44. Journal of Lower Genital Tract Disease
45. Journal of Maternal Fetal and Neonatal Medicine
46. Journal of Midwifery & Women's Health
47. Journal of Minimally Invasive Gynecology
48. Journal of Obstetrics & Gynaecology
49. Journal of Obstetrics and Gynaecology Canada
50. Journal of Obstetrics and Gynecology Research
51. Journal of Obstetric, Gynecologic & Neonatal Nursing
52. Journal of Ovarian Research
53. Journal of Pediatric & Adolescent Gynecology (JPAG)
54. Journal of Perinatal & Neonatal Nursing
55. Journal of Perinatal Medicine
56. Maternal and Child Nutrition
57. Maternal Health, Neonatology and Perinatology
60. MCN The American Journal of Maternal Child Nursing
61. Menopause Review (Przegląd Menopauzalny)
62. Menopause: The Journal of The North American Menopause Society
63. Neurourology and Urodynamics
64. Nederlands Tijdschrift voor Obstetrie en Gynaecologie (NTOG)
65. New Zealand College of Midwives (NZCOM) Journal
66. Obstetrics & Gynecology
67. Paediatric and Perinatal Epidemiology
69. Post Reproductive Health
70. Prenatal Diagnosis
71. Reproductive Health
72. Reproductive Health Library
73. Russian Journal of Obstetrics and Gynaecology
74. The Breast Journal
75. The European Journal of Contraception and Reproductive Health Care
76. The Obstetrician & Gynaecologist (TOG)
77. Twin Research and Human Genetics
78. Ultrasound in Obstetrics & Gynecology
79. Women and Birth
80. Women’s Midlife Health
81. Current Obstetrics & Gynecology Reports
The authors declare that they have no competing interest.
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.
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- 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
- 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:https://doi.org/10.1111/1471-0528.
- 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