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

Clinical trials, systematic reviews and guidelines compare beneficial and nonbeneficial 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]Williamson P.R. Altman D.G. Blazeby J.M. Clarke M. Devane D. Gargon E. et al.Developing core outcome sets for clinical trials: issues to consider.Trials. 2012; 13: 132-139Crossref PubMed Scopus (1077) Google Scholar]. 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]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; https://doi.org/10.1111/1471-0528Crossref PubMed Google Scholar]. 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]Williamson P.R. Altman D.G. Blazeby J.M. Clarke M. Devane D. Gargon E. et al.Developing core outcome sets for clinical trials: issues to consider.Trials. 2012; 13: 132-139Crossref PubMed Scopus (1077) Google Scholar]. 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 CoRe Outcomes in WomeN health (CROWN) Initiative (Box 1).Box 1Aims of the CROWN Initiative1.Form a consortium among all gynaecology–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.Organise 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 1.Form a consortium among all gynaecology–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.Organise 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 data sets for all medical specialties [[3]Williamson P.R. Altman D.G. Blazeby J.M. Clarke M. Gargon E. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative.Trials. 2011; 12: A70Crossref PubMed Google Scholar]. 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]Williamson P.R. Altman D.G. Blazeby J.M. Clarke M. Devane D. Gargon E. et al.Developing core outcome sets for clinical trials: issues to consider.Trials. 2012; 13: 132-139Crossref PubMed Scopus (1077) Google Scholar]. 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 themselves will 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 that 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 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 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 Gynaecology9.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 (Przegląd 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 Reproductive Health Care54.The Obstetrician & Gynaecologist (TOG)55.Twin Research and Human Genetics56.Ultrasound in Obstetrics & Gynecology Reproduced from CROWN Initiative with permission from the Royal College of Obstetricians and Gynaecologists and John Wiley & Sons Ltd. 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.

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