Clearly defined and relevant clinical outcomes of importance to all key stakeholders are essential if clinical trials, systematic reviews, and guidelines are to translate to the real world and improve patient care. Unfortunately, we have a long way to go in perinatal and pediatric health care. A recent systematic review of interventions for the prevention preterm birth included 103 randomized clinical trials in which 72 different outcomes were reported. This heterogeneity of outcomes limits the synthesis and usability of research,1 and contributes to research waste.2 Core outcome sets (COS) have been developed to address this problem. These are the agreed minimum set of outcomes to be reported in all clinical trials in a specific health condition or area and are also suitable for use in clinical audit or research other than randomized trials.
The Core Outcome Measures in Effectiveness Trials (COMET) Initiative (http://www.comet-initiative.org/) involves individuals interested in the development and application of agreed standardized sets of outcomes, known as “COSs”. Core outcome sets are not meant to be restrictive, and clinical trials would ideally include core outcomes as well as other outcomes of interest. The COMET initiative describes a 5-step COS development process.3 These involve a review of existing knowledge and consensus development approaches to agreeing the COS. Similar to the publication of clear guidelines on clinical trial reporting such as CONSORT (http://www.equator-network.org/reporting-guidelines/consort/) and PRISMA for systematic reviews (http://www.equator-network.org/reporting-guidelines/prisma/), standardized guidelines have been developed for COS. COS-STAD4 establishes minimum standards for the development of COS, and COS-STAR5 provides guidance on the final reporting of COS. The importance of incorporating patient perspectives, including patient-reported outcome measures,6 in COS is increasingly recognized.7
The CROWN collaboration (http://www.crown-initiative.org/) involves over 54 journals related to women’s and newborn health who have come together to support The CoRe Outcomes in Women’s and Newborn health (CROWN) Initiative (Aims of CROWN initiative: Box 1). This group has recently published the COS for studies aimed at preterm birth prevention8 and is committed to publishing and disseminating core outcomes to improve Women’s and Newborn health.
Duffy et al. recently performed a systematic review of core outcomes in women’s and newborn health; although this identified 49 COSs registered in women and newborn, only 3 of these related to newborn health.9 One of these is the COIN project: Core Outcomes In Neonatology (http://neoepoch.com/core-outcomes/), which is establishing the most important outcomes for parents, children, and adults who received neonatal care, health-care professionals, and researchers.10
Over 20 years ago, perinatal health-care pioneered the application of systematic reviews to improve care.11 We propose that women’s and newborn's health should again lead the way, reducing research waste and making research more relevant, by developing, disseminating, and applying core outcome sets. The journal Pediatric Research is delighted to demonstrate our interest in publishing core outcomes in newborn and child health, encouraging their use in clinical trials and furthering their wide dissemination, by becoming part of the CROWN Initiative.
List of CROWN member journals
|1||Acta Obstetricia et Gynaecologica Scandinavica|
|2||American Journal of Obstetrics & Gynaecology (AJOG)|
|3||American Journal of Perinatology|
|4||Archives of Gynaecology and Obstetrics|
|5||Australian and New Zealand Journal of Obstetrics and Gynaecology, The|
|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||Breast Journal, The|
|12||Chinese Journal of Perinatal Medicine(中华围产医学杂志)|
|14||Clinical Obstetrics and Gynecology|
|15||Clinics in Perinatology|
|16||Cochrane Gynecology and Fertility Group|
|17||Cochrane Pregnancy and Childbirth Group|
|19||Contraception & Reproductive Medicine|
|20||Current Opinion in Obstetrics and Gynecology|
|21||European Journal of Contraception and Reproductive Health Care, The|
|22||European Journal of Obstetrics & Gynecology and Reproductive Biology|
|23||Female Pelvic Medicine and Reconstructive Surgery|
|24||Fertility and Sterility|
|25||Fertility Research and Practice|
|26||Fetal Diagnosis and Therapy|
|27||Geburtshilfe und Frauenhelikunde|
|29||Gynecologic and Obstetric Investigation|
|31||Gynecologic Oncology Reports|
|35||Human Reproduction Update|
|36||Hypertension in Pregnancy|
|37||International Breastfeeding Journal|
|38||International Journal of Childbirth|
|39||International Journal of Fertility and Sterility|
|40||International Journal of Gynecological Cancer|
|41||International Journal of Gynecology and Obstetrics|
|42||International Urogynecology Journal|
|43||Journal de Gynecologie Obstétrique et Biologie de la Reproduction|
|44||Journal of Family Planning and Reproductive Health Care|
|45||Journal of Gynecologic Oncology|
|46||Journal of Lower Genital Tract Disease|
|47||Journal of Maternal Fetal and Neonatal Medicine, The|
|48||Journal of Midwifery & Women’s Health|
|49||Journal of Minimally Invasive Gynecology|
|50||Journal of Obstetric, Gynecologic & Neonatal Nursing|
|51||Journal of Obstetrics & Gynecology|
|52||Journal of Obstetrics and Gynaecology Canada|
|53||Journal of Obstetrics and Gynecology Research|
|54||Journal of Ovarian Research|
|55||Journal of Pediatric & Adolescent Gynecology|
|56||Journal of Perinatal & Neonatal Nursing|
|57||Journal of Perinatal Medicine|
|58||Maternal and Child Nutrition|
|59||Maternal Health, Neonatology and Perinatology|
|60||MCN American Journal of Maternal Child Nursing, The|
|61||Menopause Review (Przegląd Menopauzalny)|
|62||Menopause: Journal of The North American Menopause Society, The|
|64||Nederlands Tijdschrift voor Obstetrie en Gynaecologie (NTOG)|
|65||Neurourology and Urodynamics|
|66||New Zealand College of Midwives Journal|
|67||Obstetrician & Gynaecologist, The (TOG)|
|68||Obstetrics & Gynecology|
|69||Paediatric and Perinatal Epidemiology|
|72||Post Reproductive Health|
|75||Reproductive Health Library|
|76||Russian Journal of Obstetrics and Gynaecology|
|77||Twin Research and Human Genetics|
|78||Ultrasound in Obstetrics & Gynecology|
|79||Women and Birth|
|80||Women’s Midlife Health|
Meher S., Alfirevic Z. Choice of primary outcomes in randomised trials and systematic reviews evaluating interventions for preterm birth prevention: a systematic review. (2014). BJOG https://doi.org/10.1111/1471-0528.12593
Moher, D. et al. Increasing value and reducing waste in biomedical research: who’s listening? Lancet. 387, 1573–1586 (2016).
Williamson, P.R. et al. The COMET Handbook: version 1.0.Trials. 18, 280 (2017).
Kirkham, J. J. et al. Core Outcome Set-STAndards for Development: the COS-STAD recommendations. PLoS Med. 14, e1002447 (2017). https://doi.org/10.1371/journal.pmed.1002447.
Kirkham, J. J. et al. Core Outcome Set–STAndards for Reporting: the COS-STAR Statement. PLoS Med. 13, e1002148 (2016).
Macefield, R. C. et al. Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs). Trials 15, 49 (2014). https://doi.org/10.1186/1745-6215-15-49.
Biggane, A. M., Brading, L., Ravaud, P., Young, B. & Williamson, P. R. Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys. Trials 19, 113 (2018). https://doi.org/10.1186/s13063-018-2493-y.
van ‘t Hooft, J. et al. CROWN initiative and preterm birth prevention: researchers and editors commit to implement core outcome sets. BJOG 125, 8–11 (2017).
Duffy, J. et al. International Collaboration to Harmonise Outcomes in Pre-eclampsia (iHOPE). Core outcome sets in women’s and newborn health: a systematic review. BJOG 124, 1481–1489 (2017).
Webbe, J. et al. Developing, implementing and disseminating a core outcome set for neonatal medicine. Br. Med. J. Paediatr. Open 1, e000048 (2017).
Crowley P. Prophylactic corticosteroids for preterm birth. Cochrane Database Syst Rev. CD000065 (2000).
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Molloy, E.J., Gale, C., Marsh, M. et al. Developing core outcome set for women’s, newborn, and child health: the CROWN Initiative. Pediatr Res 84, 316–317 (2018). https://doi.org/10.1038/s41390-018-0041-9
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