The CROWN Initiative: journal editors invite researchers to develop core outcomes in women’s health
Khan Women's Midlife Health
The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health
Research design/standards; Treatment outcome; Endpoint determination/standards; Clinical trials; Systematic reviews; Guidelines; Bias (Epidemiology); Evidence-based medicine; Consensus
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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 randomised 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 standardised collection of
outcomes – a “core outcomes set” – for all trials in a specific
clinical area [
1
]. 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 CROWN (CoRe
Outcomes in WomeN’s health) Initiative (Table 1).
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 [
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
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
advancing the usefulness of research, in informing readers,
including guideline and policy developers, who are
involved in decision-making, and in improving
evidencebased practice.
Competing interests
The author declares he has no competing interests.
Acknowledgements
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
by Professor Khalid Khan with permission from the Royal College of
Obstetricians and Gynaecologists and John Wil (...truncated)