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 randomized 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
standardized collection of outcomes—a “core outcomes set”—for all trials in a specific
clinical area.[1] Recognizing 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]).
Table 1
Aims of The CROWN Initiative
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1. Form a consortium among all gynecology-obstetrics and related journals to promote
core outcome sets in all areas of our specialty
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2. Encourage researchers to develop core outcome sets using robust consensus methodology
involving multiple stakeholders, including patients
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3. Strongly encourage the reporting of results for core outcome sets
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4. Organize robust peer-review and effective dissemination of manuscripts describing
core outcome sets
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5. Facilitate embedding of core outcome sets in research practice, working closely
with researchers, reviewers, funders, and guideline makers (www.crown-initiative.org)
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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 datasets 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 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.
