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The CROWN Initiative: Journal Editors Invite Researchers to Develop Core Outcomes in Women’s Health
Authors: Mohammad Hossein Nasr Esfahani
Number of views: 384
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
(Box 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 setswill 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.