Introduction
Clinical trials should be aimed towards a common goal: improving patient
care. Well-designed trials can have positive impacts on healthcare,
through the incorporation of their findings into clinical guidelines and
health policy.1 However, for clinical and policy
decisions to be informed, it is pertinent that trials ask relevant
questions and base conclusions on outcomes considered important by
patients and all stakeholders involved in their care.
In clinical research, outcomes are defined as measures or observations
used to capture the effect of treatment,2 and can be
broadly categorized into the core areas of mortality, morbidity
(clinical/physiological), life-impact (functioning), adverse events, and
resource-use.3 While each of these areas are important
to the general wellness of patients, trials do not report outcomes from
all core areas, thereby failing to represent all aspects of the patient
experience.4 Interviews conducted with pregnant women
and healthcare providers, frequently identify salient themes related to
life-impact, resource-use, and adverse events of
interventions,5-7 but these outcomes are not often
reported in published studies on the topic.8, 9 This
brings to question whether the reporting of outcomes in trials are
indeed complete and representative of aspects considered important by
healthcare users and professionals. If outcomes are arbitrarily
selected, incorrect conclusions may be drawn, amounting to considerable
waste in health research funding.4, 10, 11
Although tools to assess conduct and quality of trials exist, such as
Cochrane’s Risk-of-Bias (ROB) tool, these do not assess
comprehensiveness of outcome reporting and instead propose the use of
core outcome sets (COS) to address this gap.12 While
COS for obstetric studies are being developed by a number of independent
researchers13 and organizations, such as the Outcome
Reporting in Obstetric Studies (OROS) project,14 it
must be noted that COS are aimed at ensuring a ‘minimum set of outcomes’
that should be reported in all studies, and not at the comprehensiveness
of outcome reporting. Along with limited guidance, no tool exists to
determine whether developed COS truly represent the patients and
professionals they aim to serve.15, 16 An independent
assessment of whether outcomes reported in clinical trials are complete
and representative is therefore vital.
We have developed a tool that will enable trialists to determine the
comprehensiveness of outcome selection for their trials, and for
systematic reviewers, critical appraisers, and clinicians to evaluate
the appropriate reporting of outcomes, complementing the assessment of
ROB in obstetric trials, to provide a more thorough evaluation of trial
integrity.