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.