Assessing the Comprehensiveness of Outcome Reporting in Obstetric
Trials: Development of a Reporting Tool
Abstract
Objective: Clinical trials provide fundamental evidence used to inform
healthcare decisions at patient- and population levels. It is therefore
important that trials evaluate outcomes considered relevant by patients
and relevant stakeholders. Although validated tools assessing other
aspects of trial integrity exist, there is no tool for assessing the
breadth and completeness of outcomes being measured. We have developed
the Comprehensiveness of Outcome Reporting (COR) Tool to assist
systematic reviewers and trialists in evaluating and choosing trial
outcomes within the dynamic context of obstetrics. Methods: We
identified five core outcome areas – mortality, clinical/physiological,
functioning/life-impact, resource-use, and adverse events – from a
published taxonomy for outcomes in medical research, and programmed an
excel-based tool capable of producing a heatmap to enable users to
visualize whether trial outcomes appropriately represent all outcomes
areas for both mother and fetus. We used a mock-heatmap to demonstrate
the tool’s utility in assessing comprehensiveness of outcome reporting
in obstetric trials. Results: This excel-based tool guides users through
a series of simple questions regarding the clinical trial(s) being
assessed, producing a heatmap output that depicts the spread of reported
outcome areas. Trends are readily interpreted with a heatmap, with
over/under-reported maternal and fetal-neonatal outcome areas clearly
highlighted. Conclusions: Comprehensive reporting of outcomes is
necessary to ensure that interventions truly result in improved outcomes
in all core areas. The COR Tool will enable systematic reviewers and
trialists to determine and select outcomes with more breadth and
completeness, encouraging transparency and the drawing of valid clinical
conclusions. Funding: None