Abstract

ObjectivesThere is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials. The lack of a standardized outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trial registries, patient registries, the Cochrane Database of Systematic Reviews, and the Core Outcome Measures in Effectiveness Trials (COMET) database of core outcome sets (COS), thus aiding knowledge discovery. Study Design and SettingA literature review was carried out to determine existing outcome classification systems, none of which were sufficiently comprehensive or granular for classification of all potential outcomes from clinical trials. A new taxonomy for outcome classification was developed, and as proof of principle, outcomes extracted from all published COS in the COMET database, selected Cochrane reviews, and clinical trial registry entries were classified using this new system. ResultsApplication of this new taxonomy to COS in the COMET database revealed that 274/299 (92%) COS include at least one physiological outcome, whereas only 177 (59%) include at least one measure of impact (global quality of life or some measure of functioning) and only 105 (35%) made reference to adverse events. ConclusionsThis outcome taxonomy will be used to annotate outcomes included in COS within the COMET database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project. Wider implementation of this standard taxonomy in trial and systematic review databases and registries will further promote efficient searching, reporting, and classification of trial outcomes.

Highlights

  • Recognition that insufficient attention has been paid to the choice of outcomes to measure in clinical trials is increasing

  • This outcome taxonomy will be used to annotate outcomes included in core outcome sets’’ (COS) within the Core Outcome Measures in Effectiveness Trials (COMET) database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project

  • A review of the literature identified several vocabularies which exist to organize and classify text relating to health research, many of which are included within the Unified Medical Language System (UMLS, [E8])

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Summary

Introduction

Recognition that insufficient attention has been paid to the choice of outcomes to measure in clinical trials is increasing. The Core Outcome Measures in Effectiveness Trials (COMET) Initiative [E1], [2] brings together people interested in the development and application of agreed standardized sets of outcomes, known as ‘‘core outcome sets’’ (COS). These sets represent the minimum that should be measured and reported in all clinical trials of a specific condition and are suitable for use in clinical audit or research other than randomized trials.

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