The use and reporting of primary and secondary outcome measures in trials evaluating childhood obesity treatment interventions

Abstract

Background: Existing systematic reviews aimed at comparing effectiveness of childhood obesity treatment interventions are limited by a lack of quality in the conduct and reporting of trials in this area. This study aimed to identify the number and types of primary and secondary outcomes used within trials of childhood obesity treatments and to determine the degree to which these trials correctly report their use of outcome measures. A systematic literature review was conducted to identify phase II (i.e. pilot and feasibility studies) and phase III (e.g. determining effectiveness) trials of childhood obesity treatments across 11 databases. Data were extracted from eligible manuscripts pertaining to the number and type of outcome measures used, in addition to details of citations provided for these measures. Results: 145 different outcome measures were reported to be used within 200 identified eligible trial manuscripts. Citations were provided to indicate the provenance for 417 measures, but only 13% of these were correctly linked to papers describing the development and/or evaluation of measures. Conclusions: This study identified inconsistencies and inaccuracies in the use and reporting of outcome measures used by eligible trials. Researchers in this area are urged to consider guidelines such as CONSORT and the National Obesity Observatory Standard Evaluation Framework in the design and reporting of future trials.