How well do randomised controlled trials of physical interventions for people with spinal cord injury adhere to the CONSORT guidelines? An analysis of trials published over a 10-year period

Abstract

Study design: Cross-sectional descriptive study of randomised controlled trials involving physical interventions for people with spinal cord injury (SCI) published between 2003 and 2013.

Objectives: To determine how well randomised controlled trials of physical interventions for people with SCI adhere to the CONSORT (Consolidated Standards of Reporting Trials) guidelines.

Setting: University of Sydney, Sydney, NSW, Australia.

Methods: A search was conducted for randomised controlled trials designed to determine the effectiveness of physical interventions for people with SCI published between 2003 and 2013. The CONSORT checklist for the reporting of randomised controlled trials was used to determine how well each trial adhered to the guidelines. Two independent reviewers rated each trial on each of the 37 items on the CONSORT checklist using the following criteria: 'fully reported', 'partially reported', 'not reported', 'not relevant' or 'not reported but unable to determine if relevant/done'.

Results: Fifty-three trials were retrieved. None of the trials 'fully reported' all items of the CONSORT guidelines. The median (IQR) number of items that was 'fully reported' was 11/37 (7-20). The median (IQR) number of items that was either 'fully reported' or 'not relevant' or 'not reported but unable to determine if relevant' was 20/37 items (17-27).

Conclusion: The reporting of randomised controlled trials in SCI is only partially adhering to the CONSORT guidelines. Journals can help lift standards by encouraging authors of randomised controlled trials to adhere to the CONSORT guidelines.