PAPER 1: WHAT AUTHORS DON’T TELL US? THE QUALITY OF REPORTING OF ORTHOPAEDIC RANDOMIZED TRIALS USING A CHECKLIST FOR NON-PHARMACOLOGICAL THERAPIES

Abstract

Purpose: The CLEAR NPT checklist provides guidelines for the reporting of non-pharmacological randomized controlled trials (RCTs). We aimed to

1. apply the CLEAR NPT to orthopaedic RCTs and

2. survey authors when items in the CLEAR NPT were not reported, to determine if they were actually conducted.

Methods: We searched for orthopaedic RCTs across eight journals in the period from January 2004 through December 2005. We applied the CLEAR NPT to all eligible studies, and then contacted authors to determine what methodological safeguards were actually used.

Results: We included eighty-seven RCTs from eighty-five scientific reports. In assessing the RCTs with the CLEAR NPT, seventy-three (84%) studies had unclear reporting of allocation concealment. Only seventeen (20%) studies made mention of operator skill or experience. Participant, ward staff, rehabilitation staff, clinical outcome assessor and non-clinical outcome assessor blinding were found to be unclear in forty-eight (55%), sixty-three (72%), sixty-four (74%), forty (46%) and thirty-three (38%) studies respectively. Authors from forty-three RCTs responded to our survey. In direct contact, authors reported adequate allocation concealment 41% (95% CI = 25–58%) of the time when this was unclear from the RCT report. 70% of authors acknowledged that they had set objective measures such as minimum case criteria and/or comparison to good clinical outcomes. Authors specified that they had blinded relevant groups 28–40% of the time, despite unclear reporting in the publications.

Conclusions: The quality of reporting in the orthopaedic literature was highly variable. Readers should not assume that bias reducing safeguards not reported in an RCT did not occur.