Application of the CONSORT Statement to Randomized Controlled Trials Comparing Endoscopic Carpal Tunnel Release (ECTR) and Open Carpal Tunnel Release (OCTR)

ABSTRACT

A randomized controlled trial is the optimal study design to evaluate the effect of surgical interventions. The mere reporting of a study as “randomized” does not imply validity. In 1996, the Consolidated Standards of Reporting Trials (CONSORT) statement was introduced as a means to improve the quality of randomized controlled trial reports. The CONSORT statement comprises a checklist and a flow diagram for reporting a randomized controlled trial. It asks the method of randomization, concealment of allocation, blinding, etc.

This study assessed the reporting quality of published randomized controlled trials that compared endoscopic carpal tunnel release and open carpal tunnel release based on the CONSORT statement.

A computerized literature search between 1989 and 2003 was conducted to identify randomized controlled trials that compared open carpal tunnel release to endoscopic carpal tunnel release. Two investigators independently reviewed each randomized controlled trial and determined whether it reported on each of the 22 items of the CONSORT statement. A maximum score of 22 was possible. Disagreements between the reviewers were resolved by consensus. Comparison of the studies before and after CONSORT statement publication year (1996) was performed using Mann-Whitney test to determine the impact on reporting quality.

Fifteen randomized controlled trials were identified (9 English, 4 German, 1 French, and 1 Spanish). The reviewers disagreed on 8 items in 7 studies. The kappa agreement was 0.95. The total score ranged from 3-15 with a mean of 8.93±2.91. None of the studies reported sample size determination a priori or clearly reported the flow of participants through each stage of the study. Although all of these studies were reported as randomized controlled trials, few provided adequate details of randomization (20%-33%). Only 4 (26.7%) studies reported adequate information regarding study participants and only 1 (6.7%) study reported whether the analysis was by “intention to treat.” Eleven studies were published before or in 1996. Mean scores for studies published after 1996 were slightly higher than those in 1996 or prior (10.5±0.87 versus 8.36±0.94) but this was not statistically significant (P>.05). Of the studies published in foreign languages, mean scores were significantly lower (7±1.13 versus 10.22±0.78; P<.05).

The overall reporting quality of published randomized controlled trials was poor. Inadequate reporting of methodology in studies limits the reader’s ability to assess the validity of results and may be associated with bias of these studies’ findings. No significant improvement was noted in the quality of reporting in the randomized controlled trials after 1996. Future investigators of randomized controlled trials in hand surgery field should follow the CONSORT statement.