INTRODUCTION: A Randomized Controlled Trial (RCT) 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 CONSORT (Consolidated Standards of Reporting Trials) statement was introduced as a means to improve the quality of reports of RCTs. The CONSORT statement comprises a checklist and a flow diagram for reporting an RCT. It asks the method of randomization, concealment of allocation, blinding, etc.

PURPOSE: To assess the reporting quality of published RCTs that compared ECTR and OCTR based on the CONSORT statement.

MATERIAL AND METHODS

A computerized literature search between 1989 and 2003 was conducted to identify RCTs that compared OCTR to ECTR. Two investigators independently reviewed each RCT 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.

RESULTS:

15 RCTs were identified (9 English, 4 German, 1 French, 1 Spanish). The reviewers disagreed on 8 items in 7 studies. The kappa agreement was 0.95. The total score ranged from 3 to 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. While all of these studies were reported as RCTs, few provided adequate details of randomization (20-33%). Only 4 studies (26.7%) reported adequate information regarding study participants and only one study (6.7%) reported whether the analysis was by “intention to treat”. Eleven studies were published before or in 1996. Mean scores for studies published after 1996 was slightly higher than those in 1996 or prior (10.50±0.87 vs. 8.36±0.94) but this was not statistically significant (p>0.05). Of the studies published in foreign languages, mean scores were found to be significantly lower (7.00±1.13 vs 10.22±0.78, p<0.05).

CONCLUSIONS:

The overall quality of reporting of published RCTs was extremely 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. There was no significant improvement in the quality of reporting in the RCTs after 1996. Future investigators of RCTs in hand surgery field should follow the CONSORT statement.