Fecal incontinence: the quality of reported randomized, controlled trials in the last ten years.

PURPOSE This study was designed to analyze the characteristics and the quality of reporting of randomized, controlled trials published during the last ten years on fecal incontinence. METHODS An electronic search for all randomized, controlled trials on fecal incontinence was undertaken by using the MEDLINE database via PubMed. The data collected were divided into general data, characteristics of reporting, methodology quality assessment using the Jadad scale and a validated methodology quality score (MINCIR score), evaluation of the items published in the CONSORT statement, and the journal impact factor. Reports were divided into two groups: published articles from 1996 to 2000 (Group 1), and from 2001 to 2005 (Group 2). RESULTS Forty-two trials fulfilled the inclusion criteria of the study (Group 1, n = 15; and Group 2, n = 27). There were no significant differences in general characteristics of randomized, controlled trials between the two groups. In Group 2, there were a statistically significant higher number of studies that reported a flow chart (P < 0.001), written informed consent (P = 0.008), sample size calculation (P = 0.023), and withdrawals and dropouts (P < 0.001). We found a statistically significant higher score in Jadad scale (P = 0.046) and MINCIR score (P = 0.016) in the published studies in Group 2. Also we found higher journal impact factor of journals that published these randomized, controlled trials during the most recent years (P = 0.04). CONCLUSIONS There is a lack of high-quality reported randomized, controlled trials on fecal incontinence during the last ten years. Reports of randomized, controlled trials involving patients with fecal incontinence published after 2001 were better reported than in the previous five years.