Low quality of evidence for robot-assisted laparoscopic prostatectomy: results of a systematic review of the published literature.

BACKGROUND Robot-assisted laparoscopic prostatectomy (RALP) is displacing radical retropubic prostatectomy as the gold standard surgical approach for clinically localised prostate cancer in the United States and is also being increasingly used in Europe and other parts of the world. This trend has occurred despite the paucity of high-quality evidence to support its relative superiority to more established treatment modalities. OBJECTIVE We performed this study to critically assess the quality of published evidence on RALP to support this major shift in practice patterns. DESIGN, SETTING, AND PARTICIPANTS We conducted a systematic review of the published literature through Medline and Embase (1966 to December 2008). All original research publications on RALP were included. Editorials, letters to the editor, and review articles were excluded. MEASUREMENTS Two reviewers independently performed the data abstraction using a standardised form derived from the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria. RESULTS AND LIMITATIONS Seventy-five original research publications met eligibility criteria. Fifty-five (73.3%) studies were published between 2005 and 2008, and 20 studies (26.7%) were published between 2001 and 2004. Approximately three-quarters of the studies were case series (74.7%), and only two (2.7%) randomised, controlled trials (RCT) were identified. Twelve authors cowrote 72% (54 of 75) of the published studies. Reporting of STROBE criteria ranged from 100.0% (scientific rationale/background explained) to 1.3% (consideration of sample size), with no improvement over time. The study was limited to published literature in the English language. CONCLUSIONS The published RALP literature is limited to observational studies of mostly low methodologic quality. Our findings draw into question to what extent valid conclusions about the relative superiority or equivalence of RALP to other surgical approaches can be drawn and whether published outcomes can be generalised to the broader community. There is an urgent need to raise the methodologic standards for clinical research on new urologic procedures and devices.