The role of early adopter bias for new technologies in robot assisted laparoscopic prostatectomy.

PURPOSE: We determined the potential influence of an early adopter bias in patients undergoing robot assisted laparoscopic prostatectomy. MATERIALS AND METHODS: We compared baseline demographic, clinical and health related quality of life characteristics of patients undergoing 3 different surgical procedures for clinically localized prostate cancer following the introduction of robot assisted laparoscopic prostatectomy at our institution. Patients included in this analysis were participating in a prospective health related quality of life study using the SF-12(R) and Expanded Prostate Cancer Index Composite validated questionnaires. RESULTS: Of 402 patients 159 (39%) underwent robot assisted laparoscopic, 144 (36%) underwent radical perineal and 99 (25%) underwent radical retropubic prostatectomy. There were no statistically significant associations between procedure type and patient age (p = 0.267), race (p = 0.725), number of medical comorbidities (p = 0.490), income (p = 0.056) and level of education (p = 0.495). Mean prostate specific antigen was 5.9 +/- 3.3, 7.3 +/- 5.5 and 5.7 +/- 5.0 ng/ml for robot assisted laparoscopic, radical perineal and radical retropubic prostatectomy, respectively (p = 0.030). The proportion of robot assisted laparoscopic, radical perineal and radical retropubic prostatectomy patients with a final Gleason score of 4-6 was 55%, 45% and 39%, respectively (p = 0.037). The proportion of robot assisted laparoscopic, radical perineal and radical retropubic prostatectomy patients with stage T2 disease was 91%, 68% and 80%, respectively (p = 0.001). Statistically significant associations of higher income and education with higher baseline health related quality of life scores were seen in the sexual and physical domains (each p <0.01). CONCLUSIONS: We failed to find evidence of an early adopter bias for patients undergoing robot assisted laparoscopic prostatectomy. Nevertheless, observational studies comparing robot assisted laparoscopic prostatectomy to radical perineal and radical retropubic prostatectomy should account carefully for patient baseline characteristics to allow meaningful comparisons of surgical outcomes.

Factors associated with the full publication of studies presented in abstract form at the annual meeting of the American Urological Association.

PURPOSE: Many abstracts presented at scientific meetings never come to full text publication, which is a prerequisite for the critical appraisal of a given study for its validity, impact and generalizability. We determined factors associated with the publication of abstracts presented at the American Urological Association national meeting. MATERIALS AND METHODS: All abstracts addressing clinical research accepted for presentation at the 2002 and 2003 meetings of the American Urological Association were reviewed. A comprehensive MEDLINE search was performed for evidence of publication in full manuscript form. Data abstraction and literature searches were done between June 15 and August 30, 2005. Univariate and multivariate analyses were performed to determine the association between abstract characteristics and time to publication. RESULTS: Of the 1,683 abstracts reviewed 740 (44.0%) were published within a median followup of 27.8 months (range 25.9 to 39.7). Time to publication was associated with abstract origin in the United States and the reporting of statistical testing (HR 1.2, 95% CI 1.0-1.4, p=0.040 and HR 1.2, 95% CI 1.1-1.4, p=0.010, respectively). Other variables, such as presentation type, study design, clinical question type and negative outcome, were not predictive. CONCLUSIONS: Nonpublication of research findings is a problematic issue that affects more than half of studies 2 years after presentation at the American Urological Association national meeting. Abstracts from the United States and those providing statistical testing were more likely to be published in full text form. Further efforts are warranted to identify and eliminate factors that hinder publication of research to bring it to the scrutiny of a broad audience of urologists.

Prospective health-related quality-of-life assessment in an initial cohort of patients undergoing robotic radical prostatectomy.

OBJECTIVES: To prospectively assess the health-related quality-of-life outcomes of patients undergoing robot-assisted laparoscopic prostatectomy using a validated patient self-assessment questionnaire. METHODS: Patients undergoing robot-assisted laparoscopic prostatectomy between September 2003 and May 2005 were given the Expanded Prostate Cancer Index Composite questionnaire preoperatively and 1, 3, 6, 9, 12, and 18 months postoperatively. Patients with a minimum follow-up of 3 months were included in the analysis. The mean domain-specific health-related quality-of-life scores +/- SD and the proportion of patients achieving their baseline scores were calculated. Multivariate proportional hazards regression analysis was used to determine the potential prognostic factors for a return to baseline of the domain scores and continence. RESULTS: The median follow-up was 9.5 months. The median time to recovery of the baseline summary scores was 6.6 months (95% confidence interval [CI] 5.9 to 7.2) in the urinary domain, 2.8 months (95% CI 2.0 to 3.7) in the bowel domain, and 3.0 months (95% CI 2.2 to 3.9) in the hormonal domain. The baseline sexual summary score was recovered by 19.2% of patients at 12 months. The median time to return of continence (0 to 1 pads/day) was 4.0 months (95% CI 3.0 to 4.9). The median time to the return of erections firm enough for intercourse was 13.5 months (95% CI 9.9 to 17.1). On multivariate proportional hazards regression analysis, age, body mass index, prostate size, nerve-sparing technique, and number of comorbidities were not significantly associated with the time to recovery of the baseline domain scores or continence. CONCLUSIONS: Patients undergoing robot-assisted laparoscopic prostatectomy have a favorable health-related quality-of-life recovery profile that appears comparable to those of established surgical approaches.

Radical perineal prostatectomy for treatment of localized prostate cancer in obese and nonobese patients: a matched control study.

OBJECTIVES: To compare the perioperative outcomes of severely obese and nonobese patients undergoing radical perineal prostatectomy (RPP). METHODS: A cohort of 71 severely obese patients, as defined by a body mass index of 35 kg/m2 or more, who underwent RPP between 1992 and 2003 was retrospectively identified. These patients were matched by age, American Society of Anesthesiologists class, and year of surgery to a cohort of 71 nonobese patients (body mass index less than 25 kg/m2). Statistical testing was performed to compare the estimated blood loss, transfusion requirements, and complication rates (primary endpoints), as well as the length of surgery, intraoperative anesthesia requirements, postoperative hematocrit level, length of stay, and surgical margin status (secondary endpoints). RESULTS: The mean body mass index +/- standard deviation of patients in the obese and nonobese group was 38.9 +/- 4.7 and 22.9 +/- 1.6 kg/m2 (P = 0.001), respectively. Patients were similar with regard to baseline characteristics. Obese and nonobese patients did not demonstrate significant differences in mean estimated blood loss (571 +/- 391 and 494 +/- 317 mL, respectively; P = 0.06), transfusion rates (2.8% and 7.0%, respectively; P = 0.45), or positive surgical margin rates (14.1% and 9.9%, respectively; P = 0.22). The overall complication rates were significantly different at 16.9% and 7.0% (P = 0.03). CONCLUSIONS: Severely obese patients undergoing RPP had blood transfusion rates similar to those of the nonobese patients. Obese RPP patients were at increased risk of surgical and anesthesia-related perioperative complications, many of which might be avoidable. Specifically, efforts should be directed toward preventing the development of lower extremity neurapraxia by minimizing the operative time and optimizing patient positioning.