Prostate Cancer and Prostatic Diseases (2010) 13, 52–57 & 2010 Nature Publishing Group All rights reserved 1365-7852/10 $32.00 www.nature.com/pcan ORIGINAL ARTICLE Can residents perform transrectal ultrasound-guided prostate biopsy with patient comfort comparable to biopsy performed by attending staff urologists? CT Nguyen1, T Gao2, AV Hernandez2 and JS Jones1 1Department of Regional Urology, Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Cleveland, OH, USA and 2Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH, USA Transrectal ultrasound (TRUS)-guided prostate biopsy is a critical diagnostic tool in urology. Residents require adequate training but resident education could have a deleterious effect on patient comfort and morbidity. We compared pain associated with prostate biopsy when performed by staff versus resident urologists in order to determine the impact of resident training. Male patients scheduled to undergo prostate biopsy were assigned to either a staff urologist or a resident as the primary surgeon. All residents were directly assisted by the staff surgeon. The patients were given a visual analogue scale (VAS; 0–100 mm) and were asked to assess the pain associated with each component of prostate biopsy, including probe insertion, anesthetic injection and the biopsies themselves. The mean VAS scores for probe insertion, anesthetic injection and biopsies were 31.0, 30.4 and 30.1, respectively, for patients in the staff cohort and 37.1, 28.9 and 33.6, respectively, for those in the resident cohort. There was a statistically significant difference between staff and resident VAS scores, marked by a higher odds of greater pain with ultrasound probe placement (odds ratio (OR) ¼ 1.48, P ¼ 0.012) and the biopsies themselves (OR ¼ 1.52, P ¼ 0.01) in the resident cohort. TRUS biopsy can be performed by adequately trained and supervised resident urologists of all levels, but there is the potential for increased patient pain, particularly with ultrasonic probe insertion and obtaining core biopsies. However, the absolute magnitude of the differences in pain scores between residents and staff was small and may not be clinically meaningful. Such data indicate that urological resident training can be accomplished without compromising patient care and comfort. Prostate Cancer and Prostatic Diseases (2010) 13, 52–57; doi:10.1038/pcan.2009.36; published online 22 September 2009 Keywords: prostate biopsy; pain score; morbidity; resident training Introduction patient discomfort and morbidity as well as to optimize diagnostic accuracy. Despite advances in tumor markers and the develop- Instruction in the technique of TRUS biopsy is ment of screening tests (for example, PSA test), the gold typically provided in residency, and until recently, standard for detection of prostate cancer continues to be there has been a distinct paucity of data regarding the transrectal ultrasound (TRUS)-guided prostate biopsy. impact of surgical experience and resident training TRUS biopsy is an invasive, complex and highly on patient morbidity from urological procedures. We sensitive procedure with the potential for inducing have recently published studies showing that there significant pain for the patient.1 Proper technique in are no clinically significant differences in patient pain prostate biopsy requires the mastering of several intricate with cystoscopy or vasectomy, whether performed by steps, including inserting the probe, injecting peripro- staff or resident urologists.2,3 However, among ambu- static block (PPB) and performing multiple, appropri- latory urological operations, prostate biopsy is arguably ately placed core biopsies. Adequate training of the most complex and invasive, and may have a steeper urologists in TRUS biopsy has the potential to minimize learning curve and a higher potential for adverse effects on patients who have biopsies performed by a resident. Correspondence: Dr JS Jones, Department of Regional Urology, In this study we analyze whether resident urologists, Glickman Urological & Kidney Institute, Cleveland Clinic with proper instruction and supervision, are able to Foundation, 9500 Euclid Avenue, A100, Cleveland, OH 44195, USA. E-mail: [email protected] perform TRUS biopsy with comparable proficiency to Received 30 June 2009; accepted 21 July 2009; published online 22 staff surgeons. On the basis of our previous work in this September 2009 field, we hypothesized that there would be no significant TRUS-guided prostate biopsy by staff vs resident urologists CT Nguyen et al differences in patient pain between biopsies performed levels, and the proportional odds assumption was tested. 53 by resident and those performed by staff urologists. The effect of resident versus staff performance of TRUS biopsy on patient pain was adjusted for other possible confounders, including patient age, block site, probe type and anesthesia usage. A P-value o0.05 indicated Patients and methods statistical significance. All statistical analyses were carried out using SAS 9.1 (SAS Institute Inc., Cary, NC, A total of 865 men scheduled for elective office-based USA). TRUS prostate biopsy were included in our prospective institutional review board-approved protocol between January 2006 and December 2008. Indications for TRUS biopsy included elevated or rising PSA level, abnormal findings on digital rectal examination, active surveillance Results for patients with low-risk prostate cancer and rising PSA The mean pain scores for each component of TRUS level after previous non-extirpative therapy for prostate biopsy for both resident and staff patient groups are cancer. Fourteen staff urologists and residents in their summarized in Table 1. Patients in the resident group second, third or fifth year of training participated in the showed slightly higher mean VAS scores for probe study. Fourth-year residents in our program were insertion (37.1 versus 31.0, P ¼ 0.0004) and the core assigned entirely to research and did not participate in biopsies (33.6 versus 30.1, P ¼ 0.03) compared with those the study. Patients were assigned to either the staff in the staff group. In contrast, there were no significant urologist or a resident as the primary surgeon, based differences in the pain associated with the PPB between primarily on whether the resident was in the clinic at the resident and staff patient groups. time (the default is for the resident to perform the Table 1 also delineates the relative distribution of procedure if present in the clinic). In addition, the staff potential confounders between the two patient groups, demonstrated the first of any given procedure each including age, block site, probe type and use of a topical month when a new resident rotated on service. anesthetic. Previous work from Cleveland Clinic has The residents assigned to a given patient’s TRUS shown that apical periprostatic injection of an anesthetic biopsy performed all components of the procedure results in reduced biopsy pain compared with basilar themselves. Operations were performed by residents injection, but it does not increase the pain of the PPB under the direct supervision of the staff urologist. In itself.5 In addition, preliminary data from our group have brief, a lubricated ultrasound probe was inserted into the suggested that pain associated with probe insertion may rectum and correct positioning was confirmed by depend, in part, on the specific design and make of the ultrasonic image. To perform the PPB, a 7-inch 22-gauge ultrasound probe, potentially introducing a confounding spinal needle was inserted though the biopsy needle 3 effect (JS Jones, unpublished data/personal communi- guide, and 5 cm of 1% lidocaine was then injected cation). Hurricaine, a topical anesthetic gel commonly bilaterally at either the apex or the base of the prostate. used to facilitate gastroenterological endoscopic proce- Prostatic biopsy was then performed using a disposable 4 dures, has been used by some of the staff urologists at spring-loaded biopsy needle as described earlier. our institution, given its potential utility in reducing the Immediately after completion of the procedure, patients discomfort of probe insertion. As such, the distribution were given an unmarked 100-mm visual analogue scale and frequency of these variables between the two patient (VAS) and were asked to assign a separate pain score for groups were examined. each component of the procedure, including probe The average age of patients in either the staff or the insertion, the PPB and the core biopsies. resident cohorts was similar (63.8 versus 64.1, P ¼ 0.62). Patients in the resident group had a higher rate of apical PPB compared with those in the staff group (60 versus Statistical analysis 43%, Po0.0001), on the basis of their working more Sample size calculations, which assumed that pain scores closely with a staff urologist (JSJ) who recommends had a coefficient of variation of 0.95, indicated that a apical injection based on the above data. Regarding sample size of at least 200 patients per group was needed probe type distribution, most residents used a Siemens to detect a 5-point difference in pain scores, with 80% Prima ultrasound probe with a long plastic guide, power and a two-sided significance level of 0.05. whereasthe majority of the staff used the Sonoline G50 The pain scores in the scale of 0–100 were not normally (Malvern, PA, USA) probe. The staff urologists showed a distributed (Figure 1). Transformation of the scores could wider distribution regarding usage of different probe not completely overcome the problem of non-normality, types when compared with the residents. The choice of and therefore continuous regression techniques with a probe type was determined mainly by the clinic site as normality assumption were not applicable. Instead, pain different facilities have different equipments. There was scores were placed into five ordered categories, and the no difference in the rate of usage of Hurricaine between association between the factors of interest and the the resident and staff patient groups, and it was used in ordered pain categories was modeled through ordinal only a small number of patients.