- Email: [email protected]
Challenges of Interpreting and Improving Radical Prostatectomy Outcomes: Technique, Technology, Training, and Tactical Reporting
EUROPEAN UROLOGY 59 (2011) 1073–1074
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Letter to the Editor NOT referring to a recent journal article Challenges of Interpreting and Improving Radical Prostatectomy Outcomes: Technique, Technology, Training, and Tactical Reporting Rigorous scientific methodology hinges on accuracy (the extent to which a measurement is close to the true value), on precision (reproducibility with repeated measurement), and on minimizing bias (systematic favoritism present in data collection, analysis, or reporting). The randomized controlled trial (RCT) eliminates immeasurable biases, and in 1996, Lancet editor Richard Horton questioned the rarity of RCTs in surgical literature and the usefulness of the surgical case series when commenting on an RCT of laparoscopic versus open cholecystectomy [1]: ‘‘I should like to shame [surgeons] out of the comic opera performances which they suppose are statistics of operations [2].’’ Anachronistically, the RCT favored open cholecystectomy due to longer operative times of the laparoscopic approach and no demonstrable differences in hospital stay or postoperative recovery, thereby illustrating the Achilles heel of surgical RCTs that compare traditional versus novel approaches. RCTs comparing surgical technique differ starkly from medical RCTs for placebo versus a new drug or for high-dose versus low-dose drug versus a standard medication, primarily because intrasurgeon heterogeneity in surgical technique [3] is difficult to quantify and statistically adjust for in contrast to standardized dosages of medication or radiation exposure. Moreover, variations in surgical technique are often more pronounced than the variation in surgical approach targeted for comparison, such as robotassisted versus open radical prostatectomy (RP). Until the RP technique is standardized, idealistic calls for RCTs to compare surgical approach or technique are pedantic, and retrospective case series, although flawed, remain relevant. Moreover, although conformity with guidelines for RCT reporting has become commonplace [4], heterogeneity in reporting of RP outcomes remains rampant, despite the relative ease of standardization of outcomes reporting versus standardization of surgical technique. The Massachusetts Male Aging Study demonstrated that 34.8% of men aged 40–70 yr experienced moderate to complete erectile dysfunction (ED), and the combined prevalence of minimal, moderate, and complete ED was 52% [5]. This overlaps with the age range for prostate cancer diagnosis and treatment, and data from this observational
study conflicts with lower post-RP ED outcomes from numerous published series that inaccurately use physicianassessed outcomes, that eschew validated quality of life instruments, and that censor men with some degree of baseline ED. Moreover, additional bias is introduced with subjective post-RP surgeon suturing of ‘‘incidental’’ capsular incisions prior to pathologic processing that goes unmentioned in the methods of papers reporting positive surgical margins. Curiously, some RP studies do not incur loss to follow-up or censorship due to adjuvant hormones, radiation, or death from other causes when reporting 2-yr continence and potency outcomes and/or long-term prostate-specific antigen–free survival. These studies are imprecise because they are not reproducible by others. Rather than advancing the field by demonstrating reproducible technique and conveying realistic expectations that improve the quality of care for men with prostate cancer, the tactical reporting from these studies markets to unsuspecting patients and referring providers [6]. Additionally, inexperienced surgeons may cite these outcomes as their own when counseling patients about RP, leading to unrealistic portrayal of risks and expectations. RP has many purposeful steps, and subtle variation in RP technique significantly affects recovery of functional outcomes. Although the term nerve sparing appears ubiquitously, there is tremendous variability from surgeon to surgeon in the execution of this critical step [3]. Surgical technique and habits developed during training contribute to this variation. First, operative techniques within an institution may not change due to strong hierarchy, fear of failure, and adherence to traditions. Many department heads may introduce technical modifications; however, departments exist where surgeries continue to be performed like they were first described and transferred from one generation to the next [7]. Second, delayed recovery of continence and potency may hinder surgeons and rotating trainees from correlating intraoperative maneuvers with long-term outcomes that may take >24 months to plateau [8]. Surgeons who do not record and review operative videos and detailed notes or who do not historicize objective outcomes are doomed to repeat and suffer the outcomes of stagnant technique and do not know what they do not know. Third, the tendency of trainees not to follow RP beyond the operating theater to the clinic leads to false worship of immediate-gratification outcomes (ie, rapid operative time and hospital stay, low blood loss and few
0302-2838/$ – see back matter # 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.
doi:10.1016/j.eururo.2011.02.028
1074
EUROPEAN UROLOGY 59 (2011) 1073–1074
transfusions) rather than patient-centric outcomes such as cancer control, continence, and potency. Finally, trainees often lack an appreciation for subtle yet exacting maneuvers that translate into better outcomes unless there is explicit intraoperative instruction. Although the trust of meticulous attendings must be earned after many cases of observation and assisting with graduated intraoperative responsibility, trainees may preferentially scrub with gregarious attendings that allow them more freedom as the primary surgeon. Unfortunately, ‘‘town and gown’’ training is typically accompanied by an absence of strong opinion regarding RP technique and outcomes, leading to propagation of suboptimal technique. These factors contribute to intrasurgeon heterogeneity in positive surgical margin status [9], continence, and potency outcomes [3]. Innovation and technological advancement in medicine are rewarded in different ways. Rewards for innovation in development of pharmaceuticals and medical devices include patents and venture capital, whereas surgical technical innovation is more modestly rewarded with better outcomes, patient referrals, and the respect of peers. Although the chemical structure for new medications is readily available after patenting and clinical trials demonstrating better outcomes, the majority of published RP case series offer few intraoperative technical details that allow others to reproduce good outcomes while reporting better results than multicenter or observational studies with third-party data collection. Similar to celebrity chefs, top RP surgeons have little incentive to share the secret recipe for highly sought-after outcomes. Moreover, publishing imprecise outcomes propagates suboptimal technique. Macroscopically, this short-sightedness contributes to RP heterogeneity and dilution of RP outcomes, potentially misleading comparison-shopping patients studying average RP versus radiation outcomes [10]. True technical advancement should be openly shared to standardize technique and to contribute to reproducible outcomes and realistic patient expectations. In summary, the RP learning curve is prolonged regardless of surgical approach [11,12]. Variation in outcomes is due not only to differences in surgical approach but also to heterogeneity in RP technique, to training, and to ‘‘comic opera performances’’ of inaccurate, imprecise, and biased outcomes assessment that are not generalizable to a significant proportion of aging men. An RCT comparing open versus robotic RP may not be currently feasible, but surgical case series should share recipes for success to standardize RP technique while conveying accurate, precise, and unbiased outcomes assessment to educate peers and patients alike while advancing the field.
salary support from an American Urological Association Foundation Research Fellowship Award. Dr. Kowalczyk receives salary support from the Robert and Kathy Salipante Minimally Invasive Urologic Oncology Fellowship.
References [1] Majeed AW, Troy G, Smythe A, et al. Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy. Lancet 1996;347:989–94. [2] Horton R. Surgical research or comic opera: questions, but few answers. Lancet 1996;347:984–5. [3] Vickers A, Savage C, Bianco F, et al. Cancer control and functional outcomes after radical prostatectomy as markers of surgical quality: analysis of heterogeneity between surgeons at a single cancer center. Eur Urol 2011;59:317–22. [4] Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276:637–9. [5] Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54–61. [6] Eastham JA. Robotic-assisted prostatectomy: is there truth in advertising? Eur Urol 2008;54:720–2. [7] Stark M, Gerli S, Di Renzo GC. The importance of analyzing and standardizing surgical methods. J Minim Invasive Gynecol 2009;16:122–5. [8] Litwin MS, Melmed GY, Nakazon T. Life after radical prostatectomy: a longitudinal study. J Urol 2001;166:587–92. [9] Eastham JA, Kattan MW, Riedel E, et al. Variations among individual surgeons in the rate of positive surgical margins in radical prostatectomy specimens. J Urol 2003;170:2292–5. [10] Sanda MG, Dunn RL, Michalski J, et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med 2008;358:1250–61. [11] Vickers AJ, Bianco FJ, Serio AM, et al. The surgical learning curve for prostate cancer control after radical prostatectomy. J Nat Cancer Inst 2007;99:1171–7. [12] Freire MP, Choi WW, Lei Y, Carvas F, Hu JC. Overcoming the learning curve for robotic-assisted laparoscopic radical prostatectomy. Urol Clin North Am 2010;37:37–47. Jim C. Hu* Hua-yin Yu Keith J. Kowalczyk Division of Urologic Surgery and Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA *Corresponding author. Brigham and Women’s/Faulkner Hospital, 1153 Centre Street, Suite 4420, Boston, MA 02130, USA. Tel. +1 617 983 4570; Fax: +1 617 983 7945 E-mail address: [email protected] (J.C. Hu) February 13, 2011
Conflicts of interest: The authors have nothing to disclose. Funding support: Dr. Hu receives salary support from a Department of Defense Physician Training Award W81XWH-08-1-0283. Dr. Yu receives
Published online ahead of print on February 24, 2011
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Letter to the Editor NOT referring to a recent journal article Challenges of Interpreting and Improving Radical Prostatectomy Outcomes: Technique, Technology, Training, and Tactical Reporting Rigorous scientific methodology hinges on accuracy (the extent to which a measurement is close to the true value), on precision (reproducibility with repeated measurement), and on minimizing bias (systematic favoritism present in data collection, analysis, or reporting). The randomized controlled trial (RCT) eliminates immeasurable biases, and in 1996, Lancet editor Richard Horton questioned the rarity of RCTs in surgical literature and the usefulness of the surgical case series when commenting on an RCT of laparoscopic versus open cholecystectomy [1]: ‘‘I should like to shame [surgeons] out of the comic opera performances which they suppose are statistics of operations [2].’’ Anachronistically, the RCT favored open cholecystectomy due to longer operative times of the laparoscopic approach and no demonstrable differences in hospital stay or postoperative recovery, thereby illustrating the Achilles heel of surgical RCTs that compare traditional versus novel approaches. RCTs comparing surgical technique differ starkly from medical RCTs for placebo versus a new drug or for high-dose versus low-dose drug versus a standard medication, primarily because intrasurgeon heterogeneity in surgical technique [3] is difficult to quantify and statistically adjust for in contrast to standardized dosages of medication or radiation exposure. Moreover, variations in surgical technique are often more pronounced than the variation in surgical approach targeted for comparison, such as robotassisted versus open radical prostatectomy (RP). Until the RP technique is standardized, idealistic calls for RCTs to compare surgical approach or technique are pedantic, and retrospective case series, although flawed, remain relevant. Moreover, although conformity with guidelines for RCT reporting has become commonplace [4], heterogeneity in reporting of RP outcomes remains rampant, despite the relative ease of standardization of outcomes reporting versus standardization of surgical technique. The Massachusetts Male Aging Study demonstrated that 34.8% of men aged 40–70 yr experienced moderate to complete erectile dysfunction (ED), and the combined prevalence of minimal, moderate, and complete ED was 52% [5]. This overlaps with the age range for prostate cancer diagnosis and treatment, and data from this observational
study conflicts with lower post-RP ED outcomes from numerous published series that inaccurately use physicianassessed outcomes, that eschew validated quality of life instruments, and that censor men with some degree of baseline ED. Moreover, additional bias is introduced with subjective post-RP surgeon suturing of ‘‘incidental’’ capsular incisions prior to pathologic processing that goes unmentioned in the methods of papers reporting positive surgical margins. Curiously, some RP studies do not incur loss to follow-up or censorship due to adjuvant hormones, radiation, or death from other causes when reporting 2-yr continence and potency outcomes and/or long-term prostate-specific antigen–free survival. These studies are imprecise because they are not reproducible by others. Rather than advancing the field by demonstrating reproducible technique and conveying realistic expectations that improve the quality of care for men with prostate cancer, the tactical reporting from these studies markets to unsuspecting patients and referring providers [6]. Additionally, inexperienced surgeons may cite these outcomes as their own when counseling patients about RP, leading to unrealistic portrayal of risks and expectations. RP has many purposeful steps, and subtle variation in RP technique significantly affects recovery of functional outcomes. Although the term nerve sparing appears ubiquitously, there is tremendous variability from surgeon to surgeon in the execution of this critical step [3]. Surgical technique and habits developed during training contribute to this variation. First, operative techniques within an institution may not change due to strong hierarchy, fear of failure, and adherence to traditions. Many department heads may introduce technical modifications; however, departments exist where surgeries continue to be performed like they were first described and transferred from one generation to the next [7]. Second, delayed recovery of continence and potency may hinder surgeons and rotating trainees from correlating intraoperative maneuvers with long-term outcomes that may take >24 months to plateau [8]. Surgeons who do not record and review operative videos and detailed notes or who do not historicize objective outcomes are doomed to repeat and suffer the outcomes of stagnant technique and do not know what they do not know. Third, the tendency of trainees not to follow RP beyond the operating theater to the clinic leads to false worship of immediate-gratification outcomes (ie, rapid operative time and hospital stay, low blood loss and few
0302-2838/$ – see back matter # 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.
doi:10.1016/j.eururo.2011.02.028
1074
EUROPEAN UROLOGY 59 (2011) 1073–1074
transfusions) rather than patient-centric outcomes such as cancer control, continence, and potency. Finally, trainees often lack an appreciation for subtle yet exacting maneuvers that translate into better outcomes unless there is explicit intraoperative instruction. Although the trust of meticulous attendings must be earned after many cases of observation and assisting with graduated intraoperative responsibility, trainees may preferentially scrub with gregarious attendings that allow them more freedom as the primary surgeon. Unfortunately, ‘‘town and gown’’ training is typically accompanied by an absence of strong opinion regarding RP technique and outcomes, leading to propagation of suboptimal technique. These factors contribute to intrasurgeon heterogeneity in positive surgical margin status [9], continence, and potency outcomes [3]. Innovation and technological advancement in medicine are rewarded in different ways. Rewards for innovation in development of pharmaceuticals and medical devices include patents and venture capital, whereas surgical technical innovation is more modestly rewarded with better outcomes, patient referrals, and the respect of peers. Although the chemical structure for new medications is readily available after patenting and clinical trials demonstrating better outcomes, the majority of published RP case series offer few intraoperative technical details that allow others to reproduce good outcomes while reporting better results than multicenter or observational studies with third-party data collection. Similar to celebrity chefs, top RP surgeons have little incentive to share the secret recipe for highly sought-after outcomes. Moreover, publishing imprecise outcomes propagates suboptimal technique. Macroscopically, this short-sightedness contributes to RP heterogeneity and dilution of RP outcomes, potentially misleading comparison-shopping patients studying average RP versus radiation outcomes [10]. True technical advancement should be openly shared to standardize technique and to contribute to reproducible outcomes and realistic patient expectations. In summary, the RP learning curve is prolonged regardless of surgical approach [11,12]. Variation in outcomes is due not only to differences in surgical approach but also to heterogeneity in RP technique, to training, and to ‘‘comic opera performances’’ of inaccurate, imprecise, and biased outcomes assessment that are not generalizable to a significant proportion of aging men. An RCT comparing open versus robotic RP may not be currently feasible, but surgical case series should share recipes for success to standardize RP technique while conveying accurate, precise, and unbiased outcomes assessment to educate peers and patients alike while advancing the field.
salary support from an American Urological Association Foundation Research Fellowship Award. Dr. Kowalczyk receives salary support from the Robert and Kathy Salipante Minimally Invasive Urologic Oncology Fellowship.
References [1] Majeed AW, Troy G, Smythe A, et al. Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy. Lancet 1996;347:989–94. [2] Horton R. Surgical research or comic opera: questions, but few answers. Lancet 1996;347:984–5. [3] Vickers A, Savage C, Bianco F, et al. Cancer control and functional outcomes after radical prostatectomy as markers of surgical quality: analysis of heterogeneity between surgeons at a single cancer center. Eur Urol 2011;59:317–22. [4] Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276:637–9. [5] Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54–61. [6] Eastham JA. Robotic-assisted prostatectomy: is there truth in advertising? Eur Urol 2008;54:720–2. [7] Stark M, Gerli S, Di Renzo GC. The importance of analyzing and standardizing surgical methods. J Minim Invasive Gynecol 2009;16:122–5. [8] Litwin MS, Melmed GY, Nakazon T. Life after radical prostatectomy: a longitudinal study. J Urol 2001;166:587–92. [9] Eastham JA, Kattan MW, Riedel E, et al. Variations among individual surgeons in the rate of positive surgical margins in radical prostatectomy specimens. J Urol 2003;170:2292–5. [10] Sanda MG, Dunn RL, Michalski J, et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med 2008;358:1250–61. [11] Vickers AJ, Bianco FJ, Serio AM, et al. The surgical learning curve for prostate cancer control after radical prostatectomy. J Nat Cancer Inst 2007;99:1171–7. [12] Freire MP, Choi WW, Lei Y, Carvas F, Hu JC. Overcoming the learning curve for robotic-assisted laparoscopic radical prostatectomy. Urol Clin North Am 2010;37:37–47. Jim C. Hu* Hua-yin Yu Keith J. Kowalczyk Division of Urologic Surgery and Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA *Corresponding author. Brigham and Women’s/Faulkner Hospital, 1153 Centre Street, Suite 4420, Boston, MA 02130, USA. Tel. +1 617 983 4570; Fax: +1 617 983 7945 E-mail address: [email protected] (J.C. Hu) February 13, 2011
Conflicts of interest: The authors have nothing to disclose. Funding support: Dr. Hu receives salary support from a Department of Defense Physician Training Award W81XWH-08-1-0283. Dr. Yu receives
Published online ahead of print on February 24, 2011