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Prospective Health-related Quality of Life Analysis for Patients Undergoing Radical Cystectomy and Urinary Diversion
Health Services Research Prospective Health-related Quality of Life Analysis for Patients Undergoing Radical Cystectomy and Urinary Diversion Michael C. Large, Rena Malik, Joshua A. Cohn, Kyle A. Richards, Cory Ganshert, Rangesh Kunnavakkum, Norm D. Smith, and Gary D. Steinberg OBJECTIVE MATERIALS AND METHODS
RESULTS
CONCLUSION
To better define health-related quality of life (HRQOL) for patients undergoing radical cystectomy (RC) and urinary diversion. Patients undergoing RC and urinary diversion for urothelial carcinoma by 1 of 2 surgeons (G.D.S. or N.D.S.) had a HRQOL assessment at baseline and at follow-up using the validated, bladder cancerespecific Functional Assessment of Cancer TherapyeVanderbilt Cystectomy Index questionnaire. The primary outcome was change in HRQOL between baseline and follow-up. From September 15, 2011, to July 23, 2012, 74 of 103 eligible patients were enrolled, and all but 1 completed the baseline Functional Assessment of Cancer TherapyeVanderbilt Cystectomy Index leaving 73 patients in the study. Median age was 68 years (interquartile range, 60-74 years), 58 (78%) were Caucasian, 53 (73%) were cT2, 45 (62%) underwent incontinent diversion, and the mean age-adjusted Charlson Comorbidity Index score was 2.4 1.8, with no significant differences among the 73 participants and 30 nonparticipants. The median time from surgery to response was 175 days (interquartile range, 102-232 days), and the response rate was 67%, with 9 deaths during follow-up. Baseline HRQOL scores did not significantly differ between respondents and nonrespondents or between those living vs deceased. Overall, RC-specific, physical, social, and functional HRQOL scores did not differ from baseline to follow-up, whereas emotional HRQOL scores were significantly improved (15.7 5.8 vs 18.1 3.9, P ¼ .03). Overall or domain-specific HRQOL measures did not differ significantly between patients undergoing incontinent (n ¼ 27) vs continent (n ¼ 16) diversions. Overall, HRQOL scores did not statistically differ from baseline to the median 6-month followup for patients undergoing RC and urinary diversion for urothelial carcinoma. Patients undergoing continent vs incontinent urinary diversions had similar overall HRQOL scores at follow-up. UROLOGY 84: 808e814, 2014. 2014 Elsevier Inc.
A
major impetus for the development of continent urinary diversion is to improve the healthrelated quality of life (HRQOL) of patients undergoing radical cystectomy (RC). Although the first continent urinary diversion was performed more than 150 years ago,1 the last 50 years have witnessed a blossoming of diversion types and techniques.2-7 The perioperative and long-term complication of several continent urinary diversions have been well described, but the HRQOL of those patients has not been adequately studied.8,9 A review of the post-RC HRQOL literature by Porter and Penson10 in 2005 revealed that only 1 of 15 eligible studies
Financial Disclosures: The authors declare that they have no relevant financial interests. From the Department of Surgery, Section of Urology, The University of Chicago Medical Center, Chicago, IL; the Urology of Indiana, Greenwood, IN; and the Department of Statistics, The University of Chicago Medical Center, Chicago, IL Reprint requests: Kyle A. Richards, M.D., Department of Surgery, Section of Urology, The University of Chicago Medical Center, 5841 S. Maryland Ave., MC 6038 Chicago, IL 60637. E-mail: [email protected] Submitted: April 11, 2014, accepted (with revisions): May 29, 2014
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ª 2014 Elsevier Inc. All Rights Reserved
were of a prospective design. Since that time, there has been increased interest in the subject along with the development of 2 bladder cancerespecific, validated HRQOL questionnaires.11,12 The European Organization for Research and Treatment of Cancer (EORTC) is in the process of validating a third group of bladder cancer-specific HRQOL instruments, the EORTC QLQ-BLS24 and QLQ-BLM30.13 In this study, we have used the validated, bladder cancerespecific Functional Assessment of Cancer TherapyeVanderbilt Cystectomy Index (FACT-VCI). The absolute and change in HRQOL from baseline to follow-up were compared across patients undergoing RC and continent vs incontinent diversions. Preoperative and postoperative characteristics were assessed alongside diversion type in a multivariate fashion to study the effect of diversion on HRQOL.
MATERIALS AND METHODS From September 15, 2011, to July 23, 2012, patients undergoing RC and urinary diversion by 1 of 2 surgeons (G.D.S. or N.D.S.) http://dx.doi.org/10.1016/j.urology.2014.05.046 0090-4295/14
Table 1. Demographics of trial participants vs nonparticipants Variables Age median (IQR), y Gender, No. Male Female Race, No. Caucasian Non-Caucasian Diversion type Incontinent Continent (ONB þ IP ¼ sum) Preoperative chemotherapy or radiotherapy, No. (%) BMI median (IQR), kg/m2 Pathologic tumor stage, No. (%) pT2 pT3/T4 Pathologic node positive, No. (%) Age-adjusted Charlson Comorbidity Index, mean SD Clavien complications, No. (%) Class 1-2 Deep venous thrombus Infectious Cardiac Ileus/GI related Blood transfusion Class 3 GI bleeding Wound dehiscence Intra-abdominal abscess Myocardial infarction Sepsis Acute renal failure Death
Participant (n ¼ 73)
Nonparticipant (n ¼ 30)
P Value
68 (60-74)
69 (65-80)
.22
57 16
21 9
.45
57 16
23 7
.88
45 19 þ 9 ¼ 28 22 (30) 28 (24-32)
18 11 þ 1 ¼12 10 (33) 27 (23-29)
1.00
37 (50.7) 36 (49.3) 20 (27.4) 2.4 1.8
18 (60) 12 (40) 8 (26.7) 2.2 1.5
.39
30 7 10 4 4 5 22 2 4 6 1 3 1 5
15 (50) 1 (3.3) 4 (13.3) 0 8 (26.7) 2 (6.7) 8 (27) 1 (3.3) 2 (6.7) 2 (6.7) 0 2 (6.7) 1 (3.3) 0
(41) (9.6) (13.7) (5.5) (5.5) (6.8) (30) (2.7) (5.5) (8.2) (1.4) (4.2) (1.4) (6.8)
.82 .08
.94 .62 .38
BMI, body mass index; GI, gastrointestinal; IP, Indiana pouch; IQR, interquartile range; ONB, orthotopic neobladder; SD, standard deviation.
were approached by a member of the clinical research staff for enrollment into this institutional review boardeapproved study. All patients underwent RC for oncologic indication. Both operating surgeons are senior faculty with expertise in the management of bladder cancer. Of 103 eligible patients, 74 consented for participation. Once consented, patients completed a preoperative HRQOL assessment using the validated FACT-VCI questionnaire and provided baseline education level, marital status, and income data. The FACT-VCI is a validated tool that includes the 27-item FACT-General (G) questionnaire and 17 urology-specific questions. All items are scored on a Likert scale of 0-4, with higher scores indicating higher HRQOL. Ten questions are reverse-ordered. The FACTG questionnaire is divided into 4 domains: physical, social, emotional, and functional well-being. The questions, “I am able to have and maintain an erection,” and “I am satisfied with my sex life,” were studied separately from the overall HRQOL scores because the first was for men only and the second was optional. A follow-up FACT-VCI questionnaire was mailed 2 months or more postoperatively to the 64 patients who were living. We waited 2 months to allow the patients to recover completely from surgery and minimize the effect of convalescence on HRQOL. Patients who failed to initially respond were contacted by a member of the research team and encouraged to complete the follow-up FACT-VCI. The tool has a reported correlation between first and second completions of 0.79, with a Cronbach a of >0.70 for internal consistency.11 The primary outcomes were overall HRQOL and the change in HRQOL at baseline vs UROLOGY 84 (4), 2014
follow-up. The patient completed both questionnaires in the absence of a physician. A comprehensive, prospectively maintained database was queried for all clinical, pathologic, and outcome data. All complications were graded according to the Clavien classification system.14 Charlson Comorbidity Index scores were ageadjusted, with 1 point added per decade beyond 50 years. The online Social Security Death Index was queried when necessary. Statistical analysis was performed using STATA 12 software (StataCorp LP, College Station, TX). Continuous and categoric variables were compared using 2-sided t tests and c2 tests, respectively. Univariate and multivariate analyses of HRQOL end points were performed using linear regression. A P value of <.05 was considered statistically significant. Using a paired 2-sample t test to examine a difference in mean overall HRQOL between baseline and follow-up, with 43 subjects at significance level (a) of 0.05 and standard deviation of the difference of 24.5, we have 80% power to show a difference of 11 in overall HRQOL. Comparing adjusted overall HRQOL (follow-up baseline) for continent vs incontinent patients, with 16 and 27 patients and standard deviation of the mean difference of 19.2, we have 80% power to show a difference of 20 with significance level of 0.05.
RESULTS Of the 103 consecutive, eligible patients, 74 enrolled, and 73 completed the baseline FACT-VCI and were included 809
Table 2. Mean baseline and follow-up and adjusted (follow-up baseline) domain-specific health-related quality of life scores for the entire cohort and by diversion type All Participants Variables Cystectomy-specific Physical Social Emotional Functional Overall
Baseline (n ¼ 43)
Follow-up (n ¼ 43)
Mean SD
Mean SD
P Value
.51 .65 .92 .03 .52 1.00
41.6 22.6 20.1 15.7 19.1 119.1
8.8 4.3 4.1 5.8 6.0 19.9
40.4 22.2 20.2 18.1 18.3 119.1
8.3 4.2 4.6 3.9 5.4 18.2
By Diversion Type Incontinent (n ¼ 27) Cystectomy-specific Physical Social Emotional Functional Overall
41.5 22.2 19.7 17.8 18.2 119.4
7.0 4.2 5.1 4.0 5.9 17.7
Continent (n ¼ 16) 38.4 22.2 20.9 18.6 18.4 118.6
10.1 4.2 3.5 3.7 4.5 19.6
P Value .24 1.00 .41 .90 .88 .88
Overall HRQOL Scores by Diversion Type Overall Baseline Follow-up Adjusted difference (follow-up baseline)
Incontinent (n ¼ 27)
Continent (n ¼ 16)
P Value
116.2 19.6 119.4 17.7 þ3.2 26.7
124.5 20.1 118.6 19.6 5.9 19.2
.88 .19 .25
HRQOL, health-related quality of life.
in the HRQOL analysis. Preoperative characteristics, including age, gender, race, body mass index, diversion type, receipt of preoperative chemotherapy or radiotherapy, clinical stage, 30-day Clavien complications, and age-adjusted Charlson Comorbidity Index scores, did not significantly differ between participants and nonparticipants (Table 1). Of the 64 patients who were alive at least 2 months from the time of surgery, the response rate for the followup questionnaire was 67.2% (n ¼ 43). Median time from surgery to response was 175 days (interquartile range [IQR], 101.5-232). Overall HRQOL scores did not differ between baseline and follow-up, at 119 20 and 119 18, respectively (P ¼ 1.00). Mean cystectomy-specific, physical, social, and functional domain HRQOL scores did not significantly differ from baseline to follow-up, whereas emotional scores increased from 15.7 5.8 to 18.1 3.9 (P ¼ .03; Table 2). For all baseline surveys, 2.7% of cells were incomplete; at response, 1.6% of cells were incomplete, and thus imputation analysis was not indicated. Of note, 1 patient had initially undergone Indiana pouch creation but was converted to an ileal conduit (IC) due to a persistent Indiana pouch-cutaneous fistula. Because she responded 4 months after IC creation, her HRQOL was documented as pertaining to incontinent diversion. Baseline HRQOL scores did not significantly differ between the 43 respondents and 20 nonrespondents, with mean cystectomy-specific values of 41.6 vs 41.8 (P ¼ .93); physical, 22.6 vs 21.7 (P ¼ .51); social, 20.1 vs 19.3 (P ¼ .52); emotional, 15.7 vs 16.8 (P ¼ .48); functional, 810
19.1 vs 17.3 (P ¼ .33), and overall, 199.1 vs 116.9 (P ¼ .72), respectively. Comparing baseline HRQOL scores for those alive (n ¼ 64) vs dead (n ¼ 9) at the follow-up assessment, mean cystectomy-specific scores were 41.7 vs 35.3 (P ¼ .09); physical, 22.3 vs 20.1 (P ¼ .25); social, 19.2 vs 19.0 (P ¼ .68); functional, 18.5 vs 16.2 (P ¼ .32); and overall, 113.9 vs 106.7 (P ¼ .14), respectively. With regard to diversion type, mean overall, cystectomyspecific, physical, social, emotional, and functional domain follow-up HRQOL scores did not significantly differ between the 27 patients with incontinent diversions and the 16 with continent diversions (Table 2). When the overall baseline HRQOL score was subtracted from the follow-up score, a mean difference of 3.2 26.7 was seen for those with incontinent diversions vs 5.9 19.2 for continent diversions (P ¼ .25; Table 2). Figure 1A depicts adjusted HRQOL (follow-up baseline) vs days from surgery for each patient. The linear regression line was R2 ¼ 0.0004 for incontinent diversions and R2 ¼ 0.0045 for continent diversions. Figure 1B depicts overall HRQOL at follow-up vs days from surgery, showing linear regression lines of R2 ¼ 0.0295 for incontinent diversion and R2 ¼ 0.0194 for continent diversion. Univariate analysis found the adjusted overall HRQOL (follow-up baseline) was not associated with age, diversion type, complications at 30 days, age-adjusted Charlson Comorbidity Index score, race, or marital status. The adjusted HRQOL was negatively associated with increased UROLOGY 84 (4), 2014
Figure 1. (A) Change in health-related quality of life (HRQOL) vs time from surgery by diversion type. (B) Overall HRQOL at follow-up vs time from surgery to follow-up questionnaire. (Color version available online.)
pathologic stage (b ¼ 7.6; 95% confidence interval [CI], 12.7 to 2.6; P <.01) and male gender (b ¼ 24.1; 95% CI, 41.3 to 7.0; P <.01). Multivariate analysis, including age, race, gender, marital status, age-adjusted Charlson Comorbidity Index score, and diversion type, found that only pathologic stage was significantly associated with adjusted overall HRQOL (b ¼ 8.1; 95% CI, 14.2 to 1.9; P ¼ .01).
COMMENT The results of this prospective study revealed no change in HRQOL using the validated FACT-VCI questionnaire from baseline to follow-up in patients undergoing open RC and urinary diversion at a high-volume bladder cancer center. Furthermore, when evaluating type of urinary diversion and controlling for perioperative variables, the type of urinary diversion did not impact change in HRQOL. Several prospective studies have compared follow-up HRQOL scores vs baseline (Table 3).15-19 Using the FACT-Bladder (BL), Yuh et al15 concluded that QOL returns to baseline levels by 6 months after robot-assisted RC (RARC).15 Patients’ post-RARC scores were compared with baseline, but because only 3 patients underwent continent diversion, diversion-based comparisons were not possible. Månsson et al19 compared preoperative and postoperative FACT-G, FACT-BL, and Hospital Anxiety and Depression Scale scores between Swedish and Egyptian men undergoing RC with orthotopic neobladder and found Swedish men had higher scores on the FACT-BL and Hospital Anxiety and Depression Scale at 3 months postoperatively.19 Similarly, UROLOGY 84 (4), 2014
their study design precluded the analysis of HRQOL by diversion type. Lastly, Anderson et al18 examined the Vanderbilt experience of 111 patients (84 men and 27 women) who provided FACT-VCI scores at baseline and 1 year.18 Their data suggested that patients undergoing IC had a higher VCI-15 score at 1 year vs orthotopic neobladder patients, although controlling for perioperative variables was not attempted.18 Two additional prospective HRQOL studies of cancer patients undergoing RC were recently published but did not use bladder-specific HRQOL tools. Stegeman et al16 noted that patients undergoing RARC returned to baseline Convalescence and Recovery Evaluation scores by 90 days, whereas Kulaksizoglu et al17 suggested that patients’ Beck’s Depression Inventory and EORTC-QLQ C-30 scores returned to baseline by 1 year. The present study does not show a significant difference in mean overall HRQOL for patients with incontinent vs continent diversion when controlling for the baseline score. There are several plausible explanations: First, the study is only powered to detect a difference of 20 or greater, which is approximately 1 standard deviation of the mean difference in score from baseline to follow-up. Although the overall score for FACT-VCI can range from 0 to 168, with a mean of 119 at follow-up in our cohort, whether a difference of 20 would be clinically significant may be debated. Second, an absence of difference may reflect a successful method-to-patient matching of diversion to patient.20 All patients were extensively counseled preoperatively and met with stomal therapists so that expectations were appropriate among patients and their families. 811
Table 3. Studies of health-related quality of life scores at follow-up compared with baseline across diversion types using validated instruments First Author
Year
Population Studied (No.)
Yuh15
2008
Stegeman16
2012
Kulaksizoglu17
2002
Anderson18
2012
RARC with open: IP (1) IC (31) ONB (2) RARC with open: IC (32) ONB (6) RARC with intracorporeal IC (52) Open RC with: IC (49) Cutaneous ureterostomy (2) Studer ONB (10) Hautmann ONB (5) Mainz II (2) IC or ONB (111 total)
Instrument
Findings
FACT-G, FACT-BL
QOL returned to baseline by 6 months
Convalescence and Recovery Evaluation (CARE)
Pain, cognition and activity but not gastrointestinal domains approached baseline by 90 days QOL and psychological measures returned to baseline and stabilized after 12 months
Beck’s Depression Inventory, EORTC-QOL questionnaire C-30 V.2
FACT-VCI
IC patients had 5-point higher VCI-15 scores at 1 year than ONB patients
BL, bladder; EORTC, European Organisation for Research and Treatment of Cancer; FACT, Functional Assessment of Cancer Therapy; G, general; IC, ileal conduit; QOL, quality of life; RARC, robot-assisted radical cystectomy; RC, radical cystectomy; VCI, Vanderbilt Cystectomy Index.
Third, because patients were queried a median time of 175 days after the surgery, the absence of difference in HRQOL may simply reflect the adaptation of patients to their new circumstances in life. The relatively flat linear regression lines for change in HRQOL vs days from surgery for both incontinent and continent diversions, suggest, however that an adequate amount of recovery time had elapsed between surgery and the HRQOL assessment for the population studied. Lastly, it may be argued that the variance in time between surgery and completion of follow-up questionnaire affected the ability to perceive differences in HRQOL. The change in HRQOL from baseline to follow-up vs time from surgery was analyzed across diversion type, and neither incontinent nor continent type demonstrated a trend in score against time. The study design has several inherent limitations that deserve mention. Although the response rate of 67.2% for the follow-up survey captured most of the patients in this cohort, it is plausible that the 32.8% of unaccounted for patients could have had a greater effect on the overall results, especially if their HRQOL suffered significantly, thus prohibiting them from completing the survey. Also, perhaps patients waited until they felt well enough to return their surveys and we were unable to capture a significant change in HRQOL without earlier and more frequent follow-up questionnaires. In addition, these results may not be applicable outside the setting of a high-volume bladder cancer practice because experience is likely to play a role in outcomes after RC and urinary diversion. Finally, as previously noted, a larger cohort of patients with differential follow-up periods might yield other results that our study cohort was not powered to detect. Nonetheless, this study does reveal that properly selected patients in a high-volume bladder cancer practice achieve a brisk return to baseline HRQOL after RC and urinary 812
diversion independent of the choice of urinary diversion. This information is reassuring when counseling complex patients about the implications of choice of urinary diversion before surgery. If the patient’s expectations are managed appropriately before surgery, HRQOL should be maintained regardless of type of urinary diversion.
CONCLUSION HRQOL after RC and urinary diversion remains an important area of ongoing research. Prospective studies using bladder cancerespecific, validated studies remain scarce. Our study found no change in HRQOL from baseline to a median 6-month follow-up in patients undergoing RC and urinary diversion for bladder cancer at a high-volume center. Furthermore, the type of urinary diversion did not significantly affect HRQOL scores when controlling for perioperative factors. Patient selection remains critical in the choice of urinary diversion, and when patient selection and expectations are managed appropriately, HRQOL can be maintained. Further studies are needed to assess for differences in HRQOL across socioeconomic and cultural differences in patients undergoing RC and urinary diversion. References 1. Simon J. Ectopia vesicae (absence of anterior walls of the bladder and pubic abdominal parietes), operation for directing the orifices of the ureters into the rectum; temporary success; subsequent death; autopsy. Lancet II. 1852:568-570. 2. Gilchrist RK, Merricks JW, Hamlin HH, Rieger IT. Construction of a substitute bladder and urethra. Surg Gynecol Obstet. 1950;90:752-760. 3. Kock NG, Nilson AE, Nilsson LO, et al. Urinary diversion via a continent ileal reservoir: clinical results in 12 patients. J Urol. 1982; 128:469-475. 4. Camey M, Le Duc A. L’enterocystoplastie avec cystoprostatectomie totale pour cancer de la vessie. Ann Urol. 1979;13:114-123. 5. Hautmann RE, Egghart G, Frohneberg D, Miller K. The ileal neobladder. J Urol. 1988;139:39-42.
UROLOGY 84 (4), 2014
6. Studer UE, Ackermann D, Casanova GA, Zingg EJ. Three years’ experience with an ileal low pressure bladder substitute. Br J Urol. 1989;63:43-52. 7. Rowland RG, Mitchell ME, Bihrle R, et al. Indiana continent urinary reservoir. J Urol. 1987;137:1136-1139. 8. Studer UE, Burkhard FC, Schumacher M, et al. Twenty years experience with an ileal orthotopic low pressure bladder substituteelessons to be learned. J Urol. 2006;176:161-166. 9. Hautmann RE, De Petriconi RC, Volkmer BG. 25 years of experience with 1,000 neobladders: long-term complications. J Urol. 2011;185:2207-2212. 10. Porter MP, Penson DF. Health related quality of life after radical cystectomy and urinary diversion for bladder cancer: a systematic review and critical analysis of the literature. J Urol. 2005;173: 1318-1322. 11. Cookson MS, Dutta SC, Chang SS, et al. Health related quality of life in patients treated with radical cystectomy and urinary diversion for urothelial carcinoma of the bladder: development and validation of a new disease specific questionnaire. J Urol. 2003;170:1926-1930. 12. Gilbert SM, Wood DP, Dunn RL, et al. Measuring health-related quality of life outcomes in bladder cancer patients using the Bladder Cancer Index (BCI). Cancer. 2007;109:1756-1762. 13. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life. Bladder Cancer: EORTC QLQ-BLS24, EORTC QLQ-BLM30. Available at http://groups.eortc.be/qol/ bladder-cancer-eortc-qlq-bls24-eortc-qlq-blm30. Accessed April 19, 2013. 14. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205-213. 15. Yuh B, Butt Z, Fazili A, et al. Short-term quality-of-life assessed after robot-assisted radical cystectomy: a prospective analysis. BJU Int. 2009;103:800-804. 16. Stegemann A, Rehman S, Brewer K, et al. Short-term patient-reported quality of life after robot-assisted radical cystectomy using the Convalescence and Recovery Evaluation. Urology. 2012;79:1274-1279. 17. Kulaksizoglu H, Toktas G, Kulaksizoglu IB, et al. When should quality of life be measured after radical cystectomy? Eur Urol. 2002; 42:350-355. 18. Anderson CB, Feurer ID, Large MC, et al. Psychometric characteristics of a condition-specific, health-related quality-of-life survey: the FACT-Vanderbilt Cystectomy Index. Urology. 2012;80:77-83. 19. Månsson A, Al Amin M, Malmstr€om PU, et al. Patient-assessed outcomes in Swedish and Egyptian men undergoing radical cystectomy and orthotopic bladder substitutionea prospective comparative study. Urology. 2007;70:1086-1090. 20. Gerharz EW, Månsson A, Hunt S, et al. Quality of life after cystectomy and urinary diversion: an evidence based analysis. J Urol. 2005;174:1729-1736.
EDITORIAL COMMENT No randomized controlled studies have investigated quality of life (QOL) after radical cystectomy (RC). Such studies are desirable but are difficult to conduct. Several nonrandomized studies are available in the literature, but only a few are prospective, and all are limited by biases, the most recognized of which is the lack of a universal definition of the term “QOL.” QOL assessment in patients with bladder cancer (BC) has primarily been accomplished through generic or cancer-specific validated instruments. Several validated questionnaires have been proposed to assess QOL after RC and urinary diversion (UD). All questionnaires should be self-administered during a scheduled follow-up visit. Effective measurement of QOL must consider: (1) general health, (2) physical and mental health, and (3) the organ-specific function (urinary and sexual). UROLOGY 84 (4), 2014
The following validated questionnaires are considered to be the most accurate to assess QOL after RC and UD: The European Organization of Research and Treatment of Cancer, cancer specific-bladder muscle invasive,1 and the Functional Assessment of Cancer Therapy (FACT) for Bladder CancereVanderbilt Cystectomy Index that uses the 28 items of the FACT-General instrument as the core set of items, with addition of new subscale items specific to BC diagnosis and treatment.2,3 Two points make the study interesting and important: 1. The study is prospective and uses a validated questionnaire. The results of this prospective study revealed no change in QOL using the validated FACT-Vanderbilt Cystectomy Index questionnaire from baseline to follow-up in patients undergoing open RC and UD at a high-volume BC center. 2. Patients with neobladders have enhanced cosmesis and the potential for normal voiding without an abdominal stoma. Nevertheless, the assumption that orthotopic reconstruction provides better QOL than an ileal conduit is still debated. The present study does not show a significant difference in mean overall QOL for patients with incontinent vs continent diversion when controlling for baseline score. There are several plausible explanations. The little old lady living in social isolation is much better served with a conduit than with a neobladder; however, younger individuals with an interest in body image and sexuality are better off with a neobladder. So, an absence of difference in QOL may reflect a successful method-to-patient matching of diversion to patient. All patients were extensively counseled preoperatively and met with stomal therapists so that expectations were appropriate among patients and their families. In the future, more studies should also consider behavioral profile and human adaptation of survivors after RC and UD. Patient’s satisfaction is related to the degree of adaptation of the new life with UD and the correct management. Life with UD may well represent a new phase of life and not a deterioration. Richard E. Hautmann, M.D., Department of Urology, University of Ulm, Ulm, Germany
References 1. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life. Bladder Cancer: EORTC QLQ-BLS24, EORTC QLQ-BLM30. Available at http://groups.eortc.be/qol/bladdercancer-eortc-qlq-bls24-eortc-qlq-blm30. Accessed April 19, 2013. 2. Cookson MS, Dutta SC, Chang SS, et al. Health related quality of life in patients treated with radical cystectomy and urinary diversion for urothelial carcinoma of the bladder: development and validation of a new disease specific questionnaire. J Urol. 2003; 170:1926-1930. 3. Gilbert SM, Wood DP, Dunn RL, et al. Measuring health-related quality of life outcomes in bladder cancer patients using the Bladder Cancer Index (BCI). Cancer. 2007;109:1756-1762.
http://dx.doi.org/10.1016/j.urology.2014.05.048 UROLOGY 84: 813, 2014. 2014 Elsevier Inc.
REPLY We appreciate the editorial comments about our prospective health-related quality of life (HRQOL) study in a consecutive series of patients undergoing radical cystectomy and urinary diversion for the treatment of bladder cancer. As alluded to, using well-validated tools when performing these types of studies 813
is critical. Furthermore, the patient should be allowed to complete the questionnaire at the completion of convalescence in the absence of the medical team to avoid potential bias and confounding. The results from this study are encouraging because they suggest that with appropriate preoperative counseling, education, and teaching, HRQOL can be maintained on average regardless of choice of urinary diversion. However, not all patients are “average” in the real-world follow-up after radical cystectomy and urinary diversion. Some patients clearly have deterioration of their HRQOL that may or may not be related to their urinary diversion. They might struggle with the emotional and psychiatric components of aggressive or recurrent bladder cancer, issues related to adverse effects from adjuvant therapy, or residual debility from perioperative complications. In this scenario, the HRQOL assessment can also be used in real-time to better meet the cognitive, emotional, psychiatric, and functional needs of these complex patients. Additional prospective, multi-institutional studies are needed for the ongoing assessment of HRQOL after radical
814
cystectomy and urinary diversion. Although optimizing oncologic outcomes in patients with bladder cancer remains a top priority, ongoing efforts to maintain HRQOL in these patients is critical as well. Kyle A. Richards, M.D., Rena Malik, M.D., Joshua A. Cohn, M.D., Cory Ganshert, B.S., Norm D. Smith, M.D., and Gary D. Steinberg, M.D., Department of Surgery, Section of Urology, The University of Chicago Medical Center, Chicago, IL Michael C. Large, M.D., Department of Surgery, Section of Urology, The University of Chicago Medical Center, Chicago, IL; Urology of Indiana, Greenwood, IN Rangesh Kunnavakkum, M.D., Department of Statistics, The University of Chicago Medical Center, Chicago, IL http://dx.doi.org/10.1016/j.urology.2014.05.049 UROLOGY 84: 813e814, 2014. 2014 Elsevier Inc.
UROLOGY 84 (4), 2014
RESULTS
CONCLUSION
To better define health-related quality of life (HRQOL) for patients undergoing radical cystectomy (RC) and urinary diversion. Patients undergoing RC and urinary diversion for urothelial carcinoma by 1 of 2 surgeons (G.D.S. or N.D.S.) had a HRQOL assessment at baseline and at follow-up using the validated, bladder cancerespecific Functional Assessment of Cancer TherapyeVanderbilt Cystectomy Index questionnaire. The primary outcome was change in HRQOL between baseline and follow-up. From September 15, 2011, to July 23, 2012, 74 of 103 eligible patients were enrolled, and all but 1 completed the baseline Functional Assessment of Cancer TherapyeVanderbilt Cystectomy Index leaving 73 patients in the study. Median age was 68 years (interquartile range, 60-74 years), 58 (78%) were Caucasian, 53 (73%) were cT2, 45 (62%) underwent incontinent diversion, and the mean age-adjusted Charlson Comorbidity Index score was 2.4 1.8, with no significant differences among the 73 participants and 30 nonparticipants. The median time from surgery to response was 175 days (interquartile range, 102-232 days), and the response rate was 67%, with 9 deaths during follow-up. Baseline HRQOL scores did not significantly differ between respondents and nonrespondents or between those living vs deceased. Overall, RC-specific, physical, social, and functional HRQOL scores did not differ from baseline to follow-up, whereas emotional HRQOL scores were significantly improved (15.7 5.8 vs 18.1 3.9, P ¼ .03). Overall or domain-specific HRQOL measures did not differ significantly between patients undergoing incontinent (n ¼ 27) vs continent (n ¼ 16) diversions. Overall, HRQOL scores did not statistically differ from baseline to the median 6-month followup for patients undergoing RC and urinary diversion for urothelial carcinoma. Patients undergoing continent vs incontinent urinary diversions had similar overall HRQOL scores at follow-up. UROLOGY 84: 808e814, 2014. 2014 Elsevier Inc.
A
major impetus for the development of continent urinary diversion is to improve the healthrelated quality of life (HRQOL) of patients undergoing radical cystectomy (RC). Although the first continent urinary diversion was performed more than 150 years ago,1 the last 50 years have witnessed a blossoming of diversion types and techniques.2-7 The perioperative and long-term complication of several continent urinary diversions have been well described, but the HRQOL of those patients has not been adequately studied.8,9 A review of the post-RC HRQOL literature by Porter and Penson10 in 2005 revealed that only 1 of 15 eligible studies
Financial Disclosures: The authors declare that they have no relevant financial interests. From the Department of Surgery, Section of Urology, The University of Chicago Medical Center, Chicago, IL; the Urology of Indiana, Greenwood, IN; and the Department of Statistics, The University of Chicago Medical Center, Chicago, IL Reprint requests: Kyle A. Richards, M.D., Department of Surgery, Section of Urology, The University of Chicago Medical Center, 5841 S. Maryland Ave., MC 6038 Chicago, IL 60637. E-mail: [email protected] Submitted: April 11, 2014, accepted (with revisions): May 29, 2014
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ª 2014 Elsevier Inc. All Rights Reserved
were of a prospective design. Since that time, there has been increased interest in the subject along with the development of 2 bladder cancerespecific, validated HRQOL questionnaires.11,12 The European Organization for Research and Treatment of Cancer (EORTC) is in the process of validating a third group of bladder cancer-specific HRQOL instruments, the EORTC QLQ-BLS24 and QLQ-BLM30.13 In this study, we have used the validated, bladder cancerespecific Functional Assessment of Cancer TherapyeVanderbilt Cystectomy Index (FACT-VCI). The absolute and change in HRQOL from baseline to follow-up were compared across patients undergoing RC and continent vs incontinent diversions. Preoperative and postoperative characteristics were assessed alongside diversion type in a multivariate fashion to study the effect of diversion on HRQOL.
MATERIALS AND METHODS From September 15, 2011, to July 23, 2012, patients undergoing RC and urinary diversion by 1 of 2 surgeons (G.D.S. or N.D.S.) http://dx.doi.org/10.1016/j.urology.2014.05.046 0090-4295/14
Table 1. Demographics of trial participants vs nonparticipants Variables Age median (IQR), y Gender, No. Male Female Race, No. Caucasian Non-Caucasian Diversion type Incontinent Continent (ONB þ IP ¼ sum) Preoperative chemotherapy or radiotherapy, No. (%) BMI median (IQR), kg/m2 Pathologic tumor stage, No. (%) pT2 pT3/T4 Pathologic node positive, No. (%) Age-adjusted Charlson Comorbidity Index, mean SD Clavien complications, No. (%) Class 1-2 Deep venous thrombus Infectious Cardiac Ileus/GI related Blood transfusion Class 3 GI bleeding Wound dehiscence Intra-abdominal abscess Myocardial infarction Sepsis Acute renal failure Death
Participant (n ¼ 73)
Nonparticipant (n ¼ 30)
P Value
68 (60-74)
69 (65-80)
.22
57 16
21 9
.45
57 16
23 7
.88
45 19 þ 9 ¼ 28 22 (30) 28 (24-32)
18 11 þ 1 ¼12 10 (33) 27 (23-29)
1.00
37 (50.7) 36 (49.3) 20 (27.4) 2.4 1.8
18 (60) 12 (40) 8 (26.7) 2.2 1.5
.39
30 7 10 4 4 5 22 2 4 6 1 3 1 5
15 (50) 1 (3.3) 4 (13.3) 0 8 (26.7) 2 (6.7) 8 (27) 1 (3.3) 2 (6.7) 2 (6.7) 0 2 (6.7) 1 (3.3) 0
(41) (9.6) (13.7) (5.5) (5.5) (6.8) (30) (2.7) (5.5) (8.2) (1.4) (4.2) (1.4) (6.8)
.82 .08
.94 .62 .38
BMI, body mass index; GI, gastrointestinal; IP, Indiana pouch; IQR, interquartile range; ONB, orthotopic neobladder; SD, standard deviation.
were approached by a member of the clinical research staff for enrollment into this institutional review boardeapproved study. All patients underwent RC for oncologic indication. Both operating surgeons are senior faculty with expertise in the management of bladder cancer. Of 103 eligible patients, 74 consented for participation. Once consented, patients completed a preoperative HRQOL assessment using the validated FACT-VCI questionnaire and provided baseline education level, marital status, and income data. The FACT-VCI is a validated tool that includes the 27-item FACT-General (G) questionnaire and 17 urology-specific questions. All items are scored on a Likert scale of 0-4, with higher scores indicating higher HRQOL. Ten questions are reverse-ordered. The FACTG questionnaire is divided into 4 domains: physical, social, emotional, and functional well-being. The questions, “I am able to have and maintain an erection,” and “I am satisfied with my sex life,” were studied separately from the overall HRQOL scores because the first was for men only and the second was optional. A follow-up FACT-VCI questionnaire was mailed 2 months or more postoperatively to the 64 patients who were living. We waited 2 months to allow the patients to recover completely from surgery and minimize the effect of convalescence on HRQOL. Patients who failed to initially respond were contacted by a member of the research team and encouraged to complete the follow-up FACT-VCI. The tool has a reported correlation between first and second completions of 0.79, with a Cronbach a of >0.70 for internal consistency.11 The primary outcomes were overall HRQOL and the change in HRQOL at baseline vs UROLOGY 84 (4), 2014
follow-up. The patient completed both questionnaires in the absence of a physician. A comprehensive, prospectively maintained database was queried for all clinical, pathologic, and outcome data. All complications were graded according to the Clavien classification system.14 Charlson Comorbidity Index scores were ageadjusted, with 1 point added per decade beyond 50 years. The online Social Security Death Index was queried when necessary. Statistical analysis was performed using STATA 12 software (StataCorp LP, College Station, TX). Continuous and categoric variables were compared using 2-sided t tests and c2 tests, respectively. Univariate and multivariate analyses of HRQOL end points were performed using linear regression. A P value of <.05 was considered statistically significant. Using a paired 2-sample t test to examine a difference in mean overall HRQOL between baseline and follow-up, with 43 subjects at significance level (a) of 0.05 and standard deviation of the difference of 24.5, we have 80% power to show a difference of 11 in overall HRQOL. Comparing adjusted overall HRQOL (follow-up baseline) for continent vs incontinent patients, with 16 and 27 patients and standard deviation of the mean difference of 19.2, we have 80% power to show a difference of 20 with significance level of 0.05.
RESULTS Of the 103 consecutive, eligible patients, 74 enrolled, and 73 completed the baseline FACT-VCI and were included 809
Table 2. Mean baseline and follow-up and adjusted (follow-up baseline) domain-specific health-related quality of life scores for the entire cohort and by diversion type All Participants Variables Cystectomy-specific Physical Social Emotional Functional Overall
Baseline (n ¼ 43)
Follow-up (n ¼ 43)
Mean SD
Mean SD
P Value
.51 .65 .92 .03 .52 1.00
41.6 22.6 20.1 15.7 19.1 119.1
8.8 4.3 4.1 5.8 6.0 19.9
40.4 22.2 20.2 18.1 18.3 119.1
8.3 4.2 4.6 3.9 5.4 18.2
By Diversion Type Incontinent (n ¼ 27) Cystectomy-specific Physical Social Emotional Functional Overall
41.5 22.2 19.7 17.8 18.2 119.4
7.0 4.2 5.1 4.0 5.9 17.7
Continent (n ¼ 16) 38.4 22.2 20.9 18.6 18.4 118.6
10.1 4.2 3.5 3.7 4.5 19.6
P Value .24 1.00 .41 .90 .88 .88
Overall HRQOL Scores by Diversion Type Overall Baseline Follow-up Adjusted difference (follow-up baseline)
Incontinent (n ¼ 27)
Continent (n ¼ 16)
P Value
116.2 19.6 119.4 17.7 þ3.2 26.7
124.5 20.1 118.6 19.6 5.9 19.2
.88 .19 .25
HRQOL, health-related quality of life.
in the HRQOL analysis. Preoperative characteristics, including age, gender, race, body mass index, diversion type, receipt of preoperative chemotherapy or radiotherapy, clinical stage, 30-day Clavien complications, and age-adjusted Charlson Comorbidity Index scores, did not significantly differ between participants and nonparticipants (Table 1). Of the 64 patients who were alive at least 2 months from the time of surgery, the response rate for the followup questionnaire was 67.2% (n ¼ 43). Median time from surgery to response was 175 days (interquartile range [IQR], 101.5-232). Overall HRQOL scores did not differ between baseline and follow-up, at 119 20 and 119 18, respectively (P ¼ 1.00). Mean cystectomy-specific, physical, social, and functional domain HRQOL scores did not significantly differ from baseline to follow-up, whereas emotional scores increased from 15.7 5.8 to 18.1 3.9 (P ¼ .03; Table 2). For all baseline surveys, 2.7% of cells were incomplete; at response, 1.6% of cells were incomplete, and thus imputation analysis was not indicated. Of note, 1 patient had initially undergone Indiana pouch creation but was converted to an ileal conduit (IC) due to a persistent Indiana pouch-cutaneous fistula. Because she responded 4 months after IC creation, her HRQOL was documented as pertaining to incontinent diversion. Baseline HRQOL scores did not significantly differ between the 43 respondents and 20 nonrespondents, with mean cystectomy-specific values of 41.6 vs 41.8 (P ¼ .93); physical, 22.6 vs 21.7 (P ¼ .51); social, 20.1 vs 19.3 (P ¼ .52); emotional, 15.7 vs 16.8 (P ¼ .48); functional, 810
19.1 vs 17.3 (P ¼ .33), and overall, 199.1 vs 116.9 (P ¼ .72), respectively. Comparing baseline HRQOL scores for those alive (n ¼ 64) vs dead (n ¼ 9) at the follow-up assessment, mean cystectomy-specific scores were 41.7 vs 35.3 (P ¼ .09); physical, 22.3 vs 20.1 (P ¼ .25); social, 19.2 vs 19.0 (P ¼ .68); functional, 18.5 vs 16.2 (P ¼ .32); and overall, 113.9 vs 106.7 (P ¼ .14), respectively. With regard to diversion type, mean overall, cystectomyspecific, physical, social, emotional, and functional domain follow-up HRQOL scores did not significantly differ between the 27 patients with incontinent diversions and the 16 with continent diversions (Table 2). When the overall baseline HRQOL score was subtracted from the follow-up score, a mean difference of 3.2 26.7 was seen for those with incontinent diversions vs 5.9 19.2 for continent diversions (P ¼ .25; Table 2). Figure 1A depicts adjusted HRQOL (follow-up baseline) vs days from surgery for each patient. The linear regression line was R2 ¼ 0.0004 for incontinent diversions and R2 ¼ 0.0045 for continent diversions. Figure 1B depicts overall HRQOL at follow-up vs days from surgery, showing linear regression lines of R2 ¼ 0.0295 for incontinent diversion and R2 ¼ 0.0194 for continent diversion. Univariate analysis found the adjusted overall HRQOL (follow-up baseline) was not associated with age, diversion type, complications at 30 days, age-adjusted Charlson Comorbidity Index score, race, or marital status. The adjusted HRQOL was negatively associated with increased UROLOGY 84 (4), 2014
Figure 1. (A) Change in health-related quality of life (HRQOL) vs time from surgery by diversion type. (B) Overall HRQOL at follow-up vs time from surgery to follow-up questionnaire. (Color version available online.)
pathologic stage (b ¼ 7.6; 95% confidence interval [CI], 12.7 to 2.6; P <.01) and male gender (b ¼ 24.1; 95% CI, 41.3 to 7.0; P <.01). Multivariate analysis, including age, race, gender, marital status, age-adjusted Charlson Comorbidity Index score, and diversion type, found that only pathologic stage was significantly associated with adjusted overall HRQOL (b ¼ 8.1; 95% CI, 14.2 to 1.9; P ¼ .01).
COMMENT The results of this prospective study revealed no change in HRQOL using the validated FACT-VCI questionnaire from baseline to follow-up in patients undergoing open RC and urinary diversion at a high-volume bladder cancer center. Furthermore, when evaluating type of urinary diversion and controlling for perioperative variables, the type of urinary diversion did not impact change in HRQOL. Several prospective studies have compared follow-up HRQOL scores vs baseline (Table 3).15-19 Using the FACT-Bladder (BL), Yuh et al15 concluded that QOL returns to baseline levels by 6 months after robot-assisted RC (RARC).15 Patients’ post-RARC scores were compared with baseline, but because only 3 patients underwent continent diversion, diversion-based comparisons were not possible. Månsson et al19 compared preoperative and postoperative FACT-G, FACT-BL, and Hospital Anxiety and Depression Scale scores between Swedish and Egyptian men undergoing RC with orthotopic neobladder and found Swedish men had higher scores on the FACT-BL and Hospital Anxiety and Depression Scale at 3 months postoperatively.19 Similarly, UROLOGY 84 (4), 2014
their study design precluded the analysis of HRQOL by diversion type. Lastly, Anderson et al18 examined the Vanderbilt experience of 111 patients (84 men and 27 women) who provided FACT-VCI scores at baseline and 1 year.18 Their data suggested that patients undergoing IC had a higher VCI-15 score at 1 year vs orthotopic neobladder patients, although controlling for perioperative variables was not attempted.18 Two additional prospective HRQOL studies of cancer patients undergoing RC were recently published but did not use bladder-specific HRQOL tools. Stegeman et al16 noted that patients undergoing RARC returned to baseline Convalescence and Recovery Evaluation scores by 90 days, whereas Kulaksizoglu et al17 suggested that patients’ Beck’s Depression Inventory and EORTC-QLQ C-30 scores returned to baseline by 1 year. The present study does not show a significant difference in mean overall HRQOL for patients with incontinent vs continent diversion when controlling for the baseline score. There are several plausible explanations: First, the study is only powered to detect a difference of 20 or greater, which is approximately 1 standard deviation of the mean difference in score from baseline to follow-up. Although the overall score for FACT-VCI can range from 0 to 168, with a mean of 119 at follow-up in our cohort, whether a difference of 20 would be clinically significant may be debated. Second, an absence of difference may reflect a successful method-to-patient matching of diversion to patient.20 All patients were extensively counseled preoperatively and met with stomal therapists so that expectations were appropriate among patients and their families. 811
Table 3. Studies of health-related quality of life scores at follow-up compared with baseline across diversion types using validated instruments First Author
Year
Population Studied (No.)
Yuh15
2008
Stegeman16
2012
Kulaksizoglu17
2002
Anderson18
2012
RARC with open: IP (1) IC (31) ONB (2) RARC with open: IC (32) ONB (6) RARC with intracorporeal IC (52) Open RC with: IC (49) Cutaneous ureterostomy (2) Studer ONB (10) Hautmann ONB (5) Mainz II (2) IC or ONB (111 total)
Instrument
Findings
FACT-G, FACT-BL
QOL returned to baseline by 6 months
Convalescence and Recovery Evaluation (CARE)
Pain, cognition and activity but not gastrointestinal domains approached baseline by 90 days QOL and psychological measures returned to baseline and stabilized after 12 months
Beck’s Depression Inventory, EORTC-QOL questionnaire C-30 V.2
FACT-VCI
IC patients had 5-point higher VCI-15 scores at 1 year than ONB patients
BL, bladder; EORTC, European Organisation for Research and Treatment of Cancer; FACT, Functional Assessment of Cancer Therapy; G, general; IC, ileal conduit; QOL, quality of life; RARC, robot-assisted radical cystectomy; RC, radical cystectomy; VCI, Vanderbilt Cystectomy Index.
Third, because patients were queried a median time of 175 days after the surgery, the absence of difference in HRQOL may simply reflect the adaptation of patients to their new circumstances in life. The relatively flat linear regression lines for change in HRQOL vs days from surgery for both incontinent and continent diversions, suggest, however that an adequate amount of recovery time had elapsed between surgery and the HRQOL assessment for the population studied. Lastly, it may be argued that the variance in time between surgery and completion of follow-up questionnaire affected the ability to perceive differences in HRQOL. The change in HRQOL from baseline to follow-up vs time from surgery was analyzed across diversion type, and neither incontinent nor continent type demonstrated a trend in score against time. The study design has several inherent limitations that deserve mention. Although the response rate of 67.2% for the follow-up survey captured most of the patients in this cohort, it is plausible that the 32.8% of unaccounted for patients could have had a greater effect on the overall results, especially if their HRQOL suffered significantly, thus prohibiting them from completing the survey. Also, perhaps patients waited until they felt well enough to return their surveys and we were unable to capture a significant change in HRQOL without earlier and more frequent follow-up questionnaires. In addition, these results may not be applicable outside the setting of a high-volume bladder cancer practice because experience is likely to play a role in outcomes after RC and urinary diversion. Finally, as previously noted, a larger cohort of patients with differential follow-up periods might yield other results that our study cohort was not powered to detect. Nonetheless, this study does reveal that properly selected patients in a high-volume bladder cancer practice achieve a brisk return to baseline HRQOL after RC and urinary 812
diversion independent of the choice of urinary diversion. This information is reassuring when counseling complex patients about the implications of choice of urinary diversion before surgery. If the patient’s expectations are managed appropriately before surgery, HRQOL should be maintained regardless of type of urinary diversion.
CONCLUSION HRQOL after RC and urinary diversion remains an important area of ongoing research. Prospective studies using bladder cancerespecific, validated studies remain scarce. Our study found no change in HRQOL from baseline to a median 6-month follow-up in patients undergoing RC and urinary diversion for bladder cancer at a high-volume center. Furthermore, the type of urinary diversion did not significantly affect HRQOL scores when controlling for perioperative factors. Patient selection remains critical in the choice of urinary diversion, and when patient selection and expectations are managed appropriately, HRQOL can be maintained. Further studies are needed to assess for differences in HRQOL across socioeconomic and cultural differences in patients undergoing RC and urinary diversion. References 1. Simon J. Ectopia vesicae (absence of anterior walls of the bladder and pubic abdominal parietes), operation for directing the orifices of the ureters into the rectum; temporary success; subsequent death; autopsy. Lancet II. 1852:568-570. 2. Gilchrist RK, Merricks JW, Hamlin HH, Rieger IT. Construction of a substitute bladder and urethra. Surg Gynecol Obstet. 1950;90:752-760. 3. Kock NG, Nilson AE, Nilsson LO, et al. Urinary diversion via a continent ileal reservoir: clinical results in 12 patients. J Urol. 1982; 128:469-475. 4. Camey M, Le Duc A. L’enterocystoplastie avec cystoprostatectomie totale pour cancer de la vessie. Ann Urol. 1979;13:114-123. 5. Hautmann RE, Egghart G, Frohneberg D, Miller K. The ileal neobladder. J Urol. 1988;139:39-42.
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6. Studer UE, Ackermann D, Casanova GA, Zingg EJ. Three years’ experience with an ileal low pressure bladder substitute. Br J Urol. 1989;63:43-52. 7. Rowland RG, Mitchell ME, Bihrle R, et al. Indiana continent urinary reservoir. J Urol. 1987;137:1136-1139. 8. Studer UE, Burkhard FC, Schumacher M, et al. Twenty years experience with an ileal orthotopic low pressure bladder substituteelessons to be learned. J Urol. 2006;176:161-166. 9. Hautmann RE, De Petriconi RC, Volkmer BG. 25 years of experience with 1,000 neobladders: long-term complications. J Urol. 2011;185:2207-2212. 10. Porter MP, Penson DF. Health related quality of life after radical cystectomy and urinary diversion for bladder cancer: a systematic review and critical analysis of the literature. J Urol. 2005;173: 1318-1322. 11. Cookson MS, Dutta SC, Chang SS, et al. Health related quality of life in patients treated with radical cystectomy and urinary diversion for urothelial carcinoma of the bladder: development and validation of a new disease specific questionnaire. J Urol. 2003;170:1926-1930. 12. Gilbert SM, Wood DP, Dunn RL, et al. Measuring health-related quality of life outcomes in bladder cancer patients using the Bladder Cancer Index (BCI). Cancer. 2007;109:1756-1762. 13. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life. Bladder Cancer: EORTC QLQ-BLS24, EORTC QLQ-BLM30. Available at http://groups.eortc.be/qol/ bladder-cancer-eortc-qlq-bls24-eortc-qlq-blm30. Accessed April 19, 2013. 14. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205-213. 15. Yuh B, Butt Z, Fazili A, et al. Short-term quality-of-life assessed after robot-assisted radical cystectomy: a prospective analysis. BJU Int. 2009;103:800-804. 16. Stegemann A, Rehman S, Brewer K, et al. Short-term patient-reported quality of life after robot-assisted radical cystectomy using the Convalescence and Recovery Evaluation. Urology. 2012;79:1274-1279. 17. Kulaksizoglu H, Toktas G, Kulaksizoglu IB, et al. When should quality of life be measured after radical cystectomy? Eur Urol. 2002; 42:350-355. 18. Anderson CB, Feurer ID, Large MC, et al. Psychometric characteristics of a condition-specific, health-related quality-of-life survey: the FACT-Vanderbilt Cystectomy Index. Urology. 2012;80:77-83. 19. Månsson A, Al Amin M, Malmstr€om PU, et al. Patient-assessed outcomes in Swedish and Egyptian men undergoing radical cystectomy and orthotopic bladder substitutionea prospective comparative study. Urology. 2007;70:1086-1090. 20. Gerharz EW, Månsson A, Hunt S, et al. Quality of life after cystectomy and urinary diversion: an evidence based analysis. J Urol. 2005;174:1729-1736.
EDITORIAL COMMENT No randomized controlled studies have investigated quality of life (QOL) after radical cystectomy (RC). Such studies are desirable but are difficult to conduct. Several nonrandomized studies are available in the literature, but only a few are prospective, and all are limited by biases, the most recognized of which is the lack of a universal definition of the term “QOL.” QOL assessment in patients with bladder cancer (BC) has primarily been accomplished through generic or cancer-specific validated instruments. Several validated questionnaires have been proposed to assess QOL after RC and urinary diversion (UD). All questionnaires should be self-administered during a scheduled follow-up visit. Effective measurement of QOL must consider: (1) general health, (2) physical and mental health, and (3) the organ-specific function (urinary and sexual). UROLOGY 84 (4), 2014
The following validated questionnaires are considered to be the most accurate to assess QOL after RC and UD: The European Organization of Research and Treatment of Cancer, cancer specific-bladder muscle invasive,1 and the Functional Assessment of Cancer Therapy (FACT) for Bladder CancereVanderbilt Cystectomy Index that uses the 28 items of the FACT-General instrument as the core set of items, with addition of new subscale items specific to BC diagnosis and treatment.2,3 Two points make the study interesting and important: 1. The study is prospective and uses a validated questionnaire. The results of this prospective study revealed no change in QOL using the validated FACT-Vanderbilt Cystectomy Index questionnaire from baseline to follow-up in patients undergoing open RC and UD at a high-volume BC center. 2. Patients with neobladders have enhanced cosmesis and the potential for normal voiding without an abdominal stoma. Nevertheless, the assumption that orthotopic reconstruction provides better QOL than an ileal conduit is still debated. The present study does not show a significant difference in mean overall QOL for patients with incontinent vs continent diversion when controlling for baseline score. There are several plausible explanations. The little old lady living in social isolation is much better served with a conduit than with a neobladder; however, younger individuals with an interest in body image and sexuality are better off with a neobladder. So, an absence of difference in QOL may reflect a successful method-to-patient matching of diversion to patient. All patients were extensively counseled preoperatively and met with stomal therapists so that expectations were appropriate among patients and their families. In the future, more studies should also consider behavioral profile and human adaptation of survivors after RC and UD. Patient’s satisfaction is related to the degree of adaptation of the new life with UD and the correct management. Life with UD may well represent a new phase of life and not a deterioration. Richard E. Hautmann, M.D., Department of Urology, University of Ulm, Ulm, Germany
References 1. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life. Bladder Cancer: EORTC QLQ-BLS24, EORTC QLQ-BLM30. Available at http://groups.eortc.be/qol/bladdercancer-eortc-qlq-bls24-eortc-qlq-blm30. Accessed April 19, 2013. 2. Cookson MS, Dutta SC, Chang SS, et al. Health related quality of life in patients treated with radical cystectomy and urinary diversion for urothelial carcinoma of the bladder: development and validation of a new disease specific questionnaire. J Urol. 2003; 170:1926-1930. 3. Gilbert SM, Wood DP, Dunn RL, et al. Measuring health-related quality of life outcomes in bladder cancer patients using the Bladder Cancer Index (BCI). Cancer. 2007;109:1756-1762.
http://dx.doi.org/10.1016/j.urology.2014.05.048 UROLOGY 84: 813, 2014. 2014 Elsevier Inc.
REPLY We appreciate the editorial comments about our prospective health-related quality of life (HRQOL) study in a consecutive series of patients undergoing radical cystectomy and urinary diversion for the treatment of bladder cancer. As alluded to, using well-validated tools when performing these types of studies 813
is critical. Furthermore, the patient should be allowed to complete the questionnaire at the completion of convalescence in the absence of the medical team to avoid potential bias and confounding. The results from this study are encouraging because they suggest that with appropriate preoperative counseling, education, and teaching, HRQOL can be maintained on average regardless of choice of urinary diversion. However, not all patients are “average” in the real-world follow-up after radical cystectomy and urinary diversion. Some patients clearly have deterioration of their HRQOL that may or may not be related to their urinary diversion. They might struggle with the emotional and psychiatric components of aggressive or recurrent bladder cancer, issues related to adverse effects from adjuvant therapy, or residual debility from perioperative complications. In this scenario, the HRQOL assessment can also be used in real-time to better meet the cognitive, emotional, psychiatric, and functional needs of these complex patients. Additional prospective, multi-institutional studies are needed for the ongoing assessment of HRQOL after radical
814
cystectomy and urinary diversion. Although optimizing oncologic outcomes in patients with bladder cancer remains a top priority, ongoing efforts to maintain HRQOL in these patients is critical as well. Kyle A. Richards, M.D., Rena Malik, M.D., Joshua A. Cohn, M.D., Cory Ganshert, B.S., Norm D. Smith, M.D., and Gary D. Steinberg, M.D., Department of Surgery, Section of Urology, The University of Chicago Medical Center, Chicago, IL Michael C. Large, M.D., Department of Surgery, Section of Urology, The University of Chicago Medical Center, Chicago, IL; Urology of Indiana, Greenwood, IN Rangesh Kunnavakkum, M.D., Department of Statistics, The University of Chicago Medical Center, Chicago, IL http://dx.doi.org/10.1016/j.urology.2014.05.049 UROLOGY 84: 813e814, 2014. 2014 Elsevier Inc.
UROLOGY 84 (4), 2014