Short-term patient reported health-related quality of life (HRQL) outcomes after robot-assisted radical cystectomy (RARC)

Authors


Abstract

Objective

  • To determine short-term health-related quality of life (HRQL) outcomes after robot-assisted radical cystectomy (RARC) using the Bladder Cancer Index (BCI) and European Organisation for Research and Treatment of Cancer (EORTC) Body Image Scale (BIS).

Patients and Methods

  • All patients undergoing RARC were enrolled in a quality assurance database.
  • The patients completed two validated questionnaires, BCI and BIS, preoperatively and at standardised postoperative intervals.
  • The primary outcome measure was difference in interval and baseline BCI and BIS scores.
  • Complications were identified and classified by Clavien grade.

Results

  • In all, 43 patients completed pre- and postoperative questionnaires
  • There was a decline in the urinary domain at 0–1 month after RARC (P = 0.006), but this returned to baseline by 1–2 months.
  • There was a decline in the bowel domain at 0–1 month (P < 0.001) and 1–2 months (P = 0.024) after RARC, but this returned to baseline by 2–4 months.
  • The decline in BCI scores was greatest for the sexual function domain, but this returned to baseline by 16–24 months after RARC.
  • Body image perception using BIS showed no significant change after RARC except at the 4–10 months period (P = 0.018).

Conclusions

  • Based on BCI and BIS scores HRQL outcomes after RARC show recovery of urinary and bowel domains ≤6 months. Longer follow-up with a larger cohort of patients will help refine HRQL outcomes.
Abbreviations
BCI

Bladder Cancer Index

BIS

Body Image Scale

EORTC

European Organisation for Research and Treatment of Cancer

HRQL

Health-related quality of life

IQR

interquartile range

(RA)RC

(robot-assisted) radical cystectomy

Introduction

Patients treated with radical cystectomy (RC) and urinary diversion present with changes in urinary, bowel and sexual function that can be significant and prolonged. Previous studies have reported that patients undergoing surgery for urological malignancies show a decline in health, with more anxiety and depression, than benign disease [1].

Health-related quality of life (HRQL) outcomes are measures of impact of a health condition and its treatment on relevant aspects of life [2]. Physical and functional domains, body image, emotional well-being, social/family interactions are all impacted by surgery, especially oncological procedures. Understanding the influence of RC and urinary diversion allows physicians to establish quality standards, set expectations and identify areas that need improvement [3]. These domains have been incorporated in previous HRQL analyses but have been limited by a lack of validation and poor study design [4-7].

The short-term efficacy of robot-assisted RC (RARC) has been confirmed [8, 9] and defining and improving HRQL outcomes is necessary to demonstrate its efficacy [10]. The goal of the present study was to evaluate the HRQL outcomes of patients undergoing RARC using two validated questionnaires: the Bladder Cancer Index (BIC) and the European Organisation for Research and Treatment of Cancer (EORTC) Body Image Scale (BIS).

Patients and Methods

As part of an Institutional Review Board-approved quality assurance database, all patients with muscle-invasive bladder cancer were asked to complete two validated questionnaires assessing HRQL outcomes: BIC and BIS.

Patients who underwent RARC at Roswell Park Cancer Institute from July 2008 to August 2010 by a single surgeon (K.A.G.) were enrolled in the study [11]. In all, 43 patients had 38 ileal conduits and five neobladders and were asked to complete preoperative questionnaires. Follow-up questionnaires were completed at the first postoperative appointment (6 weeks). This was followed by an additional 6-week visit then visits every 3 months for the first year, then every 6 months. Exclusion criteria were prior RC and metastatic disease. To improve the power of the study an additional analysis of patients who had follow-up BCI and BIS scores was included but lacked a baseline score. Multivariable analysis included conduit technique, age, and complication grade. Complications were graded according to the Clavien classification system.

Outcome Measurement

The BCI is a validated disease-specific questionnaire [12]. The index consists of 34 items within three primary domains measuring urinary, bowel, and sexual health, responses are measured on a 5-point Likert scale. Each primary domain is divided into two sub-domains (function and bother) and are quantified on a 0–100 scale.

The BIS was initially created to the assess diagnosis and treatment of a broad range of cancers, patient body image and it is currently part of the EORTC [13]. The BIS has been adopted by urological oncologists to measure postoperative outcomes [14]. BIS incorporates 10 items specific to body image perception, satisfaction, and sexuality. Each question is scored on a 0–3 scale for a total score of 30. Higher scores reflect greater dissatisfaction.

Statistical Analysis

All patients who met the inclusion criteria completed both the BCI and BIS. The outcomes of these questionnaires were considered baseline values for which comparisons were made. Primary endpoints included time to return to baseline for each of the domain values. Associations between pairs of categorical variables were assessed using Fisher's exact test, while continuous variables were analysed using the two-sample t-test. Change in outcome variables (BCI scores) over time was assessed using a mixed model, to accommodate repeated measures, with compound symmetric covariance structure. A nominal significance level of 0.05 was used.

Results

In all, 43 patients underwent RARC with pre- and postoperative follow-up data available. In all, 33 patients (84%) were male with a mean (sd) age of 70 (9) years. The median (interquartile range, IQR) operating time was 391 (331, 444) min and median (IQR) estimated blood loss was 325 (200, 500) mL. The median (IQR) length of stay was 7 (6, 9) days. In all, 20 patients (47%) underwent extracorporeal and 23 (53%) underwent intracorporeal urinary diversion. The mean (sd) body mass index was 29 (5) kg/m2. In all, 13 patients (30%) had a maximum Clavien grade complication score of ≥3. The mean time from baseline questionnaire to RARC was 1.2 months.

In all, 70 patients had no preoperative but only postoperative HRQL data available. Of these, 52 (74%) were male with a mean age of 68 years. The median (IQR) operating time was 373 (315, 427) min and estimated blood loss was 400 (225, 500) mL. The median (IQR) length of stay was 8 (7, 12) days and 56 (80%) patients underwent extracorporeal diversion. In all, 13 patients had a maximum Clavien grade complication of ≥3 within 90 days of RARC (Table 1).

Table 1. Patient demographics
Patient CharacteristicsWith baseline BCI and BIS scoresWithout baseline BCI and BIS scores
  1. BMI, body mass index; EBL, estimated blood loss.
n4370
Mean (sd) age, years69.79 (9.06)67.77 (10.19)
Gender, n, %  
Male36 (84)52 (74)
Female7 (16)18 (26)
Race, n, %  
White42 (98)68 (97)
Black1 (2)2 (3)
Mean (sd) BMI, kg/m228.75 (4.76)28.49 (4.93)
Median (IQR) operating time, min391 (331, 444)373 (315, 427)
Diversion, n, %  
Extracorporeal20 (47)56 (80)
Intracorporeal23 (53)14 (20)
Median (IQR) EBL, mL325 (200, 500)400 (225, 500)
Median (IQR) length of stay, days7 (6, 9)8 (7, 12)
Pathological stage, n  
T0710
Ta20
Tis37
T1411
T21216
T31321
T425
Maximum Clavien grade, n (%)  
0–228 (68)57 (81)
≥313 (32)13 (19)

The mean (sd) baseline scores for the RARC group were 76.9 (23.7), 84.8 (15.8), and 44.5 (25.9) for the urinary, bowel and sexual domains, respectively (Table 2). Urinary domain scores declined by 12.9 immediately after surgery (P < 0.01) and returned to baseline thereafter. Bowel domain scores also declined immediately after surgery. At 0–1 month and 1–2 months there were decreases of 20.6 (P < 0.001) and 9.9 (P < 0.05), respectively. The bowel domain scores returned to baseline by 2–4 months and remained at baseline >24 months. The decline in BCI scores were greatest for the sexual function domain, with immediate decrease of 25.7 (P < 0.05) after RARC. The sexual domain scores remained lower than baseline until 16–24 months (Fig. 1). Perception of overall body image using BIS showed no significant change after RARC except at 4–10 months (P < 0.05) with a return to baseline by 24 months (Fig. 2).

Figure 1.

BCI urinary, bowel, and sexual function domain scores of 43 patients undergoing RARC.

Figure 2.

BIS scores of 43 patients undergoing RARC.

Table 2. BCI and BIS scores (baseline to ≥24-month follow-up)
 Score at:
Baseline0–1 month1–2 months2–4 months4–10 months10–16 months16–24 months>24 months
  1. P value based on difference in mean BCI and BIS scores from baseline. BCI scores are quantified on a 0–100 scale with a higher score representing better HRQL. BIS scores are quantified on a 0–30 scale with lower scores representing better HRQL.
BIC domain
Urinary        
Mean (sd)76.9 (23.7)64.0 (25.0)83.5 (15.2)81.2 (20.1)78.3 (20.1)82.6 (17.9)86.9 (14.3)84.3 (13.7)
P 
Bowel        
Mean (sd)84.8 (15.8)64.2 (16.9)74.9 (17.3)80.3 (20.8)81.2 (14.7)83.3 (14.5)87.3 (14.4)85.4 (14.9)
P <0.0010.024
Sexual        
Mean (sd)44.5 (25.9)18.8 (13.7)24.1 (16.6)26.8 (17.2)26.0 (14.3)27.6 (13.7)30.5 (22.4)48.1 (19.2)
P <0.001<0.0010.003<0.0010.003
BIS        
Mean (sd)2.1 (3.2)6.7 (7.2)5.2 (6.2)5.9 (7.1)6.8 (6.8)5.1 (4.7)3.3 (4.7)4.0 (5.1)
P 0.018

After incorporating the additional 70 patients for follow-up analysis, similar HRQL trends were identified. The urinary domain scores decreased immediately after surgery (P < 0.05), and subsequently returned to baseline by 1–2 months. The bowel domain scores decreased immediately after RARC (P < 0.01) and returned to baseline at 2–4 months. The sexual domain scores decreased immediately after surgery and remained lower until 24 months after surgery (Fig. 3).

Figure 3.

BIC urinary, bowel, and sexual domain scores and BIS scores of 113 patients undergoing RARC.

On subset analysis, patients undergoing intracorporeal diversion had higher baseline urinary function scores and quicker recovery of urinary function than patients with extracorporeal diversion (P < 0.05). BIS scores for intracorporeal diversion were similar to extracorporeal diversions at baseline. However, BIS scores returned to baseline more quickly in the extracorporeal group (by 1–2 months). BIS scores for patients with intracorporeal diversion were lower except at 4–10 months, representing better body image perception (Fig. 4).

Figure 4.

BIS based on diversion technique (intra- vs extracorporeal).

Patients aged >75 years had significantly better recovery of urinary, bowel and body image scores than patients aged <75 years (P = 0.004, P = 0.044, P = 0.044, respectively). There was no difference in recovery of sexual scores between those two groups.

When separated by maximum Clavien grade complication, there was no difference in recovery of urinary (P = 0.29) or bowel scores (P = 0.96) between patients with Clavien grade <3 complication and ≥3 complications. There was a longer recovery of sexual function scores (P < 0.05) and body images scores (P < 0.05) for those patients with Clavien grade ≥3 complications.

Discussion

As a novel surgical technique, RARC must be evaluated not only on oncological and perioperative outcomes but on HRQL measures as well. The present study, first of its kind using bladder-specific HRQL, shows the effect of RARC on HRQL outcomes using the BCI and BIS. As anticipated, in the present study patients undergoing RARC recovered urinary and bowel function within the first 4 months after surgery, while recovery of sexual function lagged up to 24 months.

These findings are similar to previous studies evaluating HRQL outcomes and RARC. Yuh et al. [10] measured early postoperative HRQL outcomes for patients undergoing RARC using the Functional Assessment of Cancer Therapy – Bladder Cancer (FACT-BL), which evaluates physical, social/family, emotional, and functional domains. As anticipated all domains except for the emotional domain, saw an initial decline after surgery and returned to baseline by 6 months.

Similar to the findings by Yuh et al., in the present series recovery to baseline urinary and bowel function occurred within the first 4 months, while sexual function returned to baseline at 24 months. Previous cross-sectional studies have shown similar postoperative scores for all BCI domains for patients undergoing open RC and ileal conduit diversion [12, 14]. One advantage of the present study was that changes in HRQL over time were assessed rather than at a single follow-up time point. Therefore these findings have the advantage of being applied to various postoperative patient encounters when discussing expectations of recovery after surgery.

Gilbert et al. [12] reported BCI scores for patients with bladder cancer after all treatment types including cystoscopy, intravesical therapy and urinary diversion. Domain scores in that study were subdivided by function and bother. For patients who had an ileal conduit, urinary function scores were similar to those who underwent intravesical therapy and better than those patients with a neobladder. The mean postoperative urinary function and bother scores were 86.5 and 88.4, respectively. The mean bowel function and bother scores were 77.6 and 80.8, respectively. The mean sexual domain function and bother scores were 20.0 and 50.3, respectively. That series was cross-sectional and did not assess baseline BCI scores or change in BCI scores over time.

Hedgepeth et al. [14] measured pre- and postoperative BCI and BIS scores of 224 patients who underwent RC and urinary diversion. In all, 85 patients underwent ileal conduit diversion and the remaining 139 had an orthotopic neobladder. Similar to the study by Gilbert et al. [12] these patients were compared with a reference group of patients with bladder cancer who underwent cystoscopy alone. BCI and BIS scores were followed over time. In patients who underwent ileal conduit diversion, urinary function and bother scores improved over time. The urinary function scores were higher in the ileal conduit group compared with those undergoing a neobladder. Similar to the present study, body image scores were similar at baseline between RC and non-RC groups. There were initial declines in body image scores in both studies; however, body image scores appeared to return to baseline at a much quicker rate in the present study.

When divided by age, older patients returned to baseline more quickly than their younger counterparts. This may be due to patient expectations. Younger patients may expect to recover at quicker rates and when these expectations are not achieved they feel that recovery is slower. There was no difference in the sexual recovery rate between the two age groups. This may be explained by overall poor sexual function scores at baseline. Patients aged above and below 75 years had poor sexual function before surgery and therefore demonstrating a difference in recovery between the two groups is difficult.

When divided by type of diversion, body image scores appeared to recover more quickly in the extracorporeal group. While not statistically significant the body image scores for the intracorporeal group at baseline appeared lower (better body image scores) and may account for a slower recovery. Another explanation in the slower recovery of BIS scores in the intracorporeal group is patient expectation. Patients who perceive intracorporeal diversion may anticipate immediate improvement in body image scores, which may not be met. Therefore potential patient misconceptions may help explain these differences.

The incidence of complications of RC and urinary diversion has been reported to be between 30 and 50% [15, 16]. Reports of the influence of complications on HRQL measures are limited as well. The present study was unique because of the evaluation of postoperative complications on return to baseline BCI scoring. In the present series, grade of complication was not associated with a difference in recovery of urinary or bowel function. In contrast, sexual function and body image scores recovered more slowly for patients with a maximum Clavien complication grade of ≥3. The exact date of complication and subsequent influence of the HRQL outcome could not be calculated.

The present study has several limitations. First, the number of patients undergoing RC may not have enough power to distinguish subtle variations in the change in BCI scores. To improve the power of the study we performed an additional analysis of patients who had follow-up BCI and BIS scores but lacked a baseline score. While this type of analysis has been done before as a cross-sectional design it requires the assumption that those patients with follow-up only were similar to those patients with baseline and follow-up questionnaires. Second, direct evaluations between RARC and open RC were not performed and therefore non-inferiority assessment was not evaluated. While there were differences in BCI and BIS scores in the present study it is unclear how much of a change in score represents a clinical meaningful difference for the patient. The few patients in the study also account for large standard deviations among the outcome parameters. With a larger patient sample these large standard deviations could be mitigated.

In conclusion, based on the BCI and BIS scores, HRQL outcomes after RARC showed recovery of urinary and bowel domains ≤6 months. Longer follow-up with a larger cohort of patients will help refine HRQL outcomes.

Conflict of Interest

None declared.

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