In the context of a health-care system that is burdened by the overuse of costly and possibly unnecessary tests, medications, and procedures, we found marked underuse of guideline-recommended care for invasive bladder cancer. According to NCCN guidelines, the majority of patients with muscle-invasive bladder cancer should undergo radical cystectomy and urinary diversion. However, only 21% of the subjects in the study cohort underwent radical surgery. This pronounced underuse of recommended care may harm patients who receive alternative treatment regimens. Subjects who underwent chemotherapy, radiation, or surveillance for their muscle-invasive bladder cancer had a higher hazard of death over time than those who underwent radical cystectomy.
Unlike many contemporary surgical procedures for which guidelines may lag behind evidence for their preferred use (22
), national guidelines for the management of muscle-invasive bladder cancer have recommended radical cystectomy for years (30
). Nevertheless, our data indicate that much of the variance in the receipt of radical cystectomy is attributable to the diagnosing surgeon. Some of this variance may reflect the evidence base behind the NCCN guidelines: Its recommendation for cystectomy is based on expert opinion rather than on data from randomized clinical trials. Because the evidence base for the cystectomy recommendation is limited, providers may have substantial uncertainty about the best clinical management of muscle-invasive bladder cancer patients. Other barriers may also preclude widespread adoption of cystectomy at the provider level. For example, the primary urologist may be unwilling to offer radical cystectomy and urinary diversion. It is a complex procedure with an operative time ranging from 4 to 8 or more hours depending on the cancer severity and the amount of urinary reconstruction involved. Medicare reimbursement rates for this procedure, adjusted for inflation, declined by 32% from 1995 to 2004 (31
). Because most physicians operate essentially as small business owners, the economic incentive to do less risky but better remunerated work in the clinic or in an ambulatory surgery center may compel them to avoid providing cystectomy. Beyond financial concerns, radical cystectomy confers high rates of morbidity and mortality (32
) and requires intensive perioperative nursing care as patients learn to manage their new urinary reconstructions. High-volume providers may have the infrastructure to manage this care efficiently and effectively, whereas low-volume providers may be dissuaded by these concerns. If, for any reason, the primary urologist is not comfortable performing cystectomy, the patient must be referred, typically to a tertiary academic center, for appropriate treatment.
To a large extent, such regionalization of cystectomy care has already occurred (33
) and may represent a positive change: Volume–outcome studies for radical cystectomy suggest lower rates of mortality for patients who undergo surgery by high-volume providers (34
). Conversely, regionalization of radical cystectomy may explain the low rates of cystectomy documented in this study. The reduction of available surgeons is likely to differentially affect patients who live in urban vs rural underserved areas, which could exacerbate existing disparities in bladder cancer care. Rural patients who receive care at a tertiary referral center may have to return to their primary urologist for follow-up care, which could create a burden that many community urologists may be unwilling to accept. This transition of care may harm patients; readmissions to secondary hospitals for other complex procedures were found to be associated with worse morbidity and mortality outcomes compared with readmission to the hospital where the surgery was performed (37
). Although regionalization of cystectomy care may benefit those who undergo surgery, the larger impact of this process may be to compromise invasive bladder cancer care.
We found that longer travel distance was associated with lower odds of radical cystectomy for invasive bladder cancer. Regionalization of cystectomy care evokes concern about urban–rural disparities in health-care delivery, a concern that is validated by our findings. Patients who had to travel more than 50 miles to an available surgeon had a lower likelihood of undergoing cystectomy compared with patients who had shorter travel distances. Rural patients are known to have reduced access to cancer screening services and surgical treatment after diagnosis (38
). Long travel times to providers further limit their treatment options (41
). Rural cancer patients also tend to be older than urban cancer patients, which may further restrict their access to transportation and affect their medical candidacy for needed complex surgical services (42
). Our findings confirm those of a previous study (20
) that reported that patients sacrifice survival benefits—in our study, those conferred by surgery for invasive bladder cancer—when confronted with an extensive travel burden.
Patient factors were also associated with the treatment that was received. Younger healthier patients had higher odds, independent of the other covariates in our model, of undergoing radical cystectomy for their invasive bladder cancers. It is understandable that surgery is more common in patients who are better able to withstand the medical stress of a long surgery and sufficiently functionally capable of adapting to their new urinary tract reconstructions. Furthermore, older age and increased comorbidity are often intertwined (43
). However, prognosis for patients with invasive bladder cancer is more highly correlated with cancer severity than with patient age (44
). Moreover, radical cystectomy has previously demonstrated survival benefits even among the elderly (46
). Thus, although age and comorbidity should determine medical candidacy for this surgery, the majority of invasive bladder cancer patients without contraindication to prolonged anesthesia should undergo potentially curative radical surgery.
Our results beg the question that underlies all studies that identify disparate or inappropriate care: What next? How do we ensure broader use of radical surgery for invasive bladder cancer? Guidelines confirm that radical cystectomy is the gold standard treatment for invasive bladder cancer. Our results support that designation: patients who received cystectomy had substantially better survival outcomes compared with patients who received alternative treatments. So how should we address the dual reluctance of providers to commit to managing this complex surgery and of patients to submitting to its life-altering consequences? Although a regionalization of cystectomy care resulting from established physician referral patterns and patient self-referrals may have contributed to the underuse we document, some form of organized regionalization of cystectomy may be an answer. For example, invasive bladder cancer care could revolve around a prescribed network of cystectomy providers to which all patients would have access rather than being dependent on the primary urologist and his or her clinical biases, tendencies, and local referral practices. Patients themselves must also become more empowered in the decision-making process. It seems unlikely that a majority of patients would willingly select a treatment (ie, a treatment other than cystectomy) with up to an 80% increase in the risk of death over time. Increasing the health literacy of bladder cancer patients may increase the proportion that chooses to undergo radical cystectomy.
This study has a number of limitations that may have biased the results. First, restriction of the study sample to Medicare beneficiaries may compromise the generalizability of the results. However, the majority of incident bladder cancers occur in Medicare-aged men and women (47
). Second, patients may have appropriately received treatments other than cystectomy on the basis of patient clinical characteristics and life expectancy. Although we attempt to capture patient comorbidity through Medicare claims data, this approach provides an imperfect estimation. Patients who did not receive cystectomy may have had more severe comorbidity than could be identified by using a claims-based methodology. Third, chemotherapy use was underreported in 2004 and 2005 in the SEER–Medicare sample that we analyzed. However, because our cohort included cancers diagnosed through 2002, this underreporting is likely to have had a very small effect on the distribution of patients to the chemotherapy and/or radiation and surveillance treatment groups. Fourth, we excluded patients with stage III or IV cancers (ie, cancers that extend into the perivesical fat or invade local structures and metastatic cancers) to minimize the number of patients who received appropriate alternative treatment regimens, such as chemotherapy. However, cancer stage in SEER is classified at diagnosis and may not capture clinical understaging. Many patients in our sample may have been found to have stage III or IV cancers at the time of cystectomy. Fifth, any comparison of treatment groups derived from nonrandomized cohorts as in this study is prone to bias, especially from unmeasured confounders. We attempted to adjust for both the measured differences among treatment groups, such as age and comorbidity, and the unmeasured group differences by using an instrumental variable analysis. We contend that the two-stage residual inclusion estimation that we applied to the data, a technique that has been shown to be reliable for addressing selection bias in observational data (28
), permits a valid interpretation of our survival outcomes.
Sixth, we could not account for patient preferences in care. Radical cystectomy is a life-altering intervention because it requires urinary tract reconstruction. Although most cancer surgeries require convalescence, few require such a profound alteration to daily living as changing how one empties the bladder. Patients who receive an incontinent intestinal conduit reconstruction have a urostomy that is covered with a bag that collects the voided urine. Those who undergo continent urinary diversion with a neobladder void either by performing the Valsalva maneuver to increase abdominal pressure or through intermittent self-catheterization. Some radical cystectomy patients may also incur some degree of bowel dysfunction depending on the length of intestine that was used in their reconstruction (48
). Sexual dysfunction is nearly universal among patients who have undergone radical cystectomy (48
). It can be difficult to convince a patient to sacrifice these aspects of quality of life, despite the proven benefit of cystectomy to the quantity of life. That balance, between quantity and quality of life, may drive many of the decisions that underlie the underuse of cystectomy that we have documented. Even with radical surgery or radiation therapy, survival after an invasive bladder cancer diagnosis is limited. Quality of life may be paramount in patients’ minds as they opt for less beneficial therapies that offer bladder preservation.
Finally, our results conflict with those of population-based studies from other countries that demonstrated similar survival outcomes between cystectomy and radiation therapy treatment groups. For example, population-based cancer registries in the United Kingdom and Canada have shown equivalent survival outcomes for surgery and radiation on comparative retrospective analyses (49–52). Yet the majority of patients in these countries receive radiation therapy as the initial treatment with curative intent. The patients who underwent cystectomy had higher rates of lymph node involvement (52) or locally advanced stage T4 cancers compared with patients who received radiation, thereby predisposing cystectomy patients to worse survival outcomes (49
). Furthermore, these analyses did not address known and unmeasured imbalances between these treatment groups nor did they stratify survival outcomes by clinical stage at presentation.
Despite these limitations, we demonstrated substantial underuse of radical cystectomy for muscle-invasive bladder cancer. This underuse of guideline-recommended care may have condemned patients who received alternative treatments to premature mortality. Maximizing the number of patients who receive appropriate care for muscle-invasive bladder cancer requires overcoming the formidable obstacles of patient and provider resistance to this procedure. To increase the use of radical cystectomy and urinary diversion for invasive bladder cancer, we must ensure that patients have access to available surgeons and promote patient knowledge so they may fully understand the risks and benefits of their treatment options.