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Re: Managing Localized Prostate Cancer by Radical Prostatectomy or Watchful Waiting: Cost Analysis of a Randomized Trial (SPCG-4)
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lates of IDM were also assessed. Results: Approximately half of the sample had a prior PSA test, although only 35% reported having made an explicit screening decision. Across the sample, CaP knowledge was low (mean ⫽ 56%), although decision self-efficacy was high (mean ⫽ 78%), and the majority of men (81%) made decisions consistent with their stated values. Compared with those who were undecided, men who made an explicit screening decision had significantly higher levels of knowledge, greater decisional self-efficacy, and were more consistent in terms of making a decision in alignment with their values. They tended to be white, have high levels of income and education, and had discussed screening with their health care provider. Conclusions: Many men undergo CaP screening without being fully informed about the decision. These findings support the need for interventions aimed at improving IDM about screening, particularly among men of color, those with lower levels of income and education, and those who have not discussed screening with their provider. Editorial Comment: Most guidelines for prostate cancer screening suggest that men be informed about the risks and benefits of testing, and be allowed to make their own informed decision. However, in the real world this just does not happen. This randomized clinical trial of a decision aid for screening shows that most patients currently are not fully informed about the screening process, although many of the men in the study were screened. The study confirms that most patients do not understand and are not informed about the issues surrounding screening, and that primary care providers often just order prostate specific antigen tests without any discussion. Anyone who routinely treats prostate cancer is probably not surprised by these results. What is surprising is our continued insistence that a patient can be adequately educated and make a truly informed decision about prostate cancer screening in the setting of a 20-minute primary care office visit. We continue to hold out hope that patients can somehow assimilate the confusing and contradictory information on screening that many of us so-called experts have problems genuinely understanding. We develop decision aids (like the one being evaluated in the parent study described here) in the hopes of improving our understanding, yet in the end these aids are not all that helpful either. So what are we to do? Although I remain a staunch supporter of shared medical decision making (particularly in the setting of prostate cancer treatment), it is high time we recognize that a more guided approach may be preferred in certain situations. Prostate cancer screening is one of those situations. It is time for firmer and more concrete guideline recommendations beyond stating that patients should be educated and allowed to make an informed decision. Our patients want real evidence-based guidance in this area, and we need to give it to them. David F. Penson, M.D., M.P.H.
Re: Managing Localized Prostate Cancer by Radical Prostatectomy or Watchful Waiting: Cost Analysis of a Randomized Trial (SPCG-4) S. O. Andersson, O. Andrén, J. Lyth, J. R. Stark, M. Henriksson, H. O. Adami, P. Carlsson and J. E. Johansson Department of Urology, Örebro University Hospital, Örebro, Sweden Scand J Urol Nephrol 2011; 45: 177–183.
Objective: The cost of radical prostatectomy (RP) compared to watchful waiting (WW) has never been estimated in a randomized trial. The goal of this study was to estimate long-term total costs per patient associated with RP and WW arising from inpatient and outpatient hospital care. Material and Methods: This investigation used the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) trial, comparing RP to WW, and included data from 212 participants living in two counties in Sweden from 1989 to 1999 (105 randomized to WW and 107 to RP). All costs were included from randomization date until death or end of follow-up in July 2007. Resource use arising from inpatient and outpatient hospital costs was measured in physical units and multiplied by a unit cost to come up with
SOCIOECONOMIC FACTORS, UROLOGICAL EPIDEMIOLOGY AND PRACTICE PATTERNS
a total cost per patient. Results: During a median follow-up of 12 years, the overall cost in the RP group was 34% higher (P ⬍ 0.01) than in the WW group, corresponding to €6123 in Sweden. The difference was driven almost exclusively by the cost of the surgical procedure. The cost difference between RP and WW was two times higher among men with low (2– 6) than among those with high (7–10) Gleason score. Conclusion: In this economic evaluation of RP versus WW of localized prostate cancer in a randomized study, RP was associated with 34% higher costs. This difference, attributed exclusively to the cost of the RP procedure, was not overcome during extended follow-up. Editorial Comment: It is standard practice to perform economic analyses of randomized clinical trials, and the SPCG-4 study is no exception. The authors compared costs in the surgery arm to the watchful waiting arm and concluded that costs in the surgery arm were higher due to the up-front costs of the procedure. This finding is not surprising. In an era of active surveillance, where conservatively treated patients undergo numerous prostate specific antigen screenings and biopsies and there is a higher incidence of delayed prostatectomy, it is likely that the cost difference will be considerably less. However, the concept of cost has to be considered in the setting of cost-effectiveness. Assuming that in 2011 the surgical arm still incurs greater costs than the active surveillance/watchful waiting arm, does the relatively modest survival benefit justify the intervention? This is an important question that has gotten a lot of play in the media recently, given the national coverage determination by Medicare to cover sipuleucel-T (Provenge®), which is quite costly but has just a 4-month median survival benefit. It is critical that we have this national discourse. However, we cannot stop at expensive agents for use in terminal disease. We need to discuss the cost-effectiveness of earlier interventions, including intensity-modulated radiotherapy, robotic prostatectomy and even prostate specific antigen screening, if we are to deploy our limited resources in an efficient and sensible manner. David F. Penson, M.D., M.P.H.
Re: Overtreatment of Men With Low-Risk Prostate Cancer and Significant Comorbidity T. J. Daskivich, K. Chamie, L. Kwan, J. Labo, R. Palvolgyi, A. Dash, S. Greenfield and M. S. Litwin Department of Urology, David Geffen School of Medicine, University of California, Los Angeles, California Cancer 2011; 117: 2058 –2066.
Background: Men with low-risk prostate cancer and significant comorbidity are susceptible to overtreatment. The authors sought to compare the impact of comorbidity and age on treatment choice in men with low-risk disease. Methods: The authors sampled 509 men with low-risk prostate cancer diagnosed at the Greater Los Angeles and Long Beach Veterans Affairs Medical Centers between 1997 and 2004. Rates of aggressive treatment (radical prostatectomy, radiation therapy, brachytherapy) were determined among men of different ages and with different Charlson comorbidity scores. Multivariate modeling was used to determine the influence of both variables in predicting nonaggressive treatment, and Cox proportional hazards analysis was used to compare the risk of othercause mortality among groups according to Charlson score and age. Results: Men with Charlson scores ⱖ 3 were treated aggressively in 54% of cases (30 of 56 men), while men aged ⬎75 years at diagnosis were treated aggressively in 16% of cases (7 of 44 men). In multivariate analysis, age ⬎75 years was a much stronger predictor of nonaggressive treatment (relative risk, 12.0; 95% confidence interval [CI], 5.4 –28.3) than a Charlson score ⱖ 3 (relative risk, 2.0; 95% CI, 1.3–2.9). In survival analysis, men with Charlson scores ⱖ 3 had an 8-fold increased risk (hazard ratio, 8.4; 95% CI, 4.2–16.6) and 70% probability of other-cause mortality at 10 years, whereas age ⬎75 years was associated with a 5-fold increased risk (hazard ratio, 4.9; 95%CI, 1.7–13.8) and a 24% probability of
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SOCIOECONOMIC FACTORS, UROLOGICAL EPIDEMIOLOGY AND PRACTICE PATTERNS
lates of IDM were also assessed. Results: Approximately half of the sample had a prior PSA test, although only 35% reported having made an explicit screening decision. Across the sample, CaP knowledge was low (mean ⫽ 56%), although decision self-efficacy was high (mean ⫽ 78%), and the majority of men (81%) made decisions consistent with their stated values. Compared with those who were undecided, men who made an explicit screening decision had significantly higher levels of knowledge, greater decisional self-efficacy, and were more consistent in terms of making a decision in alignment with their values. They tended to be white, have high levels of income and education, and had discussed screening with their health care provider. Conclusions: Many men undergo CaP screening without being fully informed about the decision. These findings support the need for interventions aimed at improving IDM about screening, particularly among men of color, those with lower levels of income and education, and those who have not discussed screening with their provider. Editorial Comment: Most guidelines for prostate cancer screening suggest that men be informed about the risks and benefits of testing, and be allowed to make their own informed decision. However, in the real world this just does not happen. This randomized clinical trial of a decision aid for screening shows that most patients currently are not fully informed about the screening process, although many of the men in the study were screened. The study confirms that most patients do not understand and are not informed about the issues surrounding screening, and that primary care providers often just order prostate specific antigen tests without any discussion. Anyone who routinely treats prostate cancer is probably not surprised by these results. What is surprising is our continued insistence that a patient can be adequately educated and make a truly informed decision about prostate cancer screening in the setting of a 20-minute primary care office visit. We continue to hold out hope that patients can somehow assimilate the confusing and contradictory information on screening that many of us so-called experts have problems genuinely understanding. We develop decision aids (like the one being evaluated in the parent study described here) in the hopes of improving our understanding, yet in the end these aids are not all that helpful either. So what are we to do? Although I remain a staunch supporter of shared medical decision making (particularly in the setting of prostate cancer treatment), it is high time we recognize that a more guided approach may be preferred in certain situations. Prostate cancer screening is one of those situations. It is time for firmer and more concrete guideline recommendations beyond stating that patients should be educated and allowed to make an informed decision. Our patients want real evidence-based guidance in this area, and we need to give it to them. David F. Penson, M.D., M.P.H.
Re: Managing Localized Prostate Cancer by Radical Prostatectomy or Watchful Waiting: Cost Analysis of a Randomized Trial (SPCG-4) S. O. Andersson, O. Andrén, J. Lyth, J. R. Stark, M. Henriksson, H. O. Adami, P. Carlsson and J. E. Johansson Department of Urology, Örebro University Hospital, Örebro, Sweden Scand J Urol Nephrol 2011; 45: 177–183.
Objective: The cost of radical prostatectomy (RP) compared to watchful waiting (WW) has never been estimated in a randomized trial. The goal of this study was to estimate long-term total costs per patient associated with RP and WW arising from inpatient and outpatient hospital care. Material and Methods: This investigation used the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) trial, comparing RP to WW, and included data from 212 participants living in two counties in Sweden from 1989 to 1999 (105 randomized to WW and 107 to RP). All costs were included from randomization date until death or end of follow-up in July 2007. Resource use arising from inpatient and outpatient hospital costs was measured in physical units and multiplied by a unit cost to come up with
SOCIOECONOMIC FACTORS, UROLOGICAL EPIDEMIOLOGY AND PRACTICE PATTERNS
a total cost per patient. Results: During a median follow-up of 12 years, the overall cost in the RP group was 34% higher (P ⬍ 0.01) than in the WW group, corresponding to €6123 in Sweden. The difference was driven almost exclusively by the cost of the surgical procedure. The cost difference between RP and WW was two times higher among men with low (2– 6) than among those with high (7–10) Gleason score. Conclusion: In this economic evaluation of RP versus WW of localized prostate cancer in a randomized study, RP was associated with 34% higher costs. This difference, attributed exclusively to the cost of the RP procedure, was not overcome during extended follow-up. Editorial Comment: It is standard practice to perform economic analyses of randomized clinical trials, and the SPCG-4 study is no exception. The authors compared costs in the surgery arm to the watchful waiting arm and concluded that costs in the surgery arm were higher due to the up-front costs of the procedure. This finding is not surprising. In an era of active surveillance, where conservatively treated patients undergo numerous prostate specific antigen screenings and biopsies and there is a higher incidence of delayed prostatectomy, it is likely that the cost difference will be considerably less. However, the concept of cost has to be considered in the setting of cost-effectiveness. Assuming that in 2011 the surgical arm still incurs greater costs than the active surveillance/watchful waiting arm, does the relatively modest survival benefit justify the intervention? This is an important question that has gotten a lot of play in the media recently, given the national coverage determination by Medicare to cover sipuleucel-T (Provenge®), which is quite costly but has just a 4-month median survival benefit. It is critical that we have this national discourse. However, we cannot stop at expensive agents for use in terminal disease. We need to discuss the cost-effectiveness of earlier interventions, including intensity-modulated radiotherapy, robotic prostatectomy and even prostate specific antigen screening, if we are to deploy our limited resources in an efficient and sensible manner. David F. Penson, M.D., M.P.H.
Re: Overtreatment of Men With Low-Risk Prostate Cancer and Significant Comorbidity T. J. Daskivich, K. Chamie, L. Kwan, J. Labo, R. Palvolgyi, A. Dash, S. Greenfield and M. S. Litwin Department of Urology, David Geffen School of Medicine, University of California, Los Angeles, California Cancer 2011; 117: 2058 –2066.
Background: Men with low-risk prostate cancer and significant comorbidity are susceptible to overtreatment. The authors sought to compare the impact of comorbidity and age on treatment choice in men with low-risk disease. Methods: The authors sampled 509 men with low-risk prostate cancer diagnosed at the Greater Los Angeles and Long Beach Veterans Affairs Medical Centers between 1997 and 2004. Rates of aggressive treatment (radical prostatectomy, radiation therapy, brachytherapy) were determined among men of different ages and with different Charlson comorbidity scores. Multivariate modeling was used to determine the influence of both variables in predicting nonaggressive treatment, and Cox proportional hazards analysis was used to compare the risk of othercause mortality among groups according to Charlson score and age. Results: Men with Charlson scores ⱖ 3 were treated aggressively in 54% of cases (30 of 56 men), while men aged ⬎75 years at diagnosis were treated aggressively in 16% of cases (7 of 44 men). In multivariate analysis, age ⬎75 years was a much stronger predictor of nonaggressive treatment (relative risk, 12.0; 95% confidence interval [CI], 5.4 –28.3) than a Charlson score ⱖ 3 (relative risk, 2.0; 95% CI, 1.3–2.9). In survival analysis, men with Charlson scores ⱖ 3 had an 8-fold increased risk (hazard ratio, 8.4; 95% CI, 4.2–16.6) and 70% probability of other-cause mortality at 10 years, whereas age ⬎75 years was associated with a 5-fold increased risk (hazard ratio, 4.9; 95%CI, 1.7–13.8) and a 24% probability of
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