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PURPOSE: Prediction models are recommended by national guidelines to support clinical decision making in prostate cancer. Existing models to predict pathological outcomes of radical prostatectomy (RP)-the Memorial Sloan Kettering (MSK) models, Partin tables, and the Briganti nomogram-have been developed using data from tertiary care centers and may not generalize well to other settings. MATERIALS AND METHODS: Data from a regional cohort (Michigan Urological Surgery Improvement Collaborative [MUSIC]) were used to develop models to predict extraprostatic extension (EPE), seminal vesicle invasion (SVI), lymph node invasion (LNI), and nonorgan-confined disease (NOCD) in patients undergoing RP. The MUSIC models were compared against the MSK models, Partin tables, and Briganti nomogram (for LNI) using data from a national cohort (Surveillance, Epidemiology, and End Results [SEER] registry). RESULTS: We identified 7,491 eligible patients in the SEER registry. The MUSIC model had good discrimination (SEER AUC EPE: 0.77; SVI: 0.80; LNI: 0.83; NOCD: 0.77) and was well calibrated. While the MSK models had similar discrimination to the MUSIC models (SEER AUC EPE: 0.76; SVI: 0.80; LNI: 0.84; NOCD: 0.76), they overestimated the risk of EPE, LNI, and NOCD. The Partin tables had inferior discrimination (SEER AUC EPE: 0.67; SVI: 0.76; LNI: 0.69; NOCD: 0.72) as compared to other models. The Briganti LNI nomogram had an AUC of 0.81 in SEER but overestimated the risk. CONCLUSIONS: New models developed using the MUSIC registry outperformed existing models and should be considered as potential replacements for the prediction of pathological outcomes in prostate cancer.
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Técnicas de Apoio para a Decisão , Metástase Linfática/diagnóstico , Nomogramas , Prostatectomia , Neoplasias da Próstata/cirurgia , Idoso , Tomada de Decisão Clínica/métodos , Humanos , Linfonodos/patologia , Metástase Linfática/patologia , Masculino , Pessoa de Meia-Idade , Invasividade Neoplásica/diagnóstico , Próstata/diagnóstico por imagem , Próstata/patologia , Próstata/cirurgia , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/patologia , Programa de SEER/estatística & dados numéricos , Glândulas Seminais/patologiaRESUMO
This study aimed to estimate the rates of biopsy undersampling and progression for four prostate cancer (PCa) active surveillance (AS) cohorts within the Movember Foundation's Global Action Plan Prostate Cancer Active Surveillance (GAP3) consortium. We used a hidden Markov model (HMM) to estimate factors that define PCa dynamics for men on AS including biopsy under-sampling and progression that are implied by longitudinal data in four large cohorts included in the GAP3 database. The HMM was subsequently used as the basis for a simulation model to evaluate the biopsy strategies previously proposed for each of these cohorts. For the four AS cohorts, the estimated annual progression rate was between 6%-13%. The estimated probability of a biopsy successfully sampling undiagnosed non-favorable risk cancer (biopsy sensitivity) was between 71% and 80%. In the simulation study of patients diagnosed with favorable risk cancer at age 50, the mean number of biopsies performed before age 75 was between 4.11 and 12.60, depending on the biopsy strategy. The mean delay time to detection of non-favorable risk cancer was between 0.38 and 2.17 years. Biopsy undersampling and progression varied considerably across study cohorts. There was no single best biopsy protocol that is optimal for all cohorts, because of the variation in biopsy under-sampling error and annual progression rates across cohorts. All strategies demonstrated diminishing benefits from additional biopsies.
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Detecção Precoce de Câncer/métodos , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/patologia , Conduta Expectante/métodos , Idoso , Biópsia , Estudos de Coortes , Bases de Dados Factuais , Progressão da Doença , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Estatísticos , Gradação de Tumores , Neoplasias da Próstata/sangue , Medição de Risco/métodosRESUMO
INTRODUCTION: We compared cumulative reimbursement to urologists following implementation of surveillance vs immediate treatment. Active surveillance for prostate cancer is widely considered beneficial and cost-effective for low risk patients, although many still receive immediate therapy. It is unknown whether reduced reimbursement may be a barrier to urologists recommending surveillance. METHODS: We used Medicare claims and a validated natural history model for low risk prostate cancer to simulate annual reimbursements associated with active surveillance and immediate treatments, including surgery and radiation therapy. The model accounts for misclassification due to biopsy under sampling, grade progression and discontinuation of surveillance due to patient preferences. RESULTS: Active surveillance provided approximately $907 to $2,041 less in the net present value of expected cumulative reimbursements for urologists over 10 years ($1,711.80 to $2,740.40 less over 5 years) compared to initial treatment. Sensitivity analysis showed that use of magnetic resonance imaging/ultrasound fusion based biopsy and frequency of biopsies and clinic visits under surveillance are major sources of uncertainty regarding reimbursement. CONCLUSIONS: Urologists have little financial incentive to implement active surveillance. New payment models may be needed to bring financial incentives in line with the recommended treatment for patients with low risk prostate cancer.
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The objective of this study was to evaluate the cost-effectiveness of 18F-choline PET/multiparametric MRI (mpMRI) versus mpMRI alone for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 in men with elevated prostate-specific antigen levels. Methods: A Markov model of prostate cancer onset and progression was used to estimate the health and economic consequences of 18F-choline PET/mpMRI for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 in men with elevated prostate-specific antigen levels. Multiple simultaneous hybrid 18F-choline PET/mpMRI strategies were evaluated using Likert or Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) scoring; the first was biopsy for Likert 5 mpMRI lesions or Likert 3-4 lesions with 18F-choline target-to-background ratios of greater than or equal to 1.58, and the second was biopsy for PI-RADSv2 5 mpMRI lesions or PI-RADSv2 3-4 mpMRI lesions with 18F-choline target-to-background ratios of greater than or equal to 1.58. These strategies were compared with universal standard biopsy, mpMRI alone with biopsy only for PI-RADSv2 3-5 lesions, and mpMRI alone with biopsy only for Likert 4-5 lesions. For each mpMRI strategy, either no biopsy or standard biopsy could be performed after negative mpMRI results were obtained. Deaths averted, quality-adjusted life years (QALYs), cost, and incremental cost-effectiveness ratios were estimated for each strategy. Results: When the results of 18F-choline PET/mpMRI were negative, performing a standard biopsy was more expensive and had lower QALYs than performing no biopsy. The best screening strategy among those considered in this study performed hybrid 18F-choline PET/mpMRI with Likert scoring on men with elevated PSA, performed combined biopsy (targeted biopsy and standard 12-core biopsy) for men with positive imaging results, and no biopsy for men with negative imaging results ($22,706/QALY gained relative to mpMRI alone); this strategy reduced the number of biopsies by 35% in comparison to mpMRI alone. When the same policies were compared using PI-RADSv2 instead of Likert scoring, hybrid 18F-choline PET/mpMRI cost $46,867/QALY gained relative to mpMRI alone. In a threshold analysis, the best strategy among those considered remained cost-effective when the sensitivity and specificity of PET/mpMRI and combined biopsy (targeted biopsy and standard 12-core biopsy) were simultaneously reduced by 20 percentage points. Conclusion:18F-choline PET/mpMRI for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 is cost-effective and can reduce the number of unneeded biopsies in comparison to mpMRI alone.
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Colina , Análise Custo-Benefício , Radioisótopos de Flúor , Imagem Multimodal/economia , Imageamento por Ressonância Magnética Multiparamétrica/economia , Tomografia por Emissão de Pósitrons/economia , Neoplasias da Próstata/diagnóstico por imagem , Idoso , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Gradação de Tumores , Neoplasias da Próstata/patologiaRESUMO
PURPOSE: To assess the temporary health impact of prostate multiparametric MRI (mpMRI) and transrectal prostate biopsy in an active surveillance prostate cancer population. METHODS: A two-arm institutional review board-approved HIPAA-compliant prospective observational patient-reported outcomes study was performed from November 2017 to July 2018. Inclusion criteria were men with Gleason 6 prostate cancer in active surveillance undergoing either prostate mpMRI or transrectal prostate biopsy. A survey instrument was constructed using validated metrics in consultation with the local patient- and family-centered care organization. Study subjects were recruited at the time of diagnostic testing and completed the instrument by phone 24 to 72 hours after testing. The primary outcome measure was summary testing-related quality of life (summary utility score), derived from the testing morbidities index (TMI) (scale: 0 = death and 1 = perfect health). TMI is stratified into seven domains, with each domain scored from 1 (no health impact) to 5 (extreme health impact). Testing-related quality-of-life measures in the two cohorts were compared with Mann-Whitney U test. RESULTS: In all, 122 subjects were recruited, and 90% (110 of 122 [MRI 55 of 60, biopsy 55 of 62]) successfully completed the survey instrument. The temporary quality-of-life impact of transrectal biopsy was significantly greater than that of prostate mpMRI (0.82, 95% confidence interval [CI] 0.79-0.85, versus 0.95, 95% CI 0.94-0.97; P < .001). The largest mean domain-level difference was for intraprocedural pain (transrectal biopsy 2.6, 95% CI 2.4-2.8, versus mpMRI 1.3, 95% CI 1.1-1.5; P < .001). CONCLUSION: Transrectal prostate biopsy has greater temporary health impact (lower testing-related quality-of-life measure) than prostate mpMRI.
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Imageamento por Ressonância Magnética , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/patologia , Qualidade de Vida , Conduta Expectante , Idoso , Biópsia , Humanos , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To determine how best to use magnetic resonance imaging (MRI) and targeted MRI/ultrasonography fusion biopsy for early detection of prostate cancer (PCa) in men with elevated prostate-specific antigen (PSA) concentrations and whether it can be cost-effective. METHODS: A Markov model of PCa onset and progression was developed to estimate the health and economic consequences of PCa screening with MRI. Patients underwent PSA screening from ages 55 to 69 years. Patients with elevated PSA concentrations (>4 ng/mL) underwent MRI, followed by targeted fusion or combined (standard + targeted fusion) biopsy on positive MRI, and standard or no biopsy on negative MRI. Prostate Imaging Reporting and Data System (PI-RADS) score on MRI was used to determine biopsy decisions. Deaths averted, quality-adjusted life-years (QALYs), cost and incremental cost-effectiveness ratio (ICER) were estimated for each strategy. RESULTS: With a negative MRI, standard biopsy was more expensive and had lower QALYs than performing no biopsy. The optimum screening strategy (ICER $23 483/QALY) recommended combined biopsy for patients with PI-RADS score ≥3 and no biopsy for patients with PI-RADS score <3, and reduced the number of screening biopsies by 15%. Threshold analysis suggests MRI continues to be cost-effective when the sensitivity and specificity of MRI and combined biopsy are simultaneously reduced by 19 percentage points. CONCLUSIONS: Our analysis suggests MRI followed by targeted MRI/ultrasonography fusion biopsy can be a cost-effective approach to the early detection of PCa.
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Próstata/patologia , Neoplasias da Próstata/economia , Idoso , Análise Custo-Benefício , Detecção Precoce de Câncer/economia , Detecção Precoce de Câncer/métodos , Humanos , Biópsia Guiada por Imagem/economia , Biópsia Guiada por Imagem/métodos , Imagem por Ressonância Magnética Intervencionista/economia , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Gradação de Tumores , Antígeno Prostático Específico/metabolismo , Neoplasias da Próstata/sangue , Neoplasias da Próstata/patologia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: Active surveillance (AS) for prostate cancer includes follow-up with serial prostate biopsies. The optimal biopsy frequency during follow-up has not been determined. The goal of this investigation was to use longitudinal AS biopsy data to assess whether the frequency of biopsy could be reduced without substantially prolonging the time to the detection of disease with a Gleason score ≥ 7. METHODS: With data from 1375 men with low-risk prostate cancer enrolled in AS at Johns Hopkins, a hidden Markov model was developed to estimate the probability of undersampling at diagnosis, the annual probability of grade progression, and the 10-year cumulative probability of reclassification or progression to Gleason score ≥ 7. It simulated 1024 potential AS biopsy strategies for the 10 years after diagnosis. For each of these strategies, the model predicted the mean delay in the detection of disease with a Gleason score ≥ 7. RESULTS: The model estimated the 10-year cumulative probability of reclassification from a Gleason score of 6 to a Gleason score ≥ 7 to be 40.0%. The probability of undersampling at diagnosis was 9.8%, and the annual progression probability for men with a Gleason score of 6 was 4.0%. On the basis of these estimates, a simulation of an annual biopsy strategy estimated the mean time to the detection of disease with a Gleason score ≥ 7 to be 14.1 months; however, several strategies eliminated biopsies with only small delays (<12 months) in detecting grade progression. CONCLUSIONS: Although annual biopsy for low-risk men on AS is associated with the shortest time to the detection of disease with a Gleason score ≥ 7, several alternative strategies may allow less frequent biopsying without sizable delays in detecting grade progression. Cancer 2018;124:698-705. © 2017 American Cancer Society.
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Detecção Precoce de Câncer , Vigilância da População/métodos , Próstata/patologia , Neoplasias da Próstata/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Biópsia , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Gradação de Tumores , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/sangue , Neoplasias da Próstata/patologia , Fatores de Risco , Fatores de TempoRESUMO
BACKGROUND: Intensive blood pressure (BP) treatment can avert cardiovascular disease (CVD) events but can cause some serious adverse events. We sought to develop and validate risk models for predicting absolute risk difference (increased risk or decreased risk) for CVD events and serious adverse events from intensive BP therapy. A secondary aim was to test if the statistical method of elastic net regularization would improve the estimation of risk models for predicting absolute risk difference, as compared to a traditional backwards variable selection approach. METHODS AND FINDINGS: Cox models were derived from SPRINT trial data and validated on ACCORD-BP trial data to estimate risk of CVD events and serious adverse events; the models included terms for intensive BP treatment and heterogeneous response to intensive treatment. The Cox models were then used to estimate the absolute reduction in probability of CVD events (benefit) and absolute increase in probability of serious adverse events (harm) for each individual from intensive treatment. We compared the method of elastic net regularization, which uses repeated internal cross-validation to select variables and estimate coefficients in the presence of collinearity, to a traditional backwards variable selection approach. Data from 9,069 SPRINT participants with complete data on covariates were utilized for model development, and data from 4,498 ACCORD-BP participants with complete data were utilized for model validation. Participants were exposed to intensive (goal systolic pressure < 120 mm Hg) versus standard (<140 mm Hg) treatment. Two composite primary outcome measures were evaluated: (i) CVD events/deaths (myocardial infarction, acute coronary syndrome, stroke, congestive heart failure, or CVD death), and (ii) serious adverse events (hypotension, syncope, electrolyte abnormalities, bradycardia, or acute kidney injury/failure). The model for CVD chosen through elastic net regularization included interaction terms suggesting that older age, black race, higher diastolic BP, and higher lipids were associated with greater CVD risk reduction benefits from intensive treatment, while current smoking was associated with fewer benefits. The model for serious adverse events chosen through elastic net regularization suggested that male sex, current smoking, statin use, elevated creatinine, and higher lipids were associated with greater risk of serious adverse events from intensive treatment. SPRINT participants in the highest predicted benefit subgroup had a number needed to treat (NNT) of 24 to prevent 1 CVD event/death over 5 years (absolute risk reduction [ARR] = 0.042, 95% CI: 0.018, 0.066; P = 0.001), those in the middle predicted benefit subgroup had a NNT of 76 (ARR = 0.013, 95% CI: -0.0001, 0.026; P = 0.053), and those in the lowest subgroup had no significant risk reduction (ARR = 0.006, 95% CI: -0.007, 0.018; P = 0.71). Those in the highest predicted harm subgroup had a number needed to harm (NNH) of 27 to induce 1 serious adverse event (absolute risk increase [ARI] = 0.038, 95% CI: 0.014, 0.061; P = 0.002), those in the middle predicted harm subgroup had a NNH of 41 (ARI = 0.025, 95% CI: 0.012, 0.038; P < 0.001), and those in the lowest subgroup had no significant risk increase (ARI = -0.007, 95% CI: -0.043, 0.030; P = 0.72). In ACCORD-BP, participants in the highest subgroup of predicted benefit had significant absolute CVD risk reduction, but the overall ACCORD-BP participant sample was skewed towards participants with less predicted benefit and more predicted risk than in SPRINT. The models chosen through traditional backwards selection had similar ability to identify absolute risk difference for CVD as the elastic net models, but poorer ability to correctly identify absolute risk difference for serious adverse events. A key limitation of the analysis is the limited sample size of the ACCORD-BP trial, which expanded confidence intervals for ARI among persons with type 2 diabetes. Additionally, it is not possible to mechanistically explain the physiological relationships explaining the heterogeneous treatment effects captured by the models, since the study was an observational secondary data analysis. CONCLUSIONS: We found that predictive models could help identify subgroups of participants in both SPRINT and ACCORD-BP who had lower versus higher ARRs in CVD events/deaths with intensive BP treatment, and participants who had lower versus higher ARIs in serious adverse events.
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Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Hipertensão/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hipertensão/complicações , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/tratamento farmacológico , Modelos de Riscos Proporcionais , Fatores de Risco , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/prevenção & controle , Resultado do TratamentoRESUMO
BACKGROUND: New cancer biomarkers are being discovered at a rapid pace; however, these tests vary in their predictive performance characteristics, and it is unclear how best to use them. METHODS: We investigated 2-stage biomarker-based screening strategies in the context of prostate cancer using a partially observable Markov model to simulate patients' progression through prostate cancer states to mortality from prostate cancer or other causes. Patients were screened every 2 years from ages 55 to 69. If the patient's serum prostate-specific antigen (PSA) was over a specified threshold in the first stage, a second stage biomarker test was administered. We evaluated design characteristics for these 2-stage strategies using 7 newly discovered biomarkers as examples. Monte Carlo simulation was used to estimate the number of screening biopsies, prostate cancer deaths, and quality-adjusted life-years (QALYs) per 1000 men. RESULTS: The all-cancer biomarkers significantly underperformed the high-grade cancer biomarkers in terms of QALYs. The screening strategy that used a PSA threshold of 2 ng/mL and a second biomarker test with high-grade sensitivity and specificity of 0.86 and 0.62, respectively, maximized QALYs. This strategy resulted in a prostate cancer death rate within 1% of using PSA alone with a threshold of 2 ng/mL, while reducing the number of biopsies by 20%. Sensitivity analysis suggests that the results are robust with respect to variation in model parameters. CONCLUSIONS: Two-stage biomarker screening strategies using new biomarkers with risk thresholds optimized for high-grade cancer detection may increase quality-adjusted survival and reduce unnecessary biopsies.
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Biomarcadores Tumorais/sangue , Sistemas de Apoio a Decisões Clínicas , Detecção Precoce de Câncer/métodos , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/diagnóstico , Idoso , Detecção Precoce de Câncer/normas , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Método de Monte Carlo , Neoplasias da Próstata/patologia , Anos de Vida Ajustados por Qualidade de Vida , Sensibilidade e EspecificidadeRESUMO
OBJECTIVE: To compare the predictive performance of a logistic regression model developed with contemporary data from a diverse group of urology practices to that of the Prostate Cancer Prevention Trial (PCPT) Risk Calculator version 2.0. MATERIALS AND METHODS: With data from all first-time prostate biopsies performed between January 2012 and March 2015 across the Michigan Urological Surgery Improvement Collaborative (MUSIC), we developed a multinomial logistic regression model to predict the likelihood of finding high-grade cancer (Gleason score ≥7), low-grade cancer (Gleason score ≤6), or no cancer on prostate biopsy. The performance of the MUSIC model was evaluated in out-of-sample data using 10-fold cross-validation. Discrimination and calibration statistics were used to compare the performance of the MUSIC model to that of the PCPT risk calculator in the MUSIC cohort. RESULTS: Of the 11,809 biopsies included, 4289 (36.3%) revealed high-grade cancer; 2027 (17.2%) revealed low-grade cancer; and the remaining 5493 (46.5%) were negative. In the MUSIC model, prostate-specific antigen level, rectal examination findings, age, race, and family history of prostate cancer were significant predictors of finding high-grade cancer on biopsy. The 2 models, based on similar predictors, had comparable discrimination (multiclass area under the curve = 0.63 for the MUSIC model and 0.62 for the PCPT calculator). Calibration analyses demonstrated that the MUSIC model more accurately predicted observed outcomes, whereas the PCPT risk calculator substantively overestimated the likelihood of finding no cancer while underestimating the risk of high-grade cancer in this population. CONCLUSION: The PCPT risk calculator may not be a good predictor of individual biopsy outcomes for patients seen in contemporary urology practices.
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Tomada de Decisões , Detecção Precoce de Câncer/métodos , Neoplasias da Próstata/diagnóstico , Medição de Risco/métodos , Urologia/métodos , Idoso , Algoritmos , Biópsia/métodos , Estudos de Coortes , Exame Retal Digital , Humanos , Masculino , Michigan , Pessoa de Meia-Idade , Gradação de Tumores , Valor Preditivo dos Testes , Próstata/patologia , Antígeno Prostático Específico/sangue , Sistema de Registros , Análise de RegressãoRESUMO
PURPOSE: The aim of this study was to establish the criteria defining an anticipatory positive test for bladder cancer. METHODS: We reviewed all patients at our institution who underwent urine cytology or UroVysion fluorescence in situ hybridization (FISH) and cystoscopy from 2003 to 2012. Test performance and cancer anticipation was assessed using generalized linear mixed models, mixed-effects proportional hazards models, and cumulative incidence curves using tests performed within 30 days of each other as well as within a lag time of 1 year. RESULTS: Overall, 6729 urine tests (4729 cytology and 2040 UroVysion FISH) were paired with gold-standard cystoscopies. Sensitivity and specificity were 63 and 41% for cytology, and 37 and 84% for UroVysion FISH, respectively. A 1-year lag time allowed for cancer anticipation and neither test improved. Among patients with positive cytology and initially negative cystoscopy, the hazard ratio of developing a bladder tumor at 1 year was 1.83; 76% of these patients developed a tumor within 1 year. Similarly, among patients with a positive FISH and initially negative cystoscopy, the hazard ratio of developing a bladder tumor at 1 year was 1.56; 40% of these patients developed a tumor within 1 year. CONCLUSIONS: Urine-based tests for bladder cancer are frequently falsely positive. With further follow-up time, some of these false positive tests are vindicated as true (anticipatory) positive tests, although many will remain false positives. We developed statistical criteria to determine if a test anticipates future cancers or not.
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Cistoscopia/métodos , Citodiagnóstico , Hibridização in Situ Fluorescente/métodos , Urinálise/métodos , Neoplasias da Bexiga Urinária/diagnóstico , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Retrospectivos , Neoplasias da Bexiga Urinária/urinaRESUMO
PURPOSE: We implemented a statewide intervention to improve imaging utilization for the staging of patients with newly diagnosed prostate cancer. MATERIALS AND METHODS: MUSIC (Michigan Urological Surgery Improvement Collaborative) is a quality improvement collaborative comprising 42 diverse practices representing approximately 85% of the urologists in Michigan. MUSIC has developed imaging appropriateness criteria (prostate specific antigen greater than 20 ng/ml, Gleason score 7 or higher and clinical stage T3 or higher) which minimize unnecessary imaging with bone scan and computerized tomography. After baseline rates of radiographic staging were established in 2012 and 2013, we used multidimensional interventions to deploy these criteria in 2014. Imaging utilization was then remeasured in 2015 to evaluate for changes in practice patterns. RESULTS: A total of 10,554 newly diagnosed patients with prostate cancer were entered into the MUSIC registry from January 1, 2012 through December 31, 2013 and January 1, 2015 through December 31, 2015. Of these patients 7,442 (79%) and 7,312 (78%) met our criteria to avoid bone scan and computerized tomography imaging, respectively. The use of bone scan imaging when not indicated decreased from 11.0% at baseline to 6.5% after interventions (p <0.0001). The use of computerized tomography when not indicated decreased from 14.7% at baseline to 7.7% after interventions (p <0.0001). Variability among practices decreased substantially after the interventions as well. The use of recommended imaging remained stable during these periods. CONCLUSIONS: An intervention aimed at appropriate use of imaging was associated with decreased use of bone scans and computerized tomography among men at low risk for metastases.
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Diagnóstico por Imagem/estatística & dados numéricos , Estadiamento de Neoplasias/métodos , Próstata/diagnóstico por imagem , Neoplasias da Próstata/diagnóstico por imagem , Melhoria de Qualidade , Procedimentos Desnecessários/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias Ósseas/diagnóstico por imagem , Neoplasias Ósseas/secundário , Serviços de Saúde , Humanos , Masculino , Saúde do Homem , Michigan/epidemiologia , Pessoa de Meia-Idade , Estadiamento de Neoplasias/normas , Próstata/patologia , Neoplasias da Próstata/patologia , Melhoria de Qualidade/estatística & dados numéricos , Cintilografia/estatística & dados numéricos , Sistema de Registros , Tomografia Computadorizada por Raios X/estatística & dados numéricos , Adulto JovemRESUMO
OBJECTIVE: To determine how well demographic and clinical factors predict the initiation of Active Surveillance (AS). METHODS: AS has been suggested as a way to reduce overtreatment of men who have prostate cancer; however, factors associated with the decision to choose AS are poorly quantified. Using the Michigan Urological Surgery Improvement Collaborative registry, we identified 2977 men with prostate cancer who made treatment decisions from January 1, 2012, through December 31, 2013. We used chi-square and Wilcoxon tests to examine the association between factors and initiation of AS. Logistic regression models were fit for D'Amico risk categories. Measures of model discrimination and calibration were estimated, including area under the curve (AUC) and Brier score (BS). RESULTS: Patient age, Gleason score, clinical T-stage, urology practice, and tumor volume (greatest percent of a core involved with cancer and proportion of positive cores) were associated with the decision to choose AS in the intermediate-risk cohort (AUC = 0.875, BS = 0.07) and the complete cohort (AUC = 0.89, BS = 0.10). Patient age, urology practice, and tumor volume were significant in the low-risk cohort (AUC = 0.71, BS = 0.22). The addition of urology practice increased AUC in the low-risk cohort from 0.71 to 0.76 and reduced BS from 0.22 to 0.21. CONCLUSION: The urology practice at which a patient is seen is an important predictor for whether patients will initiate AS. Predictions were least accurate for low-risk patients, suggesting that factors such as patient preference play a role in treatment decisions.
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Seleção de Pacientes , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/terapia , Conduta Expectante/métodos , Idoso , Idoso de 80 Anos ou mais , Biópsia por Agulha , Distribuição de Qui-Quadrado , Estudos de Coortes , Humanos , Imuno-Histoquímica , Modelos Logísticos , Masculino , Michigan , Pessoa de Meia-Idade , Monitorização Fisiológica/métodos , Análise Multivariada , Gradação de Tumores , Invasividade Neoplásica/patologia , Estadiamento de Neoplasias , Preferência do Paciente/estatística & dados numéricos , Prognóstico , Prostatectomia/estatística & dados numéricos , Neoplasias da Próstata/mortalidade , Estudos Retrospectivos , Medição de Risco , Estatísticas não Paramétricas , Taxa de Sobrevida , Estados Unidos , Conduta Expectante/estatística & dados numéricosRESUMO
BACKGROUND: In men with clinically localized prostate cancer who have undergone at least 1 previous negative biopsy and have elevated serum prostate-specific antigen (PSA) levels, long-term health outcomes associated with the assessment of urinary prostate cancer antigen 3 (PCA3) and the transmembrane protease, serine 2 (TMPRSS2):v-ets erythroblastosis virus E26 oncogene homolog (avian) (ERG) gene fusion (T2:ERG) have not been investigated previously in relation to the decision to recommend a repeat biopsy. METHODS: The authors performed a decision analysis using a decision tree for men with elevated PSA levels. The probability of cancer was estimated using the Prostate Cancer Prevention Trial Risk Calculator (version 2.0). The use of PSA alone was compared with the use of PCA3 and T2:ERG scores, with each evaluated independently, in combination with PSA to trigger a repeat biopsy. When PCA3 and T2:ERG score evaluations were used, predefined thresholds were established to determine whether the patient should undergo a repeat biopsy. Biopsy outcomes were defined as either positive (with a Gleason score of <7, 7, or >7) or negative. Probabilities and estimates of 10-year overall survival and 15-year cancer-specific survival were derived from previous studies and a literature review. Outcomes were defined as age-dependent and Gleason score-dependent 10-year overall and 15-year cancer-specific survival rates and the percentage of biopsies avoided. RESULTS: Incorporating the PCA3 score (biopsy threshold, 25; generated based on the urine PCA3 level normalized to the amount of PSA messenger RNA) or the T2:ERG score (biopsy threshold, 10; based on the urine T2:ERG level normalized to the amount of PSA messenger RNA) into the decision to recommend repeat biopsy would have avoided 55.4% or 64.7% of repeat biopsies for the base-case patient, respectively, and changes in the 10-year survival rate were only 0.93% or 1.41%, respectively. Multi-way sensitivity analyses suggested that these results were robust with respect to the model parameters. CONCLUSIONS: The use of PCA3 or T2:ERG testing for repeat biopsy decisions can substantially reduce the number of biopsies without significantly affecting 10-year survival.
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Antígenos de Neoplasias/urina , Fusão Gênica , Próstata/patologia , Neoplasias da Próstata/patologia , Serina Endopeptidases/genética , Transativadores/genética , Idoso , Biópsia , Humanos , Masculino , Pessoa de Meia-Idade , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/genética , Neoplasias da Próstata/urina , Proteínas Recombinantes/urina , Regulador Transcricional ERGRESUMO
OBJECTIVE: To identify clinical variables associated with a positive computed tomography (CT) scan and estimate the performance of imaging recommendations in patients from a diverse sample of urology practices. MATERIALS AND METHODS: This study comprised 2380 men with newly diagnosed prostate cancer seen at 28 practices in the Michigan Urological Surgery Improvement Collaborative from March 2012 through September 2013. Data included age, prostate-specific antigen (PSA) level, Gleason score (GS), clinical T stage, total number of positive biopsy cores, whether or not the patient received a staging abdominal and/or pelvic CT scan, and CT scan result. We fit a multivariate logistic regression model to identify clinical variables associated with metastases detected by CT scan. We estimated the sensitivity and specificity of existing imaging recommendations. RESULTS: Among 643 men (27.4%) who underwent a staging CT scan, 62 men (9.6%) had a positive study. In the multivariate analysis, PSA, GS, and clinical T stage were independently associated with the occurrence of a positive CT scan (all P values <.05). The American Urological Association's Best Practice Statements' recommendations for imaging when PSA level >20 ng/mL or GS ≥ 8 or locally advanced cancer had a sensitivity of 87.3% and specificity of 82.6%. Compared with current practice, implementing this recommendation in the Michigan Urological Surgery Improvement Collaborative population was estimated to result in approximately 0.5% of positive study results being missed, and 26.1% of fewer study results overall. CONCLUSION: Successful implementation of CT imaging criterion of PSA level >20, GS ≥ 8, or clinical stage ≥ T3 would ensure that CT scans are performed for almost all men who would have positive study results while reducing the number of negative study results.
Assuntos
Adenocarcinoma/diagnóstico por imagem , Adenocarcinoma/patologia , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/patologia , Tomografia Computadorizada por Raios X/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Biópsia por Agulha , Estudos de Coortes , Humanos , Imuno-Histoquímica , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Invasividade Neoplásica/patologia , Estadiamento de Neoplasias , Guias de Prática Clínica como Assunto , Valor Preditivo dos Testes , Sistema de Registros , Sensibilidade e Especificidade , Estados UnidosRESUMO
OBJECTIVE: To evaluate the performance of published guidelines compared with that of current practice for radiographic staging of men with newly diagnosed prostate cancer. MATERIALS AND METHODS: Using data from the Michigan Urological Surgery Improvement Collaborative clinical registry, we identified 1509 men diagnosed with prostate cancer from March 2012 through June 2013. Clinical data included age, prostate-specific antigen (PSA) level, Gleason score (GS), clinical trial stage, number of biopsy cores, and bone scan (BS) results. We then fit a multivariate logistic regression model to examine the association between clinical variables and the occurrence of bone metastases. Because some patients did not undergo BS, we used established methods to correct for verification bias and estimate the diagnostic accuracy of published guidelines. RESULTS: Among 416 men who received a BS, 48 (11.5%) had evidence of bone metastases. Patients with bone metastases were older, with higher PSA levels and GS (all P <.05). In multivariate analyses, PSA (P <.001) and GS (P = .004) were the only independent predictors of positive BS. Guidelines from the American Urological Association and the National Comprehensive Cancer Network demonstrated similar performance in detecting bone metastases in our population, with fewer negative study results than those of the European Association of Urology guideline. Applying the American Urological Association recommendations (ie, image when PSA level >20 ng/mL or GS ≥ 8) to current clinical practice, we estimate that <1% of positive study results would be missed, whereas the number of negative study results would be reduced by 38%. CONCLUSION: Based on current practice patterns, more uniform application of existing guidelines would ensure that BS is performed for almost all men with bone metastases, while avoiding many negative imaging studies.
Assuntos
Neoplasias Ósseas/diagnóstico por imagem , Neoplasias Ósseas/secundário , Neoplasias da Próstata/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Guias de Prática Clínica como Assunto , CintilografiaRESUMO
OBJECTIVE: To measure the cost of nonattendance ("no-shows") and benefit of overbooking and interventions to reduce no-shows for an outpatient endoscopy suite. METHODS: We used a discrete-event simulation model to determine improved overbooking scheduling policies and examine the effect of no-shows on procedure utilization and expected net gain, defined as the difference in expected revenue based on Centers for Medicare & Medicaid Services reimbursement rates and variable costs based on the sum of patient waiting time and provider and staff overtime. No-show rates were estimated from historical attendance (18% on average, with a sensitivity range of 12%-24%). We then evaluated the effectiveness of scheduling additional patients and the effect of no-show reduction interventions on the expected net gain. RESULTS: The base schedule booked 24 patients per day. The daily expected net gain with perfect attendance is $4433.32. The daily loss attributed to the base case no-show rate of 18% is $725.42 (16.4% of net gain), ranging from $472.14 to $1019.29 (10.7%-23.0% of net gain). Implementing no-show interventions reduced net loss by $166.61 to $463.09 (3.8%-10.5% of net gain). The overbooking policy of 9 additional patients per day resulted in no loss in expected net gain when compared with the reference scenario. CONCLUSIONS: No-shows can significantly decrease the expected net gain of outpatient procedure centers. Overbooking can help mitigate the impact of no-shows on a suite's expected net gain and has a lower expected cost of implementation to the provider than intervention strategies.
Assuntos
Instituições de Assistência Ambulatorial/economia , Agendamento de Consultas , Custos e Análise de Custo , Centers for Medicare and Medicaid Services, U.S. , Endoscopia , Modelos Econométricos , Estados UnidosRESUMO
OBJECTIVE: Low-grade noninvasive disease comprises approximately half of incident bladder cancer cases. These lesions have exceedingly low rates of progression to aggressive, muscle-invasive bladder cancer, and there is salient discordance with regard to management recommendations for these patients between the principal clinical practice guidelines. In this context, we compare the international guidelines with alternative surveillance strategies for low-risk bladder cancer patients. METHODS: We used a partially observable Markov model based on states that defined patient risk levels associated with recurrence and progression of bladder cancer. The model also included states defining the effects of treatment, death from bladder cancer, and all other-cause mortality. Simulation was done to estimate quality-adjusted life years (QALYs), expected lifelong progression probability, and lifetime number of cystoscopies. RESULTS: We compared current international guidelines and additional proposed surveillance strategies on the basis of QALYs. We conducted a bicriteria analysis to compare expected lifelong progression rate v. the number of cystoscopies. One-way sensitivity analysis was used to evaluate the influence of model parameters, including a patient's disutility associated with cystoscopy, bladder cancer mortality, and all other-cause mortality. CONCLUSIONS: Age and comorbidity significantly affect the optimal surveillance strategy. Results suggest that younger patients should be screened more intensively than older patients, and patients having comorbidity should be screened less intensively.