Virtual care for prostate cancer survivorship: protocol for an evaluation of a nurse-led algorithm-enhanced virtual clinic implemented at five cancer centres across Canada.

INTRODUCTION: Prostate cancer (PCa) is the most common cancer in Canadian men. Current models of survivorship care are no longer adequate to address the chronic and complex survivorship needs of patients today. Virtual care models for cancer survivorship have recently been associated with comparable clinical outcomes and lower costs to traditional follow-up care, with patients favouring off-site and on-demand visits. Building on their viability, our research group conceived the Ned Clinic-a virtual PCa survivorship model that provides patients with access to lab results, collects patient-reported outcomes, alerts clinicians to emerging issues, and promotes patient self-care. Despite the promise of the Ned Clinic, the model remains limited by its dependence on oncology specialists, lack of an autonomous triage algorithm, and has only been implemented among PCa survivors living in Ontario. METHODS AND ANALYSIS: Our programme of research comprises two main research objectives: (1) to evaluate the process and cost of implementing and sustaining five nurse-led virtual PCa survivorship clinics in three provinces across Canada and identify barriers and facilitators to implementation success and (2) to assess the impact of these virtual clinics on implementation and effectiveness outcomes of enrolled PCa survivors. The design phase will involve developing an autonomous triage algorithm and redesigning the Ned Clinic towards a nurse-led service model. Site-specific implementation plans will be developed to deploy a localised nurse-led virtual clinic at each centre. Effectiveness will be evaluated using a historical control study comparing the survivorship outcomes of 300 PCa survivors enrolled in the Ned Clinic with 300 PCa survivors receiving traditional follow-up care. ETHICS AND DISSEMINATION: Appropriate site-specific ethics approval will be secured prior to each research phase. Knowledge translation efforts will include diffusion, dissemination, and application approaches to ensure that knowledge is translated to both academic and lay audiences.

Direct-to-consumer Internet promotion of robotic prostatectomy exhibits varying quality of information.

Robotic surgery to remove a cancerous prostate has become a popular treatment. Internet marketing of this surgery provides an intriguing case study of direct-to-consumer promotions of medical devices, which are more loosely regulated than pharmaceutical promotions. We investigated whether the claims made in online promotions of robotic prostatectomy were consistent with evidence from comparative effectiveness studies. After performing a search and cross-sectional analysis of websites that mentioned the procedure, we found that many sites claimed benefits that were unsupported by evidence and that 42 percent of the sites failed to mention risks. Most sites were published by hospitals and physicians, which the public may regard as more objective than pages published by manufacturers. Unbalanced information may inappropriately raise patients' expectations. Increasing enforcement and regulation of online promotions may be beyond the capabilities of federal authorities. Thus, the most feasible solution may be for the government and medical societies to promote the production of balanced educational material.

Outcomes after resection of postchemotherapy residual neck mass in patients with germ cell tumors--an update.

OBJECTIVE: To examine histologic findings and clinical outcomes of patients who underwent neck dissection for residual neck masses. METHODS: From 1987 to 2008, 968 postchemotherapy retroperitoneal lymph node dissections (RPLND) were performed at our institution. We identified 41 of these patients who underwent a postchemotherapy residual neck mass resection. RESULTS: Thirty-nine patients presented with primary testis, one with retroperitoneal, and one with mediastinal GCT. Teratoma was present in 54% of patients at diagnosis. During the neck dissection, 23 (56.1%) patients had teratoma, 14 (34.2%) had fibrosis, three (7.3%) had viable GCT, and one had benign lymph nodes. There was histologic discordance between the neck and the RPLND in 22.5% of patients and between the neck and other extraretroperitoneal resection sites in 26.5% of patients. At a median follow-up of 49.5 months from diagnosis, 16 patients had recurrence, and seven had died of testis cancer. No patient had recurrence in the neck. Five of seven patients with residual viable cancer at extraretroperitoneal resection sites died of disease compared with two of 23 with teratoma and none with fibrosis (P = .0005). CONCLUSIONS: Resection of residual postchemotherapy neck masses is indicated because of the high incidence of viable tumor or teratoma in the residual mass and the inability to accurately predict the histology of the neck masses. Resection of residual neck masses leads to excellent local control and can contribute to long-term disease control and survival.

Temporal trends and predictors of pelvic lymph node dissection in open or minimally invasive radical prostatectomy.

BACKGROUND: Pelvic lymph node dissection (PLND) is an important component of prostate cancer staging and treatment, especially for surgical patients who have high-risk tumor features. It is not clear how the shift from open radical prostatectomy (ORP) to minimally invasive radical prostatectomy (MIRP) has affected the use of PLND. The objectives of this study were to identify predictors of PLND and to assess the impact of surgical technique in a contemporary, population-based cohort. METHODS: In Surveillance, Epidemiology, and End Results (SEER) cancer registry data linked with Medicare claims, the authors identified men who underwent ORP or MIRP for prostate cancer during 2003 to 2007. The impact of surgical approach on PLND was evaluated, and interactions were examined between surgical procedure, prostate-specific antigen (PSA), and Gleason score with the analysis controlled for patient and tumor characteristics. RESULTS: Of 6608 men who underwent ORP or MIRP, 70% (n = 4600) underwent PLND. The use of PLND declined over time both overall and within subgroups defined by procedure type. PLND was 5 times more likely in men who underwent ORP than in men who underwent MIRP when the analysis was controlled for patient and tumor characteristics. Elevated PSA and biopsy Gleason score, but not clinical stage, were associated with a greater odds of PLND in both the ORP group and the MIRP group. However, the magnitude of the association between these factors and PLND was significantly greater for patients in the ORP group. CONCLUSIONS: PLND was less common among men who underwent MIRP, independent of tumor risk factors. A decline in PLND rates was not fully explained by an increase in MIRP. The authors concluded that these trends may signal a surgical approach-dependent disparity in prostate cancer staging and therapy.

Maximizing cure for muscle-invasive bladder cancer: integration of surgery and chemotherapy.

CONTEXT: The optimal treatment strategy for muscle-invasive bladder cancer remains controversial. OBJECTIVE: To determine optimal combination of chemotherapy and surgery aimed at preserving survival of patients with locally advanced bladder cancer. EVIDENCE ACQUISITION: We performed a critical review of the published abstract and presentation literature on combined modality therapy for muscle-invasive bladder cancer. We emphasized articles of the highest scientific level, combining radical cystectomy and perioperative chemotherapy with curative intent to affect overall and disease-specific survival. EVIDENCE SYNTHESIS: Locally invasive, regional, and occult micrometastases at the time of radical cystectomy lead to both distant and local failure, causing bladder cancer deaths. Neoadjuvant and adjuvant chemotherapy regimens have been evaluated, as well as the quality of cystectomy and pelvic lymph node dissection. CONCLUSIONS: Prospective, randomized clinical trials argue strongly for neoadjuvant cisplatin-based chemotherapy followed by high-quality cystectomy performed by an experienced surgeon operating in a high-volume center. Adjuvant chemotherapy after surgery is also effective when therapeutic doses can be given in a timely fashion. Both contribute to improved overall survival; however, many patients receive only one or none of these options, and the barriers to receiving optimal, combined, systemic therapy and surgery remain to be defined. An aging, comorbid, and often unfit population increasingly affected by bladder cancer poses significant challenges in management of individual patients.

Utility of urine cytology in the workup of asymptomatic microscopic hematuria in low-risk patients.

OBJECTIVES: To evaluate performance and cost-effectiveness of voided cytology in patients with pure asymptomatic microscopic hematuria (AMH). Although voided cytology has been validated for use in patients with a history of urothelial carcinoma (UC), its use in low-risk patients with AMH is controversial. METHODS: A total of 200 consecutive low-risk patients (median age, 64 years) with AMH were referred to the urology clinic between 2005 and 2007. All underwent cystoscopy, upper tract imaging, and voided urinary cytology. Results of voided cytology were classified as positive, atypical, or negative. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and costs were calculated. RESULTS: None had positive cytology, 23 (11.5%) had atypical cytology, and 177 (88.5%) had negative urinary cytology. Of 200 patients, 8 (4%) were found to have low-grade UC of bladder via cystoscopy; the cytology was negative in 4 patients and atypical in 4. Of 8, 4 were Ta and 4 were pT1 tumors. There was no upper urinary tract or renal malignancy identified. If atypical cytology was considered as positive, the sensitivity, specificity, PPV, and NPV of cytology were 50%, 90%, 17%, and 98%, respectively. If atypical cytology was considered as negative, the sensitivity, specificity, PPV, and NPV of cytology were 0%, 100%, 0%, and 96%, respectively. Cost of performing urinary cytology was estimated at $262.50 per patient. CONCLUSIONS: Although this study supports evaluating patients with AMH because a significant percentage of patients will have UC, voided urine cytology added a significant cost without any diagnostic benefit in the work-up of low-risk patients with AMH.

Analytical accuracy and reliability of commonly used nutritional supplements in prostate disease.

PURPOSE: We determine the analytical accuracy and reliability of commonly used nutritional supplements for prostate disease by comparing the amounts of active ingredients of several brands of vitamin E, vitamin D, selenium, lycopene and saw palmetto. We also compared the amounts of active compound in different lots of the same brand to determine the consistency of the manufacturing process. MATERIALS AND METHODS: Samples purchased at pharmacies and specialty stores were sent for independent chemical analysis. The measured dose was compared to the stated dose on the product label. Analysis of variance was performed to test for significance in interlot reliability. RESULTS: Vitamin E (7 samples) and selenium (5) were within a range of -41% to +57% and -19% to +23% of the stated dosage, respectively. All vitamin D brands (4 samples) were within 15% of the stated dose. Saw palmetto (6 samples) were within a range -97% to +140% of the stated dosages with 3 containing less than 20% of the stated dosages. Lycopene brands were between -38% and +143% of stated dosages. Among the reliability assays 1 of 3 brands of vitamin E, 1 of 2 brands of selenium and 1 of 2 brands of saw palmetto demonstrated statistical differences in interlot dosage (p <0.0055, approximate 20% to 25% differences in dose). The 1 assayed form of vitamin D was reliable between lots. CONCLUSIONS: Commonly used nutritional supplements for prostate disease vary widely in measured dose. Saw palmetto demonstrated tremendous variability with some samples containing virtually no active ingredients. In contrast, the more regulated substances we measured, such as vitamins and minerals, demonstrated less variation.