A qualitative study on healthcare professional and patient perspectives on nurse-led virtual prostate cancer survivorship care.

BACKGROUND: Virtual nurse-led care models designed with health care professionals (HCPs) and patients may support addressing unmet prostate cancer (PCa) survivor needs. Within this context, we aimed to better understand the optimal design of a service model for a proposed nurse-led PCa follow-up care platform (Ned Nurse). METHODS: A qualitative descriptive study exploring follow-up and virtual care experiences to inform a nurse-led virtual clinic (Ned Nurse) with an a priori convenience sample of 10 HCPs and 10 patients. We provide a health ecosystem readiness checklist mapping facilitators onto CFIR and Proctor's implementation outcomes. RESULTS: We show that barriers within the current standard of care include: fragmented follow-up, patient uncertainty, and long, persisting wait times despite telemedicine modalities. Participants indicate that a nurse-led clinic should be scoped to coordinate care and support patient self-management, with digital literacy considerations. CONCLUSION: A nurse-led follow-up care model for PCa is seen by HCPs as acceptable, feasible, and appropriate for care delivery. Patients value its potential to provide role clarity, reinforce continuity of care, enhance mental health support, and increase access to timely and targeted care. These findings inform design, development, and implementation strategies for digital health interventions within complex settings, revealing opportunities to optimally situate these interventions to improve care.

Prostate cancer (PCa) survivors in Canada receive follow-up care after treatment through a specialist-led model, which is currently straining to meet patient needs. We interviewed healthcare providers (HCPs) and patients to investigate the design and development of a healthcare service that uses technology, also known as virtual care, to provide nurse-led follow-up care. Mixed experiences with virtual care informed participant feedback and concerns, including impacts of the pandemic and digital literacy considerations. We show that HCPs and patients see potential benefit in virtual nurse-led follow-up care if it can increase access to resources, clarify patient and provider care roles, and improve access and continuity of care. This type of approach to follow-up care may help to improve survivor quality of life and PCa follow-up care while extending the reach of healthcare systems with limited resources.

An Actionable Expert-System Algorithm to Support Nurse-Led Cancer Survivorship Care: Algorithm Development Study.

BACKGROUND: Comprehensive models of survivorship care are necessary to improve access to and coordination of care. New models of care provide the opportunity to address the complexity of physical and psychosocial problems and long-term health needs experienced by patients following cancer treatment. OBJECTIVE: This paper presents our expert-informed, rules-based survivorship algorithm to build a nurse-led model of survivorship care to support men living with prostate cancer (PCa). The algorithm is called No Evidence of Disease (Ned) and supports timelier decision-making, enhanced safety, and continuity of care. METHODS: An initial rule set was developed and refined through working groups with clinical experts across Canada (eg, nurse experts, physician experts, and scientists; n=20), and patient partners (n=3). Algorithm priorities were defined through a multidisciplinary consensus meeting with clinical nurse specialists, nurse scientists, nurse practitioners, urologic oncologists, urologists, and radiation oncologists (n=17). The system was refined and validated using the nominal group technique. RESULTS: Four levels of alert classification were established, initiated by responses on the Expanded Prostate Cancer Index Composite for Clinical Practice survey, and mediated by changes in minimal clinically important different alert thresholds, alert history, and clinical urgency with patient autonomy influencing clinical acuity. Patient autonomy was supported through tailored education as a first line of response, and alert escalation depending on a patient-initiated request for a nurse consultation. CONCLUSIONS: The Ned algorithm is positioned to facilitate PCa nurse-led care models with a high nurse-to-patient ratio. This novel expert-informed PCa survivorship care algorithm contains a defined escalation pathway for clinically urgent symptoms while honoring patient preference. Though further validation is required through a pragmatic trial, we anticipate the Ned algorithm will support timelier decision-making and enhance continuity of care through the automation of more frequent automated checkpoints, while empowering patients to self-manage their symptoms more effectively than standard care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2020-045806.

Genetic testing practices among specialist physicians who treat prostate cancer A Canadian, cross-sectional survey.

INTRODUCTION: In patients with prostate cancer (PCa), the identification of an alteration in genes associated with homologous recombination repair (HRR) has implications for prognostication, optimization of therapy, and familial risk mitigation. The aim of this study was to assess the genomic testing landscape of PCa in Canada and to recommend an approach to offering germline and tumor testing for HRR-associated genes. METHODS: The Canadian Genitourinary Research Consortium (GURC) administered a cross-sectional survey to a largely academic, multidisciplinary group of investigators across 22 GURC sites between January and June 2022. RESULTS: Thirty-eight investigators from all 22 sites responded to the survey. Germline genetic testing was initiated by 34%, while 45% required a referral to a genetic specialist. Most investigators (82%) reported that both germline and tumor testing were needed, with 92% currently offering germline and 72% offering tissue testing to patients with advanced PCa. The most cited reasons for not offering testing were an access gap (50%), uncertainties around who to test and which genes to test, (33%) and interpreting results (17%). A majority reported that patients with advanced PCa (74-80%) should be tested, with few investigators testing patients with localized disease except when there is a family history of PCa (45-55%). CONCLUSIONS: Canadian physicians with academic subspecialist backgrounds in genitourinary malignancies recognize the benefits of both germline and somatic testing in PCa; however, there are challenges in accessing testing across practices and specialties. An algorithm to reduce uncertainty for providers when ordering genetic testing for patients with PCa is proposed.

Development, multi-institutional external validation, and algorithmic audit of an artificial intelligence-based Side-specific Extra-Prostatic Extension Risk Assessment tool (SEPERA) for patients undergoing radical prostatectomy: a retrospective cohort study.

BACKGROUND: Accurate prediction of side-specific extraprostatic extension (ssEPE) is essential for performing nerve-sparing surgery to mitigate treatment-related side-effects such as impotence and incontinence in patients with localised prostate cancer. Artificial intelligence (AI) might provide robust and personalised ssEPE predictions to better inform nerve-sparing strategy during radical prostatectomy. We aimed to develop, externally validate, and perform an algorithmic audit of an AI-based Side-specific Extra-Prostatic Extension Risk Assessment tool (SEPERA). METHODS: Each prostatic lobe was treated as an individual case such that each patient contributed two cases to the overall cohort. SEPERA was trained on 1022 cases from a community hospital network (Trillium Health Partners; Mississauga, ON, Canada) between 2010 and 2020. Subsequently, SEPERA was externally validated on 3914 cases across three academic centres: Princess Margaret Cancer Centre (Toronto, ON, Canada) from 2008 to 2020; L'Institut Mutualiste Montsouris (Paris, France) from 2010 to 2020; and Jules Bordet Institute (Brussels, Belgium) from 2015 to 2020. Model performance was characterised by area under the receiver operating characteristic curve (AUROC), area under the precision recall curve (AUPRC), calibration, and net benefit. SEPERA was compared against contemporary nomograms (ie, Sayyid nomogram, Soeterik nomogram [non-MRI and MRI]), as well as a separate logistic regression model using the same variables included in SEPERA. An algorithmic audit was performed to assess model bias and identify common patient characteristics among predictive errors. FINDINGS: Overall, 2468 patients comprising 4936 cases (ie, prostatic lobes) were included in this study. SEPERA was well calibrated and had the best performance across all validation cohorts (pooled AUROC of 0·77 [95% CI 0·75-0·78] and pooled AUPRC of 0·61 [0·58-0·63]). In patients with pathological ssEPE despite benign ipsilateral biopsies, SEPERA correctly predicted ssEPE in 72 (68%) of 106 cases compared with the other models (47 [44%] in the logistic regression model, none in the Sayyid model, 13 [12%] in the Soeterik non-MRI model, and five [5%] in the Soeterik MRI model). SEPERA had higher net benefit than the other models to predict ssEPE, enabling more patients to safely undergo nerve-sparing. In the algorithmic audit, no evidence of model bias was observed, with no significant difference in AUROC when stratified by race, biopsy year, age, biopsy type (systematic only vs systematic and MRI-targeted biopsy), biopsy location (academic vs community), and D'Amico risk group. According to the audit, the most common errors were false positives, particularly for older patients with high-risk disease. No aggressive tumours (ie, grade >2 or high-risk disease) were found among false negatives. INTERPRETATION: We demonstrated the accuracy, safety, and generalisability of using SEPERA to personalise nerve-sparing approaches during radical prostatectomy. FUNDING: None.

Meningeal metastases in prostate cancer: Institutional series and comprehensive systematic review.

Meningeal metastases (MM) are a rare progression in advanced prostate. Here we aimed to characterize the incidence, clinical presentation, and outcomes of patients with MM, including dural and leptomeningeal metastases, from primary prostate cancer. A systematic search was performed on MEDLINE, EMBASE, Scopus, and Web of Science. Studies that included patients who developed MM from primary prostate cancer were abstracted. Assessed outcomes included time from primary cancer to MM and MM to death, and clinical presentation of MM, among others. Case reports were compared qualitatively, while observational studies were pooled for quantitative synthesis. The systematic review was prospectively registered on PROSPERO (CRD42020205378). Our institutional series, 11 observational studies, and 46 case reports were synthesized, comprising a total of 191 patients. From the observational studies, the mean age at developing MM was 63.0 years (range: 58.4, 70.9). Presenting neurological symptoms were variable and largely depended on location of MM. The mean time from prostate cancer to MM was 54.6 months (range: 21.0, 101.5), and the mean time from MM to death was 9.0 months (range: 2.6, 23.0). Patients requiring resection for MM had shorter survival after disease progression compared to patients receiving radiation or supportive therapy. All articles had at least moderate risk of bias. We describe the largest synthesis of patients with progression to MM from prostate cancer. Current evidence is very low-quality and primarily stems from small observational studies. Neurological symptoms in the setting of advanced prostate cancer, especially in high-risk disease, warrants radiographic imaging for MM. Further prospective research on risk factors and treatment for MM is warranted.

Explainable artificial intelligence to predict the risk of side-specific extraprostatic extension in pre-prostatectomy patients.

INTRODUCTION: We aimed to develop an explainable machine learning (ML) model to predict side-specific extraprostatic extension (ssEPE) to identify patients who can safely undergo nerve-sparing radical prostatectomy using preoperative clinicopathological variables. METHODS: A retrospective sample of clinicopathological data from 900 prostatic lobes at our institution was used as the training cohort. Primary outcome was the presence of ssEPE. The baseline model for comparison had the highest performance out of current biopsy-derived predictive models for ssEPE. A separate logistic regression (LR) model was built using the same variables as the ML model. All models were externally validated using a testing cohort of 122 lobes from another institution. Models were assessed by area under receiver-operating-characteristic curve (AUROC), precision-recall curve (AUPRC), calibration, and decision curve analysis. Model predictions were explained using SHapley Additive exPlanations. This tool was deployed as a publicly available web application. RESULTS: Incidence of ssEPE in the training and testing cohorts were 30.7 and 41.8%, respectively. The ML model achieved AUROC 0.81 (LR 0.78, baseline 0.74) and AUPRC 0.69 (LR 0.64, baseline 0.59) on the training cohort. On the testing cohort, the ML model achieved AUROC 0.81 (LR 0.76, baseline 0.75) and AUPRC 0.78 (LR 0.75, baseline 0.70). The ML model was explainable, well-calibrated, and achieved the highest net benefit for clinically relevant cutoffs of 10-30%. CONCLUSIONS: We developed a user-friendly application that enables physicians without prior ML experience to assess ssEPE risk and understand factors driving these predictions to aid surgical planning and patient counselling (https://share.streamlit.io/jcckwong/ssepe/main/ssEPE_V2.py).

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.

Virtual care models for cancer survivorship.

Virtual care models for cancer survivorship are needed to support patients living with the chronic effects of cancer treatment, while increasing health system capacity. Characteristics that may be critical to their success have not been adequately studied. This scoping review summarizes previous efforts to virtualize survivorship care to inform future innovations in the field. Four databases were searched for articles published before January 2020, and 24 articles that met selection criteria were included in this analysis. Rationale for pursuing virtual models of care shared two common objectives: (1) the need for sustainable survivorship care, and (2) the opportunity to improve survivorship outcomes. Breast cancer (N = 10) and prostate cancer (N = 4) were the most targeted cancers for virtual survivorship care. The implemented technologies included web platforms (N = 15), telephone calls (N = 12), and smartphone or tablet applications (N = 5). A variety of healthcare professionals were effectively involved in the provision of virtual care. Future virtual care models may benefit from integrating with existing health systems and services, repurposing common technologies, involving allied health professionals, and engaging patients and caregivers from diverse communities in the design of virtual services.

Real-world evidence in patient-reported outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate + prednisone (AA+P) across Canada: Final results of COSMiC.

INTRODUCTION: Abiraterone acetate plus prednisone (AA+P) has shown to significantly improve survival. COSMiC, a Canadian Observational Study in Metastatic Cancer of the Prostate, set out to prospectively amass real-world data on metastatic castration-resistant prostate cancer (mCRPC) patients managed with AA+P in Canada. Herein, we report their patient-reported outcomes (PROs). METHODS: After a median followup of 67.1 weeks, 254 patients were enrolled across 39 sites. Functional Assessment of Cancer Therapy-Prostate (FACT-P), Montreal Cognitive Assessment (MoCA), Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), and Current Health Satisfaction in Prostate Cancer (CHS-PCa) were evaluated at baseline, as well as at weeks 12, 24, 48, and 72 after AA+P initiation. Descriptive analysis was used with continuous variables. Changes from baseline were summarized using mean (standard deviation [SD]). RESULTS: At a median age of 76.6 (8.94), baseline FACT-P total score was 111.3 (19.56) with no significant change in their functional status observed from baseline over time. The median baseline MoCA score was 25.2 (4.52), yet subsequent assessments showed an absence of cognitive decline while under treatment. Similarly, no meaningful changes were detected in BPI, BFI, and CHS-PCa during the 72-week study period, thus suggesting that patients' PROs were well-maintained throughout AA+P treatment. Prostate-specific antigen (PSA) response with >50% decline was 66.4%. Safety profile was consistent with the known side effect of AA+P. CONCLUSIONS: COSMiC represents the largest Canadian mCRPC cohort treated with AA+P with real-world, prospective evaluation of PROs. This data demonstrated the maintenance in quality of life and cognitive status over the course of the study and underscores the importance of PRO use in this complex patient population.

Surgical Management of Patients with Advanced Germ Cell Tumors Following Salvage Chemotherapy: Memorial Sloan Kettering Cancer Center (MSKCC) Experience.

OBJECTIVE: To characterize clinical and pathologic outcomes of cisplatin-refractory or relapsed germ cell tumor (GCT) patients who underwent retroperitoneal lymph node dissection (RPLND) following salvage chemotherapy with either conventional or high dose regimens. METHODS: Data were reviewed to identify all patients treated with TIP or TICE salvage chemotherapy between 1994 and 2011(n = 184) at our institution. We report clinicopathologic and outcomes data on 131 patients who were further managed with surgical resection. Using Cox-proportional hazards models, predictors of disease-specific survival (DSS) were analyzed. RESULTS: Median follow-up was 7.3 years. Of the 112 patients who underwent postsalvage chemotherapy RPLND, histology was reported as viable GCT in 30 (27%), teratoma only in 26 (23%) and fibrosis in 56 (50%). 5-year DSS for the entire cohort was 74% (95% confidence interval 63%-80%). On multivariable analysis, viable GCT histology at RPLND or extra-RPLND resection predicted for worse DSS (hazard ratio 7.37, P = .003). CONCLUSIONS: Our data suggest that approximately half of the patient with cisplatin-refractory or relapsed GCT salvaged with TIP or TICE chemotherapy and evidence of residual disease are at risk of harboring either viable GCT or teratoma. This finding underlines the critical role of surgery in the multimodality approach to the management of this advanced disease entity. If retroperitoneal disease exists prior to salvage chemotherapy, we recommend postchemotherapy resection in all eligible patients.

Clinically Localized Prostate Cancer: ASCO Clinical Practice Guideline Endorsement of an American Urological Association/American Society for Radiation Oncology/Society of Urologic Oncology Guideline.

PURPOSE: In April 2017, the American Urological Association, American Society for Radiation Oncology, and Society of Urologic Oncology released a joint evidence-based practice guideline on clinically localized prostate cancer. The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations. METHODS: The Clinically Localized Prostate Cancer guideline was reviewed for developmental rigor by methodologists. An ASCO Expert Panel then reviewed the content and the recommendations. RESULTS: The ASCO Expert Panel determined that the recommendations from the Clinically Localized Prostate Cancer guideline were clear, thorough, and based upon the most relevant scientific evidence. ASCO endorsed the Clinically Localized Prostate Cancer guideline except for two recommendations on cryosurgery. The two recommendations covering cryosurgery were not endorsed because the panel found that there is insufficient evidence to support the use of cryotherapy in this setting. RECOMMENDATIONS: The ASCO Expert Panel endorsed all but two of the original guideline recommendations as written and offered a series of discussion points to guide practice.

Validation of a Postoperative Nomogram Predicting Recurrence in Patients with Conventional Clear Cell Renal Cell Carcinoma.

BACKGROUND: Clear cell renal cell carcinoma (RCC) continues to be the most commonly diagnosed subtype and is associated with more aggressive behavior than papillary and chromophobe RCC. Predicting disease recurrence after surgical extirpation is important for counseling and targeting those at high risk for adjuvant therapy clinical trials. OBJECTIVE: To validate a postoperative nomogram predicting 5-yr recurrence-free probability (RFP) for clinically localized clear cell RCC. DESIGN, SETTING, AND PARTICIPANTS: We identified all patients who underwent nephrectomy for clinically localized clear cell RCC from 1990 to 2009 at Memorial Sloan Kettering Cancer Center. After excluding patients with bilateral renal masses, familial RCC syndromes, and T3c or T4 tumors due to the limited number, 1642 participants were available for analysis. INTERVENTIONS: Partial or radical nephrectomy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Disease recurrence was defined as any new tumor after nephrectomy or kidney cancer-specific mortality, whichever occurred first. A postoperative nomogram was used to calculate the predicted 5-yr RFP, and these values were compared with the actual 5-yr RFP. Nomogram performance was evaluated by concordance index and calibration plot. RESULTS AND LIMITATIONS: Median follow-up was 39 mo (interquartile range: 14-79 mo), and disease recurrence was observed in 50 patients. The nomogram concordance index was 0.81. The calibration curve showed that the nomogram underestimated the actual 5-yr RFP. We updated the nomogram by including the entire patient population, which maintained performance and significantly improved calibration. CONCLUSIONS: The updated clear cell RCC postoperative nomogram performed well in the combined cohort. Underestimation of actual 5-yr RFP by the original nomogram may be due to increased surgeon experience and other unknown variables. PATIENT SUMMARY: We updated a valuable prediction tool used for assessing the disease recurrence probability after nephrectomy for clear cell renal cell carcinoma.

Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalized Prostate Cancer Survivorship Care: Protocol for a Realist Case Study of the Ned App.

BACKGROUND: By 2030, prostate cancer will be the most commonly diagnosed cancer in North America. To mitigate this impending challenge, comprehensive support mechanisms for disease- and treatment-specific changes in health and well-being must be proactively designed and thoughtfully implemented for streamlined survivorship care. mHealth apps have been lauded as a promising complement to current outpatient treatment and monitoring strategies, but have not yet been widely used to support prostate cancer survivorship needs. A realist evaluation is needed to examine the impact of such apps on the prostate cancer survivorship experience. OBJECTIVE: We seek to gain an understanding of how an mHealth app for prostate cancer survivorship care called Ned (No Evident Disease) is adopted and accepted by patients, caregivers, and clinicians. We also aim to determine the effect of Ned on health-related quality of life, satisfaction with cancer care, unmet needs, self-efficacy, and prostate cancer-related levels of anxiety. METHODS: The Ned case study is a 12-month mixed-methods embedded single-case study with a nested within-group pre-post comparison of health outcomes. We will give 400 patients, 200 caregivers, and 10 clinicians access to Ned. Participants will be asked to complete study assessments at baseline, 2 months, 6 months, and 12 months. We will conduct 30 semistructured qualitative interviews with patients (n=20) and their caregivers (n=10) poststudy to gain insight into their experience with the app. RESULTS: We recruited our first survivor in October 2017 and anticipate completing this study by May 2019. CONCLUSIONS: This will, to our knowledge, be the first realist case study to evaluate an app for prostate cancer survivorship care. Prostate cancer survivors are set to increase in number and longevity, heightening the need for integrated survivorship solutions to provide them with optimal and durable outcomes. The knowledge gained from this study will comprehensively inform how and why Ned works, for whom, and in what circumstances. Understanding the impact of digital health interventions such as Ned on how survivors care for themselves is critical to realizing patient-centered care.

Brachytherapy for Patients With Prostate Cancer: American Society of Clinical Oncology/Cancer Care Ontario Joint Guideline Update.

Purpose To jointly update the Cancer Care Ontario guideline on brachytherapy for patients with prostate cancer to account for new evidence. Methods An Update Panel conducted a targeted systematic literature review and identified more recent randomized controlled trials comparing dose-escalated external beam radiation therapy (EBRT) with brachytherapy in men with prostate cancer. Results Five randomized controlled trials provided the evidence for this update. Recommendations For patients with low-risk prostate cancer who require or choose active treatment, low-dose rate brachytherapy (LDR) alone, EBRT alone, and/or radical prostatectomy (RP) should be offered to eligible patients. For patients with intermediate-risk prostate cancer choosing EBRT with or without androgen-deprivation therapy, brachytherapy boost (LDR or high-dose rate [HDR]) should be offered to eligible patients. For low-intermediate risk prostate cancer (Gleason 7, prostate-specific antigen < 10 ng/mL or Gleason 6, prostate-specific antigen, 10 to 20 ng/mL), LDR brachytherapy alone may be offered as monotherapy. For patients with high-risk prostate cancer receiving EBRT and androgen-deprivation therapy, brachytherapy boost (LDR or HDR) should be offered to eligible patients. Iodine-125 and palladium-103 are each reasonable isotope options for patients receiving LDR brachytherapy; no recommendation can be made for or against using cesium-131 or HDR monotherapy. Patients should be encouraged to participate in clinical trials to test novel or targeted approaches to this disease. Additional information is available at www.asco.org/Brachytherapy-guideline and www.asco.org/guidelineswiki .

Impact of a common clinical pathway on length of hospital stay in patients undergoing open and minimally invasive kidney surgery.

PURPOSE: Clinical pathways are designed to reduce variability in patient care practices and improve clinical outcomes. We evaluated the effect of implementing a clinical care pathway on length of stay in patients undergoing kidney surgery. MATERIALS AND METHODS: After receiving institutional review board approval we evaluated prospective data on consecutive cases of partial and radical nephrectomy performed at our institution from 2000 to 2011. We identified 1,775 partial nephrectomies (1,449 open and 326 minimally invasive) and 1,025 radical nephrectomies (857 open and 168 minimally invasive). We used multivariate linear regression to test for an interaction between procedure type and surgery before vs after the clinical pathway was begun. RESULTS: Median length of stay decreased 40% (from 5 to 3 days) for open surgery and 33% (from 3 to 2 days) for minimally invasive surgery after clinical pathway implementation. Length of stay in patients treated with minimally invasive or open partial nephrectomy and open radical nephrectomy decreased while it remained stable in those who underwent minimally invasive radical nephrectomy. The difference in length of stay between open and minimally invasive partial nephrectomy before and after implementing the clinical pathway decreased by 1.5 days (95% CI 0.56-2.5, p = 0.002). At 30 days postoperatively major complication rates remained similar. CONCLUSIONS: The clinical pathway resulted in a significantly shorter length of stay in patients treated with partial and radical nephrectomy without a discernible impact on safety or quality of care. Clinical pathways for kidney surgery should be used and continually optimized to enhance efficiency, patient safety and outcomes.

Effect of aspirin and warfarin therapy on thromboembolic events in patients with univentricular hearts and Fontan palliation.

BACKGROUND: Patients with univentricular hearts and Fontan palliation are at risk for thromboembolic complications. While aspirin and warfarin therapies are currently the mainstay of prophylaxis, controversy exists as to the optimal prevention strategy. METHODS: A cohort study was conducted on the New England registry of patients born in 1985 or earlier with Fontan surgery at Boston Children's Hospital, in order to assess and compare the effect of prophylactic aspirin and warfarin on incident thromboembolic events. RESULTS: A total of 210 qualifying patients (49% male) underwent Fontan surgery at a median age of 8.5 years: 48.6% had a right atrium to pulmonary artery anastomosis, 11% a right atrium to right ventricle conduit, 38.6% a lateral tunnel, and 1.9% an extracardiac conduit. No thromboembolic prophylaxis was prescribed to 50.0%, whereas 24.3% received aspirin, and 25.7% warfarin. In multivariate analyses, lack of aspirin or warfarin was associated with a significantly higher thromboembolic event rate when compared to therapy with either [hazard ratio 8.5, 95% confidence interval (3.6-19.9), P < 0.001], with no difference between the two treatment strategies (P = 0.768). Twenty-year freedom from thromboemboli was 86% versus 52% in patients with and without thromboprophylaxis, respectively. Other factors independently associated with thromboemboli were a low post-operative cardiac index [hazard ratio 2.6, 95% confidence interval (1.2, 5.9)] and atrial fibrillation or flutter [hazard ratio 3.1, 95% confidence interval (1.2, 8.0)]. CONCLUSIONS: Prophylaxis with either aspirin or warfarin was associated with a significantly lower rate of incident thromboembolic events following Fontan palliation, with no difference between the two therapies.

Neutrophil gelatinase-associated lipocalin (NGAL) levels in response to unilateral renal ischaemia in a novel pilot two-kidney porcine model.

OBJECTIVES: To test a novel porcine two-kidney model for evaluating the effect of controlled acute kidney injury (AKI) related to induced unilateral ischaemia on both renal units (RUs) To use neutrophil gelatinase-associated lipocalin (NGAL) and physiological serum and urinary markers to assess AKI and renal function. METHODS: Twelve female Yorkshire pigs had bilateral cutaneous ureterostomies placed laparoscopically with identical duration of pneumoperitoneum for all cases. An experimental group (n = 9) underwent induced unilateral renal ischaemia with left hilar clamping of timed duration (15, 30, 60 min) and a control group (n = 3) had no induced renal ischaemia. Urine was collected and analysed from each RU to assess creatinine and NGAL concentration preoperatively and at multiple postoperative time points. Serum was collected and analysed daily for creatinine and NGAL levels. Statistical comparisons were made using the rank-sum and sign-rank tests. RESULTS: Three pigs were excluded because of intra-operative and postoperative complications. In the RUs that experienced renal ischaemia (n = 7),the median urine volume was lower (P = 0.04) at 6, 12, 24 and 48 h and the median NGAL concentration was higher (P = 0.04) at 12 and 48 h compared with the RUs of control pigs that experienced no renal ischaemia (n = 2). When comparing the ischaemic (left) RU of the pigs in the experimental group with their contralateral non-ischaemic (right) RU, ischaemic RUs had a lower median cumulative urine volume at 6, 12, 24 and 48 h (P = 0.05) and a higher median NGAL concentration at 12, 24 and 48 h (P < 0.05). At 48 h, no significant increase was found in serum NGAL in pigs in the experimental group compared with controls (P = 0.2). Creatinine clearance (CC) was lower in ischaemic RUs compared with non-ischaemic RUs 1 day after surgery (P = 0.04) with decreasing CC as the duration of ischaemia increased. CONCLUSIONS: We have developed a promising novel small-scale pilot surgical model that allowed the evaluation of bilateral RU function separately during and after unilateral renal ischaemia. The induction of unilateral renal ischaemia corresponds with physiological changes in both the ischaemic and contralateral RU. AKI as measured by increases in NGAL and decreased renal function as measured by decreases in CC, are specific to the RU exposed to ischaemia.

Urine neutrophil gelatinase-associated lipocalin as a marker of acute kidney injury after kidney surgery.

PURPOSE: We evaluated urine NGAL as a marker of acute kidney injury in patients undergoing partial nephrectomy. We sought to identify the preoperative clinical features and surgical factors during partial nephrectomy that are associated with renal injury, as measured by increased urine NGAL vs controls. MATERIALS AND METHODS: Using patients treated with radical nephrectomy or thoracic surgery as controls, we prospectively collected and analyzed urine and serum samples from patients treated with partial or radical nephrectomy, or thoracic surgery between April 2010 and April 2012. Urine was collected preoperatively and at multiple time points postoperatively. Differences in urine NGAL levels were analyzed among the 3 surgical groups using a generalized estimating equation model. The partial nephrectomy group was subdivided based on a preoperative estimated glomerular filtration rate of less than 60, or 60 ml/minute/1.73 m(2) or greater. RESULTS: Of 162 patients included in final analysis more than 65% had cardiovascular disease. The median estimated glomerular filtration rate was greater than 60 ml/minute/1.73 m(2) in the radical and partial nephrectomy, and thoracic surgery groups (61, 78 and 84.5 ml/minute/1.73 m(2), respectively). Preoperatively, a 10 unit increase in the estimated glomerular filtration rate was associated with a 4 unit decrease in urine NGAL in the partial nephrectomy group. Postoperatively, urine NGAL in the partial nephrectomy group was not higher than in controls and did not correlate with ischemia time. Patients with partial nephrectomy with a preoperative estimated glomerular filtration rate of less than 60 ml/minute/1.73 m(2) had higher urine NGAL postoperatively than those with a higher preoperative estimated rate. CONCLUSIONS: Urine NGAL does not appear to be a useful marker for detecting renal injury in healthy patients treated with partial nephrectomy. However, patients with poorer preoperative renal function have higher baseline urine levels and appear more susceptible to acute kidney injury, as detected by urine levels and Acute Kidney Injury Network criteria, than those with a normal estimated glomerular filtration rate.

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.