Search

CONTEXT: The epidemiological signature of renal cell carcinoma (RCC) during the past decades is explained by overdetection and overtreatment of indolent cancers; furthermore, a non-negligible proportion of patients undergoing surgery for suspected RCC harbour benign renal tumours. As the gold standard for RCC diagnosis remains histopathological analysis of surgical or biopsy specimens, implementation of noninvasive diagnostic strategies to discriminate between benign and malignant renal masses is an urgent unmet need. OBJECTIVE: To systematically review novel liquid biomarkers and imaging modalities for RCC diagnosis. EVIDENCE ACQUISITION: A systematic review of the recent English-language literature was conducted according to the European Association of Urology guidelines and the PRISMA statement recommendations (PROSPERO ID: CRD42020190773) using the MEDLINE, Cochrane Central Register of Controlled Trials, Web of Science, and ClinicalTrials.gov databases. Risk-of-bias assessment was performed according to the QUADAS 2 tool. EVIDENCE SYNTHESIS: Overall, 15 studies (six on biomarkers and nine on imaging) and eight clinical trials were included. None of the biomarkers or imaging modalities has been validated or shown to have a distinct clinical value for RCC. Specific combinations of urinary cell-free and exosomal miRNAs, urinary miR-15a, and specific panels of urinary metabolites assessed by metabolomics appear promising. In addition, machine/deep learning algorithms and radiomics applied to cross-sectional images may have potential to improve RCC diagnosis. Most studies are limited by the retrospective design, size, and lack of external validation. CONCLUSIONS: Liquid biomarkers or imaging modalities are not ready for integration in the clinic and further well-designed studies must validate preliminary findings and explore utility in clinical decision-making. PATIENT SUMMARY: We provide a comprehensive overview of the currently available biomarkers (measured in blood or urine) and novel imaging tests (other than conventional imaging) to discriminate kidney cancer from benign renal masses in a noninvasive fashion. None of the biomarkers or imaging modalities studied was validated or added clinical value; therefore, none of them can be implemented in the clinic. However, these approaches appear to be promising for improving the diagnosis of kidney cancer in the future.

Context The epidemiological signature of renal cell carcinoma (RCC) during the past decades is explained by overdetection and overtreatment of indolent cancers; furthermore, a non-negligible proportion of patients undergoing surgery for suspected RCC harbour benign renal tumours. As the gold standard for RCC diagnosis remains histopathological analysis of surgical or biopsy specimens, implementation of noninvasive diagnostic strategies to discriminate between benign and malignant renal masses is an urgent unmet need. Objective To systematically review novel liquid biomarkers and imaging modalities for RCC diagnosis. Evidence acquisition A systematic review of the recent English-language literature was conducted according to the European Association of Urology guidelines and the PRISMA statement recommendations (PROSPERO ID: CRD42020190773) using the MEDLINE, Cochrane Central Register of Controlled Trials, Web of Science, and ClinicalTrials.gov databases. Risk-of-bias assessment was performed according to the QUADAS 2 tool. Evidence synthesis Overall, 15 studies (six on biomarkers and nine on imaging) and eight clinical trials were included. None of the biomarkers or imaging modalities has been validated or shown to have a distinct clinical value for RCC. Specific combinations of urinary cell-free and exosomal miRNAs, urinary miR-15a, and specific panels of urinary metabolites assessed by metabolomics appear promising. In addition, machine/deep learning algorithms and radiomics applied to cross-sectional images may have potential to improve RCC diagnosis. Most studies are limited by the retrospective design, size, and lack of external validation. Conclusions Liquid biomarkers or imaging modalities are not ready for integration in the clinic and further well-designed studies must validate preliminary findings and explore utility in clinical decision-making. Patient summary We provide a comprehensive overview of the currently available biomarkers (measured in blood or urine) and novel imaging tests (other than conventional imaging) to discriminate kidney cancer from benign renal masses in a noninvasive fashion. None of the biomarkers or imaging modalities studied was validated or added clinical value; therefore, none of them can be implemented in the clinic. However, these approaches appear to be promising for improving the diagnosis of kidney cancer in the future.

Traumatic penetrating arteriovenous fistulas (AVFs) are very rare. The majority of these injuries occur secondary to penetrating trauma. Objectives of this study: review their incidence, clinical presentation, radiologic identification, management, complications and outcomes.A literature search was performed on MEDLINE Complete-Pubmed from 1829-2019. PRISMA guidelines were utilized. Of 305 potentially eligible articles, 201 articles were selected.patients age ≥ 18, articles with title and abstract in English, AVFs secondary to penetrating trauma, articles which specified vessels involved in AVFs, and those reporting complete information on patient presentation, diagnosis, imaging, surgical and/or endovascular surgical management, and outcomes of penetrating AVF's.articles reporting blunt or iatrogenic AVFs, pediatric patients, fistulas used for dialysis and their complications, articles lacking complete information, cranial/spinal AVFs or cardiac AVFs, and duplicate articles. Mechanism of injury (MOI), diagnosis, involved vessels, management and outcomes of patients with AVFs secondary to penetrating trauma were recorded.There were a total of 291 patients with AVFs secondary to penetrating injuries. Mechanism of injury (MOI): stab wounds (SW)-126 (43.3%), Gunshot wounds (GSW)-94 (32.3%), miscellaneous-35 (12%), mechanism unspecified-36 (12.4%). Anatomic area: neck-69 (23.7%) patients, thorax-46 (15.8%), abdomen-87 (30%), upper and lower extremities-89 (30.6%). Most commonly involved vessels-vertebral artery-38 (13%), popliteal vein-32 (11.7%). Angiography was diagnostic-265 patients (91.1%).Surgical- 202 (59.6%), Endovascular-118 (34.8%). Associated: aneurysms/pseudoaneurysms-129 (44.3%).Most AVFs occur secondary to penetrating injuries. Stab wounds account for the majority of these injuries. Most frequently injured vessels are vertebral artery and superficial femoral vein. Surgical interventions are the most common mode of management followed by endovascular surgical techniques.

Introduction Designing adjuvant trials is challenging because of uncertainties of prevalence and outcome of high-risk renal cell cancer (RCC) despite use of validated risk scores. Our objective is to investigate how differences in eligibility criteria may impact on potential study results in RCC adjuvant trials. Patients and Methods RECUR is a multicenter European database capturing patient and tumor characteristics, recurrence patterns, and survival of those curatively treated for non-metastatic RCC from 2006 to 2011 without any adjuvant therapy. We used RECUR to evaluate prevalence, disease-free survival (DFS), and overall survival (OS) according to eligibility criteria of immunotherapy-based adjuvant trials IMMotion 010 ( NCT03024996 ), Checkmate 914 ( NCT03138512 ), Keynote-564 ( NCT03142334 ), RAMPART ( NCT03288532 ), and PROSPER ( NCT03055013 ). Results Of 3024 relevant patients in RECUR, 408 (13.5%), 725 (24%), 609 (20.1%), 1363 (45.1%), and 1071 (35.4%) met eligibility criteria for IMMotion-010, CheckMate-914, Keynote-564, RAMPART, and PROSPER, respectively. The median and 5-year DFS Kaplan-Meier estimates in RECUR corresponding to each trial eligibility criteria were: not reached and 69.6% for RAMPART; not reached and 64.5% for PROSPER; 109.3 months (95% confidence interval [CI], 83.9-134.6 months) and 57% for CheckMate-914; 75.8 months (95% CI, 52.7-98.8 months) and 54.3% for Keynote-564; and 43.6 months (95% CI, 30.8-56.4 months) and 45% for IMMotion-010. Our analysis may be limited by the retrospective design. Conclusions RECUR provides estimated DFS and OS benchmarks for placebo arms of adjuvant checkpoint inhibitor studies and hence likely time to trial reporting. Well-documented contemporary registries rather than past risk models should be used to design future adjuvant trials.

Purpose Utilization of hydroxychloroquine, chloroquine, and supportive therapy drugs in hospitals in New York during the early weeks of the coronavirus disease 2019 (COVID-19) pandemic was analyzed. Summary Drug utilization trends for 7 medications used to treat patients with suspected or confirmed COVID-19 at 47 New York hospitals were identified. The data demonstrated sharp increases in aggregate utilization of hydroxychloroquine and chloroquine and the number of patients receiving either drug beginning on March 15, with a notable 20% median increase per day through March 31. The net quantity of drug charge units per day for midazolam, propofol, ketamine, cisatracurium, and fentanyl also increased during the study period. Following peak utilization, use of all study drugs decreased at different times throughout April 2020. The data were used to provide information to various stakeholders in the drug supply chain during the initial surge of the pandemic. Conclusion This analysis describes the increased use, beginning in mid-March 2020, of hydroxychloroquine, chloroquine, midazolam, propofol, ketamine, cisatracurium, and fentanyl in 47 hospitals in New York State. The increased utilization of supportive therapy drugs was consistent with the surge in patients with presumed or confirmed COVID-19 during the study period. These data and observations can help clinicians, health-system leaders, manufacturers, wholesalers, and policymakers understand the impact of current and future pandemics on the drug supply chain.

Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose To describe our hospital pharmacy department’s preparation for an influx of critically ill patients during the coronavirus disease 2019 (COVID-19) pandemic and offer guidance on clinical pharmacy services preparedness for similar crisis situations. Summary Personnel within the department of pharmacy at a medical center at the US epicenter of the COVID-19 pandemic proactively prepared a staffing and pharmacotherapeutic action plan in anticipation of an expected surge in admissions of critically ill patients with COVID-19 and expansion of acute care and intensive care unit (ICU) capacity. Guidance documents focusing on supportive care and pharmacotherapeutic treatment options were developed. Repurposing of non–ICU-trained clinical pharmacotherapy specialists to work collaboratively with clinician teams in ICUs was quickly implemented; staff were prepared for these duties through use of shared tools to facilitate education and practice standardization. Conclusion As challenges were encountered at the peak of the pandemic, interdisciplinary collaboration and teamwork was crucial to ensure that all patients were proactively assessed and that their respective pharmacotherapeutic regimens were optimized.

The quality of drug products in the United States, which are largely produced overseas, has been a matter of growing concern.1 Buyers and payers of pharmaceuticals, whether they are health-systems, insurers, PBMs, pharmacies, physicians, or patients, have little to no visibility into any quality metrics for the manufacturers of drug products or the products themselves. A system of “quality scores” is proposed to enable health-systems and other purchasers and payers of medication to differentiate among drug products according to evidence-based metrics. Metrics influencing the quality scores described herein include both broadly applicable regulatory information and more drug-specific, third-party chemical analysis information. The aggregation of these metrics through a proposed set of rules results in numerical values on a 0-100 scale that may be further simplified into a red/yellow/green designation. The simplicity of such scores enables seamless integration into existing healthcare systems and an integration scheme is proposed. Using real-world data from currently on-market valsartan drug products, this proposed system generated a variety of quality scores for six major manufacturers. These scores were further evaluated according to their current market price showing no significant correlation between quality score and price. The implementation of drug quality scores at healthcare institutions in the United States and their potential utilization by regulators, could create a much-needed, market-driven incentive for pharmaceutical manufacturers to produce quality medications that would reduce drug shortages and improve public health.

Purpose: The intent of this article is to evaluate a novel approach, using rapid cycle analytics and real world evidence, to optimize and improve the medication evaluation process to help the formulary decision making process, while reducing time for clinicians. Summary: The Pharmacy and Therapeutics (P&T) Committee within each health system is responsible for evaluating medication requests for formulary addition. Members of the pharmacy staff prepare the drug monograph or a medication use evaluation (MUE) and allocate precious clinical resources to review patient charts to assess efficacy and value. We explored a novel approach to evaluate the value of our intravenous acetaminophen (IV APAP) formulary admittance. This new methodology, called rapid cycle analytics, can assist hospitals in meeting and/or exceeding the minimum criteria of formulary maintenance as defined by the Joint Commission Standards. In this particular study, we assessed the effectiveness of IV APAP in total hip arthroplasty (THA) and total knee arthroplasty (TKA) procedures. We assessed the correlation to same-stay opioid utilization, average length of inpatient stay and post anesthesia care unit (PACU) time. Conclusion: We were able to explore and improve our organization’s approach in evaluating medications by partnering with an external analytics expert to help organize and normalize our data in a more robust, yet time efficient manner. Additionally, we were able to use a significantly larger external data set as a point of reference. Being able to perform this detailed analytical exercise for thousands of encounters internally and using a data warehouse of over 130 million patients as a point of reference in a short time has improved the depth of our assessment, as well as reducing valuable clinical resources allocated to MUEs to allow for more direct patient care. This clinically real-world and data-rich analytics model is the necessary foundation for using Artificial or Augmented Intelligence (AI) to make real-time formulary and drug selection decisions

OBJECTIVE Traumatic arteriovenous fistulas (AVFs) are rare. The vast majority occur secondary to penetrating injuries. High-output cardiac failure is a well-recognized serious complication of AVFs, associated with high morbidity and mortality. The objective of the present study was to identify predictors of heart failure (HF) in patients with traumatic AVF. METHODS Both PubMed/MEDLINE (Ovid) and CINAHL were searched (up to June 2019) for studies reporting individual patient data on the clinical and demographic characteristics of patients with AVF secondary to penetrating trauma. Exclusion criteria were age

The optimal follow-up (FU) strategy for patients treated for localised renal cell carcinoma (RCC) remains unclear. Using the RECUR database, we studied imaging intensity utilised in contemporary FU to evaluate its association with outcome after detection of disease recurrence. Consecutive patients with nonmetastatic RCC (n = 1612) treated with curative intent at 12 institutes across eight European countries between 2006 and 2011 were included. Recurrence occurred in 336 patients. Cross-sectional (computed tomography, magnetic resonance imaging) and conventional (chest X-ray, ultrasound) methods were used in 47% and 53%, respectively. More intensive FU imaging (more than twofold) than recommended by the European Association of Urology (EAU) was not associated with improved overall survival (OS) after recurrence. Overall, per patient treated for recurrence remaining alive with no evidence of disease, the number of FU images needed was 542, and 697 for high-risk patients. The study results suggest that use of more imaging during FU than that recommended in the 2017 EAU guidelines is unlikely to improve OS after recurrence. Prospective studies are needed to design optimal FU strategies for the future. Patient summary: After curative treatment for localised kidney cancer, follow-up is necessary to detect any recurrence. This study illustrates that increasing the imaging frequency during follow-up, even to double the number of follow-up imaging procedures recommended by the European Association of Urology guidelines, does not translate into improved survival for those with recurrence. After curative treatment for localised kidney cancer, a more intensive follow-up regimen than that recommended in the 2017 European Association of Urology guidelines did not improve overall survival among those experiencing recurrence, irrespective of the risk of recurrence. This suggests that an increase in follow-up imaging frequency is not cost-efficient. Prospective studies to identify more optimal follow-up strategies are needed.

Brachial artery injuries are rare. The objectives of the study are to report our experience and identify predictors of outcome. The hypothesis of the study is that maintaining ischemic times less than six hours results in improved outcomes.This is a retrospective 118-month study. The outcome measure is total operative time from admission to restoration of blood flow, and outcomes are survival and limb salvage. Statistical analyses used in the study are univariate and multivariate stepwise logistic regression.There were 124 patients with 131 brachial artery injuries. Mechanism of injury (MOI) included the following: penetrating: 108 (87%) and blunt: 16 (13%). Operative management included the following: 77 (62%) reverse saphenous vein interposition grafts, 37 (29.8%) end-to-end anastomosis, and 4 (3.2%) ligation. Fasciotomies were performed in 23 (19.2%) patients. Outcomes of the study were as follows: 120 patients survived and the overall survival rate was 96.8%, adjusted survival rate excluding intraoperative deaths was 100%, overall limb salvage/amputation rate was 95.1%/4.9%, and adjusted limb salvage/amputation rates excluding intraoperative deaths were 98.3%/1.67%. Univariate analysis showed the mean ischemic times for survivors as 5 ± 3.1 hrs (300 ± 186 min) versus ischemic times for non survivors as 3 ± 2.2 hrs (180 ± 132 min) (P = 0.017); Injury Severity Score (ISS) (P = 0.002); and estimated blood loss (EBL) (P = 0.024). Logistic regression identified independent predictors of outcome for survival: MOI: penetrating [P = 0.015, RR - 4.29, 95% CI: 1.49-12.36]; Glasgow Coma Score7 [P0.001, RR - 21.71, 95% CI: 9.37-50.32]; ISS15 [P0.005, RR - 4.98, 95% CI: 1.68-14.73]; and patients not requiring ED thoracotomy [P = 0.009, RR - 7.48, 95% CI: 2.58-21.69].Brachial artery injuries are rare. For patients not requiring ED thoracotomy, Glasgow Coma Score, ISS, and EBL predicted survival. The adjusted limb salvage rate was 98.3%. Patients with brachial artery injuries die from associated injuries, experiencing less ischemic times than survivors who are able to undergo repairs.