Routine Chest Radiography Following Tunneled Hemodialysis Catheter: Use and Clinical Outcomes

Highlights Abstract Background: A postoperative chest x-ray (CXR) remains part of some hospital protocols following tunneled hemodialysis catheter placement despite the use of operative imaging-guided techniques. The aim is to assess the usefulness of this practice and its impact on clinical outcomes and resource use. Methods: A review of medical records and postoperative CXR was done for 78 adult patients who had tunneled hemodialysis catheters placed in the operating room under fluoroscopy guidance. Catheters were inserted by ultrasound-guided puncture (51.3%) or exchanged from an existing catheter over a guide wire (48.7%). The postoperative CXRs were also examined by an independent reviewer to assess the catheter tip position and the need for repositioning to mimic a real-life postoperative setting. Procedural, nursing, and billing records were also reviewed. Results: No patients had a pneumothorax or major complications. On postoperative CXRs, 29 (37.2%) patients had the catheter tips in the right atrium, 23 (29.5%) in the cavoatrial junction, 25 (23.1%) in the superior vena cava, and 1 (1.3%) in the brachiocephalic vein. The independent reviewer found the catheter tips in acceptable anatomical positions in 75 of 78 patients. Only 3 (3.9%) patients had catheter malfunctions during dialysis and exchanged their catheters (2 had high catheters in the superior vena cava and brachiocephalic vein, 1 had a kinked catheter). Postoperative CXRs also caused delays in patient discharge from postanesthesia care units and significant increases in medical expenses (around $199 per patient). Conclusion: Routine CXR after tunneled hemodialysis central venous catheter insertion is unnecessary and does not add to the procedure's safety or to the patient's outcome.

NIMG-69. FREQUENCY OF TUMOR-RELATED VASCULATURE IN PRIMARY CNS LYMPHOMA ON ROUTINE MRI

Primary central nervous system lymphoma (PCNSL) is known to express angiogenic factors and can have spontaneous or biopsy-related hemorrhage. Radiographically, PCNSL is characterized by homogenous enhancement and diffusion restriction, as well as T2/FLAIR abnormalities. A higher frequency of tumor-related vessels has been reported in gliomas compared to brain metastases, but this has not been assessed in PCNSL. We used a clinical database of patients with PCNSL treated at the University of Washington and reviewed pretreatment MRIs for 48 patients treated between 2014-2021 for whom susceptibility sequences were available. Median age at diagnosis was 64 years (range 35-90 years). Patients were 27.1% male and 72.9% female. Each lesion was scored by at least two independent reviewers for the presence of a prominent vessel located either centrally or eccentrically, and for the presence of hemorrhage. Lesions that were scored differently by the two reviewers (n=26) were then scored by a third independent reviewer. In several cases the findings were felt to be indeterminate. Lesions were considered measurable if they were greater than 5 mm in two perpendicular planes, and a total of 93 measurable lesions were categorized. Prominent vessels were seen in 56/93 (60.2%) lesions, with 26/56 (46.4%) being central and 30/56 (55.4%) being eccentric. An additional 7/93 (7.5%) lesions were indeterminate. Hemorrhage was seen in 11/93 (11.8%) lesions. We conclude that prominent vessels can be seen in a majority of PCNSL lesions on standard MRI.

Overall Survival in Patients with Myelofibrosis Who Have Discontinued Ruxolitinib: A Literature Review

Introduction: Myelofibrosis (MF) is a rare bone marrow cancer characterized by bone marrow fibrosis and abnormal cytokine expression, often leading to splenomegaly, constitutional symptoms, and cytopenia. Prognostic scoring systems (the International Prognostic Scoring System and the Dynamic International Prognostic Scoring System) classify patients into low-, intermediate-1-, intermediate-2-, or high-risk categories. Most patients with MF have either intermediate-2- or high-risk disease, indicating a poor overall prognosis and short survival time (5-year survival rate in Europe: 35%). Ruxolitinib is the first Janus kinase inhibitor (JAKi) treatment for MF approved by the US Food and Drug Administration and the European Medicines Agency. However, the rate of discontinuation of ruxolitinib in the first 2-3 years of treatment is high (> 50%) due to treatment resistance, disease recurrence, and worsening of anemia. This literature review aimed to assess overall survival (OS) in patients with MF who have discontinued ruxolitinib. Methods: A systematic literature review (SLR) was conducted in which Embase®, MEDLINE®, and the Cochrane Library were searched to identify published evidence from database inception until August 2018. Conference proceedings, health technology assessments, and bibliographies were also searched. Additionally, this SLR was updated in a targeted manner using Embase® until February 2019 to identify and update the OS evidence among patients with MF who have discontinued ruxolitinib. Retrieved studies were included if they were published in English and reported OS data in the targeted patient population of interest. Two independent reviewers assessed the studies against pre-defined eligibility criteria (Table 1) to include or exclude the studies, and any uncertainty was resolved by a third independent reviewer, in the case of the SLR, or by mutual agreement, in the case of the update. All extracted data were quality checked by a second independent reviewer. A descriptive, qualitative analysis was conducted to assess OS in patients with MF who have used and discontinued ruxolitinib. Results: Of the 4,011 publications retrieved, 11 studies were included (Table 2). Six were retrospective observational studies, 2 were randomized controlled trials (RCTs), and 3 were non-RCTs. Across all the included studies, 5 reported estimates of median OS. Across the 4 studies reporting median OS for standard of care or approved treatments, median OS ranged from 4.9-30 months (Kuykendall et al. 2017, Mehra et al. 2016, Newberry et al. 2017, Palandri et al. 2018). Patients receiving no treatment after ruxolitinib had a median OS of 4.9 months (Kuykendall et al., 2017). Median OS in patients who received treatment with salvage therapy or conventional agents (e.g. hydroxyurea, danazol, anagrelide) was typically around 14 months (14, 14, and 15 months in Mehra et al. 2016, Newberry et al. 2017, and Kuykendall et al. 2017, respectively). Estimated median OS following ruxolitinib discontinuation for early discontinuers and spleen responders in the COMFORT-II study was approximately 16.5 months (NICE, 2015). One study reported median OS for an investigational agent (Mascarenhas et al. 2018); median OS was 19.9 and 29.9 months for imetelstat 4.7 mg/kg and 9.4 mg/kg, respectively. Conclusions: This literature review revealed that patients with MF generally experience poor OS after discontinuing ruxolitinib, especially in patients who receive no further treatments. Line of therapy definitions were rarely reported across studies, which may contribute to variations across study findings. In addition, survival estimates after prior ruxolitinib therapy varied depending on the treatment received and the reason for discontinuation of ruxolitinib. Limited survival data for investigational therapies were available from early-stage trials and may be subject to substantial variations in large-scale registrational trials. Some of the studies included in this literature review may be ongoing as they are currently available in abstract form only, and new data may become available in the near future. Sustained efforts to develop more effective treatments for patients with MF who have discontinued ruxolitinib are imminently needed. Disclosures Tang: Celgene Corporation: Employment, Equity Ownership. Taneja:BresMed Health Solutions Ltd: Employment. Rajora:BresMed Health Solutions Ltd: Employment. Sly:BresMed Health Solutions Ltd: Employment. Davison:BresMed Health Solutions Ltd: Employment.

Systematic Literature Review of the Economic Burden and Cost of Illness in Patients with Myelofibrosis

Introduction: Myelofibrosis (MF) is a rare bone marrow cancer classified as a myeloproliferative neoplasm in which bone marrow is replaced by fibrous (scar) tissue, impairing the production of normal blood cells. MF has a global incidence of approximately 0.58 new cases per 100,000 person-years, with many patients experiencing short survival (approximately 6 years). Most patients with MF are found to have either intermediate-2 or high-risk MF, as per their prognostic score (International Prognostic Scoring System [IPSS] or Dynamic IPSS). The economic impact of MF has been studied in individual real-world settings, each of which may have limited generalizability; however, the holistic economic burden of MF is not well understood. The objective of this systematic literature review (SLR) was to describe economic evidence for patients with MF including cost and resource use data. Methods: A SLR was conducted in Embase®, MEDLINE®, the National Health Service Economic Evaluation Database (NHS EED), and the American Economic Association (AEA) EconLit® to identify evidence published from database inception to July 2018. Conference proceedings and bibliographies were also searched. Studies were included if they were published in the English language and reported economic burden associated with adult patients with MF. The evidence was not restricted by any country or time limits. Two reviewers assessed each citation against predefined eligibility criteria, with discrepancies reconciled by a third independent reviewer. All the extracted data were quality checked by a second independent reviewer. A descriptive qualitative analysis was conducted to identify the patterns of economic burden in MF across different countries. Results: A total of 771 potentially relevant abstracts were identified and screened, of which 23 studies were included in the final analysis. Eleven studies reported cost data only, 10 studies reported both cost and resource use data, and 2 studies reported on the budget impact of treatment for MF. Eight of the included studies were conducted in the USA, 2 each in the UK, Canada, and Ireland, and the remaining 9 reported data from other countries. Eight of the included studies reported total MF costs, 4 studies reported productivity losses related to employment, and 3 studies reported indirect costs related to productivity and informal care. The remaining studies reported cost-effectiveness data for the treatment of MF. Of the 5 studies that reported categorical costs, 3 reported that outpatient costs were the major driver of costs, followed by inpatient costs. Among the studies conducted in the USA, total medical healthcare costs associated with MF ranged from USD 21,000 to USD 66,000 per patient. Three European studies reported that the annual productivity losses per patient ranged from EUR 7,774 to EUR 11,000, with total annual productivity losses as high as EUR 217,975. Two US studies compared the total MF-related healthcare costs with age- and sex-matched controls; costs were significantly higher in the MF cohort compared with matched controls (P < 0.05), especially for inpatient costs, outpatient costs, and pharmacy costs (Figure). Four studies, with a majority of the MF patients aged > 50 years, reported that 20-60% of the patients were absent from work, with a mean of 6.2 hours of work missed in the past 7 days. Among the hospitalized patients, 3 studies reported that the median length of stay for patients with MF ranged from 2.5 to 6.6 days, with 46% of patients utilizing emergency room visits and services. Conclusions: MF is associated with significant economic burden and work productivity loss to the health system, patients, and their families. Sustained efforts to develop more effective treatments are required in order to reduce the economic burden associated with MF and help patients and physicians improve disease management. Disclosures Tang: Celgene Corporation: Employment, Equity Ownership. Taneja:BresMed Health Solutions Ltd: Employment. Rajora:BresMed Health Solutions Ltd: Employment. Patel:BresMed: Employment.

RDI as a method for reviewer performance monitoring in BICR setup for improving data quality.

e18082 Background: Double read with adjudication is a preferred independent review model of regulatory authorities for blinded independent central review (BICR) in order to minimize reviewer bias in clinical trials. Adjudication rate (AR) and adjudication agreement rate (AAR) are commonly used indicators for monitoring independent reviewer performance quality. We will present data on Reader Disagreement Index (RDI), an innovative indicator for accurately monitoring reviewer performance and triggering timely intervention when applicable. Methods: A detailed review of BICR adjudication data was performed for 12 oncology clinical trials, with a total of 5,369 subjects (ranging from 119 to 894 per individual study) with 27,056 time points using RECIST, the Lugano classification or iwCLL assessment criteria. RDI for each reviewer was calculated as RDI = (# of cases where adjudicator disagreed with given reviewer ÷ Total # of all cases read) × 100, with high RDI indicating high % disagreement. RDI was used to identify the discordant reader (i.e. reviewer with the highest level of cases disagreed with by the adjudicator) when approximately 10% of the total reads were completed for each study. RDI was also calculated and compared with AR and AAR on an ongoing basis throughout the study. Mean RDI + standard deviation (SD) were used to identify outlier readers. Results: RDI reliably identified the most discordant reader consistently across all 12 studies, while AR & AAR did not. The results confirm the advantage of RDI as a lagging and leading indicator for independent reviewer performance across indications and criteria using double read with adjudication review model. RDI, when calculated as early as at the 10% of total reviewed cases benchmark, demonstrated a positive predictive value of 91% and negative predictive value of 93% (Sensitivity 71%; Specificity 98%). Conclusions: Early identification of an outlier reviewer as per RDI (i.e. after reviews completed for ~ 10% study visits), followed by detailed analysis and corrective measures, such as retraining of the reviewer can serve as timely intervention to improve review quality. Thus, RDI proves to be a better indicator for not just monitoring reviewer performance, but also as an excellent tool for triggering timely corrective intervention. [Table: see text]

Hybrid institutions in the national security constitution: the case of the Commissioners

This paper proposes the concept of a ‘hybrid institution’, defined with reference to certain institutions within the UK's constitutional order which provide oversight of national security processes. It focuses in particular on the Commissioners who have overseen and oversee the use of investigatory powers and the work of the intelligence services. These institutions, as was once said of another hybrid institution – the Independent Reviewer of Terrorism Legislation – are designed in order to operate within situations in which ‘potential conflicts between state power and civil liberties are acute, but information is tightly rationed’. They are ‘hybrid’ institutions in that they marry certain of the features characteristic of political institutions with others characteristic of legal institutions. The paper considers the relevant institutions and the role they play within the national security constitution, showing how their hybrid status facilitates the performance of a function which neither fully legal nor fully political institutions could fulfil.

Ecclesiastical Law

This fourth edition has been revised and updated to take account of significant changes in the substantive law, specifically: the effects of the Ecclesiastical Jurisdiction and Care of Churches Measure 2017; the overhaul of the procedure in the Consistory Court in consequence of the Faculty Jurisdiction Rules 2015; substantial repeals in the Statute Law (Repeals) Measure 2017 and the new procedure under the Legislative Reform Measure 2017; the effect of the House of Bishops' Declaration on the Ministry of Bishops and Priests concerning provision for traditionalists; and the role of the Independent Reviewer under the Priests (Resolution of Disputes Procedure) Regulations 2014. The book offers commentary, analysis, and various materials. Materials include: the Canons of the Church of England, together with the Measures and Rules (updated to 2018) regulating the faculty jurisdiction and clergy discipline.

The 1999 draft Bill: the retreat becomes a rout

This chapter follows the process from January 1998 to the much delayed publication of the draft bill in 1999. The FOI bill ‘swapped’ policy team and, at this point, shifted the source of policy drive. With no internal champions the push came from a combination of the legislature, the media and the government’s own waning sense of duty to its manifesto. The chapter focuses on the growing internal pressure from within the government to change the FOI commitment. Irvine’s combative approach led to short term success but a lack of consensus for moving forward. The proposed policy was threatening to key politicians and officials but also vulnerable due to the flaws within it. As Irvine’s radical plans stalled, senior figures, including the Prime Minister had growing doubts about the policy. Flaws in the White Paper were used to revise and weaken the policy while the fading power of the radical FOI group was reduced by Lord Irvine’s own personal loss of influence. The key moment came in 1998 when FOI was transferred from supporter Irvine to sceptic Jack Straw and the Cabinet Office team broken up. This led to a much more detailed but much weaker draft FOI bill, which inserted a veto power for government and reduced the power of the independent reviewer. The original proposals were modified within the Cabinet committee. Yet the bill survived in part due to the insertion of a ‘five year’ implementation gap and the government’s lukewarm commitment to its reform agenda. However, the bill was not a wholesale watering down, as it added Parliament to the Act’s coverage.

PENELAAHAN BUKU TEKS PELAJARAN KURIKULUM 2013 DITINJAU DARI ASPEK KELAYAKAN ISI, PENYAJIAN, BAHASA, DAN KEGRAFIKAAN

The purpose of this research is to examine the results of the review of the Independent Reviewer Team. The researcher uses a qualitative descriptive method to describe valuations of the reviewer. Furthermore, she reduces the data and sets 18 textbooks for this research data (23,68%). Overall, the aspectsof the feasibility of textbooks in Curriculum 2013 is divided into two categories, namely 'quite decent ' and ' worthy '. However, to make it a textbook in use nationally, aspects of the content, the presentation, the language, and the printing quality of the book have to be repaired, fitted, and maximized again.