The Adherence to an Intraoperative Blood Product Transfusion Algorithm Is Associated With Reduced Blood Product Transfusions in Cardiac Surgical Patients Undergoing Coronary Artery Bypass Grafts and Aortic and/or Valve Replacement Surgery: A Single-Center, Observational Study.

OBJECTIVE: To demonstrate the value of a viscoelastic-based intraoperative transfusion algorithm to reduce non-RBC product administration in adult cardiac surgical patients. DESIGN: A prospective observational study. SETTING: At a quaternary academic teaching hospital. PARTICIPANTS: Cardiac surgical patients. INTERVENTIONS: Viscoelastic-based intraoperative transfusion algorithm. MEASUREMENTS AND MAIN RESULTS: The study authors compared intraoperative blood product transfusion rates in 184 cardiac surgical patients to 236 historic controls after implementing a viscoelastic-based algorithm. The authors found a non-significant reduction in transfusion of 23.8% for fresh frozen plasma (FFP) units (0.84 ± 1.4 v 0.64 ± 1.38; p = ns), 33.4% for platelet units (0.90 ± 1.39 v 0.60 ± 131; p = ns), and 15.8% for cryoprecipitate units (0.19 ± 0.54 v 0.16 ± 0.50; p = ns). They found a 43.9% reduction in red blood cell (RBC) units transfused (1.98 ± 2.24 v 0.55 ± 1.36; p = 0.008). There were no statistically significant differences in time to extubation (8.0 hours (4.0-21.0) v 8.0 (4.0-22.3), reoperation for bleeding (15 [12.3%] v 10 [10.6%]), intensive care unit length of stay (ICU LOS) (51.0 hours [28.0-100.5] v 53.5 [33.3-99.0]) or hospital LOS (9.0 days [6.0-15.0] v 10.0 [7.0-17.0]). Deviation from algorithm adherence was 32.7% (48/147). Packed RBC, FFP, platelets, cryoprecipitate, and cell saver were significantly reduced in the Algorithm Compliant Cohort compared with historic controls, whereas times to extubation, ICU LOS, and hospital LOS did not reach significance. CONCLUSIONS: After the implementation of a viscoelastic-based algorithm, patients received fewer packed RBC, FFP, platelets, cryoprecipitate, and cell saver. Algorithm-compliant patients received fewer transfusions; however, reductions in times to extubation, ICU LOS, and hospital LOS were not statistically significant compared with historic controls.

Open-source Software Sustainability Models: Initial White Paper From the Informatics Technology for Cancer Research Sustainability and Industry Partnership Working Group.

BACKGROUND: The National Cancer Institute Informatics Technology for Cancer Research (ITCR) program provides a series of funding mechanisms to create an ecosystem of open-source software (OSS) that serves the needs of cancer research. As the ITCR ecosystem substantially grows, it faces the challenge of the long-term sustainability of the software being developed by ITCR grantees. To address this challenge, the ITCR sustainability and industry partnership working group (SIP-WG) was convened in 2019. OBJECTIVE: The charter of the SIP-WG is to investigate options to enhance the long-term sustainability of the OSS being developed by ITCR, in part by developing a collection of business model archetypes that can serve as sustainability plans for ITCR OSS development initiatives. The working group assembled models from the ITCR program, from other studies, and from the engagement of its extensive network of relationships with other organizations (eg, Chan Zuckerberg Initiative, Open Source Initiative, and Software Sustainability Institute) in support of this objective. METHODS: This paper reviews the existing sustainability models and describes 10 OSS use cases disseminated by the SIP-WG and others, including 3D Slicer, Bioconductor, Cytoscape, Globus, i2b2 (Informatics for Integrating Biology and the Bedside) and tranSMART, Insight Toolkit, Linux, Observational Health Data Sciences and Informatics tools, R, and REDCap (Research Electronic Data Capture), in 10 sustainability aspects: governance, documentation, code quality, support, ecosystem collaboration, security, legal, finance, marketing, and dependency hygiene. RESULTS: Information available to the public reveals that all 10 OSS have effective governance, comprehensive documentation, high code quality, reliable dependency hygiene, strong user and developer support, and active marketing. These OSS include a variety of licensing models (eg, general public license version 2, general public license version 3, Berkeley Software Distribution, and Apache 3) and financial models (eg, federal research funding, industry and membership support, and commercial support). However, detailed information on ecosystem collaboration and security is not publicly provided by most OSS. CONCLUSIONS: We recommend 6 essential attributes for research software: alignment with unmet scientific needs, a dedicated development team, a vibrant user community, a feasible licensing model, a sustainable financial model, and effective product management. We also stress important actions to be considered in future ITCR activities that involve the discussion of the sustainability and licensing models for ITCR OSS, the establishment of a central library, the allocation of consulting resources to code quality control, ecosystem collaboration, security, and dependency hygiene.

Pasta Drying Defects as a Novel Ingredient for Hard Dough Biscuits: Effect of Drying Temperature and Granulation on Its Functionality.

Various drying temperatures impact the texture of pasta and cause different drying defects. These by-products could reflect techno-functional characteristics which are suitable for cereal products. This research addresses the influence of low (LT) and high (HT) drying pasta defects with two granulations on the theoretical and functional characteristics of hard dough biscuits. By shifting from a LT to HT drying temperature, a higher onset and peak temperature was found due to the higher mobility of starch molecules with increasing crystalline stability. The lowest transition enthalpy of biscuit formulation was also observed for higher incorporation of fine HT pasta regrinds. The algebraic model of dough with consistography determined the poor-extensible gluten and a high resistance with a greater value of P/L and P indices for LT regrinds. Scanning electron microscopy revealed a heavy and dense texture with immersed starch granules for additional fine regrinds while coarse samples caused swell granules with greater diameter. Moreover, fine HT regrinds reflected the lowest L* value for biscuit due to heat gradient tension with the hard milling process which leads to protein denaturation with decreasing nitrogenous.

An evaluation of the use of topical tranexamic acid in total knee arthroplasty.

The purpose of this study was to evaluate the effectiveness of topical tranexamic acid in primary TKA from a clinical and economic standpoint. We retrospectively reviewed 683 primary total knee arthroplasties performed at a single institution over a 2-year period. We compared 373 cases performed in 2010 without tranexamic acid to 310 cases performed in 2011 with tranexamic acid. Demographic data, hemoglobin levels, transfusion rates, hospital length of stay, cost, and perioperative complications during the first 3 months were collected. Statistical analysis was performed using two sample t-tests and Fisher's exact tests. There was no difference in age, sex, height, or pre-operative hemoglobin between the two groups. The tranexamic acid group had significantly higher post-operative hemoglobin (P<0.0001), lower transfusion rate (P<0.0001), decreased length of stay (P<0.0001), decreased blood bank costs (P<0.0001), increased pharmacy cost (P<0.0001), and decreased total direct cost to the hospital (P<0.0001). The average savings was approximately $1500 per patient. There were no differences in thromboembolic events or infection. The use topical tranexamic acid in primary TKA is safe, effective, and results in significant cost savings.

Improving blood product management in placenta accreta patients with severe bleeding: institutional experience.

BACKGROUND: Placenta accrete spectrum (PAS) is a significant risk factor for postpartum hemorrhage and effective blood product management is critical in ensuring patient safety. In PAS patients undergoing cesarean section (CS) blood transfusion management guided by the combined clinical experience of the anesthesiologist and surgeon with point-of-care coagulation testing appears safe and effective. We describe and evaluate our experience and identify potential areas for improvement with blood product management in this patient population. METHODS: A retrospective chart review of peri-operative demographic, anesthetic, and obstetric data was conducted for all patients with PAS undergoing CS between 2012 and 2018 at our center. To facilitate a practical evaluation of blood product management, we divided patients into two groups based on the severity of bleeding. RESULTS: A total of 221 parturients with PAS underwent CS, with 133 in group 1 requiring excessive amounts of transfusion and 88 in group 2 requiring management similar to other uncomplicated CS cases. There were no deaths or instances of disseminated intravascular coagulation, and intensive care unit admission occurred in five cases (2.2%). Patients in group 1 had higher mean nadir values of intra-operative hemoglobin and platelet count. We observed a high rate of missing data for peri-operative measurement of lactate and fibrinogen, PAS grade documentation, and temperature monitoring. CONCLUSION: Given no significant morbidity or mortality, clinical judgment in experienced centers appears safe for the management of PAS patients undergoing CS. The adoption of an institutional protocol and point-of-care coagulation testing could decrease over-transfusion and associated complications.

Software Product System Model: A Customer-Value Oriented, Adaptable, DevOps-Based Product Model.

DevOps pipelines have brought notable advantages, such as fast and frequent software delivery to software production paradigms, but dynamically dealing with quality attributes desired by the customer employing a DevOps pipeline remains a challenge. This work aims to define the design of a systems thinking inspired model, called Software Product System Model (SPSM), applying a customer-value oriented, holistic approach for implementing quality requirements, and its application and evaluation in a large software house. The main features include dynamic control of quality gates, the parameters of which are driven by customer requirements and feedback from surveys. All of the inputs are collected in a product backlog and fed forward to the quality gates over the DevOps pipeline. SPSM was successfully deployed in a large software house extending a DevOps pipeline with an accompanying improvement of customer-value oriented key performance indicators for projects. In a 2-year-long case study, security and code quality were the main quality attributes, with the metrics on security vulnerabilities and unit test coverage. At the end of the 2020, the DevOps pipeline within SPSM provided a 69.50% decrease of security vulnerabilities of all software products, and a 29.43% increase in unit test coverage for the whole code base for increasing code quality. At the end of 2020, the project completion ratio was measured to be 99.50% and the Schedule Performance Index (SPI) was measured to be 99.78% as the average of 762 projects delivered. The flexibility of SPSM allowed the software house to adapt to changing customer expectations. A checklist is provided for the replicability of the model application.

Highly Effective Model for Implementation of In-House Platelets in a Tertiary Veteran Hospital Setting Without a Trauma Center.

BACKGROUND: Platelet products have a limited shelf life and are costly. Therefore, to balance clinical usage/availability and wastage in a tertiary hospital setting without a trauma center, an innovative system model was established. This system reduced wastage by transferring platelet unit approaching their expiration date to a nearby facility (with the same blood supplier and a trauma center) before expiration, when there is no anticipated need for the product at the original location. METHODS: A review of data to determine the degree of platelet wastage and wastage costs one year before implementation of this measure in October 2017 and one year after implementation of this measure. RESULTS: Since the implementation of this measure, no platelet units have expired on the shelf. In contrast, from October 2016 to October 2017, before implementation of platelet transfer, platelet products expired regularly. CONCLUSION: This new system model is highly effective in maintaining platelet inventory without wastage.

Usefulness of perioperative rotational thrombelastometry during scoliosis surgery in children.

OBJECTIVE: Surgical correction of scoliosis in pediatric patients is associated with significant blood loss. Rotational thrombelastometry (ROTEM) might help to decrease the use of blood transfusion products by enabling an early point of care (POC) diagnosis of coagulopathy, thus helping to provide targeted therapy. The aim of this case-control study was to find out whether POC use of ROTEM during scoliosis surgery in children helps to reduce the need for blood transfusion products. METHODS: Data were prospectively analyzed from all patients treated during 2016-2018 who received ROTEM-based therapy during scoliosis surgery. These patients were compared with a group of historical controls treated during 2014-2016 whose scoliosis treatment did not include ROTEM. Perioperative blood loss, consumption of blood transfusion products, and hospital LOS were compared between the groups. RESULTS: A total of 37 patients were analyzed, 22 patients in the non-ROTEM group and 15 patients in the ROTEM group. In the ROTEM group compared with the non-ROTEM group, there was significantly lower perioperative blood loss and administration of packed red blood cell units, no administration of fresh-frozen plasma, and shorter overall hospital LOS (p < 0.05). CONCLUSIONS: ROTEM use during scoliosis surgery in children seems to help to decrease blood loss and the use of blood transfusion products and may also shorten the hospital LOS.Clinical trial registration no.: NCT03699813 (clinicaltrials.gov).

Sustainable applications utilizing sulfur, a by-product from oil and gas industry: A state-of-the-art review.

This paper presents a review of current routes to utilize sulfur and sulfuric acid. Sulfur is a by-product from sour gas and crude oil processing and the precursor of sulfuric acid. As an oversupply is projected for the near-term future, it is prudent to investigate new sulfur applications and market domains that may facilitate a balancing of supply and demand. This consideration is especially relevant for the UAE, and the Middle East in general, due to the requirement to develop sulfur-rich sour gas resources to meet increasing energy needs. The goal of this review is to understand current sulfur oversupply, not as a problem, but as an opportunity to develop more sustainable technologies. Current routes are reviewed, and possible new applications and their potential as a sulfur sink and a sustainable alternative to existing technologies are discussed. Although sulfur is currently in oversupply, less than 5% positive balance according to Harrisson (2016), it must be noted that it is also a critical component in fertilizer production, having a direct impact on the food supply for the world's growing population. Should the world find itself in a sulfur shortage in the future (which could be possible in the long-term (beyond 2030) as a result of growth in renewable energies, shale gas/oil proliferation and population growth), this would be a much greater problem than the current slight oversupply situation, thus making it important to consider sulfur recoverability as a key factor for any sulfur sink technologies explored.

Improving blood product utilization at an ambulatory surgery center: a retrospective cohort study on 50 patients with lumbar disc replacement.

BACKGROUND: There is minimal literature discussing anterior lumbar spine surgery in ambulatory surgery centers (ASCs). The main concern with the anterior approach to the lumbar spine is the potential for injury to great vessels. In our facility, there are two units of crossmatched blood available in addition to cell saver during the procedure. We retrospectively looked at 50 cases of lumbar total disc arthroplasty (TDA) in our ASC to determine utilization of blood products. METHODS: Medical records of 50 consecutive patients who underwent a lumbar TDA at a single ASC were reviewed. Surgeries completed at the ASC were all transferred from the post anesthesia care unit to an attached convalescence care center which allows up to 3 days of observation. Patients who had either a 1 or 2 level lumbar TDA were included in the study. Data consisting of demographics, American Society of Anesthesiologist Physical Status Classification System, length of stay, estimated blood loss, cell saver volume, transfusion, perioperative and postoperative complications were recorded. Preoperative, perioperative and postoperative medical records were reviewed. RESULTS: Medical records of 50 consecutive patients were reviewed. The mean age was 40.86 ± 9.45. Of these, 48 (96%) had a 1-level lumbar TDA, 1(2%) had a 2-level lumbar TDA, 1 (2%) had a lumbar TDA at L4/5 and an anterior lumbar interbody fusion at L5/S1. There were no mortalities; no patient had recorded perioperative complications. No patients received allogeneic blood transfusion, 4 (8%) were re-transfused with cell saver (2 receiving approximately 400 ml and 2 receiving approximately 200 ml of re-transfused blood). All 50 (100%) were discharged home in stable condition. We had 30-day follow-up data on 35 of 50 patients. Of the 35 patients reviewed, three (8.5%) of the patients were readmitted to the hospital. One additional patient was seen in the emergency department and discharged home after negative testing. No patient was readmitted for post-operative anemia. CONCLUSION: The routine use of both cell saver and crossmatched blood in the operating suite for lumbar TDA may be an over-utilization of healthcare resources. In our review of 50 patients, we had no need for transfusion of allogeneic packed red blood cells (PRBCs) and only four of the 50 patients had enough blood output for re-transfusion from the cell saver. This opens the conversation for alternatives to crossmatched PRBCs being held in the operating room. Such alternatives may be the use of cell salvage, only type O blood in a cooler for each patient or keeping type O blood on constant hold in ASCs.

Utility of intraoperative rotational thromboelastometry in thoracolumbar deformity surgery.

OBJECTIVE Blood loss during surgery for thoracolumbar scoliosis often requires blood product transfusion. Rotational thromboelastometry (ROTEM) has enabled the more targeted treatment of coagulopathy, but its use in deformity surgery has received limited study. The authors investigated whether the use of ROTEM reduces transfusion requirements in this case-control study of thoracolumbar deformity surgery. METHODS Data were prospectively collected on all patients who received ROTEM-guided blood product management during long-segment (≥ 7 levels) posterior thoracolumbar fusion procedures at a single institution from April 2015 to February 2016. Patients were matched with a group of historical controls who did not receive ROTEM-guided therapy according to age, fusion segments, number of osteotomies, and number of interbody fusion levels. Demographic, intraoperative, and postoperative transfusion requirements were collected on all patients. Univariate analysis of ROTEM status and multiple linear regression analysis of the factors associated with total in-hospital transfusion volume were performed, with p < 0.05 considered to indicate statistical significance. RESULTS Fifteen patients who received ROTEM-guided therapy were identified and matched with 15 non-ROTEM controls. The mean number of fusion levels was 11 among all patients, with no significant differences between groups in terms of fusion levels, osteotomy levels, interbody fusion levels, or other demographic factors. Patients in the non-ROTEM group required significantly more total blood products during their hospitalization than patients in the ROTEM group (8.5 ± 4.2 units vs 3.71 ± 2.8 units; p = 0.001). Multiple linear regression analysis showed that the use of ROTEM (p = 0.016) and a lower number of fused levels (p = 0.022) were associated with lower in-hospital transfusion volumes. CONCLUSIONS ROTEM use during thoracolumbar deformity correction is associated with lower transfusion requirements. Further investigation will better define the role of ROTEM in transfusion during deformity surgery.

Decision-making in product portfolios of pharmaceutical research and development--managing streams of innovation in highly regulated markets.

Decision-making is a core function of any drug development firm. Developing drugs demands a firm to be highly innovative, while at the same time the activity is strictly regulated. Successful drug development offers the right to apply for a long-term patent that confers exclusive marketing rights. This article addresses the issue of what constitutes an adequate portfolio of drugs for a drug development firm and how it might be managed successfully. The paper investigates decision-making in the industry and specifically in the development of oncology drugs from various perspectives: the need for decisions, their timing, decision-making at the project level, the optimal portfolio, tools for portfolio analysis, the evaluation of patents, and finally the importance of the drug portfolio. Drug development decisions as important organizational elements should get more emphasis, and decisions in drug portfolio using modern decision-making methods should be used more widely than what currently happens. Structured, informed decisions would help avoiding late terminations of drugs in Phase III development. An improved research and development pipeline and drug portfolio management are the major elements in the general strategy targeting success.