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Pediatric Surgery International Jun 2022We aimed to evaluate a complicated appendicitis clinical practice guideline at our institution.
PURPOSE
We aimed to evaluate a complicated appendicitis clinical practice guideline at our institution.
METHODS
Records were compared before and after protocol implementation. We standardized an ED consult pathway, antibiotic use and need for early appendectomy (EA) versus interval appendectomy (IA). We evaluated demographics, clinical characteristics, and outcomes. Subgroup analysis was performed to compare patients with small abscess treated with IA pre-protocol versus similar patients treated by EA post-protocol.
RESULTS
In total 246 patients were reviewed (Pre-protocol = 152, Post-protocol = 94). Pre-protocol early appendectomy rate was 51% versus 82% on post-protocol patients. There were no differences in demographics. Post-protocol the use of preoperative imaging significantly decreased (Pre 92% vs. 56%, p = 0.0001), as well as the use of discharge antibiotics (Pre 93% vs. Post 27%, p = 0.0001) with no change in abscess rate. Overall, post-protocol patients had fewer total CT scans performed (Pre 40% vs. Post 28%, p = 0.03) and decreased total length of stay (Pre 7.7 vs. Post 6.5 days, p = 0.049). On subgroup analysis, post-protocol EA with no or small abscess had lower median number of admissions, decreased total LOS (Pre IA 9 days vs. Post EA 5 days, p = 0.00001) and fewer complications (Pre IA 42% vs. EA 22%, p = 0.022).
CONCLUSION
The establishment of a standardized pediatric complicated appendicitis protocol may lead to improved outcomes and resource utilization. Patients presenting with no or small abscess may be the least likely to benefit from interval appendectomy.
LEVEL OF EVIDENCE
Level III.
Topics: Abscess; Anti-Bacterial Agents; Appendectomy; Appendicitis; Child; Humans; Length of Stay; Retrospective Studies
PubMed: 35396951
DOI: 10.1007/s00383-022-05124-z -
Echo Research and Practice Aug 2022The present CEUS Cardiac Exam Protocols represent the first effort to promulgate a standard set of protocols for optimal administration of ultrasound enhancing agents... (Review)
Review
The present CEUS Cardiac Exam Protocols represent the first effort to promulgate a standard set of protocols for optimal administration of ultrasound enhancing agents (UEAs) in echocardiography, based on more than two decades of experience in the use of UEAs for cardiac imaging. The protocols reflect current clinical CEUS practice in many modern echocardiography laboratories throughout the world. Specific attention is given to preparation and dosing of three UEAs that have been approved by the United States Food and Drug Administration (FDA) and additional regulatory bodies in Europe, the Americas and Asia-Pacific. Consistent with professional society guidelines (J Am Soc Echocardiogr 31:241-274, 2018; J Am Soc Echocardiogr 27:797-810, 2014; Eur Heart J Cardiovasc Imaging 18:1205, 2017), these protocols cover unapproved "off-label" uses of UEAs-including stress echocardiography and myocardial perfusion imaging-in addition to approved uses. Accordingly, these protocols may differ from information provided in product labels, which are generally based on studies performed prior to product approval and may not always reflect state of the art clinical practice or guidelines.
PubMed: 35996167
DOI: 10.1186/s44156-022-00008-3 -
Physics in Medicine and Biology Jun 2023To characterize for the first timea novel bismuth-based nanoparticular contrast agent developed for preclinical applications. Then, to design and testa multi-contrast...
To characterize for the first timea novel bismuth-based nanoparticular contrast agent developed for preclinical applications. Then, to design and testa multi-contrast protocol for functional cardiac imaging using the new bismuth nanoparticles and a well-established iodine-based contrast agent.A micro-computed tomography scanner was assembled and equipped with a photon-counting detector. Five mice were administered with the bismuth-based contrast agent and systematically scanned over 5 h to quantify the contrast enhancement in relevant organs of interest. Subsequently, the multi-contrast agent protocol was tested on three mice. Material decomposition was performed on the acquired spectral data to quantify the concentration of bismuth and iodine in multiple structures, e.g. the myocardium and vasculature.In the vasculature, the bismuth agent provides a peak enhancement of 1100 HU and a half-life of about 260 min. After the injection, it accumulates in the liver, spleen and intestinal wall reaching a CT value of 440 HU about 5 h post injection. Phantom measurements showed that the bismuth provides more contrast enhancement than iodine for a variety of tube voltages. The multi-contrast protocol for cardiac imaging successfully allowed the simultaneous decomposition of the vasculature, the brown adipose tissue and the myocardium.The new bismuth-based contrast agent was proven to have a long circulation time suitable for preclinical applications and to provide more contrast than iodine agents. The proposed multi-contrast protocol resulted in a new tool for cardiac functional imaging. Furthermore, thanks to the contrast enhancement provided in the intestinal wall, the novel contrast agent may be used to develop further multi contrast agent protocols for abdominal and oncological imaging.
Topics: Mice; Animals; X-Ray Microtomography; Iodine; Contrast Media; Bismuth; Abdomen; Phantoms, Imaging; Photons
PubMed: 37267991
DOI: 10.1088/1361-6560/acdb42 -
Contemporary Clinical Trials Aug 2023Oxaliplatin is a key chemotherapeutic agent in the treatment of local and metastatic gastrointestinal (GI) malignancies. Dose density and treatment adherence can be...
Use of acupuncture with acupressure in addition to standard-of-care cryotherapy to decrease chemotherapy-associated neuropathy in patients with gastrointestinal malignancies receiving oxaliplatin-based chemotherapy: Study protocol for a randomized, controlled pilot and feasibility study.
BACKGROUND
Oxaliplatin is a key chemotherapeutic agent in the treatment of local and metastatic gastrointestinal (GI) malignancies. Dose density and treatment adherence can be limited by chemotherapy-induced peripheral neuropathy (CIPN). Early research suggests CIPN incidence and severity may be mitigated by acupuncture, but rigorous data in GI oncology patients is limited. Here, we describe the protocol of a randomized, waitlist-controlled pilot study testing the use of preemptive of acupuncture plus acupressure to decrease CIPN and chemotherapy-related toxicities.
METHODS
Patients with a GI malignancy (n = 56) with planned 5-fluorouracil (5-FU) and oxaliplatin IV (FOLFOX, FOLFIRINOX) every 2 weeks are being recruited. Additional concurrent anti-neoplastic agents may be used. Enrolled patients are randomized 1:1 to a 3-month intervention of Arm A: acupuncture with acupressure and standard-of-care treatment, or Arm B: standard-of-care alone. In Arm A, on days 1 and 3 of each chemotherapy cycle a standardized acupuncture protocol is administered and patients are taught self-acupressure to perform daily between chemotherapy treatments. Patients in both arms are given standard-of-care oral and peripheral (hands/feet) ice chip cryotherapy during oxaliplatin administration. CIPN and other symptoms are assessed at baseline, 6 weeks, and 3 months from registration. The primary endpoint is CIPN severity at 3 months (EORTC-CIPN 20). Additional endpoints evaluate CIPN incidence (CTCAE, Neuropen, tuning fork); incidence of pain, fatigue, nausea, oral dysesthesia, and anxiety; and feasibility (recruitment, retention, adherence, acceptability). If warranted, trial results will inform the design of a multi-center trial to expand testing of the intervention to a larger patient cohort.
Topics: Humans; Oxaliplatin; Antineoplastic Combined Chemotherapy Protocols; Feasibility Studies; Acupressure; Pancreatic Neoplasms; Antineoplastic Agents; Peripheral Nervous System Diseases; Acupuncture Therapy; Gastrointestinal Neoplasms; Cryotherapy; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
PubMed: 37380021
DOI: 10.1016/j.cct.2023.107273 -
Pharmacy (Basel, Switzerland) Aug 2019Antimicrobial desensitization represents a last-line option for patients with no alternative therapies, where the benefits of this intensive process must outweigh the... (Review)
Review
Antimicrobial desensitization represents a last-line option for patients with no alternative therapies, where the benefits of this intensive process must outweigh the potential harm from drug exposure. The goal of antimicrobial desensitization procedures is to establish a temporary state of tolerance to drugs that may otherwise cause hypersensitivity reactions. While no universal antimicrobial desensitization protocols exist, this review critically analyzes previously published desensitization protocols. The purpose of this review is to provide a greater insight for clinicians and institutions to ensure desensitization procedures are efficacious while minimizing potential for patient harm. With an increasing rate of antimicrobial resistance and the critical need to preserve antimicrobial agents, desensitization may represent another option in our antimicrobial stewardship toolkit.
PubMed: 31405062
DOI: 10.3390/pharmacy7030112 -
Autonomous Agents and Multi-agent... 2021We propose a formalism to model and reason about reconfigurable multi-agent systems. In our formalism, agents interact and communicate in different modes so that they...
We propose a formalism to model and reason about reconfigurable multi-agent systems. In our formalism, agents interact and communicate in different modes so that they can pursue joint tasks; agents may dynamically synchronize, exchange data, adapt their behaviour, and reconfigure their communication interfaces. Inspired by existing multi-robot systems, we represent a system as a set of agents (each with local state), executing independently and only influence each other by means of message exchange. Agents are able to sense their local states and partially their surroundings. We extend ltl to be able to reason explicitly about the intentions of agents in the interaction and their communication protocols. We also study the complexity of satisfiability and model-checking of this extension.
PubMed: 34776761
DOI: 10.1007/s10458-021-09521-x -
International Journal of Molecular... Nov 2021Corneal cryopreservation can partially solve the worldwide concern regarding donor cornea shortage for keratoplasties. In this study, human corneas were cryopreserved...
Corneal cryopreservation can partially solve the worldwide concern regarding donor cornea shortage for keratoplasties. In this study, human corneas were cryopreserved using two standard cryopreservation protocols that are employed in the Tissue Bank of the Teresa Herrera Hospital (Spain) to store corneas for tectonic keratoplasties (TK protocol) and aortic valves (AV protocol), and two vitrification protocols, VS55 and DP6. Endothelial viability and general corneal state were evaluated to determine the protocol that provides the best results. The potential corneal cryopreservation protocol was studied in detail taking into consideration some cryopreservation-related variables and the endothelial integrity and stroma arrangement of the resulting cryopreserved corneas. TK corneas showed mostly viable endothelial cells, while the others showed few (AV) or none (DP6 and VS55). The corneal structure was well maintained in TK and AV corneas. TK corneas showed endothelial acellular areas surrounded by injured cells and a normal-like stromal fiber arrangement. Cryoprotectant solutions of the TK protocol presented an increasing osmolality and a physiological pH value. Cooling temperature rate of TK protocol was of 1 °C/min to -40 °C and 3 °C/min to -120 °C, and almost all of dimethyl sulfoxide left the tissue after washing. Future studies should be done changing cryopreservation-related variables of the TK protocol to store corneas of optical grade.
Topics: Cold Temperature; Cornea; Corneal Transplantation; Cryopreservation; Dimethyl Sulfoxide; Endothelium, Corneal; Humans; Microscopy, Electron, Scanning; Spain; Tissue Banks
PubMed: 34830446
DOI: 10.3390/ijms222212564 -
EFSA Journal. European Food Safety... Oct 2023EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA...
EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the 'Draft framework for protocol development for EFSA's scientific assessments' published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub-questions is proposed: the 'APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross-cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub-questions, including uncertainty analysis. Five possible approaches to answering individual (sub-)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi-formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and - not covered in this guidance - generating empirical evidence . The guidance is complemented by a standalone 'template' for EFSA protocols that guides the users step by step through the process of planning an EFSA scientific assessment.
PubMed: 37908452
DOI: 10.2903/j.efsa.2023.8312 -
Breast (Edinburgh, Scotland) Jun 2022The introduction of human epidermal growth factor receptor 2 (HER2) directed therapy has transformed the outcomes of patients with advanced breast cancer (BC). However,... (Review)
Review
IMPORTANCE
The introduction of human epidermal growth factor receptor 2 (HER2) directed therapy has transformed the outcomes of patients with advanced breast cancer (BC). However, HER2 positive breast cancer has a predilection for the central nervous system (CNS) which is associated with significant morbidity and mortality. Understanding the intracranial activity of novel HER2 directed agents is key to developing treatments as well as possible preventative strategies for HER2-positive CNS disease.
OBSERVATIONS
Using protocols and data from published phase III clinical trials for locally advanced/metastatic HER2-positive breast cancer since the licensing of single agent trastuzumab for advanced BC we review the central nervous system related aspects. This includes CNS related entry criteria, use of baseline and on study cross-sectional imaging of the CNS and protocol and non-protocol defined CNS end points and reported data.
CONCLUSIONS
and Relevance: This review found heterogeneity between studies with regard to the entry criteria, use of CNS imaging and reported end points within the pivotal phase III studies. Based on these data, a standardisation of both entry criteria and end points with regard to the CNS should be developed and applied to future studies of HER2-positive advanced BC. Such an approach would enable the generation of comparable data and allow a meaningful analysis of different treatment approaches with regard to the CNS. This in turn would allow the development of the most optimal treatment approaches for HER2 positive CNS disease and ultimately the development of preventative strategies.
Topics: Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Central Nervous System Diseases; Clinical Trials, Phase III as Topic; Female; Humans; Receptor, ErbB-2; Trastuzumab
PubMed: 35344688
DOI: 10.1016/j.breast.2022.03.013 -
Journal of Pharmacy Practice Dec 2022The dramatic increase in the acquisition cost of injectable calcitonin led to creating a pharmacy-driven calcitonin protocol to improve the appropriate use of calcitonin...
BACKGROUND
The dramatic increase in the acquisition cost of injectable calcitonin led to creating a pharmacy-driven calcitonin protocol to improve the appropriate use of calcitonin and other treatment modalities for hypercalcemia.
OBJECTIVE
This study aimed to characterize the use of calcitonin before and after implementation of a pharmacy-driven calcitonin protocol.
METHODS
This was a multi-center, retrospective study of the use of injectable calcitonin in adult hospitalized patients with hypercalcemia. The study included patients treated with calcitonin from October 2014 to September 2016 and from October 2017 to September 2019. The primary outcomes were percentage of patients with a complete response, partial response, and non-responders. The secondary outcomes were time to relapse, duration of partial response, number of doses, and associated costs of calcitonin.
RESULTS
Of the 131 patients included in this study, 93 were included in a pre-protocol group and 38 were included in a post-protocol group. The primary outcome of complete response by 3 days was met in 28% of patients in the pre-protocol group and 53% of patients in the post-protocol group ( = 0.007). Calcitonin spending in dollars in the pre-protocol group was $818,956 compared to $224,320 in the post-protocol group; a difference of $594,636.
CONCLUSION
Implementation of a pharmacy-driven calcitonin protocol effectively improved calcium levels, reduced inappropriate calcitonin use, and reduced calcitonin spending during a period of 2 fiscal years.
Topics: Adult; Humans; Calcitonin; Calcium; Calcium-Regulating Hormones and Agents; Hypercalcemia; Pharmacy; Retrospective Studies; Clinical Protocols
PubMed: 33955282
DOI: 10.1177/08971900211013187