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Serum tryptase is a biomarker used to aid in the identification of certain myeloid neoplasms, most notably systemic mastocytosis, where basal serum tryptase (BST) levels >20 ng/mL are a minor criterion for diagnosis. Although clonal myeloid neoplasms are rare, the common cause for elevated BST levels is the genetic trait hereditary α-tryptasemia (HαT) caused by increased germline TPSAB1 copy number. To date, the precise structural variation and mechanism(s) underlying elevated BST in HαT and the general clinical utility of tryptase genotyping, remain undefined. Through cloning, long-read sequencing, and assembling of the human tryptase locus from an individual with HαT, and validating our findings in vitro and in silico, we demonstrate that BST elevations arise from overexpression of replicated TPSAB1 loci encoding canonical α-tryptase protein owing to coinheritance of a linked overactive promoter element. Modeling BST levels based on TPSAB1 replication number, we generate new individualized clinical reference values for the upper limit of normal. Using this personalized laboratory medicine approach, we demonstrate the clinical utility of tryptase genotyping, finding that in the absence of HαT, BST levels >11.4 ng/mL frequently identify indolent clonal mast cell disease. Moreover, substantial BST elevations (eg, >100 ng/mL), which would ordinarily prompt bone marrow biopsy, can result from TPSAB1 replications alone and thus be within normal limits for certain individuals with HαT.
Several commonly used procedures for knee osteoarthritis (OA) are not supported by evidence-based guidelines. The objective of this study was to identify the proportion of patients who underwent knee arthroscopy or magnetic resonance imaging (MRI) and the timing of these procedures before total knee arthroplasty (TKA).
Background and Objectives: Magnetic resonance imaging (MRI) and the Prostate Imaging-Reporting and Data System (PI-RADS) have become essential tools for prostate cancer evaluation. We evaluated the ability of PI-RADS scores in identifying significant prostate cancer, which would help avoid unnecessary prostate biopsies. Materials and Methods: Patients with prostate-specific antigen (PSA) levels ≤ 20 ng/mL, who underwent prostate MRI for evaluation from January 2018 to November 2019, were analyzed. Among them, 105 patients who received transrectal ultrasonography (TRUS)-guided biopsy were included. PSA, PI-RADS scores (low 1-2, high 3-5), biopsy results, and Gleason scores (GS) were evaluated. Biopsies with GS higher than 3 + 4 were considered as significant cancers and biopsies with no cancer or Gleason 3 + 3 were considered insignificant or no cancers. Results: Among the 105 patients, 45 patients had low PI-RADS and 60 had high PI-RADS scores. There were no patients with significant prostate cancer in the low PI-RADS groups. For the high PI-RADS group, 28 (46.7%) patients had significant cancer and 32 (53.3%) had insignificant or no cancer. The sensitivity and specificity of high PI-RADS to detect significant cancer was 100% and 58.4%, respectively. Positive predictive value was 46.7% and negative predictive value was 100%. Conclusions: Low PI-RADS scores on MRI did not show significant prostate cancer and surveillance should be considered in selected cases to prevent unnecessary invasive procedures and overdiagnosis.
The proper clinical evaluation of pituitary and adrenal disorders depends on the accurate measurement of plasma ACTH. The modern two-site sandwich ACTH immunoassay is a great improvement compared with older methods but still has the potential for interferences such as heterophile antibodies and pro-opiomelanocortin (POMC) and ACTH fragments. We report the cases of five patients in whom the diagnosis or differential diagnosis of Cushing syndrome was confounded by erroneously elevated results from the Siemens ACTH Immulite assay [ACTH(Immulite)] that were resolved using the Roche Cobas or Tosoh AIA [ACTH(Cobas) and ACTH(AIA), respectively]. In one case, falsely elevated ACTH(Immulite) results owing to interfering antibodies resulted in several invasive differential diagnostic procedures (including inferior petrosal sinus sampling), MRI, and unnecessary pituitary surgery. ACTH(Cobas) measurements were normal, and further studies excluded the diagnosis of Cushing syndrome. In three cases, either Cushing disease or occult ectopic ACTH were suspected owing to elevated ACTH(Immulite) results. However, adrenal (ACTH-independent) Cushing syndrome was established using ACTH(AIA) or ACTH(Cobas) and proved surgically. In one case, ectopic ACTH was suspected owing to elevated ACTH(Immulite) results; however, the ACTH(Cobas) findings led to the diagnosis of alcohol-induced hypercortisolism that resolved with abstinence. We have concluded that ACTH(Immulite) results can be falsely increased and alternate ACTH assays should be used in the diagnosis or differential diagnosis of clinical disorders of the hypothalamic-pituitary-adrenal axis.
In patients undergoing colonoscopy procedures (CPs), inadequate dosing of hypnotic drugs (HD) and opioid analgesics (OA) during intravenous sedoanalgesia (ISA) may lead to intraprocedural awareness with recall (IAwR), intraprocedural (IPP) and postprocedural pain (PPP), as well as postoperative nausea and vomiting (PONV). The aim of this study was to evaluate whether the titration of HD and OA based on the observance of changing values of state entropy (SE) and surgical pleth index (SPI) (adequacy of anesthesia-AoA), state entropy alone, or standard practice may reduce the number of adverse events. One hundred and fifty-eight patients were included in the final analysis. The rate of IAwR and IPP was statistically more frequent in patients from the C group in comparison with the AoA and SE groups (p < 0.01 and p < 0.05, respectively). In turn, the rate of PPP, PONV, and patients' and operators' satisfaction with ISA between groups was not statistically significant (p > 0.05). Changes in hemodynamic parameters, demand for HD, and OA were statistically significant, but of no clinical value. In patients undergoing CPs under ISA using propofol and FNT, as compared to standard practice, intraprocedural SE monitoring reduced the rate of IAwR and IPP, with no influence on the rate of PPP, PONV, or patients' and endoscopists' satisfaction. AoA guidance on propofol and FNT titration, as compared to SE monitoring only, did not reduce the occurrence of the aforementioned studied parameters, imposing an unnecessary extra cost.
Prostate cancer (PCa) is one of the most common cancers among men globally. The authors aimed to evaluate the ability of the Prostate Imaging Reporting and Data System version 2 (PI-RADS v2) to classify men with PCa, clinically significant PCa (CSPCa), or no PCa, especially among those with serum total prostate-specific antigen (tPSA) levels in the "gray zone" (4-10 ng ml-1). A total of 308 patients (355 lesions) were enrolled in this study. Diagnostic efficiency was determined. Univariate and multivariate analyses, receiver operating characteristic curve analysis, and decision curve analysis were performed to determine and compare the predictors of PCa and CSPCa. The results suggested that PI-RADS v2, tPSA, and prostate-specific antigen density (PSAD) were independent predictors of PCa and CSPCa. A PI-RADS v2 score ≥4 provided high negative predictive values (91.39% for PCa and 95.69% for CSPCa). A model of PI-RADS combined with PSA and PSAD helped to define a high-risk group (PI-RADS score = 5 and PSAD ≥0.15 ng ml-1 cm-3, with tPSA in the gray zone, or PI-RADS score ≥4 with high tPSA level) with a detection rate of 96.1% for PCa and 93.0% for CSPCa while a low-risk group with a detection rate of 6.1% for PCa and 2.2% for CSPCa. It was concluded that the PI-RADS v2 could be used as a reliable and independent predictor of PCa and CSPCa. The combination of PI-RADS v2 score with PSA and PSAD could be helpful in the prediction and diagnosis of PCa and CSPCa and, thus, may help in preventing unnecessary invasive procedures.
Ion mobility (IM) is a method that measures the time taken for an ion to travel through a pressurized cell under the influence of a weak electric field. The speed by which the ions traverse the drift region depends on their size: large ions will experience a greater number of collisions with the background inert gas (usually N(2;)) and thus travel more slowly through the IM device than those ions that comprise a smaller cross-section. In general, the time it takes for the ions to migrate though the dense gas phase separates them, according to their collision cross-section (Omega). Recently, IM spectrometry was coupled with mass spectrometry and a traveling-wave (T-wave) Synapt ion mobility mass spectrometer (IM-MS) was released. Integrating mass spectrometry with ion mobility enables an extra dimension of sample separation and definition, yielding a three-dimensional spectrum (mass to charge, intensity, and drift time). This separation technique allows the spectral overlap to decrease, and enables resolution of heterogeneous complexes with very similar mass, or mass-to-charge ratios, but different drift times. Moreover, the drift time measurements provide an important layer of structural information, as Omega is related to the overall shape and topology of the ion. The correlation between the measured drift time values and Omega is calculated using a calibration curve generated from calibrant proteins with defined cross-sections(1). The power of the IM-MS approach lies in its ability to define the subunit packing and overall shape of protein assemblies at micromolar concentrations, and near-physiological conditions(1). Several recent IM studies of both individual proteins(2,3) and non-covalent protein complexes(4-9), successfully demonstrated that protein quaternary structure is maintained in the gas phase, and highlighted the potential of this approach in the study of protein assemblies of unknown geometry. Here, we provide a detailed description of IMS-MS analysis of protein complexes using the Synapt (Quadrupole-Ion Mobility-Time-of-Flight) HDMS instrument (Waters Ltd; the only commercial IM-MS instrument currently available)(10). We describe the basic optimization steps, the calibration of collision cross-sections, and methods for data processing and interpretation. The final step of the protocol discusses methods for calculating theoretical Omega values. Overall, the protocol does not attempt to cover every aspect of IM-MS characterization of protein assemblies; rather, its goal is to introduce the practical aspects of the method to new researchers in the field.
Background and Objectives: This project was developed from anecdotal evidence of varied practices around antibiotic prescribing in dental procedures. The aim of the study was to ascertain if there is evidence to support whether antibiotic (AB) use can effectively reduce postoperative infections after dental implant placements (DIPs). Materials and Methods: Following PRISMA-P© methodology, a systematic review of randomised controlled clinical trials was designed and registered on the PROSPERO© database. Searches were performed using PubMed®, Science Direct® and the Cochrane© Database, plus the bibliographies of studies identified. The efficacy of prophylactic antibiotics, independent of the regimen used, versus a placebo, control or no therapy based on implant failure due to infection was the primary measured outcome. Secondary outcomes were other post-surgical complications due to infection and AB adverse events. Results: Twelve RCTs were identified and analysed. Antibiotic use was reported to be statistically significant in preventing infection (p < 001). The prevention of complications was not statistically significant (p = 0.96), and the NNT was >5 (14 and 2523 respectively), which indicates that the intervention was not sufficiently effective to justify its use. The occurrence of side effects was not statistically significant (p = 0.63). NNH was 528 indicating that possible harm caused by the use of ABs is very small and does not negate the AB use when indicated. Conclusion: The routine use of prophylactic antibiotics to prevent infection in dental implant placement was found to be not sufficiently effective to justify routine use. Clear clinical assessment pathways, such as those used for medical conditions, based on the patients' age, dental risk factors, such as oral health and bone health, physical risk factors, such as chronic or long-term conditions and modifiable health determinants, such as smoking, are required to prevent the unnecessary use of antibiotics.
Improvements in software for image analysis have enabled advances in both medical and engineering industries, including the use of medical analysis tools to recreate internal parts of the human body accurately. A research analysis found that FDM-sourced elements have shown viability for a customized and reliable approach in the orthopedics field. Three-dimensional printing has allowed enhanced accuracy of preoperative planning, leading to reduced surgery times, fewer unnecessary tissue perforations, and fewer healing complications. Furthermore, using custom tools chosen for each procedure has shown the best results. Bone correction-related surgeries require customized cutting guides for a greater outcome. This study aims to assess the biopolymer-based tools for surgical operations and their ability to sustain a regular heat-sterilization cycle without compromising the geometry and fit characteristics for a proper procedure. To achieve this, a DICOM and FDM methodology is proposed for fast prototyping of the cutting guide by means of 3D engineering. A sterilization test was performed on HTPLA, PLA, and nylon polymers. As a result, the unique characteristics within the regular autoclave sterilization process allowed regular supplied PLA to show there were no significant deformations, whilst annealed HTPLA proved this material's capability of sustaining repeated heat cycles due to its crystallization properties. Both of these proved that the sterilization procedures do not compromise the reliability of the part, nor the safety of the procedure. Therefore, prototypes made with a similar process as this proposal could be safely used in actual surgery practices, while nylon performed poorly because of its hygroscopic properties.
Methylotrophs are organisms that are able to grow on C1 compounds as carbon and energy sources. They play important roles in the global carbon cycle and contribute largely to industrial wastewater treatment. To identify and characterize methylotrophs that are involved in methanol degradation in wastewater-treatment plants, methanol-fed activated-sludge (MAS) microbiomes were subjected to phylogenetic and metagenomic analyses, and genomic features of dominant methylotrophs in MAS were compared with those preferentially grown in laboratory enrichment cultures (LECs). These analyses consistently indicate that Hyphomicrobium plays important roles in MAS, while Methylophilus occurred predominantly in LECs. Comparative analyses of bin genomes reconstructed for the Hyphomicrobium and Methylophilus methylotrophs suggest that they have different C1-assimilation pathways. In addition, function-module analyses suggest that their cell-surface structures are different. Comparison of the MAS bin genome with genomes of closely related Hyphomicrobium isolates suggests that genes unnecessary in MAS (for instance, genes for anaerobic respiration) have been lost from the genome of the dominant methylotroph. We suggest that genomic features and coded functions in the MAS bin genome provide us with insights into how this methylotroph adapts to activated-sludge ecosystems.
Background and purpose - To minimize the risk of hematogenous periprosthetic joint infection (HPJI), international and Dutch guidelines recommended antibiotic prophylaxis prior to dental procedures. Unclear definitions and contradictory recommendations in these guidelines have led to unnecessary antibiotic prescriptions. To formulate new guidelines, a joint committee of the Dutch Orthopaedic and Dental Societies conducted a systematic literature review to answer the following question: can antibiotic prophylaxis be recommended for patients (with joint prostheses) undergoing dental procedures in order to prevent dental HPJI? Methods - The Medline, Embase, and Cochrane databases were searched for randomized controlled trials (RCTs), reviews, and observational studies up to July 2015. Studies were included if they involved patients with joint implants undergoing dental procedures, and either considered HPJI as an outcome measure or described a correlation between HPJI and prophylactic antibiotics. A guideline was formulated using the GRADE method and AGREE II guidelines. Results - 9 studies were included in this systematic review. All were rated "very low quality of evidence". Additional literature was therefore consulted to address clinical questions that provide further insight into pathophysiology and risk factors. The 9 studies did not provide evidence that use of antibiotic prophylaxis reduces the incidence of dental HPJI, and the additional literature supported the conclusion that antibiotic prophylaxis should be discouraged in dental procedures. Interpretation - Prophylactic antibiotics in order to prevent dental HPJI should not be prescribed to patients with a normal or an impaired immune system function. Patients are recommended to maintain good oral hygiene and visit the dentist regularly.
Surgical innovation has generally occurred in an unstandardised manner. This has led to unnecessary exposure of patients to harm, research waste and inadequate evidence. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) Collaboration provided a set of recommendations for evaluating surgical innovations based on their stage of innovation. Despite further refinements and guidance, adoption of the IDEAL recommendations has been slow; an important reason may be that determining the stage of innovation is often difficult. To facilitate evaluation of surgical innovations, there is a need for a detailed insight into what stage of innovation means, and how it can be determined. The aim of this study is to understand the concept of stage of innovation as reported in the literature.
End-of-life care and protection of the patient in the near-death moments are part of a patient's rights and the duties of the medical staff. As the beginning and end of human life are most sensitive moments, there are various religious rules associated with them. The ethical issues regarding practicing medical procedures on nearly dead patients are of particular complexity and are consistent with invaluable and profoundly religious recommendations. In addition, the purpose of medical training is to provide physicians with the knowledge and skills necessary to practice appropriately and within legal and ethical frameworks. Therefore, respecting patients' cultural and religious beliefs is an ethically accepted principle in the health systems of different countries and is the basis of respect for human dignity. The present study used a qualitative content analysis to explain how to practice medical procedures on a dying or nearly dead patient in accordance with Islamic jurisprudential rules. It was finally concluded that according to the Islamic jurisprudential rules of "authority", "no harm", "necessity", and "public interest", procedures performed on a dying patient could be used for training purposes under certain circumstances. Nevertheless, such activities should only be done with the patient's permission and provided they cause no unnecessary harassment, and they may take place in the absence of alternative methods.
A blood-based integrated classifier (IC) has been clinically validated to improve accuracy in assessing probability of cancer risk (pCA) for pulmonary nodules (PN). This study evaluated the clinical utility of this biomarker for its ability to reduce invasive procedures in patients with pre-test pCA ≤ 50%. This was a propensity score matching (PSM) cohort study comparing patients in the ORACLE prospective, multicenter, observational registry to control patients treated with usual care. This study enrolled patients meeting the intended use criteria for IC testing: pCA ≤ 50%, age ≥40 years, nodule diameter 8-30 mm, and no history of lung cancer and/or active cancer (except for non-melanomatous skin cancer) within 5 years. The primary aim of this study was to evaluate invasive procedure use on benign PNs of registry patients as compared to control patients. A total of 280 IC tested, and 278 control patients met eligibility and analysis criteria and 197 were in each group after PSM (IC and control groups). Patients in the IC group were 74% less likely to undergo an invasive procedure as compared to the control group (absolute difference 14%, p <0.001) indicating that for every 7 patients tested, one unnecessary invasive procedure was avoided. Invasive procedure reduction corresponded to a reduction in risk classification, with 71 patients (36%) in the IC group classified as low risk (pCA < 5%). The proportion of IC group patients with malignant PNs sent to surveillance were not statistically different than the control group, 7.5% vs 3.5% for the IC vs. control groups, respectively (absolute difference 3.91%, p 0.075). The IC for patients with a newly discovered PN has demonstrated valuable clinical utility in a real-world setting. Use of this biomarker can change physicians' practice and reduce invasive procedures in patients with benign pulmonary nodules. Trial registration: Clinical trial registration: ClinicalTrials.gov NCT03766958.
In any infectious disease, understanding the modes of transmission is key to selecting effective public health measures. In the case of COVID-19 spread, the strictness of the imposed measures outlined the lack of understanding on how SARS-CoV-2 transmits, particularly via airborne pathways. With the aim to characterize the transmission dynamics of airborne SARS-CoV-2, 165 and 62 air and environmental samples, respectively, were collected in four COVID-19 wards and ICUs in Cyprus and analyzed by RT-PCR. An alternative method for SARS-CoV-2 detection in air that provides comparable results but is less cumbersome and time demanding, is also proposed. Considering that all clinics employed 14 regenerations per hour of full fresh air inside patient rooms, it was hypothesized that the viral levels and the frequency of positive samples would be minimum outside of the rooms. However, it is shown that leaving the door opened in patient rooms hinders the efficiency of the ventilation system applied, allowing the virus to escape. As a result, the highest observed viral levels (135 copies m-3) were observed in the corridor of a ward and the frequency of positive samples in the same area was comparable to that inside a two-bed cohort. SARS-CoV-2 in that corridor was found primarily to lie in the coarse mode, at sizes between 1.8 and 10 μm. Similar to previous studies, the frequency of positive samples and viral levels were the lowest inside intensive care units. However, if a patient with sufficient viral load (Ct-value 31) underwent aerosol generating procedures, positive samples with viral levels below 45 copies m-3 were acquired within a 2 m distance of the patient. Our results suggest that a robust ventilation system can prevent unnecessary exposure to SARS-CoV-2 but with limitations related to foot traffic or the operations taking place at the time.
Acute appendicitis (AA) develops in a progressive and irreversible manner, even if the clinical course of AA can be temporarily modified by intentional medications. Reliable and real-time diagnosis of AA can be made based on findings of the white blood cell count and enhanced computed tomography. Emergent laparoscopic appendectomy (LA) is considered as the first therapeutic choice for AA. Interval/delayed appendectomy at 6-12 wk after disease onset is considered as unsafe with a high recurrent rate during the waiting time. However, this technique may have some advantages for avoiding unnecessary extended resection in patients with an appendiceal mass. Non-operative management of AA may be tolerated only in children. Postoperative complications increase according to the patient's factors, and temporal avoidance of emergent general anesthesia may be beneficial for high-risk patients. The surgeon's skill and cooperation of the hospital are important for successful LA. Delaying appendectomy for less than 24 h from diagnosis is safe. Additionally, a semi-elective manner (i.e., LA within 24 h after onset of symptoms) may be paradoxically acceptable, according to the factors of the patient, physician, and institution. Prompt LA is mandatory for AA. Fortunately, the Japanese government uses a universal health insurance system, which covers LA.
Chagas disease (CD) is a neglected disease that induces heart failure and arrhythmias in approximately 30% of patients during the chronic phase of the disease. Despite major efforts to understand the cellular pathophysiology of CD there are still relevant open questions to be addressed. In the present investigation we aimed to evaluate the contribution of the Na+/Ca2+ exchanger (NCX) in the electrical remodeling of isolated cardiomyocytes from an experimental murine model of chronic CD.
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