Search Results (75)

Background: Intravenous vancomycin remains a key agent in the treatment of complex orthopedic infections, particularly those involving methicillin-resistant Staphylococcus aureus (MRSA). However, its use is associated with significant risks, most notably nephrotoxicity. Despite guideline recommendations, standardized dosing and monitoring protocols are often absent in orthopedic settings, leading to inconsistent therapeutic drug exposure and preventable adverse events. This study evaluated the clinical impact of implementing a structured standard operating procedure (SOP) for intravenous vancomycin therapy in orthopedic inpatients. Methods: We conducted a single-center, pre-post cohort study at a university orthopedic department. The intervention consisted of a standard operating procedure (SOP) for intravenous vancomycin therapy, which mandated weight-based loading doses, renal function-adjusted maintenance dosing, trough level monitoring, and defined dose adjustments. Patients treated before SOP implementation (n = 58) formed the control group; those treated under the SOP (n = 56) were prospectively included. The primary outcome was the incidence of vancomycin-associated acute kidney injury (VA-AKI) defined by KDIGO Stage 1 criteria. Secondary outcomes included therapeutic trough level attainment and infusion-related or ototoxic adverse events. Results: All patients in the post-SOP group received a loading dose (100% vs. 31% pre-SOP, p < 0.001). The range of measured vancomycin trough levels narrowed substantially after SOP implementation (7.1–36.2 mg/L vs. 4.0–80.0 mg/L). The proportion of patients reaching therapeutic trough levels increased, although this was not statistically significant. Most notably, VA-AKI occurred in 17.2% of patients in the control group, but in none of the patients after SOP implementation (0%, p = 0.0013). No cases of ototoxicity were observed in either group. Infusion-related reactions decreased after the implementation of the SOP, though not significantly. Conclusions: The introduction of a structured vancomycin protocol significantly reduced adverse drug events and improved dosing control in orthopedic inpatients. Incorporating such protocols into routine practice represents a feasible and effective strategy to strengthen antibiotic stewardship and clinical quality in surgical disciplines. Full article

Background/Objectives: Dual task (DT) training consists of practicing exercises while simultaneously performing a concurrent motor or cognitive task. This training modality seems to have beneficial effects on both domains. Various forms of DT training have been implemented for older adults in recent years, but no official guidelines currently exist. This review sought to analyze the studies published on this topic in the last ten years and provide a standard operating procedure (SOP) for healthy older adults in this context. Methods: The review collected articles from PubMed, Web of Science, and Scopus, adopting a designated set of keywords. Selected manuscripts and relevant information were selected, extrapolated, including information related to the training frequency, intensity, time, and type, and secondary tasks adopted. The secondary tasks were grouped according to previously published studies, and the SOP was created based on the frequency of the parameters collected from the included articles. Results: A total of 44 studies were included in the review. Based on the results, the SOP recommends postural balance or resistance training as primary tasks, combined with a mental tracking task as a secondary component. Two 60-min sessions per week for at least 12 weeks are required to achieve measurable results. Conclusions: Despite heterogeneity in the literature reviewed, the findings support the proposal of a SOP to guide future research on DT training in healthy older adults. Given its feasibility and positive effects on both motor and cognitive functions, this type of training can also be implemented in everyday settings. Full article

Process anomaly detection in financial services systems is crucial for operational compliance and risk management. However, traditional process mining techniques frequently neglect the detection of significant low-frequency abnormalities due to their dependence on frequency and the inadequate incorporation of domain-specific knowledge. Therefore, we develop an enhanced process mining algorithm by incorporating a domain-specific follow-relationship matrix derived from standard operating procedures (SOPs). We empirically evaluated the effectiveness of the proposed algorithm based on real-world event logs from a corporate account-opening process conducted from January to December 2022 in a Chinese commercial bank. Additionally, we employed large language models (LLMs) for root cause analysis and process optimization recommendations. The empirical results demonstrate that the E-Heuristic Miner significantly outperforms traditional machine learning methods and process mining algorithms in process anomaly detection. Furthermore, the integration of LLMs provides promising capabilities in semantic reasoning and offers explainable optimization suggestions, enhancing decision-making support in complex financial scenarios. Our study significantly improves the precision of process anomaly detection in financial contexts by incorporating banking-specific domain knowledge into process mining algorithms. Meanwhile, it extends theoretical boundaries and the practical applicability of process mining in intelligent, semantic-aware financial service management. Full article

Wheelchair tennis (WT) is a Paralympic sport designed for athletes with physical impairments. Assessing physical fitness characteristics using appropriate field-based tests and standardized protocols is essential for individualized training, injury prevention, and performance monitoring. However, there is currently limited information on which field-based tests are most suitable and how they should be applied in WT athletes, resulting in inconsistency across studies and practical use. Establishing a standard operating procedure (SOP) enables replicable, cost-effective testing routines that improve data consistency and comparability. We conducted a scoping review to synthesize the existing evidence on field-based physical fitness assessment in WT athletes and to propose a structured SOP for these tests. A comprehensive search was conducted in three electronic databases—NLM PubMed, Web of Science, and Scopus—using predefined keywords and Boolean operators. The inclusion criteria were limited to peer-reviewed, English-language original articles focusing exclusively on field tests in WT athletes. Studies with other populations, reviews, and abstracts were excluded. Eleven studies met the eligibility criteria. This scoping review identified various field tests assessing key fitness components, including cardiorespiratory endurance, muscle strength, agility, and body composition. The most frequently employed tests were the 20 m sprint test, isometric handgrip test, spider test, Illinois Agility Test, and skinfold thickness. These findings highlight the lack of standardized fitness assessments in WT. The proposed SOP offers a practical step toward consistent, replicable, and relevant evaluation in these athletes. Full article

Inefficient material tracking continues to be a major challenge in sustainable construction, often leading to unnecessary waste, budget overruns, and project delays. While many digital tools have been introduced in recent years, there is still a lack of practical, field-tested frameworks that combine these technologies with clear, structured procedures, especially in resource-constrained environments. This study introduces a Standard Operating Procedure (SOP) framework designed to improve materials tracking systems (MTSs) by integrating QR codes, GPS tracking, and cloud-based dashboards. Together, these tools support more accurate planning, smoother coordination, and real-time monitoring from the early design stages to on-site implementation. A mixed-methods approach was used, combining surveys with construction professionals and focus group discussions with engineers, IT specialists, and logistics staff. The findings highlight procurement and implementation as the phases most prone to inefficiencies, particularly around material receiving, quality checks, and on-site placement. The validated SOP framework shows strong potential to improve tracking accuracy, reduce material waste, and streamline construction workflows. It offers a flexible, easy-to-use system for integrating sustainability into everyday project practices. Looking ahead, this study also points to future opportunities for applying AI-based tools—such as predictive tracking and automated quality checks—to further improve decision-making and resource efficiency in construction projects. Full article

Objective: Current good manufacturing practice (cGMP) guidance for positron emission tomography (PET) drugs has been established in Europe and the United States. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) approved the use of radiosynthesizers as medical devices for the in-house manufacturing of PET drugs in hospitals and clinics, regardless of the cGMP environment. Without adequate facilities, equipment, and personnel required by cGMP regulations, the quality assurance (QA) and clinical effectiveness of PET drugs largely depend on the radiosynthesizers themselves. To bridge the gap between radiochemistry standardization and site qualification, the Japanese Society of Nuclear Medicine (JSNM) has issued guidance for the in-house manufacturing of small-scale PET drugs under academic GMP (a-GMP) environments. The goals of cGMP and a-GMP are different: cGMP focuses on process optimization, certification, and commercialization, while a-GMP facilitates the small-scale, in-house production of PET drugs for clinical trials and patient-specific standard of care. Among PET isotopes, N-13 has a short half-life (10 min) and must be synthesized on site. [¹³N]Ammonia ([¹³N]NH₃) is used for myocardial perfusion imaging under the Japan Health Insurance System (JHIS) and was thus selected as a working example for the manufacturing of PET drugs in an a-GMP environment. Methods: A [¹³N]NH₃-radiosynthesizer was installed in a hot cell within an a-GMP-compliant radiopharmacy unit. To comply with a-GMP regulations, the air flow was adjusted through HEPA filters. All cabinets and cells were disinfected to ensure sterility once a month. Standard operating procedures (SOPs) were applied, including analytical methods. Batch records, QA data, and radiation exposure to staff in the synthesis of [¹³N]NH₃ were measured and documented. Results: 2.52 GBq of [¹³N]NH₃ end-of-synthesis (EOS) was obtained in an average of 13.5 min in 15 production runs. The radiochemical purity was more than 99%. Exposure doses were 11 µSv for one production run and 22 µSv for two production runs. The pre-irradiation background dose rate was 0.12 µSv/h. After irradiation, the exposed dosage in the front of the hot cell was 0.15 µSv/h. The leakage dosage measured at the bench was 0.16 µSv/h. The exposure and leakage dosages in the manufacturing of [¹³N]NH₃ were similar to the background level as measured by radiation monitoring systems in an a-GMP environments. All QAs, environmental data, bacteria assays, and particulates met a-GMP compliance standards. Conclusions: In-house a-GMP environments require dedicated radiosynthesizers, documentation for batch records, validation schedules, radiation protection monitoring, air and particulate systems, and accountable personnel. In this study, the in-house manufacturing of [¹³N]NH₃ under a-GMP conditions was successfully demonstrated. These findings support the international harmonization of small-scale PET drug manufacturing in hospitals and clinics for future multi-center clinical trials and the development of a standard of care. Full article

Background: Staphylococcus aureus bacteremia (SAB) is of great clinical relevance, as it is the most common type of bacteremia. Several studies show that the quality of care and thus the outcome can be positively influenced by the involvement of infectious disease specialists and structured programs like Antimicrobial Stewardship (AMS). In 2020, the SARS-CoV-2 pandemic occurred, which dominated the healthcare system and global events during this time. At the same time, a standard operational procedure (SOP) for SAB quality management (SABQM) was introduced in a German maximum-care hospital with 500 beds. Additionally, voluntary AMS team consultations were introduced in June 2021. This work addresses whether the introduction of SABQM has led to an improvement in the quality of care for SAB, despite the possible negative influences of the pandemic. Methods: Retrospective statistical analyses were conducted on all 145 cases coded as SAB at this hospital during the “pre-pandemic” period (2017 to 2019, 75 cases) and the pandemic period (2020 to 2022, 70 cases). Population parameters and quality management parameters were extracted from the clinical patient documentation. In a first analysis, the SARS-CoV-2 status served as a discriminatory parameter to determine its influence on the quality of care within the “pandemic period”. In a second analysis, the period served as a discriminatory parameter to determine its influence on the quality of care. In a third analysis, the use of AMS team consultation served as a discriminatory parameter to determine its influence on the quality of care in a subgroup of 42 cases from June 2021 to 2022. Results: The SARS-CoV-2 status had no influence on the population parameters or the quality management parameters. Between both analyzed periods, there was an improvement in the quality management parameters, with statistically significant higher rates of follow-up blood cultures, transthoracic echocardiography and adequate antibiotic therapy. AMS team consultation led to a relevant, but not statistically significant improvement in the quality management indicators. Conclusions: An SOP for SABQM leads to an improvement in the quality of care, even under the possible negative influences of a pandemic. AMS team consultations further strengthen this positive influence, even if this is not statistically significant due to the small number of cases in the subgroup analyzed. Full article

Background: Sickle cell disease (SCD) individuals in India are mostly identified when they become symptomatic. To provide a timely diagnosis of SCD to participants, healthcare workers should be competent in using the point-of-care test (POCT). In this study, we aimed to evaluate the competence of healthcare workers to screen infants and adult populations through POCT. Methodology: This study was conducted in pilot mode over 8 months from April to November 2023. A random sampling method was used to select ten auxiliary nursing midwives (ANMs), ten lab technicians (LTs), and five medical officers (MOs). Each selected ANM and LT was supposed to conduct ten tests and MOs to conduct five tests. The POCT used to diagnose sickle cell disease was HemoTypeSC. Results: Among the healthcare workers who participated in the study, 67% belonged to the scheduled tribes. When the ANM and LT competencies were compared for the pre-analytical phase (phase I), ANMs were more competent than the LTs. ANMs were more adept at handling people, whereas the LTs were more competent in conducting the test procedures. When the comparison was made for the analytical phase (phase II), both the ANMs and LTs were found to be equally competent. ANMs followed the standard operating procedure (SOP) more precisely than MOs and LTs. In the post-analytical phase, LTs were found to be more competent than ANMs. The approach used in this study with sub-centers and primary health centers (PHCs) appears to have encouraged the feasibility of the screening program. Conclusions: The results of this study conclude that the healthcare workers in the region are competent to perform the POCT for the diagnosis of sickle cell disease. The POCT may be introduced in the program for the diagnosis of SCD. Full article

Clinical trials inform cancer care, yet real-world outcomes often diverge due to patient-related factors, like age, organ dysfunction, and nonadherence to oral anticancer agents (OAAs). While oncology organizations emphasize patient support programs, practical guidance on designing and implementing these programs is limited. We conducted a two-phase, mixed-methods study to enhance the adoption, implementation, and sustainability of an OAA adherence program (OAP). In phase 1, we used implementation mapping (IM) with a multidisciplinary expert panel to develop six strategies: (1) memorandum of understanding (MOU), (2) data-driven presentation, (3) standard operating procedures (SOPs), (4) motivational interviewing (MI) training, (5) electronic health record (EHR) templates, and (6) key performance indicators (KPIs). In phase 2, oncology professionals (n = 34) completed surveys, and a subset (n = 10) participated in interviews to assess feasibility, acceptability, and appropriateness. EHR templates and SOPs were rated as the most feasible and acceptable strategies, while MI training and formal agreements received moderate ratings. Interviews highlighted the importance of leadership buy-in, incremental implementation, and clear documentation. Participants valued KPIs for tracking adherence and outcomes but noted resource constraints and staff workload as challenges. Using IM, we co-developed strategies to activate OAA adherence-focused clinical programs. Tools standardizing care, like EHR templates and SOPs, were highly endorsed. Future work will test these strategies in a hybrid trial to improve real-world oncology outcomes. Full article

Developing theory-informed standard operating procedures (SOPs) for the continuous crystallisation of pharmaceuticals still remains a bottleneck. For the continuous manufacturing of pharmaceuticals, the current methods rely on the laborious trial-and-error approach to identify process conditions such as the dilution rate (flow per unit volume of reactor) and initial supersaturation, where the productivity will be at maximum at steady-state conditions. This approach, while proven and considered to be useful, lacks or ignores the information obtained from batch kinetics. Herein for the first time, we propose a theoretical method to develop batch kinetics-informed theoretical procedures for the continuous manufacturing of a model compound curcumin in isopropanol. The theoretical approach uses batch kinetic constants to theoretically identify the optimum dilution rate and the corresponding mass of the model compound curcumin when crystallised, as well as its productivity at steady-state conditions as a function of initial supersaturation. The theory-informed procedures will serve as a valuable guideline to develop operating procedures for the continuous production of the target compound and thus eliminate the trial-and-error approach used to develop the protocols for the continuous manufacturing of pharmaceuticals. We also showed that our methods allow for the estimation of the dilution rate that corresponds to washout conditions (i.e., where all the crystals in the crystalliser will be washed out due to the high flow rate of the input stream) during the continuous manufacturing of crystals. Full article

In 2015, U.K. newborn screening (NBS) laboratory guidelines were introduced to standardize dried blood spot (DBS) specimen quality acceptance and specify a minimum acceptable DBS diameter of ≥7 mm. The UK ‘acceptable’ avoidable repeat rate (AVRR) is ≤2%. To assess inter-laboratory variability in specimen acceptance/rejection, two sets of colored scanned images (n = 40/set) of both good and poor-quality DBS specimens were distributed to all 16 U.K. NBS laboratories for evaluation as part of an external quality assurance (EQA) assessment. The mean (range) number of specimens rejected in the first EQA distribution was 7 (1–16) and in the second EQA distribution was 7 (0–16), demonstrating that adherence to the 2015 guidelines was highly variable. A new minimum standard for DBS size of ≥8 mm (to enable a minimum of six sub-punches from two DBS) was discussed. NBS laboratories undertook a prospective audit and demonstrated that using ≥8 mm as the minimum acceptable DBS diameter would increase the AVRR from 2.1% (range 0.55% to 5.5%) to 7.8% (range 0.55% to 22.7%). A significant inverse association between the number of specimens rejected in the DBS EQA distributions and the predicted AVVR (using ≥8 mm minimum standard) was observed (r = −0.734, p = 0.003). Before implementing more stringent standards, the impact of a standard operating procedure (SOP) designed to enable a standardized approach of visual assessment and using the existing ≥7 mm diameter (to enable a minimum of four sub-punches from two DBS) as the minimum standard was assessed in a retrospective audit. Implementation of the SOP and using the ≥7 mm DBS diameter would increase the AVRR from 2.3% (range 0.63% to 5.3%) to 6.5% (range 4.3% to 20.9%). The results demonstrate that there is inconsistency in applying the acceptance/rejection criteria, and that a low AVVR is not an indication of good-quality specimens being received into laboratories. Further work is underway to introduce and maintain standards without increasing the AVRR to unacceptable levels. Full article

Introduction: Cytoreductive surgery (CRS) coupled with hyperthermic intraperitoneal chemotherapy (HIPEC) is a potentially curative approach to peritoneal disease (PD) and corresponds to the needs of patients with dire survival rates. However, the oncological community remains cautious toward this procedure because of its significant morbidity and mortality rates. This evolving evidence around CRS and HIPEC and its impact suggests a need for more standardized procedures in existing centers. Because of its complexity and potential for high morbidity and mortality, critical observation of our center’s complication rates using complication management documentation tools were crucial to further develop our standard operating procedures (SOP) and maximize patient safety. Methods: Our prospectively maintained institutional database was queried to identify all patients who underwent CRS and HIPEC and had a filled-out quality management (QM) and complication management documentation tool at discharge at the surgical department of the Charité—Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany, between January 2018 and December 2023. Results: A total of 155 patients had a surgical and/or medical complication recorded. In total, 305 surgeries were surveyed. Some patients had more than one postoperative complication; hence, 344 events in 50 categories were recorded, of which 267 were graded 3a or higher in 92 patients. The most common medical complications were of pulmonary and renal origin. On the surgical side, surgical site infections (SSI) were most common. The incidence of anastomotic leakage (AL) was 5% (n = 8), with no events between 2021 and the present. Patients with longer surgery duration times were at higher risk for developing postoperative complications. Conclusions: Major abdominal surgeries like CRS and HIPEC are associated with significant patient morbidity despite achieving optimal oncological outcomes. Postoperative complications are managed through strict surveillance and transparency, particularly in our large reference centers, to minimize patient risk. Quality management programs in our department have successfully maintained high standards of care without compromising patient safety. Full article

Portal vein arterialization (PVA) is a surgical procedure that plays a crucial role in hepatic vascular salvage when hepatic artery flow restoration remains elusive. Dedicated diagnostic vascular imaging and the timely management of PVA shunts are paramount to preventing complications, such as portal hypertension and thrombosis. Regrettably, a lack of standardized postoperative management protocols for PVA has increased morbidity and mortality rates post-procedure. In response to this challenge, we developed a PVA standard operating procedure (SOP) tailored to the needs of interventional radiologists. This SOP is designed to harmonize postoperative care, fostering scientific comparability across cases. This concise brief report aims to offer radiologists valuable insights into the PVA technique and considerations for post-PVA care and foster effective interdisciplinary collaboration. Full article

Background: To support clinical decision-making at the point of care, the “best next step” based on Standard Operating Procedures (SOPs) and actual accurate patient data must be provided. To do this, textual SOPs have to be transformed into operable clinical algorithms and linked to the data of the patient being treated. For this linkage, we need to know exactly which data are needed by clinicians at a certain decision point and whether these data are available. These data might be identical to the data used within the SOP or might integrate a broader view. To address these concerns, we examined if the data used by the SOP is also complete from the point of view of physicians for contextual decision-making. Methods: We selected a cohort of 67 patients with stage III melanoma who had undergone adjuvant treatment and mainly had an indication for a sentinel biopsy. First, we performed a step-by-step simulation of the patient treatment along our clinical algorithm, which is based on a hospital-specific SOP, to validate the algorithm with the given Fast Healthcare Interoperability Resources (FHIR)-based data of our cohort. Second, we presented three different decision situations within our algorithm to 10 dermatooncologists, focusing on the concrete patient data used at this decision point. The results were conducted, analyzed, and compared with those of the pure algorithmic simulation. Results: The treatment paths of patients with melanoma could be retrospectively simulated along the clinical algorithm using data from the patients’ electronic health records. The subsequent evaluation by dermatooncologists showed that the data used at the three decision points had a completeness between 84.6% and 100.0% compared with the data used by the SOP. At one decision point, data on “patient age (at primary diagnosis)” and “date of first diagnosis” were missing. Conclusions: The data needed for our decision points are available in the FHIR-based dataset. Furthermore, the data used at decision points by the SOP and hence the clinical algorithm are nearly complete compared with the data required by physicians in clinical practice. This is an important precondition for further research focusing on presenting decision points within a treatment process integrated with the patient data needed. Full article

The establishment of a compliant radiopharmacy facility within a university setting is crucial for supporting fundamental and preclinical studies, as well as for the production of high-quality radiopharmaceuticals for clinical testing in human protocols as part of Investigational New Drug (IND) applications that are reviewed and approved by the U.S. Food and Drug Administration (FDA). This manuscript details the design and construction of a 550 ft² facility, which included a radiopharmacy and a radiochemistry laboratory, to support radiopharmaceutical development research and facilitate translational research projects. The facility was designed to meet FDA guidelines for the production of aseptic radiopharmaceuticals in accordance with current good manufacturing practice (cGMP). A modular hard-panel cleanroom was constructed to meet manufacturing classifications set by the International Organization of Standardization (ISO), complete with a gowning room and an anteroom. Two lead-shielded hot cells and two dual-mini hot cells, connected via underground trenches containing shielded conduits, were installed to optimize radioactive material transfer while minimizing personnel radiation exposure. Concrete blocks and lead bricks provided sufficient and cost-effective radiation shielding for the trenches. Air quality was controlled using pre-filters and high-efficiency particulate air (HEPA) filters to meet cleanroom ISO7 (Class 10,000) standards. A laminar-flow biosafety cabinet was installed in the cleanroom for preparation of sterile dose vials. Noteworthy was a laminar-flow insert in the hot cell that provided a shielded laminar-flow sterile environment meeting ISO5 (class 100) standards. The design included the constant control and monitoring of differential air pressures across the cleanroom, anteroom, gowning room, and controlled research space, as well as maintenance of temperature and humidity. The facility was equipped with state-of-the-art equipment for quality control and release testing of radiopharmaceuticals. Administrative controls and standard operating procedures (SOPs) were established to ensure compliance with manufacturing standards and regulatory requirements. Overall, the design and construction of this radiopharmacy facility exemplified a commitment to advancing fundamental, translational, and clinical applications of radiopharmaceutical research within an academic environment. Full article