Standard Definition Research Articles

Adaptation of the technology readiness levels for impact assessment in implementation sciences: The TRL-IS checklist

BackgroundIntervention development is a critical process in implementation research. There are key stages involved in the process to design, pilot, demonstrate and release a technology or an intervention. The Technology Readiness Level (TRL) is a globally accepted instrument for assessing the maturity of research development. However, the original levels do not fit all, and some adjustments are required for its applicability in implementation sciences. AimsThis study aimed to gather the prior knowledge base on TRL in public and population health research; to develop a standard definition of readiness, and to adapt and validate the TRL to an implementation science context (TRL-IS). Materials and methodsA Mixed methods approach has been followed in this study. A scoping review using the PRISMA extension (PRISMA-ScR) informed a nominal expert panel for developing a standard definition of readiness and to modify the TRL following an ontoterminology approach. Then the maturity of six practical case study examples were rated by ten researchers using the modified TRL to estimate inter-rater reliability, and a group of experts provided final content and face validity and feasibility.This mixed methods study included 1) a scoping review to examine the current literature and develop a knowledge base, identify knowledge gaps and to clarify concepts; 2) the development of a standard definition of ‘Readiness’ and related terms; and 3) adaptation of the TRL to implementation science and development of a checklist to rate the maturity of applications.A standard definition of readiness and related terms was produced by the core team, and an international nominal group (n = 30) was conducted to discuss and validate the definition and terms, and the location of ‘Readiness’ in the initiation and early development phases of implementation.Following feedback from the nominal group, the development of the TRL-IS was finalised and a TRL-IS rating checklist was developed to rate the maturity of applications. The TRL-IS checklist was tested using six cases based on real world studies on implementation research.The inter-rater reliability of the TRL-IS was evaluated by ten raters and finally six raters evaluated the content and face validity, and feasibility, of the TRL-IS checklist using the System Usability Scale (SUS). ResultsFew papers (n = 11) utilised the TRL to evaluate the readiness of readiness of health and social science implementation research. The main changes in the adaption of the TRL-IS included the removal of laboratory testing, limiting the use of “operational” environment and a clearer distinction between level 6 (pilot in a relevant environment) and 7 (demonstration in the real world prior to release). The adapted version was considered relevant by the expert panel. The TRL-IS checklist showed evidence of good inter-rater reliability (ICC = 0.90 with 95 % confident interval = 0.74–0.98, p < .001) and provides a consistent metric. ConclusionsIn spite of recommendations made by national and international research funding agencies, few health and social science implementation studies include the TRL as part of their evaluation protocol. The TRL-IS offers a high degree of conceptual clarity between scientific maturity phases or readiness levels, and good reliability among raters of varying experience. This study highlights that adoption of the TRL-IS framework in implementation sciences will bolster the scientific robustness and comparability of research maturity in this domain.

The Bacterial Meningitis Epidemic in Banalia in the Democratic Republic of Congo in 2021.

The Banalia health zone in the Democratic Republic of Congo reported a meningitis epidemic in 2021 that evolved outside the epidemic season. We assessed the effects of the meningitis epidemic response. The standard case definition was used to identify cases. Care was provided to 2651 in-patients, with 8% of them laboratory tested, and reactive vaccination was conducted. To assess the effects of reactive vaccination and treatment with ceftriaxone, a statistical analysis was performed. Overall, 2662 suspected cases of meningitis with 205 deaths were reported. The highest number of cases occurred in the 30-39 years age group (927; 38.5%). Ceftriaxone contributed to preventing deaths with a case fatality rate that decreased from 70.4% before to 7.7% after ceftriaxone was introduced (p = 0.001). Neisseria meningitidis W was isolated, accounting for 47/57 (82%), of which 92% of the strains belonged to the clonal complex 11. Reactive vaccination of individuals in Banalia aged 1-19 years with a meningococcal multivalent conjugate (ACWY) vaccine (Menactra®) coverage of 104.6% resulted in an 82% decline in suspected meningitis cases (incidence rate ratio, 0.18; 95% confidence interval, 0.02-0.80; p = 0.041). Despite late detection (two months) and reactive vaccination four months after crossing the epidemic threshold, interventions implemented in Banalia contributed to the control of the epidemic.

Improving Data Infrastructure for Person-Centered Outcomes Research on Intellectual and Developmental Disabilities.

Individuals with intellectual and developmental disabilities (IDD) continue to experience disparities in health and well-being despite improved provisions of person-centered care. Patient-centered outcomes research (PCOR) translates evidence into practice for meaningful outcomes. This piece describes findings from an environmental scan and stakeholder outreach to identify and prioritize opportunities to enhance IDD PCOR data infrastructure. These opportunities include developing a standardized research definition; advancing data standards for service systems; improving capture of IDD at point of care; developing standardized outcome measures; and encouraging Medicaid data use for IDD research. Within this piece, we discuss the implications of addressing data gaps for enhanced research. While the identified activities provide a path towards advancing IDD PCOR data infrastructure, collaborative efforts between government, researchers, and others are paramount.

OA23 Time to address the challenge of difficult-to-treat psoriatic arthritis: results from an international survey

Abstract Background/Aims The term difficult-to-treat psoriatic arthritis (D2TPsA) is increasingly used to describe a small but growing number of patients who fail to respond to multiple biological disease-modifying treatments (bDMARDs). There is, however, no consensus on the scope and treatment of so-called D2TPsA. This study aimed to explore international rheumatologists’ emerging perceptions of the terminology, scope and treatment of D2TPsA Methods A web-based survey consisting of 19 questions, including multiple choice and free text responses was designed, peer-reviewed and piloted by a team of expert rheumatology consultants with a special interest in PsA. The purpose of the survey was to characterise rheumatologist opinions of D2TPsA. The survey was distributed internationally via professional organisations, mailing lists and social media between 1st June - 31stJuly 2023. Results were analysed using R Studio. Results Two-hundred and forty-four (244) rheumatologists responded to the survey across 5 continents (Europe=79.4%, South America=11.5%, Asia=3.7%, North America=3.3%, Australia=0.8%). The majority (96.2%) were aged 30-69, therefore reflecting opinions spanning the entirety of the workforce, including junior trainees and senior consultants. Most (72.5%) worked in academic/teaching institutions and 37.5% cared for &amp;gt;300 PsA patients in their service. Despite this, only 20.5% of clinicians worked in a combined rheumatology/dermatology service.[HMO1] There was a range of opinion on what constituted D2TPsA, the most popular definition being failure of ≥ 2 b/tsDMARD classes (34.8%) with 68.3% wanting failure of ≥ 1 csDMARD to be included. Considering the subgroup with true resistant or refractory disease, 74.3% supported a more pragmatic definition, that being “failure of all available bDMARD classes”. Nearly all respondents felt that “low disease activity” was a more realistic target to achieve than “remission” (86.5%). There was disagreement on use of single (38.1%) vs. composite measures (40.6%) for the assessment of disease activity, and thus treatment response. Of note, 41% preferred the term “difficult-to-manage” as opposed to “difficult-to-treat” as this would encompass factors other than drug non-response such as presence of comorbidities, mental health and lack of efficacy. Others suggested that a holistic approach to the diagnosis and management of D2TPsA was important. Yet, most physicians felt that the diagnosis and treatment of D2TPsA should include reference to relevant physical and psychosocial comorbidities such as cardiometabolic disease, mental health, infection and malignancy. Conclusion This survey showcases the breadth of rheumatologist opinions of what may constitute D2T PsA, highlighting commonalities and disagreements in the terminology. These now require further discussion and debate in a consensus working group including allied specialties and patient representatives in order to agree a standardized definition for D2TPsA to be used in the clinical and research settings and enable guidelines and management pathways to be developed. Disclosure H. Marzo-Ortega: Honoraria; HMO recieved honoraria/speaker fees from AbbVie, Biogen, Eli-Lily, Janssen, Moonlake, Novartis, Pfizer, Takeda and UCB. Grants/research support; HMO received grant support from Janssen, Novartis and UCB. S.R. Harrison: Honoraria; SRH recieved fees from Novartis and Janssen to give a non-promotional educational lecture. Other; SRH received support from UCB and Janssen to attend EULAR conference. G. Nagy: Honoraria; •GN has received consulting/speaker’s fees from Abbvie, Amgen, Astra Zeneca, Lilly, Janssen, Miltényi, Novartis, Pfizer, Richter, Roche, Sobi and Swixx. P.M. Machado: Honoraria; PMM has received consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB. D.G. McGonagle: None. S.Z. Aydin: Consultancies; SZA received consultancy feeds from: AbbVie, Janssen, Lilly, Novartis, Pfizer, Fresenius-Kabi, UCB. Grants/research support; SZA received research grants from AbbVie, Lilly, Novartis, UCB, Pfizer, Fresenius-Kabi. R. Almodovar: Honoraria; RA has received consulting/speaker’s fees from Abbvie, Almirall, Amgen, Galápagos, Gebro, Janssen, Lilly, MSD, Nordic, Novartis, Pfizer, UCB. W. Bautista-Molano: None. L. Gossec: Consultancies; LG recieved consultancy fees from: AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB. Grants/research support; LG received research grants from: AbbVie, Biogen, Lilly, Novartis, UCB. E. Lobrano: None. P. Nash: None. F. Pimentel dos Santos: None. E. Soriano: Consultancies; ERS has received consulting/speaker’s fees and/or grant support from Abbvie, Amgen, BMS, Lilly, Janssen, Novartis, Pfizer, Roche and UCB. S. Siebert: Consultancies; SS has recieved consultancy/ speakers fees from: consultancy/speaker fees from AbbVie, Amgen, AstraZeneca, Eli Lilly, GSK, Janssen, UCB. Grants/research support; SS has received institutional research grants from Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, GSK, Janssen and UCB.

Prevalence and implications of bilateral and solely contralateral lymph node metastases in oral squamous cell carcinoma

ObjectivesEffective management of neck in oral squamous cell carcinoma (OSCC) is pivotal for oncological outcomes. Although consensus exists for ipsilateral neck dissection (ND), the necessity for contralateral ND remains controversial. This study aimed to assess the prevalence and implications of bilateral/solely contralateral (B/SC) lymph node metastases (LNMs) to determine the need for contralateral elective ND. Additionally, it examined the prevalence and implications of occult B/SC metastases.Materials and methodsIn a retrospective cohort study, 420 OSCC patients underwent primary surgical treatment following German guidelines at a tertiary center. Preoperative contrast-enhanced computed tomography was conducted, and ND adhered to a standardized approach.ResultsSolely contralateral metastases occurred in 0.95% of patients, with bilateral metastases observed in 7.13%. Occult B/SC metastases occurred in 3.81% of the cases. Correlation analysis revealed a statistically significant association between B/SC metastases and higher tumor stages, tumor localization at the upper jaw or floor of the mouth, proximity to the midline, ipsilateral LNMs, and lymphatic invasion (all p < 0.05). Patients with B/SC metastases showed poorer disease-free survival, with statistical significance reached in the bilateral LNMs group (p = 0.010). Similarly, a significant difference was noted in overall survival between patients with bilateral and solely ipsilateral metastases (p = 0.044).ConclusionsB/SC LNMs are rare in patients with OSCC, especially in those who present with clinico-radiologically negative ipsilateral necks. Higher rates of B/SC metastases occur in case of advanced tumors and those localized at the upper jaw or floor of the mouth. Ipsilateral LNMs significantly elevate the risk of contralateral LNMs, tripling the associated risk.Clinical relevanceThese findings provide valuable insights for surgeons considering contralateral ND or extended adjuvant treatment for OSCC patients. However, the absence of high-level evidence from randomized controlled trials impedes the establishment of a definitive standard of care.

Applicability of Intentional Topographic Revascularization Following the Angiosome Model in Patients with Chronic Limb-Threatening Ischemia: From Theory, to Current Clinical Challenges

Since its first description almost four decades ago in the plastic surgery field, the angiosome theory has shown encouraging clinical success in Chronic Limb-Threatening Ischemia (CLTI) revascularization in recent years. Gradual scientific knowledge and evidence-based feedback are necessary to assess its usefulness and to overcome various challenges lingering in its practical application at the patient’s bedside. Despite the increasing number of publications in recent years indicating its acceptable suitability in clinical practice, only a few provide conspicuous information regarding the applicability of angiosome-guided Direct Revascularization (DR) compared with the analysis of hurdles in the vascular approach, regardless of its clinical results. The current review aimed to provide an updated interpretation of DR applicability rates in daily practice, delineated through tangible assessments of feasibility, clinical match, and technical success (as previously mentioned). This analysis considered the applicability of DR, Indirect Revascularization via collaterals, (IRc), and “Wound-Targeted Revascularization” (WTR) within the broader perspective of “Intentional Topographic Revascularization” (ITR) in patients with CLTI foot. ITR affords a novel conceptualization of regional foot reperfusion via deliberate anatomical and functional orientation of the foot arterial flow to the ischemic zones (owing specific pedal arteries and regional collaterals). The analysis of data revealed significant differences in the current clinical definitions, interpretation, and application methods of TR. Inconsistent views on DR were also observed in the context of “wound-dependent” localization and the identification of the most suitable target foot artery for treatment. Unfortunately, a standardized definition of angiosome-oriented DR, IR, IRc, and WTR has not been established. Owing to the lack of a universally accepted definition and unified anatomical and functional foot arterial occlusive disease stratification, evidence supporting the applicability of ITR (by all its variants) is still awaited.

Central venous access device terminologies, complications, and reason for removal in oncology: a scoping review.

Lack of agreed terminology and definitions in healthcare compromises communication, patient safety, optimal management of adverse events, and research progress. The purpose of this scoping review was to understand the terminologies used to describe central venous access devices (CVADs), associated complications and reasons for premature removal in people undergoing cancer treatment. It also sought to identify the definitional sources for complications and premature removal reasons. The objective was to map language and descriptions used and to explore opportunities for standardisation. A systematic search of MedLine, PubMed, Cochrane, CINAHL Complete and Embase databases was performed. Eligibility criteria included, but were not limited to, adult patients with cancer, and studies published between 2017 and 2022. Articles were screened and data extracted in Covidence. Data charting included study characteristics and detailed information on CVADs including terminologies and definitional sources for complications and premature removal reasons. Descriptive statistics, tables and bar graphs were used to summarise charted data. From a total of 2363 potentially eligible studies, 292 were included in the review. Most were observational studies (n = 174/60%). A total of 213 unique descriptors were used to refer to CVADs, with all reasons for premature CVAD removal defined in 84 (44%) of the 193 studies only, and complications defined in 56 (57%) of the 292 studies. Where available, definitions were author-derived and/or from national resources and/or other published studies. Substantial variation in CVAD terminology and a lack of standard definitions for associated complications and premature removal reasons was identified. This scoping review demonstrates the need to standardise CVAD nomenclature to enhance communication between healthcare professionals as patients undergoing cancer treatment transition between acute and long-term care, to enhance patient safety and rigor of research protocols, and improve the capacity for data sharing.

Detecting Metastatic Patterns of Oligometastatic Breast Cancer: A Comparative Analysis of 18F-FDG PET/CT and Conventional CT Imaging.

Metastasis-directed therapy has the potential to improve progression-free and overall survival in oligometastatic disease (OMD). For breast cancer, however, randomized trials have failed so far to confirm this finding. Because the concept of metastasis-directed therapy in OMD is highly dependent on the accuracy of the imaging modality, we aimed to assess the impact of 18F-FDG PET/CT on the definition of OMD in breast cancer patients. Methods: Eighty patients with a total of 150 18F-FDG PET/CT images (between October 2006 and January 2022) were enrolled in this retrospective study at the Technical University of Munich. The inclusion criteria were OMD, defined as 1-5 distant metastases, at the time of 18F-FDG PET/CT. For the current study, we systemically compared the metastatic pattern on 18F-FDG PET/CT with conventional CT. Results: At the time of 18F-FDG PET/CT, 21.3% of patients (n = 32) had a first-time diagnosis of metastatic disease, 40.7% (n = 61) had a previous history of OMD, and 38% (n = 57) had a previous history of polymetastatic disease. In 45.3% of cases, the imaging modality (18F-FDG PET/CT vs. conventional CT) had an impact on the assessment of whether OMD was present. An identical metastatic pattern was observed in only 32% of cases.18F-FDG PET/CT detected additional metastases in 33.3% of cases, mostly in the nonregional lymph node system. Conclusion: The use of 18F-FDG PET/CT had a substantial impact on the definition of OMD and detection of metastatic pattern in breast cancer. Our results emphasize the importance of establishing a standardized definition for imaging modalities in future trials and clinical practices related to metastasis-directed therapy in breast cancer patients.

The new 2023 ESC guidelines for the management of cardiomyopathies: a guiding path for cardiologist decisions.

In the ESC 2023 guidelines, cardiomyopathies are conservatively defined as 'myocardial disorders in which the heart muscle is structurally and functionally abnormal, in the absence of coronary artery disease, hypertension, valvular disease, and congenital heart disease sufficient to cause the observed myocardial abnormality'. They are morpho-functionally classified as hypertrophic, dilated, restrictive, and arrhythmogenic right ventricular cardiomyopathy with the addition of the left ventricular non-dilated cardiomyopathy that describes intermediate phenotypes not fulfilling standard disease definitions despite the presence of myocardial disease on cardiac imaging or tissue analysis. The new ESC guidelines provide 'a guide to the diagnostic approach to cardiomyopathies, highlight general evaluation and management issues, and signpost the reader to the relevant evidence base for the recommendations'. The recommendations and suggestions included in the document provide the tools to build up pathways tailored to specific cardiomyopathy (phenotype and cause) and define therapeutic indications, including target therapies where possible. The impact is on clinical cardiology, where disease-specific care paths can be assisted by the guidelines, and on genetics, both clinics and testing, where deep phenotyping and participated multi-disciplinary evaluation provide a unique tool for validating the pathogenicity of variants. The role of endomyocardial biopsy remains underexploited and confined to particular forms of restrictive cardiomyopathy, myocarditis, and amyloidosis. New research and development will be needed to cover the gaps between science and clinics. Finally, the opening up to disciplines such as bioinformatics, bioengineering, mathematics, and physics will support clinical cardiologists in the best governance of the novel artificial intelligence-assisted resources.

New 2023 global definition of acute respiratory distress syndrome: progress and limitation

Acute respiratory distress syndrome (ARDS) presents a challenge in clinical diagnosis as it lacks a definitive gold standard. Over the past 55 years, there have been several revisions to the definition of ARDS. With the progress of clinical practice and scientific research, the limitations of the "Berlin definition" have become increasingly evident. In response to these changes, the 2023 global definition of ARDS aims to address these issues by expanding the diagnostic targets, chest imaging, and methods for assessing hypoxia. Additionally, the new definition increases the diagnostic criteria to accommodate resource-constrained settings. The expansion facilitates early identification and treatment interventions for ARDS, thereby advancing epidemiological and clinically related research. Nevertheless, the broad nature of this revision may include patients who do not actually have ARDS, thus raising the risk of false-positive diagnoses. Therefore, additional verification is crucial to ascertain the validity and accuracy of the 2023 global definition of ARDS.

Variant Effect Prediction in the Age of Machine Learning.

Over the years, many computational methods have been created for the analysis of the impact of single amino acid substitutions resulting from single-nucleotide variants in genome coding regions. Historically, all methods have been supervised and thus limited by the inadequate sizes of experimentally curated data sets and by the lack of a standardized definition of variant effect. The emergence of unsupervised, deep learning (DL)-based methods raised an important question: Can machines learn the language of life from the unannotated protein sequence data well enough to identify significant errors in the protein "sentences"? Our analysis suggests that some unsupervised methods perform as well or better than existing supervised methods. Unsupervised methods are also faster and can, thus, be useful in large-scale variant evaluations. For all other methods, however, their performance varies by both evaluation metrics and by the type of variant effect being predicted. We also note that the evaluation of method performance is still lacking on less-studied, nonhuman proteins where unsupervised methods hold the most promise.

Retrospective analysis of the standardized BARD criteria for acute cholangitis in biliary atresia patients.

In 2022, the Biliary Atresia and Related Diseases (BARD) community reached a consensus for the definition of suspected and confirmed cholangitis for biliary atresia (BA) patients after hepatoportoenterostomy (HPE). This study assessed the new standardized BARD definition in a retrospective, multicenter cohort study. We included BA cases managed between 2010 and 2020 at the Hannover Medical School and Geneva University Hospitals'Swiss Pediatric Liver Center. The standardized BARD cholangitis definition assesses fourclinical items and fourimaging/laboratory items to define cholangitis. The definition was retrospectively applied to all BA cases having presented, according to their physician, cholangitis within the first year after the HPE. The diagnosis defined by the standardized BARD definition was compared with the final clinical diagnosis made by physicians. The Spearman's correlation coefficient was used to test for correlation between diagnoses made by standardized and clinical appreciation. Of 185 consecutive BA patients, 59 (32%) had at least one episode of cholangitis within the first year after HPE. The correlation between the clinician's impression and the standardized BARD definition was very strong (r = 0.8). Confirmed cholangitis definition coincided with the clinician's impression (2.5 [±0.7]/4 clinical items, 2.6 [±0.5]/4 imaging/laboratory items). For suspected cholangitis, the threshold for diagnosis was lower within the standardized BARD definition (1.1 [±0.3]/4 clinical items, 2.2 [±0.8]/4 laboratory/imaging items). This first retrospective application of the standardized BARD cholangitis definition reveals a very strong correlation with the physician's assessment before standardization. A prospective study is needed to further refine the standardized definition for cholangitis in BA patients.

Post-COVID-19 syndrome, who at risk and why: an insight from Qatar 2022.

Despite the recovery from the COVID-19 pandemic, many people experience post-COVID-19 syndrome, which negatively impacts their health and function. This condition has become a significant public health problem that requires immediate attention. To study the prevalence, clinical characteristics, and predictors of post-COVID-19 Syndrome in Qatar during 2022. An analytic cross-sectional study was conducted among COVID-19 confirmed cases from January 2022 to July 2022 in Qatar. A simple random sample was employed to include (n = 588) participants from the list of cases and invited to participate in a telephone survey. The World Health Organization's standard case definition for PCS was adopted. Out of 368, the prevalence of post-COVID-19 syndrome was 43.2% (n = 159). Most PCS cases were females (67.9%; n = 108), married (73.6%; n = 117), and university and higher educational level (83.6%; n = 133). However, 78.7% (n = 125) reported poor to moderate levels of social support. Only 30.2% (n = 48) of PCS patients had a history of chronic diseases, and 5.7% (n = 9) required hospital admission during acute illness. Among PCS cases, the most commonly reported symptoms were fatigue (75.5%), followed by anxiety (49.1%), forgetfulness (46.5%), mood alteration (45.3%), and general weakness (39.6%). The logistic regression revealed that female gender (AOR: 2.58 95%CI: 1.58-4.225, p < 0.0001), university and high educational level (AOR: 2.2, 95%CI: 1.256-3.98, p < 0.006), poor level of social support (AOR: 2.45; 95%CI: 1.55-4.13; p < 0.002), were significant predictors for PCS. Post-COVID-19 syndrome may go under-recognized. More efforts are needed to raise awareness and mobilize the resources to respond to this ongoing public health problem.

Development and use of a novel diver-operated ski for surveying nearshore rocky reef habitats.

The use of camera and video technologies for conducting underwater surveys has rapidly expanded over the past several decades. However, the utility of these systems can be significantly hampered by numerous logistical factors, including limited underwater visibility, rough bottom topography, and ease of use for the operator. Video studies can be difficult to compare when methods and terminologies differ. Here, we describe the development of a cost-effective diver-propelled underwater ski-based video system for rapidly acquiring videos in challenging shallow high-energy rocky benthic habitats for quantifying fish, macroalgae, and invertebrates in a coastal temperate system. The ski held the camera at a (relatively) fixed distance from the seafloor, we used parallel lasers to quantify our observations, and we used the standardized language and definitions in the Coastal and Marine Ecological Classification Standard (CMECS) to acquire consistent quantitative data to serve as an ecological baseline, also including archived images. Our results indicate that the ski proved to be an effective tool for capturing insightful data that would otherwise be very difficult and time consuming to collect. Our baseline and repeatable methods can be used by other investigators at this or other locations for monitoring, re-evaluation, or comparisons to other sites.

Diagnostics in Late Periprosthetic Infections-Challenges and Solutions.

The rising number of arthroplasties is combined with a rising number of periprosthetic joint infections, which leads to life-concerning consequences for the patients, including extended antibiotic treatment, further surgery and increased mortality. The heterogeneity of the symptoms and inflammatory response of the patients due to, e.g., age and comorbidities and the absence of a single diagnostic test with 100% accuracy make it very challenging to choose the right parameters to confirm or deny a periprosthetic joint infection and to establish a standardized definition. In recent years, additional diagnostic possibilities have emerged primarily through the increasing availability of new diagnostic methods, such as genetic techniques. The aim of the review is to provide an overview of the current state of knowledge about the various tests, including the latest developments. The combination of different tests increases the accuracy of the diagnosis. Each physician or clinical department must select the tests from the available methods that can be best implemented for them in organizational and technical terms. Serological parameters and the cultivation of the samples from aspiration or biopsy should be combined with additional synovial tests to create an accurate figure for the failure of the prosthesis, while imaging procedures are used to obtain additional information for the planned therapeutic procedure.

Measles outbreak investigation in Tocha district, southwestern Ethiopia: an unmatched case-control study.

Measles continues to be a public health challenge in Ethiopia. Rumors of suspected measles were notified on April 8, 2023 from Tocha district. We conducted an assessment to describe measles outbreak and determine risk factors for measles infection in the Tocha district of the Dawuro zone, Southwest Ethiopia. We conducted a 1:2 unmatched case-control studies from April to May 2023. We took all 147 cases registered on line list for descriptive analyses. We used a total of 74 randomly selected cases and 147 controls for case-control part. Any person in Tocha district with laboratory-confirmed measles IgM antibody; or any suspected person epidemiologically linked to confirmed measles cases from March 23 to April 26 2023, were included in the case. Neighborhood who did not fulfill this standard case definition were included in controls. Data were collected using standardized questionnaires deployed on Kobo Collect. Descriptive analyses were conducted using Epi info version 7.2.5.0. The analyses were performed using Statistical Package for Social Science (SPSS) version 26. Binary logistic regression analyses were utilized to select candidate variables. We conducted multiple logistic regression analysis to identify determinants of measles infection at a p value ≤0.05 with 95% confidence interval. The overall attack rate of 22.64/10,000 for general population and 104.59/10,000 among under-five children were attributed to the outbreak with a case fatality rate of 2.72%. Vaccine coverage in the last year and this year were 73.52 and 53.88%, respectively, while vaccine effectiveness in the district was 79%. Poor house ventilation (AOR = 3.540, 95% CI: 1.663-7.535) and having contact history with the case (AOR = 2.528, 95% CI: 1.180-4.557) were positively related to measles infection while being previously vaccinated for measles (AOR = 0.209, 95% CI: 0.180-4.577) reduce risk of measles infections. The highest attack rate was observed among children under 5 years of age, with a case fatality rate of 2.72%. Vaccination coverage was less than what expected to develop herd immunity. Strategies to increase vaccination coverage and strengthening surveillance systems for rumor identification and early responses to prevent person to person transmission are recommended.

Not yet another BPM lifecycle: A synthesis of existing approaches using BPMN

ContextBusiness Process Management (BPM) is considered an important management approach that encompasses a set of methods for managing the business processes of an organization. To maximize the benefits of BPM, scholars have conceptualized its steps in schematic diagrams with interrelated phases called BPM lifecycles. As this approach has been established, the phenomenon of perpetual proposition of BPM lifecycles has been observed in relevant literature. This practice obscures what should be relatively straightforward: a consensus among researchers and practitioners regarding the steps that a business process should flow through during its lifecycle. ObjectiveThe aim of this work is to investigate the existing BPM lifecycle models proposed in literature, identify convergences and variations in these models, analyze their core components and locate common patterns that will enable the synthesis of a BPM lifecycle that is conceptualized with Business Process Model and Notation (BPMN), the community de-facto business process modeling notation. MethodTo formalize the research problem and develop the design of a solution, the Design Science Research Process (DSRP) model was adopted. To investigate the perpetual proposition of BPM lifecycles in literature, the authors conducted a Systematic Literature Review (SLR). On whether recurring patterns can emerge from the BPM lifecycles, a normalization process was introduced to homogenize the data and four metrics were used to evaluate the results. The emerging patterns were assembled into a graph that formed the basis for proposing a synthetic BPM lifecycle. ResultsThe outcome of the paper is three-fold: First, the identification of four major inefficiencies of existing BPM lifecycles, namely varying granularity, inconsistent nomenclature, subjective polysemy, and lack of formal conceptualization approaches. Also, a standardized definition of the inclusive steps that exist in the lifecycles by clustering the existing ones in a conceptually systematic manner. Finally, a synthetic BPM lifecycle is conceptualized that systematizes the existing concepts and their interrelations based on a formalized BPMN model in two levels of granularity: a basic version that illustrates the functional and control-flow aspects of the BPM lifecycle and an enhanced version incorporating additionally the resource and data perspectives. ConclusionThis paper proposes a BPMN-based conceptualization of the BPM lifecycle that can facilitate the management of business processes by providing enhanced clarity, improved resource management, and predefined error handling in a BPM initiative. By systematizing the control-flow, data, and resource perspective of the BPM lifecycle, stakeholders can gain a clear understanding of the sequence of steps, the interrelated data flows, and the distribution of work.

Reporting time toxicity in prospective cancer clinical trials: A scoping review.

This review aimed to assess the measurement and reporting of time toxicity (i.e., time spent receiving care) within prospective oncologic studies. On July 23, 2023, PubMed, Scopus, and Embase were queried for prospective or randomized controlled trials (RCT) from 1984 to 2023 that reported time toxicity as a primary or secondary outcome for oncologic treatments or interventions. Secondary analyses of RCTs were included if they reported time toxicity. The included studies were then evaluated for how they reported and defined time toxicity. The initial query identified 883 records, with 10 studies (3 RCTs, 2 prospective cohort studies, and 5 secondary analyses of RCTs) meeting the final inclusion criteria. Treatment interventions included surgery (n = 5), systemic therapies (n = 4), and specialized palliative care (n = 1). The metric "days alive and out of the hospital" was used by 80% (n = 4) of the surgical studies. Three of the surgical studies did not include time spent receiving ambulatory care within the calculation of time toxicity. "Time spent at home" was assessed by three studies (30%), each using different definitions. The five secondary analyses from RCTs used more comprehensive metrics that included time spent receiving both inpatient and ambulatory care. Time toxicity is infrequently reported within oncologic clinical trials, with no standardized definition, metric, or methodology. Further research is needed to identify best practices in the measurement and reporting of time toxicity to develop strategies that can be implemented to reduce its burden on patients seeking cancer care.

A common data model for the standardization of intensive care unit medication features.

Common data models provide a standard means of describing data for artificial intelligence (AI) applications, but this process has never been undertaken for medications used in the intensive care unit (ICU). We sought to develop a common data model (CDM) for ICU medications to standardize the medication features needed to support future ICU AI efforts. A 9-member, multi-professional team of ICU clinicians and AI experts conducted a 5-round modified Delphi process employing conference calls, web-based communication, and electronic surveys to define the most important medication features for AI efforts. Candidate ICU medication features were generated through group discussion and then independently scored by each team member based on relevance to ICU clinical decision-making and feasibility for collection and coding. A key consideration was to ensure the final ontology both distinguished unique medications and met Findable, Accessible, Interoperable, and Reusable (FAIR) guiding principles. Using a list of 889 ICU medications, the team initially generated 106 different medication features, and 71 were ranked as being core features for the CDM. Through this process, 106 medication features were assigned to 2 key feature domains: drug product-related (n = 43) and clinical practice-related (n = 63). Each feature included a standardized definition and suggested response values housed in the electronic data library. This CDM for ICU medications is available online. The CDM for ICU medications represents an important first step for the research community focused on exploring how AI can improve patient outcomes and will require ongoing engagement and refinement.

Not Just Scraping By: Experimental Evidence for Large Cutting Tools in the High Lodge Non-handaxe Industry

The presence or absence of handaxes endures as the major criterion of Lower Palaeolithic classification, with contemporaneous core-and-flake industries modelled as simpler counterparts to Acheulean technology. This is based on the supposed absence of formal tools, particularly of large cutting tools (LCTs) which are understood to be important within Acheulean lifeways, functioning as butchery knives among other uses. Scrapers from the core-and-flake industry of High Lodge (MIS 13) evidence formalised flake-tool production techniques, geared towards large tools with long cutting edges and acute angles, comparable in many respects to Acheulean handaxes. A holistic set of experiments was designed to test the production, efficiency, and practical utility of these scrapers. The experiments compared these scraper forms against handaxes and Quina scrapers. Their use in roe deer butchery indicates functional differences but demonstrates the appropriacy of both large, refined scrapers, and handaxes for processing carcasses of this size. The results support the inclusion of High Lodge scraper forms within the standard definition of LCTs. This interpretation challenges perceived discrepancies between handaxe and non-handaxe industries and deterministic explanations for Acheulean material culture. The feasibility of alternative LCTs supports the argument that the Acheulean represents socially inherited behaviours rather than latent reinventions.