Cross-mapping of terms used in chemical risk assessment with those used in systematic review: research protocol.

The focus on implementation of systematic review (SR) principles in chemical risk assessments (CRAs) is growing as it has the potential to advance the rigour and transparency of the CRAs. However, the SR and CRA communities use their own specific terminologies. Understanding the meaning of core SR and CRA terms and where they overlap is critical for application of SR methods and principles in CRAs. Moreover, it will increase the possibility for cross-sectorial collaboration, avoid misunderstandings, and improve communication among risk assessors, researchers, and policy makers. We present a process for the cross-mapping of core CRA terms and core SR terms. Core terms for study appraisal, evidence synthesis and integration used in the SR and CRA communities will be included. The outcome will be an overview of how core SR terms map onto core CRA terms and vice versa, and a description of the relationship and conceptual overlap between the terms. The cross-mapping is divided in three phases, where in the first phase the core SR and CRA terms will be identified. In the second phase, existing SR and CRA definitions will be mapped. In the third phase, descriptions of the relationship and conceptual overlap between the terms will be derived. The third phase will include weekly one-hour online meetings for SR and CRA experts.

Development and Preliminary Validation of a Central Venous Access Device-Associated Skin Impairment Classification Tool Using Modified Delphi and Clinimetric Methods.

BACKGROUND: An evidence and consensus-based instrument is needed to classify central venous access device-associated skin impairments. AIM: The aim of this study was to design and evaluate the central venous access device-associated skin impairment classification tool. DESIGN: A two-phase modified Delphi study. METHODS: This two-phase study consisted of a literature review, followed by the development and validation of a classification instrument, by experts in the fields of central venous access devices and wound management (Phase 1). The instrument was tested (Phase 2) using 38 clinical photographs of a range of relevant skin impairments by the same expert panel. The expert panel consisted of registered nurses who were clinical researchers (n = 4) and clinical experts (n = 3) with an average of 24 years of nursing and research experience and 11 years of experience in wound management. Measures to assess preliminary content validity and inter-rater reliability were used. RESULTS: The instrument consists of five overarching aetiological classifications, including contact dermatitis, mechanical injury, infection, pressure injury and complex clinical presentation, with 14 associated subcategory diagnoses (e.g., allergic dermatitis, skin tear and local infection), with definitions and signs and symptoms. High agreement was achieved for preliminary scale content validity and item content validity (I-CVI = 1). Inter-rater reliability of aetiologies was high. The overall inter-rater reliability of individual definitions and signs and symptoms had excellent agreement. CONCLUSION: The development and preliminary validation of this classification tool provide a common language to guide the classification and assessment of central venous access device-associated skin impairment. IMPACT: The comprehensive and validated classification tool will promote accurate identification of central venous access device-associated skin impairment by establishing a common language for healthcare providers. The availability of this tool can reduce clinical uncertainty, instances of misdiagnosis and the potential for mismanagement. Consequently, it will play a pivotal role in guiding clinical decision-making, ultimately enhancing the quality of treatment and improving patient outcomes. REPORTING METHOD: The Guidance on Conducting and Reporting Delphi Studies (CREDES) was adhered to. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

International consensus-based ranking of definitions for poor response to primary total knee arthroplasty: a Delphi study.

INTRODUCTION: This study aimed to rank definitions for measuring poor response one year after TKA, after assessing the face validity and feasibility of existing or newly proposed definitions. MATERIALS AND METHODS: An international, three-round, online modified Delphi study was conducted with sixty-nine panelists from twenty-three countries. Definitions were derived from a literature review or were newly proposed by an expert group. Panelists rated the face validity and feasibility of definitions, and could propose additional new definitions in round 1. Panelists reconsidered their rating of existing definitions, and rated newly suggested definitions (round 2). Definitions with a median score for face validity < 6.5 were removed from the list, and panelists distributed 100 points among the remaining definitions for ranking (round 3). RESULTS: Fifty-one panelists completed all three rounds (response rate 74%), and the prioritized list of definitions in round 3 comprised seventeen definitions. The single-item definition of (dis)satisfaction with the outcome of TKA obtained the highest scores for face validity and feasibility (7.5, and 8.5 respectively), and the definition "No improvement in pain OR daily knee functioning compared to pre-operative status" was the highest prioritized. In general, definitions reflecting change from the perception of patients were higher ranked than definitions requiring both preoperative and postoperative assessment of validated questionnaires. CONCLUSIONS: This study identified seventeen potential definitions of poor response to TKA, offering valuable options for integration into quality assessment investigations. Remarkably, all identified definitions were patient-centered and none were clinician-centered. Single-item questions, capturing change from the patient's viewpoint, appear to be the most practicable format to assess response.

Comparative analysis of adolescent hypertension definitions for predicting early-adulthood carotid artery intima-media thickness: Tehran lipid and glucose study.

Background: Definitions of childhood and adolescent hypertension (HTN) do not precisely elucidate the relationship between HTN and cardiovascular outcomes. Carotid intima-media thickness (CIMT), as a substitute for cardiovascular outcomes, enables the early identification of cardiovascular events throughout early adulthood. Purpose: This study aimed to compare the ability of childhood HTN definitions to predict a high CIMT in early adulthood. Methods: This prospective cohort study included 921 individuals aged 10-17 years from the Tehran Lipid and Glucose Study (TLGS). The CIMT was measured after 18 years of follow-up. Participants were categorized into normal blood pressure (BP), high-normal BP, HTN stage 1, and HTN stage 2 groups based on the childhood HTN definitions of the 4th report, European Society of Hypertension (ESH), and American Academy of Pediatrics Clinical Practice Guidelines (AAP-CPG). Akaike's information criterion (AIC) and relative efficiencies (RE) were calculated to compare the ability of each to predict a high CIMT (≥95th percentile) during early adulthood. Results: The highest and lowest prevalence of stage 1 HTN was observed with the AAP-CPG (17.7%) and ESH (8.8%), respectively. Similarly, the highest and lowest prevalence of stage 2 HTN was noted with the AAP-CPG (1.5%) and ESH (0.8%), respectively. According to the RE values, the highest to lowest predictive abilities belonged to the 4th report, ESH, and AAP-CPG, respectively. In all models, the 4th report's pediatric HTN definition had the lowest AIC value and offered the best predictive ability. Conclusion: Among the various definitions of pediatric HTN, the 4th report offered the best ability to predict a high CIMT during early adulthood, followed by the ESH and AAP-CPG. Because the reference population of the 4th report includes overweight, obese, and normal-weight individuals, our findings suggest that excessive adiposity is among the main predictors of early adulthood atherosclerosis risk.

Cutting edge confusion about cut-off settings in autoimmune diagnostics.

In autoimmune diagnostics results are interpreted in relation to a single or multiple cut-off value(s) in order to decide if the test is negative, weak positive, positive, or even strong positive. The way a cut-off is established appears to be very heterogeneous and this hampers harmonization of test results obtained in assays, either established in-house or obtained from different companies. In this context it is surprising that in diagnostic and classification criteria for distinct autoimmune diseases referral is made to cut-off values with the intention of harmonization. In this review article distinct ways to establish cut-off values will be described and discussed in relation to some disease criteria in order to increase the awareness of the confusion matrix of cut-off values and, as a consequence, the implications for test result interpretation.

A Comparison of Denoising Approaches for Spoken Word Production Related Artefacts in Continuous Multiband fMRI Data.

It is well-established from fMRI experiments employing gradient echo echo-planar imaging (EPI) sequences that overt speech production introduces signal artefacts compromising accurate detection of task-related responses. Both design and post-processing (denoising) techniques have been proposed and implemented over the years to mitigate the various noise sources. Recently, fMRI studies of speech production have begun to adopt multiband EPI sequences that offer better signal-to-noise ratio (SNR) and temporal resolution allowing adequate sampling of physiological noise sources (e.g., respiration, cardiovascular effects) and reduced scanner acoustic noise. However, these new sequences may also introduce additional noise sources. In this study, we demonstrate the impact of applying several noise-estimation and removal approaches to continuous multiband fMRI data acquired during a naming-to-definition task, including rigid body motion regression and outlier censoring, principal component analysis for removal of cerebrospinal fluid (CSF)/edge-related noise components, and global fMRI signal regression (using two different approaches) compared to a baseline of realignment and unwarping alone. Our results show the strongest and most spatially extensive sources of physiological noise are the global signal fluctuations arising from respiration and muscle action and CSF/edge-related noise components, with residual rigid body motion contributing relatively little variance. Interestingly, denoising approaches tended to reduce and enhance task-related BOLD signal increases and decreases, respectively. Global signal regression using a voxel-wise linear model of the global signal estimated from unmasked data resulted in dramatic improvements in temporal SNR. Overall, these findings show the benefits of combining continuous multiband EPI sequences and denoising approaches to investigate the neurobiology of speech production.

Resurgence and Behavioral Contrast, Compared and Contrasted.

This is a review of the relation between operant response resurgence and behavioral contrast. Both are defined by rate changes in a target response as a function of environmental changes spatially or temporally distal to the location of the target response. The typical procedures for investigating these two phenomena differ in that (1) resurgence is studied using concurrent schedules and behavioral contrast predominantly with multiple schedules and (2) resurgence is assessed against an extinction baseline of the target response and behavioral contrast has been assessed under a variety of reinforcement schedules. The distinctions between concurrent and multiple schedules, however, may be ones of degree rather than kind. Research into both phenomena reveals considerable overlap in the controlling variables of the two. With certain caveats, resurgence appears to be an instance of behavioral contrast measured against an extinction baseline. Because of Point 2 above, most instances of behavioral contrast do not meet the definition of resurgence. Investigating resurgence while maintaining target responding by a schedule of reinforcement might be useful, but such a procedure would not qualify as resurgence because it violates the definition of resurgence as the return of a previously reinforced but currently extinguished response. Several implications of the similarities and differences between the two are discussed.

Impact of Procedural Success Definitions on Long-Term Outcomes in Patients With Rheumatic Mitral Stenosis Treated With Percutaneous Balloon Mitral Valvuloplasty: A Multicenter, Retrospective Cohort Study.

BACKGROUND: It is uncertain which percutaneous balloon mitral valvuloplasty (PBMV) success definitions should be used because there are no studies comparing the effects of these definitions on subsequent outcomes. We evaluated the association between 3 success definitions and long-term clinical outcomes in patients with rheumatic mitral stenosis who underwent PBMV. METHODS AND RESULTS: This multicenter retrospective study included patients with severe rheumatic mitral stenosis who underwent PBMV. Three definitions were used as follows: (A) post-PBMV mitral valve area (MVA) ≥1.5 cm2 or ≥50% increase in MVA with MR <3+; (B) post-PBMV MVA ≥1.5 cm2 and MR ≤2+; and (C) post-PBMV MVA ≥1.5 cm2 or ≥50% increase in MVA, with no more than 1-grade increment in MR. Multivariable Cox regression analyses were performed to evaluate the associations between PBMV success and the composite of all-cause mortality, mitral surgery, and repeat PBMV. Successful PBMV, according to definitions A, B, and C was associated with a lower risk of the composite outcomes (definition A-hazard ratio [HR], 0.55 [95% CI, 0.43-0.69], definition B-HR, 0.55 [95% CI, 0.43-0.69], definition C-HR, 0.55 [95% CI, 0.44-0.69]). Patients meeting all 3 success definitions had the lowest risk compared with those who did not meet any definition or met 1 or 2 definitions. CONCLUSIONS: All 3 success definitions had a prognostic impact on outcomes. Patients who achieved post-PBMV MVA ≥1.5 cm2, irrespective of the percentage increase in MVA, and MR ≤grade 2, with no more than a 1-grade increment in MR, had the most favorable outcomes.

What Is a Working Equid? Analysis of Current Terminology and a Suggested Definition.

Equids are engaged in myriad types of work across the world, with contexts and industries varying widely between high-, middle- and low-income countries as classified by the World Bank. Through a comprehensive abstract search and literature review, we examined the usage and context of terms associated with working equids in high-income countries (HICs), upper-middle-income countries (UMICs), lower-middle-income countries (LMICs), and low-income countries (LICs). Analysis showed that the search term used was significantly associated with World Bank country income classification. All search terms except two returned a significantly higher number of papers for higher-income countries compared to lower-income countries. The two exceptions were "working equid" and "draft equid", which returned significantly more papers for lower-income countries than higher-income countries. Both terms also returned papers from high-income and upper-middle-income countries, but these were always in the context of low-resource settings and rural or marginalised communities, of which we provide examples in the discussion. We propose that the term "working equid" should be used to describe "any equid engaged in physical labour that provides a significant or direct contribution to the economic livelihood, sustenance or support of the owner/user's family, typically within a low resource setting". Our review highlights the intricate interplay between socioeconomic factors and examines how equids are described in the literature. The lack of a universally accepted definition leads to challenges in policy formulation, resource allocation, and welfare standards development, particularly in LMICs and LICs where working equids are crucial to livelihoods. This study underscores the need for a more inclusive and comprehensive approach to terminology, advocating for future research to bridge linguistic and cultural gaps in understanding working equids globally. Such efforts are vital for equitable and effective welfare standards and policy development for these animals.

Scientific support for preparing an EU position in the 55th Session of the Codex Committee on Pesticide Residues (CCPR).

The European Commission asked EFSA to provide support in the framework of Article 43 of Regulation (EC) No 396/2005 for the preparation of the EU position for 55th Session of the Codex Committee on Pesticide Residues (CCPR). In the current report, EFSA provided comments and recommendations on the Codex maximum residue level (MRL) proposals derived by the Joint Meeting on Pesticide Residues (JMPR) that will be discussed in the upcoming CCPR meeting. The current report should serve as the basis for deriving the EU position for the CCPR meeting.

Exercise-induced pain within endurance exercise settings: Definitions, measurement, mechanisms and potential interventions.

Pain can be defined as an unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage. Though consistent with this definition, different types of pain result in different behavioural and psychophysiological responses. For example, the transient, non-threatening, acute muscle pain element of exercise-induced pain (EIP) is entirely different from other pain types like delayed onset muscle soreness, muscular injury or chronic pain. However, studies often conflate the definitions or assume parity between distinct pain types. Consequently, the mechanisms through which pain might impact exercise behaviour across different pain subcategories may be incorrectly assumed, which could lead to interventions or recommendations that are inappropriate. Therefore, this review aims to distinguish EIP from other subcategories of pain according to their aetiologies and characteristics, thereby providing an updated conceptual and operational definition of EIP. Secondly, the review will discuss the experimental pain models currently used across several research domains and their relevance to EIP with a focus on the neuro-psychophysiological mechanisms of EIP and its effect on exercise behaviour and performance. Finally, the review will examine potential interventions to cope with the impact of EIP and support wider exercise benefits. HIGHLIGHTS: What is the topic of this review? Considerations for future research focusing on exercise-induced pain within endurance exercise settings. What advances does it highlight? An updated appraisal and guide of research concerning exercise-induced pain and its impact on endurance task behaviour, particularly with reference to the aetiology, measurement, and manipulation of exercise-induced pain.

Measuring and increasing rates of self-isolation in the context of COVID-19: a systematic review with narrative synthesis.

OBJECTIVES: This study aimed to investigate (1) definitions of self-isolation used during the COVID-19 pandemic; (2) measures used to quantify adherence and their reliability, validity, and acceptability; (3) rates of self-isolation adherence; and (4) factors associated with adherence. STUDY DESIGN: This was a systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Synthesis Without Meta-analysis (PRISMA) guidelines (PROSPERO record CRD42022377820). METHODS: MEDLINE, PsycINFO, Embase, Web of Science, PsyArXiv, medRxiv, and grey literature sources were searched (1 January 2020 to 13 December 2022) using terms related to COVID-19, isolation, and adherence. Studies were included if they contained original, quantitative data of self-isolation adherence during the COVID-19 pandemic. We extracted definitions of self-isolation, measures used to quantify adherence, adherence rates, and factors associated with adherence. RESULTS: We included 45 studies. Self-isolation was inconsistently defined. Four studies did not use self-report measures. Of 41 studies using self-report, one reported reliability; another gave indirect evidence for the lack of validity of the measure. Rates of adherence to self-isolation for studies with only some concerns of bias were 51%-86% for COVID-19 cases, 78%-94% for contacts, and 16% for people with COVID-19-like symptoms. There was little evidence that self-isolation adherence was associated with sociodemographic or psychological factors. CONCLUSIONS: There was no consensus in defining, operationalising, or measuring self-isolation, resulting in significant risk of bias in included studies. Future definitions of self-isolation should state behaviours to be enacted and duration. People recommended to self-isolate should be given support. Public health campaigns should aim to increase perceived effectiveness of self-isolation and promote accurate information about susceptibility to infection.

Validated administrative data based ICD-10 algorithms for chronic conditions: A systematic review.

OBJECTIVE: This systematic review aimed to identify ICD-10 based validated algorithms for chronic conditions using health administrative data. METHODS: A comprehensive systematic literature search using Ovid MEDLINE, Embase, PsycINFO, Web of Science and CINAHL was performed to identify studies, published between 1983 and May 2023, on validated algorithms for chronic conditions using administrative health data. Two reviewers independently screened titles and abstracts and reviewed full text of selected studies to complete data extraction. A third reviewer resolved conflicts arising at the screening or study selection stages. The primary outcome was validated studies of ICD-10 based algorithms with both sensitivity and PPV of ≥70 %. Studies with either sensitivity or PPV <70 % were included as secondary outcomes. RESULTS: Overall, the search identified 1686 studies of which 54 met the inclusion criteria. Combining a previously published literature search, a total of 61 studies were included for data extraction. The study identified 40 chronic conditions with high validity and 22 conditions with moderate validity. The validated algorithms were based on administrative data from different countries including Canada, USA, Australia, Japan, France, South Korea, and Taiwan. The algorithms identified included several types of cancers, cardiovascular conditions, kidney diseases, gastrointestinal disorders, and peripheral vascular diseases, amongst others. CONCLUSION: With ICD-10 prominently used across the world, this up-to-date systematic review can prove to be a helpful resource for research and surveillance initiatives using administrative health data for identifying chronic conditions.

Optimizing Antifungal Treatment Strategies to Prevent Invasive Pulmonary Aspergillosis Infection-Related Deaths in Intensive Care Unit Patients: The Need for Standardization of Research Definitions.

The clinical spectrum of invasive pulmonary aspergillosis (IPA) has expanded in recent decades. A large group of patients admitted to intensive care units (ICU) is indeed susceptible to the development of IPA. Although timely diagnosis and antifungal therapy of IPA in this expanding population is crucial to prevent IPA-related deaths, the magnitude of the favorable prognostic impact of antifungal therapy is difficult to measure precisely. In our opinion, the development of standardized research definitions could have favorable implications for further improving our ability both to measure the favorable effect of antifungal treatment and to prevent IPA-related death in ICU patients.

Consensus Definitions of Cytomegalovirus (CMV) Infection and Disease in Transplant Patients Including Resistant and Refractory CMV for Use in Clinical Trials: 2024 Update From the Transplant Associated Virus Infections Forum.

Cytomegalovirus (CMV) infection and disease are important causes of morbidity and mortality in transplant recipients. For the purpose of developing consistent reporting of CMV outcomes in clinical trials, definitions of CMV infection and disease were developed and most recently published in 2017. Since then, there have been major developments, including registration of new antiviral agents. Therefore, the Transplant Associated Virus Infections Forum, which consists of scientists, clinicians, regulators, and industry representatives, has produced an updated version of these definitions that incorporates recent knowledge with the aim of supporting clinical research and drug development. This also includes an update regarding the definition of resistant and refractory CMV infections previously published in 2019. As the field evolves, the need for updates of these definitions is clear, and collaborative efforts among clinicians, scientists, regulators, and industry representatives can provide a platform for this work.

Pitfalls in definitions on respiratory viruses and particularities of Adenovirus infection in hematopoietic cell transplantation patients: Recommendations from the EBMT practice harmonization and guidelines committee.

In 2023, the EBMT Practice harmonization and Guidelines Committee partnered with the EBMT Infection Diseases Working Party (IDWP) to undertake the task of delivering best practice recommendations, aiming to harmonize by expert consensus, the already existing definitions and future epidemiological and clinical studies among centers of the EBMT network. To attain this objective, a group of experts in the field was convened. The workgroup identified and discussed some critical aspects in definitions of community-acquired respiratory viruses (CARV) and adenovirus (ADV) infections in recipient of hematopoietic cell transplant (HCT). The methodology involved literature review and expert consensus. For CARV, expert consensus focused on defining infection severity, infection duration, and establishing criteria for lower respiratory tract disease (LRTD). For ADV, the expert consensus focused on surveillance methods and the definitions of ADV infection, certainty levels of disease, response to treatment, and attributable mortality. This consensus workshop provided indications to EBMT community aimed at facilitating data collection and consistency in the EBMT registry for respiratory viral infectious complications.

Applicability of selected Brighton Collaboration case definitions in low-resource settings: A prospective hospital-based active surveillance in Addis Ababa, Ethiopia.

INTRODUCTION: Standardizing case definitions for priority vaccine safety conditions facilitates uniform evaluation and consolidation of data obtained from different settings. The Brighton Collaboration case definitions (BCCD) were created to support this harmonization and enable classification from level 1 (most certain) to level 5 (not a case) of certainty. Assessing the performance of BCCD in practice is critical, particularly in resource-limited settings, where many new vaccines may be introduced without prior monitoring in high-income countries. We assessed the performance of BCCD in Addis Ababa, Ethiopia, as applicable to COVID-19 and other vaccines. METHODS: Active surveillance was conducted at Tikur Anbessa Specialized Hospital, the largest referral hospital in Ethiopia. During June 1, 2022-May 31, 2023, three trained physicians prospectively identified patients eligible for COVID-19 vaccination (regardless of vaccine receipt) who presented with one or more of eleven pre-specified adverse events of special interest (AESI) from the emergency department and inpatient wards. Standardized data collection forms were used to capture patient information and assign level of certainty (LOC), regardless of vaccination status for COVID-19. We conducted descriptive analysis to characterize cases and the LOCs reached for each AESI. RESULTS: We detected 203 AESI cases. The most detected conditions were thrombosis and thromboembolism (n = 100, 49 %) and generalized convulsions (n = 38, 19 %). Ninety-six percent of the cases were confirmed at levels 1-3 (n = 187) or level 5 (n = 9) LOC. Non-classifiable (level 4) cases were observed for pericarditis (n = 2), encephalitis (n = 2), myelitis (n = 2), and generalized convulsion (n = 1). CONCLUSION: The BCCD were successfully applied in > 95 % of cases in a large referral hospital in Ethiopia, with generalized convulsion, pericarditis, and encephalomyelitis as the exceptions. We recommend further evaluation in other low-resource settings, particularly in rural or non-referral hospitals, to gain additional insights into performance of these definitions for revision or adaptation, as needed.

Standards for quantitative assessments by coronary computed tomography angiography (CCTA): An expert consensus document of the society of cardiovascular computed tomography (SCCT).

In current clinical practice, qualitative or semi-quantitative measures are primarily used to report coronary artery disease on cardiac CT. With advancements in cardiac CT technology and automated post-processing tools, quantitative measures of coronary disease severity have become more broadly available. Quantitative coronary CT angiography has great potential value for clinical management of patients, but also for research. This document aims to provide definitions and standards for the performance and reporting of quantitative measures of coronary artery disease by cardiac CT.

Dyslexia in the twenty-first century: a commentary on the IDA definition of dyslexia.

In offering a commentary upon the IDA definition, we address its main components in turn. While each is technically accurate, we argue that, when taken together, the definition, or more accurately, the use to which it is often put, becomes problematic. We outline different current conceptions of dyslexia and conclude that the operationalisation of the definition for diagnostic purposes often results in scientifically questionable diagnoses and inadvertently leads to significant educational inequity. We propose a simpler definition that describes the primary difficulty, avoids reference to causal explanation, unexpectedness, and secondary outcomes, and redirects practitioner and policymaker focus to the importance of addressing and meeting the needs of all struggling readers.