BACKGROUND: Various explicit screening tools, developed mostly in central Europe and the USA, assist clinicians in optimizing medication use for older adults. The Turkish Inappropriate Medication use in oldEr adults (TIME) criteria set, primarily based on the STOPP/START criteria set, is a current explicit tool originally developed for Eastern Europe and subsequently validated for broader use in Central European settings. Reviewed every three months to align with the latest scientific literature, it is one of the most up-to-date tools available. The tool is accessible via a free mobile app and website platforms, ensuring convenience for clinicians and timely integration of updates as needed. Healthcare providers often prefer to use their native language in medical practice, highlighting the need for prescribing tools to be translated and adapted into multiple languages to promote optimal medication practices. OBJECTIVE: To describe the protocol for cross-cultural and language validation of the TIME criteria in various commonly used languages and to outline its protocol for clinical validation across different healthcare settings. METHODS: The TIME International Study Group comprised 24 geriatric pharmacotherapy experts from 12 countries. In selecting the framework for the study, we reviewed the steps and outcomes from previous research on cross-cultural adaptations and clinical validations of explicit tools. Assessment tools were selected based on both their validity in accurately addressing the relevant issues and their feasibility for practical implementation. The drafted methodology paper was circulated among the study group members for feedback and revisions leading to a final consensus. RESULTS: The research methodology consists of two phases. Cross-cultural adaptation/language validation phase follows the 8-step approach recommended by World Health Organization. This phase allows regions or countries to make modifications to existing criteria or introduce new adjustments based on local prescribing practices and available medications, as long as these adjustments are supported by current scientific evidence. The second phase involves the clinical validation, where participants will be randomized into two groups. The control group will receive standard care, while the intervention group will have their treatment evaluated by clinicians who will review the TIME criteria and consider its recommendations. A variety of patient outcomes (i.e., number of hospital admissions, quality of life, number of regular medications [including over the counter medications], geriatric syndromes and mortality) in different healthcare settings will be investigated. CONCLUSION: The outputs of this methodological report are expected to promote broader adoption of the TIME criteria. Studies building on this work are anticipated to enhance the identification and management of inappropriate medication use and contribute to improved patient outcomes.
BACKGROUND: Patients with severe aortic stenosis present frequently (∼50%) with concomitant obstructive coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as the preferred treatment. Transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) represent a valid treatment alternative. We aimed to test the non-inferiority of FFR-guided PCI plus TAVI versus SAVR plus CABG in patients with severe aortic stenosis and complex coronary artery disease. METHODS: This international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial was conducted at 18 tertiary medical centres across Europe. Patients (aged ≥70 years) with severe aortic stenosis and complex coronary artery disease, deemed feasible for percutaneous or surgical treatment according to the on-site Heart Team, were randomly assigned (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG according to a computer-generated sequence with random permuted blocks sizes stratified by site. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularisation, valve reintervention, and life-threatening or disabling bleeding at 1 year post-treatment. The trial was powered for non-inferiority (with a margin of 15%) and if met, for superiority. The primary and safety analyses were done per an intention-to-treat principle. This trial is registered with ClinicalTrials.gov (NCT03424941) and is closed. FINDINGS: Between May 31, 2018, and June 30, 2023, 172 patients were enrolled, of whom 91 were assigned to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age of patients was 76·5 years (SD 3·9). 118 (69%) of 172 patients were male and 54 (31%) patients were female. FFR-guided PCI plus TAVI resulted in favourable outcomes for the primary endpoint (four [4%] of 91 patients) versus SAVR plus CABG (17 [23%] of 77 patients; risk difference -18·5 [90% CI -27·8 to -9·7]), which was below the 15% prespecified non-inferiority margin (pnon-inferiority<0·001). FFR-guided PCI plus TAVI was superior to SAVR plus CABG (hazard ratio 0·17 [95% CI 0·06-0·51]; psuperiority<0·001), which was driven mainly by all-cause mortality (none [0%] of 91 patients vs seven (10%) of 77 patients; p=0·0025) and life-threatening bleeding (two [2%] vs nine [12%]; p=0·010). INTERPRETATION: The TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment. FUNDING: Isala Heart Centre and Medtronic.
- MeSH
- Aortic Valve Stenosis * surgery complications MeSH
- Heart Valve Prosthesis Implantation methods MeSH
- Fractional Flow Reserve, Myocardial * MeSH
- Percutaneous Coronary Intervention * methods MeSH
- Coronary Artery Bypass * methods MeSH
- Humans MeSH
- Coronary Artery Disease * surgery complications therapy MeSH
- Prospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Transcatheter Aortic Valve Replacement * methods MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Equivalence Trial MeSH
- Multicenter Study MeSH
- Comparative Study MeSH
BACKGROUND: Spasticity is a common feature in patients with disruptions in corticospinal pathways. However, the term is used ambiguously. Here, spasticity is defined as enhanced velocity-dependent stretch reflexes and placed within the context of deforming spastic paresis encompassing other forms of muscle overactivity. OBJECTIVE: This scoping review aims at evaluating the clinimetric quality of clinical outcome assessments (COAs) for spasticity across different pathologies and to make recommendations for their use. METHODS: A literature search was conducted to identify COAs used to assess spasticity. An international expert panel evaluated the measurement properties in the included COAs. Recommendations were based on the MDS-COA program methodology based on three criteria: if the COA was (1) applied to patients with spastic paresis, (2) used by others beyond the developers, and (3) determined to be reliable, valid, and sensitive to change in patients with spasticity. RESULTS: We identified 72 COAs of which 17 clinician-reported outcomes (ClinROs) and 6 patient-reported outcomes (PROs) were reviewed. The Tardieu Scale was the only ClinRO recommended for assessing spasticity. One ClinRO-Composite Spasticity Index-and two PROs-Spasticity 0-10 Numeric Rating Scale and 88-Item Multiple Sclerosis Spasticity Scale-were recommended with caveats. The Ashworth-derived COAs were excluded after evaluation due to their focus on muscle tone rather than spasticity, as defined in this review. CONCLUSIONS: The Tardieu Scale is recommended for assessing spasticity, and two PROs are recommended with caveats. Consistent terminology about the various types of muscle overactivity is necessary to facilitate their assessment and treatment. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
- MeSH
- Outcome Assessment, Health Care * standards MeSH
- Humans MeSH
- Muscle Spasticity * physiopathology diagnosis etiology MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
OBJECTIVE AND BACKGROUND: The 10-item Edinburgh Postnatal Depression Scale (EPDS) is a widely-used screening measure for postnatal depression. Factor analysis studies have suggested an embedded sub-scale could be used for screening for anxiety disorders. The current investigation sought to replicate and extend a recent study supporting this assertion. METHODS: A cross-sectional design. EPDS data were collected at up to two years postpartum. Confirmatory factor analysis, correlational and distributional characteristics of the measure were examined. Participants were a large sample (N = 985) of postpartum women in the Czech Republic. RESULTS: Factor structure findings substantially replicated the models evaluated by Della Vedova et al. (2022). Bifactor models, however, offered a better fit to data. A general factor of depression explained most of the variance in data in most models compared to embedded sub-scales across models. CONCLUSION: The model proposed by Della Vedova et al. (2022) offered an excellent fit to data. However, the findings from the bifactor modelling suggest the dominance of a general factor of depression which indicates the potential application of an embedded anxiety sub-scale for screening may be overstated.
- MeSH
- Adult MeSH
- Factor Analysis, Statistical MeSH
- Humans MeSH
- Young Adult MeSH
- Depression, Postpartum * diagnosis psychology MeSH
- Cross-Sectional Studies MeSH
- Psychiatric Status Rating Scales * standards MeSH
- Psychometrics MeSH
- Reproducibility of Results MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Young Adult MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Czech Republic MeSH
Minimal residual disease (MRD) is one of the most important prognostic factors in multiple myeloma (MM) and a valid surrogate for progression-free survival (PFS) and overall survival (OS). Recently, MRD negativity was approved as an early clinical endpoint for accelerated drug approval in MM. Nevertheless, there is limited evidence of MRD utility in real-world setting. In this retrospective multicenter study, we report outcomes of 331 newly diagnosed MM patients with MRD evaluation at Day+100 after autologous stem cell transplantation using flow cytometry with a median limit of detection of 0.001%. MRD negativity was reached in 47% of patients and was associated with significantly prolonged median PFS (49.2 months vs. 18.4 months; hazard ratios (HR) = 0.37; p < 0.001) and OS (not reached vs. 74.9 months; HR = 0.50; p = 0.007). Achieving MRD negativity was associated with PFS improvements regardless of age, International Staging System (ISS) stage, lactate dedydrogenase (LDH) level, or cytogenetic risk. Importantly, MRD positive patients benefited from lenalidomide maintenance versus no maintenance (18-months PFS: 81% vs. 46%; HR = 0.24; p = 0.002) while in MRD negative patients such benefit was not observed (p = 0.747). The outcomes of our real-world study recapitulate results from clinical trials including meta-analyses and support the idea that MRD positive patients profit more from lenalidomide maintenance than MRD negative ones.
- MeSH
- Transplantation, Autologous MeSH
- Adult MeSH
- Lenalidomide administration & dosage therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Multiple Myeloma * diagnosis mortality therapy pathology MeSH
- Prognosis MeSH
- Flow Cytometry * methods MeSH
- Retrospective Studies MeSH
- Neoplasm, Residual * diagnosis MeSH
- Aged MeSH
- Neoplasm Staging MeSH
- Hematopoietic Stem Cell Transplantation methods MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
BACKGROUND: Mucosal visualization during upper gastrointestinal (UGI) endoscopy can be impaired by the presence of foam, bubbles, and mucus. Some UGI endoscopy visibility scales have been proposed but have not undergone multicenter validation. This study aimed to develop and validate the Gastroscopy RAte of Cleanliness Evaluation (GRACE) scale. METHODS: A multicenter, international, cross-sectional study was conducted. The GRACE scale is based on a score from 0 (worst) to 3 (excellent) for esophagus, stomach, and duodenum, for a total ranging from 0 to 9. In phase 1, four expert endoscopists evaluated 60 images twice, with a 2-week interval between rounds; in phase 2, the same 60 images were scored twice by one expert and one nonexpert endoscopist from 27 endoscopy departments worldwide. For reproducibility assessment and real-time validation, the scale was applied to consecutive patients undergoing gastroscopy at each center. RESULTS: On internal validation, interobserver agreement was 0.81 (95 %CI 0.73-0.87) and 0.80 (95 %CI 0.72-0.86), with reliability of 0.73 (95 %CI 0.63-0.82) and 0.72 (95 %CI 0.63-0.81), in the two rounds, respectively. On external validation, overall interobserver agreement was 0.85 (95 %CI 0.82-0.88) and reliability was 0.79 (95 %CI 0.73-0.84). In real-time evaluation, the overall proportion of correct classifications was 0.80 (95 %CI 0.77-0.82). CONCLUSIONS: The GRACE scale showed good interobserver agreement, reliability, and validity. The widespread use of this scale could enhance quality and standardize the assessment of mucosal cleanliness during UGI endoscopy, pushing endoscopists to strive for excellent visibility and reducing the risk of missed lesions.
- MeSH
- Adult MeSH
- Duodenum MeSH
- Gastroscopy * methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Observer Variation * MeSH
- Cross-Sectional Studies MeSH
- Reproducibility of Results MeSH
- Aged MeSH
- Gastric Mucosa MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Validation Study MeSH
The UPPS-P Impulsive Behavior Model and the various psychometric instruments developed and validated based on this model are well established in clinical and research settings. However, evidence regarding the psychometric validity, reliability, and equivalence across multiple countries of residence, languages, or gender identities, including gender-diverse individuals, is lacking to date. Using data from the International Sex Survey (N = 82,243), confirmatory factor analyses and measurement invariance analyses were performed on the preestablished five-factor structure of the 20-item short version of the UPPS-P Impulsive Behavior Scale to examine whether (a) psychometric validity and reliability and (b) psychometric equivalence hold across 34 country-of-residence-related, 22 language-related, and three gender-identity-related groups. The results of the present study extend the latter psychometric instrument's well-established relevance to 26 countries, 13 languages, and three gender identities. Most notably, psychometric validity and reliability were evidenced across nine novel translations included in the present study (i.e., Croatian, English, German, Hebrew, Korean, Macedonian, Polish, Portuguese-Portugal, and Spanish-Latin American) and psychometric equivalence was evidenced across all three gender identities included in the present study (i.e., women, men, and gender-diverse individuals).
- MeSH
- Adult MeSH
- Factor Analysis, Statistical MeSH
- Gender Identity * MeSH
- Impulsive Behavior * MeSH
- Language MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Surveys and Questionnaires MeSH
- Psychometrics MeSH
- Reproducibility of Results MeSH
- Cross-Cultural Comparison MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Validation Study MeSH
Úvod: Současný demografický vývoj zvyšuje potřebu hledání efektivních způsobů podpory starší populace, zejména v oblasti duševního zdraví, životní pohody a soběstačnosti. V ordinacích praktických lékařů se stále častěji objevují pacienti, jejichž potřeby přesahují rámec farmakologické léčby. Jedním z možných přístupů jak s touto tendencí pracovat je tzv. „social prescribing“ – doporučování nefarmakologických a komunitních intervencí jako součást komplexní zdravotní péče. Přehled konceptu: Social prescribing je inovativní mezioborový přístup, který propojuje zdravotní a sociální profesionální péči s neformální podporou a dostupnými komunitními zdroji. Jeho cílem je poskytovat individualizovanou podporu přizpůsobenou potřebám jednotlivce i charakteru komunity, ve které žije, a zároveň odlehčit systému profesionální zdravotní péče. Důraz je kladen na aktivní zapojení člověka do života v komunitě s ohledem na jeho zdravotní, sociální, emocionální i praktické potřeby ovlivňující jeho zdraví. Příklad z praxe: Článek dále představuje mezinárodní studii RECETAS, která zkoumá potenciál social prescribing aktivit v přírodním prostředí při snižování osamělosti a zlepšování kvality života u seniorů žijících ve městech. Studie se zaměřuje na možnosti propojení zdravotní péče s komunitními programy podporujícími duševní zdraví a jedním z míst, kde studie probíhá je Praha. Závěr: Social prescribing představuje perspektivní doplněk klasické profesionální péče, který může obohatit praxi i v českém prostředí. Podporuje aktivní stárnutí, duševní pohodu a propojení formální a neformální péče o seniory. Pro jeho širší využití je však klíčová další odborná diskuse, výzkumné ověření a institucionální ukotvení v systému zdravotní a sociální péče.
Novotná B, Bártová A, Šlemarová G, Macháčová K, Holmerová I. Beyond medications: Social prescribing for older persons Introduction: Current demographic trends are increasing the need to develop effective approaches to support the growing older population, particularly in areas such as mental health, well-being, and self-sufficiency. General practitioners are increasingly encountering patients whose needs extend beyond pharmacological treatment. One emerging approach is known as social prescribing – the recommendation of non-pharmacological and community-based interventions as part of comprehensive care. Conceptual Framework: Social prescribing is an innovative, interdisciplinary approach that integrates professional healthcare and social services with informal support and locally available community resources while also reducing the burden on the health care system. Its primary aim is to provide individualized care tailored to the needs of each person and their community context. The emphasis is on encouraging meaningful participation and active engagement in community life, considering the individual’s health, social, emotional, and practical needs. Research-Based example: The article also presents the international RECETAS study, which investigates the potential of nature-based social prescribing interventions to reduce loneliness and enhance the quality of life among older adults living in urban environments. The study explores how healthcare can be meaningfully linked to community programs that support mental health and social inclusion. Conclusion: Social prescribing offers a promising complement to traditional care and has the potential to enrich clinical practice in the Czech Republic. It promotes active aging, mental well-being, and the integration of formal and informal support systems for older people. However, broader implementation requires further expert discussion, empirical validation, and institutional integration into the health and social care systems.
- Keywords
- social prescribing,
- MeSH
- Quality of Life * MeSH
- Humans MeSH
- Loneliness MeSH
- Delivery of Health Care MeSH
- Aged MeSH
- Social Welfare MeSH
- Aging * MeSH
- Check Tag
- Humans MeSH
- Aged MeSH
- Publication type
- Research Support, Non-U.S. Gov't MeSH
Carotid plaque composition represents one of the main risk factors of future ischemic stroke. MRI provides excellent soft tissue contrast that can distinguish plaque characteristics. Our objective was to analyze the diagnostic accuracy of MRI imaging in the detection of carotid plaque characteristics compared to histology in patients with symptomatic and asymptomatic carotid atherosclerosis through a systematic review. After prospective registration in PROSPERO (ID CRD42022329690), Medline Ovid, Embase.com, Cochrane Library, and Web of Science Core were searched without any search limitation up to May 27, 2022 to identify eligible articles. Of the 8168 studies, 53 (37 × 1.5 T MRI, 17 × 3 T MRI) evaluated MRI accuracy in the detection of 13 specific carotid plaque characteristics in 169 comparisons. MRI demonstrated high diagnostic accuracy for detection of calcification (3 T MRI: mean sensitivity 92%/mean specificity 90%; 1.5 T MRI: mean sensitivity 81%/mean specificity 91%), fibrous cap (1.5 T: 89%/87%), unstable plaque (1.5 T: 89%/87%), intraplaque hemorrhage (1.5 T: 86%/88%), and lipid-rich necrotic core (1.5 T: 89%/79%). MRI also proved to have a high level of tissue discrimination for the carotid plaque characteristics investigated, allowing potentially for a better risk assessment and follow-up of patients who may benefit from more aggressive treatments. These results emphasize the role of MRI as the first-line imaging modality for comprehensive assessment of carotid plaque morphology, particularly for unstable plaque. EVIDENCE LEVEL: 2 TECHNICAL EFFICACY: Stage 2.
- MeSH
- Carotid Arteries * diagnostic imaging pathology MeSH
- Plaque, Atherosclerotic * diagnostic imaging MeSH
- Humans MeSH
- Magnetic Resonance Imaging * methods MeSH
- Carotid Artery Diseases * diagnostic imaging pathology MeSH
- Reproducibility of Results MeSH
- Sensitivity and Specificity MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Comparative Study MeSH
- Systematic Review MeSH
INTRODUCTION: Plasma phosphorylated tau (p-tau)181, glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), and amyloid beta ratio (Aβ42/40) may have diagnostic and prognostic value in Alzheimer's disease (AD). Here we assess which markers can best identify AD from controls and other non-AD dementias in a large international multi-center study. METHODS: Plasma samples (n = 1298) were collected from six international centers. Aβ40, Aβ42, GFAP, NfL, and p-tau181 were measured using single molecule array. In each group, AD diagnosis/co-pathology was defined according to cerebrospinal fluid biomarkers or amyloid positron emission tomography. Validations were performed in three separate cohorts via single and dual cut-off models. RESULTS: p-tau181 showed the best area under the curve value to separate AD from frontotemporal dementia, controls, and Aβ- dementia with Lewy bodies. However, this discriminative power could not be reproduced by applying pre-defined cut-offs. DISCUSSION: p-tau181 was the best single plasma marker for detecting AD at any stage. Specific cut-offs are needed to maximize diagnostic performances. HIGHLIGHTS: Phosphorylated tau (p-tau)181 provided a clear differentiation between controls and Alzheimer's disease (AD) participants, with evidence of increased levels in the preclinical stage of AD. Plasma biomarkers demonstrated that when amyloid co-pathology is removed from dementia with Lewy bodies (DLB), only glial fibrillary acidic protein and neurofilament light chain remain to predict DLB. Given the low prevalence of amyloid co-pathology in frontotemporal dementia (FTD), p-tau181 and its ratio with amyloid beta 42 are strong biomarkers to differentiate FTD from AD.
- MeSH
- Alzheimer Disease * blood diagnosis MeSH
- Amyloid beta-Peptides * blood MeSH
- Biomarkers blood MeSH
- Dementia * blood diagnosis MeSH
- Phosphorylation MeSH
- Glial Fibrillary Acidic Protein * blood MeSH
- Middle Aged MeSH
- Humans MeSH
- Neurofilament Proteins * blood MeSH
- Peptide Fragments * blood MeSH
- tau Proteins * blood MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
