Clinical trials in oncology are important tools to identify and establish new effective drugs for cancer treatment. Since the development of the concept of precision oncology, a huge number of multi-centric biomarker-driven clinical trials have been performed and promoted by either academic institutions or pharmaceutical companies. In this scenario, the role of pathologists is essential in multiple aspects, with new challenges that should be addressed. In this position paper of the European Society of Pathology, the role of pathologists as contributors to the design of the clinical trial, as local collaborators, or as members of central review laboratories is discussed. Moreover, the paper emphasizes the important role of pathologists in guiding methods and criteria of tissue biomarker testing in the biomarker-driven clinical trials. The paper also addresses issues regarding quality control, training, and the possible role of digital pathology.

• MeSH
• klinické zkoušky jako téma * MeSH
• laboratorní medicína normy   metody   MeSH
• lidé MeSH
• nádorové biomarkery * analýza   MeSH
• nádory * patologie   farmakoterapie   MeSH
• patologové * MeSH
• společnosti lékařské MeSH
• výzkumný projekt normy   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• Geografické názvy
• Evropa MeSH

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.

• MeSH
• lidé MeSH
• nevhodné předepisování statistika a číselné údaje   prevence a kontrola   MeSH
• senioři MeSH
• seznam potenciálně nevhodných léčiv * MeSH
• srovnání kultur MeSH
• Check Tag
• lidé MeSH
• senioři MeSH
• Publikační typ
• časopisecké články 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
• hodnocení výsledků zdravotní péče * normy   MeSH
• lidé MeSH
• svalová spasticita * patofyziologie   diagnóza   etiologie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

BACKGROUND: The knowledge and proficiency of primary care practitioners (PCPs) in diagnosing and managing irritable bowel syndrome (IBS) remain generally low and variable internationally. This variability is partly due to a lack of familiarity with the Rome Foundation diagnostic criteria and treatment guidelines for this condition. METHODS: We conducted an electronic survey of PCPs in the United States and nine European countries to assess their understanding of IBS pathophysiology; the use of Rome IV criteria in diagnosis, knowledge of and frequency in prescribing various recommended treatments; and the likelihood of referring patients with suspected IBS to subspecialists. RESULTS: Most PCPs in the United States and Europe perceive IBS as a diagnosis of exclusion rather than a definitive diagnosis. They also believe IBS is underdiagnosed in primary care and challenging to diagnose confidently. The majority of PCPs consider diet as a crucial component of IBS management. Notably, US PCPs reported greater confidence than their European counterparts in recommending dietary interventions such as increased dietary fiber, a low FODMAP diet, and gluten restriction. Conversely, both groups exhibited moderate to high confidence in recommending over-the-counter treatments. European PCPs showed greater confidence in treating IBS with antispasmodics and secretagogues, while US PCPs expressed greater confidence in prescribing neuromodulators. Additionally, US PCPs were more likely to refer patients with suspected IBS to a gastroenterologist, whereas both US and European PCPs showed similar referral patterns to dietitians and referred very few patients to mental health providers. Both US and European PCPs reported that IBS is moderately to extremely difficult to treat effectively and emphasized the importance of a strong and longitudinal doctor-patient relationship in managing the condition. CONCLUSION: Despite the Rome Foundation recommendations and criteria to support a positive diagnosis of IBS, most PCPs still rely on exclusionary investigations such as endoscopy and a serologic workup, while a significant percentage suggest referring patients to gastroenterologists.

• MeSH
• lékaři primární péče MeSH
• lékařská praxe - způsoby provádění * statistika a číselné údaje   MeSH
• lidé MeSH
• postoj zdravotnického personálu MeSH
• primární zdravotní péče MeSH
• průzkumy a dotazníky MeSH
• syndrom dráždivého tračníku * diagnóza   terapie   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Evropa MeSH
• Spojené státy americké MeSH

BACKGROUND: As the healthcare sector evolves, Artificial Intelligence's (AI's) potential to enhance laboratory medicine is increasingly recognized. However, the adoption rates and attitudes towards AI across European laboratories have not been comprehensively analyzed. This study aims to fill this gap by surveying European laboratory professionals to assess their current use of AI, the digital infrastructure available, and their attitudes towards future implementations. METHODS: We conducted a methodical survey during October 2023, distributed via EFLM mailing lists. The survey explored six key areas: general characteristics, digital equipment, access to health data, data management, AI advancements, and personal perspectives. We analyzed responses to quantify AI integration and identify barriers to its adoption. RESULTS: From 426 initial responses, 195 were considered after excluding incomplete and non-European entries. The findings revealed limited AI engagement, with significant gaps in necessary digital infrastructure and training. Only 25.6 % of laboratories reported ongoing AI projects. Major barriers included inadequate digital tools, restricted access to comprehensive data, and a lack of AI-related skills among personnel. Notably, a substantial interest in AI training was expressed, indicating a demand for educational initiatives. CONCLUSIONS: Despite the recognized potential of AI to revolutionize laboratory medicine by enhancing diagnostic accuracy and efficiency, European laboratories face substantial challenges. This survey highlights a critical need for strategic investments in educational programs and infrastructure improvements to support AI integration in laboratory medicine across Europe. Future efforts should focus on enhancing data accessibility, upgrading technological tools, and expanding AI training and literacy among professionals. In response, our working group plans to develop and make available online training materials to meet this growing educational demand.

• MeSH
• klinické laboratoře MeSH
• lidé MeSH
• průzkumy a dotazníky MeSH
• umělá inteligence * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Evropa MeSH

PURPOSE OF REVIEW: This review explores the design and endpoints of perioperative platforms in clinical trials for muscle-invasive bladder cancer (MIBC). RECENT FINDINGS: The choice of clinical trial design in perioperative platforms for MIBC must align with specific research objectives to ensure robust and meaningful outcomes. Novel designs in perioperative platforms for MIBC integrate bladder-sparing approaches. Primary endpoints such as pathological complete response and disease-free survival are highlighted for their role in expediting trial results in perioperative setting. Incorporating patient-reported outcomes is important to inform healthcare decision makers about the outcomes most meaningful to patients. Given the growing body of evidence, potential biomarkers, predictive and prognostic tools should be considered and implemented when designing trials in perioperative platforms for MIBC. SUMMARY: Effective perioperative platforms for MIBC trials are critical in enhancing patient outcomes. The careful selection and standardization of study designs and endpoints in the perioperative platform are essential for the successful implementation of new therapies and the advancement of personalized treatment approaches in MIBC.

• MeSH
• cystektomie metody   škodlivé účinky   MeSH
• invazivní růst nádoru * MeSH
• klinické zkoušky jako téma MeSH
• lidé MeSH
• nádory močového měchýře * chirurgie   patologie   terapie   mortalita   MeSH
• perioperační péče metody   normy   MeSH
• stanovení cílového parametru MeSH
• výsledek terapie MeSH
• výzkumný projekt MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

OBJECTIVE: This scoping review aims to identify, catalogue, and characterize previously reported tools, techniques, methods, and processes that have been recommended or used by evidence synthesizers to detect fraudulent or erroneous data and mitigate its impact. INTRODUCTION: Decision-making for policy and practice should always be underpinned by the best available evidence-typically peer-reviewed scientific literature. Evidence synthesis literature should be collated and organized using the appropriate evidence synthesis methodology, best exemplified by the role systematic reviews play in evidence-based health care. However, with the rise of "predatory journals," fraudulent or erroneous data may be invading this literature, which may negatively affect evidence syntheses that use this data. This, in turn, may compromise decision-making processes. INCLUSION CRITERIA: This review will include peer-reviewed articles, commentaries, books, and editorials that describe at least 1 tool, technique, method, or process with the explicit purpose of identifying or mitigating the impact of fraudulent or erroneous data for any evidence synthesis, in any topic area. Manuals, handbooks, and guidance from major organizations, universities, and libraries will also be considered. METHODS: This review will be conducted using the JBI methodology for scoping reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Databases and relevant organizational websites will be searched for eligible studies. Title and abstract, and, subsequently, full-text screening will be conducted in duplicate. Data from identified full texts will be extracted using a pre-determined checklist, while the findings will be summarized descriptively and presented in tables. REVIEW REGISTRATION: Open Science Framework https://osf.io/u8yrn.

• MeSH
• lidé MeSH
• podvod prevence a kontrola   MeSH
• systematický přehled jako téma MeSH
• vědecký podvod * MeSH
• výzkumný projekt normy   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

Cohort studies are a robust analytical observational study design that explore the difference in outcomes between two cohorts, differentiated by their exposure status. Despite being observational in nature, they are often included in systematic reviews of effectiveness, particularly when randomized controlled trials are limited or not feasible. Like all studies included in a systematic review, cohort studies must undergo a critical appraisal process to assess the extent to which a study has considered potential bias in its design, conduct, or analysis. Critical appraisal tools facilitate this evaluation. This paper introduces the revised critical appraisal tool for cohort studies, completed by the JBI Effectiveness Methodology Group, who are currently revising the suite of JBI critical appraisal tools for quantitative study designs. The revised tool responds to updates in methodological guidance from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group and reporting guidance from PRISMA 2020, providing a robust framework for evaluating risk of bias in a cohort study. Transparent and rigorous assessment using this tool will assist reviewers in understanding the validity and relevance of the results and conclusions drawn from a systematic review that includes cohort studies. This may contribute to better evidence-based decision-making in health care. This paper discusses the key changes made to the tool, outlines justifications for these changes, and provides practical guidance on how this tool should be interpreted and applied by systematic reviewers.

• MeSH
• kohortové studie MeSH
• lidé MeSH
• výzkumný projekt * normy   MeSH
• zkreslení výsledků (epidemiologie) * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

Cieľ: Zmapovať anamnestické charakteristiky a polysomnografické nálezy pacientov s NREM (non rapid eye movement) parasomniou pri zrovnaní s kontrolným súborom a zistiť, či parametry spánku majú súvislosť s klinickými kvalitatívnymi parametrami a komorbiditami. Metodika: Do retrospektívnej štúdie sme zahrnuli 53 pacientov (31 mužov), priemerný vek 31,5 ± 8 rokov. Boli hodnotené anamnestické údaje, vrátane údajov cielených na spánok a jeho poruchy a výsledky polysomnografického vyšetrenia. Polysomnografické nálezy boli porovnané s kontrolnou skupinou 42 zdravých ľudí (23 mužov), priemerný vek 34,1 ± 8 rokov. Výsledky: Najčastejším typom parasomnie hodnoteným podľa anamnézy bol somnambulizmus (88,6 %). Väčšina pacientov udávala začiatok v detstve (86,7 %). Najvýznamnejším triggerom epizód bol stres (26,4 %) a menej často alkohol (3,7 %) a cudzie prostredie (9,4 %). Z komorbidných ochorení sa vyskytovali najčastejšie alergické ochorenia (45,2 %), následne psychiatrické ochorenia (13 %). Počas polysomnografie bola epizóda NREM parasomnie zaznamenaná u 50,9 % pacientov. V porovnaní s kontrolným súborom, mali pacienti s NREM parasomniou kratšiu latenciu zaspania, lepšiu spánkovú efektivitu, nižší podiel bdelosti a vyšší podiel NREM 2 spánku. V skupine pacientov s familiárnym výskytom parasomnie bol zistený nižší podiel NREM 3 spánku. Záver: Najčastejším komorbidným ochorením u pacientov s NREM parasomniou boli alergické ochorenia. Stres bol u NREM parasomnií dominantným triggerom parasomnických epizód, preto má zmysel sa na jeho management zameriavať v klinickej praxi. Zistená súvislosť úbytku NREM 3 spánku a rodinného výskytu podporuje súčasný názor, že dysregulácia NREM 3 má dedičnú predispozíciu.

Objective: To map the anamnestic characteristics and polysomnographic profile of patients with NREM (non rapid eye movement) parasomnia compared to a control group and to determine whether sleep parameters are related to clinical qualitative parameters and comorbidities. Methodology: We included 53 patients (31 men), average age 31.5 ± 8 years, in the retrospective study. We evaluated anamnestic data, including data focused on sleep and sleep disorders, and the results of polysomnographic examination. Polysomnographic findings were compared with a control group of 42 healthy people (23 men), average age 34.1 ± 8 years. Results: The most frequent type of parasomnia evaluated according to the anamnesis was somnambulism (88.6%). The majority of patients reported onset in childhood (86.7%). The most important trigger of episodes was stress (26.4%) and less often alcohol (3.7%), and a foreign environment (9.4%). Among comorbid diseases, allergic diseases were the most frequent (45.2%), followed by psychiatric diseases (13%). During polysomnography, an episode of NREM parasomnia was noted in 50.9% of patients. Compared to the control group, patients with NREM parasomnia had shorter sleep latency, better sleep efficiency, lower proportion of wakefulness, and higher proportion of NREM 2 sleep. A lower proportion of NREM 3 sleep was found in the group of patients with a familial occurrence of parasomnia. Conclusion: The most common comorbid diseases in patients with NREM parasomnia were allergic diseases. Stress was the dominant trigger of parasomnia episodes in NREM parasomnias, so it is important to focus on its management in clinical practice. The association found between NREM 3 sleep loss and familial occurrence supports the current view that NREM 3 dysregulation has a heritable predisposition.

• MeSH
• alergie MeSH
• komorbidita MeSH
• lidé MeSH
• parasomnie * MeSH
• polysomnografie MeSH
• retrospektivní studie MeSH
• spánek pomalých vln MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• práce podpořená grantem MeSH

Cíl: Přehled možností využití nelékařského zdravotnického oboru ergoterapie v onkogynekologii, popis role ergoterapeuta v prehabilitaci, zhodnocení dat z pilotní studie. Soubor a metodika: Do studie probíhající od listopadu 2023 do října 2024 bylo zařazeno celkem 18 pacientek, prospektivní studie probíhala po dobu 9 měsíců. Jednalo se o pacientky přijaté k 3týdenní intenzivní multimodální prehabilitaci v režimu 4/7 před plánovaným operačním výkonem pro primární nebo recidivující maligní nádor ovaria, endometria nebo děložního hrdla. Pacientkám se v rámci prehabilitace věnoval kromě lékařů i fyzioterapeut, psycholog, nutriční specialista a ergoterapeut. Klinická práce ergoterapeuta byla změřena na vyšetření a následnou terapii v oblasti kognitivních funkcí, jemné motoriky horních končetin, soběstačnosti a kvality života. Ergoterapeut aplikoval vybrané funkční testy a dotazníky (MKF klasifikace, Hand grip test, MoCA test, 5× Sit-to-Stand test, WHODAS 2.0) pro zjištění efektu rehabilitační intervence. Výsledky a závěry: Důležitými sledovanými ukazateli byly vybrané funkční schopnosti, které mají významný dopad na kvalitu života pacientek. Výsledky funkčních testů prokázaly významné zlepšení klíčových parametrů vlivem intenzivní prehabilitace, což potvrzuje zásadní roli intervence ergoterapeuta v onkogynekologické prehabilitaci.

Objective: Overview of the possibilities of using non-medical occupational therapy in oncogynecology, description of the role of an occupational therapist in prehabilitation, and evaluation of data from a pilot study. Methods: The study cohort consisted of 18 patients enrolled between November 2023 and October 2024. The prospective study was conducted over a period of nine months. Patients were admitted for a 3-week intensive multimodal prehabilitation program scheduled on a 4/7 basis prior to elective surgery for primary or recurrent malignant ovarian, endometrial, or cervical cancer. In addition to the physicians, patients received prehabilitation by a physiotherapist, psychologist, nutritionist, and occupational therapist. Clinical work of the occupational therapist was measured upon examination and subsequent therapy in the areas of cognitive function, fine motor skills of the upper limbs, self-sufficiency, and quality of life. The occupational therapist applied selected functional tests and questionnaires (MKF classification, Hand grip test, MoCA test, 5× Sit-to-Stand test, WHODAS 2.0) to determine the effect of the rehabilitation intervention. Results and conclusions: Important indicators were selected functional abilities that have a significant impact on the quality of life of patients. The results of functional tests showed a significant improvement of key parameters due to intensive prehabilitation, confirming the essential role of occupational therapist intervention in oncogynecological prehabilitation.

• MeSH
• ergoterapie * metody   statistika a číselné údaje   MeSH
• fyzioterapie v předoperační přípravě MeSH
• hodnocení výsledků péče pacientem MeSH
• kvalita života MeSH
• lidé MeSH
• nádory ženských pohlavních orgánů * rehabilitace   MeSH
• pilotní projekty MeSH
• prospektivní studie MeSH
• průzkumy a dotazníky MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• práce podpořená grantem MeSH