Analytical analysis
Dotaz
Zobrazit nápovědu
BACKGROUND: Psychotherapy outcomes are typically measured in terms of symptom relief. However, this method might overlook important changes from clients' perspectives when they are asked to report on them. A more client-centred approach might bring a deeper understanding of psychotherapy outcomes. We aimed to evaluate the outcomes identified by clients within qualitative psychotherapy research. METHODS: The PsycArticles, PsycInfo, and MEDLINE Complete databases were searched for English language studies published until Nov 11, 2023. Additional studies were identified through references in the primary studies and previous meta-analyses or systematic reviews. Search terms were related to psychotherapy and counselling, clients' or patients' experiences, psychotherapy outcomes and changes, post-treatment perspectives, and types of qualitative methods. Qualitative studies on client-identified outcomes of individual psychotherapy were included. Findings related to clients' perceptions of psychotherapy outcomes were extracted (by ML and checked by TR and LT) and analysed (by all authors) using the descriptive-interpretative meta-analytic approach. All authors have personally experienced psychotherapy as clients. This study was pre-registered with PROSPERO (CRD42021277330). FINDINGS: We included 177 studies in the qualitative meta-analysis, from 24 countries, including descriptions from 2908 clients. Most of the studies were of good quality; they covered a wide range of therapeutic approaches and diagnoses. The descriptions of psychotherapy outcomes were classified into 60 meta-categories and grouped into ten clusters. These clusters related to clients' relational and social functioning; their emotional functioning; self-awareness, self-understanding, and more adaptive cognitive processing; behavioural functioning; developing their own resources; clients' attitudes towards themselves; generally embracing life; symptom and problem change; and more general wellbeing. The tenth cluster was outcomes that could not be clearly attributed to psychotherapy, which was considered outside the scope of this study. INTERPRETATION: The meta-analysis showed that clients value outcome dimensions beyond symptom reduction, such as deeper self-understanding, enhanced self-agency, and greater social engagement. By examining psychotherapy outcomes across various diagnoses and therapeutic approaches, we highlight limitations in traditional outcome measures, showing the need for more comprehensive, client-centred assessment tools and the value of incorporating qualitative methods into understanding dimensions of change. FUNDING: European Union.
- MeSH
- duševní poruchy terapie psychologie MeSH
- kvalitativní výzkum MeSH
- lidé MeSH
- psychoterapie * metody MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- práce podpořená grantem MeSH
BACKGROUND AND OBJECTIVE: Non-muscle-invasive bladder cancer (NMIBC) poses a significant clinical challenge, particularly when failing bacillus Calmette-Guérin (BCG) therapy, necessitating alternative treatments. Despite radical cystectomy being the recommended treatment, many patients are unfit or unwilling to undergo this invasive procedure, highlighting the need for effective bladder-sparing therapies. This review aims to summarize and report the evidence on the efficacy and to estimate the costs of bladder-preserving strategies used in NMIBC recurrence after failure of intravesical BCG therapy. METHODS: We systematically searched online databases for prospective studies investigating intravesical therapy, systemic therapy, or combination of both in patients treated previously with BCG. Owing to significant heterogeneity across the studies, a meta-analysis was inappropriate. A sensitivity analysis was performed in an exploratory manner. We used a decision-analytic Markov model to compare novel U.S. Food and Drug Administration-approved treatments with a 2-yr time horizon. KEY FINDINGS AND LIMITATIONS: A total of 57 studies published between 1998 and 2024, with 68 unique study arms and consisting of 2589 patients, were identified. The 3-mo overall response rate (ORR) across all studies, complete response rate (CRR) in concomitant carcinoma in situ (CIS) or CIS only disease, and recurrence-free rate (RFR) in papillary disease were estimated to be 52.4% (95% confidence interval [CI]: 45.4-59.2), 52.8% (95% CI: 42.9-62.6), and 26.4% (95% CI: 13.3-45.6), respectively. The 12-mo ORR, CRR, and RFR were estimated to be 78% (95% CI: 52.9-91.8), 27.8% (95% CI: 21.3-35.4), and 25.4% (95% CI: 18.2-34.2), respectively. The progression rate was estimated to be 13% (95% CI: 9-18.2). The mean proportion of patients treated with radical cystectomy was estimated to be 24.7 (range 0-85.7). The reported toxicity grades were overall mild, with a median of 3.4% (range 0-33.3%) participants experiencing a dose limiting toxicity. Compared with using radical cystectomy to treat patients failing BCG therapy, at a willingness-to-pay threshold of 100 000 USD, nadofaragene firadenovec was cost effective, with an incremental cost-effectiveness ratio (ICER) of 10 014 USD per quality-adjusted life year (QALY), while nogapendekin alfa inbakicept was less cost effective than nadofaragene firadenovec (ICER of 44 602 USD per QALY). Pembrolizumab, which dominated, was both less costly and more effective than the other strategies. CONCLUSIONS AND CLINICAL IMPLICATIONS: Salvage bladder-sparing therapies show a response rate of around 50% at 3 mo in patients with NMIBC failing BCG. However, long-term data are heterogeneous. Nevertheless, recently developed agents show promising tumor control activity. In the rapidly evolving landscape of urothelial cancer, some of these treatment strategies might be cost effective and improve patients' quality of life. The findings of our review highlight the need for novel, more effective therapeutic strategies. PATIENT SUMMARY: In this study, we reviewed the evidence on the efficacy of bladder-preserving strategies used in patients with bladder cancer recurrence after failing bacillus Calmette-Guérin (BCG) therapy. We found that these strategies show a response rate of around 50% at 3 mo. However, long-term data are heterogeneous. Nevertheless, recently developed agents show promising tumor control activity. In the rapidly evolving landscape of urothelial cancer, some of these treatment strategies might be cost effective and improve patients' quality of life.
- MeSH
- adjuvancia imunologická * terapeutické užití ekonomika MeSH
- analýza nákladů a výnosů * MeSH
- aplikace intravezikální MeSH
- BCG vakcína * terapeutické užití ekonomika MeSH
- invazivní růst nádoru MeSH
- lidé MeSH
- lokální recidiva nádoru MeSH
- nádory močového měchýře neinvadující svalovinu MeSH
- nádory močového měchýře * farmakoterapie patologie terapie ekonomika MeSH
- neúspěšná terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- systematický přehled MeSH
OBJECTIVES: Decision-analytic models assessing the value of emerging Alzheimer's disease (AD) treatments are challenged by limited evidence on short-term trial outcomes and uncertainty in extrapolating long-term patient-relevant outcomes. To improve understanding and foster transparency and credibility in modeling methods, we cross-compared AD decision models in a hypothetical context of disease-modifying treatment for mild cognitive impairment (MCI) due to AD. METHODS: A benchmark scenario (US setting) was used with target population MCI due to AD and a set of synthetically generated hypothetical trial efficacy estimates. Treatment costs were excluded. Model predictions (10-year horizon) were assessed and discussed during a 2-day workshop. RESULTS: Nine modeling groups provided model predictions. Implementation of treatment effectiveness varied across models based on trial efficacy outcome selection (clinical dementia rating - sum of boxes, clinical dementia rating - global, mini-mental state examination, functional activities questionnaire) and analysis method (observed severity transitions, change from baseline, progression hazard ratio, or calibration to these). Predicted mean time in MCI ranged from 2.6 to 5.2 years for control strategy and from 0.1 to 1.0 years for difference between intervention and control strategies. Predicted quality-adjusted life-year gains ranged from 0.0 to 0.6 and incremental costs (excluding treatment costs) from -US$66 897 to US$11 896. CONCLUSIONS: Trial data can be implemented in different ways across health-economic models leading to large variation in model predictions. We recommend (1) addressing the choice of outcome measure and treatment effectiveness assumptions in sensitivity analysis, (2) a standardized reporting table for model predictions, and (3) exploring the use of registries for future AD treatments measuring long-term disease progression to reduce uncertainty of extrapolating short-term trial results by health-economic models.
- MeSH
- Alzheimerova nemoc * ekonomika farmakoterapie MeSH
- analýza nákladů a výnosů * MeSH
- ekonomické modely MeSH
- kognitivní dysfunkce * ekonomika MeSH
- kvalitativně upravené roky života MeSH
- lidé MeSH
- metody pro podporu rozhodování MeSH
- progrese nemoci MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie 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
Background: Advances in the field of facial reanimation surgery have resulted in an increase in the quantity of published research in the international literature. The aim of this work is to provide the reader a synthesized view of the most influential themes, articles and authors in this field. Material and methods: We searched the Clarivate Analytics Web of Science Citation Index to identify the 50 most cited papers in dynamic facial reanimation in the past 70 years. Data regarding article title, authors, year of publication, total citations and citation index was obtained. Results are presented using descriptive statistics. Results: The most cited articles were distributed in 16 journals. Plastic and Reconstructive Surgery had the highest number of highly cited works with 27 articles, followed by JPRAS (5 papers) and the Journal of Neurosurgery (4 papers). The United States contributed most (17 papers), followed by Canada and Japan (6 each). Dr. Julia K. Terzis was the most cited author (7 works). Case series and comparative studies were the most prevalent type of article published (96%) from 1953 to 2015. The most cited paper focused on free functional muscle transfer (FFMT). Most articles were level IV research, with a mean citation index of 5.27 ± 2.85. Conclusion: This collection offers a clear overview of the key milestones and advancements in the field. We expect it serves as a practical resource for clinicians and researchers striving to advance the science and practice of facial reanimation surgery.
During pregnancy the alterations of kynurenine and tryptophan metabolism play an important role in local signalling and the prevention of fetal rejection. The aim was to investigate urinary levels of kynurenine and tryptophan during physiological pregnancy, and to determine their stability in urine during sample storage at different conditions. Urinary samples were obtained from 73 healthy pregnant women (median age 31 years), during the 1st, 2nd, and 3rd trimesters and from 42 healthy non-pregnant women (median age 30 years). Liquid chromatography methods using selective and sensitive mass spectrometry detection were used for analysis. Urinary neopterin, kynurenine, and tryptophan increased during the pregnancy and in comparison to the non-pregnant women. No correlation of the analytes with gestation age within each trimester and among the different analytes was observed. Kynurenine and tryptophan were stable in urine for 14 days at 4 °C, 6 months at - 22 °C, and 12 months at - 84 °C. Present results demonstrate differences in urinary concentrations of kynurenine, tryptophan, and neopterin between women with physiological pregnancy and healthy women. Simultaneous determination of kynurenine, tryptophan and neopterin may be explored in the disorders of pregnancy in future investigations.
- MeSH
- chromatografie kapalinová MeSH
- dospělí MeSH
- kynurenin * moč MeSH
- lidé MeSH
- mladý dospělý MeSH
- neopterin * moč MeSH
- těhotenství MeSH
- tryptofan * moč MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladý dospělý MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
INTRODUCTION: The provision of optimal care for older adults with complex chronic conditions (CCCs) poses significant challenges due to the interplay of multiple medical, pharmacological, functional and psychosocial factors. To address these challenges, the I-CARE4OLD project, funded by the EU-Horizon 2020 programme, developed an advanced clinical decision support tool-the iCARE tool-leveraging large longitudinal data from millions of home care and nursing home recipients across eight countries. The tool uses machine learning techniques applied to data from interRAI assessments, enriched with registry data, to predict health trajectories and evaluate pharmacological and non-pharmacological interventions. This study aims to pilot the iCARE tool and assess its feasibility, usability and impact on clinical decision-making among healthcare professionals. METHODS AND ANALYSIS: A minimum of 20 participants from each of the seven countries (Italy, Belgium, the Netherlands, Poland, Finland, Czechia and the USA) participated in the study. Participants were general practitioners, geriatricians and other medical specialists, nurses, physiotherapists and other healthcare providers involved in the care of older adults with CCC. The study design involved pre-surveys and post-surveys, tool testing with hypothetical patient cases and evaluations of predictions and treatment recommendations. Two pilot modalities-decision loop and non-decision loop-were implemented to assess the effect of the iCARE tool on clinical decisions. Descriptive statistics and bivariate and multivariate analysis will be conducted. All notes and text field data will be translated into English, and a thematic analysis will be performed. The pilot testing started in September 2024, and data collection ended in January 2025. At the time this protocol was submitted for publication, data collection was complete but data analysis had not yet begun. ETHICS AND DISSEMINATION: Ethical approvals were granted in each participating country before the start of the pilot. All participants gave informed consent to participate in the study. The results of the study will be published in peer-reviewed journals and disseminated during national and international scientific and professional conferences and meetings. Stakeholders will also be informed via the project website and social media, and through targeted methods such as webinars, factsheets and (feedback) workshops. The I-CARE4OLD consortium will strive to publish as much as possible open access, including analytical scripts. Databases will not become publicly available, but the data sets used and/or analysed as part of the project can be made available on reasonable request and with the permission of the I-CARE4OLD consortium.
Multidimensional chromatography coupled to tandem mass spectrometry (MS/MS), including simple sample preparation with protein precipitation, anion conversion with ammonium hydroxide, and solid-phase extraction using mixed-mode anion exchange in a 96-well plate format, has been validated for rapid simultaneous analysis of human insulin and its six analogs (lispro, glulisine, glargine, degludec, detemir, and aspart) in human plasma. This method is critical for clinical diagnostics, forensic investigations, and anti-doping efforts due to the widespread use of these substances. In the present study, improved chromatographic resolution was achieved using a first-dimension trap-and-elute configuration with an XBridge C18 (2.1 × 20 mm, 3.5 μm) trap column combined with second dimension separation on a Cortecs Ultra-High-Performance Liquid Chromatography (UHPLC) C18+ (2.1 × 100 mm, 1.6 μm) analytical column implemented within a two-dimensional-LC-MS/MS system. The total chromatographic run time was 11 min. This setup increases both the resolution and sensitivity of the method. A mobile phase consisting of 0.8% formic acid (FA) in water and 0.7% FA in acetonitrile was used for gradient elution. Bovine insulin was used as the internal standard. MS detection was performed in positive electrospray ionization mode, and the ion suppression due to matrix effects was evaluated. Validation criteria included linearity, precision, accuracy, recovery, lower limit of quantitation, matrix effect, and stability tests with and without protease inhibitor cocktail under different conditions (short-term stability, long-term stability, and freeze-thaw stability). The concentration range for all insulins was 50-15 000 pg/mL, with limits of quantification below the therapeutic reference range for all analytes. Intra-run precision ranged from 1.1% to 5.7%, inter-run precision from 0.7% to 5.9%, and overall recovery from 96.9% to 114.3%. The validated method has been implemented successfully by the Department of Forensic Medicine at our hospital for the investigation of unexplained deaths.
Epilepsy, affecting over 50 million people globally, presents a significant neurological challenge. Effective prevention of epileptic seizures relies on proper administration and monitoring of Anti-Seizure Medication (ASMs). Therapeutic Drug Monitoring (TDM) ensures optimal dosage adjustment, minimizing adverse effects and potential drug interactions. While traditional venous blood collection for TDM may be stressful, emerging alternative sampling methods, particularly Dried Blood Spot (DBS) or oral fluid offer less invasive way of sampling. This study aimed to develop and validate an analytical method for the determination of lamotrigine in such alternative samples. The sample, either DBS or oral fluid, was subjected to extraction, evaporation, and reconstitution in 15 % acetonitrile containing 0.1 % formic acid. A Kinetex C18 Polar column was used for liquid chromatographic separation and MS in ESI+ mode was used for detection and quantitation of lamotrigine using an isotopically labelled internal standard according to EMA guidelines. The calibration range of the developed method enables the determination of lamotrigine in the concentration range of 1-30 μg/mL in DBS and 0.5-20 μg/mL in oral fluid. Oral fluid and DBS samples from patients treated with lamotrigine analysed by the developed method were compared to plasma concentrations measured by the hospital's accredited laboratory. Preliminary results indicate a promising potential for these alternative matrices in clinical TDM applications. By offering a less invasive sampling approach, this method improves the accessibility and safety of pharmacotherapy for epilepsy patients. The results of this study lay the foundation for further clinical applications by implementing alternative matrix TDM, which may significantly advance personalized care in epilepsy management.
- MeSH
- antikonvulziva * analýza krev MeSH
- chromatografie kapalinová metody MeSH
- epilepsie farmakoterapie MeSH
- kalibrace MeSH
- kapalinová chromatografie-hmotnostní spektrometrie MeSH
- lamotrigin * analýza krev MeSH
- lidé MeSH
- limita detekce MeSH
- monitorování léčiv * metody MeSH
- reprodukovatelnost výsledků MeSH
- sliny * chemie MeSH
- tandemová hmotnostní spektrometrie metody MeSH
- test suché kapky krve * metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- validační studie MeSH
OBJECTIVES: Risk-based stratification approaches using measurable residual disease (MRD) successfully help to identify T-acute lymphoblastic leukemia (T-ALL) patients at risk of relapse, whose treatment outcomes are very poor. Because of T-ALL heterogeneity and rarity, a reliable and standardized approach for flow cytometry (FC)-based MRD measurement and analysis is often missing. METHODS: Within the international AIEOP-BFM-ALL-FLOW study group we made a consensus on markers and a standard operating procedure for common 8- and 12-color T-ALL MRD panels. Custom manufactured tubes with dried backbone antibodies were tested in parallel to local FC standards. RESULTS: Altogether, 66 diagnostic and 67 day 15 samples were analyzed. We designed two guided MRD gating strategies to identify blast cells in parallel to expert-based evaluation. We proved that the optimized tubes allowed the correct identification of blast cells in all diagnostic samples. Both, expert and guided analysis of day 15 samples correlated to local standard (Spearman R=0.98 and R=0.94, respectively). Only in 2 (3 %) and 4 (6 %) patients expert gating and guided analysis results were substantially discordant from local standard, respectively. The cases that require an individualized approach may be partially identified at diagnosis through a rare immunophenotype or mixed phenotype acute leukemia status. CONCLUSIONS: Our work shows that standardized operating procedures together with guided analysis are applicable in a great majority of T-ALL cases. Further improvement of MRD detection is needed, as in some cases an individualized analytical approach is still required due to the challenging nature of the T-ALL phenotype.
- MeSH
- dítě MeSH
- kojenec MeSH
- konsensus MeSH
- lidé MeSH
- lymfoblastická leukemie-lymfom z prekurzorových T-buněk * diagnóza patologie MeSH
- mladiství MeSH
- předškolní dítě MeSH
- průtoková cytometrie * normy metody MeSH
- reziduální nádor * diagnóza MeSH
- Check Tag
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
