external validity
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OBJECTIVES: To prospectively validate the diagnostic performance of a non-invasive point-of-care tool (Rapid IAI System), including vaginal alpha-fetoprotein and interleukin-6, to predict the occurrence of intra-amniotic inflammation in a Spanish cohort of patients admitted with a diagnosis of preterm labor and intact membranes. METHODS: From 2017 to 2022, we prospectively evaluated a cohort of pregnant women diagnosed with preterm labor and intact membranes admitted below 34+0 weeks who underwent amniocentesis to rule-in/out intra-amniotic infection and/or inflammation. Vaginal sampling was performed at the time of amniocentesis or within 24-48 h. Amniotic fluid IL-6, vaginal alpha-fetoprotein and vaginal IL-6 concentrations were measured using a point-of-care tool provided by Hologic Inc., "Rapid IAI System". We defined intra-amniotic inflammation when amniotic fluid IL-6 values were greater than 11.3 ng/mL. During recruitment, clinicians were blinded to the results of the point-of-care tool. The original prediction model proposed by Hologic Inc. to predict intra-amniotic inflammation was validated in this cohort of patients. RESULTS: We included 151 patients diagnosed with preterm labor and intact membranes. Among these, 29 (19.2 %) had intra-amniotic inflammation. The algorithm including vaginal IL-6 and alpha-fetoprotein showed an area under curve to predict intra-amniotic inflammation of 80.3 % (±5.3 %) with a sensitivity of 72.4 %, specificity of 84.6 %, positive predictive valuve (PPV) of 52.5 %, negative predictive value (NPV) of 92.9 %, and a positive likelihood ratio (LR+) of 4.6 and negative likelihood ratio (LR-) of 0.33. CONCLUSIONS: External validation of a non-invasive rapid point-of-care tool, including vaginal alpha-fetoprotein and IL-6, showed very good diagnostic performance for predicting the absence of intra-amniotic inflammation in women with preterm labor and intact membranes.
- MeSH
- alfa-fetoproteiny * analýza metabolismus MeSH
- amniocentéza metody MeSH
- chorioamnionitida * diagnóza MeSH
- dospělí MeSH
- hodnocení rizik metody MeSH
- interleukin-6 * analýza krev metabolismus MeSH
- lidé MeSH
- plodová voda * metabolismus chemie MeSH
- point of care testing MeSH
- předčasná porodní činnost * diagnóza MeSH
- prediktivní hodnota testů MeSH
- prospektivní studie MeSH
- těhotenství MeSH
- vagina metabolismus MeSH
- vyšetření u lůžka MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- validační studie MeSH
PURPOSE: While anal cancer is a very rare oncological diagnosis representing less than 2% of lower gastrointestinal tract cancers, the incidence has doubled in the past 20 years. Radical radiochemotherapy with sequential or simultaneous boost is now the standard treatment modality. Interstitial HDR brachytherapy is one of the boost application options. Implementation of new radiotherapy techniques has resulted in improved therapeutic outcomes; however, it is still associated with acute and especially late toxicity. Gastrointestinal disorders and sexual dysfunction are the most frequent factors affecting the long-term quality of cured patients' lives. METHODS: A total of 96 patients consecutively treated between 2000 and 2022 with external beam radio-/chemotherapy and an interstitial brachytherapy boost for histologically verified nonmetastatic anal squamous cell carcinoma were evaluated. The median follow-up time was 15.4 years (range 13.4-17.3 years). The primary objective of the study was to assess local control (LC) and quality of life (QoL). The Czech versions of internationally validated EORTC questionnaires were used to evaluate life quality-the basic EORTC QOL-C30 v.3 and the specific QOL-ANL 27 questionnaire. RESULTS: Local control was 85.5% at 5 years, 83.4% at 10 years, 83.4% at 15 years, and 83.4% at 20 years, and there was no dependence on clinical stage. The most common forms of acute toxicity were cutaneous and hematological but were gastrointestinal for late toxicities. In the evaluation of quality of life, 80.5% of patients alive at the time participated. In the EORTC quality of life questionnaire C30 v.3, patients rated the functional scale score as 86.2 points (standard deviation [SD] = 12.6) and the symptom score as 15.5 points (SD = 12.5). The global health score achieved 68.4 points (SD = 23.6). The most common symptoms were fatigue with 25.6 points (SD = 20.2) and diarrhea with 19.0 points (SD = 27.8). In the QOL-ANL 27 questionnaire, symptom scales assessing bowel symptoms were scored 27.5 points (SD = 19) in non-stoma patients and 11.9 points (SD = 17.2) in stoma patients. In the single-item symptom scales, the highest scores were rated for frequency of urination with 26.4 points (SD = 30.8), need to be close to a toilet with 22.4 points (SD = 27.3), and self-cleaning more often with 25.3 points (SD = 31.8). In the functional scales assessing sex life and interest, men and women reported scores of 45.2 (SD = 23) and 45.5 points (SD = 19), respectively. CONCLUSION: Boost with interstitial HDR brachytherapy is an established safe method of anal cancer treatment, with excellent results and limited late toxicity. Functioning scales were rated relatively highly in QoL questionnaires, and the overall global health score was comparable to published data. Gastrointestinal difficulties, fatigue, and sexual dysfunction dominated the symptom scales in our cohort.
- MeSH
- brachyterapie * metody MeSH
- celková dávka radioterapie MeSH
- dospělí MeSH
- kvalita života * psychologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory anu * radioterapie psychologie patologie MeSH
- následné studie MeSH
- průzkumy a dotazníky MeSH
- radiační poranění * psychologie etiologie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- spinocelulární karcinom * radioterapie patologie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
AIM: A diabetes-related foot ulcer (DFU) is a major risk factor for lower-extremity amputation (LEA). To help clinicians predict the risk of LEA in people with DFU, the Diabetic Foot Risk Assessment (DIAFORA) system was developed but has never been externally validated. METHODS: In this study, 317 people presenting with a new DFU were included. At baseline, participants were grouped into three groups based on their DIAFORA score: low-risk (<15), medium-risk (15-25), and high-risk (>25). Participants were followed until healing, LEA, death, or at least 3 months. Discriminative accuracy was evaluated using sensitivity, specificity, likelihood ratios (LRs) and the area under the curve (AUC). RESULTS: All 317 participants completed at least 3 months of follow-up for a median duration of 146 days, during which 12.6% underwent minor amputation and 2.5% major amputation. People in the low- and medium-risk categories had major amputation rates of 0.9% and 2.1%, respectively, and negative LR of major LEA of 0.10 and 0.38, respectively, while the people in the high-risk category had an amputation rate of 25.0% and a positive LR of 12.9. The DIAFORA risk groups had a sensitivity of 75.0% and a specificity of 65.7%, with a corresponding AUC of 0.78 (95% CI 0.68-0.87) for the prediction of major LEA. CONCLUSION: The DIAFORA score is a useful tool for risk stratification of people presenting with a newly occurred DFU, with the external validation presenting results similar to those presented in the original study. The DIAFORA score may guide clinicians towards more individualized DFU treatment regimens.
- MeSH
- amputace * statistika a číselné údaje MeSH
- diabetická noha * chirurgie epidemiologie MeSH
- dolní končetina chirurgie MeSH
- hodnocení rizik metody MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- prediktivní hodnota testů MeSH
- prospektivní studie MeSH
- rizikové faktory MeSH
- senioři MeSH
- senzitivita a specificita MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- validační studie MeSH
- Geografické názvy
- Dánsko 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
- dospělí MeSH
- duodenum MeSH
- gastroskopie * metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- odchylka pozorovatele * MeSH
- průřezové studie MeSH
- reprodukovatelnost výsledků MeSH
- senioři MeSH
- žaludeční sliznice MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- validační studie MeSH
INTRODUCTION: This study aimed to validate the Sargent risk stratification algorithm for the prediction of placenta accreta spectrum (PAS) severity using data collected from multiple centers and using the multicenter data to improve the model. MATERIAL AND METHODS: We conducted a multicenter analysis using data collected for the IS-PAS database. The Sargent model's effectiveness in distinguishing between abnormally adherent placenta (FIGO grade 1) and abnormally invasive placenta (FIGO grades 2 and 3) was evaluated. A new model was developed using multicenter data from the IS-PAS database. RESULTS: The database included 315 cases of suspected PAS, of which 226 had fully documented standardized ultrasound signs. The final diagnosis was normal placentation in 5, abnormally adherent placenta/FIGO grade 1 in 43, and abnormally invasive placenta/FIGO grades 2 and 3 in 178. The external validation of the Sargent model revealed moderate predictive accuracy in a multicenter setting (C-index 0.68), compared to its higher accuracy in a single-center context (C-index 0.90). The newly developed model achieved a C-index of 0.74. CONCLUSIONS: The study underscores the difficulty in developing universally applicable PAS prediction models. While models like that of Sargent et al. show promise, their reproducibility varies across settings, likely due to the interpretation of the ultrasound signs. The findings support the need for updating the current ultrasound descriptors and for the development of any new predictive models to use data collected by different operators in multiple clinical settings.
- MeSH
- algoritmy MeSH
- dospělí MeSH
- hodnocení rizik MeSH
- lidé MeSH
- placenta accreta * diagnostické zobrazování MeSH
- prediktivní hodnota testů MeSH
- prospektivní studie MeSH
- reprodukovatelnost výsledků MeSH
- stupeň závažnosti nemoci MeSH
- těhotenství MeSH
- ultrasonografie prenatální * MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- validační studie 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
- arteriae carotides * diagnostické zobrazování patologie MeSH
- aterosklerotický plát * diagnostické zobrazování MeSH
- lidé MeSH
- magnetická rezonanční tomografie * metody MeSH
- nemoci arterie carotis * diagnostické zobrazování patologie MeSH
- reprodukovatelnost výsledků MeSH
- senzitivita a specificita MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- srovnávací studie MeSH
- systematický přehled MeSH
PURPOSE: Fuchs endothelial corneal dystrophy (FECD) is a common, age-related cause of visual impairment. This systematic review synthesizes evidence from the literature on artificial intelligence (AI) models developed for the diagnosis and management of FECD. METHODS: We conducted a systematic literature search in MEDLINE, PubMed, Web of Science, and Scopus from January 1, 2000, to June 31, 2024. Full-text studies utilizing AI for various clinical contexts of FECD management were included. Data extraction covered model development, predicted outcomes, validation, and model performance metrics. We graded the included studies using the Quality Assessment of Diagnostic Accuracies Studies 2 tool. This review adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations. RESULTS: Nineteen studies were analyzed. Primary AI algorithms applied in FECD diagnosis and management included neural network architectures specialized for computer vision, utilized on confocal or specular microscopy images, or anterior segment optical coherence tomography images. AI was employed in diverse clinical contexts, such as assessing corneal endothelium and edema and predicting post-corneal transplantation graft detachment and survival. Despite many studies reporting promising model performance, a notable limitation was that only three studies performed external validation. Bias introduced by patient selection processes and experimental designs was evident in the included studies. CONCLUSIONS: Despite the potential of AI algorithms to enhance FECD diagnosis and prognostication, further work is required to evaluate their real-world applicability and clinical utility. TRANSLATIONAL RELEVANCE: This review offers critical insights for researchers, clinicians, and policymakers, aiding their understanding of existing AI research in FECD management and guiding future health service strategies.
- MeSH
- Fuchsova endoteliální dystrofie * diagnóza terapie MeSH
- lidé MeSH
- optická koherentní tomografie metody MeSH
- umělá inteligence * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- systematický přehled MeSH
OBJECTIVE: To ensure wider use of the internationally recommended Fugl-Meyer Assessment (FMA) of sensorimotor function for people with stroke, official translations of the scale are needed. This study aimed to perform a translation and cross-cultural adaptation/validation of the FMA into the Czech language. DESIGN: Translation and cross-cultural adaptation/validation. SUBJECTS/PATIENTS: Five clinical experts and 1 external expert participated as reviewers; 11 individuals with stroke in the early subacute phase were included in the pilot testing. METHODS: A standardized process using forward-backward translations, expert panel reviews, and pilot testing between and within the raters (inter- and intra-rater reliability) were employed to ensure conceptual, semantic, and operational validity of the new Czech FMA. Agreement between raters was assessed in 11 individuals with stroke on 2 consecutive days at University Hospital Olomouc by using Svensson's rank-based statistics. RESULTS: Percentage of agreement between and within raters ranged between 70-100% and 55-100%, respectively. Systematic disagreements, found in 7 out of 96 FMA items, were discussed and revised in the final version. CONCLUSION: The Czech FMA offers a more unified and standardized assessment of sensorimotor impairment in clinical and research settings. This will improve stroke rehabilitation care and allow for wider international collaboration.
- MeSH
- cévní mozková příhoda * patofyziologie MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- pilotní projekty MeSH
- posuzování pracovní neschopnosti * MeSH
- překlady MeSH
- rehabilitace po cévní mozkové příhodě * MeSH
- reprodukovatelnost výsledků MeSH
- senioři MeSH
- srovnání kultur MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- validační studie MeSH
- Geografické názvy
- Česká republika MeSH
This study presents a systematic review conducted according to the PRISMA 2020 guidelines, evaluating pharmacokinetic-pharmacodynamic (PK-PD) models for target-controlled infusion (TCI) of propofol. A structured search was performed across PubMed, Summon, Google Scholar, Web of Science, and Scopus, identifying 427 sources, of which 17 met the inclusion criteria. The analysis revealed that nine studies compared existing models, six focused on the development of new PK-PD models, and two explored broader implications of TCI in anesthesia. Comparative studies indicate that while the Eleveld model generally offers superior predictive accuracy, it does not consistently outperform the Marsh and Schnider models across all populations. The Schnider model demonstrated better bias control in elderly patients, while the Eleveld model improved drug clearance estimation in obese patients. However, inconsistencies remain in predicting brain concentrations of propofol. Newly proposed models introduce adaptive dosing strategies, incorporating allometric scaling, lean body weight, and machine learning techniques, yet require further external validation. The results highlight ongoing challenges in achieving universal applicability of TCI models, underscoring the need for future research in refining precision dosing and personalized anesthesia management.
- MeSH
- anestetika intravenózní * aplikace a dávkování farmakokinetika farmakologie MeSH
- biologické modely MeSH
- intravenózní infuze MeSH
- lidé MeSH
- propofol * aplikace a dávkování farmakokinetika farmakologie MeSH
- strojové učení MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- systematický přehled MeSH
BACKGROUND: Secondary progressive MS is associated with a worse prognosis, warranting the need for early predictive tools. The DAAE score estimates the five-year risk of transition to clinical diagnosis of SPMS, showing a 38 % risk in high-risk patients in Amsterdam and Buffalo data. The DAAE score remains to be validated against objective disease progression criteria. METHODS: External validation using data from the Prague MS cohort and MSBase-Lorscheider criteria. RESULTS: Among 2022 patients from the Prague MS database, 14.3 % clinically progressed according to MSbase-Lorscheider criteria over five years. Risk increased with higher DAAE scores comparable to the Amsterdam and Buffalo data; secondary validation showed an AUROC of 0.742 with faster progression for higher risk groups (p < 0.05), therapy-adjusted. CONCLUSION: The DAAE score performs similarly between centers and using objective criteria. These validation steps support its use in personalized MS management and treatment.
- MeSH
- chronicko-progresivní roztroušená skleróza * diagnóza patofyziologie MeSH
- dospělí MeSH
- hodnocení rizik MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- prognóza MeSH
- progrese nemoci * MeSH
- roztroušená skleróza * diagnóza MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- validační studie MeSH