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
The International Staging System for multiple myeloma recently underwent a second revision (R2-ISS) to include gain/amplification of 1q21 and account for the additive prognostic significance of multiple high-risk features. The phase 3 ICARIA-MM (isatuximab-pomalidomide-dexamethasone vs. pomalidomide-dexamethasone) and IKEMA (isatuximab-carfilzomib-dexamethasone vs. carfilzomib-dexamethasone) studies provide large datasets for retrospectively validating the prognostic value of the R2-ISS in relapsed/refractory multiple myeloma. Of 609 pooled patients, 68 (11.2%) were reclassified as R2-ISS stage I, 136 (22.3%) as R2-ISS stage II, 204 (33.5%) as R2-ISS stage III, 55 (9.0%) as stage IV, and 146 (24.0%) "Not classified". Median progression-free survival was shorter among those reclassified as R2-ISS stage II (HR 1.52, 95% CI 0.979-2.358), stage III (HR 2.59, 95% CI 1.709-3.923), and stage IV (HR 3.51, 95% CI 2.124-5.784) versus stage I. Adding isatuximab led to longer progression-free survival versus doublet therapy (adjusted HR 0.544 [95% CI 0.436-0.680]), with a consistent treatment effect observed across all R2-ISS stages. This is the first study to validate the R2-ISS with novel agents, including anti-CD38 monoclonal antibodies, and to show that R2-ISS, as a prognostic scoring system, can be applied to patients with relapsed/refractory multiple myeloma.
- MeSH
- dexamethason terapeutické užití aplikace a dávkování MeSH
- dospělí MeSH
- humanizované monoklonální protilátky * terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom * patologie farmakoterapie mortalita diagnóza MeSH
- oligopeptidy terapeutické užití MeSH
- prognóza MeSH
- protokoly antitumorózní kombinované chemoterapie * terapeutické užití MeSH
- retrospektivní studie MeSH
- senioři MeSH
- staging nádorů * MeSH
- thalidomid analogy a deriváty terapeutické užití aplikace a dávkování MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
- validační studie MeSH
AIMS: Tailored education is recommended for cardiac patients, yet little is known about information needs in areas of the world where it is most needed. This study aims to assess (i) the measurement properties of the Information Needs in Cardiac Rehabilitation short version (INCR-S) scale and (ii) patient's information needs globally. METHODS AND RESULTS: In this cross-sectional study, English, simplified Chinese, Portuguese, or Korean versions of the INCR-S were administered to in- or out-patients via Qualtrics (January 2022-November 2023). Members of the International Council of Cardiovascular Prevention and Rehabilitation community facilitated recruitment. Importance and knowledge sufficiency of 36 items were rated. Links to evidence-based lay education were provided where warranted. A total of 1601 patients from 19 middle- and high-income countries across the world participated. Structural validity was supported upon factor analysis, with five subscales extracted: symptom response/medication, heart diseases/diagnostic tests/treatments, exercise and return-to-life roles/programmes to support, risk factors, and healthy eating/psychosocial management. Cronbach's alpha was 0.97. Construct validity was supported through significantly higher knowledge sufficiency ratings for all items and information importance ratings for all subscales in cardiac rehabilitation (CR) enrolees vs. non-enrolees (all P < 0.001). All items were rated as very important-particularly regarding cardiac events, nutrition, exercise benefits, medications, symptom response, risk factor control, and CR-but more so in high-income countries in the Americas and Western Pacific. Knowledge sufficiency ranged from 30.0 to 67.4%, varying by region and income class. Ratings were highest for medications and lowest for support groups, resistance training, and alternative medicine. CONCLUSION: Identification of information needs using the valid and reliable INCR-S can inform educational approaches to optimize patients' health outcomes across the globe.
- MeSH
- dospělí MeSH
- kardiovaskulární rehabilitace * normy metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci srdce rehabilitace diagnóza psychologie MeSH
- odhad potřeb * MeSH
- průřezové studie MeSH
- průzkumy a dotazníky MeSH
- psychometrie * MeSH
- reprodukovatelnost výsledků MeSH
- senioři MeSH
- vzdělávání pacientů jako téma * MeSH
- zdraví - znalosti, postoje, praxe * 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
BACKGROUND: Prediction of side-specific extraprostatic extension (EPE) is crucial in selecting patients for nerve-sparing radical prostatectomy (RP). Multiple nomograms, which include magnetic resonance imaging (MRI) information, are available predict side-specific EPE. It is crucial that the accuracy of these nomograms is assessed with external validation to ensure they can be used in clinical practice to support medical decision-making. METHODS: Data of prostate cancer (PCa) patients that underwent robot-assisted RP (RARP) from 2017 to 2021 at four European tertiary referral centers were collected retrospectively. Four previously developed nomograms for the prediction of side-specific EPE were identified and externally validated. Discrimination (area under the curve [AUC]), calibration and net benefit of four nomograms were assessed. To assess the strongest predictor among the MRI features included in all nomograms, we evaluated their association with side-specific EPE using multivariate regression analysis and Akaike Information Criterion (AIC). RESULTS: This study involved 773 patients with a total of 1546 prostate lobes. EPE was found in 338 (22%) lobes. The AUCs of the models predicting EPE ranged from 72.2% (95% CI 69.1-72.3%) (Wibmer) to 75.5% (95% CI 72.5-78.5%) (Nyarangi-Dix). The nomogram with the highest AUC varied across the cohorts. The Soeterik, Nyarangi-Dix, and Martini nomograms demonstrated fair to good calibration for clinically most relevant thresholds between 5 and 30%. In contrast, the Wibmer nomogram showed substantial overestimation of EPE risk for thresholds above 25%. The Nyarangi-Dix nomogram demonstrated a higher net benefit for risk thresholds between 20 and 30% when compared to the other three nomograms. Of all MRI features, the European Society of Urogenital Radiology score and tumor capsule contact length showed the highest AUCs and lowest AIC. CONCLUSION: The Nyarangi-Dix, Martini and Soeterik nomograms resulted in accurate EPE prediction and are therefore suitable to support medical decision-making.
- MeSH
- lidé středního věku MeSH
- lidé MeSH
- magnetická rezonanční tomografie * metody MeSH
- nádory prostaty * diagnostické zobrazování patologie chirurgie MeSH
- nomogramy * MeSH
- prognóza MeSH
- prostata diagnostické zobrazování patologie chirurgie MeSH
- prostatektomie * metody MeSH
- retrospektivní studie MeSH
- roboticky asistované výkony metody MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- validační studie MeSH
AIMS: While heart failure (HF) symptoms are associated with adverse prognosis after myocardial infarction (MI), they are not routinely used for patients' stratification. The primary objective of this study was to develop and validate a score to predict mortality risk after MI, combining remotely recorded HF symptoms and clinical risk factors, and to compare it against the guideline-recommended Global Registry of Acute Coronary Events (GRACE) score. METHODS AND RESULTS: A cohort study design using prospectively collected data from consecutive patients hospitalized for MI at a large tertiary heart centre between June 2017 and September 2022 was used. Data from 1135 patients (aged 64 ± 12 years, 26.7% women), were split into derivation (70%) and validation cohort (30%). Components of the 23-item Kansas City Cardiomyopathy Questionnaire and clinical variables were used as possible predictors. The best model included the following variables: age, HF history, admission creatinine and heart rate, ejection fraction at hospital discharge, and HF symptoms 1 month after discharge including walking impairment, leg swelling, and change in HF symptoms. Based on these variables, the PragueMi score was developed. In the validation cohort, the PragueMi score showed superior discrimination to the GRACE score for 6 months [the area under the receiver operating curve (AUC) 90.1, 95% confidence interval (CI) 81.8-98.4 vs. 77.4, 95% CI 62.2-92.5, P = 0.04) and 1-year risk prediction (AUC 89.7, 95% CI 83.5-96.0 vs. 76.2, 95% CI 64.7-87.7, P = 0.004). CONCLUSION: The PragueMi score combining HF symptoms and clinical variables performs better than the currently recommended GRACE score.
- MeSH
- časové faktory MeSH
- hodnocení rizik MeSH
- infarkt myokardu * mortalita diagnóza MeSH
- lidé středního věku MeSH
- lidé MeSH
- metody pro podporu rozhodování MeSH
- prediktivní hodnota testů MeSH
- prognóza MeSH
- prospektivní studie MeSH
- reprodukovatelnost výsledků MeSH
- rizikové faktory MeSH
- senioři MeSH
- srdeční selhání * mortalita diagnóza patofyziologie 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
BACKGROUND: Alcohol use is one of the leading public health concerns in the Czech Republic. Drinking motives play a vital role in both initiation and subsequent alcohol use. A revised version of the self-report Drinking Motives Questionnaire (DMQ-R) has been proposed to assess these motives. The present study aims to validate the DMQ-R in the Czech general population. METHODS: A total sample of 1,784 Czech participants completed a national survey. For the analysis, only a sub-sample of the past 12 months alcohol users was used: N = 1,123; 52.8% male; mean (SD) age = 40.2 (13.3). Drinking motives were assessed by the adopted Czech version of the DMQ-R. Both confirmatory (CFA) and exploratory factor analysis (EFA) were conducted to examine the factorial structure of the instrument. The age of the participant was additionally considered in the analysis (15-24 years as opposed to 25-64 years). RESULTS: The CFA supported the four-factor model in the 25-64 age group. The analysis supported the construct validity of the Social, Conformity, and Coping factors. The Enhancement factor retained only two items and was found to refer more to a domain of 'Pleasant Feeling'. For the 15-24 age group, the hypothesised four-factor structure was not corroborated. CONCLUSIONS: The Czech version of the DMQ-R was found to be a reliable measurement tool of the Social, Conformity, and Coping motives. Future research should investigate the dimensionality of the instrument items presumed to correspond to the Enhancement motives. This should be conducted particularly among adolescents and young adults aged 15-24 years, where administering the DMQ-R with a large enough sample is also needed.
- MeSH
- adaptace psychologická MeSH
- dospělí MeSH
- faktorová analýza statistická MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- motivace * MeSH
- pití alkoholu * psychologie epidemiologie MeSH
- průzkumy a dotazníky normy MeSH
- psychometrie MeSH
- reprodukovatelnost výsledků MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- validační studie MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND: In-vivo monitoring methods of carbon ion radiotherapy (CIRT) includes explorations of nuclear reaction products generated by carbon-ion beams interacting with patient tissues. Our research group focuses on in-vivo monitoring of CIRT using silicon pixel detectors. Currently, we are conducting a prospective clinical trial as part of the In-Vivo Monitoring project (InViMo) at the Heidelberg Ion Beam Therapy Center (HIT) in Germany. We are using an innovative, in-house developed, non-contact fragment tracking system with seven mini-trackers based on the Timepix3 technology developed at CERN. PURPOSE: This article focuses on the implementation of the mini-tracker in Monte Carlo (MC) based on FLUKA simulations to monitor secondary charged nuclear fragments in CIRT. The main objective is to systematically evaluate the simulation accuracy for the InViMo project. METHODS: The implementation involved integrating the mini-tracker geometry and the scoring mechanism into the FLUKA MC simulation, utilizing the finely tuned HIT beam line. The systematic investigation included varying mini-tracker angles (from 15∘$15^\circ$ to 45∘$45^\circ$ in 5∘$5^\circ$ steps) during the irradiation of a head-sized phantom with therapeutic carbon-ion pencil beams. To evaluate our implemented FLUKA framework, a comparison was made between the experimental data and data obtained from MC simulations. To ensure the fidelity of our comparison, experiments were performed at the HIT using the parameters and setup established in the simulations. RESULTS: Our research demonstrates high accuracy in reproducing characteristic behaviors and dependencies of the monitoring method in terms of fragment distributions in the mini-tracker, track angles, emission profiles, and fragment numbers. Discrepancies in the number of detected fragments between the experimental data and the data obtained from MC simulations are less than 4% for the angles of interest in the InViMo detection system. CONCLUSIONS: Our study confirms the potential of our simulation framework to investigate the performance of monitoring inter-fractional anatomical changes in patients undergoing CIRT using secondary nuclear charged fragments escaping from the irradiated patient.
- MeSH
- fantomy radiodiagnostické MeSH
- lidé MeSH
- metoda Monte Carlo * MeSH
- radioterapie těžkými ionty * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- validační studie MeSH
OBJECTIVES: To externally and prospectively validate the International Ovarian Tumor Analysis (IOTA) Simple Rules (SRs), Logistic Regression model 2 (LR2) and Assessment of Different NEoplasias in the adneXa (ADNEX) model in a Portuguese population, comparing these approaches with subjective assessment and the risk-of-malignancy index (RMI), as well as with each other. This study also aimed to retrospectively validate the IOTA two-step strategy, using modified benign simple descriptors (MBDs) followed by the ADNEX model in cases in which MBDs were not applicable. METHODS: This was a prospective multicenter diagnostic accuracy study conducted between January 2016 and December 2021 of consecutive patients with an ultrasound diagnosis of at least one adnexal tumor, who underwent surgery at one of three tertiary referral centers in Lisbon, Portugal. All ultrasound assessments were performed by Level-II or -III sonologists with IOTA certification. Patient clinical data and serum CA 125 levels were collected from hospital databases. Each adnexal mass was classified as benign or malignant using subjective assessment, RMI, IOTA SRs, LR2 and the ADNEX model (with and without CA 125). The reference standard was histopathological diagnosis. In the second phase, all adnexal tumors were classified retrospectively using the two-step strategy (MBDs + ADNEX). Sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios and overall accuracy were determined for all methods. Receiver-operating-characteristics curves were constructed and corresponding areas under the curve (AUC) were determined for RMI, LR2, the ADNEX model and the two-step strategy. The ADNEX model calibration plots were constructed using locally estimated scatterplot smoothing (LOESS). RESULTS: Of the 571 patients included in the study, 428 had benign disease and 143 had malignant disease (prevalence of malignancy, 25.0%), of which 42 had borderline ovarian tumor, 93 had primary invasive adnexal cancer and eight had metastatic tumors in the adnexa. Subjective assessment had an overall sensitivity of 97.9% and a specificity of 83.6% for distinguishing between benign and malignant lesions. RMI showed high specificity (95.6%) but very low sensitivity (58.7%), with an AUC of 0.913. The IOTA SRs were applicable in 80.0% of patients, with a sensitivity of 94.8% and specificity of 98.6%. The IOTA LR2 had a sensitivity of 84.6%, specificity of 86.9% and an AUC of 0.939, at a malignancy risk cut-off of 10%. At the same cut-off, the sensitivity, specificity and AUC for the ADNEX model with vs without CA 125 were 95.8% vs 98.6%, 82.5% vs 79.7% and 0.962 vs 0.960, respectively. The ADNEX model gave heterogeneous results for distinguishing between benign masses and different subtypes of malignancy, with the highest AUC (0.991) for discriminating benign masses from primary invasive adnexal cancer Stages II-IV, and the lowest AUC (0.696) for discriminating primary invasive adnexal cancer Stage I from metastatic lesion in the adnexa. The calibration plot suggested underestimation of the risk by the ADNEX model compared with the observed proportion of malignancy. The MBDs were applicable in 26.3% (150/571) of cases, of which none was malignant. The two-step strategy using the ADNEX model in the second step only, with and without CA 125, had AUCs of 0.964 and 0.961, respectively, which was similar to applying the ADNEX model in all patients. CONCLUSIONS: The IOTA methods showed good-to-excellent performance in the Portuguese population, outperforming RMI. The ADNEX model was superior to other methods in terms of accuracy, but interpretation of its ability to distinguish between malignant subtypes was limited by sample size and large differences in the prevalence of tumor subtypes. The IOTA MBDs are reliable in identifying benign disease. The two-step strategy comprising application of MBDs followed by the ADNEX model if MBDs are not applicable, is suitable for daily clinical practice, circumventing the need to calculate the risk of malignancy in all patients. © 2024 International Society of Ultrasound in Obstetrics and Gynecology.
- MeSH
- antigen CA-125 krev MeSH
- diferenciální diagnóza MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- logistické modely MeSH
- nádory vaječníků * diagnostické zobrazování patologie klasifikace krev MeSH
- nemoci děložních adnex * diagnostické zobrazování MeSH
- prediktivní hodnota testů MeSH
- prospektivní studie MeSH
- reprodukovatelnost výsledků MeSH
- retrospektivní studie MeSH
- ROC křivka MeSH
- senioři MeSH
- senzitivita a specificita MeSH
- ultrasonografie * metody MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- validační studie MeSH
- Geografické názvy
- Portugalsko MeSH
BACKGROUND: The topic of adolescent mental health is currently a subject of much debate due to the increasing prevalence of mental health problems among this age group. Therefore, it is crucial to have high-quality and validated mental well-being measurement tools. While such tools do exist, they are often not tailored specifically to adolescents and are not available in Czech language. The aim of this study is to validate and test the Czech version of the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) on a large sample of Czech adolescents aged 15 to 18 years. METHODS: The analysis is based on data from the first wave of the Czech Education Panel Survey (CZEPS) and was mainly conducted using Item Response Theory (IRT), which is the most appropriate method for this type of analysis. Specifically, the Graded Response Model (GRM) was applied to the data. This comprehensive validation study also included reliability and three types of validity (construct, convergent and criterion) testing. RESULTS: The study found that the Czech version of the SWEMWBS for adolescents aged 15 to 18 years (N = 22,498) has good quality and psychometric properties. The data was analysed using the GRM model as it met the assumptions for the use of IRT. The estimated parameter values by GRM demonstrated good discriminant and informative power for all items, except for item 7, which showed poorer results compared to the others. However, excluding it from the scale would not enhance the overall quality of the scale. The five-category response scale functions effectively. Additionally, the results demonstrated high reliability, and all types of validity tested were also confirmed. CONCLUSIONS: The Czech version of the SWEMWBS for adolescents has been validated as a psychometrically sound, reliable and valid instrument for measuring mental well-being. It can therefore be used with confidence in future studies.
- MeSH
- duševní zdraví * MeSH
- lidé MeSH
- mladiství MeSH
- průzkumy a dotazníky normy MeSH
- psychometrie * MeSH
- reprodukovatelnost výsledků MeSH
- Check Tag
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- validační studie MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND: Ultra high dose rate (UHDR) radiotherapy using ridge filter is a new treatment modality known as conformal FLASH that, when optimized for dose, dose rate (DR), and linear energy transfer (LET), has the potential to reduce damage to healthy tissue without sacrificing tumor killing efficacy via the FLASH effect. PURPOSE: Clinical implementation of conformal FLASH proton therapy has been limited by quality assurance (QA) challenges, which include direct measurement of UHDR and LET. Voxel DR distributions and LET spectra at planning target margins are paramount to the DR/LET-related sparing of organs at risk. We hereby present a methodology to achieve experimental validation of these parameters. METHODS: Dose, DR, and LET were measured for a conformal FLASH treatment plan involving a 250-MeV proton beam and a 3D-printed ridge filter designed to uniformly irradiate a spherical target. We measured dose and DR simultaneously using a 4D multi-layer strip ionization chamber (MLSIC) under UHDR conditions. Additionally, we developed an "under-sample and recover (USRe)" technique for a high-resolution pixelated semiconductor detector, Timepix3, to avoid event pile-up and to correct measured LET at high-proton-flux locations without undesirable beam modifications. Confirmation of these measurements was done using a MatriXX PT detector and by Monte Carlo (MC) simulations. RESULTS: MC conformal FLASH computed doses had gamma passing rates of >95% (3 mm/3% criteria) when compared to MatriXX PT and MLSIC data. At the lateral margin, DR showed average agreement values within 0.3% of simulation at 100 Gy/s and fluctuations ∼10% at 15 Gy/s. LET spectra in the proximal, lateral, and distal margins had Bhattacharyya distances of <1.3%. CONCLUSION: Our measurements with the MLSIC and Timepix3 detectors shown that the DR distributions for UHDR scenarios and LET spectra using USRe are in agreement with simulations. These results demonstrate that the methodology presented here can be used effectively for the experimental validation and QA of FLASH treatment plans.
