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1.
Ultraschall Med ; 2021 Nov 03.
Artigo em Inglês | MEDLINE | ID: mdl-34734405

RESUMO

PURPOSE: The goal of this survey was to describe the use and diffusion of lung ultrasound (LUS), the level of training received before and during the COVID-19 pandemic, and the clinical impact LUS has had on COVID-19 cases in intensive care units (ICU) from February 2020 to May 2020. MATERIALS AND METHODS: The Italian Lung Ultrasound Survey (ITALUS) was a nationwide online survey proposed to Italian anesthesiologists and intensive care physicians carried out after the first wave of the COVID-19 pandemic. It consisted of 27 questions, both quantitative and qualitative. RESULTS: 807 responded to the survey. The median previous LUS experience was 3 years (IQR 1.0-6.0). 473 (60.9 %) reported having attended at least one training course on LUS before the COVID-19 pandemic. 519 (73.9 %) reported knowing how to use the LUS score. 404 (52 %) reported being able to use LUS without any supervision. 479 (68.2 %) said that LUS influenced their clinical decision-making, mostly with respect to patient monitoring. During the pandemic, the median of patients daily evaluated with LUS increased 3-fold (p < 0.001), daily use of general LUS increased from 10.4 % to 28.9 % (p < 0.001), and the daily use of LUS score in particular increased from 1.6 % to 9.0 % (p < 0.001). CONCLUSION: This survey showed that LUS was already extensively used during the first wave of the COVID-19 pandemic by anesthesiologists and intensive care physicians in Italy, and then its adoption increased further. Residency programs are already progressively implementing LUS teaching. However, 76.7 % of the sample did not undertake any LUS certification.

2.
BMC Med Res Methodol ; 21(1): 256, 2021 Nov 22.
Artigo em Inglês | MEDLINE | ID: mdl-34809559

RESUMO

BACKGROUND: Propensity score matching is a statistical method that is often used to make inferences on the treatment effects in observational studies. In recent years, there has been widespread use of the technique in the cardiothoracic surgery literature to evaluate to potential benefits of new surgical therapies or procedures. However, the small sample size and the strong dependence of the treatment assignment on the baseline covariates that often characterize these studies make such an evaluation challenging from a statistical point of view. In such settings, the use of propensity score matching in combination with oversampling and replacement may provide a solution to these issues by increasing the initial sample size of the study and thus improving the statistical power that is needed to detect the effect of interest. In this study, we review the use of propensity score matching in combination with oversampling and replacement in small sample size settings. METHODS: We performed a series of Monte Carlo simulations to evaluate how the sample size, the proportion of treated, and the assignment mechanism affect the performances of the proposed approaches. We assessed the performances with overall balance, relative bias, root mean squared error and nominal coverage. Moreover, we illustrate the methods using a real case study from the cardiac surgery literature. RESULTS: Matching without replacement produced estimates with lower bias and better nominal coverage than matching with replacement when 1:1 matching was considered. In contrast to that, matching with replacement showed better balance, relative bias, and root mean squared error than matching without replacement for increasing levels of oversampling. The best nominal coverage was obtained by using the estimator that accounts for uncertainty in the matching procedure on sets of units obtained after matching with replacement. CONCLUSIONS: The use of replacement provides the most reliable treatment effect estimates and that no more than 1 or 2 units from the control group should be matched to each treated observation. Moreover, the variance estimator that accounts for the uncertainty in the matching procedure should be used to estimate the treatment effect.

3.
Cancers (Basel) ; 13(21)2021 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-34771634

RESUMO

BCR-ABL1 mRNA levels represent the key molecular marker for the evaluation of minimal residual disease (MRD) in chronic myeloid leukemia (CML) patients and real-time quantitative PCR (RT-qPCR) is currently the standard method to monitor it. In the era of tyrosine kinase inhibitors (TKIs) discontinuation, droplet digital PCR (ddPCR) has emerged to provide a more precise detection of MRD. To hypothesize the use of ddPCR in clinical practice, we designed a multicentric study to evaluate the potential value of ddPCR in the diagnostic routine. Thirty-seven RNA samples from CML patients and five from healthy donors were analyzed using both ddPCR QXDxTMBCR-ABL %IS Kit and LabNet-approved RT-qPCR methodologies in three different Italian laboratories. Our results show that ddPCR has a good agreement with RT-qPCR, but it is more precise to quantify BCR-ABL1 transcript levels. Furthermore, we did not find differences between duplicate or quadruplicate analysis in terms of BCR-ABL1% IS values. Droplet digital PCR could be confidently introduced into the diagnostic routine as a complement to the RT-qPCR.

4.
J Pers Med ; 11(10)2021 Sep 23.
Artigo em Inglês | MEDLINE | ID: mdl-34683086

RESUMO

The COVID-19 pandemic has had a severe impact on nursing care. This cross-sectional survey-based study compared aspects of nursing care and nurses' satisfaction with care provided before and during the first wave of the COVID-19 pandemic. A total of 936 registered nurses (RNs) rated the frequency with which they performed fundamental care, nursing techniques, patient education, symptom management, and nurse-patient relationships before and during the pandemic. A recursive partitioning for ordered multivariate response in a conditional inference framework approach was applied. More frequent fundamental cares were associated with their frequency before the pandemic (p < 0.001), caring for COVID-19 patients (p < 0.001), and workplace reassignment (p = 0.004). Caring for COVID-19 patients (p < 0.001), workplace reassignment (p = 0.030), and caring for ≤7.4 COVID-19 patients (p = 0.014) increased nursing techniques. RNs in high-intensity COVID-19 units (p = 0.002) who educated patients before the pandemic, stopped this task. RNs caring for COVID-19 patients reported increased symptom management (p < 0.001), as did RNs caring for more non-COVID-19 patients (p = 0.037). Less frequent nurse-patient relationships before the pandemic and working in high-intensity COVID-19 units decreased nurse-patient relationships (p = 0.002). Despite enormous challenges, nurses continued to provide a high level of care. Ensuring the appropriate deployment and education of nurses is crucial to personalize care and to maintain nurses' satisfaction with the care provided.

5.
Disaster Med Public Health Prep ; : 1-6, 2021 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-34649630

RESUMO

OBJECTIVE: The present study aims to explore whether a relationship exists between the immediate sharp increase in intensive care unit (ICU) admissions and the mortality rates in Italy. METHODS: Official epidemiological data on coronavirus disease (COVID-19) were employed. The forward lagged (0, 3, 7, 14 days) daily variations in the number of deaths according to the number of days after the outbreak started and the daily increases in ICU admissions were estimated. RESULTS: A direct relationship between the sharp increase of ICU admissions and mortality rates has been shown. Furthermore, the analysis of the forward lagged daily variations in the number of deaths showed that an increase in the daily number of ICU admissions resulted in significantly higher mortality after 3, 7, and 14 days. The most pronounced effect was detected after 7 days, with 250 deaths (95% CI: 108.1-392.8) for the highest increase in the ICU admissions, from 100 to 200. CONCLUSIONS: These results would serve as a warning for the scientific community and the health care decision-makers to prevent a quick and out-of-control saturation of the ICU beds in case of a relapse of the COVID-19 outbreak.

6.
Artigo em Inglês | MEDLINE | ID: mdl-34501665

RESUMO

Treatment of lung cancer depends on the stage of the tumor and the histological type. In recent years, the histological confirmation of lung non-small-cell lung cancer has become crucial since the availability of selective target therapeutic approaches. The aim of the study was to develop a validated procedure to estimate the incidence and prevalence of non-small-cell and small-cell lung cancer from healthcare administrative data. A latent class model for categorical variables was applied. The following observed variables were included in the analysis: ICD-9-CM codes in the Hospital Discharge Registry, ATC codes of medications dispensed present in the Drugs Prescriptions Registry, and the procedure codes in the Outpatient Registry. The proportion of non-small-cell lung cancer diagnoses was estimated to be 85% of the total number of lung cancer on the cohort of incident cases and 89% on the cohort of prevalent cases. External validation on a cohort of 107 patients with a lung cancer diagnosis and histological confirmation showed a sensitivity of 95.6% (95%CI: 89-98.8%) and specificity of 94.1% (95%CI: 71.3-99.9%). The procedure is an easy-to-use tool to design subpopulation-based studies on lung cancer and to better plan resource allocation, which is important since the introduction of new targeted therapies in non-small-cell lung carcinoma.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Carcinoma de Pequenas Células do Pulmão , Carcinoma Pulmonar de Células não Pequenas/epidemiologia , Humanos , Incidência , Neoplasias Pulmonares/epidemiologia , Prevalência , Carcinoma de Pequenas Células do Pulmão/epidemiologia
7.
Artigo em Inglês | MEDLINE | ID: mdl-34360051

RESUMO

BACKGROUND: In a randomized controlled trial (RCT) with binary outcome the estimate of the marginal treatment effect can be biased by prognostic baseline covariates adjustment. Methods that target the marginal odds ratio, allowing for improved precision and power, have been developed. METHODS: The performance of different estimators for the treatment effect in the frequentist (targeted maximum likelihood estimator, inverse-probability-of-treatment weighting, parametric G-computation, and the semiparametric locally efficient estimator) and Bayesian (model averaging), adjustment for confounding, and generalized Bayesian causal effect estimation frameworks are assessed and compared in a simulation study under different scenarios. The use of these estimators is illustrated on an RCT in type II diabetes. RESULTS: Model mis-specification does not increase the bias. The approaches that are not doubly robust have increased standard error (SE) under the scenario of mis-specification of the treatment model. The Bayesian estimators showed a higher type II error than frequentist estimators if noisy covariates are included in the treatment model. CONCLUSIONS: Adjusting for prognostic baseline covariates in the analysis of RCTs can have more power than intention-to-treat based tests. However, for some classes of model, when the regression model is mis-specified, inflated type I error and potential bias on treatment effect estimate may arise.


Assuntos
Modelos Estatísticos , Viés , Causalidade , Simulação por Computador , Humanos , Probabilidade
8.
Children (Basel) ; 8(7)2021 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-34202693

RESUMO

One of the most relevant public health issues among pediatric injuries concerns foreign body (FB) aspiration. The risk perception of choking hazards (CH) and risk perception, in general, are complex multifactorial problems that play a significant role in defining protective behavior. Risk prevention policies should take this aspect into account. A lack of scientific knowledge of FB injury risk perception may be evidenced in Brazil and other newly developed countries. This study aims to characterize the differences and peculiarities in risk perception of CH between Italian and Brazilian populations. The risk perception among adults in Italy and Brazil between September and October 2017 was investigated in a survey. A Multiple Correspondence Analysis was carried out to identify the latent components characterizing the risk perception in Italian and Brazilian population samples. The most relevant dimension characterizing risk perception is the "Professional-educational status and the related perception of Risk" (13% of factorial inertia). The Italians identify batteries and magnets as the most dangerous choking risks (20% of responses). On the other hand, Brazilian people, mainly manual laborers (22%) with secondary or primary education (94%), perceive coins as the most dangerous items (30% of responses, p < 0.001). Socio-economic issues characterize the subjective risk perception of Italian and Brazilian survey respondents. In this framework, data-driven prevention strategies could be helpful to tailor intervention strategies to the cultural context to which they are addressed.

9.
Artigo em Inglês | MEDLINE | ID: mdl-34281067

RESUMO

BACKGROUND: Lung transplantation is a specialized procedure used to treat chronic end-stage respiratory diseases. Due to the scarcity of lung donors, constructing fair and equitable lung transplant allocation methods is an issue that has been addressed with different strategies worldwide. This work aims to describe how Italy's "national protocol for the management of surplus organs in all transplant programs" functions through an online app to allocate lung transplants. We have developed two probability models to describe the allocation process among the various transplant centers. An online app was then created. The first model considers conditional probabilities based on a protocol flowchart to compute the probability for each area and transplant center to receive each n-th organ in the period considered. The second probability model is based on the generalization of the binomial distribution to correlated binary variables, which is based on Bahadur's representation, to compute the cumulative probability for each transplant center to receive at least nth organs. Our results show that the impact of the allocation of a surplus organ depends mostly on the region where the organ was donated. The discrepancies shown by our model may be explained by a discrepancy between the northern and southern regions in relation to the number of organs donated.


Assuntos
Obtenção de Tecidos e Órgãos , Humanos , Itália , Pulmão , Doadores de Tecidos , Listas de Espera
10.
Artigo em Inglês | MEDLINE | ID: mdl-34206234

RESUMO

(1) Background: Propensity score methods gained popularity in non-interventional clinical studies. As it may often occur in observational datasets, some values in baseline covariates are missing for some patients. The present study aims to compare the performances of popular statistical methods to deal with missing data in propensity score analysis. (2) Methods: Methods that account for missing data during the estimation process and methods based on the imputation of missing values, such as multiple imputations, were considered. The methods were applied on the dataset of an ongoing prospective registry for the treatment of unprotected left main coronary artery disease. The performances were assessed in terms of the overall balance of baseline covariates. (3) Results: Methods that explicitly deal with missing data were superior to classical complete case analysis. The best balance was observed when propensity scores were estimated with a method that accounts for missing data using a stochastic approximation of the expectation-maximization algorithm. (4) Conclusions: If missing at random mechanism is plausible, methods that use missing data to estimate propensity score or impute them should be preferred. Sensitivity analyses are encouraged to evaluate the implications methods used to handle missing data and estimate propensity score.


Assuntos
Modelos Estatísticos , Projetos de Pesquisa , Interpretação Estatística de Dados , Humanos , Estudos Longitudinais , Pontuação de Propensão
11.
Sci Rep ; 11(1): 12581, 2021 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-34131221

RESUMO

Deferasirox (DFX) is the newest among three different chelators available to treat iron overload in iron-loading anaemias, firstly released as Dispersible Tablets (DT) and more recently replaced by Film-Coated Tablets (FCT). In this retrospective observational study, pharmacokinetics, pharmacodynamics, and safety features of DFX treatment were analyzed in 74 patients that took both formulations subsequently under clinical practice conditions. Bioavailability of DFX FCT compared to DT resulted higher than expected [Cmax: 99.5 (FCT) and 69.7 (DT) µMol/L; AUC: 1278 (FCT) and 846 (DT), P < 0.0001]. DFX FCT was also superior in scalability among doses. After one year of treatment for each formulation, no differences were observed between the treatments in the overall iron overload levels; however, DFX FCT but not DT showed a significant dose-response correlation [Spearman r (dose-serum ferritin variation): - 0.54, P < 0.0001]. Despite being administered at different dosages, the long-term safety profile was not different between formulations: a significant increase in renal impairment risk was observed for both treatments and it was reversible under strict monitoring (P < 0.002). Altogether, these data constitute a comprehensive comparison of DFX formulations in thalassaemia and other iron-loading anaemias, confirming the effectiveness and safety characteristics of DFX and its applicability for treatment tailoring.


Assuntos
Anemia/tratamento farmacológico , Deferasirox/administração & dosagem , Sobrecarga de Ferro/tratamento farmacológico , Talassemia/tratamento farmacológico , Adulto , Anemia/sangue , Anemia/epidemiologia , Anemia/patologia , Terapia por Quelação/tendências , Deferasirox/farmacocinética , Feminino , Ferritinas/sangue , Humanos , Ferro/sangue , Ferro/metabolismo , Quelantes de Ferro/administração & dosagem , Quelantes de Ferro/farmacocinética , Sobrecarga de Ferro/sangue , Sobrecarga de Ferro/epidemiologia , Sobrecarga de Ferro/patologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Talassemia/sangue , Talassemia/epidemiologia , Talassemia/patologia
12.
J Dig Dis ; 22(8): 496-502, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34189839

RESUMO

OBJECTIVE: In this study we aimed to compare patient outcomes between the use of transarterial radioembolization (TARE) and sorafenib in patients with hepatocellular carcinoma (HCC) and intrahepatic portal vein tumor thrombosis (PVTT). METHODS: A total of 65 patients with HCC and intrahepatic PVTT treated in five Italian hospitals between 2012 and 2018 were included in the analysis. Those with any previous treatment, extension of PVTT to the main portal tract and extrahepatic involvement were excluded. Propensity score matching analysis and Bayesian model averaging analysis were performed. RESULTS: Of the 41 patients treated with TARE and 24 with sorafenib, 11 patients were downstaged to curative-intent surgery (liver transplant in three and hepatectomy in eight), including 10 treated with TARE and one with sorafenib. TARE was more effective than sorafenib in downstaging patients to surgery, achieving a mean survival of 54 months. In the 54 patients without downstaging after treatment, of whom 31 were treated with TARE and 23 with sorafenib, median survival was 20.3 and 9.1 months, respectively (P = 0.001), with different 1-, 2- and 3-year OS rates (64.5%, 42.6% and 37.3% vs 39.1%, 13.0% and 0%). Both propensity score and Bayesian model averaging confirmed an improvement in overall survival in the TARE group compared with sorafenib treatment. CONCLUSIONS: TARE was more effective than sorafenib in downstaging patients with HCC to surgery, providing a significant improvement in survival. Even in patients who were not downstaged to surgery, survival appeared to be superior with TARE over sorafenib.


Assuntos
Carcinoma Hepatocelular , Quimioembolização Terapêutica , Neoplasias Hepáticas , Trombose Venosa , Teorema de Bayes , Carcinoma Hepatocelular/complicações , Carcinoma Hepatocelular/tratamento farmacológico , Carcinoma Hepatocelular/terapia , Humanos , Neoplasias Hepáticas/complicações , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/terapia , Veia Porta , Pontuação de Propensão , Estudos Retrospectivos , Sorafenibe/uso terapêutico , Resultado do Tratamento , Trombose Venosa/etiologia , Trombose Venosa/terapia
13.
Artigo em Inglês | MEDLINE | ID: mdl-34070561

RESUMO

Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is a novel laparoscopic intraperitoneal chemotherapy approach offered in selected patients affected by non-resectable peritoneal carcinomatosis. Drugs doses currently established for nebulization are very low: oxaliplatin (OXA) 120 mg/sm, cisplatin (CDDP) 10.5 mg/sm and doxorubicin (DXR) 2.1 mg/sm. A model-based approach for dose-escalation design in a single PIPAC procedure and subsequent dose escalation steps is planned. The starting dose of oxaliplatin is 100 mg/sm with a maximum estimated dose of 300 mg/sm; an escalation with overdose and under-dose control (for probability of toxicity less than 16% in case of under-dosing and probability of toxicity greater than 33% in case of overdosing) will be further applied. Cisplatin is used in association with doxorubicin: A two-dimensional dose-finding design is applied on the basis of the estimated dose limiting toxicity (DLT) at all combinations. The starting doses are 15 mg/sm for cisplatin and 3 mg/sm for doxorubicin. Safety is assessed according to Common Terminology Criteria for Adverse Events (CTCAE version 4.03). Secondary endpoints include radiological response according to Response Evaluation Criteria in Solid Tumor (version 1.1) and pharmacokinetic analyses. This phase I study can provide the scientific basis to maximize the optimal dose of cisplatin, doxorubicin and oxaliplatin applied as PIPAC.


Assuntos
Cisplatino , Neoplasias Peritoneais , Aerossóis , Ensaios Clínicos Fase I como Assunto , Doxorrubicina , Humanos , Oxaliplatina , Neoplasias Peritoneais/tratamento farmacológico , Peritônio
14.
Diseases ; 9(2)2021 May 05.
Artigo em Inglês | MEDLINE | ID: mdl-34062996

RESUMO

In recent years, the digital polymerase chain reaction has received increasing interest as it has emerged as a tool to provide more sensitive and accurate detection of minimal residual disease. In order to start the process of data alignment, we assessed the consistency of the BCR-ABL1 quantification results of the analysis of 16 RNA samples at different levels of disease. The results were obtained by two different laboratories that relied on The Qx100/Qx200 Droplet Digital PCR System (Bio-Rad) and Quant Studio 3D dPCR System (Thermofisher) platforms. We assessed the compatibility between the estimated values by linear regression, Bland-Altman bias-plot, and Mann-Whitney nonparametric test. The results confirmed the compatibility of the measures, allowing us tocompute an 'alignment factor' (AF), equal to 1.41, which was further validated by a different series of experiments. We conclude that the performed measurements by the two laboratories are comparable, and also equalized through the introduction of an alignment factor.

15.
Artigo em Inglês | MEDLINE | ID: mdl-34073448

RESUMO

Recent literature has reported a high percentage of asymptomatic or paucisymptomatic cases in subjects with COVID-19 infection. This proportion can be difficult to quantify; therefore, it constitutes a hidden population. This study aims to develop a proof-of-concept method for estimating the number of undocumented infections of COVID-19. This is the protocol for the INCIDENT (Hidden COVID-19 Cases Network Estimation) study, an online, cross-sectional survey with snowball sampling based on the network scale-up method (NSUM). The original personal network size estimation method was based on a fixed-effects maximum likelihood estimator. We propose an extension of previous Bayesian estimation methods to estimate the unknown network size using the Markov chain Monte Carlo algorithm. On 6 May 2020, 1963 questionnaires were collected, 1703 were completed except for the random questions, and 1652 were completed in all three sections. The algorithm was initialized at the first iteration and applied to the whole dataset. Knowing the number of asymptomatic COVID-19 cases is extremely important for reducing the spread of the virus. Our approach reduces the number of questions posed. This allows us to speed up the completion of the questionnaire with a subsequent reduction in the nonresponse rate.


Assuntos
COVID-19 , Teorema de Bayes , Estudos Transversais , Humanos , SARS-CoV-2 , Rede Social
16.
Eur J Psychotraumatol ; 12(1): 1894736, 2021 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-33889310

RESUMO

Background: In recent years, eye movement desensitization and reprocessing (EMDR) has been applied to different psychiatric conditions beyond post-traumatic stress disorder (PTSD), and an increasing number of studies have evaluated its effect on depression. To date, no quantitative synthesis of the efficacy of EMDR on depression has been conducted. Objective: To meta-analytically review the studies on EMDR for depression as the primary target for treatment. Method: Studies with a controlled design evaluating the effect of EMDR on depression were searched on six electronic databases (PubMed, Embase, CINAHL, PsycINFO, Cochrane database, and Francine Shapiro Library) and then selected by two independent reviewers. A systematic review and meta-analysis was conducted. Results: Eleven studies were included for qualitative synthesis. Nine studies were included in the meta-analysis, involving 373 participants. The overall effect size of EMDR for depressive symptoms is large (n = 9, Hedges' g = - 1.07; 95%CI [-1.66; - 0.48]), with high heterogeneity (I 2 = 84%), and corresponds to a 'number needed to treat' of 1.8. At follow-up (range 3-6 months), the effect remains significant but moderate (n = 3, Hedges' g = - 0.62; 95%CI [-0.97; - 0.28]; I 2 = 0%). The effect of EMDR compared with active controls is also moderate (n = 7, g = - 0.68; 95%CI [-0.92; - 0.43]; I 2 = 0%). No publication bias was found, although the results are limited by the small number and poor methodological quality of the included studies. Conclusions: Review findings suggest that EMDR may be considered an effective treatment for improving symptoms of depression, with effects comparable to other active treatments. However, findings need to be interpreted in light of the limited number of the studies and their quality. Further research is required to understand the longer-term of effects EMDR in treating depression and preventing depression relapse. Protocol registration: PROSPERO (CRD42018090086).

17.
BMC Public Health ; 21(1): 797, 2021 04 26.
Artigo em Inglês | MEDLINE | ID: mdl-33902527

RESUMO

BACKGROUND: Italy has been the first European country to be affected by the COVID-19 epidemic which started out at the end of February. In this report, we focus our attention on the Veneto Region, in the North-East of Italy, which is one of the areas that were first affected by the rapid spread of SARS-CoV-2. We aim to evaluate the trend of all-cause mortality and to give a description of the characteristics of the studied population. METHODS: Data used in the analyses were released by the majority of municipalities and cover the 93% of the total population living in the Veneto Region. We evaluated the trend of overall mortality from Jan.01 to Jun.30. 2020. Moreover we compared the COVID-19-related deaths to the overall deaths. RESULTS: From March 2020, the overall mortality rate increased exponentially, affecting males and people aged > 76 the most. The confirmed COVID-19-related death rate in the Veneto region between Mar.01 and Apr.302020 is 30 per 100,000 inhabitants. In contrast, the all-cause mortality increase registered in the same months in the municipalities included in the study is 219 per 100,000 inhabitants. CONCLUSIONS: COVID-19 has a primary role in the increase in mortality but does not entirely explain such a high number of deaths. Strategies need to be developed to reduce this gap in case of future waves of the pandemic.


Assuntos
COVID-19 , Idoso , Cidades , Surtos de Doenças , Europa (Continente) , Humanos , Itália/epidemiologia , Masculino , Mortalidade , SARS-CoV-2
18.
Cancers (Basel) ; 13(5)2021 Mar 03.
Artigo em Inglês | MEDLINE | ID: mdl-33802269

RESUMO

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) is an innovative laparoscopic intraperitoneal chemotherapy approach with the advantage of a deeper tissue penetration. Thus far, oxaliplatin has been administered at an arbitrary dose of 92 mg/m2, cisplatin at 7.5 mg/m2 and doxorubicin 1.5 mg/m2. This is a model-based approach phase I dose escalation study with the aim of identifying the maximum tolerable dose of the three different drugs. The starting dose of oxaliplatin was 100 mg/m2; cisplatin was used in association with doxorubicin: 15 mg/m2 and 3 mg/m2 were the respective starting doses. Safety was assessed according to Common Terminology Criteria for Adverse Events (CTCAE version 4.03). Thirteen patients were submitted to one PIPAC procedure. Seven patients were treated with cisplatin and doxorubicin and 6 patients with oxaliplatin; no dose limiting toxicities and major side effects were found. Common adverse events included postoperative abdominal pain and nausea. The maximum tolerable dose was not reached. The highest dose treated cohort (oxaliplatin 135 mg/m2; cisplatin 30 mg/m2 and doxorubicin 6 mg/m2) tolerated PIPAC well. Serological analyses revealed no trace of doxorubicin at any dose level. Serum levels of cis- and oxaliplatin reached a peak at 60-120 min after PIPAC and were still measurable in the circulation 24 h after the procedure. Cisplatin and doxorubicin may be safely used as PIPAC at a dose of 30 mg/m2 and 6 mg/m2, respectively; oxaliplatin can be used at an intraperitoneal dose of 135 mg/m2. The dosages achieved to date are the highest ever used in PIPAC.

19.
J Pers Med ; 11(4)2021 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-33916613

RESUMO

A relevant issue on the treatment of adrenocortical carcinoma (ACC) concerns the optimal duration of adjuvant mitotane treatment. We tried to address this question, assessing whether a correlation exists between the duration of adjuvant mitotane treatment and recurrence-free survival (RFS) of patients with ACC. We conducted a multicenter retrospective analysis on 154 ACC patients treated for ≥12 months with adjuvant mitotane after radical surgery and who were free of disease at the mitotane stop. During a median follow-up of 38 months, 19 patients (12.3%) experienced recurrence. We calculated the RFS after mitotane (RFSAM), from the landmark time-point of mitotane discontinuation, to overcome immortal time bias. We found a wide variability in the duration of adjuvant mitotane treatment among different centers and also among patients cared for at the same center, reflecting heterogeneous practice. We did not find any survival advantage in patients treated for longer than 24 months. Moreover, the relationship between treatment duration and the frequency of ACC recurrence was not linear after stratifying our patients in tertiles of length of adjuvant treatment. In conclusion, the present findings do not support the concept that extending adjuvant mitotane treatment over two years is beneficial for ACC patients with low to moderate risk of recurrence.

20.
Artigo em Inglês | MEDLINE | ID: mdl-33668623

RESUMO

Bayesian inference is increasingly popular in clinical trial design and analysis. The subjective knowledge derived from an expert elicitation procedure may be useful to define a prior probability distribution when no or limited data is available. This work aims to investigate the state-of-the-art Bayesian prior elicitation methods with a focus on clinical trial research. A literature search on the Current Index to Statistics (CIS), PubMed, and Web of Science (WOS) databases, considering "prior elicitation" as a search string, was run on 1 November 2020. Summary statistics and trend of publications over time were reported. Finally, a Latent Dirichlet Allocation (LDA) model was developed to recognise latent topics in the pertinent papers retrieved. A total of 460 documents pertinent to the Bayesian prior elicitation were identified. Of these, 213 (45.4%) were published in the "Probability and Statistics" area. A total of 42 articles pertain to clinical trial and the majority of them (81%) reports parametric techniques as elicitation method. The last decade has seen an increased interest in prior elicitation and the gap between theory and application getting narrower and narrower. Given the promising flexibility of non-parametric approaches to the experts' elicitation, more efforts are needed to ensure their diffusion also in applied settings.


Assuntos
Projetos de Pesquisa , Teorema de Bayes , Probabilidade
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