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Actas del VIII Congreso Nacional de Derecho Agrario Provincial
Get PDFEste libro, que recoge las actas de las ponencias presentadas durante el VIII Congreso
Nacional de Derecho Agrario Provincial es la continuidad del trabajo iniciado en 2009 con mi
libro Derecho agrario argentino donde propuse una visión de los distintos institutos, contenidos
y disposiciones especiales de derecho agrario en las constituciones provinciales y continuado
en 2011 con Derecho agrario provincial, obra colectiva que dirigí y con la que se constituyó una
red de expertos, sobre todo académicos, en derecho agrario y sus extensiones derecho
agroambiental y derecho agroalimentario
Supplemental parenteral nutrition within an enhanced recovery program for open pancreatoduodenectomy for cancer: a pragmatic, multicenter, randomized controlled trial
Get PDFBackground
The role of supplemental parenteral nutrition (SPN) following pancreatoduodenectomy (PD) in the context of an enhanced recovery program is unexplored. This study aimed to determine whether SPN is superior to early oral feeding alone in reducing postoperative complications.
Methods
This pragmatic, multicenter, randomized controlled, trial, across five centers in Italy, enrolled patients aged 18–89 years undergoing open PD for cancer. We excluded patients with an American Society of Anaesthesiology physical status >3 and a preoperative body weight loss of ≥15%. Patients were randomly assigned (1:1) postoperatively to either SPN from day 1 to 5 or no-SPN. All patients were free to begin oral feeding after the operation as desired in the context of a full enhanced recovery after surgery (ERAS) program. The primary outcome was morbidity burden, measured using the comprehensive complication index (CCI). Secondary outcomes included the overall rate of morbidity. Outcomes were assessed up to 90 days postoperatively. Overall, 120 patients per group were required to achieve 80% power and detect at least 30% reduction in the CCI in the SPN group, which was expected to be 23 (median) (interquartile range 21–31). The expected complication rate was 60%, and the type I error rate was set at 5%. Registration at ClinicalTrials.gov (#NCT04438447).
Findings
From June 1, 2022, to December 20, 2023, 405 patients were screened for eligibility and 254 patients were randomly allocated to control (no-SPN; n = 129) or treatment (SPN; n = 125) group. All patients were included in the primary and secondary outcome analysis according to the intent-to-treat principle. The median CCI was 20.9 in both arms (median difference 0 [95% CI: −1.07 to 1.7]). The proportion of patients with at least one complication (CCI >0) was similar in both groups [(29.6% vs 29.2%; risk difference 0.4 (95% CI −11.1 to 7.0)]. The overall 90-day morbidity was 67.4% and 63.2% in the no-SPN arm and SPN arm groups, respectively [risk difference −4.2 (95% CI −16.7 to 8.2)]. In high nutritional risk patients (nutritional risk score ≥3), SPN was not protective against the primary outcome when compared with low-risk patients [OR 1.16 (95% CI 0.71–1.91)].
Interpretation
In an ERAS program emphasizing early postoperative oral feeding, SPN does not affect outcome measures, even in patients at high nutritional risk. However, these results do not apply to severely malnourished patients or with critical comorbidities
Rainbow ballots: introducing the Italian LGBTIQ+ electoral survey 2024
Get PDFThe development of an empirics-based political science agenda on the electoral dimension of LGBTIQ+ citizens has been traditionally hindered by the widespread lack of individual-level data related to the sensitivity of their identity, including in Italy. In this paper, we contribute to the literature by first presenting an innovative survey, providing novel public-opinion data on the political participation, issue attitudes, and vote choice of a large number of Italian LGBTIQ+ citizens. We detail the rationale and challenges related to our research, leading to our strategic approach to the development of a self-selected sample based on an original sampling technique. On this basis, in an area of public debate often dominated by clichés rather than scientific evidence, we introduce first empirics on Italian LGBTIQ+ respondents. In line with existing studies from other Western national contexts, our LGBTIQ+ sample is active in civil society and politics – albeit not “activist” –, consistently votes in elections, and is markedly left-wing in values, issue attitudes, and vote choice. We discuss the scientific and societal contributions of our paper in detail
Enhancing Recurrence-Free Survival Prediction in Hepatocellular Carcinoma: A Time-Updated Model Incorporating Tumor Burden and AFP Dynamics
No full textBackground Existing models to predict recurrence-free survival (RFS) after hepatectomy for hepatocellular carcinoma (HCC) rely on static preoperative factors such as alpha-fetoprotein (AFP) and tumor burden score (TBS). These models overlook dynamic postoperative AFP changes, which may reflect evolving recurrence risk. We sought to develop a dynamic, real-time model integrating time-updated AFP values with TBS for improved recurrence prediction. Patients and Methods Patients undergoing curative-intent hepatectomy for HCC (2000-2023) were identified from an international, multi-institutional database with RFS as the primary outcome. AFP trajectory was monitored from preoperative to 6- and 12-month postoperative values, using time-varying Cox regression with AFP as a time-dependent covariate. The predictive accuracy of this time-updated model was compared with a static preoperative Cox model excluding postoperative AFP. Results Among 1911 patients, AFP trajectories differed between recurrent and nonrecurrent cases. While preoperative AFP values were similar, recurrent cases exhibited higher AFP at 6 and 12 months. Multivariable analysis identified TBS (hazard ratio (HR):1.043 [95% confidence interval (CI): 1.002-1.086]; p = 0.039) and postoperative log AFP dynamics (HR:1.216 [CI 1.132-1.305]; p < 0.001) as predictors. Contour plots depicted TBS's influence decreasing over time, while postoperative AFP became more predictive. The time-varying Cox model was created to update RFS predictions continuously on the basis of the latest AFP values. The preoperative Cox model, developed with age, AFP, TBS, and albumin-bilirubin score, had a baseline C-index of 0.61 [0.59-0.63]. At 6 months, the time-varying model's C-index was 0.70 [0.67-0.73] versus 0.59 [0.56-0.61] for the static model; at 12 months, it was 0.70 [0.66-0.73] versus 0.56 [0.53-0.59]. The model was made available online (https://nm49jf-miho-akabane.shinyapps.io/AFPHCC/). Conclusions Incorporating postoperative AFP dynamics into RFS prediction after HCC resection enhanced prediction accuracy over time, as TBS's influence decreased. This adaptive, time-varying model provides refined RFS predictions throughout follow-up
How to distinguish promotion, prevention, and treatment trials in public mental health: development and validation of the VErona-LUgano Tool (VELUT)
Get PDFBackground: Promoting mental health, preventing mental disorders and providing effective treatments are public health priorities. Randomized controlled trials (RCTs) frequently evaluate mental health and psychosocial support interventions to achieve one or more of these objectives. Distinguishing between RCTs focused on mental health promotion, prevention or treatment remains conceptually and methodologically challenging. No standardized tool exists to position RCTs along a promotion-to-treatment continuum in mental health. We aimed to develop and validate the VErona-LUgano Tool (VELUT) for distinguishing RCTs along the promotion-to-treatment continuum. Methods: An interdisciplinary tool development group (TDG) was established. The Population, Intervention, Comparison and Outcome framework was used to define key constructs. Items in the tool were devised, categorized and reduced through qualitative and quantitative methods. Finally, we performed a preliminary validation of the VELUT applying item response theory (IRT) using data from 180 RCTs. Results: The TDG generated 33 items for the initial version of the VELUT, reduced to 16 through review, cognitive interviews and psychometric analysis. Analyses of 180 RCTs using the 16-item tool showed high internal consistency (α = 0.94) and unidimensionality. Following item reduction and IRT, a final 8-item version was retained, and IRT models confirmed strong item discrimination for the 8 items and high scale reliability (marginal reliability >0.90 across most of the range of the scale), good response distribution, item performance and alignment with the Institute of Medicine (IOM) promotion-to-treatment continuum. Conclusions: The VELUT addresses methodological gaps in global mental health research by helping to position RCTs of MHPSS interventions along the IOM promotion-to-treatment continuum
IBRUTINIB DOSE MODIFICATION IN MANTLE CELL LYMPHOMA: AN ITALIAN REAL‐LIFE MULTICENTER EXPERIENCE. RESULTS FROM THE REDOT_MCL STUDY
No full textIntroduction: Although BTK inhibitors (BTKi) have reshaped the therapeutic algorithm of lymphoproliferative diseases, class-specific toxicities such as bleeding, atrial fibrillation and cytopenia have emerged. Dose modification (DM) is often attempted to mitigate these adverse events (AEs), particularly with ibrutinib, the first-in-class BTKi approved for relapsed/refractory (R/R) mantle cell lymphoma (MCL). The impact of ibrutinib DM has not been specifically evaluated in MCL. The REDOT study aimed to describe ibrutinib DM (reduction/interruption/discontinuation) in R/R MCL from 14 Italian centers, evaluating DM impact on AEs, responses and outcomes.
Methods: We assessed DM rate in a real-life series of consecutive MCL patients who started ibrutinib between 2016 and 2023. We calculated single patient’s relative cumulative ibrutinib dose as a percentage of the expected full dose during the entire treatment period. Patients were grouped into 4 dose levels (DL1a 95%–100%, DL1b 75%–94%, DL2a 50%–74%, DL2b < 50% of expected dose). We evaluated ibrutinib-related AEs, change in responses, progression free survival (PFS), overall survival (OS) and time to next treatment (TTNT) between groups.
Results: Our cohort included 226 MCL patients. Median age at ibrutinib start was 73 years, with 74% of patients receiving ibrutinib as second line. Overall, 34% of patients started ibrutinib at reduced dose, in most cases (67%) due to clinician’s choice (age, comorbidities), followed by concomitant therapies (16%), cytopenia (9%) or unknown reason (9%). Forty-four percent of patients reduced ibrutinib either at start or during treatment. Median time to first reduction was 5 months. In 73% of cases, reductions were caused by AEs. Thirty-five percent of patients interrupted ibrutinib, mainly due to AEs (65% of interruptions). Thirty-five percent of interruptions were due to surgical procedures or patient choice. Sixty-five percent of patients permanently discontinued ibrutinib due to progressive disease (70%), AEs or other reasons (15% each) including allogeneic stem cell transplant. Overall, 54% and 15% of patients were grouped into DL1a and 1b, 22% and 9% into DL2a and 2b, respectively. No statistically significant difference in response rates emerged between the 4 DLs (p = 0.516) (Figure 1A). We showed similar 3y-PFS (DL1a 25%, 1b 40%, 2a 30%, 2b 36%, p = 0.426) (Figure 1B). Accordingly, there was no statistically significant difference in 3y-OS (DL1a 42%, 1b 45%, 2a 37%, 2b 51%, p = 0.657). Contrarily, regarding TTNT, DL2b patients tended to stay in treatment longer than those who took higher doses (p = 0.058).
Conclusions: This is the first report evaluating ibrutinib DM in MCL in a real-life setting. We showed higher DM rates than in clinical trials, probably due to advanced age and number of comorbidities. Ibrutinib dose did not significantly impact responses and outcomes. Therefore, DM is a viable strategy especially for elderly MCL patients with comorbidities or drug-related AEs
The role of time to first progression and fitness status in elderly patients with mantle cell lymphoma: results from the ELDERLY MANTLE-FIRST study
No full textMantle cell lymphoma (MCL) is an incurable disease. Elderly patients have heterogeneous but unsatisfactory outcomes. We aimed to confirm the prognostic impact of time to progression of disease (early-POD≤24 versus late-POD>24 months) in a multicenter cohort of elderly MCL patients, and to assess the role of fitness status, defined by a simplified geriatric assessment.
We collected a real-life series of 231 MCL patients aged ≥65 years, in first relapse or refractory to frontline non-intensive chemo-immunotherapy (CIT). We evaluated safety and effectiveness of second-line treatments comparing Bruton Tyrosine Kinase inhibitors (BTKi, 124 patients) versus salvage CIT (65 patients).
Median progression free survival (PFS) after BTKi was significantly longer compared to CIT (1.39 versus 0.98 years, p-value 0.037), though slightly inferior to previous studies, probably due to higher median age (77 years) and inferior fitness (>50% unfit/frail) of our cohort.
Early-POD patients showed dismal prognosis, with median PFS from second-line therapy (PFS-2) 0.66 versus 1.47 years for late-POD (p-value 0.007), and median overall survival from second-line therapy (OS-2) 1.34 versus 3.17 years (p-value 0.007).
Fitness status emerged as crucial prognostic parameter: late relapsed fit patients had the best prognosis (3-year PFS-2 34%, OS-2 62%), whereas unfit/frail patients showed similar outcomes regardless of time to POD.
In conclusion, in a real-life cohort of elderly MCL patients we confirmed the role of BTKi as standard salvage therapy and the prognostic impact of early-POD. Moreover, fitness emerged as an essential prognostic tool, apparently stronger than time to POD, and should be incorporated in future trials
Dialogo: forma conoscitiva, genere autonomo
No full textIl volume raccoglie i contributi presentati in occasione del quarto Convegno Dottorale internazionale del Corso di Dottorato in Filologia, Letteratura e Scienze dello Spettacolo, svoltosi presso l'Università di Verona dal 14 al 16 ottobre 2024. Attraverso molteplici approcci disciplinari, i saggi indagano il genere del dialogo nelle declinazioni tematiche, formali, filologiche e linguistiche che esso ha assunto dall'antichità fino ai giorni nostri
Exercise therapy to improve mobility, active behaviour and quality of life of chronic kidney disease patients with peripheral artery disease: study protocol for the EXACT-CKDPAD multicentre randomised controlled trial
No full textThe combination of chronic kidney disease (CKD) and peripheral artery disease (PAD) enhances the already present high cardiovascular risk, exposing the affected patients to unfavourable long-term clinical outcomes. Physical exercise is considered an effective treatment for reducing sedentary behaviour and improving quality of life, but several barriers limit patient participation. In this parallel-design, single-blinded, randomised controlled trial, we will enrol 130 patients with concomitant CKD at stages III and IV and PAD at the claudication stage to be randomised into a 6-month exercise (Ex) or control (Co) intervention. The Ex programme will consist of two daily 10 min interval walking sessions (1 min of walking followed by 1 min of resting), with gait speed controlled via a metronome and increased approximately weekly. The Co group will receive standard nephrological care. Outcomes will be assessed before and after treatment, as well as at the 12-month follow-up. The primary outcome will be the 6 min walking distance. The secondary outcomes will include quality of life, lower limb and handgrip strength, body composition and bone mineral density, as well as circulating indexes of kidney function and long-term clinical outcomes. Since no trials have been published that purposely enrol this high-risk population (CKD-PAD), the eventual positive results will validate a simple, pain-free exercise intervention that can be carried out at home to improve patients' mobility and quality of life. Trial registration number: NCT06621264