Publications by authors named "Giovanni Tripepi"

357 Publications

Telecommuting, Off-Time Work, and Intrusive Leadership in Workers' Well-Being.

Int J Environ Res Public Health 2021 03 24;18(7). Epub 2021 Mar 24.

Department of Educational Sciences, University of Genova (Italy), 16126 Genova, Italy.

Telecommuting is a flexible form of work that has progressively spread over the last 40 years and which has been strongly encouraged by the measures to limit the COVID-19 pandemic. There is still limited evidence on the effects it has on workers' health. In this survey we invited 905 workers of companies that made a limited use of telecommuting to fill out a questionnaire to evaluate intrusive leadership of managers (IL), the request for work outside traditional hours (OFF-TAJD), workaholism (Bergen Work Addiction Scale (BWAS)), effort/reward imbalance (ERI), happiness, and common mental issues (CMIs), anxiety and depression, assessed by the Goldberg scale (GADS). The interaction between these variables has been studied by structural equation modeling (SEM). Intrusive leadership and working after hours were significantly associated with occupational stress. Workaholism is a relevant moderator of this interaction: intrusive leadership significantly increased the stress of workaholic workers. Intrusive leadership and overtime work were associated with reduced happiness, anxiety, and depression. These results indicate the need to guarantee the right to disconnect to limit the effect of the OFF-TAJD. In addition to this, companies should implement policies to prevent intrusive leadership and workaholism.
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http://dx.doi.org/10.3390/ijerph18073330DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8037393PMC
March 2021

Points of attention when conducting etiological research.

Nephrology (Carlton) 2021 Mar 17. Epub 2021 Mar 17.

ERA-EDTA Registry, Department of Medical Informatics, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Epidemiological studies often aim to investigate the causal contribution of a risk factor to a disease or other outcome. In etiological research, one is usually interested in the (biological) mechanism(s) underlying the studied relationship. Inappropriate conduct of an etiological study may have major implications for the correctness of the results and interpretation of the findings. Therefore, in this paper, we aim to describe step by step how etiological research should be carried out, together with its  common pitfalls. These steps involve finding and formulating a well-defined etiological research question, choosing an appropriate study design including a suitable comparison group, adequate modelling, and adequate reporting and interpretation of the results.
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http://dx.doi.org/10.1111/nep.13875DOI Listing
March 2021

Mutual effect modification between adiponectin and HDL as risk factors of cardiovascular events in Type 2 diabetes individuals: a cohort study.

Int Urol Nephrol 2021 Mar 5. Epub 2021 Mar 5.

Institute of Clinical Physiology (IFC-CNR), Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, 89127, Reggio Calabria, Italy.

Purpose: We aimed to assess whether high-density lipoprotein (HDL) cholesterol modifies the association between adiponectin and incident cardiovascular (CV) morbidity and mortality in Type 2 Diabetes Mellitus (T2DM) and vice versa.

Methods: At baseline, 106 T2DM participants with various degrees of renal function were enrolled and followed up over a period of 7 years with fatal/nonfatal CV events as outcome.

Results: During the follow-up, 49 participants experienced incident CV events (28 fatal, 21 nonfatal). On univariate Fine and Gray sub-hazard models, HDL cholesterol was a strong modifier of the association between adiponectin and CV outcomes both on crude (P = 0.011) and gender- and eGFR-adjusted models (P = 0.010). The protective effect for CV events portended by a fixed increase in adiponectin (1 μg/ml) was progressively higher across increasing values of HDL cholesterol. Moreover, plasma adiponectin also modified the protective effect of HDL on CV outcomes both in crude and multivariate analyses. We found a mutual effect modification between adiponectin and HDL as risk factors of CV events in participants with T2DM.

Conclusion: Our results are coherent with the hypothesis that HDL cholesterol might play a pivotal role in the interpretation of the association between adiponectin and the risk of adverse CV outcomes in this population.
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http://dx.doi.org/10.1007/s11255-021-02828-4DOI Listing
March 2021

Validation of the Alternative International Prognostic Score-E (AIPS-E): Analysis of Binet stage A chronic lymphocytic leukemia patients enrolled into the O-CLL1-GISL protocol.

Eur J Haematol 2021 Mar 4. Epub 2021 Mar 4.

Hematology Unit AO of Cosenza, Cosenza, Italy.

Objectives: To validate the predictive value on time to first treatment (TTFT) of AIPS-E and IPS-E evaluated in an independent cohort of newly diagnosed and non-referred Binet stage A CLL patients enrolled in the O-CLL1-GISL protocol (clinicaltrial.gov identifier: NCT00917540).

Methods: A cohort of 292 newly diagnosed Binet A CLL cases has been enrolled in the study. Patients from several Italian Institutions were prospectively enrolled within 12 months of diagnosis into the O-CLL1-GISL protocol.

Results: The majority of patients were male (62%); median age was 60.4 years, 102 cases (34.9%) showed unmutated IGHV genes, 8 cases (2.8) the presence of del(11q)/del(17p), 142 cases (48.6%) the presence of palpable lymph nodes and 146 cases (50%) and ALC > 15 × 10 /l. After a median follow-up of 7.2 years, 130 patients underwent treatment. According to the AIPS-E, 96 patients were classified as low-risk, 128 as intermediate-risk, and 68 as high-risk. These groups showed significant differences in terms of TTFT. The C-statistic was 0.71 (P < .0001) for predicting TTFT. According to IPS-E, 77 patients were classified as low-risk, 135 as intermediate-risk, and 80 as high-risk. These groups showed significant differences in terms of TTFT. The C-statistic was 0.705 (P < .0001) for predicting TTFT.

Conclusions: Our data confirm an accurate prognostic utility of both AIPS-E and IPS-E at the individual patient level. These data may be useful for a precise stratification of early-stage patients.
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http://dx.doi.org/10.1111/ejh.13614DOI Listing
March 2021

Epidemiology of hyperkalemia in CKD patients under nephrological care: a longitudinal study.

Intern Emerg Med 2021 Feb 11. Epub 2021 Feb 11.

Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension, CNR-IFC of Reggio Calabria, Reggio Calabria, Italy.

Hyperkalemia is a potential life-threatening condition among chronic kidney disease (CKD) patients. Available estimates of the burden of this alteration in CKD are mainly derived from large administrative databases. Since K measurements in patients in these databases are often dictated by clinical reasons, longitudinal studies including pre-planned measurements of potassium independently of clinical complication/symptoms may produce more reliable estimates of the frequency and the risk factors underlying hyperkalemia in CKD patients. We estimated the prevalence and the incidence of hyperkalemia in a longitudinal study in 752 stages 2-5 CKD patients lasting 3 years and including up to seven pre-planned assessment of key biochemical measurements including K. At baseline, 203 out of 752 patients (27%) had serum K > 5.0 mM/L and 33% had acidosis (HCO ≤ 22 mmol/L). Among those without hyperkalemia at baseline (n = 549), 284 patients developed this alteration across the 3-year follow-up. The point prevalence of hyperkalemia rose from 27% (baseline) to 30% (last visit) (P = 0.001). In a multivariate model, hyperkalemia at baseline [odds ratio (OR):7.29, 95% CI 5.65-9.41, P < 0.001], venous bicarbonate levels [OR (1 mmol/l): 0.92, 0.89-0.96, P < 0.001], eGFR [OR (1 ml/min/1.73m): 0.98, 0.97-0.99, P < 0.001], use of ACE inhibitors (OR: 1.68, 1.28-2.19, P < 0.001) and angiotensin II antagonists (OR: 1.30, 1.01-1.68, P = 0.045) were related to hyperkalemia over time. Of note, venous bicarbonate levels emerged as an independent risk factor of hyperkalemia over time also in a separate analysis of patients with and without hyperkalemia at baseline. In a cohort of CKD patients including pre-planned measurements of K, 27% of patients had hyperkalemia. Metabolic acidosis and the use of drugs interfering with renin-angiotensin system were the strongest modifiable risk factors for this potentially life-threatening alteration in CKD in longitudinal analyses in the whole study cohort and in patients developing de novo hyperkalemia over time.
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http://dx.doi.org/10.1007/s11739-021-02653-8DOI Listing
February 2021

Be careful with ecological associations.

Nephrology (Carlton) 2021 Feb 11. Epub 2021 Feb 11.

Institute of Clinical Physiology (IFC-CNR), Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, Reggio Calabria, Italy.

Ecological studies are observational studies commonly used in public health research. The main characteristic of this study design is that the statistical analysis is based on pooled (i.e., aggregated) rather than on individual data. Thus, patient-level information such as age, gender, income and disease condition are not considered as individual characteristics but as mean values or frequencies, calculated at country or community level. Ecological studies can be used to compare the aggregated prevalence and incidence data of a given condition across different geographical areas, to assess time-related trends of the frequency of a pre-defined disease/condition, to identify factors explaining changes in health indicators over time in specific populations, to discriminate genetic from environmental causes of geographical variation in disease, or to investigate the relationship between a population-level exposure and a specific disease or condition. The major pitfall in ecological studies is the ecological fallacy, a bias which occurs when conclusions about individuals are erroneously deduced from results about the group to which those individuals belong. In this paper, by using a series of examples, we provide a general explanation of the ecological studies and provide some useful elements to recognize or suspect ecological fallacy in this type of studies.
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http://dx.doi.org/10.1111/nep.13861DOI Listing
February 2021

Distance from the outbreak of infection, ozone pollution and public health consequences of SARS-CoV-2 epidemic: the HOPE method.

Eur J Public Health 2021 02;31(1):7-12

Institute of Clinical Physiology of the National Research Council (CNR), Pisa, Italy.

Background: Italy was the second country in the world, after China, to be hit by SARS-CoV-2 pandemic. Italy's experience teaches that steps to limit people's movement by imposing 'red zones' need to be put in place early by carefully identifying the cities to be included within these areas of quarantine. The assessment of the relationship between the distance from an established outbreak of SARS-CoV-2 infection with transmission-linked cases and mortality observed in other sites could provide useful information to identify the optimal radius of red zones.

Methods: We investigated the relationship between SARS-CoV-2 cases and the distance of each Italian province from the first outbreak of SARS-CoV-2 epidemic in Italy (the city of Lodi placed in the Lombardia region). In 38 provinces of Lombardia and neighboring regions, we performed a breakpoint analysis to identify the radius of the red zone around Lodi minimizing epidemic spread and mortality in neighboring cities.

Results: In all Italian provinces, a non-linear relationship was found between SARS-CoV-2 cases and distance from Lodi. In an analysis including the provinces of Lombardia and neighboring regions, SARS-CoV-2 cases and mortality increased when the distance from Lodi reduced below 92 and 140 km, respectively, and such relationships were amplified by ozone (O3) pollution.

Conclusions: The breakpoint analysis identifies the radius around the outbreak of Lodi minimizing the public health consequences of SARS-CoV-2 in neighboring cities. Such an approach can be useful to identify the red zones in future epidemics due to highly infective pathogens similar to SARS-CoV-2.
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http://dx.doi.org/10.1093/eurpub/ckaa221DOI Listing
February 2021

Effectiveness of In-Hospital Cholecalciferol Use on Clinical Outcomes in Comorbid COVID-19 Patients: A Hypothesis-Generating Study.

Nutrients 2021 Jan 14;13(1). Epub 2021 Jan 14.

Internal Medicine, Department of Medicine, University Hospital AOUI, 37134 Verona, Italy.

Little information is available on the beneficial effects of cholecalciferol treatment in comorbid patients hospitalized for COVID-19. The aim of this study was to retrospectively examine the clinical outcome of patients receiving in-hospital high-dose bolus cholecalciferol. Patients with a positive diagnosis of SARS-CoV-2 and overt COVID-19, hospitalized from 15 March to 20 April 2020, were considered. Based on clinical characteristics, they were supplemented (or not) with 400,000 IU bolus oral cholecalciferol (200,000 IU administered in two consecutive days) and the composite outcome (transfer to intensive care unit; ICU and/or death) was recorded. Ninety-one patients (aged 74 ± 13 years) with COVID-19 were included in this retrospective study. Fifty (54.9%) patients presented with two or more comorbid diseases. Based on the decision of the referring physician, 36 (39.6%) patients were treated with vitamin D. Receiver operating characteristic curve analysis revealed a significant predictive power of the four variables: (a) low (<50 nmol/L) 25(OH) vitamin D levels, (b) current cigarette smoking, (c) elevated D-dimer levels (d) and the presence of comorbid diseases, to explain the decision to administer vitamin D (area under the curve = 0.77, 95% CI: 0.67-0.87, < 0.0001). Over the follow-up period (14 ± 10 days), 27 (29.7%) patients were transferred to the ICU and 22 (24.2%) died (16 prior to ICU and six in ICU). Overall, 43 (47.3%) patients experienced the combined endpoint of transfer to ICU and/or death. Logistic regression analyses revealed that the comorbidity burden significantly modified the effect of vitamin D treatment on the study outcome, both in crude ( = 0.033) and propensity score-adjusted analyses ( = 0.039), so the positive effect of high-dose cholecalciferol on the combined endpoint was significantly amplified with increasing comorbidity burden. This hypothesis-generating study warrants the formal evaluation (i.e., clinical trial) of the potential benefit that cholecalciferol can offer in these comorbid COVID-19 patients.
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http://dx.doi.org/10.3390/nu13010219DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7828675PMC
January 2021

Radiation dose from medical imaging in end stage renal disease patients: a Nationwide Italian Survey.

J Nephrol 2021 Jan 2. Epub 2021 Jan 2.

Fisica Sanitaria, AOU Maggiore Della Carità, Novara, Italy.

Background And Objectives: End stage renal disease (ESRD) patients are exposed to the risk of ionizing radiation during repeated imaging studies. The variability in diagnostic imaging policies and the accompanying radiation doses across various renal units is still unknown. We studied this variability at the centre level and quantified the associated radiation doses at the patient level.

Methods: Fourteen Italian nephrology departments enrolled 739 patients on haemodialysis and 486 kidney transplant patients. The details of the radiological procedures performed over one year were recorded. The effective doses and organ doses of radiation were estimated for each patient using standardized methods to convert exposure parameters into effective and organ doses RESULTS: Computed tomography (CT) was the major contributor (> 77%) to ionizing radiation exposure. Among the haemodialysis and kidney transplant patients, 15% and 6% were in the high (≥ 20 mSv per year) radiation dose groups, respectively. In haemodialysis patients, the most exposed organs were the liver (16 mSv), the kidney (15 mSv) and the stomach (14 mSv), while the uterus (6.2 mSv), the lung (5.7 mSv) and the liver (5.5 mSv) were the most exposed in kidney transplant patients. The average cumulative effective dose (CED) of ionizing radiation among centres in this study was highly variable both in haemodialysis (from 6.4 to 18.8 mSv per patient-year; p = 0.018) and even more so in kidney transplant (from 0.6 to 13.7 mSv per patient-year; p = 0.002) patients.

Conclusions: Radiation exposure attributable to medical imaging is high in distinct subgroups of haemodialysis and transplant patients. Furthermore, there is high inter-centre variability in radiation exposure, suggesting that nephrology units have substantially different clinical policies for the application of diagnostic imaging studies.
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http://dx.doi.org/10.1007/s40620-020-00911-0DOI Listing
January 2021

Comparison of ibrutinib and idelalisib plus rituximab in real-life relapsed/resistant chronic lymphocytic leukemia cases.

Eur J Haematol 2021 Apr 28;106(4):493-499. Epub 2021 Jan 28.

Biothecnology Research Unit, AO of Cosenza, Cosenza, Italy.

Objectives: To compare the capacity of ibrutinib (IB) and idelalisib-rituximab (IDELA-R) of prolonging overall survival (OS) as in CLL patients, previously treated with chemotherapy only.

Methods: A real-life cohort of 675 cases has been identified and investigated in the database of the groups participating in the study.

Results: At an unadjusted univariate analysis, a significant death risk reduction was observed favoring IB (IDELA-R vs IB HR = 0.5, 95% CI = 0.36-0.71) although with some limitations due to the non-randomized and retrospective nature of the study and to the lower number of patients in the IDELA-R group (112 cases) related to the current prescribing practice. To overcome the potential problem of confounding by indication, we adjusted the association between the type of therapy and mortality for all variables significantly associated with OS at Cox univariate analysis. Furthermore, those variables, differently distributed between the two study groups, were introduced into the multivariate Cox model to improve the effectiveness of the analysis. By introducing all these variables into the multiple Cox regression model, we confirmed the protective effect of IB vs IDELA-R (HR = 0.67, 95% CI = 0.45-0.98, P = .04) independent of potential confounders.

Conclusions: Although our analysis presents some constraints, that is, the unavailability of additional potential confounders, and the retrospective nature of the study, this observation may be of help for the daily clinical practice, particularly in the absence of randomized trials comparing the two schedules.
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http://dx.doi.org/10.1111/ejh.13573DOI Listing
April 2021

Can the assessment of ultrasound lung water in haemodialysis patients be simplified?

Nephrol Dial Transplant 2020 Dec 29. Epub 2020 Dec 29.

CNR-IFC, Clinical Epidemiology and Pathophysiology of Hypertension and Renal Diseases Unit, Ospedali Riuniti, Reggio Calabria, Italy.

Background: Lung ultrasound (US) reliably estimates lung water and it is increasingly applied in clinical practice in dialysis patients. A semi-quantitative US score summing up the US-B lines (an equivalent of B lines in the standard chest X-ray) at 28 sites in the intercostal spaces (Jambrik et al. Usefulness of ultrasound lung comets as a non-radiologic sign of extravascular lung water. Am J Cardiol 2004; 93: 1265-1270) is the most used score.

Methods: We compared the prognostic performance for death, and cardiovascular (CV) events of the 28-sites US score with a score restricted to eight sites in a cohort of 303 haemodialysis (HD) patients.

Results: The 8- and the 28-sites scores were highly inter-related (Spearman's ρ = 0.93, P < 0.001), and their concordance index was fairly good (k = 0.79, 95% confidence interval 0.74-0.84). During a mean follow-up of 3 years, 112 patients died, and 129 experienced a CV event. At univariate and multivariate analysis, both scores were associated with mortality (P ≤ 0.01) and CV events (P ≤ 0.05). The explained variances (R2) for death and CV events of the 28-sites score in multivariate models including major risk factors for these outcomes in the end-stage kidney disease (ESKD) population were 3.9 and 2.2%, and those of the 8-sites score were 3.1 and 2.4%, respectively. The median time needed to perform the examination was 3.05 min [interquartile range (IQR) 2.22-5.00 min] for the 28-sites score and 1.35 min (IQR 1.16-2.00 min) for the 8-sites score.

Conclusion: The 8-sites score is tightly related to the classical Jambrik 28-sites score and this score holds an almost identical predictive power to the reference score. Even though the 28-sites score can be completed just in ∼3 min, the 8-sites score requires only ∼1.30 min, and it is, therefore, better suited for application in everyday clinical practice in HD units.
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http://dx.doi.org/10.1093/ndt/gfaa285DOI Listing
December 2020

Targeting COVID-19 prevention in hemodialysis facilities is associated with a drastic reduction in central venous catheter-related infections.

J Nephrol 2021 04 28;34(2):345-353. Epub 2020 Dec 28.

Nephrology Unit, ASST Fatebenefratelli Sacco, Milano, Italy.

Background: In hemodialysis (HD) patients, central venous catheter (CVC) related bloodstream infections are a major cause of morbidity and mortality. Hygienic precautions are a key aspect of dialysis care for infection prevention, but they are not sufficient to completely avoid the occurrence of CVC related infections. During the COVID-19 pandemic, hygienic precautions for preventing viral transmission have been markedly reinforced. We evaluated their effects on CVC-related infection rates.

Methods: An observational retrospective study was conducted in two hemodialysis units of the same institution treating 215 chronic hemodialysis patients, 71 of whom are currently (33%) using a CVC. In the CVC cohort, we compared data on catheter-related infection rates during the maximum spread of the COVID-19 pandemic in Italy (February to May 2020) with data from the same period of the previous year and with the whole of 2019.

Results: In 2019, we recorded a catheter-related bloodstream infection (CRBSI) rate of 1.19 (95% CI 0.81-1.68)/1000 days [2.07 (95% CI 1.12-3.52)/1000 days in the Feb-May 2019 period] and a tunnel and exit-site infection rate of 0.82 (95% CI 0.51-1.24)/1000 days [1.04 (95% CI 0.41-2.15)/1000 days in the Feb-May 2019 period]. Infection rates drastically decreased during the COVID-19 pandemic, with just one catheter-related bloodstream infection being recorded. Catheter-related bloodstream infection rates showed a significant reduction to 0.20 (95% CI 0.01-0.9)/1000 days (p < 0.05 and p < 0.005 compared to 2019 and to Feb-May 2019, respectively) and a non-significant reduction in tunnel and exit-site infections to 0.6 (95% CI 0.15-1.6)/1000 days.

Conclusions: The observed 91% reduction in catheter-related bloodstream infections compared to the same period in 2019 [IRR 0.09 (95% CI 0.002-0.64)] and the 83% reduction compared to the whole of 2019 [IRR 0.17 (95% CI 0.004-1.009)] suggest that a stricter implementation of hygienic precautions in the dialysis setting can markedly improve the problem of CVC-related infections.
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http://dx.doi.org/10.1007/s40620-020-00900-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768271PMC
April 2021

Reducing salt intake by urine chloride self-measurement in non-compliant patients with chronic kidney disease followed in nephrology clinics: a randomized trial.

Nephrol Dial Transplant 2020 Dec 8. Epub 2020 Dec 8.

Institute of Clinical Physiology (IFC), Clinical Epidemiology of Renal Diseases and Hypertension Unit, Reggio Calabria, Italy.

Background: Adherence to low salt diets and control of hypertension remain unmet clinical needs in chronic kidney disease (CKD) patients.

Methods: We performed a 6-month multicentre randomized trial in non-compliant patients with CKD followed in nephrology clinics testing the effect of self-measurement of urinary chloride (69 patients) as compared with standard care (69 patients) on two primary outcome measures, adherence to a low sodium (Na) diet (<100 mmol/day) as measured by 24-h urine Na (UNa) excretion and 24-h ambulatory blood pressure (ABPM) monitoring.

Results: In the whole sample (N = 138), baseline UNa and 24-h ABPM were143 ± 64 mmol/24 h and 131 ± 18/72 ± 10 mmHg, respectively, and did not differ between the two study arms. Patients in the active arm of the trial used >80% of the chloride strips provided to them at the baseline visit and at follow-up visits. At the third month, UNa was 35 mmol/24 h (95% CI 10.8-58.8 mmol/24 h; P = 0.005) lower in the active arm than the control arm, whereas at 6 months the between-arms difference in UNa decreased and was no longer significant [23 mmol/24 h (95% CI -5.6-50.7); P = 0.11]. The 24-h ABPM changes as well as daytime and night-time BP changes at 3 and 6 months were similar in the two study arms (Month 3, P = 0.69-0.99; Month 6, P = 0.73-0.91). Office BP, the use of antihypertensive drugs, estimated Glomerular Filtration Rate (eGFR) and proteinuria remained unchanged across the trial.

Conclusions: The application of self-measurement of urinary chloride to guide adherence to a low salt diet had a modest effect on 24-h UNa and no significant effect on 24-h ABPM.
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http://dx.doi.org/10.1093/ndt/gfaa262DOI Listing
December 2020

The Burden in Caregivers of Multiple Myeloma Patients Undergoing Outpatient Autologous Stem-Cell Transplantation Compared to Inpatient Transplantation.

Clin Lymphoma Myeloma Leuk 2021 Apr 20;21(4):e402-e409. Epub 2020 Nov 20.

CNR-IFC, Rome, Italy.

Background: The application of different models of autologous stem-cell transplantation (ASCT) in multiple myeloma has demonstrated the feasibility and safety of outpatient-based programs of care. Although several systematic reviews have evaluated the burden of caregivers, only a few studies have included outpatient ASCT.

Patients And Methods: The feelings of lack of family support, daily activities, and general health were compared between caregivers of 2 groups of patients with multiple myeloma who underwent inpatient (n = 71) or outpatient (n = 25) ASCT.

Results: The 3 features did not significantly differ between the 2 study groups at baseline, before, and 3 months after ASCT. Multivariate modeling showed that the baseline values were significantly related to the changes in study outcomes independent of patient and caregiver characteristics. Other correlates were caregivers' work and patient age for impact on daily activities and disease burden across time for impact on general health (all P < .05).

Conclusion: The outpatient model neither improves nor impairs global caregivers' burden compared to standard ASCT care. Further research is needed to confirm this observation and to better assess the burden and quality of life of caregivers and their influence on patient outcomes and quality of life.
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http://dx.doi.org/10.1016/j.clml.2020.11.011DOI Listing
April 2021

Vitamin K and Osteoporosis.

Nutrients 2020 Nov 25;12(12). Epub 2020 Nov 25.

Department of Medicine, University Health Network, University of Toronto, 200 Elizabeth Street, Eaton North 7-221, Toronto, ON M5G 2C4, Canada.

Vitamin K acts as a coenzyme of carboxylase, catalyzing the carboxylation of several vitamin K dependent proteins. Beyond its well-known effects on blood coagulation, it also exerts relevant effects on bone and the vascular system. In this review, we point out the relevance of an adequate vitamin K intake to obtain sufficient levels of carboxylated (active form) vitamin K dependent proteins (such as Osteocalcin and matrix Gla protein) to prevent bone health. Another bone-related action of Vitamin K is being a ligand of the nuclear steroid and xenobiotic receptor (SXR). We also discuss the recommended intake, deficiency, and assessment of vitamin K. Furthermore, we review the few available studies that have as pre-specified outcome bone fractures, indicating that we need more clinical studies to confirm that vitamin K is a potential therapeutic agent for bone fractures.
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http://dx.doi.org/10.3390/nu12123625DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7760385PMC
November 2020

Distance from the outbreak of infection, ozone pollution and public health consequences of SARS-CoV-2 epidemic.

Eur J Public Health 2020 Nov 24. Epub 2020 Nov 24.

Institute of Clinical Physiology of the National Research Council (CNR), Pisa, Italy and Department of Medicine, University of Padua, Padova, Italy.

Background: Italy was the second country in the world, after China, to be hit by SARS-CoV-2 pandemic. The Italy's experience teaches that steps to limit people's movement by imposing "red zones" need to be put in place early by carefully identifying the cities to be included within these areas of quarantine. The assessment of the relationship between the distance from an established outbreak of SARS-CoV-2 infection with transmission-linked cases and mortality observed in other sites could provide useful information to identify the optimal radius of red zones.

Methods: We investigated the relationship between SARS-CoV-2 cases and the distance of each Italian province from the first outbreak of SARS-CoV-2 epidemic in Italy (the city of Lodi placed in the Lombardia region). In 38 provinces of Lombardia and neighboring regions, we performed a breakpoint analysis to identify the radius of the red zone around Lodi minimizing epidemic spread and mortality in neighboring cities.

Results: In all Italian provinces a non-linear relationship was found between SARS-CoV-2 cases and distance from Lodi. In an analysis including the provinces of Lombardia and neighboring regions, SARS-CoV-2 cases and mortality increased when the distance from Lodi reduced below 92 km and 140 km, respectively, and such relationships were amplified by ozone (O3) pollution.

Conclusions: The breakpoint analysis identifies the radius around the outbreak of Lodi minimizing the public health consequences of SARS-CoV-2 in neighboring cities. Such an approach can be useful to identify the red zones in future epidemics due to highly infective pathogens similar to SARS-CoV-2.
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http://dx.doi.org/10.1093/eurpub/ckaa221DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717309PMC
November 2020

Sevelamer Use, Vitamin K Levels, Vascular Calcifications, and Vertebral Fractures in Hemodialysis Patients: Results from the VIKI Study.

J Bone Miner Res 2021 Mar 3;36(3):500-509. Epub 2020 Dec 3.

Division of Nephrology, Department of Medicine, Columbia University Irving Medical Center, New York City, NY, USA.

Hyperphosphatemia is a risk factor for vascular calcifications (VCs), which are part of the chronic kidney disease-mineral and bone disorders (CKD-MBD). Vitamin K-dependent proteins such as matrix Gla protein (MGP) and bone Gla proteins (BGP, or osteocalcin) can inhibit VCs and regulate bone mineralization. In this analysis of the Vitamin K Italian (VIKI) study, the relationship between vitamin K status, vertebral fractures (VFs) and VCs in 387 hemodialysis (HD) patients with (N = 163; 42.1%) or without N = 224; 57.9%) sevelamer was evaluated. Levels of vitamin K vitamers K1 and K2 or menaquinones (MK; MK4-7), total and undercarboxylated (uc) forms for both BGP and MGP were determined. Although no differences in clinical characteristics were noted, lower levels of MK4 (0.45 versus 0.6 ng/mL, p = .01) and a greater MK4 deficiency was observed in sevelamer-treated patients (13.5% versus 5.4%, p = .005). Multivariate logistic regression revealed that MK4 deficiency was associated with sevelamer use (odds ratio [OR] = 2.64, 95% confidence interval [CI] 1.25-5.58, p = .011) and aortic calcification (OR = 8.04, 95% CI 1.07-60.26, p = .04). In the same logistic model, sevelamer amplified the effect of total BGP levels on the odds of VFs in patients with total BGP <150 μg/L compared with those with total BGP ≥150 μg/L (OR = 3.15, 95% CI 1.46-6.76, p = .003). In contrast, there was no such effect in those untreated (total BGP <150 μg/L versus total BGP ≥150 μg/L: OR = 1.21, 95% CI 0.66-2.23, p = .54]; p = .049 for effect modification by sevelamer). Sevelamer may interfere with MK4 levels in HD patients and interact with low BGP levels to increase bone fractures in CKD patients. © 2020 American Society for Bone and Mineral Research (ASBMR).
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http://dx.doi.org/10.1002/jbmr.4214DOI Listing
March 2021

Sleep Health Promotion in the Workplace.

Int J Environ Res Public Health 2020 10 29;17(21). Epub 2020 Oct 29.

Post-Graduate School of Occupational Medicine, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.

Poor sleep and sleepiness in the workplace are associated with accidents. A workplace sleep health promotion program was implemented in an Italian police unit. Of the 242 police officers in the unit, 218 (90%) agreed to take part in the program. A crossover trial was made in which the police officers were divided into two groups that performed sleep health promotion activities in the first and second year, respectively. The first group of officers showed significant sleep improvements at the end of the first year, while the second group had similar or worse parameters than at baseline. At follow-up, a significant improvement in the quantity and quality of sleep was reported in both groups. Sleep improvements at follow-up were associated with a marked reduction in the frequency of accidents at work and near-misses. Before the intervention, sleepiness was the best predictor of injuries (aOR 1.220; CI95% 1.044-1.426) and near-misses (aOR 1.382; CI95% 1.182-1.615). At follow-up, when sleep conditions had improved, insomnia symptoms were the most significant predictors of work accidents (aOR 13.358; CI95% 2.353-75.818). Sleep health promotion can be useful in police officers.
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http://dx.doi.org/10.3390/ijerph17217952DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7663389PMC
October 2020

Correction to: Methodological aspects of superiority, equivalence, and non-inferiority trials.

Intern Emerg Med 2021 Jan;16(1):247

Institute of Clinical Physiology (IFC‑CNR), Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension, Ospedali Riuniti, via Vallone Petrara, Reggio Calabria, Italy.

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http://dx.doi.org/10.1007/s11739-020-02479-wDOI Listing
January 2021

Vitamin K and Kidney Transplantation.

Nutrients 2020 Sep 5;12(9). Epub 2020 Sep 5.

Nephrology Unit, ASST Fatebenefratelli Sacco, 20157 Milano, Italy.

The assessment of the vitamin K status and its effects on clinical outcomes in kidney transplantation (KT) patients has sparked interest, but it is still largely unfulfilled. In part, this is due to difficulties in laboratory measurements of vitamin K, especially K2 vitamers. Vitamin K status is currently best assessed by measuring undercarboxylated vitamin-K-dependent proteins. The relative contribution of vitamin K1 and K2 to the health status of the general population and CKD (chronic kidney disease) patients, including KT patients, is also poorly studied. Through a complete and first review of the existing literature, we summarize the current knowledge of vitamin K pathophysiology and its potential role in preventing KT complications and improving organ survival. A specific focus is placed on cardiovascular complications, bone fractures, and the relationship between vitamin K and cancer. Vitamin K deficiency could determine adverse outcomes, and KT patients should be better studied for vitamin K assessment and modalities of effective therapeutic approaches.
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http://dx.doi.org/10.3390/nu12092717DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551925PMC
September 2020

Development and testing of an artificial intelligence tool for predicting end-stage kidney disease in patients with immunoglobulin A nephropathy.

Kidney Int 2020 Sep 2. Epub 2020 Sep 2.

Research Laboratory, Fondazione Ricerca Molinette, Torino, Italy.

We have developed an artificial neural network prediction model for end-stage kidney disease (ESKD) in patients with primary immunoglobulin A nephropathy (IgAN) using a retrospective cohort of 948 patients with IgAN. Our tool is based on a two-step procedure of a classifier model that predicts ESKD, and a regression model that predicts development of ESKD over time. The classifier model showed a performance value of 0.82 (area under the receiver operating characteristic curve) in patients with a follow-up of five years, which improved to 0.89 at the ten-year follow-up. Both models had a higher recall rate, which indicated the practicality of the tool. The regression model showed a mean absolute error of 1.78 years and a root mean square error of 2.15 years. Testing in an independent cohort of 167patients with IgAN found successful results for 91% of the patients. Comparison of our system with other mathematical models showed the highest discriminant Harrell C index at five- and ten-years follow-up (81% and 86%, respectively), paralleling the lowest Akaike information criterion values (355.01 and 269.56, respectively). Moreover, our system was the best calibrated model indicating that the predicted and observed outcome probabilities did not significantly differ. Finally, the dynamic discrimination indexes of our artificial neural network, expressed as the weighted average of time-dependent areas under the curve calculated at one and two years, were 0.80 and 0.79, respectively. Similar results were observed over a 25-year follow-up period. Thus, our tool identified individuals who were at a high risk of developing ESKD due to IgAN and predicted the time-to-event endpoint. Accurate prediction is an important step toward introduction of a therapeutic strategy for improving clinical outcomes.
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http://dx.doi.org/10.1016/j.kint.2020.07.046DOI Listing
September 2020

Granisetron transdermal system and dexamethasone for the prevention of nausea and vomiting in multiple myeloma patients receiving chemo-mobilization: An observational real-world study of effectiveness and safety.

Transfus Apher Sci 2020 Dec 24;59(6):102911. Epub 2020 Aug 24.

CNR-IFC, Research Unit of Reggio Calabria, Reggio Calabria, Italy.

Purpose: Cyclophosphamide (CY) in a dose of 2-4 g/m is widely used for hemopoietic progenitor stem cells mobilization. CY administration is associated with several adverse effects, including chemotherapy-induced nausea and vomiting (CINV). This study aimed to evaluate the efficacy and tolerability of granisetron transdermal system (GTDS) plus dexamethasone in the management of CINV in MM patients undergoing chemo-mobilization with CY.

Methods: In this single-center, prospective, observational, real world study, GTDS plus dexamethasone was administered to MM patients receiving chemo-mobilization based on CY 2 g/m2 plus G-CSF in an outpatient setting. The rate of complete response was evaluated as the main outcome. Other outcomes were rate of complete control of CINV, incidence of nausea/vomiting of any grade and safety.

Results: A total of 88 patients were enrolled. A complete response was achieved in 45.5 % of patients; among them, 39.77 % attained complete control of CINV. Nausea and vomiting never occurred in 34.1 % and 45.5 % of patients, respectively. No episodes of grade 3-4 nausea and/or vomiting were documented. GTDS was safe and well tolerated.

Conclusion: In real world, GTDS provided an innovative, effective, and well-tolerated control of CINV in MM patients after chemo-mobilization with CY. The study found out effectiveness of a non-invasive delivery system of antiemetic.
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http://dx.doi.org/10.1016/j.transci.2020.102911DOI Listing
December 2020

Ferritin modifies the relationship between inflammation and arterial stiffness in hypertensive patients with different glucose tolerance.

Cardiovasc Diabetol 2020 08 5;19(1):123. Epub 2020 Aug 5.

Department of Medical and Surgical Sciences, University Magna Græcia of Catanzaro, Campus Universitario di Germaneto, V.le Europa, 88100, Catanzaro, Italy.

Background: Ferritin, a crucial element for iron homeostasis, is associated with chronic diseases characterized by subclinical inflammation such as essential arterial hypertension and type 2 diabetes mellitus (T2DM), showing a prognostic value in different clinical settings. We investigated whether ferritin is associated with arterial stiffness (AS), an early indicator of atherosclerosis, and if it could act as effect modifier on the relationship between inflammation and AS in hypertensive patients with different glucose tolerance.

Methods: We enrolled 462 newly diagnosed untreated hypertensive (HT) patients. All subjects underwent an oral glucose tolerance test. Insulin sensitivity was assessed by MATSUDA index and ferritin levels were estimated by immunoradiometric assay. AS was defined by carotid-femoral pulse wave velocity (PWV).

Results: Out of 462 patients, 271 showed normal glucose tolerance (HT/NGT), 146 impaired glucose tolerance (HT/IGT) and 45 were diabetic (HT/T2DM). Iron levels significantly decreased and transferrin and ferritin significantly increased from the first to the third group. PWV values were significantly higher in HT/IGT and HT/T2DM patients. PWV was related directly with ferritin, high sensitivity C reactive protein (hs-CRP), transferrin, and inversely with MATSUDA index. Ferritin resulted the strongest determinant of PWV explaining a 14.9% of its variation; moreover it was a strong modifier of the relationship between hs-CRP and PWV. The estimated augmentation in PWV portended by a fixed increase in hs-CRP, was higher across increasing values of ferritin.

Conclusion: Ferritin represents an independent risk factor of arterial stiffness in our study population and a strong effect modifier on the relationship between inflammation and PWV. However, further studies are needed to fully elucidate the potential role of this biomarker in human atherosclerosis.
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http://dx.doi.org/10.1186/s12933-020-01102-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7409693PMC
August 2020

The performance improvement-score algorithm applied to endoscopic stone. Treatment step 1 protocol.

Minerva Urol Nefrol 2020 Aug 4. Epub 2020 Aug 4.

Department of Urology, University of Southampton, Southampton, UK.

Background: Pi-score (Performance Improvement score) has been proven to be reliable to measure performance improvement during E-BLUS hands-on training sessions. Our study is aimed to adapt and test the score to EST s1 (Endoscopic Stone Treatment step 1) protocol, in consideration of its worldwide adoption for practical training.

Methods: The Pi-score algorithm considers time measurement and number of errors from two different repetitions (first and fifth) of the same training task and compares them to the relative task goals, to produce an objective score. Data were obtained from the first edition of 'ART in Flexible Course', during 4 courses in Barcelona and Milan. Collected data were independently analysed by the experts for Pi assessment. Their scores were compared for inter-rater reliability. The average scores from all tutors were then compared to the PI-score provided by our algorithm for each participant, in order to verify their statistical correlation. Kappa Statistics was used for comparison analysis.

Results: 16 Hands-on Training expert tutors and 47 3rd year residents in Urology were involved. Concordance found between the 16 proctors' scores was the following: Task1=0.30 ("fair"); Task2=0.18 ("slight"); Task3=0.10 ("slight"); Task4=0.20, ("slight"). Concordance between Pi-score results and proctor average scores per-participant was the following: Task1=0.74 ("substantial"); Task2=0.71 ("substantial"); Task3=0.46 ("moderate"); Task4=0.49 ("moderate").

Conclusions: Our exploratory study demonstrates that Pi-score can be effectively adapted to EST s1. Our algorithm successfully provided an objective score that equals the average performance improvement scores assigned by of a cohort of experts, in relation to a small amount of training attempts.
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http://dx.doi.org/10.23736/S0393-2249.20.03747-9DOI Listing
August 2020

Methodological aspects of superiority, equivalence, and non-inferiority trials.

Intern Emerg Med 2020 09 23;15(6):1085-1091. Epub 2020 Jul 23.

Institute of Clinical Physiology (IFC-CNR), Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension, Ospedali Riuniti, via Vallone Petrara, Reggio Calabria, Italy.

Depending on the scientific hypothesis to be addressed, randomized-controlled trials (RCT) are accordingly designed. RCTs that aim to determine whether a novel, experimental therapeutic intervention (either a drug or a treatment) is superior to a placebo or control intervention, are called superiority trials. Less common are the non-inferiority RCTs, designed to assess whether a new intervention is not unacceptably worse than an already existing reference intervention. An equivalence RCT is designed to investigate whether a novel treatment is equivalently effective to another, already existing, control intervention. In equivalence and non-inferiority RCTs, the efficacy of the reference intervention (active comparator) is already established, and therefore, an untreated control group would not be ethical. In this review, using a series of examples derived from equivalence and non-inferiority/superiority RCTs, we describe the main differences and methodological aspects among these three different types of RCTs.
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http://dx.doi.org/10.1007/s11739-020-02450-9DOI Listing
September 2020

Symptoms in Health Care Workers during the COVID-19 Epidemic. A Cross-Sectional Survey.

Int J Environ Res Public Health 2020 07 20;17(14). Epub 2020 Jul 20.

Postgraduate School of Occupational Health, Università Cattolica del Sacro Cuore, 00168 Roma, Italy.

In March-April 2020, the Corona Virus Disease 19 (COVID-19) pandemic suddenly hit Italian healthcare facilities and in some of them many staff members became infected. In this work 595 health care workers from a public company were tested for Severe acute respiratory syndrome coronavirus 2 (82 positive) and asked to complete a questionnaire on early COVID-19 symptoms. Respiratory symptoms were present in 56.1% of cases. Anosmia and dysgeusia in COVID-19 cases were found to have an odds ratio (OR) = 100.7 (95% Confidence Interval [CI] = 26.5-382.6) and an OR = 51.8 (95%CI 16.6-161.9), respectively. About one in three of the cases (29.3%) never manifested symptoms. Anxiety was reported by 16.6% of COVID-19 cases and depression by 20.3%, with a significant increase in the estimated risk (OR = 4.3; 95%CI = 2.4-7.4 for anxiety, OR = 3.5; 95%CI = 2.0-6.0 for depression). In cases, sleep was a significant moderating factor in the relationship between occupational stress, or organizational justice, and anxiety. The early diagnosis of COVID-19 in health care workers, must consider, in addition to respiratory disorders and fever, anosmia, dysgeusia, exhaustion, myalgias and enteric disorders. The frequency of anxiety and depression disorders in the population examined was not higher than that commonly recorded in the same company during periodic checks in the years preceding the epidemic. In COVID-19 cases there was a significant risk of anxiety, especially in those who had low sleep quality. Mental health support and improvement interventions must mainly concern workers with positive tests and should also tend to improve sleep quality.
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http://dx.doi.org/10.3390/ijerph17145218DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7400440PMC
July 2020

Treatment-resistant hypertension in the hemodialysis population: a 44-h ambulatory blood pressure monitoring-based study.

J Hypertens 2020 09;38(9):1849-1856

CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension, Reggio Calabria, Italy.

Background: Uncontrolled hypertension notwithstanding the use of at least three drugs or hypertension controlled with at least four drugs, the widely accepted definition of treatment-resistant hypertension (TRH), is considered as a common problem in the hemodialysis population. However, to date there is no estimate of the prevalence of this condition in hemodialysis patients.

Method: We estimated the prevalence of TRH by 44-h ambulatory BP monitoring (ABPM) in 506 hemodialysis patients in 10 renal units in Europe included in the registry of the European Renal and Cardiovascular Medicine (EURECAm,), a working group of the European Association, European Dialysis and Transplantation Association (ERA EDTA). In a sub-group of 114 patients, we tested the relationship between fluid overload (Body Composition monitor) and TRH.

Results: The prevalence of hypertension with 44-h ABPM criteria was estimated at 85.6% (434 out of 506 patients). Of these, 296 (58%) patients were classified as uncontrolled hypertensive patients by 44-h ABPM criteria (≥130/80 mmHg). Two hundred and thirteen patients had uncontrolled hypertension while on treatment with less than three drugs and 210 patients were normotensive while on drug therapy (n = 138) or off drug treatment (n = 72). The prevalence of TRH was 24% (93 among 386 treated hypertensive patients). The prevalence of predialysis fluid overload was 33% among TRH patients, 34% in uncontrolled hypertensive patients and 26% in normotensive patients. The vast majority (67%) of hemodialysis patients with TRH had no fluid overload.

Conclusion: TRH occurs in about one in four treated hypertensive patients on hemodialysis. Fluid overload per se only in part explains TRH and the 67% of these patients show no fluid overload.
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http://dx.doi.org/10.1097/HJH.0000000000002448DOI Listing
September 2020