This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Background: Delirium is a common feature in COVID-19 patients. Although its association with in-h... more Background: Delirium is a common feature in COVID-19 patients. Although its association with in-hospital mortality has previously been reported, scarce results concern post-discharge mortality and delirium subtypes. We evaluated the association between delirium and its subtypes and both in-hospital and medium-term mortality. Methods : This is a multicenter longitudinal clinical-based study settled in Monza and Brescia, Italy. 1324 patients (median age: 68) with COVID-19 admitted to four acute clinical wards in Northern Italy during the first and second pandemic waves. Delirium was assessed through validated scores and/or clinical assessment. The association between the presence of delirium - and its subtypes- and in-hospital and medium-term mortality was evaluated through Cox proportional hazards models. Findings: 223 patients (16.8%) presented delirium within 24-48 hours of hospital admission. Those with delirium had around a two-fold increased risk of in-hospital (HR=1.94, 95%CI: 1.38, 2.73) and medium-term mortality (HR=2.01, 95%CI: 1.48, 2.73), than those without delirium. All delirium subtypes were associated with greater risk of death compared to the absence of delirium, but hypoactive delirium revealed the strongest associations, with both in-hospital (HR=2.03, 95%CI: 1.32, 3.13) and medium-term mortality (HR=2.22, 95%CI: 1.52, 3.26). Interpretation: In patients with COVID-19, delirium at hospital admission is not only associated with in-hospital mortality but also with shorter post-discharge survival. This suggests that delirium might be a marker of disease severity and/or patient vulnerability. Its detection and management are crucial to improving the clinical prognosis of COVID-19 patients. Funding: This work was supported by grants from the Cariplo Foundation, Lombardia Region, Italy. Declaration of Interest: The authors declare no conflict of interest.
Conclusions: Despite the intrinsic differences in ejection fraction, both HFpEF and HFrEF shares ... more Conclusions: Despite the intrinsic differences in ejection fraction, both HFpEF and HFrEF shares similar cardiopulmonary mechanisms and cardiovascular responses to exercise. CPET may represent a useful tool in order to identify and stratify hypertensive heart patients with HFpEF with high diagnostic accuracy.
In patients with COVID-19, frailty has been shown to better predict outcomes than age alone. We i... more In patients with COVID-19, frailty has been shown to better predict outcomes than age alone. We investigated factors associated with mechanical ventilation (MV) during hospitalization for COVID-19 among older adults in a multicentre study during the first two waves in Italy. Using data from the FRACOVID project, we included consecutive patients admitted to the participating centres during the first and second waves. We recorded sociodemographics, comorbidities, time since symptom onset, ventilatory support at admission, and chest X-ray findings. Frailty was assessed using a frailty index (FI). Results are reported as hazard ratios (HR) with 95%CI. 1,344 patients were included; 487 females (36.2%), median age 68 (56; 79) years; 52.4% had hypertension, 10.6% had chronic obstructive pulmonary disease, 15.2% were obese. Median FI was 0.088 (0.03, 0.20), and 67% had bilateral consolidations at admission. Median time since symptom onset was 7 days (4, 10). During hospitalization, 47 patients (3.6%, 95%CI 0.33-13.6%) received MV. Multivariable Cox regression analysis found that the likelihood of intubation decreased with increasing age (HR 0.945 (95%CI 0.921-0.969), p<0.0001), while heart rate >110bpm (HR 3.429 (95%CI 1.583-7.429), p=0.0018), and need for continuous positive airway pressure (CPAP) at admission (HR 2.626 (95%CI 1.330-5.186), p=0.0054) were significantly associated with a greater likelihood of intubation. Older patients are less likely to receive intubation, while those with heart rate >110 bpm and need for CPAP at admission are more likely to receive MV during hospitalization for COVID-19.
When performing single arm meta‐analyses of rare events in small populations, if the outcome of i... more When performing single arm meta‐analyses of rare events in small populations, if the outcome of interest is incidence, it is not uncommon to have at least one study with zero events, especially in the presence of competing risks. In this paper, we address the problem of how to include studies with zero events in inverse variance meta‐analyses when individual patient data are not available, going beyond the naïve approach of not including the study or the use of a continuity correction. The proposed solution is the arcsine transformation of the crude cumulative incidence as its approximate variance, which is inversely proportional to the sample size, can be calculated also for studies with a zero estimate. As an alternative, generalized linear mixed models (GLMM) can be used. Simulations were performed to compare the results from inverse variance method meta‐analyses of the arcsine transformed cumulative incidence to those obtained from meta‐analyses of the cumulative incidence itself and of the logit transformation of the cumulative incidence. The comparisons have been carried out for different scenarios of heterogeneity, incidence, and censoring and for competing and not competing risks. The arcsine transformation showed the smallest bias and the highest coverage among models assuming within study normality. At the same time, the GLMM model had the best performance at very low incidences. The proposed method was applied to the clinical context that motivated this work, i.e. a meta‐analysis of 5‐year crude cumulative incidence of central nervous system recurrences in children treated for acute lymphoblastic leukemia.
European Journal of Cardiovascular Nursing, Jul 1, 2022
Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Center... more Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Center of Excellence for Nursing Scholarship, Rome, Italy. Background Caregiver self-efficacy, which is caregiver confidence in her own abilities to help the patient in performing self-care, directly influences caregiver contribution (CC) to self-care, while acting as a mediator between predictors of CC to self-care and CC to self-care itself. Although caregiver self-efficacy is associated with patient and caregiver outcomes, evidence on interventions aiming to improve this variable, as well as CC to self-care, is scarce. Purpose To evaluate the effect of Motivational Interviewing (MI) on caregiver self-efficacy and CC to self-care in heart failure. Methods Secondary outcome analysis of the MOTIVATE-HF RCT. A total of 235 caregivers and 238 patients completed the study. Participants were recruited from three centres in Italy and randomized into Arm 1 (MI for patients), Arm 2 (MI for patients and caregivers), Arm 3 (standard care). The intervention consisted in one face-to-face MI session followed by three telephone contacts delivered to patients (Arm 1) or to patients and caregivers (Arm 2). Caregiver self-efficacy and CC to self-care were assessed with the Caregiver Contribution to Self-Care of HF Index. Data were collected at baseline, before the intervention, and after 3, 6, 9, 12 months from enrolment. Results Among the three arms, caregivers median age was 55 years, they were mainly female (76%), married (72%), spouses (37%), employed (73.5%), with a high school level or higher education (55%), and living with the patients (60%). Patients median age was 74 years, they were mainly male (58%), retired (76%), in NYHA Class II (61.9%). Over the year of the study, caregiver self-efficacy significantly improved in all arms, and was significantly higher in Arm 2 compared to Arm 3 at 9-month follow-up (difference: 8.36, 95% CI (3.13; 13.59), p = 0.002). At 12-month follow-up, caregiver self-efficacy was still higher in Arm 2 compared to Arm 3, but this difference only approached statistical significance (difference: 6.59, 95% CI (-0.41; 13.60), p = 0.064). The longitudinal mixed linear model on self-efficacy, accounting for time, living with the patient, randomization arm and their interaction, confirmed a significantly higher improvement of caregiver self-efficacy in Arm 2 compared to Arm 3 (β ̂ = 1.39, 95% CI (0.02; 2.75), p = 0.046). CC to self-care significantly improved over time in all Arms, but without significant differences among the three Arms. Conclusion Our results show that MI was effective in improving caregiver self-efficacy, but not CC to self-care. This may indicate that MI was able to improve how well caregivers were supporting patients, as showed by improvements in self-efficacy, but not how much they were doing it, as showed by the lack of improvement in CC to self-care. Further studies need to better understand how caregiver self-efficacy affects CC to self-care, how caregiver self-efficacy can be further improved, and the necessary intensity of MI to improve CC to self-care.
European Journal of Cardiovascular Nursing, Jul 1, 2022
Background: Caregiver contribution (CC) to self-care can improve patient outcomes in heart failur... more Background: Caregiver contribution (CC) to self-care can improve patient outcomes in heart failure (HF). However, caring for a person with HF can be a burdensome experience for caregivers. Experimental studies aimed at improving caregiver self-efficacy and CC to HF self-care are scarce. Moreover, it is underexplored if interventions aiming to improve caregiver self-efficacy and CC to HF self-care consequently affect caregiver anxiety, depression, quality of life and sleep. Purpose: To evaluate if the delivery of a Motivational Interviewing intervention aimed at improving caregiver self-efficacy and CC to HF self-care affects caregiver anxiety, depression, quality of life, and sleep. Methods: Secondary outcome analysis of the MOTIVATE-HF randomized controlled trial. Participants were recruited from three centers in Italy, and they were randomized into three arms: Arm 1 (Motivational Interview for patients), Arm 2 (Motivational Interview for patients and caregivers), Arm 3 (standard care). The intervention consisted in one face-to-face MI session, plus three telephone contacts within two months from enrollment with patients (Arm 1) or with patients and caregivers (Arm 2). Data were collected at baseline and after 3, 6, 9, 12 months. Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale, quality of life was measured with the 12-Item Short-Form Health Survey, and sleep was evaluated with the Pittsburgh Sleep Quality Index. Results: A total of 510 patient and caregiver dyads were enrolled. Caregiver median age ranged between 53 and 57, they were mainly female (76%), married (72%), spouses (37%), educated at high school or university level (55%), employed (73.5%), and living with the patient (60%). At baseline, anxiety, depression, quality of life and sleep scores were comparable among the three Arms. Over the year of follow-up, anxiety, depression, and sleep disturbances decreased, while quality of life slightly increased in all the three Arms. However, these changes were not significant in any of the study arms. When comparing these changes between Arm 2 and Arm 1 and 3, we did not observe any significant difference. Conclusion: Delivering Motivational Interview to caregivers to improve their self-efficacy and contribution towards patient self-care did not increase caregivers' own levels of anxiety and depression and did not decrease their quality of life and sleep. This may help tailoring future interventions for caregivers knowing that such an intervention does not worsen caregivers' conditions and wellbeing.
Questa nota è stata redatta nell'ambito di una ricerca supportata dal Consiglio Nazionale delle R... more Questa nota è stata redatta nell'ambito di una ricerca supportata dal Consiglio Nazionale delle Ricerche (contratto n. CU02.00264.ST97).
About 11% of the adult global populations is estimated to be living with type 2 diabetes mellitus... more About 11% of the adult global populations is estimated to be living with type 2 diabetes mellitus (T2DM) by 2040. T2DM requires people to make decisions regarding complex therapeutic regimes, to maintain their well-being and quality of life, to manage symptoms and to reduce disease complications. All these behaviours, requiring knowledge, motivation, experience, and skills, have been referred to the concept of self-care. The intricacy and multidimensionality of T2DM self-care requires a complex approach to its overall comprehension. This Embedded Mixed Method study aims to investigate the experience of self-care in Type 2 Diabetes Mellitus adult patients. It comprises a prospective observational design, and an interpretive description. Quantitative data will be collected with validated questionnaires from 300 patients at baseline and once a year for two years on: diabetes self-care, quality of life, diabetes related distress, and sleep quality. Socio-demographic and clinical data will be collected from medical records. Qualitative data will be collected using semi-structured interviews on circa 10-20 patients, at baseline and once a year for two years, analysed according to interpretive description. Quantitative and qualitative data will be analysed separately and then merged and interpreted. This study will expand our understanding of self-care in people with T2DM. The expected outcome will be a better understanding of the effect of self-care on glycaemic control and therefore clinical outcomes and costs.
The aims of this study were to describe self-care in US T2DM patients and to identify clinical an... more The aims of this study were to describe self-care in US T2DM patients and to identify clinical and sociodemographic determinants of self-care maintenance, monitoring, and management in US T2DM patients. A secondary analysis was performed using data from a cross-sectional study done to test the psychometric performance of the Self-Care of Diabetes Inventory in US English speaking adults with diabetes. In our sample (n = 207), self-care maintenance was adequately performed (median = 75), self-care monitoring was borderline (median = 67.6) and self-care management was poor (median = 55.6). Low income (p = .0019) and low self-care confidence (p < .0001) were associated with relatively lower self-care maintenance. Not taking insulin (p = .0153) and low self-care confidence (p < .0001) were associated with relatively low self-care monitoring. Low self-care confidence (p < .0001) was associated with low self-care management. Self-care confidence is a strong determinant of self-care. Interventions designed to improve self-care confidence are urgently needed.
Nutrition Metabolism and Cardiovascular Diseases, May 1, 2021
BACKGROUND AND AIMS Uric Acid (UA) has been related to the development of Cardio-Vascular (CV) ev... more BACKGROUND AND AIMS Uric Acid (UA) has been related to the development of Cardio-Vascular (CV) events in patients affected by Chronic Coronary Syndromes (CCS). Among various hypothesis, two arise: UA may negatively act on coronary artery determining a higher degree of atherosclerotic disease, and/or on heart determining a higher prevalence of diastolic dysfunction. Both the above hypothesized effects are object of our investigation. METHODS AND RESULTS 231 patients who were admitted to the cardiological department of the Niguarda Hospital (Milan, Italy) for CCS from January 2017 to June 2018 were enrolled. Coronary atherosclerotic burden was evaluated from coronary angiography as the number and type of involved vessels, as well as with both Gensini and Syntax scores. All subjects underwent a complete echocardiogram. At unadjusted and adjusted/multivariable analysis, UA levels were not significantly associated with variables analysed from the coronary angiography (number and type of vessels involved, neither the Gensini and Syntax scores) as well as with echocardiographic parameters regarding systolic and diastolic function. CONCLUSIONS In conclusion, the main finding of our work is the absence of a role for UA in determining coronary arteries disease as well as LV diastolic dysfunction in CCS subjects. Taking together the results of previous studies with ours, we hypothesize that UA could act on heart (both on coronary arteries and on LV function) in an early phase of the disease, whereas while in the advanced stages other factors (previous myocardial infarction, previous myocardial revascularization and so on) may overshadow its effects.
Purpose There is a lack of real-world studies evaluating the impact on survival of an evidence-ba... more Purpose There is a lack of real-world studies evaluating the impact on survival of an evidence-based pathway of care in breast cancer. The aim of this work is to investigate the effect of adherence to guidelines on long-term survival for a cohort of Italian breast cancer patients. Methods The cohort included incident female breast cancer cases (2007-12), from the registry of the Milan province (Italy), not metastatic at diagnosis and receiving primary surgery. We selected sets of indicators, according to patient and tumor characteristics. We then defined the pathway of care as adherent to guidelines if it fulfilled at least 80% of the indicators. Indicators were measured using different administrative health databases linked on a unique key. A causal inference approach was used, drawing a directed acyclic graph and fitting an inverse probability weighted marginal structural model, accounting for patient's demographic, socioeconomic and tumor characteristics. Results The analysis included 6333 patients, 69% of them were classified as having an adherent care. Mean age was 61 years (standard deviation, 13.6 years) and half of the patients were in Stage I (50%) at diagnosis. Median follow-up time was 5.6 years. Overall, 5-year survival was 90% (95% CI, 89-91%). The estimated risk of death was 30% lower for patients with adherent than nonadherent care (hazard ratio [HR], 0.66; 95% CI, 0.55-0.77). Conclusions Our study confirms, in real-world care, the impact on survival of receiving a care pathway adherent to guidelines in non-metastatic breast cancer patients. Keywords Breast cancer care Á Adherence to guidelines Á Survival Á Causal inference Á Administrative health databases Á Process indicators Abbreviations CI Confidence interval DAG Directed acyclic graph HR Hazard ratio IPW Inverse probability weighted RCT Randomized controlled trial Electronic supplementary material The online version of this article (
Understanding the cause of sex disparities in COVID-19 outcomes is a major challenge. We investig... more Understanding the cause of sex disparities in COVID-19 outcomes is a major challenge. We investigate sex hormone levels and their association with outcomes in COVID-19 patients, stratified by sex and age. This observational, retrospective, cohort study included 138 patients aged 18 years or older with COVID-19, hospitalized in Italy between February 1 and May 30, 2020. The association between sex hormones (testosterone, estradiol, progesterone, dehydroepiandrosterone) and outcomes (ARDS, severe COVID-19, in-hospital mortality) was explored in 120 patients aged 50 years and over. STROBE checklist was followed. The median age was 73.5 years [IQR 61, 82]; 55.8% were male. In older males, testosterone was lower if ARDS and severe COVID-19 were reported than if not (3.6 vs. 5.3 nmol/L, p =0.0378 and 3.7 vs. 8.5 nmol/L, p =0.0011, respectively). Deceased males had lower testosterone (2.4 vs. 4.8 nmol/L, p =0.0536) and higher estradiol than survivors (40 vs. 24 pg/mL, p = 0.0006). Testosterone was negatively associated with ARDS (OR 0.849 [95% CI 0.734, 0.982]), severe COVID-19 (OR 0.691 [95% CI 0.546, 0.874]), and in-hospital mortality (OR 0.742 [95% CI 0.566, 0.972]), regardless of potential confounders, though confirmed only in the regression model on males. Higher estradiol was associated with a higher probability of death (OR 1.051 [95% CI 1.018, 1.084]), confirmed in both sex models. In males, higher testosterone seems to be protective against any considered outcome. Higher estradiol was associated with a higher probability of death in both sexes.
Aim: In the AIEOP-BFM 2000 trial, 15% of pediatric patients treated according to risk-adapted pol... more Aim: In the AIEOP-BFM 2000 trial, 15% of pediatric patients treated according to risk-adapted polychemotherapeutic regimens relapsed. The present study aimed to investigate the influence of GST-M1 and GST-T1 deletions on clinical outcome of children with acute lymphoblastic leukemia treated according to the AIEOP-BFM ALL 2000 study protocol. Materials & methods: A novel-design, two-phase study was applied to select a subsample of 614 children to be genotyped for the deletions of GST genes. Cumulative incidence of relapse was then estimated by weighted Kaplan-Meier analysis, and the Cox model was applied to evaluate the effect of GST-M1 and GST-T1 isoenzyme deletions on relapse. Results: No overall effect was found, but the GST-M1 deletion was associated with better clinical outcome within prednisone poor-responder patients (hazard ratio [HR]: 0.45; 95% CI: 0.23-0.91; p = 0.026), whereas the GST-T1 deletion was associated with worse outcome in the standard-risk group (HR: 4.62; 95% CI: 1.04-20.6; p = 0.045) and within prednisone good responders (HR: 1.62; 95% CI: 1.02-2.58; p = 0.041). Conclusion: Our results show that GST-M1 and GST-T1 homozygous deletions have opposite correlation with relapse, the former being protective and the latter unfavourable in specific subsets of acute lymphoblastic leukemia patients.
The clinical course of cirrhosis is mostly determined by the progressive increase of portal hyper... more The clinical course of cirrhosis is mostly determined by the progressive increase of portal hypertension, hyperdynamic circulation, bacterial translocation and activation of systemic inflammation. Different disease states, encompassing compensated and decompensated cirrhosis and a late decompensated state, are related to the progression of these mechanisms and may be recognised by haemodynamic or clinical characteristics. While these disease states do not follow a predictable sequence, they correspond to varying mortality risk. Acute-on-chronic liver failure may occur either in decompensated or in compensated cirrhosis and is always associated with a high short-term mortality. The increasing severity of these disease states prompted the concept of clinical states of cirrhosis. A multistate approach has been considered to describe the clinical course of the disease. Such an approach requires the assessment of the probabilities of different outcomes in each state, which compete with each other to occur first and mark the transition towards a different state. This requires the use of competing risks analysis, since the traditional Kaplan-Meier analysis should only be used in two-state settings. Accounting for competing risks also has implications for prognosis and treatment efficacy research. The aim of this review is to summarise relevant clinical states and to show examples of competing risks analysis in multistate models of cirrhosis.
This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Background: Delirium is a common feature in COVID-19 patients. Although its association with in-h... more Background: Delirium is a common feature in COVID-19 patients. Although its association with in-hospital mortality has previously been reported, scarce results concern post-discharge mortality and delirium subtypes. We evaluated the association between delirium and its subtypes and both in-hospital and medium-term mortality. Methods : This is a multicenter longitudinal clinical-based study settled in Monza and Brescia, Italy. 1324 patients (median age: 68) with COVID-19 admitted to four acute clinical wards in Northern Italy during the first and second pandemic waves. Delirium was assessed through validated scores and/or clinical assessment. The association between the presence of delirium - and its subtypes- and in-hospital and medium-term mortality was evaluated through Cox proportional hazards models. Findings: 223 patients (16.8%) presented delirium within 24-48 hours of hospital admission. Those with delirium had around a two-fold increased risk of in-hospital (HR=1.94, 95%CI: 1.38, 2.73) and medium-term mortality (HR=2.01, 95%CI: 1.48, 2.73), than those without delirium. All delirium subtypes were associated with greater risk of death compared to the absence of delirium, but hypoactive delirium revealed the strongest associations, with both in-hospital (HR=2.03, 95%CI: 1.32, 3.13) and medium-term mortality (HR=2.22, 95%CI: 1.52, 3.26). Interpretation: In patients with COVID-19, delirium at hospital admission is not only associated with in-hospital mortality but also with shorter post-discharge survival. This suggests that delirium might be a marker of disease severity and/or patient vulnerability. Its detection and management are crucial to improving the clinical prognosis of COVID-19 patients. Funding: This work was supported by grants from the Cariplo Foundation, Lombardia Region, Italy. Declaration of Interest: The authors declare no conflict of interest.
Conclusions: Despite the intrinsic differences in ejection fraction, both HFpEF and HFrEF shares ... more Conclusions: Despite the intrinsic differences in ejection fraction, both HFpEF and HFrEF shares similar cardiopulmonary mechanisms and cardiovascular responses to exercise. CPET may represent a useful tool in order to identify and stratify hypertensive heart patients with HFpEF with high diagnostic accuracy.
In patients with COVID-19, frailty has been shown to better predict outcomes than age alone. We i... more In patients with COVID-19, frailty has been shown to better predict outcomes than age alone. We investigated factors associated with mechanical ventilation (MV) during hospitalization for COVID-19 among older adults in a multicentre study during the first two waves in Italy. Using data from the FRACOVID project, we included consecutive patients admitted to the participating centres during the first and second waves. We recorded sociodemographics, comorbidities, time since symptom onset, ventilatory support at admission, and chest X-ray findings. Frailty was assessed using a frailty index (FI). Results are reported as hazard ratios (HR) with 95%CI. 1,344 patients were included; 487 females (36.2%), median age 68 (56; 79) years; 52.4% had hypertension, 10.6% had chronic obstructive pulmonary disease, 15.2% were obese. Median FI was 0.088 (0.03, 0.20), and 67% had bilateral consolidations at admission. Median time since symptom onset was 7 days (4, 10). During hospitalization, 47 patients (3.6%, 95%CI 0.33-13.6%) received MV. Multivariable Cox regression analysis found that the likelihood of intubation decreased with increasing age (HR 0.945 (95%CI 0.921-0.969), p<0.0001), while heart rate >110bpm (HR 3.429 (95%CI 1.583-7.429), p=0.0018), and need for continuous positive airway pressure (CPAP) at admission (HR 2.626 (95%CI 1.330-5.186), p=0.0054) were significantly associated with a greater likelihood of intubation. Older patients are less likely to receive intubation, while those with heart rate >110 bpm and need for CPAP at admission are more likely to receive MV during hospitalization for COVID-19.
When performing single arm meta‐analyses of rare events in small populations, if the outcome of i... more When performing single arm meta‐analyses of rare events in small populations, if the outcome of interest is incidence, it is not uncommon to have at least one study with zero events, especially in the presence of competing risks. In this paper, we address the problem of how to include studies with zero events in inverse variance meta‐analyses when individual patient data are not available, going beyond the naïve approach of not including the study or the use of a continuity correction. The proposed solution is the arcsine transformation of the crude cumulative incidence as its approximate variance, which is inversely proportional to the sample size, can be calculated also for studies with a zero estimate. As an alternative, generalized linear mixed models (GLMM) can be used. Simulations were performed to compare the results from inverse variance method meta‐analyses of the arcsine transformed cumulative incidence to those obtained from meta‐analyses of the cumulative incidence itself and of the logit transformation of the cumulative incidence. The comparisons have been carried out for different scenarios of heterogeneity, incidence, and censoring and for competing and not competing risks. The arcsine transformation showed the smallest bias and the highest coverage among models assuming within study normality. At the same time, the GLMM model had the best performance at very low incidences. The proposed method was applied to the clinical context that motivated this work, i.e. a meta‐analysis of 5‐year crude cumulative incidence of central nervous system recurrences in children treated for acute lymphoblastic leukemia.
European Journal of Cardiovascular Nursing, Jul 1, 2022
Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Center... more Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Center of Excellence for Nursing Scholarship, Rome, Italy. Background Caregiver self-efficacy, which is caregiver confidence in her own abilities to help the patient in performing self-care, directly influences caregiver contribution (CC) to self-care, while acting as a mediator between predictors of CC to self-care and CC to self-care itself. Although caregiver self-efficacy is associated with patient and caregiver outcomes, evidence on interventions aiming to improve this variable, as well as CC to self-care, is scarce. Purpose To evaluate the effect of Motivational Interviewing (MI) on caregiver self-efficacy and CC to self-care in heart failure. Methods Secondary outcome analysis of the MOTIVATE-HF RCT. A total of 235 caregivers and 238 patients completed the study. Participants were recruited from three centres in Italy and randomized into Arm 1 (MI for patients), Arm 2 (MI for patients and caregivers), Arm 3 (standard care). The intervention consisted in one face-to-face MI session followed by three telephone contacts delivered to patients (Arm 1) or to patients and caregivers (Arm 2). Caregiver self-efficacy and CC to self-care were assessed with the Caregiver Contribution to Self-Care of HF Index. Data were collected at baseline, before the intervention, and after 3, 6, 9, 12 months from enrolment. Results Among the three arms, caregivers median age was 55 years, they were mainly female (76%), married (72%), spouses (37%), employed (73.5%), with a high school level or higher education (55%), and living with the patients (60%). Patients median age was 74 years, they were mainly male (58%), retired (76%), in NYHA Class II (61.9%). Over the year of the study, caregiver self-efficacy significantly improved in all arms, and was significantly higher in Arm 2 compared to Arm 3 at 9-month follow-up (difference: 8.36, 95% CI (3.13; 13.59), p = 0.002). At 12-month follow-up, caregiver self-efficacy was still higher in Arm 2 compared to Arm 3, but this difference only approached statistical significance (difference: 6.59, 95% CI (-0.41; 13.60), p = 0.064). The longitudinal mixed linear model on self-efficacy, accounting for time, living with the patient, randomization arm and their interaction, confirmed a significantly higher improvement of caregiver self-efficacy in Arm 2 compared to Arm 3 (β ̂ = 1.39, 95% CI (0.02; 2.75), p = 0.046). CC to self-care significantly improved over time in all Arms, but without significant differences among the three Arms. Conclusion Our results show that MI was effective in improving caregiver self-efficacy, but not CC to self-care. This may indicate that MI was able to improve how well caregivers were supporting patients, as showed by improvements in self-efficacy, but not how much they were doing it, as showed by the lack of improvement in CC to self-care. Further studies need to better understand how caregiver self-efficacy affects CC to self-care, how caregiver self-efficacy can be further improved, and the necessary intensity of MI to improve CC to self-care.
European Journal of Cardiovascular Nursing, Jul 1, 2022
Background: Caregiver contribution (CC) to self-care can improve patient outcomes in heart failur... more Background: Caregiver contribution (CC) to self-care can improve patient outcomes in heart failure (HF). However, caring for a person with HF can be a burdensome experience for caregivers. Experimental studies aimed at improving caregiver self-efficacy and CC to HF self-care are scarce. Moreover, it is underexplored if interventions aiming to improve caregiver self-efficacy and CC to HF self-care consequently affect caregiver anxiety, depression, quality of life and sleep. Purpose: To evaluate if the delivery of a Motivational Interviewing intervention aimed at improving caregiver self-efficacy and CC to HF self-care affects caregiver anxiety, depression, quality of life, and sleep. Methods: Secondary outcome analysis of the MOTIVATE-HF randomized controlled trial. Participants were recruited from three centers in Italy, and they were randomized into three arms: Arm 1 (Motivational Interview for patients), Arm 2 (Motivational Interview for patients and caregivers), Arm 3 (standard care). The intervention consisted in one face-to-face MI session, plus three telephone contacts within two months from enrollment with patients (Arm 1) or with patients and caregivers (Arm 2). Data were collected at baseline and after 3, 6, 9, 12 months. Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale, quality of life was measured with the 12-Item Short-Form Health Survey, and sleep was evaluated with the Pittsburgh Sleep Quality Index. Results: A total of 510 patient and caregiver dyads were enrolled. Caregiver median age ranged between 53 and 57, they were mainly female (76%), married (72%), spouses (37%), educated at high school or university level (55%), employed (73.5%), and living with the patient (60%). At baseline, anxiety, depression, quality of life and sleep scores were comparable among the three Arms. Over the year of follow-up, anxiety, depression, and sleep disturbances decreased, while quality of life slightly increased in all the three Arms. However, these changes were not significant in any of the study arms. When comparing these changes between Arm 2 and Arm 1 and 3, we did not observe any significant difference. Conclusion: Delivering Motivational Interview to caregivers to improve their self-efficacy and contribution towards patient self-care did not increase caregivers' own levels of anxiety and depression and did not decrease their quality of life and sleep. This may help tailoring future interventions for caregivers knowing that such an intervention does not worsen caregivers' conditions and wellbeing.
Questa nota è stata redatta nell'ambito di una ricerca supportata dal Consiglio Nazionale delle R... more Questa nota è stata redatta nell'ambito di una ricerca supportata dal Consiglio Nazionale delle Ricerche (contratto n. CU02.00264.ST97).
About 11% of the adult global populations is estimated to be living with type 2 diabetes mellitus... more About 11% of the adult global populations is estimated to be living with type 2 diabetes mellitus (T2DM) by 2040. T2DM requires people to make decisions regarding complex therapeutic regimes, to maintain their well-being and quality of life, to manage symptoms and to reduce disease complications. All these behaviours, requiring knowledge, motivation, experience, and skills, have been referred to the concept of self-care. The intricacy and multidimensionality of T2DM self-care requires a complex approach to its overall comprehension. This Embedded Mixed Method study aims to investigate the experience of self-care in Type 2 Diabetes Mellitus adult patients. It comprises a prospective observational design, and an interpretive description. Quantitative data will be collected with validated questionnaires from 300 patients at baseline and once a year for two years on: diabetes self-care, quality of life, diabetes related distress, and sleep quality. Socio-demographic and clinical data will be collected from medical records. Qualitative data will be collected using semi-structured interviews on circa 10-20 patients, at baseline and once a year for two years, analysed according to interpretive description. Quantitative and qualitative data will be analysed separately and then merged and interpreted. This study will expand our understanding of self-care in people with T2DM. The expected outcome will be a better understanding of the effect of self-care on glycaemic control and therefore clinical outcomes and costs.
The aims of this study were to describe self-care in US T2DM patients and to identify clinical an... more The aims of this study were to describe self-care in US T2DM patients and to identify clinical and sociodemographic determinants of self-care maintenance, monitoring, and management in US T2DM patients. A secondary analysis was performed using data from a cross-sectional study done to test the psychometric performance of the Self-Care of Diabetes Inventory in US English speaking adults with diabetes. In our sample (n = 207), self-care maintenance was adequately performed (median = 75), self-care monitoring was borderline (median = 67.6) and self-care management was poor (median = 55.6). Low income (p = .0019) and low self-care confidence (p < .0001) were associated with relatively lower self-care maintenance. Not taking insulin (p = .0153) and low self-care confidence (p < .0001) were associated with relatively low self-care monitoring. Low self-care confidence (p < .0001) was associated with low self-care management. Self-care confidence is a strong determinant of self-care. Interventions designed to improve self-care confidence are urgently needed.
Nutrition Metabolism and Cardiovascular Diseases, May 1, 2021
BACKGROUND AND AIMS Uric Acid (UA) has been related to the development of Cardio-Vascular (CV) ev... more BACKGROUND AND AIMS Uric Acid (UA) has been related to the development of Cardio-Vascular (CV) events in patients affected by Chronic Coronary Syndromes (CCS). Among various hypothesis, two arise: UA may negatively act on coronary artery determining a higher degree of atherosclerotic disease, and/or on heart determining a higher prevalence of diastolic dysfunction. Both the above hypothesized effects are object of our investigation. METHODS AND RESULTS 231 patients who were admitted to the cardiological department of the Niguarda Hospital (Milan, Italy) for CCS from January 2017 to June 2018 were enrolled. Coronary atherosclerotic burden was evaluated from coronary angiography as the number and type of involved vessels, as well as with both Gensini and Syntax scores. All subjects underwent a complete echocardiogram. At unadjusted and adjusted/multivariable analysis, UA levels were not significantly associated with variables analysed from the coronary angiography (number and type of vessels involved, neither the Gensini and Syntax scores) as well as with echocardiographic parameters regarding systolic and diastolic function. CONCLUSIONS In conclusion, the main finding of our work is the absence of a role for UA in determining coronary arteries disease as well as LV diastolic dysfunction in CCS subjects. Taking together the results of previous studies with ours, we hypothesize that UA could act on heart (both on coronary arteries and on LV function) in an early phase of the disease, whereas while in the advanced stages other factors (previous myocardial infarction, previous myocardial revascularization and so on) may overshadow its effects.
Purpose There is a lack of real-world studies evaluating the impact on survival of an evidence-ba... more Purpose There is a lack of real-world studies evaluating the impact on survival of an evidence-based pathway of care in breast cancer. The aim of this work is to investigate the effect of adherence to guidelines on long-term survival for a cohort of Italian breast cancer patients. Methods The cohort included incident female breast cancer cases (2007-12), from the registry of the Milan province (Italy), not metastatic at diagnosis and receiving primary surgery. We selected sets of indicators, according to patient and tumor characteristics. We then defined the pathway of care as adherent to guidelines if it fulfilled at least 80% of the indicators. Indicators were measured using different administrative health databases linked on a unique key. A causal inference approach was used, drawing a directed acyclic graph and fitting an inverse probability weighted marginal structural model, accounting for patient's demographic, socioeconomic and tumor characteristics. Results The analysis included 6333 patients, 69% of them were classified as having an adherent care. Mean age was 61 years (standard deviation, 13.6 years) and half of the patients were in Stage I (50%) at diagnosis. Median follow-up time was 5.6 years. Overall, 5-year survival was 90% (95% CI, 89-91%). The estimated risk of death was 30% lower for patients with adherent than nonadherent care (hazard ratio [HR], 0.66; 95% CI, 0.55-0.77). Conclusions Our study confirms, in real-world care, the impact on survival of receiving a care pathway adherent to guidelines in non-metastatic breast cancer patients. Keywords Breast cancer care Á Adherence to guidelines Á Survival Á Causal inference Á Administrative health databases Á Process indicators Abbreviations CI Confidence interval DAG Directed acyclic graph HR Hazard ratio IPW Inverse probability weighted RCT Randomized controlled trial Electronic supplementary material The online version of this article (
Understanding the cause of sex disparities in COVID-19 outcomes is a major challenge. We investig... more Understanding the cause of sex disparities in COVID-19 outcomes is a major challenge. We investigate sex hormone levels and their association with outcomes in COVID-19 patients, stratified by sex and age. This observational, retrospective, cohort study included 138 patients aged 18 years or older with COVID-19, hospitalized in Italy between February 1 and May 30, 2020. The association between sex hormones (testosterone, estradiol, progesterone, dehydroepiandrosterone) and outcomes (ARDS, severe COVID-19, in-hospital mortality) was explored in 120 patients aged 50 years and over. STROBE checklist was followed. The median age was 73.5 years [IQR 61, 82]; 55.8% were male. In older males, testosterone was lower if ARDS and severe COVID-19 were reported than if not (3.6 vs. 5.3 nmol/L, p =0.0378 and 3.7 vs. 8.5 nmol/L, p =0.0011, respectively). Deceased males had lower testosterone (2.4 vs. 4.8 nmol/L, p =0.0536) and higher estradiol than survivors (40 vs. 24 pg/mL, p = 0.0006). Testosterone was negatively associated with ARDS (OR 0.849 [95% CI 0.734, 0.982]), severe COVID-19 (OR 0.691 [95% CI 0.546, 0.874]), and in-hospital mortality (OR 0.742 [95% CI 0.566, 0.972]), regardless of potential confounders, though confirmed only in the regression model on males. Higher estradiol was associated with a higher probability of death (OR 1.051 [95% CI 1.018, 1.084]), confirmed in both sex models. In males, higher testosterone seems to be protective against any considered outcome. Higher estradiol was associated with a higher probability of death in both sexes.
Aim: In the AIEOP-BFM 2000 trial, 15% of pediatric patients treated according to risk-adapted pol... more Aim: In the AIEOP-BFM 2000 trial, 15% of pediatric patients treated according to risk-adapted polychemotherapeutic regimens relapsed. The present study aimed to investigate the influence of GST-M1 and GST-T1 deletions on clinical outcome of children with acute lymphoblastic leukemia treated according to the AIEOP-BFM ALL 2000 study protocol. Materials & methods: A novel-design, two-phase study was applied to select a subsample of 614 children to be genotyped for the deletions of GST genes. Cumulative incidence of relapse was then estimated by weighted Kaplan-Meier analysis, and the Cox model was applied to evaluate the effect of GST-M1 and GST-T1 isoenzyme deletions on relapse. Results: No overall effect was found, but the GST-M1 deletion was associated with better clinical outcome within prednisone poor-responder patients (hazard ratio [HR]: 0.45; 95% CI: 0.23-0.91; p = 0.026), whereas the GST-T1 deletion was associated with worse outcome in the standard-risk group (HR: 4.62; 95% CI: 1.04-20.6; p = 0.045) and within prednisone good responders (HR: 1.62; 95% CI: 1.02-2.58; p = 0.041). Conclusion: Our results show that GST-M1 and GST-T1 homozygous deletions have opposite correlation with relapse, the former being protective and the latter unfavourable in specific subsets of acute lymphoblastic leukemia patients.
The clinical course of cirrhosis is mostly determined by the progressive increase of portal hyper... more The clinical course of cirrhosis is mostly determined by the progressive increase of portal hypertension, hyperdynamic circulation, bacterial translocation and activation of systemic inflammation. Different disease states, encompassing compensated and decompensated cirrhosis and a late decompensated state, are related to the progression of these mechanisms and may be recognised by haemodynamic or clinical characteristics. While these disease states do not follow a predictable sequence, they correspond to varying mortality risk. Acute-on-chronic liver failure may occur either in decompensated or in compensated cirrhosis and is always associated with a high short-term mortality. The increasing severity of these disease states prompted the concept of clinical states of cirrhosis. A multistate approach has been considered to describe the clinical course of the disease. Such an approach requires the assessment of the probabilities of different outcomes in each state, which compete with each other to occur first and mark the transition towards a different state. This requires the use of competing risks analysis, since the traditional Kaplan-Meier analysis should only be used in two-state settings. Accounting for competing risks also has implications for prognosis and treatment efficacy research. The aim of this review is to summarise relevant clinical states and to show examples of competing risks analysis in multistate models of cirrhosis.
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Papers by Paola Rebora