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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... 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.
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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... 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.
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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... 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.
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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... 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.
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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... 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.
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Research Interests: Pharmacogenomics, Treatment Outcome, Medicine, Italy, Humans, and 15 moreChild, Internal Medicine, Female, Male, Infant, Recurrence, Genotype, Prognosis, Glutathione Transferase, Proportional Hazards Models, Cumulative Incidence, Child preschool, Prednisone, Medical and Health Sciences, and hazard ratio
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Research Interests: Incidence Geometry, Cancer, Breast Cancer, Medicine, Family history, and 15 moreHumans, Female, Incidence, Aged, Middle Aged, Adult, Odds ratio, Age Factors, Poisson Distribution, Age of Onset, Confidence Interval, Family Characteristics, Breast Neoplasms, mass Screening, and Genetic predisposition to disease
Research Interests: Cancer, Risk assessment, Medicine, Population, Humans, and 15 moreInternal Medicine, Mathematical Sciences, Female, Male, Incidence, Risk factors, Registries, Middle Aged, Retrospective Studies, Risk Factors, Risk Assessment, Medical Records, Cancer Registry, Relative Risk, and Medical and Health Sciences
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Research Interests: Nursing, Cardiology, Medical Humanities, Self Care, Preventive medicine, and 15 moreBehavioral Medicine, Medicine, Heart Failure, Self Efficacy, Humans, Diabetes mellitus, Female, Male, Aged, Diabetes complications, Nursing Studies, Cardiovascular Diseases, Medicine and Health Sciences, Cross Sectional Studies, and Social Determinants
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In these "statistical notes", equivalence and non-inferiority randomized controlled clinical trials (RCCT) are considered. Equivalence trials are designed to confirm the absence of a meaningful difference between the effect of two... more
In these "statistical notes", equivalence and non-inferiority randomized controlled clinical trials (RCCT) are considered. Equivalence trials are designed to confirm the absence of a meaningful difference between the effect of two treatments. Non-inferiority trials are designed to prove that the new treatment is no less effective than an existing one: it may be more effective or it may have a similar effect. In this note the attention is addressed to suitable criteria for the choice of the tolerance margin epsilon, i.e. the largest difference which is clinically acceptable, so that a difference bigger than that would matter in practice. In particular, the procedures for the determination of the margin epsilon, used by the authors of the non-inferiority RCCT COBALT and INJECT, are presented and discussed in detail. The ethical implications of equivalence and non-inferiority RCCT are here considered and the reader is repeatedly invited to consider the appropriateness of the basic arguments asserted by the supporters of this kind of studies.
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In long-term studies researchers are mainly concerned with occurrence of death during the follow-up period. This statistical note is focused on survival analysis which is the main tool to process this kind of data. Survival curve,... more
In long-term studies researchers are mainly concerned with occurrence of death during the follow-up period. This statistical note is focused on survival analysis which is the main tool to process this kind of data. Survival curve, cumulative mortality curve and hazard curve are here introduced together with an appropriate effect indicator: hazard ratio. In particular, the use of the latter is shown by resorting to the randomized controlled clinical trial TARGET.
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The aim of this statistical note, the fourth in the series, is to describe and critically appraise the randomized controlled clinical trial (RCCT) GUSTO V, which combined in a single RCCT both the superiority and non-inferiority... more
The aim of this statistical note, the fourth in the series, is to describe and critically appraise the randomized controlled clinical trial (RCCT) GUSTO V, which combined in a single RCCT both the superiority and non-inferiority hypotheses. In this note we present the logical path that the authors have presumably followed in planning a RCCT of such a kind. The results are reported and possible critical aspects are highlighted and debated upon. Finally the cardiologist reader is stimulated to give his own opinion on this kind of approach.
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The aim of this statistical note is to describe the results of the randomized controlled clinical trial TARGET, which compared the effect of tirofiban (new treatment) and abciximab (standard treatment) in patients who were expected to... more
The aim of this statistical note is to describe the results of the randomized controlled clinical trial TARGET, which compared the effect of tirofiban (new treatment) and abciximab (standard treatment) in patients who were expected to undergo coronary stenting. Primary aim of TARGET was to evaluate the non-inferiority of tirofiban with respect to abciximab, but it concluded in favor of superiority of the standard treatment. The authors of this study point out that a deep consideration regarding a priori available evidence could have avoided to expose 2398 patients randomized to tirofiban to the risk of death or non-fatal myocardial infarction.
Research Interests: Treatment Outcome, Medicine, Stents, Humans, Confidence intervals, and 12 moreMonoclonal Antibodies, Anticoagulants, Risk factors, Myocardial Infarction, Randomized Controlled Trial, Risk Factors, Proportional Hazards Models, Tyrosine, Tirofiban, Randomized Controlled Trials as Topic, Platelet Aggregation Inhibitors, and Physician-Patient Relations
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Two-phase studies are attractive for their economy and efficiency in research settings where large cohorts are available for investigating the prognostic and predictive role of novel genetic and biological factors. In this type of study,... more
Two-phase studies are attractive for their economy and efficiency in research settings where large cohorts are available for investigating the prognostic and predictive role of novel genetic and biological factors. In this type of study, information on novel factors is collected only in a convenient subcohort (phase II) drawn from the cohort (phase I) according to a given (optimal) sampling strategy. Estimation of survival in the subcohort needs to account for the design. The Kaplan–Meier method, based on counts of events and of subjects at risk in time, must be applied accounting, with suitable weights, for the sampling probabilities of the subjects in phase II, in order to recover the representativeness of the subcohort for the entire cohort. The authors derived a proper variance estimator of survival by linearization. The proposed method is applied in the context of a two-phase study on childhood acute lymphoblastic leukemia, which was planned in order to evaluate the role of genetic polymorphisms on treatment failure due to relapse. The method has shown satisfactory performance through simulations under different scenarios, including the case–control setting, and proved to be useful for describing results in the clinical example.