(1) Background: The objective of this rapid review is to assess whether new potassium binders (NPBs) could enable the optimization of RAASi therapy more than usual care or placebo in patients with or ...at risk of heart failure and hyperkalemia. (2) Methods: We searched for RCTs that included patients with or at risk of hyperkalemia and patients treated with Patiromer or sodium zirconium cyclosilicate (ZSC). The comparators were placebo, usual care, and potassium binders with different doses or different treatment protocols. We searched the Cochrane CENTRAL, MEDLINE, and ClinicalTrials.gov databases. The risk of bias was assessed using the Cochrane risk of bias tool for RCTs. Data were pooled using the random effects model, and the fixed effects model was used for sensitivity analysis. (3) Results: We included 12 studies with 2800 enrolled patients. Only three of these trials (412 patients) were included in the meta-analysis. NPBs seemed to have an effect on the optimization of MRA therapy, with an RR (95% CI) of 1.24 (1.09, 1.42) (moderate certainty evidence); Patiromer seemed to have an effect on MRA optimization, with an RR (95% CI) or 1.25 (1.08, 1.45) (high certainty evidence). ZSC seemed to have no effect on enabling MRA therapy, with an RR (95% CI) of 1.19 (0.89, 1.59) (low certainty evidence). The AEs in HF patients with hyperkalemia treated with Patiromer were GI disorders and hypomagnesemia. ZSC The AEs included chronic cardiac failure, hypokalemia, and edema. (4) Conclusions: This meta-analysis included three studies with a small number of patients and a short follow-up period (1–3 months). The evidence of the effect of NPBs on MRA optimization had a moderate certainty for imprecision. Data on the effect on MRA optimization and less severe AEs in long-term treatment seem to suggest the use of Patiromer for the optimization of MRA therapy in patients with or at risk of heart failure and hyperkalemia. Future adequately powered RCTs are needed to assess the benefits and potential harms of potassium binders.
Clinical trials are an essential source of high-quality evidence for the assessment of efficacy and safety of healthcare interventions. Nowadays the main criticality of the traditional clinical trial ...model is perhaps the need to improve patient selection and management, in terms of initial identification, recruitment and retention.
Digital technology offers operational solutions that can facilitate many of the activities involved in clinical investigation. Decentralized Clinical Trials (DCTs) could be a new option that provides for the use of remote instruments/methods/activities in the different stages of a clinical trial, so that a range of procedures (such as informed consent, medical visits, administration of a drug or use of a medical device, measurement of clinical parameters, diagnostic testing etc.) can be moved from the research hospital to the patient’s home.
Also in Italy the interest in DCTs is progressively growing, and thanks to their potential benefits DCTs can lead to significant advantages not only for patients, but also for the National Health Service and for the country as a whole. It is important that this interest should act as a stimulus, prompting timely initiatives in order to promote and regulate this new methodology for conduct of clinical trials to avoid the risk that, while other countries will be actively involved in the promotion and leading of DCTs, Italy will be selected only as “control arm”.
The aim of this study is to develop a new predictive model to measure complexity of patients in medical wards.
29 Internal Medicine departments in Italy.
The study cohort was made of 541 consecutive ...patients hospitalized for any cause, aged more than 40 years and with at least two chronic diseases. First, we applied a hierarchical cluster analysis and the principal component analysis (PCA) to a panel of questionnaires comorbidity (Charlson, CIRS), clinical stability (MEWS), social frailty (Flugelman), cognitive dysfunction (SPSMQ), depression (5-item GDS), functional dependence (ADL, IADL, Barthel), risk of sore threats (Exton-Smith scale), nutrition (MNA), pain (NRPS), adherence to therapy (Morisky scale), in order to select domains informative for the definition of complexity. The following step was to create the score(s) needed to quantify it.
Two main clusters were identified: the first includes 7 questionnaires whose common denominator is dependence and frailty, the second consists of 3 questionnaires representative of comorbidity. Globally, they account for about 70% of the total variance (55.2% and 13.8%, respectively). The first principal component was simplified in "Complimed Score 1" (CS1) as a recalibrated average between the Barthel Index and the Exton Smith score, whereas the second cluster was approximated to "Complimed Score 2" (CS2), by using the Charlson score only.
Complexity is a two-dimensional clinical phenomenon. The FADOI-Complimed Score(s) is a new tool useful for the routine evaluation of complexity in medical patients, simple to use and taking around 10 minutes to complete.
Recently we defined a user-friendly tool (FADOI-COMPLIMED scores-FCS) to assess complexity of patients hospitalized in medical wards. FCS-1 is an average between the Barthel Index and the Exton-Smith ...score, while FCS-2 is obtained by using the Charlson score. The aim of this paper is to assess the ability of the FCS to predict mortality in-hospital and after 1-3-6-12-months. In this perspective, we performed comparisons with the validated Multidimensional Prognostic Index (MPI).
It is a multicenter, prospective observational study, enrolling patients aged over 40, suffering from at least two chronic diseases and consecutively admitted to Internal Medicine departments. For each patient, data from 13 questionnaires were collected. Survival follow-up was conducted at 1-3-6-12 months after discharge. The relationships between cumulative incidences of death with FCS were investigated with logistic regression analyses. ROC curve analyses were performed in order to compare the predictiveness of the logistic models based on FCS with respect to those with MPI taken as reference.
A cohort of 541 patients was evaluated. A 10-point higher value for FCS-1 and FCS-2 leads to an increased risk of 1-year death equal to 25.0% and 27.1%, respectively. In case of in-hospital mortality, the relevant percentages were 63.1% and 15.3%. The logistic model based on FCS is significantly more predictive than the model based on MPI (which requires an almost doubled number of items) for all the time-points considered.
Assessment of prognosis of patients has the potential to guide clinical decision-making and lead to better care. We propose a new, efficient and easy-to-use instrument based on FCS, which demonstrated a good predictive power for mortality in patients hospitalized in medical wards. This tool may be of interest for clinical practice, since it well balances feasibility (requiring the compilation of 34 items, taking around 10 minutes) and performance.
In Italy, Internal Medicine Units hospitalize approximately 1,300,000 patients, often elderly and comorbid. The prevalent diagnoses are respiratory diseases, heart failure, or pneumonia. As a matter ...of fact, anemia is probably underestimated in the compilation of the official discharge forms (SDO) according to ICD-9 diagnostic codes. We promoted a survey among the Members the Italian Scientific Society of Internal Medicine (FADOI) with the aim to investigate the prevalence of anemia and iron deficiency, over than certain aspects related to the therapeutic management of patients with anemia. Furthermore, we performed a review summarizing current evidence for iron intravenous therapy in these patients. According to the survey, anemia is present in around half of the patients hospitalized in Internal Medicine, and about a quarter of them shows iron metabolism alterations. In the evaluation of iron metabolism, the dosage of ferritin is the most requested exam, whereas transferrin saturation is less considered. By focusing on some categories of patients, the awareness of the usefulness of intravenous iron therapy in patients with heart failure seems to be sufficiently common (76% of physicians), while it seems lower (60%) in the management of patients with chronic kidney disease (CKD) and anemia. Finally, more than 75% of the physicians answered that, in their hospital, there are few outpatients’ offices or diagnostic pathways dedicated to patients with anemia. Anemia due to absolute or functional iron deficiency is particularly prevalent in Internal Medicine inpatients. For this reason, an accurate evaluation of iron profile and an adequate iron therapy is mandatory in these patients. Recent studies show that, in patients with heart failure, intravenous iron therapy is an effective way of improving patients’ health, regardless of the presence of anemia. Similarly, iron therapy results fundamental to optimize erythropoiesis-stimulating agent efficacy in patients with chronic renal failure. In the next future, other therapeutic aspects of intravenous iron therapy will be probably clarified by several interesting ongoing studies focused on these patients.
Abstract Patients with venous thromboembolism (VTE), and particularly those with cancer, are at increased risk of recurrences, major bleeding, and short- / medium-term mortality. Data from 35,539 ...patients (6,075 of these with cancer), presenting with symptomatic VTE in the previous three months and enrolled in the worldwide RIETE registry, were evaluated to assess overall and pulmonary embolism (PE)-related mortality, and their potential predictors, with particular focus on patients with cancer. Overall 3-month mortality in the total RIETE population was 7.9%, and death was considered PE-related in 1.4%. Significantly more patients died among those with cancer (26.4%, vs 4.1% in no-cancer group, p < 0.001). In 3.0% of cancer patients death was considered PE-related, compared to 1.0% in no-cancer group (p < 0.001). Cancer was the strongest independent risk factor for both all-cause and PE-related mortality, and in the subgroup of cancer patients those with advanced disease, reduced mobility, chronic pulmonary disease, and those experiencing PE (vs isolated deep vein thrombosis) were at increased risk of PE-related death. According to the findings of our very large, real-world registry, in the three months following an acute episode VTE remains a substantial cause of mortality. Cancer patients are at particular high risk of VTE-related death. Clinical factors predicting a fatal PE identified in this study (cancer, immobility, comorbidities, increasing age, PE at presentation), could be considered for risk stratification scheme for secondary prophylaxis in daily practice.
Atrial fibrillation (AF) is the most common cardiac arrhythmia. This analysis aimed to determine the sex-gender differences in patients with AF enrolled in the observational AntiThrombotic Agents in ...Atrial Fibrillation (ATA-AF) study. The study was conducted in 360 centers in Italy. During a 4-week period, all consecutive inpatients and outpatients aged ≥18 years, with a documented primary or secondary diagnosis of AF, were included. A total of 7148 patients (47% females) were enrolled. Females were significantly older, they more frequently needed assistance and were affected by severe cognitive impairment. The preferred anti-arrhythmic strategy in both genders was heart rate control (females: 54.7%, males: 48.4%, P<0.0001). Among non-valvular AF patients (n=4845, females=2139), females displayed greater prevalence of CHA2DS2-VASc ≥2 (96.1% vs 80.7%; P<0.0001) and CHADS2 ≥2 (68.2% vs 60.4%; P<0.0001). More females were at high risk of bleeding (31.3% vs 26.1%; P<0.0001). Oral anticoagulants (OAC) were used in 55.5% of non-valvular AF patients, less frequently in females (50.9% vs 59.2%; P<0.0001). High hemorrhagic risk odds ratio (OR) 5.94, 95% confidence interval (CI) 4.70-7.51, paroxysmal AF (OR 3.88, 95% CI 3.11-4.83), cognitive (OR 2.18, 95% CI 1.57-3.02) and functional impairment (OR 1.31, 95% CI 1.02-1.67) were significantly related with non-prescription of OAC, while age 75 was not (1.00, 95% CI 0.79-1.26). This study defines sex-gender differences in AF patients, including lower OAC prescription in females despite of higher thrombotic risk. Concomitant higher hemorrhagic risk and other characteristics that were more frequent in females (i.e., severe cognitive and functional impairment) may at least partly explain this trend towards gender-related under-prescription of OAC.
The clinical benefit of extended prophylaxis for venous thromboembolism (VTE) after laparoscopic surgery for cancer is unclear. The efficacy and safety of direct oral anticoagulants for this ...indication are unexplored. PROphylaxis of venous thromboembolism after LAParoscopic Surgery for colorectal cancer Study II (PROLAPS II) was a randomized, double-blind, placebo-controlled, investigator-initiated, superiority study aimed at assessing the efficacy and safety of extended prophylaxis with rivaroxaban after laparoscopic surgery for colorectal cancer. Consecutive patients who had laparoscopic surgery for colorectal cancer were randomized to receive rivaroxaban (10 mg once daily) or a placebo to be started at 7 ± 2 days after surgery and given for the subsequent 3 weeks. All patients received antithrombotic prophylaxis with low-molecular-weight heparin from surgery to randomization. The primary study outcome was the composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected deep vein thrombosis (DVT), or VTE-related death at 28 ± 2 days after surgery. The primary safety outcome was major bleeding. Patient recruitment was prematurely closed due to study drug expiry after the inclusion of 582 of the 646 planned patients. A primary study outcome event occurred in 11 of 282 patients in the placebo group compared with 3 of 287 in the rivaroxaban group (3.9 vs 1.0%; odds ratio, 0.26; 95% confidence interval CI, 0.07-0.94; log-rank P = .032). Major bleeding occurred in none of the patients in the placebo group and 2 patients in the rivaroxaban group (incidence rate 0.7%; 95% CI, 0-1.0). Oral rivaroxaban was more effective than placebo for extended prevention of VTE after laparoscopic surgery for colorectal cancer without an increase in major bleeding. This trial was registered at www.clinicaltrials.gov as #NCT03055026.
•Rivaroxaban is superior to placebo for extended prevention of venous thromboembolism after laparoscopic surgery for colorectal cancer.•Rivaroxaban did not increase bleeding during extended prevention of venous thromboembolism after laparoscopic surgery for colorectal cancer.
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Internal medicine (IM) patients are mostly elderly, with multiple complex co-morbidities, usually chronic. The complexity of these patients involves the intricate entanglement of two or more systems ...(e.g. body and disease, family-socio-economic and environmental status, coordination of care and therapies) and this requires comprehensive, multi-dimensional assessment (MDA). Despite attempts to improve management of chronic conditions, and the availability of several MDA tools, defining the complex patient is still problematic. The complex profile of our patients can only be described through the best assessment tools designed to identify their characteristics. In order to do this, the Federation of Associations of Hospital Doctors on Internal Medicine FADOI has created its own vision of IM. This involves understanding the different needs of the patient, and analyzing diseases clusters and the possible relationships between them. By exploring the real complexity of our patients and selecting their real needs, we can exercise holistic, anthropological and appropriate choices for their treatment and care. A simpler assessment approach must be adopted for our complex patients, and alternative tools should be used to improve clinical evaluation and prognostic stratification in a hierarchical selection of priorities. Further investigation of complex patients admitted to IM wards is needed.
Recently we defined a user-friendly tool (FADOI-COMPLIMED scores-FCS) to assess complexity of patients hospitalized in medical wards. FCS-1 is an average between the Barthel Index and the Exton-Smith ...score, while FCS-2 is obtained by using the Charlson score. The aim of this paper is to assess the ability of the FCS to predict mortality in-hospital and after 1-3-6-12-months. In this perspective, we performed comparisons with the validated Multidimensional Prognostic Index (MPI). It is a multicenter, prospective observational study, enrolling patients aged over 40, suffering from at least two chronic diseases and consecutively admitted to Internal Medicine departments. For each patient, data from 13 questionnaires were collected. Survival follow-up was conducted at 1-3-6-12 months after discharge. The relationships between cumulative incidences of death with FCS were investigated with logistic regression analyses. ROC curve analyses were performed in order to compare the predictiveness of the logistic models based on FCS with respect to those with MPI taken as reference. A cohort of 541 patients was evaluated. A 10-point higher value for FCS-1 and FCS-2 leads to an increased risk of 1-year death equal to 25.0% and 27.1%, respectively. In case of in-hospital mortality, the relevant percentages were 63.1% and 15.3%. The logistic model based on FCS is significantly more predictive than the model based on MPI (which requires an almost doubled number of items) for all the time-points considered. Assessment of prognosis of patients has the potential to guide clinical decision-making and lead to better care. We propose a new, efficient and easy-to-use instrument based on FCS, which demonstrated a good predictive power for mortality in patients hospitalized in medical wards. This tool may be of interest for clinical practice, since it well balances feasibility (requiring the compilation of 34 items, taking around 10 minutes) and performance.
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