Few data are available regarding the adherence to treatment guidelines in individuals with type 2 diabetes mellitus (T2DM) admitted to Internal Medicine Wards (IMW) while no information is available concerning the possible efficacy of an educational intervention aimed at improving adherence in this setting. To explore guidelines adherence and the associated impact on glycemic control in subjects with T2DM hospitalized in IMW before and after an educational intervention, we conducted a 3-phase, cluster-randomized, multicenter study. During Phase 1, we retrospectively collected data from patients with T2DM hospitalized for any cause in IMW for ≥5 days. In Phase 2, an educational training, based on the method of the educational outreach visits (EOV), was developed in 36 out of the 54 centers involved. In Phase 3, conducted 6 months after the training, we replicated the collection of data performed in Phase 1. Overall, we analyzed data from 1909 and 1662 individuals with T2DM during Phase 1 and Phase 3 of the study, respectively. No changes were observed in the difference between mean fasting glycemia levels at discharge vs at admission in Phase 3 comparing EOV vs NO EOV groups. A statistically significant increase in adherence to guidelines was observed from Phase 1 to Phase 3 and a trend toward higher adherence was detected when comparing the EOV and the no EOV groups. A structured educational intervention improves adherence to guidelines for managing T2DM in individuals admitted to IMW but has no effect on short-term glycemic control.

Background Serum thromboxane B-2 (sTXB(2)) is a validated biomarker of low-dose aspirin pharmacodynamics. In the original method, nonanticoagulated blood samples must be incubated at 37 degrees C immediately after withdrawal, centrifuged and serum supernatant should be frozen until assayed. Timely completion of all preanalytical steps may affect the feasibility and quality of sTXB(2) measurements. The storage duration of frozen serum can also affect sTXB(2) stability. Objectives We assessed the stability of sTXB(2) in clotted blood samples stored at 4 degrees C before further processing and in sera stored at -40 degrees C for over a decade. Methods Venous whole blood withdrawn from individuals on chronic low-dose aspirin was dispensed in different tubes and immediately incubated at 37 degrees C for 1 hour. The reference tube was promptly processed following the original protocol; the remaining tubes were stored at 4 degrees C for 12 to 72 hours before further processing. Sera stored at a controlled -40 degrees C temperature for <1 to 15 years were reassayed. Values within the interassay variation limits (+/- 9%) vs baseline were considered acceptable. Results Baseline sTXB(2) values (median, 5.4 ng/mL; IQR, 2.4-13.4 ng/mL; n = 40) were comparable with those in samples at 4 degrees C up to 48 hours (median, 97% [IQR, 86%-104%] of the reference; n = 26), but at 72 hours, the variability exceeded the interassay variation. Thromboxane B-2 levels were stable in frozen sera for up to 10 years (median, 101% [IQR, 87%-108%] of the reference; n = 32) but decreased significantly afterward (median, 87% [IQR, 74%-109%] at 15 years; P = .005; n = 32). Conclusion Thromboxane B-2 is stable in clotted blood samples stored at 4 degrees C for up to 48 hours before further processing and in serum samples stored at -40 degrees C over 10 years.

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”.

Background and aims:There is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in Internal Medicine (IM) Departments in Italy. The aim of this study is to evaluate: 1) the characteristics of patients and possible deviations from national and international clinical practice recommendations (CPRs) in evidence-based guidelines (EBGs); 2) the improvement of patient management by means of a standardized educational programme (EP). Methods:A nationwide multicentre study, comprising two replications of a retrospective survey (phases 1 and 3) with an intervening EP (phase 2) in half of the centres and no EP in the other half, was conducted. The EP was based on outreach visits. Centres were assigned to the two arms of the study, labelled the training group (TG) and control group (CG) respectively, by cluster randomization. Four EBGs and 39 CPRs provided the basis on which 22 treatment management indicators were identified (7 referring to the time of hospital admission, 15 to post-admission). Results:The 21 participating centres recruited 587 hospitalized patients with hypothyroidism, 421 of which were females (71.7%, mean age 74.1 + 14.4 yrs): 318 in phase 1 and 269 in phase 3. The cause of hypothyroidism was unknown in 282 patients (48%). Evaluation at the time of admission identified satisfactory adherence to CPRs (>50%) for 63.6% of the indicators. In the phase 3, TG centres showed significant improvement vs CG in 4 of the 15 post-admission indicators, while 1 out of 15 was significantly worse. Conclusions:The EP based on outreach visits significantly improved some indicators in the management of patients with hypothyroidism, with specific reference to appropriateness of TSH dosage and levothyroxine (LT4) treatment modality. Clinical Trial Registration:ClinicalTrials.gov, identifier NCT05314790.

Invasive candidiasis (IC) is a challenging clinical condition, burdened by relevant mortality and morbidity. There is limited knowledge on the occurrence and management of IC in Internal Medicine Units (IMUs). Aim of this study was to provide real-world data on this topic. Consecutive objectively diagnosed cases of IC were collected in this prospective registry, which involved 18 IMUs in Italy. Patients were followed-up to 90 days from the diagnosis of candidemia. A total of 111 patients were observed (median age 78, IQR 67–83) for an overall incidence of infection of 1.89 cases/1000 hospital admissions. Candida albicans was the most frequent isolated species (62%), followed by Candida parapsilosis (17%) and Candida glabrata (13%). Echinocandins and fluconazole were used as initial therapy in 56.8 and 43.2% of patients, respectively. Antifungal therapy was started within 24 h in 18.9% of patients, in 40.6% in the period 1–3 days, and in 40.5% of patients more than 3 days after blood cultures. Death rate was 19.8% at 30 days and 40.5% at 90 days. At multivariable analysis concomitant bacteremia (i.e. polymicrobial sepsis), and fluconazole as the initial therapy were associated with an increased risk of death at 90 days. The incidence of IC is not negligible, and our registry confirmed that these patients have a relevant mortality rate at 90 days. Concomitant bacteremia, featuring polymicrobial sepsis, and starting antifungal treatment with fluconazole instead of echinocandins independently increase the risk of death. Efforts are needed to improve the awareness and management of IC in IMUs.

Since Internal Medicine (IM) is the most frequent setting of hospitalization for both patients with advanced liver disease and those with comorbidities and risk factors for infection, through this position paper FADOI aims to promote and disseminates its vision regarding the current and potential role of IM in managing hepatitis C virus (HCV) infection (screening, diagnosis, linkage-to-care, treatment). The Internist plays an important role in identifying new cases, in selecting the appropriate diagnostic work-up for liver disease staging and prognosis, and in initiating antiviral therapy, coordinating care and communication with other specialists, the Hepatology outpatient clinic and General Practitioners. Since the Internist is naturally accustomed to the management of multiple comorbidities, he has a fundamental role in the identification of extrahepatic diseases associated with HCV infection and in the diagnosis of comorbidities, some of which are potential factors of liver disease progression. Moreover, in the prescription of the antiviral therapy, it is important to consider the possible drug interactions, and this ideally fits the role of the Internist who can weigh the risk/benefit ratio of possible alternatives, by considering the patient’s clinical situation, especially in case of multiple comorbidities. Moreover, it seems appropriate that the ability to prescribe antiviral therapy is guaranteed to all IM hepatology clinics, favoring a spread of awareness as well as an increase in national coverage and therefore patient access to therapies. The network of IM can also contribute to homogenizing the management policies of HCV treatment, which sometimes differ between Italian Regions.