A randomized clinical trial of home telemonitoring in patients with advanced heart and lung diseases.

BRIEF SUMMARY: The addition of home monitoring to an integrated care model in patients with advanced chronic heart/lung diseases decreases mortality, hospital and emergency admissions, improves functional status, HRQoL, and is cost-effective. BACKGROUND: Telemonitoring is a promising implement for medicine, but its efficacy is unknown in patients with advanced heart and lung failure (AHLF). OBJECTIVE: To determine the efficacy of a telemonitoring system added to coordinated clinical care in patients with AHLF. DESIGN: Randomized phase 3 multicenter clinical trial with parallel groups in adult patients. PARTICIPANTS: Five spanish centers including patients with AHLF at discharge or in out-patient clinics. INTERVENTION: Patients were randomly assigned to receive a remote bio-parameters telemonitoring system (TELECARE) or best usual care (UCARE). TELECARE patients were provided with devices that collected symptoms and bio-parameters, and transferred them synchronously to a call-center, with a real-time health-care response. MAIN MEASURES: Primary end point was the need of admissions/emergency room visits at 45, 90, 180 days. Secondary end points included health care requirements, mortality, functional assessment, health related quality of life (HRQoL), perceived satisfaction, and cost-efficacy. RESULTS: 510 patients were included (54.5% women, median age 76.5 years; 63.1% suffered heart failure, 13.9% lung failure, and 22.9% both conditions). Clinical and functional features were comparable in both arms. TELECARE globally needed less admissions with respect UCARE after 45 days of inclusion (35.4% vs. 46.9%, p < 0.05). This tendency was maintained in the subgroups of patients with multimorbidity (34.2% vs. 46.9%, p < 0.05), intermediate risk of mortality (36.5% vs. 51.1%, p < 0.05), and those included after hospital discharge (34.9% vs. 50.5%, p < 0.01). HRQoL significantly improved (TELECARE/UCARE EuroQol baseline of 56.2 ± 18.2/55.1 ± 19.7, p = 0.054, and 64 ± 19.9/56.3 ± 21.6; p < 0.01 at the end), and perceived satisfaction was also higher (6.77 ± 0.52 vs. 6.62 ± 0.81, p < 0.001; highest possible score = 7). A trend to mortality decrease was also observed (12.9% vs. 19.3%, p = 0.13). TELECARE was cost-efficacious (TELECARE/UCARE QALY 3.94 Euros/0.81Euros). CONCLUSIONS: The addition of a telemonitoring system to an integrated care model in patients with AHLF decreases hospital and emergency admissions, improves functional status as well as HRQoL, and is cost-efficacious.

Epilepsy diagnosis based on one unprovoked seizure and ≥60% risk. A systematic review of the etiologies.

BACKGROUND: According to the International League Against Epilepsy (ILAE) criteria, epilepsy can be diagnosed after one unprovoked (or reflex) seizure when there is a ≥60% of seizure recurrence in the next decade. The application of this diagnostic criterion, however, is challenging because the risk of recurrence based on different etiologies is not easily retrievable from the literature. OBJECTIVE: To assess etiologies that permit a diagnosis of epilepsy after a single unprovoked seizure. METHODS: We conducted a systematic review of the literature search using PubMed, Scopus, and Cochrane library from January 1950 to December 2020 with the keywords: recurrence, risk of recurrence, absolute risk, risk ratio, risk, seizures, epilepsy, structural, infectious, metabolic, immune, and genetic. We included articles that reported estimates of risks of a subsequent unprovoked seizure. Etiologies were categorized according to the ILAE epilepsy classification. The quality of the evidence was evaluated with PRISMA. Descriptive statistics were used. RESULTS: A total of 25,044 articles resulted from searching three databases. After authors removed duplicates, 18,911 articles remained. We screened by title and abstract, 40 articles were reviewed and finally, two articles were included. The mean follow-up was 8 years and the mean for a risk to present a subsequent unprovoked seizure was 66.6% and included structural etiologies as stroke, traumatic brain injury, cavernous malformation, arteriovenous malformation, and neuroinfections (unspecified agents). Study quality characteristics are classified with low strength of evidence and moderate-quality cohort. CONCLUSIONS: We found that stroke, traumatic brain injury, cavernous or arteriovenous malformations, and unspecified CNS infections can meet the epilepsy diagnosis after one unprovoked seizure based on low strength of evidence and moderate quality of cohorts.

Anakinra versus Baricitinib: Different Strategies for Patients Hospitalized with COVID-19.

BACKGROUND: Immunomodulatory drugs have been used in patients with severe COVID-19. The objective of this study was to evaluate the effects of two different strategies, based either on an interleukin-1 inhibitor, anakinra, or on a JAK inhibitor, such as baricitinib, on the survival of patients hospitalized with COVID-19 pneumonia. METHODS: Individuals admitted to two hospitals because of COVID-19 were included if they fulfilled the clinical, radiological, and laboratory criteria for moderate-to-severe disease. Patients were classified according to the first immunomodulatory drug prescribed: anakinra or baricitinib. All subjects were concomitantly treated with corticosteroids, in addition to standard care. The main outcomes were the need for invasive mechanical ventilation (IMV) and in-hospital death. Statistical analysis included propensity score matching and Cox regression model. RESULTS: The study subjects included 125 and 217 individuals in the anakinra and baricitinib groups, respectively. IMV was required in 13 (10.4%) and 10 (4.6%) patients, respectively (p = 0.039). During this period, 22 (17.6%) and 36 (16.6%) individuals died in both groups (p = 0.811). Older age, low functional status, high comorbidity, need for IMV, elevated lactate dehydrogenase, and use of a high flow of oxygen at initially were found to be associated with worse clinical outcomes. No differences according to the immunomodulatory therapy used were observed. For most of the deceased individuals, early interruption of anakinra or baricitinib had occurred at the time of their admission to the intensive care unit. CONCLUSIONS: Similar mortality is observed in patients treated with anakinra or baricitinib plus corticosteroids.

A multicenter randomized clinical trial to evaluate the efficacy of telemonitoring in patients with advanced heart and lung chronic failure. Study protocol for the ATLAN_TIC project.

BACKGROUND: Using technologies of information and communication (TICs) is emerging in medical assistance. TICs application for medical assistance is promising. Its applicability in advanced heart and/or respiratory failure is still controversial because studies have shown methodological weakness which could put in danger their conclusions. Our objective is to evaluate efficacy of the application of home monitoring biological parameters in a multi-level model of coordinated clinical care for patients with chronic diseases with advanced heart (HF) and/or respiratory failure (RF) in comparison with conventional clinical care. METHOD: /Design: Multicentric, phase III, randomized, parallel groups, controlled clinical trial. Patients with advanced HF and/or RF were eligible to participate. Patients received medical assistance by a multi-level model of coordinated clinical care with or without home monitoring. Follow up was performed until 180 days after inclusion. Primary efficacy outcome was defined as the percentage of patients with hospitalization/emergency room visits. Secondary efficacy outcomes were hospital admissions, admissions to hospital emergencies and Primary Care Emergencies, number of days of hospital stay, total cost per patient in euros, mortality, change in functional status, quality of life, assistance and technology devices. Intention to treat, as well as per protocol, and incremental cost-effectiveness analysis will be performed. The number of recruits patients per arm is set at 255, a total of 510 patients. DISCUSSION: This trial could provide some knowledge about the real impact of home monitoring for patients with advanced HF and/or RF within a multi-level model of integrated care.

Environmental sampling protocol devised and implemented to resolve a nosocomial outbreak due to carbapenem-resistant Klebsiella oxytoca.

We describe a method for investigating wet foci in the hospital environment of a nosocomial outbreak due to carbapenem-resistant Klebsiella oxytoca. By searching in areas that are usually inaccessible, by immersing sampling swabs in thioglycolate broth, and by concentrating the sampled water, reservoirs of infection that would have gone unnoticed can be detected.

Control strategies for carbapenemase-producing Enterobacteriaceae at different levels of the healthcare system.

There has been a rapid increase in recent years in the incidence of infection and colonization by carbapenemase-producing Enterobacteriaceae (CPE). A number of clusters and outbreaks have been reported, some of which have been contained, providing evidence that these clusters and outbreaks can be managed effectively when the appropriate control measures are implemented. This review outlines strategies recommended to control CPE dissemination both at the healthcare facility level (acute and long-term care) and from the public health point of view. A dedicated prepared plan should be required to prevent the spread of CPE at the hospital level. At the front line, activities should include management of patients at admission and new cases, active surveillance culturing and definition of high-risk groups. High compliance with standard precautions for all patients and full or modified contact precautions for defined categories of patients should be implemented. Long-term care facilities are areas where dissemination can also take place but more importantly they can become a reservoir as patients are admitted and released to other Health care facilities. From the public health point of view, surveillance must be tailored to identify regional spread and interfacility transmission to prevent further dissemination. Finally, a comprehensive set of activities at various levels is necessary to prevent further spread of these bacteria in the community.

[Descriptive analysis of diseases associated with Streptococcus bovis bacteremia]. / Análisis descriptivo de las enfermedades asociadas a bacteriemia por Streptococcus bovis.

BACKGROUND AND OBJECTIVE: It is well-known the relationship between Streptococcus bovis (S. bovis) bacteremia and colon cancer, liver cirrhosis and others neoplasms. However, a study protocol to rule out these underlying diseases has not been carried out yet. Our objective was to describe S. bovis bacteremia and associated diseases. PATIENTS AND METHOD: Multicenter, retrospective cohort study. S. bovis bacteremias episodes between 2001 and 2009 were included. Mean variables: colon neoplasm, non-colonic neoplasm or liver cirrhosis. Epidemiologist aspects, bacteremia related variables, personal and familiar history and clinical and analytical data were collected. RESULTS: Ninety three patients were included. One out of four individuals had a colon neoplasm. Fifty seven per cent were concomitant cases with bacteremia and six cases were diagnosed after bacteremia (time bacteremia-diagnosis of neoplasm [months], median [Q1-Q3], 2.6 [1-11]). Fourteen (15%) patients were diagnosed with any non-colonic neoplasm (mainly biliary and pancreatic [6 cases] or esophagus-gastric [3 cases]). There were three patients (21%) with concomitant bacteremia non-colonic neoplasm and two after it (1.2 and 10.4 months). Twenty-one (23%) patients suffered from liver cirrhosis. CONCLUSIONS: Patients with S. bovis bacteremia must undergo a study designed to rule out underlying diseases. We suggest that this study should include: a colonic evaluation, ideally by colonoscopy, a liver evaluation by serum chemistry, an abdominal ultrasound scan or a method of liver fibrosis assessment, a gastroscopy and an evaluation of biliary and pancreatic areas by magnetic resonance imaging.

[Prevalence and risk factors of methicillin-resistant Staphylococcus aureus colonization among residents living in long-term care facilities in southern Spain]. / Prevalencia y factores asociados a la colonización por Staphylococcus aureus resistente a meticilina en centros de larga estancia en el sur de España.

INTRODUCTION: Methicillin-resistant Staphylococcus aureus (MRSA) has become the most important problem related to multiresistant microorganisms in the health care system. Long-term-care facilities (LTCFs) are one of the main reservoirs of this microorganism. The objective of our study was to determine the prevalence and factors associated with MRSA colonization among subjects living in LTCFs in southern Spain. METHODS: During the period from 1st April 2009 to 30th June 2010, all subjects living in 17 LTCFs of our area were included in a cross-sectional study. Patients were screened by using nasal swabs and these were cultured in a chromogenic media. Suspected S. aureus colonies were identified by the latex agglutination test. Testing for antimicrobial identification and susceptibility was performed by an automated system. A logistic regression model was built, in which to be colonized by MRSA was the dependent variable, and covariates were entered if a difference with P<.2 was detected in the bivariate analysis. Residents were classified as MRSA carriers, methicillin-susceptible S. aureus carriers and non-carriers. RESULTS: Seven hundreds and forty-four subjects were included. There were 481 (65%) females. The median (Q1-Q3) age was 81 (74-86) years. Seventy-nine (10.6%) and 67 (9%) were colonized by MRSA and methicillin-susceptible S. aureus, respectively. Significant risk factors for MRSA carriers were recent antibiotic use, previous hospital admission in the last three months, a high comorbidity measured by Charlson index and a history of colonization by MRSA. CONCLUSIONS: The prevalence of MRSA colonization in the LTCFs of our area is similar to that described in others European countries. In our institutions, subjects with recent antibiotic use, a high comorbidity, a history of MRSA colonization and a hospital admission in the last three months are more susceptible to be colonized by MRSA.

Incidence of and factors associated with hepatocellular carcinoma among hepatitis C virus and human immunodeficiency virus coinfected patients with decompensated cirrhosis.

We compared the incidence of and factors associated with hepatocellular carcinoma (HCC) among hepatitis C virus (HCV)-monoinfected subjects and human immunodeficiency virus (HIV)/HCV-coinfected individuals, both with decompensated cirrhosis. In a retrospective study, a cohort of 180 individuals with HIV coinfection and 1037 HCV-monoinfected patients with decompensated HCV-related cirrhosis from eight centres in Spain were analyzed. HCC was found in 234 (23%) HCV-monoinfected subjects and in four (2%) HIV-coinfected subjects (p<0.001). At the time of the first hepatic decompensation, 188 (17%) and 4 (2%) (p<0.001) patients in the former and in the latter group, respectively, showed HCC. Fifty-four (11%) patients without HCC at baseline developed such a disease during follow-up. There were no incident cases among the HIV-coinfected population. The density of incidence (95% IC) of HCC in HIV/HCV-coinfected and HCV-monoinfected patients was 0 (0-1.70) and 3.31 (2.70-4.64) cases per 100 person-years (p<0.001), respectively. Lack of HIV infection [adjusted odds risk (AOR) (95% IC)=16.7 (3.9-71.1)] and high alanine aminotransferase levels [AOR (95% IC)=2.5 (1.1-5)] were the only two independent predictors of the emergence of HCC. In the group of patients in whom the date of HCV infection could be estimated, the time elapsed until HCC diagnosis was shorter among HIV-coinfected subjects. The incidence of HCC in patients with HCV-related cirrhosis after the first hepatic decompensation is lower in HIV-coinfected patients. This is probably due to the fact that HIV infection shortens the survival of HCV-coinfected patients with end-stage liver disease to such an extent that HCC not had a chance to emerge.

[Kinetics of Bartonella spp. IgG antibodies in cat-scratch disease and in asymptomatic HIV-infected patients]. / Dinámica de anticuerpos IgG frente a Bartonella spp. en la enfermedad por arañazo de gato y en pacientes asintomáticos infectados por el virus de la inmunodeficiencia humana.

BACKGROUND AND OBJECTIVE: Our goal was to investigate the kinetics of serum IgG antibodies against Bartonella spp. in patients with cat-scratch disease and in HIV-infected indiviuals. PATIENTS AND METHOD: Sequential determinations were made in seven patients with cat scratch disease and in seven HIV-infected individuals who were seropositive for this bacteria. RESULTS: In five patients from each group, serum antibodies fell under the positivity threshold within two years. Two HIV coinfected patients harbored Bartonella spp. DNA in bone marrow. CONCLUSIONS: These results suggest that the finding of a positive titer of serum IgG against Bartonella spp. is a marker of acute or recent infection.