Patient safety implications of wearing a face mask for prevention in the era of COVID-19 pandemic: a systematic review and consensus recommendations.

In the past, the use of face masks in western countries was essentially limited to occupational health. Now, because of the COVID-19 pandemic, mask-wearing has been recommended as a public health intervention. As potential side effects and some contraindications are emerging, we reviewed the literature to assess the impact of them in daily life on patient safety and to provide appropriate guidelines and recommendations. We performed a systematic review of studies investigating physiological impact, safety, and risk of masks in predefined categories of patients, which have been published in peer-reviewed journals with no time and language restrictions. Given the heterogeneity of studies, results were analyzed thematically. We used PRISMA guidelines to report our findings. Wearing a N95 respirator is more associated with worse side effects than wearing a surgical mask with the following complications: breathing difficulties (reduced FiO2, SpO2, PaO2 increased ETCO2, PaCO2), psychiatric symptoms (panic attacks, anxiety) and skin reactions. These complications are related to the duration of use and/or disease severity. Difficulties in communication is another issue to be considered especially with young children, older person and people with hearing impairments. Even if benefits of wearing face masks exceed the discomfort, it is recommended to take an "air break" after 1-2 h consecutively of mask-wearing. However, well-designed prospective studies are needed. The COVID-19 pandemic could represent a unique opportunity for collecting large amount of real-world data.

Outbreak of SARS-CoV-2 Lineage 20I/501Y.V1 in a Nursing Home Underlines the Crucial Role of Vaccination in Both Residents and Staff.

Elderly residents in nursing homes are at very high risk of life-threatening COVID-19-related outcomes. In this report, an epidemiological and serological investigation of a SARS-CoV-2 outbreak in an Italian nursing home is described. Among the residents, all but one (19/20) were regularly vaccinated against SARS-CoV-2. In mid-February 2021, a non-vaccinated staff member of the nursing home was diagnosed with the SARS-CoV-2 infection. Following the outbreak investigation, a total of 70% (14/20) of residents aged 77-100 years were found positive. The phylogenetic analysis showed that the outbreak was caused by the SARS-CoV-2 variant of concern 202012/01 (the so-called "UK variant"). However, all but one positive subjects (13/14) were fully asymptomatic. The only symptomatic patient was a vaccinated 86-year-old female with a highly compromised health background and deceased approximately two weeks later. The subsequent serological investigation showed that the deceased patient was the only vaccinated subject that did not develop the anti-spike protein antibody response, therefore being likely a vaccine non-responder. Although the available mRNA SARS-CoV-2 vaccine was not able to prevent several asymptomatic infections, it was able to avert most symptomatic disease cases caused by the SARS-CoV-2 variant of concern 202012/01 in nursing home residents.

Padua prediction score and IMPROVE score do predict in-hospital mortality in Internal Medicine patients.

Padua prediction score (PPS) and IMPROVE bleeding score are validated tools for venous thromboembolism (VTE) risk assessment recommended by guidelines, albeit not frequently used. Some data suggest that a positive PPS and IMPROVE score may be were associated with early mortality in Internal Medicine patients. Aim of the study was to characterize the predictive ability on mortality of the two scores using two different populations, respectively, as derivation and validation cohort. The derivation cohort consisted of 1956 Internal Medicine patients admitted to La Spezia Hospital in 2013. 399 Internal Medicine patients admitted to Carate Brianza Hospital in 2016 constituted the validation cohort. PPS and IMPROVE scores were applied to each patient using their validated cutoffs. Frequency of positive PPS and mortality were significantly higher in La Spezia patients. In the derivation cohort, the positivity of at least one of the two scores was associated with a significantly higher mortality compared to both negative scores. Similar results were observed in the validation cohort. In the derivation cohort, the sensitivity of a positive PPS score in predicting mortality was 0.97 (0.94, 0.98) but the specificity was 0.21 (0.19, 0.23), the negative likelihood ratio being 0.15. Sensitivity and specificity of a positive IMPROVE gave specular findings but the positive likelihood ratio was 2.19. The accuracy data in the validation cohort were in the same direction. Both PPS and IMPROVE are associated with in-hospital mortality but their additional predictive accuracy is modest. It is unlikely that both scores could be useful in clinical practice to predict death in hospitalized Internal Medicine patients.

What Quality and Safety of Care for Patients Admitted to Clinically Inappropriate Wards: a Systematic Review.

BACKGROUND: In countries with public health system, hospital bed reductions and increasing social and medical frailty have led to the phenomenon of "outliers" or "outlying hospital in-patients." They are often medical patients who, because of unavailability of beds in their clinically appropriate ward, are admitted wherever unoccupied beds are. The present work is aimed to systematically review literature about quality and safety of care for patients admitted to clinically inappropriate wards. METHODS: We performed a systematic review of studies investigating outliers, published in peer-reviewed journals with no time restrictions. Search and screening were conducted by two independent researchers (MLR and ER). Studies were considered potentially eligible for this systematic review if aimed to assess the quality and/or the safety of care for patients admitted to clinically inappropriate units. Our search was supplemented by a hand search of references of included studies. Given the heterogeneity of studies, results were analyzed thematically. We used PRISMA guidelines to report our findings. RESULTS: We collected 17 eligible papers and grouped them into six thematic categories. Despite their methodological limits, the included studies show increased trends in mortality and readmissions among outliers. Quality of care and patient safety are compromised as patients and health professionals declare and risk analysis displays. Reported solutions are often multicomponent, stress early discharge but have not been investigated in the control group. CONCLUSIONS: Published literature cannot definitely conclude on the quality and safety of care for patients admitted to clinically inappropriate wards. As they may represent a serious threat for quality and safety, and moreover often neglected and under valued, well-designed and powered prospective studies are urgently needed.

[EBM, guidelines, protocols: knowledge, attitudes and utilization in the era of law on professional responsibility and safety of health care.] / EBM, linea guida, protocolli: conoscenze, attitudini e utilizzo all'epoca della legge sulla responsabilità professionale e sicurezza delle cure.

INTRODUCTION: The knowledge of principles and methods of Evidence Based Medicine (EBM) and the use of Clinical Practice Guidelines to inform clinical decisions are recognised as key instruments to improve the quality of care. In Italy the Parliament has revised the legal system that rules the responsibilities of health professionals and health care safety, prescribing health professionals to adhere to guidelines and good practice recommendations. The objective of the study was to evaluate guidelines and clinical pathways developed at local level and to assess knowledge and attitudes of healthcare workers toward EBM and guidelines. METHODS: At the l'ASL 5 Liguria La Spezia we performed a census of all the documents registered as "guidelines" or "clinical pathways" at the Direzione Generale by the end of May 2016. We assessed their methodological quality by the "Recognition Card for Clinical Pathways Production and Revision Activity" prepared by the Ligurian Region. We conducted semi-structured interviews to assess attitudes and knowledge of healthcare workers. RESULTS: We found 17 clinical pathways, 41% contained organizational/management recommendations, and 59% contained mainly clinical recommendations. 41% was produced by assimilating already existing guidelines. 29% did not describe the method of production. Only one document linked directly each recommendation with scientific evidence. 10 healthcare workers out of 32 invited actually accepted to conduct the interview. Respondents showed a positive attitude toward the EBM and guidelines but a poor knowledge of the methodology of production and the instruments and principles for critical appraising of scientific literature. Nobody knew the GRADE approach. The most relevant barriers identified were: lack of time, poor knowledge of English and statistical methods, poor applicability of the international guidelines to local setting and real patients encountered in clinical practice. DISCUSSION: Despite the initiatives of the legislator toward civil responsibility and safety of care that should increase the use of guidelines, we found an overall poor knowledge of the concepts of EBM and method of guidelines production. Though the attitudes of responders to the interview were positive, barriers to use seemed to be predominant and considered more as obstacles than as a stimulus. In peripheral settings or in hospitals of medium/small size, clinical guidelines could remain confined to a merely juridical role, with weak impact on professional practice.

Prevalence of erectile dysfunction in a cohort of Italian hypertensive subjects.

The aim of this study was to evaluate the prevalence of erectile dysfunction (ED) in a cohort of Italian hypertensive men and the association with clinical and biochemical data. The study involved 270 consecutive hypertensive subjects aged 40-70 years evaluated in Italian Hypertension Centers of six hospitals from Liguria and Piedmont. ED was assessed through the self-administered questionnaire of the International Index of Erectile Function. Clinical history with ongoing drug treatment, various clinical parameters, biochemical data and evidence about the presence of subclinical target organ damage was collected. Twenty-seven subjects refused to answer the questionnaire (10%). Among the 243 remained subjects, 123 presented ED (50.6%). ED was highly related to age, systolic blood pressure, pulse pressure, smoking status, statin therapy and kidney function. The addition of a thiazide diuretic to an inhibitor of the renin-angiotensin system significantly increased the prevalence of ED. The prevalence of ED increased in relation with the number of hypotensive drug classes taken by the patients. ED was highly prevalent in this cohort of Italian hypertensive subjects and was associated with other cardiovascular risk factors, such as age, smoking status and kidney function. The role of ED as an early marker of cardiovascular disease is discussed.

Combined assessment of thrombotic and haemorrhagic risk in acute medical patients.

Acute medical patients have a high risk of venous thromboembolic events (VTE). Unfortunately, the fear of bleeding complications limits the use of antithrombotic prophylaxis in this setting. To stratify the VTE and haemorrhagic risk, two clinical scores (PADUA, IMPROVE) have recently been developed. However, it is not clear how many patients have a concomitant high VTE and haemorrhagic risk and what is the use of prophylaxis in this situation. To clarify these issues we performed a prospective cohort study enrolling consecutive patients admitted to internal medicine. Patients admitted to internal medicine (January to December 2013) were included. VTE and haemorrhagic risk were evaluated in all the included patients. Use and type of anti-thrombotic prophylaxis was recorded. A total of 1761 patients (mean age 77.6 years) were enrolled; 76.8% (95% CI 74.7-78.7) were at high VTE risk and 11.9% (95% CI 10.4-13.5) were at high haemorrhagic risk. Anti-thrombotic prophylaxis was used in 80.5% of patients at high VTE risk and in 6.5% at low VTE risk (p<0.001), and in 16.6% at high haemorrhagic risk and in 72.5% at low haemorrhagic risk (p<0.001). Prophylaxis was used in 20.4% at both high VTE and haemorrhagic risk and in 88.9% at high VTE risk but low haemorrhagic risk. At multivariate-analysis, use of prophylaxis appeared highly influenced by the VTE risk (OR 68.2, 95% CI 43.1 - 108.0). In conclusion, many patients admitted to internal medicine were at high risk of VTE. Since almost 90% of them were at low haemorrhagic risk, pharmacological prophylaxis may be safely prescribed in most of these patients.

Gender Difference in Efficacy and Safety of Nonvitamin K Antagonist Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation or Venous Thromboembolism: A Systematic Review and a Meta-Analysis of the Literature.

INTRODUCTION: Limited information exists on gender-related differences in the safety and efficacy of non-vitamin K antagonist oral anticoagulants (NOACs). AIM OF THE STUDY: To assess the safety and efficacy of direct oral anticoagulants (DOACs)/NOACs in men and women pooling data from randomized controlled trials on the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF) and on the acute and extended treatment of venous thromboembolism (VTE). METHODS: MEDLINE and EMBASE databases were searched up to June 2014. The efficacy outcome was defined as the prevention of stroke and systemic embolism (AF studies), or as the prevention of recurrent VTE or VTE-related death (VTE studies). The safety outcome was defined as the occurrence of major and/or clinically relevant non-major bleeding. Differences in the efficacy and safety outcomes were expressed as risk ratio (RR) with pertinent 95% confidence intervals (95% CI). RESULTS: A total of 13 studies (> 100,000 patients) were included. DOACs appeared to have a similar efficacy and safety compared with vitamin K antagonists in female and male patients treated for nonvalvular AF and acute VTE. In the extended treatment of VTE NOACs had a RR of bleeding of 4.97 (95% CI 1.06, 23.41) in males and 1.33 (95% CI 0.63, 2.83) in females compared with placebo (subgroup difference chi-square test: 2.25, p = 0.13). CONCLUSIONS: No gender-related difference in the efficacy and safety of NOACs in patients with AF or acute VTE was found. A trend toward an increased risk of bleeding in male patients as compared with female patients was detected in the extended treatment of VTE.

Acute Complex Care Model: An organizational approach for the medical care of hospitalized acute complex patients.

BACKGROUND: Chronic diseases are the major cause of death (59%) and disability worldwide, representing 46% of global disease burden. According to the Future Hospital Commission of the Royal College of Physicians, Medical Division (MD) will be responsible for all hospital medical services, from emergency to specialist wards. The Hospital Acute Care Hub will bring together the clinical areas of the MD that focus on the management of acute medical patients. The Chronic Care Model (CCM) places the patient at the center of the care system enhancing the community's social and health support, pathways and structures to keep chronic, frail, poly-pathological people at home or out of the hospital. The management of such patients in the hospital still needs to be solved. Hereby, we propose an innovative model for the management of the hospital's acute complex patients, which is the hospital counterpart of the CCM. ACUTE COMPLEX CARE MODEL (ACCM): The target population are acutely ill complex and poly-pathological patients (AICPPs), admitted to hospital and requiring high technology resources. The mission is to improve the management of medical admissions through pre-defined intra-hospital tracks and a global, multidisciplinary, patient-centered approach. The ACCM leader is an internal medicine specialist (IMS) who summarizes health problems, establishes priorities, and restores health balance in AICPPs. CONCLUSIONS: The epidemiological transition leading to a progressive increase in "chronically unstable" and complex patients needing frequent hospital treatment, inevitably enhances the role of hospital IMS in the coordination and delivery of care. ACCM represents a practical response to this epochal change of roles.

Autoinflammatory diseases: a possible cause of thrombosis?

Autoinflammatory diseases are a group of disorders due to acquired or hereditary disfunction of innate immune system and characterized by systemic or localized manifestations. The prototype is Familial Mediterranean Fever, a monogenic hereditary disorder, whose causing gene (MeFV gene) was identified in 1997 and opened the way to a new fascinanting chapter of rheumatology. A growing body of monogenic and poligenic autoinflammatory disorders has been described since then. Arterial and venous thrombosis is a common medical problem, with significant morbidity and mortality. Strong evidences from basic research and clinical epidemiological studies support the theory that inflammation and thrombosis can be associated. Because of their recurrent/chronic inflammatory nature, autoinflammatory diseases are a putative cause of thrombotic manifestations. In the present work, we reviewed the available evidences about monogenic autoinflammatory disorders, complicated by thrombotic manifestations.

Thromboprophylaxis in acutely ill medical patients: results of a survey among Italian physicians.

AIMS: acutely ill medical patients are at increased risk of venous thromboembolism (VTE) and often require thromboprophylaxis, but patient selection and adequate therapeutic decisions may be difficult due to the heterogeneity and the complexity of this population. We conducted a survey among a large cohort of Italian physicians to assess their approach to some important "grey" areas of VTE prevention in this setting. METHODS: a questionnaire was distributed during the meeting of a national society of Internal Medicine (FADOI), held in May 2013. Four clinical scenarios describing areas of clinical uncertainty were administered to participants: the first on a patient with acute ischemic stroke; the second on a patient with severe renal insufficiency; the third on the duration of prophylaxis in the post-acute setting; and the last on a patient at high risk of VTE and at moderate risk of bleeding with preserved mobility. RESULTS: 453 questionnaires were returned (participants mean age 48.5 years). About 70% of participants systematically assess VTE and bleeding risk in their clinical practice, but a minority of them use risk assessment models. Prolonged prophylaxis in the post-acute setting was voted by more than eighty percent of participants; replies to the other three clinical scenarios were more heterogeneous with none of the options selected by more than 60% of participant. CONCLUSION: physicians approach to "grey" areas of antithrombotic prophylaxis in the medical setting is quite heterogeneous and sometimes partially in contrast to recent guidelines, reinforcing the need for educational programs and high quality studies in this setting.

Homocysteine in vascular Behcet disease: a meta-analysis.

OBJECTIVE: Behçet disease (BD) is a vasculitis of unknown etiology, characterized by oral or genital aphtosis and uveitis. Homocysteine (hcy) is an independent risk factor for venous and arterial thrombosis. The association between hyperhomocysteinemia and thrombosis has been investigated in some studies in BD patients. However, information on this association is based only on the results of small studies with conflicting results. To overcome such limitations, we performed a metaanalysis comparing the plasma levels of hcy in BD patients with and without history of thrombosis. METHODS AND RESULTS: We searched for all published studies using the Medline and Embase databases. Two reviewers performed study selection independently. Studies were included if hcy was measured in adult BD patients with and without thrombosis. Two reviewers independently extracted data on study and population characteristics. The mean value of hcy in BD patients and the presence of hyperhomocysteinemia in patients with and without thrombosis were collected. Association between thrombosis and hyperhomocysteinemia, and the mean difference of hcy levels in BD patients with and without thrombosis were calculated. Sixteen studies, for a total of 979 patients, were included. Hyperhomocysteinemia was more prevalent in patients with thrombosis than in those without (odds ratio 3.14; 95% CI 1.26 to 7.80) Mean levels of hcy were significantly higher in patients with thrombosis in comparison with patients without (mean difference 3.30 µmol/L; 95% CI 2.09 to 4.51). CONCLUSIONS: Our results suggest that hyperhomocysteinemia may be considered to be associated with thrombosis in BD patients.

Behçet's Disease as a Model of Venous Thrombosis.

Behçet's disease (BD) is a chronic inflammatory disease of unknown aetiology characterized by recurrent oral, genital aphthous ulcerations, uveitis, skin lesions and other multisystem affections associated with vasculitis. Different types of vessels, predominantly veins, can be affected in BD. The frequency of vascular lesions in BD, such as superficial and deep venous thromboses, arterial aneurysms and occlusions, ranges between 7-29%. In this review, various factors of thrombogenesis in BD, particularly pro- and antithrombotic endothelial and non-endothelial factors, factors of coagulation, platelet activation and rheological changes are presented and discussed from positions of Virchow's triad of venous thrombosis. Despite advances in understanding of thrombogenesis in BD, still many issues of diagnosis and targeted preventive and therapeutic measures remain unresolved. Further studies are needed to clarify the pathobiology of BD-related thrombosis and to provide the clinicians with recommendations over the utility, safety and effectiveness of the antithrombotic therapy in BD.

Early improvement in cardiac function detected by tissue Doppler and strain imaging after melphalan-dexamethasone therapy in a 51-year old subject with severe cardiac amyloidosis.

We report the case of a 51-year old man with symptoms of heart failure due to severe cardiac amyloidosis, in whom treatment with melphalan and dexamethasone yielded significant improvement in clinical status and both systolic and diastolic left ventricular (LV) function over a 12-week follow-up. The improvement in LV performance was detected by Tissue Doppler (TD) and strain analysis, despite no changes in standard indices such as ejection fraction and Doppler pattern of mitral inflow. Color TD-derived myocardial velocity and deformation indices also revealed a reduction in intra-ventricular early diastolic asynchrony after therapy. In addition, an improvement in intra-ventricular systolic synchrony was detected by strain rate and strain, but not by color TD velocity imaging. These findings suggest that treatment with melphalan and dexamethasone may improve symptoms of heart failure and LV performance in subjects with cardiac amyloidosis, and that TD and particularly strain imaging could represent useful techniques to monitor the effect of therapy on LV function in the follow-up of these patients.