Publications by authors named "Luca Carmisciano"

30 Publications

  • Page 1 of 1

A retrospective study on the prevalence of anti-phospholipid antibodies, thrombotic events and cutaneous signs of vasculopathy in 173 hospitalized COVID-19 patients.

Int J Immunopathol Pharmacol 2021 Jan-Dec;35:20587384211042115

Section of Dermatology, Department of Health Sciences (DISSAL), 9302University of Genoa, Genoa, Italy.

Background: Hypercoagulability is a risk factor of thromboembolic events in COVID-19. Anti-phospholipid (aPL) antibodies have been hypothesized to be involved. Typical COVID-19 dermatological manifestations of livedo reticularis and digital ischemia may resemble cutaneous manifestations of anti-phospholipid syndrome (APS).

Objectives: To investigate the association between aPL antibodies and thromboembolic events, COVID-19 severity, mortality, and cutaneous manifestations in patients with COVID-19.

Methods: aPL antibodies [anti-beta2-glycoprotein-1 (B2GP1) and anti-cardiolipin (aCL) antibodies] were titered in frozen serum samples from hospitalized COVID-19 patients and the patients' clinical records were retrospectively analyzed.

Results: 173 patients were enrolled. aPL antibodies were detected in 34.7% of patients, anti-B2GP1 antibodies in 30.1%, and aCL antibodies in 10.4%. Double positivity was observed in 5.2% of patients. Thromboembolic events occurred in 9.8% of patients, including 11 pulmonary embolisms, 1 case of celiac tripod thrombosis, and six arterial ischemic events affecting the cerebral, celiac, splenic, or femoral-popliteal arteries or the aorta. aPL antibodies were found in 52.9% of patients with vascular events, but thromboembolic events were not correlated to aPL antibodies (adjusted OR = 1.69, = 0.502). Ten patients (5.8%) had cutaneous signs of vasculopathy: nine livedo reticularis and one acrocyanosis. No significant association was observed between the presence of cutaneous vasculopathy and aPL antibodies ( = 0.692).

Conclusions: Anti-phospholipid antibodies cannot be considered responsible for hypercoagulability and thrombotic events in COVID-19 patients. In COVID-19 patients, livedo reticularis and acrocyanosis do not appear to be cutaneous manifestations of APS.
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http://dx.doi.org/10.1177/20587384211042115DOI Listing
September 2021

Engineered glove to evaluate hand disability in rheumatoid arthritis: a pilot-study.

Joint Bone Spine 2021 Sep 15:105272. Epub 2021 Sep 15.

Laboratory of Experimental Rheumatology and Academic Division of Clinical Rheumatology, Department of Internal Medicine and Specialties - DIMI, University of Genova, Italy - IRCCS Rheumatology Unit, San Martino Polyclinic, Viale Benedetto XV, n°6 -, 16132 Genova, Italy. Electronic address:

Objective: The Hand Test System (HTS) is an engineered-sensorized glove that has been originally developed in the neuroscientific field for the evaluation of hand fingers' speed movement. This pilot study aimed to evaluate the reproducibility of HTS analysis in rheumatoid arthritis (RA), correlating glove-derived parameters with clinical disease activity indexes, self-reported disability-related questionnaires and hand strength.

Methods: Fifty-five RA patients and fifty age and sex matched healthy controls (HCs) performed HTS analysis. The glove recognized the touch speed between the finger tips during standard sequences of movements, providing three quantitative parameters: Touch Duration (TD), Inter Tapping Interval (ITI) and Movement Rate (MR). These variables were correlated with Health Assessment Questionnaire (HAQ), Health Assessment Questionnaire-Disease Index (HAQ-DI), Hand Disability Index (HDI), Hand Grip Strength (HGS), DAS28-CRP, CDAI and SDAI.

Results: Intraclass correlation coefficient was 0.93 (CI 0.92,0.95). RA patients showed significantly slower TD, ITI and MR than HCs, for all classes of disease activity (p<0.001). All HTS parameters correlated significantly with HAQ, HAQ-DI, HDI, HGS, DAS28-CRP, SDAI, CDAI (between p<0.05 and p<0.001). Of note, also RA patients in clinical remission showed a significantly higher TD compared with HCs (p<0.001).

Conclusion: HTS seems a new safe and fast tool to evaluate rheumatoid hand's functionality, measuring the speed of finger movements. Furthermore, the HTS parameters significantly correlate with quality of life, disease activity, hand strength and perceived hand disability, evaluating also potential hand motor impairment in RA clinical remission.
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http://dx.doi.org/10.1016/j.jbspin.2021.105272DOI Listing
September 2021

Ten Daily Fractions for Whole Breast Cancer Irradiation: Long Term Results.

In Vivo 2021 Sep-Oct;35(5):2875-2880

Department of Health Science (DISSAL), University of Genoa, Genoa, Italy.

Background/aim: To report the feasibility and oncological outcomes in breast cancer patients treated with a short hypofractionated radiotherapy schedule.

Patients And Methods: We evaluated 380 breast cancer patients treated with ten daily fractions of radiotherapy up to 39 Gy on tumor bed. Primary endpoint was local relapse rate (LRR). Secondary endpoints were overall survival (OS) and metastasis-free survival (MFS).

Results: The median follow up was 5.0 years. Two- and 5-year LRR rates were 0.2 and 2%, respectively. Two- and 5-year MFS rates were 96.1% and 90.5%, respectively. Two and 5-year OS rates were 97.4% and 95%, respectively.

Conclusion: This short schedule may represent an alternative option to standard mild hypofractionated radiotherapy in breast cancer patients due to its excellent feasibility and very low recurrence rate.
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http://dx.doi.org/10.21873/invivo.12576DOI Listing
August 2021

Digital work engagement among Italian neurologists.

Ther Adv Chronic Dis 2021 20;12:20406223211029616. Epub 2021 Jul 20.

Department of Advanced Medical and Surgical Sciences, II Clinic of Neurology, University of Campania 'Luigi Vanvitelli,' Caserta, Italy.

Background: Digital health, including telemedicine, is increasingly recommended for the management of chronic neurological disorders, and it has changed the roles of patients and clinicians.

Methods: In this cross-sectional study we aimed to investigate the digital work engagement of Italian neurologists through a survey collected between September 2020 and January 2021. Questionnaires were anonymous and collected demographic characteristics, attitudes towards digital devices and social media, and details about the clinician-patient relationship. We used logistic-regression models to identify characteristics associated with the propensity to communicate with patients using social media.

Results: Among the 553 neurologists who participated to the study, smartphones and computers were widely preferred compared with tablets; wearable devices were not common, although some neurologists desired them. A total of 48% of participants reported communicating with patients using social media but only a few were in favor of social friendship with patients; WhatsApp was the social media most popular for professional (86%) and personal (98%) purposes. Propensity to communicate with social media was significantly higher among those who were older ( < 0.001) and lived in regions outside northern Italy (center:  = 0.006; south and the islands:  < 0.001). For 58% of responders, social media improved their relationship with patients, but 72% usually warned patients about unreliable websites.

Conclusions: The preferred social media were those which were rapid and which safeguard privacy more effectively; neurologists made many efforts to disprove fake news circulating online, providing help to patients in various ways. This analysis can help direct future interventions for the management of chronic neurological disorders.
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http://dx.doi.org/10.1177/20406223211029616DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299881PMC
July 2021

Sacubitril/valsartan in real-life European patients with heart failure and reduced ejection fraction: a systematic review and meta-analysis.

ESC Heart Fail 2021 Aug 2. Epub 2021 Aug 2.

Cardiovascular Disease Unit, IRCCS Ospedale Policlinico San Martino, IRCCS Italian Cardiology Network, Genoa, Italy.

Aims: We systematically reviewed the European real-world evidence (RWE) about sacubitril-valsartan for heart failure with reduced ejection fraction.

Methods And Results: Twenty-one articles, including 16 952 subjects, were identified until 31 October 2020. Taking as reference the PARADIGM-HF cohort, few baseline characteristics were presented in >80% of these studies, most often with high heterogeneity. In random-effects model meta-analysis, age was higher (mean difference +3.84, 95% CI 1.92-5.76), ischaemic aetiology (OR 0.76, 95% CI 0.64-0.91), hypertension (OR 0.55, 95% CI 0.37-0.82), and diabetes (OR 0.77, 95% CI 0.64-0.92) were less common, and the use of mineralocorticoid receptor antagonists was more frequent (OR 3.54, 95% CI 2.27-5.53) in real-life than in PARADIGM-HF. Other clinical and medical features were presented in 19-76% of the selected publications and suggested more severe heart failure with reduced ejection fraction. Sacubitril-valsartan was titrated to 97/103 mg b.i.d. in 35% (95% CI 23-47) and discontinued in 12.8% (95% CI 7.4-18.3) patients. When reported, the incidence of hyperkalaemia (six studies, no. 1076), all-cause mortality (five studies, no. 684), and any hospitalization (three studies, no. 390) was 12 (95% CI 5-19)/100 person-year, 8 (95% CI 4-12)/100 person-year, and 24 (95% CI 5-42)/100 person-year, respectively. Knowledge contribution, a metric measuring the proportion of RWE provided by each article based on the number of reported variables and the sample size, was 58.8% and 13.6% for the two biggest investigations (12 082 and 2037 patients), and <5% for all others (most with <100 subjects).

Conclusions: Limited-quality RWE indicates that there are important differences between European patients prescribed sacubitril-valsartan and the PARADIGM-HF population, including the frequency of target dose achievement.
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http://dx.doi.org/10.1002/ehf2.13547DOI Listing
August 2021

Coronavirus disease 2019 in Latin American patients with multiple sclerosis.

Mult Scler Relat Disord 2021 Jul 25;55:103173. Epub 2021 Jul 25.

Section of Biostatistics, Department of Health Sciences, University of Genoa, Genoa, Italy; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

Patients with multiple sclerosis (MS) who present coronavirus disease 2019 (COVID-19) are of particular interest to neurologists. These patients have a neuroimmune disease and receive immunomodulatory or immunosuppressive therapies in the long-term. We present here data from 73 patients with MS and a confirmed diagnosis of COVID-19 from five Latin American countries. Fifteen patients (20.5%) were hospitalized and two patients died. The use of anti-CD20 therapies was the only risk factor associated to hospitalization and death. Despite the small sample size, this study highlights the awareness regarding therapeutic options for MS during the pandemic.
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http://dx.doi.org/10.1016/j.msard.2021.103173DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8310568PMC
July 2021

SARS-CoV-2 serology after COVID-19 in multiple sclerosis: An international cohort study.

Mult Scler 2021 Jul 30:13524585211035318. Epub 2021 Jul 30.

Department of Neuroscience, Mental Health and Sensory Organs, Sapienza University of Rome, Rome, Italy/Unit of Neurology, IRCCS Neuromed, Isernia, Italy.

Background: The MuSC-19 project is an Italian cohort study open to international partners that collects data on multiple sclerosis (MS) patients with COVID-19. During the second wave of the pandemic, serological tests became routinely available.

Objective: To evaluate the seroprevalence of anti-SARS-CoV-2 antibodies according to the use of disease-modifying therapy (DMT) in a subset of patients included in the MuSC-19 data set who had undergone a serological test.

Methods: We evaluated the association between positive serological test results and time elapsed since infection onset, age, sex, Expanded Disability Status Scale score, comorbidities and DMT exposure using a multivariable logistic model.

Results: Data were collected from 423 patients (345 from Italy, 61 from Turkey and 17 from Brazil) with a serological test performed during follow-up. Overall, 325 out of 423 tested patients (76.8%) had a positive serological test. At multivariate analysis, therapy with anti-CD20 was significantly associated with a reduced probability of developing antibodies after COVID-19 (odds ratio (OR) = 0.20,  = 0.002).

Conclusion: Patients with MS maintain the capacity to develop humoral immune response against SARS-COV-2, although to a lesser extent when treated with anti-CD20 drugs. Overall, our results are reassuring with respect to the possibility to achieve sufficient immunization with vaccination.
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http://dx.doi.org/10.1177/13524585211035318DOI Listing
July 2021

DMTs and Covid-19 severity in MS: a pooled analysis from Italy and France.

Ann Clin Transl Neurol 2021 08 7;8(8):1738-1744. Epub 2021 Jul 7.

Department of Neurology, CIC INSERM 1434, CHU de Strasbourg, Strasbourg, France.

We evaluated the effect of DMTs on Covid-19 severity in patients with MS, with a pooled-analysis of two large cohorts from Italy and France. The association of baseline characteristics and DMTs with Covid-19 severity was assessed by multivariate ordinal-logistic models and pooled by a fixed-effect meta-analysis. 1066 patients with MS from Italy and 721 from France were included. In the multivariate model, anti-CD20 therapies were significantly associated (OR = 2.05, 95%CI = 1.39-3.02, p < 0.001) with Covid-19 severity, whereas interferon indicated a decreased risk (OR = 0.42, 95%CI = 0.18-0.99, p = 0.047). This pooled-analysis confirms an increased risk of severe Covid-19 in patients on anti-CD20 therapies and supports the protective role of interferon.
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http://dx.doi.org/10.1002/acn3.51408DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8351392PMC
August 2021

Correlation Between Skin and Affected Organs in 52 Sclerodermic Patients Followed in a Diseases Management Team: Development of a Risk Prediction Model of Organ-Specific Complications.

Front Immunol 2021 2;12:588753. Epub 2021 Jun 2.

Dermatologic Unit, University of Genoa, DiSSal, Ospedale-Policlinico San Martino, IRCCS, Genova, Italy.

Objective: To identify the existence of a correlation among the various organs affected, focusing primarily on immuno-dermatological aspects, and to create a risk prediction model of organ-specific complications.

Material And Methods: Fifty-two patients with stable scleroderma, followed between 2015 and 2019, were investigated through an extensive multidisciplinary evaluation in the last year.

Results: Patients with lung involvement presented a worse degree of skin fibrosis than patients without it (p <0.001). No relationship was observed for the heart, kidney, and esophagus. Patients with pulmonary involvement had a lower pressure of the low esophagus sphincter and a higher Warrick score than patients without it (p <0.05). Age was significantly higher in patients with kidney involvement. Diffuse scleroderma patients had a worse pulmonary impairment than limited scleroderma patients (p <0.05). The manometric "sclerodermic" pattern was observed to be the most frequent (55.6%, p <0.05) in dcSSc patients while the sclerodermic and normal pattern were equally represented (41.2 and 32.4% respectively, p <0.05) in lcSSc patients. When compared to the negative serological groups, anti-Scl-70 positive patients presented a worse lung involvement while anti-centromere patients presented a better lung outcome (p <0.05). PM-Scl 100/75 positive patients presented mostly a pulmonary fibrotic pattern (p <0.05) and, also, heart complications were more likely associated with anti PM-Scl 100/75 positivity (p <0.05). The risk prediction model for organ-specific complications had an accuracy of 84.4% (95%CI 78, 89) in complication-site prediction, AUC of 0.871, 86% of sensitivity, and 83% of specificity, Cohen's Kappa (k) of 0.68.

Conclusions: Out of all the organs studied, the skin is the one that correlates with the lung. Patients with a diffuse form of disease presented more frequently the anti Scl-70 antibody and had a worse lung and esophageal involvement (scleroderma pattern) than the negative group. Conversely, patients with limited disease presented all positive for the anti-centromere antibody with a better lung involvement than the negative group, without any difference among the esophageal manometric pattern. Anti PM-Scl 100/75 antibody patients were associated with pulmonary fibrosis and presented cardiac involvement. The model created has demonstrated excellent values of sensitivity, specificity, and accuracy, but further studies are needed for validation.
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http://dx.doi.org/10.3389/fimmu.2021.588753DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8207468PMC
August 2021

Diagnostic interpretation of non-contrast qualitative MR imaging features for characterisation of uterine leiomyosarcoma.

Br J Radiol 2021 Sep 16;94(1125):20210115. Epub 2021 Jun 16.

Cancer Research UK Cambridge Centre, University of Cambridge, Cambridge, UK.

Objective: To assess the value of non-contrast MRI features for characterisation of uterine leiomyosarcoma (LMS) and differentiation from atypical benign leiomyomas.

Methods: This study included 57 atypical leiomyomas and 16 LMS which were referred pre-operatively for management review to the specialist gynaeoncology multidisciplinary team meeting. Non-contrast MRIs were retrospectively reviewed by five independent readers (three senior, two junior) and a 5-level Likert score (1-low/5-high) was assigned to each mass for likelihood of LMS. Evaluation of qualitative and quantitative MRI features was done using uni- and multivariable regression analysis. Inter-reader reliability for the assessment of MRI features was calculated by using Cohen's κ values.

Results: In the univariate analysis, interruption of the endometrial interface and irregular tumour shape had the highest odds ratios (ORs) (64.00, < 0.001 and 12.00, = 0.002, respectively) for prediction of LMS. Likert score of the mass was significant in prediction (OR, 3.14; < 0.001) with excellent reliability between readers (ICC 0.86; 95% CI, 0.76-0.92). The post-menopausal status, interruption of endometrial interface and thickened endometrial stripe were the most predictive independent variables in multivariable estimation of the risk of leiomyosarcoma with an accuracy of 0.88 (95%CI, 0.78-0.94).

Conclusion: At any level of expertise as a radiologist reader, the loss of the normal endometrial stripe (either thickened or not seen) in a post-menopausal patient with a myometrial mass was highly likely to be LMS.

Advances In Knowledge: This study demonstrates the potential utility of non-contrast MRI features in characterisation of LMS over atypical leiomyomas, and therefore influence on optimal management of these cases.
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http://dx.doi.org/10.1259/bjr.20210115DOI Listing
September 2021

Osteosarcopenia in Very Old Age Adults After Hip Fracture: A Real-World Therapeutic Standpoint.

Front Med (Lausanne) 2021 20;8:612506. Epub 2021 May 20.

Istituto di Ricovero e Cura a Carattere Scientifico Ospedale Policlinico San Martino, Genoa, Italy.

Loss of bone and muscle mass and strength (i. e., osteosarcopenia) is a highly prevalent clinical condition in older adults, associated with an increased risk of fragility fractures and unfavorable clinical outcomes. Although sarcopenia is a potential risk factor for osteoporosis and subsequent fracture, and the management of this hazardous duet is the key to preventing osteoporotic fracture, evidence pertaining to the treatment of sarcopenia for the purpose of preventing fragile fractures remains insufficient. Given this scenario we aimed at prospectively compare the long-term effectiveness of bisphosphonates vs. denosumab, on bone and muscle, in a cohort of old age hip fractured patients by virtue of a timely osteo-metabolic and sarcopenic assessment. Ninety-eight patients consecutively enrolled at the IRCCS Hospital San martino, Genoa, Italy, received at baseline comprehensive geriatric assessment and Bone Densitometry (DXA) with the quantitative and quantitative bone analysis and evaluation of relative skeletal muscle index (RSMI) and longitudinally after 1 year form hip surgery. The results showed a slightly and non-significant osteo-metabolic improvement in the Alendronate group compared to the Denosumab group, and a positive trend of RSMI measurements in the Denosumab group. Although preliminary in nature, this is the first report to longitudinally analyze osteosarcopenia in a real-world cohort of very old age patients after hip fracture and moved a step forward in the understanding of the best osteo-metabolic therapy for long- term treatment, exploring as well the potential dual role of denousumab as antiresorptive and muscle strength specific drug for osteosarcopenia in this vulnerable population.
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http://dx.doi.org/10.3389/fmed.2021.612506DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8172785PMC
May 2021

A Wide Database for Future Studies Aimed at Improving Early Recognition of Candidemia.

Stud Health Technol Inform 2021 May;281:1081-1082

Department of Informatics, Bioengineering, Robotics and System Engineering.

Invasive candidiasis is associated with high morbidity and mortality in critically ill patients, i.e. patients admitted to Intensive Care Units (ICUs) or in surgical wards. There are no clinical signs or specific symptoms and even though early diagnosis risk scores and rapid tests are available, none of such strategies has an equally-optimal level of sensitivity and specificity. In the era of Electronic Health Records (EHRs), several clinical studies exploited Machine Learning (ML) models and large database of features to improve the diagnosis accuracy. The main aim of this work is to build a wide dataset which can be exploited to apply ML models to further improve the early recognition of candidemia at the bedside of patients with compatible signs and symptoms.
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http://dx.doi.org/10.3233/SHTI210354DOI Listing
May 2021

Predictive ability of a drug-based score in patients with advanced non-small-cell lung cancer receiving first-line immunotherapy.

Eur J Cancer 2021 Jun 3;150:224-231. Epub 2021 May 3.

Medical Oncology, Campus Bio-Medico University, Rome, Italy.

Background: We previously demonstrated the cumulative poor prognostic role of concomitant medications on the clinical outcome of patients with advanced cancer treated with immune checkpoint inhibitors, creating and validating a drug-based prognostic score to be calculated before immunotherapy initiation in patients with advanced solid tumours. This 'drug score' was calculated assigning score 1 for each between proton-pump inhibitor and antibiotic administration until a month before cancer therapy initiation and score 2 in case of corticosteroid intake. The good risk group included patients with score 0, intermediate risk with score 1-2 and poor risk with score 3-4.

Methods: Aiming at validating the prognostic and putative predictive ability depending on the anticancer therapy, we performed the present comparative analysis in two cohorts of advanced non-small-cell lung cancer (NSCLC), respectively, receiving first-line pembrolizumab or chemotherapy through a random case-control matching and through a pooled multivariable analysis including the interaction between the computed score and the therapeutic modality (pembrolizumab vs chemotherapy).

Results: Nine hundred fifty and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. After the case-control random matching, 589 patients from the pembrolizumab cohort and 589 from the chemotherapy cohort were paired, with no statistically significant differences between the characteristics of the matched subjects. Among the pembrolizumab-treated group, good, intermediate and poor risk evaluable patients achieved an objective response rate (ORR) of 50.0%, 37.7% and 23.4%, respectively, (p < 0.0001), whereas among the chemotherapy-treated group, patients achieved an ORR of 37.0%, 40.0% and 32.4%, respectively (p = 0.4346). The median progression-free survival (PFS) of good, intermediate and poor risk groups was 13.9 months, 6.3 months and 2.8 months, respectively, within the pembrolizumab cohort (p < 0.0001), and 6.2 months, 6.2 months and 4.3 months, respectively, within the chemotherapy cohort (p = 0.0280). Among the pembrolizumab-treated patients, the median overall survival (OS) for good, intermediate and poor risk patients was 31.4 months, 14.5 months and 5.8 months, respectively, (p < 0.0001), whereas among the chemotherapy-treated patients, it was 18.3 months, 16.8 months and 10.6 months, respectively (p = 0.0003). A similar trend was reported considering the two entire populations. At the pooled analysis, the interaction term between the score and the therapeutic modality was statistically significant with respect to ORR (p = 0.0052), PFS (p = 0.0003) and OS (p < 0.0001), confirming the significantly different effect of the score within the two cohorts.

Conclusion: Our 'drug score' showed a predictive ability with respect to ORR in the immunotherapy cohort only, suggesting it might be a useful tool for identifying patients unlikely to benefit from first-line single-agent pembrolizumab. In addition, the prognostic stratification in terms of PFS and OS was significantly more pronounced among the pembrolizumab-treated patients.
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http://dx.doi.org/10.1016/j.ejca.2021.03.041DOI Listing
June 2021

Clinical efficacy of eucaloric ketogenic nutrition in the COVID-19 cytokine storm: A retrospective analysis of mortality and intensive care unit admission.

Nutrition 2021 09 7;89:111236. Epub 2021 Mar 7.

Infectious Disease Clinic Genoa University, IRCCS-Policlinic Hospital San Martino, Genoa, Italy.

Objectives: Our primary objective was to explore the effect of a eucaloric ketogenic diet (EKD) on mortality, admission to the intensive care unit, and need for non-invasive ventilation in hospitalized patients with COronaVIrus Disease 19 (COVID-19), in comparison to a eucaloric standard diet. Secondary objectives were verification of the safety and feasibility of the diet and its effects on inflammatory parameters, particularly interleukin-6.

Methods: The study is a retrospective analysis of 34 patients fed with an EKD in comparison to 68 patients fed with a eucaloric standard diet, selected and matched using propensity scores 1:2 to avoid the confounding effect of interfering variables. Our hypothesis was that an EKD would reduce mortality, admission to the intensive care unit, and need for non-invasive ventilation in patients with COVID-19.

Results: The preliminary multivariate analysis showed a statistically significant difference in survival (P = 0.046) and need for the intensive care unit (P = 0.049) for the EKD compared with a eucaloric standard diet. Even considering the EKD start day as a time-dependent variable, the results maintain a positive trend for application of the diet, and it is not possible to reject the null hypothesis (P < 0.05). Interleukin-6 concentrations between t0 and t7 (7 d after the beginning of the diet) in the ketogenic nutrition group show a trend that is almost significant (P = 0.062). The EKD was safe and no adverse events were observed.

Conclusions: These results show a possible therapeutic role of an EKD in the clinical management of COVID-19. Currently, a prospective controlled randomized trial is running to confirm these preliminary data.
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http://dx.doi.org/10.1016/j.nut.2021.111236DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937042PMC
September 2021

Early Detection of Sepsis With Machine Learning Techniques: A Brief Clinical Perspective.

Front Med (Lausanne) 2021 12;8:617486. Epub 2021 Feb 12.

Infectious Diseases Unit, San Martino Policlinico Hospital - IRCCS for Oncology and Neurosciences, Genoa, Italy.

Sepsis is a major cause of death worldwide. Over the past years, prediction of clinically relevant events through machine learning models has gained particular attention. In the present perspective, we provide a brief, clinician-oriented vision on the following relevant aspects concerning the use of machine learning predictive models for the early detection of sepsis in the daily practice: (i) the controversy of sepsis definition and its influence on the development of prediction models; (ii) the choice and availability of input features; (iii) the measure of the model performance, the output, and their usefulness in the clinical practice. The increasing involvement of artificial intelligence and machine learning in health care cannot be disregarded, despite important pitfalls that should be always carefully taken into consideration. In the long run, a rigorous multidisciplinary approach to enrich our understanding in the application of machine learning techniques for the early recognition of sepsis may show potential to augment medical decision-making when facing this heterogeneous and complex syndrome.
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http://dx.doi.org/10.3389/fmed.2021.617486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906970PMC
February 2021

Correlation between peri-operative complication in middle ear cholesteatoma surgery using STAMCO, ChOLE, and SAMEO-ATO classifications.

Eur Arch Otorhinolaryngol 2021 Feb 22. Epub 2021 Feb 22.

Department of Otorhinolaryngology-Head and Neck Surgery, IRCCS Ospedale Policlinico San Martino, University of Genoa, largo Rosanna Benzi 10, 16132, Genoa, Italy.

Purpose: To compare the relationship between the variable "complication" and the other variables of middle ear cholesteatoma classifications (STAMCO, ChOLE, and SAMEO-ATO).

Methods: Retrospective study of 110 patients that underwent 132 middle ear surgeries between the 1 January 2012 and the 31 December 2019 for chronic otitis with cholesteatoma classified according to STAMCO, ChOLE, and SAMEO-ATO classifications in a tertiary health care centre.

Results: Older age, male gender, STAMCO-T, and SAMEO-ATO [O, T, O, (s -)] and mastoid involvement (STAMCO-M and ChOLE-Ch) were associated with an increased risk of complication report.

Conclusions: In our series, statistical analysis pointed out a relationship between surgical complications and age, gender, site, mastoidectomy type, and ossicular chain status at surgery. The choice of variables to be recorded for cholesteatoma staging should be carefully balanced, considering that "complication" variable could be a repetitive item.
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http://dx.doi.org/10.1007/s00405-021-06679-8DOI Listing
February 2021

Disease-Modifying Therapies and Coronavirus Disease 2019 Severity in Multiple Sclerosis.

Ann Neurol 2021 04 9;89(4):780-789. Epub 2021 Feb 9.

Department of Neuroscience, Mental Health, and Sensory Organs, Sapienza University of Rome, Rome, Italy.

Objective: This study was undertaken to assess the impact of immunosuppressive and immunomodulatory therapies on the severity of coronavirus disease 2019 (COVID-19) in people with multiple sclerosis (PwMS).

Methods: We retrospectively collected data of PwMS with suspected or confirmed COVID-19. All the patients had complete follow-up to death or recovery. Severe COVID-19 was defined by a 3-level variable: mild disease not requiring hospitalization versus pneumonia or hospitalization versus intensive care unit (ICU) admission or death. We evaluated baseline characteristics and MS therapies associated with severe COVID-19 by multivariate and propensity score (PS)-weighted ordinal logistic models. Sensitivity analyses were run to confirm the results.

Results: Of 844 PwMS with suspected (n = 565) or confirmed (n = 279) COVID-19, 13 (1.54%) died; 11 of them were in a progressive MS phase, and 8 were without any therapy. Thirty-eight (4.5%) were admitted to an ICU; 99 (11.7%) had radiologically documented pneumonia; 96 (11.4%) were hospitalized. After adjusting for region, age, sex, progressive MS course, Expanded Disability Status Scale, disease duration, body mass index, comorbidities, and recent methylprednisolone use, therapy with an anti-CD20 agent (ocrelizumab or rituximab) was significantly associated (odds ratio [OR] = 2.37, 95% confidence interval [CI] = 1.18-4.74, p = 0.015) with increased risk of severe COVID-19. Recent use (<1 month) of methylprednisolone was also associated with a worse outcome (OR = 5.24, 95% CI = 2.20-12.53, p = 0.001). Results were confirmed by the PS-weighted analysis and by all the sensitivity analyses.

Interpretation: This study showed an acceptable level of safety of therapies with a broad array of mechanisms of action. However, some specific elements of risk emerged. These will need to be considered while the COVID-19 pandemic persists. ANN NEUROL 2021;89:780-789.
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http://dx.doi.org/10.1002/ana.26028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8013440PMC
April 2021

Is ultraviolet radiation avoidance affecting bone health in melanoma patients?

Photodermatol Photoimmunol Photomed 2021 Jul 28;37(4):329-333. Epub 2021 Jan 28.

Section of Dermatology, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.

Background: Ultraviolet (UV) radiation has numerous beneficial effects on human health, including stimulating vitamin D and serotonin production and immuno-regulatory activities. Conversely, UV radiation is also classified as a group one carcinogen by the International Agency for Research on Cancer.

Purpose: To investigated the effects of UV radiation avoidance in melanoma patients in terms of vitamin D levels but also of bone mineral density and trabecular bone microarchitecture.

Methods: We conducted an observational study investigating the effects of UV radiation avoidance in 31 melanoma patients in terms of vitamin D levels but also of bone mineral density and trabecular bone microarchitecture by using dual-energy X-ray absorptiometry scan. Data were compared with two control groups of healthy subjects, who were chronically exposed or not exposed to UV radiation during their lifetime.

Results: Melanoma patients had on average slightly lower levels of vitamin D, without reaching statistical significance (P = .135). No significant difference was found across the three groups on T-scores of femoral neck (P = .544), of total hip (P = .617) and of lumbar spine P = .155). No significant difference was found on and trabecular bone score across exposure groups (P = .895).

Conclusion: UV radiation avoidance does not seem to significantly impact vitamin D levels nor bone health in melanoma patients. Thus, UV protective behavior is advisable for all melanoma patients.
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http://dx.doi.org/10.1111/phpp.12657DOI Listing
July 2021

Cross-Cultural Adaptation and Validation of the Italian Version of the Observational Scale of Level of Arousal.

J Am Med Dir Assoc 2021 Aug 30;22(8):1615-1620.e4. Epub 2020 Nov 30.

Geriatrics Clinic, Department of Internal Medicine and Medical Specialties (DIMI), University of Genoa, Genoa, Italy; IRCCS Ospedale Policlinico San Martino, Genoa, Italy. Electronic address:

Objectives: Along with deficit of attention, level of arousal is a primary criterion for the diagnosis of delirium. The Observational Scale of Level of Arousal (OSLA) is a quick, simple, and observational instrument used to evaluate the variation of arousal for rapid screening of delirium in clinical practice. The current study aims to perform a cross-cultural adaption of and to validate the Italian version of the OSLA scale to detect delirium in older aged, hospitalized patients.

Design: Longitudinal study.

Setting And Participants: In hospital and transitional care setting. Old age patients.

Methods: A cross-cultural adaptation of the OSLA from English into Italian was conducted, including back-translation. The validation of the OSLA was assessed in 116 older patients (age >65 years) admitted to geriatric, internal medicine, and transitional care wards. The 4 "A"s Test serves as the gold standard for the measurement of delirium.

Results: Incident delirium was assessed longitudinally at different time points during hospitalization. The Italian version of OSLA demonstrated adequate internal consistency, specificity, sensitivity, agreement, test-retest reliability, and sensitivity to change, indicating adequate its clinometric properties in the detection of delirium in a real world hospitalized cohort of older adults.

Conclusions And Implications: The current study is among the few studies to assess arousal as a core feature of delirium by virtue of a longitudinal assessment of delirium, moving a step forward in the implementation of a brief and easy to use delirium-screening tool for the measurement of important clinical outcomes in a frail, old aged hospitalized population.
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http://dx.doi.org/10.1016/j.jamda.2020.11.002DOI Listing
August 2021

Frailty assessment, hip fracture and long-term clinical outcomes in older adults.

Eur J Clin Invest 2021 Apr 23;51(4):e13445. Epub 2020 Dec 23.

IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

Background: The primary aim of the study was determining the validation of the modified 19-item Frailty Index (mFI-19), based on the standard procedure for creating a frailty index scoring in the accumulation deficit theory of Rockwood and comparing it with the gold standard comprehensive geriatric assessment (CGA) in old age patients with hip fracture. As a secondary aim, we compared prognostic accuracies of mFI-19 and CGA in predicting long-term mortality after surgery.

Materials And Methods: A total of 364 older patients with hip fractures, each a candidate for surgery, were consecutively enrolled. All were subjected to CGA and mFI-19 at baseline and time to death (years from hip surgery) were collected prospectively.

Results: Mean patient age was 86.5 (SD: 5.65) years. The most common clinical phenotype (77%) was frail. Both CGA and mFI-19 performed similarly in predicting long-term mortality (Harrell's C-index: 0.66 and 0.68, respectively).

Conclusions: The mFI-19 was validated, compared to the gold standard CGA, based on a systematic process for creating a frailty index in relation to the accumulation deficit. This is one of few prospective studies addressing long-term mortality in older adults with hip fractures, invoking a methodologically robust frailty screening assessment.
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http://dx.doi.org/10.1111/eci.13445DOI Listing
April 2021

The HLA-Cw6 Dilemma: Is It Really an Outcome Predictor in Psoriasis Patients under Biologic Therapy? A Monocentric Retrospective Analysis.

J Clin Med 2020 Sep 28;9(10). Epub 2020 Sep 28.

Di.S.Sal. Section of Dermatology, University of Genoa, Via Pastore 1, 16132 Genoa, Italy.

HLA-Cw6 is one of the most strongly associated psoriasis susceptibility alleles. Data regarding correlation between HLA-Cw6 status and biologic treatment outcomes are divergent. The aim of our study in our cohort of psoriatic patients was to explore if the HLA-Cw6 status influences the response rate to biologic therapies at 16 and 48 weeks. One hundred and one psoriatic patients eligible for biologic therapies were enrolled. HLA-C*06 alleles were detected from their blood samples. The effectiveness of antipsoriatic treatments was reported as 90% Psoriasis Area and Severity Index reduction (PASI90). All biologics showed efficacy at week 16, without significant differences between one another. HLA-Cw6 status did not seem to affect baseline characteristics, or treatment response at week 16. At week 48, IL-12/23 and IL-17 targeting drugs were more effective on Cw6-positive patients than on Cw6-negative patients. Conversely, TNF-targeting drugs seemed to be more effective on Cw6- negative patients than on Cw6-positive patients. The HLA-Cw6 test could well deserve to be integrated into the clinical laboratory work-up supporting the choice of the correct biologic.
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http://dx.doi.org/10.3390/jcm9103140DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7600180PMC
September 2020

Comparison of Likert and PI-RADS version 2 MRI scoring systems for the detection of clinically significant prostate cancer.

Br J Radiol 2020 Aug 11;93(1112):20200298. Epub 2020 Jun 11.

Department of Radiology, Addenbrooke's Hospital and University of Cambridge, Cambridge, UK.

Objective: To compare the performance of Likert and Prostate Imaging-Reporting and Data System (PI-RADS) multiparametric (mp) MRI scoring systems for detecting clinically significant prostate cancer (csPCa).

Methods: 199 biopsy-naïve males undergoing prostate mpMRI were prospectively scored with Likert and PI-RADS systems by four experienced radiologists. A binary cut-off (threshold score ≥3) was used to analyze histological results by three groups: negative, insignificant disease (Gleason 3 + 3; iPCa), and csPCa (Gleason ≥3 +4). Lesion-level results and prostate zonal location were also compared.

Results: 129/199 (64.8%) males underwent biopsy, 96 with Likert or PI-RADS score ≥3, and 21 with negative MRI. A further 12 patients were biopsied during follow-up (mean 507 days). Prostate cancer was diagnosed in 87/199 (43.7%) patients, 65 with (33.6%) csPCa. 30/92 (32.6%) patients with negative MRI were biopsied, with an NPV of 83.3% for cancer and 86.7% for csPCa. Likert and PI-RADS score differences were observed in 92 patients (46.2%), but only for 16 patients (8%) at threshold score ≥3. Likert scoring had higher specificity than PI-RADS (0.77 0.66), higher area under the curve (0.92 0.87, = 0.002) and higher PPV (0.66 0.58); NPV and sensitivity were the same. Likert had more five score results (58%) compared to PI-RADS (36%), but with similar csCPa detection (81.0 and 80.6% respectively). Likert demonstrated lower proportion of false positive in the predominately AFMS-involving lesions.

Conclusion: Likert and PI-RADS systems both demonstrate high cancer detection rates. Likert scoring had a higher AUC with moderately higher specificity and lower positive call rate and could potentially help to reduce the number of unnecessary biopsies performed.

Advances In Knowledge: This paper illustrates that the Likert scoring system has potential to help urologists reduce the number of prostate biopsies performed.
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http://dx.doi.org/10.1259/bjr.20200298DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7446003PMC
August 2020

A survey of psoriasis patients on biologics during COVID-19: a single centre experience.

J Dermatolog Treat 2020 May 25. Epub 2020 May 25.

Dermatology Unit, DissaL, Policlinico San Martino-IRCCS Hospital, Genoa, Italy.

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http://dx.doi.org/10.1080/09546634.2020.1770165DOI Listing
May 2020

First therapy choice in newly diagnosed Multiple Sclerosis patients: A multicenter Italian study.

Mult Scler Relat Disord 2020 Jul 16;42:102059. Epub 2020 Mar 16.

Department of Neurology, Valduce Hospital, Como.

Background: The approval of an increasing number of disease modifying drugs for the treatment of Multiple Sclerosis (MS) creates new challenges for patients and clinicians on the first treatment choice. The main aim of this study was to assess factors impacting first therapy choice in a large Italian MS cohort.

Methods: Newly diagnosed relapsing-remitting (RR) MS patients (2010-2018) followed in 24 Italian MS centres were included in the study. We evaluated the association of baseline demographics, clinical and MRI characteristics to the first treatment choice by logistic regression models applied to pre-defined binary alternatives: dimethyl fumarate vs injectables (interferon and glatiramer acetate), teriflunomide vs injectables, fingolimod vs dimethyl fumarate and fingolimod vs natalizumab.

Results: We enrolled 3025 patients in the period between January 2010 and June 2018. Relapses in the previous year (OR = 2.75; p = 0.001), presence of spinal cord lesions (OR = 1.80; p = 0.002) and higher number (>9) of T2 lesions on the baseline brain MRI scan (OR = 1.65; p = 0.022) were the factors associated to dimethyl fumarate choice as first therapy vs an injectable drug. Older age (OR = 1.06; p < 0.001), male sex (OR = 2.29; p = 0.001) and higher EDSS (OR = 1.36; p < 0.001) were the factors associated with the choice of teriflunomide vs injectables. In more recent years, dimethyl fumarate (OR = 3.23; p < 0.001) and teriflunomide (OR = 2.53; p < 0.001) were chosen more frequently than injectables therapies. The main determinant for the choice of fingolimod as compared with dimethyl fumarate was a higher EDSS (OR = 1.56; p = 0.001), while there was a weak association with a longer disease duration (p = 0.068) and a longer time from onset to diagnosis (p = 0.085). Compared to fingolimod, natalizumab was preferred in patients with a younger age (OR = 0.95; p = 0.003) and higher EDSS (OR = 1.45; p = 0.007) and a shorter disease duration (OR = 0.52; p = 0.076).

Conclusion: Many factors guided therapeutic decision for our Italian cohort of MS patients; they are mainly related to MS disease activity, baseline EDSS, disease duration and age.
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http://dx.doi.org/10.1016/j.msard.2020.102059DOI Listing
July 2020

Diagnostic accuracy of biparametric versus multiparametric prostate MRI: assessment of contrast benefit in clinical practice.

Eur Radiol 2020 Jul 12;30(7):4039-4049. Epub 2020 Mar 12.

Department of Radiology, Addenbrooke's Hospital and University of Cambridge, Cambridge, UK.

Purpose: To assess the added value of dynamic contrast-enhanced (DCE) in prostate MR in clinical practice.

Methods: Two hundred sixty-four patients underwent prostate MRI, with T2 and DWI sequences initially interpreted, prior to full multiparametric magnetic resonance imaging (mpMRI) interpretation using a Likert 1-5 scale. A prospective opinion was given on likely benefit of contrast prior to review of the DCE sequence, and retrospectively following full mpMRI review. The final histology result following targeted and/or systematic biopsy of the prostate was used for outcome purposes.

Results: Biparametric magnetic resonance imaging (bpMRI) and mpMRI were assigned the same score in 86% of cases; when dichotomising to a negative or positive MRI (Likert score ≥ 3), concordance increased to 92.8%. At Likert score ≥ 3 bpMRI detected 89.9% of all cancers and 93.5% clinically significant prostate cancers (csPCa) and mpMRI 90.7% and 94.6%, respectively. mpMRI had fewer false positives than bpMRI (11.4% vs 18.9%) and a lower Likert 3 rate (8.3% vs 17%), conferring higher specificity (74% vs 67%), but similar sensitivity (95% versus 94%) and ROC-AUC (90% vs 89%). At a positive MRI threshold of Likert ≥ 4, mpMRI had a higher sensitivity than bpMRI (89% versus 80%) and detected more csPCa (89.2% versus 79.6%). DCE was prospectively considered of potential benefit in 27.3%, but readers would only recall 11% of patients for DCE sequences, mainly to assess score 3 peripheral zone lesions. Following full mpMRI review, DCE was considered helpful in 28.4% of cases; in 23/75 (30.6%) of these cases this only became apparent after reviewing the sequence, reasons included increased confidence, presence of "safety-net" lesions or inflammatory lesions.

Conclusion: BpMRI has equivalent cancer detection rates to mpMRI; however, mpMRI had fewer Likert 3 call rates and increased specificity and was subjectively considered of benefit by readers in 28.4% of cases.

Key Points: • bpMRI has similar cancer detection rates to the full mpMRI protocol at a positive MRI threshold of Likert 3. • mpMRI had fewer intermediate category 3 calls (8.3%) than bpMRI (17%) and fewer false positives than bpMRI (11.4% vs 18.9%), conferring higher specificity (74% vs 67%). • Readers considered DCE beneficial in 28.4% of cases, but in a relatively high number (30.6%) this only became apparent after reviewing the sequence.
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http://dx.doi.org/10.1007/s00330-020-06782-0DOI Listing
July 2020

Biological therapy in genital psoriasis in women.

Dermatol Ther 2020 01 4;33(1):e13110. Epub 2019 Dec 4.

DISSAL Department of Dermatology, Ospedale Policlinico San Martino, Genoa, Italy.

Genital psoriasis (GenPs) is a frequent manifestation of psoriasis, causing distress, especially in women. We prospectively studied a population of 74 psoriatic women with severe and generalized psoriasis eligible to biologic therapy, to examine which biologic therapy is more effective on GenPs and to study possible associations between PASI severity and GenPs. Overall, 25/74 (34%) had GenPs: 6 received Ixekizumab, 7 Ustekinumab, 8 Adalimumab, 2 Secukinumab, 1 Etanercept, 1 Certolizumab. Therapies were administered based on PASI severity, independently from the presence of GenPs. Side effects, PASI score, sPGA-G scale for GenPs were recorded at time 0 and after 6 month of therapy. The mean sPGA-G scale value was 2.8 before treatment. After biologic therapy, all patients except one, improved of at least one point. Mostly, patients treated with anti-IL17 (Secukinumab, Ixekizumab) and anti-IL12/23 (Ustekinumab) improved. Mean PASI ranged from 10 to 16.3 before treatment. After 6 months of therapy, 4 anti-TNFα patients, 6 anti-IL17 and 1 anti-IL12/23, reached PASI 90. At time 0, no correlation between PASI and sPGA-G was visible (Pearson r = 0.10, p = .620). From our data, GenPs apparently responds favorably to IL17A inhibitors, but further studies, based on larger numbers of patients, are needed.
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http://dx.doi.org/10.1111/dth.13110DOI Listing
January 2020

Defining responders to therapies by a statistical modeling approach applied to randomized clinical trial data.

BMC Med 2019 06 18;17(1):113. Epub 2019 Jun 18.

Department of Health Sciences (DISSAL), University of Genova, Via Pastore 1, 16132, Genova, Italy.

Background: Personalized medicine is the tailoring of treatment to the individual characteristics of patients. Once a treatment has been tested in a clinical trial and its effect overall quantified, it would be of great value to be able to use the baseline patients' characteristics to identify patients with larger/lower benefits from treatment, for a more personalized approach to therapy.

Methods: We show here a previously published statistical method, aimed at identifying patients' profiles associated to larger treatment benefits applied to three identical randomized clinical trials in multiple sclerosis, testing laquinimod vs placebo (ALLEGRO, BRAVO, and CONCERTO). We identified on the ALLEGRO patients' specific linear combinations of baseline variables, predicting heterogeneous response to treatment on disability progression. We choose the best score on the BRAVO, based on its ability to identify responders to treatment in this dataset. We finally got an external validation on the CONCERTO, testing on this new dataset the performance of the score in defining responders and non-responders.

Results: The best response score defined on the ALLEGRO and the BRAVO was a linear combination of age, sex, previous relapses, brain volume, and MRI lesion activity. Splitting patients into responders and non-responders according to the score distribution, in the ALLEGRO, the hazard ratio (HR) for disability progression of laquinimod vs placebo was 0.38 for responders, HR = 1.31 for non-responders (interaction p = 0.0007). In the BRAVO, we had similar results: HR = 0.40 for responders and HR = 1.24 for non-responders (interaction p = 0.006). These findings were successfully replicated in the CONCERTO study, with HR = 0.44 for responders and HR=1.08 for non-responders (interaction p = 0.033).

Conclusions: This study demonstrates the possibility to refine and personalize the treatment effect estimated in randomized studies by using the baseline demographic and clinical characteristics of the included patients. The method can be applied to any randomized trial in any medical condition to create a treatment-specific score associated to different levels of response to the treatment tested in the trial. This is an easy and affordable method toward therapy personalization, indicating patient profiles related to a larger benefit from a specific drug, which may have implications for taking clinical decisions in everyday clinical practice.
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http://dx.doi.org/10.1186/s12916-019-1345-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6580611PMC
June 2019

Healthy Hands: a pilot study for the prevention of chronic hand eczema in healthcare workers of an Italian University Hospital.

G Ital Dermatol Venereol 2020 Dec 12;155(6):760-763. Epub 2019 Jun 12.

Section of Dermatology, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.

Background: Healthcare workers are at risk for occupational chronic hand eczema (CHE) because of frequent handwashing and prolonged use of occlusive gloves. Prevention programs based on skin care education have been shown to be beneficial. We developed and assessed the efficacy of a skin care educational intervention for healthcare workers of our hospital.

Methods: The intervention consisted of two sessions, one week apart, each divided in a theoretical and a practical part, focusing on the skin barrier, types of eczema, risk factors for CHE, hand hygiene measures respectful of the skin, proper use of protective gloves and emollient creams. Its efficacy was assessed by a questionnaire, administered before and after the intervention, investigating the participants' knowledge of risk factors for CHE and risk behaviors.

Results: Twenty-three subjects, mostly (65.2%) nurses, took part in the intervention; 60.9% had a self-reported atopic background and 65.2% participants reported a history of CHE. The intervention improved significantly the participants' knowledge on CHE risk factors, i.e. frequent handwashing (P=0.023), surgical scrubbing (P=0.016) and prolonged glove wearing (P=0.022). The frequency of hand washing was significantly reduced (P=0.022). The participants gave a positive unanimous feedback.

Conclusions: Our intervention was effective, by significantly improving the participants' knowledge and by inducing significant behavioral changes. Improving the formulation of alcoholic hand rubs may be a key factor to encourage their use. Coexisting nonoccupational risk behaviors are just as important in the prevention of CHE.
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http://dx.doi.org/10.23736/S0392-0488.19.06220-5DOI Listing
December 2020

Expanded disability status scale progression assessment heterogeneity in multiple sclerosis according to geographical areas.

Ann Neurol 2018 10 4;84(4):621-625. Epub 2018 Oct 4.

Department of Health Sciences, Section of Biostatistics, University of Genoa, Genoa, Italy.

Using placebo data from 3 randomized multiple sclerosis (MS) trials with uniform inclusion criteria, we investigated heterogeneity of Expanded Disability Status Scale (EDSS) progression by geographical areas. Our analysis revealed a significantly lower EDSS progression in Eastern European countries (10.8%) compared with Western Europe (13.1%) or the USA/Canada (21.4%, p < 0.001); EDSS improvement behaved the same way. This heterogeneity is not explained by differences of baseline variables. No differences were detected on more easily quantifiable measures, the Timed 25-Foot Walk or the Multiple Sclerosis Functional Composite. At a time when disease progression represents the target for future interventions in MS, establishment of more quantitative and objective outcomes remains a key priority of MS research. Ann Neurol 2018;84:621-625.
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http://dx.doi.org/10.1002/ana.25323DOI Listing
October 2018
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