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articles by Luigia Scudeller

A multicenter prospective study has been planned, in a large sample of Italian end-stage renal di... more A multicenter prospective study has been planned, in a large sample of Italian end-stage renal disease (ESRD) patients, aiming to assess the vascular access (VA) site-related infection rates and to identify variables associated with them. All ESRD patients undergoing chronic hemodialysis (HD) in the participating centers will be enrolled in the study. Participating centers were selected on a voluntary basis. Patients will be enrolled within an 18-month recruitment period. Primary study end points are the overall incidence rate of VA-related infections in ESRD patients on chronic HD (defined as infection episodes/100 patient-months), and the incidence rate of different types of VA-related infections (exit site, tunnel and bacteraemia/sepsis). All VA types in use will be evaluated: fistula, graft, tunneled (permanent) central venous catheter (CVC) and temporary CVC.

BACKGROUND: Toxicity and other drug adherence-related factors have contributed to decreased compl... more BACKGROUND: Toxicity and other drug adherence-related factors have contributed to decreased compliance to antiretroviral regimens amongst HIV-infected patients. Irregular therapy disruption causes loss of CD4 T cells, onset of drug resistance and rapid rebound of plasma viral load (VL). However, an appropriate choice of drugs and properly scheduled structured treatment interruptions (STIs) may limit VL rebound, maintain CD4 counts and minimize resistance. METHODS: We conducted a clinical study of STIs, RIGHT 901, involving 60 drug-naive patients with chronic HIV infection (CD4 \textgreater300, VL \textgreater10,000) randomized to receive didanosine-stavudine-indinavir (IDV group) or didanosine-stavudine-hydroxyurea (HU group), for 12 weeks. Subsequently, all patients were randomized again to start STI (short induction) or to continue the therapy for an additional 24 weeks before starting STI (long induction). Both groups underwent four STI cycles and then stopped therapy as long as viraemia remained below 10,000 copies/ml before reinitiating another four cycles of STI. RESULTS: During continuous therapy VLs were suppressed at similar rates in both the HU and IDV groups, while a blunted CD4 count was documented in the HU group. Following the first stop median VL rebounded close to baseline values in both groups, however, during the following STI median VL rebound decreased in the HU group, while in the IDV group VL continued to rebound to values close to baseline, and the difference between the two groups was statistically significant. Moreover, patients treated with HU had a constant and stable CD4 increase during STI, whereas CD4 counts fluctuated in the IDV group, with sharp falls during treatment interruptions and partial CD4 recovery following treatment restart. Even in the presence of IDV resistance predisposing mutations at baseline, no genotypic change in the protease sequence was observed during STI. A relevant mutation in the reverse transcriptase sequence (K70R) emerged in one patient interrupting treatment after 36 weeks of continuous therapy and in one patient after four STI cycles. Side effects (no major events) were similar among groups. CONCLUSIONS: An appropriate choice of STI schedule and regimens containing drugs less prone to resistance and/or able to prevent CD4 fluctuation may contribute to optimizing STI for chronically infected patients with respect to limiting viral rebound, improving CD4 counts and maintaining a resistance profile comparable to continuous highly active antiretroviral therapy.

The relationship between phenotypic susceptibility to lopinavir (LPV) and genotypic pattern was i... more The relationship between phenotypic susceptibility to lopinavir (LPV) and genotypic pattern was investigated in LPV-naive, protease inhibitor (PI)-experienced subjects. Protease sequences of 100 HIV isolates with ascertained susceptibility (determined by Antivirogram) to LPV were analyzed (VircoGen). Two different thresholds (2.5- and 10-fold) were used for defining reduced susceptibility. Mutations were classified as LPV/r (the actual formulation of LPV that combines LPV with low-dose ritonavir) mutations according to the International AIDS Society-USA. Thirty-four isolates showed reduced LPV susceptibility (2.6- to 75.9-fold). Fold resistance to LPV correlated with the number of total and LPV/r mutations (Spearman coefficient = 0.62 and 0.74, respectively; P \textless 0.001). Current PI therapy (P = 0.002) and indinavir administration (P \textless 0.001), \textgreater5 LPV/r mutations (P \textless 0.0012), and detection of L10FIRV, K20MR, M46IL, I54VL, A71VT, G73SA, V82AFTS, I84V, and M90L were associated with LPV resistance in univariate analysis. Factors independently associated with LPV resistance were K20MR (odds ratio [OR], 13.9; 95\% confidence interval [CI], 1.3-145.1; P = 0.028), I54VL (OR, 131.7; 95\% CI, 10.5-1654.7; P \textless 0.001), G73SA (OR, 19.2; 95\% CI, 1.4-273.7; P = 0.029), and I84V (OR, 177.5; 95\% CI, 6.0-5232.5; P = 0.003) mutations and \textgreater9 protease mutations (OR, 18.6; 95\% CI, 1.6-213.0; P = 0.019). Sixteen of 34 and 18 of 34 isolates with reduced LPV susceptibility showed \textgreater10-fold or \textless 10-fold LPV resistance, respectively. Linear regression analysis demonstrated that each additional LPV mutation and I54VL accounted for much of the fold resistance to LPV (adjusted R2 = 0.70). In conclusion, for PI-experienced patients requiring salvage therapy, switching to LPV should be based on the number of baseline mutations and the presence of mutation 54.

We compared viroimmunologic response after real phenotype (r-PHT) versus virtual phenotype (v-PHT... more We compared viroimmunologic response after real phenotype (r-PHT) versus virtual phenotype (v-PHT) in patients failing highly active antiretroviral therapy (HAART). A total of 201 patients with \textgreater2 years of exposure, more than six experienced drugs, \textgreater1000 HIV RNA copies/mL, and on stable HAART for \textgreater6 months were randomized to the r-PHT or v-PHT arm. The primary end point was the proportion of HIV plasma viral load (pVL) \textless 400 copies/mL. Secondary end points were absolute pVL change, proportion of pVL reduction \textgreater0.5 log(10) copies/mL, and absolute CD4 cell change. In the intention-to-treat-last observation carried forward analysis, study outcomes were not significantly different between arms over 48 weeks of follow-up: 20\% and 24\% pVL \textless 400 copies/mL; 58\% and 61\% pVL reduction \textgreater0.5 log(10) copies/mL; -0.92 and -0.94(10) log copies/mL mean pVL decrease; and +41.6 and +94.4 cells/mm(3) mean absolute CD4 increase in the r-PHT and v-PHT arms, respectively. On-treatment analyses gave similar results. In the multivariate analysis of pVL \textless 400 copies/mL, the following covariates were independent predictors at week 48: adherence (OR p= 0.25; p=.002), baseline CD4 (OR = 4.39; p=.007), intravenous drug use as risk factor for HIV acquisition (OR = 0.33; p=.024), and sensitivity score of the new regimens by biologic cut-offs (OR = 1.84; p=.029). Prescribed drugs for which patients were naive resulted in marginal prediction (OR = 1.93; p=.054). In conclusion, virologic and immunologic outcomes did not differ when r-PHT or v-PHT was used in this cohort of heavily pretreated patients. Several factors should be considered to take better advantage of resistance testing, including treatment history, clinical status, and patients' ability to adhere to treatment.

American Journal of Infection Control, 2006

BACKGROUND: Surveillance activities have been considered of paramount importance for effective in... more BACKGROUND: Surveillance activities have been considered of paramount importance for effective infection control programs in health care organizations. OBJECTIVES: Our objective was to design a capture system able to assure surveillance of hospital-acquired ...

International Journal of Antimicrobial Agents, 2009

Objectives: To assess if non-specific clinical signs or biological results can identify patients ... more Objectives: To assess if non-specific clinical signs or biological results can identify patients with high probability of IE to improve outcome. Design: All patients tested for IE were included in a cohort and classified according to the modified Duke criteria. Patients with rejected endocarditis served as controls. Univariate and multivariate analyses were performed and a score was calculated by adding 1 when a variable independently associated with IE (excluding major Duke criteria) was present and 0 when the variable was absent. Scores were evaluated using the ROC curve method. Results: IE was diagnosed in 402 of 2039 participants (19.7%). By multivariate analysis, PVD, fever, emboli, stroke, splenomegaly, finger clubbing, leukocytosis, and ESR > 50 were independently associated with IE. The rate of IE increased significantly from 4% (10/254) for a score of 0 to 83% (10/12) for a score of 6. The area under the ROC curve was 0.75. Conclusions: This simple score can be used to identify in the emergency room or on admission patients with high probability of IE to speed up diagnosis, or initiate empirical antimicrobial therapy without replacing

Journal of Antimicrobial Chemotherapy, 2003

Results: Among 180 samples available, 56 (31.1%) were discordant with the observed genotype inter... more Results: Among 180 samples available, 56 (31.1%) were discordant with the observed genotype interpretation results, as a result of being judged as sensitive by r-PHT or v-PHT but resistant by VGI (S/R). Only the I84V mutation was almost invariably found in concordant resistant isolates compared with S/R isolates (60% versus 0%, respectively; P < 0.0001). Notwithstanding this, the number of multi-protease inhibitor-associated mutations (PAMs) was significantly higher in the concordant resistant isolates; the prevalence of >3 PAMs was 56.52% versus 33.93% in R/R and S/R isolates, respectively (P = 0.01). Correspondence analysis confirmed the relevance of PAMs, although additional mutations appeared to be correlated with APV resistance.

The Journal of Infectious Diseases, 2003

We compared 2 rules-based genotype interpretation systems and real or virtual phenotype through a... more We compared 2 rules-based genotype interpretation systems and real or virtual phenotype through a retrospective analysis of a prospective trial. Genotypes were determined with VircoGEN II (VIRCO) and were interpreted with either RetroGram 1.4 or TRUGENE HIV-1 (guidelines 3.0) or original virtual phenotype (Virtual Phenotype; VIRCO), as available in the year 2000. Among 188 human immunodeficiency virus (HIV) type 1 isolates, overall concordance (k agreement) was observed for the 2 rules-based systems, whereas striking discordances were noted between them and real and virtual phenotype interpretations for stavudine, didanosine, zalcitabine, abacavir, and amprenavir ( ). Clinical evaluation of a subset of 173 patients showed k ! 0.4 that both rules-based sensitivity scores were independently associated with HIV RNA loads !400 copies/mL at week 16 of during-treatment analysis (TRUGENE: odds ratio [OR], 2.90; 95% confidence interval [CI], 1.52-5.52;

The Journal of Pain, 2014

The Journal of Pain, 2014

Expert opinion on drug safety, Jan 10, 2015

To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patie... more To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patients previously treated with benzalkonium chloride (BAK)-preserved Latanoprost. Cohort 6-month study on open-angle glaucoma or ocular hypertension patients. Complete ophthalmic examination, intraocular pressure (IOP) measurement and ocular surface status (tear film break-up time [TF-BUT], corneal staining and ocular surface disease index [OSDI]) were evaluated at baseline and 6 months later. A total of 44 patients were enrolled. Median (interquartile range [IQR]) baseline IOP was 18 (15.5 - 21) and 16 (14 - 17) mmHg (p < 0.0001) after 6 months. At baseline, 18 (40.9%) patients presented an IOP of < 18 mmHg, 11 (25%) < 16 mmHg, 2 (4.3%) < 14 mmHg and 1 (2.3%) < 12 mmHg; 6 months later the proportions were 36 (81.8%) (p < 0.0001), 21 (47.7%) (p = 0.00075), 8 (18.2%) (p = 0.0143) and 6 (13.6%) (p = 0.0253). Concerning safety, TF-BUT improved from 8 [IQR 6 - 10] to 10 [IQR 8...

Introduction Novel bibliometric indexes (commonly known as altmetrics) are gaining interest withi... more Introduction
Novel bibliometric indexes (commonly known as altmetrics) are gaining interest within the scientific community and might represent an important alternative measure of research quality and output.

Aims
We evaluate how these new metrics correlate with established bibliometric indexes such as the impact factor (IF), currently used as a measure of scientific production as well as a criterion for scientific research funding, and how they might be helpful in assessing the impact of research.

Methods
We calculated altmetrics scores for all the articles published at our institution during a single year and examined the correlation between altmetrics scores and IFs as a measure of research quality and impact in all departments.

Results
For all articles from the various departments published in a single year, the altmetrics score and the sum of all IFs showed a strong and significant correlation (Spearman’s rho 0.88). The correlation was significant also when the major components of altmetrics, including Facebook, Twitter and Mendeley, were analyzed. The implementation of altmetrics has been found to be easy and effective at both the researcher and librarian levels.

Conclusions
The novel bibliographic index altmetrics is consistent and reliable and can complement or be considered a valid alternative to standard bibliometric indexes to benchmark output and quality of research for academic and funding purposes.

The Journal of Pain, 2014

Archives of Internal Medicine, 2009

International Journal of Antimicrobial Agents, 2009

Objectives: To assess if non-specific clinical signs or biological results can identify patients ... more Objectives: To assess if non-specific clinical signs or biological results can identify patients with high probability of IE to improve outcome. Design: All patients tested for IE were included in a cohort and classified according to the modified Duke criteria. Patients with rejected endocarditis served as controls. Univariate and multivariate analyses were performed and a score was calculated by adding 1 when a variable independently associated with IE (excluding major Duke criteria) was present and 0 when the variable was absent. Scores were evaluated using the ROC curve method. Results: IE was diagnosed in 402 of 2039 participants (19.7%). By multivariate analysis, PVD, fever, emboli, stroke, splenomegaly, finger clubbing, leukocytosis, and ESR > 50 were independently associated with IE. The rate of IE increased significantly from 4% (10/254) for a score of 0 to 83% (10/12) for a score of 6. The area under the ROC curve was 0.75. Conclusions: This simple score can be used to identify in the emergency room or on admission patients with high probability of IE to speed up diagnosis, or initiate empirical antimicrobial therapy without replacing

CHEST Journal, 2011

Rapid on-site evaluation (ROSE) of transbronchial needle aspirates has long been used during flex... more Rapid on-site evaluation (ROSE) of transbronchial needle aspirates has long been used during flexible bronchoscopy, but its usefulness in the diagnosis of hilar and mediastinal adenopathy is controversial. The aim of the present study was to evaluate the extent to which ROSE can be valuable in patients undergoing transbronchial needle aspiration (TBNA) for the diagnosis of hilar and mediastinal adenopathy. A total of 168 consecutive patients with enlarged lymph nodes were randomized to undergo TBNA with or without ROSE. The primary outcome measure of the study was the diagnostic yield of TBNA on a per-patient basis. Secondary outcome measures included the percentage of adequate specimens on a per-lymph node basis, the number of biopsy sites on a per-patient basis, and the complication rate of bronchoscopy on a per-patient basis. We found no significant difference between the TBNA group and the ROSE group in terms of diagnostic yield (75.3% vs 78.3%, respectively; P = .64), and percentage of adequate specimens (86.5% vs 78.4%, respectively; P = .11). The median (interquartile range) number of biopsy sites was significantly lower in the ROSE group (1 [1-2] vs 2 [1-2], respectively; P = .0005). The complication rate of bronchoscopy was significantly lower in patients undergoing on-site review (6% vs 20%; P = .01), whereas the complication rate of TBNA was similar among the study groups. ROSE of transbronchial aspirates from hilar and mediastinal nodes enables avoidance of additional biopsy without loss in diagnostic yield and reduces the complication rate of bronchoscopy. ClinicalTrials.gov; No.: NCT00915330; URL: www.clinicaltrials.gov

Purpose: Induced labor is associated with a higher request for analgesia than spontaneous labor. ... more Purpose: Induced labor is associated with a higher request for analgesia than spontaneous labor. This study compared duration of labor, mode of delivery, quantity of blood loss, type of perineal outcome and neonatal outcomes between women in induced labor and women in spontaneous labor, both on epidural analgesia (administered at cervical dilation 4 cm). Methods: In a two-year longitudinal cohort study, data were gathered from nulliparous women with a single cephalic pregnancy of at least 37 weeks attending the labor and delivery ward in Policlinico San Matteo Fundation-Pavia. Data were compared for women with early labor analgesia in (1) spontaneous labor (Robson group 1) and (2) induced labor (dinoprostonevaginal insert or gel, Robson group 2a). Results: Of the 1104 women who underwent epidural analgesia in the study period, 531 were included: 326 in spontaneous labor and 205 in induced labor. The only significant difference found was duration of the first stage, which lasted 305 (200-390) min in spontaneous labor compared to 205 min (120-345) in induced labor (p 50.001). Conclusions: In women on early epidural analgesia, induction is associated with a shorter duration of the first stage of labor and does not affect other outcomes.

Current ocular GvHD (oGvHD) treatments are suboptimal. We investigated the safety and efficacy of... more Current ocular GvHD (oGvHD) treatments are suboptimal. We investigated the safety and efficacy of long-term continuous treatment with autologous platelet lysate (PL) drops in patients with oGvHD Dry Eye Syndrome (DES) score 2–3 refractory to topical conventional therapy. Ophthalmic evaluation was performed at 6 month intervals. Symptoms were assessed using the Glaucoma Symptom Scale (GSS). Patients were defined 'responders' when showing a reduction at least one grade on National Institutes of Health Eye Score from baseline at the 6 month visit. Thirty-one patients were included, and 16 (51%) completed 36 months of follow-up (range 6.5–72.7). At 6 months all patients were classified as responders: median GSS symptom score decreased from 70 to 41 (33 at 36 months), median GSS function score reduced from 68 to 46 (33 at 36 months) (all Po 0.001). Median Tear Break Up Time improved from 3 to 6 s after 6 months and was maintained over time. All signs improved at 6 and 36 months (clinical and statistical significance). No severe adverse events occurred. Long-term treatment with PL drops is secure and effective for oGvHD and can be an efficient therapy option from initial stages of oGvHD to prevent permanent ocular impairment and improving quality of life.

Key points: 2  Mortality in patients with severe sepsis and septic shock (SS/SS) attending emerg... more Key points: 2  Mortality in patients with severe sepsis and septic shock (SS/SS) attending emergency department (ED) is considerably high.

A multicenter prospective study has been planned, in a large sample of Italian end-stage renal di... more A multicenter prospective study has been planned, in a large sample of Italian end-stage renal disease (ESRD) patients, aiming to assess the vascular access (VA) site-related infection rates and to identify variables associated with them. All ESRD patients undergoing chronic hemodialysis (HD) in the participating centers will be enrolled in the study. Participating centers were selected on a voluntary basis. Patients will be enrolled within an 18-month recruitment period. Primary study end points are the overall incidence rate of VA-related infections in ESRD patients on chronic HD (defined as infection episodes/100 patient-months), and the incidence rate of different types of VA-related infections (exit site, tunnel and bacteraemia/sepsis). All VA types in use will be evaluated: fistula, graft, tunneled (permanent) central venous catheter (CVC) and temporary CVC.

BACKGROUND: Toxicity and other drug adherence-related factors have contributed to decreased compl... more BACKGROUND: Toxicity and other drug adherence-related factors have contributed to decreased compliance to antiretroviral regimens amongst HIV-infected patients. Irregular therapy disruption causes loss of CD4 T cells, onset of drug resistance and rapid rebound of plasma viral load (VL). However, an appropriate choice of drugs and properly scheduled structured treatment interruptions (STIs) may limit VL rebound, maintain CD4 counts and minimize resistance. METHODS: We conducted a clinical study of STIs, RIGHT 901, involving 60 drug-naive patients with chronic HIV infection (CD4 \textgreater300, VL \textgreater10,000) randomized to receive didanosine-stavudine-indinavir (IDV group) or didanosine-stavudine-hydroxyurea (HU group), for 12 weeks. Subsequently, all patients were randomized again to start STI (short induction) or to continue the therapy for an additional 24 weeks before starting STI (long induction). Both groups underwent four STI cycles and then stopped therapy as long as viraemia remained below 10,000 copies/ml before reinitiating another four cycles of STI. RESULTS: During continuous therapy VLs were suppressed at similar rates in both the HU and IDV groups, while a blunted CD4 count was documented in the HU group. Following the first stop median VL rebounded close to baseline values in both groups, however, during the following STI median VL rebound decreased in the HU group, while in the IDV group VL continued to rebound to values close to baseline, and the difference between the two groups was statistically significant. Moreover, patients treated with HU had a constant and stable CD4 increase during STI, whereas CD4 counts fluctuated in the IDV group, with sharp falls during treatment interruptions and partial CD4 recovery following treatment restart. Even in the presence of IDV resistance predisposing mutations at baseline, no genotypic change in the protease sequence was observed during STI. A relevant mutation in the reverse transcriptase sequence (K70R) emerged in one patient interrupting treatment after 36 weeks of continuous therapy and in one patient after four STI cycles. Side effects (no major events) were similar among groups. CONCLUSIONS: An appropriate choice of STI schedule and regimens containing drugs less prone to resistance and/or able to prevent CD4 fluctuation may contribute to optimizing STI for chronically infected patients with respect to limiting viral rebound, improving CD4 counts and maintaining a resistance profile comparable to continuous highly active antiretroviral therapy.

The relationship between phenotypic susceptibility to lopinavir (LPV) and genotypic pattern was i... more The relationship between phenotypic susceptibility to lopinavir (LPV) and genotypic pattern was investigated in LPV-naive, protease inhibitor (PI)-experienced subjects. Protease sequences of 100 HIV isolates with ascertained susceptibility (determined by Antivirogram) to LPV were analyzed (VircoGen). Two different thresholds (2.5- and 10-fold) were used for defining reduced susceptibility. Mutations were classified as LPV/r (the actual formulation of LPV that combines LPV with low-dose ritonavir) mutations according to the International AIDS Society-USA. Thirty-four isolates showed reduced LPV susceptibility (2.6- to 75.9-fold). Fold resistance to LPV correlated with the number of total and LPV/r mutations (Spearman coefficient = 0.62 and 0.74, respectively; P \textless 0.001). Current PI therapy (P = 0.002) and indinavir administration (P \textless 0.001), \textgreater5 LPV/r mutations (P \textless 0.0012), and detection of L10FIRV, K20MR, M46IL, I54VL, A71VT, G73SA, V82AFTS, I84V, and M90L were associated with LPV resistance in univariate analysis. Factors independently associated with LPV resistance were K20MR (odds ratio [OR], 13.9; 95\% confidence interval [CI], 1.3-145.1; P = 0.028), I54VL (OR, 131.7; 95\% CI, 10.5-1654.7; P \textless 0.001), G73SA (OR, 19.2; 95\% CI, 1.4-273.7; P = 0.029), and I84V (OR, 177.5; 95\% CI, 6.0-5232.5; P = 0.003) mutations and \textgreater9 protease mutations (OR, 18.6; 95\% CI, 1.6-213.0; P = 0.019). Sixteen of 34 and 18 of 34 isolates with reduced LPV susceptibility showed \textgreater10-fold or \textless 10-fold LPV resistance, respectively. Linear regression analysis demonstrated that each additional LPV mutation and I54VL accounted for much of the fold resistance to LPV (adjusted R2 = 0.70). In conclusion, for PI-experienced patients requiring salvage therapy, switching to LPV should be based on the number of baseline mutations and the presence of mutation 54.

We compared viroimmunologic response after real phenotype (r-PHT) versus virtual phenotype (v-PHT... more We compared viroimmunologic response after real phenotype (r-PHT) versus virtual phenotype (v-PHT) in patients failing highly active antiretroviral therapy (HAART). A total of 201 patients with \textgreater2 years of exposure, more than six experienced drugs, \textgreater1000 HIV RNA copies/mL, and on stable HAART for \textgreater6 months were randomized to the r-PHT or v-PHT arm. The primary end point was the proportion of HIV plasma viral load (pVL) \textless 400 copies/mL. Secondary end points were absolute pVL change, proportion of pVL reduction \textgreater0.5 log(10) copies/mL, and absolute CD4 cell change. In the intention-to-treat-last observation carried forward analysis, study outcomes were not significantly different between arms over 48 weeks of follow-up: 20\% and 24\% pVL \textless 400 copies/mL; 58\% and 61\% pVL reduction \textgreater0.5 log(10) copies/mL; -0.92 and -0.94(10) log copies/mL mean pVL decrease; and +41.6 and +94.4 cells/mm(3) mean absolute CD4 increase in the r-PHT and v-PHT arms, respectively. On-treatment analyses gave similar results. In the multivariate analysis of pVL \textless 400 copies/mL, the following covariates were independent predictors at week 48: adherence (OR p= 0.25; p=.002), baseline CD4 (OR = 4.39; p=.007), intravenous drug use as risk factor for HIV acquisition (OR = 0.33; p=.024), and sensitivity score of the new regimens by biologic cut-offs (OR = 1.84; p=.029). Prescribed drugs for which patients were naive resulted in marginal prediction (OR = 1.93; p=.054). In conclusion, virologic and immunologic outcomes did not differ when r-PHT or v-PHT was used in this cohort of heavily pretreated patients. Several factors should be considered to take better advantage of resistance testing, including treatment history, clinical status, and patients' ability to adhere to treatment.

American Journal of Infection Control, 2006

BACKGROUND: Surveillance activities have been considered of paramount importance for effective in... more BACKGROUND: Surveillance activities have been considered of paramount importance for effective infection control programs in health care organizations. OBJECTIVES: Our objective was to design a capture system able to assure surveillance of hospital-acquired ...

International Journal of Antimicrobial Agents, 2009

Objectives: To assess if non-specific clinical signs or biological results can identify patients ... more Objectives: To assess if non-specific clinical signs or biological results can identify patients with high probability of IE to improve outcome. Design: All patients tested for IE were included in a cohort and classified according to the modified Duke criteria. Patients with rejected endocarditis served as controls. Univariate and multivariate analyses were performed and a score was calculated by adding 1 when a variable independently associated with IE (excluding major Duke criteria) was present and 0 when the variable was absent. Scores were evaluated using the ROC curve method. Results: IE was diagnosed in 402 of 2039 participants (19.7%). By multivariate analysis, PVD, fever, emboli, stroke, splenomegaly, finger clubbing, leukocytosis, and ESR > 50 were independently associated with IE. The rate of IE increased significantly from 4% (10/254) for a score of 0 to 83% (10/12) for a score of 6. The area under the ROC curve was 0.75. Conclusions: This simple score can be used to identify in the emergency room or on admission patients with high probability of IE to speed up diagnosis, or initiate empirical antimicrobial therapy without replacing

Journal of Antimicrobial Chemotherapy, 2003

Results: Among 180 samples available, 56 (31.1%) were discordant with the observed genotype inter... more Results: Among 180 samples available, 56 (31.1%) were discordant with the observed genotype interpretation results, as a result of being judged as sensitive by r-PHT or v-PHT but resistant by VGI (S/R). Only the I84V mutation was almost invariably found in concordant resistant isolates compared with S/R isolates (60% versus 0%, respectively; P < 0.0001). Notwithstanding this, the number of multi-protease inhibitor-associated mutations (PAMs) was significantly higher in the concordant resistant isolates; the prevalence of >3 PAMs was 56.52% versus 33.93% in R/R and S/R isolates, respectively (P = 0.01). Correspondence analysis confirmed the relevance of PAMs, although additional mutations appeared to be correlated with APV resistance.

The Journal of Infectious Diseases, 2003

We compared 2 rules-based genotype interpretation systems and real or virtual phenotype through a... more We compared 2 rules-based genotype interpretation systems and real or virtual phenotype through a retrospective analysis of a prospective trial. Genotypes were determined with VircoGEN II (VIRCO) and were interpreted with either RetroGram 1.4 or TRUGENE HIV-1 (guidelines 3.0) or original virtual phenotype (Virtual Phenotype; VIRCO), as available in the year 2000. Among 188 human immunodeficiency virus (HIV) type 1 isolates, overall concordance (k agreement) was observed for the 2 rules-based systems, whereas striking discordances were noted between them and real and virtual phenotype interpretations for stavudine, didanosine, zalcitabine, abacavir, and amprenavir ( ). Clinical evaluation of a subset of 173 patients showed k ! 0.4 that both rules-based sensitivity scores were independently associated with HIV RNA loads !400 copies/mL at week 16 of during-treatment analysis (TRUGENE: odds ratio [OR], 2.90; 95% confidence interval [CI], 1.52-5.52;

The Journal of Pain, 2014

The Journal of Pain, 2014

Expert opinion on drug safety, Jan 10, 2015

To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patie... more To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patients previously treated with benzalkonium chloride (BAK)-preserved Latanoprost. Cohort 6-month study on open-angle glaucoma or ocular hypertension patients. Complete ophthalmic examination, intraocular pressure (IOP) measurement and ocular surface status (tear film break-up time [TF-BUT], corneal staining and ocular surface disease index [OSDI]) were evaluated at baseline and 6 months later. A total of 44 patients were enrolled. Median (interquartile range [IQR]) baseline IOP was 18 (15.5 - 21) and 16 (14 - 17) mmHg (p < 0.0001) after 6 months. At baseline, 18 (40.9%) patients presented an IOP of < 18 mmHg, 11 (25%) < 16 mmHg, 2 (4.3%) < 14 mmHg and 1 (2.3%) < 12 mmHg; 6 months later the proportions were 36 (81.8%) (p < 0.0001), 21 (47.7%) (p = 0.00075), 8 (18.2%) (p = 0.0143) and 6 (13.6%) (p = 0.0253). Concerning safety, TF-BUT improved from 8 [IQR 6 - 10] to 10 [IQR 8...

Introduction Novel bibliometric indexes (commonly known as altmetrics) are gaining interest withi... more Introduction
Novel bibliometric indexes (commonly known as altmetrics) are gaining interest within the scientific community and might represent an important alternative measure of research quality and output.

Aims
We evaluate how these new metrics correlate with established bibliometric indexes such as the impact factor (IF), currently used as a measure of scientific production as well as a criterion for scientific research funding, and how they might be helpful in assessing the impact of research.

Methods
We calculated altmetrics scores for all the articles published at our institution during a single year and examined the correlation between altmetrics scores and IFs as a measure of research quality and impact in all departments.

Results
For all articles from the various departments published in a single year, the altmetrics score and the sum of all IFs showed a strong and significant correlation (Spearman’s rho 0.88). The correlation was significant also when the major components of altmetrics, including Facebook, Twitter and Mendeley, were analyzed. The implementation of altmetrics has been found to be easy and effective at both the researcher and librarian levels.

Conclusions
The novel bibliographic index altmetrics is consistent and reliable and can complement or be considered a valid alternative to standard bibliometric indexes to benchmark output and quality of research for academic and funding purposes.

The Journal of Pain, 2014

Archives of Internal Medicine, 2009

International Journal of Antimicrobial Agents, 2009

Objectives: To assess if non-specific clinical signs or biological results can identify patients ... more Objectives: To assess if non-specific clinical signs or biological results can identify patients with high probability of IE to improve outcome. Design: All patients tested for IE were included in a cohort and classified according to the modified Duke criteria. Patients with rejected endocarditis served as controls. Univariate and multivariate analyses were performed and a score was calculated by adding 1 when a variable independently associated with IE (excluding major Duke criteria) was present and 0 when the variable was absent. Scores were evaluated using the ROC curve method. Results: IE was diagnosed in 402 of 2039 participants (19.7%). By multivariate analysis, PVD, fever, emboli, stroke, splenomegaly, finger clubbing, leukocytosis, and ESR > 50 were independently associated with IE. The rate of IE increased significantly from 4% (10/254) for a score of 0 to 83% (10/12) for a score of 6. The area under the ROC curve was 0.75. Conclusions: This simple score can be used to identify in the emergency room or on admission patients with high probability of IE to speed up diagnosis, or initiate empirical antimicrobial therapy without replacing

CHEST Journal, 2011

Rapid on-site evaluation (ROSE) of transbronchial needle aspirates has long been used during flex... more Rapid on-site evaluation (ROSE) of transbronchial needle aspirates has long been used during flexible bronchoscopy, but its usefulness in the diagnosis of hilar and mediastinal adenopathy is controversial. The aim of the present study was to evaluate the extent to which ROSE can be valuable in patients undergoing transbronchial needle aspiration (TBNA) for the diagnosis of hilar and mediastinal adenopathy. A total of 168 consecutive patients with enlarged lymph nodes were randomized to undergo TBNA with or without ROSE. The primary outcome measure of the study was the diagnostic yield of TBNA on a per-patient basis. Secondary outcome measures included the percentage of adequate specimens on a per-lymph node basis, the number of biopsy sites on a per-patient basis, and the complication rate of bronchoscopy on a per-patient basis. We found no significant difference between the TBNA group and the ROSE group in terms of diagnostic yield (75.3% vs 78.3%, respectively; P = .64), and percentage of adequate specimens (86.5% vs 78.4%, respectively; P = .11). The median (interquartile range) number of biopsy sites was significantly lower in the ROSE group (1 [1-2] vs 2 [1-2], respectively; P = .0005). The complication rate of bronchoscopy was significantly lower in patients undergoing on-site review (6% vs 20%; P = .01), whereas the complication rate of TBNA was similar among the study groups. ROSE of transbronchial aspirates from hilar and mediastinal nodes enables avoidance of additional biopsy without loss in diagnostic yield and reduces the complication rate of bronchoscopy. ClinicalTrials.gov; No.: NCT00915330; URL: www.clinicaltrials.gov

Purpose: Induced labor is associated with a higher request for analgesia than spontaneous labor. ... more Purpose: Induced labor is associated with a higher request for analgesia than spontaneous labor. This study compared duration of labor, mode of delivery, quantity of blood loss, type of perineal outcome and neonatal outcomes between women in induced labor and women in spontaneous labor, both on epidural analgesia (administered at cervical dilation 4 cm). Methods: In a two-year longitudinal cohort study, data were gathered from nulliparous women with a single cephalic pregnancy of at least 37 weeks attending the labor and delivery ward in Policlinico San Matteo Fundation-Pavia. Data were compared for women with early labor analgesia in (1) spontaneous labor (Robson group 1) and (2) induced labor (dinoprostonevaginal insert or gel, Robson group 2a). Results: Of the 1104 women who underwent epidural analgesia in the study period, 531 were included: 326 in spontaneous labor and 205 in induced labor. The only significant difference found was duration of the first stage, which lasted 305 (200-390) min in spontaneous labor compared to 205 min (120-345) in induced labor (p 50.001). Conclusions: In women on early epidural analgesia, induction is associated with a shorter duration of the first stage of labor and does not affect other outcomes.

Current ocular GvHD (oGvHD) treatments are suboptimal. We investigated the safety and efficacy of... more Current ocular GvHD (oGvHD) treatments are suboptimal. We investigated the safety and efficacy of long-term continuous treatment with autologous platelet lysate (PL) drops in patients with oGvHD Dry Eye Syndrome (DES) score 2–3 refractory to topical conventional therapy. Ophthalmic evaluation was performed at 6 month intervals. Symptoms were assessed using the Glaucoma Symptom Scale (GSS). Patients were defined 'responders' when showing a reduction at least one grade on National Institutes of Health Eye Score from baseline at the 6 month visit. Thirty-one patients were included, and 16 (51%) completed 36 months of follow-up (range 6.5–72.7). At 6 months all patients were classified as responders: median GSS symptom score decreased from 70 to 41 (33 at 36 months), median GSS function score reduced from 68 to 46 (33 at 36 months) (all Po 0.001). Median Tear Break Up Time improved from 3 to 6 s after 6 months and was maintained over time. All signs improved at 6 and 36 months (clinical and statistical significance). No severe adverse events occurred. Long-term treatment with PL drops is secure and effective for oGvHD and can be an efficient therapy option from initial stages of oGvHD to prevent permanent ocular impairment and improving quality of life.

Key points: 2  Mortality in patients with severe sepsis and septic shock (SS/SS) attending emerg... more Key points: 2  Mortality in patients with severe sepsis and septic shock (SS/SS) attending emergency department (ED) is considerably high.