Background: Gadolinium is known to produce side effects and has recently been shown to accumulate... more Background: Gadolinium is known to produce side effects and has recently been shown to accumulate in the brain parenchyma especially in the basal ganglia. Since RRMS patients do undergo several MR examinations, these potential risks have to be considered in this group of patients. Although guidelines advocate the use of gadolinium enhanced imaging in the follow-up of RRMS patients, the benefit of the use of gadolinium enhancement in the subgroup treated with natalizumab could be questionable. Methods and materials: After IRB approval 201 brain scans and 24 spine exams were reviewed in consensus by 3 readers in a series of 27 patients treated with natalizumab (PS, EC, PwdG). These 27 patients were followed during a time span of 6 to 84 months (mean 49 months). Evolution of lesion load and contrast enhancement were scored. Particular interest was given to the diagnosis of PML. The results were compared with the clinical status and the treatment as reported in the patient charts. Results: Clinical evaluation resulted in 12 episodes of clinical relapse in patients treated with natalizumab, 5 patients demonstrated respectively 1, 2 or 3 relapses. None of the MR scans in the asymptomatic patients nor in the symptomatic patient group demonstrated contrast enhancement. No sign of PML were detected. Conclusion: The benefit of T1 MR sequences post contrast as put forward in many guidelines could be questionable in the subgroup of RRMS patients treated with natalizumab.
Objectives: The aim of this study was to conduct a discrete choice experiment with patients affec... more Objectives: The aim of this study was to conduct a discrete choice experiment with patients affected by colorectal cancer to understand their preferences for different attributes of the chemotherapy supply. Our overall goal is to provide evidence on the relative importance of each attribute in order to tailor chemotherapy supply according to patients' priorities in the design or reorganization processes of cancer services. Methods: Focus groups were used to identify the attributes and levels for the discrete choice experiment. The attributes were: continuity of care, understanding, information, treatment choice, and time for therapy. Respondents were asked to choose between two mutually exclusive hypothetical alternatives of chemotherapy supply. Patients completed the discrete choice experiment along with health-related quality of life and patients' satisfaction questions. Conditional and mixed logistic models were used to analyses the data. Results: Patients with colorectal cancer treated with chemotherapy (n=76) completed the survey. The most important aspects of chemotherapy supply were: "Providing detailed and complete information" and "High ability in understanding" patients. Preferences were also influenced by the availability of a trusted doctor. Except for one attribute (waiting time for therapy), all other characteristics significantly influenced respondents' preferences. Conclusions: Results should support a policy of strengthening medical doctors' capabilities to communicate with patients, providing them complete information and involving them in the clinical decisions. Specifically, the findings should be used to improve current provision of cancer care by identifying areas of preferred intervention from the perspectives of patients in order to tailor the service supply accordingly.
Aims: Adult survivors of childhood cancer experience a high cumulative burden of therapy-related ... more Aims: Adult survivors of childhood cancer experience a high cumulative burden of therapy-related chronic health conditions (CHCs). However, longitudinal evaluation of patient-reported symptoms has not been examined as an indicator of CHCs in this population. Methods: 735 long-term adult survivors of childhood cancer completed three symptom surveys through participation in both St. Jude Lifetime Cohort Study (SJLIFE) and Childhood Cancer Survivor Study (CCSS) across 25 years (1992-2016). Surveys included ten symptom domains related to late treatment effects, including sensory, cardiac, pulmonary, musculoskeletal, memory, pain, fatigue, nausea,
Journal of Evaluation in Clinical Practice, Feb 26, 2020
Rationale, aims and objectives. Missing data represent a challenge in longitudinal studies. The a... more Rationale, aims and objectives. Missing data represent a challenge in longitudinal studies. The aim of the study is to compare the performance of the multivariate normal imputation and the fully conditional specification methods, using real dataset with missing data partially completed two years later. Method. The data used came from an ongoing randomized controlled trial with five-year follow-up. At a certain time, we observed a number of patients with missing data and a number of patients whose data were unobserved because they were not yet eligible for a given follow-up. Both unobserved and missing data were imputed. The imputed unobserved data were compared with the corresponding real information obtained two years later. Results. Both imputation methods showed similar performance on the accuracy measures and produced minimally biased estimates. Conclusion. Despite the large number of repeated measures with intermittent missing data and the non-normal multivariate distribution of data, both methods performed well and was not possible to determine which was better.
Cyclooxygenase 2 (COX-2) is an inflammation-associated enzyme involved in the pathogenesis of man... more Cyclooxygenase 2 (COX-2) is an inflammation-associated enzyme involved in the pathogenesis of many solid tumors, but little is known about its presence and role in hematologic neoplasms. Multiple myeloma (MM) is known to involve a deregulated cytokine network with secretion of inflammatory mediators. We thus decided to investigate the involvement of COX-2 in this neoplasm. Western blotting (WB) was used to evaluate 142 bone marrow (BM) specimens, including MM and monoclonal gammopathy of undetermined significance (MGUS). Selected cases under-went further evaluation by WB on purified CD138+ cells, immunohistochemistry (IC), and real-time polymerase chain reaction (PCR) for mRNA expression. COX-2 was expressed in 11% (2 of 18) of MGUS specimens, 31% (29 of 94) of MM at diagnosis, and 47% (14 of 30) of MM with relapsed/refractory disease. COX-2 positivity was associated with a poor outcome in terms of progression-free (18 vs 36 months; P < .001) and overall survival (28 vs 52 months; P < .05). Real-time PCR showed COX-2 mRNA overexpression. IC and cell separation studies demonstrated COX-2 expression to be restricted to malignant plasma cells. This is the first report of the presence and prognostic role of COX-2 expression in MM. Future studies will assess COX-2 involvement in other hematologic tumors and its potential use as a therapeutic or chemo-preventive target in onco-hematology. (Blood. 2005; 105:4784-4791)
Take-down policy If you believe that this document breaches copyright please contact us providing... more Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim.
Background: Response shift (RS) has been defined as a change in the meaning of an individual's se... more Background: Response shift (RS) has been defined as a change in the meaning of an individual's self-evaluation that needs to be accounted for when assessing longitudinal changes in health-related quality of life (HRQoL). RS detection through structural equation modeling is accomplished by adopting Oort's procedure based on a measurement model in which the observed variables are defined as reflective indicators of the HRQoL latent variable; that is, the latent variable causes the variation in the reflective indicators. This study aims to propose a procedure that assesses RS when formative indicators are used in measuring HRQoL; in this last case, the latent variable is considered to be a function of some formative indicators. A secondary aim is to compare the new procedure with Oort's procedure to highlight similarities and differences. Methods: The data were retrieved from a consecutive series of 258 patients newly diagnosed with colorectal cancer and undergoing chemotherapy and/or surgery. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QOL-C30) was administered twice, once before and once six months after treatment. Structural equation modeling was used to evaluate RS and true change with the newly proposed method (in which fatigue and pain were defined as formative indicators) and with Oort's procedure (in which fatigue and pain were defined as reflective indicators). Results: According to the new procedure, there was no measurement bias, and on average, patients' quality of life improved by 3.53 points (on a scale ranging from 0 to 100) at the 6-month follow-up. With Oort's procedure, the loading of the pain indicator was not invariant across the two time points, suggesting the presence of reprioritization, whereas the estimation of true change was very similar to the previous one: 3.87. Conclusions: RS and true change in HRQoL can be evaluated in the presence of formative indicators. Defining a measurement model by formative or reflective indicators can lead to different results.
Introduction Testicular cancer is one of the most treatable cancers, with a 10-year survival of m... more Introduction Testicular cancer is one of the most treatable cancers, with a 10-year survival of more than 95%. Many patients will be long-term survivors and this disease strikes men in an important phase of their lives, therefore the quality of life (QoL) among these patients is an area of particular interest. We aimed to study whether QoL in testicular cancer survivors depends on the time since cancer diagnosis. Methods Data were collected from the EPSAM (Esposizioni postnatali e salute maschile) study, a case-control study on patients with testicular cancer, diagnosed between 1997 and 2008 in the province of Turin, Northern Italy, and interviewed between 2008 and 2010 (response rate among cases 57%). Patients were contacted through their oncologist at the San Giovanni Batista Hospital in Turin or through their general practitioner (GP) in the rest of the Province of Turin. QoL was assessed cross-sectionally using the short form 12 (SF-12) questionnaire, a generic short-form health survey that produces two summary scores, PCS (physical component score) and MCS (mental component score), to evaluate physical and mental health, respectively. Results Out of 234 study patients, 125 cases were seminomas and 109 cases were nonseminomas. The mean age at diagnosis was 34.5 years. After adjusting for age, time since diagnosis was not associated with PCS and MCS scores. Among nonseminomas, the median PCS slightly increased (adjusted OR (odds ratio) for 5+ vs < 2 years since cancer diagnosis: 1.78 (1.17-2.73), p = 0.008) and MCS slightly decreased (adjusted OR per 1-year increase since cancer diagnosis: 0.92, 95% CI: 0.82-1.05, p = 0.23) with time. Similar findings of no association between time since diagnosis and PCS and MCS were found when the analyses
Background The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is one of the most commonly-used ... more Background The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is one of the most commonly-used MS-specific health-related quality of life (HRQOL) measures. It is a multidimensional, MS-specific HRQOL inventory, which includes the generic SF-36 core items, supplemented with 18 MS-targeted items. Availability of an adaptive short version providing immediate item scoring may improve instrument usability and validity. However, multidimensional computerized adaptive testing (MCAT) has not been previously applied to MSQOL-54 items. We thus aimed to apply MCAT to the MSQOL-54 and assess its performance. Methods Responses from a large international sample of 3669 MS patients were assessed. We calibrated 52 (of the 54) items using bifactor graded response model (10 group factors and one general HRQOL factor). Then, eight simulations were run with different termination criteria: standard errors (SE) for the general factor and group factors set to different values, and change in factor estim...
Mediterranean Journal of Hematology and Infectious Diseases
Background and objectives: acute myeloid leukemia (AML) patients are at high risk of infections d... more Background and objectives: acute myeloid leukemia (AML) patients are at high risk of infections during post induction neutropenia. Recently, the role of antibacterial prophylaxis has been reconsidered due to concerns about the emergence of multi-resistant pathogens. Aim of the present study was to evaluate the impact of prophylaxis omission on the rate of induction death (primary endpoint), neutropenic fevers, bloodstream infections (BSIs), resistant pathogens BSIs and septic shocks (secondary endpoints). Methods: we performed a retrospective single center study including 373 AML patients treated with intensive induction chemotherapy, divided in two groups according to levofloxacin prophylaxis given (group A, gA) or not (group B, gB). Results: neutropenic fever was observed in 91% of patients in gA and 97% in gB (OR 0.35, IC95% 0.08 – 1.52, p=0162).The rate of BSIs was 27% in gA compared to 34% in gB (OR 0.69, 0.38 – 1.25, p=0.222). Induction death rate was 5% in gA and 3% in gB (O...
Gestational diabetes mellitus (GDM) is one of the most common pregnancy complications, associated... more Gestational diabetes mellitus (GDM) is one of the most common pregnancy complications, associated with an increased risk of maternal and perinatal outcomes. It has been hypothesized that interventions on life style can have beneficial effects due to the modulation of the maternal gut microbiota during pregnancy. Microbiota is remodeled at several body sites during pregnancy and dietary habits and quality of micronutrients may affect gut microbial composition. Increased knowledge of how change in foods and nutrients can modulate gut composition in pregnant women is thus of importance, not only for the mother but also for the unborn child. We performed a prospective observational study evaluating the microbiota of 41 patients with GDM from the second to the third trimester of pregnancy after following a diet in line with given guidelines. The fecal microbiota was assessed by 16S amplicon based sequencing and daily dietary information as well as blood metabolites were analyzed. Overall we found a higher bacterial richness as pregnancy progressed in our GDM patients with strong correlation between pro-inflammatory taxa associated with GDM and metabolic and inflammatory variables. After the dietary counselling, 34.1% of the participants showed to be adherent to the given dietary recommendations. Adherent patients showed significantly reduced intakes of simple sugars and increased consumption of fiber, oligosaccharides and polyunsaturated fatty acids (PUFA) if compared with non-adherents. C-reactive Protein (CRP) values, blood glucose, fasting insulin and Homeostasis Model Assessment Insulin Resistance (HOMA-IR) score were significantly lower in adherents. This reduction in inflammatory variables was strictly correlated with the increase in Faecalibacterium, Blautia and R-Ruminococcus. In addition adherent showed significant reduction of Bacteroides, Veillonella and Rikenellaceae. We then observed a negative correlation between Blautia and total cholesterol, CRP and HOMA-IR. At sub-genus level, we observed a higher number of Blautia oligotypes and several oligotypes were associated with PUFA or negatively correlated with cholesterol. That evidence suggests an effect of the dietary intake at sub-genus level highlighting a possible different strain-dependent effect on gut. Patients with adherence to the given dietary recommendations showed a significant reduction in inflammatory variables and pro-inflammatory microbiota with respect to non-adherents.
Background. The Multiple Sclerosis Walking Scale (MSWS-12) has showed good psychometric propertie... more Background. The Multiple Sclerosis Walking Scale (MSWS-12) has showed good psychometric properties in reports exploring its validity using Classical Test Theory methods. Findings from recent studies using Item Response Theory methods advance the idea that some aspects of the MSWS-12 does not fully comply with some requirements of sound measurement. Research question. The present study investigated whether the measurement properties of the Italian version of the MSWS-12 met the assumptions of the Rasch model. Methods. Sample consisted of 199 patients with a diagnosis of MS (50% female; Mean age (SD) = 48.15 (12.33)). Analyses were performed using both unidimensional and multidimensional Rasch modeling techniques. Results. Rating scale for items assessing need for support when walking, and ability to run, showed significant functioning problems. A revision of the rating scale improved the measurement properties of these items. Items assessing need for support showed signs of multidimensionality and differential item functioning when controlling for patients' disease course and EDSS score. Additionally, included items did not appear to cover the full range of impairment as observed in the sample. Significance. Emerging findings are consistent with those from previous studies in highlighting the need for a revision of the current content of the MSWS-12, and the inclusion of new items assessing impairment at the lower end of the disability continuum.
Background: Gadolinium is known to produce side effects and has recently been shown to accumulate... more Background: Gadolinium is known to produce side effects and has recently been shown to accumulate in the brain parenchyma especially in the basal ganglia. Since RRMS patients do undergo several MR examinations, these potential risks have to be considered in this group of patients. Although guidelines advocate the use of gadolinium enhanced imaging in the follow-up of RRMS patients, the benefit of the use of gadolinium enhancement in the subgroup treated with natalizumab could be questionable. Methods and materials: After IRB approval 201 brain scans and 24 spine exams were reviewed in consensus by 3 readers in a series of 27 patients treated with natalizumab (PS, EC, PwdG). These 27 patients were followed during a time span of 6 to 84 months (mean 49 months). Evolution of lesion load and contrast enhancement were scored. Particular interest was given to the diagnosis of PML. The results were compared with the clinical status and the treatment as reported in the patient charts. Results: Clinical evaluation resulted in 12 episodes of clinical relapse in patients treated with natalizumab, 5 patients demonstrated respectively 1, 2 or 3 relapses. None of the MR scans in the asymptomatic patients nor in the symptomatic patient group demonstrated contrast enhancement. No sign of PML were detected. Conclusion: The benefit of T1 MR sequences post contrast as put forward in many guidelines could be questionable in the subgroup of RRMS patients treated with natalizumab.
Objectives: The aim of this study was to conduct a discrete choice experiment with patients affec... more Objectives: The aim of this study was to conduct a discrete choice experiment with patients affected by colorectal cancer to understand their preferences for different attributes of the chemotherapy supply. Our overall goal is to provide evidence on the relative importance of each attribute in order to tailor chemotherapy supply according to patients' priorities in the design or reorganization processes of cancer services. Methods: Focus groups were used to identify the attributes and levels for the discrete choice experiment. The attributes were: continuity of care, understanding, information, treatment choice, and time for therapy. Respondents were asked to choose between two mutually exclusive hypothetical alternatives of chemotherapy supply. Patients completed the discrete choice experiment along with health-related quality of life and patients' satisfaction questions. Conditional and mixed logistic models were used to analyses the data. Results: Patients with colorectal cancer treated with chemotherapy (n=76) completed the survey. The most important aspects of chemotherapy supply were: "Providing detailed and complete information" and "High ability in understanding" patients. Preferences were also influenced by the availability of a trusted doctor. Except for one attribute (waiting time for therapy), all other characteristics significantly influenced respondents' preferences. Conclusions: Results should support a policy of strengthening medical doctors' capabilities to communicate with patients, providing them complete information and involving them in the clinical decisions. Specifically, the findings should be used to improve current provision of cancer care by identifying areas of preferred intervention from the perspectives of patients in order to tailor the service supply accordingly.
Aims: Adult survivors of childhood cancer experience a high cumulative burden of therapy-related ... more Aims: Adult survivors of childhood cancer experience a high cumulative burden of therapy-related chronic health conditions (CHCs). However, longitudinal evaluation of patient-reported symptoms has not been examined as an indicator of CHCs in this population. Methods: 735 long-term adult survivors of childhood cancer completed three symptom surveys through participation in both St. Jude Lifetime Cohort Study (SJLIFE) and Childhood Cancer Survivor Study (CCSS) across 25 years (1992-2016). Surveys included ten symptom domains related to late treatment effects, including sensory, cardiac, pulmonary, musculoskeletal, memory, pain, fatigue, nausea,
Journal of Evaluation in Clinical Practice, Feb 26, 2020
Rationale, aims and objectives. Missing data represent a challenge in longitudinal studies. The a... more Rationale, aims and objectives. Missing data represent a challenge in longitudinal studies. The aim of the study is to compare the performance of the multivariate normal imputation and the fully conditional specification methods, using real dataset with missing data partially completed two years later. Method. The data used came from an ongoing randomized controlled trial with five-year follow-up. At a certain time, we observed a number of patients with missing data and a number of patients whose data were unobserved because they were not yet eligible for a given follow-up. Both unobserved and missing data were imputed. The imputed unobserved data were compared with the corresponding real information obtained two years later. Results. Both imputation methods showed similar performance on the accuracy measures and produced minimally biased estimates. Conclusion. Despite the large number of repeated measures with intermittent missing data and the non-normal multivariate distribution of data, both methods performed well and was not possible to determine which was better.
Cyclooxygenase 2 (COX-2) is an inflammation-associated enzyme involved in the pathogenesis of man... more Cyclooxygenase 2 (COX-2) is an inflammation-associated enzyme involved in the pathogenesis of many solid tumors, but little is known about its presence and role in hematologic neoplasms. Multiple myeloma (MM) is known to involve a deregulated cytokine network with secretion of inflammatory mediators. We thus decided to investigate the involvement of COX-2 in this neoplasm. Western blotting (WB) was used to evaluate 142 bone marrow (BM) specimens, including MM and monoclonal gammopathy of undetermined significance (MGUS). Selected cases under-went further evaluation by WB on purified CD138+ cells, immunohistochemistry (IC), and real-time polymerase chain reaction (PCR) for mRNA expression. COX-2 was expressed in 11% (2 of 18) of MGUS specimens, 31% (29 of 94) of MM at diagnosis, and 47% (14 of 30) of MM with relapsed/refractory disease. COX-2 positivity was associated with a poor outcome in terms of progression-free (18 vs 36 months; P &lt; .001) and overall survival (28 vs 52 months; P &lt; .05). Real-time PCR showed COX-2 mRNA overexpression. IC and cell separation studies demonstrated COX-2 expression to be restricted to malignant plasma cells. This is the first report of the presence and prognostic role of COX-2 expression in MM. Future studies will assess COX-2 involvement in other hematologic tumors and its potential use as a therapeutic or chemo-preventive target in onco-hematology. (Blood. 2005; 105:4784-4791)
Take-down policy If you believe that this document breaches copyright please contact us providing... more Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim.
Background: Response shift (RS) has been defined as a change in the meaning of an individual's se... more Background: Response shift (RS) has been defined as a change in the meaning of an individual's self-evaluation that needs to be accounted for when assessing longitudinal changes in health-related quality of life (HRQoL). RS detection through structural equation modeling is accomplished by adopting Oort's procedure based on a measurement model in which the observed variables are defined as reflective indicators of the HRQoL latent variable; that is, the latent variable causes the variation in the reflective indicators. This study aims to propose a procedure that assesses RS when formative indicators are used in measuring HRQoL; in this last case, the latent variable is considered to be a function of some formative indicators. A secondary aim is to compare the new procedure with Oort's procedure to highlight similarities and differences. Methods: The data were retrieved from a consecutive series of 258 patients newly diagnosed with colorectal cancer and undergoing chemotherapy and/or surgery. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QOL-C30) was administered twice, once before and once six months after treatment. Structural equation modeling was used to evaluate RS and true change with the newly proposed method (in which fatigue and pain were defined as formative indicators) and with Oort's procedure (in which fatigue and pain were defined as reflective indicators). Results: According to the new procedure, there was no measurement bias, and on average, patients' quality of life improved by 3.53 points (on a scale ranging from 0 to 100) at the 6-month follow-up. With Oort's procedure, the loading of the pain indicator was not invariant across the two time points, suggesting the presence of reprioritization, whereas the estimation of true change was very similar to the previous one: 3.87. Conclusions: RS and true change in HRQoL can be evaluated in the presence of formative indicators. Defining a measurement model by formative or reflective indicators can lead to different results.
Introduction Testicular cancer is one of the most treatable cancers, with a 10-year survival of m... more Introduction Testicular cancer is one of the most treatable cancers, with a 10-year survival of more than 95%. Many patients will be long-term survivors and this disease strikes men in an important phase of their lives, therefore the quality of life (QoL) among these patients is an area of particular interest. We aimed to study whether QoL in testicular cancer survivors depends on the time since cancer diagnosis. Methods Data were collected from the EPSAM (Esposizioni postnatali e salute maschile) study, a case-control study on patients with testicular cancer, diagnosed between 1997 and 2008 in the province of Turin, Northern Italy, and interviewed between 2008 and 2010 (response rate among cases 57%). Patients were contacted through their oncologist at the San Giovanni Batista Hospital in Turin or through their general practitioner (GP) in the rest of the Province of Turin. QoL was assessed cross-sectionally using the short form 12 (SF-12) questionnaire, a generic short-form health survey that produces two summary scores, PCS (physical component score) and MCS (mental component score), to evaluate physical and mental health, respectively. Results Out of 234 study patients, 125 cases were seminomas and 109 cases were nonseminomas. The mean age at diagnosis was 34.5 years. After adjusting for age, time since diagnosis was not associated with PCS and MCS scores. Among nonseminomas, the median PCS slightly increased (adjusted OR (odds ratio) for 5+ vs < 2 years since cancer diagnosis: 1.78 (1.17-2.73), p = 0.008) and MCS slightly decreased (adjusted OR per 1-year increase since cancer diagnosis: 0.92, 95% CI: 0.82-1.05, p = 0.23) with time. Similar findings of no association between time since diagnosis and PCS and MCS were found when the analyses
Background The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is one of the most commonly-used ... more Background The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is one of the most commonly-used MS-specific health-related quality of life (HRQOL) measures. It is a multidimensional, MS-specific HRQOL inventory, which includes the generic SF-36 core items, supplemented with 18 MS-targeted items. Availability of an adaptive short version providing immediate item scoring may improve instrument usability and validity. However, multidimensional computerized adaptive testing (MCAT) has not been previously applied to MSQOL-54 items. We thus aimed to apply MCAT to the MSQOL-54 and assess its performance. Methods Responses from a large international sample of 3669 MS patients were assessed. We calibrated 52 (of the 54) items using bifactor graded response model (10 group factors and one general HRQOL factor). Then, eight simulations were run with different termination criteria: standard errors (SE) for the general factor and group factors set to different values, and change in factor estim...
Mediterranean Journal of Hematology and Infectious Diseases
Background and objectives: acute myeloid leukemia (AML) patients are at high risk of infections d... more Background and objectives: acute myeloid leukemia (AML) patients are at high risk of infections during post induction neutropenia. Recently, the role of antibacterial prophylaxis has been reconsidered due to concerns about the emergence of multi-resistant pathogens. Aim of the present study was to evaluate the impact of prophylaxis omission on the rate of induction death (primary endpoint), neutropenic fevers, bloodstream infections (BSIs), resistant pathogens BSIs and septic shocks (secondary endpoints). Methods: we performed a retrospective single center study including 373 AML patients treated with intensive induction chemotherapy, divided in two groups according to levofloxacin prophylaxis given (group A, gA) or not (group B, gB). Results: neutropenic fever was observed in 91% of patients in gA and 97% in gB (OR 0.35, IC95% 0.08 – 1.52, p=0162).The rate of BSIs was 27% in gA compared to 34% in gB (OR 0.69, 0.38 – 1.25, p=0.222). Induction death rate was 5% in gA and 3% in gB (O...
Gestational diabetes mellitus (GDM) is one of the most common pregnancy complications, associated... more Gestational diabetes mellitus (GDM) is one of the most common pregnancy complications, associated with an increased risk of maternal and perinatal outcomes. It has been hypothesized that interventions on life style can have beneficial effects due to the modulation of the maternal gut microbiota during pregnancy. Microbiota is remodeled at several body sites during pregnancy and dietary habits and quality of micronutrients may affect gut microbial composition. Increased knowledge of how change in foods and nutrients can modulate gut composition in pregnant women is thus of importance, not only for the mother but also for the unborn child. We performed a prospective observational study evaluating the microbiota of 41 patients with GDM from the second to the third trimester of pregnancy after following a diet in line with given guidelines. The fecal microbiota was assessed by 16S amplicon based sequencing and daily dietary information as well as blood metabolites were analyzed. Overall we found a higher bacterial richness as pregnancy progressed in our GDM patients with strong correlation between pro-inflammatory taxa associated with GDM and metabolic and inflammatory variables. After the dietary counselling, 34.1% of the participants showed to be adherent to the given dietary recommendations. Adherent patients showed significantly reduced intakes of simple sugars and increased consumption of fiber, oligosaccharides and polyunsaturated fatty acids (PUFA) if compared with non-adherents. C-reactive Protein (CRP) values, blood glucose, fasting insulin and Homeostasis Model Assessment Insulin Resistance (HOMA-IR) score were significantly lower in adherents. This reduction in inflammatory variables was strictly correlated with the increase in Faecalibacterium, Blautia and R-Ruminococcus. In addition adherent showed significant reduction of Bacteroides, Veillonella and Rikenellaceae. We then observed a negative correlation between Blautia and total cholesterol, CRP and HOMA-IR. At sub-genus level, we observed a higher number of Blautia oligotypes and several oligotypes were associated with PUFA or negatively correlated with cholesterol. That evidence suggests an effect of the dietary intake at sub-genus level highlighting a possible different strain-dependent effect on gut. Patients with adherence to the given dietary recommendations showed a significant reduction in inflammatory variables and pro-inflammatory microbiota with respect to non-adherents.
Background. The Multiple Sclerosis Walking Scale (MSWS-12) has showed good psychometric propertie... more Background. The Multiple Sclerosis Walking Scale (MSWS-12) has showed good psychometric properties in reports exploring its validity using Classical Test Theory methods. Findings from recent studies using Item Response Theory methods advance the idea that some aspects of the MSWS-12 does not fully comply with some requirements of sound measurement. Research question. The present study investigated whether the measurement properties of the Italian version of the MSWS-12 met the assumptions of the Rasch model. Methods. Sample consisted of 199 patients with a diagnosis of MS (50% female; Mean age (SD) = 48.15 (12.33)). Analyses were performed using both unidimensional and multidimensional Rasch modeling techniques. Results. Rating scale for items assessing need for support when walking, and ability to run, showed significant functioning problems. A revision of the rating scale improved the measurement properties of these items. Items assessing need for support showed signs of multidimensionality and differential item functioning when controlling for patients' disease course and EDSS score. Additionally, included items did not appear to cover the full range of impairment as observed in the sample. Significance. Emerging findings are consistent with those from previous studies in highlighting the need for a revision of the current content of the MSWS-12, and the inclusion of new items assessing impairment at the lower end of the disability continuum.
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