Bland and Altman agreement method: to plot differences against means or differences against standard? An endless tale?

OBJECTIVES: In the Bland and Altman analysis of agreement studies, there is some controversy whether "to plot the differences between the Standard/actual measurement method and the test/new measurement method against their mean" or "to plot the differences against the standard method". Of course, this is not just a "graphic dispute" as a regression model is inherent in the graphical choice to test the proportional and systematic biases. METHODS: We revised two relevant papers claiming to plot the differences against the standard and outlined their pitfalls taking into account the underlying statistical methodology. Furthermore, we have considered the conditions (correlation between the two measurement methods and ratio of their variances) leading correlation coefficient and regression slope between differences and means or differences and standard different from zero. RESULTS: We have shown the situations in which the regression slope and the correlation coefficient calculated from the differences and means according to Bland and Altman approach or calculated from the differences and standard are closer to zero giving the minimum possible value of spurious proportional error between the two methods. CONCLUSIONS: We highlighted how the calculation of the expected values of the correlation coefficients and, above all, of the regression slope can be very useful for choosing the statistical model in the context of an agreement study between two measurement methods. Finally, we outlined some recommendations for understanding the real possibility of carrying out agreement or calibration studies.

Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study.

BACKGROUND: Monoclonal antibodies (mAbs) and antivirals have been approved for early therapy of coronavirus disease (COVID-19), however, in the real-life setting, there are difficulties to prescribe these therapies within few days from symptom onset as recommended, and effectiveness of combined use of these drugs have been hypothesised in most-at-risk patients (such as those immunocompromised) but data supporting this strategy are limited. METHODS: We describe the real-life experience of SARS-CoV-2 antivirals and/or monoclonal antibodies (mAbs) and focus on the hospitalisation rate due to the progression of COVID-19. Clinical results obtained through our risk-stratification algorithm and benefits achieved through a strategic proximity territorial centre are provided. We also report a case series with an in-depth evaluation of SARS-CoV-2 genome in relationship with treatment strategy and clinical evolution of patients. RESULTS: Two hundred eighty-eight patients were analysed; 94/288 (32.6%) patients were treated with mAb monotherapy, 171/288 (59.4%) patients were treated with antivirals, and 23/288 (8%) patients received both mAbs and one antiviral drug. Haematological malignancies were more frequent in patients treated with combination therapy than in the other groups (p = 0.0003). There was a substantial increase in the number of treated patients since the opening of the centre dedicated to early therapies for COVID-19. The provided disease-management and treatment appeared to be effective since 98.6% patients recovered without hospital admission. Moreover, combination therapy with mAbs and antivirals seemed successful because all patients admitted to the hospital for COVID-19 did not receive such therapies, while none of the most-at-risk patients treated with combination therapy were hospitalized or reported adverse events. CONCLUSIONS: A low rate of COVID-19 progression requiring hospital admission was observed in patients included in this study. The dedicated COVID-19 proximity territorial service appeared to strengthen the regional sanitary system, avoiding the overwhelming of other services. Importantly, our results also support early combination therapy: it is possible that this strategy reduces the emergence of escape mutants of SARS-CoV-2, thereby increasing efficacy of early treatment, especially in immunocompromised individuals.

Factors associated with lifetime suicide attempts in bipolar disorder: results from an Italian nationwide study.

The purpose of the present study was to detect demographic and clinical factors associated with lifetime suicide attempts in Bipolar Disorder (BD). A total of 1673 bipolar patients from different psychiatric departments were compared according to the lifetime presence of suicide attempts on demographic/clinical variables. Owing to the large number of variables statistically related to the dependent variable (presence of suicide attempts) at the univariate analyses, preliminary multiple logistic regression analyses were realized. A final multivariable logistic regression was then performed, considering the presence of lifetime suicide attempts as the dependent variable and statistically significant demographic/clinical characteristics as independent variables. The final multivariable logistic regression analysis showed that an earlier age at first contact with psychiatric services (odds ratio [OR] = 0.97, p < 0.01), the presence of psychotic symptoms (OR = 1.56, p < 0.01) or hospitalizations (OR = 1.73, p < 0.01) in the last year, the attribution of symptoms to a psychiatric disorder (no versus yes: OR = 0.71, partly versus yes OR = 0.60, p < 0.01), and the administration of psychoeducation in the last year (OR = 1.49, p < 0.01) were all factors associated with lifetime suicide attempts in patients affected by BD. In addition, female patients resulted to have an increased association with life-long suicidal behavior compared to males (OR: 1.02, p < 0.01). Several clinical factors showed complex associations with lifetime suicide attempts in bipolar patients. These patients, therefore, require strict clinical monitoring for their predisposition to a less symptom stabilization. Future research will have to investigate the best management strategies to improve the prognosis of bipolar subjects presenting suicidal behavior.

Bone Strain Index: preliminary distributional characteristics in a population of women with normal bone mass, osteopenia and osteoporosis.

PURPOSE: Bone Strain Index (BSI) is a recently developed dual-energy X-ray absorptiometry (DXA) software, applying a finite element analysis on lumbar spine and femoral DXA scans. BSI is a parameter of bone deformation, providing information on bone resistance to applied loads. BSI values indicate the average bone strain in the explored site, where a higher strain (higher BSI values) suggests a higher fracture risk. This study reports the distributional characteristics of lumbar BSI (L-BSI) in women with normal bone mass, osteopenia or osteoporosis and their relationships with BMD, weight, height and BMI. MATERIAL AND METHODS: Two-hundred-fifty-nine consecutive unfractured women who performed DXA were divided into three groups based on BMD T-score: normal bone mass (n = 43, 16.6%), osteopenia (n = 82, 31.7%) and osteoporosis (n = 134, 51.7%). The distribution of L-BSI was evaluated with conventional statistical methods, histograms and by calculating parametric and nonparametric 95% confidence intervals, together with the 90%, 95% and 99% bilateral tolerance limits with a 95% confidence. RESULTS: Ninety percent bilateral tolerance limits with 95% confidence for L-BSI distribution are 1.0-2.40, 0.95-2.63 and 0.84-3.15 in the group of patients with normal bone mass, 1.34-2.78, 1.24-2.95 and 1.05-3.32 in the osteopenic group and 1.68-3.79, 1.58-4.15 and 1.40-4.96 in the osteoporotic group. CONCLUSION: In women without vertebral fractures at baseline, L-BSI values from 1.68 (osteoporotic group) and 2.40 (upper of the normal bone mass group) can be tentatively chosen as a lower and upper threshold to stratify postmenopausal women according to their bone resistance to loads.

Usefulness of Dual X-ray Absorptiometry-Derived Bone Geometry and Structural Indexes in Mastocytosis.

Reduced bone mass with or without fragility fractures is a common feature of mastocytosis, particularly in adult males. However, bone mineral density does not account for all the fragility fractures, being a part of them attributable to impairment in bone quality. Aim of this study is to assess the usefulness of DXA-derived geometry and structural indexes in the assessment of bone status in mastocytosis. Ninety-six consecutive patients (46 women and 50 men) affected by cutaneous (CM) or systemic (SM) mastocytosis were studied. Mean age (± SD) was 53.3 ± 14.23. Spine lateral X-rays for Genant's scale, DXA for lumbar (L) and femoral (F) bone mineral density (BMD), bone strain index (BSI), lumbar trabecular bone score (TBS), and hip structural analysis (HSA) were performed. Among the laboratory variables, data of serum tryptase were reported. Tryptase was higher in SM (p = 0.035), inversely correlated with LBMD (r = - 0.232; p = 0.022) and TBS (r = - 0.280; p = 0.005), and directly with L-BSI (r = 0.276; p = 0.006). L-BSI remained statistically significant (p = 0.006; adjusted R2 = 0.101) together with mastocytosis (SM or CM: p = 0.034) in the multivariate regression model with tryptase as dependent variable, being LBMD and TBS not statistically significant (p = 0.887, and p = 0.245, respectively). Tryptase increased about 22 units for each unit increase of L-BSI and about 18 units for SM against CM. L-BSI was lower (p = 0.012), while FN-BSI and FT-BSI were higher in women (p < 0.001) than in men. HSA indexes were significantly higher in men, particularly with SM. SM is a risk factor for reduced bone mass, texture and strength. Since mean L-BSI and Z-modulus of all the femoral sites are statistically higher in men than in female, it could be argued that men have a better femoral bone resistance to bending forces than women, but a worse lumbar bone resistance to compressive loads. DXA indexes of bone quality are useful in mastocytosis' bone assessment and its clinical management.

Respiratory Mechanics, Lung Recruitability, and Gas Exchange in Pulmonary and Extrapulmonary Acute Respiratory Distress Syndrome.

OBJECTIVES: Acute respiratory distress syndrome is a clinical syndrome characterized by a refractory hypoxemia due to an inflammatory and high permeability pulmonary edema secondary to direct or indirect lung insult (pulmonary and extrapulmonary form). Aim of this study was to evaluate in a large database of acute respiratory distress syndrome patients, the pulmonary versus extrapulmonary form in terms of respiratory mechanics, lung recruitment, gas exchange, and positive end-expiratory pressure response. DESIGN: A secondary analysis of previously published data. PATIENTS: One-hundred eighty-one sedated and paralyzed acute respiratory distress syndrome patients (age 60 yr [46-72 yr], body mass index 25 kg/m [22-28 kg/m], and PaO2/FIO2 184 ± 66). INTERVENTIONS: Lung CT scan performed at 5 and 45 cm H2O. Two levels of positive end-expiratory pressure (5 and 15 cm H2O) were randomly applied. MEASUREMENTS AND MAIN RESULTS: Ninety-seven and 84 patients had a pulmonary and extrapulmonary acute respiratory distress syndrome. The median time from intensive care admission to the CT scan and respiratory mechanics analysis was 4 days (interquartile range, 2-6). At both positive end-expiratory pressure levels, pulmonary acute respiratory distress syndrome presented a significantly lower PaO2/FIO2 and higher physiologic dead space compared with extrapulmonary acute respiratory distress syndrome. The lung and chest wall elastance were similar between groups. The intra-abdominal pressure was significantly higher in extrapulmonary compared with pulmonary acute respiratory distress syndrome (10 mm Hg [7-12 mm Hg] vs 7 mm Hg [5-8 mm Hg]). The lung weight and lung recruitability were significantly higher in pulmonary acute respiratory distress syndrome (1,534 g [1,286-1,835 g] vs 1,342 g [1,090-1,507 g] and 16% [9-25%] vs 9% [5-14%]). CONCLUSIONS: In the early stage, pulmonary acute respiratory distress syndrome is characterized by a greater impairment of gas exchange and higher lung recruitability. The recognition of the origin of acute respiratory distress syndrome is important for a more customized ventilatory management.

Gender-related differences in patients with bipolar disorder: a nationwide study.

OBJECTIVE: The possible presence of gender-related differences in patients with bipolar disorder (BD) may have diagnostic and therapeutic implications. This multicenter study aimed to investigate gender differences in BD in the largest Italian database collected to date, on behalf of the Italian Chapter of the International Society of Bipolar Disorders. METHODS: A total of 1674 patients (males: n = 714; females: n = 960) from different psychiatric departments were compared according to gender on demographic/clinical variables. Owing to the large number of variables statistically related to the dependent variable (gender) at the univariate analyses, preliminary multiple logistic regression analyses were performed. A final multivariable logistic regression was then performed, considering gender as the dependent variable and statistically significant demographic/clinical characteristics as independent variables. RESULTS: The results of the final multivariable logistic regression analysis with previous statistically significant demographic and clinical variables were the following: female gender was less frequently associated with employment (odds ratio [OR] = 0.7, P < 0.01), lifetime single marital status (OR = 0.45, P < 0.01), and substance abuse in the last year (OR = 0.35, P < 0.01), whereas it was more frequently associated with a major number of lifetime major depressive episodes (OR = 1.78, P < 0.01) and psychiatric visits in the last year (OR = 1.38, P = 0.01). CONCLUSION: Few significant differences were found between genders in BD, particularly for those clinical features that are associated with poor prognosis (substance abuse for males and number of depressive episodes for females). Transcultural studies are needed to identify cultural versus illness-related variables possibly explaining the different clinical presentation of BD in relation to gender.

Psychotic versus non-psychotic bipolar disorder: Socio-demographic and clinical profiles in an Italian nationwide study.

OBJECTIVE: Psychotic versus non-psychotic patients with bipolar disorder have been traditionally associated with different unfavorable clinical features. In this study on bipolar Italian patients, we aimed to compare clinical and demographic differences between psychotic and non-psychotic individuals, exploring clinical factors that may favor early diagnosis and personalized treatment. METHODS: A total of 1671 patients (males: n = 712 and females: n = 959; bipolar type 1: n = 1038 and bipolar type 2: n = 633) from different psychiatric departments were compared according to the lifetime presence of psychotic symptoms in terms of socio-demographic and clinical variables. Chi-square tests for qualitative variables and Student's t-tests for quantitative variables were performed for group comparison, and a multivariable logistic regression was performed, considering the lifetime psychotic symptoms as dependent variables and socio-demographic/clinical characteristics as independent variables. RESULTS: Psychotic versus non-psychotic bipolar subjects resulted to: be more frequently unemployed (p < 0.01) and never married/partnered (p < 0.01); have an earlier age at onset (p < 0.01); more frequently receive a first diagnosis different from a mood disorder (p < 0.01); have a shorter duration of untreated illness (p < 0.01); have a more frequently hypomanic/manic prevalent polarity (p < 0.01) and a prevalent manic-depressive type of cycling (p < 0.01); present a lower lifetime number of depressive episodes (p < 0.01), but have more manic episodes (p < 0.01); and less insight (p < 0.01) and more hospitalizations in the last year (p < 0.01). Multivariable regression analysis showed that psychotic versus non-psychotic bipolar patients received more frequently a first diagnosis different from bipolar disorder (odds ratio = 0.64, 95% confidence interval = [0.46, 0.90], p = 0.02) or major depressive disorder (odds ratio = 0.66, 95% confidence interval = [0.48, 0.91], p = 0.02), had more frequently a prevalent manic polarity (odds ratio = 1.84, 95% confidence interval = [1.14, 2.98], p < 0.01) and had a higher number of lifetime manic episodes (more than six) (odds ratio = 8.79, 95% confidence interval = [5.93, 13.05], p < 0.01). CONCLUSION: Lifetime psychotic symptoms in bipolar disorder are associated with unfavorable socio-demographic and clinical features as well as with a more frequent initial misdiagnosis.

Morphological and clinical characteristics of myopic posterior staphyloma in Caucasians.

PURPOSE: We aimed to study the morphological characteristics of myopic posterior staphyloma in Caucasians and to evaluate the correlation between posterior staphyloma, myopic macular lesions and visual acuity. METHODS: Ninety eyes of 67 consecutive patients affected by high myopia associated with posterior staphyloma were recruited between January 2012 and December 2013. Posterior staphyloma was classified according to Curtin's criteria. Every patient underwent fundoscopic examination and best corrected visual acuity measurement (BCVA). A and B-scan ultrasound (US), high-resolution, three-dimensional magnetic resonance image (MRI), optical coherence tomography (OCT), fundus autofluorescence (FAF), red free (RF) and color fundus photography studies were performed. RESULTS: The mean age was 64.4 ± 9.48 years (range: 41-82). The mean BCVA was 0.7 ± 0.5 logMAR (range: 0-2). The mean axial length was 29.92 ± 2.39 millimeters (range: 24.25-36.53). The authors found four types of posterior staphyloma according to Curtin's classification: I, II, IV and IX. Significant prevalence of posterior staphyloma in female sex was observed (p = 0.0235). Significant correlation between the depth and the diameters of posterior staphyloma was demonstrated (p < 0.0001). Significant association between posterior staphyloma type and tomographic foveal patterns (p = 0.0230) was highlighted. Posterior staphyloma type I was more frequently associated with peripapillary atrophy and less with macular atrophy compared to type II and IX (p = 0.0169). The prevalence of macular atrophy was more than double in posterior staphyloma type II (33.3 %) in comparison to posterior staphyloma type I (12.5 %). CONCLUSIONS: This study confirms that the type I and II are the most common types of posterior staphyloma, as already highlighted in the literature. A significant association between the type of posterior staphyloma and the MRI ocular shape pattern, the OCT patterns of macular profile and the location of chorioretinal atrophy was highlighted. The correlation between the depth and the width of posterior staphyloma has demonstrated that the deeper the staphyloma, the wider it was. The deepest area of the posterior staphyloma was characterized by a greater thinning of the sclera and by a higher prevalence of chorioretinal atrophy compared to the other parts of the eye. More studies are necessary to support our findings and to add more information on the natural evolution of posterior staphyloma and on its associated complications.

Effects and outcome of a policy of intermittent imatinib treatment in elderly patients with chronic myeloid leukemia.

We report a study of an alternative treatment schedule of imatinib (IM) in chronic myeloid leukemia (CML). Seventy-six Philadelphia-positive (Ph+), BCR-ABL-positive patients aged 65 years or older who had been treated with IM for more than 2 years and who were in stable complete cytogenetic response (CCgR) and major molecular response (MMR) were enrolled in a single-arm study to test the effects of a policy of intermittent IM (INTERIM) therapy for 1 month on and 1 month off. With a minimum follow-up of 4 years, 13 patients (17%) lost CCgR and MMR and 14 (18%) lost MMR only. All these patients resumed continuous IM and all but one (lost to follow-up) regained CCgR and MMR. No patients progressed to accelerated or blastic phase or developed clonal chromosomal abnormalities in Ph+ cells or BCR-ABL mutations. In elderly Ph+ CML patients carefully selected for a stable CCgR (lasting >2 years), the policy of INTERIM treatment affected the markers of residual disease, but not the clinical outcomes (overall and progression-free survival). This trial was registered at www.clinicaltrials.gov as NCT 00858806.

Cystoid macular edema after pars plana vitrectomy for idiopathic epiretinal membrane.

BACKGROUND: To evaluate the incidence of cystoid macular edema (CME) after 23-gauge pars plana vitrectomy (PPV) with or without combined cataract surgery for the treatment of idiopathic epiretinal membrane (ERM). METHODS: Retrospective, non-comparative, interventional case series. Data included patient age, indication for surgery, and intra- and post-operative complications. The follow-up lasted 1 year. Best-corrected visual acuity (BCVA logMAR), central foveal thickness (CFT micron-µ) and the incidence of intra-retinal cysts were evaluated. CME was defined as post-operative observation of intra-retinal cysts at optical coherence tomography, preventing improvement or causing reduction of BCVA when compared to the pre-operative value. Statistical analysis was performed to identify the risk factors of CME. RESULTS: Two hundred and forty two eyes of 242 patients underwent PPV for the treatment of idiopathic ERM. Statistical analysis showed that the presence of preoperative intra-retinal cysts were associated with persistent CME following surgery (odds ratio 3.89; 95%CI: 1.63-9.28, P = 0.0004). However, postoperative CME occurred in 10 % of eyes that did not show preoperative CME. In addition, there was a significant correlation between the baseline value of CFT and the values of CFT at each time point during the follow up (p < 0.0001), with greater values of the pre-operative thickness correlating to greater values of post-operative thickness. CONCLUSIONS: Persistent or new CME following surgery for idiopathic ERM are frequently identified after PPV for ERM. The statistical results of the current study suggest that intraretinal cysts and increased preoperative CFT are associated with reduced visual acuity after surgery.

The progression trajectory of Bipolar Disorder: Results from the application of a staging model over a ten-year observation.

BACKGROUND: Trying to better define Bipolar Disorder (BD) progression, different staging models have been conceptualized, each one emphasizing different aspects of illness. In a previous article we retrospectively applied the main staging models to a sample of 100 bipolar patients at four time points over a ten-year observation. In the present study, focusing on Kupka & Hillegers's model, we aimed to assess the transition of the same sample through the different stages of illness and to explore the potential role of clinical variables on the risk of progression. METHODS: Multistate Model using the mstate package in R and Markov model with stratified hazards were used for statistical analysis. RESULTS: A high hazard of transition from stage 2 to 3 emerged, with a probability of staying in stage 2 decreasing to 14 % after 3 years. BD II and depressive predominant polarity were significantly associated with transition from stage 1 to 2, whereas the number of lifetime episodes >3 and the elevated predominant polarity with transition from stage 3 to 4. CONCLUSION: Our results corroborated the evidence on BD progression and contributed to outline its trajectory over time. Further effort may help to define a standardized staging approach towards ever increasing tailored interventions.

Utility, acceptability and applicability of a nucleic acid amplification test in comparison with a syndromic approach in the management of sexually transmitted diseases at Mulago National Referral Hospital in Uganda (ASTRHA): protocol for an open-label, randomised controlled trial.

INTRODUCTION: Sexually transmitted diseases (STDs) are a major cause of long-term disability. Urethral discharge syndrome (UDS), abnormal vaginal discharge (AVD) and genital ulcer disease (GUD) are very common in low-income and middle-income countries (LMICs), where, due to lack of resources, these infections are managed according to a syndromic approach. Although microbiological diagnosis using nuclear acid amplification tests (NAAT) is already a standard to prescribe targeted treatments in industrialised countries, no randomised clinical trials have been conducted to evaluate clinical usefulness and acceptability of NAAT in comparison with syndromic approach in LMICs. The results of this study could inform diagnostic guidelines since they may suggest an update of the current recommendation if microbiological diagnosis using NAAT in the management of STD is demonstrated to be both useful and acceptable in an LMIC context. METHODS AND ANALYSIS: The primary objective of this randomised, open-label trial is to evaluate the clinical usefulness of a NAAT and its acceptability in comparison with a clinical syndromic approach and to explore whether this test could replace the syndromic approach in the management of STDs at a national referral hospital in Uganda. 220 patients presenting to the STD clinic at Mulago Hospital in Kampala, Uganda with AVD, UDS or GUD will be randomised to either standard of care (syndromic management) or NAAT-based treatment with a 1:1 ratio. All the patients will be asked to return after 2 or 3 weeks for a control visit. Primary outcome will be therapeutic appropriateness. ETHICS AND DISSEMINATION: This trial was approved by the Mulago Hospital Research and Ethical Committee (MHREC2023-97) and the Uganda National Council for Science and Technology (HS31000ES). Patients will give informed consent to participate before taking part in the study. Results will be published in peer-reviewed journals in open-access formats and data made available in anonymised form. TRIAL REGISTRATION NUMBER: NCT05994495.

Predictors of Nursing Home Placement in a Cohort of European People with Alzheimer's Disease and Other Dementia Cases Enrolled in SCU-B or Non SCU-B Centers: The RECage Study.

Background: Nursing home placement (NHP) can be the final step of patients with Alzheimer's disease. Objective: We aimed to identify NHP predictors among 508 people with dementia with a 3-year follow-up. Methods: We analyzed data from the international observational RECage study, involving 508 people with especially Alzheimer's disease and comparing a cohort enrolled by five centers with a Special Care Unit for BPSD (behavioral and psychological symptoms of dementia) and another one enrolled by six centers lacking this facility. The tertiary objective of the study was to assess the possible role of the SCU-B in delaying NHP. We assessed the relationship of the baseline characteristics with NHP by means of univariate analysis followed by Cox's multivariate model. Results: Patients' mean age was 78.1 years, 54.9% were women. Diagnosis mean age was 75.4 (±8.32) years; the main diagnosis was Alzheimer's disease (296; 58.4%). During follow-up, 96 (18.9%) patients died and 153 (30.1%) were institutionalized without a statistically significant difference between the two cohorts (p = 0.9626). The mean NHP time was 902 (95% CI: 870-934). The multivariable analysis without death as a competing risk retained four independent predictors of NHP: age increase (hazard ratio (HR) = 1.023, 95% CI: 1.000-1.046), patient education level increase (HR = 1.062, 95% CI: 1.024-1.101), Neuropsychiatric Inventory total increase (HR = 1.018; 95% CI: 1.011-1.026), and total Mini-Mental State Examination as a favorable factor (HR = 0.948, 95% CI: 0.925-0.971). Gender (females versus males: HR = 1.265, 95% CI: 0.899-1.781) was included in the final Cox's model for adjusting the estimates for. Conclusions: Our data partially agree with the predictors of NHP in literature including the effect of high education level. No caregivers' factors were statistically significant. Clinical trial registration: NCT03507504.

Stroke-Unit and emergency medical service: a 48-month experience in northern Italy.

Since the therapeutic window for acute ischaemic stroke is very short, early arrival at emergency care rooms is mandatory. Emergency medical service (EMS), assuring fast patients transportations, plays a fundamental role in the management of stroke. We have prospectively analysed the utilisation of EMS in the management of stroke patients in a countryside area of northern Italy. Among patients presenting with an acute stroke during the period January 2007-December 2010, those with an ascertained time of onset and documented ongoing brain ischaemia at neuroimaging were included in the study. For all of those patients, the personal data, means of arrival, nature of stroke, whether first stroke or recurrence, severity of stroke and the in-hospital outcome were recorded. Of 1,188 patients hospitalised with a definite diagnosis of stroke, 757 patients were included in the study. Of those, 285 patients (37.6 %) were transported by EMS. EMS allowed earlier admissions (75 % within 3 h of stroke onset), but also transportation of patients of an older age (75 vs. 71 years, p < 0.001), and with more severe strokes (62 % of total anterior circulation infarctions). Our study confirms that EMS is essential in delivering the earliest therapy to patients with acute cerebral infarction living in an extra-urban area of northern Italy. However, work is needed in optimising EMS, since transported patients are often not prone to therapy.

Staging models applied in a sample of patients with bipolar disorder: Results from a retrospective cohort study.

BACKGROUND: Bipolar Disorder (BD) is a life-long illness with compelling evidence of progression. Although different staging models have been proposed to evaluate its course, clinical data remain limited. The aim of the present study was to retrospectively assess applicability of available staging approaches and their pattern of progression in a sample of bipolar patients. METHODS: In a naturalistic sample of 100 BD patients, retrospective assessment of clinical stages was performed at four time points over 10 years, according to four staging models. Staging progression with potential associations between stages and unfavourable illness characteristics were analyzed. RESULTS: A pattern of stage worsening emerged for each model, with a significant increase at every time point. Greater stage increases emerged in patients with lower educational level, age at first elevated episode ≤35 years, duration of illness ≤25 years, and duration of untreated illness ≤5 years. Lower stage values were associated with BD II, no psychiatric hospitalization, depressive onset and predominant polarity, ≤three lifetime episodes, age at first mood stabilizer >40 years, duration of illness ≤25 years, and engaged/employed status. Higher stage values were associated with lower age at first elevated episode and mood stabilizing treatment instead. LIMITATIONS: Naturalistic and retrospective design, recruitment at a 2nd level specialistic clinic. CONCLUSIONS: Reported findings support the progressive nature of BD and the application of staging models for early intervention, suggesting a conceptualization of a standardized approach to better characterize patients, predict their clinical course, and deliver tailored treatment options.

A Confirmatory and an Exploratory Factor Analysis of the Cohen-Mansfield Agitation Inventory (CMAI) in a European Case Series of Patients with Dementia: Results from the RECage Study.

BACKGROUND: One of the most widely used instruments for assessing agitation in dementia patients is the Cohen-Mansfield Agitation Inventory (CMAI), nevertheless no global score has been proposed. The aim of this study is: (a) to conduct a confirmatory (CFA) and exploratory factor analysis (EFA) of CMAI on people with dementia and Psychological and Behavioral Symptoms (BPSD), and (b) to propose an alternative structure, based on clinical criteria including all CMAI items. METHODS: Confirmatory and exploratory factor analyses were carried out on the CMAI 29 items administered at baseline to 505 patients with dementia (PwD) and BPSD enrolled in the international observational RECage study. RESULTS: The three-factor structure has not been confirmed by the CFA, whilst the EFA was carried out respectively on 25 items disregarding 4 items with a prevalence ≤5% and then on 20 items disregarding 9 items with a prevalence ≤10%. The four-factor structure explaining 56% of the variance comprised Physically Aggressive behavior, Verbally Aggressive behavior, Physically non-aggressive behavior, and Physically and verbally aggressive behavior. CONCLUSIONS: A new grouping of all items according to a clinical criterion is proposed, allowing for a more sensible evaluation of the symptoms leading to better differentiation.