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Primary diffuse large B-cell lymphoma of the primary central nervous system (CNS-DLBCL) is an aggressive disease, with dismal prognosis despite the use of high-dose methotrexate-based polychemotherapy. Our study aimed to expand the biologic profiles of CNS-DLBCL and to correlate them with clinical/imaging findings to gain diagnostic insight and possibly identify new therapeutic targets. We selected 61 CNS-DLBCL whose formalin-fixed paraffin-embedded samples were available at first diagnosis. These were investigated by immunohistochemistry, cMYC rearrangements were explored by fluorescence in situ hybridization, and CNS-DLBCL mutated genes were evaluated by next-generation sequencing. CD10, BCL6, and IRF4 were observed in 16%, 83.6%, and 93% of cases, respectively. As typical of CNS lymphoma, 10 (16.4%) of 61 cases were classified as germinal center (GCB) type and 51 (83.6%) of 61 as non-germinal center (non-GCB) type according to the Hans algorithm. Double-expression status for BCL2 and cMYC was detected in 36 (59%) of 61 cases whereas 25 (41%) of 61 were non-DE. Rearrangement of the cMYC gene was detected in 2 cases, associated with BCL6 translocation only in 1 case MYD88, PIM1, CD79B, and TP53 were mutated in 54.5%, 53.5%, 30.2%, and 18.4% cases, respectively. Novel mutations not previously reported in CNS-DLBCL were found: AIP in 23.1%, PI3KCA in 15%, NOTCH1 in 11.4%, GNAS in 8.1%, CASP8 in 7.9%, EGFR in 6.4%, PTEN in 5.1, and KRAS in 2.6% of cases. Survival was significantly longer for patients with mutated MYD88 (8.7 months vs 1.7 months; log-rank test = 5.43; P = .020) and for patients with mutated CD79B (10.8 months vs 2.5 months; log-rank test = 4.64; P = .031). MYD88 and CD79B predicted a longer survival in patients affected by CNS-DLBCL. Notably, we identified novel mutations that enrich the mutational landscape of CNS-DLBCL, suggest a role of PTEN-PI3K-AKT and receptor tyrosine kinase-RAS-mitogen-activated protein kinase signaling in a subset of CNS-DLBCL, and provide new potential therapeutic targets.
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Linfoma Difuso de Grandes Células B , Fator 88 de Diferenciação Mieloide , Humanos , Hibridização in Situ Fluorescente , Fator 88 de Diferenciação Mieloide/genética , Fator 88 de Diferenciação Mieloide/metabolismo , Fosfatidilinositol 3-Quinases/genética , Linfoma Difuso de Grandes Células B/tratamento farmacológico , Linfoma Difuso de Grandes Células B/genética , Linfoma Difuso de Grandes Células B/patologia , Sistema Nervoso Central/metabolismo , Sistema Nervoso Central/patologia , Prognóstico , GenômicaRESUMO
BACKGROUND: Preterm infants are at enhanced risk of brain injury due to altered cerebral haemodynamics during postnatal transition. This observational study aimed to assess the clinical determinants of transitional cerebrovascular reactivity and its association with intraventricular haemorrhage (IVH). METHODS: Preterm infants <32 weeks underwent continuous monitoring of cerebral oxygenation and heart rate over the first 72 h after birth. Serial cranial and cardiac ultrasound assessments were performed to evaluate the ductal status and to diagnose IVH onset. The moving correlation coefficient between cerebral oxygenation and heart rate (TOHRx) was calculated. Linear mixed-effect models were used to analyse the impact of relevant clinical variables on TOHRx. The association between TOHRx and IVH development was also assessed. RESULTS: Seventy-seven infants were included. A haemodynamically significant patent ductus arteriosus (hsPDA) (ß = 0.044, 95% CI: 0.007-0.081) and ongoing dopamine treatment (ß = 0.096, 95% CI: 0.032-0.159) were associated with increasing TOHRx, indicating impaired cerebrovascular reactivity. A significant association between TOHRx, mean arterial blood pressure (ß = -0.004, 95% CI: -0.007, -0.001) and CRIB-II score (ß = 0.007, 95% CI: 0.001-0.015) was also observed. TOHRx was significantly higher in infants developing high-grade IVH compared to those without IVH. CONCLUSIONS: Dopamine treatment, low blood pressure, hsPDA and high CRIB-II are associated with impaired cerebrovascular reactivity during postnatal transition, with potential implications on IVH development. IMPACT: The correlation coefficient between cerebral oxygenation and heart rate (TOHRx) provides a non-invasive estimation of cerebrovascular reactivity, whose failure has a potential pathogenic role in the development of IVH in preterm infants. This study shows that cerebrovascular reactivity during the transitional period improves over time and is affected by specific clinical and therapeutic factors, whose knowledge could support the development of individualized neuroprotective strategies in at-risk preterm infants. The evidence of increased TOHRx in infants developing high-grade compared to low-grade or no IVH during the transitional period further supports the role of impaired cerebrovascular reactivity in IVH pathophysiology.
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Permeabilidade do Canal Arterial , Doenças do Prematuro , Hemorragia Cerebral , Circulação Cerebrovascular/fisiologia , Dopamina , Feminino , Retardo do Crescimento Fetal , Humanos , Lactente , Recém-Nascido , Recém-Nascido PrematuroRESUMO
The Italian National Healthcare Service relies on per capita allocation for healthcare funds, despite having a highly detailed and wide range of data to potentially build a complex risk-adjustment formula. However, heterogeneity in data availability limits the development of a national model. This paper implements and ealuates machine learning (ML) and standard risk-adjustment models on different data scenarios that a Region or Country may face, to optimize information with the most predictive model. We show that ML achieves a small but generally statistically insignificant improvement of adjusted R2 and mean squared error with fine data granularity compared to linear regression, while in coarse granularity and poor range of variables scenario no differences were observed. The advantage of ML algorithms is greater in the coarse granularity and fair/rich range of variables set and limited with fine granularity scenarios. The inclusion of detailed morbidity- and pharmacy-based adjustors generally increases fit, although the trade-off of creating adverse economic incentives must be considered.
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Programas Nacionais de Saúde , Risco Ajustado , Algoritmos , Humanos , Itália , Modelos LinearesRESUMO
INTRODUCTION: Six in ten patients with obsessive-compulsive disorder (OCD) do not respond to the first-line treatments with serotonin reuptake inhibitor (SRI) or cognitive behavioural therapy including exposure and response prevention (CBT/ERP), and several do not respond to second-line treatments, i.e., SRI-second generation antipsychotic (SGA) or SRI-CBT/ERP augmentation. Evidence on third-line treatments is inconsistent. OBJECTIVE: We investigated the 1-year response to SRI-CBT/ERP-SGA combination in patients with severe treatment-resistant OCD, who failed to respond to SRI and to SRI-SGA or SRI-CBT/ERP augmentation. METHODS: Twenty-eight patients were consecutively recruited and treated with SRI (drug(s) and doses previously administered), SGA (risperidone median dosage 1 mg/day in 14 cases, aripiprazole median dosage 3 mg/day in 14 cases) and CBT/ERP (median hours 32.5). Exclusion criteria: mental retardation and organic brain syndrome. RESULTS: The mean Y-BOCS total score reduction at 12 months was 28.2%, 60.7% of patients improved, 46.4% partially responded, 32.1% responded, and 28.6% remitted. Patients previously resistant to SRI-SGA and SRI-CBT/ERP did not significantly differ in the rates of improvement, partial response, response and remission. CONCLUSIONS: This study suggests that SRI-SGA-CBT/ERP combination could be useful for severe treatment-resistant OCD. Small sample size is a limitation.Key pointsUp to 6 in 10 patients with OCD do not respond to first line treatments (CBT/ERP or SRIs) and several to second-line treatments (SRI-SGA or SRI CBT/ERP augmentation).In our study, patients with OCD resistant to the first and the second line treatment improved (61%), partially responded (46%), responded (32%), or remitted (29%) combining SRI, SGA and CBT/ERP.In our patients the SRI-SGA-CBT/ERP augmentation improved working/school, social and family impairment.SRI-SGA-CBT/ERP augmentation is easier to use than other treatments for severe treatment-resistant OCD.
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Antipsicóticos , Terapia Cognitivo-Comportamental , Transtorno Obsessivo-Compulsivo , Humanos , Inibidores Seletivos de Recaptação de Serotonina , Antipsicóticos/efeitos adversos , Resultado do Tratamento , Resistência a Medicamentos , Transtorno Obsessivo-Compulsivo/tratamento farmacológico , Transtorno Obsessivo-Compulsivo/psicologia , Risperidona , Quimioterapia CombinadaRESUMO
BACKGROUND AND OBJECTIVES: Pemphigus has been associated with physical and psychiatric comorbid diseases. This study aims to further investigate these associations in patients with pemphigus, and to analyze the relationships of comorbid conditions with sex and age, pemphigus disease area index score, diagnostic delay and cutaneous/mucous involvement. PATIENTS AND METHODS: Patients with pemphigus were matched by age, gender and area of residence with eight controls each. The odds of comorbid conditions in patients vs. matched controls was determined using univariate conditional logistic regression models. Comorbid diseases significantly associated with the diagnosis of pemphigus at P < 0.05 in univariate models were subsequently included in a multivariable conditional logistic regression model with a forward procedure. RESULTS: The study sample included 163 patients with pemphigus. Cardiovascular diseases, hyperlipidemia, autoimmune thyroid disorders, dermatological autoimmune/inflammatory conditions and cancer were the most prominent conditions at the time of diagnosis. In the multiple conditional regression analysis, the two diagnoses independently associated with patients with pemphigus were cancer and dermatological autoimmune/inflammatory conditions. In sensitivity analyses excluding four patients with paraneoplastic pemphigus, these associations were still significant. CONCLUSIONS: Cancer and dermatological autoimmune/inflammatory conditions may represent possible triggering conditions for pemphigus and should be considered as early warning signs for the disease.
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Doenças Autoimunes , Pênfigo , Doenças Autoimunes/epidemiologia , Estudos de Casos e Controles , Comorbidade , Diagnóstico Tardio , Humanos , Pênfigo/diagnóstico , Pênfigo/epidemiologiaRESUMO
HINTERGRUND UND ZIELE: Pemphigus ist mit physischen und psychischen Erkrankungen assoziiert. Diese Studie soll derartige Zusammenhänge bei Patienten mit Pemphigus näher untersuchen sowie die Komorbidität nach Geschlecht, Alter, dem Pemphigus Disease Area Index, der Diagnoseverzögerung und der Beteiligung von Haut/Schleimhaut analysieren. PATIENTEN UND METHODEN: Jedem Pemphigus-Patienten wurden acht Kontrollen mit ähnlichem Alter, Geschlecht und Wohnsitz zugeordnet. Die Wahrscheinlichkeit für Begleiterkrankungen bei Patienten und Kontrollpersonen wurde anhand univariater konditionaler Regressionsmodelle bestimmt. Begleiterkrankungen, die in den univariaten Modellen mit P < 0,05 mit der Diagnose Pemphigus assoziiert waren, wurden dann in einem Vorwärtsverfahren in ein multivariates konditionales Regressionsmodell eingefügt. ERGEBNISSE: Die Studie umfasste 163 Patienten mit Pemphigus. Die hauptsächlichen Erkrankungen zum Diagnosezeitpunkt waren kardiovaskuläre Erkrankungen, Hyperlipidämie, Autoimmunerkrankungen der Schilddrüse, autoimmune/entzündliche Dermatosen und Krebs. In der multivariaten konditionalen Regressionsanalyse waren Krebs und autoimmune/entzündliche Dermatosen unabhängig mit Pemphigus assoziiert. In Sensitivitätsanalysen, in denen vier Patienten mit paraneoplastischem Pemphigus ausgeschlossen wurden, waren diese Assoziationen ebenfalls signifikant. SCHLUSSFOLGERUNGEN: Krebs und autoimmune/entzündliche Dermatosen sind möglicherweise auslösende Faktoren für Pemphigus dar und sollten als frühe Warnsignale für diese Erkrankung angesehen werden.
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AIMS: A wide range of post-radiotherapy (RT) vascular lesions can occur, ranging from benign lymphangiomatous papules of the skin (BLAPs), to atypical vascular lesions (AVLs) and post-RT angiosarcomas (ASs). The relationship between benign and malignant post-RT breast lesions and their prognostic features are still controversial. The aims of this study were to investigate the relationship between benign and malignant mammary post-RT vascular lesions and to define post-RT AS prognostic features. METHODS AND RESULTS: Seventy-four post-RT vascular lesion cases were obtained and stained with antibodies against CD34, CD31, D2-40, Ki67, and c-Myc. Mutational analysis was performed by deep sequencing for the following genes: KRAS, NRAS, HRAS, BRAF, PIK3CA, TP53, NOTCH1, PTEN, CDKN2A, EGFR, AKT1, CTNNB1, hTERT, and PTPRB. Post-RT AS cases were graded according to a previously reported breast AS grading system. AVL cases showed a low number of HRAS and hTERT mutations, whereas post-RT AS cases showed a high frequency of EGFR, TP53, HRAS and hTERT mutations. On follow-up, all BLAP and AVL patients were alive with no evidence of disease. Post-RT AS 5-year overall survival declined with the increase in grade, as follows: 85.7% for grade 1, 83.3% for grade 2, and 40.4% for grade 3. CONCLUSIONS: Our findings confirm that BLAP and AVL have a good prognosis, and that post-RT AS prognosis is strongly related to histological grading. On molecular analysis, AVL and post-RT AS shared HRAS and hTERT mutations, suggesting a relationship between the two lesions.
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Neoplasias Induzidas por Radiação/patologia , Radioterapia/efeitos adversos , Malformações Vasculares/patologia , Adulto , Idoso , Mama/patologia , Neoplasias da Mama/patologia , Análise Mutacional de DNA , Feminino , Seguimentos , Hemangiossarcoma/patologia , Humanos , Imuno-Histoquímica , Pessoa de Meia-Idade , Mutação , Gradação de Tumores , Oncogenes/genética , Fragmentos de Peptídeos/genética , Fragmentos de Peptídeos/metabolismo , Prognóstico , Proteínas Proto-Oncogênicas p21(ras)/genética , Proteínas Proto-Oncogênicas p21(ras)/metabolismo , Neoplasias Cutâneas/patologia , Telomerase/genética , Telomerase/metabolismoRESUMO
BACKGROUND: Administrative healthcare databases are widespread and are often standardized with regard to their content and data coding, thus they can be used also as data sources for surveillance and epidemiological research. Chronic dialysis requires patients to frequently access hospital and clinic services, causing a heavy burden to healthcare providers. This also means that these patients are routinely tracked on administrative databases, yet very few case definitions for their identification are currently available. The aim of this study was to develop two algorithms derived from administrative data for identifying incident chronic dialysis patients and test their validity compared to the reference standard of the regional dialysis registry. METHODS: The algorithms are based on data retrieved from hospital discharge records (HDR) and ambulatory specialty visits (ASV) to identify incident chronic dialysis patients in an Italian region. Subjects are included if they have at least one event in the HDR or ASV databases based on the ICD9-CM dialysis-related diagnosis or procedure codes in the study period. Exclusion criteria comprise non-residents, prevalent cases, or patients undergoing temporary dialysis, and are evaluated only on ASV data by the first algorithm, on both ASV and HDR data by the second algorithm. We validated the algorithms against the Emilia-Romagna regional dialysis registry by searching for incident patients in 2014 and performed sensitivity analyses by modifying the criteria to define temporary dialysis. RESULTS: Algorithm 1 identified 680 patients and algorithm 2 identified 676 initiating dialysis in 2014, compared to 625 patients included in the regional dialysis registry. Sensitivity for the two algorithms was respectively 90.8 and 88.4%, positive predictive value 84.0 and 82.0%, and percentage agreement was 77.4 and 74.1%. CONCLUSIONS: Algorithms relying on retrieval of administrative records have high sensitivity and positive predictive value for the identification of incident chronic dialysis patients. Algorithm 1, which showed the higher accuracy and has a simpler case definition, can be used in place of regional dialysis registries when they are not present or sufficiently developed in a region, or to improve the accuracy and timeliness of existing registries.
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Algoritmos , Diálise Renal , Bases de Dados Factuais , Feminino , Humanos , Classificação Internacional de Doenças , Itália/epidemiologiaRESUMO
AIMS: To examine whether age at type 2 diabetes onset is an independent predictor of dementia risk. METHODS: Retrospective cohort drawn from healthcare administrative records of all inhabitants within Romagna's catchment area, Italy, with an estimated onset of type 2 diabetes in 2008-2017 and aged ≥ 55, with follow-up until 2020. Time to dementia or censoring was estimated with the Kaplan-Meier method, using diabetes onset as the time origin. Age groups were compared with the log-rank test. Multivariable competing-risks analysis was used to assess predictors of dementia. RESULTS: In patients aged ≥ 75 years, dementia-free survival (DFS) declined to below 90 % within five years and linearly decreased to 68.8 % until the end of follow-up. In contrast, DFS for those aged 55-64 years showed a marginal decrease, reaching 97.4 % after 13 years. Competing-risks regression showed that individuals aged ≥ 75 and 65-74 had a significantly higher risk of dementia compared to those aged 55-64 years. Having more comorbidities at diabetes onset and initial treatment with ≥ 2 antidiabetics were clinical predictors. CONCLUSIONS: Later age at onset of diabetes is strongly associated with dementia. A better understanding of the diabetes-dementia relationship is needed to inform strategies for promoting specific healthcare pathways.
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Idade de Início , Demência , Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/epidemiologia , Estudos Retrospectivos , Idoso , Demência/epidemiologia , Demência/etiologia , Masculino , Feminino , Pessoa de Meia-Idade , Fatores de Risco , Idoso de 80 Anos ou mais , Itália/epidemiologiaRESUMO
Background: Pirfenidone and Nintedanib have significantly improved the prognosis of patients with idiopathic pulmonary fibrosis (IPF), reducing mortality risk and exacerbations. This study aimed to analyze antifibrotic treatment utilization and its association with clinical outcomes (i.e., acute exacerbation or death) during 2014-2021 in newly diagnosed IPF patients, using Healthcare Utilization Databases of the Marche Region, Italy. Methods: The first 12-month adherence to antifibrotic was estimated using the Proportion of Days Covered (PDC), defining adherence as PDC ≥ 75%. State Sequence Analysis over the initial 52 weeks of treatment was used to identify adherence patterns. The role of adherence patterns on acute exacerbations/death, adjusted by demographic, clinical features, and monthly adherence after the 52-week period (time-dependent variable), was assessed with Cox regression. Results: Among 667 new IPF cases, 296 received antifibrotic prescriptions, with 62.8% being adherent in the first year. Three antifibrotic utilization patterns emerged-high adherence (37.2%), medium adherence (42.5%), and low adherence (20.3%)-with median PDCs of 95.3%, 79.5%, and 18.6%, respectively. These patterns did not directly influence three-year mortality/exacerbation probability, but sustained adherence reduced risk over time. Conclusions: Good adherence was observed in in this population-based study, emphasizing the importance of continuous antifibrotics therapy over time to mitigate adverse outcomes.
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AIMS: To investigate the risk of major depression and dementia in patients with type 2 diabetes, including dementia resulting from depression, and their impact on diabetes-related complications and mortality. METHODS: We conducted a population-based retrospective cohort study including 11,441 incident cases of diabetes in 2015-2017, with follow-up until 2022. A multi-state survival analysis was performed on a seven-state model with 15 transitions to capture disease progression and onset of mental disorders. RESULTS: Eight-year probabilities of depression, dementia, diabetes-related complications, and death were 9.7% (95%âCI 8.7-10.7), 0.9% (95%âCI 0.5-1.3), 10.4% (95%âCI 9.5-11.4), and 14.8% (95%âCI 13.9-15.7), respectively. Depression increased the risk of dementia up to 3.7% (95%âCI 2.0-5.4), and up to 10.3% (95%âCI 0.3-20.4) if coupled with diabetes complications. Eight-year mortality was 37.5% (95%âCI 33.1-42.0) after depression, 74.1% (95%âCI 63.7-84.5) after depression plus complications, 76.4% (95%âCI 68.8-83.9) after dementia, and 98.6% (95%âCI 96.1-100.0) after dementia plus complications. CONCLUSIONS: The interconnections observed across depression, dementia, complications, and mortality underscore the necessity for comprehensive and integrated approaches in managing diabetes. Early screening for depression, followed by timely and targeted interventions, may mitigate the risk of dementia and improve diabetes prognosis.
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Demência , Complicações do Diabetes , Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/epidemiologia , Estudos Retrospectivos , Transição Epidemiológica , Dados de Saúde Coletados Rotineiramente , Demência/epidemiologia , Complicações do Diabetes/complicações , Fatores de RiscoRESUMO
AIMS: A set of indicators to assess the quality of care for patients hospitalized for heart failure was developed by an expert working group of the Italian Health Ministry. Because a better performance profile measured using these indicators does not necessarily translate to better outcomes, a study to validate these indicators through their relationship with measurable clinical outcomes and healthcare costs supported by the Italian National Health System was carried out. METHODS AND RESULTS: Residents of four Italian regions (Lombardy, Marche, Lazio, and Sicily) who were newly hospitalized for heart failure (irrespective of stage and New York Heart Association class) during 2014-2015 entered in the cohort and followed up until 2019. Adherence to evidence-based recommendations [i.e. renin-angiotensin-aldosterone system (RAS) inhibitors, beta-blockers, mineralocorticoid receptor antagonists (MRAs), and echocardiograms (ECCs)] experienced during the first year after index discharge was assessed. Composite clinical outcomes (cardiovascular hospital admissions and all-cause mortality) and healthcare costs (hospitalizations, drugs, and outpatient services) were assessed during the follow-up. The restricted mean survival time at 5 years (denoted as the number of months free from clinical outcomes), the hazard of clinical outcomes (according to the Cox model), and average annual healthcare cost (expressed in euros per person-year) were compared between adherent and non-adherent patients. A non-parametric bootstrap method based on 1000 resamples was used to account for uncertainty in cost-effectiveness estimates. A total of 41 406 patients were included in this study (46.3% males, mean age 76.9 ± 9.4 years). Adherence to RAS inhibitors, beta-blockers, MRAs, and ECCs were 64%, 57%, 62%, and 20% among the cohort members, respectively. Compared with non-adherent patients, those who adhered to ECCs, RAS inhibitors, beta-blockers, and MRAs experienced (i) a delay in the composite outcome of 1.6, 1.9, 1.6, and 0.6 months and reduced risks of 9% (95% confidence interval, 2-14%), 11% (7-14%), 8% (5-11%), and 4% (-1-8%), respectively; and (ii) lower (262, 92, and 571 per year for RAS inhibitors, beta-blockers, and MRAs, respectively) and higher costs (511 per year for ECC). Adherence to RAS inhibitors, beta-blockers, and MRAs showed a delay in the composite outcome and a saving of costs in 98%, 84%, and 93% of the 1000 bootstrap replications, respectively. CONCLUSIONS: Strict monitoring of patients with heart failure through regular clinical examinations and drug therapies should be considered the cornerstone of national guidelines and audits.
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BACKGROUND: Pramipexole is a dopamine full agonist approved for the treatment of Parkinson's disease and restless legs syndrome. Its high affinity for the D3 receptor and neuroprotective, antioxidant, and anti-inflammatory activity provides a rationale for the treatment of depression. In this paper, we review studies on the effectiveness and safety of antidepressant pramipexole augmentation in treatment-resistant depression. METHODS: This comprehensive systematic review and meta-analysis of observational studies on pramipexole-antidepressant augmentation included patients with resistant unipolar and bipolar depression. The primary outcome measure was the treatment response, measured at the study endpoint. RESULTS: We identified 8 studies including 281 patients overall, 57% women and 39.5% with bipolar disorder and 60.5% with major depressive disorder. The mean follow-up duration was 27.3 weeks (range 8-69). The pooled estimate of treatment response was 62.5%, without significant differences between unipolar and bipolar depression. Safety was good, with nausea and somnolence the most frequent side effects. CONCLUSIONS: The findings of this systematic review, needing further confirmation, show that off-label use of pramipexole as augmentation of antidepressant treatment could be a useful and safe strategy for unipolar and bipolar treatment-resistant depression.
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AIMS: The aim of the study was to adapt the German version of the insulin pump therapy (IPA) questionnaire to Italian (IT-IPA) and to evaluate its psychometric properties in adults with type 1 diabetes. METHODS: We conducted a cross-sectional study, data were collected through an online survey. In addition to IT-IPA, questionnaires evaluating depression, anxiety, diabetes distress, self-efficacy, and treatment satisfaction were administered. The six factors identified in the IPA German version were assessed using confirmatory factor analysis; psychometric testing included construct validity and internal consistency. RESULTS: The online survey was compiled by 182 individuals with type 1 diabetes: 45.6% continuous subcutaneous insulin infusion (CSII) users and 54.4% multiple daily insulin injection users. The six-factor model had a very good fit in our sample. The internal consistency was acceptable (Cronbach's α = 0.75; 95% IC [0.65-0.81]). Diabetes treatment satisfaction was positively correlated with a positive attitude towards CSII therapy (Spearman's rho = 0.31; p < 0.01), less Technology Dependency, higher Ease of Use, and less Impaired Body Image. Furthermore, less Technology Dependency was associated with lower diabetes distress and depressive symptoms. CONCLUSIONS: The IT-IPA is a valid and reliable questionnaire evaluating attitudes towards insulin pump therapy. The questionnaire can be used for clinical practice during consultations for shared decision-making to CSII therapy.
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Diabetes Mellitus Tipo 1 , Adulto , Humanos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/diagnóstico , Hipoglicemiantes/uso terapêutico , Estudos Transversais , Inquéritos e Questionários , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , Satisfação do Paciente , ItáliaRESUMO
Pramipexole is a dopamine agonist with potential antidepressant, neuroprotective, antioxidant and anti-inflammatory activity. In the present study we investigated the 24 weeks effect and safety of traditional AD augmentation with pramipexole for treatment-resistant depression. The study includes 116 patients, 37 (32%) with bipolar disorders and 79 (68%) with major depressive disorder, who failed to respond to at least 2 ADs trials of different classes and that were treated with AD augmented with pramipexole. Mood stabilizers and/or second-generation antipsychotics were added in patients with bipolar or mixed depression. Exclusion criteria were psychotic depression, rapid cycling bipolar course and previous unsuccessful treatment with pramipexole. After 24 weeks of pramipexole augmentation (median max dose 1.05 mg/day, IQR 0.72-1.08) 74.1% of patients responded (≥50% reduction of baseline Hamilton Depression Rating Scale21 total score) and 66.4% remitted (Hamilton Depression Rating Scale21 total score < 7). Global Assessment of Functioning score significantly increase from 53 (50-60) at baseline to 80 (71-81) at 24 weeks (Wilcoxon signed rank test = 8.174, p < 0.001]. Ten patients (8.6%) dropped out (8 due to side effects and 2 for lack of efficacy) and 1 experienced an induced hypomanic switch. No patient committed a suicide attempt, had suicidal ideation, needed hospitalization, reported lethargy, gambling, hypersexuality and compulsive shopping. The limitations of the study are the observational design, the lack of a control group, the inclusion of outpatients only, the unblinded outcomes assessment, and the flexibility of the add-on schedule. The findings of the present study showed that off-label use of pramipexole as augmentation of traditional AD is an effective and safe 24 weeks treatment of resistant unipolar and bipolar depression. These results need confirmation from randomized clinical trials on larger samples.
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Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Agonistas de Dopamina/uso terapêutico , Quimioterapia Combinada , Pramipexol/uso terapêutico , Antidepressivos de Segunda Geração/uso terapêutico , Transtorno Bipolar/tratamento farmacológico , Escalas de Graduação Psiquiátrica Breve , Transtorno Depressivo Maior/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Uso Off-Label , Estudos Retrospectivos , Resultado do TratamentoRESUMO
We estimate the effects of a chronic disease management program (CDMP) which adapts various supply-side interventions to specific demand-side conditions (disease-staging) for patients with chronic kidney disease (CKD). Using a unique dataset on the entire population of the Emilia-Romagna region of Italy with hospital-diagnosed CKD, we estimate the causal effects of the CDMP on adherence indicators and health outcomes. As CKD is a progressive disease with clearly-defined disease stages and a treatment regimen that can be titrated by disease severity, we calculate dynamic, severity-specific, indicators of adherence as well as several long-term health outcomes. Our empirical work produces statistically significant and sizeable causal effects on many adherence and health outcome indicators across all CKD patients. More interestingly, we show that the CDMP produces larger effects on patients with early-stage CKD, which is at odds with some of the literature on CDMP that advocates intensifying interventions for high-cost (or late-stage) patients. Our results suggest that it may be more efficient to target early-stage patients to slow the deterioration of their health capital. The results contribute to a small, recent literature in health economics that focuses on the marginal effectiveness of CDMPs after controlling either for supply- or demand-side sources of heterogeneity.
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Insuficiência Renal Crônica , Gerenciamento Clínico , Hospitais , Humanos , Avaliação de Resultados em Cuidados de Saúde , Insuficiência Renal Crônica/terapia , Índice de Gravidade de DoençaRESUMO
The aim was to evaluate the determinants of acute exacerbation (AE) and death in new cases of idiopathic pulmonary fibrosis (IPF) using administrative databases in the Marche Region. Adults at their first prescription of antifibrotics or hospitalization with a diagnosis of IPF occurring in 2014-2019 were considered as new cases. Multiple Cox regression was used to estimate the risk of AE and of all-cause mortality adjusted by demographic and clinical characteristics, stratifying patients according to antifibrotic treatment. Overall, 676 new cases of IPF were identified and 276 deaths and 248 AE events occurred. In never-treated patients, the risk of AE was higher in patients with poor health conditions at diagnosis; the risk of death was higher in males, in patients aged ≥75 and in those with poor health conditions at baseline. The increasing number of AEs increased the risk of death in treated and never-treated patients. Within the limits of an observational study based on secondary data, the combined use of healthcare administrative databases allows the accurate analysis of progression and survival of IPF from the beginning of the antifibrotic therapy era, suggesting that timely and early diagnosis is critical to prescribing the most suitable treatment to increase survival and maintain a healthy life expectancy.
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Fibrose Pulmonar Idiopática , Masculino , Humanos , Progressão da Doença , Fibrose Pulmonar Idiopática/tratamento farmacológico , Itália/epidemiologia , Atenção à Saúde , Aceitação pelo Paciente de Cuidados de Saúde , Estudos RetrospectivosRESUMO
BACKGROUND: Psoriasis is associated with comorbid psychiatric conditions. However, its relationship with suicidality is not completely understood. The aim of this study was to analyze the prevalence and the correlates of depressive symptoms and suicide risk in patients with psoriasis. METHODS: Adult psoriatic patients referring to the Outpatient Service of the Sant'Orsola-Malpighi Polyclinic were enrolled. Depressive symptoms and suicidality were assessed using the Patient Health Questionnaire (PHQ-9) and section C of Mini-International Neuropsychiatric Interview (M.I.N.I. 5.0.0). Psoriasis was evaluated using the Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA) and the Dermatology Life Quality Index (DLQI). RESULTS: The prevalence of depressive symptoms was 14.9% and that of suicidality 6.3%. PHQ-9 scores were higher in patients with moderate-to-severe psoriasis (PASI≥10, Mann-Whitney U Test=4014.5; P<0.001; BSA≥10, Mann-Whitney Test=3930.5; P<0.001) and poorer quality of life (Mann-Whitney Test=805.5; P=0.024). Moreover, PHQ-9 scores were higher in females (Mann-Whitney Test U=3612.5; P=0.008) and were unrelated to age (r
Assuntos
Depressão , Psoríase , Adulto , Feminino , Humanos , Depressão/epidemiologia , Depressão/etiologia , Qualidade de Vida , Psoríase/complicações , Psoríase/epidemiologia , Ideação Suicida , PacientesRESUMO
BACKGROUND: Lichen sclerosus is an autoimmune dermatosis that in women typically involves vulvar area. This condition can strongly impact on the quality of life. To date, topical steroids are the most effective treatment, although adverse effects are possible, especially in long-term application. The aims of this study are: 1) to investigate the efficacy of fractional CO
Assuntos
Lasers de Gás , Líquen Escleroso e Atrófico , Líquen Escleroso Vulvar , Adulto , Feminino , Humanos , Lasers de Gás/uso terapêutico , Estudos Prospectivos , Qualidade de Vida , Líquen Escleroso Vulvar/complicaçõesRESUMO
BACKGROUND: Mortality of bullous pemphigoid (BP) is a variable parameter, depending especially on the area where the study was conducted. The 1-year mortality rate and the identification of clinic-therapeutic factors with potential prognostic value in patients with BP were evaluated in a cohort from a single referral center. METHODS: We have reviewed medical records of patients with BP diagnosed at the Sant' Orsola-Malpighi Hospital in Bologna (Italy) between 2005 and 2019. Data collected included sex, age at diagnosis, laboratory findings, severity of disease, dosage of systemic treatments, age at death and comorbidities. Only patients who had at least 1 year of follow-up were included. RESULTS: Eighty-five patients were included; the mortality rate was 7.1%. The mortality rate of patients treated with a moderate dosage of corticosteroids was no higher than that of patients treated with a low dosage. The log-rank test showed a statistically significant correlation between mortality and patients aged ≥85, BP230 positive, and CCIS≥4. CONCLUSIONS: Compared with similar studies, our results show a lower 1-year mortality rate. Advanced age at diagnosis and CCIS were confirmed as major independent factors associated with poor prognosis in BP. Administration of moderate dosage of oral corticosteroids seems to have an overall positive benefit-risk ratio, providing a good control of the disease and minimizing the risk of hospitalization, possible related complications and the mortality rate.