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BACKGROUND: Secondary conditions may reduce function and participation in individuals with chronic Spinal Cord Injury (SCI). The knowledge of reasons for readmission to the hospital may be enlightening to prevent them and remodel the health services. STUDY DESIGN: Multicenter prospective observational study of all consecutive readmissions of persons with SCI after rehabilitation completion. OBJECTIVES: To explore the characteristics of individuals with SCI readmitted to the hospital, the reasons for readmissions and the burden on hospitalization in terms of length of stay (LoS) for different conditions. SETTING: 31 Italian specialized SCI centers. METHODS: Data on people with traumatic SCI readmitted to SCI centers were recorded about: age, sex, SCI level and severity group, geographical origin, readmission causes, clinical interventions during hospitalization, LoS and discharge destination. Linear and multiple logistic regression analyses were performed considering LoS (days) as dependent variable for correlations with independent variables. All tests were two-sided. RESULTS: Among 1039 persons with traumatic SCI enrolled (mean age 46, males 85%, tetraplegia 43%), 59.09% of the readmissions were caused by urological problems, 39.74% by pressure injury and 35.41% by spasticity (68% readmitted for ≥2 causes, associated with longer LoS). The mean LoS was 48 days: pressure injury, rehabilitative needs, sexual, bowel, and pain problems were associated with longer and urological problems with shorter LoS. People from the South of the country were frequently (68%) readmitted to the northern centers. CONCLUSIONS: Urological problems, pressure injury and spasticity were the most frequent causes of re-hospitalization in individuals with traumatic SCI. The migration trend seeking SCI-specific treatments suggests geographic areas to which health care organizations need to pay more attention.
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Úlcera por Presión , Traumatismos de la Médula Espinal , Masculino , Humanos , Persona de Mediana Edad , Tiempo de Internación , Readmisión del Paciente , Traumatismos de la Médula Espinal/complicaciones , Traumatismos de la Médula Espinal/epidemiología , Traumatismos de la Médula Espinal/terapia , Úlcera por Presión/etiología , Estudios ProspectivosRESUMEN
OBJECTIVE: To evaluate the effects of rehabilitation (physical and cognitive) treatments on the diagnosis severity and Disability Rating Scale (DRS) scores, adjusted for a number of potential confounders measured at baseline, in a large cohort of patients with disorders of consciousness across time. DESIGN AND SETTING: An observational, longitudinal (2 evaluations), multicenter project was made in 90 Italian centers. PARTICIPANTS: Patients (N=364) with a diagnosis of disorders of consciousness. MAIN OUTCOME MEASURES: Primary outcome was the severity of diagnosis, expressed on an ordinal scale (OtherAsunto(s)
Trastornos de la Conciencia/rehabilitación
, Evaluación de la Discapacidad
, Adulto
, Anciano
, Protocolos Clínicos
, Femenino
, Humanos
, Italia
, Estudios Longitudinales
, Masculino
, Persona de Mediana Edad
, Puntaje de Propensión
, Recuperación de la Función
, Índice de Severidad de la Enfermedad
, Resultado del Tratamiento
RESUMEN
STUDY DESIGN: Multicenter prospective observational study of people with acute traumatic spinal cord injury (TSCI) admitted to rehabilitation. OBJECTIVES: To update epidemiological characteristics of a TSCI Italian population and verify the impact of patient characteristics at admission on two outcomes: functional gain (SCIM III) and discharge destination. SETTING: Thirty-one SCI centers for comprehensive rehabilitation in 13 Italian regions. METHODS: All consecutive individuals admitted with acute TSCI were enrolled from October 1, 2013 to September 30, 2014; data were recorded on rehabilitation admission and discharge. Functional gain and discharge destination were identified as outcome measures and statistically analyzed with patient characteristics at admission to identify early outcome predictors. RESULTS: Five hundred and ten individuals with TSCI met inclusion criteria; falls represented the most frequent etiology (45%). On admission, AIS A-B-C tetraplegia was reported in 35% of cases; AIS A-B-C paraplegia in 40%; AIS D paraplegia/tetraplegia in 25%. The majority were discharged home (72%). The mean (SD) SCIM gain was 38 ± 26 points. A predictive model was found for discharge setting: individuals with fall-related injuries, severe SCI (AIS A-B-C tetraplegia), tracheal cannula or indwelling catheter on admission, were less likely to be discharged home (OR 95% CI 0.15 [0.06, 0.35]). A model with a lower predictive power was found for SCIM gain, with lower score expected for females, older age, higher severity of SCI, a longer onset of injury admission interval (OAI), and mechanical ventilation on admission. CONCLUSIONS: Prognostic factors in early rehabilitation are still hard to identify, making it difficult to correctly approach customized rehabilitation.
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Accidentes por Caídas/estadística & datos numéricos , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Índice de Severidad de la Enfermedad , Traumatismos de la Médula Espinal/epidemiología , Traumatismos de la Médula Espinal/rehabilitación , Adulto , Anciano , Femenino , Estudios de Seguimiento , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Paraplejía/epidemiología , Paraplejía/etiología , Paraplejía/rehabilitación , Alta del Paciente/estadística & datos numéricos , Pronóstico , Cuadriplejía/epidemiología , Cuadriplejía/etiología , Cuadriplejía/rehabilitación , Respiración Artificial/estadística & datos numéricos , Factores Sexuales , Traumatismos de la Médula Espinal/complicaciones , Traumatismos de la Médula Espinal/etiologíaRESUMEN
Incidence of neuroepithelial Primary Brain Tumors (nPBT) varies, ranging from 7.3 to 11.6 cases/100,000/year across Europe. We present incidence and survival of nPBT in the Emilia-Romagna region (ER), Italy. This study is the largest in Southern Europe. Specialists in neurosurgery, neurology, neuroradiology, oncology, radiotherapy, genetics, and pathology of ER notified all suspected nPBT adult cases residing in ER (4,337,966 inhabitants) observed during 2009. Furthermore, through ICD-9 discharge codes, we identified and reviewed all possible cases. Neuroepithelial PBT diagnosis was based on histological or radiological findings. We included 400 incident nPBT cases, of which 102 (25%) were retrospectively identified. These latter were significantly older. The standardized incidence was 10.5/100,000/year (95% CI 9.4-11.5), higher for men. It was 9.2/100,000/year (95% CI 8.3-10.2) for astrocytic tumors, 0.6/100,000/year (95% CI 0.4-0.9) for oligodendroglial tumors, and 7.1 (95% CI 6.3-8.0) for glioblastoma (GBM). Among GBM patients, median survival was 249 days if prospectively identified vs. 132 days when identified through ICD-9 codes (p < 0.0001). The incidence of nPBT in the ER region is among the highest in the literature. Older patients were more likely to escape an active surveillance system. This should be considered when comparing incidence rates across studies, giving the increasing number of elderly people in the general population.
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Neoplasias Encefálicas/epidemiología , Neoplasias Neuroepiteliales/epidemiología , Sistema de Registros/estadística & datos numéricos , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias Encefálicas/mortalidad , Femenino , Glioblastoma/epidemiología , Humanos , Incidencia , Italia/epidemiología , Masculino , Persona de Mediana Edad , Neoplasias Neuroepiteliales/mortalidadRESUMEN
Very few studies examined trend over time of the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) and factors influencing it; previous studies, then, included only patients attending tertiary ALS Centres. We studied ALSFRS-R decline, factors influencing this trend and survival in a population-based setting. From 2009 onwards, a prospective registry records all incident ALS cases among residents in Emilia Romagna (population: 4.4 million). For each patient, demographic and clinical details (including ALSFRS-R) are collected by caring physicians at each follow-up. Analysis was performed on 402 incident cases (1279 ALSFRS-R assessments). The average decline of the ALSFRS-R was 0.60 points/month during the first year after diagnosis and 0.34 points/month in the second year. ALSFRS-R decline was heterogeneous among subgroups. Repeated measures mixed model showed that ALSFRS-R score decline was influenced by age at onset (p < 0.01), phenotype (p = 0.01), body mass index (BMI) (p < 0.01), progression rate at diagnosis (ΔFS) (p < 0.01), El Escorial Criteria-Revised (p < 0.01), and FVC% at diagnosis (p < 0.01). Among these factors, at multivariate analysis, only age, site of onset and ΔFS independently influenced survival. In this first population-based study on ALSFRS-R trend, we confirm that ALSFRS-R decline is not homogeneous among ALS patients and during the disease. Factors influencing ALSFRS-R decline may not match with those affecting survival. These disease modifiers should be taken into consideration for trials design and in clinical practice during discussions with patients on prognosis.
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Esclerosis Amiotrófica Lateral/epidemiología , Esclerosis Amiotrófica Lateral/mortalidad , Sistema de Registros , Adulto , Factores de Edad , Edad de Inicio , Anciano , Anciano de 80 o más Años , Esclerosis Amiotrófica Lateral/diagnóstico , Progresión de la Enfermedad , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Pronóstico , Estudios ProspectivosRESUMEN
BACKGROUND AND AIMS: Quality monitoring has great relevance in stroke care. The Project "How to guarantee adherence to effective interventions in stroke care" aimed to estimate adherence to acute-phase guidelines in stroke care in Italy. METHODS: A prospective observational study was performed in 27 hospitals of 13 Italian Regions. Adherence to 15 process indicators was evaluated, comparing also stroke units (SU) with conventional wards. An overall score of care, defined as the sum of achieved indicators, was calculated. A multilevel hierarchical model described performance at patient, hospital and regional level. RESULTS: Overall, 484 consecutive stroke patients (mean age, 73.4 years; 52.7 % males) were included. Total score ranged from 2 to 15 (mean 8.5 ± 2.4). SU patients were more often evaluated with the National Institutes of Health Stroke Scale (NIHSS) within 24 h, had more frequently an assessment of pre- and post-stroke disability, and a CT scan the same or the day after admission. Regional-hospital- and patient-level variability explained, respectively, 25, 34, and 41 % of total score variance. In multivariate models, patients >80 years vs. younger showed a change in total score of -0.45 (95 % CI -0.79 to -0.12), and those with NIHSS ≥14 vs. ≤5 of -0.92 (95 % CI -1.53 to -0.30). A negative change means a worse adjusted average adherence to process indicators. SU admission increased total score of 1.55 (95 % CI 0.52-2.58). CONCLUSIONS: Our data confirm the need of quality monitoring in stroke care. Although SU patients showed a better adherence to quality indicators, overall compliance was unsatisfactory.
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Indicadores de Calidad de la Atención de Salud , Accidente Cerebrovascular/terapia , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Hospitales/normas , Hospitales/estadística & datos numéricos , Humanos , Italia , Masculino , Persona de Mediana Edad , Modelos Teóricos , Análisis Multivariante , Guías de Práctica Clínica como Asunto , Estudios Prospectivos , Nivel de Atención , Accidente Cerebrovascular/diagnósticoRESUMEN
ALS is characterized by a highly heterogeneous course, ranging from slow and uncomplicated to rapid progression with severe extra-motor manifestations. This study investigated ALS-related hospitalizations and their connection to clinical aspects, comorbidities, and prognosis. We performed a retrospective cohort study including patients residing in Modena, Italy, newly diagnosed between 2007 and 2017 and followed up until 31 December 2022. Data were obtained from the Emilia Romagna ALS registry, regional hospitals, and medical records. Among the 249 patients, there were 492 hospital admissions, excluding those for diagnostic purposes; 63% of the patients had at least one hospitalization post-diagnosis, with an average stay of 19.90 ± 23.68 days. Younger patients were more likely to be hospitalized multiple times and experienced longer stays (44.23 ± 51.71 days if <65 years; 26.46 ± 36.02 days if older, p < 0.001). Patients who were hospitalized at least once more frequently underwent gastrostomy (64.97%) or non-invasive (66.24%) and invasive (46.50%) ventilation compared to those never hospitalized (21.74%, 31.52%, 13.04%, respectively, p < 0.001 for all). Emergency procedures led to longer hospitalizations (62.84 ± 48.91 days for non-invasive ventilation in emergencies vs. 39.88 ± 46.46 days electively, p = 0.012). Tracheostomy-free survival was not affected by hospitalizations. In conclusion, younger ALS patients undergo frequent and prolonged hospitalizations, especially after emergency interventions, although these do not correlate with reduced survival.
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Access to effective acute stroke services is a crucial factor to reduce stroke-related death and disability, but is limited in different parts of Italy. Our study addresses this inequality across the Italian regions by examining the regional legislations issued to adopt and implement the State-Regional Council agreement 03/02/2005 as to the acute stroke management. All decrees and resolutions as to acute stroke were collected from each region and examined by the means of a check list including quantitative and qualitative characteristics, selected in accordance with the recommendations from the State-Regional Council document. Each completed check list was then sent to each regional reference person, who filled in the section on the implementation of the indications and compliance, with the collaboration of stroke specialists if necessary. The study was carried out from November 2009 to September 2010. The documents and information were collected from 19 regions. Our survey revealed disparities both in terms of number of decrees and resolutions and of topics covered by the regional legislations about stroke care. Most legislations lacked practical and economical details. This feedback from national and regional stroke regulations revealed a need of more concrete indications. Involvement of various stakeholders (legislators, consumers, providers) might possibly ensure that policies are actually adopted, implemented and maintained. Although considerable challenges are present to the development of standard and optimal stroke care more widely across Italian regions, the potential gains from such developments are substantial.
Asunto(s)
Neurología/legislación & jurisprudencia , Neurología/normas , Accidente Cerebrovascular/terapia , Humanos , Italia , Factores SocioeconómicosRESUMEN
Background: Oral tauroursodeoxycholic acid (TUDCA) is a commercial drug currently tested in patients with amyotrophic lateral sclerosis (ALS) both singly and combined with sodium phenylbutyrate. This retrospective study aimed to investigate, in a real-world setting, whether TUDCA had an impact on the overall survival of patients with ALS who were treated with this drug compared to those patients who received standard care only. Methods: This propensity score-matched study was conducted in the Emilia Romagna Region (Italy), which has had an ALS regional registry since 2009. Out of 627 patients with ALS diagnosed from January 1st, 2015 to June 30th, 2021 and recorded in the registry with available information on death/tracheostomy, 86 patients took TUDCA and were matched in a 1:2 ratio with patients who received only usual care according to age at onset, sex, phenotype, diagnostic latency, ALS Functional Rating Scale-Revised (ALSFRS-R) at first visit, disease progression rate at first visit, and BMI at diagnosis. The primary outcome was survival difference (time from onset of symptoms to tracheostomy/death) between TUDCA exposed and unexposed patients. Findings: A total of 86 patients treated with TUDCA were matched to 172 patients who did not receive treatment. TUDCA-exposed patients were stratified based on dosage (less than or equal to 1000 mg/day or greater) and duration (less than or equal to 12 months or longer) of treatment. The median overall survival was 49.6 months (95% CI 41.7-93.5) among those treated with TUDCA and 36.2 months (95% CI 32.7-41.6) in the control group, with a reduced risk of death observed in patients exposed to a higher dosage (defined as ≥ 1000 mg/day) of TUDCA (HR 0.56; 95% CI 0.38-0.83; p = 0.0042) compared to both the control group and those with lower TUDCA dosages (defined as < 1000 mg/day). TUDCA was generally well-tolerated, except for a minority of patients (n = 7, 8.1%) who discontinued treatment due to side effects, primarily gastrointestinal and mild in severity; only 2 adverse events required hospital access but resolved without sequelae. Interpretation: In this population-based exploratory study, patients with ALS who were treated with TUDCA may have prolonged survival compared to patients receiving standard care only. Additional prospective randomized studies are needed to confirm the efficacy and safety of this drug. Funding: Emilia-Romagna Region.
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Few studies have focused on elderly (>80 years) amyotrophic lateral sclerosis (ALS) patients, who represent a fragile subgroup generally not included in clinical trials and often neglected because they are more difficult to diagnose and manage. We analyzed the clinical and genetic features of very late-onset ALS patients through a prospective, population-based study in the Emilia Romagna Region of Italy. From 2009 to 2019, 222 (13.76%) out of 1613 patients in incident cases were over 80 years old at diagnosis, with a female predominance (F:M = 1.18). Elderly ALS patients represented 12.02% of patients before 2015 and 15.91% from 2015 onwards (p = 0.024). This group presented with bulbar onset in 38.29% of cases and had worse clinical conditions at diagnosis compared to younger patients, with a lower average BMI (23.12 vs. 24.57 Kg/m2), a higher progression rate (1.43 vs. 0.95 points/month), and a shorter length of survival (a median of 20.77 vs. 36 months). For this subgroup, genetic analyses have seldom been carried out (25% vs. 39.11%) and are generally negative. Finally, elderly patients underwent less frequent nutritional- and respiratory-supporting procedures, and multidisciplinary teams were less involved at follow-up, except for specialist palliative care. The genotypic and phenotypic features of elderly ALS patients could help identify the different environmental and genetic risk factors that determine the age at which disease onset occurs. Since multidisciplinary management can improve a patient's prognosis, it should be more extensively applied to this fragile group of patients.
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BACKGROUND: The aim of this article was to review the clinical practice of "bone flap decompression" in Regional Neurosurgical Units with no particular protocol in use. METHODS: From January 2005 to December 2008, a retrospective and multicentre study was conducted on patients who were treated with decompressive craniectomy (DC) in seven departments of neurosurgery in Italy. This study included patients with traumatic brain injury, stroke, aneurysmal subarachnoid haemorrhage and cerebral arteriovenous malformations. Data were retrieved from individual medical records. RESULTS: We identified 526 patients with DC. Age was the most significant predictor factor of survival, together with pupil reactivity, time of decompression and size of the bone flap. The effect of age in predicting survival was so important that in patients over 65 years old we did not find any other significant factor related to survival. In younger patients, the survival rate was much better with a large bone flap (p = 0.01). Unfortunately, 57% of patients were decompressed with a bone flap of less than 12 cm in diameter. This was probably due to the association in 80% of cases between haematoma evacuation and decompression. CONCLUSIONS: The current practice in many centres is different from published papers. Decompression is common over the age of 65 years, is associated with haematoma evacuation and often the bone flaps are inadequate in terms of size.
Asunto(s)
Craniectomía Descompresiva , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Craniectomía Descompresiva/efectos adversos , Femenino , Humanos , Lactante , Italia , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Estudios Retrospectivos , Tasa de Supervivencia , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: The impact of COVID-19 outbreak in the neurosurgical practice has been dramatic, imposing several limitations. The aim of this study is to present how the neurosurgical departments of Emilia-Romagna, a northern Italian region, have re-set their organization to maintain the higher standard of care as possible. METHODS: All operative room and outpatient activities performed during the COVID-19 emergency in the neurosurgical department of Emilia-Romagna have been collected and compared to the means of the same timeframe in 2018 and 2019. RESULTS: In 2020, 205 surgical procedures and 466 outpatient consultations have been performed, representing respectively 28.8% and 26.4% of the previous biennium. The most of OR procedures had been emergencies/urgencies and oncological patients (113 and 66 vs. 164.5 and 84.5, respectively, of the previous biennium), while elective surgeries decrease up to -97.1%, as for spinal nerves and endoscopic skull base procedures. The patients phone contacts and telemedicine evaluations of their examinations have permitted to reduce the hospital access for outpatients of 75.6%, but these modalities have, also, permitted to follow-up a large number of cases. CONCLUSIONS: The outbreak of COVID-19 has imposed several limits to our current practice, however this should not represent an excuse to reduce the standard of care. In our experience, the net integration of different local centers has permitted for each of them to effectively cope the crisis, managing the local cases requiring a prompt surgery and keeping the care continuity with already discharged patients.
Asunto(s)
COVID-19 , Telemedicina , Procedimientos Quirúrgicos Electivos , Humanos , Italia/epidemiología , Nivel de AtenciónRESUMEN
Obstructive sleep apnoea syndrome (OSA) in paediatrics is a rather frequent pathology caused by pathophysiological alterations leading to partial and prolonged obstruction (hypoventilation) and/or intermittent partial (hypopnoea) or complete (apnoea) obstruction of the upper airways. Paediatric OSA is characterised by daytime and night-time symptoms. Unfortunately, there are few data on shared diagnostic-therapeutic pathways that address OSA with a multidisciplinary approach in paediatric age. This document summarizes recommendations from the Emilia-Romagna Region, Italy, developed in order to provide the most appropriate tools for a multidisciplinary approach in the diagnosis, treatment and care of paediatric patients with OSA. The multidisciplinary group of experts distinguished two different 'step' pathways, depending on the age group considered (i.e., under or over two years). In most cases, these pathways can be carried out by the primary care paediatrician, who represents the first filter for approaching the problem. For this reason, it is essential that the primary care paediatrician receives adequate training on how to formulate the diagnostic suspicion of OSA and on what criteria to use to select patients to be sent to the hospital centre. The relationship between the paediatrician of the patient and her/his parents must see a synergy of behaviour between the various players in order to avoid uncertainty about the diagnostic and therapeutic decisions as well as the follow-up phase. The definition and evaluation of the organizational process and outcome indicators of the developed flow-chart, and the impact of its implementation will remain fundamental.
RESUMEN
Increased incidence rates of amyotrophic lateral sclerosis (ALS) have been recently reported across various Western countries, although geographic and temporal variations in terms of incidence, clinical features and genetics are not fully elucidated. This study aimed to describe demographic, clinical feature and genotype-phenotype correlations of ALS cases over the last decade in the Emilia Romagna Region (ERR). From 2009 to 2019, our prospective population-based registry of ALS in the ERR of Northern Italy recorded 1613 patients receiving a diagnosis of ALS. The age- and sex-adjusted incidence rate was 3.13/100,000 population (M/F ratio: 1.21). The mean age at onset was 67.01 years; women, bulbar and respiratory phenotypes were associated with an older age, while C9orf72-mutated patients were generally younger. After peaking at 70-75 years, incidence rates, among women only, showed a bimodal distribution with a second slight increase after reaching 90 years of age. Familial cases comprised 12%, of which one quarter could be attributed to an ALS-related mutation. More than 70% of C9orf72-expanded patients had a family history of ALS/fronto-temporal dementia (FTD); 22.58% of patients with FTD at diagnosis had C9orf72 expansion (OR 6.34, p = 0.004). In addition to a high ALS incidence suggesting exhaustiveness of case ascertainment, this study highlights interesting phenotype-genotype correlations in the ALS population of ERR.
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BACKGROUND: The aim of the present study was to assess the cost-effectiveness of cement-less versus hybrid prostheses in total hip replacement (THR) in patients diagnosed with primary osteoarthritis. METHODS: Effectiveness data were obtained from the Emilia-Romagna Regional Registry on Orthopaedic Prosthesis (RIPO), which collects information on all orthopaedic intervention performed in Emilia-Romagna (41,199 total hip replacements performed from 2000 to 2007), and from which we obtained survival curves and transition probabilities for the cement-less and hybrid prostheses, respectively. Conversely, costs were derived from regional databases through a specific procedure, which allowed us to register individual component's costs for both primary and subsequent revision interventions. A specific Markov transition model was constructed in order to consider the 3 types of revisions that an implant could possibly undergo through its life-span: total, cup or stem, head insert or neck. The cost-effectiveness was expressed in terms of cost per "revision-free" life year. RESULTS AND CONCLUSIONS: Considering a 70-y old patient undergoing THR, the cementless strategy resulted more effective but more costly than the hybrid solution, with an incremental cost effectiveness ratio of 2401.63 per revision-free life year. Following a deterministic sensitivity analysis, hybrid and cementless fixation showed, respectively, a dominance profile for patients older than 83 y and younger than 43 y, whereas for all ages in between, we report a progressive increase in the ICER of cementless prostheses. Our results proved to be robust, as underlined by the probabilistic sensitivity analysis performed using cost distributions.
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Artroplastia de Reemplazo de Cadera/economía , Artroplastia de Reemplazo de Cadera/métodos , Modelos Económicos , Osteoartritis/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Cementos para Huesos , Estudios de Casos y Controles , Análisis Costo-Beneficio , Prótesis de Cadera , Humanos , Italia , Cadenas de Markov , Persona de Mediana Edad , Osteoartritis/economía , Sistema de Registros , Estudios RetrospectivosRESUMEN
PURPOSE: Patients with advanced urothelial carcinoma who fail platinum-containing chemotherapy (treatment fails) have a poor prognosis and limited treatment options. Recent approvals of immune-checkpoint inhibitors confirmed the value of immunomodulatory therapy in urothelial carcinoma. Tremelimumab is a selective human immunoglobulin G2 (IgG2) monoclonal antibody against cytotoxic T-lymphocyte-associated antigen 4 with demonstrated durable response rate in metastatic melanoma. This is the first study to report the efficacy and safety of tremelimumab in urothelial carcinoma. PATIENTS AND METHODS: We report the results of the urothelial carcinoma cohort from a phase II, open-label, multicenter study of patients with advanced solid tumors (NCT02527434). Patients with locally advanced/metastatic urothelial carcinoma were treated with tremelimumab monotherapy (750 mg via intravenous infusion every 4 weeks for seven cycles, then every 12 weeks for two additional cycles) for up to 12 months or until disease progression, initiation of other anticancer therapy, unacceptable toxicity, or consent withdrawal. RESULTS: In 32 evaluable patients with metastatic urothelial carcinoma, objective response rate was 18.8% (95% confidence interval, 7.2-36.4), including complete response (CR) in 2 (6.3%), and partial response in 4 patients (12.5%). Median duration of response has not been reached. Stable disease of ≥12 months was reported in 1 patient (3.1%), yielding a disease control rate at 12 months of 21.9%. Overall, tremelimumab was generally well tolerated; safety results were consistent with the known safety profile. CONCLUSIONS: Tremelimumab monotherapy demonstrated clinical activity and durable responses in patients with metastatic urothelial carcinoma. This study is the first in which CR has been observed with tremelimumab as a single agent in urothelial carcinoma.
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Anticuerpos Monoclonales Humanizados/uso terapéutico , Carcinoma de Células Transicionales/tratamiento farmacológico , Resistencia a Antineoplásicos/efectos de los fármacos , Recurrencia Local de Neoplasia/tratamiento farmacológico , Compuestos Organoplatinos/farmacología , Terapia Recuperativa , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma de Células Transicionales/secundario , Femenino , Humanos , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia , Recurrencia Local de Neoplasia/patología , Estadificación de Neoplasias , Seguridad del Paciente , Tasa de Supervivencia , Resultado del Tratamiento , Neoplasias de la Vejiga Urinaria/patologíaRESUMEN
BACKGROUND: Despite the importance of walking recovery in real life contexts, only 7% of stroke survivors at discharge from neuro-rehabilitation units recover independent walking in the community. However, studies on outcome indicators of walking ability restoration following stroke rarely regard the community ambulation. AIM: The aim of the study is to investigate how sociodemographic and sub-acute clinical characteristics of stroke survivors at admission and at discharge may predict a good participation in community walking activity 6 months post-stroke. DESIGN: Retrospective observational study. SETTING: Inpatient neuro-rehabilitation centers. POPULATION: Three-hundred-ten stroke survivors. METHODS: A secondary analysis were performed on collected sociodemographic and clinical data of subjects after first-ever stroke within 72 hours of admission to acute care facilities (T1), at discharge (T2), and subsequently after 6-months post-stroke (T3). The regression analysis between every independent variable at T1 and T2 and Walking Handicap Scale-WHS (negative: 1-3; positive: 4-6) assessed at T3 were performed to identify the most important early predictors. RESULTS: At T1, being younger, having a good ability to walk, early mobilization out of bed, not having TACI, and being female are significant positive indicators while, clinical complications are significantly negative for a WHS:4-6 at T3. No correlation was found between WHS and gender, etiology, the side of lesion, the presence of aphasia, and the presence of risk factors. The combination of risk factors indicates a negative WHS at T3. CONCLUSIONS: The presence of risk factors and clinical complications delay significantly the walking ability restoration and return to social life. Such status consistently with the patient's compliance must not postpone the rehabilitation relatively, rehabilitation must be facilitated with targeted programs taking care particularly of people with negative indicators for recovery of community ambulation 6 months post-stroke. CLINICAL REHABILITATION IMPACT: Early indicators are considerable in order to predict a targeted prognosis and better provide a tailored rehabilitation program.
Asunto(s)
Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular/fisiopatología , Caminata/fisiología , Actividades Cotidianas , Anciano , Anciano de 80 o más Años , Ambulación Precoz , Femenino , Humanos , Masculino , Persona de Mediana Edad , Recuperación de la Función/fisiología , Centros de Rehabilitación , Estudios Retrospectivos , Factores Socioeconómicos , Accidente Cerebrovascular/complicacionesRESUMEN
PURPOSE: The aim of the study was to assess early poststroke prognostic factors in patients admitted for postacute phase rehabilitation. METHODS: A 1-yr multicenter prospective project was conducted in four Italian regions on 352 patients who were hospitalized after a first stroke and were eligible for postacute rehabilitation. Clinical data were collected in the stroke or acute care units (acute phase), then in rehabilitation units (postacute phase), and, subsequently, after a 6-mo poststroke period (follow-up). Clinical outcome measures were represented using the Barthel Index and the modified Rankin Scale. Univariate and multivariate analyses were performed to identify the most important prognostic index. RESULTS: Modified Rankin Scale score, minor neurologic impairment, and early out-of-bed mobilization (within 2 days after the stroke) proved to be important factors related to a better recovery according to Barthel Index (power of prediction = 37%). Similarly, age, premorbid modified Rankin Scale score, and early out-of-bed mobilization were seen to be significant factors in achieving better overall participation and activity according to the modified Rankin Scale (power of prediction = 48%). Barthel Index at admission and certain co-morbidities were also significant prognostic factors correlated with a better outcome. CONCLUSIONS: According to the Barthel Index and modified Rankin Scale, early mobilization is an early predictor of favorable outcome. TO CLAIM CME CREDITS: Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME CME OBJECTIVES: Upon completion of this article, the reader should be able to: (1) Incorporate prognostic factors of good clinical outcomes after stroke in developing treatment plans for patients admitted to rehabilitation; (2) Identify acute phase indicators associated with favorable 6-mo outcome after stroke; and (3) Recognize the cut-off for early mobilization linked to better outcome in stroke survivors admitted to rehabilitation. LEVEL: Advanced ACCREDITATION: The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.The Association of Academic Physiatrists designates this Journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Asunto(s)
Enfermedad Crítica/rehabilitación , Ambulación Precoz/métodos , Rehabilitación de Accidente Cerebrovascular/estadística & datos numéricos , Accidente Cerebrovascular/terapia , Anciano , Evaluación de la Discapacidad , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Alta del Paciente/estadística & datos numéricos , Estudios Prospectivos , Recuperación de la Función , Accidente Cerebrovascular/fisiopatología , Rehabilitación de Accidente Cerebrovascular/métodos , Factores de Tiempo , Resultado del TratamientoRESUMEN
The outcome of stroke patients is complex and multidimensional. We evaluated the impact of acute-phase variables, including clinical state, complications, resource use and interventions, on 6-month survival after first-ever stroke, taking into account baseline conditions exerting a possible effect on outcome. As part of a National Research Program, we performed a prospective observational study of acute stroke patients in four Italian Regions. Consecutive patients admitted for a period of 3 months to the emergency rooms of participating hospitals were included. A total of 1030 patients were enrolled (median age 76.0 years, 52.1% males). At 6 months, 816 (79.2%) were alive, and 164 (15.9%) deceased. Survival status at the 6-month follow-up was missing for 50 (4.9%). Neurological state in the acute phase was significantly worse in patients deceased at 6 months, who showed also higher frequency of acute-phase complications. Cox regression analysis adjusted for demographics, pre-stroke function, baseline diseases and risk factors, indicated as significant predictors of 6-month death altered consciousness (HR, 1.70; 95% CI, 1.14-2.53), total anterior circulation infarct (HR, 2.13; 95% CI, 1.44-3.15), hyperthermia (HR, 1.70; 95% CI, 1.18-2.45), pneumonia (HR, 1.76; 95% CI, 1.18-2.61), heart failure (HR, 2.87; 95% CI, 1.34-6.13) and nasogastric feeding (HR, 2.35; 95% CI, 1.53-3.60), while antiplatelet therapy during acute phase (HR, 0.56; 95% CI, 0.39-0.79), and early mobilisation (HR, 0.55; 95% CI, 0.36-0.84) significantly increased 6-month survival. In a prospective observational study, stroke severity and some acute-phase complications, potentially modifiable, significantly increased the risk of 6-month death, independently of baseline variables. Early mobilisation positively affected survival, highlighting the role of early rehabilitation after stroke.