Comparison of "IN-REC-SUR-E" and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial).

BACKGROUND: Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). The goals of different methods of surfactant administration are to reduce the duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD); however, the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less-invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration. METHODS: In this study, 382 infants born at 24+0-27+6 weeks' gestation, not intubated in the delivery room and failing nasal continuous positive airway pressure (nCPAP) or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 h of life, will be randomized 1:1 to receive IN-REC-SUR-E or LISA surfactant administration. The primary outcome is a composite outcome of death or BPD at 36 weeks' postmenstrual age. The secondary outcomes are BPD at 36 weeks' postmenstrual age; death; pulse oximetry/fraction of inspired oxygen; severe intraventricular hemorrhage; pneumothorax; duration of respiratory support and oxygen therapy; pulmonary hemorrhage; patent ductus arteriosus undergoing treatment; percentage of infants receiving more doses of surfactant; periventricular leukomalacia, severe retinopathy of prematurity, necrotizing enterocolitis, sepsis; total in-hospital stay; systemic postnatal steroids; neurodevelopmental outcomes; and respiratory function testing at 24 months of age. Randomization will be centrally provided using both stratification and permuted blocks with random block sizes and block order. Stratification factors will include center and gestational age (24+0 to 25+6 weeks or 26+0 to 27+6 weeks). Analyses will be conducted in both intention-to-treat and per-protocol populations, utilizing a log-binomial regression model that corrects for stratification factors to estimate the adjusted relative risk (RR). DISCUSSION: This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24+0-27+6 weeks' gestation affected by RDS and failing nCPAP or NIPPV during the first 24 h of life, comparing IN-REC-SUR-E to LISA technique, in increasing BPD-free survival at 36 weeks' postmenstrual age of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.

Timing of oral feeding changes in premature infants who underwent osteopathic manipulative treatment.

BACKGROUND: The delayed transition from gavage-to-nipple feeding is one of the most significant factors that may prolong hospital length of stay (LOS). Osteopathic manipulative treatment (OMT) has been demonstrated to be effective regarding LOS reduction, but no investigations have documented its clinical validity for attaining oral feeding. OBJECTIVES: To assess OMT utility regarding the timing of oral feeding in healthy preterm infants. DESIGN: Preliminary propensity score-matched retrospective cohort study. SETTING: Data were extrapolated from the neonatal intensive care unit (NICU) of Del Ponte Hospital in Varese, Italy, during the period between March 2012 and December 2013. INTERVENTIONS: Two propensity score-matched groups of healthy preterm infants aged 28+0 to 33+6 were compared, observing those supported with OMT until hospital discharge and control subjects. MAIN OUTCOME MEASURES: Days from birth to the attainment of oral feeding was the primary endpoint. Body weight, body length, head circumference and LOS were considered as secondary endpoints. RESULTS: Seventy premature infants were included in the study as the control group (n = 35; body weight (BW) = 1457.9 ± 316.2 g; gestational age (GA) = 31.5 ± 1.73 wk) and the osteopathic group (n = 35; BW = 1509.6 ± 250.8 g; GA = 31.8 ± 1.64 wk). The two groups had analogous characteristics at study entry. In this cohort, we observed a significant reduction in TOF (-5.00 days; p = 0.042) in the osteopathic group with a greater effect in very low birth weight infants. CONCLUSIONS: These data demonstrate the utility and potential efficacy of OMT for the attainment of oral feeding. Further adequately powered clinical trials are recommended.

A surveillance system for diseases of companion animals in the Veneto region (Italy).

Experts and international public health organisations stress the lack of surveillance systems for companion animal diseases and the need to implement such surveillance as a priority of the 'One Health' perspective. This paper presents the features of a system for the collection, analysis, interpretation and dissemination of data regarding the health status of pets in the Veneto region (Italy). The system involved the construction of a Web-based database containing the diagnoses of transmissible and non-transmissible diseases of dogs and cats made by veterinarians in their practices, hospitals, kennels and catteries. Each diagnosis constitutes a single record, also containing data on the identification of the individual animal and on several characteristics of epidemiological relevance. The World Health Organization (WHO) 10th revision of the International Classification of Diseases (ICD-10) for human diseases has been adapted to canine and feline diseases to standardise the diagnostic nomenclature. Software has been specifically created for online data entry and data management. The first results show that the main disorders were digestive (21%), dermatological (18%) and cardiovascular (11%) among 1,087 diagnostic records in dogs, and digestive (23%), dermatological (15%) and urinary (14%) among 289 diagnostic records in cats. The main causes of death are represented by cardiovascular (21%) and gastrointestinal (21%) diseases in dogs and by urinary (31%) disorders in cats. At present, no institutional surveillance system for companion animal health exists in Italy, and veterinarians joining this project and sharing the outcomes of their clinical activity are acting on a voluntary basis.

Aussi bien les experts que les organisations internationales oeuvrant dans le domaine de la santé publique soulignent l'absence de systèmes de surveillance dédiés aux maladies des animaux de compagnie, alors que la mise en place de cette surveillance constitue une priorité dans une perspective « Une seule santé ¼. Les auteurs décrivent les caractéristiques d'un système introduit en Vénétie (Italie) pour collecter, analyser, interpréter et diffuser des données sur la situation sanitaire des animaux de compagnie. Le système repose sur une base de données en ligne alimentée par les rapports de diagnostic sur les maladies transmissibles et non transmissibles des chiens et des chats établis par les vétérinaires dans leur cabinet, à l'hôpital ou dans les élevages ou pensions pour chiens et chats. Chaque diagnostic fait l'objet d'une notification spécifique où sont également consignées les données d'identification individuelle de l'animal et les caractéristiques pertinentes au plan épidémiologique. La classification internationale statistique des maladies (ICD­10) de l'Organisation mondiale de la santé (OMS), qui concerne les maladies humaines, a été adaptée aux maladies des chiens et des chats afin d'utiliser une nomenclature standardisée des diagnostics. Un logiciel spécifique a été créé pour la saisie en ligne des données et leur gestion. D'après les premiers résultats, les principales affections diagnostiquées étaient, chez le chien (sur 1 087 rapports de diagnostic), des maladies digestives (21 %), dermatologiques (18 %) et cardio-vasculaires (11 %) et, chez le chat (sur 289 rapports de diagnostic), des maladies digestives (23 %), dermatologiques (15 %) et urinaires (14 %). Les principales causes de mortalité étaient respectivement les maladies cardio-vasculaires (21 %) et gastro-intestinales (21 %) chez le chien et les maladies du système urinaire (31 %) chez le chat. À l'heure actuelle, aucun système institutionnel de surveillance n'est en place en Italie pour les animaux de compagnie, de sorte que les vétérinaires qui participent à ce projet et partagent leurs résultats cliniques le font sur une base volontaire.

Tanto especialistas como organizaciones internacionales dedicadas a temas de salud pública hacen hincapié en la ausencia de sistemas de vigilancia de las enfermedades de los animales de compañía y en la necesidad de instaurar tal vigilancia como elemento prioritario de los planteamientos de «Una sola salud¼. Los autores presentan las características de un sistema destinado a reunir, analizar, interpretar y difundir datos sobre el estado de salud de los animales de compañía en la región italiana del Veneto. Para instituir ese sistema se creó una base de datos en línea que centraliza información sobre los diagnósticos de enfermedades transmisibles y no transmisibles de perros y gatos realizados por veterinarios en el ejercicio de su labor en consultorios, hospitales y residencias caninas y felinas. Cada diagnóstico constituye un registro único, que también contiene datos sobre la identidad del animal en cuestión y sobre una serie de aspectos de importancia epidemiológica. Con objeto de normalizar la nomenclatura de diagnóstico se adaptó a las enfermedades caninas y felinas la Clasificación Internacional de Enfermedades, décima revisión (CIE­10), de la Organización Mundial de la Salud (OMS), que se aplica a las enfermedades humanas. También se crearon programas informáticos destinados específicamente a la introducción de datos en línea y a su gestión. Los primeros resultados muestran que los principales trastornos en los perros, de los 1.087 diagnósticos registrados, fueron los digestivos (21%), seguidos de los dermatológicos (18%) y los cardiovasculares (11%). En el caso de los gatos, con 289 diagnósticos registrados, las dolencias más importantes fueron las digestivas (23%), las dermatológicas (15%) y las urinarias (14%). En el perro, las principales causas de mortalidad fueron las enfermedades cardiovasculares (21%) y gastrointestinales (21%), y en el gato las patologías urinarias (31%). Actualmente no existe en Italia ningún sistema institucional de vigilancia de la salud de los animales de compañía, y los veterinarios que participan en este proyecto y comparten los resultados de su praxis clínica lo hacen con carácter voluntario.

Interobserver reliability to interpret intrapartum electronic fetal heart rate monitoring: Does a standardized algorithm improve agreement among clinicians?

Our aim was to investigate the accuracy in predicting intrapartum fetal acidaemia and the interobserver reproducibility of a mathematical algorithm for the interpretation of electronic fetal heart rate (FHR) monitoring throughout labour. Eight physicians (blinded to the clinical outcomes of the deliveries) evaluated four randomly selected intrapartum FHR tracings by common visual interpretation, trying to predict umbilical artery base excess at birth. They subsequently were asked to re-evaluate the tracings using a mathematical algorithm for FHR tracing interpretation. Common visual interpretation allowed a correct estimation of the umbilical artery base excess in 34.4% of cases, with a poor interobserver reproducibility (Kappa correlation coefficient = 0.24). After implementation of the algorithm, the proportion of correct estimates significantly increased to 90.6% (p < 0.001), with excellent inter-clinician agreement (κ: 0.85). To conclude, incorporation of a standardised algorithm reduces the interobserver variability and allows a better estimation of fetal acidaemia at birth.

Cross-cultural adaptation and preliminary test-retest reliability of the Italian version of the Complexity Rehabilitation Scale-Extended (13th version).

BACKGROUND: In Italy, the lack of appropriate use of intensive rehabilitative services is an acknowledged issue, as demonstrated by periodic epidemiological surveys. Rehabilitation activities are planned without considering the clinical complexity, known to be one of the most fundamental factors able to outline the real patients' needs on recently clinical practice rehabilitation guidelines. Alternative diagnostic systems become, therefore, necessary. For this reason, we would like to propose the Rehabilitation Complexity Scale - Extended version (RCS-E) within intensive rehabilitation units in Emilia Romagna. AIM: This study aims at submitting an Italian translation, cross-cultural adaptation and preliminary reliability evaluation of the Rehabilitation Complexity Scale Extended (13th Version) (RCS-E). DESIGN: Face validity and test-retest reliability. SETTING: The study was conducted in three different rehabilitation units of the Emilia Romagna region, Northern Italy. POPULATION: Ten expert physicians and 51 Intensive (code 56) rehabilitation in-patients were recruited. METHODS: A cross-cultural adaptation of the scale was built from English into Italian, closely complying with international guidelines. Face validity and test-retest reliability were carried out to evaluate the comprehensibility and goodness of fit of the new scale. RESULTS: An overall positive judgement was obtained with the face validity test. No significant differences were observed between the original and the adapted scale scoring. Internal consistency measured on 51 patients by Cronbach's alpha was 0.702 for the scale. The estimated SEM was 1.211. ICCconsistency was 0.702. Split-Half reliability and the Spearman-Brown prophecy were 0.633 and 0.775, respectively. Test-retest reliability of the RCS-E measured with ICCagreement was 0.903. CONCLUSION: The adapted RCS-E provides a sensitive and reliable tool that appears to be suitable for measuring clinical complexity in Italian code 56 rehabilitation units. It is the first Italian version of the scale to be devised. CLINICAL REHABILITATION IMPACT: Further statistical validation will assess the Italian RCS-E as a possible instrument for guiding the patients' assignment to the rehabilitation settings that best suit their specific needs. These preliminary data represent the first step through this purpose.

Prediction of fetal base excess values at birth using an algorithm to interpret fetal heart rate tracings: a retrospective validation.

OBJECTIVE: To evaluate whether a standardised algorithm to interpret fetal heart rate (FHR) tracings during the entire length of labour can predict umbilical artery base excess at birth, and to investigate its inter- and intra-observer reproducibility. DESIGN: Retrospective study. SETTING: Obstetrics and gynaecology department at a tertiary referral centre in a university hospital. POPULATION: Group 1: 152 consecutive, generally low-risk, labouring women. Group 2: mixed group of 30 women who delivered a fetus with pH < 7.00 and 30 women who delivered a fetus with pH ≥ 7.00. METHODS: Intrapartum FHR tracings were retrospectively and blindly evaluated by two independent assessors using an algorithm proposed by Ross and Gala to predict fetal base excess at birth. MAIN OUTCOME MEASURES: The accuracy in predicting the base excess values of newborns was expressed as the proportion of FHR tracings in which the operator was able to correctly calculate the actual base excess at birth (approximation of ± 2 mmol/l). Inter- and intra-observer reproducibility were estimated using the Pearson correlation coefficient. RESULTS: In the group of 152 low-risk labouring women, the two assessors correctly predicted the umbilical artery base excess in 73.1 and 76.3% of cases, respectively. Inter-observer (Pearson correlation coefficient = 0.75) and intra-observer (Pearson correlation coefficient = 0.80 and 0.82 for the first and second assessor, respectively) reproducibility was very good. In the 30 fetuses that were acidemic, the first and second observers correctly predicted base excess values in 23 (76.7%) and 21 (70%) cases, respectively (inter-observer reproducibility, Pearson correlation coefficient = 0.72). CONCLUSIONS: The algorithm proposed by Ross and Gala may be a valuable tool to estimate changes in umbilical base excess during active labour, with a high inter- and intra-observer reproducibility.

High-flow nasal cannula: transient fashion or new method of non-invasive ventilatory assistance?

Respiratory failure in the premature infants remains a difficult challenge. An alternative to the use of nasal continuous positive airway pressure (NCPAP) as a non-invasive modality to support respiratory distress in premature infants has been the recent introduction of high flow nasal cannula (HFNC) devices in many neonatal units. There has been increased use of HFNC presumably because of anecdotal reports and experience that it is easy to use, and well tolerated by the infants, while experiencing decreased nasal septumerosion. The paucity of evidence regarding its efficacy and safety, would support a caution approach to the use of HFNC. Particular concern has focused on the imprecise regulation and generation of pressure that may occur at higher flows especially in the smallest of infants.

Early retinol-binding protein levels are associated with growth changes in infants born to diabetic mothers.

BACKGROUND: Biochemical predictors of infants' growth changes are not available. OBJECTIVES: We tested whether retinol-binding protein (RBP), docosahexaenoic acid and insulin (I) measured within 72 h from birth are associated with growth changes in infants born to mothers with gestational diabetes mellitus (GDM). METHODS: Fifty-six children, 32 born to diabetic mothers treated with insulin (GDM-I) and 24 born to diabetic mothers treated with diet (GDM-D), were evaluated at 0, 1, 3, 6 and 12 months of life. RESULTS: At multivariable regression performed using generalized estimating equations, early RBP levels and maternal body mass index were associated to average weight changes and early RBP and insulin levels to average length changes, respectively. There was no difference between GDM-I and GDM-D infants. CONCLUSIONS: This exploratory study suggests that early RBP levels may be a predictor of growth changes.

Sport, free time and hobbies in people with spinal cord injury.

STUDY DESIGN: Prospective, multicenter follow-up (F-U) observational study. OBJECTIVES: To investigate the changes in participation and sports practice of people after spinal cord injury (SCI) and their impact on perceived quality of life (QoL). METHODS: The questionnaire investigated the health status and management of clinical conditions and attendance of social integration, occupation, autonomy, car driving, sentimental relationships and perceived QoL in a SCI population 4 years after the first rehabilitation hospitalization. RESULTS: Respondents were 403, 83.4% male; 39% was tetraplegic. At F-U, 42.1% worked and studied, 42.2% still held their jobs or studies, and 69% drove the car. In all, 77.2% had bowel continence and 40.4% urinary continence. The results showed that for the 68.2% of respondents, the attendance of friends, relatives and colleagues during their free time was the same or increased compared with the time before the injury, whereas 31.8% showed a decrease. The amount of time the 52.1% of respondents left home was the same or increased compared with before the trauma, whereas 50.6% of the respondents said that the time they were engaged in hobbies was either the same or increased. CONCLUSION: SCI people who perceived their QoL as being higher, and whose attendance, autonomy and time was increased in respect to hobbies, were mainly men with an age range between 36 and 40 years, unmarried, paraplegic and with A-B Asia Score. Regarding the amount of time dedicated to practicing sports, the only difference was the most of that respondents, who indicated a decrease, were women.

Is health-related-quality of life of stroke patients influenced by neurological impairments at one year after stroke?

AIM: The aim of this study was to evaluate which neurological impairments on discharge from rehabilitation services are associated with a worse outcome in terms of health related-quality of life (HRQoL) one year after stroke. METHODS: We enrolled 528 first-time stroke patients in a multicenter observational study involving 18 Italian inpatients rehabilitation centers. Neurological impairment-related factors, socio-demographic and general clinical variables and process indicators were considered independent variables at discharge. Outcome was represented by the following dependent variables of HRQoL: EuroQoL-5D questionnaire (5D-EQoL) and its derived index (Eq-Index) and a Visual Analogue Score (QoL-VAS). RESULTS: The strongest predictors of lower HRQoL were an incomplete limbs motor recovery. An incomplete lower limb motor recovery was associated with a lower HRQoL only in the "mobility" domains, whereas a incomplete upper limb motor recovery could predict a lower HRQoL in all domains except "mobility". Regarding cognitive impairments, the presence of neglect at discharge was associated with a lower HRQoL in "self-care", "pain-discomfort" and "anxiety-depression". Female gender, presence of urinary catheter seemed to exert a much lesser role in predicting HRQoL. CONCLUSION: The results of this study suggest that upper limb motor impairments may have a detrimental impact on the patient's perceived HRQoL one year after stroke.

Rehabilitation in patients affected by different types of stroke. A one-year follow-up study.

AIM: Stroke is the third highest cause of death and the leading cause of chronic disability in adults in Italy. More than half of patients who survive the first month after a stroke will require specialised rehabilitation. Rehabilitation is, however, an expensive and limited resource, and its success depends on careful selection of patients. The aim of this study was to identify the functional ability at discharge and after one-year of follow-up in a large sample of first-time stroke patients from a rehabilitation hospital according to the stroke Oxfordshire Community Stroke Project (OCSP) criteria. METHODS: A multicenter observational study was conducted among 1023 first-time stroke patients who were admitted to 18 different Italian inpatient rehabilitation centres between February 1999 and November 2000. The study population consisted of 946 (92.4%) of the 1023 enrolled at baseline. Each patient has been first evaluated within 72 h after admission and, on a second occasion, within 72 h before discharge. From the 722 ischemic strokes evaluated at baseline, after one-year of follow-up 76 participants died. From the survived 646 patients, we had 513 (79.0%) participants both evaluated at baseline and after one-year of follow-up. Clinical data regarding stroke type and ischemic stroke clinical syndrome, according to the Oxfordshire Community Stroke Project (OCSP) criteria; the degree of impairment, both motor (assessed by Barthel Index [BI], Motricity Index, and Trunk Control Test) and neuropsychological (assessed by the Mini Mental State Examination, and the presence of aphasia or neglect); the extent of disability, as assessed by Functional Independence Scale (FIM) and the evidence of concomitant prespecified medical complications, as well as of dysphasia and of the need of indwelling urinary catheter. Other variables were taken into account, such as the time interval between stroke onset and admission to rehabilitation ward and the length of stay. To assess stroke outcome, two different indexes were selected: the frequency of home discharge and the extent of functional recovery. RESULTS: There were 722 (76.3%) ischemic and 224 (23.7%) hemorrhagic strokes. Among ischemic strokes, the partial anterior circulation infarct was the most frequent syndrome, accounting for the 33.2% of cases. The posterior circulation infarct syndrome was the less frequent (14.1%). Lacunar anterior circulation infarct was present for the 29.5% and finally, the total anterior circulation infarct (TACI) was present for the 23.2%. According to the OCSP criteria, the TACI syndrome received 76.1±52.9 (mean±SD) days of rehabilitation, which were statistically different from the other three types of stroke. At discharge, the BI and the FIM of patients affected by TACI was significantly lower and higher, respectively, from the other three type of stroke. However, this difference disappear after one-year of follow-up. CONCLUSION: The TACI subtype of stroke required higher days of rehabilitation from the other type of stroke according to the OCSP criteria. Rehabilitation program is efficacious for improving functional ability of patients affected by stroke although the program should be tailored according to the stroke type.

Mirror neurons: action observation treatment as a tool in stroke rehabilitation.

BACKGROUND: The observation of actions performed by others activate in an observer the same neural structures (including mirror neurons) as when he/she actually performs the same actions. AIM: The aim of the present study was to assess whether action observation treatment may improve upper limb motor impairment in chronic stroke patients. DESIGN: This was an observational study. SETTING: Patients were recruited by three Italian Centres for Neurorehabilitation between 2006 and 2008. POPULATION: Twenty-eight chronic stroke patients with upper limb impairment have undergone for four weeks, five days a week, a rehabilitation treatment based on observation of video-clips presenting hand daily actions, followed by the imitation of those same actions with the affected limb. METHODS: Functional evaluation by means of Modified Barthel Index (MBI), Frenchay Arm Test (FAT) and Fugl Meyer (FM) was carried out twice before treatment (BT1 and BT2), at an interval of 15 days, then after treatment (AT1) and finally at a two-month follow-up (AT2). Wilcoxon Signed Rank test was applied to test differences between scores obtained from functional scales before and after treatment (BT1 vs. BT2; BT2 vs. AT1; AT1 vs. AT2). RESULTS: In all scales, scores did not differ when comparing BT1 with BT2. Scores improved significantly in all scales at AT1 as compared to BT2 (MBI, P=0.026; FAT, P=0.005; FM, P=0.001). This improvement was still present at the two-month follow-up as testified by no score difference between AT1 and AT2. CONCLUSION: Action Observation Treatment may become a useful strategy in the rehabilitation of stroke patients. CLINICAL REHABILITATION IMPACT: The present preliminary study suggests that stimulation of neural structures (including mirror neurons), activated when the patients actually perform the same actions as those observed could constitute a good alternative rehabilitative approach in chronic stroke patients.

The Italian version of the Mayo-Portland Adaptability Inventory-4. A new measure of brain injury outcome.

AIM: The assessment of major obstacles to community integration which may result from an acquired brain injury (ABI) is needed for rational planning and effective management of ABI patients' social adjustment. Currently, such a generally acceptable measure is not available for the Italian population. This paper reports the translation process, the internal consistency, and the inter-rater reliability data for the Italian version of the Mayo-Portland Adaptability Inventory-4 (MPAI-4), a useful measure with highly developed and well documented psychometric properties. The MPAI-4 is specifically designed to assess socially relevant aspects of physical status and cognitive-behavioural competence following ABI. It is a 29-item inventory which is divided into three subdomains (Abilities, Adjustment, and Participation indices) covering a reasonably representative range METHODS: Twenty ABI patients with at least one-year discharge from the rehabilitation facilities were submitted to the Italian MPAI-4. They were independently rated by two different rehabilitation professionals and a family member/significant other serving as informant (SO). Internal consistency was assessed by calculating the Cronbach's alpha values. Inter-rater agreement for individual items was statistically examined by determining the interclass correlation coefficient (ICC). RESULTS: In addition to the 8% of perfectly correspondent sentences, a clear prevalence (75.5%) of minor semantic variations and formal variations with no semantic value at the sentence-to-sentence matching was found. Full-scale Cronbach's alpha was 0.951 and 0.947 for the two professionals (rater #1 and rater #2, respectively), and was 0.957 for the family member serving as informant (rater #3). Full-Scale ICC (2.1) between professionals and SOs was 0.804 (CI=95%; lower-upper bound=0.688-0.901). CONCLUSIONS: The Italian MPAI-4 shares many psychometric features with the original English version, demonstrates both good internal consistency and good inter-rater reliability. The MPAI-4 confirms to be suitable for research applications in postacute settings as an efficient, broad and inclusive outcome measure for adult subjects with ABI.

Developing a minimum data set for stroke patients assessment: the " Protocollo di Minima per l'Ictus (PMIC) as a starting point towards an Italian stroke registry.

AIM: The complex nature of stroke sequelae requires several assessment instruments to quantify correctly every residual symptom. As there was no general consensus on stroke evaluation among Italian Physiatrists, in 2004 the Italian Society of Physical Medicine and Rehabilitation and S. Lucia Foundation (a Scientific Institute for hospitalization and treatment) established a Project Group to propose a standardized assessment tool (''Protocollo di Minima per l'Ictus PMIC'') for acute, post-acute and community-living stroke patients. This tool aimed to be easy to use and comprehensive of all the elements necessary for accurately address the great range of different rehabilitation needs. The objective was to provide physiatrists with a standard assessment battery and to make prognostic factors available on large community samples. METHODS: From end 2004 to early 2006, the Project Group examined literature data on stroke assessment, prognostic factors and outcome and selected the specific data elements to be included in a data collection tool. RESULTS: A consensus was reached on a ''minimum'' core set of data. This protocol was peer submitted in early 2006, to test the burden of data collection, and to allow modifications and adjustments. Specific forms (file to download) for data collection and database to be shared (a dedicated ''Client'' software) are now freely offered by the Project Group for data collection. CONCLUSION: PMIC is an evaluation procedure manageable in every-day practice and in every setting, a quick screening instrument that, given its large diffusion, can be expanded from a National Database into a National Rehabilitation Stroke Registry.

Outcome predictors of rehabilitation for first stroke in the elderly.

AIM: The prediction of stroke outcome in the elderly can be rather difficult, due to the potential interference into disability and handicap development of several clinical modifiers, such as comorbidity, medical complications, neuropsychological impairment proper to the aging brain and social issues. These factors can strongly affect old patient response to rehabilitation and need to be taken into account, along with ageing per se, to optimize health resource efficiency for the care of disability due to stroke. In this study, we tried to identify outcome determinants of stroke rehabilitation specific for the elderly. METHODS: A total of 359 first-stroke patients aged 75 years, admitted for active rehabilitation treatment to hospital rehabilitation wards, were enrolled into a multicenter cohort (prospective) study. They all underwent a comprehensive medical rehabilitation program. We considered as primary outcomes the frequency of home discharge and the extent of functional recovery, assessed by Functional Independence Scale (FIM) and expressed as the Montebello Rehabilitation Factor Score (MRFS) efficacy. Each measure of outcome was related to age, as well as other potential clinical and functional confounders, according to a multivariate model. For each dependent variable, two models were developed, using either FIM total score or FIM domains scores at admission among predictors. RESULTS: FIM total score increased from 55.8+/-24 to 75.3+/-30 (P<0.0001), with a mean MRFS efficacy of 0.33+/-0.25. Most patients (79.9%) were discharged home. Age turned out as independently and inversely related to MRFS, explaining at the most 3.6% of its variance, although FIM at admission was its most powerful predictor. Home discharge was not related to age, but to social issues, such as living in family before admission, and cognition. CONCLUSION: The present study suggests that rehabilitation can be effective in elderly stroke patients, in improving function as well as in favorably affecting discharge destination. In fact, age per se predicts the outcome at a lesser extent than other clinical covariates, such as functional and cognitive status at admission and social situation.

Severity of meningococcal infections is related to anthropometrical parameters.

BACKGROUND: Invasive meningococcal infections remain an important cause of death in children. In addition, malnutrition has been classically associated with increased severity of infectious diseases. However, in our experience lethal meningococcaemia in clinically malnourished children is extremely rare. Our purpose was to determine whether there is an association between nutritional status and outcome in children with invasive meningococcal infection. METHODS: We carried out an observational study and prospectively determined anthropometrical parameters in 127 children aged 1 month to 4 years with invasive meningococcal infection seen in our inpatient facilities from August 1999 to May 2004. Severity and survival were the clinical end points analysed. RESULTS: Children with severe disease had higher weight for age (1.02 vs -0.19) and height for age (1.12 vs -0.58) z scores than those with non-severe disease. Non-survivors had higher weight for age (0.90 vs -0.16) and height for age (0.73 vs -0.57) z scores than survivors. Clinical and biological variables usually accepted as predictors of high mortality or severity in patients with meningococcal infection were not significantly associated with weight for age and height for age z scores. CONCLUSION: In the present prospective series of children with invasive meningococcal disease, severity and death were linked to anthropometrical parameters and seemed to be associated with a very good nutritional status, which confirmed our previous uncontrolled observations.

A multicentre follow-up of clinical aspects of traumatic spinal cord injury.

STUDY DESIGN: Prospective, multicentred follow-up (FU) observational study. OBJECTIVES: Prospectively evaluate survival, complications, re-admissions and maintenance of clinical outcome in people experiencing traumatic spinal cord injury (SCI). SETTING: Seven spinal units and 17 rehabilitation centres participating in the previous GISEM (ie Italian Group for the Epidemiological Study of Spinal Cord Injuries) study. METHOD: A total of 511 persons with SCI, discharged between 1997 and 1999 after their first hospitalisation, were enrolled. A standardised questionnaire was administered via telephone. RESULTS: Of the 608 persons originally enrolled, 36 died between discharge and follow-up (mean 3.8+/-0.64 years). Of the remainder, 403 completed telephone interviews, 72 refused to participate and 97 could not be contacted. More than half of the patients interviewed (53.6%) experienced at least one SCI-related clinical problem in the 6 months preceding interview; the most frequent being urological complications (53.7%). At least one re-admission was recorded in 56.8% of patients between discharge and FU interview. Of the patients interviewed, 70.5% reported bowel autonomy and 86% bladder management autonomy. On multivariate analysis, lack of bowel/bladder autonomy was the most common variable with a strong predicting value for mortality, occurrence of complications and re-admissions. CONCLUSION: Re-admission and major complications seem common after SCI and should be considered when planning facilities. Failure to obtain bowel/bladder autonomy upon discharge from rehabilitation proved to be the most common predictive factor of poor outcome during the period between discharge and FU interview.

Quality of life and aphasia. Multicentric standardization of a questionnaire.

AIM: It is important to assess aphasics' quality of life in order to plan a rehabilitation treatment. To date such a tool is still missing for Italian patients. This paper reports normative data of the Italian version of SAQOL-39, a British questionnaire aimed to assess aphasics' quality of life. It consists of 39 items, divided into 4 subdomains (Physical, Communication, Psychosocial and Energy). METHODS: Forty-two patients coming from 3 different Speech Therapy Services were enrolled. All patients completed speech therapy before examination. They were submitted to the Italian SAQOL-39 and 2 screening tests for aphasia: 1) Communication Assessment Scale according Goodglass and Kaplan; 2) Franchay Aphasia Screening Test (FAST). A receptive FAST score of 7 out of 15 was used as a cut-off score for SAQOL-39 administration. RESULTS: The Italian SAQOL-39 showed good internal consistency (full scale Cronbach's alpha 0.939). Cronbach's alpha for every subdomains ranged from 0.950 (Communication) to 0.720 (Energy). Fluent aphasics gave significantly higher scores than nonfluent ones on full scale, and all out of Energy subdomains. Furthermore gravity of aphasia correlated with both full scale and Communication subdomain scores. CONCLUSIONS: In authors' opinion, the Italian SAQOL-39 shares many psychometric features with the English one. This questionnaire seems to be suitable for clinical practice.

Molecular and genomic characterisation of cryptic chromosomal alterations leading to paternal duplication of the 11p15.5 Beckwith-Wiedemann region.

BACKGROUND: Beckwith-Wiedemann syndrome (BWS) is an overgrowth disorder with increased risk of paediatric tumours. The aetiology involves epigenetic and genetic alterations affecting the 11p15 region, methylation of the differentially methylated DMR2 region being the most common defect, while less frequent aetiologies include mosaic paternal 11p uniparental disomy (11patUPD), maternally inherited mutations of the CDKN1C gene, and hypermethylation of DMR1. A few patients have cytogenetic abnormalities involving 11p15.5. METHODS: Screening of 70 trios of BWS probands for 11p mosaic paternal UPD and for cryptic cytogenetic rearrangements using microsatellite segregation analysis identified a profile compatible with paternal 11p15 duplication in two patients. RESULTS: Fluorescence in situ hybridisation analysis revealed in one case the unbalanced translocation der(21)t(11;21)(p15.4;q22.3) originated from missegregation of a cryptic paternal balanced translocation. The second patient, trisomic for D11S1318, carried a small de novo dup(11)(p15.5p15.5), resulting from unequal recombination at paternal meiosis I. The duplicated region involves only IC1 and spares IC2/LIT1, as shown by fluorescent in situ hybridisation (FISH) mapping of the proximal duplication breakpoint within the amino-terminal part of KvLQT1. CONCLUSIONS: An additional patient with Wolf-Hirschorn syndrome was shown by FISH studies to carry a der(4)t(4;11)(p16.3;p15.4), contributed by a balanced translocation father. Interestingly, refined breakpoint mapping on 11p and the critical regions on the partner 21q and 4p chromosomal regions suggested that both translocations affecting 11p15.4 are mediated by segmental duplications. These findings of chromosomal rearrangements affecting 11p15.5-15.4 provide a tool to further dissect the genomics of the BWS region and the pathogenesis of this imprinting disorder.