rubrica

Comparabilità e valutazione dei servizi sanitari

  • Marina Davoli1

  • Nerina Agabiti1

  1. Dipartimento di epidemiologia del servizio sanitario regionale, Lazio
Nera Agabiti -

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Ricerca bibliografica periodo 16 gennaio 2011 – 1 aprile 2011

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Database: Pubmed/MEDline
Stringa: (((“Quality Indicators, Health Care"[Mesh] OR "Quality Assurance, Health Care"[Mesh] OR "Outcome Assessment (Health Care)" [Mesh:NoExp] OR Outcome* [tiab] OR “quality indicators” [tiab], OR appropriateness [tiab] OR indicator* [TIAB] OR procedure [TIAB] OR efficacy[tiab] OR effectiveness[tiab]) AND ("hospitals"[MeSH] OR hospital[tiab] OR mortality[tw] OR patient* [tiab]) AND (italy[mesh] OR ital* [tiab] OR ita [la] OR ital* [ad]) AND ("2011/01/16"[PDAT] : "2011/04/01"[PDAT])) NOT ((animals [mesh] NOT humans [mesh]) OR "Genetics"[Mesh] OR "Neurophysiology"[Mesh] "Drug Therapy"[Mesh] OR "Naturopathy"[Mesh] OR "drug therapy "[Subheading] OR Editorial[ptyp] OR "Case Reports "[Publication Type] OR Letter[ptyp] OR Clinical Trial, Phase I[ptyp] OR Clinical Trial, Phase II[ptyp]))

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1. Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, Antoniucci D, Napodano M, De Carlo M, Fiorina C, Ussia GP. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011 Jan 25;123(3):299-308. Epub 2011 Jan 10.
Cardiology Department, Ferrarotto Hospital, University of Catania, Catania, Italy. dcapodanno@gmail.com
Abstract
BACKGROUND: There is a lack of information on the incidence and predictors of early mortality at 30 days and late mortality between 30 days and 1 year after transcatheter aortic valve implantation (TAVI) with the self-expanding CoreValve Revalving prosthesis.
METHODS AND RESULTS: A total of 663 consecutive patients (mean age 81.0 ± 7.3 years) underwent TAVI with the third generation 18-Fr CoreValve device in 14 centers. Procedural success and intraprocedural mortality were 98% and 0.9%, respectively. The cumulative incidences of mortality were 5.4% at 30 days, 12.2% at 6 months, and 15.0% at 1 year. The incidence density of mortality was 12.3 per 100 person-year of observation. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year. Paravalvular leakages were trace to mild in the majority of cases. Conversion to open heart surgery (odds ratio [OR] 38.68), cardiac tamponade (OR 10.97), major access site complications (OR 8.47), left ventricular ejection fraction <40% (OR 3.51), prior balloon valvuloplasty (OR 2.87), and diabetes mellitus (OR 2.66) were independent predictors of mortality at 30 days, whereas prior stroke (hazard ratio [HR] 5.47), postprocedural paravalvular leak ≥ 2+ (HR 3.79), prior acute pulmonary edema (HR 2.70), and chronic kidney disease (HR 2.53) were independent predictors of mortality between 30 days and 1 year.
CONCLUSIONS: Benefit of TAVI with the CoreValve Revalving System is maintained over time up to 1 year, with acceptable mortality rates at various time points. Although procedural complications are strongly associated with early mortality at 30 days, comorbidities and postprocedural paravalvular aortic regurgitation ≥ 2+ mainly impact late outcomes between 30 days and 1 year.
2. Foti C, Cisari C, Carda S, Giordan N, Rocco A, Frizziero A, Della Bella G. A prospective observational study of the clinical efficacy and safety of intra-articular sodium hyaluronate in synovial joints with osteoarthritis. Eur J Phys Rehabil Med. 2011 Mar 15. [Epub ahead of print]
Physical and Rehabilitation Medicine Chair, Tor Vergata University, Rome, Italy2 Division of Physical and Rehabilitative Medicine, Amedeo Avogadro Piemonte Orientale University, Novara, Italy3 Fidia Farmaceutici, Clinical Research, Abano Terme, Padua, Italy4 Department of Anatomic Science and Musculo-skeletal Physiopathology, Movement Analysis Laboratory, Rizzoli Orthopedic InstituteBologna University, Bologna, Italy - foti@med.uniroma2.it.
Abstract
BACKGROUND: Clinical trials have demonstrated the safety and efficacy of hyaluronic acid-based products for the treatment of synovial joints affected by osteoarthritis (OA), but data from observational studies of normal medical practice are sparse. AIM: This study investigated the safety and efficacy of intra-articular (IA) sodium hyaluronate (MW 1500-2000 KDa; Hyalubrix®) in the treatment of synovial joint OA.
DESIGN: This is prospective, and observational study.
SETTING: This study was carried out at 47 specialist centers for physiatrists, orthopedics and rheumatology in Italy; the enrolled population, 1266 outpatient, was predominantly female (66%, 840/1266), with a mean age of 66 years, and a mean weight of 74 kg.
POPULATION: The Participants with OA received IA injections of the study treatment (2 mL) once per week for 3 weeks. The knee was the joint most commonly affected by OA (right knee 802/1266 [63%]; left knee 598/1266 [47%]), and the longest median duration of disease occurred in the carpal joint (right carpal joint 40 months; left carpal joint 60 months). METHODS: The primary endpoints were tolerability and details of usage of the IA sodium hyaluronate syringe device. Efficacy parameters included assessment of self-reported pain via the Visual Analogue Scale (VAS), and evaluation of motor function via the Health Assessment Questionnaire (HAQ). Quality of life (QoL) was assessed using the Euro QoL questionnaire (Clinical Trial Registration Number: ISRCTN 42690497).
RESULTS: Data from 1266 participants were collected. The adverse event (AE) rate was 0.8% (95% CI, 0.4 to 1.5). Thirteen AEs were reported, 12 of which were mild or moderate in severity. Only one participant discontinued study treatment following an AE. No serious adverse events occurred. Co-administration of local anesthetic was required by up to 10% of patients. Statistically significant improvements in VAS, HAQ and EuroQoL were recorded in multiple joints (P<0.0001 for each).
CONCLUSION: The study treatment was safe and well tolerated. Clinical rehabilitation impact. The study treatment reduced pain, improved mobility, and increased QoL in participants with OA.
3. Biagi P, Gussoni G, Iori I, Nardi R, Mathieu G, Mazzone A, Panuccio D, Scanelli G, Cicatello C, Rinollo C, Muriago M, Galasso D, Bonizzoni E, Vescovo G; on behalf of the CONFINE Study Group. Clinical profile and predictors of in-hospital outcome in patients with heart failure: The FADOI "CONFINE" Study. Int J Cardiol. 2011 Mar 10. [Epub ahead of print]
Internal Medicine, Hospital of Montepulciano, Italy.
Abstract
BACKGROUND: Heart failure (HF) is a major health and social problem. Internal Medicine (IM) wards admit a high proportion of patients with HF, frequently with advanced age and comorbidities. Few recent data are available in this setting, especially on predictors of in-hospital outcome.
METHODS: In this observational study, we recruited patients admitted with diagnosis of HF and present in five index days, in 91 units of IM in Italy. Characteristics and management of HF, comorbidities, functional and cognitive status, and quality of life, were analyzed.
RESULTS: We observed 1411 patients, with a mean age of 78.7±9.6years. At admission, 81.7% of the patients were in NYHA classes III-IV. Ninety percent of the patients had at least one comorbidity. Dementia or severely impaired functional status were registered in 21.5% and 22.8% of the patients. In 89 patients (6,3%) a negative outcome (death or clinical worsening) occurred during hospitalization. A number of variables were significantly related to negative outcome by means of univariate analysis (systolic blood pressure <100mmHg, pulse pressure ≥55mmHg, anaemia, brain deficit, permanent bed rest, Barthel Index ≤30). At multivariable analysis, significant correlation was retained by anaemia and Barthel Index ≤30, the latter being the strongest predictor.
CONCLUSIONS: Real-world patients with HF and hospitalized in IM are frequently very old, frail and with multiple comorbidities. Functional and cognitive status significantly influence patients' outcome, and this could lead to a rethinking of the overall (in-hospital but also home-based) management of HF.
4. Dal Negro R, Bonadiman L, Tognella S, Micheletto C, Turco P. The impact of LABA+ICS fixed combinations on morbidity and economic burden of COPD in Italy: a six-year observational study. Ther Adv Respir Dis. 2011 Apr;5(2):83-90. Epub 2010 Nov 18.
Lung Department, Orlandi General Hospital, via Ospedale 2, Bussolengo 37012, Verona, Italy.
Abstract
BACKGROUND: In Italy, chronic obstructive pulmonary disease (COPD) has progressively received increasing attention in the last decade, and its impact has been investigated extensively in both clinical and pharmacoeconomic terms.
METHODS: In 2004, the national health authorities stated the appropriateness of long-acting β(2) agonists (LABA) and inhaled corticosteroids (ICS) fixed combinations for treating COPD, even though this pharmaceutical option was limited to the severe and very severe stages of the disease (forced expiratory volume in one second [FEV(1)] <50% predicted). The effectiveness in primary care of this official recommendation has been investigated in 1125 COPD patients together with the appropriateness of the therapeutic approach to the disease.
RESULTS and CONCLUSIONS: Clinical and economic outcomes were monitored over the 3 years before (2001-2003) and the 3 years following this recommendation (2004-2006), and statistically compared (t-test). In general, the overall impact of COPD changed progressively after the pronunciation of the public health authorities. In particular, since the point when LABA/ICS fixed combinations were officially recommended, both morbidity of COPD and the corresponding consumption of healthcare resources have progressively lowered. Moreover, the appropriateness of the pharmaceutical approach increased in the same period, thus emphasizing the importance of the optimization of therapeutic strategies in reducing the long-term impact of the disease.
5. Gaita F, Leclercq JF, Schumacher B, Scaglione M, Toso E, Halimi F, Schade A, Froehner S, Ziegler V, Sergi D, Cesarani F, Blandino A. Incidence of Silent Cerebral Thromboembolic Lesions After Atrial Fibrillation Ablation May Change According To Technology Used: Comparison of Irrigated Radiofrequency, Multipolar Nonirrigated Catheter and Cryoballoon. J Cardiovasc Electrophysiol. 2011 Mar 31. doi: 10.1111/j.1540-8167.2011.02050.x. [Epub ahead of print]
Cardiology Division, Department of Internal Medicine, San Giovanni Battista Hospital, University of Turin Division of Cardiology, Cardinal Guglielmo Massaia Hospital, Asti, Italy Department of Rythmology, CMC Parly II Le Chesnay, Le Chesnay, France Department of Cardiology, Center of Cardiovascular Medicine Department of Radiology Department of Neurology, Bad Neustadt/Saale, Germany Division of Radiology, Cardinal Guglielmo Massaia Hospital, Asti, Italy.
Abstract
Introduction:  AF Ablation Technologies and Silent Cerebral Ischemic Lesions. Silent cerebral ischemic lesions have recently emerged as the most frequent complications after pulmonary vein isolation (PVI). To reduce thromboembolic complications, new types of catheters and energy source have been introduced in clinical practice. The study purpose is to compare the incidence of new silent cerebral ischemic events in patients with paroxysmal atrial fibrillation (PAF) undergoing PVI with different ablation technologies.
Methods and Results: One hundred and eight patients (67% men; age 56 ± 9 years) with PAF were enrolled in a consecutive manner to undergo PVI performed with irrigated radiofrequency (RF) catheter (Group 1, 36 patients), multielectrode catheter (PVAC) associated with duty-cycled RF generator (Group 2, 36 patients) and cryoballoon (Group 3, 36 patients). The protocol included a cerebral magnetic resonance imaging before and after the procedure. After PVI, the following patients showed new silent cerebral ischemic lesions at postprocedural cerebral MRI: 3 patients in Group 1 (8.3%), 14 patients in Group 2 (38.9%), 2 patients in Group 3 (5.6%). PVAC related to higher incidence of silent cerebral ischemic events compared to irrigated RF (P = 0.002) and cryoballoon (P = 0.001), whereas no statistical differences were found between irrigated RF catheter and cryoballoon groups (8.3% vs 5.6%, P = 0.5). At the multivariate analysis, the only independent predictor of new ischemic asymptomatic cerebral lesions after PVI was ablation performed with PVAC (OR 1.48 95% CI 1.19-1.62, P < 0.001).
Conclusion: The incidence of silent cerebral lesions after PVI is different depending on technologies used: PVAC increases the (J risk of 1.48 times compared to irrigated RF and cryoballoon ablation. Cardiovasc Electrophysiol, Vol. pp. 1-8).
6. Fumagalli S, Valsecchi S, Boriani G, Gasparini M, Landolina M, Lunati M, Padeletti M, Tronconi F, Marchionni N, Padeletti L. Comparison of the Usefulness of Cardiac Resynchronization Therapy in Three Age-Groups (<65, 65-74 and ≥75 Years) (from the InSync/InSync ICD Italian Registry). Am J Cardiol. 2011 Mar 17. [Epub ahead of print]
Gerontology and Geriatric Medicine Unit, Critical Care Medicine and Surgery Department, University of Florence and AOU Careggi, Florence, Italy.
Abstract
Chronic heart failure is one of the most important geriatric syndromes, associated with disability, increased hospital admissions, and high mortality. The aim of this study was to evaluate the existence of age-related differences in clinical effectiveness and outcomes of cardiac resynchronization therapy (CRT), alone or in combination with an implantable cardioverter-defibrillator (CRT-D), in a large, real-world registry. A total of 1,787 patients admitted for CRT or CRT-D to the 117 centers participating in the InSync/InSync ICD Italian Registry from 1999 to 2005 were evaluated. Patients were divided into 3 age groups: <65 years (n = 571), 65 to 74 years (n = 740), and ≥75 years (n = 476). The left ventricular ejection fraction did not differ in the 3 groups (26 ± 8% vs 26 ± 7% vs 27 ± 8%, p = 0.123). Atrial fibrillation prevalence demonstrated an age-related increase. The use of recommended medical therapy for chronic heart failure decreased with age, as well as CRT-D implantation (p <0.001). The percentage of echocardiographic responders to CRT was similar in the 3 groups, and New York Heart Association class significantly improved independent of age. During the follow-up period (19 ± 13 months), all-cause mortality was higher in patients aged ≥75 years than in those aged <65 years (p = 0.005). In the whole population, mortality was associated with the nonresponder condition, the presence of atrial fibrillation and the lack of prescription of recommended medical therapy. In conclusion, CRT improved left ventricular performance and functional capacity independent of age. The proportion of the responder condition to CRT was the same in all groups. Pharmacologic undertreatment is an important issue in a "real-world" geriatric population.

Breve commento a cura di Nerina Agabiti
E’ in pubblicazione su Am J Cardiol uno studio a cura di Fumagalli S et al uno studio sull’efficacia delle tecniche di re-sincronizzazione cardiaca in pazienti anziani con scompenso cardiaco. Lo studio è interessante in quanto, nonostante la diffusione di questa tecnica per la prevenzione della morte improvvisa in pazienti con funzione cardiaca alterata, non ci sono RCTs che includano persone con età oltre 70 anni e ci sono ancora dubbi sull’utilità nella popolazione anziana. Sono stati arruolati 1787 pazienti in un periodo di 7 anni (1999-2005) nell’ambito di un Registro dedicato che coinvolge 117 centri in Italia (InSync/InSync ICD Italian Registry). Il protocollo dello studio prevede una complessa valutazione clinico-strumentale dei pazienti ed un follow-up ad intervalli regolari (6 e 12 mesi). L’ipotesi principale che viene testata è se esistano differenze di efficacia della resincronizzazione cardiaca, in combinazione o meno con defibrillatore cardiaco (“cardioverter defibrillator”), a seconda dell’età (< 65, 65-74, >=75 anni). Lo studio dimostra che, indipendentemente dall’età, l’intervento si associa ad un miglioramento della funzionalità cardiaca, misurata attraverso tecnica ecocardiografica. Nel periodo di 12 mesi di follow up l’incidenza di riammissioni ospedaliere è simile nelle diverse categorie di età (circa 12%), mentre la mortalità alla fine del periodo (media di osservazione per questo esito: 19 mesi) è significativamente maggiore tra i più anziani (14% vs 10% nei più giovani). Un risultato collaterale dello studio è il sotto-utilizzo della terapia farmacologica raccomandata in età anziana, che sembra avere un ruolo rilevante nella prognosi dei pazienti, insieme ad altri parametri clinico-anamnestici come la fibrillazione atriale. Studi come questo confermano l’utilità dell’approccio di tipo osservazionale per valutare l’efficacia nella “real world practice” di tecnologie di recente introduzione, a supporto ed integrazione di conoscenze che provengono da studi sperimentali, con la possibilità di analisi su popolazioni su cui finora non si hanno molti dati e su nuovi end-points.

7. Pelosi P, Ferguson ND, Frutos-Vivar F, Anzueto A, Putensen C, Raymondos K, Apezteguia C, Desmery P, Hurtado J, Abroug F, Elizalde J, Tomicic V, Cakar N, Gonzalez M, Arabi Y, Moreno R, Esteban A; for the Ventila Study Group. Management and outcome of mechanically ventilated neurological patients. Crit Care Med. 2011 Mar 3. [Epub ahead of print]
From the Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate (PP), Universita' degli Studi di Genova, Genova, Italy; the Interdepartmental Division of Critical Care Medicine (NDF) and the Department of Medicine, Division of Respirology, University Health Network and Mount Sinai Hospital, University of Toronto, Toronto, Canada; Hospital Universitario de Getafe (FFV, AE) and CIBER Enfermedades Respiratorias, Madrid, Spain; South Texas Veterans Health Care System and University of Texas Health Science Center (AA), San Antonio, TX; the Department of Anesthesiology and Intensive Care Medicine (CP), University of Bonn, Bonn, Germany; Medizinische Hochschule (KR), Hannover, Germany; Hospital Profesor A. Posadas (CA), El Palomar, Buenos Aires, Argentina; Sanatorio Mitre (PD), Buenos Aires, Argentina; Hospital de Clínicas (JH), Montevideo, Uruguay; Fattouma Bourguiba Monastir (FA), Tunicia; Hospital ABC (JE), México DF, México; Clínica Las Lilas (VT), Santiago, Chile; Istanbul Medical Faculty (NC), Istanbul, Turkey; Clínica Medellín y Universidad Pontificia Bolivariana (MG), Medellín, Colombia; King Abdulaziz Medical City (YA), Riyadh, Saudi Arabia; and Hospital de Santo António dos Capuchos (RM), Lisboa, Portugal.
Abstract
OBJECTIVE: To describe and compare characteristics, ventilatory practices, and associated outcomes among mechanically ventilated patients with different types of brain injury and between neurologic and nonneurologic patients. DESIGN:: Secondary analysis of a prospective, observational, and multicenter study on mechanical ventilation.
SETTING: Three hundred forty-nine intensive care units from 23 countries.
PATIENTS: We included 552 mechanically ventilated neurologic patients (362 patients with stroke and 190 patients with brain trauma). For comparison we used a control group of 4030 mixed patients who were ventilated for nonneurologic reasons.
INTERVENTIONS: None.
MEASUREMENTS AND MAIN RESULTS: We collected demographics, ventilatory settings, organ failures, and complications arising during ventilation and outcomes. Multivariate logistic regression analysis was performed with intensive care unit mortality as the dependent variable. At admission, a Glasgow Coma Scale score ≤8 was observed in 68% of the stroke, 77% of the brain trauma, and 29% of the nonneurologic patients. Modes of ventilation and use of a lung-protective strategy within the first week of mechanical ventilation were similar between groups. In comparison with nonneurologic patients, patients with neurologic disease developed fewer complications over the course of mechanical ventilation with the exception of a higher rate of ventilator-associated pneumonia in the brain trauma cohort. Neurologic patients showed higher rates of tracheotomy and longer duration of mechanical ventilation. Mortality in the intensive care unit was significantly (p < .001) higher in patients with stroke (45%) than in brain trauma (29%) and nonneurologic disease (30%). Factors associated with mortality were: stroke (in comparison to brain trauma), Glasgow Coma Scale score on day 1, and severity at admission in the intensive care unit.
CONCLUSIONS: In our study, one of every five mechanically ventilated patients received this therapy as a result of a neurologic disease. This cohort of patients showed a higher mortality rate than nonneurologic patients despite a lower incidence of extracerebral organ dysfunction.
8. Capurso G, Bettini R, Rinzivillo M, Boninsegna L, Delle Fave G, Falconi M. Role of Resection of the Primary Pancreatic Neuroendocrine Tumour Only in Patients with Unresectable Metastatic Liver Disease: A Systematic Review. Neuroendocrinology. 2011 Feb 25. [Epub ahead of print]
Digestive and Liver Disease Unit, II School of Medicine, 'Sapienza' University of Rome, Rome, Italy.
Abstract
Background: Surgery remains the only curative option for pancreatic neuroendocrine tumours (PNETs), but its indication is limited by metastatic disease in most patients. Indication for removing the primary lesion only in the setting of unresectable liver disease is controversial. The present systematic review aims at determining the potential bene- fits (survival, progression-free survival) or harms (morbidity, mortality) of surgical resection of the primary lesion only in patients with PNETs and unresectable metastases.
Methods: Medline was queried for studies reporting the outcome of PNET patients with unresectable liver metastases whenever there was an explicit comparison between resection of the primary lesion only ('active treatment') and no resection ('non-active treatment'). The primary outcome was survival; possible secondary outcomes were progression-free survival, treatment-related mortality and morbidity, and relief of symptoms.
Results: Only 3 cohort studies found were eligible and analysed; no meta-analysis could be performed. The number of patients undergoing 'active treatment' varied from 16 to 20, with a percentage ranging from 17 to 39% of cohorts. Survival was longer in patients who received 'active treatment' in 2 studies, and the 5-year survival rate also seemed higher, without significant complications.
Discussion: Available data suggest a possible benefit of resection of the primary lesion only in this setting. However, a bias towards a more aggressive surgical approach in patients with a better performance status or less advanced disease seems likely, and no conclusion can be drawn except for the need of randomised trials. We calculated that such a trial would require at least 118 patients per arm.
9. Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch C, Cameron D, Mano M, Pedrini JL, Veronesi A, Mendiola C, Pluzanska A, Semiglazov V, Vrdoljak E, Eckart MJ, Shen Z, Skiadopoulos G, Procter M, Pritchard KI, Piccart-Gebhart MJ, Bell R; for the Herceptin Adjuvant (HERA) Trial Study Team. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):236-244. Epub 2011 Feb 25.
Department of Medical Oncology, San Raffaele Institute, Milan, Italy.
Abstract
BACKGROUND: Treatment with adjuvant trastuzumab for 1 year improves disease-free survival and overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We aimed to assess disease-free survival and overall survival after a median follow-up of 4 years for patients enrolled on the Herceptin Adjuvant (HERA) trial.
METHODS: The HERA trial is an international, multicentre, randomised, open-label, phase 3 trial comparing treatment with trastuzumab for 1 and 2 years with observation after standard neoadjuvant, adjuvant chemotherapy, or both in patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival. After a positive first interim analysis at a median follow-up of 1 year for the comparison of treatment with trastuzumab for 1 year with observation, event-free patients in the observation group were allowed to cross over to receive trastuzumab. We report trial outcomes for the 1-year trastuzumab and observation groups at a median follow-up of 48•4 months (IQR 42•0-56•5) and assess the effect of the extensive crossover to trastuzumab. Our analysis was by intention-to-treat. The HERA trial is registered with the European Clinical Trials Database, number 2005-002385-11.
FINDINGS: The HERA trial population comprised 1698 patients randomly assigned to the observation group and 1703 to the 1-year trastuzumab group. Intention-to-treat analysis of disease-free survival showed a significant benefit in favour of patients in the 1-year trastuzumab group (4-year disease-free survival 78•6%) compared with the observation group (4-year disease-free survival 72•2%; hazard ratio [HR] 0•76; 95% CI 0•66-0•87; p<0•0001). Intention-to-treat analysis of overall survival showed no significant difference in the risk of death (4-year overall survival 89•3%vs 87•7%, respectively; HR 0•85; 95% CI 0•70-1•04; p=0•11). Overall, 885 patients (52%) of the 1698 patients in the observation group crossed over to receive trastuzumab, and began treatment at median 22•8 months (range 4•5-52•7) from randomisation. In a non-randomised comparison, patients in the selective-crossover cohort had fewer disease-free survival events than patients remaining in the observation group (adjusted HR 0•68; 95% CI 0•51-0•90; p=0•0077). Higher incidences of grade 3-4 and fatal adverse events were noted on 1-year trastuzumab than in the observation group. The most common grade 3 or 4 adverse events, each in less than 1% of patients, were congestive cardiac failure, hypertension, arthralgia, back pain, central-line infection, hot flush, headache, and diarrhoea.
INTERPRETATION: Treatment with adjuvant trastuzumab for 1 year after chemotherapy is associated with significant clinical benefit at 4-year median follow-up. The substantial selective crossover of patients in the observation group to trastuzumab was associated with improved outcomes for this cohort.
FUNDING: F Hoffmann-La Roche, Michelangelo Foundation.
10. Aliberti S, Peyrani P, Filardo G, Mirsaeidi M, Amir A, Blasi F, Ramirez JA. Association between time to clinical stability and outcomes after discharge in hospitalized patients with community-acquired pneumonia. Chest. 2011 Feb 17. [Epub ahead of print]
Dipartimento toraco-polmonare e cardio-circolatorio, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
Abstract
ABSTRACT BACKGROUND: Adverse outcomes after discharge in patients hospitalized for community-acquired pneumonia (CAP) might be associated to the inflammatory response during hospitalization, recognized by the length of time needed for the patient to reach clinical stability (TCS). The objective of this study was to assess the association between TCS and outcomes after discharge in hospitalized patients with CAP.
METHODS: A retrospective cohort study of consecutive patients discharged alive after an episode of CAP was conducted at the Veterans Hospital of Louisville, Kentucky, USA, between 2001 and 2006.
RESULTS: Among the 464 patients enrolled in the study, 82 (18%) experienced an adverse outcome within 30 days after discharge, either readmission or death. Patients with a TCS > 3 days showed a significantly higher rate of adverse outcomes after discharge in comparison to those with a TCS ≤ 3 days (26% vs. 15%, respectively, p= 0.008, OR: 1.98, 95% CI: 1.19-3.3), as well as adverse outcomes after discharge related to pneumonia (16% vs. 4.6%, respectively, p<0.001, OR: 4.07, 95% CI: 2-8.2). The propensity-adjusted analysis showed that delay in reaching TCS during hospitalization was associated with a significant increased risk of adverse outcomes. Adjusted odds ratios comparing patients who reached TCS at day two, three, four, and five to those who reached TCS at day one were 1.06, 1.54, 2.40, 10.53, respectively.
CONCLUSIONS: CAP patients who experienced a delay in reaching clinical stability during hospitalization are at high risk of adverse outcomes after discharge and should receive a close observation and an early follow-up.
11. De Rango P, Parlani G, Verzini F, Giordano G, Panuccio G, Barbante M, Cao P. Long-term prevention of stroke: a modern comparison of current carotid stenting and carotid endarterectomy. J Am Coll Cardiol. 2011 Feb 8;57(6):664-71.
Unit of Vascular and Endovascular Surgery, University of Perugia, Hospital S. M. Misericordia, Italy. plderango@gmail.com
Abstract
OBJECTIVES: This study sought to evaluate long-term outcomes of carotid stenting (CAS) versus carotid endarterectomy (CEA) based on physician-guided indications.
BACKGROUND: The issue regarding long-term outcome of CAS versus CEA in patients with carotid stenosis is clinically relevant but remains unsettled.
METHODS: Consecutive patients (71% men, mean age 71.3 years) treated by CEA (n = 1,118) or CAS (n = 1,084) after a training phase were reviewed. Selection of treatment was based on better-suitability characteristics (morphology and clinical). Data were adjusted with propensity score analysis and stratified by symptoms, age, and sex.
RESULTS: Thirty-day stroke/death rates were similar: 2.8% in CAS and 2.0% in CEA (p = 0.27). The risk was higher in symptomatic (3.5%) versus asymptomatic (2.0%) patients (p = 0.04) but without significant difference between CAS and CEA groups. Five-year survival rates were 82.0% in CAS and 87.7% in CEA (p = 0.05). Kaplan-Meier estimates of the composite of any periprocedural stroke/death and ipsilateral stroke at 5 years after the procedure were similar in all patients (4.7% vs. 3.7%; p = 0.4) and the subgroups of symptomatic (8.7% vs. 4.9%; p = 0.7) and asymptomatic (2.5% vs. 3.3%; p = 0.2) patients in CEA versus CAS, respectively. Cox analysis, adjusted by propensity score, identified statin treatment (p = 0.016) and symptomatic disease (p = 0.003) associated with the composite end point. There were no sex- or age-related significant outcome differences.
CONCLUSIONS: When physicians use their clinical judgment to select the appropriate technique for carotid revascularization CAS can offer efficacy and durability comparable to CEA with benefits persisting at 5 years.

Breve commento a cura di Nerina Agabiti
Il trattamento della stenosi carotidea ha come obiettivo la prevenzione dell’ictus cerebrale. L’efficacia comparativa dello stenting carotideo verso l’endoarterectomia carotidea è stata valutata in diversi RCTs, ma i risultati non sono conclusivi. Un interessante studio osservazionale sull’argomento è stato pubblicato su J American College of Cardiology a cura di De Rango et al in cui vengono analizzati gli esiti a 5 anni dell’intervento sulla stenosi carotidea, confrontando le due tecniche. E’ stata arruolata prospetticamente una popolazione di persone affette da stenosi carotidea in un periodo di nove anni (2001-2009) presso due centri di chirurgia vascolare a Roma e Perugia. La scelta dell’una o dell’altra tecnica si basa su una complessa valutazione clinica e strumentale secondo metodologie standardizzate. Per un totale di 1118 pazienti trattati con endoarterectomia carotidea e 1084 trattati con stenting carotideo sono stati misurati esiti a intervalli regolari in un periodo di 5 anni attraverso misure cliniche e strumentali. Il rischio di ictus/morte nei 30 giorni successivi all’intervento è pari a 2.5% complessivamente. Non si osservano differenze significative tra le due tecniche in relazione al rischio di eventi avversi periprocedurali (ictus, morte, eventi maggior cardiovascolari). Il TIA (attacco ischemico transitorio) ha maggiore incidenza nei pazienti trattati con lo stenting carotideo, mentre il danneggiamento dei nervi cranici è più frequente nei casi trattati con endoarterectomia. Gli eventi sfavorevoli sono più frequenti nelle persone con sintomatologia manifesta rispetto ai casi con lesione carotidea senza sintomi. Risultati interessanti vengono dal follow up a lungo termine. La sopravvivenza a 5 anni dopo l’intervento è oltre l’80% e la proporzione di casi con risoluzione della stenosi a 5 anni e definita a basso rischio di ictus è oltre il 96%. Le due tecniche sembrano essere molto soddisfacenti ed equivalenti complessivamente nei risultati. Questo studio dà un contributo alla conoscenza sull’efficacia a breve e lungo termine delle tecniche di trattamento della stenosi carotidea, fornendo dati provenienti da uno scenario di “real world parctice” e dimostrando che lo stenting è una valida alternativa alla chirurgia.

12. Vianello A, Arcaro G, Braccioni F, Gallan F, Marchi MR, Chizio S, Zampieri D, Pegoraro E, Salvador V. Prevention of extubation failure in high-risk patients with neuromuscular disease. J Crit Care. 2011 Jan 25. [Epub ahead of print]
Respiratory Intensive Care Unit, City Hospital of Padova, Padova, Italy.
Abstract
BACKGROUND: A substantial proportion of patients with neuromuscular disease (NMD) who undergo positive pressure ventilation via endotracheal intubation for acute respiratory failure fail to pass spontaneous breathing trials and should be considered at high risk for extubation failure. In our study, we prospectively investigated the efficacy of early application of noninvasive ventilation (NIV) combined with assisted coughing as an intervention aimed at preventing extubation failure in patients with NMD.
METHODS: This study is a prospective analysis of the short-term outcomes of 10 patients with NMD who were treated by NIV and assisted coughing immediately after extubation and comparison with the outcomes of a population of 10 historical control patients who received standard medical therapy (SMT) alone. The participants were composed of 10 patients with NMD who were submitted to NIV and assisted coughing after extubation (group A) and 10 historical control patients who were administered SMT (group B), who were admitted to a 4-bed respiratory intensive care unit (RICU) in a university hospital. Need for reintubation despite treatment was evaluated. Mortality during RICU stay, need for tracheostomy, and length of stay in the RICU were also compared.
RESULTS: Significantly fewer patients who received the treatment protocol required reintubation and tracheostomy compared with those who received SMT (reintubation, 3 vs 10; tracheostomy, 3 vs 9; P = .002 and .01, respectively). Mortality did not differ significantly between the 2 groups. Patients in group A remained for a shorter time in the RICU compared with group B (7.8 ± 3.9 vs 23.8 ± 15.8 days; P = .006).
CONCLUSIONS: Preventive application of NIV combined with assisted coughing after extubation provides a clinically important advantage to patients with NMD by averting the need for reintubation or tracheostomy and shortening their stay in the RICU; its use should be included in the routine approach to patients with NMD at high risk for postextubation respiratory failure.
13. Bielory L, Chun Y, Bielory BP, Canonica GW. Impact of mometasone furoate nasal spray on individual ocular symptoms of allergic rhinitis: a meta-analysis. Allergy. 2011 Jan 25. doi: 10.1111/j.1398-9995.2010.02543.x. [Epub ahead of print]
Center for Environmental Prediction & STAR Allergy and Asthma Center, Rutgers University, Springfield, NJ UMDNJ - New Jersey Medical School, Newark, NJ Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA Allergy and Respiratory Diseases Clinic, DIMI, University of Genoa, Genoa, Italy.
To cite this article: Bielory L, Chun Y, Bielory BP, Canonica GW. Impact of mometasone furoate nasal spray on individual ocular symptoms of allergic rhinitis: a meta-analysis. Allergy 2011; DOI: 10.1111/j.1398-9995.2010.02543.x.
Abstract
Background: treatment of allergic rhinitis (AR) nasal symptoms. The INS mometasone furoate nasal spray (MFNS) has well-documented efficacy and safety for the treatment and prophylaxis of nasal symptoms of seasonal AR (SAR) and for the treatment of nasal symptoms of perennial AR (PAR). Increasing interest has focused on whether INSs, including MFNS, may have beneficial effects on the ocular symptoms frequently We performed a meta-analysis of 10 randomized, associated with AR.
Methods: mcg daily in relieving placebo-controlled trials of the efficacy of MFNS 200 ocular allergy symptoms, including itching/burning, redness, and tearing/watering in both SAR and PAR. Four PAR studies and six SAR studies are included in the analysis. A fixed-effect inverse variance model was used to calculate weighted mean differences, 95% confidence intervals (CIs) for each comparison, and a In both analyses of combined overall treatment effect (Z) with P-value.
Results: SAR and PAR studies, including 3132 patients, all individual ocular symptoms were reduced in patients treated with MFNS. Overall treatment effect was significant 9.18 for = for all three individual ocular symptoms in the SAR studies (Z  8.88 for redness; P = 10.15 for itching, and Z = tearing, Z<0.00001 for all)  5.94, P = and in the PAR studies (Z<0.02 for = 2.43, P = 0.00001 for tearing; Z  Our findings add to 0.02 for redness).
Conclusions:  = 2.42, P = itching; and Z the growing body of literature supporting the positive class effect of INSs, including MFNS, on ocular symptoms associated with SAR and PAR.
14. Salvatore D, Buzzetti R, Baldo E, Forneris MP, Lucidi V, Manunza D, Marinelli I, Messore B, Neri AS, Raia V, Furnari ML, Mastella G. An overview of nternational literature from cystic fibrosis registries. Part 3. Disease incidence, genotype/phenotype correlation, microbiology, pregnancy, clinical complications, lung transplantation, and miscellanea. J Cyst Fibros. 2011 Mar;10(2):71-85. Epub 2011 Jan 22.
Cystic Fibrosis Centre, Ospedale San Carlo, Potenza, Italy.
Abstract
This is the third article related to a review of the literature based on data from national cystic fibrosis (CF) patient registries up to June 2008 and covering a total of 115 published studies. It focuses on several topics: CF incidence, genotype/phenotype correlation, microbiology, pregnancy/paternity, clinical complications, lung transplantation, and others. Seventy seven papers meeting the inclusion criteria were found to be related to the topics listed above. Another seven studies, already evaluated in previous papers of this series, were recalled for specific topics. Incidence is described by several studies, results being quite different from one country to another and quite inhomogeneous among regions within the same country. Studies on genetics address the genotype/phenotype correlation and look for a predictive value of CFTR mutations in terms of clinical outcome, with controversial results. Papers on microbiology describe the clinical relevance of different pathogens and their role in the progress of CF lung disease. A few articles give information on the features of CF women undergoing a pregnancy and try to identify the ones associated with a better outcome. Studies on clinical complications discuss prevalence and the role of haemoptysis, pneumothorax, CF related diabetes, ABPA and cancer. Papers on lung transplantation focus on models able to improve the selection criteria for transplantation candidates and the factors linked to post transplantation survival. Finally, several studies deal with a number of interesting topics related to CF epidemiology: clinical trial methodology, quality of care comparison among countries and centers, relationship between diagnosis and age/gender, and evaluation of pharmacological therapy. On the whole, CF Registries have already contributed to important advances in the knowledge of the natural history of CF, establishing the foundations for future improvement in CF research and care.
15. Papalia R, Del Buono A, Osti L, Denaro V, Maffulli N. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. Br Med Bull. 2011 Jan 19. [Epub ahead of print]
†Department of Orthopaedic and Trauma Surgery, Campus Biomedico University of Rome, Via Alvaro del Portillo, Rome, Italy.
Abstract
This review defines the recognized risk factors responsible for the development of knee osteoarthritis after surgical management of meniscal tears. We performed a literature search using Medline, Ovid, Cochrane and Google Scholar using the keywords: 'Meniscal tears', 'meniscectomy', 'osteoarthritis', 'complications' and 'risk factors'. Thirty-two published studies were identified. In the long term, osteoarthritis develops in the knee of patients undergoing surgery for meniscal tears. The Coleman methodology score showed great heterogeneity in terms of patient characteristics and outcome assessment. Amount of meniscus removed, duration of pre-operative symptoms and lateral meniscectomy show strong statistical association to onset of knee osteoarthritis. We did not find univocal findings defining the risk factors responsible for the development of post-operative knee osteoarthritis. There is a need for standardized clinical and imaging validated scale to improve definition of post-operative knee osteoarthritis to allow easier and more reliable comparison of outcomes in different studies. Appropriately powered randomized controlled trials reporting clinical and imaging-related outcomes in patients undergoing arthroscopic minimally invasive procedures and meniscal suturing should be performed. Comparing imaging findings of patients undergoing arthroscopic partial and open meniscectomy, a lower incidence of knee osteoarthritic evolution was detected after arthroscopy. The amount of removed meniscus is the most important predictor factor for the development of osteoarthritis. Minimally invasive procedures seem to reduce the incidence of long-term osteoarthritic changes of the knee compared with more invasive open and or arthroscopic procedures.