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Valutazione

  • Marina Davoli

  1. Dipartimento di epidemiologia del Servizio sanitario regionale Lazio

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Database: Pubmed/MEDLINE  
Strategie di ricerca: ((“Quality Indicators, Health Care"[Mesh] OR "Quality Assurance, Health Care"[Mesh] OR "Outcome Assessment (Health Care)"[Mesh:NoExp] OR Outcome* [tiab] OR appropriateness [tiab] OR indicator* [TIAB] OR procedure [TIAB], efficacy[tiab] OR effectiveness[tiab]) “quality indicators” [tiab], AND (HOSPITAL[MESH] OR hospital[tiab] OR mortality [tw] OR patient*[tiab]) AND (italy[mesh] OR ital* [tiab] OR ita [la] OR ital*[ad]))NOT (animals [mesh] NOT humans [mesh])
Limiti: pubblicati da 1gennaio 2010 al 26 ottobre 2010
Esclusi: commenti editoriali e lettere, studi di clinici di fase I o II, studi di genetica  e  di neurofisiologia. Gli studi multicentrici sono inclusi nella ricerca, per l’importante contributo italiano

Clicca sul titolo dell'articolo per leggere l'abstract

1.     Catheter Cardiovasc Interv. 2010 Feb 15; 75(3):327-34. Comparison of 2-year clinical outcomes with sirolimus and paclitaxel-eluting stents for patients with diabetes: results of the Registro Regionale AngiopLastiche Emilia-Romagna Registry. Balducelli, M.; Ortolani, P.; Marzaroli, P.; Piovaccari, G.; Menozzi, A.; Manari, A.; Sangiorgio, P.; Tarantino, F.; Rossi, R.; Maresta, A.; Tondi, S.; Passerini, F.; Guastaroba, P.; Grilli, R., and Marzocchi, A.

Abstract:
BACKGROUND: Long-term outcomes of percutaneous coronary interventions (PCI) with  sirolimus-eluting stents (SES) compared to paclitaxel-eluting-stents (PES) in unselected diabetics in routine practice is still debated.
OBJECTIVE: This study  compared the 2-year incidence of MACE (all-cause mortality, nonfatal myocardial infarction and target vessel revascularization) of SES and PES in a real-world setting of patients with diabetes.
DESIGN: Observational, multicenter, nonrandomized study.
SETTING: Prospective web-based registry (REAL Registry; study period, 2002-2005) comprising all 13 hospitals performing PCI. PATIENTS: Among the 945 eligible patients treated with either SES alone (n = 606) or PES alone (n = 339), 29% were insulin-requiring, 72% had multivessel coronary disease, 26% had prior myocardial infarction and 10% had poor left ventricular function.
MEASUREMENTS: Unadjusted and propensity score-adjusted 2-year clinical  outcome.
RESULTS: After propensity score adjustment, 2-year MACE incidence in the SES and PES groups was equivalent (23.3% vs. 23.7%, HR 1.01, 95%CI 0.72-1.42, P = 0.96). Adjusted 2-year angiographic stent thrombosis occurred in 1.1% of the SES  patients versus 2.6% of the PES patients (P = 0.15). In this large, real-world, diabetic population treated with DES, there was no difference in outcome between  SES and PES. Further studies are needed to demonstrate the long-term safety of different types of DES in patients with diabetes.

Breve commento a cura di Nerina Agabiti
Non si osservano differenze negli esiti clinici a lungo termìne tra due tipologie di stent medicato (stent medicato sirolimus e stend medicato paclitaxel) in pazienti diabetici sottoposti ad angioplastica coronarica. E’ il principale risultato del lavoro di Balduccelli et al basato sui dati del Registro Regionale delle Angioplastiche Emilia Romagna, un sistema “web-based” di registrazione prospettica di tutti i casi di rivascolarizzazione cardiaca attivo già dal 2002 su base regionale (REAL Registry). Sono stati reclutati in maniera prospettica 945 persone nel periodo 2002-2005 trattati in 13 ospedali della Regione dove sono eseguite le angioplastiche. Gli esiti a breve, medio e lungo termine (2 anni) sono l’incidenza di eventi cardiovascolari maggiori (MACE) e la mortalità per tutte le cause, attraverso l’uso integrato dei sistemi informativi di mortalità ed ospedaliero. L’analisi basata sul “propensity adjustment” limita l’effetto dell”indication bias” frequente in questo tipo di studi osservazionali, come indicato in discussione. L’argomento è di grande attualità sia per i professionisti cardiologi sia per gli operatori di sanità pubblica. Nonostante i limiti, questo lavoro rappresenta un valido esempio di studio osservazionale su base di popolazione in grado di esaminare il reale impatto nella pratica clinica di presidi terapeutici in uso già da tempo tra i cardiologi interventisti. La possibilità di confrontare l’efficacia dei trattamento in un sottogruppo particolarmente a rischio di esiti sfavorevoli quali i pazienti diabetici è un valore aggiunto e contribuisce al dibattito scientifico su un tema in cui le evidenze non sono ancora consolidate.

2. Intensive Care Med. 2010 Aug; 36(8):1403-9. Outcome of children admitted to adult intensive care units in Italy between 2003  and 2007. Cogo, P. E.; Poole, D.; Codazzi, D.; Boniotti, C.; Capretta, A.; Langer, M.; Luciani, D.; Rossi, C., and Bertolini, G.

Abstract:
BACKGROUND: Centralisation of critically ill children to paediatric intensive care units is supported by a strong rationale, but evidence is not overwhelming. 
OBJECTIVE: To compare the outcome of children admitted to adult intensive care units (ICUs) in Italy between 2003 and 2007 with that of children admitted to paediatric intensive care units (PICUs) in Italy between 1994 and 1995.
METHODS:  Prospective, multicenter cohort study and historical controls. Risk of ICU mortality was assessed with the PRISM score in both study and historical control  groups. Descriptive statistics, standardized mortality ratios (SMRs) with their 95% confidence intervals, and the calibration plots were reported. RESULTS: A total of 1,265 children admitted to 124 adult ICUs between 2003 and 2007 were compared with an historical control group formed by 1,533 children admitted to 26 PICUs between 1994 and 1995. The PRISM score slightly underestimated hospital deaths for low-risk patients in both groups. The overall SMR was 1.11 (95% CI 0.91-1.31) for adult ICUs and 1.04 (95% CI: 0.88-1.19) for PICUs.
CONCLUSIONS: The level of care provided nowadays to children admitted to adult ICUs in Italy is similar to that provided by Italian PICUs 10 years earlier. On the other hand, there is evidence that Italian PICUs have improved the level of care in the same  period. These findings, if confirmed, suggest a better quality of care for children admitted to PICUs as compared to adult ICUs and support the indication,  when possible, of early referral to more specialized units in countries where paediatric intensive care is not centralised.

3. J Vasc Surg. 2010 Feb; 51(2):337-44; discussion 344. De Rango, P.; Parlani, G.; Caso, V.; Verzini, F.; Giordano, G.; Cieri, E., and Cao, P. A comparative analysis of the outcomes of carotid stenting and carotid endarterectomy in women.

Abstract:
OBJECTIVE: Randomized controlled trials (RCTs) of carotid endarterectomy (CEA) advised little benefit from surgery in women because of high operative risk. Whether these findings are also applicable to carotid angioplasty and stenting (CAS) is subject of investigation. Our aim was to determine the risk of perioperative and late complications related to CAS and CEA in women.
METHODS: Data from a single-center carotid surgery database including 1065 individuals with CAS (306 women and 759 men) and 1131 with CEA (325 women and 806 men) were analyzed in a consecutive series of patients. Perioperative risks of death, stroke, and local complications in women undergoing CAS and CEA were compared. Rates of restenosis >50% and stroke at 5 years in symptomatic and asymptomatic women were also assessed.
RESULTS: The perioperative risks of stroke or death were no different in women who underwent CAS and CEA women (1.9% vs 3.0%; odds ratio [OR] = 0.63; 95% confidence interval [CI], 0.20-1.7; P = .45) whether they  were symptomatic or not. Other perioperative complications were also similarly distributed between the two groups of women. Life-table estimates of any periprocedural stroke/death and ipsilateral stroke at 5 years after the procedure did not differ between women with CAS and CEA (4.1% vs 8.1%; P = .18). Five-year  rates of restenosis >50% were nonsignificantly higher in women after CEA than after CAS (1.8% vs 8.1%; P = .058).
CONCLUSION: Women with carotid stenosis might have favorable early and late outcomes from CAS with complication rates similar and even lower than those attained with CEA. CAS, performed by trained operators, may be a valid primary choice for treatment of carotid stenosis, particularly in  asymptomatic women for whom the risk of surgery seems to be higher. However, before claiming CAS for women, these results need to be confirmed by large RCTs.

4. Eur J Neurol. 2010 Sep 14. Stroke unit care in clinical practice: an observational study in the Florence center of the European Registers of Stroke (EROS) Project. Di Carlo A.; Lamassa, M.; Wellwood, I.; Bovis, F.; Baldereschi, M.; Nencini, P.; Poggesi, A.; Cramaro, A.; Pescini, F.; Lucente, G.; Wolfe, C. D., and Inzitari, D.

Abstract:
Background: Randomized trials and meta-analyses indicate positive effects of stroke unit (SU) care on survival and dependency of patients with stroke. However, data on the advantages of SU in 'real-world' settings are limited. We prospectively assessed, in a large University Hospital, the effect of SU versus other conventional wards (OCW) care on all-cause mortality, death or dependency,  death or institutionalization. Methods: In a prospective observational study in the European Registers of Stroke Project, patients hospitalized for first-in-a-lifetime stroke were evaluated for demographics, risk factors, clinical presentation, resource use, 3-month and 1-year survival, and functional  outcome.
Results: Overall, 355 patients (54.1% men, mean age 73.4 +/- 14.5 years) were registered, 140 (39.4%) admitted to the SU, and 215 (60.6%) to OCW. OCW patients were older, whilst SU patients had more severe strokes according to NIHSS (P for trend = 0.025). SU patients were significantly more often treated by specialists in stroke medicine, stroke nurses, physiotherapists and speech therapists (all P < 0.001), psychologists (P = 0.025), dietitians (P < 0.001), and social workers (P = 0.003). MRI, carotid, and transcranial Doppler were significantly more often performed in SU patients (all P < 0.001). Intravenous fluids (P = 0.003) and intravenous anticoagulation (P < 0.001) were more often prescribed in SU. Controlling for case-mix, SU significantly reduced 1-year mortality (P = 0.020), death or dependency at 3 months (P = 0.006) and 1 year (P  = 0.043), and death or institutionalization at 3 months (P = 0.001) and 1 year (P = 0.009).
Conclusions: We confirmed the benefits of SU care in a clinical setting. Further analyses should define the contribution of individual components of care to stroke outcome.

Breve commento a cura di Nerina Agabiti
Nello studio di Di Carlo et al. viene analizzata  comparativamente l’efficacia nella pratica clinica di due modalità di gestione e terapia della fase acuta dell’ictus cerebrale. L’ictus è una patologia di grande impatto epidemiologico e socio-sanitario e l’interesse del lavoro sta nel fatto che, sebbene esistano solide evidenze  a favore della Stroke Unit da studi clinici randomizzati, sono ancora limitate le evidenze da studi osservazionali. Lo studio di tipo prospettico condotto a Firenze rappresenta il contributo italiano ad una iniziativa europea di “Registro per l’Ictus” (European Registers of Stroke” EROS). Tenendo conto delle differenze di gravità clinica, il trattamento in “Stroke Unit”  si dimostra più efficace del trattamento in “Altri Reparti”in termini di diversi esiti clinici quali la sopravvivenza a un anno, lo stato di dipendenza o morte a 3 mesi e a un anno, l’istituzionalizzazione o morte a 3 mesi e a un anno. Nonostante i numeri limitati della casistica (140 pazienti in “Stroke Unit” vs. 215 pazienti in “Altri Reparti”) e la difficoltà di valutare il ruolo della riabilitazione post-acuzie sugli esiti a lungo termine, lo studio propone alla riflessione il valore determinante della organizzazione assistenziale multisdisciplinare nelle prime fasi dell’ictus. 

5. Trials. 2010; 11:5. Improving the management of non-ST elevation acute coronary syndromes: systematic evaluation of a quality improvement programme European QUality Improvement Programme for Acute Coronary Syndrome: the EQUIP-ACS project protocol and design. Flather, M. D.; Booth, J.; Babalis, D.; Bueno, H.; Steg, P. G.; Opolski, G.; Ottani, F.; Machecourt, J.; Bardaji, A.; Bojestig, M.; Brady, A. R., and Lindahl, B.

Abstract:
BACKGROUND:
Acute coronary syndromes, including myocardial infarction and unstable angina, are important causes of premature mortality, morbidity and hospital admissions. Acute coronary syndromes consume large amounts of health care resources, and have a major negative economic and social impact through days lost at work, support for disability, and coping with the psychological consequences of illness. Several registries have shown that evidence based treatments are under-utilised in this patient population, particularly in high-risk patients. There is evidence that systematic educational programmes can  lead to improvement in the management of these patients. Since application of the results of important clinical trials and expert clinical guidelines into clinical practice leads to improved patient care and outcomes, we propose to test a quality improvement programme in a general group of hospitals in Europe.
METHODS/DESIGN: This will be a multi-centre cluster-randomised study in 5 European countries: France, Spain, Poland, Italy and the UK. Thirty eight hospitals will be randomised to receive a quality improvement programme or no quality improvement programme. Centres will enter data for all eligible non-ST segment elevation acute coronary syndrome patients admitted to their hospital for a period of approximately 10 months onto the study database and the sample size is estimated at 2,000-4,000 patients. The primary outcome is a composite of eight measures to assess aggregate potential for improvement in the management and treatment of this patient population (risk stratification, early coronary angiography, anticoagulation, beta-blockers, statins, ACE-inhibitors, clopidogrel as a loading dose and at discharge). After the quality improvement programme, each of the eight measures will be compared between the two groups, correcting for cluster effect.
DISCUSSION: If we can demonstrate important improvements in the quality of patient care as a result of a quality improvement programme, this  could lead to a greater acceptance that such programmes should be incorporated into routine health training for health professionals and hospital managers. TRIAL REGISTRATION: Clinicaltrials.gov NCT00716430.

6. J Clin Oncol. 2010 May 10; 28(14):2331-8. Improved survival of children with neuroblastoma between 1979 and 2005: a report  of the Italian Neuroblastoma Registry. Haupt, R.; Garaventa, A.; Gambini, C.; Parodi, S.; Cangemi, G.; Casale, F.; Viscardi, E.; Bianchi, M.; Prete, A.; Jenkner, A.; Luksch, R.; Di Cataldo, A.; Favre, C.; D'Angelo, P.; Zanazzo, G. A.; Arcamone, G.; Izzi, G. C.; Gigliotti, A. R.; Pastore, G., and De Bernardi, B.

Abstract:
PURPOSE: To describe treatment, clinical course, and survival of a cohort of Italian patients with neuroblastoma.
PATIENTS AND METHODS: The study includes data from 2,216 children (age 0 to 14 years) diagnosed between 1979 and 2005. Overall survival (OS) was analyzed by clinical and biologic features at presentation and periods of diagnosis: 1979 to 1984, 1985 to 1991, 1992 to 1998,  and 1999 to 2005. The relative risk of second malignant neoplasm (SMN) was assessed by the standardized incidence ratio (SIR), with the Italian population selected as referent.
RESULTS: Yearly patient accrual increased over time from 58 to 102. Patients age 0 to 17 months represented 45.6% of the total population, and their incidence increased over time from 36.5% to 48.5%. The incidence of stage 1 patients increased over time from 5.8% to 23.2%. A total of 898 patients  (40.5%) developed disease progression or relapse, 19 patients developed SMN, and  two patients developed myelodysplasia. The cumulative risk of SMN at 20 years was 7.1%, for an SIR of 8.4 (95% CI, 5.1 to 13.2). A total of 858 patients (39%) died (779 of disease, 71 of toxicity, six of SMN, and two of tumor-unrelated surgical  complications). Ten-year OS was 55.3% (95% CI, 53.0% to 57.6%) and increased over time from 34.9% to 65.0%; it was significantly better for females and patients age 0 to 17 months at diagnosis, with extra-abdominal primary, and stage 1 and 2  disease. OS improved significantly over time in stage 1 and 3 patients. In patients with stage 4 disease, the improvement occurred between the first and second time cohorts (6.7% v 23.5%), but not afterward.
CONCLUSION: The outcome of children with neuroblastoma has progressively improved. Long-term survivors bear  a significant risk of SMN.

7. J Am Coll Cardiol. 2010 Feb 16; 55(7):613-16. Long-term effectiveness and safety of sirolimus stent implantation for coronary in-stent restenosis results of the TRUE (Tuscany Registry of sirolimus for unselected in-stent restenosis) registry at 4 years. Liistro, F.; Fineschi, M.; Grotti, S.; Angioli, P.; Carrera, A.; Ducci, K.; Gori, T.; Falsini, G.; Pierli, C., and Bolognese, L.

Abstract:
OBJECTIVES: The aim of this study was to evaluate the long-term clinical outcome  of the efficacy and safety of sirolimus-eluting stents (SES) for in-stent restenosis (ISR) in the TRUE (Tuscany Registry of Unselected In-Stent Restenosis) database.
BACKGROUND: The TRUE registry demonstrated that SES in the treatment of bare-metal stent ISR is efficacious (5% of target lesion revascularization [TLR]) and safe (stent thrombosis <1%) at 9 months. Clinical outcome at 4 years is reported.
METHODS: A total of 244 patients with ISR who were treated with SES implantation represent the study population. The incidence of major adverse cardiac events was collected at 4 years.
RESULTS: At 4-year follow-up, overall mortality was 9.8% (24 patients). Cardiac death occurred in 11 (4.5%), nonfatal myocardial infarction in 8 (3.2%), and TLR in 27 (11.1%) patients for a cumulative event-free survival rate of 80.3%. Definite stent thrombosis occurred  in 5 (2%) patients and possible stent thrombosis in 2 (0.8%). Diabetes remained an independent negative predictor of freedom from TLR (odds ratio [OR]: 0.38; 95% confidence interval [CI]: 0.20 to 0.71, p = 0.002) and major adverse cardiac events (OR: 0.38; 95% CI: 0.20 to 0.71, p = 0.002).
CONCLUSIONS: The clinical benefit of SES implantation for bare-metal stent ISR is maintained at 4 years with a low TLR rate and an overall incidence of stent thrombosis of 0.7% per year.

8. Fertil Steril. 2010 May 1; 93(7):2368-73. Laparoscopy versus minilaparotomy in women with symptomatic uterine myomas: short-term and fertility results. Malzoni, M.; Tinelli, R.; Cosentino, F.; Iuzzolino, D.; Surico, D., and Reich, H.

Abstract:
OBJECTIVE: To retrospectively compare the feasibility, safety, morbidity, and pregnancy outcome of laparoscopy (LPS) and minilaparotomy (LPT) in the treatment  of symptomatic uterine myomas. DESIGN: Retrospective, nonrandomized study.
SETTING: Advanced Gynecological Endoscopy Center, Malzoni Medical Center, Avellino, Italy.
PATIENT(S): 680 nonconsecutive patients with symptomatic uterine myomas. INTERVENTION(S): 350 women underwent LPS, and 330 underwent LPT myomectomy. MAIN OUTCOME MEASURE(S): Operative time, blood loss, hospital stay, pregnancy rate, and spontaneous abortion rate.
RESULT(S): The mean operative time was 63 +/- 21 minutes (95% CI, 48-143) in the LPS group and 57 +/- 23 minutes (95% CI, 38-121) in the LPT group. The mean length of hospital stay was statistically significantly greater in the LPT group (3.1 +/- 0.5; 95% CI, 1-5) than the LPS group (2.1 +/- 0.8; 95% CI, 1-4). The overall spontaneous pregnancy  rate after myomectomy was 53%; the pregnancy rate after LPS myomectomy (56%) was  not statistically significantly higher than the rate for LPT (50%).
CONCLUSION(S): Laparoscopy showed a lower morbidity than reported for the open approach and was characterized by less blood loss and a shorter postoperative hospitalization with an higher pregnancy rate. The operating time was not much longer in the laparoscopic group, and the intraoperative and postoperative complications appeared acceptable and not more than what is traditionally expected with the open approach.

9. Pediatr Cardiol. 2010 Oct 22. Antiplatelet Versus Anticoagulation Therapy After Extracardiac Conduit Fontan: A  Systematic Review and Meta-Analysis. Marrone, C.; Galasso, G.; Piccolo, R.; de Leva, F.; Paladini, R.; Piscione, F., and Santoro, G.

Abstract
The benefits of prophylactic anticoagulation or antiplatelet therapy for patients undergoing extracardiac conduit (ECC) Fontan procedure still are a matter of debate. Through a systematic review and meta-analysis, this study aimed to determine the incidence of thromboembolism among patients undergoing ECC Fontan who received anticoagulation or antiplatelet therapy. Until February 2010, MEDLINE studies describing the incidence of thromboembolic events after ECC Fontan were reviewed. Information on type of drugs and clinical outcome was extracted. The 20 studies analyzed involved 1,075 patients: 220 (20.4%) in the antiplatelet group and 855 (79.5%) in the anticoagulation group. The mean follow-up period ranged from 2 to 144 months. The overall thromboembolism rate was 5.2% (95% confidence interval [CI], 3.8-7%; I(2) = 0%; p(het) = 0.32). The effect of different therapeutic strategies on the occurrence of thromboembolic and bleeding events was analyzed. Interestingly, the anticoagulation therapy compared with the antiplatelet therapy was not associated with a significant reduction in the incidence of overall thromboembolic complications (5% vs 4.5%, respectively; I(2) = 0%; p(het) = 0.80). Only two cases of bleeding were observed among patients receiving anticoagulant therapy at the time of the event. For patients undergoing ECC Fontan, the rate of thromboembolic and bleeding events associated with antiplatelet therapy is similar to that associated with anticoagulation therapy.

10. Surg Endosc. 2010 Jun 10. Laparoscopy-assisted gastrectomy versus open gastrectomy for gastric cancer: a monoinstitutional Western center experience. Orsenigo, E.; Di Palo, S.; Tamburini, A., and Staudacher, C.

Abstract:
BACKGROUND: Laparoscopic gastrectomy (LAG) is safe for benign lesions; however, such surgery for cancer remains controversial. The aim of this study was to compare technical feasibility and oncologic efficacy of laparoscopic versus open  gastrectomy for gastric carcinoma.
METHODS: Between January 2002 and November 2008, 109 gastric cancer patients underwent LAG (92 distal gastrectomy and 17 total gastrectomy) at our hospital. These patients were compared with 269 gastric cancer patients who underwent conventional open gastrectomy (OG; 171 distal gastrectomy and 98 total gastrectomy) during the same period.
RESULTS: Operation  time was significantly longer in the LAG group than in the OG group. Estimated blood loss in the LAG group was significantly less than in the OG group. The morbidity rate was higher than in the OG group (p < 0.0001). The distance of the  proximal resection margin was significantly lower in the OG group (2.8 +/- 1.9 vs. 3.8 +/- 2.5; p = 0.014). The mean number of nodes resected with LAG was 31 +/- 14 and that with OG was 27 +/- 13 (p = 0.002). The mean survival time was 53  months in both groups. There were no differences regarding overall patient survival at a mean time of follow-up of 33 months.
CONCLUSIONS: LAG with extended lymphadenectomy for gastric cancer is a feasible and safe procedure and has several advantages despite a higher rate of morbidity. Moreover, this method can  achieve a radical oncologic equivalent resection and it does not have a deleterious effect on cancer-related outcome.

11. Am J Cardiol. 2010 Jul 15; 106(2):167-174.e1. Comparison by meta-analysis of eptifibatide and tirofiban to abciximab in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention.  Ottani, F.; La Vecchia, L.; De Vita, M.; Catapano, O.; Tarantino, F., and Galvani, M.

Abstract
Adjunctive therapy with abciximab during primary percutaneous coronary intervention (PPCI) in patients with ST-elevation myocardial infarction (STEMI) determines a better short-term outcome compared to placebo. Tirofiban and eptifibatide represent a valid option with lower cost, but these have been less studied. The aim of the present study was to combine all randomized trials and registries to demonstrate the noninferiority of tirofiban and eptifibatide compared to abciximab in patients with STEMI treated with PPCI. We identified 6 randomized trials and 4 registries. Overall, 4,653 received small molecules and 2,696 abciximab, and the rate of combined death and nonfatal reinfarction did not differ (4.6% vs 4.5%, odds ratio 0.99, 95% confidence interval [CI] 0.78 to 1.27, p = 0.95) up to 30 days of follow-up, with an absolute difference of 0.1% (95% CI -1.06 to 0.8). Because the noninferiority limit was set at +1.5%, and because the upper point estimate (0.8%) of the 95% CI did not cross the prespecified limit, the noninferiority of the small molecules was documented. In-hospital major bleeding was also similar (8.8% vs 6.1%, odds ratio 0.92, 95% CI 0.75 to 1.13, p  = 0.43). Sensitivity analysis comparing randomized trials to registries and tirofiban or eptifibatide to abciximab did not show any significant differences.  In conclusion, our results documented noninferiority of "small molecules" compared to abciximab and, therefore, support their alternative use as adjunctive therapy during PPCI for patients with STEMI.

12. Eur J Phys Rehabil Med. 2010 Sep 8. Outcomes from ischemic stroke subtypes classified by the Oxfordshire Community Stroke Project: a systematic review. Paci, M.; Nannetti, L.; D'ippolito, P., and B Lombardi, B.

Abstract:
BACKGROUND: Stroke is a highly heterogeneous disorder with distinct subtypes, each presenting specific clinical aspects. Information on prognosis of ischemic stroke subtypes help to improve clinical management and rehabilitation treatments.
AIM: Summarize findings of studies on outcome in stroke subtypes categorized by use of the Oxfordshire Community Stroke Project (OCSP) classification.
DESIGN: Systematic review. SETTING: Not applicable. POPULATION: Adult post-stroke patients.
METHODS: Systematic literature research of five databases was undertaken to identify relevant studies. Outcomes were examined in  terms of impairment, activity restriction and participation restriction. Quality  of Life and mortality was also examined for each study.
RESULTS: Sixteen studies  met inclusion criteria. Most studies measure outcome in terms of activity limitations and participation restriction. Only one study measures impairment. TACI group have poor outcomes in comparison with other groups. Outcomes of LACI,  PACI and POCI groups are controversial.
CONCLUSION: Stroke subtype is a factor influencing outcome. However, differences among groups, overall in terms of impairment, should be further investigated. Clinical rehabilitation impact. Different prognosis of stroke subtypes may imply different rehabilitation managements.

13. Acute Card Care. 2010 Jun; 12(2):42-50. Lower long-term mortality within a regional system of care for ST-elevation myocardial infarction. Saia, F.; Marrozzini, C.; Guastaroba, P.; Ortolani, P.; Palmerini, T.; Pavesi, P. C.; Gordini, G.; Pancaldi, L. G.; Taglieri, N.; Palma, R.; Pasquale, G.; Branzi, A., and Marzocchi, A.

Abstract:
INTRODUCTION: Organization of regional systems of care (RSC) with an emphasis on  pre-hospital triage and primary percutaneous coronary intervention (PCI) has been recommended to implement guidelines and improve clinical outcome in ST-segment elevation myocardial infarction (STEMI).
PATIENTS AND METHODS: All STEMI patients (n = 1,823) admitted to any of the 13 hospitals of the province of Bologna, Italy, before (pre-RSC, n = 858) and after (RSC, n = 965) the implementation of a RSC were enrolled in the study. Primary evaluation was mortality. Secondary outcomes included death, myocardial infarction, stroke, and coronary revascularization procedures up to three-year follow-up.
RESULTS: Among patients  admitted <12 h from symptom onset, reperfusion was performed in 68.7% pre-RSC versus 89.8% RSC, P <0.001. Within the RSC, primary PCI became the main reperfusion treatment (34.5% pre-RSC versus 85.9% RSC; P <0.001 for both), and one-year mortality was lower (23.9% pre-RSC versus 18.8% RSC; P = 0.0015). At three-year, this advantage was maintained and actually increased (31.7% pre-RSC versus 24.8% RSC; P = 0.0031). Independent predictors of mortality at three-years were RSC, age, heart failure, cerebrovascular disease, renal disease, shock, peripheral vascular disease, and malignancies.
CONCLUSIONS: In this study, RSC for the treatment of STEMI was associated with increased rates of reperfusion and reduction of long-term mortality.

14. Cochrane Database Syst Rev. 2010; 9:CD008363. Utero-placental Doppler ultrasound for improving pregnancy outcome. Stampalija, T.; Gyte, G. M., and Alfirevic, Z.

Abstract
BACKGROUND: Impaired placentation can cause some of the most important obstetrical complications such as pre-eclampsia and intrauterine growth restriction and has been linked to increased fetal morbidity and mortality. The failure to undergo physiological trophoblastic vascular changes is reflected by the high impedance to the blood flow at the level of the uterine arteries. Doppler ultrasound study of utero-placental blood vessels, using waveform indices or notching, may help to identify the 'at-risk' women in the first and second trimester of pregnancy, such that interventions might be used to reduce maternal  and fetal morbidity and/or mortality.
OBJECTIVES: To assess the effects on pregnancy outcome, and obstetric practice, of routine utero-placental Doppler ultrasound in first and second trimester of pregnancy in pregnant women at high and low risk of hypertensive complications.
SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (June 2010) and the reference lists of identified studies.
SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of Doppler ultrasound for the investigation of utero-placental vessel waveforms in first and second trimester compared with no Doppler ultrasound. We have excluded studies where uterine vessels have been assessed together with fetal and umbilical vessels.
DATA COLLECTION AND ANALYSIS: Two authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. We checked data entry.
MAIN RESULTS: We found two studies involving 4993 participants. The methodological quality of the  trials was good. Both studies included women at low risk for hypertensive disorders, with Doppler ultrasound of the uterine arteries performed in the second trimester of pregnancy. In both studies, pathological finding of uterine arteries was followed by low-dose aspirin administration.We identified no difference in short-term maternal and fetal clinical outcomes.We identified no randomised studies assessing the utero-placental vessels in the first trimester or in women at high risk for hypertensive disorders.
AUTHORS' CONCLUSIONS: Present evidence failed to show any benefit to either the baby or the mother when utero-placental Doppler ultrasound was used in the second trimester of pregnancy  in women at low risk for hypertensive disorders. Nevertheless, this evidence cannot be considered conclusive with only two studies included. There were no randomised studies in the first trimester, or in women at high risk. More research is needed to investigate whether the use of utero-placental Doppler ultrasound may improve pregnancy outcome.

15. Am J Gastroenterol. 2010 Aug; 105(8):1753-61. Risk factors for post-ERCP pancreatitis in high- and low-volume centers and among expert and non-expert operators: a prospective multicenter study. Testoni, P. A.; Mariani, A.; Giussani, A.; Vailati, C.; Masci, E.; Macarri, G.; Ghezzo, L.; Familiari, L.; Giardullo, N.; Mutignani, M.; Lombardi, G.; Talamini, G.; Spadaccini, A.; Briglia, R., and Piazzi, L.

Abstract
OBJECTIVES: Prospective studies have identified a number of patient- and procedure-related independent risk factors for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, with different conclusions, so various questions are still open. The endoscopist's expertise, case volume, and case mix can all significantly influence the outcome of ERCP procedures, but have been investigated little to date.
METHODS: We identified patient- and procedure-related risk factors for post-ERCP pancreatitis and the impact of the endoscopist's experience and the center's case volume, using univariate and multivariate analysis, in a multicenter, prospective study involving low- and high-volume centers, over a 6-month period.
RESULTS: A total of 3,635 ERCP procedures were included; 2,838 (78%) ERCPs were performed in the 11 high-volume  centers (median 257 each) and 797 in the 10 low-volume centers (median 45 each).  Overall, 3,331 ERCPs were carried out by expert operators and 304 by less-skilled operators. There were significantly more grade 3 difficulty procedures in high-volume centers than in low-volume ones (P<0.0001). Post-ERCP pancreatitis occurred in 137 patients (3.8%); the rates did not differ between high- and low-volume centers (3.9% vs. 3.1%) and expert and non-expert operators (3.8% vs.  5.5%). However, in high-volume centers, there were 25% more patients with patient- and procedure-related risk factors, and the pancreatitis rate was one-third higher among non-expert operators. Univariate analysis found a significant association with pancreatitis for history of acute pancreatitis, either non-ERCP- or ERCP-related and recurrent, young age, absence of bile duct stones, and biliary pain among patient-related risk factors, and >10 attempts to  cannulate the Vater's papilla, pancreatic duct cannulation, contrast injection of the pancreatic ductal system, pre-cut technique, and pancreatic sphincterotomy, among procedure-related risk factors. Multivariate analysis also showed that a history of post-ERCP pancreatitis, biliary pain, >10 attempts to cannulate the Vater's papilla, main pancreatic duct cannulation, and pre-cut technique were significantly associated with the complication.
CONCLUSIONS: A history of pancreatitis among patient-related factors, and multiple attempts at cannulation  among procedure-related factors, were associated with the highest rates of post-ERCP pancreatitis. Pre-cut sphincterotomy, although identified as another significant risk factor, appeared safer when done early (fewer than 10 attempts at cannulating), compared with repeated multiple cannulation. The risk of post-ERCP pancreatitis was not associated with the case volume of either the single endoscopist or the center; however, high-volume centers treated a larger proportion of patients at high risk of pancreatitis and did a significantly greater number of difficult procedures.