rubrica

Comparabilità e valutazione dei servizi sanitari

  • Nerina Agabiti1

  • Marina Davoli1

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

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Ricerca bibliografica periodo 02 agosto 2011 – 01 ottobre 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 (“2011/08/02”[PDAT] : “2011/10/01”[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. Marrelli D, Pedrazzani C, Morgagni P, de Manzoni G, Pacelli F, Coniglio A, Marchet A, Saragoni L, Giacopuzzi S, Roviello F; Italian Research Group for Gastric Cancer. Changing clinical and pathological features of gastric cancer over time. Br J Surg. 2011 Sep;98(9):1273-83. doi: 10.1002/bjs.7528. Epub 2011 May 10.
Collaborators: Vindigni C, Tomezzoli A, Vittimberga G, Rosa F, Tiberio G, Baiocchi GL, Rossi GM, Nitti D.
Department of Human Pathology and Oncology, Section of Surgical Oncology, University of Siena, Siena, Italy. marrelli@unisi.it.

BACKGROUND:
The aim of the present multicentre observational study was to evaluate potential changes in clinical and pathological features of patients with gastric cancer (GC) treated in a 15-year interval.
METHODS:
A centralized prospective database including clinical, surgical, pathological and follow-up data from 2822 patients who had resection of a primary GC was analysed. The analysis focused on three periods: 1991-1995 (period 1), 1996-2000 (period 2) and 2001-2005 (period 3). Surgical procedure, pathological classification and follow-up were standardized among centres.
RESULTS:
The number of resections decreased from 1024 in period 1 to 955 and 843 in periods 2 and 3 respectively. More advanced stages and a smaller number of intestinal-type tumours of the distal third were observed over time. Five-year survival rates after R0 resection (2320 patients) did not change over time (overall: 56•6 and 51•2 per cent in periods 1 and 3; disease-free: 66•8 and 61•1 per cent respectively). Decreases in survival in more recent years were related particularly to more advanced stage, distal tumours and tumours in women. Multivariable analysis showed a lower probability of overall and disease-free survival in the most recent interval: hazard ratio 1•22 (95 per cent confidence interval 1•06 to 1•40) and 1•29 (1•06 to 1•58) respectively compared with period 1. Recurrent tumours were more frequently peritoneal rather than locoregional.
CONCLUSION:

Overall and disease-free survival rates after R0 resection of GC were unchanged over time.

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 Sep;47(3):407-15.
Physical and Rehabilitation Medicine Chair, Tor Vergata University, Rome, Italy -foti@med.uniroma2.it.

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. Coadministration 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. Capodanno D, Stone GW, Morice MC, Bass TA, Tamburino C. Percutaneous coronary intervention versus coronary artery bypass graft surgery in left main coronary artery disease: a meta-analysis of randomized clinical data. J Am Coll Cardiol. 2011 Sep 27;58(14):1426-32.
Ferrarotto Hospital and ETNA Foundation, Catania, Italy. dcapodanno@gmail.com

OBJECTIVES:
The purpose of this study was to determine the safety and efficacy of percutaneous coronary intervention (PCI) compared with coronary artery bypass graft (CABG) in patients with left main coronary artery (LMCA) disease.
BACKGROUND:
Previous meta-analyses of PCI versus CABG in LMCA disease mainly included nonprospective, observational studies. Several new randomized trials have recently been reported.
METHODS:
We identified 1,611 patients from 4 randomized clinical trials for the present meta-analysis. The primary endpoint was the 1-year incidence of major adverse cardiac and cerebrovascular events (MACCE), defined as death, myocardial infarction (MI), target vessel revascularization (TVR), or stroke.
RESULTS:
PCI was associated with a nonsignificantly higher 1-year rate of MACCE compared with CABG (14.5% vs. 11.8%; odds ratio [OR]: 1.28; 95% confidence interval [CI]: 0.95 to 1.72; p = 0.11), driven by increased TVR (11.4% vs. 5.4%; OR: 2.25; 95% CI: 1.54 to 3.29; p < 0.001). Conversely, stroke occurred less frequently with PCI (0.1% vs. 1.7%; OR: 0.15; 95% CI: 0.03 to 0.67; p = 0.013). There were no significant differences in death (3.0% vs. 4.1%; OR: 0.74; 95% CI: 0.43 to 1.29; p = 0.29) or MI (2.8% vs. 2.9%; OR: 0.98; 95% CI: 0.54 to 1.78; p = 0.95).
CONCLUSIONS:
In patients with LMCA disease, PCI was associated with nonsignificantly different 1-year rates of MACCE, death, and MI, a lower risk of stroke, and a higher risk of TVR compared with CABG.

Breve commento a cura di Nerina Agabiti
In tema di trattamento invasivo delle cardiopatia ischemica è stata pubblicata da Capodanno et al su J Am Coll Cardiology, una metanalisi che aggiorna le evidenze di efficacia dell’angioplastica percutanea confrontata con la chirurgia coronarica (bypass aortocoronarico) utilizzando i risultati dei più recenti trials clinici (RCTs) condotti a livello internazionale. Sono stati esaminati dati provenienti da 4 RCTs per un totale di 1611 pazienti.
L’esito primario è l’incidenza a un anno di eventi cardiovascolari e cerebrovascolari maggiori che includono: decesso, infarto acuto del miocardio, rivascolarizzazione cardiaca, ictus cerebrale (MACCE). L’angioplastica percutanea rispetto al bypass aortocoronarico è associata con un aumento di rischio di almeno un evento avverso (MACCE) ma non significativo (14.5% vs 11.8%, OR=1.28, 95% CI 0.95-1.72), tuttavia si associa ad un rischio significativamente minore di ictus cerebrale. Mentre non si osservano differenze significative per l’evento decesso o infarto acuto del miocardio, si segnala – confermando precedente evidenza scientifica - un aumentato rischio di nuova rivascolarizzazione per l’angioplastica rispetto al bypass aortocoronarico (11.4% vs 5.4%, OR=2.25, 95% CI= 1.54-3.29).

4. Menditto VG, Gabrielli B, Marcosignori M, Screpante F, Pupita G, Polonara S, Salvi A, Raggetti GM, Pomponio G. A Management of Blunt Thoracic Trauma in an Emergency Department Observation Unit: Pre-Post Observational Study. J Trauma. 2011 Sep 15. [Epub ahead of print]
From the Department of Emergency Medicine (V.G.M., S.P.), Medicina e Chirurgia d'Accettazione e d'Urgenza Ospedali Riuniti di Ancona, Ancona, Italy; Department of Internal Medicine (B.G., M.M., G. Pupita, G. Pomponio), Clinica Medica Università Politecnica delle Marche, Ancona, Italy; Centro per il Management Sanitario Università Politecnica delle Marche (F.S., G.M.R.), Ancona, Italy; and Department of Internal Medicine (A.S.), Medicina Generale Ospedali Riuniti di Ancona, Ancona, Italy.

BACKGROUND:
The best management of patients with isolated blunt thoracic trauma at high risk of pulmonary complications (HRPC-BTT: ≥3 isolated rib fractures, sternal fracture, single or few pulmonary contusions or minimal pneumothorax) is still unclear. We compared efficacy and cost-effectiveness of a new clinical pathway involving an Emergency Department Observation Unit (EDOU) with routine care.
METHODS:
Design: Retrospective before-after study. Setting: Level II Trauma Center within a Regional Teaching Hospital. Participants: A consecutive series of patients with HRPC-BTT. Interventions: a new clinical pathway involving EDOU was implemented. Main outcomes: Death rate, tube thoracostomy, and re-admission of discharged patients. Hospital admission rate, length of hospital occupancy, overall costs, and cost-effectiveness were also compared in pre- and post-EDOU period.
RESULTS:
Two hundred forty patients were eligible for the study: 110 patients in the pre-EDOU period and 130 in the post-EDOU period. Thirteen (12%) of the treated patients were re-admitted to the ED in the pre-EDOU period compared with only 5 (4%) when the EDOU was available (p = 0.03). The rate of tube thoracostomy performed in admitted patients significantly increased after EDOU implementation: 1 of 54 (1.9%) versus 4 of 32 (12.5%; p < 0.05). The rate of hospitalization decreased from 49% in the pre-EDOU period to 24% in the post-EDOU period (p < 0,005) and the length of stay in hospital in the pre-EDOU period was longer than in the EDOU period: mean 94.7 ± 79.6 versus 65.7 ± 60.6, respectively (p < 0.02). Cost analysis revealed no relevant change in cost-effectiveness per patient (median; interquartile range): &OV0556;487; &OV0556;103 to 1959 versus &OV0556;616; &OV0556;124 to 1455, respectively, in the pre- and post-EDOU period.
CONCLUSIONS:
In managing patients affected by HRPC-BTT, a clinical pathway involving the EDOU seems to be more effective than routine care with little impact on cost.

Breve commento a cura di Nerina Agabiti
La recente letteratura sui traumi sottolinea l’importanza di ridurre le ospedalizzazioni ed i costi e sono necessari studi che dimostrino l’efficacia di nuove modalità organizzative e cliniche di gestione del paziente in emergenza. Lo studio condotto da Giannicola Menditto et al pubblicato su J Trauma dà un contributo al tema proponendosi di valutare l’efficacia di un nuovo percorso di servizi in emergenza (“new clinical pathway” che coinvolge l’ Unità di Osservazione in Pronto Soccorso) di un Trauma Center di II livello localizzato in una struttura ospedaliera di tipo universitario in Ancona in confronto alle cure standard (“routine care”). Il disegno dello studio è un “before-after study”.
La popolazione in studio comprende 240 pazienti con grave trauma toracico ad alto rischio di complicanza polmonari ricoverati nel periodo 2006-07 . Vengono confrontati due periodi, prima e dopo l’introduzione del nuovo percorso in emergenza. Gli esiti primari sono la morte o altra complicanza di rilievo, il tasso di riammissione in ospedale e la durata della degenza, ricorso al pronto soccorso nei 30 giorni successivi alla dimissione per cause correlate al trauma toracico. Il tasso di ospedalizzazione risulta molto diminuito (da 49% a 24%) dopo l’introduzione del nuovo percorso così come la durata della degenza. 12% sono gli accessi successivi in pronto soccorso tra i pazienti con trauma toracico nel periodo prima del nuovo percorso mente sono solo il 5% nel periodo successivo. L’introduzione del nuovo percorso non risulta aver avuto un impatto sui costi. Si suggerisce che un percorso di gestione clinico-organizzativa che coinvolga l’uso della “Unità di Osservazione i Pronto Soccorso” – disponibilità di letti per l’osservazione dei pazienti per poche ore o pochi giorni – è efficace nel ridurre l’impatto sulle ospedalizzazioni e relativi costi per i pazienti con trauma toracico.

5. Volpe A, Cadeddu JA, Cestari A, Gill IS, Jewett MA, Joniau S, Kirkali Z, Marberger M, Patard JJ, Staehler M, Uzzo RG. Contemporary management of small renal masses. Eur Urol. 2011 Sep;60(3):501-15. Epub 2011 Jun 1.
Department of Urology, University of Eastern Piedmont, Maggiore della Carità Hospital, Novara, Italy. alessandro.volpe@med.unipmn.it

CONTEXT:
An increasing number of small renal masses (SRMs) with heterogeneous histology and clinical behaviour are being detected with modern radiologic imaging. Although surgical removal is the standard of care for small renal tumours, alternative minimally invasive and conservative treatment options are possible in selected patients with shorter life expectancy.
OBJECTIVE:
To systematically review indications, techniques, and outcomes of surgical and conservative treatments of SRMs.
EVIDENCE ACQUISITION:
A literature search of English-language publications was performed using the Medline database from January 2000 to February 2011 using the terms renal mass and renal carcinoma in conjunction with the evaluated management options. The articles that provided the highest level of evidence were selected with the consensus of all the authors and reviewed.
EVIDENCE SYNTHESIS:
Only one randomised controlled trial comparing the results of elective nephron-sparing surgery and radical nephrectomy for low-stage renal tumours is available. Few comparative studies of different treatment options for SRMs have been published. The assessment of oncologic outcomes is therefore based mainly on observational studies. Most series of nonsurgical therapies have strong selection biases and relatively short follow-up. Treatment selection is based on the clinical and histologic characteristics of SRMs, on patient age and comorbidities, and on personal preferences and experience of the urologist.
CONCLUSIONS:
Partial nephrectomy (PN) is the standard treatment for solitary SRMs whenever it is technically feasible. Laparoscopic PN is an alternative to open PN in experienced hands. The rationale of ablative treatments is to treat incidental cortical SRMs in patients at high surgical risk with potentially reduced morbidity. Active surveillance is considered an appropriate strategy for the elderly or for patients with significant comorbidity who have a shorter life expectancy. Percutaneous biopsies are increasingly being used to establish histology of SRMs and support treatment decisions, especially for patients who are candidates for nonsurgical treatment.

6. Landoni G, Biondi-Zoccai G, Greco M, Greco T, Bignami E, Morelli A, Guarracino F, Zangrillo A. Effects of levosimendan on mortality and hospitalization. A meta-analysis of randomized controlled studies. Crit Care Med. 2011 Sep 29. [Epub ahead of print]
From the Department of Anesthesia and Intensive Care (GL, MG, TG, EB, AZ), Università Vita-Salute San Raffaele, Milano, Italy; Interventional Cardiology, Division of Cardiology (GBZ), University of Turin, Turin, Italy; Department of Anesthesiology and Intensive Care (AM), University of Rome, "La Sapienza," Rome, Italy; Cardiothoracic Department (FG), Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.

OBJECTIVE:
Catecholaminergic inotropes have a place in the management of low output syndrome and decompensated heart failure but their effect on mortality is debated. Levosimendan is a calcium sensitizer that enhances myocardial contractility without increasing myocardial oxygen use. A meta-analysis was conducted to determine the impact of levosimendan on mortality and hospital stay.
DATA SOURCES:
BioMedCentral, PubMed, Embase, and the Cochrane Central Register of clinical trials were searched for pertinent studies. International experts and the manufacturer were contacted.
STUDY SELECTION:
Articles were assessed by four trained investigators, with divergences resolved by consensus. Inclusion criteria were random allocation to treatment and comparison of levosimendan vs. control. There were no restrictions on dose or time of levosimendan administration or on language. Exclusion criteria were: duplicate publications, nonadult studies, oral administration of levosimendan, and no data on main outcomes.
DATA EXTRACTION:
Study end points, main outcomes, study design, population, clinical setting, levosimendan dosage, and treatment duration were extracted.
DATA SYNTHESIS:
Data from 5,480 patients in 45 randomized clinical trials were analyzed. The overall mortality rate was 17.4% (507 of 2915) among levosimendan-treated patients and 23.3% (598 of 2565) in the control group (risk ratio = 0.80 [0.72; 0.89], p for effect < .001, number needed to treat = 17 with 45 studies included). Reduction in mortality was confirmed in studies with placebo (risk ratio = 0.82 [0.69; 0.97], p = .02) or dobutamine (risk ratio = 0.68 [0.52-0.88]; p = .003) as comparator and in studies performed in cardiac surgery (risk ratio = 0.52 [0.35; 0.76] p = .001) or cardiology (risk ratio = 0.75 [0.63; 0.91], p = .003) settings. Length of hospital stay was reduced in the levosimendan group (weighted mean difference = -1.31 [-1.95; -0.31], p for effect = .007, with 17 studies included). A trend toward a higher percentage of patients experiencing hypotension was noted in levosimendan vs. control (risk ratio = 1.39 [0.97-0.1.94], p = .053).
CONCLUSIONS:
Levosimendan might reduce mortality in cardiac surgery and cardiology settings of adult patients.

7. Baracchini C, Mazzalai F, Gruppo M, Lorenzetti R, Ermani M, Ballotta E. Carotid endarterectomy protects elderly patients from cognitive decline: A prospective study. Surgery. 2011 Sep 21. [Epub ahead of print]
Department of Neurological Sciences, University of Padua, School of Medicine, Padova, Italy.

BACKGROUND:
Carotid endarterectomy (CEA) reduces the risk of stroke in selected patients with symptomatic and asymptomatic carotid disease, but its beneficial influence on cognitive performance in the elderly remains debatable. This prospective study sought to determine early and long-term neurocognitive outcomes after CEA for severe unilateral carotid artery stenosis.
METHODS:
From July 2006 to December 2008, 75 symptomatic (group A) and 70 asymptomatic patients (group B) aged 65 years and older underwent CEA under general anesthesia. Sixty-eight age- and sex-matched individuals who underwent laparoscopic cholecystectomy during the same period at our institution served as a control group (group H). Patients with contralateral severe carotid stenosis or occlusion and those with dementia, depression, or a history of major stroke were excluded. Cognitive function was assessed using 2 neuropsychological tests (the Mini-Mental State Examination [MMSE] and the Montreal Cognitive Assessment [MoCA]) performed preoperatively (T0) and then 3 (T1) and 12 months (T2) after operation. A change of at least 2 points between the scores at T0 and T2 was arbitrarily considered as clinically significant.
RESULTS:
At T0, group A revealed significant cognitive impairments in both mean test scores by comparison with group H (P = .005 and P < .01, respectively), whereas there were no significant differences between groups A and B, or between groups B and H. Postoperatively, symptomatic patients had significant improvements in their mean cognitive performance scores in both tests (P < .01 and P < .01, respectively), whereas there were no changes in the asymptomatic and control patients' scores. No significant differences emerged for the MMSE scores in the 3 groups, whereas there was a marginally significant difference in the MoCA scores between groups A and H (P = .08), but not for A versus B or B versus H when clinically significant scores were considered.
CONCLUSION:
Our study showed that only elderly symptomatic patients with severe carotid lesions had a significant improvement in cognitive performance scores after CEA, although the benefit was considered clinically not significant. This suggests that CEA does not diminish neurocognitive functions, but it might provide some protection against cognitive decline in the elderly.

8. Seghieri C, Francesconi P, Cipriani S, Rapanà M, Anichini R, Franconi F, Del Prato S, Seghieri G. Gender Effect on the Relation between Diabetes and Hospitalization for Heart Failure. Exp Clin Endocrinol Diabetes. 2011 Sep 13. [Epub ahead of print]
Department of Internal Medicine.

Cardiovascular risk among diabetic patients is at least twice as much the one for non-diabetic individuals and even greater when diabetic women are considered. Heart failure (HF) is a common unfavorable outcome of cardiovascular disease in diabetes. However, since the comparison among sexes of heart failure prevalence in diabetic patients remains limited, this study is aimed at expanding the information about this point.We have evaluated the association between diabetes and HF by reviewing the medical records of all subjects discharged from the Internal Medicine and Cardiology Units of all hospitals in the Tuscany region, Italy, during the period January 2002 through December 2008. In particular we sought concomitance of ICD-9-CM codes for diabetes and HF.Patients discharged by Internal Medicine were on average older, more represented by women, and had a lesser number of individuals coded as diabetic (p<0.05 for all). Relative risk for HF (95% CI) was significantly higher in patients with diabetes, irrespective of gender 1.39 (1.36-1.41) in males; 1.40 (1.37-1.42) in females. When the diabetes-HF association was analyzed according to decades of age, a "horse-shoe" pattern was apparent with an increased risk in 40-59 years old in female patients discharged by Internal Medicine.Although there is not a difference in the overall HF risk between hospitalized male and female diabetic patients, women have an excess risk at perimenopausal age.

9. Maconi G, Barbara G, Bosetti C, Cuomo R, Annibale B. Treatment of diverticular disease of the colon and prevention of acute diverticulitis: a systematic review. Dis Colon Rectum. 2011 Oct;54(10):1326-38.
Gastroenterology Unit, Department of Clinical Sciences, L. Sacco University Hospital, Milan, Italy. giovanni.maconi@unimi.it

BACKGROUND:
Diverticular disease of the colon is a common disorder, characterized by recurrent symptoms and complications such as diverticulitis, requiring hospital admissions and surgery.
OBJECTIVE:
This study aimed to systematically review the evidence for medical therapy of diverticular disease in reducing symptoms and preventing acute diverticulitis.
DATA SOURCES:
MEDLINE and Embase databases (1966 to February 2010).
STUDY SELECTION:
The studies selected were prospective clinical trials on uncomplicated diverticular disease of the colon.
INTERVENTIONS:
Four investigators independently reviewed articles, extracted data, and assessed study quality according to standardized criteria.
MAIN OUTCOME MEASURES:
The main outcomes measured were improvement in symptoms, complete remission of symptoms, and prevention of acute diverticulitis.
RESULTS:
We identified 31 studies, including 6 placebo-controlled trials. The methodological quality of these studies was suboptimal. Only 10 trials provided a detailed description of the patient history, 8 assessed symptoms by the use of a validated questionnaire, and 14 appropriately defined inclusion and exclusion criteria. Only one long-term double-blind placebo-controlled study was identified. This reported a significant improvement in symptoms and greater prevalence of symptom-free patients at 1 year with fiber plus rifaximin in comparison with fiber alone. The efficacy of treatment in preventing acute diverticulitis was evaluated in 11 randomized trials. Four trials compared rifaximin plus fiber vs fiber alone and failed to show a significant difference between treatments. However, cumulative data from these trials revealed a significant benefit following rifaximin and fiber (1-year rate of acute diverticulitis: 11/970 (1.1%) vs 20/690 (2.9%); P = .012), but with a number needed to treat of 57, to prevent an attack of acute diverticulitis.
LIMITATIONS:
Heterogeneity of the study design, patients' characteristics, regimens and combination of studied treatment, and outcome reporting precluded the pooling of results and limited interpretation.
CONCLUSIONS:
The treatment for diverticular disease relies mainly on data from uncontrolled studies. Treatment showed some evidence of improvement in symptoms, but its role in the prevention of acute diverticulitis remains to be defined.

10. Picone S, Paolillo P, Franco F, Di Lallo D. The appropriateness of early discharge of very low birth weight newborns. J Matern Fetal Neonatal Med. 2011 Oct;24 Suppl 1:138-43. Epub 2011 Sep 2.
Neonatology-NICU O.U., Casilino Polyclinic , Rome , Italy.

Preterm newborns may be discharged when clinical conditions are stable and maturity of physiological functions has been gained, but no precise indications on weight and GA to be reached before discharge are available. In our NICU we have observed in the last five years 234 newborns < 32 weeks of GA; we have decided to transfer from incubators at the mean weight of 1737 g, regardless of their GA and birth weight and to discharge at a mean weight of 1966 g, the lowest mean weight in comparison to the other twelve NICUs of the Lazio region. We have analyzed if the major diseases affecting those newborns (RDS, mechanical ventilation, PDA, IVH/PVL, PHH, NEC, ROP, sepsis ) have influenced weight at discharge in 13 NICUs of Lazio region. Conclusions: in our NICU the discharge of ELBW/VLBW preterm newborns < 32 weeks GA and/or < 1500 g can be feasible at a mean weight close to 1900 g. An early transfer from incubator at a mean weight of 1737 g promotes an early discharge from hospital. Major diseases affecting those newborn haven't influenced weight at discharge.

11. Bertani E, Chiappa A, Biffi R, Bianchi PP, Radice D, Branchi V, Cenderelli E, Vetrano I, Cenciarelli S, Andreoni B. Assessing appropriateness for elective colorectal cancer surgery: clinical, oncological, and quality-of-life short-term outcomes employing different treatment approaches. Int J Colorectal Dis. 2011 Oct;26(10):1317-27. Epub 2011 Jul 13.
Division of General and Laparoscopic Surgery, European Institute of Oncology, Via G. Ripamonti, 435, 20141, Milan, Italy. emilio.bertani@ieo.it

PURPOSE:
In recent years, colorectal cancer surgery has benefitted from new techniques such as laparoscopy and robotic surgery. However, many treatment disparities exist among different centers for patients affected by the same kind of tumors.
METHODS:
Forty-five (41%) open (OCO) vs. 30 (28%) laparoscopic (LCO) vs. 34 (31%) robotic-assisted (RCO) colectomies and 34 (40%) open (ORR) vs. 52 (60%) robotic (ROR) rectal resections performed during a 15-month period, in elective setting, were compared. Patients presenting contraindications for minimally invasive procedures were excluded from the study, so that all the enrolled patients were suitable for either of the surgical procedures.
RESULTS:
Overall morbidity rates were similar among groups. Perioperative mortality was nil. No significant differences were noted as for total number of lymph nodes harvested between arms. Mean time (days) to first bowel movement to gas was 3.3 vs. 2.3 vs. 2.6 for OCO, LCO, and RCO, respectively (p < 0.001), and 3.3 vs. 2.0 for ORR and ROR, respectively (p = 0.003). Among several European Organization in Research and Treatment of Cancer QLQ-C30 functional scales considered only physical functioning was significantly better at 30 days for RCO vs. OCO (96.3 ± 10 RCO vs. 85.5 ± 12.6 OCO; p = 0.015). Robotic surgery was much more expensive in comparison to open as well as laparoscopic procedures.
CONCLUSIONS:
Laparoscopic and robotic surgeries for colorectal cancer present both the same advantages in comparison to open procedures in terms of faster recovery. However, our data do not seem to support the routine use of RCO as a cost-effective procedure.

12. Alecci V, Valente M, Crucil M, Minerva M, Pellegrino CM, Sabbadini DD. Comparison of primary total hip replacements performed with a direct anterior approach versus the standard lateral approach: perioperative findings. J Orthop Traumatol. 2011 Sep;12(3):123-9. Epub 2011 Jul 12.
Department of Orthopaedics and Traumatology, San Polo Hospital, via Galvani, 1, 34074 Monfalcone, GO, Italy.

BACKGROUND:
Given the increasing demand for tissue-sparing surgery, the surgical approach is the subject of lively debate in total hip replacement. The aim of this paper is to compare the efficacy of the minimally invasive direct anterior approach and the standard lateral approach to total hip replacement surgery by observing intra- and perioperative outcomes.
MATERIALS AND METHODS:
The authors conducted a retrospective study on a group of 419 consecutive patients undergoing total hip replacement for coxarthrosis. The patients were divided into a first group (A) of 198 patients who had surgery with the standard lateral approach, and a second control group (B) of 221 patients who had the same procedure via the minimally invasive direct anterior approach. Assessment of the two groups considered the following perioperative parameters: length of the surgical procedure, intraoperative complications, intra- and postoperative blood loss, postoperative pain, postoperative nausea and vomiting, length of stay, and type of discharge.
RESULTS:
The two groups were homogeneous when compared in relation to mean age, sex and body weight. The minimally invasive direct anterior approach was performed within an acceptable time (89 ± 19 min vs. 81 ± 15 min) and with modest blood loss (3.1 ± 0.9 g/dL vs. 3,5 ± 1 g/dL). Patients experienced less pain (1.4 ± 1.5 NRS score vs. 2.5 ± 2 NRS score), and PONV affected only 5% versus 10% of cases. Times to discharge were shorter (7 ± 2 days vs. 10 ± 3.5 days), and 58.4% versus 11.6% of patients were discharged to home.
CONCLUSIONS:
In our study, patients treated with a minimally invasive direct anterior approach had a better perioperative outcome than patients treated with the lateral approach. The longer time of surgery for the minimally invasive direct anterior approach may be attributed to the learning curve. Further studies are necessary to investigate the advantages of a minimally invasive direct anterior approach in terms of clinical results in the short and long run.

13. Pezzilli R, Cariani G, Santini D, Calculli L, Casadei R, Morselli-Labate AM, Corinaldesi R. Therapeutic management and clinical outcome of autoimmune pancreatitis. Scand J Gastroenterol. 2011 Sep;46(9):1029-38. Epub 2011 May 30.
Pancreas Unit, Department of Digestive Diseases and Internal Medicine, Sant'Orsola-Malpighi Hospital, University of Bologna, Italy. raffaele.pezzilli@aosp.bo.it

BACKGROUND:
Autoimmune pancreatitis, in comparison to other benign chronic pancreatic diseases, is characterized by the possibility of curing the illness with immunosuppressant drugs. The open question is whether to differentiate autoimmune pancreatitis as a primary or secondary disease based on the presence or absence of other autoimmune diseases or whether to consider autoimmune pancreatitis a clinical and pathological systemic entity, called IgG4-related sclerosing disease, since this aspect is also very important from a therapeutic point of view.
METHODS:
In this paper, we reviewed the conventional therapeutic approach used to treat autoimmune pancreatitis patients and the clinical outcome related to each treatment modality. We also reviewed some aspects which are important for the correct management of autoimmune pancreatitis, such as the surgical approach, the outcome of surgically treated autoimmune pancreatitis patients, whether medical treatment is always necessary, and, finally, when medical treatment should be initiated.
CONCLUSIONS:
Steroids are useful in alleviating the symptoms of the acute presentation of autoimmune pancreatitis, but some questions remain open such as the dosage of steroids in the acute phase and the duration of steroid therapy; finally, it should be assessed if other immunosuppressive non-steroidal drugs may become the first-line therapy in patients with AIP without jaundice and without atrophic pancreas.

14. Spada C, Hassan C, Munoz-Navas M, Neuhaus H, Deviere J, Fockens P, Coron E, Gay G, Toth E, Riccioni ME, Carretero C, Charton JP, Van Gossum A, Wientjes CA, Sacher-Huvelin S, Delvaux M, Nemeth A, Petruzziello L, de Frias CP, Mayershofer R, Aminejab L, Dekker E, Galmiche JP, Frederic M, Johansson GW, Cesaro P, Costamagna G. Second-generation colon capsule endoscopy compared with colonoscopy. Gastrointest Endosc. 2011 Sep;74(3):581-589.e1. Epub 2011 May 20.
Digestive Endoscopy Unit, Catholic University, Rome, Italy. cristianospada@gmail.com
Comment in Gastrointest Endosc. 2011 Sep;74(3):590-2.

BACKGROUND:
Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system.
OBJECTIVE:
To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy.
DESIGN AND SETTING:
Prospective, multicenter trial including 8 European sites.
PATIENTS:
This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed.
INTERVENTION:
CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day.
MAIN OUTCOME MEASUREMENTS:
CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopy-negative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed.
RESULTS:
Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients.
LIMITATIONS:
Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients.
CONCLUSION:
In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging.

15. 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 Sep;22(9):961-8. doi: 10.1111/j.1540-8167.2011.02050.x. Epub 2011 Mar 31.
Cardiology Division, Department of Internal Medicine, San Giovanni Battista Hospital, University of Turin, Italy. gaitaf@libero.it
Comment in J Cardiovasc Electrophysiol. 2011 Sep;22(9):969-72.

INTRODUCTION:
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 risk of 1.48 times compared to irrigated RF and cryoballoon ablation.

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