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Comparabilità e valutazione dei servizi sanitari

  • Nerina Agabiti1

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

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Ricerca bibliografica periodo dal 16 novembre 2013 al 1 febbraio 2014

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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 (“2013/11/16”[PDat] : “2014/02/01”[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. Ciarrocchi A, Amicucci G. Laparoscopic versus open appendectomy in obese patients: A meta-analysis of prospective and retrospective studies. J Minim Access Surg. 2014 Jan;10(1):4-9.
Author information: Department of General and Emergency Surgery, University of L'Aquila, L'Aquila, Italy. Abstract
BACKGROUND: A meta-analysis of different kinds of studies was performed to assess outcomes of laparoscopic versus open appendectomy in obese patients. MATERIALS AND METHODS: Retrospective and prospective studies enrolling patients with a body mass index greater than 30 kg/m(2) were included. Primary outcomes were days of hospital stay, surgical procedure duration, and overall post-operative complication rate. Secondary outcomes were wound infection and intra-abdominal abscesses formation rate, hospital charges. RESULTS: Laparoscopic appendectomy showed to be significantly associated with lower wound infection (P < 0.001) and post-operative complication rate (P < 0.001). Surgical time was considered as a hallmark of technical challenge and resulted diminished in the laparoscopic group (P = 0.018). Although not clinically relevant per se, the statistically significant shorter hospital stay (P < 0.001) was probably the reason of decreased hospital charges (P < 0.001). Intra-abdominal abscesses formation rate was higher in the open appendectomy group (P = 0.058), although slightly above the statistical significance threshold. CONCLUSION: Laparoscopic approach seemed to show relevant advantages compared to open appendectomy, but a large prospective trial is necessary to collect high quality data and investigate long-term outcomes.
2. Sodergren SC(1), White A(2), Efficace F(3), Sprangers M(4), Fitzsimmons D(5), Bottomley A(6), Johnson CD(2). Systematic review of the side effects associated with tyrosine kinase inhibitors used in the treatment of gastrointestinal stromal tumours on behalf of the EORTC Quality of Life Group. Crit Rev Oncol Hematol. 2014 Jan 17. pii: S1040-8428(14)00012-2. doi: 10.1016/j.critrevonc.2014.01.002. [Epub ahead of print]
Author information: (1)Cancer Sciences, University of Southampton, Southampton SO16 6YD, UK. Electronic address: S.C.Sodergren@soton.ac.uk. (2)Cancer Sciences, University of Southampton, Southampton SO16 6YD, UK. (3)Health Outcomes Research Unit, Gimema, 00161 Rome, Italy. (4)Department of Medical Psychology, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands. (5)Swansea Centre for Health Economics, Swansea University, Swansea SA2 8PP, UK. (6)European Organisation for Research and Treatment of Cancer Quality of Life Department, 1200 Brussels, Belgium. Abstract
Tyrosine kinase inhibitors (TKIs) have revolutionised the treatment of advanced gastrointestinal stromal tumours (GISTs). Imatinib is approved as first line therapy and sunitinib is used in cases of imatinib resistance or intolerance. Compared with conventional treatments, TKIs are delivered over longer periods of time and are more specific in their targets (i.e., molecularly targeted), thus presenting different side effect profiles. We review the safety profiles of imatinib and sunitinib, documenting a total of 95 side effects including patient based as well as medically defined outcomes. Gastrointestinal complaints, particularly diarrhoea and nausea, oedema, fatigue and haematological disorders, notably anaemia, are amongst the most prevalent side effects. While there is overlap between the side effect profiles of imatinib and sunitinib, important differences emerge in the frequencies of oedema, hypertension, thyroid functioning, muscle and joint pains, as well as skin and oral conditions. Awareness of potential side effects is informative to both clinician and patient in terms of treatment decision making and can have important implications for treatment adherence and clinical outcome.
3. Blasi F, Ostermann H, Racketa J, Medina J, McBride K, Garau J; REACH study group. Early versus later response to treatment in patients with community-acquired pneumonia: analysis of the REACH study. Respir Res. 2014 Jan 22;15(1):6. doi: 10.1186/1465-9921-15-6.
Author information: Department of Pathophysiology and Transplantation, University of Milan, IRCCS Fondazione Ospedale Maggiore, Policlinico Cà Granda Milano, Italy. francesco.blasi@unimi.it. Abstract
BACKGROUND: Key goals in the treatment of CAP include early response to treatment and achievement of clinical stability. The US FDA recommends early response endpoints (72 hours after initiation of treatment) in clinical trials for the treatment of community-acquired bacterial pneumonia. REACH (REtrospective Study to Assess the Clinical Management of Patients With Moderate-to-Severe Complicated Skin and Soft Tissue Infections [cSSTI] or CAP in the Hospital Setting) was a retrospective observational study, providing current data on the clinical management and resource burden of CAP in real-life settings in European hospitals. This analysis reviews the characteristics and outcomes of patients showing early positive response to treatment (time to clinical stability [TCS] ≤4 days, as assessed by Halm's criteria) compared with patients with later positive response (TCS >4 days). METHODS: Patients were adults, hospitalized with CAP (2010-2011) and requiring in-hospital treatment with intravenous antibiotics. RESULTS: Of the 2039 patients included in REACH, 585 (28.7%) had TCS assessed by Halm's criteria: 332 (56.8%) showed early response (median 3.0 days), and 253 (43.2%) showed later response to treatment (median 7.0 days). Use of Halm's criteria varied across participating countries, ranging from 0% (Belgium) to 49.1% (UK). Patient characteristics and relevant medical history were similar between the two groups. There were no notable differences in initial antibiotic therapy between groups, except that more early responders had been treated with amoxicillin-clavulanate and amoxicillin monotherapy (22.6%; 7.5%, respectively) than later responders (5.9%; 1.2%, respectively). Initial treatment modification and re-infection or recurrences were less frequent in early responders compared with later responders (14.2% and 3.3% vs. 34.8% and 5.9%, respectively). Early responders had a shorter duration of hospitalization (mean 9.4 ± SD 7.0; median 8.0 days vs. mean 15.6 ± SD 10.5; median 12.0 days, respectively), lower rate of ICU admission (3.3% vs. 21.3%) and shorter duration of ICU stay (mean 6.2 ± SD 5.7; median 4.0 days vs. mean 10.4 ± SD 10.1; median 8.0 days, respectively) compared with later responders. Mortality was low in both groups. CONCLUSIONS: Achieving early clinical stabilization in CAP (≤4 days) is associated with improved outcomes, lower requirement for initial treatment modification or readmission and lower resource use, compared with a later response. TRIAL REGISTRATION: NCT01293435.
4. Nistor I(1), Palmer SC(2), Craig JC(3), Saglimbene V(4), Vecchio M(5), Covic A(6), Strippoli GF(7). Convective Versus Diffusive Dialysis Therapies for Chronic Kidney Failure: An Updated Systematic Review of Randomized Controlled Trials. Am J Kidney Dis. 2014 Jan 13. pii: S0272-6386(13)01621-1. doi: 10.1053/j.ajkd.2013.12.004. [Epub ahead of print]
Author information: (1)Department of Nephrology, "Gr. T. Popa" University of Medicine and Pharmacy, Iasi, Romania; European Renal Best Practice Methods Support Team, Ghent University Hospital, Ghent, Belgium. (2)Department of Medicine, University of Otago Christchurch, Christchurch, New Zealand. (3)School of Public Health, University of Sydney, Sydney, New South Wales, Australia. (4)Diaverum Medical Scientific Office, Lund, Sweden. (5)Consorzio Mario Negri Sud, S. Maria Imbaro, Chieti, Italy. (6)Department of Nephrology, "Gr. T. Popa" University of Medicine and Pharmacy, Iasi, Romania. (7)School of Public Health, University of Sydney, Sydney, New South Wales, Australia; Diaverum Medical Scientific Office, Lund, Sweden; Consorzio Mario Negri Sud, S. Maria Imbaro, Chieti, Italy. Electronic address: strippoli@negrisud.it. Abstract
BACKGROUND: Convective dialysis therapies (hemofiltration or hemodiafiltration) are associated with lower mortality compared to hemodialysis in observational studies. A previous meta-analysis of randomized trials comparing convective modalities with hemodialysis in 2006 was inconclusive due to insufficient data. Additional randomized trials recently have reported conflicting results. STUDY DESIGN: Systematic review and meta-analysis of randomized trials to February 27, 2013. SETTING & POPULATION: Patients with chronic kidney failure treated by hemodialysis, hemodiafiltration, hemofiltration, or biofiltration. SELECTION CRITERIA FOR STUDIES: Randomized controlled trials. INTERVENTION: Convective therapies (hemodiafiltration, hemofiltration, and acetate-free biofiltration) compared with hemodialysis. OUTCOMES: All-cause and cardiovascular mortality, nonfatal cardiovascular events, hospitalization, change in dialysis modality, health-related quality of life, adverse events, blood pressure, and clearances of urea and β2-microglobulin. RESULTS: 35 trials (4,039 participants) were included. In low-quality evidence, convective dialysis had little or no effect on all-cause mortality (relative risk [RR], 0.87; 95% CI, 0.70-1.07) and may reduce cardiovascular mortality (RR, 0.75; 95% CI, 0.58-0.97) and hypotension (RR, 0.72; 95% CI, 0.66-0.80) during dialysis, but had uncertain effects on nonfatal cardiovascular events (RR, 1.14; 95% CI, 0.85-1.52) and hospitalization (RR, 1.21; 95% CI, 0.12-12.05). Adverse events were not reported systematically and health-related quality-of-life outcomes were sparse. Convective therapies reduced predialysis levels of β2-microglobulin (mean difference, -5.77 [95% CI, -10.97 to -0.56]mg/dL) and increased dialysis dose (Kt/Vurea mean difference, 0.10; 95% CI, 0.02-0.19), but these effects were very heterogeneous. Sensitivity analyses limited to trials comparing hemodiafiltration with hemodialysis showed similar results. LIMITATIONS: Studies had important risks of bias leading to low confidence in the summary estimates and generally were limited to patients who had adequate dialysis vascular access. CONCLUSIONS: Treatment effects of convective dialysis are unreliable due to limitations in trial methods and reporting. Convective dialysis may reduce cardiovascular but not all-cause mortality, and effects on nonfatal cardiovascular events and hospitalization are inconclusive.
5. Pisanu A(1), Porceddu G(2), Podda M(2), Cois A(2), Uccheddu A(2). Systematic review with meta-analysis of studies comparing intraoperative neuromonitoring of recurrent laryngeal nerves versus visualization alone during thyroidectomy. J Surg Res. 2013 Dec 25. pii: S0022-4804(13)02200-2. doi: 10.1016/j.jss.2013.12.022. [Epub ahead of print]
Author information: (1)Department of Surgery, Clinica Chirurgica, University of Cagliari, Monserrato, Italy. Electronic address: adolfo.pisanu@unica.it. (2)Department of Surgery, Clinica Chirurgica, University of Cagliari, Monserrato, Italy. Abstract
BACKGROUND: The role of intraoperative neuromonitoring (IONM) of the recurrent laryngeal nerve (RLN) during thyroid surgery is still debatable. The aim of this meta-analysis was to evaluate the potential improvement of IONM versus RLN visualization alone (VA) in reducing the incidence of vocal cord palsy. METHODS: A literature search for studies comparing IONM versus VA during thyroidectomy was performed. Studies were reviewed for primary outcome measures: overall, transient, and permanent RLN palsy per nerve and per patients at risk; and for secondary outcome measures: operative time; overall, transient and permanent RLN palsy per nerve at low and high risk; and the results regarding assistance in RLN identification before visualization. RESULTS: Twenty studies comparing thyroidectomy with and without IONM were reviewed: three prospective, randomized trials, seven prospective trials, and ten retrospective, observational studies. Overall, 23,512 patients were included, with thyroidectomy performed using IONM compared with thyroidectomy by VA. The total number of nerves at risk was 35,513, with 24,038 nerves (67.7%) in the IONM group, compared with 11,475 nerves (32.3%) in the VA group. The rates of overall RLN palsy per nerve at risk were 3.47% in the IONM group and 3.67% in the VA group. The rates of transient RLN palsy per nerve at risk were 2.62% in the IONM group and 2.72% in the VA group. The rates of permanent RLN palsy per nerve at risk were 0.79% in the IONM group and 0.92% and in the VA group. None of these differences were statistically significant, and no other differences were found. CONCLUSIONS: The current review with meta-analysis showed no statistically significant difference in the incidence of RLN palsy when using IONM versus VA during thyroidectomy. However, these results must be approached with caution, as they were mainly based on data coming from non-randomized observational studies. Further studies including high-quality multicenter, prospective, randomized trials based on strict criteria of standardization and subsequent clustered meta-analysis are required to verify the outcomes of interest.
6. Lakkireddy D(1), Reddy YM(2), Di Biase L(3), Vallakati A(2), Mansour MC(4), Santangeli P(5), Gangireddy S(6), Swarup V(7), Chalhoub F(4), Atkins D(2), Bommana S(2), Verma A(8), Sanchez JE(5), Burkhardt JD(5), Barrett CD(9), Baheiry S(10), Ruskin J(4), Reddy V(6), Natale A(11). Feasibility & Safety of Uninterrupted Rivaroxaban for Periprocedural Anticoagulation in Patients Undergoing Radiofrequency Ablation for Atrial Fibrillation: Results from a Multicenter Prospective Registry. J Am Coll Cardiol. 2013 Dec 23. pii: S0735-1097(13)06543-1. doi: 10.1016/j.jacc.2013.11.039. [Epub ahead of print]
Author information: (1)Division of Cardiovascular Diseases, Cardiovascular Research Institute, Mid America Cardiology, University of Kansas Hospital & Medical Center, Kansas City, KS. Electronic address: dlakkireddy@kumc.edu. (2)Division of Cardiovascular Diseases, Cardiovascular Research Institute, Mid America Cardiology, University of Kansas Hospital & Medical Center, Kansas City, KS. (3)Texas Cardiac Arrhythmia Institute, Austin, TX; Department of Cardiology, University of Foggia, Foggia, Italy; Department of Biomedical Engineering, University of Texas, Austin, Texas. (4)Massachussets General Hospital, Boston, MA. (5)Texas Cardiac Arrhythmia Institute, Austin, TX. (6)Mount Sinai Medical Center, New York, NY. (7)Arizona Heart Rhythm Center, Phoenix, AZ. (8)Southlake Regional Medical Center, Toronto, Canada. (9)St. Lukes Roosevelt Hospital, New York, NY. (10)California Pacific Medical Center, San Francisco, CA. (11)Texas Cardiac Arrhythmia Institute, Austin, TX; Department of Biomedical Engineering, University of Texas, Austin, Texas. Abstract
OBJECTIVES: The purpose of this study was to evaluate the feasibility and safety of uninterrupted rivaroxaban during atrial fibrillation (AF) ablation. BACKGROUND: Optimal periprocedural anticoagulation strategy is essential for minimizing bleeding and thrombo-embolic complications during and after AF ablation. The safety and efficacy of uninterrupted rivaroxaban as a periprocedural anticoagulant for AF ablation are unknown. METHODS: We performed a multicenter, observational study from a prospective registry of patients undergoing AF ablation in 8 centers in the North America. Patients on uninterrupted periprocedural rivaroxaban were matched by age, gender and type of AF with an equal number of patients on uninterrupted warfarin therapy undergoing AF ablation during the same period. RESULTS: A total of 642 patients were included in the study with 321 in each group. Mean age was 63 ±10years with 442 (69%) males and 328 (51%) having paroxysmal AF; equally distributed between both the groups. Patients in the warfarin group had a slightly higher mean HAS BLED score (1.70 ±1.0 vs 1.47 ±0.9; p=0.032). Bleeding and embolic complications occurred in 47 (7.3%) and 2 (0.3%) patients (both transient ischemic attacks) respectively. There were no differences in the major bleeding complications (5/1.6% vs 7/1.9%; p=0.772), minor bleeding complications (16/5.0% vs 19/5.9%; p=0.602) or embolic complications (1/0.3% vs 1;0.3%; p=1.0) between rivaroxaban and warfarin groups respectively in the first 30days. CONCLUSIONS: Uninterrupted rivaroxaban therapy appears to be equally safe and efficacious in preventing bleeding and thrombo-embolic events in patients undergoing AF ablation when compared to uninterrupted warfarin.
7. Barbui C, Conti V, Cipriani A. Antipsychotic drug exposure and risk of venous thromboembolism: a systematic review and meta-analysis of observational studies. Drug Saf. 2014 Feb;37(2):79-90. doi: 10.1007/s40264-013-0127-6.
Author information: Section of Psychiatry, Department of Public Health and Community Medicine, University of Verona, Policlinico GB Rossi, Piazzale Scuro 10, 37134, Verona, Italy, corrado.barbui@univr.it. Abstract
BACKGROUND: Venous thromboembolism (VTE) is a serious disorder that may be complicated by pulmonary embolism (PE). Case reports and observational studies published in the early 1950s suggested that antipsychotic (AP) drugs may represent a risk factor, while observational studies conducted in the last 3 decades have provided conflicting results. OBJECTIVE: The aim was to investigate whether AP drugs increase the risk of VTE and PE, and to ascertain the risk associated with first- and second-generation AP drugs and with exposure to individual drugs. DATA SOURCE: Relevant studies were located by searching MEDLINE, PubMed, EMBASE, PsychINFO, CINAHL and Scopus up to March 2013. Reference lists of relevant papers and previous review articles were hand searched for other relevant studies. STUDY SELECTION: Based on the titles and abstracts of 1,386 citations, we identified 30 potentially relevant studies. Of these, 17 studies were eligible for inclusion and were included in the meta-analysis. MAIN OUTCOMES AND MEASURES: The primary outcome measure of this meta-analysis was the occurrence of VTE or PE in individuals exposed to AP drugs in comparison with individuals unexposed or with past exposure to AP drugs. RESULTS: Antipsychotic exposure was associated with a significant increase in risk of developing VTE [odds ratio (OR) 1.54, 95 % confidence interval (CI) 1.28-1.86, 11 studies]. Exposure to APs did not significantly increase the risk of PE (OR 4.90, 95 % CI 0.77-30.98, three studies), but the overall estimate was highly heterogeneous and the CI included the possibility of substantial harm. Random-effects meta-analysis on the risk of VTE associated with exposure to first- (OR 1.74, 95 % CI 1.28-2.37, six studies) and second-generation (OR 2.07, 95 % CI 1.74-2.52, five studies) APs revealed an increased risk. Only a few studies provided data on individual drugs, and estimates of effect were very uncertain. CONCLUSIONS: Antipsychotic exposure in unselected patient populations may be associated with a 50 % increase in the risk of developing VTE. However, between-study heterogeneity limits the confidence in this estimate. This increased risk similarly applies to first- and second-generation AP drugs.
8. Candoni A, Caira M, Cesaro S, Busca A, Giacchino M, Fanci R, Delia M, Nosari A, Bonini A, Cattaneo C, Melillo L, Caramatti C, Milone G, Scime' R, Picardi M, Fanin R, Pagano L. Multicentre surveillance study on feasibility, safety and efficacy of antifungal combination therapy for proven or probable invasive fungal diseases in haematological patients: the SEIFEM real-life combo study. Mycoses. 2013 Dec 23. doi: 10.1111/myc.12161. [Epub ahead of print]
Author information: Division of Hematology, University of Udine, Italy. Abstract
This multicentre observational study evaluated the feasibility, efficacy and toxicity of antifungal combination therapy (combo) as treatment of proven or probable invasive fungal diseases (IFDs) in patients with haematological malignancies. Between January 2005 and January 2010, 84 cases of IFDs (39 proven and 45 probable) treated with combo were collected in 20 Hematological Italian Centres, in patients who underwent chemotherapy or allogeneic haematopoietic stem cell transplantation for haematological diseases. Median age of patients was 34 years (range 1-73) and 37% had less than 18 years. Acute leukaemia was the most common underlying haematological disease (68/84; 81%). The phase of treatment was as follows: first induction in 21/84 (25%), consolidation phase in 18/84 (21%) and reinduction/salvage in 45/84 (54%). The main site of infection was lung with or without other sites. The principal fungal pathogens were as follows: Aspergillus sp. 68 cases (81%), Candida sp. six cases (8%), Zygomycetes four cases (5%) and Fusarium sp. four cases (5%). The most used combo was caspofungin+voriconazole 35/84 (42%), caspofungin + liposomal amphotericin B (L-AmB) 20/84 (24%) and L-AmB+voriconazole 15/84 (18%). The median duration of combo was 19 days (range 3-180). The overall response rate (ORR) was 73% (61/84 responders) without significant differences between the combo regimens. The most important factor that significantly influenced the response was granulocyte (PMN) recovery (P 0.009). Only one patient discontinued therapy (voriconazole-related neurotoxicity) and 22% experienced mild and reversible adverse events (hypokalaemia, ALT/AST increase and creatinine increase). The IFDs-attributable mortality was 17%. This study indicates that combo was both well tolerated and effective in haematological patients. The most used combo regimens were caspofungin + voriconazole (ORR 80%) and caspofungin + L-AmB (ORR 70%). The ORR was 73% and the mortality IFD related was 17%. PMN recovery during combo predicts a favourable outcome. Clinical Trials Registration: NCT00906633.
9. Nicolo M(1), Eandi CM(2), Alovisi C(3), Grignolo FM(3), Traverso CE(4), Musetti D(4), Piccolino FC(5). Half-fluence versus half-dose photodynamic therapy in chronic central serous chorioretinopathy. Am J Ophthalmol. 2014 Jan 29. pii: S0002-9394(14)00052-X. doi: 10.1016/j.ajo.2014.01.022. [Epub ahead of print]
Author information: (1)Clinica Oculistica Università di Genova, Dipartimento di Neuroscienze, Oftalmologia, Genetica e Scienze Materno Infantili - Viale Benedetto XV, Genova, Italy; Fondazione per la Macula onlus - Viale Bebedetto XV, Genova, Italy. Electronic address: massimonicolo@occhioallaretina.it. (2)Fondazione per la Macula onlus - Viale Bebedetto XV, Genova, Italy; Clinica Oculistica - Dipartimento di Scienze Chirurgiche, Università di Torino. (3)Clinica Oculistica - Dipartimento di Scienze Chirurgiche, Università di Torino. (4)Clinica Oculistica Università di Genova, Dipartimento di Neuroscienze, Oftalmologia, Genetica e Scienze Materno Infantili - Viale Benedetto XV, Genova, Italy. (5)Fondazione per la Macula onlus - Viale Bebedetto XV, Genova, Italy. Abstract
PURPOSE: To compare the efficacy and safety of half-fluence versus half-dose photodynamic therapy (PDT) in chronic central serous chorioretinopathy (CSC). DESIGN: of the study: Multicenter retrospective comparison study METHODS: Retrospective review of 56 patients affected by chronic CSC, including 28 patients (31 eyes) who received half-fluence PDT and 28 patients (29 eyes) who received half-dose PDT. Best-corrected visual acuity (BCVA), central foveal thickness (CFT) and resolution of subretinal fluid on optical coherence tomography at 1 and 12 months were assessed. RESULTS: The mean logmar BCVA improved significantly (p<0.001) both in the half-fluence group from 0.187 (±0.187) to 0.083 (±0.164) and in the half-dose group from 0.126 (±0.091) to 0.068 (±0.091) at 12 months, without significant difference between the 2 groups. At 1 month a complete resolution of subretinal fluid was observed in 19 (61.3%) half-fluence treated eyes and in 25 (86.2%) half-dose treated eyes (p =0.04). At 12 months, a complete resolution of sub-retinal fluid was achieved in 26 (83.9%) half-fluence treated eyes and 29 (100%) half-dose treated eyes (p = 0.0529). Nine (29%) eyes in the half-fluence group and 5 (17.2%) eyes in the half-dose group had at least one recurrence of subretinal fluid during the follow-up. Overall there were15 and 5 recurrences in the half-fluence PDT and half-dose PDT groups respectively (p=0.07). In no eye of both groups atrophy of the RPE was observed in the area of treatment. CONCLUSION: Half-dose PDT induced a more rapidly reabsorption of the fluid, a more lasting effect and an equal safety with respect to half-fluence PDT.
10. Agresti R(1), Crippa F(2), Sandri M(3), Martelli G(4), Tagliabue E(3), Alessi A(2), Pellitteri C(4), Maccauro M(2), Maugeri I(4), Barbara P(2), Rampa M(4), Moscaroli A(4), Ferraris C(4), Carcangiu ML(5), Bianchi G(6), Greco M(4), Bombardieri E(2). Different biological and prognostic breast cancer populations identified by FDG-PET in sentinel node-positive patients: Results and clinical implications after eight-years follow-up. Breast. 2014 Jan 30. pii: S0960-9776(14)00002-2. doi: 10.1016/j.breast.2014.01.001. [Epub ahead of print]
Author information: (1)Breast Surgery Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: roberto.agresti@istitutotumori.mi.it. (2)Nuclear Medicine Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. (3)Molecular Targeting Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. (4)Breast Surgery Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. (5)Pathology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. (6)Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Abstract
BACKGROUND: Sentinel node (SN) biopsy is the standard method to evaluate axillary node involvement in breast cancer (BC). Positron emission tomography with 2-(fluorine-18)-fluoro-2-deoxy-D-glucose (FDG-PET) provides a non-invasive tool to evaluate regional nodes in BC in a metabolic-dependent, biomolecular-related way. In 1999, we initiated a prospective non-randomized study to compare these two methods and to test the hypothesis that FDG-PET results reflect biomolecular characteristics of the primary tumor, thereby yielding valuable prognostic information. PATIENTS AND METHODS: A total of 145 cT1N0 BC patients, aged 24-70 years, underwent FDG-PET and lymphoscintigraphy before surgery. SN biopsy was followed in all cases by complete axillary dissection. Pathologic evaluation in tissue sections for involvement of the SN and other non-SN nodes served as the basis of the comparison between FDG-PET imaging and SN biopsy. RESULTS: FDG-PET and SN biopsy sensitivity was 72.6% and 88.7%, respectively, and negative predictive values were 80.5% and 92.2%, respectively. A subgroup of more aggressive tumors (ER-GIII, Her2+) was found mainly in the FDG-PET true-positive (FDG-PET+) patients, whereas LuminalA, Mib1 low-rate BCs were significantly undetected (p = 0.009) in FDG-PET false-negative (FDG-PET-) patients. Kaplan-Meier survival estimates after a median follow-up of more than 8 years showed significantly worse overall survival for FDG-PET+ patients in node-positive (N+) patients (p = 0.035) as compared to N+/FDG-PET- patients, which overlapped with survival curves of N- and FDG-PET+ or - patients. CONCLUSIONS: Our findings suggest that FDG-PET results reflect intrinsic biologic features of primary BC tumors and have prognostic value with respect to nodal metastases. FDG-PET false negative cases appear to identify less aggressive indolent metastases. The possibility to identify a subgroup of N+ BC patients with an outcome comparable with N- BC patients could reduce the surgical and adjuvant therapeutic intervention.
11. Lupi A, Gabrio Secco G, Rognoni A, Lazzero M, Fattori R, Sheiban I, Sante Bongo A, Bolognese L, Agostoni P, Porto I. Meta-analysis of bioabsorbable versus durable polymer drug-eluting stents in 20,005 patients with coronary artery disease: An update. Catheter Cardiovasc Interv. 2014 Jan 30. doi: 10.1002/ccd.25416. [Epub ahead of print]
Author information: Hospital Cardiology, "Maggiore della Carità" Hospital, Novara, Italy. Abstract
OBJECTIVES: To perform an updated meta-analysis comparing biodegradable polymer drug eluting stents (BP-DES) and durable polymer drug eluting stents (DP-DES). BACKGROUND: BP-DES have been suggested to reduce late stent thrombosis (LST) rates as compared to first generation DP-DES. Recently, second generation DP-DES have replaced older DES, but comparison of these stents with BP-DES has not yielded consistent results. METHODS: Medline/Web databases were searched for studies comparing BP-DES and DP-DES, and reporting rates of overall/cardiac mortality, myocardial infarction (MI), LST, target lesion revascularization (TLR) and target vessel revascularization (TVR) and late lumen loss (LLL), with a follow-up ≥6 months. RESULTS: Twenty studies (20,005 patients) were included in the meta-analysis. Median follow-up time was 1 year. Compared with DP-DES, BP-DES showed lower LLL (in stent: weighted mean difference WMD -0.45 mm, 95% CI -0.66 to -0.24 mm, P = 0.00001; in segment: WMD -0.15 mm, 95% CI = -0.24 to -0.06 mm, P = 0.001) and lower rates of LST (OR 0.51, 95% CI = 0.30 to 0.86, P = 0.01), although they did not improve mortality, MI, TLR, and TVR rates. BP-DES coated with sirolimus or novolimus, in comparison with biolimus or paclitaxel, were associated with reduced LLL (P < 0.0001 for subgroups). CONCLUSIONS: In comparison with DP-DES, BP-DES significantly reduce LLL and LST rates, without clear benefits on harder endpoints. The efficacy of BP-DES in preserving lumen patency seems larger for sirolimus and novolimus DES. © 2014 Wiley Periodicals, Inc.

Breve commento a cura di Nerina Agabiti
Gli Autori riportano i risultati di una meta-analisi sull’interessante tema della terapia con stent per la malattia coronarica aterosclerotica. Continue sono le novità e le proposte in commercio di nuove tecniche e prodotti per la rivascolarizzazione coronarica nella cardiopatia ischemica, ma non sempre sono noti benefici e rischi in termini comparativi. Il lavoro si propone di confrontare l’efficacia di due tipi di stent (ovvero di procedure di rivascolarizzazione coronarica con uso di stent): stent con polimero biodegradabile (BP-DES) e stent con polimero duraturo (DP-DES). Il primo dei due, quello che utilizza il polimero biodegradabile, è stato introdotto in quanto capace di ridurre il rischio di trombosi tardiva, una complicanza grave della procedura coronarica invasiva, rispetto allo stent con polimero duraturo di prima generazione. Sono stati poi introdotti gli stent con polimero duraturo di nuova generazione ma non sono ancora ben noti e definitivi i risultati sulla loro efficacia. Nella meta-analisi sono stati inclusi 20 studi randomizzati controllati in cui i pazienti (oltre 20.000) sono stati seguiti con una mediana di follow up di un anno. In confronto allo stent con polimero duraturo (DP-DES), lo stent con polimero biodegradabile (BP-DES) sembra associarsi a una minore probabilità di restrizione tardiva del lume arterioso e minore probabilità di trombosi tardiva dello stent, ma non sembra avere benefici di rilievo in termini di sopravvivenza, incidenza di infarto del miocardio e di altre complicanze (come la “target vessel revascularization”). Nell’ambito dei BP-DES l’uso di sirolimus o novolimus piuttosto che biolimus o paclitaxel si associa a una minore incidenza di restringimento tardivo del lume coronarico. In sintesi, l’uso dei BP-DES si associa a una riduzione di alcuni esiti sfavorevoli specifici ma non sembra avere effetti su endpoints clinici più importanti. Alcune molecole usate per gli stent medicati hanno efficacia maggiore di altre nel mantenere la pervietà del lume del vaso sottoposto alla procedura.

12. Bogani G, Cromi A, Uccella S, Serati M, Casarin J, Mariani A, Ghezzi F. Laparoscopic staging in women older than 75 years with early-stage endometrial cancer: comparison with open surgical operation. Menopause. 2014 Jan 27. [Epub ahead of print]
Author information: From the 1Department of Obstetrics and Gynecology, University of Insubria, Del Ponte Hospital, Varese, Italy; and 2Section of Gynecological Surgery, Mayo Clinic, Rochester, MN. Abstract
OBJECTIVE: Older age is a relevant risk factor for developing endometrial cancer (EC) and has been traditionally regarded as a relative contraindication to laparoscopy. Our aim was to analyze the safety and effectiveness of laparoscopic staging in older women with EC. METHODS: Consecutive women aged 75 years or older who underwent laparoscopic staging for EC between May 2002 and October 2012 were compared with consecutive women aged 75 years or older who underwent abdominal staging before the adoption of the laparoscopic approach in our institution. Postoperative complications were graded according to the Accordion Severity Grading System. RESULTS: Fifty-nine women aged 75 years or older who underwent laparoscopy were compared with a cohort of 66 women aged 75 years or older who underwent open staging before the incorporation of laparoscopy. Demographic and disease characteristics, as well as the Charlson comorbidity index, were balanced between groups. Women who underwent laparoscopy had similar operative time (P = 0.14), lower blood loss (P = 0.005), and shorter length of stay (P < 0.001) in comparison with women who underwent open surgical operation. Overall, women who underwent laparoscopy experienced less postoperative complications than women in the control group (P < 0.001). In addition, focusing only on complications grade 3 or higher, we observed a trend toward decreased complication rates in the laparoscopic group (P = 0.06). No differences in survival outcomes (including time of recurrence, site of recurrence, disease-free survival, and overall survival) were recorded (P > 0.05). CONCLUSIONS: Our findings suggest that EC patients older than 75 years may benefit from minimally invasive surgical operation and should not be denied laparoscopy based on mere chronological age.
13. Nava F, Tramacere I, Fittipaldo A, Bruzzone MG, Dimeco F, Fariselli L, Finocchiaro G, Pollo B, Salmaggi A, Silvani A, Farinotti M, Filippini G. Survival effect of first- and second-line treatments for patients with primary glioblastoma: a cohort study from a prospective registry, 1997-2010. Neuro Oncol. 2014 Jan 23. [Epub ahead of print]
Author information: Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy (F.N., I.T., A.F., M.F., G.F.); Unit of Neuroradiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy (M.G.B., L.F.); Department of Neurosurgery, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy; Department of Neurological Surgery, Johns Hopkins Medical School, Baltimore, Maryland (F.D.); Unit of Molecular Neuro-oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy (G.F.); Unit of Neuropathology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy (B.P.); Department of Neurology, Ospedale Alessandro Manzoni, Lecco, Italy (A.S.); Unit of Clinical Neuro-oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy (A.S.). Abstract
BackgroundProspective follow-up studies of large cohorts of patients with glioblastoma (GBM) are needed to assess the effectiveness of conventional treatments in clinical practice. We report GBM survival data from the Brain Cancer Register of the Fondazione Istituto Neurologico Carlo Besta (INCB) in Milan, Italy, which collected longitudinal data for all consecutive patients with GBM from 1997 to 2010.MethodsSurvival data were obtained from 764 patients (aged>16 years) with histologically confirmed primary GBM who were diagnosed and treated over a 7-year period (2004-2010) with follow-up to April 2012 (cohort II). Equivalent data from 490 GBM patients diagnosed and treated over the preceding 7 years (1997-2003) with follow-up to April 2005 (cohort I) were available for comparison. Progression-free survival (PFS) was available from 361 and 219 patients actively followed up at INCB in cohorts II and I, respectively.ResultsSurvival probabilities were 54% at 1 year, 21% at 2 years, and 11% at 3 years, respectively, in cohort II compared with 47%, 11%, and 5%, respectively, in cohort I. PFS was 22% and 12% at 1 year in cohorts II and I. Better survival and PFS in cohort II was significantly associated with introduction of the Stupp protocol into clinical practice, with adjusted hazard ratios (HRs) of 0.78 for survival and 0.73 for PFS, or a 22% relative decrease in the risk of death and a 27% relative decrease in the risk of recurrence. After recurrence, reoperation was performed in one-fifth of cohort I and in one-third of cohort II but was not effective (HR, 1.05 in cohort I and 1.02 in cohort II). Second-line chemotherapy, mainly consisting of nitrosourea-based chemotherapy, temozolomide, mitoxantrone, fotemustine, and bevacizumab, improved survival in both cohorts (HR, 0.57 in cohort I and 0.74 in cohort II). Radiosurgery was also effective (HR, 0.52 in cohort II).ConclusionsWe found a significant increase in overall survival, PFS, and survival after recurrence after 2004, likely due to improvements in surgical techniques, introduction of the Stupp protocol as a first-line treatment, and new standard protocols for second-line chemotherapy and radiosurgery after tumor recurrence. In both cohorts, reoperation after tumor recurrence did not improve survival.

Breve commento a cura di Nerina Agabiti
Il tema dell’efficacia dei trattamenti per il glioblastoma nella reale pratica clinica è argomento del lavoro condotto da Nava et al e pubblicato recentemente su Neuro-Oncology. Il glioblastoma è uno dei tumori maligni cerebrali più frequenti nell’adulto. Si tratta di uno studio prospettico basato sui dati del “Registro dei Tumori Cerebrali” della Fondazione Istituto Carlo Besta (INCB) in Milano. Sono state arruolate e analizzate due coorti di pazienti. La prima coorte fa riferimento a 764 pazienti, di età 16+ anni, arruolati consecutivamente e trattati dal 2004 al 2010. La diagnosi era confermata istologicamente e i pazienti sono stati seguiti per il follow up di mortalità fino al 2012. Come confronto è stata utilizzata una coorte di pazienti, con la stessa diagnosi, arruolati in un periodo precedente (1997-2003) con un follow up fino al 2005. La probabilità di morire è risultata pari al 54% a un anno, 21% a 2 anni e 11% a 3 anni nella coorte “più vecchia” rispetto al 47%, 11% e 5% rispettivamente nella coorte arruolata nel periodo più recente. Nella coorte più recente il beneficio in termini sia di sopravvivenza sia di rischio di recidiva è risultato associato con l’uso del trattamento di prima linea denominato “Stupp protocol”, considerato standard di riferimento con evidenze scientifiche di efficacia da trials clinici (terapia combinata con farmaci specifici e radioterapia). In caso di recidiva l’intervento chirurgico veniva eseguito in un quinto della coorte “più vecchia” e in un terzo della coorte più recente, ma senza evidenza di beneficio in termini di sopravvivenza. La chemioterapia di seconda linea con nitrosurea, temozolomide, mitotraxontone, fotemustine e bevacizumab sono in grado di migliorare la sopravvivenza in maniera significativa in entrambe le coorti. Anche la radiochirurgia è risultata una tecnica efficace. In conclusione questo studio molto interessante e ben fatto mostra un miglioramento nel tempo dell’efficacia dei trattamenti sia di prima sia di seconda linea a fronte di una mancata evidenza di efficacia, in termini di sopravvivenza, della chirurgia eseguita in seguito a recidiva.

14. Sinagra E, Perricone G, D'Amico M, Tinè F, D'Amico G. Systematic review with meta-analysis: the haemodynamic effects of carvedilol compared with propranolol for portal hypertension in cirrhosis. Aliment Pharmacol Ther. 2014 Jan 26. doi: 10.1111/apt.12634. [Epub ahead of print]
Author information: Internal Medicine Unit, A.O. Ospedali Riuniti Villa Sofia Cervello - P.O. Vincenzo Cervello, Palermo, Italy; Endoscopy and Gastroenterology Unit, Fondazione Istituto San Raffaele Giglio, Cefalù, Italy. Abstract
BACKGROUND: Propranolol is recommended for prophylaxis of variceal bleeding in cirrhosis. Carvedilol is a nonselective beta-blocker with a mild anti-alfa-1-adrenergic activity. Several studies have compared carvedilol and propranolol, yielding inconsistent results. AIM: To perform a systematic review and meta-analysis of the randomised clinical trials comparing carvedilol with propranolol for hepatic vein pressure gradient reduction. METHODS: Studies were searched on the MEDLINE, EMBASE and Cochrane library databases up to November 2013. The weighted mean difference in percent hepatic vein pressure gradient reduction and the relative risk of failure to achieve a hemodynamic response (reduction ≥20% of baseline or to ≤12 mmHg) with each drug were used as measures of treatment efficacy. RESULTS: Five studies (175 patients) were included. Indication to treatment was primary prophylaxis of variceal bleeding in 76% of patients. There were overall three acute (60-90 min after drug administration) and three long-term (after 7-90 days of therapy) comparisons. The summary mean weighted difference in % of reduction in hepatic vein pressure gradient was: acute -7.70 (CI -12.40, -3.00), long-term -6.81 (CI -11.35, -2.26), overall -7.24 (CI -10.50, -3.97), favouring carvedilol. The summary relative risk of failure to achieve a hemodynamic response with carvedilol was 0.66 (CI 0.44, 1.00). Adverse events were nonsignificantly more frequent and serious with carvedilol. However, quality of trials was mostly unsatisfactory. CONCLUSIONS: Carvedilol reduces portal hypertension significantly more than propranolol. However, available data do not allow a satisfactory comparison of adverse events. These results suggest a potential for a cautious clinical use.
15. Omboni S, Malacco E, Mallion JM, Fabrizzi P, Volpe M. Olmesartan vs. Ramipril in Elderly Hypertensive Patients: Review of Data from Two Published Randomized, Double-Blind Studies. High Blood Press Cardiovasc Prev. 2014 Jan 17. [Epub ahead of print]
Author information: Italian Institute of Telemedicine, Via Colombera 29, 21048, Solbiate Arno (Varese), Italy, stefano.omboni@iitelemed.org. Abstract
Hypertension is a frequent condition among individuals over 65 years of age worldwide and is one of the most important risk factors for cardiovascular (CV) disease. Effective drug treatment of elderly hypertensives is usually associated with a marked reduction in CV morbidity and mortality. Among the different classes of antihypertensive agents, angiotensin receptor blockers (ARBs) and ACE-inhibitors are supposed to provide the best efficacy in lowering blood pressure (BP) and protecting target organ damage while featuring a good tolerability profile. However, up to date, few randomized clinical studies have directly compared the activity and safety of ARBs and ACE-inhibitors in elderly hypertensive patients. Aim of this review of published and unpublished pooled data from two recent randomized, double-blind, controlled trials, is to offer a comprehensive head-to-head comparison of the antihypertensive efficacy of the ARB olmesartan medoxomil vs. the ACE-inhibitor ramipril in a large study population including more than 1,400 hypertensive subjects aged 65-89 years with mild-to-moderate essential hypertension. The efficacy of the two drugs was separately evaluated in subgroups of patients classified according to the presence of metabolic syndrome, reduced renal function, CV risk level, gender, class of age, type of arterial hypertension and previous antihypertensive treatments. Olmesartan showed a greater efficacy than ramipril both in terms of clinic BP reduction and rate normalization. Olmesartan appeared significantly superior to ramipril in providing a more homogeneous and long-lasting 24-h BP control and maintaining an effective antihypertensive action in the last 6-h period from drug intake. In subgroups of patients with additional clinical conditions, olmesartan gave comparable, and in some cases greater, BP responses than those achieved with the ACE-inhibitor. The incidence of adverse events was similar for both drugs. Olmesartan may thus represent an effective alternative to ACE-inhibitors among first-line drug treatments for hypertension in older people.

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