rubrica

Comparabilità e valutazione dei servizi sanitari

  • Nerina Agabiti1

  1. Comparabilità e valutazione dei servizi sanitari
Nera Agabiti -

  • Se sei abbonato scarica il PDF nella colonna in alto a destra
  • Se non sei abbonato ti invitiamo ad abbonarti online cliccando qui
  • Se vuoi acquistare solo questo articolo scrivi a: abbonamenti@inferenze.it (20 euro)


Ricerca bibliografica periodo dal 16 giugno al 31 agosto 2013

Per leggere le caratteristiche di questa ROUTINE di ricerca clicca qui

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 (“2013/06/16”[PDat] : “2013/08/31”[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]))

Di ogni articolo è disponibile l'abstract. Per visualizzarlo basta cliccare sul titolo.

1. Faggioli G, Pini R, Mauro R, Freyrie A, Gargiulo M, Stella A. Contralateral carotid occlusion in endovascular and surgical carotid revascularization: a single centre experience with literature review and meta-analysis. Eur J Vasc Endovasc Surg. 2013 Jul;46(1):10-20. doi: 10.1016/j.ejvs.2013.03.021. Epub 2013 Apr 29.
Vascular Surgery, University of Bologna, Bologna, Italy.

Abstract
OBJECTIVE/BACKGROUND: The influence of contralateral carotid occlusion (CCO) on the outcome of carotid endarterectomy (CEA) and stenting (CAS) is debated. This study aims to evaluate CEA and CAS results in patients with CCO. METHODS: All carotid revascularizations from 2005 to 2011 were analyzed, focusing on the role of CCO on 30-day cerebral events and death (CED). A meta-analysis was performed to evaluate the results of the literature by random effect. RESULTS: Of the 1,218 carotid revascularizations performed in our institution, 706 (57.9%) were CEA and 512 (42.1%) were CAS. CED occurred in 3.6% of the CEAs and 8.2% of the CASs (p = .001). CCO was present in 37 (5.2%) CEAs and 38 (7.4%) CASs. In CEA, CCO patients had a higher CED compared with the non-CCO patients (16.2% vs. 2.9%, p = .001), as confirmed by multiple regression analysis (OR [odds ratio]: 5.1[1.7-14.5]). In CAS, CED was not significantly different in the CCO and non-CCO patients (2.6% vs. 8.7%, p = 0.23). The comparative analysis of the CCO patients showed a higher CED in CEA compared with that in CAS (16.2% vs. 2.6%, p = 0.04). Meta-analysis of 33 papers (27 on CEA and 6 on CAS) revealed that CCO was associated with a higher CED in CEA, but not in CAS (OR: 1.82 [1.57-2.11]; OR: 1.22 [0.60-2.49], respectively). CONCLUSION: CCO can be considered as a risk factor for CED in CEA, but not in CAS. CAS appears to be associated with lower CED than CEA in CCO patients.

Breve commento a cura di Nerina Agabiti
Faggioli et al hanno condotto uno studio prospettico basato su dati raccolti in un centro di Chirurgia Vascolare a Bologna per testare l’ipotesi che l’occlusione carotidea controlaterale possa influenzare gli esiti dell’intervento di rivascolarizzazione carotidea. L’argomento infatti è ancora molto controverso così come è ancora non chiara l’efficacia relativa di diverse tecniche chirurgiche per il trattamento dell’occlusione carotidea. Sono stati studiati 1218 pazienti arruolati tra il 2001 ed il 2005 sottoposti ad endoarterectomia carotidea carotidea (58%) e a stent carotidea (42%. L’esito in studio è “eventi cerebrovascolari e morte nei 30 giorni successivi all’intervento”.
L’occorrenza di esito sfavorevole è stato pari a 3.6% nel caso dell’endoarterectomia e 8.2% nel caso dello stent. L’occlusione controlaterale era presente in 5.2% di casi con endoarterectomia e nel 7.4% nei casi di stent. La probabilità di avere esiti sfavorevoli nei 30 giorni successivi all’intervento è 5 volte maggiore nei pazienti con occlusione controlaterale nei casi di endoarterectomia carotidea. Invece tra i pazienti con stent la presenza di occlusione controlaterale non influenza gli esiti. Tra tutti i pazienti con occlusione controlaterale una maggiore occorrenza di esiti sfavorevoli è stata trovata in caso di endoarterectomia rispetto allo stent (16% vs 2.4%, p=004). I dati sono confortati da una metanalisi che gli autori presentano in questo lavoro, basata su 33 articoli sul tema. I risultati confermano che la presenza di occlusione controlaterale è associata ad esiti sfavorevoli nei casi di chirurgia carotidea ma non nei casi di stent.
Da questo lavoro si evince che l’occlusione controlaterale carotidea è un fattore di rischio di eventi cerebrovascolari in caso di chirurgia carotidea ma non nello stent. Inoltre lo stent si associa a minor rischio di eventi sfavorevoli rispetto alla endoarterectomia nei pazienti con occlusione controlaterale. Questo studio ben condotto e ben analizzato contribuisce al dibattito sull’efficacia relativa tra due tecniche di trattamento per la aterosclerosi carotidea, tuttavia molte evidenze sono ancora necessarie per comprendere a pieno vantaggi e svantaggi della endoerterectomia carotidea versus lo stent carotideo.

2. Iudici M, van der Goes MC, Valentini G, Bijlsma JW. Glucocorticoids in systemic sclerosis: weighing the benefits and risks - a systematic review. Clin Exp Rheumatol. 2013 Mar-Apr;31(2 Suppl 76):157-65. Epub 2013 Jul 23.
Rheumatology Unit, Second University of Naples, Italy. michele_iudici@hotmail.com

Abstract
OBJECTIVES: To identify indications for which different dosages of glucocorticoids (GCs) have been prescribed in systemic sclerosis (SSc), and to assess the efficacy and safety of GCs in SSc. METHODS: A literature search focusing on experimental studies, observational studies, and case reports describing GC use in SSc was conducted using PubMed, EMBASE and Cochrane databases. Information about the study population, GC therapy and its effects was recorded. Available data have been summarised, and efficacy and safety of GCs have been assessed for different indications and dosages. RESULTS: Forty-four studies and 93 case reports were included in this review. GCs were applied in the treatment of interstitial lung disease (ILD), diffuse cutaneous disease, myopathy, painful hands and cardiac involvement, or accompanying anti-thymocyte globulin to prevent serum sickness in the context of stem cell transplantation. GCs were used in different dosages, predominantly in combination with other immunosuppressive treatments. Monotherapy with GCs led to inconsistent results. Most adverse events recorded were infections. Twenty-three cases of scleroderma renal crisis (SRC) have been reported, mainly in patients with early diffuse disease (n=10) or with anti-thymocyte treatment (n=10). These patients were treated with low to medium dose GCs (n=10), high-dose GCs (n=11) and pulse therapy (n=2). CONCLUSIONS: Evidence of a beneficial role of GCs in SSc is limited. GCs have been part of the therapeutic strategy in the management of ILD, diffuse cutaneous disease or myositis. Awareness for the risk of SRC should persist, especially in patients with diffuse disease who are also treated with possibly nephrotoxic drugs.

3. Franciosi M, Lucisano G, Lapice E, Strippoli GF, Pellegrini F, Nicolucci A. Metformin therapy and risk of cancer in patients with type 2 diabetes: systematic review. PLoS One. 2013 Aug 2;8(8):e71583. doi: 10.1371/journal.pone.0071583. Print 2013.
Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, S. Maria Imbaro (CH), Chieti, Italy.

Abstract
AIMS/HYPOTHESIS: Diabetes treatments were related with either an increased or reduced risk of cancer. There is ongoing debate about a potential protective action of metformin. To summarize evidence on the association between metformin and risk of cancer and cancer mortality in patients with diabetes. METHODS: DATA SOURCE: MEDLINE and EMBASE (January 1966-April 2012). We selected randomized studies comparing metformin and other hypoglycaemic agents and observational studies exploring the association between exposure to metformin and cancer. Outcomes were cancer mortality, all malignancies and site-specific cancers. RESULTS: Of 25307 citations identified, 12 randomized controlled trials (21,595 patients) and 41 observational studies (1,029,389 patients) met the inclusion criteria. In observational studies there was a significant association of exposure to metformin with the risk of cancer death [6 studies, 24,410 patients, OR:0.65, 95%CI: 0.53-0.80], all malignancies [18 studies, 561,836 patients, OR:0.73, 95%CI: 0.61-0.88], liver [8 studies, 312,742 patients, OR:0.34; 95%CI: 0.19-0.60] colorectal [12 studies, 871,365 patients, OR:0.83, 95%CI: 0.74-0.92], pancreas [9 studies, 847,248 patients, OR:0.56, 95%CI: 0.36-0.86], stomach [2 studies, 100701 patients, OR:0.83, 95%CI: 0.76-0.91], and esophagus cancer [2 studies, 100694 patients, OR:0.90, 95%CI: 0.83-0.98]. No significant difference of risk was observed in randomized trials. Metformin was not associated with the risk of: breast cancer, lung cancer, ovarian cancer, uterus cancer, prostate cancer, bladder cancer, kidney cancer, and melanoma. CONCLUSIONS/INTERPRETATION: Results suggest that Metformin might be associated with a significant reduction in the risk of cancer and cancer-related mortality. Randomized trials specifically designed to evaluate the efficacy of metformin as an anticancer agent are warranted.

4. Millul A, Iudice A, Adami M, Porzio R, Mattana F, Beghi E; THEOREM Study Group. Alternative monotherapy or add-on therapy in patients with epilepsy whose seizures do not respond to the first monotherapy: An Italian multicenter prospective observational study. Epilepsy Behav. 2013 Sep;28(3):494-500. doi: 10.1016/j.yebeh.2013.05.038. Epub 2013 Jul 26.
Laboratorio di Malattie Neurologiche, IRCCS, Istituto Mario Negri di Milano, Italy. Electronic address: andrea.millul@marionegri.it.

Abstract
A prospective multicenter observational study was undertaken on children and adults with epilepsy in whom first monotherapy failed, to assess indications and effects of alternative monotherapy vs. polytherapy. Patients were followed until 12-month remission, drug withdrawal, or up to 18months. Monotherapy and polytherapy were compared for patients' baseline features, indication, retention time, remission, adverse events (AE), quality of life, and direct and indirect costs. Included were 157 men and 174 women, aged 2-86years. Of the patients, 72.2% were switched to alternative monotherapy. Baseline treatment was changed for lack of efficacy (73.9%) or adverse events (26.1%). Two hundred forty-three completed the study (remission: 175; 72.0%). Retention time, hospital admissions, days off-work and off-school, and quality of life did not differ between the two treatment groups. Patients were followed for 365.3person-years. Three hundred eighty-three incident AEs were reported by 46.4% of patients in monotherapy and 40.2% in polytherapy (serious AEs: 9.6% vs. 8.7%, mostly nondrug-related).

5. Rossi MC, Cristofaro MR, Gentile S, Lucisano G, Manicardi V, Mulas MF, Napoli A, Nicolucci A, Pellegrini F, Suraci C, Giorda C; on behalf of the AMD Annals Study Group. Sex Disparities in the Quality of Diabetes Care: Biological and Cultural Factors May Play a Different Role for Different Outcomes: A cross-sectional observational study from the AMD Annals initiative. Diabetes Care. 2013 Jul 8. [Epub ahead of print]
Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, S. Maria Imbaro (CH), Chieti, Abruzzo, Italy.

Abstract
OBJECTIVETo investigate the quality of type 2 diabetes care according to sex.RESEARCH DESIGN AND METHODSClinical data collected during the year 2009 were extracted from electronic medical records; quality-of-care indicators were evaluated. Multilevel logistic regression analysis was applied to estimate the likelihood of women versus men to be monitored for selected parameters, to reach clinical outcomes, and to be treated with specific classes of drugs. The intercenter variability in the proportion of men and women achieving the targets was also investigated.RESULTSOverall, 415,294 patients from 236 diabetes outpatient centers were evaluated, of whom 188,125 (45.3%) were women and 227,169 (54.7%) were men. Women were 14% more likely than men to have HbA1c >9.0% in spite of insulin treatment (odds ratio 1.14 [95% CI 1.10-1.17]), 42% more likely to have LDL cholesterol (LDL-C) ≥130 mg/dL (1.42 [1.38-1.46]) in spite of lipid-lowering treatment, and 50% more likely to have BMI ≥30 kg/m(2) (1.50 [1.50-1.54]). Women were less likely to be monitored for foot and eye complications. In 99% of centers, the percentage of men reaching the LDL-C target was higher than in women, the proportion of patients reaching the HbA1c target was in favor of men in 80% of the centers, and no differences emerged for blood pressure.CONCLUSIONSWomen show a poorer quality of diabetes care than men. The attainment of the LDL-C target seems to be mainly related to pathophysiological factors, whereas patient and physician attitudes can play an important role in other process measures and outcomes.

Breve commento a cura di Nerina Agabiti
Lo studio realizzato da Rossi et al ha l’obiettivo di valutare la qualità delle cure per il diabete mellito di tipo 2 e testa l’ipotesi di differenze tra generi. Si tratta di uno studio multicentrico collaborativo in cui hanno preso parte 236 centri diabetologici in Italia per un totale di oltre 415.000 pazienti di cui 54% uomini. I dati si riferiscono all’anno 2009 e sono stati derivati da archivi elettronici forniti dall’Associazione Medici Diabetologi. Sono stati analizzati diversi indicatori di processo e di esito utilizzando informazioni sulle procedure diagnostiche terapeutiche e preventive e dati sullo stato clinico dei pazienti. Rispetto agli uomini, le donne sono risultate avere valori elevati (oltre il 14% in più) di Emoglobina glicata nonostante il trattamento insulinico, valori elevati d colesterolo (42% in più) anche se in presenza si trattamento ipolipemizzante. Le donne hanno una probabilità del 50% maggiore di avere un BMI elevato (> 30Kg/m2). Le donne inoltre hanno una minore probabilità di essere monitorate per le complicanze del piede e dell’occhio. Nel 99% dei centri la percentuale di uomini che raggiungono il target relativamente al parametro LDL-C (lipoproteine seriche) è maggiore che nelle donne, simile pattern si osserva a faviore degli uomini nell’80% dei centri per l’Emoglobina glicata. Non sono state osservate differenze per la pressione arteriosa. Questo studio molto interessante e su larga scala fornisce dati rilevanti sulla qualità del percorso di cure, identifica indicatori di esito e mostra un allarmante differenziale nella qualità dell’assistenza tra uomini e donne che non si spiega facilmente in un sistema universalistico e teoricamente senza barriere. Fattori comportamentali e differente compliance, uniti a differenze biologiche ormonali, sono tra i potenziali meccanismi discussi nell’articolo.

6. Pagni F, Galimberti S, Goffredo P, Basciu M, Malachina S, Pilla D, Galbiati E, Ferrario F. The value of repeat biopsy in the management of lupus nephritis: an international multicentre study in a large cohort of patients. Nephrol Dial Transplant. 2013 Aug 24. [Epub ahead of print]
Department of Pathology, University Milano Bicocca, San Gerardo Hospital, Monza, Italy.

Abstract
BACKGROUND: The International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification represents the gold standard for the histological evaluation of Systemic Lupus Erythematosus (SLE) nephritis. A repeat biopsy (RB) might be an important tool to provide information on long-term renal outcomes and optimal therapy. Aims of this study were to evaluate the use of the ISN/RPS classification and the role of RB in routine clinical practice. METHODS: A total number of 142 patients with SLE nephritis and with adequate reference and RB samples were included in this multicentre retrospective study. A meticulous histological examination was centrally performed on first and RB and compared with clinical variables and follow-up data. RESULTS: Morphological features of the ISN/RPS classification: at first and RB, significant differences were observed between segmental classes (III, IV-S) and Class IV-G in mesangial proliferation, wire loops and tuft necrosis. Clinical features and ISN/RPS classification: the correlation between serum creatinine, proteinuria, blood pressure levels and histological classes at first and RB demonstrated more severe renal disease in Class IV-G, both at first and RB. Agreement between ISN/RPS classification at first and RB: 40.8% of patients changed the histological class. Fifty per cent of Class II (mild mesangial form) were reclassified as Class IV-G at RB, whereas 18.9% of Class IV-G were reclassified as Class II. The transition among segmental (III/IV-S) and mesangial forms (II/IV-G) was extremely rare. The comparison between the clinical parameters at the final follow-up and the ISN/RPS classification confirmed that the trend of serum creatinine and proteinuria between the different classes was better described at the RB (higher in Class IV-G) than on the first biopsy. CONCLUSIONS: The histopathological data suggest that morphological differences between segmental and global forms do exist, possibly due to different pathogenetic mechanisms. An RB strategy could provide additional information on long-term renal outcomes. A strategy of protocol biopsies could be useful in perspective future trials to better understand the therapeutic response and the natural history of this disease.

7. Monreal M, Folkerts K, Diamantopoulos A, Imberti D, Brosa M. Cost-effectiveness impact of rivaroxaban versus new and existing prophylaxis for the prevention of venous thromboembolism after total hip or knee replacement surgery in France, Italy and Spain. Thromb Haemost. 2013 Aug 22;110(5). [Epub ahead of print]
Alex Diamantopoulos, Symmetron Ltd., Kinetic Centre, Theobald Street, Elstree, Herts WD6 4PJ, UK, Tel.: +44 208 387 1595, Fax:+44 208 711 6876, E-mail: alexd@symmetron.net.

Abstract
Venous thromboembolism (VTE) has a significant impact on healthcare costs but is largely preventable with anticoagulant prophylaxis using low-molecular-weight heparins (LMWHs), such as enoxaparin or dalteparin. Rivaroxaban and dabigatran etexilate are two new oral anticoagulants (NOACs) were both compared with enoxaparin in separate trials. A decision analytic model with a healthcare and national payer perspective over a five-year time horizon was used to evaluate the cost-effectiveness of the NOACs for VTE prophylaxis after total hip replacement (THR) or total knee replacement (TKR) in France, Italy and Spain. Efficacy and safety data were obtained from randomised controlled trials of rivaroxaban vs enoxaparin and an indirect statistical comparison for rivaroxaban vs dabigatran. Rivaroxaban demonstrated dominance across all comparisons, indications and countries. In THR, total per-patient costs were reduced by up to €160 in the enoxaparin comparison and €115 in the dabigatran comparison, respectively. In addition, quality-adjusted life-years (QALYs) were increased by up to 0.0011 and 0.0012 in each comparison, respectively. Similarly, total costs were reduced in TKR by up to €137 and €28 in the enoxaparin and dabigatran comparisons, respectively. The total number of QALYs was increased by up to 0.0014 in the enoxaparin comparison and 0.0005 in the dabigatran comparison. The results were driven by costs since the incremental benefits were minimal. Rivaroxaban use could result in substantial healthcare cost savings and improved quality of life. The results are applicable across three European countries with differing healthcare systems so, potentially, could be generalised to a much wider population.

8. Luchetti R, Atzei A, Cozzolino R, Fairplay T, Badur N. Comparison between open and arthroscopic-assisted foveal triangular fibrocartilage complex repair for post-traumatic distal radio-ulnar joint instability. J Hand Surg Eur Vol. 2013 Aug 20. [Epub ahead of print]
Rimini Hand and Rehabilitation Center, Rimini, Italy.

Abstract
The aim of this study was to assess the objective and subjective functional outcomes after foveal reattachment of proximal or complete ulnar-sided triangular fibrocartilage complex lesions by two surgical procedures: an open technique or an arthroscopically assisted repair. The study was done prospectively on 49 wrists affected by post-traumatic distal radio-ulnar joint instability. Twenty-four patients were treated with the open technique (Group 1) and 25 by the arthroscopically assisted technique (Group 2). Magnetic resonance imaging demonstrated a clear foveal detachment of the triangular fibrocartilage complex in 67% of the cases. Arthroscopy showed a positive ulnar-sided detachment of the triangular fibrocartilage complex (positive hook test) in all cases. Distal radio-ulnar joint stability was obtained in all but five patients at a mean follow-up of 6 months. Both groups had improvement of all parameters with significant differences in wrist pain scores, Mayo wrist score, Disability of the Arm, Shoulder and Hand questionnaire and Patient-Rated Wrist/Hand Evaluation questionnaire scores. There were no significant post-operative differences between the two groups in the outcome parameters except for the Disability of the Arm Shoulder and Hand questionnaire score, which was significantly better in Group 2 (p < 0.001).

9. La Nasa G, Caocci G, Efficace F, Dessì C, Vacca A, Piras E, Sanna M, Marcias M, Littera R, Carcassi C, Lucarelli G. Long-term health-related quality of life evaluated more than twenty years after hematopoietic stem cell transplantation for thalassemia. Blood. 2013 Aug 19. [Epub ahead of print]
Bone Marrow Transpant Center, R. Binaghi Hospital - ASL 8, Cagliari, Italy;

Abstract
The principal aim of our study was to investigate whether patients transplanted more than 20 years ago for beta-thalassemia major had a different health-related quality-of-life (HRQoL) in comparison with the general population. The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) were received from 109 ex-thalassemia patients who underwent hematopoietic stem cell transplantation (HSCT) during the 1980s and 1990s. Adjusted comparisons were performed separately for patient age at HSCT and the presence or absence of graft versus host disease (GvHD). Socio demographic and clinical variables were also analyzed. Median age of our cohort at HSCT and the time of the survey was 12 (range 1-36) and 34 (range 21-48) years, respectively, with a median follow up of 22.8 years (range 11.7- 30.3). Statistical analysis of data collected more than 20 years after HSCT showed that the long-term HRQoL of ex-thalassemia patients was very similar to that of the general population. Meaningful differences were only found for the general health (GH) scale (-8.9; 95% CI, -15.0 to -2.7, p=0.005). Mental health, education level, employment status, marital status, living arrangements and birth rate were compatible with normal living patterns. The development of GvHD and older age at transplantation were important impairing factors. Additional analyses performed to evaluate HRQoL in an age-sex matched cohort of 124 patients receiving conventional treatment for beta-thalassemia revealed poorer outcomes in comparison with the cohort of transplanted patients.

10. De Luca G, Verdoia M, Dirksen MT, Spaulding C, Kelbæk H, Schalij M, Thuesen L, Hoeven Bv, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, Diaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Suryapranata H, Stone GW; DESERT Cooperation. Gender-related differences in outcome after BMS or DES implantation in patients with ST-segment elevation myocardial infarction treated by primary angioplasty: Insights from the DESERT cooperation.
Atherosclerosis. 2013 Sep;230(1):12-6. doi: 10.1016/j.atherosclerosis.2013.05.024. Epub 2013 Jun 27. Division of Cardiology, Ospedale "Maggiore della Carità", Eastern Piedmont University, Novara, Italy; Centro di Biotecnologie per la Ricerca Medica Applicata (BRMA), Eastern Piedmont University, Novara, Italy. Electronic address: giuseppe.deluca@maggioreosp.novara.it.

Abstract
BACKGROUND: Several studies have found that among patients with ST-segment elevation myocardial infarction (STEMI) treated by thrombolysis, female sex is associated with a worse outcome. However, still controversial is the prognostic impact of gender in primary angioplasty, especially in the era of drug-eluting stents (DES). Therefore, the aim of this study was to investigate sex-related differences in clinical outcome in patients with STEMI treated with primary angioplasty with Bare-Metal Stent (BMS) or DES. METHODS: Our population is represented by 6298 STEMI patients undergoing primary angioplasty and stent implantation included in the DESERT database. Follow-up data were collected from 3 to 6 years after primary angioplasty. RESULTS: Female gender was observed in 1466 (23.2%) out of 6298 STEMI patients. Women were older (65.3 ± 12.4 vs 59.3 ± 11.4 years, p < 0.001), with higher prevalence of diabetes (18.6% vs 14.5%, p < 0.001), hypertension (52.4% vs 41.4%, p < 0.001), slightly longer ischemia time (272 ± 247 vs 258 ± 220 min, p = 0.06). No difference was observed in terms of angiographic and procedural characteristics. Follow-up data were available at a mean of 1201 ± 441 days. At long-term follow-up female gender was associated with a significantly higher rate of death (11.7% vs 8.5%, HR [95% CI] = 1.45 [1.18-1.78], p < 0.001), while no difference was observed in terms of reinfarction (HR [95% CI] = 1.14 [0.89-1.45], p = 0.3), ST (HR [95% CI] = 1.12 [0.85-1.48], p = 0.4), with similar temporal distribution (acute, subacute, late and very late) between male and female patients, and no difference in TVR (HR [95% CI] = 1.11 [0.95-1.3], p = 0.2, p = 0.2). These results were confirmed in both patients receiving BMS or DES. The impact of female gender on mortality disappeared after correction for baseline confounding factors (HR [95% CI] = 0.88 [0.71-1.09], p = 0.25). CONCLUSIONS: This study shows that in patients with STEMI treated by primary angioplasty, female gender is associated with higher mortality rate in comparison with men, and this is mainly due to their higher clinical and angiographic risk profiles. In fact, female sex did not emerge as an independent predictor of mortality.

11. Salaffi F, Gasparini S, Ciapetti A, Gutierrez M, Grassi W. Usability of an innovative and interactive electronic system for collection of patient-reported data in axial spondyloarthritis: comparison with the traditional paper-administered format. Rheumatology (Oxford). 2013 Aug 16. [Epub ahead of print]
Department of Rheumatology, Politechnic University of the Marche, Jesi, Ancona, Italy.

Abstract
Objective. To evaluate the validity, in terms of the patients' acceptance, preference, feasibility and reliability of an innovative, interactive computerized system for collection of patient-reported outcome (PRO) data on axial SpA against the paper-and-pencil version.Methods. Fifty-five patients with axial SpA completed both the touch screen and the paper-and-pencil set of questionnaires. A computerized touch-screen system, SPEAMonitor, was developed to capture PRO data. Variables recorded included demographic data, patient's assessment of general health status, BASDAI, BASFI, BASMI and acute-phase reactant levels. In order to assess the patient's acceptance of, preference for and feasibility of computer-based questionnaires, the participants filled in an additional questionnaire. The time taken to complete both formats was measured. In a further test-retest study, 25 patients were re-evaluated.Results. The agreement between the paper-administered and computer touch-screen format of the BASFI, BASDAI questionnaires and the Ankylosing Spondylitis Disease Activity Scores was excellent. Intraclass correlation coefficients (ICCs) between data ranged from 0.90 to 0.96. Additionally the test-retest study showed a very good agreement between the scores for the two administrations (ICC ≥ 0.90). Age, computer experience and education level had no significant impact on the results. The computerized questionnaires were reported to be easier to use. The mean time spent completing the questionnaires on a touch screen was 5.1 min and on paper 7.9 min.Conclusion. Our newly developed computer-assisted touch-screen questionnaires for PRO in axial SpA were well accepted by patients, with good data quality, reliability and score agreement.

12. Ghezzi F, Fanfani F, Malzoni M, Uccella S, Fagotti A, Cosentino F, Cromi A, Scambia G. Minilaparoscopic radical hysterectomy for cervical cancer: Multi-institutional experience in comparison with conventional laparoscopy. Eur J Surg Oncol. 2013 Aug 12. pii: S0748-7983(13)00558-1. doi: 10.1016/j.ejso.2013.07.096. [Epub ahead of print]
Gynecologic Oncology Unit, University of Insubria, Piazza Biroldi 1, 21100 Varese, Italy. Electronic address: fabio.ghezzi@uninsubria.it.

Abstract
OBJECTIVE: To analyze the preliminary experience of three gynecologic oncology services with minilaparoscopic radical hysterectomy (mLRH) for the treatment of cervical cancer and to compare perioperative outcomes with those of conventional laparoscopic surgery (LRH). METHODS: Prospectively collected data on consecutive cervical cancer patients undergoing radical hysterectomy with a laparoscopic approach were analyzed retrospectively. Perioperative outcomes of women undergoing mLRH were compared to data from control patients who had undergone LRH with 5-mm instruments. Adjustment for potential selection bias in surgical approach was made with propensity score (PS) matching. RESULTS: The study cohort consisted of 257 patients, 35 undergoing mLRH and 222 undergoing LRH. The two groups were comparable in terms of demographic and tumor characteristics. No significant differences were observed between groups in terms of operative time, blood loss, lymph node yield, amount of parametrial or vaginal cuff tissue removed, and percentage of intra- or postoperative complications, both in the entire cohort and in the PS matched group. No conversions were needed from mLRH to standard laparoscopy or from minilaparoscopy to open surgery. Conversion from standard laparoscopy to open surgery was necessary in 2 patients. A shorter hospital stay was observed among women who had mLRH than in those undergoing LRH [2 (1-10) vs 4 (1-14) days, p = 0.005]. This difference remained significant after PS matching. CONCLUSION: Our preliminary study suggests that in experienced hands minilaparoscopy is a feasible and safe technique for radical hysterectomy and yields results that are equivalent to those of LRH.

13. Chierchia GB, Casado-Arroyo R, de Asmundis C, Rodriguez-Manero M, Sarkozy A, Conte G, Sieira J, Levinstein M, Baltogiannis G, di Giovanni G, Overeinder I, Ocello S, Rosas E, Isola F, Brugada P. Impact of transseptal puncture site on acute and mid-term outcomes during cryoballoon ablation: A comparison between anterior, medial and posterior transatrial access. Int J Cardiol. 2013 Aug 5. pii: S0167-5273(13)01290-4. doi: 10.1016/j.ijcard.2013.07.079. [Epub ahead of print]
Heart Rhythm Management Center, UZ Brussel-VUB, Brussels, Belgium; Modulo di Elettrofisiologia Cardiaca, Ospedale Santissima Trinità, Cagliari, Italy. Electronic address: gbchier@yahoo.it.

Abstract
BACKGROUND: Cryoballoon ablation (CBA) (Arctic Front, Medtronic, USA) has proven very effective in achieving pulmonary vein isolation (PVI). Different transseptal (TS) puncture sites might influence CBA procedure. The aim of the present study was to analyze the influence of different TS puncture sites (anterior, medial and posterior) on the acute and midterm outcomes of CBA in a series of patients undergoing PVI for drug resistant AF. METHODS AND RESULTS: A total 103 patients (78 males, mean age: 57±13years) formed the study group. Transseptal punctures were performed in the anterior, medial and posterior portion of the FO in 41 (39.8%), 35 (34%) and 27 (26.2%) patients respectively. We found no statistical significant difference between the various sites of TS puncture in 1) the grade of PV occlusion (p=ns), the rate of PV isolation (p=ns), freedom from AF at a mean 12month follow-up (p=ns) and complication rates (p=ns). Mean grade of occlusion was slightly lower in the RIPV when puncturing in the posterior FO but did not reach statistical significance. Mean procedural and fluoroscopy times were significantly lower when using the inner lumen mapping catheter (ILMC) (Achieve, Medtronic, USA) than the circular mapping catheter (CMC) (Lasso, Biosense Webster, California, USA) (107.24mn vs 97.74 (p≤0.001) and 25.7mn vs 19.2mn (p≤0.001)). CONCLUSION: Different sites of TS puncture on the horizontal axis of the FO (anterior, medial and posterior) did not influence grades of PV occlusion, rates of isolation, mid-term outcome and rates of complications during CB ablation.

14. Esposito M, Blasone R, Favaretto G, Stacchi C, Calvo M, Marin C, Felice P. A comparison of two dental implant systems in partially edentulous patients: 4-month post-loading results from a pragmatic multicentre randomised controlled trial. Eur J Oral Implantol. 2013 Summer;6(2):169-79.
Department of Biomaterials, The Sahlgrenska Academy, Göteborg University, Göteborg, Sweden. espositomarco@hotmail.com

Abstract
PURPOSE: To compare the clinical effectiveness of two implant systems: Way Milano and Kentron (Geass, Pozzuolo del Friuli, UD, Italy). MATERIALS AND METHODS: A total of 64 patients requiring at least two single crowns or partial fixed dental prostheses supported by a maximum of three implants had their sites randomised according to a split-mouth design to receive both implant systems at six centres. Patients were followed up for 4 months after initial loading. Outcome measures were prosthesis/implant failures, any complication and clinician preference. RESULTS: In total, 71 Way Milano and 73 Kentron implants were placed. One patient died 45 days after placement of 2 implants, but all remaining patients were followed up to 4 months post-loading. No Way Milano implant failed whereas 3 Kentron implants failed before loading. Two complications were reported, one at each implant type. There were no statistically significant differences for prosthesis/ implant success and complications between the implant systems. Three operators preferred Way Milano implants whereas the other 3 had no preference. CONCLUSIONS: Preliminary short-term data (4 months post-loading) showed no statistically significant differences between the two implant systems, however trends were suggestive of a better clinical performance for Way Milano implants.

15. Ascierto PA, Minor D, Ribas A, Lebbe C, O'Hagan A, Arya N, Guckert M, Schadendorf D, Kefford RF, Grob JJ, Hamid O, Amaravadi R, Simeone E, Wilhelm T, Kim KB, Long GV, Martin AM, Mazumdar J, Goodman VL, Trefzer U. Phase II Trial (BREAK-2) of the BRAF Inhibitor Dabrafenib (GSK2118436) in Patients With Metastatic Melanoma. J Clin Oncol. 2013 Aug 5. [Epub ahead of print]
Paolo A. Ascierto, Ester Simeone, Instituto Nazionale Tumori Fondazione "G. Pascale," Napoli, Italy; David Minor, California Pacific Center for Melanoma Research and Treatment, San Francisco; Antoni Ribas, Jonsson Comprehensive Cancer Center, University of California, Los Angeles; Omid Hamid, Experimental Therapeutics/Immunotherapy, The Angeles Clinic and Research Institute, Los Angeles, CA; Anne O'Hagan, Niki Arya, Mary Guckert, Anne-Marie Martin, Jolly Mazumdar, Vicki L. Goodman, GlaxoSmithKline Oncology, Collegeville; Ravi Amaravadi, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Kevin B. Kim, The University of Texas MD Anderson Cancer Center, Houston, TX; Celeste Lebbe, Assistance Publique-Hôpitaux de Paris, Hôpital Saint Louis, Paris, Université Paris Diderot, Paris; Jean-Jacques Grob, Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille, Hôpital Timone, Marseille, France; Dirk Schadendorf, University Hospital Essen, Essen; Tabea Wilhelm, Uwe Trefzer, Charité-Universitätsmedizin, Berlin, Germany; Richard F. Kefford, Georgina V. Long, Westmead Hospital and Melanoma Institute Australia, University of Sydney, Sydney, Australia.

Abstract
PURPOSE: Dabrafenib (GSK2118436) is a potent inhibitor of mutated BRAF kinase. Our multicenter, single-arm, phase II study assessed the safety and clinical activity of dabrafenib in BRAF(V600E/K) mutation-positive metastatic melanoma (mut(+) MM). PATIENTS AND METHODS: Histologically confirmed patients with stage IV BRAF(V600E/K) mut(+) MM received oral dabrafenib 150 mg twice daily until disease progression, death, or unacceptable adverse events (AEs). The primary end point was investigator-assessed overall response rate in BRAF(V600E) mut(+) MM patients. Secondary end points included progression-free survival (PFS) and overall survival (OS). Exploratory objectives included the comparison of BRAF mutation status between tumor-specific circulating cell-free DNA (cfDNA) and tumor tissue, and the evaluation of cfDNA as a predictor of clinical outcome. RESULTS: Seventy-six patients with BRAF(V600E) and 16 patients with BRAF(V600K) mut(+) MM were enrolled onto the study. In the BRAF(V600E) group, 45 patients (59%) had a confirmed response (95% CI, 48.2 to 70.3), including five patients (7%) with complete responses. Two patients (13%) with BRAF(V600K) mut(+) MM had a confirmed partial response (95% CI, 0 to 28.7). In the BRAF(V600E) and BRAF(V600K) groups, median PFS was 6.3 months and 4.5 months, and median OS was 13.1 months and 12.9 months, respectively. The most common AEs were arthralgia (33%), hyperkeratosis (27%), and pyrexia (24%). Overall, 25 patients (27%) experienced a serious AE and nine patients (10%) had squamous cell carcinoma. Baseline cfDNA levels predicted response rate and PFS in BRAF(V600E) mut(+) MM patients. CONCLUSION: Dabrafenib was well tolerated and clinically active in patients with BRAF(V600E/K) mut(+) MM. cfDNA may be a useful prognostic and response marker in future studies.

Inserisci il tuo commento

L'indirizzo mail è privato e non verrà mostrato pubblicamente.
Refresh Type the characters you see in this picture. Type the characters you see in the picture; if you can't read them, submit the form and a new image will be generated. Not case sensitive.  Switch to audio verification.