Comparabilità e valutazione dei servizi sanitari

  • Marina Davoli1

  • Nerina Ababiti1

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

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Ricerca bibliografica periodo dal 1 novembre 2012 al 15 gennaio 2013

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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 (“2012/11/01”[PDat] : “2013/01/15”[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. Lodi G, Figini L, Sardella A, Carrassi A, Del Fabbro M, Furness S. Antibiotics to prevent complications following tooth extractions. Cochrane Database Syst Rev. 2012 Nov 14;11:CD003811. doi: 10.1002/14651858.CD003811.pub2.
Dipartimento di Scienze Biomediche, Chirurgiche e Odontoiatriche, Università degli Studi di Milano, Milan, Italy.

BACKGROUND: The most frequent indications for tooth extractions are dental caries and periodontal infections, and these extractions are generally done by general dental practitioners. Antibiotics may be prescribed to patients undergoing extractions to prevent complications due to infection. OBJECTIVES: To determine the effect of antibiotic prophylaxis on the development of infectious complications following tooth extractions. SEARCH METHODS: The following electronic databases were searched: the Cochrane Oral Health Group's Trials Register (to 25 January 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 1), MEDLINE via OVID (1948 to 25 January 2012), EMBASE via OVID (1980 to 25 January 2012) and LILACS via BIREME (1982 to 25 January 2012). There were no restrictions regarding language or date of publication. SELECTION CRITERIA: We included randomised double-blind placebo-controlled trials of antibiotic prophylaxis in patients undergoing tooth extraction(s) for any indication. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias for the included studies and extracted data. We contacted trial authors for further details where these were unclear. For dichotomous outcomes we calculated risk ratios (RR) and 95% confidence intervals (CI) using random-effects models. For continuous outcomes we used mean differences (MD) with 95% CI using random-effects models. We examined potential sources of heterogeneity. The quality of the body of evidence has been assessed using the GRADE tool. MAIN RESULTS: This review included 18 double-blind placebo-controlled trials with a total of 2456 participants. Five trials were assessed at unclear risk of bias, thirteen at high risk, and none at low risk of bias. Compared to placebo, antibiotics probably reduce the risk of infection in patients undergoing third molar extraction(s) by approximately 70% (RR 0.29 (95% CI 0.16 to 0.50) P < 0.0001, 1523 participants, moderate quality evidence) which means that 12 people (range 10-17) need to be treated with antibiotics to prevent one infection following extraction of impacted wisdom teeth. There is evidence that antibiotics may reduce the risk of dry socket by 38% (RR 0.62 (95% CI 0.41 to 0.95) P = 0.03, 1429 participants, moderate quality evidence) which means that 38 people (range 24-250) need to take antibiotics to prevent one case of dry socket following extraction of impacted wisdom teeth. There is also some evidence that patients who have prophylactic antibiotics may have less pain (MD -8.17 (95% CI -11.90 to -4.45) P < 0.0001, 372 participants, moderate quality evidence ) overall 7 days after the extraction compared to those receiving placebo, which may be a direct result of the lower risk of infection. There is no evidence of a difference between antibiotics and placebo in the outcomes of fever (RR 0.34, 95% CI 0.06 to 1.99), swelling (RR 0.92, 95% CI 0.65 to 1.30) or trismus (RR 0.84, 95% CI 0.42 to 1.71) 7 days after tooth extraction.Antibiotics are associated with an increase in generally mild and transient adverse effects compared to placebo (RR 1.98 (95% CI 1.10 to 3.59) P = 0.02) which means that for every 21 people (range 8-200) who receive antibiotics, an adverse effect is likely. AUTHORS' CONCLUSIONS: Although general dentists perform dental extractions because of severe dental caries or periodontal infection, there were no trials identified which evaluated the role of antibiotic prophylaxis in this group of patients in this setting. All of the trials included in this review included healthy patients undergoing extraction of impacted third molars, often performed by oral surgeons. There is evidence that prophylactic antibiotics reduce the risk of infection, dry socket and pain following third molar extraction and result in an increase in mild and transient adverse effects. It is unclear whether the evidence in this review is generalisable to those with concomitant illnesses or immunodeficiency, or those undergoing the extraction of teeth due to severe caries or periodontitis. However, patients at a higher risk of infection are more likely to benefit from prophylactic antibiotics, because infections in this group are likely to be more frequent, associated with complications and be more difficult to treat. Due to the increasing prevalence of bacteria which are resistant to treatment by currently available antibiotics, clinicians should consider carefully whether treating 12 healthy patients with antibiotics to prevent one infection is likely to do more harm than good.

2. Levin GP, Robinson-Cohen C, de Boer IH, Houston DK, Lohman K, Liu Y, Kritchevsky SB, Cauley JA, Tanaka T, Ferrucci L, Bandinelli S, Patel KV, Hagström E, Michaëlsson K, Melhus H, Wang T, Wolf M, Psaty BM, Siscovick D, Kestenbaum B. Genetic variants and associations of 25-hydroxyvitamin D concentrations with major clinical outcomes. JAMA. 2012 Nov 14;308(18):1898-905. doi: 10.1001/jama.2012.17304.
Department of Biostatistics, University of Washington, Seattle, USA.

CONTEXT: Lower serum 25-hydroxyvitamin D concentrations are associated with greater risks of many chronic diseases across large, prospective community-based studies. Substrate 25-hydroxyvitamin D must be converted to 1,25-dihydroxyvitamin D for full biological activity, and complex metabolic pathways suggest that interindividual variability in vitamin D metabolism may alter the clinical consequences of measured serum 25-hydroxyvitamin D. OBJECTIVE: To investigate whether common variation within genes encoding the vitamin D-binding protein, megalin, cubilin, CYP27B1, CYP24A1, and the vitamin D receptor (VDR) modify associations of low 25-hydroxyvitamin D with major clinical outcomes. DESIGN, SETTING, AND PARTICIPANTS: Examination of 141 single-nucleotide polymorphisms in a discovery cohort of 1514 white participants (who were recruited from 4 US regions) from the community-based Cardiovascular Health Study. Participants had serum 25-hydroxyvitamin D measurements in 1992-1993 and were followed up for a median of 11 years (through 2006). Replication meta-analyses were conducted across the independent, community-based US Health, Aging, and Body Composition (n = 922; follow-up: 1998-1999 through 2005), Italian Invecchiare in Chianti (n = 835; follow-up: 1998-2000 through 2006), and Swedish Uppsala Longitudinal Study of Adult Men (n = 970; follow-up: 1991-1995 through 2008) cohort studies. MAIN OUTCOME MEASURE: Composite outcome of incident hip facture, myocardial infarction, cancer, and mortality over long-term follow-up. RESULTS: Interactions between 5 single-nucleotide polymorphisms and low 25-hydroxyvitamin D concentration were identified in the discovery phase and 1 involving a variant in the VDR gene replicated in independent meta-analysis. Among Cardiovascular Health Study participants, low 25-hydroxyvitamin D concentration was associated with hazard ratios for risk of the composite outcome of 1.40 (95% CI, 1.12-1.74) for those who had 1 minor allele at rs7968585 and 1.82 (95% CI, 1.31-2.54) for those with 2 minor alleles at rs7968585. In contrast, there was no evidence of an association (estimated hazard ratio, 0.93 [95% CI, 0.70-1.24]) among participants who had 0 minor alleles at this single-nucleotide polymorphism. CONCLUSION: Known associations of low 25-hydroxyvitamin D with major health outcomes may vary according to common genetic differences in the vitamin D receptor.

Breve commento a cura di Nerina Agabiti
La Vitamina D è considerata un fattore molto importante per lo sviluppo e la prognosi di malattie croniche. Una bassa concentrazione di concentrazione serica di Vitamina D (25-idrossi-vitamina D) è stata messa in relazione con un aumentato rischio di frattura di femore, infarto del miocardio, cancro e morte. Sono stati condotti diversi studi clinici controllati per dimostrare se il supplemento di Vitamina D possa ridurre il rischio di sviluppo di malattie e l’interesse scientifico è molto alto. L’uso di Vitamina D come supplemento dietetico è aumentato in molti paesi sviluppati con rilevanti costi. La Vitamina D ovvero il substrato 25-idrossi-vitamina D, per poter agire nell’organismo, ha bisogno di essere convertito in 1,25-diidrossi-vitamina D. Questi processi molecolari sono regolati geneticamente. Nello studio prospettico multicentrico di Levin et al pubblicato su Jama viene testata l’ipotesi che il polimorfismo genico relativo ai geni che regolano il metabolismo della Vitamina D possa modificare l’asssociazione tra Vitamina D ed un esiti clinici. Nell’analisi principali sono in studio 1514 individui, di età 65+ anni, arruolti dello studio di coorte Cardiovascular Health Study (CHS) nel 1992-93 e seguiti per 11 anni. Sono state condotte analisi usando altre base dati indipendenti: 922 persone di età compresa tra 70 e 79 anni arruolati nello studio di coorte americano “Health, aging and Body conmposition” nel 1998-99 e seguiti fino al 2006, 835 partecipanti allo studio italiano “Invecchiare in Chianti”) arruolati nel periodo 1998-2000 e seguiti fino al 2006, 970 adulti oltre 50 anni di età dell’Upsala Longitudinal Study in Adult Men in 1991-95 seguiti fino al 2008. L’esito in studio è un indicatore composito che include frattura di femore, infarto del miocardio, cancro e morte nell’arco di un lungo periodo di follow up (variabile tra le basi dei dati dei diversi studi). E’ stato dimostrato che l’effetto di basse concentrazioni di Vitamina D sul maggiore rischio di esito sfavorevole varia a seconda delle differenze genetiche del recettore della Vitamina D. Questo studio contribuisce alla conoscenza sull’impatto biologico della variabilità generica sugli effetti della Vitamina D, fattore di crescente interesse nello sviluppo di malattia.

3. Zampieri N, Castellani R, Andreoli R, Geccherle A. Long-term results and quality of life in patients treated with hemorrhoidectomy using two different techniques: Ligasure versus transanal hemorrhoidal dearterialization. Am J Surg. 2012 Nov;204(5):684-8. doi: 10.1016/j.amjsurg.2012.01.014.
Multispecialistic Rectal-Perineal Disease Centre, Sacro Cuore, Don Calabria Hospital, Negrar, Verona, Italy.

BACKGROUND: Hemorrhoids are the most frequent anal pathology. We evaluated the results of 2 techniques at 1 year after surgery. METHODS: The clinical charts and data of patients who underwent hemorrhoidectomy between January 2008 and June 2010 were considered and analyzed. Patients underwent surgery with 2 techniques: transanal hemorrhoidal dearterialization (THD) hemorrhoidectomy or LigaSure-vessel sealing system (Valleylab, Boulder, CO). Patients were chosen randomly to receive one technique or the other. The primary objectives were quality of life, quality of defecation, and regression of symptoms. RESULTS: Forty-six patients treated with THD and 68 patients treated with Ligasure were enrolled in the study. No significant differences were observed in the rate of postoperative surgical complications or readmissions. Short- and medium-term (1-6 mo) results showed that THD patients had a higher rate of pain resolution compared with Ligasure patients (P < .05). Functionally, all patients treated with Ligasure showed more postoperative constipation despite administration of laxatives than patients treated with THD. CONCLUSIONS: THD is an effective technique and is associated with the best short-term clinical and surgical outcomes if compared with Ligasure.

4. Lombardi CP, Raffaelli M, De Crea C, Boniardi M, De Toma G, Marzano LA, Miccoli P, Minni F, Morino M, Pelizzo MR, Pietrabissa A, Renda A, Valeri A, Bellantone R. Open versus endoscopic adrenalectomy in the treatment of localized (stage I/II) adrenocortical carcinoma: results of a multiinstitutional Italian survey. Surgery. 2012 Dec;152(6):1158-64. doi: 10.1016/j.surg.2012.08.014. Epub 2012 Oct 13.
Division of Endocrine and Metabolic Surgery, Università Cattolica del Sacro Cuore, Rome, Italy.

BACKGROUND: We compared the oncologic effectiveness of open adrenalectomy and endoscopic adrenalectomy in the treatment of patients with localized adrenocortical carcinoma. METHODS: One hundred fifty-six patients with localized adrenocortical carcinoma (stage I/II) who underwent R0 resection were included in an Italian multiinstitutional surgical survey. They were divided into 2 groups based on the operative approach (either conventional or endoscopic). RESULTS: One hundred twenty-six patients underwent open adrenalectomy and 30 patients underwent endoscopic adrenalectomy. The 2 groups were well matched for age, sex, lesion size, and stage (P = NS). The mean follow-up time was similar for the 2 groups (P = NS). The local recurrence rate was 19% for open adrenalectomy and 21% for endoscopic adrenalectomy, whereas distant metastases were recorded in 31% of patients in the conventional adrenalectomy group and 17% in the endoscopic adrenalectomy group (P = NS). The mean time to recurrence was 27 ± 27 months in the conventional open adrenalectomy group and 29 ± 33 months in the endoscopic adrenalectomy group (P = NS). No significant differences were found between the 2 groups in terms of 5-year disease-free survival (38.3% vs 58.2%) and 5-year overall survival rates (48% vs 67%; P = NS). CONCLUSION: The operative approach does not affect the oncologic outcome of patients with localized adrenocortical carcinoma, if the principles of surgical oncology are respected.

5. D'Onofrio A, Messina A, Lorusso R, Alfieri OR, Fusari M, Rubino P, Rinaldi M, Di Bartolomeo R, Glauber M, Troise G, Gerosa G. Sutureless aortic valve replacement as an alternative treatment for patients belonging to the "gray zone" between transcatheter aortic valve implantation and conventional surgery: a propensity-matched, multicenter analysis. J Thorac Cardiovasc Surg. 2012 Nov;144(5):1010-6. doi: 10.1016/j.jtcvs.2012.07.040. Epub 2012 Sep 10.
Division of Cardiac Surgery, University of Padova, Padova, Italy. Comment in J Thorac Cardiovasc Surg. 2012 Nov;144(5):1016-8.

OBJECTIVE: The aim of this propensity-matched, multicenter study was to compare early clinical and echocardiographic outcomes of patients undergoing transapical aortic valve implantation (TA-TAVI) versus patients undergoing sutureless aortic valve replacement (SU-AVR) for severe symptomatic aortic valve stenosis. METHODS: We reviewed 468 TA-TAVIs performed in 20 centers from April 2008 to May 2011, and 51 SU-AVRs performed in 3 centers from March to September 2011. Based on a propensity score analysis, 2 groups with 38 matched pairs were created. Variables used in the propensity analysis were age, sex, body surface area, New York Heart Association class, logistic EuroSCORE, peripheral vascular disease, chronic obstructive pulmonary disease, aortic valve area, mitral regurgitation, and left ventricular ejection fraction. RESULTS: Preoperative characteristics of the 2 groups were comparable. Hospital mortality was 5.3% and 0% in the TA-TAVI and SU-AVR groups, respectively (P = .49). We did not observe stroke or acute myocardial infarction in the 2 groups. Permanent pacemaker implantation was needed in 2 patients of each group (5.3%, P = 1.0). Dialysis was required in 2 patients (5.3%) in the SU-AVR group and in 1 patient (2.7%) in the TA-TAVI group (P = 1.0). Predischarge echocardiographic data showed that the incidence of paravalvular leak (at least mild) was greater in the TA-TAVI group (44.7% vs 15.8%, P = .001), but there were no differences in terms of mean transprosthetic gradient (10.3 ± 5 mm Hg vs 11 ± 3.7 mm Hg, P = .59). CONCLUSIONS: This preliminary experience showed that, in patients at high risk for conventional surgery, SU-AVR is as safe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular leak.

6. Marulli G, Rea F, Melfi F, Schmid TA, Ismail M, Fanucchi O, Augustin F, Swierzy M, Di Chiara F, Mussi A, Rueckert JC. Robot-aided thoracoscopic thymectomy for early-stage thymoma: a multicenter European study. J Thorac Cardiovasc Surg. 2012 Nov;144(5):1125-30. doi: 10.1016/j.jtcvs.2012.07.082. Epub 2012 Aug 31.
Thoracic Surgery Division, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy. Comment in J Thorac Cardiovasc Surg. 2012 Nov;144(5):1130-2.

OBJECTIVE: Minimally invasive thymectomy for stage I to stage II thymoma has been suggested in recent years and considered technically feasible. However, because of the lack of data on long-term results, controversies still exist on surgical access indication. We sought to evaluate the results after robot-assisted thoracoscopic thymectomy in early-stage thymoma. METHODS: Data were collected from 4 European centers. Between 2002 and 2011, 79 patients (38 men and 41 women; median age, 57 years) with early-stage thymoma were operated by left-sided (82.4%), right-sided (12.6%), or bilateral (5%) robotic thoracoscopic approach. Forty-five patients (57%) had associated myasthenia gravis. RESULTS: Average operative time was 155 minutes (range, 70-320 minutes). One patient needed open conversion, in 1 patient a standard thoracoscopy was performed after robotic system breakdown, and in 5 patients an additional access was required. No vascular and nervous injuries were recorded, and no perioperative mortality occurred. Ten patients (12.7%) had postoperative complications. Median hospital stay was 3 days (range, 2-15 days). Median diameter of tumor resected was 3 cm (range, 1-12 cm), and Masaoka stage was stage I in 30 patients (38%) and stage II in 49 patients (62%). At a median follow-up of 40 months, 74 patients were alive and 5 had died (4 patients from nonthymoma-related causes and 1 from a diffuse intrathoracic recurrence), with a 5-year survival rate of 90%. CONCLUSIONS: Our data indicate that robot-enhanced thoracoscopic thymectomy for early-stage thymoma is a technically sound and safe procedure with a low complication rate and a short hospital stay. Oncologic outcome seems good, but a longer follow-up is needed to consider this as a standard approach definitively.

7. Fanfani F, Fagotti A, Salerno MG, Margariti PA, Gagliardi ML, Gallotta V, Vizzielli G, Panico G, Monterossi G, Scambia G. Elderly and very elderly advanced ovarian cancer patients: does the age influence the surgical management? Eur J Surg Oncol. 2012 Dec;38(12):1204-10. doi: 10.1016/j.ejso.2012.08.003. Epub 2012 Aug 28.
Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, L.go A. Gemelli 8, 00168 Rome, Italy.

BACKGROUND: To examine the surgical treatment and clinical outcome of elderly and very elderly advanced epithelial ovarian cancer patients. METHODS: We retrospectively analyzed FIGO stage IIIC-IV ovarian cancer patients, divided in elderly (Group A, >65 and <75 years) and very elderly patients (Group B, ≥ 75 years) treated by primary debulking surgery (PDS) or by interval debulking surgery (IDS) at the Catholic University at Rome and Campobasso, Italy. RESULTS: 164 patients were included: 123 (Group A) and 41 (Group B). Complete cytoreduction was achieved in 60 patients (60.6%) in Group A and in 20 patients (62.5%) in Group B (p = 0.75). In the remaining cases, optimal cytoreduction was performed (39 cases (39.4%) in Group A and 12 (37.5%) in Group B; p = 0.75). In Group A complete/optimal debulking was achieved in 53 patients (53.5%) at PDS and in 46 patients (46.5%) at IDS (p = 0.55). In the Group B a higher rate of patients was debulked at IDS with respect to PDS (10 (31.3%) vs. 22 patients (68.7%); p = 0.02). In Group A patients debulked at PDS showed better DFS (p = 0.007) and OS (p = 0.003) with respect to patients submitted to successful IDS, whereas in group B we did not observed any survival difference according to time of cytoreduction. CONCLUSIONS: Our data suggest that elderly and very elderly patients may tolerate radical and ultra-radical surgery. These patients should be managed in a gynecologic oncology unit, with prudent but complete approach.

8. Capodanno D, Caggegi A, Capranzano P, Milino V, Chisari A, Mangiameli A, Monaco S, Barrano G, Di Salvo ME, Tamburino C. Comparative one-year effectiveness of percutaneous coronary intervention versus coronary artery bypass grafting in patients <75 versus ≥75 years with unprotected left main disease (from the CUSTOMIZE Registry). Am J Cardiol. 2012 Nov 15;110(10):1452-8. doi: 10.1016/j.amjcard.2012.07.005. Epub 2012 Jul 30.
Cardiovascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy; Excellence Through Newest Advances Foundation, Catania, Italy.

There is a lack of knowledge on the interaction between age and left main coronary artery revascularization. The aim of this study was to investigate the comparative effectiveness of percutaneous coronary intervention (PCI) with drug-eluting stents and coronary artery bypass grafting (CABG) in patients with left main coronary artery disease aged <75 versus ≥75 years. Of a total of 894 patients included, 692 (77.4%) were aged <75 years and 202 (23.6%) ≥75 years. PCI was found to be significantly different from CABG with respect to the composite of major adverse cardiac events at 1-year follow-up in patients aged <75 years (15.5% vs 8.5%, p = 0.01) but not in those aged ≥75 years (16.4% vs 13.9%, p = 0.65). This finding was consistent after statistical adjustment for baseline confounders in the 2 groups (adjusted hazard ratio [AHR] 2.2, 95% confidence interval 1.2 to 4.1, p = 0.016 in younger patients; AHR 0.9, 95% confidence interval 0.3 to 3.0, p = 0.88 in older patients). In the 2 groups, PCI and CABG showed similar adjusted risks for all-cause death, cardiac death, and myocardial infarction. Target lesion revascularization occurred more frequently in patients aged <75 years treated with PCI compared to CABG (AHR 5.1, 95% confidence interval 1.9 to 13.6, p = 0.001) but not in those aged ≥75 years. A significant interaction between age and treatment with regard to major adverse cardiac events was identified (adjusted p for interaction = 0.034). In conclusion, compared to younger patients, elderly patients with left main disease are likely to derive the maximal gain from a less invasive procedure such as PCI.

9. Gubitosi A, Ruggiero R, Ortolani R, Podzemny V, Parmeggiani D, Esposito E, Foroni F, Esposito A, Villaccio G. Ambulatory laser-assisted surgery: a multicenter application and experience. Ann Ital Chir. 2012 Nov-Dec;83(6):515-21.
Second University Naples, Italy.

BACKGROUND: The widespread use of surgical lasers has found place in dermatologic and aesthetic surgery largely because they are well tolerated with a reduced incidence of postoperative haemorrhage and oedema, few associated adverse events and a high rate of patient satisfaction. PATIENTS AND METHODS: A retrospective analysis of 1232 consecutive patients was performed on patients undergoing a range of laser treatments between January 2005 and January 2010. A mixed variety of indications for laser use included dermatologic surgeries for the removal of fibromas, angiomas and naevi, aesthetic surgeries for acne, superficial vascular conditions, facial rejuvenations and remodelling and tattoo removals as well as many miscellaneous conditions. A range of lasers were employed including CO2, Erbium: Yttrium Aluminum Garnet (Er:YAG), diodes, Alexandrite, Ruby and Neodymium:Yttrium Aluminum Garnet (Nd:YAG) lasers with variable use for different indications in combination with a selective protocol of topical anaesthesia and local cooling systems. RESULTS: Patient satisfaction was high overall (92.4%) with most reported failures amongst those treated for general surgical conditions where there were the highest recorded complication rates. The main failures occurred in those with small cutaneous telangiectases (36.2% incomplete treatment response and 31.9% dissatisfaction rate). In those patients where lasers were used for aesthetic reasons,(most notably in those undergoing tattoo or scar removal and in those with hypertrichosis and dermatofolliculitis), incomplete results occurred in 7.2% with an 11.8% dissatisfaction rate and rare complications (0.9%). In this group, the highest reported incomplete results occurred in patients undergoing tattoo removal (13.9%), followed by scar removal (12.5%) and then by those undergoing treatment for hypertrichosis and dermatofolliculitis (8.8%). CONCLUSIONS: Laser use in general surgery is associated with a high success rate for a wide variety of conditions with high patient satisfaction and a low incidence of adverse events in experienced hands. The advantages and disadvantages as well as the specific recommendations for different laser types are presented with clinical advances resulting from the development of non-ablative laser systems designed for dermal remodeling.

10. Tubach F, Ravaud P, Martin-Mola E, Awada H, Bellamy N, Bombardier C, Felson DT, Hajjaj-Hassouni N, Hochberg M, Logeart I, Matucci-Cerinic M, van de Laar M, van der Heijde D, Dougados M. Minimum clinically important improvement and patient acceptable symptom state in pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, hand osteoarthritis, and hip and knee osteoarthritis: Results from a prospective multinational study. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1699-707. doi: 10.1002/acr.21747.
INSERM, Université Paris Diderot, France.

OBJECTIVE: To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries. METHODS: We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4-week cohort study involving 1,532 patients who were prescribed nonsteroidal antiinflammatory drugs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis, or rheumatoid arthritis. The MCII and PASS values were estimated with the 75th percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability, and physician global assessment, all normalized to a 0-100 score. RESULTS: For the whole sample, the estimated MCII values for absolute change at 4 weeks were -17 (95% confidence interval [95% CI] -18, -15) for pain; -15 (95% CI -16, -14) for patient global assessment; -12 (95% CI -13, -11) for functional disability assessment; and -14 (95% CI -15, -14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (95% CI 40, 44) for pain; 43 (95% CI 41, 45) for patient global assessment; 43 (95% CI 41, 44) for functional disability assessment; and 39 (95% CI 37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups ≥20 patients). CONCLUSION: This work allows for promoting the use of values of MCII (15 of 100 for absolute improvement, 20% for relative improvement) and PASS (40 of 100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function, or physician global assessment used as outcome criteria.

11. Forti P, Maioli F, Procaccianti G, Nativio V, Lega MV, Coveri M, Zoli M, Sacquegna T. Independent predictors of ischemic stroke in the elderly: Prospective data from a stroke unit. Neurology. 2013 Jan 1;80(1):29-38. doi: 10.1212/WNL.0b013e31827b1a41. Epub 2012 Dec 12.
From the Department of Medical and Surgical Sciences (P.F., M.-V.L., M.Z.), University of Bologna; and the Geriatric Stroke Unit, Medical Department (F.M., V.N., M.C.), and Neurology Stroke Unit (G.P., T.S.), Maggiore Hospital, IRCSS, Bologna, Italy.

OBJECTIVE: Incidence of ischemic stroke (IS) increases with age. Knowledge of factors associated with IS acute outcomes in the oldest-old (≥80 years) is needed to improve quality of care and resource allocation in this age group. METHODS: Data are for 769 consecutive IS patients aged ≥60 years (436 aged ≥80 years) admitted to an Italian stroke unit in a 4-year period. Demographics, prestroke disability (modified Rankin Scale ≥3) and comorbidities, IS etiology and subtype, NIH Stroke Scale (NIHSS) score, clinical and laboratory admission parameters, and medical complications were prospectively registered. Independent predictors of in-hospital death, incident disability, length of stay, discharge without rehabilitation, and no direct discharge home were identified by multiple logistic regression. Risk profiles before and after age 80 were compared. RESULTS: Poor outcomes were more frequent in the oldest-old compared to the younger patients. NIHSS score, clinical parameters of IS severity (need for oxygen, indwelling catheter, or nasogastric tube), incident disability, and medical complications predicted most of the study outcomes in both age groups. After age 80, IS etiology and subtype proved additional independent determinants for most outcomes along with age, sex, and prestroke functional and health status. CONCLUSIONS: Characteristics related to neurologic impairment on admission were the main predictors of acute outcomes of IS in this cohort. Specific IS etiology and subtype influenced IS outcomes only after age 80. In oldest-old patients, demographics and prestroke functional and health status also influenced IS outcomes with peculiar associations.

Breve commento a cura di Nerina Agabiti
Sono presentati i risultati di uno studio prospettico raccolti in una stroke unit in Italia (Bologna) per valutare i fattori predittivi di ictus ischemico, con particolare attenzione all’età molto anziana. Sono state arruolate consecutivamente 769 persone con ictus ischemico con età maggiore di 60 anni, di cui 436 con età 80+ anni. All’ingresso veniva registrato il profilo di rischio che è stato poi confrontato tra individui sopra e sotto gli 80 anni. Lo studio dimostra come 1) gli esiti siano più sfavorevoli nell’età molto anziana, 2) la disabilità all’ammissione e la gravità della ictus e delle condizioni cliniche generali siano predittori di esiti sfavorevoli in entrambi i gruppi di età e 3) l’eziologia ed il sottotipo hanno un ruolo importante nella prognosi nel gruppo di età maggiore di 80 anni. Nonostante alcuni limiti metodologici, lo studio è interessante e si basa sulla dati di un registro raccolti su formato elettronico contenenti molti dati clinici e di laboratorio seguendo metodologie standardizzate ed utilizzate anche in altri studi di coorte europei.

12. Romeo F, Acconcia MC, Sergi D, Romeo A, Gensini GF, Chiarotti F, Caretta Q. Lack of intra-aortic balloon pump effectiveness in high-risk percutaneous coronary interventions without cardiogenic shock: A comprehensive meta-analysis of randomised trials and observational studies. Int J Cardiol. 2013 Jan 4. pii: S0167-5273(12)01656-7. doi: 10.1016/j.ijcard.2012.12.027. [Epub ahead of print]
Department of Cardiovascular Disease, University of Rome, Tor Vergata - Rome, Italy.

BACKGROUND: Although controversial, using prophylactic intra-aortic balloon pump (IABP) in patients undergoing high-risk percutaneous coronary intervention (PCI) has been reported to be effective by numerous registry studies. However, conflicting findings were observed in observational studies (Obs.) and randomised controlled trials (RCTs). OBJECTIVE: The purpose of this meta-analysis was to assess the impact of IABP on in-hospital deaths, major adverse cardiovascular events (MACCE), access-site complications and stroke in high-risk PCI cases from Obs. and RCTs published from 1st January, 1990 to 31st March, 2012 and indexed in PubMed. METHODS AND RESULTS: We retrieved 1125 studies from the database; 11 studies compared the effects of IABP support, i.e., prophylactic administration (P-IABP) vs. no support (No-IABP), in high-risk patients undergoing PCI. These studies were included in the meta-analysis. We then calculated risk ratios (RRs) and risk differences (RDs) between the two groups of patients (P-IABP vs. No-IABP). We did not observe significant in-hospital mortality, MACCE, access-site complications or stroke differences in the RRs and RDs of the two groups. CONCLUSIONS: The results suggest that PCI plus P-IABP support does not result in reduced in-hospital mortality or MACCE nor in significant higher access-site complications or stroke incidence compared with PCI alone in patients at high risk for peri-procedural PCI complications.

13. Proclemer A, Muser D, Campana A, Zoni-Berisso M, Zecchin M, Locatelli A, Brieda; M, Gramegna L, Santarone M, Chiodi L, Mazzone P, Rebellato L, Facchin D. Indication to cardioverter-defibrillator therapy and outcome in real world primary prevention. Data from the IRIDE [Italian registry of prophylactic implantation of defibrillators] study. Int J Cardiol. 2012 Dec 31. pii: S0167-5273(12)01671-3. doi: 10.1016/j.ijcard.2012.12.042. [Epub ahead of print]
Azienda Ospedaliero Universitaria "S. Maria della Misericordia" and IRCAB Foundation, SOC Cardiologia, Udine, Italy. Electronic address:

AIMS: Several trials demonstrated the life saving role of implantable cardioverter-defibrillators (ICD) in primary prevention of sudden cardiac death (SCD). The aim was to evaluate the clinical characteristics and 4-year outcome of consecutive patients treated in clinical practice by prophylactic ICD implantation on the basis of class I recommendations and up-to-date ICD programming. METHODS AND RESULTS: IRIDE multi-center, prospective and observational study enrolled 604 consecutive patients (mean age: 66±10years) treated by ICD between 01/01/2006 and 30/06/2010. Main characteristics were similarly distributed among the inclusion criteria of MADIT II (24%), SCD-HeFT (24%), COMPANION (26%) and MADIT-CRT (18%) trials, while a small number of patients met the MUSTT and MADIT (7%) inclusion criteria. Single-chamber ICDs were implanted in 168 (28%) patients, dual-chamber in 167 (28%) and biventricular in 269 (43%) patients. ATP programming was activated in 546 (90%) patients. Overall survival and rate of appropriate ICD intervention by ATP and/or shock at 12-24-36-48months of follow-up were 94%, 89%, 80%, 75% and 16%, 28%, 37% and 50%, respectively. No difference in mortality rate between the groups who received or did not receive appropriate ICD interventions was demonstrated (p=ns). CONCLUSIONS: The IRIDE study confirms the effectiveness in real world practice of ICD implantation in patients at risk of SCD. The life saving role of ICD therapy increases as the duration of follow-up is prolonged and the survival benefit is similar in patients who received or did not receive appropriate device treatment, thus suggesting a beneficial effect of up-to-date device programming.

14. Factors related to difficulties with employment in patients with multiple sclerosis: a review of 2002-2011 literature. Schiavolin S, Leonardi M, Giovannetti AM, Antozzi C, Brambilla L, Confalonieri P, Mantegazza R, Raggi A. Int J Rehabil Res. 2012 Dec 12. [Epub ahead of print]
Departments of aNeurology, Public Health and Disability Unit bNeurology IV, Neuromuscular Diseases and Neuroimmunology, Neurological Institute C. Besta, IRCCS Foundation, Milano Italy.

We assess the knowledge available on the difficulties experienced by multiple sclerosis (MS) patients in work-related activities. A literature review was carried out using the keywords 'multiple sclerosis' and 'employment' or 'work' through PubMed and EMBASE. Papers reporting patient-derived data on difficulties at work as primary or secondary outcome measures and published in the period 2002-December 2011 were searched. A total of 26 papers were selected, for a total of 32 507 patients (mean age 46.2 years; 42.1% with relapsing-remitting MS). Most papers reported observational studies or cross-sectional surveys focused on health-related quality of life and MS costs. Symptoms more frequently addressed are fatigue, mobility and cognitive impairments. Limited research has been carried out on the working environment. We found a relatively small number of papers published in the last 10 years on the difficulties that patients with MS can experience at work, and this kind of information always appeared as a secondary outcome. In general, it is possible to affirm that MS has a strong impact on patients' employment status, as the mean unemployment rate was 59%. Research on factors promoting maintenance of remunerative employment is required.

15. Lanas A, Aabakken L, Fonseca J, Mungan Z, Papatheodoridis G, Piessevaux H, Rotondano G, Nuevo J, Tafalla M. Variability in the management of nonvariceal upper gastrointestinal bleeding in europe: an observational study. Adv Ther. 2012 Dec;29(12):1026-36. doi: 10.1007/s12325-012-0069-x. Epub 2012 Dec 6.
Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain,

INTRODUCTION: Despite recent advances in endoscopic and pharmacological management, nonvariceal upper gastrointestinal bleeding (NVUGIB) is still associated with considerable mortality and morbidity that vary between countries. The European Survey of Nonvariceal Upper Gastrointestinal Bleeding (ENERGiB) reported clinical outcomes across Europe (Belgium, Greece, Italy, Norway, Portugal, Spain, and Turkey) and evaluated management strategies in a "real-world" European setting. This article presents the differences in clinical management strategies among countries participating in ENERGiB. METHODS: Adult patients consecutively presenting with overt NVUGIB at 123 participating hospitals over a 2-month period were included. Data relevant to the initial NVUGIB episode and for up to 30 days afterwards were collected retrospectively from patient medical records. RESULTS: The number of evaluable patients was 2,660; patient demographics and clinical characteristics were similar across countries. There was wide between-country variability in the area and speciality of the NVUGIB management team and unit transfer rates after the initial hospital assessment. The mean time from admission to endoscopy was <1 day only in Italy and Spain. Wide variation in the use of preendoscopy (35.0-88.7%) and relatively consistent (86.5-96.0%) postendoscopic pharmacological therapy rates were observed. There was substantial by-country variability in the rate of therapeutic procedures performed during endoscopy (24.9-47.6%). NVUGIB-related healthcare resource consumption was high and variable (days hospitalized, mean 5.4-8.7 days; number of endoscopies during hospitalization, mean 1.1-1.7). CONCLUSIONS: ENERGiB demonstrates that there are substantial differences in the management of patients with acute NVUGIB episodes across Europe, and that in many cases the guideline recommendations for the management of NVUGIB are not being followed.

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