rubrica

Valutazione

  • Marina Davoli1

  • Nerina Agabiti1

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

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Ricerca bibliografica periodo 15 ottobre 2010 – 26 gennaio 2011

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Database: Pubmed/MEDline
Stringa di ricerca: (((“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 ("2010/10/15"[PDAT] : "2011/1/26"[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])) AND (Review[ptyp] OR "adult"[MeSH Terms] OR "infant"[MeSH Terms] OR "child"[MeSH Terms] OR "adolescent"[MeSH Terms]) OR "Primary Health Care"[Mesh] OR ("Prospective Studies"[Mesh] AND "Hospitals"[Mesh]) OR ("Rehabilitation"[Mesh] OR "rehabilitation "[Subheading]) OR ("Equipment and Supplies"[Mesh] AND Comparison$[Title/Abstract]) OR "Neoplasms"[Mesh] OR "Heart Failure"[Mesh] OR "Cardiovascular Diseases"[Majr] OR "Surgical Procedures, Operative"[Mesh] OR "Myocardial Ischemia"[Mesh] OR "Respiration Disorders"[Mesh] OR "Diabetes Mellitus"[Mesh] OR ("Stroke"[Mesh] or stroke unit$ [ti/ab]) OR "Chronic Disease"[Mesh] OR ("observational study" [Title/Abstract] OR "observational studies" [Title/Abstract]) OR (Comparison$[Title/Abstract]))

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1. Fedeli U, Fedewa SA, Ward EM. Treatment of muscle invasive bladder cancer: evidence from the National Cancer Database, 2003 to 2007. J Urol. 2011 Jan;185(1):72-8. Epub 2010 Nov 12.
Epidemiological Department, Veneto Region, Castelfranco Veneto, Italy.
Abstract
PURPOSE: We describe nationwide treatment patterns of muscle invasive bladder cancer, investigated determinants of cystectomy and provide contemporary trends in process of care measures in patients undergoing cystectomy.
MATERIALS AND METHODS: We selected 40,388 patients 18 to 99 years old diagnosed with muscle invasive (stages II to IV) bladder cancer in 2003 to 2007 from the National Cancer Database. Treatment included cystectomy, neoadjuvant and adjuvant chemotherapy, chemotherapy without surgery and radiation therapy. In patients undergoing cystectomy we retrieved the procedure type (partial vs radical), lymphadenectomy extent and 30-day followup. Cystectomy determinants were assessed by Poisson regression with robust error variance. Perioperative mortality was analyzed by multilevel logistic regression.
RESULTS: The proportion of patients treated with cystectomy (42.9%) and radiation therapy (16.6%) remained stable with time while the incidence of those who received chemotherapy increased from 27.0% in 2003 to 34.5% in 2007 due to an increase in neoadjuvant chemotherapy and chemotherapy without surgery. The cystectomy rate decreased with age and was lower in racial/ethnic minorities (especially black patients), uninsured or Medicaid patients, patients residing in the South and Northeast, and those treated at nonteaching/research hospitals. The partial cystectomy rate decreased and lymphadenectomy extent increased with time. The perioperative mortality rate was 2.6% and it was higher at low vs very high volume hospitals (OR 1.71, 95% CI 1.26-2.32).
CONCLUSIONS: Recent nationwide data confirm ongoing improvements in process of care measures in patients who undergo cystectomy but also show marked differences in treatment patterns for muscle invasive bladder cancer by patient age, race, insurance status, geographic area and facility type. PMID: 21041579 [PubMed - indexed for MEDLINE]

Commento a cura di Nerina Agabiti
Nello studio “Treatment of muscle invasive bladder cancer: evidence from the National Cancer Database, 2003 to 2007” di Fedeli U et al pubblicato su The Journal of Urology, sono stati analizzati i dati del National Cancer Registry (USA) con lo scopo di descrivere la tipologia di trattamenti offerti , la loro variabilità sulla base delle caratteristiche dei pazienti o delle strutture, nonché l’andamento nel tempo. E’ il primo studio su scala nazionale che analizza un ampio range di fattori potenzialmente associati ai trattamenti per il cancro della vescica per una coorte molto grande di persone (n= 40.388) per periodo di 5 anni. In generale è bassa la proporzione di pazienti sottoposti a chirurgia (tra il 30 ed il 40%), specie negli stadi iniziali, e tende a diminuire progressivamente nel tempo, mentre si assiste ad un crescente aumento dell’uso di chemioterapia e di approcci meno invasivi, come la resezione endoscopica transuretrale. Nei pazienti di razza nera è inferiore il tasso di chirurgia, a parità di stadio della malattia, mentre viene più frequentemente usata la radioterapia. Gli anziani, i pazienti con molte comorbidità, e quelli appartenenti a etnie minori o razza nera hanno minore probabilità di ricevere appropriati trattamenti in base allo stadio della malattia. Molti interventi chirurgici vengono eseguiti in strutture con basso volume di attività, laddove si conferma , per questa patologia, una forte associazione tra volume e l’esito favorevole (“mortalità a 30 giorni dopo l’intervento” ). Differenze nei trattamenti si osservano anche sulla base del tipo di struttura e per area geografica. Sebbene il contesto sia diverso da quello italiano, questo studio offre interessanti spunti alla discussione sulla sorprendente grande variabilità dei trattamenti nella pratica clinica, con potenziali conseguenze sugli esiti, e sulla forte disparità nelle cure tra gruppi sociali.

2. Santangeli P, Di Biase L, Dello Russo A, Casella M, Bartoletti S, Santarelli P, Pelargonio G, Natale A. Meta-analysis: age and effectiveness of prophylactic implantable cardioverter-defibrillators. Ann Intern Med. 2010 Nov 2;153(9):592-9.
Catholic University of the Sacred Heart, Rome, Italy. pasquale.santangeli@libero.it
Abstract
BACKGROUND: Implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death have been proven effective in several clinical trials.
PURPOSE: To summarize evidence about the effectiveness of ICDs versus standard medical therapy for the primary prevention of sudden cardiac death in different age groups of patients with severe left ventricular dysfunction.
DATA SOURCES: MEDLINE, Embase, CENTRAL, BioMed Central, Cardiosource, ClinicalTrials.gov, and ISI Web of Science (January 1970 to April 2010) were searched with no language restrictions.
STUDY SELECTION: Two independent reviewers screened titles and abstracts to identify randomized, controlled trials of prophylactic ICD versus medical therapy in patients with severe left ventricular dysfunction that provided data about mortality outcomes for different age groups.
DATA EXTRACTION: Two independent reviewers assessed risk for bias of trials and extracted patient and study characteristics and hazard ratios (HRs) relevant to all-cause mortality.
DATA SYNTHESIS: Five trials (MADIT-II, DEFINITE, DINAMIT, SCD-HeFT, and IRIS) that enrolled 5783 patients (44% were elderly) were included. The primary analysis, which excluded the 2 trials enrolling patients early after acute myocardial infarction (DINAMIT and IRIS), found that prophylactic ICD therapy reduced mortality in younger patients (HR, 0.65 [95% CI, 0.50 to 0.83]; P < 0.001). A smaller and statistically nonsignificant survival benefit was found in elderly patients (HR, 0.81 [CI, 0.62 to 1.05]; P = 0.11). The inclusion of data from DINAMIT and IRIS did not change these results.
LIMITATIONS: Four potentially eligible trials were not included in the meta-analysis because mortality data by age group were not available. Adjustment for differences in comorbid conditions and medical therapies among patients enrolled in the trials was not possible.
CONCLUSION: Available data do not conclusively show that prophylactic ICD therapy improves survival in elderly patients with severe left ventricular dysfunction.

Commento a cura di Nerina Agabiti
L’introduzione sempre più rapida di nuove tecnologie per la diagnosi e la cura di molte condizioni cliniche non sempre è supportata da solide prove di efficacia. Nell’articolo “Meta-analysis: age and effectiveness of prophylactic implantable cardioverter-defibrillator” pubblicato su Annals of Internal Medicine da Santangeli et al, si affronta il tema del cardioverter-defibrillator automatico introdotto negli ultimi anni per la prevenzione della morte improvvisa in pazienti con scompenso cardiaco o gravi disturbi del ritmo. Si tratta di un apparecchio che viene inserito nella cavità destra del cuore attraverso la via venosa, in maniera simile al pacemaker, e che è in grado di riconoscere l’improvvisa comparsa di aritmia (fibrillazione ventricolare o tachicardia ventricolare) e di trasmettere impulsi elettrici impedendo l’arresto cardiaco. Oggetto del lavoro è la sintesi delle evidenze di efficacia di tale trattamento in confronto alla terapia medica standard in pazienti con grave insufficienza ventricolare sinistra, nell’ipotesi che l’efficacia sia diversa a seconda dell’età. Secondo metodologie standardizzate (protocollo Cochrane) sono stati esaminati 9 trials clinici randomizzati e ne è stata stimata la validità. Solo in 5 di essi - per un totale di 5783 individui (71% con cardiomiopatia ischemica) - è stato possibile esaminare l’efficacia in termini di mortalità (tempo di follow up mediano: 32 mesi) separatamente per due categorie di età (adulti < 65 anni di età, anziani 65+ anni di età). Tra i pazienti anziani Il cardioverter-defibrillator risulta essere associato ad riduzione non statisticamente significativa del rischio di morte improvvisa (HR 0.81, 95% CI 0.62-1.05), mentre l’impianto risulta essere protettivo tra i più giovani (HR=0.75, 95% CI 0.52-0.94). Anche se il risultato non è conclusivo e sono necessari ulteriori studi, l’evidenza di mancato effetto tra gli anziani può avere rilevanti ripercussioni nella pratica clinica, dal momento che il numero degli anziani potenzialmente candidati è in aumento nei paesi industrializzati e la tecnologia è costosa e non esente da rischi.

3. Cavanna L, Civardi G, Vallisa D, Di Nunzio C, Cappucciati L, Bertè R, Cordani MR, Lazzaro A, Cremona G, Biasini C, Muroni M, Mordenti P, Gorgni S, Zaffignani E, Ambroggi M, Bidin L, Palladino MA, Rodinò C, Tibaldi L. Ultrasound-guided central venous catheterization in cancer patients improves the success rate of cannulation and reduces mechanical complications: a prospective observational study of 1,978 consecutive catheterizations. World J Surg Oncol. 2010 Oct 19;8:91.
Oncology-Hematology Department, Hospital of Piacenza, Piacenza, Italy. l.cavanna@ausl.pc.it
Abstract
BACKGROUND: A central venous catheter (CVC) currently represents the most frequently adopted intravenous line for patients undergoing infusional chemotherapy and/or high-dose chemotherapy with hematopoietic stem-cell transplantation and parenteral nutrition. CVC insertion represents a risk for pneumothorax, nerve or arterial punctures. The aim of this prospective observational study was to explore the safety and efficacy of CVC insertion under ultrasound (US) guidance and to confirm its utility in clinical practice in cancer patients.
METHODS: Consecutive adult patients attending the oncology-hematology department were eligible if they had solid or hematologic malignancies and required CVC insertion. Four types of possible complication were defined a priore: mechanical, thrombotic, infection and malfunctioning. The patient was placed in Trendelenburg's position, a 7.5 MHZ puncturing US probe was placed in the supraclavicular site and a 16-gauge needle was advanced under real-time US guidance into the last portion of internal jugular vein. The Seldinger technique was used to place the catheter, which was advanced into the superior vena cavauntil insertion into right atrium. Within two hours after each procedure, an upright chest X-ray and ultrasound scanning were carried out to confirm the CVC position and to rule out a pneumotorax. CVC-related infections, symptomatic vein thrombosis and malfunctioning were recorded.
RESULTS: From December 2000 to January 2009, 1,978 CVC insertional procedures were applied to 1,660 consecutive patients. The procedure was performed 580 times in patients with hematologic malignancies and 1,398 times those with solid tumors. A single-needle puncture of the vein was performed on 1,948 of 1,978 procedures (98.48%); only eighteen attempts among 1,978 failed (0.9%). No pneumotorax, no major bleeding, and no nerve puncture were reported; four cases (0.2%) showed self-limiting hematomas. The mean lifespan of CVC was 189.7 +/- 18.6 days (range 7-701). Symptomatic deep-vein thrombosis of the upper limbs developed in 48 patients (2.42%). Catheter-related infections occurred in 197 (9.96%) of the catheters inserted. They were successfully treated with antibiotics and only in 48 (2.9%) patients definitive CVC removal was required for infection and/or thrombosis or malfunctioning.
CONCLUSIONS: This study represents the largest published series of consecutive patients with cancer undergoing CVC insertion under US guidance; this procedure allowed the completion of the therapeutic program for 1,930/1,978 (97.6%) of the catheters inserted. The absence of pneumotorax and other major complications indicates that US guidance should be mandatory for CVC insertion in patients with cancer.
PMCID: PMC2984400 PMID: 20958986 [PubMed - indexed for MEDLINE]
4. Rosso S, Gondos A, Zanetti R, Bray F, Zakelj M, Zagar T, Smailyte G, Ponti A, Brewster DH, Voogd AC, Crocetti E, Brenner H; EUNICE Survival Working Group. Up-to-date estimates of breast cancer survival for the years 2000-2004 in 11 European countries: the role of screening and a comparison with data from the United States. Eur J Cancer. 2010 Dec;46(18):3351-7. Epub 2010 Oct 11.
Piedmont Cancer Registry, CPO - Centre for Epidemiology and Prevention in Oncology in Piedmont, Turin, Italy. stefano.rosso@cpo.it
Abstract
INTRODUCTION: We investigated survival in breast cancer patients by age group, focussing on those covered by screening programmes, using data from 12 European population-based cancer registries participating in the European Network for Indicators on Cancer Survival Working Group.
METHODS: We calculated period estimates of 5-year relative survival for 2000-2004 and examined the change in survival estimates for four age groups between 1990-1994 and 2000-2004. Trends in age specific incidence, survival and mortality were additionally compared to those in the United States based on results from the Surveillance Epidemiology and End Results (SEER) programme.
RESULTS: Breast cancer survival uniformly increased particularly in areas with lower breast cancer survival for patients diagnosed in 1990-1994. With the exception of Geneva, Scotland and Estonia, the rise in survival was always larger among the younger age groups than in the 70+ age group and the age-gradient widened over time. The 5-year relative survival of patients aged 70 and above in the European registries was at least 7 percentage points lower than the 5-year relative survival of patients in the same age group in the US in 2000-2004. During the study period, incidence increased in all age groups and populations with a few exceptions, an observation paralleled by declining mortality.
CONCLUSIONS: Results showed that some of the geographical differences in overall survival are even larger when considering age groups, in particular between Western and Eastern European countries. Furthermore, some of the differences in survival within the Northern and Western European areas could be due to variations in the implementation of screening programmes rather than economic inequalities.
PMID: 20943375 [PubMed - in process]
5. Fiorica F, Cartei F, Licata A, Enea M, Ursino S, Colosimo C, Cammà C. Can chemotherapy concomitantly delivered with radiotherapy improve survival of patients with resectable rectal cancer? A meta-analysis of literature data. Cancer Treat Rev. 2010 Nov;36(7):539-49. Epub 2010 Mar 23.
Radiotherapy Department, University Hospital S'Anna, Ferrara, Italy. francesco.fiorica@unife.it
Abstract
BACKGROUND: There is clear evidence from two systematic reviews that radiotherapy (RT) reduces the risk of local recurrence in patients with resectable rectal cancer, though the data on survival are still equivocal.
OBJECTIVE: To assess the effects of chemotherapy combined concomitantly with radiotherapy (CRT) on the increase of overall survival, and on the prevention of local recurrence and distant metastases.
DATA SOURCES: Computerized bibliographic searches of MEDLINE and CANCERLIT (1970-2008) were supplemented with hand searches of reference lists.
STUDY SELECTION: Studies were included if they were randomized controlled trials (RCTs) comparing preoperative or postoperative CRT to preoperative or postoperative RT alone, and if they included patients with resectable, histologically-proven, rectal adenocarcinoma without metastases. Thirteen RCTs, seven of preoperative CRT vs. preoperative RT (2787 patients), four of postoperative CRT vs. postoperative RT (726 patients) and two of postoperative CRT vs. preoperative RT (1400 patients), were analyzed.
DATA EXTRACTION: Data on population, intervention, and outcomes were extracted from each RCT, in accordance with the intention-to-treat method, by three independent observers, and combined using the DerSimonian method and Laird method.
RESULTS: Preoperative CRT compared to preoperative RT alone significantly reduces the 5-year local recurrence rate (RR 1.05; 95%CI 1.01-1.10). No increase was observed in 5-year overall survival rate (RR 0.94; 95%CI 0.94-1.09), and in the occurrence of distant metastases (RR 0.97; 95%CI 0.93-1.02). Instead, postoperative CRT did not reduce local recurrence (RR 0.96; 95%CI 0.80-1.16), distant metastases (RR 1.11; 95%CI 0.94-1.31) and overall mortality (RR 1.09; 95%CI 0.83-1.41). By pooling data on postoperative CRT vs. preoperative RT a significant reduction of local recurrence was found for the preoperative approach (RR 0.93; 95%CI 0.90-0.96), though no difference was found in distant metastases rates and overall survival. Finally, the risk of mortality related to toxic events was significantly higher when adding chemotherapy to radiotherapy (RR 2.86; 95%CI 0.99-8.26).
CONCLUSIONS: In patients with resectable rectal cancer, CRT does not increase overall survival, despite the fact that preoperative CRT significantly reduces the risk of the local recurrence. No reduction in the distant metastases rate was found. Toxicity-related mortality is significantly increased by the concomitant approach, emphasizing the need for safer treatment combinations.
PMID: 20334979 [PubMed - indexed for MEDLINE]
6. Dorigo W, Pulli R, Pratesi G, Fargion A, Marek J, Innocenti AA, Pratesi C. Early and long-term results of carotid endarterectomy in diabetic patients. J Vasc Surg. 2011 Jan;53(1):44-52. Epub 2010 Nov 3.
Department of Vascular Surgery, University of Florence, Florence, Italy. dorigow@email.com
Abstract
PURPOSE: To evaluate results of carotid endarterectomy (CEA) in diabetic patients in a large single-center experience.
METHODS: Over a 13-year period ending in December 2008, 4305 consecutive CEAs in 3573 patients were performed. All patients were prospectively enrolled in a dedicated database. Interventions were performed in diabetic patients in 883 cases (20.5%; group 1) and in nondiabetics in the remaining 3422 (79.5%; group 2). Early results in terms of 30-day stroke and death rates were analyzed and compared. Follow-up results were analyzed with Kaplan-Meier curves and compared with log-rank test.
RESULTS: Diabetic patients were more likely to be females and to have coronary artery disease, peripheral arterial disease, hyperlipemia, and arterial hypertension than nondiabetics. There were no differences between the two groups in terms of preoperative clinical status or degree of carotid stenosis. Interventions were performed under general anesthesia with somatosensory-evoked potentials (SEPs) monitoring in 67% of the patients in both groups, while the remaining interventions were performed under clinical monitoring. Shunt insertion (14% and 11%, respectively) and patch closure rates (79% and 76%, respectively) were similar between the two groups. There were no differences between the two groups in terms of neurological outcomes, while the mortality rate was higher in group 1 than in group 2 (P = .002; odds ratio [OR], 3.5; 95% confidence interval [CI], 1.5-8.3); combined 30-day stroke and death rate was significantly higher in group 1 (2%) than in group 2 (0.9%; P = .006; 95% CI, 1.2-3.9; OR, 2.2). At univariate analysis, perioperative risk of stroke and death in diabetic patients was significantly higher in patients undergoing intervention with SEP cerebral monitoring (95% CI, 0.9-39.9; OR, 5.9; P = .01), and this was also confirmed by multivariate analysis (95% CI, 1.1-23.1; OR, 8.3; P = .04). The same analysis in nondiabetics demonstrated that again the need for general anesthesia significantly increased perioperative risk, but this was not significant at multivariate analysis. Follow-up was available in 96% of patients, with a mean duration of 40 months (range, 1-166 months). There were no differences between the two groups in terms of estimated 7-year survival (87.3% and 88.8%, respectively; 95% CI, 0.57-1.08; OR, 0.8) and stroke-free survival (86.8% and 88.1%, respectively; 95% CI, 0.59-1.07; OR, 0.8). Diabetic patients had decreased severe (>70%) restenosis-free survival rates at 7 years than nondiabetics (77.4% and 82.2%, respectively; 95% CI, 0.6-1; OR, 0.8; P = .05). Univariate analysis demonstrated again that the use of instrumental cerebral monitoring significantly decreased stroke-free survival in diabetics (P = .01; log rank, 10.1), and this was also confirmed by multivariate analysis (95% CI, 1.7-17.7; OR, 5.4; P = .005).
CONCLUSIONS: In our experience, the presence of diabetes mellitus increases three-fold the risk of perioperative death after CEA, while there are no differences with nondiabetics in terms of perioperative stroke. However, the rate of stroke and death at 30 days still remains below the recommended standards. During follow-up, this difference becomes negligible, and results are fairly similar to those obtained in nondiabetics. Particular attention should be paid to patients undergoing intervention under general anesthesia, who seem to represent a subgroup of diabetics at higher perioperative risk, suggesting neurologic monitoring should be used when possible.
7. Balducci S, Zanuso S, Nicolucci A, De Feo P, Cavallo S, Cardelli P, Fallucca S, Alessi E, Fallucca F, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators. Effect of an intensive exercise intervention strategy on modifiable cardiovascular risk factors in subjects with type 2 diabetes mellitus: a randomized controlled trial: the Italian Diabetes and Exercise Study (IDES). Arch Intern Med. 2010 Nov 8;170(20):1794-803.
Collaborators: Fallucca F, Pugliese G, Missori S, Ribaudo MC, Alessi E, Strollo F, Morè M, Alimonti P, Di Biase N, Lasaracina F, Santantonio G, Cruciani L, Manunta M, Di Mauro M, Sesti G, Irace C, Puccio L, Cignarelli M, Nicastro V, Piemontese S, Corigliano G, Rossi E, Corigliano M, De Feo P, Fatone C, Baggiore C, Russo R, Boemi M, Lanari L, Valentini U, Girelli A, Di Bartolo P, Pellicano F, Mazzuca P, Manicardi E, Bruno A, Sambataro M, Balducci S, Pontiroli A, Laneri M, Boggio A, Zagari N, Fernando F, Iacobini C, Menini S, Balducci G, Senigagliesi L, Spinelli E, Di Giovanni A, Pineda M, Pandolfo U, Giordano C, Settequattrini A, Gambacciani M, Fabrizi M, Ceccherini A, Balducci E, Quattrini M, Massarini M, Baggio G, Emilia R, Fornari M, Violi D, Cherubini G, Mastelloni F, Micali V, Cilano D, Di Luciano S, Canevari D. Diabetes Division, Sant'Andrea Hospital, Rome, Italy. Comment in: Arch Intern Med. 2010 Nov 8;170(20):1790-1.
Abstract
BACKGROUND: This study aimed to assess the efficacy of an intensive exercise intervention strategy in promoting physical activity (PA) and improving hemoglobin A(1c)(HbA(1c)) level and other modifiable cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM).
METHODS: Of 691 eligible sedentary patients with T2DM and the metabolic syndrome, 606 were enrolled in 22 outpatient diabetes clinics across Italy and randomized by center, age, and diabetes treatment to twice-a-week supervised aerobic and resistance training plus structured exercise counseling (exercise group) vs counseling alone (control group) for 12 months. End points included HbA(1c) level (primary) and other cardiovascular risk factors and coronary heart disease risk scores (secondary).
RESULTS: The mean (SD) volume of PA (metabolic equivalent hours per week) was significantly higher (P < .001) in the exercise (total PA [nonsupervised conditioning PA + supervised PA], 20.0 [0.9], and nonsupervised, 12.4 [7.4]) vs control (10.0 [8.7]) group. Compared with the control group, supervised exercise produced significant improvements (mean difference [95% confidence interval]) in physical fitness; HbA(1c) level (-0.30% [-0.49% to -0.10%]; P < .001); systolic (-4.2 mm Hg [-6.9 to -1.6 mm Hg]; P = .002) and diastolic (-1.7 mm Hg [-3.3 to -1.1 mm Hg]; P = .03) blood pressure; high-density lipoprotein (3.7 mg/dL [2.2 to 5.3 mg/dL]; P < .001) and low-density lipoprotein (-9.6 mg/dL [-15.9 to -3.3 mg/dL]; P = .003) cholesterol level; waist circumference (-3.6 cm [-4.4 to -2.9 cm]; P < .001); body mass index; insulin resistance; inflammation; and risk scores. These parameters improved only marginally in controls.
CONCLUSIONS: This exercise intervention strategy was effective in promoting PA and improving HbA(1c) and cardiovascular risk profile. Conversely, counselling alone, though successful in achieving the currently recommended amount of activity, was of limited efficacy on cardiovascular risk factors, suggesting the need for a larger volume of PA in these high-risk subjects. Trial Registration isrctn.org Identifier: ISRCTN04252749.
PMID: 21059972 [PubMed - indexed for MEDLINE]
8. Peris A, Zagli G, Bonizzoli M, Cianchi G, Ciapetti M, Spina R, Anichini V, Lapi F, Batacchi S. Implantation of 3951 long-term central venous catheters: performances, risk analysis, and patient comfort after ultrasound-guidance introduction. Anesth Analg. 2010 Nov;111(5):1194-201. Epub 2010 Sep 9.
Anesthesia and Intensive Care Unit of Emergency Department, Careggi Teaching Hospital, Florence, Italy.
Abstract
BACKGROUND: Despite evidence demonstrating improved safety with ultrasound-guided placement of central venous catheters (CVC) in comparison with the use of anatomical landmarks, ultrasound guidance is still not routinely used by all physicians when obtaining central venous access.
METHODS: We report data pertaining to the placement of long-term CVCs in a 7-year period before and after ultrasound guidance was introduced. We included 3951 procedures (total of 1,642,402 catheter days) in our study: 1584 using the anatomical landmark method (landmark group, January 2000 to May 2003), and 2367 with ultrasound guidance (ultrasound group, June 2003 to May 2007). All procedures were performed by the same team of intensivists. Comparison criteria included procedural data, complications, patient's comfort, and perceptions. Variables were analyzed with Student's t test and χ(2) test. Multivariate analysis was performed according to the Cox proportional hazards regression model.
RESULTS: Using ultrasound guidance, we noted a significant reduction in procedure time in both port (mean difference 4.9 ± 0.4 minutes, confidence interval [CI] 4.1 to 5.7) and tunneled catheter (mean difference 2.4 ± 0.8 minutes, CI 0.9 to 3.8) placement. The landmark method was associated with an increased risk of overall perioperative complications (4.5, CI 3.6 to 5.6). Among disease entities, acute leukemia patients had a significantly higher risk of CVC-related infections (2.6, CI 2.1 to 3.8). On the basis of questionnaires submitted to patients from both groups, ultrasound guidance was associated with improved patient comfort and satisfaction.
CONCLUSIONS: Ultrasound guidance reduces complications and improves patient comfort. Further studies are needed to define whether acute leukemia patients should be considered a separate category with regard to the higher incidence of infections.
PMID: 20829559 [PubMed - indexed for MEDLINE]
9. Fiorica F, Cartei F, Licata A, Enea M, Ursino S, Colosimo C, Cammà C. Can chemotherapy concomitantly delivered with radiotherapy improve survival of patients with resectable rectal cancer? A meta-analysis of literature data. Cancer Treat Rev. 2010 Nov;36(7):539-49. Epub 2010 Mar 23.
Radiotherapy Department, University Hospital S'Anna, Ferrara, Italy. francesco.fiorica@unife.it
Abstract
BACKGROUND: There is clear evidence from two systematic reviews that radiotherapy (RT) reduces the risk of local recurrence in patients with resectable rectal cancer, though the data on survival are still equivocal.
OBJECTIVE: To assess the effects of chemotherapy combined concomitantly with radiotherapy (CRT) on the increase of overall survival, and on the prevention of local recurrence and distant metastases.
DATA SOURCES: Computerized bibliographic searches of MEDLINE and CANCERLIT (1970-2008) were supplemented with hand searches of reference lists.
STUDY SELECTION: Studies were included if they were randomized controlled trials (RCTs) comparing preoperative or postoperative CRT to preoperative or postoperative RT alone, and if they included patients with resectable, histologically-proven, rectal adenocarcinoma without metastases. Thirteen RCTs, seven of preoperative CRT vs. preoperative RT (2787 patients), four of postoperative CRT vs. postoperative RT (726 patients) and two of postoperative CRT vs. preoperative RT (1400 patients), were analyzed.
DATA EXTRACTION: Data on population, intervention, and outcomes were extracted from each RCT, in accordance with the intention-to-treat method, by three independent observers, and combined using the DerSimonian method and Laird method.
RESULTS: Preoperative CRT compared to preoperative RT alone significantly reduces the 5-year local recurrence rate (RR 1.05; 95%CI 1.01-1.10). No increase was observed in 5-year overall survival rate (RR 0.94; 95%CI 0.94-1.09), and in the occurrence of distant metastases (RR 0.97; 95%CI 0.93-1.02). Instead, postoperative CRT did not reduce local recurrence (RR 0.96; 95%CI 0.80-1.16), distant metastases (RR 1.11; 95%CI 0.94-1.31) and overall mortality (RR 1.09; 95%CI 0.83-1.41). By pooling data on postoperative CRT vs. preoperative RT a significant reduction of local recurrence was found for the preoperative approach (RR 0.93; 95%CI 0.90-0.96), though no difference was found in distant metastases rates and overall survival. Finally, the risk of mortality related to toxic events was significantly higher when adding chemotherapy to radiotherapy (RR 2.86; 95%CI 0.99-8.26).
CONCLUSIONS: In patients with resectable rectal cancer, CRT does not increase overall survival, despite the fact that preoperative CRT significantly reduces the risk of the local recurrence. No reduction in the distant metastases rate was found. Toxicity-related mortality is significantly increased by the concomitant approach, emphasizing the need for safer treatment combinations.
PMID: 20334979 [PubMed - indexed for MEDLINE]
10. Mosca M, Tani C, Aringer M, Bombardieri S, Boumpas D, Cervera R, Doria A, Jayne D, Khamashta MA, Kuhn A, Gordon C, Petri M, Schneider M, Shoenfeld Y, Smolen JS, Talarico R, Tincani A, Ward MM, Werth VP, Carmona L. Development of quality indicators to evaluate the monitoring of SLE patients in routine clinical practice. Autoimmun Rev. 2011 Jan 9. [Epub ahead of print]
Rheumatology Unit, Department of Internal Medicine, University of Pisa, Pisa, Italy.
Abstract
The assessment of systemic lupus erythematosus (SLE) patients in routine clinical practice is mainly based on the experience of the treating physician. This carries the risk of unwanted variability. Variability may have an impact on the quality of care offered to SLE patients, thereby affecting outcomes. Recommendations represent systematically developed statements to help practitioners in reducing variability. However, major difficulties arise in the application of recommendations into clinical practice. In this respect, the use of quality indicators may raise the awareness among rheumatologists regarding potential deficiencies in services and improve the quality of health care. The aim of this study was to develop a set of quality indicators (QI) for SLE by translating into QIs the recently developed EULAR recommendations for monitoring SLE patients in routine clinical practice and observational studies. Eleven QIs have been developed referring to the use of validated activity and damage indices in routine clinical practice, general evaluation of drug toxicity, evaluation of comorbidities, eye evaluation, laboratory assessment, evaluation of the presence of chronic viral infections, documentation of vaccination and of antibody testing at baseline. A disease specific set of quality assessment tools should help physicians deliver high quality of care across populations. Routine updates will be needed.
11. Pucciarelli S, Del Bianco P, Efficace F, Serpentini S, Capirci C, De Paoli A, Amato A, Cuicchi D, Nitti D. Patient-reported outcomes after neoadjuvant chemoradiotherapy for rectal cancer: a multicenter prospective observational study. Ann Surg. 2011 Jan;253(1):71-7
Dipartimento di Scienze Oncologiche e Chirurgiche, Sezione di Clinica Chirurgica II, Università di Padova, Italy. puc@unipd.it
Abstract
OBJECTIVE: To prospectively describe patient-reported outcomes (PROs) after preoperative chemoradiotherapy (pCRT) for rectal cancer.
BACKGROUND: Little evidence is available on PROs after pCRT for rectal cancer.
PATIENTS AND METHODS: Patients with rectal cancer, candidates to receive pCRT, were enrolled in a multicenter prospective observational trial. Health-related quality of life was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and its colorectal cancer module (QLQ-CR38), and fecal incontinence and bowel function were evaluated using the fecal incontinence score questionnaire and a set of ad hoc questions. Questionnaires were filled out before CRT (t₀), 2 to 3 weeks after completion of CRT (t₁), and at 6 (t₂) and 12 months (t₃) after surgery. Primary analysis of selected scales included: global quality of life, physical functioning, social functioning, fatigue, body image, future prospective, and gender-related sexual problems.
RESULTS: Of 149 eligible patients, questionnaires were completed in 100%, 95%, 88% and 77% of cases at t0, t₁, t₂, and t₃, respectively. At t₃, 78% of patients reported stool fractionation and 72% sensation of incomplete defecation. Only 14% of patients had optimal continence. Physical/social functioning, fatigue, and body image showed a decrease just after pCRT and returned to baseline levels at 1 year after treatment. Global quality of life was stable over time. Male sexual problems were greatly impaired throughout the study period (P < 0.001) with major clinically meaningful changes between baseline and 1 year after treatment.
CONCLUSIONS: These findings add to the body of evidence available regarding pCRT and help clinicians to make more informed treatment decisions.
PMID: 21135694 [PubMed - in process]
12. Frigerio S, Di Giulio P, Gregori D, Gavetti D, Ballali S, Bagnato S, Guidi G, Foltran F, Renga G. Managing peripheral venous catheters: an investigation on the efficacy of a strategy for the implementation of evidence-based guidelines. J Eval Clin Pract. 2010 Nov 30. doi: 10.1111/j.1365-2753.2010.01590.x. [Epub ahead of print]
Research Nurse, Quality Office, CTO-CRF-M. Adelaide Hospital, Torino, Italy Associate Professor of Nursing Professor of Hygiene and Preventive Medicine, Department of Public Health and Microbiology, University of Torino, Torino, Italy Associate Professor of Biostatistics Affiliate Researcher Associate Researcher, Laboratories of Epidemiological Methods and Biostatistics, Department of Environmental Medicine and Publica Health, University of Padova, Italy Research Nurse Infection Control Nurse, CTO-CRF-M. Adelaide Hospital, Torino, Italy.
Abstract
Until now, the evaluation of the effectiveness of Rationale, aims and objectives guideline implementation in nursing and allied health professions has received relatively little attention. The aims of this study were (i) to describe the development process of guidelines concerning the management of peripheral venous catheters (PVCs) implemented in an Italian hospital; and (ii) to evaluate the effectiveness of guideline dissemination in terms of both clinical outcomes (signs of infection) and process outcomes (measures of appropriateness of PVC An observational study was conducted before and after the management). Methods adoption of a new protocol in the CTO-CRF-Maria Adelaide Hospital. Data from 306 PVCs (153 before and 153 after) were collected. For each PVC, a wide range of outcome measures was collected, including: data on fixation system type of dressing; visibility of the insertion site; registration of the insertion date; duration of catheter insertion; presence of connectors, taps and needles; and signs of infection. The effect of guideline implementation was evaluated using a logistic regression model to adjust for the confounding variable represented by The risk of using the nurses' average years of working experience. Results inappropriate dressing was significantly reduced [odds ratio (OR) 0.43; 95% confidence interval (CI) 0.27-0.70], while the use of transparent dressing Our study shows significant increased (OR 2.39; 95% CI 1.46-3.89). Conclusion improvement in practices relevant to the correct management of PVCs 2 months after guideline implementation. A second survey (after a minimum of 6 months) is necessary to assess persistence of improvement in clinical practices.
13. Marazzi G, Iellamo F, Volterrani M, Caminiti G, Madonna M, Arisi G, Massaro R, Righi D, Rosano GM. Comparison of effectiveness of carvedilol versus bisoprolol for prevention of postdischarge atrial fibrillation after coronary artery bypass grafting in patients with heart failure. Am J Cardiol. 2011 Jan 15;107(2):215-9. Epub 2010 Dec 2.
Center for Clinical and Basic Research, Department of Medical Sciences, Istituto di Ricovero e Cura a Carattere scientifico San Raffaele Pisana, Rome, Italy.
Abstract
Atrial fibrillation (AF) occurs frequently soon after coronary artery bypass grafting (CABG) and often results in increased mortality and morbidity, particularly in patients with heart failure. New-onset AF is also a common event in the early period after discharge from a cardiac surgery clinic. Current guidelines recommend β blockers as first-line medication for the prevention of AF after CABG. In this prospective study, we investigated the effectiveness of the highly selective β1 receptor antagonist bisoprolol compared to the less selective β blocker carvedilol in preventing postdischarge AF after CABG in patients with decreased left ventricular function. Three hundred twenty patients (231 men, 89 women, mean age 66 ± 10 years) with ejection fraction <40% who underwent CABG and were then referred to an in-hospital cardiac rehabilitation program were randomized to receive bisoprolol (n = 160) or carvedilol (n = 160) starting 4 to 5 days after surgery. Bisoprolol was started at 1.25 mg 1 time/day and carvedilol was started 3.125 mg 2 times/day. All patients underwent continuous telemetric electrocardiographic monitoring for 5 days after entry in the study and thereafter 2 times/day routinely up to hospital discharge. During follow-up, 23 patients (14.6%) in the bisoprolol group and 37 patients (23%) in the carvedilol group developed AF (relative risk 0.6, confidence interval 0.4 to 0.9, p = 0.032). Twenty-six percent of all AF episodes were asymptomatic. At the 4-week outpatient visit, those in the bisoprolol group showed a significantly greater decrease in heart rate, being in sinus rhythm or AF (-15.6 ± 3 vs -9.4 ± 3 beats/min, p = 0.021), whereas changes in systolic and diastolic blood pressures did not differ significantly. In conclusion, bisoprolol is more effective than carvedilol in decreasing the incidence of postdischarge AF after CABG in patients with decreased left ventricular function.
PMID: 21129714 [PubMed - in process]
14. Pizzi C, Rutjes AW, Costa GM, Fontana F, Mezzetti A, Manzoli L. Meta-Analysis of Selective Serotonin Reuptake Inhibitors in Patients With Depression and Coronary Heart Disease. Am J Cardiol. 2011 Jan 20. [Epub ahead of print]
Department of Internal Medicine, Aging and Nephrologic Diseases, University of Bologna, Italy.
Abstract
The occurrence of depression in patients with coronary heart disease (CHD) substantially increases the likelihood of a poorer cardiovascular prognosis. Although antidepressants are generally effective in decreasing depression, their use in patients with CHD is controversial. We carried out a meta-analysis to evaluate the health effects of selective serotonin reuptake inhibitors (SSRIs) versus placebo or no antidepressants in patients with CHD and depression. Observational studies and randomized controlled trials (RCTs) were searched in MEDLINE, EMBASE, PsycINFO, Cochrane Controlled Clinical Trial Register and other trial registries, and references of relevant articles. Primary outcomes were readmission for CHD (including myocardial infarction, unstable angina, and stroke) and all-cause mortality; the secondary outcome was severity of depression symptoms. Seven articles on 6 RCTs involving 2,461 participants were included. One study incorrectly randomized participants, and another was a reanalysis of RCT data. These were considered observational and analyzed separately. When only properly randomized trials were considered (n = 734 patients), patients on SSRIs showed no significant differences in mortality (risk ratio 0.39, 95% confidence interval 0.08 to 2.01) or CHD readmission rates (0.74, 0.44 to 1.23) compared to controls. Conversely, when all studies were included, SSRI use was associated with a significant decrease in CHD readmission (0.63, 0.46 to 0.86) and mortality rates (0.56, 0.35 to 0.88). A significantly greater improvement in depression symptoms was always apparent in patients on SSRIs with all selected indicators. In conclusion, in patients with CHD and depression, SSRI medication decreases depression symptoms and may improve CHD prognosis.
15. Gaia G, Holloway RW, Santoro L, Ahmad S, Di Silverio E, Spinillo A. Robotic-assisted hysterectomy for endometrial cancer compared with traditional laparoscopic and laparotomy approaches: a systematic review. Obstet Gynecol. 2010 Dec;116(6):1422-31.
Department of Obstetrics and Gynaecology, IRCCS-Fondazione Policlinico San Matteo and University of Pavia, Pavia, Italy.
Abstract
OBJECTIVE: To summarize comparative studies describing clinical outcomes of robotic-assisted surgeries compared with traditional laparoscopic or laparotomy techniques for the treatment of endometrial cancer.
DATA SOURCES: Using search words "robotic hysterectomy" and "endometrial cancer," 22 citations were identified from Medline and PubMed (2005 to February 2010).
METHODS OF STUDY SELECTION: We selected English language studies reporting at least 25 robotic cases compared with laparoscopic or laparotomy cases that also addressed surgical technique, complications, and perioperative outcomes. Patients underwent total hysterectomy, bilateral salpingo-oophorectomy, and lymphadenectomy.
TABULATION, INTEGRATION, AND RESULTS: Eight eligible comparative studies were identified that included 1,591 patients (robotic=589, laparoscopic=396, and laparotomy=606). Pooled means of the resected aortic lymph nodes for robotic hysterectomy and laparoscopy were 10.3 and 7.8 (P=.15), and robotic hysterectomy and laparotomy were 9.4 and 5.7 (P=.28). Pooled means of pelvic lymph nodes for robotic and laparoscopic hysterectomy were 18.5 and 17.8 (P=.95) and 18.0 compared with 14.5 (P=.11) for robotic hysterectomy compared with laparotomy. Estimated blood loss was reduced in robotic hysterectomy compared with laparotomy (P<.005) and laparoscopy (P=.001). Length of stay was shorter for both robotic and laparoscopic cases compared with laparotomy (P<.01). Operative time for robotic hysterectomy was similar to laparoscopic cases but was greater than laparotomy (P<.005). Conversion to laparotomy for laparoscopic hysterectomy was 9.9% compared with 4.9% for robotic cases (P=.06). Vascular, bowel, and bladder injuries; cuff dehiscence; and thromboembolic complications were similar for each surgical method. Transfusions for robotic hysterectomy compared with laparotomy was 1.7% and 7.2% (P=.06) and robotic hysterectomy compared were laparoscopy was 2.6% and 5.0% (P=.22).
CONCLUSION: Perioperative clinical outcomes for robotic and laparoscopic hysterectomy appear similar with the exception of less blood loss for robotic cases and longer operative times for robotic and laparoscopy cases.