rubrica

Comparabilità e valutazione dei servizi sanitari

  • Nerina Agabiti1

  • Marina Davoli1

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

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Ricerca bibliografica periodo 02 giugno 2011 – 01 agosto 2011

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Database: Pubmed/MEDline
Stringa: (((“Quality Indicators, Health Care"[Mesh] OR "Quality Assurance, Health Care"[Mesh] OR "Outcome Assessment (Health Care)" [Mesh:NoExp] OR Outcome* [tiab] OR “quality indicators” [tiab], OR appropriateness [tiab] OR indicator* [TIAB] OR procedure [TIAB] OR efficacy[tiab] OR effectiveness[tiab]) AND ("hospitals"[MeSH] OR hospital[tiab] OR mortality[tw] OR patient* [tiab]) AND (italy[mesh] OR ital* [tiab] OR ita [la] OR ital* [ad]) AND ("2011/06/02"[PDAT] : "2011/08/01"[PDAT])) NOT ((animals [mesh] NOT humans [mesh]) OR "Genetics"[Mesh] OR "Neurophysiology"[Mesh] "Drug Therapy"[Mesh] OR "Naturopathy"[Mesh] OR "drug therapy "[Subheading] OR Editorial[ptyp] OR "Case Reports "[Publication Type] OR Letter[ptyp] OR Clinical Trial, Phase I[ptyp] OR Clinical Trial, Phase II[ptyp]))

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1. Landolina M, Gasparini M, Lunati M, Iacopino S, Boriani G, Bonanno C, Vado A, Proclemer A, Capucci A, Zucchiatti C, Valsecchi S, Ricci RP, Santini M; Cardiovascular Centers Participating in the ClinicalService Project. Long-term complications related to biventricular defibrillator implantation: rate of surgical revisions and impact on survival: insights from the Italian Clinical Service Database. Circulation. 2011 Jun 7;123(22):2526-35. Epub 2011 May 16.
BACKGROUND:
Long-term data on device-related untoward events in patientsreceiving defibrillators for resynchronization therapy (CRT-D) are lacking. We quantified the frequency of repeat invasive procedures and the nature of long-term complications in current clinical practice and examined possible predictors of device-related events and their association with long-term patient outcome.
METHODS AND RESULTS:
We analyzed data from 3253 patients who underwent de novo successful implantation of CRT-D and were followed up for a median of 18 months (25th to 75th percentiles: 9 to 30) in 117 Italian centers. Device-related events were reported in 416 patients, and, specifically, surgical interventions for system revision were described in 390 patients. Four years after the implantation procedure, 50% of patients underwent surgical revision for battery depletion and 14% for unanticipated events. For comparison, at 4 years battery depletion occurred in 10% and 13% of patients who received single- and dual-chamber defibrillators at the study centers, and unanticipated events were reported as 4% and 9%, respectively. In CRT-D, infections occurred at a rate of 1.0%/y, and the risk of infections increased after device replacement procedures (hazard ratio, 2.04; 95% confidence interval, 1.01 to 4.09; P=0.045). Left ventricular lead dislodgements were reported at a rate of 2.3%/y and were predicted by longer fluoroscopy time and higher pacing threshold on implantation. Device-related events were not associated with a worse clinical outcome; indeed, the risk of death was similar in patients with and without surgical revision (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.47; P=0.682).
CONCLUSIONS:
In current clinical practice device-related events are more frequentin CRT-D than in single- or dual-chamber defibrillators, and are frequently managed by surgical intervention for system revision. However, a worse clinical outcome is not associated with these events.
CLINICAL TRIAL REGISTRATION:
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01007474.

Commento a cura di Nerina Agabiti
L’introduzione di nuove tecniche per la diagnosi e la terapia di molte condizioni - spesso molto sofisticate e costose – pone il problema della valutazione di costo e beneficio. La terapia di resincronizzazione cardiaca (CRT) da sola o associata all’impianto defibrillatore per cardioversione (“implantable cardioverter-defibrillator”) (CRT-D) è ormai una diffusa procedura per la cura dello scompenso cardiaco sintomatico e dei disturbi della contrattilità ventricolare. Sebbene siano stati già descritti gli eventi avversi peri-procedurali e le complicanze precoci della CRT-D, dati sull’impatto a lungo termine sono limitati. In questo studio di Landolina et al., pubblicato recentemente su Circulation, sono stati arruolati in 117 centri clinici italiani 3253 pazienti sottoposti a CRT-D, per quantificare l’incidenza di successive ripetute procedure invasive e di eventi avversi a lungo termine nella pratica clinica, ed analizzare i fattori associati. A quattro anni di distanza dall’impianto, il 50% dei pazienti con CRT-D sono sottoposti a nuovo intervento chirurgico di revisione per scaricamento della batteria e 14% per eventi avversi, quali infezioni correlate al device o dislocazione del catetere. Come confronto, nell’arco dei 4 anni di follow up, la revisione chirurgica per scaricamento della batteria è avvenuta nel 10% e nel 13% dei pazienti che avevano invece ricevuto defibrillatore monocamerale o bicamerale; eventi avversi sono occorsi rispettivamente nel 4% e 9% rispettivamente. Overall, il tasso di infezioni è pari a 1.0%/anno ed il tasso di dislocazione del catetere è di 2.3%/ anno. Tutti questi eventi correlati al funzionamento del device non si associano ad un aumentato rischio di morte nel periodo in studio. In sintesi, questo studio suggerisce che nella pratica clinica corrente complicazioni correlate all’impianto sono più frequenti nella CRT-D che nel caso di defibrillatore monocamerale o bicamerale, e frequentemente richiedono intervento chirurgico per revisione dell’impianto. Si tratta di una informazione molto importante perché, sebbene queste complicanze non si riflettano su un aumentato rischio di morte, sono fonte di costi aggiuntivi per il sistema sanitario.

2. Ballarin R, Cucchetti A, Spaggiari M, Montalti R, Di Benedetto F, Nadalin S, Troisi RI, Valmasoni M, Longo C, De Ruvo N, Cautero N, Cillo U, Pinna AD, Burra P, Gerunda GE. Long-term follow-up and outcome of liver transplantation from anti-hepatitis C virus-positive donors: a European multicentric case-control study. Transplantation. 2011 Jun 15;91(11):1265-72.

BACKGROUND:
The growing prevalence of hepatitis C virus (HCV) infection in the general population has resulted in an increased frequency of potential organ donors that carry the virus. Given the significant disparity between organ supply and demand for transplantation, it becomes essential to consider whether livers from anti-HCV-positive donors may be considered suitable for transplantation.
METHODS:
Based on a multicenter European database, 694 patients with HCV-related cirrhosis underwent liver transplantation and 11% of them received the graft from anti-HCV-positive donors. Of this group, we selected 63 patients (study group) and, after a 1:1 case-control approach, compared them with 63 patients that received an anti-HCV-negative donor graft (control group). Only grafts with preperfusion liver biopsy results with a fibrosis score of not more than 1 were used for transplantation.
RESULTS:
Patients who received anti-HCV-positive grafts had a cumulative survival rate of 83.6% and 61.7% at 1 and 5 years, respectively, vs. 95.1% and 68.2% for the control group. In comparing overall patient and graft survival, there was no statistically significant difference between the two groups (P=0.22 and 0.11). Recurrence of hepatitis C tended to be more rapid in the group of patients who received anti-HCV-positive grafts, although it did not reach statistical significance (P=0.07).
CONCLUSIONS:
We do not recommend the indiscriminate use of anti-HCV-positive donors, especially if HCV-RNA positive, as the use of this kind of graft could be linked to an advanced stage of fibrosis, the main risk factor we observed for earlier hepatitis C recurrence.

3. Villa E, Magnoni MS, Micheli D, Canonica GW. A review of the use of fluticasone furoate since its launch. Expert Opin Pharmacother. 2011 Sep;12(13):2107-17. Epub 2011 Jul 29.
Introduction:
Fluticasone furoate (FF) is the latest glucocorticoid officially approved for the treatment of allergic rhinitis. FF has shown the highest affinity and selectivity for the glucocorticoid receptors as well the longest tissue retention compared with other available intranasal steroids; these new pharmacologic characteristics provide the basis for its potent and prolonged anti-inflammatory activity at the target site.
Areas covered:
A literature review achieved through PubMed and Medline research methods supports the clinical efficacy of FF versus placebo in reducing ocular and nasal symptoms related to allergic rhinitis (at the recommended starting doses of 110 μg once daily for adults and adolescents and 55 μg once daily for children), with a good safety profile. Moreover, the present review also compares FF with other intranasal steroids: FF represents a molecular evolution of fluticasone propionate (FP), and there is scientific evidence of therapeutic advantages over FP.
Expert opinion:
Fluticasone furoate is a promising molecule in the treatment of allergic rhinitis as it fits fully all the official guidelines' criteria. It is now being considered as a topical steroid that is quite close to the ideal pharmacological model for glucocorticoids due to its satisfying safety/tolerability profile, both in adults and children, leads FF to be considered as a topical steroid that is quite close to the ideal pharmacologic model for glucocorticoids. More studies should be directed to assess the improvement of quality of life in subjects with allergic rhinitis treated with FF, in comparison with other intranasal steroids and even H1-antihistamines; in addition, it could be also interesting to analyze eventual, additional effects of FF in patients with bronchial asthma, which is frequently associated with allergic rhinitis.
4. De Felice F, Fiorilli R, Parma A, Musto C, Nazzaro MS, Confessore P, Scappaticci M, Cifarelli A, Violini R. Comparison of One-Year Outcome of Patients Aged <75 Years Versus ≥75 Years Undergoing "Rescue" Percutaneous Coronary Intervention. Am J Cardiol. 2011 Jul 24. [Epub ahead of print].
Abstract:
The influence of age on the clinical results after rescue angioplasty (percutaneous coronary intervention [PCI]) has been poorly investigated. In the present study, we evaluated the outcome of 514 consecutive patients undergoing rescue PCI who were divided into 2 groups according to age: <75 years (n = 469) and ≥75 years (n = 45). The primary end point of the study was the incidence of death at 1 year of follow-up. The secondary end point was the 1-year incidence of major cardiac adverse events (MACE) defined as a composite of death, recurrent acute myocardial infarction, and target vessel revascularization. The predictors of death and MACE at 1 year were also investigated. At 1 year of follow-up, the <75-year-old group had a significantly lower incidence of death (7% vs 24%, p = 0.0001) and MACE (14% vs 28%, p = 0.01) compared to the ≥75-year-old group. The Cox proportional hazards model identified age (adjusted hazard ratio 0.2665, 95% confidence interval 0.1285 to 0.5524, p = 0.0004), cardiogenic shock (hazard ratio 0.1057, 95% confidence interval 0.0528 to 0.2117, p <0.000001), Thrombolysis In Myocardial Infarction flow grade 2 to 3 after PCI versus 0 to 1 (hazard ratio 3.8380, 95% confidence interval 1.7781 to 8.2843, p = 0.0006), multi- versus single-vessel disease (hazard ratio 0.3716, 95% confidence interval 0.1896 to 0.7284, p = 0.0039) as independent predictors of survival at 1 year of follow-up. In conclusion, at 1 year of follow-up after rescue PCI, the patients aged ≥75 years had a greater incidence of death and MACE compared to patients aged <75 years. Age, cardiogenic shock, Thrombolysis In Myocardial Infarction flow grade 0-1 after PCI, and multivessel coronary disease were predictors of survival and freedom from MACE at 1 year of follow-up.
5. Nava MB, Pennati AE, Lozza L, Spano A, Zambetti M, Catanuto G. Outcome of different timings of radiotherapy in implant-based breast reconstructions. Plast Reconstr Surg. 2011 Aug;128(2):353-9.
BACKGROUND:
The therapeutic role of postmastectomy radiation therapy has been demonstrated both in locally advanced breast cancer and in other high-risk conditions. Implant-based breast reconstruction for irradiated patients can generate higher complication rates. In this study, the authors observed the effects of radiation on temporary expanders and permanent implants. The estimate of the totally failed reconstruction rate was the principal endpoint of this study. Capsular contracture rates and patients' and surgeons' subjective evaluations were the secondary endpoints.
METHODS:
Two hundred fifty-seven patients were consecutively involved in this study. The population was stratified into two groups: group 1, postmastectomy radiation therapy on permanent implants (n = 109 patients); and group 2, postmastectomy radiation therapy on tissue expanders (n = 50 patients). A nonirradiated control group made up of 98 patients was selected randomly. All patients underwent a two-stage immediate breast reconstruction with subpectoral temporary expanders and permanent implants.
RESULTS:
The totally failed reconstruction rate was significantly higher in group 2, with 40 percent of unsuccessful reconstructions compared with 6.4 percent in group 1 and 2.3 percent in the control group (p < 0.0001). The capsular contracture rate was significantly higher for groups 1 and 2 compared with the control group. The shape and symmetry assessment and the patients' opinions demonstrated a higher incidence of good results in group 1 in comparison with group 2. The best scores were always obtained by the control group.
CONCLUSION:
This study demonstrated that radiotherapy during tissue expansion may compromise the outcome of implant-based breast reconstruction.
CLINICAL QUESTION/LEVEL OF EVIDENCE:
Therapeutic, II.(Figure is included in full-text article.).
6. Giraldi F, Cattadori G, Roberto M, Carbucicchio C, Pepi M, Ballerini G, Alamanni F, Della Bella P, Pontone G, Andreini D, Tondo C, Agostoni PG. Long-term effectiveness of cardiac resynchronization therapy in heart failure patients with unfavorable cardiac veins anatomy comparison of surgical versus hemodynamic procedure. J Am Coll Cardiol. 2011 Jul 26;58(5):483-90.
OBJECTIVES:
This study sought to compare clinical, echocardiographic, and cardiopulmonary exercise testing response to cardiac resynchronization therapy (CRT) in patients with unfavorable anatomy of coronary sinus (CS) veins, randomized to transvenous versus surgical left ventricular (LV) lead implantation.
BACKGROUND:
CRT efficacy depends on proper positioning of the LV lead over the posterolateral wall. A detailed pre-operative knowledge of CS anatomy might be of pivotal importance to accomplish a proper LV lead placement over this area.
METHODS:
Study population included 40 patients (age 66 ± 4 years) with heart failure and indication to CRT, with unsuitable CS branches anatomy documented by pre-operative multislice computed cardiac tomography; 20 patients (Group 1) underwent surgical minithoracotomic LV lead implantation whereas 20 (Group 2) were implanted transvenously. New York Heart Association functional class, echocardiographic, and cardiopulmonary exercise testing data were assessed before and 1 year after CRT-system implant.
RESULTS:
In all Group 1 patients, the LV leads were placed over the middle-basal segments of the posterolateral wall of the LV. This was not possible in Group 2 patients. One year after CRT, in Group 1, a significant improvement of New York Heart Association functional class, LV ejection fraction (from 28.8 ± 9.2% to 33.9 ± 7.2%, p < 0.01), LV end-systolic volume (from 165 ± 53 ml to 134 ± 48 ml, p < 0.001), and peak Vo(2)/kg (from 10.4 ± 4.5 ml/kg/min to 13.1 ± 3.1 ml/kg/min, p < 0.02) was observed. However, no improvement was observed in Group 2: LV ejection fraction varied from 27.4 ± 4.8% to 27.4 ± 5.7% (p = 0.9), LV end-systolic volume from 175 ± 46 ml to 166 ± 44 ml (p = 0.15), and peak Vo(2)/kg from 11.2 ± 3.2 ml/kg/min to 11.3 ± 3.4 ml/kg/min (p = 0.9). Changes after CRT between groups were highly significant.
CONCLUSIONS:
In the setting of unfavorable CS branches of anatomy, CRT by a surgical minithoracotomic approach is preferable to transvenous lead implantation.

QUESTO QUI

7. Galassi AR, Tomasello SD, Reifart N, Werner GS, Sianos G, Bonnier H, Sievert H, Ehladad S, Bufe A, Shofer J, Gershlick A, Hildick-Smith D, Escaned J, Erglis A, Sheiban I, Thuesen L, Serra A, Christiansen E, Buettner A, Costanzo L, Barrano G, Di Mario C. In-hospital outcomes of percutaneous coronary intervention in patients with chronic total occlusion: insights from the ERCTO (European Registry of Chronic Total Occlusion) registry. EuroIntervention. 2011 Aug;7(4):472-9. doi: 10.4244/EIJV7I4A77.
Aims:
In comparison with non-occlusive lesions, percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) represents a greater challenge for the interventionalist, due to lower procedural success rates, relatively higher incidence of procedural complications and the increased rate of restenosis. The European Registry of Chronic Total Occlusion (ERCTO) was created with the goal of evaluating the real impact of CTO PCI in the European context, trying to analyse the rates of procedural success, technical information from the CTO procedures and patient outcome.
Methods and results:
Data collection was carried out in 16 centres across Europe, starting from the beginning of January 2008. In two years of activity, a total of 1,914 patients with 1,983 CTO lesions were consecutively enrolled in the registry. Overall procedural success was achieved in 1,607 lesions (82.9%); anterograde procedures obtained higher procedural success of retrograde ones (83.2% versus 64.5%, p<0.001). Coronary perforation occurred more frequently in patients who underwent retrograde approach (4.7% versus 2.1%, p=0.04). Although no differences were observed in terms of 30-day major adverse cardiac events between anterograde and retrograde treated patients, a trend toward higher periprocedural non-Q-wave myocardial infarction was found in patients in which the retrograde approach was attempted (2.1% versus 1% p=0.08). Moreover, retrograde approach was related with longer procedural and fluoroscopy times (156.9±62.5 min vs. 98.2±52.8 min and 73.3±59.9 min vs. 38.2±43.9 min respectively, p<0.001) and higher contrast load administration (402±161 cc vs. 302±184 cc, p<0.001).
Conclusions:
The first report of the ERCTO registry by the EuroCTO club shows a high procedural success rate obtained by expert European operators in a "real-world" consecutive series of patients, comparable with those reported by Japanese registries. The rate of observed procedural adverse events was low and similar to the non-CTO PCI series. In this registry, retrograde procedures were associated with extended fluoroscopy exposure and procedural time, increased contrast load administration as well as a higher incidence of coronary perforations. Such outcomes should become the standard of care that all centres undertaking CTO PCI should aspire to.
8. Bertani E, Chiappa A, Biffi R, Bianchi PP, Radice D, Branchi V, Cenderelli E, Vetrano I, Cenciarelli S, Andreoni B. Assessing appropriateness for elective colorectal cancer surgery: clinical, oncological, and quality-of-life short-term outcomes employing different treatment approaches. Int J Colorectal Dis. 2011 Jul 13. [Epub ahead of print].
PURPOSE:
In recent years, colorectal cancer surgery has benefitted from new techniques such as laparoscopy and robotic surgery. However, many treatment disparities exist among different centers for patients affected by the same kind of tumors.
METHODS:
Forty-five (41%) open (OCO) vs. 30 (28%) laparoscopic (LCO) vs. 34 (31%) robotic-assisted (RCO) colectomies and 34 (40%) open (ORR) vs. 52 (60%) robotic (ROR) rectal resections performed during a 15-month period, in elective setting, were compared. Patients presenting contraindications for minimally invasive procedures were excluded from the study, so that all the enrolled patients were suitable for either of the surgical procedures.
RESULTS:
Overall morbidity rates were similar among groups. Perioperative mortality was nil. No significant differences were noted as for total number of lymph nodes harvested between arms. Mean time (days) to first bowel movement to gas was 3.3 vs. 2.3 vs. 2.6 for OCO, LCO, and RCO, respectively (p < 0.001), and 3.3 vs. 2.0 for ORR and ROR, respectively (p = 0.003). Among several European Organization in Research and Treatment of Cancer QLQ-C30 functional scales considered only physical functioning was significantly better at 30 days for RCO vs. OCO (96.3 ± 10 RCO vs. 85.5 ± 12.6 OCO; p = 0.015). Robotic surgery was much more expensive in comparison to open as well as laparoscopic procedures.
CONCLUSIONS:
Laparoscopic and robotic surgeries for colorectal cancer present both the same advantages in comparison to open procedures in terms of faster recovery. However, our data do not seem to support the routine use of RCO as a cost-effective procedure.

Commento a cura di Nerina Agabiti
Negli ultimi anni, la chirurgia del cancro colon rettale si è arricchita di nuove tecniche quali la laparoscopia e la chirurgia robotica. Mancano dati sulla valutazione costo-efficacia e ci sono evidenze di disparità tra centri nel trattamento dei pazienti affetti dalla stessa tipologia di tumore. In Int J Colorectal Dis Bertani et al è presentato uno studio osservazionale prospettico di coorte in cui sono stati arruolati 195 pazienti consecutivi in un periodo di 15 mesi presso l’Istituto Europeo Oncologico di Milano (periodo 2009-2010) operati in elezione di chirurgia per tumore del colon retto. Sono confrontate diverse tecniche chirurgiche: 41% colectomie aperte (OCO), 28% colectomie laparoscopiche (LCO), 31% colectomie robotiche (RCO), 40% resezioni rettali aperte (ORR), 60% resezioni rettali robotiche (ROR). Sono stati esclusi dallo studio i pazienti che presentavano controindicazioni per le procedure mini-invasive. Sono stati raccolti dettagli sulle caratteristiche cliniche ed istopatologiche del tumore, sulle tecniche chirurgiche e su diversi esiti: mortalità perioperatoria, re-intervento dopo 30 giorni, degenza postoperatoria, sanguinamento intraopertorio, trasfusioni di sangue peri-operatorie, complicanze totali, deiescenza della ferita, infezione della ferita, ascesso intra-addominale, tempo per la ripresa della funzione digestiva e dell’alimentazione solida. E’ stata inoltre valutata la qualità della vita con metodologie sviluppate nell’ambito di un progetto europeo (European Organization for Research and Treatment of Cancer). Non sono state differenze significative per la maggior parte degli esiti clinici. La tecnica laparoscopica si associa a tempi ridotti per la ripresa della funzione addominale e di degenza post-operatoria. La ripresa fisica generale è risultata significativamente migliore a 30 giorni per la tecnica robotica verso la chirurgia aperta. Per quanto riguarda i costi, la tecnica robotica è risultata più costosa rispetto alle altre due tipologie. Questo studio contribuisce al dibattito sulla valutazione costo-efficacia delle tecniche chirurgiche nell’area della chirurgia del tumore colon rettale. Si conclude che gli interventi laparoscopici e robotici per il cancro colon rettale presentano entrambi gli stessi vantaggi rispetto agli interventi aperti e si associano ad un recupero funzionale più veloce; i risultati non sembrano, tuttavia, supportare l’uso routinario delle tecniche robotiche.

9. Angelo C, Vittorio M, Anna M, Antonio P. Cost-effectiveness of treating first-episode psychosis: five-year follow-up results from an Italian early intervention programme. Early Interv Psychiatry. 2011 Aug;5(3):203-11. doi: 10.1111/j.1751-7893.2011.00261.x. Epub 2011 Jul 6.
Aim:
Early intervention programmes are expected to result in the reduction of illness severity in patients with schizophrenia, and contain health-care costs by reducing hospital admissions and improving the social functioning of patients. This study aimed to investigate the cost-effectiveness of treatment in an early intervention programme in comparison to standard care.
Methods:
Retrospective analysis of data prospectively recorded in an urban area (Milan, Italy). Twenty-three patients from an early intervention programme and 23 patients from standard care with first-episode psychosis were evaluated on their use of services over a 5-year period. The Health of the Nation Outcome Scale was used to measure clinical status.
Results:
Significant changes with respect to initial assessment were recorded on the Health of the Nation Outcome Scale, with larger effect sizes in the early intervention programme than in the standard care group. Consequently, the cost-effectiveness ratio per reduced score of severity was lower in the early intervention programme than in standard care (€ 4802 vs. € 9871), with an incremental cost-effectiveness ratio, or net saving of €-1204 for every incremental reduced score of severity. Over time, greater recourse to hospital and residential facilities to obtain comparable improvement in symptoms resulted in a steady cost increase for the patients in standard care.
Conclusions:
Allocation of funds to specialized early intervention programmes is the best alternative, as it can save costs by reducing the use of hospitals and residential facilities, and may produce net savings of costs in the long term.
10. Rampinelli C, Bellomi M, Ivaldi GB, Intra M, Raimondi S, Meroni S, Orecchia R, Veronesi U. Assessment of Pulmonary Fibrosis after Radiotherapy (RT) in Breast Conserving Surgery: Comparison between Conventional External Beam RT (EBRT) and Intraoperative RT with Electrons (ELIOT). Technol Cancer Res Treat. 2011 Aug;10(4):323-9.
Abstract:
The aim of this study was to assess the frequency and the grade of RT-induced pulmonary fibrosis in patients who underwent EBRT compared to patients who underwent ELIOT. One-hundred-seventy-eight patients enrolled in a prospective randomized phase III trial to compare the efficacy of ELIOT (a single dose of 21 Gy prescribed at the 90% isodose) versus EBRT (50 Gy to the whole breast plus a 10 Gy boost to the tumour bed), underwent a spiral 16-detector row Computed Tomography (CT) examination to assess RT-induced pulmonary fibrosis: 83 patients in the EBRT arm and 95 in the ELIOT arm. All patients (age range 48-75 years) were affected by unicentric infiltrating carcinoma of the breast with diameter < 2.5 cm. This study was approved by our Institutional Ethical Committee and informed consent was obtained from each patient. Two observers, blinded to patient's randomization, independently evaluated each CT examination and assigned a fibrosis score (Grades 0 to 3). Inter-observer agreement for the fibrosis score was evaluated and a consensus between observers was obtained. Differences in fibrosis score between the two arms were evaluated by Chi Square test and Odds Ratio (OR) with 95% Confidence Intervals (CI). Pulmonary fibrosis was diagnosed in 42 patients (23.6%): 38 (90%) were in the EBRT arm and 4 (10%) in the ELIOT arm (p < 0.0001); twenty-six of them were Grade 1 (one ELIOT), fifteen were Grade 2 (three ELIOT) and one was Grade 3. The post-radiotherapy risk in the EBRT arm to develop at least Grade 1 fibrosis was 19 times higher than in the ELIOT one (OR: 19.20; 95%CI: 6.46-57.14) and 6 times higher to develop at least Grade 2 (OR: 5.70; 95%CI: 1.56-20.76). In conclusion, CT detected pulmonary fibrosis in patients treated with ELIOT is significantly less frequent compared to patients treated with EBRT.
11. Pigni A, Brunelli C, Caraceni A. The role of hydromorphone in cancer pain treatment: a systematic review. Palliat Med. 2011 Jul;25(5):471-7.
Abstract:
The aim of this systematic review is to evaluate the scientific evidence for the efficacy and side effects of hydromorphone in the management of moderate to severe cancer pain. Randomized and non-randomized clinical trials, reporting data on efficacy and/or side effects of hydromorphone, were identified. Thirteen eligible studies, involving 1208 patients, were selected. Seven studies compared hydromorphone with other opioids (five with morphine, one with oxycodone and one with fentanyl and buprenorphine) and five of them were randomized controlled trials (RCTs). Most of the studies were conducted on patients already receiving opioid treatment, often at stabilized doses, and most had methodological limitations. The RCTs comparing hydromorphone with morphine and oxycodone showed similar analgesic results, while the comparison of side effects showed minor differences, not consistent across studies. Due to clinical and methodological heterogeneity of the studies, a meta-analysis was not performed. In conclusion there is evidence to support the efficacy and tolerability of hydromorphone for moderate to severe cancer pain as an alternative to morphine and oxycodone, while there is no evidence to demonstrate its superiority or inferiority in comparison with morphine as the first choice opioid for the same indication.
12. Gridelli C, Bennouna J, de Castro J, Dingemans AM, Griesinger F, Grossi F, Rossi A, Thatcher N, Wong EK, Langer C. Randomized Phase IIIb Trial Evaluating the Continuation of Bevacizumab Beyond Disease Progression in Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer after First-Line Treatment with Bevacizumab Plus Platinum-Based Chemotherapy: Treatment Rationale and Protocol Dynamics of the AvaALL (MO22097) Trial. Clin Lung Cancer. 2011 Jun 24. [Epub ahead of print]
Abstract:
We present the treatment rationale and study design of the AvaALL (MO22097; ClinicalTrials: NCT01351415) trial, a multicenter, open-label, randomized, two-arm, phase IIIb study. Patients with advanced non-squamous non-small-cell lung cancer (NSCLC) whose disease has progressed after four to six cycles of first-line treatment with bevacizumab plus a platinum-based doublet and a minimum of two cycles of bevacizumab (monotherapy) maintenance treatment will be randomized in a 1:1 ratio to one of two study arms. Patients treated on arm A will receive bevacizumab 7.5 or 15 mg/kg intravenously (I.V.) on day 1, every 21 days plus, investigator's choice of agents indicated for use in second-line (limited to pemetrexed, docetaxel, or erlotinib) and subsequent lines of treatment. Patients treated on arm B, will receive investigator's choice of agents alone indicated for use in second-line and subsequent lines of treatment, but no further bevacizumab treatment. The primary endpoint of this study is overall survival (OS). Secondary endpoints include the 6-month, 12-month, and 18-month OS rates, progression-free survival, and time to progression at second and third progressive disease (PD), response rate, disease control rates, and duration of response at second and third PD. Additionally, efficacy in the subgroup of patients with adenocarcinoma, and the safety of bevacizumab treatment across multiple lines of treatment will be assessed. Exploratory objectives include assessment of the quality of life through multiple lines of treatment, comparison of the efficacy between Asian and non-Asian patients, and correlation of biomarkers with efficacy outcomes, disease response, and adverse events.
13. Caggegi A, Capodanno D, Capranzano P, Chisari A, Ministeri M, Mangiameli A, Ronsivalle G, Ricca G, Barrano G, Monaco S, Di Salvo ME, Tamburino C. Comparison of One-Year Outcomes of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Unprotected Left Main Coronary Artery Disease and Acute Coronary Syndromes (from the CUSTOMIZE Registry). Am J Cardiol. 2011 Aug 1;108(3):355-9. Epub 2011 May 3.
Abstract:
ncertainty surrounds the optimal revascularization strategy for patients with left main coronary artery disease presenting with acute coronary syndromes (ACSs), and adequately sized specific comparisons of percutaneous and surgical revascularization in this scenario are lacking. The aim of this study was to evaluate the incidence of 1-year major adverse cardiac events (MACEs) in patients with left main coronary artery disease and ACS treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation or coronary artery bypass grafting (CABG). A total of 583 patients were included. At 1 year, MACEs were significantly higher in patients treated with PCI (n = 222) compared to those treated with CABG (n = 361, 14.4% vs 5.3%, p <0.001), driven by a higher rate of target lesion revascularization (8.1% vs 1.7%, p = 0.001). This finding was consistent after statistical adjustment for MACEs (adjusted hazard ratio [HR] 2.7, 95% confidence interval [CI] 1.2 to 5.9, p = 0.01) and target lesion revascularization (adjusted HR 8.0, 95% CI 2.2 to 28.7, p = 0.001). No statistically significant differences between PCI and CABG were noted for death (adjusted HR 1.1, 95% CI 0.4 to 3.0, p = 0.81) and myocardial infarction (adjusted HR 4.8, 95% CI 0.3 to 68.6, p = 0.25). No interaction between clinical presentation (ST-segment elevation myocardial infarction or unstable angina/non-ST-segment elevation myocardial infarction) and treatment (PCI or CABG) was observed (p for interaction = 0.68). In conclusion, in patients with left main coronary artery disease and ACS, PCI is associated with similar safety compared to CABG but higher risk of MACEs driven by increased risk of repeat revascularization.
14. De Nunzio C, Kramer G, Marberger M, Montironi R, Nelson W, Schröder F, Sciarra A, Tubaro A. The controversial relationship between benign prostatic hyperplasia and prostate cancer: the role of inflammation. Eur Urol. 2011 Jul;60(1):106-17. Epub 2011 Apr 9.
CONTEXT:
Prostate cancer (PCa) is the most common cancer in the adult male, and benign prostatic hyperplasia (BPH) represents the most frequent urologic diagnosis in elderly males. Recent data suggest that prostatic inflammation is involved in the pathogenesis and progression of both conditions.
OBJECTIVE:
This review aims to evaluate the available evidence on the role of prostatic inflammation as a possible common denominator of BPH and PCa and to discuss its possible clinical implication for the management, prevention, and treatment of both diseases.
EVIDENCE ACQUISITION:
The National Library of Medicine Database was searched for the following Patient population, Intervention, Comparison, Outcome (PICO) terms: male, inflammation, benign prostatic hyperplasia, prostate cancer, diagnosis, progression, prognosis, treatment, and prevention. Basic and clinical studies published in the past 10 yr were reviewed. Additional references were obtained from the reference list of full-text manuscripts.
EVIDENCE SYNTHESIS:
The histologic signature of chronic inflammation is a common finding in benign and malignant prostate tissue. The inflammatory infiltrates are mainly represented by CD3(+) T lymphocytes (70-80%, mostly CD4), CD19 or CD20 B lymphocytes (10-15%), and macrophages (15%). Bacterial infections, urine reflux, dietary factors, hormones, and autoimmune response have been considered to cause inflammation in the prostate. From a pathophysiologic standpoint, tissue damage associated with inflammatory response and subsequent chronic tissue healing may result in the development of BPH nodules and proliferative inflammatory atrophy (PIA). The loss of glutathione S-transferase P1 (GSTP1) may be responsible in patients with genetic predisposition for the transition of PIA into high-grade intraepithelial neoplasia (HGPIN) and PCa. Although there is growing evidence of the association among inflammatory response, BPH, and PCa, we can only surmise on the immunologic mechanisms involved, and further research is required to better understand the role of prostatic inflammation in the initiation of BPH and PCa. There is not yet proof that targeting prostate inflammation with a pharmacologic agent results in a lower incidence and progression or regression of either BPH or PCa.
CONCLUSIONS:
Evidence in the peer-reviewed literature suggested that chronic prostatic inflammation may be involved in the development and progression of chronic prostatic disease, such as BPH and PCa, although there is still no evidence of a causal relation. Inflammation should be considered a new domain in basic and clinical research in patients with BPH and PCa.
15. Papalia R, Del Buono A, Osti L, Denaro V, Maffulli N. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. Br Med Bull. 2011 Jun 22. [Epub ahead of print].
Department of Orthopaedic and Trauma Surgery, Campus Biomedico University of Rome, Via Alvaro del Portillo, Rome, Italy.ABSTRACT:
Introduction:
This review defines the recognized risk factors responsible for the development of knee osteoarthritis after surgical management of meniscal tears. Sources of data We performed a literature search using Medline, Ovid, Cochrane and Google Scholar using the keywords: 'Meniscal tears', 'meniscectomy', 'osteoarthritis', 'complications' and 'risk factors'. Thirty-two published studies were identified.
Areas of agreement
In the long term, osteoarthritis develops in the knee of patients undergoing surgery for meniscal tears. The Coleman methodology score showed great heterogeneity in terms of patient characteristics and outcome assessment. Amount of meniscus removed, duration of pre-operative symptoms and lateral meniscectomy show strong statistical association to onset of knee osteoarthritis. Areas of controversy:
We did not find univocal findings defining the risk factors responsible for the development of post-operative knee osteoarthritis.
Growing points
There is a need for standardized clinical and imaging validated scale to improve definition of post-operative knee osteoarthritis to allow easier and more reliable comparison of outcomes in different studies. Areas timely for developing research Appropriately powered randomized controlled trials reporting clinical and imaging-related outcomes in patients undergoing arthroscopic minimally invasive procedures and meniscal suturing should be performed. Comparing imaging findings of patients undergoing arthroscopic partial and open meniscectomy, a lower incidence of knee osteoarthritic evolution was detected after arthroscopy. The amount of removed meniscus is the most important predictor factor for the development of osteoarthritis. Minimally invasive procedures seem to reduce the incidence of long-term osteoarthritic changes of the knee compared with more invasive open and or arthroscopic procedures.

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