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After more than 10 years of development, two different views of practice guidelines are emerging: either as an educational tool for the medical profession, or as a forum where health care issues can be debated by physicians and non-medical groups. Physicians use practice guidelines in the former model to set their own standards of good quality care, while the latter approach needs contributions from other components in order to decide what should be provided by our health care systems. In a survey of Italian physicians' opinions and attitudes toward practice guidelines, responders supported the “narrowest” model. More than 80% stated that improvement of quality of care and reduction of variation in clinical practice styles should be the aim of practice guidelines, without representatives from outside the medical profession being involved (61%, 79% and 86% disagreed with a possible involvement, respectively, of patients, health care administrators and representatives of the public at large). Overall, 38% of physicians had a positive attitude toward guidelines viewed as a quality assurance tool for the medical profession. Overall, physicians seem to ignore that the need to rationalize health care calls for input from other professions and members of society. Indeed, most of the issues facing medicine today are mainly a matter of how much value our societies attach to the benefit expected from the available health services. The answers as to what should be done in health care probably cannot be left to the medical profession alone.

To assess appropriateness of surgical care delivered to breast cancer patients in Italy and quantify the use of unnecessary radical procedures, a retrospective charts review of patients treated in 1988-1989 was conducted. A series of 1724 consecutive patients (median age 61 years; range 17-89) treated in 63 hospitals selected from within 8 regions with newly diagnosed operable breast carcinoma was evaluated. Overall, 541 (38%) patients had inappropriate surgery with more than two thirds of it being accounted for by the use of unnecessary mutilating Halsted mastectomy. Substantial geographic variation emerged in the overall rates of appropriateness (range 88-52%) which were not substantially affected by allowance for imbalances in patient- and hospital-related variables. Despite the important contribution given by Italian clinical researchers to the demonstration that less radical surgery can be as good as more radical procedures, still a substantial proportion of breast cancer patients are treated too aggressively. Besides pointing to the urgent need of interventions aimed at facilitating the process of technology transfer in order to promote more appropriate surgical care, these results suggest that efforts to increase patients' participation into treatment decision and awareness about alternative treatment options are warranted.

Summary Background Even though several radiological and laboratory tests are currently used in clinical practice for breast cancer surveillance, the benefits of early detection of distant metastases have never been established. Two recently published randomized clinical trials assessing the effectiveness of an intensive follow-up strategy (with periodic clinical examination, mammography, bone scan, liver echography, chest-X-ray and laboratory tests) over a minimalist one (including only periodic clinical examination and mammography) failed to show a significant advantage for the more intensive policy. Intensive follow-up, however, is quite common in clinical practice. Aim of the Consensus Conference To contribute to the definition of the state of the art in this field and develop recommendations for follow-up in clinical practice. Conduct of the Consensus Conference A Jury, including representatives from all the relevant stakeholders, (professional societies, patients and consumer associations, epidemiologists, health econ-omists and administrators) was convened to critically appraise and interpret available scientific evidence and the information provided by three specific working groups which had the task of examining the clinical, economic and psyco-social aspects of breast cancer follow-up, respectively. Conclusions This conference was planned to make explicit and properly represent the viewpoints of all the stakeholders. Furthermore, special efforts were devoted to the development of final recommendations in sufficient detail so as to provide a significant aid for decision-making in clinical practice. It is argued that the Consensus Conference model, designed to elicit and represent the interpretation of scientific evidence by all the stakeholders, would be useful for the development of clinical policies more in line with societal values.

The extent of variation in the use of breast-conserving surgery was analyzed using the 1990 and 1991 hospital discharge data of Lombardia, Italy. The proportion of patients undergoing breast-conserving surgery for unilateral breast cancer was estimated for each of the 10 geographic areas (9 provinces plus metropolitan Milano) in which the region is divided. Overall, the rate of use was 41% of 3,225 patients in 1990, and 45% of 3,736 patients in 1991. In both study years, patient age was strongly correlated with the likelihood of undergoing conservative surgery, with younger women more frequently treated with this approach. In each province, patients treated at centers located in the main city had a greater probability (OR, 1.54; 95% Cl, 1.37–1.69) of having conservative surgery. This procedure was also more often used in private hospitals (OR, 1.59; 95% Cl, 1.20–2.08) where care is paid at the point of consumption by patients, directly or through their private insurance. The observed variation in the use of the conservative procedure across the 10 regional areas was greater than that expected by chance alone (p

Objectives: Information on the impact of computed tomography coronary angiography (CTCA) on patterns of care is scarce. In particular, it is not clear if, and to what extent, its adoption actually leads to a reduction in the use of other diagnostics tools. The aim of this study was to evaluate whether the adoption of CTCA in Emilia-Romagna (an Italian region with a population of 4.4 million) had any effect on utilization rates of myocardial perfusion scintigraphy (MPS) and coronary angiography (CA).Methods: Interrupted time series (ITS) were applied to monthly volumes of MPS and CA tests performed from 2003 to 2010, to assess trends in usage rates for those procedures before and after CTCA was adopted by all the healthcare organizations operating in the region.Results: After an increase in the first year of CTCA introduction, its use remained stable over the study period. After September 2006, a significant decrease in MPS volumes (31 percent; p < .0001) and a much less tangible decrease in CA volumes (5 percent; p < .0001), were detected by ITS analyses.Conclusions: This study demonstrates that the use of CTCA had a greater impact on MPS usage rates than on CA.

We report an instrument designed for trace gas measurement of highly reactive halogenated radicals, such as bromine oxide and iodine oxide, as well as for nitrogen dioxide and formaldehyde. This compact and robust spectrometer relies on an alternated injection of a frequency-doubled femtosecond radiation at 338 and 436 nm into two parallel high-finesse cavities, for measuring BrO + H(2)CO, and IO + NO(2), respectively. The transmission of the broadband radiation through the cavity is analyzed with a high resolution, compact spectrograph consisting of an echelle grating and a high sensitivity CCD camera. The transportable instrument fits on a breadboard 120 × 60 cm size and is suitable for in situ and real time measurements of these species. A field campaign at the Marine Boundary Layer in Roscoff (in the northwest of France, 48.7°N, 4.0°W) during June 2011 illustrates the outstanding performance of the instrument, which reaches a bandwidth normalized minimum absorption coefficient of 1.3 × 10(-11) cm(-1) Hz(-1/2) per spectral element, and provides detection levels as low as 20 parts per quadrillion of IO in 5 min of acquisition.

We report an instrument designed for trace gas measurement of highly reactive halogenated radicals, such as bromine oxide and iodine oxide, as well as for nitrogen dioxide and formaldehyde. This compact and robust spectrometer relies on an alternated injection of a frequency-doubled femtosecond radiation at 338 and 436 nm into two parallel high-finesse cavities, for measuring BrO + H(2)CO, and IO + NO(2), respectively. The transmission of the broadband radiation through the cavity is analyzed with a high resolution, compact spectrograph consisting of an echelle grating and a high sensitivity CCD camera. The transportable instrument fits on a breadboard 120 × 60 cm size and is suitable for in situ and real time measurements of these species. A field campaign at the Marine Boundary Layer in Roscoff (in the northwest of France, 48.7°N, 4.0°W) during June 2011 illustrates the outstanding performance of the instrument, which reaches a bandwidth normalized minimum absorption coefficient of 1.3 × 10(-11) cm(-1) Hz(-1/2) per spectral element, and provides detection levels as low as 20 parts per quadrillion of IO in 5 min of acquisition.

Dual antiplatelet treatment with aspirin and clopidogrel is the antithrombotic treatment recommended after an acute coronary syndrome and/or coronary artery stenting. The evidence for optimal antiplatelet therapy for patients, in whom long-term treatment oral anticoagulation is mandatory, is however scarce. To evaluate the safety and efficacy of the various antithrombotic strategies adopted in this population, we reviewed the available evidence on the management of patients receiving oral anticoagulation, such as a vitamin-k-antagonists, referred for coronary artery stenting. Atrial fibrillation is the most frequent indication for oral anticoagulation. The need of starting antiplatelet therapy in this clinical scenario raises concerns about the combination to choose: triple therapy with warfarin, aspirin, and a thienopyridine being the most frequent and advised. The safety of this regimen appeared suboptimal because of an increased risk in hemorrhagic complications. On the other hand, the combination of oral anticoagulation and an antiplatelet agent is suboptimal in preventing thromboembolic events and stent thrombosis; dual antiplatelet therapy may be considered only when a high hemorrhagic risk and low thromboembolic risk are perceived. Indeed, the need for prolonged multiple-drug antithrombotic therapy increases the bleeding risks when drug eluting stents are used. Since current evidence derives mainly from small, single-center and retrospective studies, large-scale prospective multicenter studies are urgently needed.

International audience; We present a robust, compact, and transportable instrument that measures the iodine monoxide atmospheric radical at extremely low concentration, down to 40 ppqv (parts per quadrillion by volume, 1:1015). As nitrogen dioxide is strongly absorbed in the same spectral region it could be simultaneously measured down to 4 pptv (parts per trillion by volume, 1:1012). Relying on ''mode locked cavity-enhanced absorption spectroscopy,'' the instrument makes use of a free-running commercial femtosecond Titane Saphir laser. We demonstrate that this multiplex detection scheme provides shot noise limited spectra for acquisition times as long as 5 min. Moreover, this instrument is very versatile as it can be potentially tuned from the infrared to the ultraviolet (1080-340 nm) to reach various molecular absorptions. It has been recently deployed at the Station Biologique de Roscoff on the North West Atlantic coast of France.

International audience; We demonstrate quantum-noise-limited frequency-comb cavity-enhanced absorption spectroscopy with spectrally multiplexed detection for acquisition times ranging from 10 ms up to 10 min, where a record absorption sensitivity of 7×10-13 cm-1 per spectral element is attained with nW power levels. For this, a widely tuneable frequency-doubled free-running fs Ti:sapphire laser oscillator is coupled to a cavity of extreme finesse (32 000) whose length is modulated and whose output is spectrally dispersed over a linear charge coupled device array. This scheme is robust, as it does not require tight frequency locking or controlling the comb frequency offset, and works with spectrally broad combs, as it is not limited by cavity dispersion.

International audience; Pptv levels of BrO radical have been detected around 338.5-nm wavelength probing a rotationally structured A←X (7,0) electronic transition using mode-locked cavity-enhanced spectroscopy (ML-CEAS). The spectrometer is composed by a widely tunable, broadband frequency-doubled Ti:Sa mode-locked frequency comb laser injected into a high-finesse optical cavity and a high-resolution spectrometer based on a high-order diffraction grating and a high-sensitivity back-thinned CCD camera. A typical minimum detectable absorption coefficient of 1×10-9 cm-1 in 30 s of acquisition has been achieved, leading to a detection limit of 1.7 parts per trillion of BrO at atmospheric pressure. The compact and robust ultrasensitive broadband UV spectrometer is intended to be employed for in situ long-term direct measurements of BrO and other halogenated radicals, thus responding to the lack of analytical techniques to monitor the concentrations of such highly chemically reactive species.

Objective . To assess whether and how the characteristics of hospitals' surgical staff can predict utilization of breast conserving surgery. We anticipated that the use of the procedure was more frequent in hospitals with a greater proportion of younger and female surgeons on their staff. Setting . Sixty-two hospitals with different level of organization for the care of cancer patient from eight Italian regions were included. Design . We collected information on the personal characteristics (age and sex) of all surgeons on the staff of the participating centers. A concurrent pattern of care study was undertaken, in order to assess the utilization of breast conserving procedures. Results . The use of conservative surgery was 16%, 20%, 31%, in centers with 0%

The aim of this study was to evaluate the impact of the implementation of the interhospital network focused on reperfusion of ST-elevation myocardial infarction (STEMI) on the activity of intensive cardiac care units (ICCUs) of the Emilia-Romagna Region (Italy).From the Emilia-Romagna Region databank of hospital discharge records, all consecutive admissions to ICCUs from January 1, 2002 to December 31, 2007 were derived. The main discharge diagnoses were classified into three groups: ST-elevation acute coronary syndromes (STE-ACS) (ICD-9 410, with the fourth digit other than 7), non-STE ACS (ICD-9 410.7 and all code 411), and hospitalizations for other diagnosis unrelated to ACS (non-ACS).During the study period, 92 545 patients were hospitalized in ICCUs (on average, almost 15 000 patients/year). In 2007, as compared to 2002, a 14% reduction in the overall admissions for STEMI was observed, with a 26% increase for non-STE ACS. The number of non-ACS admissions was stable. Interestingly, a significant increase (+15%) in direct admissions to the ICCUs of Hub centers was reported (+17% STEMI, +26% non-STE ACS and +6% non-ACS, respectively). Within these ICCUs, a significant increase in coronary angiography and angioplasty procedures in patients with STEMI or non-STE ACS was observed. Furthermore, the median hospital length of stay was shorter in the ICCUs of Hub centers. Over the same period, a substantial decline (-14%) in admissions to the ICCUs of Spoke centers was recorded, largely due to a 57% decrease in STEMI, not offset by a 20% increase in admissions for non-STE ACS or by the number of patients transferred back from Hub centers after reperfusion or stabilization. A reduction in hospitalizations for non-ACS was also observed, as well as an increase in the number of patients sent from the Spoke centers to the cath lab of the Hub centers for outpatient procedures. In the Spoke centers, the median length of stay in the ICCU did not vary over the whole study period.Although administrative data suffer from several limitations, this survey shows substantial variations in the ICCU activity after the implementation of the interhospital network for the treatment of STEMI. This finding should stimulate a critical reconsideration of the role and function of the ICCUs involved in acute cardiac care.

Aim To assess the prognostic relevance of 64-slice computed tomography coronary angiography (CT-CA) and symptoms in diabetics and non-diabetics referred for cardiac evaluation. Methods We followed 210 patients with diabetes type 2 (DM) and 203 non-diabetic patients referred for CT-CA for ruling out coronary artery disease (CAD). Patients were without known history of CAD and were divided into four categories on the basis of symptoms at presentation (none, atypical angina, typical angina and dyspnoea). Clinical end points were major cardiac events (MACE): cardiac-related death, non-fatal myocardial infarction, unstable angina and cardiac revascularizations. Cox proportional hazard models, with and without adjustment for risk factors and multiplicative interaction term (obstructive CAD × DM), were developed to predict outcome. Results DM patients with dyspnoea or who were asymptomatic showed a higher prevalence of obstructive CAD than non-diabetics (p ≤ 0.01). At mean follow-up of 20.4 months, DM patients had worse cardiac event-free survival in comparison with non-DM patients (90% vs. 81%, p = 0.02). In multivariate analysis, CT-CA evidence of obstructive CAD (in DM patients: HR: 6.4; 95% CI: 2.3–17.5; p 100 in non-DM patients (HR: 5.6; 95% CI: 1.4–21.5; p = 0.01). In Cox regression analysis of the overall population, interaction term obstructive CAD × DM resulted in non-significance. Conclusions Among DM patients, dyspnoea carried a high event risk with a MACE rate four times higher. CT-CA findings were strongly predictive of outcome and proved valuable for further risk stratification.

Background The aim of the present study was to assess the cost-effectiveness of cement-less versus hybrid prostheses in total hip replacement (THR) in patients diagnosed with primary osteoarthritis. Methods Effectiveness data were obtained from the Emilia-Romagna Regional Registry on Orthopaedic Prosthesis (RIPO), which collects information on all orthopaedic intervention performed in Emilia-Romagna (41,199 total hip replacements performed from 2000 to 2007), and from which we obtained survival curves and transition probabilities for the cement-less and hybrid prostheses, respectively. Conversely, costs were derived from regional databases through a specific procedure, which allowed us to register individual component's costs for both primary and subsequent revision interventions. A specific Markov transition model was constructed in order to consider the 3 types of revisions that an implant could possibly undergo through its life-span: total, cup or stem, head insert or neck. The cost-effectiveness was expressed in terms of cost per “revision-free” life year. Results and conclusions Considering a 70-y old patient undergoing THR, the cementless strategy resulted more effective but more costly than the hybrid solution, with an incremental cost effectiveness ratio of 2401.63 € per revision-free life year. Following a deterministic sensitivity analysis, hybrid and cementless fixation showed, respectively, a dominance profile for patients older than 83 y and younger than 43 y, whereas for all ages in between, we report a progressive increase in the ICER of cementless prostheses. Our results proved to be robust, as underlined by the probabilistic sensitivity analysis performed using cost distributions.

The long-term effectiveness of drug eluting stents (DESs) in a real-world setting of female patients is currently unclear.We analyzed long-term follow-up (up to 3 years) data from all female patients with de novo lesions enrolled in a prospective web-based multicenter registry (REAL Registry; study period, July 2002-June 2006) including all 15 hospitals performing PCI in the Emilia-Romagna region of Italy. Among the 3549 women without ST elevation myocardial infarction, 2434 were treated with BMSs alone and 1115 with DESs alone. At 3 years, use of DESs was associated with a lower propensity score adjusted incidence of MACE [cardiac mortality, non-fatal myocardial infarction and target vessel revascularization (TVR); 19.5% vs. 24.4%; HR 0.75, p=0.006)] and TVR (11.6% vs. 15.6%; HR 0.68, p=0.004) compared with BMSs. No difference was apparent in terms of adjusted 3-year cardiac mortality or myocardial infarction. Nevertheless, after the first 6 months of follow-up, a non significantly increased risk of myocardial infarction and stent thrombosis was found in the DES group.In this real-world female registry, the use of DESs was associated with a 3-year reduction of TVR and MACE in comparison with the use of BMSs. However, the observed (non-significant) increment of late AMI makes performing larger studies to clarify the long-term safety of DESs mandatory.

PURPOSE To estimate the impact of chemotherapy on survival of patients with advanced non-small-cell lung cancer (NSCLC). METHODS Randomized controlled trials (RCTs) published in the English-language medical literature between 1970 and 1991 were identified through MEDLINE and the reference lists of relevant articles. Six RCTs that accounted for 635 patients and compared first-line chemotherapy with supportive care in advanced NSCLC and reported survival up to at least 1 year were identified. Cumulative proportions of survival at 3, 6, 9, and 12 months for chemotherapy and control groups were derived from survival curves. RESULTS Within each study, the effect of chemotherapy was estimated with a pooled relative risk (RR) across the four 3-month periods. An overall estimate of the RR of death at 1 year (RRM-H) was then calculated and a survival curve for chemotherapy-treated patients was constructed applying the pooled estimate of the RR (RRW) for each 3-month period. Overall, chemotherapy was associated with a 24% (95% confidence interval [CI], 13% to 34%) reduction in the probability of death when compared with supportive care. However, the effect of treatment appeared to decrease significantly after the first 6 months from therapy inception and the mean potential gain in survival, as compared with supportive care, was approximately 6 weeks (95% CI, 1 to 10). CONCLUSION Chemotherapy is effective in the treatment of advanced NSCLC, but its impact on the length of survival is limited. Future RCTs should still include an untreated control group and should measure quality of life in addition to survival.

Objective To evaluate diagnostic accuracy of exercise ECG (ex-ECG) versus 64-slice CT coronary angiography (CT-CA) for the detection of significant coronary artery stenosis in a population with low-to-intermediate pretest likelihood of coronary artery disease (CAD). Design Retrospective single centre. Setting Tertiary academic hospital. Patients 177 consecutive patients (88 men, 89 women, mean age 53.5 +/- 7.6 years) with chest pain and low-to-intermediate pre-test likelihood of CAD were retrospectively enrolled. Interventions All patients underwent ex-ECG, CT-CA and invasive coronary angiography (ICA). Main outcome measure A lumen diameter reduction of >= 50% was considered as significant stenosis for CTCA. Ex-ECG was classified as positive, negative or non-diagnostic. Results were compared with ICA. Diagnostic accuracy of CT-CA and ex-ECG was calculated using ICA as the reference standard. A parallel comparative analysis using a cut-off value of 70% for significant lumen reduction was also performed too. Results ICA disclosed an absence of significant stenosis (>= 50% luminal narrowing) in 85.3% (151/177) patients, single-vessel disease in 9.0% (16/177) patients and multivessel disease in 5.6% (10/177) patients. Prevalence of obstructive disease at ICA was 14.7% (26/177). Sensitivity, specificity, positive and negative predictive values at the patient level were 100.0%, 98.7%, 92.9%, 100%, respectively, for CT-CA and 46.2%, 16.6%, 8.7%, 64.1%, respectively, for ex-ECG. Agreement between CT-CA and ex-ECG was 20.9%. CTCA performed equally well in men and women, while ex-ECG had a better performance in men. After considering the cut-off value of 70% for significant stenosis, the difference between CT-CA and ex-ECG remained significant (p

This study assesses the feasibility of using hospital discharge data to identify women with incident breast cancer, and it evaluates the use of these data to assess compliance with an indicator of quality of care. The study’s goals are to: 1) compare breast cancer case-finding algorithms based upon ICD-9 CM codes found in hospital discharge data with cancer registry data and 2) compare the utility of these algorithms for use with a selected quality indicator.

Diode laser cavity ring-down spectroscopy is a versatile method for quantitative determination of trace atmospheric constituents. Examples include measurement of mixing ratios of small organic compounds, isotopologue-specific spectroscopy, and optical extinction by atmospheric aerosol particles.

Background: Long-term outcomes of percutaneous coronary interventions (PCI) with sirolimus-eluting stents (SES) compared to paclitaxel-eluting-stents (PES) in unselected diabetics in routine practice is still debated. Objective: This study compared the 2-year incidence of MACE (all-cause mortality, nonfatal myocardial infarction and target vessel revascularization) of SES and PES in a real-world setting of patients with diabetes. Design: Observational, multicenter, nonrandomized study. Setting: Prospective web-based registry (REAL Registry; study period, 2002–2005) comprising all 13 hospitals performing PCI. Patients: Among the 945 eligible patients treated with either SES alone (n = 606) or PES alone (n = 339), 29% were insulin-requiring, 72% had multivessel coronary disease, 26% had prior myocardial infarction and 10% had poor left ventricular function. Measurements: Unadjusted and propensity score-adjusted 2-year clinical outcome. Results: After propensity score adjustment, 2-year MACE incidence in the SES and PES groups was equivalent (23.3% vs. 23.7%, HR 1.01, 95%CI 0.72–1.42, P = 0.96). Adjusted 2-year angiographic stent thrombosis occurred in 1.1% of the SES patients versus 2.6% of the PES patients (P = 0.15). In this large, real-world, diabetic population treated with DES, there was no difference in outcome between SES and PES. Further studies are needed to demonstrate the long-term safety of different types of DES in patients with diabetes. © 2009 Wiley-Liss, Inc.

The interaction of cationic amphiphiles with calf thymus DNA has been investigated by physicochemical techniques (surface tension, conductometry, UV spectroscopy, thermal denaturation) and morphological microscopies (AFM and TEM). The cationic molecules were the amphiphiles cetyltrimethylammonium and cetyltributylammonium bromides (CTAB and CTBAB, respectively), compared to the nonamphiphilic tetramethyl- and tetrabutylammonium bromides (TMAB and TBAB, respectively) and, as a transfection-efficient comparison, a commercial poliethyleneimine (PEI). As a result, well below their critical micelle concentrations (cmc), CTAB and CTBAB showed a peculiar, nonlinear adsorption profile with the nucleic acid, which showed a correlation with the melting temperatures and morphological changes observed with AFM and TEM microscopies. On the other hand, TMAB and TBAB interact much less with the DNA duplexes and do not induce any modifications of the structures. The same behavior was observed with PEI; however, CTAB and CTBAB proved much less effective in condensing the nucleic acid.

Restenosis and a high incidence of new revascularisations reduce the long-term efficacy of percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease.To determine the modality of utilisation and the clinical efficacy of drug eluting stents (DES) in a real world multivessel PCI scenario.From July 2002 to December 2004, 1726 consecutive patients enrolled in the REAL Registry (Registro REgionale AngiopLastiche Emilia-Romagna) underwent elective multivessel PCI with multiple stents in at least two different vessels; among them, 939 (54%) received only bare-metal stents (BMS group), 288 (17%) only DES (DES group) and 499 (29%) were treated with BMS and DES in different vessels (MIX group). The incidence of major adverse cardiac events (MACE= death, myocardial infarction and target vessel revascularisation) during follow-up was assessed.Patients in the BMS group were older, diabetes was more frequent in the DES and MIX groups, while more lesions and more often a three vessel treatment was performed in the MIX group. In the DES group, lesions were longer, in smaller vessels and more often in the left main compared with BMS and MIX groups. In the MIX group too, lesions treated with DES were at higher risk for restenosis than those treated with BMS. Procedural success was similar in the three groups (98.9%). Notwithstanding the different risk profile, 12-month follow up did not show differences in clinical end points among the three groups. Multivariate analysis indicated that age, a modified Charlson's comorbidity index and diabetes were independent predictors of death or AMI; total lesion length, use of only DES or MIX approach and treatment of left main were predictors of TVR, while left main treatment along with only DES use, modified Charlson's index and reference vessel diameter independently affected the incidence of MACE. Use of at least one DES reduced the risk of TVR by 37% and MACE by 29%, while DES in every lesion treated reduced TVR risk by 37% and MACE by 39%.In this large multicentre registry, DES were utilised in only half of the multivessel PCI procedures, mainly to treat high-risk patients and lesions. However, this selective use of DES was independently associated with a lower incidence of 1-year TVR and MACE. Whether increasing the rate of DES utilisation would further improve the clinical outcome remains to be investigated.

Background When evaluating health technologies with insufficient scientific evidence, only innovative potentials can be assessed. A Regional policy initiative linking the governance of health innovations to the development of clinical research has been launched by the Region of Emilia Romagna Healthcare Authority. This program, aimed at enhancing the research capacity of health organizations, encourages the development of adoption plans that combine use in clinical practice along with experimental use producing better knowledge. Following the launch of this program we developed and propose a method that, by evaluating and ranking scientific uncertainty, identifies the moment (during the stages of the technology's development) where it would be sensible to invest in research resources and capacity to further its evaluation. The method was developed and tested during a research project evaluating robotic surgery. Methods A multidisciplinary panel carried out a 5-step evaluation process: 1) definition of the technology's evidence profile and of all relevant clinical outcomes; 2) systematic review of scientific literature and outline of the uncertainty profile differentiating research results into steady, plausible, uncertain and unknown results; 3) definition of the acceptable level of uncertainty for investing research resources; 4) analysis of local context; 5) identification of clinical indications with promising clinical return. Results Outputs for each step of the evaluation process are: 1) evidence profile of the technology and systematic review; 2) uncertainty profile for each clinical indication; 3) exclusion of clinical indications not fulfilling the criteria of maximum acceptable risk; 4) mapping of local context; 5) recommendations for research. Outputs of the evaluation process for robotic surgery are described in the paper. Conclusions This method attempts to rank levels of uncertainty in order to distinguish promising from hazardous clinical use and to outline a research course of action. Decision makers wishing to tie coverage policies to the development of scientific evidence could find this method a useful aid to the governance of innovations.

We sought to investigate the performance of 64-slice CT in symptomatic patients with different coronary calcium scores. Two hundred patients undergoing 64-slice CT coronary angiography for suspected coronary artery disease were enrolled into five groups based on Agatston calcium score using the Mayo Clinic risk stratification: group 1: score 0, group 2: score 1-10, group 3: score 11-100, group 4: score 101-400, and group 5: score > 401. Diagnostic accuracy for the detection of significant (a parts per thousand yen50% lumen reduction) coronary artery stenosis was assessed on a per-segment and per-patient base using quantitative coronary angiography as the gold standard. For groups 1 through 5, sensitivity was 97, 96, 91, 90, 92%, and specificity was 99, 98, 96, 88, 90%, respectively, on a per-segment basis. On a per-patient basis, the best diagnostic performance was obtained in group 1 (sensitivity 100% and specificity 100%) and group 5 (sensitivity 95% and specificity 100%). Progressively higher coronary calcium levels affect diagnostic accuracy of CT coronary angiography, decreasing sensitivity and specificity on a per-segment base. On a per-patient base, the best results in terms of diagnostic accuracy were obtained in the populations with very low and very high cardiovascular risk.

The influence of Italian physicians' attitudes, beliefs, and personal characteristics on medical decision making is examined in the case of surgical treatment of early breast cancer. Responses to a mail survey of 657 physicians from different specialties were analyzed comparing doctors recommending a radical procedure (9%) to those preferring a conservative procedure for younger patients only (25%), and those considering conservative surgery the treatment of choice regardless of patients' age (66%). The findings suggest that the likelihood of physicians' preferring a conservative procedure is influenced by their specialty and the extent to which they feel that a patient should have a role in the treatment decision more than by differences in the beliefs of treatment outcomes. Only preferences of the small group indicating radical surgery as the sole admissible treatment can be accounted for by ignorance or distrust of results of recent trials. These findings suggest that other than scientific factors guide many doctors in their decision making; they may help to explain why the diffusion of research results into clinical practice is often disappointingly slow.

We thank Barlis and colleagues for their legitimate1 query about the ability of the propensity score regression technique to balance covariates between the somewhat heterogeneous groups. Our decision to report the results of a propensity score regression analysis conducted across the overall study population was based on a number of considerations. Nevertheless, application of propensity score matching (as suggested by Barlis and colleagues) in 2 well-balanced but smaller groups (253 patients each) substantially confirms the main results. Indeed, the result for the main …

A fully automated instrument combining a continuous wave cavity ring-down spectrometer and dual-trap sample preconcentration has been implemented for monitoring C2H2 mixing ratios in ambient air. A distributed feedback diode laser operating in the near-infrared region (lambda approximately 1534.973 nm in air) detects C2H2 in absorption via the P(17) rotational line of the (v1 + v3) vibrational combination band. The instrument is shown to be capable of fast, quantitative, and precise monitoring of C2H2 mixing ratios, with a detection limit of approximately 8 pptv (parts per trillion by volume). It thus has potential to be deployed for analysis of air samples in many rural and urban environments. In situ measurements were carried out at 30 min intervals over periods of up to 15 h on several days for indoor and outdoor air samples. For indoor air monitored on a Sunday, the C2H2 mixing ratio was stable at 1.45 +/- 0.04 ppbv (parts per billion by volume). On weekdays, both indoor and outside air analyses showed peaks in the range 2-4 ppbv in the early morning and late afternoon that coincided with periods of busy road traffic.

Mass public health campaigns aim at channeling the power of the media toward the public good, ensuring adequate exposure of the target audience. Public health practitioners should learn how to harness the power of the different media and to successfully compete in a contested environment. The quality of news reporting in medicine is largely determined by medical journals, research, and health-care institutions as well as by individual scientists competing for visibility, funding, and profits. Audiences, however, are more active than usually assumed and mass campaigns should be appropriately used as legitimate spaces for debate of social issues at the science–policy interface.

Trials on chemotherapy of advanced ovarian cancer published between 1975-88 were systematically reviewed for quality (according to the method of Chalmers) and consistency of tested hypotheses with a view to a meta-analysis of all published studies in the field. Median overall, internal and external validity scores were 47%, 43% and 53%, respectively. No association was found between scores and key features of trials, such as percentage studies with significant results in response or survival or percentage studies with high or low follow-up retention (withdrawal rates less than or greater than or equal to 15%). Only 21% of trials reported a fully blind randomization procedure and only in 13% were drop-outs accounted for by the intent-to-treat method. Only 4 trials entered more than 150 patients per arm, a sample size consistent with detection of an absolute difference of 11% in mortality. The majority of trials (58%) investigated the role of combination regimens versus a single-agent control arm. The remaining trials tested different polychemotherapies. However, within these two general issues, treatment options were quite heterogeneous: seven subgroups were identified by whether cisplatin was present in either the treatment or the control arm. We conclude that the internal coherence and development of randomized clinical trials in advanced ovarian cancer and their methodologic soundness are quite poor. In this situation meta-analysis cannot go beyond a systematic attempt to answer a very general "treatment effectiveness" question.

We compared mortality rates league tables for six cardiac surgery centres developed using an administrative database (integrated with information on patients' EuroSCORE) with those drawn from a specialised clinical database. Data from 4017 patients undergoing cardiac surgery over the period January 1st-December 31st 2003, and identified both databases were used. Case mix adjusted in-hospital mortality rates were estimated relying on information provided by each database, and league tables were drawn from both. The correlation between the two league tables was assessed through the Spearman correlation coefficient. League tables drawn from the two sources identified the same 'best' and 'worst' centres and the Spearman correlation coefficient confirmed a high level of agreement between the two rankings (r=0.89; P

We investigated the impact of ambulance-based prehospital triage on treatment delay and all-cause mortality (in hospital and long term) in patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock referred for primary percutaneous coronary intervention in a prospectively collected registry. During the study period (January 2003 to December 2005), a total of 121 patients was referred for primary percutaneous coronary intervention at our intervention laboratory through 2 main triage groups: (1) after prehospital, ambulance-telemedicine-based triage (42 patients) and (2) by more conventional routes (79 patients) represented by the institutional S. Orsola-Malpighi hospital emergency department triage (44 patients) and spoke hospital triage (35 patients). Total ischemic time was shorter in the prehospital triage (142 minutes, range 106 to 187, vs 212 minutes, range 150 to 366, p = 0.003). Patients with prehospital triage showed a lower rate (29% vs 54%, p = 0.01) of severely depressed (

Goal of this paper is to address the problem of governing innovations in health care, underscoring how this issue, by its very nature, implies not only the need for better methodological approaches and instruments for technology assessment, but also, and more importantly, a profound reshaping of roles and responsibilities within the context of health care organisations. From this perspectives, the issue of innovation in health care overlaps the concept of clinical governance, indeed representing the best rationale for the need of the latter and the better exemplification of its meanings.

Background High mortality rates were reported in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary interventions (PPCI) "off-hours." The objective of this study was to evaluate this issue in a more recent population of patients with STEMI treated with PPCI in a high-volume tertiary center specifically dedicated to STEMI treatment. Methods and Results We analyzed in-hospital/1-year mortality among 985 consecutive patients with STEMI treated with PPCI between January 2003 and December 2005 in a high-volume (>1400 PCI/year) hub center in a STEMI provincial network organization during "normal-hours" (weekdays 08:00 am to 07:29 pm) and "off-hours" (weekdays 07:30 pm to 07:59 am and weekends). Most (61.2%) patients were treated during "off-hours". Clinical and angiographic characteristics of the "normal-hours" and "off-hours" groups were comparable (in both groups, glycoprotein IIb/IIIa were administered to ∼80% patients). The off-hours group tended toward higher median (25th-75th percentiles) total ischemic time (199 [135-312] minutes vs 179 [126-285] minutes; P = .052). Median electrocardiogram-to-balloon time was less than 90 minutes in both groups. Despite 20 minutes longer median total ischemic time, patients who underwent PPCI during "off-hours" showed similar post-PPCI Thrombolysis In Myocardial Infarction 3 flow grade and mean left ventricular ejection fraction. No difference could be observed between the 2 groups in terms of in-hospital and 1-year mortality rates. Conclusion This study provides evidence that the clinical effectiveness of "normal" and "off-hours" PPCI can be equivalent, at least when performed at a center specifically dedicated to STEMI treatment with frequent use of glycoprotein IIb/IIIa agents.

Background: The impact of the use of drug-eluting stents in percutaneous coronary intervention (PCI) on cardiac care is still uncertain. We examined the influence of systemic factors, such as hospital ownership status, organizational characteristics and payment structure, on the use of drug-eluting stents in PCI and the effect on cardiac surgery volume. Methods: We conducted a cross-sectional analysis of drug-eluting stent use in 12 993 patients undergoing PCI with stenting (drug-eluting or bare-metal) and time-series regression analyses of the monthly number of cardiac surgery and PCI procedures performed using data collected from 1998 to 2004 at 13 public and private hospitals in the Emilia-Romagna region of Italy. Results: Public hospitals used drug-eluting stents more selectively than private hospitals, targeting the new device to patients at high risk of adverse events. The time-series regression analyses showed that the number of PCI procedures performed per year increased during this period, both in public (slope coefficient 36.4, 95% confidence interval [CI] 30.2 to 43.1) and private centres (slope coefficient 6.4, 95% CI 3.1 to 9.2 ). Concurrently, there was a reduction in the number of isolated coronary artery bypass graft (CABG) surgeries, although the degree of change was higher in public than in private hospitals (coefficient –16.1 v. –6.2 respectively ). The number of CABG procedures associated with valve surgery decreased in public hospitals (coefficient –5.0, 95% CI –6.1 to –3.8) but increased in private hospitals (coefficient 4.1, 95% CI 2.0 to 6.1). Interpretation: Public and private hospitals behaved differently in adopting drug-eluting stents and in using PCI with drug-eluting stents as a substitute for surgical revascularization.

To explore determinants of clinical priority and of actual waiting times for elective surgical interventions. DESIGN, SETTING PARTECIPANTS: 405 patients cared for at two general surgery wards, receiving an explicit judgement of clinical priority and whose actual waiting times to surgery were assessed. Clinicalpriority was assessed through 0 (no priority) to 10 (maximum priority).Identification through multivariate regression techniques of the clinical characteristics associated with high clinical priority (score 28) and with shorter actual waiting times.Patients with cancer, severe pain, relevant impairment in functional status and relevant expert improvement on quality and duration of survival were more frequently attributed a high clinical priority. As for waiting times, presence of cancer was the only factor associated with shorter waitings. Only for cancer patients high priority judgement was associated with shorter waiting times (median 21 vs. 69 days; p0.008).These findings suggest that actual waiting times are not influenced by the same clinical characteristics that clinicians value when assigning clinical priority. That may have some relevant implications on how waiting lists are managed, if consideration of relevant aspects of patients' needs are missed.

increasingly information on individual hospital' clinical performance is disclosed to the general public through lay mass media. Usually the explicit goal of those initiatives is to guide citizens' choice identifying the "best", centres. However, these efforts rely either on simplistic approaches in comparing the clinical performance of individual hospitals or on inadequate quality indicators. Therefore, this information may easily misguide the general public. In this paper, in order to highlight the problems implied, we consider two recent cases of mass media reporting on hospitals' quality.Two recent cases of mass media reporting on cardiac surgery centres' quality are considered: the BPAC study "Esiti a breve termine di interventi di by-pass coronarico nelle cardiochirurgie italiane" coordinated by the Italian Institute of Health, and the publication by the news magazine Panorama of the list of the "best" Italian cardiac surgery centres based on a reputational index.The first example points out the problems implied by presenting hospitals' clinical performance through league tables. Using the Markov Chain Monte Carlo method, this study shows how the conclusions merely based on ranking--even when these are based on a sensible quality indicator--can be potentially misleading. As for the second case study, it is shown the inadequacy of the quality indicator (the reputation index) adopted.despite the growing awareness in the health services community of the technical problems implied by describing and comparing the quality of care provided by individual hospitals, "real life" examples of provision of information on quality of care by the mass media to the general public appear to be largely unsatisfactory and potentially misleading.

On May 2003 the Emilia-Romagna Regional Commission for Cardiology and Cardiac Surgery launched a project aimed at improving health service ability to adopt interventions of well-known effectiveness for the treatment of patients with acute myocardial infarction. One of the main goals was to stimulate the clinical and organizational responsibilities operating at the local level, in order to improve the frequency of use of primary percutaneous coronary intervention.In assessing the overall impact of this regional project, an interrupted time series regression analysis was conducted, relying on information drawn from the regional hospital discharge database. Overall, 18 957 patients admitted for acute myocardial infarction during the period January 2001-June 2004 were considered.One year after the inception of the regional project, the estimate of its effect documented a statistically significant increase in the frequency of use of percutaneous coronary angioplasty (5.8%, 95% confidence interval 4.6%-6.9%), paralleled by an increase (3.2%, 95% confidence interval 1.14%-5.0%) in the number of those directly admitted to centers with interventional cardiology facilities. No effect was observed as for the proportion of patients admitted to highly specialized departments.Despite the obvious limitations due both to source of information and study design, our findings document that the regional project had indeed some tangible impact, although variable across the different geographic areas of the region, on key aspects of the patterns of care of patients with acute myocardial infarction.

We compared the clinical outcome of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a real-world scenario.In selected patients, SES has been associated with lower late luminal loss than PES. Whether this emerging biological difference could translate into different clinical efficacy in daily practice is presently unknown.This analysis included 1,676 consecutive patients with de novo coronary lesions treated solely with drug-eluting stents (SES = 992; PES = 684). All patients were enrolled in a dynamic prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR) during follow-up.Overall, 29% of the patients had diabetes, 23% had prior MI, and 9% had poor left ventricular function. ST-segment elevation MI was diagnosed at admission in 12%. Multivessel intervention was performed in 16%. At 1-year follow-up, SES was associated with a reduced incidence of MACE (9.2% SES vs. 14.1% PES; p = 0.007) and TVR (5.0% SES vs. 10.0% PES; p = 0.0008) compared to PES. A propensity analysis with many clinical and angiographic variables was carried out to adjust for baseline differences. In this analysis, SES was associated with a 44% risk reduction of MACE (hazard ratio 0.56, 95% confidence interval 0.39 to 0.78) and a 55% reduction of TVR (hazard ratio 0.45, 95% confidence interval 0.29 to 0.70). This result was consistent across most subgroups tested. Similar rates of death and MI were observed in the 2 treatment groups.In this large real-world population, SES improved 1-year clinical results as compared to PES.

Objectives: To explore how the adoption of medical innovations challenges tax-financed health systems, drawing from the case of sirolimus eluting stents, a promising and costly innovation for percutaneous coronary interventions. Methods: The coverage decisions for the new stents adopted in Emilia-Romagna, an Italian region, are described. The innovation was adopted through a process combining the development of clinical guidelines targeting their use to selected clinical indications, negotiation with the manufacturer for reducing price, and the organization of a registry for monitoring its patterns of utilization and assessing its effectiveness. Results: Overall, 17% of the 6276 patients included in the registry over a 12-month period had the new stent. Wide differences between published trials on sirolimus eluting stents and actual clinical practice emerged. The new stents were frequently (23%) used in combination with traditional bare metal stents, and for indications (acute myocardial infarction and multivessel coronary disease) never included in clinical experiments (25% and 8% of the cases, respectively). Patients' outcomes were also different, the overall rate of major adverse cardiac events being relatively higher (12%) than that shown in clinical trials. Conclusions: The actions undertaken for the new stents allowed a timely, and at the same time targeted and monitored, adoption of the innovation. This experience highlights how policy decisions related to new medical products could benefit from the availability of clinical databases providing key information on how innovations are actually used and on their impact on clinical practice.

Assessment of the impact of the regionalisation of cardiac surgery through the organisational form of a hubspoke model introduced in the year 2000.Case mix adjusted before (1998-1999)-after (2000-2002) comparison of: (a) in-hospital and 30 days mortality rates; (b) proportion of patients timely (within one day) referred for surgery from spoke to hub centres; (c) patients' waiting times to surgery.Emilia-Romagna, an Italian region with four million residents.16,512 patients agedor =18 years and referred to cardiac surgery over the period 1998-2002.Overall, taking into account differences in case mix across the whole study period, the implementation of the regionalisation policy was associated with a 22% reduction (OR: 0.79, 95%CI: 0.66 to 0.93) in in-hospital mortality rate. The corresponding figure for 30 day mortality was 18% (OR: 0.82: 95%CI: 0.69 to 0.98). The individual centres' volume of cases changed over the study period for all hospitals but two, and the biggest reduction in mortality was seen at the centre with the largest increase in caseload.This study provides additional evidence on the benefit of regionalisation of cardiac surgery interventions. The system allowed each centre to reach the minimum caseload required to assure good quality of care. These findings suggest that policies aimed at increasing cooperation rather than competition among health service providers have a positive impact on quality of care. Timely referrals for surgery increased by 21% (95%CI: 1.12 to 1.31), and mean waiting times were reduced by 7.5 average days (95%CI: -10.33 to -4.71).

BACKGROUND The aim of this working group was to assess the appropriateness of use of radiologic examinations, laboratory tests and periodic check-ups for surgically-treated, disease-free breast cancer patients. MATERIALS AND METHODS A total of 252 clinical scenarios (36 for each of the 8 exams considered: clinical examination, mammography, chest roentgenography, hematochemical tests, markers, bone scan, liver echography/abdominal CT scan), each representing a specific surgically treated and disease-free breast cancer patient, were rated by the members of the panel. A 3 point scale was utilized as to whether the test in question was judged inappropriate (1), questionable (2), or appropriate (3) (in the latter case the panel member was also asked for the advised frequency of the exam expressed in months). RESULTS After two assessment sessions, consensus among members of the panel was reached on 216 of the 252 scenarios; disagreement remained on only 36 clinical scenarios. CONCLUSIONS The panel agreed that only clinical examinations and mammographies should be recommended for routine clinical follow-up of surgically-treated breast cancer patients. Given the current available therapeutic options, these would assure adequate medical care and psychological aid.

This audit initiative aimed at assessing the prevalence of pressure sores in the public hospitals of Emilia-Romagna, and at monitoring the rate of use of specific modalities of prevention and cure. The design was cross-sectional, with information collected on three index days during 2000 by trained personnel. Overall, the prevalence of pressure sores at the regional level was 7.1%, with remarkable variation across hospitals (from 2.9% to 9.7%), also after adjustment for case mix. As for patterns of prevention and cure, 74% of patients at risk (according to the Braden scale) of developing a pressure sores received only standard low technology devices, and 50% of those in need were included in a systematic programme of postural change. Adequate (according to the available evidence) medications were used in 45% of patients with a pressure sore. The overall prevalence of pressure sore is close (or even inferior) to that observed in similar studies. However, variation between hospitals indicates that the current health services ability to deal with pressure sore is variable and often suboptimal. This evaluation is also supported by the limited adoption of adequate preventive and curative modalities.

To assess the impact of health professionals' involvement in the implementation of practice guidelines aimed at reducing the use of pre-operative tests in patients at low anaesthetic risk undergoing elective surgery.A 6 month (September 1997 to February 1998) strategy based upon organization of local meetings involving health professionals from six hospitals of Canton Ticino (Switzerland).Observational study (pre/post) of pre-operative test utilization between March 1996 and December 1998.A total of 17,978 patients admitted for elective surgery over the study period. The latter was modelled in six intervals, three before (baseline), one during, and two after (adoption) guidelines implementation, respectively. For each time interval the proportion of patients undergoing pre-operative tests was estimated. Multilevel logistic regression analysis was used to assess patient likelihood [expressed as the odds ratio (OR)] of undergoing a diagnostic test in each period, using the implementation interval as the reference category.Change in patient probability of undergoing pre-operative tests in the adoption interval.Adoption of the recommendations was associated with 81% [OR = 0.19; 95% confidence interval (CI) 0.15-0.23] reduction of patient probability of undergoing coagulation test, 73% (OR = 0.27; 95% CI 0.23-0.33) for glycaemia, 62% (OR = 0.38; 95% CI 0.33-0.44) for azotaemia, 57% (OR = 0.43; 95% CI 0.36-0.51) for chest X-ray, 49% (OR = 0.51; 95% CI 0.44-0.60) for creatinemia, and 43% (OR = 0.57; 95% CI 0.48-0.69) for ECG. Overall, these findings corresponded to a cost saving of 67,890 Swiss francs (US$42,000) for the last quarter under study.This study indicates that an implementation strategy based upon direct involvement of end users in the identification of possible barriers to change can be successful in promoting the use of practice guidelines.