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Objectives To review the evidence of the effects of centralization of cancer surgery on postoperative mortality. Methods We searched Medline, Embase, Cinahl, Cochrane and Scopus (up to November 2019) for studies that (i) assessed the effects of centralization of cancer surgery policies on in-hospital or 30-day mortality, or (ii) described changes in both postoperative mortality for a surgical intervention and degree of centralization using reduction in the number of hospitals or increases in the proportion of patients undergoing cancer surgery at high volume hospitals as proxy. PRISMA guidelines were followed. We estimated pooled odds ratios (OR) and conducted meta-regression to assess the relationship between degree of centralization and mortality. Results A total of 41 studies met our inclusion criteria of which 15 evaluated the effect of centralization policies on postoperative mortality after cancer surgery and 26 described concurrent changes in the degree of centralization and postoperative mortality. Policy evaluation studies mainly used before-after designs (n = 13) or interrupted time series analysis (n = 2), mainly focusing on pancreatic, oesophageal and gastric cancer. All but one showed some degree of reduction in postoperative mortality, with statistically significant effects demonstrated by six studies. The pooled odds ratio for centralization policy effect was 0.68 (95% Confidence interval: 0.54–0.85; I2 = 80%). Meta-regression analysis of the 26 descriptive studies found that an increase of the proportion of patients treated at high volume hospitals was associated with greater reduction in postoperative mortality. Conclusions Centralization of cancer surgery is associated with reduced postoperative mortality. However, existing evidence tends to be of low quality and estimates of the effect size are likely inflated. There is a need for prospective studies using more robust approaches, and for centralization efforts to be accompanied by well-designed evaluations of their effectiveness.

We are presenting here the findings of the reaction to the COVID-19 epidemic during the period March to June 2020 of those centres participating in the research EASY-NET which is on-going in Italy, funded by the Ministry of Health and co-founded by the Regional Health Authorities. The objective of EASY-NET is to evaluate the effectiveness of the audit and feedback (AF) strategies in different clinical and organizational settings in seven regions. As a negative consequence of the COVID-19 epidemic, the activities of the project have suddenly slowed down; nevertheless, the COVID-19 epidemic represented an opportunity to apply the AF methodology and support the healthcare within the regional authorities in order to manage and monitor the impact of this new disease. The reaction to the crisis on behalf of EASY-NET was inconsistent across the participating regions for various reasons. Factors which influenced the reaction levels in relation to the rapidity and efficiency of the implementation of the AF strategies were as follows: the varying epidemiological impact of the COVID-19 epidemic in the various territories, the different clinical and organizational context and availability of expert research teams together with AF procedures which had already been tested before the start of the epidemic.

The first of a series of four online meetings entitled "AF CONNECTIONS. In practice and in response to Covid-19", as part of the EASY-NET network program on the topic of AuditFeedback (AF), was an opportunity to present and discuss the first results of a survey carried out by the area working on AF, to describe the characteristics of AF interventions in the EASY-NET context. A reflection on the preliminary results of the investigation and on the cultural dimension of the importance of creating a bridge between the world of clinicians and the world of epidemiology, for a real and virtuous exchange of information.

Pancreatic cancer is one of the most lethal tumours, and it is the fourth cause of cancer death in Europe. Despite its important public health impact, no effective treatments exist, nor are there high-visibility research efforts to improve care. This alarming situation is emblematic of a larger group of cancer diseases, known as neglected cancers. To address the impact of these diseases, the European Commission-supported Innovative Partnership for Action Against Cancer launched a multi-stakeholder initiative to determine key steps that healthcare systems can rapidly implement to improve their response. A working group comprising 20 representatives from European medical societies, patient associations, cancer plan organisations and other relevant European healthcare stakeholders was organised. A consensus process based on the results of different studies, discussion of research outcomes, and development and endorsement of draft statements resulted in 22 consensus recommendations (the Bratislava Statement). The statement argues that substantial improvements can be achieved in patient outcomes by centralising pancreatic cancer care around state-of-the-art reference centres, staffed by expert multidisciplinary teams capable of providing high-quality care. This organisational model requires a specific care framework encompassing primary, palliative and survivorship care, and a policy environment prioritising the use of quality criteria and performance assessments as well as research investments dedicated to prevention, risk prediction, early detection and diagnosis. In order to address the challenges posed by neglected cancers in general and pancreatic cancer in particular, a specific control strategy tailored to this reality is required.

The overuse of health care interventions is a problem which has clinical and economic implications. On a clinical level this means that ineffective interventions or effective interventions in inappropriate clinical indications are used. On an economic level it refers to allocative inefficiency which implies that these resources could possibly be used for interventions of major clinical utility. The contribution of health professionals in the context of reallocation disinvestment policies is still little investigated. This study involved 25 neurologists in the process of identifying low value interventions in the management of stroke, dementia, Parkinson's disease, amyotrophic lateral sclerosis and multiple sclerosis.The Nominal Group Technique was applied in the context of 5 Focus Groups (FG) in order to reach a consensus to identify and prioritize disinvestment opportunities in the treatment of the 5 neurodegenerative diseases. Qualitative data were coded, categorised, and analysed, applying the six-phase approach to thematic analysis, with the support of Atlas Ti7.Within 5 categories of "low value intervention", 25 clinical interventions were identified: 6 pharmacological, 16 diagnostic, 3 clinical-therapeutic. FG findings describe: how clinicians view the issue of disinvestment, both in absolute and relative terms; the factors which contribute to the use of low-value interventions; the explicit link between the disinvestment process and the reallocation of resources.This study revealed that factors that hinder the disinvestment of inappropriate practices involve elements that are not only technical or clinical, but also relational and care-related contexts.

Background The current economic context calls for rationalizing health resources that can be pursued through disinvestment from low value health technologies to invest in the best performing ones, ensuring high healthcare quality. Oncology is a field where, because of high costs of health technologies and rapid innovation, disinvestment is crucial. Methods On this basis, the research team investigated through a survey, based on a questionnaire, opinions and views of representatives of European countries about disinvestment, in terms of fields of application, potential advocates and barriers, specifically focusing on cancer care. Results A total of 17 questionnaires were filled in (response rate: 32.1%). The survey showed disinvestment is applied in several countries as a tool for containing health care expenditures and identifying obsolete technologies/ineffective interventions. Clinicians' resistance to change and industries' opposition are recognized as the most important barriers to the implementation of disinvestment policies. Potential targets of disinvestment in cancer are seen in diagnostic and therapeutic areas. Conclusion Despite the agreement on fields of waste and of disinvestment policies, operational methods to put disinvestment in place are lacking. Since they should rely on an inclusive assessment of the technology, Health Technology Assessment may represent a good approach.

Objectives We performed data collection concerning the coronavirus disease 2019 (COVID-19) pandemic-related delay in the diagnosis of cancers to individuate proper corrective procedures. Methods A comparison was made among the number of first pathologic diagnoses of malignancy made from weeks 11 to 20 of 2018, 2019, and 2020 at seven anatomic pathology units serving secondary care hospitals in northern-central Italy. Results Cancer diagnoses fell in 2020 by 44.9% compared with the average number recorded in 2018 and 2019. Melanoma and nonmelanoma skin cancer represented 56.7% of all missing diagnoses. The diagnostic decrease in colorectal (–46.6%), prostate (–45%), and bladder (–43.6%) cancer was the most relevant among internal malignancies; for prostate, however, high-grade tumors were only moderately affected (–21.7%). Conclusions Diagnosis of cutaneous malignancies was mostly affected by the lockdown; among internal malignancies, corrective actions were mostly needed for colorectal cancer and invasive bladder cancer.

Health services overuse has been acknowledged as a relevant policy issue. In this study, we assessed the informative value of research on the quality of cancer care, exploring to what extent it is actually concerned with care overuse, thus providing policy-makers with sound estimates of overuse prevalence. We searched Medline for European studies, reporting information on the rate of use of diagnostic or therapeutic procedures/interventions in breast, colorectal, lung and prostate cancer patients, published in English between 2006 and 2016. Individual studies were classified with regards to their orientation towards overuse according to the quality metrics adopted in assessing rates of use of procedures and interventions. Out of 1882 papers identified, 100 accounting for 94 studies met our eligibility criteria, most of them on breast (n = 38) and colorectal (n = 30) cancer. Of these, 46 (49%) studies relied on process indicators allowing a direct measure of under- or overuse, the latter being addressed in 22 (24%) studies. Search for overuse in patterns of care did not increase over time, with overuse being measured in 24% of the studies published before 2010, and in only 13% of those published in 2015–2016. Information on its prevalence was available only for a relatively limited number of procedures/interventions. Overall, estimates of overuse tended to be higher for diagnostic procedures (median prevalence across all studies, 24%) than for drugs, surgical procedures or radiotherapy (median overuse prevalence always lower than 10%). Despite its increasing policy relevance, overuse is still an often overlooked issue in current European research on the quality of care for cancer patients. Electronic supplementary material The online version of this article (10.1186/s12961-018-0287-z) contains supplementary material, which is available to authorized users.

Aims and background This study examines the patterns of follow-up care for breast cancer survivors in one region in Italy. Methods and study design This retrospective analysis included 10,024 surgically treated women, with incident cases of breast cancer in the years 2002–2005 who were alive 18 months after their incidence date. Rates of use of follow-up mammograms, abdominal echogram, bone scans and chest x-rays were estimated from administrative data and compared by Local Health Unit (LHU) of residence. Logistic regression analyses were performed to assess possible “overuse”, accounting for patient age, cancer stage, type of surgery and LHU of residence. Results A total of 7168 (72.1%) women received a mammogram within 18 months of their incidence date, while 6432 (64.2%) had an abdominal echogram, 3852 (38.4%) had a bone scan and 5231 (52.2%) had a chest x-ray. The rates of use of abdominal echograms, bone scans and chest x-rays were substantially higher in the population of breast cancer survivors than in the general female population. Taking account of patient age, cancer stage at diagnosis and type of surgery, multivariate analyses demonstrated significant variation in the use of these tests by LHU of residence. Conclusions The observed variation in the use of abdominal echograms, bone scans and chest x-rays supports the conclusion that there is substantial misuse of these tests in the population of postsurgical breast cancer patients in the Emilia-Romagna region in Italy. In the absence of a documented survival benefit, overtesting has both a human and financial cost. We recommend additional review of the methods of follow-up care in breast cancer patients in the LHUs of Emilia-Romagna, with the aim of developing, disseminating and evaluating the implementation of specific guidelines targeting primary care physicians and oncologists providing care to breast cancer survivors. Patient education materials may also help to reduce unnecessary testing.

To investigate the predictive value of 64-slice computed tomography coronary angiography (CTCA) for major adverse cardiac events (MACEs) in patients with suspected or known coronary artery disease (CAD).Seven hundred and sixty-seven consecutive patients (496 men, age 62±11 y) with suspected or known heart disease referred to an outpatient clinic underwent 64-slice CTCA. The patients were followed for the occurrence of MACE (ie, cardiac death, nonfatal myocardial infarction, unstable angina).Eleven thousand five hundred and sixty-four coronary segments were assessed. Of these, 178 (1.5%) were not assessable because of insufficient image quality. Overall, CTCA revealed the absence of CAD in 219 (28.5%) patients, nonobstructive CAD (coronary plaque ≤50%) in 282 (36.8%) patients, and obstructive CAD in 266 (34.7%) patients. A total of 21 major cardiac events (4 cardiac deaths, 12 myocardial infarctions, and 5 unstable angina) occurred during a mean follow-up of 20 months. One noncardiac death occurred. Seventeen events occurred in the group of patients with obstructive CAD, and 4 events occurred in the group with nonobstructive CAD. The event rate was 0% among patients with normal coronary arteries at CTCA. In multivariate analysis, the presence of obstructive CAD and diabetes were the only independent predictors of MACE.Coronary plaque evaluation by CTCA provides an independent prognostic value for the prediction of MACE. Patients with normal CTCA findings have an excellent prognosis at follow-up.

Aims and background The study evaluated the use of Italian hospital discharge data (SDO, scheda di dimissione ospedaliera) for identifying women with incident breast cancer, determining stage at diagnosis and assessing quality of care. Study design Women aged 20+ years residing in the Regione Emilia-Romagna, Italy, between 2002 and 2005 were studied. Case identification using algorithms based on ICD-9-CM codes on hospital discharge data were compared with AIRTUM-accredited cancer registry data. Sensitivity, specificity and positive predictive value were computed overall, by age and cancer stage. Compliance with guidelines for radiation therapy using registry and hospital data were compared. Results A total of 11,615 women was identified by AIRTUM-accredited cancer registries as incident cases, whereas 10,876 women were identified by the SDO algorithm. Sensitivity was 84.8%, specificity was 99.9%, and the positive predictive value was 90.6%. Of the 1,022 who were false positives, 363 (35.5%) were women identified in registry data as having an incident case prior to 2002 and therefore were not included in the analysis. There were 1,761 false negatives; nearly 50% were over 70 years of age or did not undergo a surgical procedure and therefore were not included in our SDO-based case finding. Sensitivity declined as the patient population became older. However, we observed relatively good positive predictive value for all age groups. Algorithms using the SDO data did not clearly identify specific cancer stages. However, the algorithm may have utility where stages are grouped together for use in quality measures. Conclusions Cases were identified with good sensitivity, specificity and positive predictive value with SDO data, with better rates than similar previously published algorithms based on Italian data. These hospital claims-based algorithms facilitate quality of care analyses for large populations when registry data are not available by identifying individual women and their subsequent use of health care services.

Aims To evaluate the clinical impact of early administration of glycoprotein IIb/IIIa agents (IIb/IIIa agents) in the context of a dedicated hub and spoke network allowing very prompt pharmacological/mechanical interventions. Methods and results Using a prospective database, we conducted a cohort study of ST-elevation myocardial infarction (STEMI) patients ( n = 1124) undergoing primary percutaneous coronary interventions (PPCIs) and IIb/IIIa agents administration (period, 2003–2006). Comparisons were planned between patients receiving early IIb/IIIa agents administration (in hub/spoke centre emergency departments or during ambulance transfer; early group, n = 380) or delayed administration (in the catheterization laboratory; late group, n = 744). The primary outcome measure was long-term overall mortality/re-infarction. Baseline characteristics of the two groups were largely comparable. Angiographically, early group patients more often achieved pre-PPCI TIMI Grade 2–3 and TIMI Grade 3 flow. Clinically, the early administration group experienced lower 2-year risk of unadjusted mortality/re-infarction (17 vs. 23%; P = 0.01). After adjustment for potential confounders, early administration was associated with favourable outcome in the overall population (HR = 0.71, P = 0.03) and in high-risk subgroups (TIMI risk index >25, HR = 0.64, P = 0.02; Killip class >1, HR = 0.54, P = 0.01). Conclusion In patients treated by PPCI within a STEMI network setting, early administration of IIb/IIIa agents may provide long-term clinical benefits. Notably, these results appeared magnified in high-risk patients.

Percutaneous revascularization of saphenous vein grafts (SVGs) remains a challenging task. Drug-eluting stents (DESs) have been shown to decrease the incidence of restenosis in de novo native coronary artery lesions. However, their clinical value in SVGs remains to be established. We compared long-term clinical outcomes of percutaneous coronary intervention with DESs and bare metal stents (BMSs) for de novo lesions in SVGs. In a large prospective, multicenter registry, 360 patients underwent stenting of a de novo lesion in SVGs using BMSs (288 patients) or DESs (72 patients). Incidence of major adverse cardiac events (MACEs), including all-cause mortality, reinfarction, and target vessel revascularization, was recorded at a 12-month follow-up. Compared with the DES group, patients receiving BMSs were more likely to be men, to have chronic renal insufficiency or higher Charlson scores, but less likely to have undergone previous percutaneous coronary intervention. Incidence of MACEs at 12-month follow-up was similar in the 2 groups (17.8% in DES group vs 20.3% in BMS group, respectively, p = 0.460). Cox regression analysis identified age, chronic renal failure, cardiogenic shock at presentation, and ostial location of stenosis as independent predictors of long-term MACEs. In conclusion, our data suggest that rates of 12-month MACEs associated with the use of DESs and BMSs are similar in patients undergoing treatment of de novo lesions in SVGs.

Background— The long-term effectiveness of drug-eluting stents (DES) in unselected diabetics in routine practice is currently unclear. Methods and Results— To evaluate the long-term effectiveness of bare metal stents and DES in a real-world setting of diabetic patients, we analyzed 2-year follow-up data from all diabetic patients with de novo lesions enrolled in a prospective Web-based multicenter registry (Registro Regionale Angioplastiche dell’Emilia-Romagna; study period, 2002 to 2004) comprising all 13 hospitals performing percutaneous coronary interventions in the Emilia-Romagna region of Italy. Among the 1648 eligible patients treated with either bare metal stents alone (n=1089) or DES alone (n=559), 27% were insulin dependent and 83% had multivessel coronary disease. At 2 years, use of DES was associated with lower crude incidence of major adverse cardiac advents (all-cause mortality, nonfatal myocardial infarction, and target vessel revascularization) compared with bare metal stents (22.5% versus 28.1%; P =0.01). After propensity score adjustment, only target vessel revascularization appeared significantly lower in the DES group (11.6% versus 15.0%; hazard ratio, 0.66; 95% confidence interval, 0.46 to 0.96; P =0.041). Two-year angiographic stent thrombosis occurred in 1.5% DES patients and 0.7% of the bare-metal-stents patients ( P =0.18). At Cox regression analysis, predictors of 2-year major adverse cardiac advents were left ventricular ejection fraction Conclusions— In this large, real-world, diabetic population, the use of DES was associated with a moderate reduction in the 2-year risk of target vessel revascularization, a benefit that was limited to non–insulin-dependent diabetic patients. Larger long-term studies are needed to clarify the long-term effectiveness and safety of such devices in diabetic patients.

Multislice Spiral Computed Tomography (MSCT) is an emerging non-invasive diagnostic modality to detect coronary artery disease, which may alter diagnostic pathways and change the current clinical role of conventional coronary angiography. Aims: To retrieve and critically assess information from the available literature on MSCT (>= 16-slice) concerning its diagnostic accuracy, safety, applicability, clinical impact and cost-effectiveness. Methods and results: Articles published between January 2002 and March 2007 were identified through searches of the Cochrane Library, MEDLINE, and other websites of manufacturers, cardiac professional societies, guidelines and abstracts from conference meetings. We identified 1768 potentially relevant articles: 262 out of these were considered eligible for full evaluation and 150 were selected ( 57 assessed diagnostic accuracy, 130 applicability, 103 safety, 1 clinical impact and none cost-effectiveness). The pre test probability of coronary artery disease was 56.7% (95% Confidence Interval: 55.1%-58.3%). A positive MSCT finding (pooled LR+: 5.4 (4.4-6.7)) increased the probability of CAD to 87.7% (84.3%-90.3%), whereas a negative MSCT result ( pooled LR-: 0.09 (0.07-0.12)) reduced the probability of CAD to 10.7% (7.9%-14.4%). Conclusions: MSCT is a promising technology for the assessment of coronary artery stenosis. However, the available literature is of limited value in providing guidance to support the development of policies for its appropriate utilization in clinical practice. (c) 2008 Elsevier Ireland Ltd. All rights reserved.

Aims To evaluate the predictive value of high sensitivity (hs) C-reactive protein levels on long-term survival in patients with ST-elevation myocardial infarction (STEMI) treated with primary PCI. Methods and results We conducted a retrospective analysis of 758 STEMI patients (from January 2003 to December 2005), with STEMI onset < 12 h and hs-C-reactive protein determination on admission. Patients were classified into four groups [I (hs-C-reactive protein < 0.48 mg/dL), II (hs-C-reactive protein ≥ 0.48 to < 1.2 mg/dL), III (hs-C-reactive protein ≥ 1.2 to < 3.1 mg/dL), IV (hs-C-reactive protein ≥ 3.1 mg/dL)] according to quartiles of hs-C-reactive protein serum level. The IV quartile hs-C-reactive protein group had a higher incidence of in-hospital mortality and cumulative adverse events. At a mean follow-up of 724 ± 376 days (range 0–1393), the IV quartile hs-C-reactive protein group showed lower estimated survival, lower estimated myocardial infarction-free survival and lower estimated event-free survival. At multivariable analysis hs-C-reactive protein appeared to be an independent predictor of long-term mortality (HR: 1.04, 95% CI: 1.01–1.07, P = 0.003), long-term mortality and re-infarction (HR: 1.03, 95% CI: 1.01–1.06, P = 0.008) and adverse events (HR: 1.03, 95% CI: 1.01–1.05, P = 0.03). Conclusion Evaluation of hs-C-reactive protein on admission in STEMI patients undergoing primary PCI allows reliable risk stratification of these patients.

Background— The long-term safety and efficacy of drug-eluting stents (DES) have been questioned recently. Methods and Results— Between July 2002 and June 2005, 10 629 patients undergoing elective percutaneous coronary intervention with either DES (n=3064) or bare-metal stents (BMS, n=7565) were enrolled in a prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (death, acute myocardial infarction, and target-vessel revascularization) and angiographic stent thrombosis during 2-year follow-up. A propensity score analysis to adjust for different baseline clinical, angiographic, and procedural characteristics was performed. The 2-year unadjusted cumulative incidence of major adverse cardiac events was 17.8% in the DES group and 21.0% in the BMS group ( P =0.003 by log-rank test). Angiographic stent thrombosis was 1.0% in the DES group and 0.6% in the BMS group ( P =0.09). After adjustment, the 2-year cumulative incidence of death was 6.8% in the DES group and 7.4% in the BMS group ( P =0.35), whereas the rates were 5.3% in DES and 5.8% in BMS for acute myocardial infarction ( P =0.46), 9.1% in DES and 12.9% in BMS for target-vessel revascularization ( P P Conclusions— In this large real-world population, the beneficial effect of DES in reducing the need for new revascularization compared with BMS extends to 2 years without evidence of a worse safety profile.

The Emilia-Romagna Programme for Research and Innovation "PRIER" was born in 2005 with the aim of increasing cultural and operational conditions for the development of clinical research, useful both to the Regional Health Service (SSR) and to the private sectors of pharmaceutical and biomedical areas. In this context, the PRIER had from the beginning a double connotation: a space where the SSR can explore issues related to the development of its own research capacity; and a context where new possible ways of relating and comparison with the pharmaceutical and biomedical industry are tested. Over the years the activities of PRIER were defined by: initiatives to strengthen the system of research in SSR; development of tools to monitor activities of the research; production of clinical-organizational recommendations for the governance of innovation. In 2013 a new area of discussion and a common interest have been identified on the subject of clinical registries. In particular, it wanted to build a path of work able to identify all the possible critical and relevant points (points to consider), indispensable, necessary or useful to the construction and use of clinical registries, taking into account the points of view of all actors involved. The course began with defining the rules of the game and continued with workshops that allowed to analyse together the matter. At the end of the second workshop it was decided to make the work carried out visible: first, not to miss the opportunity offered by the past but recent discussion; secondly, to facilitate the discussion both on the issue of registers and to the adopted methodology, which sees the different actors (public and private ones) to reason together in a context for once not influenced by necessities of negotiation and government resources.

Long waiting times for elective healthcare procedures may cause distress among patients, may have adverse health consequences and may be perceived as inappropriate delivery and planning of health care.To assess the effectiveness of interventions aimed at reducing waiting times for elective care, both diagnostic and therapeutic.We searched the following electronic databases: Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1946-), EMBASE (1947-), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), ABI Inform, the Canadian Research Index, the Science, Social Sciences and Humanities Citation Indexes, a series of databases via Proquest: DissertationsTheses (including UKIreland), EconLit, PAIS (Public Affairs International), Political Science Collection, Nursing Collection, Sociological Abstracts, Social Services Abstracts and Worldwide Political Science Abstracts. We sought related reviews by searching the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effectiveness (DARE). We searched trial registries, as well as grey literature sites and reference lists of relevant articles.We considered randomised controlled trials (RCTs), controlled before-after studies (CBAs) and interrupted time series (ITS) designs that met EPOC minimum criteria and evaluated the effectiveness of any intervention aimed at reducing waiting times for any type of elective procedure. We considered studies reporting one or more of the following outcomes: number or proportion of participants whose waiting times were above or below a specific time threshold, or participants' mean or median waiting times. Comparators could include any type of active intervention or standard practice.Two review authors independently extracted data from, and assessed risk of bias of, each included study, using a standardised form and the EPOC 'Risk of bias' tool. They classified interventions as follows: interventions aimed at (1) rationing and/or prioritising demand, (2) expanding capacity, or (3) restructuring the intake assessment/referral process.For RCTs when available, we reported preintervention and postintervention values of outcome for intervention and control groups, and we calculated the absolute change from baseline or the effect size with 95% confidence interval (CI). We reanalysed ITS studies that had been inappropriately analysed using segmented time-series regression, and obtained estimates for regression coefficients corresponding to two standardised effect sizes: change in level and change in slope.Eight studies met our inclusion criteria: three RCTs and five ITS studies involving a total of 135 general practices/primary care clinics, seven hospitals and one outpatient clinic. The studies were heterogeneous in terms of types of interventions, elective procedures and clinical conditions; this made meta-analysis unfeasible.One ITS study evaluating prioritisation of demand through a system for streamlining elective surgery services reduced the number of semi-urgent participants waiting longer than the recommended time (90 days) by 28 participants/mo, while no effects were found for urgent (30 days) versus non-urgent participants (365 days).Interventions aimed at restructuring the intake assessment/referral process were evaluated in seven studies. Four studies (two RCTs and two ITSs) evaluated open access, or direct booking/referral: One RCT, which showed that open access to laparoscopic sterilisation reduced waiting times, had very high attrition (87%); the other RCT showed that open access to investigative services reduced waiting times (30%) for participants with lower urinary tract syndrome (LUTS) but had no effect on waiting times for participants with microscopic haematuria. In one ITS study, same-day scheduling for paediatric health clinic appointments reduced waiting times (direct reduction of 25.2 days, and thereafter a decrease of 3.03 days per month), while another ITS study showed no effect of a direct booking system on proportions of participants receiving a colposcopy appointment within the recommended time. One RCT and one ITS showed no effect of distant consultancy (instant photography for dermatological conditions and telemedicine for ear nose throat (ENT) conditions) on waiting times; another ITS study showed no effect of a pooled waiting list on the number of participants waiting for uncomplicated spinal surgery.Overall quality of the evidence for all outcomes, assessed using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) tool, ranged from low to very low.We found no studies evaluating interventions to increase capacity or to ration demand.As only a handful of low-quality studies are presently available, we cannot draw any firm conclusions about the effectiveness of the evaluated interventions in reducing waiting times. However, interventions involving the provision of more accessible services (open access or direct booking/referral) show some promise.

Background: Health care organizations are pressured to improve the cost-effectiveness of service delivery. Clinical governance is an important trigger to improve care quality and safety and rank high in the reform agenda of health systems. The senior management team culture plays a major role in establishing clinical governance practices, because it strongly influences the values, attitudes, and behaviors of the members of an organization. Purposes: The aim of this study was to investigate the relationship between senior management team culture and clinical governance in the public health care organizations of three Italian regions. Methodology: The assessment of senior management culture was conducted using the Competing Values Framework and a corresponding instrument adapted for the Italian context. Clinical governance was assessed using an ad hoc instrument focused on the senior management team's perception and attitude toward clinical governance. Findings: The survey achieved a 54% response rate. The results of four different models demonstrate that organizations characterized by different dominant cultures are associated with significant differences in attitudes toward clinical governance. In particular, on average, dominant cultures with a prevailing external focus are associated with a more positive attitude toward clinical governance. Practice Implications: The selection and appointments of top managers should consider the style of leadership that is most apt to facilitate the growth of rational and developmental cultures. Furthermore, the training of top managers and leading doctors should reinforce leadership aptitude and approaches that are consistent with the desired organizational cultures.

We evaluated the clinical effect of selective use of sirolimus-eluting stents (SESs) in real-world, high-risk patients. A total of 4,237 consecutive patients who underwent percutaneous coronary intervention (SES, n = 872, bare metal stents [BMSs], n = 3,365) was enrolled in a prospective regional survey. A prespecified high-risk subset of patients was selected on the basis of clinical and angiographic characteristics. A propensity score analysis was performed to compare patients who received SESs with those who received BMSs. Patients in the SES group more often had diabetes and more frequently had previous myocardial infarction or coronary revascularization, type C lesions, and multivessel procedures. Patients who presented with acute myocardial infarction were treated more often with BMSs. At 9 months, the use of SESs was associated with fewer major adverse cardiac events (death, myocardial infarction, or target lesion revascularization; hazard ratio 0.56, 95% confidence interval 0.37 to 0.85) and target lesion revascularizations (hazard ratio 0.43, 95% confidence interval 0.20 to 0.91). This decrease was more evident in a prespecified high-risk subgroup of patients (major adverse cardiac events, 8.0% SES vs 15.6% BMS, hazard ratio 0.45, 95% confidence interval 0.29 to 0.72). We conclude that selective SES use in real-world patients who have high-risk clinical and angiographic characteristics is associated with significant decreases in major adverse cardiac events and repeat revascularizations compared with BMS use.

Objectives:To assess the impact of the availability of drug-eluting stents (DES) in April 2002 in Emilia-Romagna (a four-million resident Italian region), on the rate of use of revascularization procedures. DES are expected to influence the rate of use of coronary artery bypass graft (CABG) and percutaneous coronary interventions (PCI). However, to date, little empirical information is available on the actual impact of this innovation on clinical practice.Methods:A time series regression analysis of the monthly number of procedures (PCI and CABG) performed between January 1998 and March 2003.Results:DES availability was associated with statistically significant changes in the use of revascularization procedures, although the size of the effect was always small or moderate. PCI increased only by 0.36 more procedures per month (approximately four per year), whereas more evident was the concurrent reduction of isolated CABG (4.15 fewer per month, that is fifty fewer per year). Overall, considering all the surgical revascularizations (i.e., CAGB both isolated and associated with other interventions), there was a reduction of 2.52 procedures per month (thirty less per year).Conclusions:Despite DES being at a very early stage of their diffusion process, our results indicate that they are already having an impact, although moderate, on the use of revascularization procedures. If these findings will be confirmed, they will have a substantial influence on the patterns of care for patients with coronary artery disease and relevant policy implications for health services.

Objectives Develop predictive models using an administrative healthcare database that provide information for Patient-Centred Medical Homes to proactively identify patients at risk of hospitalisation for conditions that may be impacted through improved patient care. Design Retrospective healthcare utilisation analysis with multivariate logistic regression models. Data A population-based longitudinal database of residents served by the Emilia-Romagna, Italy, health service in the years 2004–2012 including demographic information and utilisation of health services by 3 726 380 people aged ≥18 years. Outcome measures Models designed to predict risk of hospitalisation or death in 2012 for problems that are potentially avoidable were developed and evaluated using the area under the receiver operating curve C-statistic, in terms of their sensitivity, specificity and positive predictive value, and for calibration to assess performance across levels of predicted risk. Results Among the 3 726 380 adult residents of Emilia-Romagna at the end of 2011, 449 163 (12.1%) were hospitalised in 2012; 4.2% were hospitalised for the selected conditions or died in 2012 (3.6% hospitalised, 1.3% died). The C-statistic for predicting 2012 outcomes was 0.856. The model was well calibrated across categories of predicted risk. For those patients in the highest predicted risk decile group, the average predicted risk was 23.9% and the actual prevalence of hospitalisation or death was 24.2%. Conclusions We have developed a population-based model using a longitudinal administrative database that identifies the risk of hospitalisation for residents of the Emilia-Romagna region with a level of performance as high as, or higher than, similar models. The results of this model, along with profiles of patients identified as high risk are being provided to the physicians and other healthcare professionals associated with the Patient Centred Medical Homes to aid in planning for care management and interventions that may reduce their patients’ likelihood of a preventable, high-cost hospitalisation.

Objectives Italian regional health authorities annually negotiate the number of residency grants to be financed by the National government and the number and mix of supplementary grants to be funded by the regional budget. This study provides regional decision-makers with a requirement model to forecast the future demand of specialists at the regional level. Methods We have developed a system dynamics (SD) model that projects the evolution of the supply of medical specialists and three demand scenarios across the planning horizon (2030). Demand scenarios account for different drivers: demography, service utilization rates (ambulatory care and hospital discharges) and hospital beds. Based on the SD outputs (occupational and training gaps), a mixed integer programming (MIP) model computes potentially effective assignments of medical specialization grants for each year of the projection. Results To simulate the allocation of grants, we have compared how regional and national grants can be managed in order to reduce future gaps with respect to current training patterns. The allocation of 25 supplementary grants per year does not appear as effective in reducing expected occupational gaps as the re-modulation of all regional training vacancies. Electronic supplementary material The online version of this article (doi:10.1186/1478-4491-13-7) contains supplementary material, which is available to authorized users.

Summary Objective To assess the impact of specialization on processes and outcomes of care for cancer patients. Data source Papers published in English between 1980 and 1995 and identified through MEDLINE and Embase (MeSH terms: NEOPLASM (exploded), and PHYSICIAN PRACTICE PATTERNS (or DECISION MAKING, ATTITUDE OF HEALTH PERSONNEL, QUALITY OF HEALTH CARE, DELIVERY OF HEALTH CARE, HEALTH EDUCATION or OUTCOME ASSESSMENT HEALTH CARE), or through the reference lists of review articles. Study selection Studies providing information on the association between quality of care indicators for cancer patients and clinician/centre degree of specialization. A total of 47 papers concerning 46 empirical studies were considered. Data extraction For studies using process of care indicators, the proportion of specific procedures performed by specialists and non-specialists was abstracted. For studies using outcome indicators (e.g., mortality), the effect of specialization was quantified in terms of odds ratio (OR) expressing relative reduction in risk of death. The quality of individual studies using process or outcome indicators was assessed according to study design, avoidance of selection bias in patient identification and data analysis, degree of adjustment of the comparison between clinicians/centres with different levels of specialization. Data synthesis Specialized centres/clinicians fared better both when process and outcome indicators were used. While the former varied widely in different studies and their clinical relevance was often questionable, mortality was consistently lower when care was provided by specialized centres/clinicians, with the effect size being greater in smaller studies. For breast cancer, where all the studies were of sufficiently good quality, a pooled estimate of the effect of specialization was performed which showed that specialized cancer care was associated with an 18% (95% CI: 12%–23%) reduction in mortality. Conclusions Despite the fact that care provided by specialized centres/clinicians appeared to be better both when assessed in relation to process indicators and to mortality, this evidence should be considered far from conclusive because of major methodological flaws in these studies. Relative to current efforts to promote evidence-based policy-making, this review underscores the limited capability of scientific information to provide reliable guidelines for structuring better health care systems.

The widespread implementation of rationing and priority-setting policies in health care opposes the stochastic practice of medicine induced by professional uncertainty and professional vested interests in market-oriented clinical environments. It also clashes with consumers' overly optimistic and “mythical” view of the effectiveness of medicine, which is bound to support a potentially unlimited provision of health services. Thus, for consumers and society at large, it is necessary to create conditions favorable for a more conscious demand of evidence-based health care. In pursuit of this goal, we suggest the adoption of a community-oriented strategy based upon delivery of information to the public in order a) to generate greater awareness (“healthy skepticism”) among consumers, through disclosure of data on the true effectiveness of health care interventions and on the existing variation in their utilization, and b) to provide tools to empower consumers in dealing better with both the uncertainty in their own individual patient-physician relationships and with the health policy issues to be faced in the future. Such a community-oriented strategy could also reinforce and support, through the generation of a “bottom-up” pressure from consumers toward physicians, a wider adoption of evidence-based interventions by health care professionals. This paper, using data from surveys on public opinions and attitudes toward the practice of medicine, focuses on how consumer demand for more evidence-based medical practice can be promoted.

Background: The study compares five-year clinical outcomes of CABG vs PCI in a real world population of diabetic patients with multivessel coronary disease since it is not clear whether to prefer surgical or percutaneous revascularization. Methods: Between July 2002 and December 2008, 2885 multivessel coronary diabetic patients underwent revascularization (1466 CABG and 1419 PCI) at hospitals in Emilia-Romagna Region, Italy and were followed for 1827±617 days by record linkage of two clinical registries with the regional administrative database of hospital admissions and the mortality registry. Five-year incidences of MACCE (mortality, acute myocardial infarction [AMI], stroke, and repeat revascularization [TVR]) were assessed with Kaplan-Meier estimates, Cox proportional hazards regression and cumulative incidence functions of death and TVR, to evaluate the competing risk of AMI on death and TVR. The same analyses were applied to the propensity score matched subgroup of patients undergoing CABG or PCI with DES and with complete revascularization. Results: PCI had higher mortality for all causes (HR: 1.8, 95% CI 1.4-2.2 p

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.

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.

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.

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

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.

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.

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 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.

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.