Search

Background: Advanced Computerized Decision Support Systems (CDSSs) assist clinicians in their decision-making process, generating recommendations based on up-to-date scientific evidence. Although this technology has the potential to improve the quality of patient care, its mere provision does not guarantee uptake: even where CDSSs are available, clinicians often fail to adopt their recommendations. This study examines the barriers and facilitators to the uptake of an evidence-based CDSS as perceived by diverse health professionals in hospitals at different stages of CDSS adoption. Methods: Qualitative study conducted as part of a series of randomized controlled trials of CDSSs. The sample includes two hospitals using a CDSS and two hospitals that aim to adopt a CDSS in the future. We interviewed physicians, nurses, information technology staff and members of the boards of directors (n=30). We used a constant comparative approach to develop a framework for guiding implementation. Findings: We identified six clusters of experiences of, and attitudes towards CDSSs, which we label as ‘positions’. The six positions represent a gradient of acquisition of control over CDSSs (from low to high) and are characterized by different types of barriers to CDSS uptake. The most severe barriers (prevalent in the first positions) include clinicians’ perception that the CDSSs may reduce their professional autonomy or may be used against them in the event of medical-legal controversies. Moving towards the last positions, these barriers are substituted by technical and usability problems related with the technology interface. When all barriers are overcome, CDSSs are perceived as a working tool at the service of its users, integrating clinicians’ reasoning and fostering organizational learning. Discussion: Barriers and facilitators to the use of CDSSs are dynamic and may exist prior to their introduction in clinical contexts; providing a static list of obstacles and facilitators, irrespective of the specific implementation phase and context, may not be sufficient or useful to facilitate uptake. Factors such as clinicians’ attitudes towards scientific evidences and guidelines, the quality of inter-disciplinary relationships and an organizational ethos of transparency and accountability need to considered when exploring the readiness of a hospital to adopt CDSSs., This work is supported by the Italian Ministry of Health (GR-2009-1606736), Regione Lombardia (D.R.G. IX/4340 26/10/2012), and the Wellcome Trust (WT097899).

Background: Advanced Computerized Decision Support Systems (CDSSs) assist clinicians in their decision-making process, generating recommendations based on up-to-date scientific evidence. Although this technology has the potential to improve the quality of patient care, its mere provision does not guarantee uptake: even where CDSSs are available, clinicians often fail to adopt their recommendations. This study examines the barriers and facilitators to the uptake of an evidence-based CDSS as perceived by diverse health professionals in hospitals at different stages of CDSS adoption. Methods: Qualitative study conducted as part of a series of randomized controlled trials of CDSSs. The sample includes two hospitals using a CDSS and two hospitals that aim to adopt a CDSS in the future. We interviewed physicians, nurses, information technology staff and members of the boards of directors (n=30). We used a constant comparative approach to develop a framework for guiding implementation. Findings: We identified six clusters of experiences of, and attitudes towards CDSSs, which we label as ‘positions’. The six positions represent a gradient of acquisition of control over CDSSs (from low to high) and are characterized by different types of barriers to CDSS uptake. The most severe barriers (prevalent in the first positions) include clinicians’ perception that the CDSSs may reduce their professional autonomy or may be used against them in the event of medical-legal controversies. Moving towards the last positions, these barriers are substituted by technical and usability problems related with the technology interface. When all barriers are overcome, CDSSs are perceived as a working tool at the service of its users, integrating clinicians’ reasoning and fostering organizational learning. Discussion: Barriers and facilitators to the use of CDSSs are dynamic and may exist prior to their introduction in clinical contexts; providing a static list of obstacles and facilitators, irrespective of the specific implementation phase and context, may not be sufficient or useful to facilitate uptake. Factors such as clinicians’ attitudes towards scientific evidences and guidelines, the quality of inter-disciplinary relationships and an organizational ethos of transparency and accountability need to considered when exploring the readiness of a hospital to adopt CDSSs.

Introduction: Most patients evaluated for suspected pulmonary embolism(PE) conclude the Emergency Department(ED) work-up with a diagnosis of PE not confirmed(PE excluded;PE-E). We aimed to investigate the clinical features, short and long-term mortality, and prognostic factors for death in elderly with PE-E, and to compare these figures with those of patients with PE confirmed(PE-C). Methods: Consecutive patients ≥65 years old evaluated in the ED for clinically suspected hemodynamically stable acute PE were included in this retrospective cohort study. Results: Study population: 657 patients with suspected PE, PE-C:162(24.65%). When compared with PE-C, patients with PE-E presented a higher prevalence of chronic cardiopulmonary disease (17.37% vs 8.02%, p = 0.003), a lower prevalence of pulse rate >110 (13.13% vs 25.93%; p0 was associated with higher short and long-term mortality (30-day:HR:5.31,p = 0.029; 5 year:HR:2.18, p < 0.001), meanwhile comorbidity (Charlson Comorbidity Index>0) only with higher long-term mortality (30-day: HR:1.60, p = 0.342; 5 year: HR:1.41, p = 0.038). Conclusion: In real world haemodinamically stable elderly patients evaluated in the ED for suspected PE, short and long-term mortality was markedly high regardless whether PE was confirmed or excluded. At the time to set management and follow up strategies, elderly patients with PE excluded should not be considered a low-risk population.

Introduction The prognostic accuracy of D-dimer for risk assessment in acute Pulmonary Embolism (APE) patients may be hampered by comorbidities. We investigated the impact of comorbidity burden (CB) by using the Charlson Comorbidity Index (CCI), on the prognostic ability of D-dimer to predict 30 and 90-day mortality in hemodynamically stable elderly patients with APE. Methods All patients aged >65 years with normotensive APE, consecutively evaluated in the Emergency Department since 2010 through 2014 were included in this retrospective cohort study. Area under the curve (AUC) and ½ Net Reclassification Improvement (NRI) were calculated. Results Study population: 162 patients, median age: 79.2 years. The optimal cut-off value of CCI score for predicting mortality was ≤1 (Low CB) and >1 (High CB), AUC = 0.786. Higher levels of D-dimer were associated with an increased risk death at 30 (HR = 1.039, 95%CI:1.000–1.080, p = 0.049) and 90 days (HR = 1.039, 95%CI:1.009–1.070, p = 0.012). When added to simplified Pulmonary Embolism Severity Index (sPESI) score, D-dimer increased significantly the AUC for predicting 30-day mortality in Low CB (AUC = 0.778, 95%CI:0.620–0.937, ½NRI = 0.535, p = 0.015), but not in High CB patients (AUC = 0.634, 95%CI:0.460–0.807, ½ NRI = 0.248, p = 0.294). Similarly, for 90-day mortality D-dimer increased significantly the AUC in Low CB (AUC = 0.786, 95%CI:0.643–0.929, ½NRI = 0.424, p-value = 0.025), but not in High CB patients (AUC = 0.659, 95%CI:0.541–0.778, ½NRI = 0.354, p-value = 0.165). Conclusion In elderly patients with normotensive APE, comorbidities condition the prognostic performance of D-dimer, which was found to be a better predictor of death in subjects with low CB. These results support multimarker strategies for risk assessment in this population.

Introduction Data on medium- and long-term prognostic factors for death in elderly patients with acute Pulmonary Embolism (APE) are lacking. The present study aimed to assess sPESI score and the Charlson Comorbidity Index (CCI) as medium- and long-term predictors of mortality in elderly patients with haemodinamically stable APE. Methods All consecutive patients aged≥65 years old, evaluated at the emergency department (ED) of our hospital from 2010 through 2014, with a final diagnosis of APE, were included in this retrospective cohort study. Results Study population:162 patients, female:36.5%, median age:79 years old, 74% presented a sPESI score>0, and 61% a CCI≥ 1. All causes mortality: 19.8%, 23.5%, 26.5%, 32.1% and 48.2% at 3, 6 months, 1, 2 and 5 years after APE. Univariate regression analysis: CCI≥1 was associated with a higher mortality at 3, 6 months, 1, 2 and 5 years. Multivariate Cox analysis: CCI≥1 associated with increased mortality at 3 months (HR:4.29; IC95%:1.46–12.59), 6 months (HR:5.33; IC95%:1.84–15.44), 1 year (HR:4.87; IC95%:1.87–12.70), 2 years (HR:3.78; IC95%:1.74–8.25), and 5 years (HR:2.30; IC95%:1.33–3.99). sPESI score≥1 was not found to be related to an increased medium-or long-term mortality. Negative predictive values (IC95%) of CCI≥1 were 93.65% (87.61–99.69), 93.65% (87.61–99.69), 92.06% (85.37–98.76), 87.3% (79.05–95.55) and 71.61% (60.13–83.1) for mortality at 3, 6 months, 1, 2 and 5 years. Conclusion In elderly patients with a confirmed normotensive APE, unlike sPESI score, CCI showed to be an independent prognostic factor for medium- and long-term mortality. In these patients, after the acute phase following a PE event, the assessment of the comorbidities burden represents the most appropriate approach for predicting medium- and long-term mortality., Public health; Cardiology; Cardiovascular system; Circulatory system; Hematological system; Respiratory system; Pulmonary embolism; Mortality; Prognosis; Aged

Elderly patients presenting with acute pulmonary embolism (PE) frequently have significant underlying comorbidities which may condition the prognosis. The current study aimed to determine the ability of Charlson comorbidity index (CCI) score to predict short and long-term mortality in elderly patients with hemodynamically stable acute PE. All hemodynamically stable patients aged >65 years with acute PE, evaluated in the Emergency Department since 2010 through 2014, were included in this retrospective cohort study. CCI, simplified pulmonary embolism severity index (sPESI) scores and vital status were recorded. Were included 162 patients with confirmed PE, out of 657 suspected cases (24.7%). Median age: 79.2 years, 74.1% presented an sPESI > 1 and 61.1% a CCI > 1. The overall 30, 90-day and 2-year mortality was 11.7% (95%CI 6.6–16.6), 19.8% (95%CI 13.4–25.7) and 31.8% (95%CI 24.1–38.8). For 30-day mortality sPESI showed an AUC 0.642 (95%CI 0.511–0.772) and adding CCI as covariate did not increase its prognostic performance. For 90-day mortality, in an adjusted model including sPESI and CCI, CCI showed a HR 1.282 (95%CI 1.151–1.429, p-value < 0.001), and sPESI a HR = NS(p-value = 0.267). For 2-year mortality, in an adjusted model including sPESI and CCI, CCI showed a HR 1.295 (95%CI 1.180–1.421, p-value < 0.001) and sPESI a HR = NS(p-value = 0.353). In elderly patients with hemodynamically stable PE, the CCI score was found to be an independent predictor of mortality. CCI shows a significantly better ability to predict 90-day and 2-year mortality than sPESI. The assessment of comorbidity burden by using the CCI score may be proposed as an useful tool to predict mortality in these patients.

The term 'biosimilars' is used to qualify products developed to be similar to an original biological drug. Biosimilars are much more complicated to develop than a generic version of small-molecule drugs and this is especially true for low-molecular-weight heparins (LMWHs). Evidence on the antithrombotic management of acute coronary syndromes (ACS) showed that the introduction into the market of biosimilars approved on the basis of simple biological criteria, without robust data from comparative clinical trials, may be hazardous. Moreover, the mixtures of LMWH polysaccharide chains, some immunoallergic properties and potential contamination during the extraction process raise safety concerns. As was the case for the biosimilar erythropoietin, there is the risk that only copies of the most commercially successful LMWHs will be marketed, thus jeopardizing the 'biodiversity' now ensured by the presence of several LMWHs, each with unique features that support the use of an individual LMWH as first-choice therapy in certain categories of patients.

It is debated whether white-coat (WCHT) and masked hypertension (MHT) are at greater risk of developing a sustained hypertensive state (SHT). In 1412 subjects of the Pressioni Arteriose Monitorate e Loro Associazioni Study, we measured office blood pressure (BP), 24-hour ambulatory BP, and home BP. The condition of WCHT was identified as office BP >140/90 mm Hg and 24-hour BP mean P

OBJECTIVE: SunTech 247 is an oscillometric blood pressure (BP) monitor manufactured by SunTech Medical Inc., Morrisville, North Carolina, USA. The aims of this study were (i) to determine its accuracy using the 1993 modified British Hypertension Society (BHS) protocol, the 2002 International Protocol (IP) and the 2002/2003 Association for the Advancement of Medical Instrumentation (AAMI) standards, (ii) to compare the performance of BHS protocol and IP. METHODS: Systolic BP (SBP) and diastolic BP (DBP) were recorded to the nearest 2 mmHg and measured with the arm supported at heart level. For each participant, nine sequential same arm measurements were taken by two trained observers, comparing the device to standard mercury sphygmomanometers. Procedures and data analysis were carried out following protocols guidelines. RESULTS: First, we recruited 33 participants required by the IP. Then, data collection continued to obtain 85 participants for the BHS protocol/AAMI standard. Readings differing by less than 5, 10 and 15 mmHg for SBP and DBP fulfilled IP recommendations. According to the BHS protocol, for the better observer, the percentage of test device readings differing from the mercury standard by 5, 10 and 15 mmHg or less were: 92.9, 100 and 100% for SBP and 94.9, 98.8 and 99.6% for DBP. The mean differences± standard deviation between the device and mercury sphygmomanometer readings were 1.7±3.1 mmHg for SBP and 1.1±3.2 mmHg for DBP, achieving AAMI requirements. Standard deviation of mean differences were 2.4 for SBP and 2.1 for DBP, following the IP, and 3.1 and 3.2, respectively, for BHS protocol. The variance of all 99 differences (total deviance), with 98 degree of freedom, was 585.6 for SBP and 444.1 for DBP. The 33 differences obtained from the mean differences for each participant (between-subject variance), with 32 degree of freedom, were 275.6 and 152.1, respectively. F test was 1.83 with P = 0.0191 for SBP, and 1.07 (P = 0.3936) for DBP. CONCLUSION: (i) The device achieved the requirements stated by the 2002 IP, fulfilled the standards stated by the AAMI, and on the basis of the standards indicated by the 1993 modified BHS protocol, can be classified as 'A' grade both for SBP and DBP. Therefore, SunTech 247 may be recommended for clinical use, (ii) IP and BHS protocol provide complementary features for device validation; the comparison of total deviance and between-subject variance confirms the estimates of IP authors for SBP

Objective: To compare the effect of macrolide and fluoroquinolone antibacterials on the onset of ventricular arrhythmia and cardiac arrest using three different observational designs. Methods: A population-based case-control study was performed by linking automated databases from the Varese Province of Italy. Cases were all subjects who experienced ventricular arrhythmia or cardiac arrest from July 1998 to December 2003. For each case, up to ten controls were randomly selected after matching for sex, age, practitioner and date of arrhythmia onset. The use of macrolides and fluoroquinolones during two time windows denoted as recent and referent intervals was ascertained. Odds ratios were estimated using case-control, case-crossover and case-time-control approaches. Results: 1275 cases and 9189 controls met the inclusion criteria. Adjusted odds ratios (and corresponding 95% CIs) associated with recent exposure to macrolides were 2.13 (1.34, 3.39), 1.70 (0.88, 3.26) and 1.62 (0.78, 3.34) by using case-control, case-crossover and case-time-control designs, respectively. The corresponding estimates for fluoroquinolones were 3.58 (2.51, 5.12), 1.98 (1.19, 3.29) and 1.59 (0.88, 2.87), respectively. Conclusions: Three observational study designs each using entirely different sets of controls consistently showed that recent use of macrolide and fluoroquinolone antibacterials may be associated with increased risk of ventricular arrhythmia and cardiac arrest. © 2009 Adis Data Information BV. All rights reserved.

OBJECTIVE: Blood pressure (BP) 'Cardiette BP one' system (BP one) is an oscillometric ambulatory BP monitor manufactured in Italy in conformity to current regulations for medical devices. We decided to determine the accuracy of measures made with BP one, using the protocol of the British Hypertension Society published in 1990, and revised in 1993, for evaluating the accuracy of BP measurement devices. METHODS: The evaluation included before-use calibration, in-use assessment, after-use calibration, and static device validation that involved 85 participants. RESULTS: The mean difference between manual readings with sphygmomanometer and automatic ones with the device were -0.36±5.74 (mean±SD) for systolic values and 2.52±4.87 for diastolic values. On the basis of the percentages of measurements differing from the mercury sphygmomanometer standard by ≤5, ≤10, and ≤15 mmHg, the device was graded 'A' for systolic and diastolic BP, for low, median, and high BP values. CONCLUSION: On the basis of the standards indicated by the 1993 modified British Hypertension Society protocol, the BP one recorder can be classified as 'A' grade both for systolic and diastolic pressure. © 2008 Lippincott Williams & Wilkins, Inc.

Background: Attention has recently been directed to a condition termed 'reversed white coat' because of an average 24 h ambulatory blood pressure (BP) uncharacteristically greater than office BP. No data are available, however, on the prevalence of this condition in the general population, as well as on its relationship to BP, age, gender, antihypertensive treatment and cardiac organ damage. Methods: In 3200 individuals (participation rate 64%), randomly selected to be representative of the residents of Monza (Milan, Italy) for sex and decades of age (25 to 74 years), we measured office BP (average of three measurements, sphygmomanometry), ambulatory BP (automatic readings every 20 min, Spacelabs 90207) and left ventricular mass (echocardiography). Results: A 'reversed white coat' condition (identified when 24-h average ambulatory systolic, diastolic or mean were higher than the corresponding office values) was seen in 15% (diastolic) to 26% (systolic) of the population as a whole. Prevalence was greater (34-40%) when the difference between office and daytime BP was considered but in both instances it remained less than the prevalence of the white-coat phenomenon. A reversed white-coat condition was similarly frequent in males and females and showed a steep reduction with age and increasing office BP values. Prevalence was greater in hypertensive subjects in whom treatment achieved BP control than in untreated or unsatisfactorily treated individuals. Within each quartile of 24-h or office BP, left ventricular mass index adjusted for demographic and biochemical values was similar in reversed white coat versus the remaining subjects. The absence of any association with left ventricular hypertrophy scores against the clinical significance of this phenomenon. © 2005 Lippincott Williams & Wilkins.

INTRODUCTION: Computerized Decision Support Systems (CDSSs) connect health care professionals with high-quality, evidence-based information at the point-of-care to guide clinical decision-making. Current research shows the potential of CDSSs to improve the efficiency and quality of patient care. The mere provision of the technology, however, does not guarantee its uptake. This qualitative study aims to explore the barriers and facilitators to the use of CDSSs as identified by health providers. METHODS: The study was performed in three Italian hospitals, each characterized by a different level of familiarity with the CDSS technology. We interviewed frontline physicians, nurses, information technology staff, and members of the hospital board of directors (n=24). A grounded theory approach informed our sampling criteria as well as the data collection and analysis. RESULTS: The adoption of CDSSs by health care professionals can be represented as a process that consists of six "positionings," each corresponding to an individual's use and perceived mastery of the technology. In conditions of low mastery, the CDSS is perceived as an object of threat, an unfamiliar tool that is difficult to control. On the other hand, individuals in conditions of high mastery view the CDSS as a helpful tool that can be locally adapted and integrated with clinicians' competences to fulfil their needs. In the first positionings, the uptake of CDSSs is hindered by representational obstacles. The last positionings, alternatively, featured technical obstacles to CDSS uptake. DISCUSSION: Our model of CDSS adoption can guide hospital administrators interested in the future integration of CDSSs to evaluate their organizational contexts, identify potential challenges to the implementation of the technology, and develop an effective strategy to address them. Our findings also allow reflections concerning the misalignment between most Italian hospitals and the current innovation trends toward the uptake of computerized decision support technologies.