Reducing clinical variations with clinical pathways: do pathways work?

OBJECTIVE: To test clinical pathways in a variety of Italian health care organizations in 2000-2002 to measure performance in decreasing process and outcome variations. DESIGN: Creation of indicators, specific for each clinical pathway, to measure variations in the care processes and outcomes. Pre- and post-analysis model to evaluate the possible effect of the clinical pathways on each indicator. SETTING: We tested the clinical pathways in six sites, each with different clinical pathways. RESULTS: Reductions in health care macro-variation phenomena (length of stay, patient pathways, etc.) and in performance micro-variation (variations in diagnostic and therapeutic prescriptions, protocol implementation, etc.) were shown in sites where pathways were implemented successfully. A significant improvement in outcome for patients who were treated according to the clinical pathway for heart failure was also demonstrated. CONCLUSIONS: The overall purpose of clinical pathways is to improve outcome by providing a mechanism to coordinate care and to reduce fragmentation, and ultimately cost. Our results demonstrated that it is possible to achieve this goal. Although controversial elements still exist, we think that clinical pathways can have a positive impact on quality in health care

5.11 'Raffaello Project': Application of the 'Disease and Care Management' Approach in Cardiovascular Disease Prevention

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Can miRNAs be useful biomarkers in improving prognostic stratification in endometrial cancer patients? An update review

Endometrial cancer (EC) is the most common gynecological cancer, with annual incidence rates in Western countries ranging between 15 and 25 per 100 000 women. About 15% to 20% of patients with EC have high-risk disease and follow an aggressive clinical course. Unfortunately, the assessment of histologic parameters is poorly reproducible and conventional clinicopathological and molecular features do not reliably predict either the patient's response to the available treatments or the definition of personalized therapeutic approaches. In this context, the identification of novel diagnostic and prognostic biomarkers, which can be integrated in the current classification schemes, represents an unmet clinical need and an important challenge. miRNAs are key players in cancer by regulating the expression of specific target genes. Their role in EC, in association with clinical and prognostic tumor biomarkers, has been investigated but, so far, with little consensus among the studies. The present review aims to describe the recent advances in miRNAs research in EC taking into consideration the current classification schemes and to highlight the most promising miRNAs. Finally, a perspective point of view sheds light on the challenges ahead in the landscape of EC

Influenza vaccine effectiveness for the elderly: a cohort study involving General Practitioners from Abruzzo, Italy

Introduction. In all Italian regions influenza vaccine is routinely administered to the elderly population. However, vaccination impact has been rarely evaluated because of the high costs of conventional cohort investigations. A promising low-cost alter- native approach uses administrative discharge data to derive vaccine effectiveness indicators (hospitalizations and/or deaths) and involves General Practitioners (GPs) to document the exposure. We conducted a cohort analysis using such approach to assess influenza vaccine effectiveness and to investigate the feasibility and validity of that methodology for routine vaccine evaluation. Methods. During October 2006, all GPs from two Local Health Units (LHUs) were requested to indicate immunization status of all their patients in a specific form containing patient?s demo- graphic records. Immunization status information were also collected from Prevention Departments. Main outcomes were hospitalizations for influenza and/or pneumonia. Analyses were based upon random-effect logistic regression. Results. Of a total of 414 GPs assisting 103,162 elderly, 116 GPs (28%) provided data on 32,457 individuals (31.5%). The sample was representative and had an overall 66.2% vaccina- tion rate. During the first semester 2007, the hospitalization rate was low in the sample, with only 7 elderly patients admitted for influenza and 135 for pneumonia. At either bivariate or multi- variate analysis, vaccination did not significantly reduce the risk of in-hospital death, influenza or pneumonia admission. Discussion. The study had minimal costs, recruited a large and representative sample size, and had no evidence of a substantial selection bias. Administrative and GP?s data may be successively pooled to provide routine assessment of vaccination effectiveness

Malignant Bowel Obstruction in Ovarian Cancer Recurrence: The Role of Palliative Surgery in a Decision-Making Process

Background: Malignant bowel obstruction (MBO) is often the latest stage in ovarian cancer (OC). The therapy of this condition ranges from medical waiting to surgery. The objective of this pilot study is to compare the two strategies so that we can provide a path forward for future studies. Methods: From 700 women diagnosed with OC in the database of the Division of Gynecologic Oncology we crossed the names of those admitted by the emergency services of the IRCSS Azienda Ospedaliero Universitaria of Bologna, Italy. We selected MBO patients with a history of OC as the only neoplastic condition and compared the results between medical conduct and surgery to restore intestinal transit. Results: Of the 700 women in our database, 36 were eligible for study according to the inclusion and exclusion criteria: 9 in surgery group and 27 in medical group. Surgical conduct (tumor biopsy and stoma) appears to be resolutory for the obstruction and have a better result than medical therapy regarding recurrence of MBO, despite the development of greater complications. Relapses of MBOs occurred in 11% of surgical patients and 44% of medical patients (p = 0.0714). Furthermore, after surgical treatment, five patients (55%) experienced postoperative complications; in four cases, severe anemia requiring blood transfusion, while one patient developed post-surgical sepsis, which evolved into multiple organ failure and death. Of the 9 patients treated surgically, 2 (22%) were given surgery as a first choice. In most cases (78%), surgery was decided upon when medical treatment failed. The only discriminative factor appears to be age. The length of hospitalization increased with the patient’s age (p = 0.0181) as statistically significant factors for a worse outcome in surgery. Conclusions: MBO requires complex and multidisciplinary management where different factors need to be considered before initiating surgical therapy. Future studies are needed to deal with this complex problem

A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491]

<p>Abstract</p> <p>Background</p> <p>Patients with stroke should have access to a continuum of care from organized stroke units in the acute phase, to appropriate rehabilitation and secondary prevention measures. Moreover to improve the outcomes for acute stroke patients from an organizational perspective, the use of multidisciplinary teams and the delivery of continuous stroke education both to the professionals and to the public, and the implementation of evidence-based stroke care are recommended. Clinical pathways are complex interventions that can be used for this purpose. However in stroke care the use of clinical pathways remains questionable because little prospective controlled data has demonstrated their effectiveness. The purpose of this study is to determine whether clinical pathways could improve the quality of the care provided to the patients affected by stroke in hospital and through the continuum of the care.</p> <p>Methods</p> <p>Two-arm, cluster-randomized trial with hospitals and rehabilitation long-term care facilities as randomization units. 14 units will be randomized either to arm 1 (clinical pathway) or to arm 2 (no intervention, usual care). The sample will include 238 in each group, this gives a power of 80%, at 5% significance level. The primary outcome measure is 30-days mortality. The impact of the clinical pathways along the continuum of care will also be analyzed by comparing the length of hospital stay, the hospital re-admissions rates, the institutionalization rates after hospital discharge, the patients' dependency levels, and complication rates. The quality of the care provided to the patients will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and rehabilitation, and by the use of key quality indicators at discharge. The implementation of organized care will be also evaluated.</p> <p>Conclusion</p> <p>The management of patients affected by stroke involves the expertise of several professionals, which can result in poor coordination or inefficiencies in patient treatment, and clinical pathways can significantly improve the outcomes of these patients. It is proposed that this study will test a new hypothesis and provide evidence of how clinical pathways can work.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov ID [NCT00673491]</p

Appropriateness of admission and days of stay in pediatric hospital in Ancona, Italy

Background: In Italy, hospital admission costs account for nearly 42% of total health expenditure; in the Marche region, this share exceeds 50%. High costs of hospitalization, however, can be partly explained by inappropriate use. The aim of this research was to assess the risk factors associated with inappropriate hospital admissions and stay for acute pediatric patients. Methods: Clinical records of children from 30 days to 14 years of age admitted to the wards of orthopedics, pediatrics, pediatric isolation, pediatric surgery and pediatric oncohematology at Salesi Pediatric Hospital of Ancona throughout 2004 were reviewed. The Italian Pediatric Appropriateness Evaluation Protocol (PRUO) was used as a tool for assessing inappropriateness of admission and days of stay. Results: Overall 21.7% (95% CI = 16.1%–22.4%) of hospital admissions and 30.3% (95% CI = 26.0%–34.9%) of days of stay were judged to be inappropriate. Multiple logistic regression analysis indicated that inappropriate admission was significantly associated with type of admission, discharge ward and place of residence. Inappropriateness of stay was significantly higher if admission was to a medical ward and if admission itself was judged inappropriate. Conclusions: In a socioeconomic context in which reducing waste is necessary, ineffective health care interventions are no longer tolerable. As a tool capable of integrating each patient’s specific features with those of the health care process, the pediatric PRUO could be a valid tool in the hands of managers for monitoring the appropriateness of admission and stay

A cluster randomized controlled trial of a clinical pathway for hospital treatment of heart failure: study design and population

<p>Abstract</p> <p>Background</p> <p>The hospital treatment of heart failure frequently does not follow published guidelines, potentially contributing to the high morbidity, mortality and economic cost of this disorder. Consequently the development of clinical pathways has the potential to reduce the current variability in care, enhance guideline adherence, and improve outcomes for patients. Despite enthusiasm and diffusion, the widespread acceptance of clinical pathways remain questionable because very little prospective controlled data demonstrated their effectiveness. The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was designed in order to conduct a rigorous evaluation of clinical pathways in hospital treatment of acute heart failure. The primary objective of the trial was to evaluate the effectiveness of the implementation of clinical pathways for hospital treatment of heart failure in Italian hospitals.</p> <p>Methods/design</p> <p>Two-arm, cluster-randomized trial. 14 community hospitals were randomized either to arm 1 (clinical pathway: appropriate use of practice guidelines and supplies of drugs and ancillary services, new organization and procedures, patient education, etc.) or to arm 2 (no intervention, usual care). 424 patients sample (212 in each group), 80% of power at the 5% significance level (two-sided). The primary outcome measure is in-hospital mortality. We will also analyze the impact of the clinical pathways comparing the length and the appropriateness of the stay, the rate of unscheduled readmissions, the customers' satisfaction and the costs treating the patients with the pathways and with the current practice along all the observation period. The quality of the care will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and by measuring key quality indicators at discharge.</p> <p>Discussion</p> <p>This paper examines the design of the evaluation of a complex intervention. Since clinical pathways are made up of various interconnecting parts we have chosen the cluster-randomized controlled trial because is widely accepted as the most reliable method of determining effectiveness when measuring cost-effectiveness in real practice.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov ID [NCT00519038]</p

Influenza vaccine uptake among community-dwelling Italian elderly: results from a large cross-sectional study

<p>Abstract</p> <p>Background</p> <p>Flu vaccination significantly reduces the risk of serious complications like hospitalization and death among community-dwelling older people, therefore vaccination programmes targeting this population group represent a common policy in developed Countries. Among the determinants of vaccine uptake in older age, a growing literature suggests that social relations can play a major role.</p> <p>Methods</p> <p>Drawing on the socio-behavioral model of Andersen-Newman - which distinguishes predictors of health care use in predisposing characteristics, enabling resources and need factors - we analyzed through multilevel regressions the determinants of influenza immunization in a sample of 25,183 elderly reached by a nationally representative Italian survey.</p> <p>Results</p> <p>Being over 85-year old (OR = 1.99; 95% CI 1.77 - 2.21) and suffering from a severe chronic disease (OR = 2.06; 95% CI 1.90 - 2.24) are the strongest determinants of vaccine uptake. Being unmarried (OR = 0.81; 95% CI 0.74 - 0.87) and living in larger households (OR = 0.83; 95% CI 0.74 - 0.87) are risk factors for lower immunization rates. Conversely, relying on neighbors' support (OR = 1.09; 95% CI 1.02 - 1.16) or on privately paid home help (OR = 1.19; 95% CI 1.08 - 1.30) is associated with a higher likelihood of vaccine uptake.</p> <p>Conclusions</p> <p>Even after adjusting for socio-demographic characteristics and need factors, social support, measured as the availability of assistance from partners, neighbors and home helpers, significantly increases the odds of influenza vaccine use among older Italians.</p

The coming decade of digital brain research: a vision for neuroscience at the intersection of technology and computing

In recent years, brain research has indisputably entered a new epoch, driven by substantial methodological advances and digitally enabled data integration and modelling at multiple scales— from molecules to the whole brain. Major advances are emerging at the intersection of neuroscience with technology and computing. This new science of the brain combines high-quality research, data integration across multiple scales, a new culture of multidisciplinary large-scale collaboration and translation into applications. As pioneered in Europe’s Human Brain Project (HBP), a systematic approach will be essential for meeting the coming decade’s pressing medical and technological challenges. The aims of this paper are to: develop a concept for the coming decade of digital brain research, discuss this new concept with the research community at large, to identify points of convergence, and derive therefrom scientific common goals; provide a scientific framework for the current and future development of EBRAINS, a research infrastructure resulting from the HBP’s work; inform and engage stakeholders, funding organisations and research institutions regarding future digital brain research; identify and address the transformational potential of comprehensive brain models for artificial intelligence, including machine learning and deep learning; outline a collaborative approach that integrates reflection, dialogues and societal engagement on ethical and societal opportunities and challenges as part of future neuroscience research