We propose to study the relationships among organisational quality improvement systems, patient empowerment, organisational culture, professionals' involvement with the quality of hospital care, including clinical effectiveness, patient safety and patient involvement. We will employ a cross-sectional, multi-level study design in which patient-level measurements are nested in hospital departments, which are in turn nested in hospitals in different EU countries. Mixed methods will be used for data collection, measurement and analysis. Hospital/care pathway level constructs that will be assessed include external pressure, hospital governance, quality improvement system, patient empowerment in quality improvement, organisational culture and professional involvement. These constructs will be assessed using questionnaires. Patient-level constructs include clinical effectiveness, patient safety and patient involvement, and will be assessed using audit of patient records, routine data and patient surveys. For the assessment of hospital and pathway level constructs we will collect data from randomly selected hospitals in eight countries. For a sample of hospitals in each country we will carry out additional data collection at patient-level related to four conditions (stroke, acute myocardial infarction, hip fracture and delivery). In addition, structural components of quality improvement systems will be assessed using visits by experienced external assessors. Data analysis will include descriptive statistics and graphical representations and methods for data reduction, classification techniques and psychometric analysis, before moving to bi-variate and multivariate analysis. The latter will be conducted at hospital and multilevel. In addition, we will apply sophisticated methodological elements such as the use of causal diagrams, outcome modelling, double robust estimation and detailed sensitivity analysis or multiple bias analyses to assess the impact of the various sources of bias.
Patient level measures include clinical effectiveness, patient safety and patient involvement. We conceptualize measures of clinical effectiveness in two ways: firstly, to address care provision in line with evidence-base standards, and, secondly, to address outcomes of care [37]. For patient safety measures we refer to any measure that potentially prevents harm caused by errors of commission or omission [38]. In order to improve relevance to quality improvement and to comply with the criteria implicit in the definitions of clinical-practice guidelines, measures of clinical effectiveness and patient safety will be initially assessed in relation to discrete patient characteristics. Measures of clinical effectiveness and patient safety will be retrieved through audit of patient records, which is a common approach in epidemiological research, quality assessment and improvement and clinical research. Previous work on comparisons of coding, documentation and completeness of patient records in European countries will guide the logistics of record audit [39]. With regard to data extraction formulae, substantial work has been done on developing quality measures in Denmark, the USA and other countries and we will draw on existing work in order to refine and standardise hospital data, data transmission and performance measures in order to construct one robust, prioritised and standard quality measure set for hospitals. The need for risk-adjustment will be assessed on the basis of the final measures selected, and whether they are process or outcome measures.
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The proposed research project also makes distinctive contributions to improving quality and safety of care in the EU using an empirical approach. From a methodological perspective, the scientific contributions of the project are three-fold. Firstly, we will advance the validation of a number of relevant constructs relevant to advancing quality improvement systems in European hospitals. For example, we will select, adapt and build measures of organisational culture, professional involvement and patient empowerment, which in themselves can be used in further studies at national or European level. Secondly, by adding these measures to the organisational assessment, we will make relevant scientific contributions to understanding the interactions between these constructs and the hospitals' quality improvement systems. Thirdly, by including measures of external pressure and hospital governance on the one hand, and using patient-level outcome data on the other, we will be able to establish associations that exist between constructs that will result in our appraisal scheme for quality improvement systems. For the analysis of the large scale database we will include a number of methodological innovations described above.
Recurrence of one or more venom effects (local pain and swelling and/or hematologic abnormalities such as coagulopathy and thrombocytopenia) following successful initial treatment with antivenom is a known problem in the management of venomous snakebite. Early issue identification revealed that prevention and treatment of these recurrence phenomena was a topic with some disagreement. Four data sources were utilized to inform the panel discussion of this issue. Statisticians reanalyzed raw data from databases created in the premarketing studies of the current antivenom to extract specific information about recurrence phenomena [11, 12]. The same statistical team reanalyzed raw data from databases created in a phase IV post-marketing study of Fab antivenom to extract specific information about recurrence phenomena [13]. The research team reviewed the results of the literature search to identify and summarize all articles containing data about recurrence phenomena. These three data sources were prepared into resource documents for the panel members. During the in-person meeting, two authors provided formal presentations. One panelist (AMR) analyzed and presented case-level data about recurrence phenomena observed at her center, while a second participant (EJL) presented a structured review of the literature related to recurrence phenomena. In addition, three panelists provided informal presentations. One panelist (SAS) presented an analysis of the prognostic significance of fibrin split products in the identification of patients at risk for late hematologic effects, while two other panelists (SPB and WB) presented data about recurrence phenomena at their centers.
Notification of a certified poison center is recommended for all cases of snake envenomation, for two reasons. First, poison center personnel can identify situations where use of this algorithm may be inappropriate, and can provide treatment recommendations based on local snake species and medical treatment resources. Second, certified poison centers provide de-identified data to the National Poison Data System, which is used by public health professionals and policy-makers. In the US, access to a certified poison center can be made through a single, toll-free number: 1-800-222-1222.
In situations where high quality evidence does not exist, clinical recommendations can be primarily influenced by factors other than the results of clinical trials. These factors include uncertainty in the estimates of likely benefit, risk, inconvenience, and cost of therapy, and varying values of clinicians and patients [91]. Available techniques for evidence-based decision-making do not provide tools for dealing with regional variations in disease characteristics, differences in treatment resources available at different centers, or situations in which the amount of unpublished experience equals or exceeds the amount of data in the peer-reviewed literature. By definition, evidence-based hypothesis testing cannot begin until each specific clinical question is defined; this creates a circular problem when creating complex, highly-branched treatment algorithms. For these reasons, we believed that an evidence-informed structured consensus process would produce a final result that was more useful to clinicians and patients than a formal evidence-based medicine approach. Notwithstanding these limitations, it is possible to describe these treatment recommendations in GRADE terms [91]. The decision to give antivenom to patients with limb-threatening envenomation or severe systemic effects is a strong recommendation based on moderate quality evidence; despite the lack of placebo-controlled trials, concordant results of a large number of observational studies and animal experiments make it clear that the benefits of therapy outweigh the associated risks and burdens. All other recommendations are weak recommendations based on very low quality evidence. 2ff7e9595c
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