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Calculation of benchmark doses from teratology data.

The benchmark dose approach has several potential advantages over the no observed adverse effect level (NOAEL) as a basis for risk assessment of toxic chemicals, based upon animal toxicity data. The practical use of the benchmark dose has been evaluated by applying dose-response models to an extensive historical database of teratology bioassays. Doses corresponding to 1 and 5% increases in incidence of lesions are calculated and compared to NOAELs. The statistical accuracy of these estimates was determined by calculating confidence intervals. The lower confidence limit on the 5% benchmark dose (LED05) is found to be comparable to the NOAEL for most datasets, and slightly higher on average. Benchmark doses at the 1% level could not be estimated accurately (i.e., they had wide confidence intervals) for a significant fraction of the datasets. LED01 values were lower on average than the NOAEL. Based on these results, it is concluded that benchmark doses for a 5% increases in incidence can be calculated for most datasets, and could be used as a satisfactory basis for risk assessment, e.g., to set reference doses or acceptable daily intakes. An exception occurs when the benchmark dose exceeds the highest dose of the study. This is only likely to occur when the chemical causes a small, but significant, increase in a finding that is uncommon in untreated animals.

Abnormalities, Drug-Induced↗

Application of benchmark dose risk assessment methodology to developmental toxicity: an industrial view.

The U.S. EPA first signalled its intention to use benchmark dose risk techniques in 1991. Subsequently, publication of draft Guidelines for the Risk Assessment of Reproductive Toxicity data indicated the Agency's intention for wide use of the technique. In developmental toxicity experiments, a number of factors need to be considered before attempting benchmark dose calculations, as compared to the conventional NOAEL approach. For example, care in the assessment of potential litter effects (the litter is the unit of such a study) on the data and whether the data are continuous (e.g. foetal body weight) or discontinuous (e.g. specific or grouped developmental defects where the abnormality is present or absent). Two examples of the use of the benchmark dose approach will be made. First, in the analysis of foetal body weight, where a benchmark dose estimate for an agent producing a 5% decrease in mean foetal weight may be calculated from a shift in the distribution of foetal weights between groups, or by conversion of data to reflect changes in the incidence of 'small' pups (i.e. those towards the extreme of the normal range). The second example involves studies conducted on the developmental toxicity of a triazole antifungal. In the first study, the agent was clearly teratogenic, but a NOAEL was not established and thus necessitated a second study. Analysis of benchmark does estimates (e.g. for % foetuses malformed) from the first study indicated that these were not significantly changed when the data from the second study were combined (i.e. the second study did not aid the risk assessment). The benchmark dose approach has significant scientific and practical advantages over the conventional NOAEL methodology in risk assessments derived from developmental toxicity studies.

Animals↗

Understanding benchmarking.

In order to meet the challenges facing health care today, organizations are turning to new approaches. Benchmarking is one such approach. Benchmarking is externally driven, encouraging organizations to look outside their own walls to learn from others and achieve exemplar performance. Organizations can benchmark within their own systems, against competitors, against "best-in-class" companies in the same general industry and against "best-in-class" companies in different industries. A four-step approach to benchmarking includes planning, collecting information, analyzing results and adapting and improving. A benchmarking study team composed of the process owner and other users of the process conducts the study. Application of benchmarking to healthcare materiel management is particularly appropriate, since many materiel management processes occur in other industries and, therefore, best practices outside the healthcare industry may be adapted. The practice, through growing in other industries, is still very new in health care.

Data Collection↗

Benchmarking in healthcare: selecting and working with partners.

The process of selecting a benchmarking partner begins with gathering information to establish industry standards, identifying potential partners and supplying data on the subject to be benchmarked. Suggested sources of information are business and trade publications; investment industry analysts; journalists; trade associations and professional organizations; government research reports; disclosure documents; current and former employees; and product and service providers. Potential partners should be approached only after careful preparation of a project plan that includes information about the benchmarking team's organization and purpose, description of the subject and a statement of benefits for the prospective partner. After obtaining a commitment from the benchmarking partner, relevant comparative data is gathered and analyzed, using some of the following methods: library research, questionnaires, telephone surveys, site visits and consultants. Because benchmarking often involves sharing information with competitors, a code of ethical conduct has been developed by the International Benchmarking Clearinghouse.

Decision Making, Organizational↗

Benchmarking PSI-BLAST in genome annotation.

The recognition of remote protein homologies is a major aspect of the structural and functional annotation of newly determined genomes. Here we benchmark the coverage and error rate of genome annotation using the widely used homology-searching program PSI-BLAST (position-specific iterated basic local alignment search tool). This study evaluates the one-to-many success rate for recognition, as often there are several homologues in the database and only one needs to be identified for annotating the sequence. In contrast, previous benchmarks considered one-to-one recognition in which a single query was required to find a particular target. The benchmark constructs a model genome from the full sequences of the structural classification of protein (SCOP) database and searches against a target library of remote homologous domains (<20 % identity). The structural benchmark provides a reliable list of correct and false homology assignments. PSI-BLAST successfully annotated 40 % of the domains in the model genome that had at least one homologue in the target library. This coverage is more than three times that if one-to-one recognition is evaluated (11 % coverage of domains). Although a structural benchmark was used, the results equally apply to just sequence homology searches. Accordingly, structural and sequence assignments were made to the sequences of Mycoplasma genitalium and Mycobacterium tuberculosis (see http://www.bmm.icnet. uk). The extent of missed assignments and of new superfamilies can be estimated for these genomes for both structural and functional annotations.

Algorithms↗

Benchmark testing the Digital Imaging Network-Picture Archiving and Communications System proposal of the Department of Defense.

The Department of Defense issued a Request for Proposal (RFP) for its next generation Picture Archiving and Communications System in January of 1997. The RFP was titled Digital Imaging Network-Picture Archiving and Communications System (DIN-PACS). Benchmark testing of the proposed vendors' systems occurred during the summer of 1997. This article highlights the methods for test material and test system organization, the major areas tested, and conduct of actual testing. Department of Defense and contract personnel wrote test procedures for benchmark testing based on the important features of the DIN-PACS Request for Proposal. Identical testing was performed with each vendor's system. The Digital Imaging and Communications in Medicine (DICOM) standard images used for the Benchmark Testing included all modalities. The images were verified as being DICOM standard compliant by the Mallinckrodt Institute of Radiology, Electronic Radiology Laboratory. The Johns Hopkins University Applied Physics Laboratory prepared the Unix-based server for the DICOM images and operated it during testing. The server was loaded with the images and shipped to each vendor's facility for on-site testing. The Defense Supply Center, Philadelphia (DSCP), the Department of Defense agency managing the DIN-PACS contract, provided representatives at each vendor site to ensure all tests were performed equitably and without bias. Each vendor's system was evaluated in the following nine major areas: DICOM Compliance; System Storage and Archive of Images; Network Performance; Workstation Performance; Radiology Information System Performance; Composite Health Care System/Health Level 7 communications standard Interface Performance; Teleradiology Performance; Quality Control; and Failover Functionality. These major sections were subdivided into workable test procedures and were then scored. A combined score for each section was compiled from this data. The names of the involved vendors and the scoring for each is contract sensitive and therefore can not be discussed. All of the vendors that underwent the benchmark testing did well. There was no one vendor that was markedly superior or inferior. There was a typical bell shaped curve of abilities. Each vendor had their own strong points and weaknesses. A standardized benchmark protocol and testing system for PACS architectures would be of great value to all agencies planning to purchase a PACS. This added information would assure the purchased system meets the needed functional requirements as outlined by the purchasers PACS Request for Proposal.

Benchmarking↗

Benchmarking in ambulatory surgery.

The health care industry is relatively new to benchmarking. More clinical benchmarking is needed because little is known about which practices and processes lead to which outcomes. Benchmarking is a valuable quality improvement tool that can be used to improve practices and performances when instituted properly. This article describes the benchmarking process, its usefulness, and how ambulatory surgery centers can improve performance by using benchmarking.

Ambulatory Surgical Procedures↗

Controller performance analysis with LQG benchmark obtained under closed loop conditions.

This paper proposes a new method for obtaining a linear quadratic Gaussian (LQG) benchmark in terms of the variances of process input and output from closed-loop data, for assessing the controller performance. LQG benchmark has been proposed in the literature to assess controller performance since the LQG tradeoff curve represents the limit of performance in terms of input and output variances. However, an explicit parametric model is required to calculate the LQG benchmark. In this work, we propose a data driven subspace approach to calculate the LQG benchmark under closed-loop conditions with certain external excitations. The optimal LQG-benchmark variances are obtained directly from the subspace matrices corresponding to the deterministic inputs and the stochastic inputs, which are identified using closed-loop data with setpoint excitation. These variances are used for assessing the controller performance. The method proposed in this paper is applicable to both univariate and multivariate systems. Profit analysis for the implementation of feedforward control to the existing feedback-only control system is also analyzed under the optimal LQG performance framework. The proposed method is illustrated through a simulation example and an application on a pilot scale process.

Benchmarking↗

Sharing the evidence: clinical practice benchmarking to improve continuously the quality of care.

It is unacceptable for health care professionals to acquiesce quietly to inconsistencies in the quality of health care received by patients. In the United Kingdom, the introduction of clinical governance has formalized the expectation that professionals' practice will meet recognized standards of care consistently. It is being stated that all available evidence is being used to identify national standards of excellence. This will inform professionals not only of expected outcomes but of also the structures and processes that need to be in place to support the attainment of such outcomes. Clinical practice benchmarking is one continuous quality improvement approach, which is being used by paediatric units in 27 National Health Service Trusts in the north-west of England to promote the utilization of available evidence in to practice. The evidence base for benchmarks of best practice is considered continuously using a hierarchy of evidence. This clarifies the different evidence available, upon which benchmarks or standards of excellence can be based, but reinforces the kudos awarded quantitative research evidence within health care. Once benchmarks have been agreed, benchmarking activity supports practitioners in a continuous cycle of comparison and sharing that is aimed at ensuring that children and their families receive evidence-based care, wherever they are admitted in the north-west of England.

Benchmarking↗

Benchmarking ambulance call-to-needle times for thrombolysis after acute myocardial infarction in Australia: a pilot study.

BACKGROUND: Thrombolysis for patients with acute myocardial infarction (AMI) is of greatest benefit when treatment is commenced as soon as possible after symptom onset. The British Heart Foundation (BHF) recently set a benchmark recommending that eligible patients with AMI receive thrombolytic therapy less than 90 min after calling for medical assistance. AIMS: The purpose of this study was to compare the performance of an urban emergency service to this benchmark. A secondary objective was to determine whether patients treated outside this time were at a greater risk of mortality. METHODS: This study consisted of an explicit retrospective analysis of medical records for all patients who presented by ambulance to the Emergency Department (ED) of Western Hospital and received thrombolysis for AMI within 12 h of symptom onset. The study was conducted for the 18-month period between 1 January 1999 and 30 June 2000. Information collected included times of: (i) symptom onset, (ii) call for ambulance, (iii) ambulance response, (iv) transport to hospital and (v) thrombolysis, as well as final diagnosis and in-hospital mortality. For the purposes of this study, call-to-needle time (CTN) was defined as the time between calling the ambulance and commencement of thrombolytic therapy. RESULTS: One hundred and twenty-seven patients met the inclusion criteria. Median CTN was 81 min (range 42-279 min). Sixty-four per cent of patients were treated within the 90-min benchmark. The relative risk of mortality for patients treated outside the 90-min benchmark was 2.6 (95% CI 0.98-6.72). CONCLUSION: This study showed that the BHF benchmark for CTN was not being met for over one-third of patients in the study region, with potential impact on mortality after AMI. Further research is needed to establish: (i) whether there is relationship between longer transportation times and mortality, (ii) whether the findings of this study may be applied to other regions and (iii) what strategies might be employed to reduce CTN.

Ambulances↗

Towards benchmarking in British acute hospitals.

The 1997 White Paper--The New NHS--on the future of the National Health Service accorded a high profile to the use of benchmarking as a means of improving efficiency over the following decade. Here, I examine the prospects for the successful adoption of benchmarking in the acute-hospital sector. A benchmarking model is superimposed upon a model of receptive contexts for change, and the components are used to explore the background to the development of benchmarking and likely attitudes towards its implementation. Where appropriate, empirical evidence is introduced to shed light on the ideas explored. I conclude that the wider political agenda accompanying benchmarking has potentially far-reaching implications for the re-distribution of resources on regional, or even national, bases. However, the steady drip-drip on stone is necessary to achieve results at local operational levels. Only by harnessing the strengths of extant cultures will efforts to identify and adopt the most efficient/effective medical practices succeed and potentially conflicting social tensions be resolved.

Benchmarking↗

Perfusion services national process improvement benchmarking.

The Joint Commission on Accreditation of Health Care Organizations recommends national and regional benchmarking in the quality improvement process. Benchmarking is comparing your organization's patient care process outcomes to the best. This communication describes a national benchmarking process for peer comparison of indicators in perfusion patient services process improvement. A databasing communication aplet was designed to facilitate national benchmarking as part of a larger perfusion service management software application. When patient information is entered in the patient database post precedure, patient-specific numeric data and 'yes'/'no' queries are entered at the clinical site. At any time, the local perfusionist system manager may transmit their own data and receive national database group results by modem and a 1-800 phone number. Local indicator outcomes are compared to national results. Strategies are employed to assure that institution and patient name remain anonymous and institution specific data are stored at the clinical site. Participating institutions employ an e-mail aplet to discuss and decide which indicators to employ as a group. Nine institutions have contributed outcome data for more than 6,425 cardiopulmonary bypass (CPB) procedures to a national database for ten months. National and institutional means for six discrete CPB outcome parameters are compared. The percent 'yes' responses to four procedure-related questions are compared. Joint Commission recommended benchmarking is accomplished while patient care is improved by comparing outcomes.

Benchmarking↗

Improving group practice performance with benchmarking.

Group practices can use benchmarking to improve physician productivity to best-practice levels. The benchmarking process can be broken down into two phases. In the first phase, the problem is identified. This phase involves identifying critical drivers, choosing an external benchmark, gathering internal data, identifying variances, and establishing targets. In the second phase, action is taken. This phase involves identifying actions to take, defining responsibilities, implementing the changes, and monitoring performance. Group practices that use benchmarking need to understand the tool's limitations. Benchmarks serve as roadmaps, but any action plan should be tailored to the practice and take a variety of factors into consideration.

Benchmarking↗

Benchmarking: finding ways to improve.

BACKGROUND: This article provides health care organizations with a benchmarking methodology to use in comparing practices and processes to identify and actualize opportunities for improvement. The 15-step model can be used to guide internal and external benchmarking activities in a variety of health care settings. EXAMPLES: Two internal benchmarking case studies are illustrated: (1) one hospital used the Baxter model to evaluate its laparoscopic cholecystectomy services, and (2) another prepared for expansion of cardiac catheterization services. CONCLUSIONS: Two key factors of a successful benchmarking initiative are highlighted: management commitment and involvement, and the need to understand internal practices and processes before benchmarking.

Cholecystectomy, Laparoscopic↗

Feasibility of national benchmarking of patient satisfaction with Australian hospitals.

PURPOSE: This paper discusses the feasibility of developing national benchmark questions on patient satisfaction with hospital care in Australian hospitals. The research was undertaken for the Australian government under the National Health Outcomes Programme. DATA SOURCES AND SELECTION: The paper draws on a review of research with consumers to identify issues of importance to them about hospital care. The Australian sources were reports by consumer and community organizations, research reports by hospitals, governments and academics, and data from complaints authorities. The emphasis was on consumers' own views. The main debates on patient satisfaction methodology were reviewed. Published material from the USA and Britain highlighting organizational policy issues was reviewed, as well as literature on benchmarking. Material was obtained through journal searches and identification of organizations which undertake consumer-oriented or service development research. CONCLUSIONS: The paper argues that national benchmarking of patient satisfaction is not reliable because patient satisfaction is a poorly understood concept and not a unitary concept. Also, the paper argues that benchmarking is about processes, and that the link between survey results and hospital processes is not well researched or understood. While patient satisfaction surveys appear to promote consumer perspectives, they remain caught within a passive approach to consumer participation in shaping service development and improving the quality of hospital care. The task of government is to mandate consumer feedback, resource the development of expertise and technologies, trial and evaluate approaches to obtaining feedback, disseminate research and effective models, and resource consumer organizations to be participants at all stages. This is described as providing the resources for benchmarking at local levels.

Australia↗

Benchmarking in the UK National Health Service.

Traces the development of benchmarking in a number of UK National Health Service trusts, highlighting practical processes and the benefits of benchmarking but also identifying common pitfalls and ways of handling them when they arise or, better still, anticipating them. Several examples of successful benchmarking initiatives are given, emphasizing the advantages of using a systematic benchmarking approach, using benchmarking clubs and the need to develop ad hoc performance measures. Concludes by emphasizing the need for a new commitment to continuous improvement by senior managers to avoid the failures of previous drives for improvement.

Efficiency, Organizational↗

Benchmark dose calculations for methylmercury-associated delays on evoked potential latencies in two cohorts of children.

Delays in evoked potential latencies were observed at increased exposures to methylmercury from seafood in two cohorts of children. Because this outcome parameter appeared to be virtually independent of confounders, including cultural differences, a joint analysis of benchmark doses was carried out. Comparable cohort members included 382 Faroese and 113 Madeiran children without middle ear infection or neurological disease at age seven years. Maternal hair-mercury concentrations at parturition in the Faroese cohort ranged from 0.6 to 39.1 microg/g (geometric average, 4.49 microg/g). In Madeira, mothers who had not changed their diet since pregnancy had current hair-mercury concentrations ranging from 1.1 to 54.4 microg/g (geometric average 10.14 microg/g). The mercury-associated delay in peak III latencies at two frequencies (20 and 40 Hz) showed similar regression equations in the two groups of children, and benchmark dose calculations were therefore carried out for the two groups separately and jointly. For a doubling of a 5% prevalence of abnormal results of the peak III latencies at 40 Hz in a linear dose-response model, the benchmark dose for the maternal hair-mercury concentration was 8.79 microg/g for the Faroese children; 8.04 microg/g for the Madeiran children; and 9.46 microg/g for both groups. Results were similar for the 20 Hz condition. Benchmark dose results were substantially lower using a logarithmic or square root curve function, although the difference in fit between the curves was far from statistically significant. The benchmark results using evoked potential latencies are in close agreement with results based on neuropsychological test performance.

Adult↗

Benchmark dose calculation from epidemiological data.

A threshold for dose-dependent toxicity is crucial for standards setting but may not be possible to specify from empirical studies. Crump (1984) instead proposed calculating the lower statistical confidence bound of the benchmark dose, which he defined as the dose that causes a small excess risk. This concept has several advantages and has been adopted by regulatory agencies for establishing safe exposure limits for toxic substances such as mercury. We have examined the validity of this method as applied to an epidemiological study of continuous response data associated with mercury exposure. For models that are linear in the parameters, we derived an approximative expression for the lower confidence bound of the benchmark dose. We find that the benchmark calculations are highly dependent on the choice of the dose-effect function and the definition of the benchmark dose. We therefore recommend that several sets of biologically relevant default settings be used to illustrate the effect on the benchmark results and to stimulate research that will guide an a priori choice of proper default settings.

Animals↗