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Comparative evaluation of five in vitro tests for assessing the eye irritation potential of hair-care products.

This study compared five methods, the isolated rabbit eye (IRE), bovine corneal opacity and permeability (BCOP), EpiOcular, fluorescein leakage (FL) and neutral red release (NRR) assays, for predicting the eye irritation potential of hair-care formulations. Ten shampoo and seven conditioner formulations of known ocular irritation potential were tested. Each group included a market-acceptable formulation as a comparative benchmark. Predictions of ocular irritation were made by using classification models (IRE, BCOP and EpiOcular assays) or by direct comparison with benchmarks (IRE, EpiOcular, FL and NRR assays). The BCOP assay was less sensitive than the IRE test in discriminating between formulations of different irritation potentials, and did not perform as well as the other assays in identifying mild formulations. All of the assays appeared to be better at discriminating correctly between the shampoos than between the conditioners. The EpiOcular assay showed the closest concordance between the in vivo results and the in vitro data from cell-based assays (particularly for shampoos). The FL assay also showed a high concordance (particularly for conditioners). There was a tendency for these in vitro assays to over-predict eye irritation potential, but there was no under-prediction and they were particularly successful at identifying mild formulations. The NRR assay was less predictive with both shampoos and conditioners. The results from this comparative evaluation fully support the continued use of the IRE test as a suitable alternative to in vivo eye irritation testing in rabbits, although it also over-predicted the irritancies of several of the formulations. The value of using concurrent benchmarks (reference standards), appropriate to the materials being tested, in interpreting the data obtained from in vitro tests, was also demonstrated. Overall, the results indicate that further comparisons of the IRE, EpiOcular and FL assays are warranted using much larger numbers of test materials.

Animal Testing Alternatives↗

Clinical quality improvement in a multihospital system: the voluntary hospitals of America/Pennsylvania experience.

Sharing of patient outcome data among hospitals hastened the evolution of continuous quality improvement at Voluntary Hospitals of American/Pennsylvania (VHA/PA) to a focus on learning from the best: clinical benchmarking. Analysis of VHA/PA MedisGroups comparative outcome data showed significant variation. In the first study, variations from 3 to 25% normal appendectomy rates were noted. A second study on primary and secondary cesarean section rates again showed variation in outcomes. A study of the benchmark hospitals showed characteristics, specific to those institutions, that resulted in excellent outcomes. To quantify best processes, VHA/PA has embarked on a clinical benchmarking project with the assistance of MediQual Systems, Inc.

Adolescent↗

Critical evaluation of the JDO API for the persistence and portability requirements of complex biological databases.

BACKGROUND: Complex biological database systems have become key computational tools used daily by scientists and researchers. Many of these systems must be capable of executing on multiple different hardware and software configurations and are also often made available to users via the Internet. We have used the Java Data Object (JDO) persistence technology to develop the database layer of such a system known as the SigPath information management system. SigPath is an example of a complex biological database that needs to store various types of information connected by many relationships. RESULTS: Using this system as an example, we perform a critical evaluation of current JDO technology; discuss the suitability of the JDO standard to achieve portability, scalability and performance. We show that JDO supports portability of the SigPath system from a relational database backend to an object database backend and achieves acceptable scalability. To answer the performance question, we have created the SigPath JDO application benchmark that we distribute under the Gnu General Public License. This benchmark can be used as an example of using JDO technology to create a complex biological database and makes it possible for vendors and users of the technology to evaluate the performance of other JDO implementations for similar applications. CONCLUSIONS: The SigPath JDO benchmark and our discussion of JDO technology in the context of biological databases will be useful to bioinformaticians who design new complex biological databases and aim to create systems that can be ported easily to a variety of database backends.

Computational Biology↗

Evidence-based referral results in significantly reduced mortality after congenital heart surgery.

OBJECTIVE: Significant interinstitutional variation in mortality after congenital heart surgery has been demonstrated. Noting an association between reduced mortality and higher volume, a center with a small annual case volume began in August 1998 to selectively refer to high-volume surgical centers based on published or "apparent" low mortality rates for specific cardiac lesions. This study was undertaken to evaluate the effect of evidence-based referral in this practice. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort comparison over a 10-year period for a small Midwestern pediatric cardiology practice. The institutional database was retrospectively reviewed for children (<18 years) undergoing surgery from August 1992 to July 2002. Data were divided into 3 time periods (August 1992 to July 1995, period 1; August 1995 to July 1998, period 2; and August 1998 to July 2002, period 3). Hospital discharge abstract data from 5 states (California, Illinois, Massachusetts, Pennsylvania, and Washington) in 1992, 1996, and 1998 provided contemporaneous benchmarks. Risk adjustment was performed using the Risk Adjustment in Congenital Heart Surgery-1 method. Risk category, age at surgery, prematurity, and major noncardiac structural anomaly were entered into a multivariate logistic regression model to compare in-hospital mortality adjusting for case-mix differences. RESULTS: A total of 514 congenital heart surgical cases were identified from August 1992 to July 2002; 507 cases (98.6%) were assigned to a risk category and analyzed further. Unadjusted in-hospital mortality rates were 9.3% in period 1, 5.9% in period 2, and 1.3% in period 3. Unadjusted mortality rates for cases from benchmark data were 6.4% in 1992, 4.8% in 1996, and 3.7% in 1998. Risk adjusted mortality was comparable to the benchmark data in periods 1 and 2, but superior outcomes (odds ratio = 0.24) were demonstrated in period 3. CONCLUSIONS: Evidence-based referrals from a small-volume pediatric cardiac center to large-volume institutions resulted in a reduction in mortality after congenital heart surgery.

Adolescent↗

[Equity and fairness in the Mexican health system reform].

OBJECTIVE: To assess the equity and fairness of the Mexican health system reform that occurred in the late 1990's. MATERIAL AND METHODS: The Mexican reform process was evaluated using the benchmark-system designed by Daniels et al. This benchmark system was adapted to the Mexican setting by adding specific indicators. A documentary review of the Mexican reform process was conducted to score its performance for each benchmark. RESULTS: Except for housing and nutrition components, the reform included few actions related to health determinants. For health care, the main reform initiatives were those related to extending the coverage of essential health services and decentralizing health care provision to the states. Reform initiatives included few activities related to fair financing, tiering, emphasis on second and third level care, accountability, and transparency. CONCLUSIONS: The late nineties reform of the Mexican health system had some positive effect on access of the poor to health care and administrative efficiency, but little impact on fair financing, quality of care, and democratic governance. The English version of this paper is available at: http://www.insp.mx/salud/index.html.

Adolescent↗

An evaluation of cause-effect relationships between polychlorinated biphenyl concentrations and sediment toxicity to benthic invertebrates.

Cause-effect sediment-quality benchmarks for the protection of benthic invertebrates are needed for polychlorinated biphenyls (PCBs) to support predictive risk assessments and retrospective evaluations of the causes of observed sediment toxicity. An in-depth evaluation of PCB aquatic toxicity and organic carbon partitioning was conducted to predict sediment effect concentrations using the equilibrium partitioning (EqP) approach. This evaluation was limited to invertebrate toxicity data, because PCBs may exert toxicity to invertebrates and fish via different toxicological mechanisms. As a result of differences in organic carbon partitioning among PCBs of differing levels of chlorination, the estimated EqP benchmarks increase with increasing degree of chlorination for various commercial and environmental PCB mixtures. Studies of spiked sediment toxicity using PCBs were reviewed, and their results generally were consistent with EqP predictions. Additionally, toxicity and benthic community data were reviewed for eight PCB-contaminated sites; these data also showed agreement with EqP predictions. None of these lines of evidence supports previously proposed, empirical sediment-quality guidelines for PCBs. Reasons for the lack of agreement between cause-effect and association-based benchmarks are discussed, and areas of future research to further refine EqP predictions for PCBs are identified.

Animals↗

The Oregon Health Plan: predictors of office-based diabetic quality of care.

OBJECTIVE: In 1994, the Oregon Health Plan (OHP) expanded basic Medicaid insurance to residents under the federal poverty limit, adopted a prioritized limited benefits package, and converted to managed care. The quality of care in predominantly Medicaid populations with diabetes has not been previously described. In OHP enrollees, we examined predictors of diabetes care based on American Diabetes Association guidelines and described OHP diabetes care compared with national benchmarks. RESEARCH DESIGN AND METHODS: Chart abstraction and Medicaid data for 1995-1996 yielded 996 nonpregnant diabetic patients who were 18-64 years of age. Using HbA1c, lipid panel, and urine protein/microalbumin documentation ordered during the study year, we constructed a standard care (SC) index: SC for all three tests, mixed care (MC) for one to two tests, or no tests documented (NTD). RESULTS: Our sample was predominantly white, 48 +/- 11 years of age, 63% women, with 8 +/- 5 provider visits. Providers ordered HbA1c (70%), urine microalbumin/protein (57%), and lipid panel (41%) tests. Patients distributed into SC (22%), MC (62%), or NTD (16%). Thirteen variables predicted SC. Patients had a higher likelihood of SC if they were 18-24 years of age, had more clinic visits, were on insulin daily, were in several comorbid groups, were enrolled in salaried or capitated health plans, or lived in counties with more hospital beds. Four studies were used as comparable national benchmarks. CONCLUSIONS: Care provided to OHP patients with diabetes compares favorably with national benchmarks. Yet, most OHP patients with diabetes are still not achieving optimal care. Examining predictors of SC may play an important role in further policy development.

Adolescent↗

Identifying features, performance, and limitations of dairy ration formulation software: a comparison of three ration formulation programs.

A method for evaluating and selecting dairy ration formulation software for microcomputers is presented. Information obtained from a survey of practicing nutritionists and from interviews with computer programmers was used to identify users' needs, desired features, and patterns of use. A benchmark problem consisting of 15 activities frequently required in designing dairy rations was developed to evaluate ease of use, ease of learning, and software performance. Ease of use was measured by counting keystrokes and recording time required by a user familiar with these ration formulation programs to complete the benchmark problem. Ease of learning was measured as the amount of help and time needed by users unfamiliar with this software to complete the benchmark problem. Software performance was measured by speed of formulation, ration costs, ingredients and amounts selected, and nutrient content of rations. Evaluation of three commercially available software applications was made using the method developed.

Animal Feed↗

AI-Driven Multi-Omics Integration of Synthetic Colon Adenocarcinoma for Cluster-Guided PROTAC Candidate Design Targeting KRASG12D.

Colorectal cancer is a leading cause of cancer death, yet its molecular heterogeneity remains poorly translated into individualized treatment. We present a reproducible artificial intelligence (AI) framework that integrates multi-omics benchmarking, sample-level drug prioritization, E3 ubiquitin ligase selection, and shape-anchored Proteolysis Targeting Chimera (PROTAC) design for KRASG12D in colon adenocarcinoma (COAD). A controlled synthetic benchmark comprising 425 tumor and 41 simulated normal profiles, parameterized to match The Cancer Genome Atlas (TCGA) distributions, was used for pipeline verification. Among sixteen methods, the Balanced Latent Integration with Stability Selection (BLISS) model achieved the highest silhouette width (0.86) and competitive agreement (Adjusted Rand Index, ARI, 0.90). The pipeline was validated on real data: a TCGA COAD cohort (186 tumors) with independent Consensus Molecular Subtype (CMS) labels and a CPTAC cohort (104 tumors). Integration modestly recovered CMS (ARI 0.28), and stage, not molecular cluster, drove survival (log-rank p = 0.005 versus 0.81). Sample-level prioritization differed from cluster-level ranking in 82.6% of profiles, below chance (p < 0.0001), without indicating efficacy. Candidate NOVEL00489 showed a good MM-GBSA estimate, matching the reference ASP3082. Compounds are computational candidates requiring experimental validation. This establishes a transparent benchmark for in silico degrader generation in precision oncology.

Humans↗

Health-related quality-of-life measure enhances acute treatment response prediction in depressed inpatients.

BACKGROUND: Many nonbiological variables are reported to predict treatment response for major depression; however, there is little agreement about which variables are most predictive. METHOD: Inpatient subjects (N = 59) diagnosed with current DSM-IV major depressive disorder completed weekly depressive symptom ratings with the Hamilton Rating Scale for Depression (HAM-D-17) and Beck Depression Inventory (BDI), and weekly health-related quality-of-life (HRQL) ratings with the Quality of Well-Being Scale (QWB). Acute responders were identified by a 50% decrease in HAM-D-17 score from baseline within 4 weeks of medication treatment. Predictor variables were initially chosen from a literature review and then tested for their association with acute treatment response. RESULTS: An initial predictive model including age at first depression, admission BDI score, and melancholia predicted acute treatment response with 69% accuracy and was designated as the benchmark model. Adding the admission QWB index score to the benchmark model did not improve the prediction rate; however, adding the admission QWB subscales for physical and social activity to the benchmark model significantly improved acute treatment response prediction to 86% accuracy (p = .001). CONCLUSION: In addition to being designed for use in cost-effectiveness analyses, the QWB subscales appear to be useful HRQL variables for predicting acute inpatient depression treatment response.

Adult↗

Q-tracks: a College of American Pathologists program of continuous laboratory monitoring and longitudinal tracking.

CONTEXT: Continuous monitoring of key laboratory indicators of quality by hundreds of laboratories in a standardized measurement program affords an opportunity to document the influence of longitudinal tracking on performance improvement by participants focused on that outcome. OBJECTIVE: To describe the results of the first 2 years of participation in a unique continuous performance assessment program for pathology and laboratory medicine. DESIGN: Participants in any of 6 modules in the 1999 and 2000 College of American Pathologists (CAP) Q-Tracks program collected data according to defined methods and sampling intervals on standardized input forms. Data were submitted quarterly to CAP for statistical analysis. Interinstitutional comparison reports returned in 6 weeks provided each laboratory with its performance profile of key indicators and its percentile ranking compared with all participants in that quarter. This also included longitudinal comparisons of performance during previous cumulative quarters. Control charts graphically displayed data with flags identifying performance points that were out of statistical control. SETTING: Hospital-based laboratories in the United States (98%), Canada, and Australia. PARTICIPANTS: Voluntary subscriber laboratories in the CAP Q-Tracks performance measurement program: roughly 70% from hospitals of 300 occupied beds or fewer, 65% from private, nonprofit institutions, slightly more than half located in cities, one third from teaching hospitals, and 20% with pathology residency training programs. MAIN OUTCOME MEASURES: Each module measured several major and additional minor quality indicators and unbenchmarked individualized data for internal use. RESULTS: Participants in 4 of 6 Q-Tracks continuous monitors demonstrated statistically significant performance improvement trends in 1999 and 2000, which were most marked for laboratories that continued participation throughout both years. These monitors were wristband patient identification, laboratory specimen acceptability, blood product wastage, and intraoperative frozen section consultation. CONCLUSIONS: Key continuous indicators chosen on the basis of a decade's experience in the CAP Q-Probes quality improvement program are useful measurement and benchmarking tools for laboratories to improve performance. In general, measures in which there is a broad range of demonstrable performance initially are most optimal for subsequent improvement using continuous monitoring. These studies have shown that quality is not static, but rather is a moving benchmark of performance as seen in the redefinition of benchmarks over time by participants in the first 2 years of the CAP Q-Tracks program.

Accreditation↗

Engineering department physical plant staffing requirements.

There is a considerable effort in the health care arena to establish credible engineering manpower yardsticks that are universally applicable as a benchmark. This document was created by using one facility's own benchmark criteria that can be used to help develop either internal or competitive benchmarking comparisons.

Contract Services↗

Measuring outbreak-detection performance by using controlled feature set simulations.

INTRODUCTION: The outbreak-detection performance of a syndromic surveillance system can be measured in terms of its ability to detect signal (i.e., disease outbreak) against background noise (i.e., normally varying baseline disease in the region). Such benchmarking requires training and the use of validation data sets. Because only a limited number of persons have been infected with agents of biologic terrorism, data are generally unavailable, and simulation is necessary. An approach for evaluation of outbreak-detection algorithms was developed that uses semisynthetic data sets to provide real background (which effectively becomes the noise in the signal-to-noise problem) with artificially injected signal. The injected signal is defined by a controlled feature set of variable parameters, including size, shape, and duration. OBJECTIVES: This report defines a flexible approach to evaluating public health surveillance systems for early detection of outbreaks and provides examples of its use. METHODS: The stages of outbreak detection are described, followed by the procedure for creating data sets for benchmarking performance. Approaches to setting parameters for simulated outbreaks by using controlled feature sets are detailed, and metrics for detection performance are proposed. Finally, a series of experiments using semisynthetic data sets with artificially introduced outbreaks defined with controlled feature sets is reviewed. RESULTS: These experiments indicate the flexibility of controlled feature set simulation for evaluating outbreak-detection sensitivity and specificity, optimizing attributes of detection algorithms (e.g., temporal windows), choosing approaches to syndrome groupings, and determining best strategies for integrating data from multiple sources. CONCLUSIONS: The use of semisynthetic data sets containing authentic baseline and simulated outbreaks defined by a controlled feature set provides a valuable means for benchmarking the detection performance of syndromic surveillance systems.

Disease Outbreaks↗

Accuracy in clinical laboratories participating in regional quality control programs.

Few studies have assessed analytic bias (accuracy) in clinical chemistry laboratories. Using the data base of a large regional quality control program, we studied, during a six-year period, analytic bias of participant "all-methods" results, as well as selected commonly used individual methods, for calcium, cholesterol, glucose, potassium, and sodium. Analytic bias was assessed by comparison with "benchmark" measurements by United States Bureau of Standards definitive methods and/or United States Centers for Disease Control clinical reference methods. The all-methods bias at selected clinically relevant analyte levels was +0.1% at 10 mg/dL for calcium; -0.7% for cholesterol at 200 mg/dL; +4.5% for glucose at 120 mg/dL; +0.5% for potassium at 4 mmole/L; and 0% for sodium at 145 mmole/L. There was sufficient agreement between benchmark and participant all-methods results for these analytes to suggest that the all-methods results may be useful analytic bias benchmarks in future regional quality control programs that use similar lyophilized human serum pools.

Blood Glucose↗

An interview with Linda Slezak.

As director of the operating room region and assistant director of nursing at Stanford University Hospital, Linda Slezak, MSN, RN, represented Stanford on the surgical services council of the University HealthSystems Consortium. She chaired a task force which initiated a Surgical Services Benchmarking Project for perioperative services in academic health centers. In this interview, Ms. Slezak discusses the importance of benchmarking, defining best practices, and achieving benchmarking success.

Humans↗

Effective outcomes management in occupational and environmental health.

In the final analysis, outcomes management is about changing behavior, specifically in the occupational and environmental health practitioner's communication process and practice patterns and in the workers' prevention and compliance behavior. Outcomes management is also about quantifying results, establishing occupational and environmental health performance benchmarks, developing a best practices model and asking even more questions. As health care embraces the use of outcomes in evaluating its effectiveness, similar developments can be anticipated in occupational and environmental health. While occupational and environmental health outcomes management is still in its infancy, nurses in the workplace are well positioned to "shape it" into a useful tool that meets the needs of all the various practice settings. As nurses in the workplace begin to evaluate, report, and benchmark results, measurement tools will be refined, data bases will grow and new, useful benchmarks will be established. Because occupational and environmental health programs usually operate as part of a larger business unit, nurses in the workplace are continually faced with the challenge of ensuring that corporate programs including workers' compensation, health and disability benefit programs, vaccination programs, injury prevention, and health promotion or wellness programs are delivered in an efficient and cost-effective manner and that the expected outcomes are achieved. Effective outcomes management programs are the vehicles to effective goal achievement.

Environmental Health↗

[To what extent are recommendations of guidelines relevant in everyday practice? An essential question for evaluation studies].

PURPOSE: To what extent are recommendations of guidelines relevant in everyday practice? METHODS: 142 general practitioners (GPs) participating in ten different quality circles administered by the statutory medical association of Hesse were interviewed by questionnaire, which of 135 recommendations selected from eight guidelines they had used during the last 6 weeks. The guidelines proposed recommendations for eight frequent indications in primary care. The findings were presented to 15 authors of the guidelines. The authors were asked to assess each recommendation as essential, important or nonessential to therapy. RESULTS: By setting a benchmark of 75% for adherence to each recommendation, 50% of all recommendations had been used by the GPs. With very few exceptions the authors of the guidelines assessed these recommendations as essential or important to therapy. On the other hand, many recommendations that missed the benchmark were assessed as nonessential by the authors. CONCLUSION: Recommendations of guidelines should be systematically assessed by users and authors together to find out which of them are really of clinical relevance.

Benchmarking↗

The reliability and quality of cognitive case formulation.

Limited research on the reliability of cognitive case formulation suggests cognitive therapists can agree about clients' presenting problems but show poor agreement about the inferential aspects of formulation. There has been no research examining the quality of practitioners' case formulations. This study assessed whether participants with different levels of experience could produce reliable cognitive formulations using a systematic cognitive therapy case formulation method: the J. Beck Case Conceptualization Diagram. As part of continuing education workshops on cognitive case formulation, 115 mental health practitioners were given the same case description and asked to provide case formulations. Inter-rater agreement and agreement with a "benchmark" formulation provided by J. Beck were measured. The results showed that participants were able to agree with each other and with the benchmark on most descriptive aspects of the formulation but rates of agreement decreased for aspects of the formulation requiring greater levels of theory-driven inference. Based on definitions and measurements of the quality of cognitive formulations derived in this study, the quality of formulations ranged from very poor to good, with only 44% rated as being at least good enough. Both reliability and quality of case formulations were associated with levels of clinical experience and accreditation status. Implications for training and supervision are discussed.

Accreditation↗