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PubMed2005

Tools for statistical analysis with missing data: application to a large medical database.

Missing data is a common feature of large data sets in general and medical data sets in particular. Depending on the goal of statistical analysis, various techniques can be used to tackle this problem. Imputation methods consist in substituting the missing values with plausible or predicted values so that the completed data can then be analysed with any chosen data mining procedure. In this work, we study imputation in the context of multivariate data and we evaluate a number of methods which can be used by today's standard statistical software packages. Imputation using multivariate classification, multiple imputation and imputation by factorial analysis are compared using simulated data and a large medical database (from the diabetes field) with numerous missing values. Our main result is to provide a control chart for assessing data quality after the imputation process. To this end, we developed an algorithm for which the input is a set of parameters describing the underlying data (e.g., covariance matrix, distribution) and the output is a chart which plots the change in the prediction error with respect to the proportion of missing values. The chart is built by means of an iterative algorithm involving four steps: (1) a sample of simulated data is drawn by using the input parameters; (2) missing values are randomly generated; (3) an imputation method is used to fill in the missing data and (4) the prediction error is computed. Steps 1 to 4 are repeated in order to estimate the distribution of the prediction error. The control chart was established for the 3 imputation methods studied here, assuming a multivariate normal distribution of data. The use of this tool on a large medical database was then investigated. We show how the control chart can be used to assess the quality of the imputation process in the pre-processing step upstream of data mining procedures.

Algorithms↗

PubMedDate not supplied

Electronic data capture (EDC)--a new mantra for clinical trials.

Pharmaceutical companies, over a period of time, have attempted to use innovative and modern technologies for quicker and more efficient methods of clinical data capture and analysis. In today's scenario, Electronic Data Capture (EDC) is considered to be the preferred technology that can provide significant benefits over existing manual methods. This article highlights the lacunae of the traditional data capture method and discusses the advantages of using EDC for better data quality, improved performance and productivity, and reduced cost in clinical trial management. It also emphasizes the need for IT infrastructure, training, and 21 CFR Part 11 compliance issues. The authors have also described the challenges to be faced by the investigators and sponsors in implementing EDC. Finally, the article concludes emphasizing the fact that EDC is the future mantra for the clinical trials and all stake holders should face challenges of infrastructure, technology, regulations, and training to make it a success.

Clinical Trials as Topic↗

PubMed2006

Including mixtures in the determination of water quality criteria for herbicides in surface water.

Monitoring programs throughout America and Europe have demonstrated the common occurrence of herbicides in surface water. Nevertheless, mixtures are rarely taken into account in water quality regulation. Taking mixtures into account is only feasible if the water quality criteria (WQC) of the single compounds are derived by a common and consistent methodology, which overcomes differences in data quality without settling on the lowest common denominator but making best use of all available data. In this paper, we present a method of defining a risk quotient for mixtures of herbicides with a similar mode of action (RQm). Consistent and comparable WQC are defined for single herbicides as a basis for the calculation of the RQm. Derived from the concentration addition model, the RQm can be expressed as the sum of the ratios of the measured environmental concentration and the WQC for each herbicide. The RQm should be less than one to ensure an acceptable risk to aquatic life. This approach has the advantage of being easy to calculate and communicate, and is proposed as a replacement for the current limit of 0.1 microg/L for herbicides in Switzerland. We illustrate the proposed approach on the example of five commonly applied herbicides (atrazine, simazine, terbuthylazine, isoproturon, and diuron). Their risk profile, i.e., the RQm as a function of time for one exemplary river, clearly shows that the single compounds rarely exceeded their individual WQC. However, the contribution of peaks of different seasonally applied herbicides, whose application periods partially overlap, together with the continuously emitted herbicides from nonagricultural use, results in the exceedance of the RQm threshold value of one upon several occasions.

Herbicides↗

PubMedDate not supplied

Tutorial reduces protocol deviations in multicenter ACTG trials with pharmacology endpoints.

PURPOSE: The AIDS Clinical Trials Group (ACTG) pharmacology quality assurance program requires clinical research staff to demonstrate minimum competencies in clinical pharmacology research. To achieve this goal, a tutorial was designed to improve the accuracy and completeness of data collected in ACTG pharmacology protocols. METHOD: Clinical research staff at AIDS Clinical Trials Units (ACTUs) access the tutorial through the network's Website. The tutorial presents pharmacokinetic study concepts by contrasting poor with perfect study conduct to illustrate the influence of data quality on conclusions. Case report forms and laboratory data were audited retrospectively to examine the pre- and posttutorial incidence of targeted errors. RESULTS: During a 2-year period, 236 study nurses at 64 main and subunit ACTUs completed the tutorial. The percentage of visits with dosing and/or sampling errors dropped from 13% to 4%. The percentage of samples with errors decreased from 6% to 3%. Sample-time errors (blood drawn outside of the 15-minute target time) decreased slightly, from 2.9% to 2.4%, but the discrepancies found in the recording of sample times decreased from 3% to <1%. CONCLUSION: The ACTG clinical pharmacology tutorial program improved accuracy of both protocol conduct and data collection for pharmacology objectives.

Acquired Immunodeficiency Syndrome↗

PubMedDate not supplied

Quality in managed care: developments and considerations.

With the rapid movement of both individuals and groups away from fee-for-service health care into managed care, concerns have been expressed appropriately that the quality of care may be affected adversely. Over the past several years, a number of developments have taken place to respond to these concerns. This quality movement in managed care has not been without some issues and considerations, however. This article first describes the National Committee for Quality Assurance (NCQA) and the prominent role it has played in this movement. Next, quality improvement study design is addressed in the context of assuring quality, controlling costs, and achieving NCQA accreditation. The effect that capitation, as a payment strategy for providers, has on data quality is then described. Fourth, the value of partnering is explored. Finally, the newest version of NCQA's performance measurement template is discussed: the Health Plan Employer Data and Information Set, version 3.0.

Accreditation↗

PubMed1992

Quality assessment in the medical intensive care unit. Continued evolution of a data model.

Quality assessment and assurance activities in the intensive care unit are complex processes that begin with the definition of the scope of services delivered in the unit with further identification of the important aspects of care. There is also a need to establish indicators of quality, gather data, and finally to organize the data into useful information. There are many approaches to these efforts ranging from establishment of indicators to data collection and analysis of patterns that lead to clarification of the indicators. We chose the latter pathway, specifically utilizing a previously described data model in which information was grouped according to structure, process, and outcome of patient care. In this paper, we focus on the application of the concept of patient days of service for quantification of the utilization of resources as an element of quality. Efficient utilization of resources cannot be effected until data on actual utilization are collected and analyzed.

Data Collection↗

PubMed1994

Developments and prospects for population statistics in countries of the former Soviet Union.

"This paper examines recent developments and prospects for population statistics in the former Soviet Union, whose dissolution provides both opportunities and problems. It is important for scholars to be aware of past limitations of Soviet data, since the formation of independent states has neither removed bureaucratic impediments to the production of high-quality data, nor has it led to a population more ready to answer questions fully. Temporarily at least, there is a decrease in the amount and comparability of available information, and in some instances, in its quality. We begin with an overview of the system used to gather population statistics in the former Soviet Union and its inherent problems. We then discuss the challenges faced by the newly independent countries and the changes they need to make to achieve global comparability, including a shift toward the use of standard international definitions and away from political restrictions on data availability."

Data Collection↗

PubMed1999

Consensus statement. Global burden of tuberculosis: estimated incidence, prevalence, and mortality by country. WHO Global Surveillance and Monitoring Project.

OBJECTIVE: To estimate the risk and prevalence of Mycobacterium tuberculosis (MTB) infection and tuberculosis (TB) incidence, prevalence, and mortality, including disease attributable to human immunodeficiency virus (HIV), for 212 countries in 1997. PARTICIPANTS: A panel of 86 TB experts and epidemiologists from more than 40 countries was chosen by the World Health Organization (WHO), with final agreement being reached between country experts and WHO staff. EVIDENCE: Incidence of TB and mortality in each country was determined by (1) case notification to the WHO, (2) annual risk of infection data from tuberculin surveys, and (3) data on prevalence of smear-positive pulmonary disease from prevalence surveys. Estimates derived from relatively poor data were strongly influenced by panel member opinion. Objective estimates were derived from high-quality data collected recently by approved procedures. CONSENSUS PROCESS: Agreement was reached by (1) participants reviewing methods and data and making provisional estimates in closed workshops held at WHO's 6 regional offices, (2) principal authors refining estimates using standard methods and all available data, and (3) country experts reviewing and adjusting these estimates and reaching final agreement with WHO staff. CONCLUSIONS: In 1997, new cases of TB totaled an estimated 7.96 million (range, 6.3 million-11.1 million), including 3.52 million (2.8 million-4.9 million) cases (44%) of infectious pulmonary disease (smear-positive), and there were 16.2 million (12.1 million-22.5 million) existing cases of disease. An estimated 1.87 million (1.4 million-2.8 million) people died of TB and the global case fatality rate was 23% but exceeded 50% in some African countries with high HIV rates. Global prevalence of MTB infection was 32% (1.86 billion people). Eighty percent of all incident TB cases were found in 22 countries, with more than half the cases occurring in 5 Southeast Asian countries. Nine of 10 countries with the highest incidence rates per capita were in Africa. Prevalence of MTB/HIV coinfection worldwide was 0.18% and 640000 incident TB cases (8%) had HIV infection. The global burden of tuberculosis remains enormous, mainly because of poor control in Southeast Asia, sub-Saharan Africa, and eastern Europe, and because of high rates of M tuberculosis and HIV coinfection in some African countries.

AIDS-Related Opportunistic Infections↗

PubMed2000

The effectiveness of old age psychiatry services.

The objective of this study was to review outcomes of acute service delivery in old age psychiatry. Sources of data included Medline, PsycINFO and Cochrane Collaboration databases of English language papers to 1998 on service delivery evaluation in 'old age psychiatry', 'psychogeriatrics' and 'geriatric psychiatry', supplemented by a manual search of references from relevant literature. All controlled trials, audits, and surveys of the outcomes of service delivery in old age psychiatry located in acute hospitals and community settings were included. Service delivery by medical, adult psychiatry and consultation/liaison services were included. With the exception of outreach services to nursing homes, long term institutional care was excluded. All data were extracted by the author. Data quality was assessed by applying an evidence hierarchy. Evaluation strategies were qualitatively reviewed. Controlled trials, audits and surveys were each found to provide important data in the evaluation of service delivery. There is better quality evidence to support the effectiveness of components of old age psychiatry services than other service types. The majority of studies indicate that old age psychiatry services have positive acute treatment outcomes, particularly with depression. There is insufficient evidence to determine which processes of care are associated with better outcomes. Pluralistic evaluations indicate that carers often have unmet needs and are not as positive about outcomes. There have been no controlled comparisons of service delivery provided by other services. In conclusion, controlled trials and audits indicate that old age psychiatry services are effective. Further pluralistic evaluations and comparisons with other services are required.

Acute Disease↗

PubMed1992

Mouse liver protein database: a catalog of proteins detected by two-dimensional gel electrophoresis.

Alterations in the abundance or structure of mouse liver proteins are being studied using two-dimensional gel electrophoresis (2-DE) to build a database of protein changes correlating with exposure to ionizing radiation or toxic chemicals. Thus far, studies have included the analysis of proteins from the offspring of exposed parents or from the exposed individuals themselves. In order to characterize and identify proteins found altered by such exposures, sex- and strain-related differences in protein patterns have been analyzed, and the subcellular locations of a large portion of the mapped proteins have been determined. As part of these studies, data are collected and stored using a variety of computer hardware and software tools that allow the accumulation of information on the origin of samples, gel identification, experiment description, and protein similarities and differences. This accumulation of information constitutes the mouse liver protein database. Relational database software is used to tie the different facets of the database together so that the results of a variety of experiments can be compared and interrelated. The database optimizes the information obtained from 2-DE gel sets by allowing use of the data for many purposes, including monitoring of gel resolution to ensure the collection of high quality data and correlation of protein effects induced by different agents. This first edition of the Argonne National Laboratory mouse liver protein database lays the foundation for future work and communication that should elucidate the significance of observed protein effects as possible markers of exposure to toxic agents.

Animals↗

PubMed2006

Time-dependent recordkeeping fatigue among youth completing health diaries of unintentional injuries.

PROBLEM: Increasingly, investigators are asking youth to self-report daily activity patterns and health outcomes in diary studies. This study assesses recordkeeping fatigue with respect to data quality and event reporting among youth participating in a health diary study. METHOD: Unintentional injury data were collected during a 13-week longitudinal diary study of Ohio youth exposed to agricultural hazards. Two analyses were conducted using data from 2000. Analysis 1 examined trends in discernable recordkeeping errors (DREs) over the course of follow-up. Analysis 2 assessed trends in injury reporting over follow-up. RESULTS: The percentage of items containing a DRE showed a slight, non-significant decline throughout follow-up. Injury reporting declined significantly (p<0.001) over follow-up. SUMMARY: There was no compelling evidence of respondent fatigue with respect to DREs. The observed decline in injury reporting is problematic because estimates of youth injury incidence in health diary studies may vary depending upon the length of the follow-up period.

Adolescent↗

PubMed2001

Dairy-cattle health in Gyeongnam, Korea.

An animal-health monitoring system in the Gyeongnam area was started in 1997 to develop statistically valid data for use in estimating disease frequencies in dairy cattle, and the associated costs. The objectives of this study were to: (1) describe what was done to implement and maintain the system in Gyeongnam; (2) present selected disease frequencies; (3) discuss the epidemiological consideration of what was done and implications for results obtained. Veterinary medical officers (VMOs), comprising professors and graduate students from Gyeongsang National University, faculty of Gyeongnam Livestock Promotion Institute and clinic veterinarians, served as data collectors. After training on current disease and management problems of dairy cattle, interview techniques, sampling methods and data-collection instruments, the VMOs participated in selection of the sample herds and data gathering. Forty (n=40) of 167 dairy herds were selected randomly using a computer-generated list of random numbers and the VMOs visited farms once in a month for 12 months to collect data about management, disease, inventory, production, preventive treatment, financial and other relevant data. Strict data-quality control devices were used. Specific feed-back was developed for the producers and data collectors. The six disorders found most frequently in cows (from the highest to the lowest) were breeding problems, clinical mastitis, birth problems, gastrointestinal problems, metabolic problems and lameness. In young stock, respiratory, multiple system, breeding and gastrointestinal problems were predominant, whereas in calves, gastrointestinal, respiratory and integumental problems predominated.

Animal Husbandry↗

PubMed1999

Development of a short-form Quadriplegia Index of Function scale.

OBJECTIVE: To develop a short-form version of the Quadriplegia Index of Function (QIF) that would be more practical to use than the original version. DESIGN: Cross-sectional data collected at 6 months post spinal cord injury. SETTING: Regional Spinal Cord Injury Center. PATIENTS: Consecutive sample of 95 patients with tetraplegia, non-ambulatory at 6 months, admitted to a regional SCI center between December 1987 and August 1992. METHODS: A short-form QIF was developed by using regression analysis to determine the best six items that would predict the sum of the 37 items selected from seven mobility and self-care categories of the original scale. This short-form QIF was evaluated for internal consistency and discriminant validity. Validity of the short-form QIF was assessed by correlation with motor scores and using analysis of variance by motor levels and motor score groupings. RESULTS: Regression analysis identified the following items as best predictors of the 37-item QIF score: (1) wash/dry hair, (2) turn supine to side in bed, (3) put on lower body clothing, (4) open carton/jar (feeding), (5) transfer from bed to chair, and (6) lock wheelchair. These items explained 99% of the variance in total scores. Short-form QIF scores (simple sum of the six best items) ranged from 0 to 24, with a median score of seven, interquartile range 0-16. Item response patterns were largely dichotomous. Item-total correlations ranged from 0.60 to 0.80; Cronbach's alpha was 0.89. Spearman correlation coefficient between upper extremity motor score and short-form QIF was 0.82. Analysis of variance indicated that the motor score groupings and motor levels accounted for 63 and 54% of the variance in short-form QIF scores, respectively. Post hoc analyses indicated that motor levels from C5 to T1 had different mean QIF scores, except for C7 versus C8. There may be ceiling effects for individuals with low level injuries. CONCLUSION: There is significant redundancy in the QIF. Six items, selected from five categories, yield results comparable to the 37-item QIF. The short-form QIF must next be assessed for sensitivity to change. A brief disability measure would improve data quality and completeness, and may permit ongoing collection of observational rather than self-report data.

Activities of Daily Living↗

PubMed1984

Report of a planning conference concerning an international network of food data systems (INFOODS).

A small international planning conference on the topic of "An International Network of Food Data Systems" was held on January 30 to February 5, 1983, at the Rockefeller Conference and Study Center, in Bellagio, Italy. It was sponsored through the Food, Nutrition and Poverty Subprogramme of the United Nations University and supported by various US government agencies, private foundations, and the food industry. Participants included representatives from FAO, WHO, IUNS, and IUFoST. The purpose was to explore the needs for, and current limitations of, food composition data bases, especially in the international context, and to propose what was needed. The conference focused on the design and scope of an organization to be called INFOODS (International Network of Food Data Systems) which would promote international participation and cooperation in the acquisition and interchange of quality data on the nutrient composition of foods, beverages, and their ingredients in forms appropriate to meet the needs of government agencies; nutrition scientists; health and agriculture professionals; policy makers and planners; food producers, processors, and retailers; consumers. The conference identified the more important aspects of INFOODS to include: 1) a network of regional data centers; 2) an organizational/administrative framework for various expert task forces; 3) the generator and repository of special international data bases; 4) the stimulator of national data base programs; 5) a general and specific resource for persons and organizations interested in food composition data on a worldwide basis.(ABSTRACT TRUNCATED AT 250 WORDS)

Computers↗

PubMed1995

Lessons learned from a prospective meta-analysis.

OBJECTIVE: To describe the unique aspects of and the lessons learned in planning and conducting a pooled analysis of multiple trials evaluating interventions to reduce functional decline in hospitalized older persons. Specific examples from the Hospital Outcomes Project for the Elderly (HOPE) meta-analysis are discussed. DESIGN: A prospective meta-analysis (PMA) that compiled and pooled data from concurrently conducted clinical trials testing related but distinct interventions. SETTING: The Data Coordinating Center for the prospective meta-analysis coordinated the collection and analysis of common outcome data from five university-affiliated hospitals and one community hospital conducting the clinical trials. PARTICIPANTS: Acutely ill hospitalized elderly participants at least 65 to 75 years old. INTERVENTIONS: Treatments being evaluated included exercise, physical therapy, a multidisciplinary geriatric care unit, a multidisciplinary in-hospital intervention with post-discharge care, a nursing-based geriatric care program, and a program to improve detection and evaluation of delirious patients. CONCLUSION: The prospective meta-analysis provides selected advantages over independently conducted clinical trials and retrospective meta-analyses. It does, however, pose special design and operational challenges that must be addressed well before initiation of the individual trials. Specific issues of concern include: maintaining scientific integrity of both the individual trials and the PMA; reaching consensus on PMA goals, what data to collect, how and when to collect them and how to maintain uniformly high quality data across all sites; defining the role of the Data Coordinating Center in a multicenter project that utilizes different trials and protocols; and establishing policies concerning analyses of the pooled data, publication of pooled analyses, and ownership of the pooled database.

Aged↗

PubMed2004

Systematic review: effects of resident work hours on patient safety.

BACKGROUND: The Accreditation Council for Graduate Medical Education (ACGME) mandated new work hours rules for all residency programs in July 2003. PURPOSE: To critically evaluate the evidence that adhering to the ACGME standards will improve patient safety. DATA SOURCES: Searches of electronic databases (MEDLINE, EMBASE, PREMEDLINE, and Current Contents) and other methods to identify the English-language literature for studies on resident work hours for the years 1966 to 2004. STUDY SELECTION: Studies that assessed a system change designed to counteract the effects of work hours, fatigue, or sleep deprivation and that included an outcome related to patient safety were included. Seven studies met these criteria. DATA EXTRACTION: Two investigators abstracted data from all included studies by using a standard data abstraction form; each study was rated according to established criteria to assess study design quality. DATA SYNTHESIS: Interventions used were float systems, other cross-coverage systems, or unspecified schedule changes. Outcomes included mortality, adverse events, and medication errors. The results suggest that introducing such interventions has an unclear effect on selected patient safety indicators. Specifically, some indicators (such as mortality) may not change after interventions, while other indicators may improve or worsen. LIMITATIONS: This analysis is limited by the study designs of the included studies, the diversity of interventions in the studies, and the possibility of publication bias favoring studies that demonstrated statistically significant differences. CONCLUSION: Evidence on patient safety is insufficient to inform the process of reducing resident work hours.

Continuity of Patient Care↗

PubMed1994

Vital links for today and tomorrow. With one stage of MIS development complete, an integrated delivery network looks to the future.

Over the past four years, Provenant Health Partners (PHP), Denver, has been developing and implementing a management information system to meet the organization's current needs. The system consists of the following information networks: Internal management; Electronic claims processing; Purchasing; Physician communications; Clinic communications; Physician practices; Other hospitals,offnaged health. In the past, PHP used the system primarily for traditional management and control purposes. Recently, however, the organization has extended the use of its data outputs to include internal and external marketing purposes as well. Clinical, service, and management quality data are now tracked and shared with internal and external constituents. PHP is also working to develop a health information system for the future. Such a system will include all the components of the current management information system, but will also facilitate effective health management of populations enrolled in the organization's integrated delivery network.

Colorado↗

PubMed2003

Performance evaluation of quality improvement team in an anesthesiology department.

BACKGROUND: In health care community, quality improvement pathway has always been treated as critical index to control cost, improve efficiency and promote service quality, particularly in the last decade. From theoretical standpoint, clinical practice as well as research data, quality improvement team has been demonstrated to play an important role in the adaptation to the changing health environment and enhancement of the competition through the improvement process. The purpose of this study was to explore members' job satisfaction, morale, organizational commitment and inventory management through quality improvement team intervention in a department of anesthesiology. METHODS: This study was of a quasi-experimental and longitudinal design. The subjects involved 45 nurse anesthetists (the experiment group, intervention of quality improvement team) and 50 operation room nurses (control group) in a general hospital. The quality improvement team had been initiated and implemented pursuant to the quality improvement process for 8 months. GEEs (Generalized Estimating Equations) model was used to examine the differences in job satisfaction, morale, organizational commitment, and the inventory management was also examined between two groups. RESULTS: After control of all variables, except education background, such as age, marital status, education, position and nursing experience, a natural growth effect was observed on quality improvement team. The results revealed that the experimental group showed significant positive effects on both job satisfaction and organizational commitment after the intervention. The morale scale did not differ significantly between two groups. In the inventory management, the experimental group successfully decreased the monthly consumable materials stock with a descending rate of 24.8%, while in the control group, the inventory was increased 16.9% in the basal stock instead. CONCLUSIONS: As other previous reports did, the present study also demonstrated that intervention of the quality improvement team improves the nurse anesthetists' job satisfaction, such as promotion of autonomy, organizational policy and positive member interaction. Moreover, it improves work efficiency, service quality as well as control of the stock inventory.

Adult↗