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PubMed1999

The Society of Thoracic Surgeons National Database: current status and future directions.

The Society of Thoracic Surgeons National Database, established seven years ago by thoracic surgeons for self improvement and quality assurance, now has 1,181,464 patients registered, including 897,914 coronary artery bypass operations. Risk-adjusted 30 day mortality for coronary bypass procedures, unadjusted mortality for other cardiothoracic procedures, unadjusted morbidity and length of stay as well as several processes of care are measured. There has been a progressive decrease in operative mortality and length of stay over the past seven years. Deaths, complications, and lengths of stay are stratified according to estimated risk of death. Definitions have been refined in conjunction with the American College of Cardiology. The database is being increasingly utilized for state analyses and is in demand by other organizations and third party carriers. Logistic regression analysis is now utilized for development of the risk models. The database has been useful for health care policy decisions and can be useful for our Professional Affairs Committee in their dealings with government. Other uses include measuring access to care and cost. Data quality improvement measures have been put in place, as well as data manager education. The General Thoracic and Congenital data acquisition packages are being modified and improved, and a goal is to begin collecting longitudinal data to demonstrate the long term efficacy of thoracic procedures. The data elements have been decreased from 500 to 200+ core variables for simplification. With the changing healthcare environment and emphasis on cost cutting, collecting valid data by a national specialty group enhances the monitoring of quality of care, thus protecting our patients from overzealous cutbacks. Data is essential to document the efficacy, quality and cost-effectiveness of the procedures we perform and is a necessary tool for each of us to have to assure the quality and continued success of our practices.

Coronary Artery Bypass↗

PubMedDate not supplied

Soils, water quality, and watershed size: interactions in the Maumee and Sandusky river basins of northwestern Ohio.

Soil variability in watersheds accounts for the problem of partitioning downstream water quality data and evaluating sources of non-point pollution. This review of previous water quality studies was conducted to examine more closely the influence of soil properties on pollutant export. The approach used in this paper was to start with data from the two largest watersheds (Maumee and Sandusky) and then compare them on a unit area export basis with data from intermediate-size and smaller watersheds. General relationships between pollutant levels at the river mouth and upstream soil conditions are vague and seemingly contradictory at the large-watershed scale. With smaller watersheds, it can be determined that soil texture, slope, and internal drainage are controlling factors for pollutant export. Although Paulding (very-fine, illitic, nonacid, mesic Typic Epiaquept) and Roselms (very-fine, illitic, mesic Aeric Epiaqualf) soils occupy only 5% of the Maumee basin, they generate more than 10 times as much sediment per unit area as the tile-drained Hoytville (fine, illitic, mesic Mollic Epiaqualf) soils that occupy 16% of the Maumee basin. Tile drainage of very poorly drained soils that are formed from either glacial till or silty to sandy lake deposits reduces runoff and increases downward movement of soluble nutrients into tile drains. The assumption that sloping moraine areas are the primary source of pollutants should be reexamined based on this review.

Environmental Monitoring↗

PubMed1983

A comparison of the quality of participation of community affiliates and that of universities in the Northern California Oncology Group.

The quality of participation in the performance of clinical trials of university members and community affiliates of the Northern California Oncology Group is evaluated and compared. The data, based on 738 patients on 33 protocols, were collected during a one year period, July 1, 1980--June 30, 1981. The comparisons are made on three types of criteria: accrual distribution, with respect to study phase and modality multiplicity; data quality, generally reflecting protocol adherence; and data completeness. The performance of the community affiliates was found to equal or surpass that of the university members in most measures. Therefore, it is concluded that the community affiliates are functioning as full and valuable participants in the Northern California Oncology Group.

California↗

PubMed2001

Assessment of teratogenic risk.

Although the association between prenatal exposure to old generation antiepileptic drugs (AEDs) and major congenital malformations has been studied for many years, it is not clear whether any specific AED, or AED combination, is more harmful than others, or whether any pattern of malformations can be considered specific for any given drug. Relationships between dosage and plasma concentrations of AEDs and the risk of malformations also need to be clarified. The greatest limitation of all studies performed to date is the fact that none included a sufficiently large number of pregnancies. For newer generation AEDs the teratogenic risk, if any, is unknown. Large prospective studies are needed. The best approach is the establishment of registries through international collaboration. Inclusion of non-epileptic controls and untreated women is not strictly necessary to evaluate the comparative teratogenic risk of AEDs. The modalities of data collection should be pre-defined; common protocols, sufficiently exhaustive but at the same time easy to perform, should be shared from the beginning. Information on the presence or absence of major malformations or prenatal growth retardation, and on all major factors that may affect the teratogenic endpoints should be obtained. Study designs should ensure high quality data recording, and adequate quality assurance and auditing procedures. Further requisites are a clear definition of congenital malformation and prolonged follow-up to detect the occurrence of congenital malformations not detected at birth.

Abnormalities, Drug-Induced↗

PubMed2005

Pitfalls and their remedies in time-resolved fluorescence spectroscopy and microscopy.

Time-resolved fluorescence spectroscopy and microscopy in both time and frequency domains provide very useful and accurate information on dynamic processes. Good quality data are essential in obtaining reliable parameter estimates. Distortions of the fluorescence response due to artifacts may have disastrous consequences. We provide here a concise overview of potential difficulties encountered under daily laboratory circumstances in the use of time- and frequency-domain equipment as well as practical remedies against common error conditions, elucidated with several graphs to aid the researcher in visual inspection and quality-control of collected data. A range of artifacts due to sample preparation or to optical and electronic pitfalls are discussed, as are remedies against them. Also recommended data analysis strategies are described.

Journal Article↗

PubMed2006

Performance comparison of one-color and two-color platforms within the MicroArray Quality Control (MAQC) project.

Microarray-based expression profiling experiments typically use either a one-color or a two-color design to measure mRNA abundance. The validity of each approach has been amply demonstrated. Here we provide a simultaneous comparison of results from one- and two-color labeling designs, using two independent RNA samples from the Microarray Quality Control (MAQC) project, tested on each of three different microarray platforms. The data were evaluated in terms of reproducibility, specificity, sensitivity and accuracy to determine if the two approaches provide comparable results. For each of the three microarray platforms tested, the results show good agreement with high correlation coefficients and high concordance of differentially expressed gene lists within each platform. Cumulatively, these comparisons indicate that data quality is essentially equivalent between the one- and two-color approaches and strongly suggest that this variable need not be a primary factor in decisions regarding experimental microarray design.

Equipment Design↗

PubMed2000

Prevalence of childhood asthma, allergic rhinitis and eczema in Urumqi and Beijing.

OBJECTIVE: To assess the prevalence of asthma and other allergies in children in Urumqi and Beijing, compared with that in Hong Kong. METHODS: A total of 7754 primary school students were randomly selected to participate in the study. Data were collected in 1995-96 using the International Study of Asthma and Allergies in Childhood (ISAAC) protocol for 6- and 7-year-olds. The study design and data quality assurance in all aspects followed the protocol, including the double entry of data. RESULTS: The questionnaire response rate was high (98.9%). Beijing children reported significantly more asthma than those living in Urumqi in three categories: wheezing or whistling in the chest in the past year (6.0%, 95% confidence interval (CI): 5.1-6.9% vs 2.9%, 2.3-3.5%, P < 0.001), sleeping disturbed due to wheezing (1.3%, 0.9-1.7% vs 0.6%, 0.3-0.9%, P < 0. 03) and having experienced asthma ever (10.7%, 9.6-11.8% vs 7.6%, 6. 6-8.6%, P < 0.001). The prevalence of allergic rhinitis (30.0% vs 31. 1% estimated as 12-month nasal symptoms in Beijing and Urumqi, respectively) and eczema (2.8% vs 2.0% recorded as 12-month itchy rash) in the two cities were not significantly different. A similar study was also performed in Hong Kong in 1995 using the same ISAAC protocol. The children in Urumqi and Beijing had fewer (P < 0.05) allergic symptoms compared to those living in Hong Kong (n = 3618). The 12-month prevalence of wheezing, nasal symptoms and itchy rash found in Hong Kong were 9.2% (95% CI: 8.2-10.2%), 35.1% (33.5-36.7%) and 4.2% (3.5-4.9%), respectively. CONCLUSION: : Urumqi, Beijing and Hong Kong represent communities at different stages of westernization and the results from these three cities reflect a worldwide trend for an increasing prevalence of allergies along with westernization. These three cities could assist in identifying risk factors involved in the increase in asthma, allergic rhinitis and eczema.

Asthma↗

PubMed2002

The use of food consumption data in assessments of exposure to food chemicals including the application of probabilistic modelling.

Emphasis on public health and consumer protection, in combination with globalisation of the food market, has created a strong demand for exposure assessments of food chemicals. The food chemicals for which exposure assessments are required include food additives, pesticide residues, environmental contaminants, mycotoxins, novel food ingredients, packaging-material migrants, flavouring substances and nutrients. A wide range of methodologies exists for estimating exposure to food chemicals, and the method chosen for a particular exposure assessment is influenced by the nature of the chemical, the purpose of the assessment and the resources available. Sources of food consumption data currently used in exposure assessments range from food balance sheets to detailed food consumption surveys of individuals and duplicate-diet studies. The fitness-for-purpose of the data must be evaluated in the context of data quality and relevance to the assessment objective. Methods to combine the food consumption data with chemical concentration data may be deterministic or probabilistic. Deterministic methods estimate intakes of food chemicals that may occur in a population, but probabilistic methods provide the advantage of estimating the probability with which different levels of intake will occur. Probabilistic analysis permits the exposure assessor to model the variability (true heterogeneity) and uncertainty (lack of knowledge) that may exist in the exposure variables, including food consumption data, and thus to examine the full distribution of possible resulting exposures. Challenges for probabilistic modelling include the selection of appropriate modes of inputting food consumption data into the models.

Consumer Product Safety↗

PubMed2003

Home-based study of anti-HIV drug regimen adherence among HIV-infected women: feasibility and preliminary results.

Collection of antiretroviral medication adherence data in the homes of HIV-infected people may have methodological advantages that can improve data quality. However, the feasibility of this approach has not been established. In addition, data on adherence, and its predictors, among HIV-infected women have been limited. Sixty-three HIV-positive women who were prescribed at least one antiretroviral drug in the last month were interviewed in their homes. A standard instrument was used to collect data on all antiretroviral medications prescribed and taken in the three days prior to the interview. Data were also collected on factors thought potentially to affect the ability to be adherent. The results of this study suggest that it is feasible to conduct home-based adherence research. Sixty-seven per cent reported taking all prescribed antiretroviral medication doses. One-third took a sub-optimal dose putting themselves at increased risk of treatment failure and the selection of resistant HIV strains. Unintentional reasons for missing doses were most commonly reported. An ability to describe the intended effect of antiretroviral therapy on HIV viral load was the best predictor of adherence. This finding is consistent with other research suggesting that adherence is associated with an understanding and belief in the effectiveness of antiretroviral therapy.

Acquired Immunodeficiency Syndrome↗

PubMed2004

The role of the clinical research coordinator--data manager--in oncology clinical trials.

BACKGROUND: The purpose of this study was to determine the standard tasks performed by clinical research coordinators (CRCs) in oncology clinical trials. METHODS: Forty-one CRCs were anonymously surveyed, using a four-page self-administered questionnaire focused on demographics, qualifications, and professional experience. The survey questions on responsibilities consisted of an ad-hoc 32-item questionnaire where respondents had to rate the frequency of involvement in the listed activities using a 3-point scale. We defined as "standard" a task that was rated as "in all or nearly all trials" by at least half of the respondents. RESULTS: A response rate of 90% (37 out of 41) was achieved after two mailings. Less than half of the respondents had received additional training in oncology, clinical research or Good Clinical Practices (GCP). Overall, all standard tasks performed by CRCs were in the category of "monitoring activities" (those usually performed by a Clinical Research Associate "CRA") and included patient registration/randomization, recruitment follow-up, case report form completion, collaboration with the CRA, serious adverse events reporting, handling of investigator files, and preparing the site for and/or attending audits. CONCLUSIONS: CRCs play a key role in the implementation of oncology clinical trials, which goes far beyond mere data collection and/or administrative support, and directly contributes to the gathering of good quality data.

Biomedical Research↗

PubMed2003

Randomised prospective study for the effect of therapy on residual beta cell function in type-1 diabetes mellitus [ISRCTN70703138].

BACKGROUND: Newly diagnosed insulin-dependent diabetes mellitus is characterised by a temporary recovery of endogeneous insulin ("remission") after the beginning of medical treatment with subcutaneous insulin injections. Although most diabetologists think, that insulin reserve is related to reduced occurrence of diabetic long-term complications, such as eye, nerve and kidney disease, there is only one prospective controlled clinical study (the DCCT) addressing this question, however as secondary hypothesis. METHODS/DESIGN: Therefore, we composed a trial consisting of two cohorts with two therapeutic options within each cohort (conventional versus intensive therapy) and a three-year follow-up. In one group the patients are randomly assigned to the treatment regimes to test the statistical alternative hypothesis if variable insulin dosage is superior to fixed insulin injection in preserving insulin reserve measured by C-peptide in serum. Another group includes patients who prefer one of the two therapies, decline randomisation, but consent to follow-up. Apart from the determination of insulin reserve as a biological parameter a second primary endpoint was defined as 'therapeutic failure' according to the criteria of the European Association for the Study of Diabetes. Patients pass a training program to help them self-manage diabetes. A standardised protocol is being set up to minimize centre effects and bias of health care providers. Potential patient dependent bias will be investigated by questionnaires measuring psychic coping processes of people with diabetes. Management of visit dates is directly navigated by the database. Automated visit-reminders are mailed to patients and caregivers to optimise the number of visits on schedule. Data quality is regularly monitored and centres are informed on the results of continuous data management.

Journal Article↗

PubMed1996

Anthracycline-induced cardiotoxicity.

PURPOSE: To review the current understanding of the clinical significance, detection, pathogenesis, and prevention of anthracycline-induced cardiotoxicity. DATA SOURCES: A MEDLINE search of the English-language medical literature and a manual search of the bibliographies of relevant articles, including abstracts from national cardiology meetings. STUDY SELECTION: Pertinent clinical and experimental studies addressing the clinical relevance, pathogenesis, detection, and prevention of anthracycline cardiotoxicity were selected from peer-reviewed journals without judgments about study design. A total of 137 original studies and 9 other articles were chosen. DATA EXTRACTION: Data quality and validity were assessed by each author independently. Statistical analysis of combined data was inappropriate given the differences in patient selection, testing, and follow-up in the available studies. DATA SYNTHESIS: Anthracycline-induced cardiotoxicity limits effective cancer chemotherapy by causing early cardiomyopathy, and it can produce late-onset ventricular dysfunction years after treatment has ceased. Detection of subclinical anthracycline-induced cardiomyopathy through resting left ventricular ejection fraction or echocardiographic fractional shortening is suboptimal. Conventional doses of anthracycline often lead to permanent myocardial damage and reduced functional reserve. Underlying pathogenetic mechanisms may include free-radical-mediated myocyte damage, adrenergic dysfunction, intracellular calcium overload, and the release of cardiotoxic cytokines. Dexrazoxane is the only cardioprotectant clinically approved for use against anthracyclines, and it was only recently introduced for selected patients with breast cancer who are receiving anthracycline therapy. CONCLUSIONS: A rapidly growing number of persons, including an alarming fraction of the 150 000 or more adults in the United States who have survived childhood cancer, will have substantial morbidity and mortality because of anthracycline-related cardiac disease. The development of effective protection against anthracycline-induced cardiotoxicity will probably have a significant effect on the overall survival of these patients.

Acute Disease↗

PubMed2006

Consultations in general practice and at an Aboriginal community controlled health service: do they differ?

INTRODUCTION: Despite the widely acknowledged health disparities between Indigenous and non-Indigenous Australians, little is known about consultations in primary care with Indigenous people. In particular, the nature of consultations in the Aboriginal Community Controlled Health Service (ACCHS) sector has been rarely studied. Data collection about consultations in primary care has been steadily improving, with good quality data now available on an ongoing basis about patient demographics, risk factors and consultation content in private general practice. This study aimed to characterise consultations at Townsville Aboriginal and Islander Health Service (TAIHS) in terms of patient demographics and consultation content. These could then be compared with existing datasets for local consultations in mainstream general practice and from a geographically distant ACCHS. METHODS: We conducted a prospective questionnaire audit of all consultations at Townsville Aboriginal and Islander Health Service (TAIHS) over two fortnights, 6 months apart in 2000 and 2001. The questionnaire was adapted from one used in previous general practice surveys, and was completed by the treating clinician at the end of each consultation. The questionnaire described consultations using the following variables: date of consultation; patient age; ethnicity and gender; postcode and whether or not they were new to the practice; where they were seen; the provider of the service (doctor, nurse, health worker etc); Medicare level of consultation; patient reasons for encounter; problems managed; treatment and medications given; investigations; admissions; follow up; and referral. Proportions with 95% confidence intervals were calculated to facilitate comparisons with other datasets. Comparison was made with previously reported data from mainstream Townsville general practice (via the local BEACH study report) and from Darwin ACCHS (Danila Dilba). RESULTS: Of 1211 consultations studied, 1994 problems managed were recorded. TAIHS patients had a significantly younger age distribution than patients in mainstream general practice (as did patients at Danila Dilba). TAIHS consultations involved the management of more problems (1.65 problems per consultation; 95%CI [1.60, 1.70]), when compared with mainstream general practice (Townsville BEACH study 1.45 problems per consultation [1.37, 1.52]; 1.48 for Indigenous patients). Danila Dilba recorded an average of 1.58 problems managed per consultation (95% CI [1.51, 1.65]). The most frequently managed problems differed between all three datasets, and at TAIHS the most common problems managed were type 2 diabetes mellitus (11.3 times per 100 consultations), upper respiratory tract infections (9.6) and hypertension (7.9). Aboriginal Health Workers (AHW) saw the patient at TAIHS in 224/1213 (18.5%) of consultations, nurses (two Indigenous) participated in 513 (42.3%) of consultations, and a (non-Indigenous) medical officer saw the patient in 1070 (88.2%) of consultations. The Danila Dilba study found that 42.6% of their consultations involved an Aboriginal health worker only, and a health worker and a doctor managed 53.5%; only 3.9% were managed by a doctor alone without input from a health worker. CONCLUSIONS: The greater number of problems managed per consultation in ACCHS, compared with Indigenous patients in mainstream general practice, supports the assertion that ACCHS fill an important role in the health system by providing care for their largely Indigenous patients with complex care needs. The Medicare system as it was structured at the time did not encourage involvement of Indigenous health workers in provision of primary medical care. It remains to be seen whether introduction of the new enhanced primary care Medicare numbers will assist in this process. These findings have implications for ACCHS in other areas of the country and for other providers of primary health care for Indigenous Australians.

Adolescent↗

PubMed1994

The SMS-CESF Medical Outcomes Research Project.

After reviewing the environment of cost, quality data collection and analysis, the State Medical Society of Wisconsin Task Force on Quality Assessment and Implementation of Practice Parameters concluded it is critical for the SMS to take a dynamic role in sponsoring the development and use of medical outcomes research. The initial emphasis will be on chronic diseases and health conditions representative of a large percentage of the Wisconsin patient population and involve physicians from diverse practice settings. The physicians of Wisconsin have a singular opportunity to seize the day by supporting and participating in a non-proprietary, regional study of patient medical outcomes.

Humans↗

PubMed2005

1 to 100: creating an air quality index in Pittsburgh.

Air pollution indices and other environmental quality indicators have often been subjects of debate. This article presents a case study of the creation and criticism of an air pollution index in Pittsburgh, Pennsylvania. Long known for its industrial production and the resulting pollution, Pittsburgh was home to engineers, scientists, institutions and corporations that developed new air pollution monitoring technologies in the years after World War II. These newly automated instruments were used as a part of a computerized monitoring network built in the late 1960s by the Allegheny County Health Department. County engineers created a daily air pollution index to summarize the information from the network, leading to public debates over the intent, meaning, and representation of air quality data. This case study serves to illustrate the inherent complexity of creating accessible, understandable, and uniformly acceptable indices of environmental quality. It also emphasizes the importance of understanding the social and political context in which data is collected, organized, and interpreted.

Abstracting and Indexing↗

PubMed1995

Verification & validation algorithms for data used in critical care decision support systems.

A decision support system is only as good as the data generating that decision support system. If the data is incorrect, doesn't relate to the other pieces of data, is missing or is not consistent, the decision support system conclusions may be incorrect and inconsistent. While collecting data from several sites during a multicenter randomized clinical trial, we found that some critical data elements were missing, out of correct ranges, totally illogical, and/or inconsistently recorded. In order to get consistent, correct, and dependable information from a our decision support system, the data elements used in that system had to be checked for completeness, valid values, consistent units of measurement, and relationships to other items. Development of data quality assurance rules and the application of those rules is imperative to using the data to generate daily scores for multiple organ failure, sepsis, and barotrauma.

Algorithms↗

PubMed2005

Water quality monitoring: a combined approach to investigate gradients of change in the Great Barrier Reef, Australia.

For the managers of a region as large as the Great Barrier Reef, it is a challenge to develop a cost effective monitoring program, with appropriate temporal and spatial resolution to detect changes in water quality. The current study compares water quality data (phytoplankton abundance and water clarity) from remote sensing with field sampling (continuous underway profiles of water quality and fixed site sampling) at different spatial scales in the Great Barrier Reef north of Mackay (20 degrees S). Five transects (20-30 km long) were conducted from clean oceanic water to the turbid waters adjacent to the mainland. The different data sources demonstrated high correlations when compared on a similar spatial scale (18 fixed sites). However, each data source also contributed unique information that could not be obtained by the other techniques. A combination of remote sensing, underway sampling and fixed stations will deliver the best spatial and temporal monitoring of water quality in the Great Barrier Reef.

Animals↗

PubMed2005

Improving case ascertainment of a population-based birth defects registry in New York State using hospital discharge data.

BACKGROUND: The assessment of the data quality of population-based registration systems is essential to understanding the reliability and usefulness of disease surveillance and research findings resulting from the use of registry data. Since the New York State Congenital Malformations Registry (CMR) uses passive case ascertainment, the completeness of the registry data is an important aspect of the quality of information. This paper presents the results of hospital audits, which were conducted to capture the unreported cases using hospital discharge files, and evaluates the effectiveness of the audits. METHODS: Children age 2 years or younger and diagnosed with reportable birth defects for the birth years 1998-2000 were selected from hospital discharge files of all reporting hospitals in the New York Statewide Planning and Research Cooperative System (SPARCS) and matched to the CMR database for the same birth year period. The unmatched reports from the SPARCS hospital discharge files that the CMR possibly missed were sent to hospitals, requesting submission of the missed reports. Two audits on all reporting hospitals in New York State were conducted: 1) 1998 and 1999 birth cohorts audited from June 2000 to March 2002, and 2) 2000 birth cohort audited from November 2001 to November 2002. RESULTS: Hospital audits using SPARCS hospital discharge data identified 5,460 reports that the CMR missed for the selected 66 hospitals analyzed. About 86% of these reports had reportable conditions and were added to the CMR, which comprised 21.4% of all reports from the 66 hospitals for the birth years 1998-2000. The number of reports that would have been missed without audits decreased from the 1998 and 1999 birth cohort (25.1%) to the 2000 birth cohort (13.9%). Low reporting rates and, thus, a high percent of added reports, were found for hospitals with a relatively small number of annual reports and for some specific birth defects such as chromosomal anomalies, anencephalus and congenital anomalies of the urinary system. CONCLUSION: The current study demonstrates that using hospital discharge data to improve case ascertainment is a valuable and effective method of enhancing birth defect surveillance, particularly for those hospitals with low reporting rates.

Abnormalities, Multiple↗