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Escherichia coli O157:H7 infection in humans.

OBJECTIVE: To review the clinical relevance of Escherichia coli O157:H7 infection, including the epidemiology of the infection and its clinical presentations, pathogenesis, microbiology, diagnosis, treatment, and prevention. DATA SOURCES: Articles on E. coli O157:H7 were identified through MEDLINE and the bibliographies of relevant articles. STUDY SELECTION: All articles and case reports describing E. coli O157:H7 and its infection were selected. DATA EXTRACTION: The data were abstracted without judgments about study design. Data quality and validity were assessed by independent author reviews. DATA SYNTHESIS: Infection with E. coli O157:H7 presents with a wide spectrum of clinical manifestations, including asymptomatic carriage, nonbloody diarrhea, hemorrhagic colitis, the hemolytic-uremic syndrome, and thrombotic thrombocytopenic purpura. Not only is E. coli O157:H7 an important agent for hemorrhagic colitis, it is also one of the leading causes of bacterial diarrhea. Patients at extremes of age have an increased risk for infection and associated complications. Transmission of E. coli O157:H7 is primarily food-borne. Undercooked meat is the most common culprit, and secondary person-to-person spread is also important. The organism produces at least two Shiga-like toxins that differ antigenically, physicochemically, immunologically, and in their biological effects. These toxins are thought to have direct pathogenic significance in E. coli O157:H7 infection. This infection is usually diagnosed from a positive stool culture, from the presence of Shiga-like toxins, or both. Timely collection (within 7 days of illness onset) of a stool sample for culture is imperative for a high recovery rate. Treatment is primarily supportive and includes the management of complications as necessary. Antibiotic therapy has not been proved beneficial. Important public health measures include educating the public on the danger of eating undercooked meat, increasing physician awareness of E. coli O157:H7 infection, and mandating case reporting. CONCLUSIONS: Infection with E. coli O157:H7 presents with many clinical manifestations and should be included in the differential diagnosis for any patient with new-onset bloody diarrhea. Development of the hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura should raise strong suspicion of E. coli O157:H7 infection and should lead to prompt evaluation. If infection is confirmed, it should be reported to public health officials.

Escherichia coli↗

Human herpesvirus-6 in transplantation: an emerging pathogen.

BACKGROUND: Human herpesvirus-6 can be an opportunistic pathogen in transplant recipients. PURPOSE: To summarize the epidemiologic and clinical aspects of human herpesvirus-6 infection, the immunologic basis of the pathogenicity of human herpesvirus-6, and the management of human herpesvirus-6 infection in transplant recipients. DATA SOURCES: English-language articles identified through a MEDLINE search from 1986 (when human herpesvirus-6 was discovered) to the present, bibliographies of identified articles, and recognized texts. STUDY SELECTION: Reports on human herpesvirus-6 infections in bone marrow transplant recipients and in solid organ transplant recipients. DATA EXTRACTION: Data on the virology, detection, epidemiology, clinical features, and treatment of human herpesvirus-6 infection were manually abstracted from the indicated sources and summarized. Data quality and validity were independently assessed by both authors. DATA SYNTHESIS: Human herpesvirus-6 infection occurred in 38% to 60% of bone marrow transplant recipients and 31% to 55% of solid organ transplant recipients, usually 2 to 4 weeks after transplantation. Human herpesvirus-6 has two variants, designated variant A and variant B; transplant recipients were infected almost exclusively with variant B. Bone marrow suppression, interstitial pneumonitis, and encephalitis were the most commonly reported types of clinical disease caused by human herpesvirus-6. The marrow-suppressive effect of human herpesvirus-6 ranged from transient or self-limited bone marrow suppression to chronic or fatal aplastic anemia; bone marrow suppression was thought to be partially cytokine-mediated. Because it can depress cell-mediated immunity, human herpesvirus-6 may facilitate superinfection by other pathogens. Human herpesvirus-6 resembles cytomegalovirus in its antiviral susceptibilities: It is resistant to acyclovir but susceptible to ganciclovir and foscarnet. Prophylaxis of human herpesvirus-6 infection is feasible in transplant recipients, but this issue must be studied further. CONCLUSION: Human herpesvirus-6 can be a pathogen in transplant recipients. Prompt recognition of disease associated with human herpesvirus-6 is important because this virus is susceptible to currently available antiviral agents. Future research should focus on delineating the complete clinical spectrum, immunologic sequelae, and efficacy of prophylactic strategies for human herpesvirus-6 infection in transplant recipients.

Antiviral Agents↗

Challenges of developing a cervical screening information system: the Ontario pilot project.

OBJECTIVE: To create a cervical screening information and reporting system in 2 geographic areas of Ontario. DESIGN: A pilot project involving access to, and linkage of, cervical screening-related cytology, colposcopy and histopathology records for women in the study areas, followed by development and production of woman-specific and aggregate reports. SETTING: Hospital cytology and pathology departments, colposcopy clinics, private cytology laboratories, and the provincial cancer agency (Cancer Care Ontario, formerly the Ontario Cancer Treatment and Research Foundation). MAIN OUTCOME MEASURES: Access to required records; data quality (i.e., standardization, completeness, accuracy); quality of record linkage; utility of reports to evaluators, data sources and physicians. RESULTS: The pilot project was not completed because of a number of major challenges, including multiple data sources requiring separate investigation and negotiations for access; variations in reporting terminology and coding; incompatibility or lack of computer systems; incompleteness of identifiers for record linkage; variation in legislation permitting data access and sharing and in its interpretation; and major financial, resource and time requirements. CONCLUSIONS: Although sufficient will and resources can overcome technical obstacles, changes in legislation will be required to overcome other challenges. Strong links with all sectors involved in cervical screening and attention to changes in the health care system are essential.

Colposcopy↗

Statistical methods for the validation of questionnaires--discrepancy between theory and practice.

OBJECTIVES: Questionnaires used in epidemiological studies should be validated. However, unclarity exists about the appropriate statistical methods and interpretation of validation studies. Thus, we investigated the theory and practice of statistical evaluation approaches. METHODS: Using three platforms, a literature review, own simulations, and a validation study performed by ourselves, we worked out relevant limitations, advantages, and new important aspects of evaluation methods. RESULTS: Our systematic literature review, based on physical activity questionnaires, revealed that correlation coefficients are still the common approach in validation studies, found in 41 of 46 reviewed publications (89.1%). This practice has been criticized in the theoretically oriented literature for more than 20 years. Appropriate evaluation methods as recommended by Bland and Altman were found in only ten publications (21.7%). We showed that serious bias in questionnaires can be revealed by Bland-Altman plots but may remain undetected by correlation coefficients. With our simulations we refuted the argument that correlation coefficients properly investigate whether a questionnaire ranks the subjects sufficiently well. Further, with Bland-Altman analyses we could evaluate differential errors with respect to case-control status in our validation study. Yet, this was not possible with correlation coefficients, because they generally do not identify systematic bias. In addition, we show a potential pitfall in the interpretation of Bland-Altman plots that might occur in specific rare instances. CONCLUSIONS: The commonly used correlation approach can yield misleading conclusions in validation studies. A more frequent and proper use of the Bland-Altman methods would be desirable to improve epidemiological data quality.

Data Interpretation, Statistical↗

Application of structural modeling with latent variables to adolescent drug use: a reply to Huba, Wingard, and Bentler.

I propose that strong claims about the superiority of latent variable (LV) structural modeling, compared to other causal approaches to nonexperimental data, are both overstated and premature. Focusing primarily on a recent article by Huba, Wingard, and Bentler (1981) appearing in this journal, I argue both that the authors' application of these models is seriously flawed and that the data employed to test the models are of questionable quality. I conclude that statements about powerful inferences that can be made from analyses of LV models should be moderated. A more prudent position is advocated in this paper: I argue that the evaluation and testing of LV models should proceed, but with caution and self-criticism; even highly sophisticated methods like LV modeling cannot substitute for the collection of high quality data and the clear operationalization of constructs and hypotheses.

Adolescent↗

Validity of breast cancer in the Danish Cancer Registry. A study based on clinical records from one county in Denmark.

Cancer registries are essential in order to monitor the incidence of cancer and, with proper follow-up, survival in a population. However, the usefulness of the registry depends upon the data quality. To validate the Danish Cancer Registry concerning breast cancer in female residents of Aarhus county 1983-1989, registry records were compared with clinical records. Completeness was validated in 2062 patients and correctness was determined for pathologically proven primary invasive breast cancer in 1949 patients. Incidence data were complete with no tumours missing. Data were coded according to ICD-7 and correctness of registry data in terms of basis of diagnosis and tumour malignancy was 99%. Information on extent of disease (stage) was not complete and there was a high disconcordance, in particular for bilateral breast tumours and cases with distant metastasis. Even crude staging into local and regional disease was inconsistent for 13% of cases, which probably hampered survival analysis by stage. The quality of registry data should be addressed when using variables, such as stage, not routinely reported by registries.

Adult↗

Prevention of colorectal cancer: guidelines based on new data. WHO Collaborating Center for the Prevention of Colorectal Cancer.

Recently published good quality data are the basis for this update. The newly reported studies include randomized trials, non-randomized cohort studies, and case-control studies; some of the data had mortality reduction as the endpoint. These guidelines, which were developed by the WHO Collaborating Center for the Prevention of Colorectal Cancer at Memorial Sloan-Kettering Cancer Center in conjunction with an International Advisory Committee, include primary prevention, screening of average-risk individuals, screening of individuals with heritable factors for colorectal cancer, surveillance of patients with colorectal polyps, and surveillance of patients with chronic ulcerative colitis. A list of papers reviewed for this update are cited, including recently published trials evaluating faecal occult-blood testing, case-control studies of sigmoidoscopy, the National Polyp study, and familial colon cancer studies. These guidelines will help inform patients and guide physicians in their approach to the prevention of colorectal cancer.

Colorectal Neoplasms↗

Daily mortality and air pollution in Atlanta: two years of data from ARIES.

Associations between daily mortality and air pollution were investigated in Fulton and DeKalb Counties, Georgia, for the 2-yr period beginning in August 1998, as part of the Aerosol Research and Inhalation Epidemiological Study (ARIES). Mortality data were obtained directly from county offices of vital records. Air quality data were obtained from a dedicated research site in central Atlanta; 15 separate air quality indicators (AQIs) were selected from the 70 particulate and gaseous air quality parameters archived in the ARIES ambient air quality database. Daily meteorological parameters, comprising 24-h average temperatures and dewpoints, were obtained from Atlanta's Hartsfield International Airport. Effects were estimated using Poisson regression with daily deaths as the response variable and time, meteorology, AQI, and days of the week as predictor variables. AQI variables entered the model in a linear fashion, while all other continuous predictor variables were smoothed via natural cubic splines using the generalized linear model (GLM) framework in S-PLUS. Knots were spaced either quarterly, monthly, or biweekly for temporal smoothing. A default model using monthly knots and AQIs averaged for lags 0 and 1 was postulated, with other models considered in sensitivity analyses. Lags up to 5 days were considered, and multipollutant models were evaluated, taking care to avoid overlapping (and thus collinear) AQIs. For this reason, PM(2.5) was partitioned into its three major constituents: SO(2-)(4), carbon (EC + 1.4 OC), and the remainder; sulfate was assumed to be (NH(4))(2)SO(4) for this purpose. Initial AQI screening was based on all-cause (ICD-9 codes <800) mortality for those aged 65 and over. For the (apparently) most important pollutants--PM(2.5) and its 3 major constituents, coarse PM mass [CM], 1-h maximum CO, 8-h maximum O(3)--we investigated 15 mortality categories in detail. (The 15 categories result from three age groups [all ages, <65, 65+] and five cause-of-death groups [all disease causes, cardiovascular, respiratory, cancer, and other "remainder" disease causes]). The GLM model outputs that were considered included mean AQI effects and their standard errors, and two indicators of relative model performance (deviance and deviance adjusted for the number of observations and model parameters). The latter indicator was considered to account for variations in the number of observations created by varying amounts of missing AQI data, which were not imputed. The single-AQI screening regressions on all-cause 65+ mortality show that CO, NO(2), PM(2.5), CM, SO(2), and O(3), followed by EC and OC, consistently have the best model fits, after adjusting for the number of observations. Their relative rankings, however, vary according to the smoothing knots used, and there is no correspondence between mean AQI effect and overall model fit.(Other regression runs often show that the best model fits are obtained with no AQI in the model.) There is no correspondence between mean AQI effect and statistical significance or between mean effect and serial correlation. There is a highly significant (.001 level) relationship between overall model fit and serial correlation; the best fitting models have the most frequent knot spacing and the most negative serial correlation. The regression analyses by cause of death find elderly circulatory deaths to be consistently associated with CO for all models.

Adult↗

Quantitative study designs used in quality improvement and assessment.

This article describes common quantitative design techniques that can be used to collect and analyze quality data. An understanding of the differences between these design techniques can help healthcare quality professionals make the most efficient use of their time, energies, and resources. To evaluate the advantages and disadvantages of these various study designs, it is necessary to assess factors that threaten the degree with which quality professionals may infer a cause-and-effect relationship from the data collected. Processes, the conduits of organizational function, often can be assessed by methods that do not take into account confounding and compromising circumstances that affect the outcomes of their analyses. An assumption that the implementation of process improvements may cause real change is incomplete without a consideration of other factors that might also have caused the same result. It is only through the identification, assessment, and exclusion of these alternative factors that administrators and healthcare quality professionals can assess the degree to which true process improvement or compliance has occurred. This article describes the advantages and disadvantages of common quantitative design techniques and reviews the corresponding threats to the interpretability of data obtained from their use.

Education, Continuing↗

Purchasing or providing nursing home care: can quality of care data provide guidance.

OBJECTIVES: To examine whether quality of care differed for veterans in Department of Veterans Affairs (VA) nursing homes and those on contract in community nursing homes, and whether the VA was contracting with nursing homes providing better quality of care than other nursing homes. DESIGN: Observational study using administrative databases from 1997 to 1999. SETTING: Ten VA and 650 community nursing homes in New York state. PARTICIPANTS: Four thousand seven hundred sixty-three veteran and 195,438 nonveteran residents of these nursing homes. MEASUREMENTS: Risk-adjusted rates of pressure ulcer development, functional decline, behavioral decline, and mortality. RESULTS: Veterans in VA nursing homes were significantly (P< .05) less likely to develop a pressure ulcer (odds ratio (OR)=0.63) but more likely to experience functional decline (OR=1.6) than veterans in community nursing homes. Residents of community nursing homes with VA contracts were significantly (P< .05) less likely to develop a pressure ulcer (OR=0.91) but more likely to die than residents in noncontract homes. Few nursing homes were consistently among the best or worst performers on all measures; only seven of 650 nursing homes were in the top or bottom decile and 34 in the top or bottom quartile for each measure. CONCLUSION: Large purchasers and providers of nursing home care such as the VA are unlikely to find information on quality of care useful in making decisions on whether they should "make" or "buy" care. Nursing homes performing well on one quality measure may perform poorly on another, and it is difficult to identify nursing homes that are consistently among the best or worst. Other consumers may encounter similar difficulties when using data on nursing home quality.

Aged↗

Assessing quality using administrative data.

Administrative data result from administering health care delivery, enrolling members into health insurance plans, and reimbursing for services. The primary producers of administrative data are the federal government, state governments, and private health care insurers. Although the clinical content of administrative data includes only the demographic characteristics and diagnoses of patients and codes for procedures, these data are often used to evaluate the quality of health care. Administrative data are readily available, are inexpensive to acquire, are computer readable, and typically encompass large populations. They have identified startling practice variations across small geographic areas and-supported research about outcomes of care. Many hospital report cards (which compare patient mortality rates) and physician profiles (which compare resource consumption) are derived from administrative data. However, gaps in clinical information and the billing context compromise the ability to derive valid quality appraisals from administrative data. With some exceptions, administrative data allow limited insight into the quality of processes of care, errors of omission or commission, and the appropriateness of care. In addition, questions about the accuracy and completeness of administrative data abound. Current administrative data are probably most useful as screening tools that highlight areas in which quality should be investigated in greater depth. The growing availability of electronic clinical information will change the nature of administrative data in the future, enhancing opportunities for quality measurement.

Abstracting and Indexing↗

Linking service climate and customer perceptions of service quality: test of a causal model.

A set of foundation issues that support employee work and service quality is conceptualized as a necessary but not sufficient cause of a climate for service, which in turn is proposed to be reflected in customer experiences. Climate for service rests on the foundation issues, but in addition it requires policies and practices that focus attention directly on service quality. Data were collected at multiple points in time from employees and customers of 134 branches of a bank and analyzed via structural equation modeling. Results indicated that the model in which the foundation issues yielded a climate for service, and climate for service in turn led to customer perceptions of service quality, fit the data well. However, subsequent cross-lagged analyses revealed the presence of a reciprocal effect for climate and customer perceptions. Implications of these results for theory and research are offered.

Commerce↗

Recombinant growth hormone for idiopathic short stature in children and adolescents.

BACKGROUND: Idiopathic short stature (ISS) refers to children who are very short compared with their peers for unknown or hereditary reasons. Recombinant human growth hormone has been used to increase growth and final height in children with idiopathic short stature. OBJECTIVES: To assess the effects of recombinant human growth hormone on short-term growth and final height in children with idiopathic short stature. SEARCH STRATEGY: Randomised controlled trials (RCTs) were sought by searching The Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, PubMed, Science Citation Index, BIOSIS and Current Controlled Trials (date of last search 10 December 2002). Article reference lists were assessed for trials and experts and pharmaceutical companies were contacted. SELECTION CRITERIA: Randomised controlled trials were included if they were carried out in children with ISS with normal growth hormone secretion. Growth hormone (GH) had to be administered for a minimum of six months and be compared with placebo or no treatment. A growth or height outcome measure had to be assessed. DATA COLLECTION AND ANALYSIS: Two reviewers assessed studies for inclusion criteria and for methodological quality. Data were extracted by one reviewer and checked by a second. The primary outcome was final height and secondary outcomes included short term growth, health related quality of life and adverse effects. To estimate summary treatment effects, data were pooled, when appropriate using a random effects model. MAIN RESULTS: Nine randomised controlled trials were included. One trial reported near final height in girls and found that girls treated with growth hormone were 7.5 cm taller than untreated controls (GH group, 155.3 cm +/- 6.4; control, 147.8 cm +/- 2.6; p = 0.003). The other trials reported short term outcomes. Results suggest that short-term height gains can range from none to approximately 0.7 SD over one year. One study reported health related quality of life and showed no significant improvement in growth hormone treated children compared with those in the control group. No serious adverse effects of treatment have been reported. REVIEWER'S CONCLUSIONS: Results suggest that growth hormone therapy can increase short-term growth and improve (near) final height. Increases in height are such that treated individuals remain relatively short when compared with peers of normal stature. Further research in the form of large, multicentre RCTs are required. These should focus on final height, which is the best outcome for assessing the effects of growth hormone, and address quality of life and cost issues.

Adolescent↗

The hazards of using administrative data to measure surgical quality.

Administrative claims data have been used to measure risk-adjusted clinical outcomes of hospitalized patients. These data have been criticized because they cannot differentiate risk factors present at the time of admission from complications that occur during hospitalization. This paper illustrates how valid risk-adjustment can be achieved by enhancing administrative data with a present-on-admission code, admission laboratory data, and admission vital signs. Examples are presented for inpatient mortality rates following craniotomy and rates of postoperative sepsis after elective surgical procedures. Administrative claims data alone yielded a risk-adjustment model with 10 variables and a C-statistic of 0.891 for mortality after craniotomy, and a model with 18 variables and a C-statistic of 0.827 for postoperative sepsis. In contrast, the combination of administrative data and clinical data abstracted from medical records increased the number of variables in the craniotomy model to 21 with a C-statistic of 0.923, and the number of variables in the postoperative sepsis model to 29 with a C-statistic of 0.858. Use of only administrative data resulted in unacceptable amounts of systematic bias in 24 per cent of hospitals for craniotomy and 19 per cent of hospitals for postoperative sepsis. Addition of a present-on-admission code, laboratory data, and vital signs reduced the percentage of hospitals with unacceptable bias to two percent both for craniotomy and for postoperative sepsis. These illustrations demonstrate suboptimal risk stratification with administrative claims data only, but show that present-on-admission coding combined with readily available laboratory data and vital signs can support accurate risk-adjustment for the assessment of surgical outcomes.

Adult↗

Automated quality assurance routines for fMRI data applied to a multicenter study.

Standard procedures to achieve quality assessment (QA) of functional magnetic resonance imaging (fMRI) data are of great importance. A standardized and fully automated procedure for QA is presented that allows for classification of data quality and the detection of artifacts by inspecting temporal variations. The application of the procedure on phantom measurements was used to check scanner and stimulation hardware performance. In vivo imaging data were checked efficiently for artifacts within the standard fMRI post-processing procedure by realignment. Standardized and routinely carried out QA is essential for extensive data amounts as collected in fMRI, especially in multicenter studies. Furthermore, for the comparison of two different groups, it is important to ensure that data quality is approximately equal to avoid possible misinterpretations. This is shown by example, and criteria to quantify differences of data quality between two groups are defined.

Artifacts↗

Influence of the method of data collection on the documentation of blood-pressure readings with an Anesthesia Information Management System (AIMS).

The influence of methods for record keeping on the documentation of vital signs was assessed for the Anesthesia Information Management System (AIMS) NarkoData. We compared manually entered blood-pressure readings with automatically collected data. These data were stored in a data-base and subsequently evaluated and analyzed. The data sets were split into two groups, "manual" and "automatic". We evaluated the effect of automatic data collection on the incidence of corrected data, data validity and data variation. Blood-pressure readings of 37,726 data sets were analyzed. We could assess that the method of documentation did influence the data quality. It could not be assessed whether the incorrectness of data during automatic data gathering was caused by artefacts or by the anesthesiologist.

Anesthesiology↗

Incomplete quality of life data in randomized trials: missing forms.

Analysing quality of life (QOL) data may be complicated for several reasons, such as: repeated measures are obtained; data may be collected on ordered categorical responses; the instrument may have multidimensional scales, and complete data may not be available for all patients. In addition, it may be necessary to integrate QOL with length of life. The major undesirable effects of missing data, in QOL research, are the introduction of biases due to inadequate modes of analysis and the loss of efficiency due to reduced sample sizes. Currently, there is no standard method for handling missing data in QOL studies. In fact, there are very few references to methods of handling missing data in this context. The aim of this paper is to provide an overview of methods for analysing incomplete longitudinal QOL data which have either been presented in the QOL literature or in the missing data literature. These methods of analysis include complete case, available case, summary measures, imputation and likelihood-based approaches. We also discuss the issue of bias and the need for sensitivity analyses.

Bias↗

[Dietary fat consumption of the French population and quality of the data on the composition of the major food groups].

The validity of estimated association between dietary fat intake and cancer depends both on the methodology of dietary assessment used and on the quality of food composition data. The food composition database of Afssa/Ciqual shows that there is a deficiency in data on fatty acids. In order to identify the priorities for improving the quality of the database, we analysed the data quality of major dietary contributors of fatty acids in the French population. These food contributors, listed according to their contribution to fat intake, have been identified by French national consumption survey Inca. Consumption studies in France show a high dietary fat contribution (37-38% even 40% of total energy) with over-consumption of saturated fatty acids, under-consumption of monounsaturated fat and, to a lesser extent of polyunsaturated fatty acids. Major food contributors of total fat and saturated fatty acids are butter, cheese, meat products, meats, dishes, dressing, cakes and pastry and, only in children, biscuits. Among contributors of monounsaturated fatty acids, vegetable oils and sauces are listed after processed meats before meats, butter, cheese and dishes. Vegetable oils and sauces are the major contributors of polyunsaturated fatty acids before "fatty" potatoes (such as chips...) in adults whereas the opposite was observed in children. Composition tables do not presently allow the identification of contributors of specific fatty acids (omega 3, omega 6, conjugated linoleic acid). If nutritional data of milk products, fats, and oils are reliable because of existing specific tables for these products, there is a need for improving quality of composition data for other major contributors such as: meats, processed meats, fish and dishes such as pizzas, pasteries...

Adolescent↗