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Thrombolytic therapy of acute myocardial infarction. Keeping the unfulfilled promises.

OBJECTIVE: To assess the use of thrombolytic therapy for acute myocardial infarction, evaluating whether inclusion and exclusion criteria should be altered as well as the public health implications of any such alterations. DATA SOURCES: Data obtained were from English-language articles on the use of thrombolytic therapy in acute myocardial infarction. Articles that reported on inclusion and exclusion criteria as well as specific complications of this therapy were specifically sought. The review included articles under the terms thrombolytic therapy and acute myocardial infarction in the National Library of Medicine's MEDLINE database. STUDY SELECTION: Studies selected for detailed review were those reporting specifics about inclusion and exclusion criteria and efficacy. Data extraction guidelines for assessing data quality included study size, patient population, detail of patient information acquired, and consecutive patient enrollment. DATA SYNTHESIS: Thrombolytic therapy can provide substantial decrements of morbidity and mortality of acute myocardial infarction in the subset of patients who receive this therapy, but is underused in the United States. Advanced age per se should not be an exclusion criterion. Improvements can be made in electrocardiographic diagnosis of acute myocardial infarction. Many of the clinical conditions initially excluded from thrombolytic consideration, such as hypertension or having received cardiopulmonary resuscitation, are only relative contraindications. The benefit/risk ratio in treatment of these patients is often acceptable. Several well-documented points of delay from onset of symptoms to treatment can be minimized, and accelerated therapy can result in a reduction in mortality rates. CONCLUSION: Significant public health benefits will result from greater use of thrombolytic therapy in acute myocardial infarction.

Contraindications↗

Methodology of the youth risk behavior surveillance system.

CDC developed the Youth Risk Behavior Surveillance System (YRBSS) to monitor six categories of priority health-risk behaviors among youth--behaviors that contribute to unintentional injuries and violence; tobacco use; alcohol and other drug use; sexual behaviors that contribute to unintended pregnancy and sexually transmitted diseases, including human immunodeficiency virus (HIV) infection; unhealthy dietary behaviors; and physical inactivity--plus overweight. These risk behaviors contribute markedly to the leading causes of death, disability, and social problems among youth and adults in the United States. YRBSS includes a national school-based survey conducted by CDC as well as state, territorial, and local school-based surveys conducted by education and health agencies. In these surveys, conducted biennially since 1991, representative samples of students in grades 9--12 are drawn. In 2003, a total of 15,214 students completed the national survey, and 32 states and 20 school districts also obtained data representative of their jurisdiction. Although multiple publications have described certain methodologic features of YRBSS, no report has included a comprehensive description of the system and its methodology. This report describes the background and rationale for YRBSS and includes a detailed description of the methodologic features of the system, including its questionnaire; operational procedures; sampling, weighting, and response rates; data-collection protocols; data-processing procedures; reports and publications; and data quality. YRBSS is evolving to meet the needs of CDC and other users of the data.

Adolescent↗

Towards automatically generating graphical user interfaces from openEHR archetypes.

One of the main challenges in the field of Electronic Health Records (EHRs) is semantic interoperability. To utilise the full potential of interoperable EHR systems they have to be accepted by their users, the health care providers. Good Graphical User Interfaces (GUIs) that support customisation and data validation play a decisive role for user acceptance and data quality. This study investigates the use of openEHR archetypes to automatically generate coherent, customizable, data-validating GUIs. Using the Mozilla XML User Interface Language (XUL) a series of prototypes has been developed. The results show that the automatic generation of GUIs from openEHR archetypes is feasible in principle. Although XUL revealed some problems, the advantages of XML-based GUI languages are evident.

Data Display↗

Survey of practice annual reports.

A questionnaire was sent to those practices known by the Royal College of General Practitioners to have produced annual reports. Practices were asked what data they included, to whom the report was circulated, what problems and benefits they encountered, and their opinion of the government's proposal to encourage such reports. The data most frequently included in reports related to practice workload, and the main benefit which respondents mentioned was facilitation of planning within the practice. Few practices used data derived from outside the practice and several commented on the difficulty of obtaining good quality data from the practice. Although annual reports are useful as internal documents, standardization of definitions and format, with support from family practitioner committees and health authorities is essential if more practices are to be encouraged to produce such documents and if the information obtained from them is to have a broader role in planning for primary health care.

Annual Reports as Topic↗

[Phase III trial of new anticancer agents from a medical oncologists viewpoint].

The purpose of a phase III study is to establish the efficacy of a new agent (whether it is a single-agent, a combination of drugs or a combined modality approach) compared with the best conventional treatment. Several cytotoxic agents with promising single-agent activity in non-small cell lung cancer have recently been defined. Among them are Navelbine, taxol, taxotere, CPT-11 and gemcitabine. A phase III study of Navelbine has been completed. A study is currently in progress defining activity for taxol in combination with cisplatin. Several aspects in designing a phase III trial of CPT-11 related to the efficiency were discussed, with particular emphasis on the following points considered particularly important, timely, or relevant to this symposium. Firstly, the value of a clinical trial is determined mostly by the importance of the question addressed. After the question of timing has been resolved, the choice of the test and appropriate control treatments is central. The keys to obtaining a reliable answer are the use of randomized treatment allocation, adequate sample size, good data quality, protocol adherence, sufficient follow-up, avoidance of exclusions, appropriate analysis, and lack of data dredging. Participation of a biostatistician is also indispensable for improving the efficiency of comparative clinical trials.

Antineoplastic Agents↗

Naltrexone maintenance treatment for opioid dependence.

BACKGROUND: Despite widespread use of naltrexone maintenance in many countries for more than ten years now (e.g., USA since 1984, UK since 1988) a sound documentation of the research on this drug is still missing. OBJECTIVES: To evaluate the effects of naltrexone maintenance treatment in preventing relapse in opioid addicts after detoxification. SEARCH STRATEGY: We searched MEDLINE, EMBASE, CCTR and handsearched the "Bolletino per le Farmacodipendenze e l'Alcolismo"; contact was sought with pharmaceutical producers of naltrexone, with authors and other CRGs; references of obtained studies. Trials were reliably identified and data extracted. Date of most recent searches: June 1998. SELECTION CRITERIA: All studies controlled for naltrexone; treatment of heroin addicts after detoxification with naltrexone. Studies were classified into three categories (high, moderate or low risk of bias) according to their methodological quality. DATA COLLECTION AND ANALYSIS: Reviewers evaluated data independently and analysed outcome measures taking into consideration adherence to and success of the study intervention. Data was extracted and analysed stratifying for the three categories of study quality. Where possible, meta-analysis was performed. MAIN RESULTS: Eleven studies were included in this review, and not all of them were randomised. Meta-analysis could be done to a low degree only, because the studies and their outcomes were very heterogeneous. The result of this quantitative analysis was statistically poor, and so was the methodological quality of the included studies. REVIEWER'S CONCLUSIONS: The available trials do not allow a final evaluation of naltrexone maintenance treatment yet. A trend in favour of treatment with naltrexone was observed for certain target groups, as described in the literature before. A well-done clinical trial is needed in order to get better evidence as soon as possible.

Humans↗

Quality of life and symptoms among older people living at home.

AIM: This paper reports a study comparing the socio-demographic data, quality of life (QoL) and symptoms of older people living at home with and without help. BACKGROUND: Despite growing numbers of older people worldwide, little is know about the differences between older people receiving help to live at home and those not receiving this, especially as regards QoL and symptoms. Not only symptoms but also dependency on others per se may reduce older people's QoL. From a nursing perspective, knowledge about such issues is important because the impact of symptoms may be reducible, even when diseases cannot be cured. METHOD: A postal questionnaire was sent to an age-stratified random sample of 1866 people aged 75 years or over. Of the respondents (n = 1248) 448 received help and 793 did not. RESULTS: The group receiving help had a significantly higher age, more women, more people widowed and living alone, more children, a higher number of self-reported diseases and symptoms, greater inability to remain alone at home and lower QoL. Loneliness, depressed mood and abdominal pain were significantly related to low QoL in both groups. Living alone, not being able to remain alone at home without help, and fatigue were also predictive of low QoL among those receiving help, and number of diseases and sleep problems in those without. CONCLUSION: Receiving help with daily living seems to be significantly related to low QoL and goes along with a high number of symptoms that need to be considered in nursing care. Through regular visits, systematic assessment and intervention, especially focusing on older people's symptoms, nurses may contribute to improved QoL for this section of the population.

Activities of Daily Living↗

Enhancing the quality and credibility of qualitative analysis.

Varying philosophical and theoretical orientations to qualitative inquiry remind us that issues of quality and credibility intersect with audience and intended research purposes. This overview examines ways of enhancing the quality and credibility of qualitative analysis by dealing with three distinct but related inquiry concerns: rigorous techniques and methods for gathering and analyzing qualitative data, including attention to validity, reliability, and triangulation; the credibility, competence, and perceived trustworthiness of the qualitative researcher; and the philosophical beliefs of evaluation users about such paradigm-based preferences as objectivity versus subjectivity, truth versus perspective, and generalizations versus extrapolations. Although this overview examines some general approaches to issues of credibility and data quality in qualitative analysis, it is important to acknowledge that particular philosophical underpinnings, specific paradigms, and special purposes for qualitative inquiry will typically include additional or substitute criteria for assuring and judging quality, validity, and credibility. Moreover, the context for these considerations has evolved. In early literature on evaluation methods the debate between qualitative and quantitative methodologists was often strident. In recent years the debate has softened. A consensus has gradually emerged that the important challenge is to match appropriately the methods to empirical questions and issues, and not to universally advocate any single methodological approach for all problems.

Data Collection↗

Randomised clinical trial on the effect of the Dutch obstetric peer review system.

The project "Obstetric Peer Review Interventions" (Verloskundige Onderlinge Kwaliteitsspiegeling Interventies, VOKSINT) was set-up in The Netherlands in 1994. It provided annual comparison data (quality ranking, league tables) for secondary care obstetric departments adjusted for population differences, based on the data registered in the Perinatal Database of The Netherlands (Landelijke Verloskunde Registratie, LVR). The aim of the so-called VOKS reports was to influence obstetricians' interventions in such a way that they led to a more homogeneous policy. To assess this influence, a trial was set-up, with departments randomly assigned to be or not to be informed about the VOKS results. Obstetric intervention rates and the morbidity of newborns including neonatal neurological examinations (NNEs) were assessed. Obstetric intervention rates were similar in the report group and the control group. Practice in the report group became more homogeneous (adjusted for population differences) than in the control departments, but this was only statistically significant for term caesarean section.

Cesarean Section↗

Medical management of advanced heart failure.

CONTEXT: Advanced heart failure, defined as persistence of limiting symptoms despite therapy with agents of proven efficacy, accounts for the majority of morbidity and mortality in heart failure. OBJECTIVE: To review current medical therapy for advanced heart failure. DATA SOURCES: We searched MEDLINE for all articles containing the term advanced heart failure that were published between 1980 and 2001; EMBASE was searched from 1987-1999, Best Evidence from 1991-1998, and Evidence-Based Medicine from 1995-1999. The Cochrane Library also was searched for critical reviews and meta-analyses of congestive heart failure. STUDY SELECTION: Randomized controlled trials of therapy for 150 patients or more were included if advanced heart failure was represented. Other common clinical situations were addressed from smaller trials as available, trials of milder heart failure, consensus guidelines, and both published and personal clinical experience. DATA EXTRACTION: Data quality was determined by publication in peer-reviewed literature or inclusion in professional society guidelines. DATA SYNTHESIS: A primary focus for care of advanced heart failure is ongoing identification and treatment of the elevated filling pressures that cause disabling symptoms. While angiotensin-converting enzyme inhibitors and beta-adrenergic agents can slow disease progression and prolong survival, titration and tolerability often present challenges. Most patients are not eligible for surgical intervention but do benefit from a medical regimen tailored to individual clinical and hemodynamic profiles and from heart failure management programs that reduce rehospitalization. Survival ranges from 80% at 2 years for patients rendered free of congestion to less than 50% at 6 months for patients with refractory symptoms, in whom end-of-life options may include hospice care and inactivation of implantable defibrillators. CONCLUSIONS: Current management of advanced heart failure is based more on consensus than on randomized trials. Systematic investigation should address not only new therapies but also strategies for selecting and optimizing therapies already available.

Cardiovascular Agents↗

Rapid evaluation methods (REM) of health services performance: methodological observations.

The rapid evaluation method (REM) was developed by WHO in order to assess the performance and quality of health care services, identify operational problems, and assist in taking managerial action. It was tested in five developing countries (Botswana, Madagascar, Papua New Guinea, Uganda and Zambia) between 1988 and 1991. REM consists of a set of observation- and survey-based diagnostic activities, carried out mainly in health care facilities. The article describes the various steps of REM, methodological issues such as setting objectives and using an issue-information matrix, preparation of survey instruments, use of computer software (Epi Info), data quality control, fieldwork, and the use of data to produce useful information for decision-makers. REM aims at bringing prompt and relevant information to planners and decision-makers who need it for a specific purpose. In the present examples, REM provided information for preparing a programme proposal for external funding, for establishing baseline data for a situation analysis, and for assessing staff performance after extensive training in order to improve the curriculum.

Botswana↗

A simplified approach to the management of non-ST-segment elevation acute coronary syndromes.

CONTEXT: While current practice guidelines provide an evidence-based approach to management of acute coronary syndromes (ACS), application of the evidence by individual physicians has been suboptimal. OBJECTIVE: To assess and synthesize the evidence regarding optimal management of non-ST-segment elevation ACS (NSTE-ACS). DATA SOURCES: Systematic searches of peer-reviewed publications were performed in MEDLINE and the Cochrane Database from January 1990 through November 2004, with consultation by content experts. Search terms included antiplatelet therapy, antithrombotic therapy, angiotensin-converting enzyme inhibition, angiotensin receptor blockade, beta-blockade, hypertension, hyperlipidemia, cigarette smoking, diet, diabetes mellitus, exercise, myocardial ischemia, and coronary artery disease. STUDY SELECTION AND DATA EXTRACTION: Criteria for selection of studies included controlled study design, English language, and clinical pertinence. Data quality was based on the publishing journal and relevance to clinical management of NSTE-ACS. DATA SYNTHESIS: While outcomes of controlled studies support a comprehensive approach in the management of patients with NSTE-ACS, many physicians perceive existing guidelines as lengthy and complex. After risk stratification to identify those patients most likely to benefit from an early invasive vs early conservative strategy, a comprehensive management plan can be assembled through an "ABCDE" approach. The elements of this include "A" for antiplatelet therapy, anticoagulation, angiotensin-converting enzyme inhibition, and angiotensin receptor blockade; "B" for beta-blockade and blood pressure control; "C" for cholesterol treatment and cigarette smoking cessation; "D" for diabetes management and diet; and "E" for exercise. CONCLUSION: An "ABCDE" approach for the management of NSTE-ACS provides a practical and systematic means to implement evidence-based medicine into clinical practice.

Adrenergic beta-Antagonists↗

Wearable Sleep Monitoring in Pediatric Acute Lymphoblastic Leukemia: Associations With Subjective Sleep Ratings and Neurocognitive Functioning.

BACKGROUND: Sleep disturbances are associated with increased fatigue, reduced quality of life, and neurocognitive dysfunction and have emerged as a common complication among pediatric cancer survivors. Sleep disturbances are particularly concerning given their potential to exacerbate existing neurocognitive impacts of cancer treatments. This pilot study examined the feasibility and acceptability of a home-wearable EEG-based sleep device (Sleep ProfilerTM) for acute lymphoblastic leukemia (ALL) survivors as well as associations between specific sleep parameters and neurocognitive functioning. PROCEDURE: Children (ages 8-12; M = 10 years, SD = 1.6; N = 23) >6 months post-treatment for ALL were enrolled at clinical visits and wore the Sleep ProfilerTM for two consecutive nights at home, followed by neurocognitive testing of attention, inhibitory control, working memory, and processing speed. Parents completed subjective measures of child sleep, anxiety, depression, and acceptability. Feasibility reflected the percentage of children wearing the device at least one night and the percentage of nights with good EEG quality data. RESULTS: All participants wore the device both nights, with 84% meeting the threshold for good quality measurement. Few children met recommended quantity and quality sleep thresholds based on objective measurement, including 5 patients with elevated snoring levels; 43.5% of subjective ratings fell above the threshold for sleep disturbance. Greater sleep latency was associated with worse inhibitory control (r = -0.42, p = 0.046), and total sleep time was positively associated with inhibitory control and attention. CONCLUSIONS: Findings confirm the feasibility and acceptability of home EEG sleep monitoring in school-age survivors, and associations of sleep latency and snoring with reduced neurocognitive functioning may offer modifiable risk factors for aspects of neuropsychological dysfunction common in pediatric survivorship. CLINICAL TRIAL REGISTRATION: At the time this study was conducted, we were not required to register the study on ClinicalTrials.gov. It was a single-institution feasibility study without intervention, which was not considered a clinical trial.

Humans↗

Using time-to-pregnancy data to study occupational exposures: methodology.

Occupational and environmental influences on fertility are for the most part unstudied, partly because sensitive methods for studying them have not been developed. We are developing a measure of fecundability, the monthly probability of pregnancy, by studying time to pregnancy, the number of noncontracepting menstrual cycles each couple requires to conceive. The relationship of this measure of reproductive impairment with others, such as spontaneous abortion, is not known. Preliminary data from two sources suggest that reduced fertility is not highly correlated with increased risk of spontaneous abortion, despite predictions to the contrary from the toxicology literature. A current study of occupational exposures of dental assistants will address questions of data quality by providing comparisons of brief responses from mail questionnaires and telephone interviews with very detailed data from telephone interviews. This study also will allow estimation of the magnitude of two potential selection biases: selection of only planned pregnancies (time-to-pregnancy data for accidental pregnancies are not meaningful), and selection against highly infertile and sterile couples (when studying currently or previously pregnant women, sterile couples are not represented at all and highly infertile couples are underrepresented).

Female↗

Surrogate measures of dietary intake.

In studying health and disease in elderly subjects, information may be needed concerning current or past dietary intake. Regardless of whether emphasis is placed on current or past intake, the validity of self-reported dietary information probably diminishes with increasing respondent age. In studying diet in elderly subjects, obtaining information from surrogate sources may improve data quality and provide information otherwise unavailable for decreased or incompetent subjects. This review addresses availability of data from surrogates, validity of surrogate responses, and methodological issues in analysis of surrogate data. This literature review documents that surrogate respondents can provide dietary information, but the data on elderly persons are extremely limited. The literature also indicates that surrogate dietary data may introduce misclassification in analytical investigations, but that surrogate data may be useful in descriptive studies. Methodological studies on surrogate reporting should facilitate research on diet and disease in elderly subjects.

Aged↗

The globalization of crystallographic knowledge.

The rapid growth of the World Wide Web provides major new opportunities for distributed databases, especially in macromolecular science. A new generation of technology, based on structured documents (SD), is being developed which will integrate documents and data in a seamless manner. This offers experimentalists the chance to publish and archive high-quality data from any discipline. Data and documents from different disciplines can be combined and searched using technology such as eXtensible Markup Language (XML) and its associated support for hypermedia (XLL), metadata (RDF) and stylesheets (XSL). Opportunities in crystallography and related disciplines are described.

Crystallography↗

Basin-wide analysis of the dynamics of fecal contamination and fecal source identification in Tillamook Bay, Oregon.

The objectives of this study were to elucidate spatial and temporal dynamics in source-specific Bacteroidales 16S rRNA genetic marker data across a watershed; to compare these dynamics to fecal indicator counts, general measurements of water quality, and climatic forces; and to identify geographic areas of intense exposure to specific sources of contamination. Samples were collected during a 2-year period in the Tillamook basin in Oregon at 30 sites along five river tributaries and in Tillamook Bay. We performed Bacteroidales PCR assays with general, ruminant-source-specific, and human-source-specific primers to identify fecal sources. We determined the Escherichia coli most probable number, temperature, turbidity, and 5-day precipitation. Climate and water quality data collectively supported a rainfall runoff pattern for microbial source input that mirrored the annual precipitation cycle. Fecal sources were statistically linked more closely to ruminants than to humans; there was a 40% greater probability of detecting a ruminant source marker than a human source marker across the basin. On a sample site basis, the addition of fecal source tracking data provided new information linking elevated fecal indicator bacterial loads to specific point and nonpoint sources of fecal pollution in the basin. Inconsistencies in E. coli and host-specific marker trends suggested that the factors that control the quantity of fecal indicators in the water column are different than the factors that influence the presence of Bacteroidales markers at specific times of the year. This may be important if fecal indicator counts are used as a criterion for source loading potential in receiving waters.

Animals↗

Spatio-temporal statistical models for river monitoring networks.

When introducing new wastewater treatment plants (WWTP), investors and policy makers often want to know if there indeed is a beneficial effect of the installation of a WWTP on the river water quality. Such an effect can be established in time as well as in space. Since both temporal and spatial components affect the output of a monitoring network, their dependence structure has to be modelled. River water quality data typically come from a river monitoring network for which the spatial dependence structure is unidirectional. Thus the traditional spatio-temporal models are not appropriate, as they cannot take advantage of this directional information. In this paper, a state-space model is presented in which the spatial dependence of the state variable is represented by a directed acyclic graph, and the temporal dependence by a first-order autoregressive process. The state-space model is extended with a linear model for the mean to estimate the effect of the activation of a WWTP on the dissolved oxygen concentration downstream.

Data Collection↗