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Limited access data sets from studies funded by the National Heart, Lung, and Blood Institute.

The NHLBI has recently developed standards for protection of subject confidentiality which enable distribution of large data sets collected in completed epidemiological studies and clinical trials. This allows other investigators to pursue research using the data these studies have generated. An ethical commitment to protect the privacy of the research subjects requires careful review and some compromise in data details prior to distribution. To meet the challenge posed by the ethical and legal requirements to protect participants' privacy and making data sets useful for researchers, the NHLBI has devised a policy which seeks to balance these two opposing forces. This paper describes this policy as well as the limited access data sets currently available from NHLBI.

Clinical Trials as Topic↗

Protease inhibitors in the clinic.

This review describes the clinical status (based on available information) of experimental drugs that inhibit enzymes called proteases, or more precisely a sub-class of proteases called peptidases that catalyse the hydrolysis of polypeptide main chain amide bonds. These peptidases are classified by the key catalytic residue in the active site of the enzyme that effects hydrolysis, namely aspartic, serine, cysteine, metallo or threonine proteases. In this review we show structures for 108 inhibitors of these enzymes and update the clinical disposition of over 100 inhibitors that have been considered worthy enough by pharmaceutical, biotechnology or academic researchers and their financial backers to be trialed in humans as prospective medicines. We outline some of their chemical and pharmacological characteristics and compare the current status of protease inhibitors in the clinic with what was observed about 5 years ago (Leung et al, J. Med. Chem. 2000, 43, 305-341). We assess the progress of protease inhibitors into man, predict their futures, and outline some of the hurdles that have been overcome and that still remain for this promising class of new therapeutic agents.

Aspartic Acid Endopeptidases↗

Antiphospholipid syndrome infectious origin.

Antiphospholipid syndrome (APS) is characterized by the presence of pathogenic autoantibodies against beta 2-glycoprotein-I (beta 2GPI). The factors causing production of anti-beta 2GPI remain unidentified, but an association with infectious agents has been reported. Studies on experimental APS models proved that molecular mimicry between beta 2GPI-related synthetic peptides and structures within bacteria, viruses, tetanus toxoid, and CMV are a cause for experimental APS. Any explanation of how microbial infections might set off APS must take into account the observation that all individuals appear to harbor potentially autoreactive lymphocytes, as well as natural antiphospholipid antibodies, but that these cells or antibodies remain innocuous unless somehow activated. Herein, we discuss the association of antiphospholipid antibodies in the infectious state, molecular mimicry as a proposed cause for development of APS, and the contribution of the database to this topic.

Animals↗

Mental health and psychiatry research in Brazil: scientific production from 1999 to 2003.

OBJECTIVE: To assess the extent of mental health scientific production in Brazil from 1999 to 2003, and to identify the nature of the publications generated, their sources of finance and the ways of publicly disseminating the research findings. METHODS: Searches for publications were conducted in the Medline and PsychInfo databases for the period 1999-2003. A semi-structured questionnaire developed by an international team was applied to 626 mental health researchers, covering each interviewee's educational background, research experience, access to funding sources, public impact and research priorities. The sample was composed by 626 mental health researchers identified from 792 publications indexed on Medline and PsychInfo databases for the period above, and from a list of reviewers of Revista Brasileira de Psiquiatria. RESULTS: In Brazil, 792 publications were produced by 525 authors between 1999 and 2003 (441 indexed in Medline and 398 in the ISI database). The main topics were: depression (29.1%), substance misuse (14.6%), psychoses (10%), childhood disorders (7%) and dementia (6.7%). Among the 626 Brazilian mental health researchers, 329 answered the questionnaire. CONCLUSIONS: There were steadily increasing numbers of Brazilian articles on mental health published in foreign journals from 1999 to 2003: the number of articles in Medline tripled and it doubled in the ISI database. The content of these articles corresponded to the priorities within mental health, but there is a need for better interlinking between researchers and mental health policymakers.

Bibliometrics↗

Merging multimedia presentations and semistructured temporal data: a graph-based model and its application to clinical information.

OBJECTIVE: In this paper, we focus on the issue of providing physicians with the capability of representing in a seamless way both temporal aspects of multimedia semistructured data and their temporal presentation requirements. BACKGROUND: Semistructured data are data having some structure, that may be irregular or incomplete and does not necessarily conform to a fixed schema. Semistructured data often contain the description of histories of the considered real world. The eXtensible Markup Language (XML) is becoming a cross compatible and standardized means for representing semistructured clinical data. In the field of medical informatics, there are many ongoing activities concerning XML. In the field of multimedia database systems, the topic related to the integration of several media objects (with their temporal aspects) have been considered both for data modeling and querying issues and for modeling multimedia presentations. METHODOLOGY: We first propose the Multimedia Temporal Graphical Model (MTGM), by representing a clinical database for cardiology patients undergoing cardiac angiographies and then describe it in a formal way. We deal with the problem of expressing MTGM data by XML and of managing MTGM clinical data through an XML-based system. We provide both a technique for translating (a part of) an MTGM database into an XML document and some techniques allowing us to obtain presentations defined by means of the Synchronized Multimedia Integration Language (SMIL) from MTGM presentations. RESULTS: MTGM allows one to represent and store clinical information in a semistructured, temporal, and multimedia database. The physician can define multimedia presentations based on the stored data. Multimedia presentations are then stored in the same MTGM database together with temporal clinical information and are thus represented according to the same data model. A prototype based on an XML native database system has been designed and implemented. DISCUSSION AND CONCLUSIONS: In this work we have considered the theoretical and methodological issues concerning the definition of a general data model for describing temporal and multimedia features of semistructured clinical information. Other research and application oriented features, which have not been considered in MTGM, could be investigated for completing MTGM with regard to its applicability to clinical domains: MTGM does not allow one to express times at different levels of granularities, i.e. with different time units, or with indeterminacy; besides the considered valid time, it could be interesting to manage also other temporal dimensions such as the transaction and availability times. Besides being useful for managing multimedia data stored according to widely accepted standards as MPEG and DICOM, nowadays semistructured data, and XML in particular, are becoming the most important way for expressing and exchanging medical knowledge and data: MTGM can be considered as a data model allowing the seamless representation of both (multimedia and temporal) clinical data and knowledge.

Artificial Intelligence↗

Using metadata to create navigation paths in the HealthInsite Internet gateway.

The objective of this study was to evaluate the HealthInsite topic query technique, which uses a dynamic database search to assign resources to a topic. It is an alternative to the explicit classification technique, which relies on the classification of each resource using a predefined classification scheme. We performed a recall-precision analysis on all topics within the broad topic area of Child Health. Recall and precision errors were checked to determine which part of the information retrieval process was at fault. We then compared the topic query technique with the explicit classification technique. The results show errors or problems at every stage of the information retrieval process. This has initiated a review of all the tools used in the process, from indexing guidelines to the search engine. While many errors could be corrected, there were still features of the explicit classification technique that could not be achieved by the topic query technique. In conclusion, the topic query technique has the advantage of flexibility, but close co-operation between the different information retrieval specialists is needed to get the best results. The HealthInsite topic navigation structure should be regarded as an organized set of predefined searches rather than a full classified listing.

Abstracting and Indexing↗

Inhaled corticosteroids and mortality in COPD.

STUDY OBJECTIVES: To assess the influence of inhaled corticosteroids (ICSs) on mortality in COPD patients, which is currently a controversial topic. SETTING: Manitoba Health maintains a population-wide research database that includes pharmaceutical information. DESIGN AND PATIENTS: We examined mortality in people 90 to 365 days after hospital discharge for COPD, comparing those persons who received inhaled steroids within 90 days of hospital discharge with those who did not. Cox proportional hazards models were used with adjustments for other respiratory drugs, comorbidities, and physician visits before and after hospital discharge. We also compared mortality in patients who received inhaled steroids with those who received other respiratory drugs, but not inhaled steroids, and those who received neither. Using nested case control analysis, we examined the time of receipt of inhaled steroids in relation to fatal events. RESULTS: In people > 65 years of age, inhaled steroids were associated with a 25% reduction in mortality between 90 and 365 days after hospital discharge, while mortality increased with bronchodilator use, physician visits, age, and comorbidities. The exclusion of people who had also received a diagnosis of asthma or had received inhaled steroids before hospitalization did not change the result. Inhaled steroids were associated with an even larger mortality reduction in people aged 35 to 64 years. People who received bronchodilators but no steroids had higher mortality than people who received no bronchodilators or received both bronchodilators and inhaled steroids. The reduction in all-cause mortality was largely due to the decreased number of cardiovascular deaths. The receipt of inhaled steroids within 30 days of death was protective, but this was not the case for greater time intervals. CONCLUSIONS: Therapy with ICSs reduced mortality in COPD patients; the effect was particularly notable for cardiovascular death and was short term in that it was dependent on recent exposure.

Administration, Inhalation↗

Mapping the literature of radiologic technology.

While analysis of the literature of radiology has been conducted in the discipline, none of the studies have focused on identifying the core journals. The bibliometric method was used to conduct research to identify the core journals in the radiologic technology field and determine the extent of indexing of those journals. This study was a part of Medical Library Association (MLA) Nursing and Allied Health Resource Section's project to map the literature of allied health. Findings indicate that there is a small core of literature with a heavy reliance on the journal literature. Books are used to a lesser extent. The majority of the citations analyzed were published during the fourteen years between 1980 and 1993. MEDLINE and EMBASE provided the best indexing coverage of the radiologic technology literature; minimal coverage was provided by the Cumulative Index to Nursing and Allied Health Literature and HEALTH.

Abstracting and Indexing↗

Mapping the literature of respiratory therapy.

Little research has been conducted on the characteristics of the literature of respiratory care. The bibliometric method was used to identify the core journals in the discipline and the extent of indexing of those journals. This study was a part of Medical Library Association (MLA) Nursing and Allied Health Resources Section's project to map the literature of allied health. Findings indicate that the research writings of the discipline cite journal articles most heavily, with the majority of the citations published between 1980 and 1993. The literature has a small core of cited journals with a wide dispersion. MEDLINE and EMBASE provided the best indexing coverage of the literature, and minimal coverage was given by the Cumulative Index to Nursing and Allied Health Literature and HEALTH.

Abstracting and Indexing↗

Promoting antenatal steroid use for fetal maturation: results from the California Perinatal Quality Care Collaborative.

OBJECTIVE: The California Perinatal Quality Care Collaborative (CPQCC) was formed to seek perinatal care improvements by creating a confidential multi-institutional database to identify topics for quality improvement (QI). We aimed to evaluate this approach by assessing antenatal steroid administration before preterm (24 to 33 weeks of gestation) delivery. We hypothesized that mean performance would improve and the number of centers performing below the lowest quartile of the baseline year would decrease. STUDY DESIGN: In 1998, a statewide QI cycle targeting antenatal steroid use was announced, calling for the evaluation of the 1998 baseline data, dissemination of recommended interventions using member-developed educational materials, and presentations to California neonatologists in 1999-2000. Postintervention data were assessed for the year 2001 and publicly released in 2003. A total of 25 centers voluntarily participated in the intervention. RESULTS: Antenatal steroid administration rate increased from 76% of 1524 infants in 1998 to 86% of 1475 infants in 2001 (P < .001). In 2001, 23 of 25 hospitals exceeded the 1998 lower-quartile cutoff point of 69.3%. CONCLUSIONS: Regional collaborations represent an effective strategy for improving the quality of perinatal care.

California↗

Emergency contraception: a review of the programmatic and social science literature.

Many biomedical aspects of emergency contraception have been investigated and documented for >30 years now. A large number of social science questions, however, remain to be answered. In this article, we review the rapidly growing but geographically lopsided literature on this topic. Using computer database searches supplemented by reference reviews and professional correspondence with those active in the field, we gathered literature on the social science and service delivery aspects of emergency contraception published in English up through December 1998, as well as a few unpublished papers from the same time and slightly later, representing regions where published material is practically nonexistent. Methodologically acceptable papers are summarized in our tables and text, and form the basis for suggested improvements in existing emergency contraceptive services. The review also offers ideas for designing new emergency contraception services where they do not yet exist. We conclude by proposing an agenda for further social science research in this area.

Adolescent↗

Use of the endometrial pipelle in the diagnosis of early abnormal gestations.

OBJECTIVE: To determine the sensitivity and specificity of the endometrial pipelle (Unimar, Wilton, CT) in detecting intrauterine chorionic villi, as compared to standard suction dilation and curettage (D and C). DESIGN: Prospective clinical study. SETTING: U. S. Navy Hospital near Tokyo, Japan. Small community hospital. PATIENT(S): All patients presenting for the surgical management of an early abnormal gestation were enrolled prospectively. The patient's age, gravidy, parity, estimated gestational age (EGA), diagnosis, preoperative beta human chorionic gonadotropin (betahCG) level, and preoperative transvaginal ultrasound (TVUS) data were recorded. INTERVENTION(S): An endometrial biopsy was performed in the operating room prior to standard suction dilatation and curettage (D and C). MAIN OUTCOME MEASURE(S): The presence of chorionic villi in the endometrial biopsy and curettage specimens were recorded for each patient. RESULT(S): The sensitivity of the endometrial pipelle in detecting intrauterine chorionic villi was 63% and the specificity was 80%. CONCLUSION(S): In the diagnosis of an early abnormal gestation, particularly in excluding an ectopic pregnancy, it would be ideal to replace the more invasive D and C with the outpatient endometrial biopsy in detecting intrauterine chorionic villi. However, the limited sensitivity of the endometrial biopsy limits its application in this clinical scenario. Our results compare with two previous studies and add to the limited patient database on this topic.

Adult↗

[Movement disorders and botulinum toxin in neurology].

Botulinum toxin has been a useful treatment in many movement disorders and more recently in other non-neurological motor dysfunctions for more than 15 years. Here, we review the various indications in neurology, mainly in the field of movement disorders. From 1973 to 2002, we searched the Medline database on this topic. We selected the most useful and relevant papers, with a special interest in dystonia. We summarized the results in the main indications (spasmodic torticollis, bleparospasm, hemifacial spasm) and in other manifestations such as writer's cramp, oromandibular dystonia, tremor, tics and myoclonus. We discuss the data of literature and compare them with the experience of the French movement disorders groups.

Anti-Dyskinesia Agents↗