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PubMed2002

Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database.

Some studies suggest that more severely ill patients with depression respond well to antidepressants and poorly to placebo, whereas those who are mildly ill respond equally well to antidepressants and placebo. This notion has implications for the design of clinical trials. To further assess and substantiate these putative predictors of antidepressant and placebo response, we assessed the Food and Drug Administration database of 45 phase II and III antidepressant clinical trials. The frequency of statistically significant differences between antidepressants and placebo was higher in the trials that included patients with more severe depression. In the antidepressant-treated groups, the magnitude of symptom reduction was significantly related to mean initial Hamilton Rating Scale for Depression (HAM-D) score; the higher the mean initial HAM-D score, the larger the change. With placebo treatment, however, the higher the mean initial HAM-D score, the smaller the change. Early discontinuation was more frequent among patients whose mean initial HAM-D scores were higher. These data may help inform the design of future antidepressant clinical trials.

Adolescent↗

PubMed1989

Review of Papyrus bibliographic database software.

Papyrus is an inexpensive bibliographic database which provides some features not found in other similar packages. Its flexibility in handling references of many types and formats, its capacity for integration with manuscripts prepared with word processors, its capacity for importing references from national databases and its ability to perform microcosmic literature searches are attractive features. Because Papyrus has tackled a complex task, mastery of the intricacies of the program may present a substantial challenge to novice computer users. Although the manipulation of an existing customized bibliographic database would seem to be attractive for any researcher or author who prepares manuscripts for publication, the optimal use of the program also requires an extensive commitment of time and labor for the initial entry of all pertinent references into the database. While this could be accomplished gradually in conjunction with the preparation of individual manuscripts, the creation of a complete file of references could require hundreds of hours of labor. Individual authors, as well as larger research groups, should be prepared for this type of commitment before acquiring the Papyrus system.

Bibliographies as Topic↗

PubMed2000

Using UMLS semantics for classification purposes.

The Unified Medical Language System (UMLS) contains semantic information about terms from various sources; each concept can be understood and located by its relationships to other concepts. We describe a method in which the semantic relationships between UMLS concepts are exploited for the purpose of classification. This method combines three existing components: 1) Mapping terms to UMLS concepts; 2) Restricting UMLS concepts to MeSH; and 3) Mapping MeSH terms to disease categories. When applied to the automatic classification of condition terms into broad disease categories in the Clinical Trials database, this method assigned relevant categories to 92% of the 1823 condition terms encountered. 135 (7%) failed to be classified and 14 (.77%) were misclassified. The limits of this method are discussed, as well as the reuse of existing components, and the tuning required to achieve automatic classification.

Algorithms↗

PubMed2006

Maximising response to postal questionnaires--a systematic review of randomised trials in health research.

BACKGROUND: Postal self-completion questionnaires offer one of the least expensive modes of collecting patient based outcomes in health care research. The purpose of this review is to assess the efficacy of methods of increasing response to postal questionnaires in health care studies on patient populations. METHODS: The following databases were searched: Medline, Embase, CENTRAL, CDSR, PsycINFO, NRR and ZETOC. Reference lists of relevant reviews and relevant journals were hand searched. Inclusion criteria were randomised trials of strategies to improve questionnaire response in health care research on patient populations. Response rate was defined as the percentage of questionnaires returned after all follow-up efforts. Study quality was assessed by two independent reviewers. The Mantel-Haenszel method was used to calculate the pooled odds ratios. RESULTS: Thirteen studies reporting fifteen trials were included. Implementation of reminder letters and telephone contact had the most significant effect on response rates (odds ratio 3.7, 95% confidence interval 2.30 to 5.97 p = or <0.00001). Shorter questionnaires also improved response rates to a lesser degree (odds ratio 1.4, 95% confidence interval 1.19 to 1.54). No evidence was found that incentives, re-ordering of questions or including an information brochure with the questionnaire confer any additional advantage. CONCLUSION: Implementing repeat mailing strategies and/or telephone reminders may improve response to postal questionnaires in health care research. Making the questionnaire shorter may also improve response rates. There is a lack of evidence to suggest that incentives are useful. In the context of health care research all strategies to improve response to postal questionnaires require further evaluation.

Correspondence as Topic↗

PubMed2003

Proposition: the benefit of cardiac transplantation in stable outpatients with heart failure should be tested in a randomized trial.

Recent data suggest that cardiac transplantation is associated with a survival benefit only in patients at high risk for dying of advanced heart failure without this procedure. To test the hypothesis that survival and quality of life advantages associated with cardiac transplantation exist in stable outpatients, a 3-stage approach is proposed: 1). to establish a database within the International Society for Heart and Lung Transplantation/United Network for Organ Sharing/Eurotransplant infrastructure that will provide an estimate of the survival benefit of heart transplantation in various heart failure risk strata by prospectively following cohorts of patients listed for heart transplantation; 2). to organize an international consensus conference that will define, based on the review of the Stage 1 data, the feasibility of a prospective randomized trial; and 3). pending consensus, to perform a clinical trial, perhaps with an augmented, randomized design that allocates cardiac transplantation to all patients at high risk for dying of heart failure while randomizing patients at low risk to either conventional treatment or cardiac transplantation. Generating such scientific evidence is important in light of today's donor organ crisis and the associated difficulties of equitable resource allocation.

Cohort Studies↗

PubMed2006

Literature search parameters marginally improved the pooled estimate accuracy for ultrasound in detecting deep venous thrombosis.

BACKGROUND AND OBJECTIVES: Data collection remains of utmost importance to avoid publication bias in systematic reviews. Our objectives were to compare search strategies with and without methodological terms in Medline, to find out how other databases complement Medline, and how these strategies affect the pooled estimates of the accuracy. STUDY DESIGN AND SETTING: A study was eligible if it prospectively compared ultrasound to venography for the diagnosis of deep venous thrombosis in the lower limbs. All relevant articles found with all databases, searched from 1966 through 2003, constitute the reference standard. Sensitivity was defined as the proportion of relevant studies found by Medline searches divided by the total number of articles in the reference standard. RESULTS: Of a total of 1,473 citations, 237 abstracts were included. The sensitivity of strategies without methodological terms was higher (96%) than those with (95%, 76%, and 95%). Searches of multiple databases found seven articles not found with Medline. Searches of congress proceedings (International Society of Thrombosis and Haemostasis) found three abstracts not published in full. The diagnostic odds ratio OR was 5.66 (95% confidence interval CI = 4.84-6.48) when multiple databases were searched and 5.57 (95% CI = 3.49-7.65) when only English-language articles in Medline were identified. CONCLUSION: Medline searches combining free text and MeSH terms were more sensitive. Single Medline search affects only marginally the pooled estimate accuracy.

Abstracting and Indexing↗

PubMedDate not supplied

Bibliography database managers. A comparative review.

Bibliography database managers (BDMs) are used to manage information resources: specifically, to maintain a database of references and create bibliographies and reference lists for written works. This comparative review provides an overview of BDMs and capsule reviews of five programs: EndNote Plus 2.0; Library Master 3.0; Papyrus 7.0.11; Pro-Cite 2.2.1; and Reference Manager 6.02.

Bibliographies as Topic↗

PubMedDate not supplied

Data extraction and ad hoc query of an entity-attribute-value database.

Entity--attribute--value (EAV) tables form the major component of several mainstream electronic patient record systems (EPRSs). Such systems have been optimized for real-time retrieval of individual patient data. Data warehousing, on the other hand, involves cross-patient data retrieval based on values of patient attributes, with a focus on ad hoc query. Attribute-centric query is inherently more difficult when data are stored in EAV form than when they are stored conventionally. The authors illustrate their approach to the attribute-centric query problem with ACT/DB, a database for managing clinical trials data. This approach is based on metadata supporting a query front end that essentially hides the EAV/non-EAV nature of individual attributes from the user. The authors' work does not close the query problem, and they identify several complex subproblems that are still to be solved.

Clinical Trials as Topic↗

PubMed2004

Lipomic profiling in drug discovery, development and clinical trial evaluation.

Dysregulation of lipid metabolism plays a crucial role in the progression of many diseases and in adverse drug response. Changes in lipid metabolism leading to disease are often not detected using biomarker analyses because these changes are defined by a subtle, long-term shift in the concentrations of many metabolites simultaneously. The application of the principals of 'omics to the study of lipids, which include the development of comprehensive, high-throughput assays and centralized reference databases, is beginning to produce an integrated and actionable knowledge of lipids and their relationship to pathology. These analytical tools and the assembled knowledge will enable the discovery, development and testing of drugs to be conducted with a deeper knowledge of their effects on lipid metabolism.

Animals↗

PubMed1999

[Systematic reviews on infectious diseases. The Cochrane Collaboration].

BACKGROUND: Theoretically, doctors update their knowledge from the scientific literature, and bibliographic databases have made it possible to overcome many of the limitations with this information, but not all of them. When faced with a therapeutic issue, the practice of evidence based medicine requires the efficient access to information derived from controlled clinical trials (CCT). Reviews of the scientific literature are of increasing importance. The Cochrane Collaboration is dedicated to preparing, maintaining and disseminating updated, systematic reviews of CCTs of health care interventions, which are published in the Cochrane Library. OBJECTIVE: To describe the Cochrane Collaboration and to locate, with the greatest exhaustiveness possible, CCTs published in the journals "Enfermedades Infecciosas y Microbiología Clínica", describe their characteristics and include them in a global database of clinical trials maintained by the Cochrane Collaboration. METHODS: The CCTs were identified by systematic manual searches of all issues of the journal. A descriptive analysis of the CCTs located was made. RESULTS: A total of 24 CCTs were published in 15 years (1.6 per year), 10 were original articles and 14 were communications at congresses. All were done in Spain and the majority were done in hospitals. The most frequently researched question was antibiotic prophylaxis and all evaluated pharmaceutical interventions. The majority of the CCTs published had important information missing (phase of study, randomization, blinding, etc.). CONCLUSIONS: The identification of CCTs is a prerequisite for the development of systematic reviews. There were few clinical trials published in the 15 years of publication of this journal, and the most common characteristic is, clearly, the absence of basic data. The most common is a lack of on the phase of the clinical trial, the follow-up period, and funding sources. The idea of what experimental clinical investigation in infectious diseases is in our country needs to include the identification of CCTs published in other Spanish and international journals.

Bibliometrics↗

PubMed2005

Caspofungin susceptibility testing of isolates from patients with esophageal candidiasis or invasive candidiasis: relationship of MIC to treatment outcome.

The caspofungin clinical trial database offers an opportunity to assess susceptibility results for Candida pathogens obtained from patients with candidiasis and allows for correlations between efficacy outcomes and MICs. Candida isolates have been identified from patients enrolled in four studies of esophageal candidiasis and two studies of invasive candidiasis. The MICs of caspofungin for all baseline isolates were measured at a central laboratory using NCCLS criteria (document M-27A); MICs for caspofungin were defined as the lowest concentration inhibiting prominent growth at 24 h. MICs were then compared to clinical and microbiological outcomes across the two diseases. Susceptibility testing for caspofungin was performed on 515 unique baseline isolates of Candida spp. obtained from patients with esophageal candidiasis. MICs for caspofungin ranged from 0.008 to 4 microg/ml; the MIC50 and MIC90 were 0.5 and 1.0 microg/ml, respectively. Susceptibility testing was also performed on 231 unique baseline isolates of Candida spp. from patients with invasive candidiasis. The majority (approximately 96%) of MICs were between 0.125 and 2 microg/ml, with MIC50 and MIC90 for caspofungin being 0.5 and 2.0 microg/ml, respectively. Overall, caspofungin demonstrated potent in vitro activity against clinical isolates of Candida species. A relationship between MIC for caspofungin and treatment outcome was not seen for patients with either esophageal candidiasis or invasive candidiasis. Patients with isolates for which the MICs were highest (>2 microg/ml) had better outcomes than patients with isolates for which the MICs were lower (<1 microg/ml). Additionally, no correlation between MIC and outcome was identified for specific Candida species.

Antifungal Agents↗

PubMed2003

Internet and information on breast cancer: an overview.

In the past few years, many Internet breast cancer resources have appeared, including medical journals and clinical trial registries. Examples of online breast cancer journals are the The Breast, The Breast Journal, and the Breast Cancer Research and Treatment. These have replicated the experience of general medical and cancer journals such as the British Medical Journal and the Journal of Clinical Oncology. One of the most important cancer registries is the Physician Data Query, which provides information on the National Cancer Institute's clinical trials, most of which are related to breast cancer. Medical guideline databases, institutional websites, medical associations, and non-profit breast cancer organizations provide users with information including news, calendars of international breast cancer events, clinical guidelines and abstracts presented at cancer and breast cancer meetings. Finding high-quality breast cancer literature and websites is relatively easy using appropriate indexes such as Cancerlit, MedlinePlus, and Cancerlinks.

Breast Neoplasms↗

PubMedDate not supplied

The exclusion of women from clinical trials of thrombolytic therapy: implications for developing the thrombolytic predictive instrument database.

The thrombolytic predictive instrument (TPI) was developed to identify those patients most likely to benefit from thrombolytic therapy for acute myocardial infarction as well as to facilitate the earliest possible administration of this treatment. The TPI consists of predictive models derived from clinical data obtained from both clinical trials and data registries. These models are subject to potential bias due to combinations of primary data from different sources. The purpose of this investigation was to assess the influence of gender in developing the TPI database. In this database, there were 1,096 (22%) women and 3,826 (78%) men; only 38% of the women were enrolled in clinical trials, whereas 46% of the men were (p < 0.0001). Within clinical trials, there were few significant eligibility differences between women and men, as the vast majority of patients met eligibility standards for entry in these trials. However, within clinical registries, the women were older (p < 0.0001) and more often had elevated blood pressure on admission (p = 0.002). Multivariate logistic regression indicated that after adjustment for significant predictors of trial inclusion, women were 25% less likely to be included in clinical trials (odds ratio = 0.76, 95% confidence interval = 0.60, 0.96). In order to counter bias introduced by the exclusion of women from clinical trials, the TPI database included patients from non-trial settings. Carefully including patients from clinical registries or non-trial settings may be an important strategy in constructing generally applicable predictive instruments.

Aged↗

PubMedDate not supplied

Lower respiratory tract infection therapy--the role of ciprofloxacin.

Lower respiratory tract infections account for a large proportion of prescribed antibiotics and, with emerging resistance to standard agents, the introduction of the fluoroquinolones, in particular ciprofloxacin, has provided a further component in the armamentarium. This review encompasses 37 published clinical trials which featured ciprofloxacin; 3274 patients with lower respiratory tract infections were treated with this agent; in 94.1% of patients treatment was clinically successful and 90.9% of cases showed eradication of the causative pathogen. When these data were supplemented with previously unpublished information from the clinical trial database, specific organism eradication rates of 86.1%, 96.2% and 94.6% for Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, respectively, were observed. These findings suggest that the high respiratory tissue penetration of ciprofloxacin and the achievable minimum inhibitory concentrations lead to acceptable clinical outcomes in lower respiratory tract infections.

Adult↗

PubMed2005

The Australian EEG database.

The Australian EEG Database is a web-based de-identified searchable database of 18,500 EEG records recorded at a regional public hospital over an 11-year period. Patients range in age from a premature infant born at 24 weeks gestation, through to people aged over 90 years. This paper will describe the history of the database, the range of patients represented in the database, and the nature of the text-based and digital data contained in the database. Preliminary results of the first two studies undertaken using the database are presented. Plans for sharing data from the Australian EEG database with researchers are discussed. We anticipate that such data will be useful in not only helping to answer clinical questions but also in the field of mathematical modeling of the EEG.

Adolescent↗

PubMed2004

The Gene Ontology (GO) database and informatics resource.

The Gene Ontology (GO) project (http://www. geneontology.org/) provides structured, controlled vocabularies and classifications that cover several domains of molecular and cellular biology and are freely available for community use in the annotation of genes, gene products and sequences. Many model organism databases and genome annotation groups use the GO and contribute their annotation sets to the GO resource. The GO database integrates the vocabularies and contributed annotations and provides full access to this information in several formats. Members of the GO Consortium continually work collectively, involving outside experts as needed, to expand and update the GO vocabularies. The GO Web resource also provides access to extensive documentation about the GO project and links to applications that use GO data for functional analyses.

Animals↗

PubMedDate not supplied

[Structure, use, and risks of biomaterial repositories of embryonal tumors].

Availability of statistically sufficient numbers of tumor samples and other biomaterials in high quality together with corresponding clinical data is crucial for biomedical research. Tumor repositories from individual scientists are mostly not sufficient to satisfy these criteria, especially since pediatric tumors are rare. In 2000 three centralized tumor repositories (neuroblastoma in Cologne, nephroblastoma in Würzburg, hepatoblastoma, brain tumors in Bonn) have been established by the "German Competence Net Pediatric Oncology und Hematology". The aim was to collect biomaterial including tumor samples, normal tissue, and blood in high quality for research and diagnostic purposes at a central institution. Informed consent of the parents or patients is a prerequisite for scientific use of the samples and is requested by the therapy trial. The samples are collected according to accepted standards and shipped in the specially designed Tumorbox. The tumor repository organizes the distribution of the samples to the cooperating diagnostic laboratories. The number of collected tumor samples has increased over the years. In 2000, samples from 200 patients were collected while the patient number increased to 321 in 2005. Over the years the tumor repositories collected more than 7,150 samples (fresh frozen tumor, fresh frozen normal tissue, and blood). Through links with clinical trial databases the samples can be connected with clinical data. 12 of 14 applications for tumor material to be used in specific scientific projects have been approved by an independent supervisory board. The establishment of central tumor repositories represents a major step for biomedical research activities and quality control in pediatric oncology.

Biocompatible Materials↗

PubMed2006

Use of an integrated clinical trial database to evaluate the effect of timing of drotrecogin alfa (activated) treatment in severe sepsis.

INTRODUCTION: Several studies have indicated that early identification and treatment of patients with severe sepsis using standard supportive care improves outcomes. Earlier treatment with drotrecogin alfa (activated) (DrotAA) may also improve outcomes in severe sepsis. Using a recently constructed integrated severe sepsis database, our objectives in this study were to describe the influence of baseline clinical characteristics on timing of DrotAA treatment in patients with severe sepsis, to evaluate the efficacy of DrotAA with respect to timing of administration, and to examine the association between early intervention with DrotAA and patient outcomes, using adjustments for imbalances. METHODS: The database comprises data from 4,459 patients with severe sepsis (DrotAA, n = 3,228; placebo, n = 1,231) included in five clinical trials conducted in tertiary care institutions in 28 countries. Placebo data came only from randomized trials, whereas data for the DrotAA group came from randomized (PROWESS) and open-label/observational (ENHANCE) trials. RESULTS: Increased time-to-treatment with DrotAA was significantly associated with more organ dysfunction, greater need of mechanical ventilation, vasopressor use, or recent surgery. Earlier treatment was associated with higher baseline Acute Physiology and Chronic Health Evaluation (APACHE II) scores. Adjusted and unadjusted survival analyses suggested that compared with placebo, DrotAA treatment provided a potential survival benefit, regardless of time to treatment. Survival curves of DrotAA patients treated early compared with those treated late began to separate at 14 days. By 28 days, patients treated earlier had higher survival than those treated later (76.4% versus 73.5%, p = 0.03). Sepsis-induced multiorgan dysfunction was the most common cause of death followed by refractory shock and respiratory failure. Modeling of the treatment effect, as a function of time to treatment, suggested increased benefit with earlier treatment. CONCLUSION: Using an integrated database of five severe sepsis trials and appropriate statistical adjustments to reduce sources of potential bias, earlier treatment with DrotAA seemed to be associated with a lower risk-adjusted mortality than later treatment. These data suggest that earlier treatment with DrotAA may provide most benefit for appropriate patients.

Adult↗