Effect of early patient enrollment on the time to completion and publication of randomized controlled trials.
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The authors evaluated whether early enrollment affects the significance of the results and the time to completion and publication of randomized controlled trials. Seventy-seven efficacy randomized controlled trials (total enrollment, 28,992 patients) initiated by the Acquired Immunodeficiency Syndrome Clinical Trials Group between 1986 and 1996 were evaluated. After adjustment for target sample size, for each 10-fold increase in the first-month accrual, the odds of a trial reaching statistically significant results increased 2.8-fold (p = 0.040). The relative enrollment during the first month over target sample size (hazard ratio (HR) = 1.40 per 10 percent increase, p = 0.004) and masking (HR = 1.78 for double-blind vs. single or unblinded studies, p = 0.031) were the major predictors of faster completion. Rapid early accrual (HR = 1.09 per 10 additional patients accrued the first month, p = 0.011) and statistical significance in favor of an experimental arm (HR = 2.47, p = 0.004) independently predicted faster publication. Early enrollment is a strong predictor of whether a study will reach formal statistical significance, and it can offer predictive information on the time needed to complete the study and publish its findings. Ongoing unpublished studies and their enrollment rates may need to be considered when interpreting the accumulated evidence. (+info)
A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.
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BACKGROUND: Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised guidelines for investigators' participation in the study design, access to data, and control over publication. It is unclear whether research conducted at academic institutions adheres to these new standards. METHODS: From November 2001 through January 2002, we interviewed officials at U.S. medical schools about provisions in their institutions' agreements with industry sponsors of multicenter clinical trials. A subgroup of the respondents were also asked about coordinating-center agreements for such trials. RESULTS: Of the 122 medical schools that are members of the Association of American Medical Colleges, 108 participated in the survey. The median number of site-level agreements executed per institution in the previous year was 103 (interquartile range, 50 to 210). Scores for compliance with a wide range of provisions--from ensuring that authors of reports on multicenter trials have access to all trial data (1 percent [interquartile range, 0 to 21]) to addressing the plan for data collection and monitoring (10 percent [interquartile range, 1 to 50])--demonstrated limited adherence to the standards embodied in the new ICMJE guidelines. Scores for coordinating-center agreements were somewhat higher for most survey items. CONCLUSIONS: Academic institutions routinely engage in industry-sponsored research that fails to adhere to ICMJE guidelines regarding trial design, access to data, and publication rights. Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed. (+info)
Recall bias, MMR, and autism.
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Parents of autistic children with regressive symptoms who were diagnosed after the publicity alleging a link with measles, mumps, and rubella (MMR) vaccine tended to recall the onset as shortly after MMR more often than parents of similar children who were diagnosed prior to the publicity. This is consistent with the recall bias expected under such circumstances. (+info)
Microbial biodiversity: approaches to experimental design and hypothesis testing in primary scientific literature from 1975 to 1999.
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Research interest in microbial biodiversity over the past 25 years has increased markedly as microbiologists have become interested in the significance of biodiversity for ecological processes and as the industrial, medical, and agricultural applications of this diversity have evolved. One major challenge for studies of microbial habitats is how to account for the diversity of extremely large and heterogeneous populations with samples that represent only a very small fraction of these populations. This review presents an analysis of the way in which the field of microbial biodiversity has exploited sampling, experimental design, and the process of hypothesis testing to meet this challenge. This review is based on a systematic analysis of 753 publications randomly sampled from the primary scientific literature from 1975 to 1999 concerning the microbial biodiversity of eight habitats related to water, soil, plants, and food. These publications illustrate a dominant and growing interest in questions concerning the effect of specific environmental factors on microbial biodiversity, the spatial and temporal heterogeneity of this biodiversity, and quantitative measures of population structure for most of the habitats covered here. Nevertheless, our analysis reveals that descriptions of sampling strategies or other information concerning the representativeness of the sample are often missing from publications, that there is very limited use of statistical tests of hypotheses, and that only a very few publications report the results of multiple independent tests of hypotheses. Examples are cited of different approaches and constraints to experimental design and hypothesis testing in studies of microbial biodiversity. To prompt a more rigorous approach to unambiguous evaluation of the impact of microbial biodiversity on ecological processes, we present guidelines for reporting information about experimental design, sampling strategies, and analyses of results in publications concerning microbial biodiversity. (+info)
Use of a MeSH-based index of faculty research interests to identify faculty publications: an IAIMSian study of precision, recall, and data reusability.
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OBJECTIVE: To determine whether MEDLINE searches based on an existing automated faculty research interest index or on author name entities can be used to automate construction of accurate online lists of faculty publications. METHODS: Curricula vitae (CVs) for 36 faculty members were selected at random. Their lists of journal publications were used to determine recall and precision of two MEDLINE search strategies. OUTCOME: Most faculty publications in the CVs (86%) were indexed in MEDLINE. The research-interest-enhanced MEDLINE searches retrieved citations in the CVs that were also in MEDLINE with a recall of 0.53 and precision of 0.85. For every 10 citations in the research interest-enhanced search, on average 8.5 were in the CVs. The name entity searches retrieved a higher proportion of citations in the CVs (recall 0.94, precision 0.59) with a higher rate of citations not in the CVs: For every 10 citations in the faculty name searches, 7.3 citations were in the CVs. Name commonness or clinical or basic sciences appointment did not change these results. CONCLUSION: MEDLINE searches, especially those based on research interests, can be used to populate faculty publication lists with high rates of accuracy. Author based searches can also be used, but they retrieve a higher proportion of irrelevant citations. This study confirms a successful instance of data reusability and integration at a large health academic sciences institution. (+info)
Protein structures and information extraction from biological texts: the PASTA system.
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MOTIVATION: The rapid increase in volume of protein structure literature means useful information may be hidden or lost in the published literature and the process of finding relevant material, sometimes the rate-determining factor in new research, may be arduous and slow. RESULTS: We describe the Protein Active Site Template Acquisition (PASTA) system, which addresses these problems by performing automatic extraction of information relating to the roles of specific amino acid residues in protein molecules from online scientific articles and abstracts. Both the terminology recognition and extraction capabilities of the system have been extensively evaluated against manually annotated data and the results compare favourably with state-of-the-art results obtained in less challenging domains. PASTA is the first information extraction (IE) system developed for the protein structure domain and one of the most thoroughly evaluated IE system operating on biological scientific text to date. AVAILABILITY: PASTA makes its extraction results available via a browser-based front end: http://www.dcs.shef.ac.uk/nlp/pasta/. The evaluation resources (manually annotated corpora) are also available through the website: http://www.dcs.shef.ac.uk/nlp/pasta/results.html. (+info)
Resuscitation training of paediatricians.
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Intensive, didactic courses teaching resuscitation training are currently not only very popular, but are also required curricula content for certain aspects of medical training. There are a number of such courses available in the field of paediatrics, each with a different emphasis and target audience. They are not inexpensive, as they utilise large amounts of training equipment and have a high instructor to student ratio. This review will examine the course structures, instructor training, the need for such courses, and effect they may have on patient outcome. (+info)
Japan's contribution to research on cardiovascular disease.
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Japan's contribution to the research on cardiovascular disease in the past decade was analyzed by accessing journal articles published in 1991-2000 in the MEDLINE database. The number of articles having an affiliation with a Japanese institution was counted and summed up as a whole and also separately for each journal with statistical time trend analysis. The proportions of randomized controlled study (RCT), case - control/cohort study, and case reports in articles from Japan were also determined. Of the total articles, Japan's contribution to the research on cardiovascular disease was 8.9% and ranked 2nd in the world. The recent increase in the contribution was not significant (p=0.25). Compared with other countries, the proportions of RCT (2.3%) and case - control/cohort study (2.3%) were smaller and that of case reports was similar (5.7%). Although the overall contribution from Japan in the field of cardiovascular disease is satisfactory, high-quality clinical research is as meager as in other clinical fields. (+info)