Interface between authorship, industry and science in the domain of therapeutics.
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BACKGROUND: Changes in the character of medical authorship. Aims To compare the impact of industry-linked and non-industry linked articles. METHOD: We compared articles on sertraline being coordinated by a medical writing agency with articles not coordinated in this way. We calculated numbers of Medline-listed articles per author, journal impact factors, literature profiles and citation rates of both sets of articles. RESULTS: Non-agency-linked articles on sertraline had an average of 2.95 authors per article, a mean length of 3.4 pages, a mean Medline listing of 37 articles per author (95% CI 27-47) and a mean literature profile of 283 per article (95% CI 130-435). Agency-linked articles on sertraline had an average of 6.6 authors per article, a mean length of 10.7 pages, a mean Medline listing of 70 articles per author (95% CI 62-79) and a mean literature profile of 1839 per article (95% CI 1076-2602). The citation rate for agency articles was 20.2 (95% CI 13.4-27.0) and for non-agency articles it was 3.7 (95% CI 3.3-8.1). CONCLUSIONS: The literature profiles and citation rates of industry-linked and non-industry-linked articles differ. The emerging style of authorship in industry-linked articles can deliver good-quality articles, but it raises concerns for the scientific base of therapeutics. (+info)
HTA responses and the classic HTA report.
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Reports produced in response to the need for health technology assessment (HTA) vary greatly in the methods they use, depending on the decision-maker's needs, the technology's characteristics and the resources available. HTA reports vary from the brief, such as 'vignettes' produced when a new technology emerges, to the exhaustive, such as 'Cochrane reviews' synthesising a mature evidence base. They may address a wide range of different questions. 'Classic HTAs', typically those reports prepared to support NICE appraisal decisions, seek to use scientifically rigorous methods to address a focused policy question. These are based on systematic reviews of the effectiveness evidence but this is often fed into economic models, in order to generate estimates of cost-effectiveness. Future developments in HTA responses will reflect both the embedding of systematic methods and a growing responsiveness to customer needs. (+info)
Does anybody read "evidence-based" articles?
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BACKGROUND: The electronic version of the British Medical Journal (eBMJ) has a unique feature in that it provides an electronic record of the number of times an article has been viewed ("hits") in the week after its publication. We sought to compare the relative popularity of primary research and "evidence-based" papers against that of narrative reviews and editorials. We surveyed four broad groupings of articles in 2001: Editorials, Clinical Reviews (which are narrative reviews), Education and Debate, and Papers (which are original research articles and systematic reviews). Clinical Reviews were the most frequently viewed articles, with an average of 4148 hits per article, while Papers were less popular (average of 1168 hits per article). Systematic reviews (23 articles, average of 1190 hits per article) were visited far less often than narrative reviews. Editorials (average of 2537 hits per article) were viewed much more frequently than Papers, even where the editorial was written as an accompanying piece with a direct link to the paper. DISCUSSION: Narrative reviews and editorials are accessed more frequently than primary research papers or systematic reviews in the first week after their publication. These findings may disappoint those who believe that it is important for readers to critically appraise the primary research data. Although the technical quality of journal articles may have been helped by recommendations on structured reporting, the readability of such articles has received little attention. Authors and journal editors must take steps to make research articles and systematic reviews more attractive to readers. This may involve using simpler language, as well as innovative use of web resources to produce shorter, snappier papers, with the methodological or technical details made available elsewhere. CONCLUSION: Primary research and "evidence-based" papers seem to be less attractive to readers than narrative reviews and editorials in the first week after publication. Authors and editors should try to improve the early appeal of primary research papers. (+info)
Moving toward evidence-based practice.
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"Evidence-based practice" involves applying the best available evidence to the care of individuals. Explicit, systematic methods have developed for determining what is the best available evidence. However, often even the highest-level evidence is not thoroughly or effectively used in practice, even if it is widely known. We must rigorously and critically analyze study results to understand their strengths, limitations, and generalizability, and bear in mind that our knowledge will evolve and thereby change our practice. The clinical question is not always how to apply the evidence but whether the available evidence applies to a particular patient. We should always ask whether the right provider is doing the right thing for the right patient at the right time in the right setting with the right resources. (+info)
WWOX, the common chromosomal fragile site, FRA16D, cancer gene.
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Gross chromosomal rearrangements and aneuploidy are among the most common somatic genomic abnormalities that occur during cancer initiation and progression, in particular in human solid tumor carcinogenesis. The loss of large chromosomal regions as consequence of gross rearrangements (e.g. deletions, monosomies, unbalanced translocations and mitotic recombination) have been traditionally associated with the existence of tumor suppressor genes within the areas affected by the loss of genetic material. The long arm of chromosome 16 was identified as being frequently associated with structural abnormalities in multiple neoplasias, that led us to focus attention on the detailed genetic dissection of this region resulting in the cloning of the putative tumor suppressor gene, WWOX (WW domain containing Oxidoreductase). Interestingly, the WWOX gene resides in the very same region as that of the common chromosomal fragile site 16D (FRA16D). The WWOX gene encodes a protein that contains two WW domains, involved in protein-protein interactions, and a short chain dehydrogenase (SDR) domain, possibly involved in sex-steroid metabolism. We have identified the WWOX WW domain ligand as the PPXY motif confirming the biochemical activity of this domain. WWOX normally resides in the Golgi and we will demonstrate that Golgi localization requires an intact SDR. Inactivation of the WWOX gene during tumorigenesis can occur by homozygous deletions and possibly mutation, however, aberrantly spliced forms of WWOX mRNA have been observed even when one allele is still intact. The aberrantly spliced mRNAs have deletions of the exons that encode the SDR and these WWOX protein isoforms display abnormal intracellular localization to the nucleus possibly functioning as dominant negative inhibitors of full length WWOX. Thus, generation of aberrant transcripts of WWOX may represent a novel mechanism to functionally inactivate WWOX without genomic alteration of the remaining allele. In this article we will review the cloning and identification of WWOX as the target of FRA16D. In addition, we will discuss the possible biochemical functions of WWOX and present evidence that ectopic WWOX expression inhibits tumor growth. (+info)
The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews.
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BACKGROUND: In the era of evidence based medicine, with systematic reviews as its cornerstone, adequate quality assessment tools should be available. There is currently a lack of a systematically developed and evaluated tool for the assessment of diagnostic accuracy studies. The aim of this project was to combine empirical evidence and expert opinion in a formal consensus method to develop a tool to be used in systematic reviews to assess the quality of primary studies of diagnostic accuracy. METHODS: We conducted a Delphi procedure to develop the quality assessment tool by refining an initial list of items. Members of the Delphi panel were experts in the area of diagnostic research. The results of three previously conducted reviews of the diagnostic literature were used to generate a list of potential items for inclusion in the tool and to provide an evidence base upon which to develop the tool. RESULTS: A total of nine experts in the field of diagnostics took part in the Delphi procedure. The Delphi procedure consisted of four rounds, after which agreement was reached on the items to be included in the tool which we have called QUADAS. The initial list of 28 items was reduced to fourteen items in the final tool. Items included covered patient spectrum, reference standard, disease progression bias, verification bias, review bias, clinical review bias, incorporation bias, test execution, study withdrawals, and indeterminate results. The QUADAS tool is presented together with guidelines for scoring each of the items included in the tool. CONCLUSIONS: This project has produced an evidence based quality assessment tool to be used in systematic reviews of diagnostic accuracy studies. Further work to determine the usability and validity of the tool continues. (+info)
Emergency management of acute apical abscesses in the permanent dentition: a systematic review of the literature.
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OBJECTIVE: To perform a systematic literature review and meta-analysis on the effectiveness of interventions used in the management of acute apical abscess in the permanent dentition. METHODS: Electronic databases were searched from their inception to March 2002. These searches, combined with manual searching, yielded 85 citations, of which 35 were relevant. Independent application of inclusion criteria by 3 reviewers yielded 8 eligible randomized controlled studies. Data on population, interventions, outcomes (reduction of pain or swelling or both, as reported by patients or clinicians) and methodological quality were determined by independent triplicate review. Disagreements were resolved by consensus. RESULTS: All papers included in the meta-analysis compared an antibiotic with an active control, a placebo or no pharmacotherapy as an adjunct for patients who had received concomitant therapy (i.e., incision and drainage, endodontic therapy or extraction). The 8 trials were randomized; in 3 of these, the method of randomization was described and appropriate. Five studies were double-blinded, and 2 of these described the method of blinding. Four trials described withdrawals, but none included an intention-to-treat analysis. Six studies compared 2 antibiotics. For the outcomes "absence of infection"and "absence of pain" the pooled odds ratios (ORs) were not statistically significant; for the outcome "absence of pain and infection," 3 studies showed an equivalent treatment effect in both treatment and control groups. One open-label study (with a quality score of 2) showed a result favouring azithromycin over co-amoxiclav (OR 0.58, 95% confidence interval 0.35-0.96). Two studies compared adjunctive antibiotic therapy with placebo; no benefit to patients was demonstrated with this intervention. CONCLUSIONS: In the management of localized acute apical abscess in the permanent dentition, the abscess should be drained through a pulpectomy or incision and drainage. This analysis indicated that antibiotics are of no additional benefit. In the event of systemic complications (e.g., fever, lymphadenopathy or cellulitis), or for an immunocompromised patient, antibiotics may be prescribed in addition to drainage of the tooth. (+info)
Systematic reviews: a cross-sectional study of location and citation counts.
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BACKGROUND: Systematic reviews summarize all pertinent evidence on a defined health question. They help clinical scientists to direct their research and clinicians to keep updated. Our objective was to determine the extent to which systematic reviews are clustered in a large collection of clinical journals and whether review type (narrative or systematic) affects citation counts. METHODS: We used hand searches of 170 clinical journals in the fields of general internal medicine, primary medical care, nursing, and mental health to identify review articles (year 2000). We defined 'review' as any full text article that was bannered as a review, overview, or meta-analysis in the title or in a section heading, or that indicated in the text that the intention of the authors was to review or summarize the literature on a particular topic. We obtained citation counts for review articles in the five journals that published the most systematic reviews. RESULTS: 11% of the journals concentrated 80% of all systematic reviews. Impact factors were weakly correlated with the publication of systematic reviews (R2 = 0.075, P = 0.0035). There were more citations for systematic reviews (median 26.5, IQR 12 - 56.5) than for narrative reviews (8, 20, P <.0001 for the difference). Systematic reviews had twice as many citations as narrative reviews published in the same journal (95% confidence interval 1.5 - 2.7). CONCLUSIONS: A few clinical journals published most systematic reviews. Authors cited systematic reviews more often than narrative reviews, an indirect endorsement of the 'hierarchy of evidence'. (+info)