Background
Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical industry sponsored studies are more often favorable to the sponsor’s product compared with studies with other sources of sponsorship. This review is an update using more stringent methodology and also investigating sponsorship of device studies.

Objectives
To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship.

Search methods
We searched MEDLINE (1948 to September 2010), EMBASE (1980 to September 2010), the Cochrane Methodology Register (Issue 4, 2010) and Web of Science (August 2011). In addition, we searched reference lists of included papers, previous systematic reviews and author files.

Selection criteria
Cross-sectional studies, cohort studies, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions.

Data collection and analysis
Two assessors identified potentially relevant papers, and a decision about final inclusion was made by all authors. Two assessors extracted data, and we contacted authors of included papers for additional unpublished data. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether the conclusions agreed with the study results. Two assessors assessed risk of bias of included papers. We calculated pooled risk ratios (RR) for dichotomous data (with 95% confidence intervals).

Main results
Forty-eight papers were included. Industry sponsored studies more often had favorable efficacy results, risk ratio (RR): 1.32 (95% confidence interval (CI): 1.21 to 1.44), harms results RR: 1.87 (95% CI: 1.54 to 2.27) and conclusions RR: 1.31 (95% CI: 1.20 to 1.44) compared with non-industry sponsored studies. Ten papers reported on sponsorship and effect size, but could not be pooled due to differences in their reporting of data. The results were heterogeneous; five papers found larger effect sizes in industry sponsored studies compared with non-industry sponsored studies and five papers did not find a difference in effect size. Only two papers (including 120 device studies) reported separate data for devices and we did not find a difference between drug and device studies on the association between sponsorship and conclusions (test for interaction, P = 0.23). Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment and follow-up. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.32 (95% CI: 1.05 to 1.65), compared with non-industry sponsored studies. In industry sponsored studies, there was less agreement between the results and the conclusions than in non-industry sponsored studies, RR: 0.84 (95% CI: 0.70 to 1.01).

Authors' conclusions
Sponsorship of drug and device studies by the manufacturing company leads to more favorable results and conclusions than sponsorship by other sources. Our analyses suggest the existence of an industry bias that cannot be explained by standard 'Risk of bias' assessments.

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Industry sponsorship and research outcome

『Google Scholar』の利点

Icmje

Reviews provide a synthesis of published literature on a topic and describe its current state-of-art. Reviews in clinical research are thus useful when designing studies or developing practice guidelines. The two standard types of reviews are (a) systematic and (b) non-systematic or narrative review. Unlike systematic reviews that benefit from guidelines such as PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement, there are no acknowledged guidelines for narrative reviews. I have attempted to define the best practice recommendations for the preparation of a narrative review in clinical research. The quality of a narrative review may be improved by borrowing from the systematic review methodologies that are aimed at reducing bias in the selection of articles for review and employing an effective bibliographic research strategy. The dynamics of narrative review writing, the organizational pattern of the text, the analysis, and the synthesis processes are also discussed.

/pdf/writing-narrative-style-literature-reviews-4m8tj4as5u.pdf

Writing narrative style literature reviews

Narrative reviews are the commonest type of articles in the medical literature. However, unlike systematic reviews and randomized controlled trials (RCT) articles, for which formal instruments exist to evaluate quality, there is currently no instrument available to assess the quality of narrative reviews. In response to this gap, we developed SANRA, the Scale for the Assessment of Narrative Review Articles. A team of three experienced journal editors modified or deleted items in an earlier SANRA version based on face validity, item-total correlations, and reliability scores from previous tests. We deleted an item which addressed a manuscript’s writing and accessibility due to poor inter-rater reliability. The six items which form the revised scale are rated from 0 (low standard) to 2 (high standard) and cover the following topics: explanation of (1) the importance and (2) the aims of the review, (3) literature search and (4) referencing and presentation of (5) evidence level and (6) relevant endpoint data. For all items, we developed anchor definitions and examples to guide users in filling out the form. The revised scale was tested by the same editors (blinded to each other’s ratings) in a group of 30 consecutive non-systematic review manuscripts submitted to a general medical journal. Raters confirmed that completing the scale is feasible in everyday editorial work. The mean sum score across all 30 manuscripts was 6.0 out of 12 possible points (SD 2.6, range 1–12). Corrected item-total correlations ranged from 0.33 (item 3) to 0.58 (item 6), and Cronbach’s alpha was 0.68 (internal consistency). The intra-class correlation coefficient (average measure) was 0.77 [95% CI 0.57, 0.88] (inter-rater reliability). Raters often disagreed on items 1 and 4. SANRA’s feasibility, inter-rater reliability, homogeneity of items, and internal consistency are sufficient for a scale of six items. Further field testing, particularly of validity, is desirable. We recommend rater training based on the “explanations and instructions” document provided with SANRA. In editorial decision-making, SANRA may complement journal-specific evaluation of manuscripts—pertaining to, e.g., audience, originality or difficulty—and may contribute to improving the standard of non-systematic reviews.

SANRA—a scale for the quality assessment of narrative review articles

Platelet activation is a link in the pathophysiology of diseases prone to thrombosis and inflammation. Numerous platelet markers, including mean platelet volume (MPV), have been investigated in connection with both thrombosis and inflammation. This review considers MPV as a prognostic and therapeutic marker as well as the factors influencing its measurement. Established cardiovascular risk factors, such as smoking, hypertension, dyslipidemia, and diabetes, can influence MPV, depending on confounding factors. Low-grade inflammation is one such factor. Evidence, particularly derived from prospective studies and a meta-analysis, suggest a correlation between an increase in MPV and the risk of thrombosis. High MPV associates with a variety of established risk factors, cardio- and cerebrovascular disorders, and low-grade inflammatory conditions prone to arterial and venous thromboses. High-grade inflammatory diseases, such as active rheumatoid arthritis or attacks of familial Mediterranean fever, present with low levels of MPV, which reverse in the course of anti-inflammatory therapy. Lifestyle modification, antihypertensive, lipid lowering and diet therapies can also affect MPV values, but these effects need to be investigated in large prospective studies with thrombotic endpoints.

Mean Platelet Volume: A Link Between Thrombosis and Inflammation?

Review articles comprehensively covering a specific topic are crucial for successful research and academic projects. Most editors consider review articles for special and regular issues of journals. Writing a review requires deep knowledge and understanding of a field. The aim of this review is to analyze the main steps in writing a narrative biomedical review and to consider points that may increase the chances of success. We performed a comprehensive search through MEDLINE, EMBASE, Scopus, and Web of Science using the following keywords: review of the literature, narrative review, title, abstract, authorship, ethics, peer review, research methods, medical writing, scientific writing, and writing standards. Opinions expressed in the review are also based on personal experience as authors, peer reviewers, and editors.

/pdf/writing-a-narrative-biomedical-review-considerations-for-g8ovxlcvaj.pdf

Writing a narrative biomedical review: considerations for authors, peer reviewers, and editors

The platelet-to-lymphocyte ratio (PLR) has emerged as an informative marker revealing shifts in platelet and lymphocyte counts due to acute inflammatory and prothrombotic states. PLR has been extensively examined in neoplastic diseases accompanied by immune suppression and thrombosis, which can be predicted by combined blood cell counts and their ratios. Several large observational studies have demonstrated the value of shifts in PLR in evaluating the severity of systemic inflammation and predicting infections and other comorbidities, in inflammatory rheumatic diseases. The value of PLR as an inflammatory marker increases when its fluctuations are interpreted along with other complementary hematologic indices, particularly the neutrophil-to-lymphocyte ratio (NLR), which provides additional information about the disease activity, presence of neutrophilic inflammation, infectious complications, and severe organ damage in systemic lupus erythematosus. PLR and NLR have high predictive value in rheumatic diseases with predominantly neutrophilic inflammation (e.g., Behcet disease and familial Mediterranean fever). High PLR, along with elevated platelet count, is potentially useful in diagnosing some systemic vasculitides, particularly giant-cell arteritis. A few longitudinal studies on rheumatic diseases have demonstrated a decrease in PLR in response to anti-inflammatory therapies. The main limitations of PLR studies are preanalytical faults, inadequate standardization of laboratory measurements, and inappropriate subject selection. Nonetheless, accumulating evidence suggests that PLR can provide valuable information to clinicians who encounter multisystem manifestations of rheumatic diseases, which are reflected in shifts in platelet, lymphocyte, neutrophil, or monocyte counts. Interpretation of PLR combined with complementary hematologic indices is advisable to more accurately diagnose inflammatory rheumatic diseases and predict related comorbidities.

/pdf/the-platelet-to-lymphocyte-ratio-as-an-inflammatory-marker-2zemojiwvq.pdf

The Platelet-to-Lymphocyte Ratio as an Inflammatory Marker in Rheumatic Diseases

Authorship problems in scholarly journals shake the foundations of research, diminish scientific quality of papers and devalue records of citation tracking services. The ‘Publish or Perish’ mantra is thought to drive some instances of unfair, honorary authorship, particularly in countries of emerging scientific power. Though causes of honorary, gift, guest and ghost authorship are still ill-defined, it is possible to avoid some of these instances by improving awareness of what constitutes authorship and by adhering to the editorial policies of learned associations. This paper overviews common cases of inappropriate authorship and suggests options to solve related problems by authors, reviewers and editors of scholarly journals.

/pdf/authorship-problems-in-scholarly-journals-considerations-for-2ybmmr3oo8.pdf

Authorship problems in scholarly journals: considerations for authors, peer reviewers and editors.

Aim
To analyze mistakes and misconduct in multidisciplinary and specialized biomedical journals.

Lilit Ayvazyan

Papers

Mean Platelet Volume: A Link Between Thrombosis and Inflammation?

Writing a narrative biomedical review: considerations for authors, peer reviewers, and editors

The Platelet-to-Lymphocyte Ratio as an Inflammatory Marker in Rheumatic Diseases

Authorship problems in scholarly journals: considerations for authors, peer reviewers and editors.

Self-correction in biomedical publications and the scientific impact