From the Editor's Desk, Editor's Highlights, Letters to the Editor.
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PROVIDER: S-EPMC4960913 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundTo identify published letters to the editor (LTE) written in response to randomized controlled trials (RCTs), determine the topics addressed in the letters, and to examine if these topics were affected by the characteristics and results of the RCTs.MethodsComparative cross-sectional study of a representative sample of RCTs from a set of high-impact medical journals (BMJ, Lancet, NEJM, JAMA, and Annals of Internal Medicine). RCTs and their published LTE were searched from these 5 journals in 2007. Data were collected on RCTs and their characteristics (author affiliation, funding source, intervention, and effect on the primary outcome) and the topics addressed in published LTE related to these RCTs. Analysis included chi-square and regression analysis (RCT characteristics) and thematic analysis (LTE topics).ResultsOf 334 identified RCTs, 175 trials had at least one LTE. Of these, 381 published LTE were identified. Most RCTs, tested drug interventions (68%), were funded by government (54%) or industry (33%), and described an intervention that had a positive impact on the primary outcome (62%). RCT authors were primarily affiliated with an academic centre (78%). Ninety percent of the 623 LTE topics concerned methodological issues regarding the analysis, intervention, and population in the RCT. There was a significant association between funding source and impact on outcomes (p?=?0.002) or type of intervention tested (p?=?0.001) in these trials. Clinical and "Other" LTE topics were more likely to be published in response to a government funded RCT (p?=?0.005 and p?=?0.033, respectively); no other comparisons were significant.ConclusionsThis study showed that most LTE are about methodological topics, but found little evidence to support that these topics are affected by the characteristics or results of the RCTs. The lack of association may be explained by editorial censorship as a small proportion of LTE that are submitted are actually published.
| S-EPMC3852599 | biostudies-literature
Project description:Letters to the Editor offer ways for readers to engage with authors' publications. Letters are the shortest manuscript for medical students to publish and medical-education journals are best suited. The UK Foundation Programme rewards medical students achieving PubMed ID publications and we hypothesise that this is a main motivation for medical students to submit Letters to the Editor. A review of 15 medical-education journals with an impact factor was conducted to identify numbers and percentages of Letters to the Editor by medical students between July 2018 and June 2020. Affiliation of medical students was collected. Our results show over two years, 299 letters were published by medical students equating to 45.9% of total letters. There was a 60% overall increase in letters by medical students published in the first 12 months compared to second 12 months. During this period overall numbers of letters published increased by 27%. 86% of the letters published by medical students over the two-year period were from UK medical schools. Five schools accounted for 60.5% of these letters. The three medical schools with highest numbers of letters published were King's College London, Imperial College London and University of Oxford for both 2018/19 and 2019/20. The increase in letters published overall with greater numbers published by students, may indicate greater awareness of Letters to the Editor as means of dissemination amongst medical students. UK medical schools published large numbers of letters, perhaps reflecting increasing importance to students of publications due to impacting on subsequent jobs. Results from our quantitative research revealing: large numbers of letters by medical students, increase in letters published from 2018/19 to 2019/20 and overrepresentation of UK medical students supports the hypothesis that medical students are publishing letters to achieve PubMed IDs. Further qualitative research is required to test our hypothesis.
| S-EPMC8057084 | biostudies-literature
Project description:ObjectivesTo analyse the relationship between first author's gender and ethnicity (estimated from first name and surname), and chance of publication of rapid responses in the British Medical Journal (BMJ). To analyse whether other features of the rapid response account for any gender or ethnic differences, including the presence of multiple authors, declaration of conflicts of interests, the presence of Twitter handle, word count, reading ease, spelling and grammatical mistakes, and the presence of references.DesignA retrospective observational study.SettingWebsite of the BMJ (BMJ.com).ParticipantsPublicly available rapid responses submitted to BMJ.com between 1998 and 2018.Main outcome measuresPublication of a rapid response as a letter to the editor in the BMJ.ResultsWe analysed 113 265 rapid responses, of which 8415 were published as letters to the editor (7.4%). Statistically significant univariate correlations were found between odds of publication and first author estimated gender and ethnicity, multiple authors, declaration of conflicts of interest, the presence of Twitter handle, word count, reading ease, spelling and grammatical mistakes, and the presence of references. Multivariate analysis showed that first author estimated gender and ethnicity predicted publication after taking into account the other factors. Compared to white authors, black authors were 26% less likely to be published (OR: 0.74, CI: 0.57-0.96), Asian and Pacific Islander authors were 46% less likely to be published (OR: 0.54, CI: 0.49-0.59) and Hispanic authors were 49% less likely to be published (OR: 0.51, CI: 0.41-0.64). Female authors were 10% less likely to be published (OR: 0.90, CI: 0.85-0.96) than male authors.ConclusionEthnic and gender differences in rapid response publication remained after accounting for a broad range of features, themselves all predictive of publication. This suggests that the reasons for the differences of these groups lies elsewhere.
| S-EPMC7754629 | biostudies-literature
Project description:This paper addresses the subject of letters to the editor as one of the longest standing forums for public discussion and debate by ordinary citizens. To show how the voice of ordinary citizens is presented in letters to the editor during national election campaigns over a period of ten years (2008, 2013 & 2017), we are focusing on the Austrian Kronen Zeitung: A newspaper with an exceptionally high market share of up to 40% during the examination period, a heavy focus on the letters section with three pages per day, and a self-declared willingness to take a stance, especially during election periods. Based on a quantitative content analysis of 530 letters to the editor and 525 articles in the politics section as well as survey data from the Austrian national election study on the political positions of the Kronen Zeitung's readers, we find that letters to the editor in the Kronen Zeitung do not reflect, but complement the articles in the politics section. The tone of the letters is more negative than that of news articles, but the letters closely reflect the readers' political positions, therefore offering identification with the paper.
| S-EPMC7307409 | biostudies-literature
Project description:This study explored whether there is a gender difference in letter-sound knowledge when children start at school. 485 children aged 5-6 years completed assessment of letter-sound knowledge, i.e., large letters; sound of large letters; small letters; sound of small letters. The findings indicate a significant difference between girls and boys in all four factors tested in this study in favor of the girls. There are still no clear explanations to the basis of a presumed gender difference in letter-sound knowledge. That the findings have origin in neuro-biological factors cannot be excluded, however, the fact that girls probably have been exposed to more language experience/stimulation compared to boys, lends support to explanations derived from environmental aspects.
| S-EPMC5599780 | biostudies-literature
Project description:In Response To: Walker RH. Reply to: Tardive dyskinesia-like syndrome due to drugs that do not block dopamine receptors: rare or non-existent: literature review. Tremor Other Hyperkinet Mov. 2019; 9. doi: 10.7916/3rez-p096 Original Article: D'Abreu A, Friedman JH. Tardive dyskinesia-like syndrome due to drugs that do not block dopamine receptors: rare or non-existent: literature review. Tremor Other Hyperkinet Mov. 2018; 8. doi: 10.7916/D8FF58Z9.
| S-EPMC6377913 | biostudies-other
Project description:PurposeTo launch a pharmaceutical product in the US market, approval from the FDA is required. Pharmaceutical companies undergo FDA pre-approval inspection (PAI for small molecule products) or pre-license approval (PLI for biological products) at their manufacturing sites (including contract development and manufacturing organization, testing laboratories, and packaging labelling facilities) prior to approval. After the products are approved by the FDA, surveillance inspections are performed by the FDA which are risk based as which company and which site will be inspected. The present study examines the causes of warning letters issued by the Center for Drug Evaluation and Research (CDER), FDA to the pharmaceutical companies after post-approval inspections.MethodsWarning letters issued from the time period 2010 to 2020 were obtained from the FDA website, and information about date of issuance, company, and type of violations was extracted for the study.ResultsPoor compliance to CGMP and misbranding were the most common reasons for the warning letters. Detailed analysis of CGMP warning letters elucidated three major types of violations, namely deficiencies in process validation, documentation practices (data integrity), and quality control corresponding to 26%, 21%, and 15% warning letters, respectively.ConclusionReview of the analysed letters demonstrates that the FDA's major concern is over CGMP compliance. To avoid these warning letters, pharmaceutical manufacturers need to improve their quality compliance and focus on creating effective quality management systems that govern the entire manufacturing process, quality control, employee training, and documentation practice. Companies should develop an internal compliance check list and also be ready for corrective measures as and when required.Supplementary informationThe online version contains supplementary material available at 10.1007/s12247-022-09678-2.
| S-EPMC9377664 | biostudies-literature