Correction to: Cross-sectional study of medical advertisements in a national general medical journal: evidence, cost, and safe use of advertised versus comparative drugs.
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ABSTRACT:
SUBMITTER: Boesen K
PROVIDER: S-EPMC8196460 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundHealthcare professionals are exposed to advertisements for prescription drugs in medical journals. Such advertisements may increase prescriptions of new drugs at the expense of older treatments even when they have no added benefits, are more harmful, and are more expensive. The publication of medical advertisements therefore raises ethical questions related to editorial integrity.MethodsWe conducted a descriptive cross-sectional study of all medical advertisements published in the Journal of the Danish Medical Association in 2015. Drugs advertised 6 times or more were compared with older comparators: (1) comparative evidence of added benefit; (2) Defined Daily Dose cost; (3) regulatory safety announcements; and (4) completed and ongoing post-marketing studies 3 years after advertising.ResultsWe found 158 medical advertisements for 35 prescription drugs published in 24 issues during 2015, with a median of 7 advertisements per issue (range 0 to 11). Four drug groups and 5 single drugs were advertised 6 times or more, for a total of 10 indications, and we made 14 comparisons with older treatments. We found: (1) 'no added benefit' in 4 (29%) of 14 comparisons, 'uncertain benefits' in 7 (50%), and 'no evidence' in 3 (21%) comparisons. In no comparison did we find evidence of 'substantial added benefit' for the new drug; (2) advertised drugs were 2 to 196 times (median 6) more expensive per Defined Daily Dose; (3) 11 safety announcements for five advertised drugs were issued compared to one announcement for one comparator drug; (4) 20 post-marketing studies (7 completed, 13 ongoing) were requested for the advertised drugs versus 10 studies (4 completed, 6 ongoing) for the comparator drugs, and 7 studies (2 completed, 5 ongoing) assessed both an advertised and a comparator drug at 3 year follow-up.Conclusions and relevanceIn this cross-sectional study of medical advertisements published in the Journal of the Danish Medical Association during 2015, the most advertised drugs did not have documented substantial added benefits over older treatments, whereas they were substantially more expensive. From January 2021, the Journal of the Danish Medical Association no longer publishes medical advertisements.
| S-EPMC8108346 | biostudies-literature
Project description:BackgroundPhysician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.Methods and findingsCross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.ConclusionsFew physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.
| S-EPMC3157354 | biostudies-literature
Project description:To help authors design rigorous studies and prepare clear and informative manuscripts, improve the transparency of editorial decisions, and raise the bar on educational scholarship, the Deputy Editors of the Journal of General Internal Medicine articulate standards for medical education submissions to the Journal. General standards include: (1) quality questions, (2) quality methods to match the questions, (3) insightful interpretation of findings, (4) transparent, unbiased reporting, and (5) attention to human subjects' protection and ethical research conduct. Additional standards for specific study types are described. We hope these proposed standards will generate discussion that will foster their continued evolution.
| S-EPMC2517930 | biostudies-literature
Project description:BACKGROUND: Assessment of authorship contribution is often based on unreliable questionnaires. OBJECTIVE: To assess if the use of different formats for the disclosure of authorship contributions influences authors' compliance with the criteria of the International Committee of Medical Journal Editors (ICMJE). DESIGN: Randomized study. PARTICIPANTS AND MEASUREMENTS: Eight hundred sixty-five authors of 181 manuscripts submitted to the Croatian Medical Journal from January to July 2005 were randomly allocated into 2 groups: 456 authors (94 manuscripts) received an ordinal rating form to rate their contributions to the submitted manuscript in 12 categories on a scale from 0 (none) to 4 (full), whereas 409 authors (87 manuscripts) received a binary rating form to tick the categories in which they made a contribution. RESULTS: The ordinal rating form identified twice as many authors (87.9%) as meeting the ICMJE criteria than the binary rating form (39.2%, P < .001). The group answering the ordinal rating form also had 5 times more manuscripts (71.6%) with all authors meeting the ICMJE criteria than the binary rating form group (15.5%, P < .001). The fraction of authors who reported contributions on each item on the binary rating form was similar to the fraction of authors who reported at least moderate participation to the same items on the ordinal rating form except "Final approval of the article." CONCLUSIONS: Ordinal scales for reporting authors' contributions to manuscripts were more sensitive than tick boxes for assessing the appropriateness of authorship. The exception is "Final approval of the article," which should be considered a dichotomous variable and may not be appropriate for the ICMJE definition of authorship.
| S-EPMC2518038 | biostudies-other
Project description:ObjectiveThe objective of this study was to determine whether, where and when manuscripts were published following rejection by the Journal of the Danish Medical Association, a general medical journal published in Danish. Similar previous studies have focused on specialty/subspecialty journals published in English.DesignManuscripts rejected during a 4-year period were searched for in PubMed and Embase in order to assess the percentage of manuscripts subsequently published in other journals. In addition, characteristics of both the published manuscripts and the journals in which they were evaluated.ResultsOf 198 rejected manuscripts, 21 (10.6%) were eventually published after a median of 685 days (range 209-1463). The majority of these were original research, published in English-language specialty/subspecialty journals. The median number of citations per article was 2-3 (IQR 0.5-9.5, depending on the database searched).Conclusions10.6% of the rejected manuscripts were eventually published in other journals, mainly English-language specialty journals. This proportion was considerably lower than that for other journals that have studied the fate of rejected manuscripts. Manuscript translation could be a barrier for resubmitting to English-language journals with larger readerships, thus hindering the dissemination of knowledge to the international community.
| S-EPMC3191426 | biostudies-literature
Project description:ObjectiveTo evaluate the consistency of causal statements in observational studies published in The BMJ.DesignReview of observational studies published in a general medical journal.Data sourceCohort and other longitudinal studies describing an exposure-outcome relationship published in The BMJ in 2018. We also had access to the submitted papers and reviewer reports.Main outcome measuresProportion of published research papers with 'inconsistent' use of causal language. Papers where language was consistently causal or non-causal were classified as 'consistently causal' or 'consistently not causal', respectively. For the 'inconsistent' papers, we then compared the published and submitted version.ResultsOf 151 published research papers, 60 described eligible studies. Of these 60, we classified the causal language used as 'consistently causal' (48%), 'inconsistent' (20%) and 'consistently not causal'(32%). Eleven out of 12 (92%) of the 'inconsistent' papers were already inconsistent on submission. The inconsistencies found in both submitted and published versions were mainly due to mismatches between objectives and conclusions. One section might be carefully phrased in terms of association while the other presented causal language. When identifying only an association, some authors jumped to recommending acting on the findings as if motivated by the evidence presented.ConclusionFurther guidance is necessary for authors on what constitutes a causal statement and how to justify or discuss assumptions involved. Based on screening these papers, we provide a list of expressions beyond the obvious 'cause' word which may inspire a useful more comprehensive compendium on causal language.
| S-EPMC8141434 | biostudies-literature
Project description:BackgroundPhysicians frequently use continuing medical education (CME) in journals. However, little is known of the evaluation of journal CME by readers and also user and participation characteristics. Deutsches Ärzteblatt, the journal of the German Medical Association, is distributed to every physician in Germany and regularly offers its readers CME articles. Therefore, it provides a unique opportunity to analyze a journal CME program directed at an entire population of physicians.ObjectiveThe aim is to show key sociodemographic characteristics of participants, frequency and temporal distributions of participations, and to analyze whether the articles are suitable for a general medical audience, how physicians rate the CME articles, how successful they were in answering simple multiple-choice questions, and to detect distinct clusters of participants.MethodsUsing obligatory online evaluation forms and multiple-choice questions, we analyzed all participations of the entire 142 CME articles published between September 2004 and February 2014. We compared demographic characteristics of participants with official figures on those characteristics as provided by the German Medical Association.ResultsA total of 128,398 physicians and therapists (male: 54.64%, 70,155/128,393; median age class 40 to 49 years) participated 2,339,802 times (mean 16,478, SD 6436 participations/article). Depending on the year, between 12.33% (44,064/357,252) and 16.15% (50,259/311,230) of all physicians in the country participated at least once. The CME program was disproportionally popular with physicians in private practice, and many participations took place in the early mornings and evenings (4544.53%, 1,041,931/2,339,802) as well as over the weekend (28.70%, 671,563/2,339,802). Participation by specialty (ranked in descending order) was internal medicine (18.25%, 23,434/128,392), general medicine (16.38%, 21,033/128,392), anesthesiology (10.00%, 12,840/128,392), and surgery (7.06%, 9059/128,392). Participants rated the CME articles as intelligible to a wider medical audience and filling clinically relevant knowledge gaps; 78.57% (1,838,358/2,339,781) of the sample gave the CME articles very good or good marks. Cluster analysis revealed three groups, one comprised of only women, with two-thirds working in private practice.ConclusionsThe CME article series of Deutsches Ärzteblatt is used on a regular basis by a considerable proportion of all physicians in Germany; its multidisciplinary articles are suitable to a broad spectrum of medical specialties. The program seems to be particularly attractive for physicians in private practice and those who want to participate from their homes and on weekends. Although many physicians emphasize that the articles address gaps in knowledge, it remains to be investigated how this impacts professional performance and patient outcomes.
| S-EPMC5394262 | biostudies-literature
Project description:To correct the incongruence of document types between the numerator and denominator in the traditional impact factor (IF), we make a corresponding adjustment to its formula and present five corrective IFs: IFTotal/Total, IFTotal/AREL, IFAR/AR, IFAREL/AR, and IFAREL/AREL. Based on a survey of researchers in the fields of ophthalmology and mathematics, we obtained the real impact ranking of sample journals in the minds of peer experts. The correlations between various IFs and questionnaire score were analyzed to verify their journal evaluation effects. The results show that it is scientific and reasonable to use five corrective IFs for journal evaluation for both ophthalmology and mathematics. For ophthalmology, the journal evaluation effects of the five corrective IFs are superior than those of traditional IF: the corrective effect of IFAR/AR is the best, IFAREL/AR is better than IFTotal/Total, followed by IFTotal/AREL, and IFAREL/AREL. For mathematics, the journal evaluation effect of traditional IF is superior than those of the five corrective IFs: the corrective effect of IFTotal/Total is best, IFAREL/AR is better than IFTotal/AREL and IFAREL/AREL, and the corrective effect of IFAR/AR is the worst. In conclusion, not all disciplinary journal IF need correction. The results in the current paper show that to correct the IF of ophthalmologic journals may be valuable, but it seems to be meaningless for mathematic journals.
| S-EPMC4792445 | biostudies-literature
Project description:OBJECTIVES:While documented plans for patient and public involvement (PPI) in research are required in many grant applications, little is known about how frequently PPI occurs in practice. Low levels of reported PPI may mask actual activity due to limited PPI reporting requirements. This research analysed the frequency and types of reported PPI in the presence and absence of a journal requirement to include this information. DESIGN AND SETTING:A before and after comparison of PPI reported in research papers published in The BMJ before and 1?year after the introduction of a journal policy requiring authors to report if and how they involved patients and the public within their papers. RESULTS:Between 1 June 2013 and 31 May 2014, The BMJ published 189 research papers and 1 (0.5%) reported PPI activity. From 1 June 2015 to 31 May 2016, following the introduction of the policy, The BMJ published 152 research papers of which 16 (11%) reported PPI activity. Patients contributed to grant applications in addition to designing studies through to coauthorship and participation in study dissemination. Patient contributors were often not fully acknowledged; 6 of 17 (35%) papers acknowledged their contributions and 2 (12%) included them as coauthors. CONCLUSIONS:Infrequent reporting of PPI activity does not appear to be purely due to a failure of documentation. Reporting of PPI activity increased after the introduction of The BMJ's policy, but activity both before and after was low and reporting was inconsistent in quality. Journals, funders and research institutions should collaborate to move us from the current situation where PPI is an optional extra to one where PPI is fully embedded in practice throughout the research process.
| S-EPMC5875637 | biostudies-literature
Project description:Data Access Committee EGAC00001001713
| EGAC00001001713 | EGA