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ICMJE authorship criteria. Answers to the question ‘How would you rate the clarity of the ICMJE criteria to evaluate authorship?’ (n = 415). Percentages might not add up to 100% because of rounding.
Source publication
Evolving standards of good publication practice (GPP) and a survey conducted in 2009 of authors, who were investigators and researchers not employed by the company prompted changes to GSK Vaccines' publication practices. We conducted a follow-up survey in 2012 to assess the company's revised practices and to evaluate understanding of GPP among inve...
Context in source publication
Context 1
... 2008 ICMJE recommendations stated that authorship should be based on: 1) substantial contributions to con- ception and design, acquisition of data or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. The ICMJE authorship criteria were regarded as 'clear' or 'very clear' to most participants, but 7.7% stated that the criteria were 'not clear' or 'not clear at all' (Figure 4). ...
Similar publications
Pharmaceutical medical writing has grown significantly in India in the last couple of decades. It includes preparing regulatory, safety, and publication documents as well as educational and communication material related to health and health-care products. Medical writing requires medical understanding, knowledge of drug development and the regulat...
Citations
... recommendations, including 3 publications identified in the literature review5,7,13 CURRENT MEDICAL RESEARCH AND OPINION 865 ...
Background:
Many biomedical journals follow the International Committee of Medical Journal Editors (ICMJE) recommendations and criteria for authorship. ICMJE criterion 1 provides the basis for selecting authors according to their substantial contributions to the work reported in the publication. Identifying substantial contributions and their application for author selection can be challenging, especially for multicenter studies with large numbers of investigators and contributors. Contributions are not frequently documented during study conduct and authorship decisions may lack transparency, objectivity, and context.
Methods:
The International Society for Medical Publication Professionals (ISMPP) Authorship Task Force surveyed members on authorship practices, reviewed the literature defining substantial contributions to ICMJE criterion 1, and assessed existing tools or algorithms for determining authorship in industry-sponsored research. Contributions were categorized under the four sub-categories of ICMJE criterion 1: study concept and design, acquisition of data, data analysis, and data interpretation.
Results:
Survey findings and literature review confirmed the need for clear and consistent interpretation, application, and documentation of ICMJE criterion 1 for transparent decisions about authorship. The Task Force reached consensus on definitions of substantial contributions to be considered when selecting authors of industry-sponsored research. The subsequent recommendations were grouped according to the sub-categories of ICMJE criterion 1. In addition, the Task Force developed recommendations regarding contributions that do not merit authorship designation.
Conclusions:
The Task Force recommendations for objective and consistent interpretation of ICMJE criterion 1 will facilitate an author selection process grounded in the core principles of substantial intellectual contribution to the work's conception or design, or to the acquisition, analysis, or interpretation of data. While these recommendations are focused on author selection practices for industry-sponsored research, they may be applicable to publications in other areas of scientific and biomedical research.
... Additionally, in a survey looking at attitudes to PMWS, academic and clinician respondents to an online survey were generally accepting of PMWS, particularly its influence on editing, journal styling and adherence to reporting guidelines, with 84% of respondents stating that they valued PMWS [40]. In this survey, 82.9% of respondents felt that it was acceptable to receive PMWS; in another survey, PMWS was seen as 'adding value to publication development' by almost 90% of participants [41]. Our systematic review appraising current research in this area helps to substantiate the positive attitude to PMWS that is held by clinical and academic professionals seeking to ensure the ethical, accurate and timely publication of clinical trials. ...
Background:
Many authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials.
Methods:
Using terms related to 'medical writer' and 'observational study', we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014-2018). We also hand-searched the journals Medical Writing and The Write Stuff (2014-2018) and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS.
Results:
Our searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed), publication in journals with an impact factor (one study), a higher quality of written English (one study), and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies).
Conclusions:
This systematic review of eight observational studies suggests that PMWS is positively associated with measures of overall quality of reporting of clinical trials and may improve the timeliness of publication.
... Many pharmaceutical companies actively support professional societies such as ISMPP, AMWA and DIA (formerly known as the Drug Information Association) and abide by GPP3. In fact, Eli Lilly 61 and GSK 62 have discussed their commitments to good publication practices and their processes to avoid ghostwriting and other authorship problems. These circumstances suggest that rather than a radical approach to the problem of ghostwriting, a better approach would be to concentrate instead on good practices. ...
Introduction: The systematic review of biomedical ghostwriting has proven challenging due to problems in consistency and in study design. Moreover, authorship guidelines established by the International Committee of Medical Journal Editors (ICMJE) may have inadvertently created opportunities to potentiate ghostwriting. Given continued interest in ghostwriting by the International Society of Medical Publication Professionals (ISMPP) and other organizations, we undertook an analysis of ghostwriting in the biomedical literature.
Methods: We searched PubMed (search terms: ghost writ*, ghostwrit*, ghost writer, ghostwriter, ghostwriting, and ghost writing). Results, including abstracts, were reviewed for relevance (relationship to ghostwriting in biomedical journals) to aid in removal of inapplicable work and duplicate publications. After review, we consolidated expert opinions for publication professionals.
Results: Overlap was poor across search terms; of 181 unique papers identified; most (112/181) were opinion pieces. An increasing number of papers are using the term “ghostwriting” to describe genetics as well as diverse phenomena of misattributed authorship, including “ghost authorship.” Eight primary studies and 1 systematic review of ghostwriting incidence were identified, reporting prevalence ranging from <1% to 91%, in varied settings using differing methods and definitions of ghostwriting. Suggestions for avoiding ghostwriting include early consensus building and better definitions of authorship among manuscript teams.
Discussion: The prevalence and definition of ghostwriting remain unclear. Increased transparency and auditable authorship practices that align with specific guidelines may aid in the avoidance of ghostwriting. In addition, MeSH or clearer indexing terms may be helpful to separate usages of ghostwriting in scientific settings (e.g., genetic research) versus biomedical publishing.
... Because of a lack of consensus on authorship criteria, ideally, the roles and responsibilities of individuals should be discussed before conducting research. A formalized author agreement at the initial publication stage ensures effective timely communication to researchers regarding authorship (Camby et al. 2014). ...
This study investigated authorship definitions listed on 1065 journal websites, representing seven social science disciplines. The results showed that 51.3% of the journals do not have an established authorship definition. Journals with high impact factors do not necessarily have an established authorship definition. Up to 81.1% of law journals lack authorship definitions, whereas the lowest proportion of journals having no authorship definitions was identified in the business domain. Authorship definitions were mostly accessible through hyperlinks embedded in the “instructions for authors” section of the journals’ websites. Only 3.8% of the journals directly listed authorship definitions in the instructions for authors section. A total of seven types of requirements were identified for authorship. The interdisciplinary influence of the authorship criteria developed by the International Committee of Medical Journal Editors (ICMJE) has expanded to the social sciences. The current version of the ICMJE authorship criteria was abided by 32.9% of the journals. Authorship definitions stated by journals primarily originated from those set by editorial associations and other professional associations. However, inconsistent authorship definitions were noted between journals published by the same publishers. Journal websites should provide clear, complete, and updated authorship criteria to efficiently communicate essential information to authors.
... Most authors who have worked with PMWs feel that professional medical writing support added value to their publication. [14] Several studies have shown PMWs actually enhance the publication. Manuscripts prepared with the help of PMWs have been shown to be associated with an improved completeness of reporting of results, more adherence to guidelines, [15][16][17] more acceptable written English as rated during peer review, [15,17] and rarer retractions due to misconduct. ...
Aim
The number of scientific papers published from India each year is low. We tried to determine how often Indian surgeons publish in biomedical journals, challenges preventing them from publishing more often, their awareness of the international guidelines that acknowledge professional medical writing as an ethical service, and their willingness to hire medical writers for their publications.
Materials and Methods
A convenience sample of 100 of the surgeons attending a national conference were explained about the survey and asked to complete a survey questionnaire. All results were expressed as absolute frequencies and percentages.
Results
Of the 81 who responded, 43 (53%) had never published. Only 31/81 (38%) had published in the last 5 years. The challenges preventing more frequent publication were reported to be the lack of support for carrying out statistical analyses (58%), lack of time (41%), lack of sufficient data (38%), and lack of support for literature search (37%). Twenty-two (27%) surgeons were aware that they could hire a professional medical writer (PMW), 26 (32%) knew that the International Committee of Medical Journal Editors allowed PMWs to contribute to articles published in the biomedical journals, 75 (93%) were interested in hiring medical writers or to consider it in the future. Only 6 (7.4%) showed no such interest.
Conclusion
There was poor awareness and great interest in hiring PMWs. It might be beneficial to increase the awareness of clinicians about the scientific expertise and communication skills of PMWs and how they can add value to biomedical publications.
... In particular, there is no injunction against the "academic frontloading" of author bylines for the purposes of credibility [14,15]. So ingrained and expected has academic frontloading become that many companies now view it as a necessity for maximizing the likelihood their work will be accepted by journals for publication [40,41]. ...
Background
The International Committee of Medical Journal Editors (ICMJE) Recommendations set ethical and editorial standards for article publication in most leading medical journals. Here, I examine the strengths and weaknesses of the Recommendations in the prevention of commercial bias in industry-financed journal literature, on three levels – scholarly discourse, article content, and article attribution.
Discussion
With respect to overall discourse, the most important measures in the ICMJE Recommendations are for enforcing clinical trial registration and controlling duplicate publication. With respect to article content, the ICMJE promotes stringent author accountability and adherence to established reporting standards. However, the ICMJE accepts the use of commercial editorial teams to produce manuscripts, which is a potential source of bias, and accepts private company ownership and analysis of clinical trial data. New ICMJE guidance on data sharing will address but not eliminate problems of commercial data access. With respect to attribution, the Recommendations oppose guest authorship and encourage clear documentation of author contributions. However, they exclude writers from coauthorship; provide no specific advice on the attribution of commercial literature, for instance with respect to company authorship, author sequence or prominent commercial labeling; and endorse the use of fine print and euphemism. The ICMJE requires detailed author interest disclosures, but overlooks the interests of non-authors and companies, and does not recommend that interests most salient to the publication are highlighted. Together, these weaknesses facilitate “advocacy”-based marketing, in which literature planned, financed and produced by companies is fronted by academics, enabling commercial messages to be presented to customers by their respected clinical peers rather than companies themselves.
Conclusions
The ICMJE Recommendations set important research and reporting standards, without which commercial bias would likely be a significantly greater problem than it is today. However, they also support practices of commercial data control, content development and attribution that run counter to science’s values of openness, objectivity and truthfulness. These weaknesses could be addressed with appropriate modifications to the Recommendations. The ICMJE should also disclose its own commercial interests and funding – not least because publishing organizations that finance it and pay the salaries of some member editors derive substantial revenues from industry.
Background
Study investigating the prevalence of citation inaccuracies occurring due to intentional misuse or failed quality control has been growing, but citation inaccuracies driven by inappropriate journal policies have not been specifically addressed. The objectives of this study were to determine the prevalence of journals’ policies requesting inconsistent citation formats between Ethiopian authors and non-Ethiopian authors for in-text citations and reference listings, and to evaluate consequences of inconsistent citation policy on publication practices and parties involved in publication.
Methods
We collected data on citation formats (author’s first, last, or full name) requested by 60 journals’ policies for citing Ethiopian authors and non-Ethiopian authors in the in-text and reference listing, and the number of references cited using each citation format type in 225 published articles published in 50 journals. We also conducted a survey of 18 Ethiopian scholars engaged in publication processes of Ethiopian journals to assess their experiences about the consequences of using inconsistent citation styles. We calculated frequencies and percentages to summarize data. We applied chi-square test and risk ratios, where appropriate, to examine the statistical significance of the prevalence of inconsistency between comparison groups and its effects on compliance with policy. We used thematic content analysis analyze the survey data.
Results
We found 19(32%) and 18(30%) citation inconsistencies between Ethiopian and non-Ethiopian authors requested by policies for in-text citation and reference listing, respectively. The corresponding inconsistencies in the published articles were 36% and 46%, respectively. In contrast, we did not find any such inconsistency for non-Ethiopian authors. Journals with inconsistent citation policies had 1.5–2.1 times risk of experiencing incompliance with policies for Ethiopian authors in the published articles than journals with consistent citation policies. Survey participants indicated that inconsistent citation formats requested and used for Ethipian authors can lead to loss of credit to cited authors and breaching scientific ethics.
Conclusions
Our study reveals a concerning inconsistency in citation styles within Ethiopian journals, sometimes deviating from established international standards. This is, to our knowledge, the first study on policy-driven citation inaccuracies that can inform national and international publishers and editors to review and amend their citation policies.
Objectives Authors may choose to work with professional medical writers when writing up their research for publication. We examined the relationship between medical writing support and the quality and timeliness of reporting of the results of randomised controlled trials (RCTs).
Design Cross-sectional study.
Study sample Primary reports of RCTs published in BioMed Central journals from 2000 to 16 July 2014, subdivided into those with medical writing support (n=110) and those without medical writing support (n=123).
Main outcome measures Proportion of items that were completely reported from a predefined subset of the Consolidated Standards of Reporting Trials (CONSORT) checklist (12 items known to be commonly poorly reported), overall acceptance time (from manuscript submission to editorial acceptance) and quality of written English as assessed by peer reviewers. The effect of funding source and publication year was examined.
Results The number of articles that completely reported at least 50% of the CONSORT items assessed was higher for those with declared medical writing support (39.1% (43/110 articles); 95% CI 29.9% to 48.9%) than for those without (21.1% (26/123 articles); 95% CI 14.3% to 29.4%). Articles with declared medical writing support were more likely than articles without such support to have acceptable written English (81.1% (43/53 articles); 95% CI 67.6% to 90.1% vs 47.9% (23/48 articles); 95% CI 33.5% to 62.7%). The median time of overall acceptance was longer for articles with declared medical writing support than for those without (167 days (IQR 114.5–231 days) vs 136 days (IQR 77–193 days)).
Conclusions In this sample of open-access journals, declared professional medical writing support was associated with more complete reporting of clinical trial results and higher quality of written English. Medical writing support may play an important role in raising the quality of clinical trial reporting.
To meet ethical and scientific obligations, authors should submit timely, high-quality manuscripts. Authors, however, can encounter ethical (eg, authorship designation) and practical (eg, time and resource limitations) challenges during manuscript preparation. Could professional medical writers-not ghostwriters-help authors address these challenges? This essay summarizes evidence countering three myths that may have hindered authors from considering the use of professional medical writers. Authors with sufficient time, writing expertise, and reporting guideline knowledge may meet their obligations without writing assistance. Unfortunately, not all authors are in this position. Decisions about writing support should be based on evidence, not myths.
