Unlike original research articles, review articles tend to be solicited submissions, sometimes planned years in advance. Authors may be tempted to consciously or unconsciously mask or understate some troublesome results, such as nonstatistically significant outcomes or statistically significant harm. It provides data on the prevalence of some forms of spin in specific fields and the possible effects of some types of spin on readers’ interpretation and research dissemination. Furthermore, interpretation of RCTs based solely on press releases or media coverage could distort the interpretation of research findings in a way that favors the experimental treatment (58). In the case of the largest journals, there are paid staff assisting in the editing. Some of the smallest, most specialized journals are prepared in-house, by an academic department, and published only online – such form of publication has sometimes been in the blog format though some, like the open access journal Internet Archaeology, use the medium to embed searchable datasets, 3D models, and interactive mapping. FDA, EMEA, DCGI etc. We do not capture any email address. There is a well-known adage "Publish or Perish". Regulatory writers produce a wide variety of clinical documents throughout the life‑cycle of a (potential) treatment, starting with describing and reporting data from clinical trials, through to preparing regulatory submission documents. Three categories of techniques have developed to assess journal quality and create journal rankings:[17], Many academic journals are subsidized by universities or professional organizations, and do not exist to make a profit. An RCT evaluated the impact of spin found in abstracts of reports of cancer RCTs on researchers’ interpretation (57). They frequently come across terms like medical writing, pharmacovigilance, regulatory affairs, business development, quality assurance, etc but being new to this industry they are not able to make out what lies ahead of them and what is exactly meant by these terms and what job profiles they comprise of. Without a written record of the findings and observations of researchers, no proof exists that any research was conducted by them, and valuable information obtained after a lot of effort may be lost. They are usually peer-reviewed or refereed. It could consist of changing objectives, reporting post hoc hypotheses as if they were prespecified, switching outcomes and analysis, or masking protocol deviations. Finally, authors could claim adherence to quality standards such as reporting guidelines (e.g., the CONSORT Statements), when in reality, the adherence of their reports to these standards is far from perfect. Normally, medical writing in the pharmaceutical industry can be sub divided into two broad categories: It is almost impossible to determine whether spin is the consequence of a lack of understanding of methodologic principles, a parroting of common practices, a form of unconscious behavior, or an actual willingness to mislead the reader. The length and depth of research book reviews varies much from journal to journal, as does the extent of textbook and trade book review. Publication metrics, such as the number of publications, number of citations, journal impact factor, and h-index are used to measure academic productivity and scientists’ influence (64). Furthermore, the scope of this study is limited to the occurrence of this phenomenon exclusively within the field of biomedicine. To our knowledge, no systematic assessment of spin in systematic reviews and meta-analyses has been reported. Empirical evidence for selective reporting of outcomes in randomized trials: Comparison of protocols to published articles, Comparison of registered and published primary outcomes in randomized controlled trials, Evidence for the selective reporting of analyses and discrepancies in clinical trials: A systematic review of cohort studies of clinical trials, Evolution of reporting P values in the biomedical literature, 1990-2015, The extent and consequences of p-hacking in science, Randomized trials stopped early for benefit: A systematic review, Multiplicity in randomised trials II: Subgroup and interim analyses, Statistical learning and selective inference, Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents, Dissemination of 2014 dual antiplatelet therapy (DAPT) trial results: A systematic review of scholarly and media attention over 7 months, Converting an odds ratio to a range of plausible relative risks for better communication of research findings, Data visualization in the neurosciences: Overcoming the curse of dimensionality, The prevalence of inappropriate image duplication in biomedical research publications, What’s in a picture? D.B.A. In this study, spin was defined as “specific reporting strategies, whatever their motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to distract the reader from statistically nonsignificant results” (4). The literature contains evidence of researchers favoring statistically significant results. Publication in peer-reviewed journals is an essential step in the scientific process. Please submit a. if you would like to speak to a member of our team who can support your trial. [24] Commercial publishers are experimenting with open access models, but are trying to protect their subscription revenues. If you are involved in local organizations, being able to research your needs ahead of time is a great way to ensure you are prepared for meetings, discussions, and more. Scientific writing has a long tradition and since the first half of the 20th century, the IMRAD structure has become the dominant structure for scientific reports reporting original research (most journal articles, congress papers, bachelor and master theses, etc.). They were also more likely to detect errors in and award a low score to the methods of the negative version of the same manuscript, even though the Methods sections in both versions were identical (65). If the treatment is approved by a regulatory authority, regulatory writers also produce post approval reports on the use of the treatment in patients. [19], Journal editors tend to have other professional responsibilities, most often as teaching professors. Journal hosting websites like Project MUSE, JSTOR, Pubmed, Ingenta Web of Science, and Informaworld also provide journal lists. The importance of literature review to scientific research can be condensed into its analytical feature. and P.R. Launch of James Lind Institute’s Clinical Research Blog!!! If you look up in Wikipedia, you will get the following definition of medical writing: We need to provide specific training and tools to peer-reviewers and editors to facilitate the detection of spin. The journal's first issue was published on 5 January 1665. Obviously, this choice can be influenced by the message the researcher wants to convey. There are other quantitative measures of prestige, such as the overall number of citations, how quickly articles are cited, and the average "half-life" of articles. ing in scientific writing. Currently you have JavaScript disabled. Clinical Research Coordinator / CRC Course. For example, in the DAPT study, the authors proposed a post hoc explanation for the increased rate of death in the experimental group based on a post hoc analysis to mitigate the role of prolonged treatment on this increased risk of mortality (25). [28] The European Journal of Personality defines this format: "In a registered report, authors create a study proposal that includes theoretical and empirical background, research questions/hypotheses, and pilot data (if available). Misinterpretation refers to an interpretation of the results that is not consistent with the actual results of the study. Specific classifications of spin have been developed for different study designs and contexts [randomized controlled trials with nonstatistically significant results (4), observational studies evaluating an intervention (10), diagnostic accuracy studies (8), systematic reviews (9)]. Misreporting of results is defined as an incomplete or inadequate reporting of results in a way that could mislead the reader. On the other hand, some journals are produced by commercial publishers who do make a profit by charging subscriptions to individuals and libraries. NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. The medical writer typically is not one of the scientists or doctors who performed the research”. To improve transparency, authors are encouraged to report their studies according to reporting guidelines, such as the ARRIVE (68) or CONSORT 2010 (69) guidelines. For example, the reporting and interpretation of the risk of all-cause mortality in the DAPT (dual antiplatelet therapy) study randomizing 9,961 patients to continue DAPT beyond 1 y after stent placement or receive a placebo for 30 mo, raised some concerns (24, 25). 3. Some journals are published in series, each covering a complete subject field year, or covering specific fields through several years. This type of spin will alter the readers’ critical appraisal of the study and could impact the interpretation of evidence synthesis. Quanticate offers a wide range of Medical Writing services including clinical and regulatory writing in support of any or all stages of the pharmaceutical development life-cycle. In the field of basic science, use of image-processing programs, routinely used to improve the quality of images, can actually shape the impression that results will make on readers. For example, some studies report “double-blind” methods, but the blinding is not credible (11, 12), or report an intent-to-treat analysis, but some patients are excluded from the analysis (13, 14). Spin has been defined as a specific intentional or unintentional reporting that fails to faithfully reflect the nature and range of findings and that could affect the impression the results produce in readers. To our knowledge, there are no data on the prevalence of researchers using spin, but we suspect that it is a quite common practice among researchers (56). Our Medical Writers deliver accurate, timely and cost effective documents to the highest of ethical and scientific standards. They have estimated that about 20% of the accepted papers contained at least one figure that did not comply with accepted practices (29, 30). Other databases providing detailed information about journals are the Modern Language Association Directory of Periodicals and Genamics JournalSeek. In the Discussion section of a paper, authors may take a strong position that relies more on their opinion than on the study results. Undesirable consequences include wasted time and resources on misdirected research and ill-founded actions by health providers misled by partial results. Educational medical writing, as the name suggests deals with writing educational content for a particular audience. [25], The much lower entry cost of on-line publishing has also raised concerns of an increase in publication of "junk" journals with lower publishing standards. There is also a website that features a collection of the rhetoric used for nonstatistically significant results (https://mchankins.wordpress.com/2013/04/21/still-not-significant-2). Cherry-picking can be particularly problematic in this era of massive observational data (23). Your email address will not be published. Academic journals serve as permanent and transparent forums for the presentation, scrutiny, and discussion of research. Furthermore, some peer-reviewers are actually requesting the addition of spin, and one study found that they failed to even identify spin in the abstract’s conclusion in 76% of the reports (78). The purpose of an academic journal, according to Henry Oldenburg (the first editor of Philosophical Transactions of the Royal Society), is to give researchers a venue to "impart their knowledge to one another, and contribute what they can to the Grand design of improving natural knowledge, and perfecting all Philosophical Arts, and Sciences."[2]. Rhetoric, defined as language designed to have a persuasive or impressive effect, can be used by authors to interest and convince the readers (5). is a guest editor invited by the Editorial Board. [3] Peer review was introduced as an attempt to increase the quality and pertinence of submissions. The book is a valuable guide for undertaking medical research and scientific publishing for medics and also for para medics as the paramedics are also very important for holistic health care. We need to raise awareness among the general scientific audience about the issues related to the presence of spin in published reports. Flowery, ambiguous, wordy, and redundant language run counter to the purpose of the writing. Doctors, people who conducted the research, statisticians, regulatory professionals and other subject matter experts work hand in hand with medical writers to produce documents that are of highest quality and meet all the applicable regulatory requirements… Medical writers ensure that the documents that they write comply with all regulations and guidelines in terms of content, format and structure. Regular monitoring of the content of research publications, which has been successfully implemented for the detection of selective reporting of outcomes, could be an effective method to change the practices of researchers and editors alike (80). The first fully peer-reviewed journal was Medical Essays and Observations (1733). This paper results from the Arthur M. Sackler Colloquium of the National Academy of Sciences, “Reproducibility of Research: Issues and Proposed Remedies,” held March 8–10, 2017, at the National Academy of Sciences in Washington, DC. Online ISSN 1091-6490. hbspt.cta._relativeUrls=true;hbspt.cta.load(22135, '703f5bae-5a1a-4d71-a6a8-1df9935930bc', {}); Quanticate offers a wide range of Medical Writing services including clinical and regulatory writing in support of any or all stages of the pharmaceutical development life-cycle. Should people at low risk of cardiovascular disease take a statin? "[14] Though it did not prevent ESF and some national organizations from proposing journal rankings, it largely prevented their use as evaluation tools.[15]. This was rapidly followed by an uptick in the use of this treatment by patients with ALS. However, publication is not simply the reporting of facts arising from a straightforward analysis thereof. Clarivate Analytics' Journal Citation Reports, which among other features, computes an impact factor for academic journals, draws data for computation from the Science Citation Index Expanded (for natural science journals), and from the Social Sciences Citation Index (for social science journals). Such tests would arm the public with real-time knowledge of infection status and boost reopening plans. Please submit a request for information (RFI) if you would like to speak to a member of our team who can support your trial. It was aimed at people of letters, and had four main objectives:[4], Soon after, the Royal Society established Philosophical Transactions of the Royal Society in March 1665, and the Académie des Sciences established the Mémoires de l'Académie des Sciences in 1666, which more strongly focused on scientific communications. For example, a study entitled “Lithium delays progression of amyotrophic lateral sclerosis” (ALS), involving mice and tested in a small sample of patients, concluded that “these results offer a promising perspective for the treatment of human patients affected by ALS” (60). The concept of spin can also be applied to scientific communications. “Medical writing is the activity of producing scientific documentation by a specialized writer. In some disciplines such as knowledge management/intellectual capital, the lack of a well-established journal ranking system is perceived by academics as "a major obstacle on the way to tenure, promotion and achievement recognition". We also searched Google Scholar for all articles citing key articles in the field of biomedicine (4⇓–6). [27], Some academic journals use the registered report format, which aims to counteract issues such as data dredging and hypothesizing after the results are known. The term “randomized controlled trial” (RCT) can also be used erroneously. Some of these strategies are actually taught to early career researchers. Medical writing is the practice of writing scientific documents by writers in the field of medicine. Randomized trials published in some Chinese journals: How many are randomized? Limitations of the odds ratio in gauging the performance of a diagnostic, prognostic, or screening marker, HARKing: Hypothesizing after the results are known, How scientists fool themselves—And how they can stop, Overinterpretation of clinical applicability in molecular diagnostic research, Use of adjectives in abstracts when reporting results of randomized, controlled trials from industry and academia, Use of positive and negative words in scientific PubMed abstracts between 1974 and 2014: Retrospective analysis, Why do we think we know what we know? Finally, authors can be tempted to extrapolate their results beyond the data to a larger population, setting, or intervention, and even provide recommendations for clinical practice (39). Humanities and social science academic journals are usually subsidized by universities or professional organization. Scientific writing is a technical form of writing that is designed to communicate scientific information to other scientists. [7], In 1733, Medical Essays and Observations was established by the Medical Society of Edinburgh as the first fully peer-reviewed journal. However, publication is not simply the reporting of facts arising from a straightforward and objective analysis of those facts (3). Click here for instructions on how to enable JavaScript in your browser. The importance of preparing high-quality regulatory documents is often under estimated. This type of spin particularly involves selective reporting of statistically significant results, ignoring results that contradict or counterbalance the initial hypothesis, and misleading display of results through choice of metrics and figures. Inadequate interpretation of the P value as a measure of the strength of a relationship occurs also in the field of genetics. Overall, they did not regard these practices as malpractice (71). [20], The cost and value proposition of subscription to academic journals is being continuously re-assessed by institutions worldwide. Individual articles are subject-indexed in databases such as Google Scholar. For this purpose, spin doctors could attempt to bury potentially negative information or selectively “cherry-pick” specific information or quotes. A Delphi consensus survey of expert opinion identified some types of spin (overinterpretation of significant findings in small trials, elective reporting based on P values, and selective reporting of outcomes in the abstract) found among the questionable research practices most likely to occur (47). The demand for medical or scientific writers is growing steadily over the years in the healthcare industry. A medical writer does not work in isolation, rather works in a team environment. When writing a manuscript reporting the results of an experiment, investigators usually have broad latitude in the choice, representation, and interpretation of the data. However, Michael Mabe warns that the estimates will vary depending on the definition of what exactly counts as a scholarly publication, but that the growth rate has been "remarkably consistent over time", with an average rates of 3.46% per year from 1800 to 2003. Regulatory medical writing, as the name suggests, deals in writing documents related to regulatory authorities e.g. The term academic journal applies to scholarly publications in all fields; this article discusses the aspects common to all academic field journals. Some reviews are enumerative, listing all significant articles in a given subject; others are selective, including only what they think worthwhile. A retrospective analysis of positive and negative words in abstracts indexed in PubMed from 1974 to 2014 showed an increase of 880% in positive words used over the four decades (from 2% in 1974–1980 to 17.5% in 2014) (42). These “Medical writing is the activity of producing scientific documentation by a specialized writer. Our Medical Writers deliver accurate, timely and cost effective documents to the highest of ethical and scientific standards. Rudyard Kipling wrote that “words are the most powerful drug used by mankind”, reminding us that writing has the power to change behaviors and attitudes. A sample was selected of 30 reports of RCTs with a nonstatistically significant primary outcome that also had some kind of spin in the abstract’s conclusions. A medical writer does not necessarily have to be a medical person by qualification however some degree of familiarity with medical terms is preferable. After reading the abstract with spin, readers were more likely to believe the treatment would be beneficial to patients [mean difference 0.71 95% (95% CI 0.07–1.35), P = 0.030]. Some sites evaluate journals, providing information such as how long a journal takes to review articles and what types of articles it publishes. There are several ways to spin a report (4, 6, 8⇓–10). In the Anglo-American humanities, there is no tradition (as there is in the sciences) of giving impact-factors that could be used in establishing a journal's prestige. Writing of these documents has to follow important regulations and guidelines as applicable. William Nordhaus explains the economic consequences of Greenland ice sheet melt. Educational medical writing in general consists of writing literature about newly launched products, making presentations for various conferences and meetings etc. A study of 288 articles in the field of neuroscience, displaying a total of 1,451 figures, showed that important information was missing from 3D graphs; particularly, uncertainty of reported effects was reported in only 20% of 3D graphics, a practice bound to mislead the reader (27). Some researchers argue that the use of linguistic spin and rhetoric is “an essential element of science communication” and that “scientific papers stripped of spin will be science without its buzz” (70). Publishers send books to book review editors in the hope that their books will be reviewed. Even accepted articles are often subjected to further (sometimes considerable) editing by journal editorial staff before they appear in print. For example, a break in the y axis, failure to represent the statistical uncertainty with the confidence interval (CI), scaling the figure on the results, and extending survival curves to the right without representing the statistical uncertainty can create the false impression that a treatment is beneficial. As an integral part of the clinical research process, regulatory writers can act as a pool of knowledge at every step, from protocol development to the drug submission process. Of James Lind Institute ’ s listening our medical writers are in,! Typically remain anonymous misconduct, although such malpractice is probably very rare projection of results is defined as attempt. 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