Writing a Clinical Manuscript in English That Has Impact


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Written by Edanz Senior Editors Amanda Hindle and Jeffrey Robens, and Edanz Science Director Daniel McGowan. The paper discusses essential elements that will help non-native English speakers publish clinical manuscripts.
English version produced with permission from the Japanese Journal of Breast Cancer: http://www.shinoharashinsha.co.jp/nyugan/ActiBook/28_6/index.html

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Writing a Clinical Manuscript in English That Has Impact

  1. 1. This article was originally published in Japanese in Japanese Journal of Breast Cancer 2013; 28(6): 575–580. The English version of this article has been reproduced with permission from the Japanese Journal of Breast Cancer. WRITING A CLINICAL MANUSCRIPT IN ENGLISH THAT HAS IMPACT Amanda Hindle, BSc*†, Jeffrey Robens, PhD*, Daniel McGowan, PhD* Edanz Group Japan, Edanz Bldg. 2-12-13 Minato, Chuo-ku, Fukuoka 810-0075, Japan *All authors contributed equally to this article † Corresponding author: Amanda Hindle Edanz Group Japan, Edanz Bldg. 2-12-13 Minato, Chuo-ku, Fukuoka 810-0075, Japan Tel: +81 92 715 7208 Fax: +81 92 715 7204 Email: ahindle@edanzgroup.com SUMMARY Writing a clinical manuscript that has impact and relevance to your intended audience is crucial for publication success. Furthermore, publishing in English will increase the visibility of your research worldwide. However, effectively communicating the clinical relevance of your research in English is particularly challenging if it is not your native language. In this article, we focus on the essentials of what makes a high-quality clinical manuscript. Understanding these essentials will assist you in writing a well-structured, ethically sound, and highly readable manuscript that clearly expresses the clinical relevance of your findings. Using these approaches, you can be confident that your work adheres to the standards of international English language journals, and improve your chances of publication success. Keywords: clinical relevance, manuscript structure, medical writing
  2. 2. This article was originally published in Japanese in Japanese Journal of Breast Cancer 2013; 28(6): 575–580. The English version of this article has been reproduced with permission from the Japanese Journal of Breast Cancer. INTRODUCTION As a clinician, you may have treated a patient with a unique presentation, or you may have been involved in a clinical trial to investigate a novel intervention. Either way, sharing your findings with the medical community is an important way to improve clinical practice both regionally and internationally. The most effective way to reach the greatest number of clinicians is through publishing your findings in a peer-reviewed journal. One important choice you will need to make as an author is in what language to publish your findings. Publishing in your native language is one option; however, the best way to reach international clinicians in your field is to publish in English. Even if your findings have a regional focus, they are likely to have broad relevance to clinicians worldwide, as observations about the effects of a drug tested in Japan will be of direct interest to clinicians in other countries treating patients of Japanese ethnicity. Before writing, however, it is important to understand what journal editors are looking for when evaluating manuscripts. Because the goal of the journal editor is to increase the status of their journal in their field, they are interested in high-quality research. This is research that is original and novel and has important clinical relevance. They are looking for manuscripts that will be interesting for their readers and will be highly cited. They also want manuscripts that are written in clear and concise English. This does not simply mean good spelling and grammar, but rather manuscripts that clearly and effectively communicate the ideas and findings of the authors. In this paper, we expand on each of these topics to ensure you have all the essentials to prepare a clinical manuscript for publication in an English journal. ELEMENTS OF A GOOD CLINICAL MANUSCRIPT Clinical relevance Although there are journals that will accept articles simply based on well-executed research, other journals (especially those with a higher impact factor) will place a greater emphasis on the significance of the findings presented. But what does this “significance” actually encompass? Broadly, it is an indication of the importance of an article’s findings, which for the purposes of this review can be divided into three components: novelty, relevance, and appeal. It is essential to perform and honest and objective evaluation of your findings and to clearly communicate the novelty, relevance and appeal of your findings in the manuscript
  3. 3. This article was originally published in Japanese in Japanese Journal of Breast Cancer 2013; 28(6): 575–580. The English version of this article has been reproduced with permission from the Japanese Journal of Breast Cancer. text. Whilst one should not overuse terms like “for the first time” and “never before”, if your findings represent a conceptual advance in the field, you should emphasize the novelty of your findings to ensure readers are aware of this advance. However, if your findings represent a smaller advance in the field, you should focus more on how they will help improve current practice or inform the next steps in a research path. With respect to the relevance of your findings, you should consider whether they have implications for only a restricted geographical location or ethnic group, or whether there are potential implications for broader regions and populations. The broader the relevance of the findings, the greater the significance and impact worldwide. However, regardless of whether you publish in an international or regional journal, you should still publish in English to make your findings available to an international audience. It is important to remember that journal editors want to publish research that will be widely read and achieve a high number of citations. In an age of blogs, newsfeeds, and social networks, research that has a high level of popular appeal will likely achieve greater numbers of citations simply because more people will be made aware of the publication. Therefore, it is important to identify important research questions and emphasize the clinical applications of your research in your manuscript. Figure 1. Novelty, relevance and appeal in a good-quality oncology manuscript. The selected article [1] was among the journal’s “most viewed” in the month of publication. The reason for this, we believe, is that it contained all of the components of significance discussed herein (novelty, relevance and appeal) and these were clearly pointed out in the manuscript text.
  4. 4. This article was originally published in Japanese in Japanese Journal of Breast Cancer 2013; 28(6): 575–580. The English version of this article has been reproduced with permission from the Japanese Journal of Breast Cancer. While all three of these components of significance are clearly inter-related, each should be considered independently and emphasized in the manuscript to ensure that the significance of the article is clearly communicated. Figure 1 illustrates how this was done in a highly viewed article in a top-tier journal [1]. As well as containing findings that were clearly of great significance, the article outlined in Figure 1 also contains many of the important qualities that editors and readers look for in a medical oncology paper (Table 1). Indeed, regardless of the significance of the findings being presented and the journal being submitted to, authors of clinical research articles should aim to include all of the items listed in the table somewhere within their manuscript. In putting these elements together, a really good clinical manuscript contains information that influences clinical practice based on the most appropriate methods for the research question [2,3]. Table 1. Qualities of a good medical oncology paper Feature Example Accurate, objective reporting of methodology and results Enough information in methods to replicate; clear rationale; calculation of statistical power; limited interpretation of results in the Results section Concise illustrations and descriptions Figures showing key outcomes such as progression-free survival, overall survival and response rates; table listing adverse events Insightful and objective discussion Findings put in context of what is known; limited speculation, but statements are supported by evidence Full disclosure and registered trial Registry and registration number provided Full ethical compliance Details of institutional review board approval and informed consent provided Multiple, complementary, well-controlled experiments Combination of imaging, pathology and clinical work-up to tell a more convincing story Mechanistic findings to complement Cellular/biochemical-level findings to support clinical findings descriptions of clinical effects Clear description of clinical implications and how the findings might influence clinical practice What the results mean for patients and how clinical decisions might be improved on the basis of the presented findings
  5. 5. This article was originally published in Japanese in Japanese Journal of Breast Cancer 2013; 28(6): 575–580. The English version of this article has been reproduced with permission from the Japanese Journal of Breast Cancer. Clear writing Good science alone, however, is not enough to make a good manuscript. Effective writing is also needed to clearly communicate your ideas. If your ideas are not expressed clearly, even experts in the field may not understand what you did and why, limiting the clinical applicability of your findings. The key element you are trying to achieve with your writing style is good readability. This refers to the logical presentation of ideas and organization of material in places where readers expect to find it. It is crucial to remember that you are writing for the reader; the purpose of a manuscript is to share your work with others, not simply create a personal record of your results. Without realizing it, readers expect certain information to appear in certain places within a text. By considering these reader expectations in your writing, you can enhance the readability of your manuscript as readers can easily find the information they are looking for. Gopen and Swan proposed a methodological approach for constructing the ideas within a manuscript that would provide the reader with the important clues and cues to properly interpret an author’s meaning [4]. The key concepts they outlined included logically connecting ideas together with the use of topic sentences and reference back to previous ideas, emphasizing shorter sentences, and keeping subjects and verbs close together. They also encouraged good use of what are known as the topic position (beginning) and stress position (end) of a sentence to introduce the reader to the next concept and emphasize the important message, respectively. However, a well-constructed paragraph can still have poor readability if you do not also consider the language being used. Many researchers think that complicated language makes their writing appear more sophisticated. Unfortunately, use of unnecessarily long words and technical jargon actually make your work harder to understand. Editors are not impressed with complicated language; they are concerned primarily with the science behind it. It is also important to consider that many of your readers might not be native English speakers. Therefore, to maximize the accessibility of your findings and ideas, simple, unambiguous language should be used. Manuscript structure and flow Equally important to the clear communication of your ideas and results in terms of language, is the logical presentation of those ideas. The sections and order of a research
  6. 6. This article was originally published in Japanese in Japanese Journal of Breast Cancer 2013; 28(6): 575–580. The English version of this article has been reproduced with permission from the Japanese Journal of Breast Cancer. paper allow your readers to logically move from an overview of your research (Abstract), to why the study was conducted (Introduction), to how your results were obtained (Methods), to the significance of your findings (Results), and finally, to the implications your results have for the field (Discussion). Figure 2 illustrates this basic structure of a manuscript and how these sections relate to one another. Figure 2. Manuscript structure and flow. Logically presenting your findings and showing how they fit into the context of current knowledge is essential to a highly readable and well-organized manuscript. This figure illustrates how to arrange your ideas from a broad introduction (upper funnel) down to the specifics of your objectives and methods (narrow center), and finally back to the broader clinical relevance of your findings (bottom triangle), producing an hourglass-type shape. To the left, the corresponding sections of the manuscript are noted. Arrows indicate the important areas where ideas should be linked back to each other to create flow and strengthen the logical presentation of your work. The first impression that the Abstract provides is part of what makes it the most important section of your manuscript. Readers are also busy with their own work, so they will use the Abstract to determine which articles to read. Thus, a well-written and well-communicated Abstract has the potential to increase the number of people who read your article, leading to more citations, and ultimately, your research having a greater impact in the field. Although Abstract structure can vary based on the journal guidelines, they generally follow a similar format. Abstracts distill the most important parts of each section of the manuscript into one concise summary, so you can consider it to be a mini version of your manuscript. However, it is important to emphasize the clinical impact of your study, as that is often what will convince a reader that your research is relevant to them.
  7. 7. This article was originally published in Japanese in Japanese Journal of Breast Cancer 2013; 28(6): 575–580. The English version of this article has been reproduced with permission from the Japanese Journal of Breast Cancer. As the start of your primary manuscript, the Introduction section should concisely present the topic being investigated and the related problem clinicians are currently facing (Figure 2). Essentially, the Introduction puts your study into context. For example, if your research evaluated the efficacy of a treatment for triple-negative breast cancer (TNBC) liver metastasis, you would briefly introduce TNBC, incidences of metastasis, and the efficacy of current treatments. Next, you should highlight an important problem in the field; in this example, the limited treatment options for TNBC that has metastasized to the liver. This will then lead to your objectives—how does your study aim to address this problem? A properly structured Introduction will make it clear to the reader why your study needed to be done and why your study is clinically relevant. During peer review, one of the most critically evaluated sections of your manuscript is the Methods section. Therefore, it is important to objectively and accurately describe patient information and enrollment details, your study design (including controls), interventions used, and statistical analyses applied. Poor descriptions of these elements will usually lead to the reviewers returning the manuscript to you for clarification. Presenting your results in a logical manner is essential. If you conducted a randomized clinical trial (RCT), including a flowchart that illustrates the flow of patients through the trial, such as that provided by CONSORT (Consolidated Standards of Reporting Trials) [5], is helpful in making an informed analysis of the course of treatment. Next, the key findings of your study should be objectively described—treatment outcomes, efficacy, and adverse events. You should emphasize the significance of your findings and include relevant data (e.g., p-values, confidence intervals, and odds ratios) to support these findings. Finally, and one of the biggest challenges for many authors, is writing a good Discussion. Readers will often look ahead to the Discussion to obtain a summary of the findings, their relevance for the field, and their clinical implications. The Discussion section should be both concise and objective. After stating your major conclusion, you should then support it by summarizing the key findings from your study and interpreting them in the context of previously published work. This demonstrates the relevance of your findings to the current state of knowledge. Your Discussion and ultimate conclusion should be based only on the evidence presented, and address any alternative explanations of the data if they exist. It is important to not be too speculative in your interpretations and to focus on
  8. 8. This article was originally published in Japanese in Japanese Journal of Breast Cancer 2013; 28(6): 575–580. The English version of this article has been reproduced with permission from the Japanese Journal of Breast Cancer. the outcome based on your initial objectives. Finally, include any clinical implications and future directions for study suggested by your research. ETHICAL CONSIDERATIONS In addition to the structural components of a manuscript, adherence to research and publication ethics is crucial to your publication success. To ensure that you are conducting your research and writing your manuscripts in accordance with the most up-to-date ethical guidelines, there are three primary resources worth keeping on hand. The International Committee of Medical Journal Editors (ICMJE) produces the industry-standard guidelines for publication ethics [6]. The Good Publication Practices (or GPP2) document [7], which provides recommendations for authors working on company-sponsored research, should also be consulted. Finally, the Committee on Publication Ethics (or COPE) forum [8], which provides resources and case examples for ethical publication issues, rounds out a solid set of resources for use when preparing studies for publication. CONSORT and STROBE Many journals will also ask clinical authors to submit a checklist from CONSORT [5] or STROBE [9] upon submission of their manuscript. CONSORT is used for RCTs, while STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) is used for observational studies. These checklists cover the essential points needed by journal editors and readers to properly assess your results and ethical compliance throughout the course of the study. Even if a journal does not require that a CONSORT or STROBE checklist is submitted, they can be a highly useful resource in manuscript preparation and to anticipate questions that reviewers might ask. How patients were chosen to participate in the study and what consideration was given to participants that might be particularly susceptible to harm are issues of concern no matter what the type of study, so working in accordance with these checklists will demonstrate that you have followed good clinical practice for working with human subjects. Clinical trial registration For authors involved in clinical trials, trial registration is required as a condition of publication for many journals. The ICMJE defines a clinical trial as “any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome”, which is supported by the World Health Organization as the world standard
  9. 9. This article was originally published in Japanese in Japanese Journal of Breast Cancer 2013; 28(6): 575–580. The English version of this article has been reproduced with permission from the Japanese Journal of Breast Cancer. [10,11]. Trial registration has become the standard practice in clinical research as it allows open sharing of potentially critical data with researchers, clinicians, and patients, and helps reduce the issue of selective reporting. The implementation of registration requirements means that all Phase II and III trials that started enrolling patients on or after July 1, 2005, and all Phase I studies started on or after July 1, 2008, should be prospectively registered before publication [10,12]. Clinical trial registration needs to be done in a public database, of which popular options include Clinicaltrials.gov (http://clinicaltrials.gov/), JAPIC (http://www.japic.or.jp/), and UMIN (http://www.umin.ac.jp/ctr/). Most medical journals follow the ICMJE guidelines, and thus are very strict about only accepting trials for publication that have been prospectively registered [13]. However, many still do accept retrospective registration in certain cases, so if your trial is not yet registered, it is worth enquiring whether your target journal will accept late registration and if a rationale for the delay is required [14]. Plagiarism Finally, with the strong increase in recent years of rejections and retractions for plagiarism [15], close analysis of the use of references and your own previously published work is needed. Copying of any previously published material, whether it is your own work or unintentional, is considered unethical, and with the increase in number of journals now using plagiarism detection software such as iThenticate (CrossCheck), it is unlikely to go unnoticed. CONCLUSION In summary, sharing your work with an international audience and having your results published in the most appropriate journal are the primary goals of manuscript publication. To do so effectively, it is essential as an author to be aware of the structural and content requirements for your manuscript, as well as the ethical guidelines underlying your research and how it is shared with the public. Active involvement and awareness of the publishing process will ensure you end up with a well-written and ethically sound manuscript that has a greater chance of acceptance.
  10. 10. This article was originally published in Japanese in Japanese Journal of Breast Cancer 2013; 28(6): 575–580. The English version of this article has been reproduced with permission from the Japanese Journal of Breast Cancer. REFERENCES 1. Verma S, Miles D, Gianni L, et al: Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 367:1783-1791, 2012. 2. Mayor S: BMJ and Lancet rank among the most clinically relevant medical journals. BMJ 329:592.6, 2004. 3. McKibbon KA, Wilczynski NL, Haynes RB: What do evidence-based secondary journals tell us about the publication of clinically important articles in primary healthcare journals? BMC Med 2:33, 2004. 4. Gopen GD, Swan JA: The science of scientific writing. Am Scientist 78:550-558, 1990. 5. Schulz KF, Altman DG, Moher D, for the CONSORT Group: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. BMJ 340:c332, 2010. 6. International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Updated August 2013. http://www.icmje.org/urm_main.html. Accessed September 24, 2013. 7. Graf C, Battisti WP, Bridges D, et al: Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ 339:b4330, 2009. 8. Committee on Publication Ethics: http://publicationethics.org/. Accessed September 24, 2013. 9. von Elm E, Altman DG, Egger M, et al; STROBE Initiative: The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol 61:344-349, 2008. 10. International Committee of Medical Journal Editors: Clinical trial registration: A statement from the International Committee of Medical Journal Editors. [Editorial]. September 2004. 11. World Health Organization: International Clinical Trials Registry Platform. http://www.who.int/ictrp/about/details/en/index.html. Accessed September 24, 2013. 12. International Committee of Medical Journal Editors. Clinical trial registration: Looking back and moving ahead. June 2007. http://www.icmje.org/update_june07.html. Accessed September 24, 2013. 13. Haller DG: Clinical trials registration: Will your study be publishable? J Clin Oncol 27:1, 2009. 14. Barbour V: Full Registration and reporting of all trials at PLOS Medicine. PLOS Blogs August 13, 2013. http://blogs.plos.org/speakingofmedicine/2013/08/13/full-registration-and-reporting-of-all-trial s-at-plos-medicine/. Accessed September 24, 2013. 15. iThenticate. Rising tide of plagiarism and misconduct in medical research. 2013 iThenticate Paper.