Medical Writers Research Articles

Краткая история формирования калмыцкого фонда Восточного отдела Научной библиотеки Санкт-Петербургского университета

Introduction. The collection of manuscripts and printed books in the Oirat Сlear Script, stored at St. Petersburg State University, is of great importance for the study of the history and culture of the Oirats, especially the Kalmyks. Although the collection of books on “clear Script”, stored at St. Petersburg State University, is one of the best in the world, the history of its formation and composition has never been the subject of special research. Meanwhile, this collection was collected by outstanding orientalists of the 19th century, and although the origin of some manuscripts is obscure, this fact does not make them less valuable. Therefore, the main purpose of this article was to find out the history of the formation of the collection to give an overview of the materials contained in it. Results. This collection brought together in the 19th century by the efforts of such outstanding Russian Mongolologists as A. V. Popov, V. P. Vasiliev, K. F. Golstunsky and A. M. Pozdneev. The collection mainly contains Buddhist books. The manuscripts collected by V. P. Vasiliev belonged to the seventeenth son of the Kangxi Emperor (reigned 1661–1722) Yunli (1697–1738) and are mostly unique or very rare. In 1860, K. F. Golstunsky handed over to the university library the manuscript of the “Biography” of Zaya Pandita (Calm C 20), written in gold on dark paper, which became a “calling card” of the Kalmyk Foundation. An important place in the collection is occupied by personal archival materials of scholars G. S. Lytkin and N. A. Lebedev. G. S. Lytkin stayed in the Kalmyk Steppe in 1859–1860 and during this time collected extensive historical and ethnographic materials. N. A. Lebedev was a translator in the Asian Department of the Ministry of Foreign Affairs and translated medical writings into Kalmyk from Russian, as well as laws and educational books. Conclusions. The collection of books in Clear Script, kept at St. Petersburg State University, is a collection of the most valuable sources for studying the history of the Kalmyks and their spiritual culture. Buddhist writings make up the bulk of the collection. Russian and Kalmyk parallel texts, as well as Russian texts with Kalmyk translations of separate words and expressions, are valuable sources for studying the vocabulary of the Kalmyk language. Many texts are valuable legal documents date back to the first half of the 19th century.

Author reply to 'Comment on ChatGPT and medical writing in dermatology: why should we keep writing?'

We read with great interest the manuscript recently published by Daungsupawong et al, commenting on our previously submitted Letter to the Editor entitled “ChatGPT and Medical Writing in Dermatology: Why Should We Keep Writing?”, and we wanted to address their comments.

Insights of Healthcare Professionals into Medical Writing Support at a Tertiary Care Hospital in Saudi Arabia.

The demand for medical writing is on the rise in academic and medical entities worldwide. However, a huge disparity in the perception of professional medical writing arises from inadequate education and regularity in service quality and potential ethical challenges. Hence, we aimed to examine the knowledge, attitude, and perception toward professional medical writing support (PMWS) of healthcare professionals at King Fahad Medical City (KFMC). An observational cross-sectional study was conducted using a questionnaire that was validated for its accuracy and clarity by an expert panel in academic integrity. The self-administered questionnaires were distributed to 200 healthcare professionals from a broad range of specialties throughout KFMC. The socio-demographic characteristics and healthcare professionals' knowledge, attitudes, and perceptions were recorded. The responses were quantitatively evaluated using a 5-point Likert Scale and analyzed using the Statistical Package for Social Sciences 25 (IBM, New York, United States). 162 healthcare professionals in KFMC filled in the questionnaire completely. Most respondents agreed that it was acceptable for medical writers to help with writing publications and that they offered a valuable service. Concerning association with socio-demographic characteristics, the mean score of knowledge was found to be significantly related to those with age ≥45 years (p<0.001), PhD degree (p=0.044), >5 years of research experience (p<0.001), and being a faculty/consultant (p=0.005). No significant association was found with the mean total score of attitude. Participants having >5 years of research experience were found to have a higher significant level of perception (p=0.004). Our study highlights that PMWS is relatively well-utilized and perceived positively within KFMC. There is a need for further research and education of ethics regarding the use of PMWS.

Emerging Perspectives in Medical Case Report Writing: How Guidelines Support Inclusion of Patient-Reported Outcomes

ABSTRACT This article examines the patient perspective as an emerging feature of medical case report writing, and through analysis of technical reporting guidelines and a corpus of published reports, shows how the biomedical community incorporates patient-authored perspectives into processes of research and publication. The author concludes by discussing the value and complexities of patient inclusion efforts and the potential for scholars of rhetoric and technical communication to take part in shaping those efforts.

Academic to AI-cademic: Challenges and Recommendations of Artificial Intelligence in Medical Writing

Academic to AI-cademic: Challenges and Recommendations of Artificial Intelligence in Medical Writing

The Impact of Data-Driven Learning on Medical Students' English Academic Writing

Introduction: Data-driven learning has emerged as a powerful method in language teaching and has drastically changed the traditional methods of teaching and learning, especially in academic writing. So, the present study was conducted to investigate the effect of data-driven learning on the English academic writing of medical students.&#x0D; Method: In this quasi-experimental intervention study, 29 MSc students of different fields of medical sciences participated in a training intervention program using a data-driven learning approach focusing on self-generated corpora of academic articles related to their fields of study. Students were asked to write an academic text related to their fields at the beginning and end of the course. Written texts were graded based on the Hemp-Lyons academic writing rubric, and the data collected from the pre-and post-test assessments were analyzed using the paired-sample t-test.&#x0D; Results: Comparison of pre-test scores with a mean of 59 (SD = 2.26) and post-test scores with a mean of 78.53 (SD = 2.33) indicated a significant improvement in the writing of the participants of this study (p &lt; 0.05).&#x0D; Conclusion: In light of confirming the educational suitability of the data-driven approach and recognizing the need for students to engage in English article writing and publication, these findings serve as a valuable aid to MSc students studying medical sciences, facilitating their academic writing in English.

Using Innovative Tools and Lean Writing Workflow Processes to Accelerate Regulatory Document Writing

Lean writing workflow processes can streamline development of complex documents, including protocols and other regulatory submissions. This paper outlines standard development timelines and describes useful lean writing workflow methods and tools to reduce protocol development timelines without sacrificing document quality. We present the results of a survey completed by 75 Medical writers (MW) that reveal the strategies used during document preparation and use real case scenarios (protocol development) that illustrate how innovative tools and approaches can be efficiently used to create a lean writing workflow process. Software tools (e.g., proofreading assistance, citation manager, collaborative authoring and reviewing) were widely accepted and used during protocol development according to the MWs surveyed. Most of the surveyed writers (62%) hypothesized a reduction in production time by about 25%. Efficient collaborative work across different time zones had a marked impact on shortening timelines while maintaining production of high-quality documents. Real case scenarios were used to illustrate how innovative tools and approaches can positively impact timelines and efficiently create a lean writing workflow process regardless of therapeutic area. The real case scenarios showed that protocol development time can be decreased by about 26% without compromising the quality of the document. This shows that software tools, templates, checklists, and collaborative writing were more impactful than hypothesized by the MWs included in the survey. With clear workflow processes, roles, and responsibilities backed by innovative software applications, template guidelines, and collaborative work processes, MWs can overcome common development challenges and improve their lean regulatory writing skills.

Understanding the Impact of Technology on Medical Writing: AMWA Survey Results from June 2023

In July 2023, the American Medical Writers Association (AMWA) developed a survey to understand the impact of technology on the role of medical writers in clinical and regulatory document development. The survey was administered using SurveyMonkey to individuals responsible for leading, training, or developing a medical writing team. Respondents were mostly regulatory writers (96%) working in pharmaceutical/biotechnology/medical device or contract research organizations (88%). Most were using technology (65%) and almost all were planning to implement authoring technology (95%). New roles for medical writers, training methods for implementation of artificial intelligence (AI), and validation of the AI output were also discussed. Quality and accuracy of the AI output were the most important considerations of the respondents with transparency and disclosure as the least important. In general, the survey respondents felt that the impact of technology in the medical writing field was an important and timely topic for AMWA to address.

Generative AI in Clinical Research: Regulatory Submissions, Clinical Data Management, and Beyond

Artificial intelligence and its subsets, such as generative artificial intelligence, have been making headlines due to their potential to accelerate the growth and expansion of various industries, including healthcare. However, the majority of application areas in healthcare revolve around diagnosing diseases, finding lead molecules for potential treatments, optimizing hospital operations, and other related aspects. This means that there are areas where the potential of these technologies is still to be realized. Examples of where such technologies could produce a significant impact across multiple elements are clinical research and its related domains, including regulatory submissions, clinical data management, clinical documentation, and other closely related areas. When artificial intelligence and its related technologies are utilized in these areas, they yield unparalleled outcomes regarding efficiency, consistency, and reproducibility. This, in turn, supports professionals involved in clinical research, like medical writers, statistical programmers, and other stakeholders, to drastically improve the speed by which they produce the initial drafts of various outputs, reduce the risk of errors that could lead to submission rejection, and optimize the overall clinical research workflow. Despite the potential of this area, the number of available solutions that support the aforementioned domains remains low. This is further complicated by the fact that there are even fewer numbers of working solutions.

2023 John P. McGovern Award Address

The John P. McGovern Award is named in honor of John P. McGovern and is presented to a member or nonmember of AMWA to recognize a preeminent contribution to any of the various modes of medical communication. The McGovern Award is presented during AMWA’s Medical Writing &amp; Communication Conference.

2023 Walter C. Alvarez Award Address

The Walter C. Alvarez Award is named in honor of Walter C. Alvarez, MD, a pioneer in the field of medical communication. The award is presented to either a member or nonmember of the American Medical Writers Association (AMWA) to honor excellence in communicating health care developments and concepts to the public. The Alvarez Award is presented during AMWA’s Medical Writing &amp; Communication Conference.

Next-Level QC Review and Editing in Medical Writing

Conference Education Session Report Speaker April Welch, ELS, Vertex Pharmaceuticals, Boston, MA

Nourish Your Niche: The Rewards and Risks of Specialized Medical Writing

What is a niche? What are the rewards and risks of nourishing a niche? How do you find a niche? As freelance medical writers, or writers considering freelance work as an option, we have to ask ourselves what kind of medical writing we are going to do. Are we going to offer a broad mix of services or tap a specialty niche? This article will help you weigh the pros and cons of whether to specialize as a freelance medical writer and how you can get started.

The Gut Microbiome–Human Body Symbiosis: Relevance of the Ubiquitous Microbial Community on Health and Development, Part 2

The human gut microbiome, comprising a range of microbial species (~100 to 1,000), is an extremely malleable ecosystem. It originates around the time of human birth and evolves as the infant grows until it matures into the relatively stable adult gut composition. Through this dynamic evolution, the composition of the gut microbiome is influenced or altered by factors such as diet, environment, mode of birth, genetics, infections, and medications. Strong associations between such alterations (dysbiosis) and diseases have led scientists to develop therapies that target a malfunctioning gut. Research is now focused on the microbiota or their associated metabolites as potential therapies. Treatment options explored include prebiotics, probiotics, postbiotics, synbiotics, fecal microbiota transplants, and live biotherapeutic products. The gut microbiome is not a panacea for all health issues; rather, it is part of a large network of interconnected operating systems within the human body. As communicators of scientific data, medical writers play a vital role in educating the public on the merits and limitations of gut microbiome therapeutics. Popular discourse, however, can be influenced by misinformation. With the ever-growing influence of social media, the lay reader must learn how to critically appraise the health information propagated by these sources. This second part of the gut microbiome series explores the association of the gut microbiome with human disease and the role that social media plays in influencing the popular perception and understanding of the importance of the gut microbiome. Approved and experimental therapies using the gut microbiome will be discussed.

Strategies to Prevent Medical Writer Burnout

Conference Education Session Report Speaker Nidhi Johal, BSc (Hons), Medical Writing Director, Trilogy Writing &amp; Consulting

From the Editor

The Spring 2024 issue of AMWA Journal is dedicated to exploring trends and opportunities in medical communication, as presented and discussed at the AMWA Medical Writing &amp; Communication Conference in November of 2023 in Baltimore, Maryland.

2023 Harold Swanberg Distinguished Service Award

Joan Affleck received the 2023 Harold Swanberg Distinguished Service Award, named in honor of one of the founders of AMWA. This award is presented to an active AMWA member who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession. At the 2023 AMWA Medical Writing &amp; Communication Conference, Joan Affleck accepted the award at a plenary session and presented a MedWrite Talk entitled “Living Your Legacy.”

The application of mirabilite in traditional Chinese medicine and its chemical constituents, processing methods, pharmacology, toxicology and clinical research.

Purpose: This study reviews the use of mirabilite in traditional Chinese medicine and various preparations by describing its chemical composition, processing methods, pharmacology, toxicology, and clinical research progress. Methods: The applications and processing methods of mirabilite are searched in traditional and modern Chinese medical writings, and the articles on chemical composition, pharmacological effects, toxicology, and clinical studies of mirabilite and its combinations in PubMed and China Knowledge Network are reviewed, sorted, and analyzed. Results: The main chemical component of mirabilite is sodium sulfate decahydrate (Na2SO4·10H2O), followed by small amounts of sodium chloride, magnesium sulfate, calcium sulfate, and other inorganic salts. This study systematically organizes the history of the medicinal use of mirabilite in China for more than 2,000years. This mineral has been used by nine Chinese ethnic groups (Han, Dai, Kazakh, Manchu, Mongolian, Tujia, Wei, Yi, and Tibetan) in a large number of prescription preparations. The Pharmacopoeia of the People's Republic of China (2020 edition) records stated that mirabilite can be used for abdominal distension, abdominal pain, constipation, intestinal carbuncle, external treatment of breast carbuncle, hemorrhoids, and other diseases. The traditional processing methods of mirabilite in China include refining, boiling, sautéing, filtration after hot water blistering, and firing. Since the Ming Dynasty, processing by radish has become the mainstream prepared method of mirabilite. Mirabilite can exhibit anti-inflammatory detumescence effects by inhibiting AMS, LPS, IL-6, IL-10, TNF-α, and NO levels and attenuating the upregulation of TNF-α and NF-κB genes. It can promote cell proliferation and wound healing by increasing the production of cytokines TGFβ1 and VEGF-A and gastrointestinal motility by increasing the release of vasoactive intestinal peptide, substance P, and motilin. It can increase the expression of low-density lipoprotein receptor and AKT phosphorylation in the liver by up-regulating bile acid synthesis genes; reduce TRB3 expression in the liver, FGF15 co-receptor KLB expression, and FGF15 production in the ileum, and JNK signal transduction; and increase the transcription of CYP7A1 to achieve a cholesterol-lowering effect. Mirabilite also has a variety of pharmacological effects, such as regulating intestinal flora, anti-muscle paralysis, anti-colon cancer, promoting water discharge, and analgesic. Only a few toxicological studies on mirabilite are available. External application of mirabilite can cause local skin to be flushed or itchy, and its oral administration is toxic to neuromuscular cells. The sulfur ions of its metabolites can also be toxic to the human body. At present, no pharmacokinetic study has been conducted on mirabilite as a single drug. This mineral has been widely used in the clinical treatment of inflammation, edema, wound healing, digestive system diseases, infusion extravasation, hemorrhoids, skin diseases, breast accumulation, muscle paralysis, intestinal preparation before microscopic examination, and other diseases and symptoms. Conclusion: Mirabilite has good application prospects in traditional Chinese medicine and ethnomedicine. In-depth research on its processing methods, active ingredients, quality control, pharmacokinetics, pharmacological and toxicological mechanisms, and standardized clinical application is needed. This paper provides a reference for the application and research of mirabilite in the future.

Ten Tips on How to Write and Publish a Case Report

Case report is a form of medical writing that describes an unusual presentation of common diseases, a rare disease / phenomenon, or a novel treatment of disease in a scientific manner. Case report is often seen as an easy and quick form of medical writing. However, it can be daunting at times, if the writer does not know where to begin and how to write different sections of a case report. We share ten easy and practical tips that can help novice and expert medical writer alike, to draft a ‘publication’ worthy case report in the minimum amount of time. These tips will help the writer to avoid common mistakes associated with case reports.

Value of Medical Writing—Using the Regulator’s Perspective (2021 Survey Results) to Educate and Empower Medical Writers

In 2021, an American Medical Writers Association (AMWA) working group conducted a survey to gain an understanding of how regulatory agencies perceive the value of medical writing. The survey showed that document quality is extremely important to the timely and efficient review of an application and identified key factors affecting document quality that negatively impact application approval. In response to this, a working group ran a series of roundtables at the AMWA and European Medical Writers Association conferences to gather opinions from medical writers about this survey and how we can best communicate these ideas to authoring teams. This article discusses the feedback obtained in those roundtable sessions and presents the working group’s proposal for a set of resources to empower medical writers to implement change.