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By Prof. Steven Kassem as part of the 5th Research Summer School by King Abdullah International Medical Research Center (KAIMRC) - Western region

By Prof. Steven Kassem as part of the 5th Research Summer School by King Abdullah International Medical Research Center (KAIMRC) - Western region

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  • 1. Scientific and Medical Writing Steven “Moustafa” Kassem
  • 2. Types of Medical and Scientific Writing Different publications
  • 3. Medical Journalism Newspaper and Magazine articles Mostly for “lay” people & general public Written in simple, non- technical language Contributing author or regular columnist
  • 4. Medical Education For Physicians and Nurses For Physicians – textbooks, Continued Medical Education (CME) programs, slide decks, e-learning modules For Patients – patient education material
  • 5. Some Contributors from the Oxford Textbook • M. R. Cooper, Freelance Science Writer • C. P. Conlon, Consultant Physician in Infectious Diseases • B. J. Cohen, Clinical Scientist • Richard E. Chaisson, Professor of Medicine • Jonathan R. Carapetis, Senior Lecturer • Paul H. Brion, Rheumatologist in Private Practice
  • 6. Publication/Presentation Journal articles / manuscripts (research articles, case reports, review articles) Posters & presentations for scientific meetings and conferences Language is technical and intended for specialists in the field
  • 7. Types of Research Documents Clinical trial protocols Investigators′ Brochure Informed Consent Documents Study reports Research proposals
  • 8. Research: Clinical trial protocols Written procedural method in the design and implementation of experiments. Standardize laboratory methods to ensure successful replication of results by others. Lists of required equipment and instruments. Information on safety precautions Provisions for avoiding bias in the interpretation of results. Approximation error, Sample bias sample size Standard deviation
  • 9. 3.7. Establishment of Primary Chinese Hamster Fibroblast Cultures 3.1.1. Embryo Culture 1, Kill a 12-d old pregnant Chinese hamster with ether. 2 Wash the animal in tap water and then with 70% ethanol 3. Make a surgical incision on the dorsal side to expose the uterus using sterile mstruments (these can be dipped m ethanol and flamed to mamtam sterility during the operation) 4 Remove the uterus in toto, and transfer it to a sterile Petri dish. Dissect the embryos, and place them m a new sterile Petri dish (see Note 4). 5. Mince the embryos very finely, and while still in the Petri dish, wash the pieces with 5 mL of 0.125% Bacto-trypsm at 37°C. 6. Tilt the Petri dish so that embryo pieces go to the side Remove the pieces into a 50-mL centrifuge tube usmg a wide-bore pipet.
  • 10. Investigator’s Brochure • TABLE OF CONTENTS OF INVESTIGATOR’S BROCHURE (Example) • - Confidentiality Statement (optional) ………………………………………………………………… • - Signature Page (optional) ………………………………………………………………………………… • 1 Table of Contents …………………………………………………………………………………………… • 2 Summary ………………………………………………………………………………………………………. • 3 Introduction …………………………………………………………………………………………………… • 4 Physical, Chemical, and Pharmaceutical Properties and Formulation ……………….. • 5 Nonclinical Studies ………………………………………………………………………………………… • 5.1 Nonclinical Pharmacology ………………………………………………………………………………. • 5.2 Pharmacokinetics and Product Metabolism in Animals …………………………………….. • 5.3 Toxicology ……………………………………………………………………………………………………… • 6 Effects in Humans ………………………………………………………………………………………….. • 6.1 Pharmacokinetics and Product Metabolism in Humans …………………………………….. • 6.2 Safety and Efficacy …………………………………………………………………………………………. • 6.3 Marketing Experience …………………………………………………………………………………….. • 7 Summary of Data and Guidance for the Investigator ………………………………………… • NB: References on 1. Publications • 2. Reports • These references should be found at the end of each chapter • Appendices (if any) compile data relevant to studies of the tested drug in human subjects gathered during preclinical and other trials. document summarizing the body of information obtained during a drug trial Used in the drug development process updated with new information as it becomes available
  • 11. Medical Case Study Reports • An article that describes a particular patient's diagnosis and treatment plan • Most cases chosen are of unusual diagnoses or include complications in treatment. • written in a specific format and can be submitted to peer-reviewed journals. • Easier and faster to publish than research articles • Can detail multiple aspects of a patients situation
  • 12. Medical Case Study Reports • can detail many different aspects of the patient’s medical situation (clinical only one) • published quickly in comparison to randomized control trials
  • 13. Medical Case Study Reports 1. Select a case • rare or unusual illnesses. • treatment plans that have an unexpected positive or negative outcomes. • Speak with senior physicians about patients whose illnesses would make an interesting case study report. • Choose additional colleagues to contribute to the report.
  • 14. Medical Case Study Reports 2. Research the Case • Review the current literature on relevant diagnosis or treatment. • Seek assistance from your hospital's library staff. • Ask senior staff members for guidance
  • 15. Medical Case Study Reports 3. Collect Patient Information and Consent • Medical ethics requires that the patient provide written consent. • Many journals have their own consent forms that must be completed and signed by the patient • patient's detailed information (age, medical history, medication use, current and past diagnoses, etc.). • copies of the patient's labs, x-rays and clinical photographs.
  • 16. Medical Case Study Reports 4. Drafting the Case Study – Abstract (Should be written last) – Introduction – Case presentation – Discussion – Conclusion – References
  • 17. Features of a Successful Research Proposal (1) a highly qualified investigator(s) or (2) a mentor with a successful track record in scientific investigation, peer‐reviewed funding, and mentorship of fellows and faculty (3) a supportive academic environment (4) a scientifically sound proposal.
  • 18. Early-Careeer Research Fellowship & Grant Opportunities for Anesthesiologists (U.S.A.) Writing Successful Research Proposals for Medical Science Schwinn, Debra A. MD; DeLong, Elizabeth R. PhD; Shafer, Steven L. MD
  • 19. Requirements for Medical and Scientific Writing What you need to develop
  • 20. General Knowledge and Skills • Language & grammar • Literature / reference searching • Ethical & legal issues • Interpretation and presentation of research data
  • 21. Avoiding Language Bias: “Sexism” “Sexist” “Non-Sexist” Give each subject his results as soon as he is finished. Give subjects their results as soon as they are finished. Anyone who wants to improve must take his medicine. All those who want to improve must take their medicine. Every person has a right to his opinion. Every person has a right to his or her opinion. chairman = chairwoman (re-gendered) • chair • chairperson (de-gendered) Male nurse Nurse Female Physician Physician
  • 22. Avoiding Language Bias: Disabilities Unacceptable Acceptable handicapped Disabled, with disability cancer victim, AIDS victim cancer patient, person with AIDS suffers from diabetes is diabetic confined/bound to a wheelchair uses a wheelchair dying of cancer living with cancer
  • 23. Avoiding Language Bias: “Racism” • Stay up-to-date on the acceptable terms Acceptable Unacceptable Negro, colored Of African Origin, black, African-American Spanish (Except for natives of spain) Latino/a, Hispanic Indian Native American Oriental Asian
  • 24. Qualities of a Good Scientific Writer • Thorough research of the subject • Ability to write for the target audience • Ability to understand the purpose and requirements of the project • Scientific accuracy • Attention to details • Ability to work across teams and independently • Critical thinking
  • 25. Step 1: Understanding the Project Brief • Understand the Purpose for the document -How it relates to the institutions mission -What the Sponsor wants to achieve -Timelines -Budgeting -Data available -Review process
  • 26. Step2: Literature and Data Review  Should be the “Fun” Part of the process  adequate planning and time to allow for development of ideas  A creative and dynamic process  classify retrieved information in usable chunks  Begin Referencing as you learn
  • 27. Step 3: Authoring & compiling the document • Usually the “Not Fun” part of the process • The more effort spent on preparation, the easier this part should be • Outline and Structure before prose • Well prepared writers need to streamline their writing, not stretch it • Model on documents for same publication
  • 28. Step 4: The review process • Try to think like a reviewer while planning and writing to • It is acceptable to suggest reviewers (referees) in your cover letter • Use the fact that others will be evaluating your work to make your work better
  • 29. Steps for Writing Scientific Documents • Understanding the project brief • Literature search & review of information • Authoring & compiling the document • The review process • Formatting & editing • Approval and sign off • Electronic publishing
  • 30. Ghost Writing: The Hidden Step • "Ghost authoring" refers to making substantial contributions without being identified as an author. • "Guest authoring" refers to being named as an author without having made substantial contributions. American Medical Writers Association
  • 31. Ghost Writing: The Hidden Step • professional writers and other parties are paid by pharmaceuticals and medical devices manufacturers to produce manuscripts • physicians may have little involvement in the research or the writing process. • authors listed in the byline are prominent clinicians paid an honorarium for their names.
  • 32. Ghost Writing: The Hidden Step • An “author” is generally considered to be someone who has made substantive intellectual contributions to a published study • must take responsibility for at least one component of the work • should be able to identify who is responsible for other components • should ideally be confident in their co-authors’ ability and integrity
  • 33. Ghost Writing: The Hidden Step • Permitted at the University of Washington School of Medicine • Considered unethical at most Institutions • Considered Plagiarism at: Tufts University School of Medicine and the University of Pennsylvania School of Medicine
  • 34. Criteria for Authorship: 1. substantial contributions to design, acquisition of, or analysis of data 2. drafting the article or revising it critically for important intellectual content And 3. final approval of the version to be published International Committee of Medical Journal Editors (ICMJE or The Vancouver Group)
  • 35. Ways to Publish Traditional Open-Source Available to those with a paid subscription Available for viewing or downloading by anyone with access to the internet. Author is paid “royalties” for each publication sold Author pays to have his/her writing included in the publication Standards for publication are usually higher Easier to publish Becoming obsolete as information- sharing proliferates Seen as threat to peer-review system
  • 36. Types of Open Access 1. Green Open Access self-archiving (OA Repositories) • Authors publish in any journal and then self-archive a version of the article for free public use in their institutional repository, central repository (such as PubMed Central), or other Open Access website.
  • 37. Types of Open Access 2. Gold Open Access publishing (O/A Journals) • Authors publish in an open-access journal that provides immediate OA to all of its articles on the publisher's website • Examples: BioMed Central, the Public Library of Science, and Dove Medical Press.
  • 38. How much can you find on OA? Björk et al. (2010). "Open Access to the Scientific Journal Literature”
  • 39. Types of Open Access Green OA self-archiving Gold OA publishing Peer-reviewed post-print is published Immediate access on the publishers website Generally free or nominal administrative fee Author fees to cover the cost of publishing (from $1,350 to $2,900) No Peer Review (assumed) Peer review Requires publishers permission No permission required Universities have repositories Privately owned or non-profit
  • 40. Fake Publications • Etymology 2013 vs. Entomology-2013 • Names almost identical to respected journals • Academics are solicited to contribute or attend a conference then charged exorbitant rates • Erroneously use academics’ credentials • Jeffrey Beall, a research librarian at the University of Colorado at Denver, has developed a blacklist of “predatory” journals. http://scholarlyoa.com/individual-journals/ Nytimes.com
  • 41. Thank you! Steven Moustafa Kassem professorkassem@gmail.com