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Staff Education & Training Command Clinical Investigations Department

Staff Education & Training Command Clinical Investigations Department. Scientific Writing By Dr. Brian Deevey, Medical Editor, National Naval Medical Center, Bethesda, MD

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Staff Education & Training Command Clinical Investigations Department

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  1. Staff Education & Training CommandClinical Investigations Department Scientific Writing By Dr. Brian Deevey, Medical Editor, National Naval Medical Center, Bethesda, MD “The National Naval Medical Center is an approved provider of continuing nursing education by the Navy Medicine Manpower, Personnel, Training and Education Command, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.”

  2. Disclosure Statement This CE/CME activity does nothave commercial support, and has noconflicts of interest. Research Course

  3. Learning Objectives • To learn a few general principles of good writing. • To understand the structure of a scientific paper. • Learn how to write for publications. • To introduce the protocol template to apply for permission to do research. Research Course

  4. Learning Objective 1:To learn a few general principles of good writing • Clarity in scientific writing is the most important consideration. Having an interesting style is less important. • Use short sentences where possible. Avoid using the passive voice except where necessary. • Avoid run-on sentences without internal punctuation. The reader has to keep backing up to figure where the different parts belong. Research Course

  5. Learning Objective 1 (cont.) • “As” should not the only word used to mean “because.” Use “because” at least occasionally. • Watch for internal consistency in superficial things—capitalization, hyphens, fonts, punctuation, and so on. Such simple things may just be cosmetic, but inconsistencies can distract the readers. Research Course

  6. Learning Objective 1 (cont.) • References should be consistent and appropriate for the type of publication. For protocols, maybe take a favorite journal and copy their style exactly, in order to be consistent. • Run spell check after everything is finished. If you make any changes, run it again. Research Course

  7. Learning Objective 1 (cont.) • After you finish your writing, set it aside for a few days if possible so you can look at it later with a fresh eye. Otherwise it is so familiar that you can’t see the mistakes. If possible have a co-author look at it who has not participated in the writing--another set of eyes always helps. Research Course

  8. Suggested sources on writing in general • U.S. Army Center for Health Promotion and Preventive Medicine http://chppm-www.apgea.army.mil/imo/DDB/writ-tip.htm#SIX-STEP provides information on SIX-STEP WRITING PROCESS Research Course

  9. Suggested sources on writing in general 2. Writer’s Helper has some good tips URL: www.writershelper.com/writingtips.html 3. WritingClasses.com http://www.writingclasses.com/InformationPages/index.php/PageID/300 Research Course

  10. Sources on writing a research paper 1. The Online Writing Lab (OWL) at Purdue University Provides FREE writing help and writing resources 24/7 Writing a Research Paper http://owl.english.purdue.edu/workshops/hypertext/ResearchW/1draft.html This site is strongly recommended for graduate students. Research Course

  11. Examples of good and bad writing • Original: In a setting where one anticipates exposures may occur, having a short-term supply of PEP is recommended. • Better: We recommend keeping a short-term supply of PEP on hand if you anticipate that an exposure might occur. Research Course

  12. Examples of good and bad writing • Original: Despite their generic appearance on CT and MRI, it is advantageous to utilize these two modalities to assess bony destruction and soft tissue components respectively. • Better: CT and MRI results may look similar, but we need both to assess bone loss and soft tissue damage, respectively. Research Course

  13. Examples of good and bad writing • Original: Specifically, most hyperlipidemia was drug-induced with the most notable difference seen in the median triglyceride values of 164mg/dL in those with normal diastolic function and 240mg/dL in those with diastolic dysfunction (p=0.09). • Better: Most hyperlipidemia was drug-induced. Notably, patients with normal diastolic function showed median triglyceride values of 164mg/dL. Those with diastolic dysfunction, however, showed values of 240mg/dL (p=0.09). Research Course

  14. Examples of good and bad writing • Original: Unlike previous studies using echocardiography in the HIV-infected population, we were able to perform a more in-depth evaluation of diastolic function with modern tissue Doppler techniques. • Better: Our study was able to perform an in-depth evaluation of diastolic function in the HIV-infected population with modern tissue Doppler techniques, unlike earlier studies using echocardiography. [The original here compares studies with people, which is not what they meant.] Research Course

  15. Examples of good and bad writing Original: The patient was simultaneously evaluated by rheumatology, and underwent diagnostic arthrocentesis of his left wrist which revealed intracellular urate crystals and was switched to oral prednisone 20 mg twice daily and allopurinol 300 mg for his gout and oxycodone for pain relief. Better: The patient was also evaluated by rheumatology. Diagnostic arthrocentesis of his left wrist revealed intracellular urate crystals. He was switched to oral prednisone 20 mg twice daily and allopurinol 300 mg for his gout, and oxycodone for pain relief. Research Course

  16. Examples of good and bad writing • Original: Although our patient had a long history of gout, the severity and extent of his pain and polyarticular synovitis resulting in hospitalization with multiple intra-articular and intravenous steroid administration was more severe than what would be predicted based on his history, and certainly more severe than the typical clinical course experienced by most patients with polyarticular gout. • Better: He had a long history of gout, but his pain was severe and extensive, and his polyarticular synovitis resulted in his hospitalization with multiple intra-articular and intravenous steroid administrations. This was more severe than what would be predicted based on his history. His clinical course was certainly more severe than that experienced by most patients with polyarticular gout. Research Course

  17. Examples of good and bad writing • Original: The known topiramate side effect of hyperchloremic metabolic acidosis is thought to be due to topiramate’s weak interaction with carbonic anhydrase, it is unknown if this mechanism or an as yet undetermined mechanism may effect renal function as assessed by serum creatinine level. • Better: The known topiramate side effect of hyperchloremic metabolic acidosis is thought to be due to topiramate’s weak interaction with carbonic anhydrase. However, we don’t know if this mechanism or something else may affect renal function as assessed by serum creatinine level. Research Course

  18. Learning Objective 2: To understand the structure of a scientific paper Types of Papers • Most scientific papers are of the hypothesis-testing type: a question is formulated and efforts are made to answer it convincingly, either positively or negatively. • A second type of paper is descriptive. • The third type is a methods paper, comparing several kinds of methods or inventing a new one. Research Course

  19. Learning Objective 2 (cont.) Title • Try to keep it short and clear. • Include key words that other researchers will look for that cover your topic. Research Course

  20. Peer Review • Most journals want complete address information, degrees, and institutional info for all authors, but not in the text. They usually don’t want reviewers to know whose work they are reading, because it might prejudice them for or against the paper. They usually don’t tell the authors who their reviewers were. Keep your names and institutions out of the body of the text, and if you have any acknowledgments, keep them separate from the text also. Research Course

  21. Learning Objective 2 (cont.) Abstract • The abstract comes next, but should be written last. • Abstracts are usually several hundred words in length, but may be much shorter. Research Course

  22. Abstract • magazine once ran a study of abstracts, and found one that was only one word long. The title of the paper was in the form of a question along the lines of “Do we need more studies of blue jay reproductive strategies?” The abstract was “No.” Research Course

  23. Learning Objective 2 (cont.) Text Four major sections: - Introduction, which establishes the research question and its importance; - Materials and methods section, describing the sample and procedures to be followed; - Results, which is what the study found; - Discussion, which hopefully makes sense of everything and points out further lines for research. Research Course

  24. Learning Objective 2 • Tables and figures may be sprinkled through the text. Do not modify any photographs you submit—that is now considered fraud. • The list of references cited appears last in the paper. • Scientific papers rarely have appendices, but many journals allow supporting online material. Research Course

  25. Learning Objective 2 Important to remember: If you are submitting your paper for a journal, they may have a variety of structures for different types of papers. If they do, follow their instructions exactly. Research Course

  26. The publishing process • Most of the best journals are published by learned societies. The primary editor and many of the peer reviewers (and most of the authors) are members of the society. They decide what papers get published. • Next the paper goes to the journal staff of editors to be cleaned up. The journal may have a lengthy style guide detailing the exact types of changes to make. • Next the paper goes to the production department to be laid out and the pictures and tables incorporated. • Next the paper comes back for another round of editing and proofing, and a copy is sent to the author to approve the corrections. • Next the papers are assembled to form an issue, a table of contents and other information is added, and the paper goes to the printer. • Next the printer sends back a “blueline” copy of what they have set up, and, when that is approved, the issue goes to press. Research Course

  27. Example: Paper #1 One recently reviewed paper is a hypothesis testing article of the effects of different types of spectacles and goggles. The abstract - 1 page. The introduction - 2 pages to explain the variety of types of protective eyewear and the need to test different combinations to see if some work better. Research Course

  28. Example: Paper #1 The methods – 4 pages to describe the subjects in the experiment and the types of equipment and tests they were put through. About 30 subjects were tested for central and peripheral vision on 12 types of goggles. The results – 2 pages to describe what they found, which was that all of the goggles worked well for looking straight ahead, but that all of them restricted peripheral vision to some extent. Research Course

  29. Examples: Paper #1 (cont.) One type worked noticeably worse than the others, and some subjects had less peripheral vision than others, which could be dangerous while driving or in combat. The discussion - 2 pages to describe the significance and implications. They conclude that people wearing goggles should turn their heads more than usual while looking around, and not rely on eye movements to detect objects on the periphery. Research Course

  30. Examples: Paper #2 Another recent paper is a case report being presented as a poster. The text - a page and a half, with sections for introduction, case presentation, discussion, and conclusion. Research Course

  31. Paper #3 Another recent paper is a case report being presented as a short article. The abstract and introduction are brief paragraphs. The case report results section itself takes about a page, but the discussion is 3 ½ pages long. Research Course

  32. Learning Objective 3: Writing for publication Resources • The Belmont Report: Ethical Principles and Guidelines for the protection of human subjects of research (http://ohsr.od.nih.gov/guidelines/belmont.html) • The Requirements for Manuscripts Submitted to Biomedical Journals by ICMJA at http://www.icmje.org Research Course

  33. Learning Objective 3: Writing for publication Choosing a Journal for Publishing Try to decide on a journal which regularly publishes in your area. While you are writing your paper quote several of their articles so that the editors will realize your topic is one that their readers are following. Match your style as much as possible to theirs to camouflage your paper to look like theirs. Research Course

  34. Learning Objective 3: Writing for publication Choosing a Journal for Publishing • Each journal has instructions for authors. • The major journals in the health and life sciences (over 3,500) and their links are at http://mulford.meduohio.edu/instr/. • Raymon H. Mulford Health Science Library at The University of Toledo, Ohio provides good resources(http://www.utoledo.edu/library/mulford/index.html) Research Course

  35. Learning Objective 3: Writing for publication Choosing a Journal for Publishing (cont.) The Journal of American Medical Association (JAMA) provides a very detailed set of instruction for authors at http://jama.ama-assn.org/misc/ifora.dtl The JAMA Instructions for Authors is available in PDF format as well at http://jama.ama-assn.org/misc/i4a.pdf Research Course

  36. Learning Objective 3: Writing for publication Abbreviations • Most journals will ask that you abbreviate journal titles in the references section. Make sure to list references consistently. • The National Library of Medicine (NLM) designed the List of Serials Indexed for Online Users (LSI) • The standard abbreviations are at ftp://nlmpubs.nlm.nih.gov/online/journals/lsiweb.pdf Research Course

  37. Learning Objective 3: Writing for publication Sending a paper to a journal If you are sending a paper to a journal which does peer review, put all information that would identify you or other authors or your institutions in the title page. When the journal sends the paper out for review, they don’t want the reviewers to know who you are—that might influence their decision. Research Course

  38. Learning Objective 4: Protocol preparation • Go to the Responsible Conduct of Research Service (RCRS) website to get the latest versions of the necessary forms available at http://www.bethesda.med.navy.mil/professional/research/responsible_conduct/forms/index.aspx It has templates and instructions for all of the forms they use. Download the ones you will need and fill them in. • Plan to work on the protocol in several stages. Research Course

  39. Learning Objective 4 • You can submit to me first to review the draft if you like. Plan on a day or two turnaround. One or two passes by me should be enough. • Then submit the protocol to the Responsible Conduct of Research Department through IRBNet. Research Course

  40. Learning Objective 4: Protocol preparation • Here are the headings of the research protocol, which is the form you need to submit in order to get approval to do a research project. HUMAN RESEARCH PROTOCOL APPLICATION SUBJECT: IRB REVIEW AND APPROVAL 1. The unified/standardized templates to request approval for a clinical investigation study were created, by a task force appointed by the BRAC Integration Research Working Group, for research conducted at the Military Medical Centers (WRAMC, NNMC, and MGMC) and the Uniformed Services University in the National Capital Area. These templates were approved by the respective institutional review boards between February and March 2007. Research Course

  41. Learning Objective 4: Protocol preparation • MEMORANDUM FOR CHIEF, DEPARTMENT OF CLINICAL INVESTIGATION (DCI), WALTER REED NATIONAL MILITARY MEDICAL CENTER (WRNMMC) AT BETHESDA, MARYLAND • 1. GENERAL INFORMATION • Please Note: All responses are left justified, Times New Roman, and 12 pitch. Please delete or type over all non-bolded notes and instructions included as guidance under each topic or section. All the bolded sections of this template are to be retained and completed in the final protocol. Answer NA to any subsection that is not applicable. Research Course

  42. Learning Objective 4: Protocol preparation • 1.1 Protocol Title • 1.2Principal Investigator • 1.3Associate Investigators • 1.4Collaborating Personnel • 1.5 Medical Monitor(State “NA” if not applicable and delete the information below.) • 2. Abstract • 2.1 Purpose • 2.2 Research Design (e.g., observational, open-label, double-blinded, prospective, randomized control trial, etc.) • 2.3 Methodology /Technical Approach (including the number of subjects to be studied.) • 3. Objectives And Specific Aims • 4. Medical Application/ Military Relevance • . Research Course

  43. Learning Objective 4: Protocol preparation • 5. Background And Significance • 5.1 Summarize recent literature and provide preliminary data and/or findings. As appropriate, include animal studies and drug or device safety and efficacy data to warrant the proposed study. • 5.2 As appropriate, provide scientific justification for the conduction of this project; explain the rationale and how it relates to the research questions/hypothesis to be tested. • 5.3 Justify the use of human subjects as research volunteers. Explain why the risks to the subjects are reasonable in relation to the anticipated benefits to the participants and/or society and in relation to the knowledge gained from performing the study. Research Course

  44. Learning Objective 4: Protocol preparation • 6. PLAN • 6.1 New Investigational Drugs/ Investigational Devices Exemption Status • 6.2 Selection of Subjects • 6.2.1 Type of the Subject Population • 6.2.2 Inclusion and Exclusion Criteria • a. Inclusion Criteria • b. Exclusion Criteria • 6.2.3 Recruitment • a. Subject selection must be equitable. • b. Describe from where and how the study subjects will be recruited. • 6.2.4 Consent Process • 6.3 Study Design and Methodology • 6.3.1Study Design • 6.3.2Study Methodology/Procedures • 6.3.3Collection of theHuman Biological Specimens • 6.3.4Data Collection • 6.3.5 Study Time Line Research Course

  45. Learning Objective 4: Protocol preparation • 6.4 Statistical Consideration • 6.4.1 The Primary Endpoints (i.e., primary outcome variables) and the secondary endpoints, if any. • 6.4.2 Data Analysis • 6.4.3 As appropriate, provide a safety monitoring and analysis plan. • 6.4.4 Sample Size Estimation • 6.5 Reporting Adverse Events • 6.5.1 Expected Adverse Events from Research Risks and Reporting Research Course

  46. Learning Objective 4: Protocol preparation • 6.5.2 Reporting Serious and Unexpected Adverse Events to the IRB • 6.6 Human Biological Specimens/Tissue (HBS/tissue) • 6.7 Subject Confidentiality Protection • 6.7.1 Certificate of Confidentiality • 6.7.2 HIPAA Authorization • 6.7.3 HIPAA Authorization Waiver • 6.8 Reporting Protocol Deviations Research Course

  47. Learning Objective 4: Protocol preparation • 7. References • 8. Facilities/Organizations to Be Used • 9. Role and Responsibilities of Each Investigator and Collaborator • 10. Time Required to Complete the Research (Including Data Analysis) • 11. Budget • 12. Environmental Impact Statement (***May Be Revised IAW Future DCI SOP) • 13. Investigator Compliance Statement (May Be Revised IAW DCI SOP) • a. I have read and understand the provisions of The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, April 18, 1979. Research Course

  48. Learning Objective 4: Protocol preparation • b. I have read and will comply with WRNMMC DOD Assurance and WRNMMC Federal-Wide Assurance for the protections of human subjects from research risks. • c. I have read and will comply with the institutional policies and guidelines as outlined in the Standard Operating Procedures (SOP) of the Department of Clinical Investigation and the Principal Investigator Guide. (See DCI web-site for a copy.) http://www.wramc.army.mil/Patients/Healthcare/Dci/Protocols/Wramctemplates/Wramc%20regulations,%20policies,%20guidance,%20sops/Piguide.Doc Research Course

  49. Learning Objective 4: Protocol preparation • 14. Responsibilities of the Principal/Associate Investigator in Human Subjects Research • 15. Medical Monitor Responsibilities • 16. Principal Investigator Signature • 17. Associate Investigator Signature (*Add As Many Associate Signatures As Necessary.) • 18. Medical Monitor Signature • 19. Department Chief and Service Chief Signature Research Course

  50. Learning Objective 4: Protocol preparation • Appendices • Appendix A – Figures / Graphs • Appendix B - Data Collection Sheets / Case Report Forms / Questionnaires (Include the Author’s Permission to Use Questionnaires/Surveys, as Applicable) • Appendix C – Signed General Impact Statement • Appendix D - All Other Impact Statements Signed by Applicable Departments • Appendix E – Signed Conflict of Interest Statement • Appendix F - Support Letters/Documents Research Course

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