Manuscript Preparation for Publication Kari L Olson BScPharm

Manuscript Preparation for Publication Kari L. Olson, BSc(Pharm), Pharm. D, FCCP, BCPS June 1, 2017

Objectives • Identify order of authorship • Review manuscript content • Write a concise abstract • Discuss proper writing techniques and style • Review manuscript submission

Why Bother Writing? • >80% of the way there • Share knowledge/progress scientific thought • Ethical • Legal protection of intellectual property • Gain reputation • Improve chances of promotion

International Committee of Medical Journal Editors (ICMJE) • Uniform requirements for manuscripts • Help create and distribute accurate, clear, easily accessible reports of biomedical studies • Guidelines for: - Ethical • Peer-review, conflicts of interest, copyright, protection of human subjects - Authorship Manuscript format and content Referencing http: //www. icmje. org

Authorship • Ideally, discuss upfront • No rule on number - Generally, <6 - Depends on article ‘type’ • Authorship order - No formula - 1 st: usually person who conceives idea, did the most work, and/or prepares 1 st manuscript draft or a junior in need of a publication - Senior: 2 nd position or last

Authorship 1. 2. 3. 4. Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; Drafting the article or revising it critically for important intellectual content; and Final approval of the version to be published and Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Authors should meet all conditions

Activities that DO NOT Qualify • • Data collection Securing funding General study supervision Administrative positions - Department heads • “Gift” authorship…No, no!

Acknowledgments • Consider when someone has contributed but does not meet “authorship” criteria • Examples: - Technical help with data collection - Editorial review - Financial granting - Department heads, supervisor • Obtain written permission from person you wish to acknowledge

Manuscript Content: Title • Spend time!!! • Indexing and abstracting rely on accuracy of title • Short and Sweet - Should accurately convey content of article - Include subject matter NOT findings • When to draft? - Debatable • Target based on journal audience

Manuscript Content: Running Title • Short version of the title • Header on the top of each page of article • Limited in length - 50 -75 characters

Manuscript Content: Title Page • Title • Authors and Affiliations (in order) - Degree(s), sometimes credentials - Include cross-appointment title • Corresponding Author/Reprint Requests - Name - Address - Phone and fax number - E-mail address

Manuscript Content: Abstract • 2 nd most important part!! • Background - 1 -2 sentences • Methods - Basic procedures, design, setting, selection criteria, stats • Results - 1º only • Conclusion • Several drafts!!

Manuscript Content: Keywords • • Used for abstracting and indexing Most important concepts 3 -10 words How to come up with? - Make them up - MESH - Something else? • Demonstration

Manuscript Content: The Body Introduction Methods Results and Discussion

Manuscript Content: Introduction Broad statement of disease In question/impact of particular topic Review of published literature regarding your topic Outline gaps in literature Research Question/Objective

Manuscript Content: Introduction • Provide sufficient information on the topic • BRIEF: - Summary of what has been done in the area - Nature of the problem and its potential significance - Provide references to prior relevant work • Allow reader to understand topic without having to read prior literature - Sometimes written or finished last

Manuscript Content: Introduction “Errors” • • • Too long/rambling Extensive list of references Extensive critique of previous work Missing important previous work Objectives unclear Reporting data from the current study

Manuscript Content: Methods Describe the research plan Describe the subjects Describe the procedures

Manuscript Content: Research Plan • Study Design - Randomized: describe treatment arms • Study setting - description of KPCO - description of specific service (CPCRS, CPAAS) • Study Sponsor • Include whether IRB approval obtained - Informed consent

Manuscript Content: Study Subjects • Study Eligibility - Inclusion - Exclusion • Sometimes get into procedures here - Matched, retrospective studies • Be specific!

Manuscript Content: Procedures • How were subjects identified, screened, enrolled - Include dates, ICD-9 codes - Administrative, other? • Describe intervention and control groups • Data collection • Study outcome - What - How assessed • Statistical Analysis

Manuscript Content: Methods • Be systematic • Do not mix results with the methods • Do not explain methods or provide background - Except in specific/unusual circumstances • Study design, statistical analysis (i. e. , CDS) • Do not include irrelevant information

Manuscript Content: Results • Subject disposition - Consider patient disposition figure • Description of subject characteristics - Table 1 - Do not repeat in text • Primary outcome results - Table/Figure 2 • Secondary outcome results - Table/Figure • Ensure results match objectives • Use tables/figures to display results

9035 patients with index event between 1/1/96 -06/30/2004 Excluded: 1754 > 80 years at time of event 411 CCC exposure prior to index event 473 died within 30 days of Index event 1501 KPCO membership criteria no met 4896 included in study cohort Continuous CCC Early CCC n= 1630 Delayed CCC n= 1211 Non. Continuous CCC No CCC Intermittent CCC n= 483 Usual Care n=1572

Example: What are the problems? Any CCC by Cohort Early Delayed Intermittent No CCC p-value Age 61. 7 61. 3 63. 2 59. 5 64. 6 NS Male 67. 9 68. 2 65. 3 73. 7 59. 9 NS Female 32. 1 31. 8 34. 7 26. 3 40. 1 NS 927 (27. 9) 472 (29. 0) 301 (24. 9) 152 (31. 5) 59. 9 (4. 1) 0. 258 172 (5) 52 (3) 79 (7) 40 (8) 64 (4) <0. 00001 1027 553 327 149 219 0. 0589 1199 (36. 1) 553 (33. 9) 504 (41. 6) 142 (29. 4) 347 (22. 1) 0. 03 Any-cause Death 7. 8 -- -- -- 29. 4 <0. 001 Cardiac-related Death 5. 3 -- -- -- 46. 9 <0. 001 Index Event (n, %) AMI w/PCI & Stent PCI w/ or w/out Stent

Example: Results (table 2) Any-Cause Death Cardiac-Related Death 46. 9† 29. 4† 7. 8 5. 3 46. 9‡ 29. 4‡ Early CCC (1630) 4. 7 3. 0 Delayed CCC (1211) 8. 6 5. 9 Intermittent CCC (483) 16. 4 11. 4 Cohort Arm (n) No CCC (1572) Any CCC (3324) Time-Varying Cohort No CCC (1572) † - P<0. 001 between groups ‡ - P<0. 001 across groups

Manuscript Content: Discussion • Do not repeat the results - “Discuss” the results • No not introduce any results not already presented in the results section • Sometimes most difficult part to write Open slate but tell the story!!

Manuscript Content: Discussion • Answer the question/problem stated in the introduction • How do your results support answer? • How does your answer fit with existing knowledge? • What do the findings mean? • What are the limitations of your research • What are the future research questions • Include a “conclusion” paragraph

Manuscript Content: Discussion • Reference to other studies are important • Summarize the finding in your own words and cite the source • Be careful how much detail you provide on prior studies - Design, intervention, number, and main result • Do not use Author name, et al • Direct quotations not practiced • Careful not to be too wordy!!

Manuscript Content: References • Any information/idea that is not your own needs a reference • Be inclusive • Style and number varies by journal • Keeping track through drafts - Use author last name, change to numbers at near final draft • Reference tools - Endnotes - Reference Manager

Manuscript Content: Tables and Figures • After Reference List: - Tables then - Figures

Questions?

Writing Techniques • Organize thoughts - Major points - Get group feedback on this • Get thoughts down on paper - Outline first - Write then “after the fact” outline • Use protocol to help get you started • Writer’s block - Take a break, come back to it

Writing Techniques • Working with a group - Identifying one writer vs. assigning sections - Discuss upfront • Handling multiple reviews at once - One reviewer at a time - Merge documents in Word - Save prior versions labeled accurately • Iterative process - Many pairs of eyes - Many drafts - Don’t take it personal

Writing Style • Use past tense • First vs. Third Person - Some journals more lenient - Limit use of first person to introduction and discussion “We”, “Our study” - Avoid in methods and results • Use terms consistently • Limit abbreviations

Writing Style • Complete sentences and easily understood • Paragraph - Introduction, body, and end of same topic - End should lead to next paragraph • Write precisely - Choose words correctly and wisely • Write concisely - As few words as possible • Avoid embellishment

Writing Style: Write Tight! • Limit words to make your point • Avoid phrases that do not contribute to understanding - “In order to. . ”, - Title of results table “Results of XX” • Careful with “it” or “they” referring to concept from previous sentence • Avoid “dangling” modifiers

Dangling Modifiers Dangling: Using the survey data, the effects of health education on patient satisfaction were examined. Corrected: We examined the effects of health education on patient satisfaction using survey data.

Dangling Modifiers Dangling: At the age of eight, my family bought a dog. Corrected: My family bought a dog when I was eight.

Writing Style • Use ACTIVE verbs "oxygen was consumed by the mouse at a higher rate. . " "the mouse consumed oxygen at a higher rate. . . "

Writing Style: Avoid Jargon • Do not assume readers know what you are referring to • CDTM protocol • Therapeutic interchange/conversion • Other examples?

Submitting the Final Manuscript • Journal Selection - Audience? - Solicit feedback from others • • Impact Factors Be realistic! Follow the Guidelines for Authors Get use to rejection

Miscellaneous • Copyright Release Forms - Include if manuscript accepted - Can wait until after manuscript is accepted • Keep study open with IRB until after it is published