Objectives. Why Bother Writing? Manuscript Preparation for Publication

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Manuscript Preparation for Publication Kari L. Olson, BSc(Pharm), PharmD, 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 1

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. Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2. Drafting the article or revising it critically for important intellectual content; and 3. Final approval of the version to be published and 4. 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 2

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 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 3

Running Title Short version of the title Header on the top of each page of article Limited in length - 50-75 characters 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 Abstract 2 nd most important part!! Background - 1-2 sentences Methods - Basic procedures, design, setting, selection criteria, stats Results - 1º only Conclusion Several drafts!! 4

Keywords Used for abstracting and indexing Most important concepts 3-10 words How to come up with? - Make them up - MESH - Something else? Demonstration The Body Introduction Methods Results and Discussion 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 5

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 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 Methods Describe the research plan Describe the subjects Describe the procedures 6

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 Study Subjects Study Eligibility - Inclusion - Exclusion Sometimes get into procedures here - Matched, retrospective studies Be specific! 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 7

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 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 Non- Continuous CCC No CCC Early CCC n= 1630 Delayed CCC n= 1211 Intermittent CCC n= 483 Usual Care n=1572 8

Example: What are the problems? Any CCC CCC by Cohort No CCC p-value Early Delayed Intermittent 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 Index Event (n,%) AMI 927 (27.9) 472 (29.0) 301 (24.9) 152 (31.5) 59.9 (4.1) 0.258 AMI w/pci 172 (5) 52 (3) 79 (7) 40 (8) 64 (4) <0.00001 AMI w/pci & Stent 1027 553 327 149 219 0.0589 PCI w/ or w/out Stent 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 Example: Results (table 2) Cohort Arm (n) Any-Cause Death Cardiac-Related Death No CCC (1572) 46.9 29.4 Any CCC (3324) 7.8 5.3 Time-Varying Cohort No CCC (1572) 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 - P<0.001 between groups - P<0.001 across groups 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!! 9

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 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!! 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 10

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 11

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 12

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. 13

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 14

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 15