ASPIRE CLASS 2: Writing Basics: Background and Protocol Katy Trinkley, PharmD, BCACP Assistant Professor, University of Colorado

Outline Research protocols Background/introduction Scientific writing pearls Writing for your audience Efficient writing Practice

Scientific Writing Phases Protocol for IRB (and grant proposal) Study conduct and analysis Abstract for poster presentation Manuscript for publication

Research Protocol: Purpose IRB reviews to evaluate from ethical standpoint Guides/grounds your study conduct Makes manuscript writing MUCH easier!

Research Protocol: Flow and key components Core Headings and Sections Background/Introduction Purpose/objectives Methods Study design, eligibility, data source(s) and collection, outcome measures, data analysis plan  Specific headings/sections guided by individual project and IRB

Background/Introduction: Purpose Explain importance Bolster excitement and interest to readers/reviewers Identify NEED for your study

Background/Introduction: Flow and key components Broad statement of disease in question/impact of particular topic Review of published literature regarding your topic Outline gaps in literature and why a solution is needed Research Question/Objective

Scientific Writing Pearls Avoid obtuse or inflammatory statements Be careful with absolute statements and conjecture Be explicit Avoid “it” or “they” in reference to a prior sentence Be objective – reference primary literature when possible/applicable (not reviews) Package inserts NOT UpToDate/LexiComp/Micromedex

Other Scientific Writing Pearls Write “tight” Avoid “fluff” and unnecessary words e.g., “that” Use active verbs Creates interest Include transitions between sentences and paragraphs  reviewed later when you are preparing your manuscript

Consider Your Audience ALWAYS write simply You are smart and likely write accordingly  complex, hard to read, disengages the reader/reviewer Use simple words e.g., utilize vs use Avoid jargon

Consider Your Audience Be consistent with terminology e.g., patients vs subjects; quality metric vs value-based metric Abbreviations – minimize and use carefully IRB protocol reviewer  Likely not familiar with your field/topic

Efficient Writing: Get it on paper! Draft 1 Don’t deliberate on each word or sentence Put your thoughts on paper as they come to you Use x’s for facts/data/references to be inserted later to keep your thoughts flowing Fix grammar, spelling, word choice and sentence structure LATER

Get in Groups of Two Sketch out the headings/sections for your research protocol Consider your specific project and IRB Draft your background/introduction Efficiently – placeholders for data and references Effectively – follow the “triangle,” consider audience and pearls Share your protocol outline and background with your partner Provide constructive feedback - use the checklist

ASPIRE CLASS 2: Writing Basics: Background and Protocol Katy Trinkley, PharmD, BCACP Assistant Professor, University of Colorado