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

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

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

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

5. 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

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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

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