VetClin 576 Introduction to Clinical Research

VetClin 576 Introduction to Clinical Research

Last update 4/7/21

Page evolves as semester progresses!

Purpose:

Provide links to handout and on-line materials for this year's class 

Sessions:  2021 - via Zoom, timing to be established by participants

Week  1  2  3  4  5  6  7   14                                            (cal pdf)

Week 1: Introduction:

Handouts:

• 2021 Syllabus - PDF - read & click through hot links - (2020 - pdf)
• Proposal Framework Guide - PDF - begin developing framework
  •  Optional Word template - docx
• Creating a collaborative peer writing group during residency. H Lukolyo, EM Keating, CA Rees (2018). Med Educ Online  24(1), 1563421- PDF

Videos to view, noting the key points about the review process and what makes proposals outstanding:

• Science Writing: Practice makes it (almost) perfect - YouTube  (25:00)  Dr. Ginger Carney, UI Dean College of Science

• NIH Peer Review Revealed - YouTube  (14:51)
• NIH Tips for Applicants -  YouTube  (4:37)

On-Line papers to read for concepts and terminology:

• Evaluation of the Evidence. Holmes, MA (2007). Vet Clin Small Anim 37:447-462. - online  (Note the study diagrams)
• Understanding and Evaluating Veterinary Clinical Research, Buhles WB, PH Kass (2012). Journal of the American Animal Hospital Association Sep/Oct 2012, 48:285-298 - pdf    (Note the Glossary!)
• Invited Review: Study Design Considerations for Clinical Research in Veterinary Radiology and Radiation Oncology, PV Scrivani, HN Erb (2013). Vet Radiol Ultrasound, 54(4):317–325 -  pdf  (Note Table 2!)

Suggested presentations to view:

• Grant Writing 101: It's not rocket surgery -  YouTube  (24:30)
• 2013 AAVC Residents' Professional Development and Leadership Conference:
  • Turning a Clinical Question into a Testable Hypothesis - LA Trepanier, U Wisc - video

Suggested reading:

• Chapters 1 and 2 in Holmes and Cockcroft, Hulley et al., or Portney and Watkins
• Chapters 1 and 2 in Ruxton and Colegrove
• selected papers from The Lancet 359 (2002) Epidemiology Series - DA Grimes, KF Shultz:
  • An overview of clinical research: The lay of the land. The Lancet 359:57-61.  online
  • Descriptive studies: What they can and cannot do. The Lancet 359:145-149.  online
  • Bias and causal associations in observational research. The Lancet 359:248-252. online
  • Cohort studies: Marching toward outcomes.  The Lancet 359:341-344.  online
  • Case-control studies: Research in reverse.  The Lancet 3359:431-434.  online

Week 2: Experimental Design / Sample Size  

Handouts:

• Clinical study design tree, study weak points, and their correction - PDF (summarizes key concepts from the three concepts and terminology papers above - Know these!)
• Ishikawa (Fishbone) variance diagram - PDF (all potential sources of variation I could think of)
• Sample size estimation steps - PDF
• Anonymous successful grant examples

Online papers addressing statistics / sample size:

• Statistics 101 for Radiologists, A Anvari, EF Halpern, AE Samir (2015). Radiographics 35:1789-1801 - pdf  (good statistics refresher)
• Why perform a priori sample size calculation? Farrokhyar F, et al Can J Surg 56(3):207-213 (2013) - pdf 
• Sample Size Determination (ILAR J 43(4):207-213, 2002 html pdf)

On-line chapters to read:

• Chapter 2 “Conceiving the Research Question and Developing the Study Plan” of Designing Clinical Research, 4th ed (Amazon)   (Note Figure 2.1 the research physiology diagram and Table 2.1 the FINER acronym!)
• Chapter 2: Sample Size - from Van Belle (2008) Statistical Rules of Thumb 2nd ed - pdf

Other Items:

• CISER WSU Center for Interdisciplinary Statistical Education and Research

Up to 6 Engaged Learning Hours annually of no-cost statistical assistance for:

• Design of experiments
• Analysis and interpretation of data
• Grant proposals

Note: Having your Proposal Framework reasonably well fleshed out so that a consultant can easy grasp the overall project will facilitate your discussions with them

• GWC WSU Graduate Writing Center
• Sample Size Determination in Health Studies: A practical manual, SK Lawanga, S Lemeshow, WHO 1991- pdf

Week 3: Rejection, Discussion and Literature Searching

On-line handouts:

• Why research grant proposals are rejected - PDF
• Combined resident grant reviews - PDF

Dr. Suzanne Fricke, Animal Health Librarian - Animal Health Library - meet in ADBF 2018, bring laptop

Sites and resources from Dr. Fricke's presentation:
• WSU Library Guides:
  • Research Support
  • EBVM Resources
  • Veterinary Medicine
  • IACUC Guide
  • Board Preparation
  • Proxy Bookmarklet
• EDA - Experimental Design Assistant
• Google Scholar
• ORCID author database
• Semantic Scholar - Allen Institute, Seattle
• The EQUATOR Network - reporting guidelines for main study types
• EBVM Resources - Databases and websites for veterinarians
  • PICO.vet - building a well-structure, focused clinical question for literature searching
  • PubMed topic specific - veterinary science
  • BestBETs for Vets - review of current best evidence for common specific clinical questions
• Love Data Week (how to take better care of your data) - formerly Love Your Data
• NCBI PubMed Help and Tutorial Section (extensive)  - Training Tutorial

Web of Science Quick Reference Guide - pdf  - Training Tutorial

• EndNote Quick Reference Guide - pdf

websites:

• EDA - Experimental Design Assistant
• 3Rs - Reduction.co.uk, MFW Festing - experimental design short course for studies using animals
• NIH NIAID Grant Proposal Examples - The "Gold Standard"

On-line applied biostatistics collections:

• Statistics Simplified (S Shott, 2011):
  • Designing studies that answer questions (S Shott, JAVMA 238(1):55-58) - pdf
  • Detecting statistical errors in veterinary research (S Shott, JAVMA 238(3):305-308) - pdf
  • Describing data (S Shott, JAVMA 238(5):588-591) - pdf
  • Testing ideas and estimating clinical importance (S Shott, JAVMA 238(7):871-876) - pdf
  • Comparing percentages (S Shott, JAVMA 238(9):1122-1125) - pdf
  • Comparing means or distributions (S Shott, JAVMA 238(11):1422-1428) - pdf
  • Relationships between two categorical variables and between two noncategorical variables (S Shott, JAVMA 239(1):70-74) - pdf
  • Relationships between categorical dependent variables and other variables and between waiting times and other variables (S Shott, JAVMA 239(3):322-327) - pdf
  • Relationships between more than two variables (S Shott, JAVMA 239(5):587-593) - pdf
  • Wrapping it all up (S Shott, JAVMA 239(7):948-950) - pdf
• Explorations in Statistics (list of 12 special papers in Advances in Physiology Educ ) - html

Week 4: Peer Discussions of Proposal Framework, Writing Grant Proposal Elements

Online handouts:

• Using the Scientific Literature for Grant Proposals - PDF  (note literature types and which to use or not!)
• Spotting Model Gaps and Errors - PDF
• Study Framework Evaluation - PDF  doc
• Thoughts on Grant Proposal Components
  • part 1 - PDF
  • part 2 - PDF
• Compiled Specific Aim Advice and Examples - PDF
• Sample Size and Statistical Analysis Statement Examples - PDF

Online Papers - Dr. Robert Porter:    (Read these!)

• A Starting Point: Six critical questions to launch a successful grant proposal - pdf
• Crafting a Sales Pitch for Your Grant Proposal - pdf
• Why Academics Have a Hard Time Writing Good Grant Proposals - pdf
• What do Grant Reviewers Really Want, Anyway? - pdf

Recent on-line writing guidance: (much in the primary scientific literature)

• Grantsmanship writing tips (European J Int Med):      (Read these!)
  • What? Who? How? (57:22-24 (2018)) - pdf
  • Background, hypothesis and aims (61:25-28 (2019)) - pdf
  • The experimental design (64:21-23 (2019)) - pdf
  • Significance, innovation and impact (65:26-28 (2019) - pdf
• Introduction to the Specific Aims Page of a Grant Proposal (Acad Emerg Med. 2018 Sep; 25(9):1042–1047) - pdf
• The Jewel in the Crown: Specific Aims Section of Investigator-Initiated Grant Proposals (J Endocrine Society. 2017 Sep; 1(9):1194–1202) - pdf
• How to Prepare for and Write a Grant: Personal Perspectives (Gastroenterology. 2017; 152:7-11) - pdf 
• Writing Clarifies Thinking - Ameet Ranadive, Lessons from McKinsey, 7/28/13 
• Writing to clarify thoughts - Beh Kuhn, 3/13

Other:

• Scoping Reviews, Systematic Reviews, and Meta-Analysis: Applications in veterinary medicine (Front Vet Sci, 28 January 2020) - html
• How to critically appraise a paper (Eq Vet Educ, 32(2):104-9, 2020) - pdf
• Observational Study Design in Veterinary Pathology, Part 1: Study Design ( Vet Path, 55(5):607-21, 2018) - pdf
• Observational Study Design in Veterinary Pathology, Part 2: Methodology ( Vet Path, 55(6):774-85, 2018) - pdf
• Reporting results with (Un)certainty ( Vet Clin Path, 48:259-69, 2019) - pdf
• Scimago Journal & Country Rank - Veterinary

Week 5: Storyline and Writing Guidance

On-line Handouts:

• Word Usage in Scientific Writing - PDF
• The Paramedic Method - PDF  (self-editing skills)

Other Online Materials:

• Ten things that can sink a grant proposal: Advice for a young psychologist - html  (Note #1 & #2!)
• Inverted Pyramid - wiki 
• Burying the lede - html - html2
• The Science of Scientific Writing, American Scientist - html  pdf
• Why proposals are rejected - html  (included in handout on rejection)
• Stanford STEM writing style guide - pdf  (excellent guidance summary)

Week 6: Getting to Clarity

On-line Handouts:

• Deconstruction, Interrogation & Construction - PDF
• Proposal Framework Guide - PDF
• Spotting Model Gaps and Errors - PDF

On-line materials to read:

• Research questions, hypotheses and objectives - Can J Surg 2010 Aug; 53(4): 278–281 - html
• The Feynman Technique - Scott Young pdf
• The Five Whys Technique - Knowledge Solutions pp 307-10 html
• Deconstructing a Research Article - pdf
• Chapter 2 “Conceiving the Research Question and Developing the Study Plan” of Designing Clinical Research, 4th ed (Amazon)   (Note Figure 2.1 the research physiology diagram and Table 2.1 the FINER acronym!)

Week 7: Simplify, Simplify!

On-line Handouts:

• Pablo Picasso's Bull: Simplify, Simplify - PDF
• How Apple Uses Picasso To Teach Employees About Product Design - FastCompany 8/11/14
• Animals in Art - Pablo Picasso 'Bull' 1945 - 8/11/14
• How The Wrong Artist Got Credit For Inspiring The Macintosh Logo - FastCompany 2/8/14
• The Secret: What Makes a Great Photo - Ken Rockwell html
• "As simple as it can, but not simpler" - Roger Sessions html
• The Paramedic Method - PDF  (self-editing skills)
• Richard Lanham - Revising Prose - 28 min YouTube
• Specific Aim Advice and Examples - PDF
• Example VCS resident/graduate student grant proposals (some details and required attachments removed for anonymity)
  • Example 1 (pilot study) - pdf
  • Example 2 (resubmission) - pdf
  • Example 3 - pdf
  • Example 4 - pdf
  • Example 5 (old) - pdf
  • Example 6 (precis) - pdf

Handouts:    

• Study Framework Evaluation and Scoring Rubric - PDF   doc
• Grant Scoring Rubric - PDF  (slightly different from Framework Scoring rubric)

Week 14: Submit Proposal

Completed proposals due as pdf to Dr. Michael Court, VCS Research Committee Chair by 5:00 PM Monday, April 19th, 2021