Charles R Clark, MD Deputy Editor, JBJS Insights into the Editorial Process in 2016 Career Development Series How to Achieve Excellence in Research Methodology Charles R Clark, MD Deputy Editor, JBJS Dr Michael Bonfiglio Professor of Orthopedic Surgery University of Iowa, Iowa City, Iowa

Introduction - Can’t learn it in a day - Can learn an approach Goal - Enable an individual, particularly a young investigator, to ask the correct questions to get answers

The Basics Know your topic Do a good literature review Many “novel” ideas have been pursued before More data doesn’t always mean better data Old adage, ‘garbage in/garbage out’

Why Studies ‘Die’ Not feasible Not vetted (not an important question) Poor study design to adequately answer the question Submitted to the wrong journal/the wrong audience

Approach Develop an idea for a study Ask the correct question is it an important question? is the answer already known? Critically analyze feasibility adequate patient numbers, large numbers needed, long follow-up needed, etcetera cost: money, time, resources, etcetera

Study Design Need appropriate design to answer the question ‘tension’ between design and feasibility ‘conflict’ between Level I/RCTs and retrospective reviews value in retrospective reviews (may be the basis for more rigorous study) RCT may be cost prohibitive

Engage ‘Partners’ Early Successful investigator surrounded by smarter and more experienced persons Seek wisdom and listen even if painful ‘Friendly fire’ better than ‘polite nods’ and preferred to manuscript rejection Statistician is not a ‘hired hand’ Partner early with statistician; serves an author Value to survey work with peers to establish value of clinical question (e.g. proving there is a lack of concensus on a treatment question)

‘Big Data’/Database Studies Useful when the topic is complicated Before electing a methodology that few understand ask whether traditional methods can answer the question; they generally can!

Know and Seek Valuable Resources Consult Instructions to Authors for the particular journal: JBJS: http://jbjs.org/instructions-for-authors Randomized Controlled Trials (RCTs): - CONSORT checklist: http://www.consort-statement.org Cohort, Case-Control and Cross-Sectional studies: - STROBE Panel format: http://www.strobe-statement.org Meta-analyses: - PRISMA criteria: http://www.prisma-statement.org

Summary Ask correct question Review the literature Seek wisdom and listen Partner with a statistician Assess feasibilty Use appropriate study design Know and use resources for study design Consult the Instructions for Authors

Developing the correct approach to answer an important question is the best way to obtain meaningful results