1. Using a journal club to review and reinforce concepts for medical researchers
Brian Healy, Amy Shui

2. Outline Approaches for journal club
Live sessions as part of a web based course: Harvard Catalyst Certificate in Applied Biostatistics
Student chosen articles: Program in Clinical and Translational Science
Participation in journal clubs for specific hospital departments: MGH PICU and Partners MS Center
Dropbox with materials for each session
me for access

3. Background
Statistical techniques used within the medical and basic science literature are becoming increasingly complex
Readers of medical papers often ignore the statistics section despite valuable information being presented due to complexity of actual approach or language
Nearly all medical researchers participate in journal clubs discussing recent articles so it is a easy to adopt format for these students

4. Harvard Catalyst Certificate in Applied Biostatistics
35 week on-line introduction to biostatistics (n~200)
In addition to the main content of the course, every 3-4 weeks we have a journal club discussing a recent article from NEJM or JAMA (n~15)
Goals:
Review concepts taught recently in class by reading through article
Reinforce ideas by seeing them from an alternative framework
Some journal clubs introduce a new topic that is an extension of what we cover in class

5. Format
Article and an associated case study with questions sent out to class prior to session
Questions focus on scientific question, analyses chosen and special features of paper (missing data, interim analyses, advanced modeling)
15-20 minutes of small group discussion of case study questions
40-45 minutes of full class discussion of case study questions

6. Review introductory concepts
After about 6 weeks of the course, we have a journal club discussing a randomized trial with a dichotomous secondary outcome
Article: Nielsen et al. Targeted Temperature Management at 33°C versus 36°C after Cardiac Arrest. NEJM 2013; 369:
Questions from session:
How was sample size calculation completed?
What analysis was performed?
Were the estimate of the effect and hypothesis test consistent?

7. Reinforce interpretation of interaction terms
About halfway through the course, we discuss an article assessing the interaction term in a logistic regression model
Article: Le Cook B et al. Trends in Smoking Among Adults With Mental Illness and Association Between Mental Health Treatment and Smoking Cessation. JAMA. 2014;311(2):
Questions from session:
What is the interpretation of each main effect and each interaction term?
How was the final model chosen?
How was missing data handled?

8. Discussion of advanced clinical trial designs
The fourth unit of the program focuses on study design including clinical trials and the associated journal clubs focus on special issues in RCTs
One journal club discusses a 2x2 factorial design
Article: Tewari KS et al. Improved Survival with Bevacizumab in Advanced Cervical Cancer. N Engl J Med 2014;370:
We discuss estimation of two treatment effects in a single trial as well as interaction between treatments
This study also has interim analyses so we discuss stopping rules
A second journal club discusses a non-inferiority trial
Article: Giugliano RP et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2013;369:

9. Interpretation of survival analysis
Near the end of the course, we introduce Cox proportional hazards models
Article: Goldenberg I et al. Survival with Cardiac-Resynchronization Therapy in Mild Heart Failure. N Engl J Med 2014;370:
In this article, one factor is a strong effect modifier for the treatment of interest
Questions from session:
How do the Kaplan-Meier curves show effect modification?
How did they test for subgroup differences?

10. Pros/Cons for on-line program
Provide a live component to review and reinforce concepts
Demonstrates application of concepts presented in the course in the literature
Allow introduction of extensions to concepts
Wide range of articles in medical literature can fit many potential scenarios
Cons
Lose flexibility of on-line program
Limited participation

11. Program in Clinical and Translational Sciences
A smaller program of students (n~20) using similar on-line course with additional mandatory in person sessions
Two hour session biweekly for 4 months with one hour devoted to journal club
One student choses articles to present using recent literature
I develop case studies associated with article

12. Phase II trial in cancer
A student was a cancer researcher whose research was impacted by a recent publication
Finn et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncology 2015;16:25-35
Questions from session:
Why do authors use a one-sided alpha level of 0.1?
What is the impact of interim analyses on final analysis?

13. Pros/Cons of student chosen articles
Student volunteers can provide perspective regarding the rationale behind the design
Can address specific statistical issues facing a student
Articles in NEJM/JAMA usually have large sample size so different statistical issues are discussed in student selected articles
Cons:
Can be challenging to engage a larger group if article is too specific
Student volunteers harder to get than I imagined

14. Department specific journal clubs
A former student of Certificate Program from PICU at MGH invited me to attend monthly journal clubs to provide a “biostatistician’s perspective” on articles they were discussing
My primary appointment is at the Partners MS Center, and I perform a similar role at the journal club there

15. Pros/Cons of department journal clubs
Attendees of journal club very appreciative
Valuable for statistician if this is their area of research
Cons:
Reasonably large time investment for the statistician
Importance of statistician attendance depends on article

16. Conclusion
Journal clubs provide an excellent way to reinforce and review statistical concepts for medical researchers
Journal clubs within a formal course provide an opportunity to review and reinforce many concepts within an on-line course
Attendance of a biostatistician at hospital department journal clubs can enhance understanding of recent literature for participants