Summary Abstract for Methodology Core

Patrick J. Heagerty

1. Provide Project investigators a centralized resource for statistical and epidemiological collaboration, coordinated protocol development, data management and data analysis.
2. Vigorously support scientific communication among project investigators as well as communication of research findings to persons outside the team through formal and informal seminars and electronic communication.
3. Ensure the highest quality scientific research by organizing formal protocol review, study monitoring, and manuscript review committees that will promote rigorous biostatistical and epidemiologic methods. Formal oversight ensures that valid, efficient, and ethical research is conducted.
4. Serve as an educational resource for issues related to study design and analysis.

Accomplishments:

The methodology core has been active in collaborating with specific projects to refine study designs, to develop/refine data collection instruments, to develop study monitoring plans, to develop data collection methods, and to develop/refine data analysis plans. The methodology core has organized seminar presentations of study protocols to core and non-core members which have lead to improvements in the design of the Carpal Tunnel Randomized Study (Project 1) and the Discogenic Back Pain Cohort Study (Project 2). Members of the methodology core have been active in helping to select items/instruments and developing the forms for projects 1 & 2. The core statistician has been working with specific project investigators to create detailed analysis plans prior to study initiation. In addition, the core computer programmer has created randomization mechanisms, data collection screens, and study databases. Database work has been initiated for the Epidemiology of Lumbar Surgery Study (Project 3) and preliminary analysis has described temporal trends in utilization. A number of educational presentations have been given to introduce the University of Washington research community to MCRC research initiatives. Finally, members of the methodology core have collaborated with center members to solicit/obtain research funding for MCRC related projects (Mirza, Kallmes, Jarvik).

Goals:

• The methodology core will continue to collaborate on statistical and epidemiological aspects of study design, conduct, and analysis.
• The methodology core will hire a programmer to develop a center web page and organize the electronic sharing of information.
• The methodology core will identify educational opportunities within UW and nationally to foster sound epidemiologic and statistical practice in the study of surgical interventions.

Questions:

• To what extent does the MCRC want to develop multi-site study coordinating capacity?
• Is there an opportunity to educate the broader surgical research community through peer-reviewed publication of review articles that discuss epidemiologic and biostatistical issues relevant to both observational and randomized studies of surgical outcomes?