Biostatistical Working Group

Conference Call Monday, March 14, 2011

Informational Items:

1. Restricted data items document shared on February call. If these data are necessary for a publication Biostats professional should contact Mary P at the CCC to determine the best approach in moving the manuscript forward (i.e. surrogate indicators, CCC leading analysis, etc)

2. New datasets while set to be released at a specific timepoint will require about 6 months of CCC “beta-testing” in the context of ms development before being released to the entire group for statistical analysis.

3. SharePoint user group is gradually expanding. The estimated time for Biostats group to have access for correspondence is summer 2011.

Conference call leadership and objectives

There was a discussion regarding planning for the Biostatisical group calls. Early on and over the past few months the purpose of the calls was to orient the RC Biostats group to the WHI data set, form a cohesive group, address emergent issues such as data access, use, policy, etc and to open communications between RC Biostats professionals and contact personnel within the CCC as well as the P&P.

As these issues have resolved and the group members have advanced their understanding of their role and the process as well as the dataset there is a need to redefine the objectives of the group and to consider internal leadership of conference calls with attendance/support from CCC and P&P representatives. The group will consider this idea and how it might formulate into a model similar to the WHI Scientific Interest Groups and we will discuss on the next call.

Methodological MS

As professionals in biostatistics it is important that you have an opportunity to develop methodological manuscripts for your own intellectual purposes beyond the more supportive role requested in non-statistical method/ more epidemiological manuscript analyses. The P&P would like to encourage this; such ms would be considered in the overall workload/assignments for RC Biostats.

Manuscript Tracking Form

There was further discussion regarding the need for ms tracking. Claudine was unable to make the call, but had previously discussed sharing the form the SE RC is using. We will try to circulate that form to the group asap so individual RCs can consider a similar approach for tracking their work.

There was follow up discussion regarding how ms are assigned. Currently Mary Pettinger is making assignments from the CCC queue of ms. She is considering previous assignments, RC-specific SIGs and interest areas, as well as whether the lead author requested an RC Biostats group to assist in the analysis (checkbox on ms proposal form revised November, 2010). It was suggested some type of flow sheet indicating the current approach/considerations in assignments be developed by Mary P in order to provide more transparency to the process. This issue was also presented as a potential discussion item for the Biostats training meeting in Seattle in May, 2011.

Items for Biostats Training in May, 2011 (Seattle)

Mary P provided an overview of her ideas for the training session that will expand upon previous experiences from data training workshops. The items include:

1. Overview of WHI protocol and changes in protocol over time

2. Review of specific issues with the dietary data (M Neuhouser)

3. CMS and medication data updates

4. Outcomes data

5. Discussion of analytical issues such as missing data, outliers, etc to assure consistency in approach across ms

6. Walk through a derivation of an analytical file from a sample ms analysis

RC Biostats members were encouraged to send any additional ideas for training session content to Mary or LeaEllen for consideration by March 31, 2011.

Next call Monday April 11 at 8:30 pacific time.