WHI Biostatistical Research Team Conference Call

WHI Biostatistical Research Team Conference Call

MINUTES

WHI Biostatistical Research Team Conference Call

January 24, 2011

1. Biostatistical Training Meeting

2. The training meeting will be held on-site in Seattle and led by the CCC Biostats group. The meeting will take place May 4, 2011. Funding is available for one representative from each RC to attend; however, RCs may decide to fund additional attendees.

There was discussion regarding attendance of the Biostatisticians at the PI meeting on May 5 and 6. It is unclear if the meeting on the 5th and 6th will be open to the biostats group.

ACTION: C. Thomson to send email to garnet and/or discuss on next SC call. Once a decision is made the group will be notified by email so that they may move forward with travel plans.

There was a call to request agenda items for the meeting. Please forward issue/ideas to Mary Pettinger who will lead this effort.

3. Manuscript Assignment Tracking

We have not yet developed an official tracking system re: RC assignments, but the WHI has a system that is used in the study overall. This can be found in the annual report along with a listing of all manuscripts. The scoring stages are summarized below:

Stage # / Definition
12 / Published
11 / In press/accepted
10 / Submitted to journal
9 / Final manuscript approved by P&P
8 / Final manuscript submitted to P&P
7 / Draft manuscript developed
6 / Analysis completed
5 / Analysis in progress
4 / Analysis proposed
3 / Manuscript proposal and writing group approved
2 / Manuscript proposal approved by P&P, writing group nominations open

Claudine is developing a tracking system for use at the regional center level and will share with the group. P&P will work with LeaEllen and the CCC to determine a tracking system for RC assignments in relation to workload. As the regional structure evolves we will query the RCs in this area to be sure the assignments are being distributed in such a way as to expedite manuscript development and publication over the entire study.

4. Progress with Assignments

Generally the individual RCs are moving along with their initial assignments and are also providing support to RC investigators who are developing new ms proposals.

A few issues did arise including access to data that could be considered identifiable. CCC has specific restrictions that must stay in place – for example in relation to zip code data or clinical site. In instances where this type of data is needed Garnet has advised the biostats group to simulate the model and have the CCC verify.

ACTION:

a. Develop a list of variables that cannot be released and consider these variables as assignments are made at the CCC versus regional level <Mary P and LeaEllen>

b. Discuss with Garnet the possibility of greater flexibility in sharing these data with RC leads <Mary P>

Additionally, it was noted that select variables developed thru the ancillary studies (AS) may or may not be available in the WHI dataset. While the sharing of variables is required for AS the timeline for doing so may vary widely. It is suggested that if variables are missing the lead author or biostats professional contact the CCC to query access and if data are not centralized contact the PI of the AS directly to request the variable (consider sharing the approved proposal letter as documentation of P&P approval).

5. Call for ideas regarding the development of WHI SharePoints website information.

Mary P requested that the Biostats group share with her any ideas regarding content or operations of the future SharePoint WHI website. Specifically she has identified a need for search tools. If there are additional ideas please forward them directly to Mary who will discuss with the web-master group. The current time estimate for opening the SharePoint website is March 1, 2011.

6. Special thank you to Mary Pettinger for her support of the Biostats group. It was noted that she has been highly responsive to questions and needs of the individual Analysist and Biostats leads as they have initiated their work with WHI data.