Evaluating a Structured Reporting Template to Increase Transparency and Reduce Review Time for Healthcare Database Studies

Focus Groups as Used by the Food and Drug Administration

Appendix D - Notification of Eligibility

Evaluating a Structured Reporting Template to Increase Transparency and Reduce Review Time for Healthcare Database Studies

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OMB Control Number: 0910-0497 Expiration Date: 10/31/2020


APPENDIX D: NOTIFICATION OF ELEGIBILITY AND SCHEDULING VIA EMAIL


Dear XXX,


Thank for agreeing to participate! We would like to schedule you for a focus group discussion.


The WebEx based focus group discussions will be held at the following times and will last about 90 minutes. Please respond with your availability to join a focus group at the times below:


Time slot 1

Time slot 2

Time slot 3

Time slot 4

Time slot 5

Time slot 6

Time slot 7

Time slot 8


I will moderate the discussion, and BWH study staff will observe the discussion and record typed notes. Attached are the following materials for your review prior to the focus group discussion:

  1. Structured template + User Guide with example entries (required)

  2. Focus group discussion questions (required)

  3. ISPE/ISPOR joint task force paper on reporting (optional)

  4. Paper on design visualization (optional)


Thank you, again, for your interest in improving transparency and reproducibility of database studies!


Cheers,

Shirley Wang, PhD

[email protected]

617-525-8376

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