OMB Amendment Memo

THE UNIVERSITY OF

CHICAGO

BIOLOGICAL SCIENCES

Department of Medicine

Section of General Internal Medicine

5841 South Maryland Avenue, MC 2007, Chicago, Illinois 60637

Phone 773-702-8157 • Fax 773-834-2238

varora@medicine.bsd.uchicago.edu

Vineet Arora, MD, MA

Associate Professor, Department of Medicine

Assistant Dean, Scholarship & Discovery

Director of GME Clinical Learning Environment Innovation

memorandum

to: Office of Management & Budget

from: VINEET ARORA, MD MA

subject: Amendment for IMPROVE Study (1U01FD005485) Focus Group Script

date: 1/24/2021

Protocol documents for the above-referenced study have been amended to incorporate minor changes. Specifically, the focus group scripts (identical besides references to oral contraceptive and anti-depressant drugs respectively) have been altered as detailed below:

1. Introduction: The introduction script was changed from bulleted notes to complete dialogue for consistency and to aid moderators.

2. Definition and Discovery:

   1. Questions were reordered for discussion flow;

   2. The question on generic drug approval were made FDA-specific;

   3. An additional probe was added to the question about participants’ experience with substitution based on consultant and Steering Committee feedback on prescribing practices and common influencing factors.

3. Dream & Design

   1. Language was edited for clarity and to facilitate moderators reading the script.

   2. Probes were added to the questions on participants’ communication and prescribing preferences to suggest potential methods and solutions based on consultant and Steering Committee feedback.

Thank you for your consideration.

Sincerely,

Vineet Arora, MD, MA

Principal Investigator, IMPROVE