Table 2.

Comprehension Testing Interview Flow

General usage: Consumers were asked a general set of questions regarding patient labeling use, including when and if they read patient labeling information, their primary language, etc

Review of patient labeling: Consumers read the patient labeling in its entirety at their own pace, which was timed to ensure it fell within the acceptable parameters of five minutes. On average, it took respondents 2.5 min to read the proposed labeling

Comprehension test (open-book questions): Patient labeling remained with the consumer. The untimed 14-question test consisted of a mix of multiple choice and true/false questions. Consumers could refer to the patient labeling at any time to find the answers

Patient labeling deep dive (open-book review): Patient labeling was reviewed with consumers in detail to gain a greater depth of understanding of their comprehension. Specific attention was paid to questions answered incorrectly during the comprehension test. Consumers were asked to identify what they believed caused those questions to be answered incorrectly (e.g., they forgot the information, missed/skipped over the information, were confused by the information, misunderstood the information, etc.)

Utilization and recall (closed-book review): Patient labeling was removed and consumers were then asked open-ended questions to assess their understanding of the medication, what it is for, how it should be taken, what important safety information they should tell their doctors, and possible side effects

Newest Vital Sign (NVS) assessment: The NVS Health Literacy Exam was administered to consumers following the interview to confirm their health literacy levels. This measurement was used to segment Limited and Adequate Health Literacy respondents