# Presentation: 718293

## Plan B Label Comprehension Study

**Karen Lechter, J.D., Ph.D.**
**Division of Surveillance, Research, and Communication Support**
**Office of Drug Safety**

**Notes:**

12/9/03

## Overview

**What are label comprehension studies?**
**Plan B label comprehension study details**
**Conclusions**

## What is a Label Comprehension Study?

**Purpose: ****Test proposed labeling with potential consumers**
**Based on Communication Objectives**
**Results used to refine labeling**
**Improved label usually used in Actual Use trial**
**Can test issues not apparent from Actual Use studies**

## How is a Label Comprehension Study Conducted?

**Test potential consumers and those who should not use the product**
**Usually in shopping malls**
**Supplement with participants from other sites**
**Include low literate**
**Sometimes specific populations**
**Particular medical conditions, drugs**
**Recruit by telephone, other means**

## Label Comprehension Study Procedure

**Collect initial data about participants**
**Administer literacy test**
**Show labeling to participant**
**Ask questions based on Communication Objectives**
**Encourage hypothetical scenarios**
**Encourage self-selection question**
**Collect medical history for self-selection**

## Plan B Study Design

**663 females age 12-50; 656 eligible**
**Literacy test for age 18+ who were not college graduates (N=532)**
**First question after looked at outside of package and package removed**
**After label questions, asked about sexual activity and contraceptive use**

## Issues Affecting Results

**Criteria for success for some **
**Communication Objectives <100%**
**Credit given for partially correct responses**
**One confusing question dropped from analysis, another not dropped**

## Questionnaire and Methodological Issues

**No follow-up questions**
**Yes/no questions with no follow-up**
**Incomplete or ambiguous responses**
**Not everyone was tested for literacy**

## Results by Communication Objective: >90%

- Results by Communication Objective: >90%

- †First number=% correct; second number = % correct or acceptable
- *Statistically significant differences between literacy groups

## Results by Communication Objective: 85%-89%

**Results by Communication Objective: ****85%-89%**

| Objective | Total
n=656 | Low Lit. n=139 | Hi Lit.
n=393
 |
| --- | --- | --- | --- |
| Side effects include nausea, vomiting | 89% | 84%* | 96% |
| Second pill 12 hours after first |  69%†
87% | 82%* | 92% |
| First pill within 72 hours | 85% | 71%* | 90% |

- †First number=% correct; second number = % correct or acceptable
-  *Statistically significant differences between literacy groups

## Results by Communication Objective: 80%-84%

**Results by Communication Objective: ****80%-84%**

| Objective | Total
n=656 | Low Lit. n=139 | Hi Lit.
n=393
 |
| --- | --- | --- | --- |
| First pill as soon as
possible after sex | 82% | 84% | 83% |
| For severe abdominal pain, seek immediate medical care | 81% | 81% | 83% |

## Results by Communication Objective: <80%

**Results by Communication Objective: **_**<**_**80%**

| Objective | Total
n=656 | Low Lit. n=139 | Hi Lit.
n=393 |
| --- | --- | --- | --- |
| Not if unexplained 
vaginal bleeding | 75% | 69%* | 81% |
| For backup, not regular contraception | 67% | 46%* | 78% |

- *Statistically significant differences between literacy groups

## Other Findings

**No effect of previous sexual experience**
**No differences due to experience with emergency contraceptives (N=32)**

## Conclusions

**Some concepts may be less well understood:**
**Not for regular use**
**Do not use if unexplained vaginal bleeding**
**Get medical help if severe abdominal pain**
**First pill as soon as possible after sex**

## Conclusions

**Some concepts well understood:**
**Plan B is for contraception**
**Does not protect against STDs**
**Do not take while pregnant**
**Do not use if allergic**
**Nausea and vomiting are side effects**
**First pill within 3 days**