Ventilator Associated Pneumonia Best Practice Amy Shay, MS, CCRN, CNS Amy Shay, MS, CCRN, CNS.
2005 4086 S1 05 Fda Shay
-
Upload
andrewboudreau -
Category
Economy & Finance
-
view
229 -
download
0
Transcript of 2005 4086 S1 05 Fda Shay
![Page 1: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/1.jpg)
Pivotal Label Pivotal Label Comprehension StudyComprehension StudyMevacorMevacor™™ OTC OTCCapt. Laura Shay, RN, MS, C-ANPCapt. Laura Shay, RN, MS, C-ANPDivision of Over-the-Counter Drug ProductsDivision of Over-the-Counter Drug Products
Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research
![Page 2: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/2.jpg)
2Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Overview
• Purpose of a label comprehension (LC) study
• Mevacor™ OTC LC study design
• Summary of the study results
![Page 3: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/3.jpg)
3Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Purpose of a Label Comprehension Purpose of a Label Comprehension StudyStudy
• To evaluate whether or not consumers can comprehend important communication objectives on the label
– Literate and low literate populations
– Diverse population: Representative of the U.S. population
![Page 4: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/4.jpg)
4Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Purpose of a Label Comprehension Purpose of a Label Comprehension Study (cont.)Study (cont.)
• Generally performed prior to the behavioral (actual use) study
• Low comprehension may be predictive of poor results in the actual use setting
• High comprehension does not necessarily guarantee success in the actual use setting
![Page 5: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/5.jpg)
5Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Primary Objective Of the Mevacor Primary Objective Of the Mevacor OTC LC studyOTC LC study
To evaluate consumer comprehension of the label used in the CUSTOM actual use study
![Page 6: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/6.jpg)
6Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Secondary ObjectivesSecondary Objectives
• Determine how well respondents correctly respond to questions designed to try to measure self-selection
• Evaluate low literacy respondents
• Evaluate non-Caucasian respondents
![Page 7: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/7.jpg)
7Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Key Communication ObjectivesKey Communication Objectives
• Provided in your FDA background package (Tab 6, page 1)
• Summary of Results
![Page 8: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/8.jpg)
8Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
21 CFR 330.10 (a)(4)(v)21 CFR 330.10 (a)(4)(v)
OTC labels must:
. . .be likely to be read and understood by the ordinary individual, including individuals of low comprehension, under customary conditions of purchase and use.
![Page 9: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/9.jpg)
9Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Assessment of Comprehension Assessment of Comprehension
Clinical Significance
0% 100%
![Page 10: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/10.jpg)
10Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
![Page 11: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/11.jpg)
11Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
![Page 12: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/12.jpg)
12Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Study DesignStudy Design
![Page 13: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/13.jpg)
13Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
RecruitmentRecruitment
Subjects were selected if they were found to be “cholesterol-concerned respondents”
Paid $20-25 for participating
![Page 14: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/14.jpg)
14Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
25 sites (shopping malls) across the country
![Page 15: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/15.jpg)
15Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Study CohortsStudy Cohorts
• 696 Total representative sample
– 203 Total low-literacy sample( < 8th grade reading level)
– 493 Non low-literate sample
– 207 Non-Caucasian sample
– 489 Caucasian sample
![Page 16: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/16.jpg)
16Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
GenderGender
• 44% male– 51% > age 45
• 56% female– 35% > age 55
![Page 17: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/17.jpg)
17Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Questionnaire Questionnaire
• Tested one label
• Structured interviews
• Refer to the label throughout the study
• Primarily multiple choice
• Scenarios were used to:
– test key communication objectives
– test decision making ability based on information found on the label
![Page 18: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/18.jpg)
18Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Scenario forScenario forUnexplained Muscle Pain Unexplained Muscle Pain
Diane has been taking MEVACOR™OTC for several weeks. She didn’t do any unusual physical activity and isn’t feeling sick but she has started to feel pain in her leg muscles
![Page 19: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/19.jpg)
19Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
![Page 20: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/20.jpg)
20Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Answer Definitions Answer Definitions • Correct:
If a respondent’s answer adhered to the label
• Acceptable:
If a respondent’s answer did not specifically adhere to the label
“but would not pose a safety risk”
![Page 21: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/21.jpg)
21Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Answer Options for the Answer Options for the Unexplained Muscle Pain ScenarioUnexplained Muscle Pain Scenario
• Stop using Mevacor OTC. Must talk to a doctor (C)
• Continue to use Mevacor OTC but must talk to a doctor (A)
• Stop using Mevacor OTC. Does not need to talk to doctor (A)
• Continue to use Mevacor OTC and does not need to talk to a doctor (I)
• Don’t know (I)
![Page 22: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/22.jpg)
22Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Results of the Unexplained Muscle Results of the Unexplained Muscle Pain Scenario:Pain Scenario:
97%79%Low Literacy
99%79%Non-Low Literacy
99%74%Non-Caucasian
98%81%Caucasian
98%79%Total
Correct plus Acceptable
CorrectCohorts
![Page 23: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/23.jpg)
23Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Scenario for Liver DiseaseScenario for Liver Disease
Barbara has liver disease:
![Page 24: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/24.jpg)
24Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
![Page 25: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/25.jpg)
25Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Answer Options for the Liver Answer Options for the Liver Disease ScenarioDisease Scenario
• This person should not use at all (C)
• Before using, this person needs to talk to a doctor (A)
• This person could start using right away (I)
• Don’t know (I)
![Page 26: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/26.jpg)
26Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Results of the Liver Disease Scenario:
100 %65 %Low Literacy
99 %70 %Non-Low Literacy
99 %71 %Non-Caucasian
99 %68 %Caucasian
99 %69 %Total
Correct plus Acceptable
CorrectCohorts
![Page 27: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/27.jpg)
27Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
StudyStudy Results Results
Based on % of Correct Answers from the Total Representative Sample
(answers adhered to the label)
![Page 28: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/28.jpg)
28Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
% Correct Answers: Dosing, Other Info:% Correct Answers: Dosing, Other Info:
• 99% What the product is used for• 99% Dosage and dosing information • 95% Need to consult with health care professional prior
to use if on a Rx drug• 92% Active ingredient• 87% Time frame for cholesterol testing• 86% Prerequisite of diet and exercise before taking the medication• 82% Evening best time of day for dosing• 78% Need to fast for cholesterol testing• 59% Cholesterol will go up if Mevacor™ OTC is stopped
![Page 29: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/29.jpg)
29Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
% Correct Answers for Scenarios that % Correct Answers for Scenarios that Indicate the Need to Stop MevacorIndicate the Need to Stop Mevacor™™ OTC: OTC:
• 47%-90%
• 79% Unexplained muscle pain
![Page 30: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/30.jpg)
30Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
% Correct Answers: Self-selection % Correct Answers: Self-selection ScenariosScenarios
• 37-81%
– 54%: average correct answers
– 72%: allergy to lovastatin
– 42%: prior Hx of muscle pain on a cholesterol-lowering
medicine
![Page 31: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/31.jpg)
31Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
% Correct Answers: Listed Under the % Correct Answers: Listed Under the “Do Not Use If”“Do Not Use If”
–74% pregnant
–77% breast feeding
–69% liver disease
![Page 32: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/32.jpg)
32Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
% Correct Answers: False Positives% Correct Answers: False Positives
Correct plus AcceptableCorrect
95%64%Constipation
95%69%Gas from Food
94%64%Poison Ivy
96%72%Tums for Indigestion
98%66%Developed a Cold
![Page 33: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/33.jpg)
33Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Self-SelectionSelf-Selection
Respondents were asked if they could start Mevacor™ OTC today. This answer was compared to the self-reported medical history questions and demographic data in order to validate if the response was correct
![Page 34: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/34.jpg)
34Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Self-selectionSelf-selection
• 696 Total Representative Sample
– 461 respondents reported they “could not start Mevacor OTC today”
– 209 respondents reported they “could start Mevacor OTC today”
– 26 respondents reported they “Did not know”
![Page 35: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/35.jpg)
35Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Self-selection ResultsSelf-selection Results
• 461 (100%) out of the 461 Respondents who reported they “could not start Mevacor OTC today” self-selected correctly according to label criteria
• 3 (1%) out of the 209 Respondents who reported they “could start Mevacor OTC today” self-selected correctly according to label criteria
• 464 (67%) out of the 696 total Respondents self–selected correctly according to label criteria
![Page 36: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/36.jpg)
36Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Summary: Study DesignSummary: Study Design
• Well designed study– Diverse population
– Non-Caucasian and low-literate
– Non-leading well constructed Questions
– Study was able to distinguish varied levels of comprehension
![Page 37: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/37.jpg)
37Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Summary: Clinically Significant Summary: Clinically Significant Communication ObjectivesCommunication Objectives
Clinical Significance
0% 100%20% 40% 80%60%
breast feeding (77%)
unexplained muscle pain (79%)
explained muscle pain (47%)
allergy to lovastatin (72%) pregnant (74%)
liver disease (69%)
![Page 38: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/38.jpg)
38Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Summary: Self-SelectionSummary: Self-Selection
• Total number who self-selected correctly according to the label
–464 out of 696 (67%)
• “Could start Mevacor ™ OTC today”
–3 out of 209 (1%)
![Page 39: 2005 4086 S1 05 Fda Shay](https://reader033.fdocuments.in/reader033/viewer/2022052912/55a10fb81a28ab65508b478f/html5/thumbnails/39.jpg)
39Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 13, 2005January 13, 2005
Summary: Correct vs. AcceptableSummary: Correct vs. Acceptable
• “acceptable” answers increased most scores >90%
• Some “acceptable responses” could be correct: – Do Not Use-Ask a doctor or pharmacist or – Do Not Use unless directed by your doctor
• The “acceptable” answers often contained “ask a doctor” even when not indicated to do so on the label
• Respondents often had a > 50% (3 out of 5) chance of selecting either a correct or “acceptable” answer