patient comprehension of fda-approved medication guides
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Northwestern University Feinberg School of Medicine
Patient Comprehension of Patient Comprehension of FDA-Approved Medication FDA-Approved Medication GuidesGuides
Allison Russell, BA Division of General Internal Medicine
Northwestern UniversityOctober 19, 2011
Acknowledgements Acknowledgements
Funded by Abbott Laboratories
UIC and Northwestern University
Principal Investigator: Michael Wolf, PhD MPH
Co-Investigators: Allison L Russell, BA; Elizabeth A H Wilson, PhD; Jennifer P King, MPH; Ashley R Bergeron, BS; James Duhig, MA; Terry Davis, PhD; Ruth Parker, MD; William Shrank, MD; Bruce L Lambert, PhD
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FDA required and approved; industry-developed
Issued to consumers for prescription medications that possess “serious and significant public health concerns.”
Essential part of a risk evaluation and mitigation strategy (REMS)
Med Guides may be the only source of important risk information for patients
Wolf et al. 2006 study Too complex and written at too high a reading grade level Only 1 in 4 patients attend to these materials
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Background – Medication Background – Medication Guides Guides
Objectives
1) Assess the readability and suitability of the 227 Med Guides available as of May 2010
2) Evaluate consumers’ ability to understand existing Med Guides, and to identify root causes of comprehension failure
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Two Complementary Two Complementary Studies Studies
Readability Analysis – Professional Lexile Analyzer - measures the level of difficulty and complexity of written passages
Lexile scores were recorded for each document, then grade levels were based on Lexile scores for ‘typical readers’ in that grade
Suitability Assessment – Suitability Assessment of Materials (SAM) - content, literacy demand, graphics, layout and typography, and learning simulation/motivation (omitted cultural appropriateness)
Subset Analysis 2006-2010 – change in suitability and readability
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Study 1 - MethodsStudy 1 - Methods
Average 1923 words (SD=1022, range 351- 8526)
Mean Readability - 10th to 11th grade reading level
Only seven Med Guides (3.8%) met the Keystone recommendations for a reading difficulty ≤ 8th grade level
Subset Analysis - 2006 to 2010 – Word count increase, though not significantly
(M=2216.3, SD=146.2 vs. M=2182.5, SD=151.0; p=0.56)
Readability improved slightly, though insignificantly (11th to 10-11th, p=0.13)
In 2006, 7 Med Guides were deemed suitable, whereas 2010 assessment found unsuitable
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Results – Study 1 Results – Study 1
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Results – Study 1 Results – Study 1
Chose existing Med Guides that were representative by content, format, and likely exposure
One Med Guide for each of the three most common routes of administration –
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Study 2 – Methods Study 2 – Methods
Oral tabletOral liquid solution
Injection
Ritalin Morphine Sulfate Aranesp
449 English-speaking, primary care patients, aged 18-85 years
In-person interviews at two general internal medicine clinics
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Study 2 – Methods Study 2 – Methods
Questions on 1) decision making prior to use, 2) general use and storage, and 3) side effects
Open book assessment
Past experience with the medication
Demographic and socioeconomic information; Rapid Estimate of Adult Literacy in Medicine (REALM).
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Study 2 – InterviewStudy 2 – Interview
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Results – Study 2 – Sample Characteristics Results – Study 2 – Sample Characteristics (N=449) (N=449)
63% Never heard of Med Guide before
48% had prior experience with ≥ 1 of these medications
Age, % 18-30 years 20.3 31-45 years 30.5 46-60 years 31.2 61-85 years 18.0Female, % 64.4Race, % NH-White 35.2 NH-Black 53.5 Other 11.4
Education, % ≤ High School 34.1 Some College 24.5 ≥ College Grad 41.4Income, % <$20,000 34.8 $20,000-$50,000 22.5 >$50,000 42.7
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Results – Study 2 – Results – Study 2 – Overall Overall
Mean Knowledge Scores for Each Guide (N=449)
MedicationPoints
PossibleMean Points
Received % correct
Oral Solution 32 19.4 60.6Pill Form 33 16.9 51.2Injectable 34 16.3 47.9All Guides Combined
99 52.7 53.2
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Results – Study 2 – Literacy Level Results – Study 2 – Literacy Level
Score
Overall Score
Mean (SD)
Mean (SD) Scores by Literacy Level
P valueLow (n=63)
Marginal (n=103)
Adequate (n=283)
Total (out of 99 pts)
52.7 (22.6) 24.9 (13.8) 37.8 (15.7)64.3
(17.1)<0.0001
Percentage Correct
53.2 % 25.2 % 38.2 % 64.9 %
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Results – Study Results – Study 2 2
Multivariate Model of Predictors of Understanding
Medication Guides
(out of 99 points; N=449)
Variables β (95% CI) p-valueLiteracy Inadequate -23.7 (-28.3 - -19.0) <0.001 Marginal -14.3 (-18.0 - -10.6) <0.001 Adequate --- --Age 18-30 years --- -- 31-45 years -2.4 (-6.3 - 1.6) 0.24 46-60 years -5.9 (-10.4 - -1.4) 0.01 61-85 years -12.2 (-17.0 - -7.4) <0.001Race White --- -- Black -9.5 (-13.3 - -5.8) <0.001 Other -7.3 (-11.8 - -2.7) 0.002Gender Male --- -- Female 2.1 (-0.83 - 5.0) 0.16Education ≤ High School -14.6 (-19.1 - -10.1) <0.001 Some College -4.1 (-8.1 - -0.1) 0.05 ≥ College Grad --- --Income <$20,000 -3.1 (-7.5 - 1.4) 0.18 $20,000-50,000 -1.7 (-5.5 - 2.0) 0.37 >$50,000 --- --Prior Experience a
Experience -1.6 (-4.3 - 1.2) 0.28 No Experience --- --
Med Guides are serving little purpose in their current state
Number of Med Guides has increased 8-fold in past 5 years, yet little improvement in usability
Too difficult, failed across all literacy levels
Guidance needed on formatting, readability, and length- Plain Writing Act of 2010
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Discussion Discussion
Participants not required to have prior experience
Cannot link Med Guide attributes to comprehension
English-speakers only….but what about translations?
Limitations Limitations
Single Document Solution
Next steps – research – develop patient-centered Med Guide prototype (via focus groups, cognitive interviews, eye-tracking)
Clinical trial…stay tuned…
Think Dissemination! Beyond pharmacy…
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Next Steps Next Steps
Allison L. RussellResearch Assistant
Health Literacy and Learning ProgramDivision of General Internal Medicine
Northwestern University750 N. Lake Shore Drive, 10th Floor
Chicago, IL 60611Phone: 312.503.5531
Email: [email protected]
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Questions? Questions?
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