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: allison-russell@northwestern.edu

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Questions? Questions?

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