Using a Drug Facts Box to Communicate Drug Benefits and Harms

  1. Lisa M. Schwartz, MD, MS;
  2. Steven Woloshin, MD, MS; and
  3. H. Gilbert Welch, MD, MPH
  1. From the Veterans Affairs Outcomes Group, White River Junction, Vermont, and the Center for Medicine in the Media at the Dartmouth Institute for Health Policy and Clinical Practice, Hanover, New Hampshire.
    1. Figure 1.
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        Figure 1. Advertisements given to trial participants.

        Appendix 1 and Appendix 2 provide full-size images of all 8 ads. PPI = proton-pump inhibitor.

      • Figure 2.
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          Figure 2. Study flow diagram.
        • Figure 3.
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            Figure 3. Pridclo (clopidogrel) drug facts box.

            FDA = U.S. Food and Drug Administration.

          • Figure 4.
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              Figure 4. Effect of the drugs facts box on the perceived benefit and side effects in the prevention drug box trial.
            • Figure 5.
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                Figure 5. Perceived absolute risk reduction in the prevention drug box trial.

                The correct answers are a 0.8% absolute risk reduction with Concor (statin) and 0.6% with Pridclo (clopidogrel).

              • Figure 6.
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                  Figure 6. Effect of the drug facts box on comparisons between drugs in the symptom drug box trial.

                  The bars show the proportion of participants who answered the question correctly. All comparisons were statistically significant (P < 0.001). PPI = proton-pump inhibitor.

                  * 14% of the drug box group and 23% of the control group said that they would not take either drug (typically because they wanted to try lifestyle treatments first or did not want to take a medicine).

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