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In reply—Risk Framing in Cardiovascular Medicine I and II

      We thank the authors for their insightful comments on our perspective published in the journal.
      • Alkhouli M.
      • Rihal C.S.
      The odyssey of risk framing in cardiovascular medicine: a patient-centered perspective.
      We agree with Dr Modarressi
      • Alkhouli M.
      • Rihal C.S.
      The odyssey of risk framing in cardiovascular medicine: a patient-centered perspective.
      that sodium-glucose cotransporter-2 inhibitors indeed represent an important new treatment for patients with heart failure. Although we used the trial definition of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or stroke) in the text and in the table’s footnote, we acknowledge that this was a secondary and not a primary end point.
      • Alkhouli M.
      • Rihal C.S.
      The odyssey of risk framing in cardiovascular medicine: a patient-centered perspective.
      ,
      • Mahaffey K.W.
      • Jardine M.J.
      • Bompoint S.
      • et al.
      Canagliflozin and cardiovascular and renal outcomes in type 2 diabetes and chronic kidney disease in primary and secondary cardiovascular prevention groups: results from the randomized CREDENCE trial.
      The purpose of our viewpoint was to illustrate the issue of risk in absolute vs relative terms. We agree that a 4.3% absolute risk reduction of the composite end point of end-stage kidney disease, doubling of the creatinine level for ≥30 days, and death due to cardiovascular or renal disease is substantial from a population health view; however, it may be less substantial to the individual patient, especially considering the marked out-of-pocket costs. Economic studies measure cost-effectiveness from a society (and often payer) perspective, not from a patient perspective. We feel patients should be fully informed as to the magnitude of treatment benefit they may experience and the associated costs they may incur.
      We concur with Dr Trejo-Gutiérrez that our presentation of “the likelihood of no benefit” in Table 1 may be overly simplistic considering that the benefit of a specific treatment reported in trials is a measure of the “average” effect for the whole study group. This is likely true for continuous variables; however, we respectfully point out that for a binary end point, such as death and stroke, the situation is likely different. All patients receiving a therapy may benefit; however, which specific individuals will realize an actual benefit is usually impossible to predict. This is analogous to purchasing insurance—any or all may benefit, but few will actually require it. More sophisticated and patient-specific risk analysis will be necessary to maximize the likelihood of benefit and minimize the risk of harm. Our nonconventional approach was meant to emphasize the need to clearly indicate absolute risk reduction values when reporting trial data and when discussing new therapies with patients.
      • Alkhouli M.
      • Rihal C.S.
      The odyssey of risk framing in cardiovascular medicine: a patient-centered perspective.
      It is well documented that patients and physicians tend to have overinflated impressions of treatment benefit. Decision aids have been developed to improve patient perception of risks/benefits, but those achieved variable success.
      • Hijazi M.
      • Aljohani S.
      • Alqahtani F.
      • et al.
      Perception of the risk of stroke and the risks and benefits of oral anticoagulation for stroke prevention in patients with atrial fibrillation: a cross-sectional study.
      ,
      • Rothberg M.B.
      • Sivalingam S.K.
      • Ashraf J.
      • et al.
      Patients’ and cardiologists’ perceptions of the benefits of percutaneous coronary intervention for stable coronary disease.
      We as a community need to identify better methods to report and communicate scientific data to live up to the “advocate” role that our patients expect from us.

      References

        • Alkhouli M.
        • Rihal C.S.
        The odyssey of risk framing in cardiovascular medicine: a patient-centered perspective.
        Mayo Clin Proc. 2020; 95: 1315-1317
        • Mahaffey K.W.
        • Jardine M.J.
        • Bompoint S.
        • et al.
        Canagliflozin and cardiovascular and renal outcomes in type 2 diabetes and chronic kidney disease in primary and secondary cardiovascular prevention groups: results from the randomized CREDENCE trial.
        Circulation. 2019; 140: 739-750
        • Hijazi M.
        • Aljohani S.
        • Alqahtani F.
        • et al.
        Perception of the risk of stroke and the risks and benefits of oral anticoagulation for stroke prevention in patients with atrial fibrillation: a cross-sectional study.
        Mayo Clin Proc. 2019; 94: 1015-1023
        • Rothberg M.B.
        • Sivalingam S.K.
        • Ashraf J.
        • et al.
        Patients’ and cardiologists’ perceptions of the benefits of percutaneous coronary intervention for stable coronary disease.
        Ann Intern Med. 2010; 153: 307-313

      Linked Article

      • Risk Framing in Cardiovascular Medicine I
        Mayo Clinic ProceedingsVol. 95Issue 11
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          We applaud the work of Drs Alkhouli and Rihal1 in examining the important topic of risk/benefit framing in patient-centered decision making. However, we disagree with the choice of a sodium-glucose cotransporter 2 inhibitor (SGLT2i), canagliflozin, as an example in their arguments and that “the other 98% [of treated patients] would see no incremental benefit from the treatment.”(p.1316) First, to clarify, the primary outcome in Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation was not a composite major adverse cardiovascular event outcome as stated, but rather a composite of end-stage kidney disease, doubling of the serum creatinine level from baseline sustained for at least 30 days, or death from renal or cardiovascular disease.
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      • The Odyssey of Risk Framing in Cardiovascular Medicine: A Patient-Centered Perspective
        Mayo Clinic ProceedingsVol. 95Issue 7
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          “The best interest of the patient is the only interest to be considered.”1— William J. Mayo, MD
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      • Risk Framing in Cardiovascular Medicine II
        Mayo Clinic ProceedingsVol. 95Issue 11
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          We read with interest the commentary by Alkhouli and Rihal.1 The authors accurately remark about the need of easily understood tools, available to clinicians and patients at point of care, that could simplify the assessment of individual patient risk benefit and harm of an intervention. In particular, they observed the paucity of intervention-specific, individualized risk/benefit scores that facilitate the identification of higher risk individuals that benefit the most from an intervention, with acceptable probability of harm.
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