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Considerations in the Interpretation of Patient Reported Outcomes in Heart Failure with Reduced and Preserved Ejection Fraction

      Patient reported outcomes (PROs) are an important and increasingly common component of clinical research, particularly in heart failure (HF), where interest in PROs has gained ground in recent years [
      • Eliya Y.
      • et al.
      Temporal Trends and Factors Associated With the Inclusion of Patient-Reported Outcomes in Heart Failure Randomized Controlled Trials: A Systematic Review.
      ]. As HF is a disease process notorious for its plethora of symptoms and vast range of available medications and therapies, PROs help focus research on patient-centered care and help balance quality of life metrics with traditional mortality reporting [
      • Thompson L.E.
      • et al.
      Patient-reported outcomes in heart failure: existing measures and future uses.
      ]. PROs are particularly important in HF studies that have have shown that patient preferences vary widely in terms of aggressiveness of medical treatment and time versus quality of life tradeoffs [
      • Lewis E.F.
      • et al.
      Preferences for quality of life or survival expressed by patients with heart failure.
      ]. Consolidated Standards of Reporting Trials (CONSORT) PRO Extension, the methodologic framework for PRO implementation and reporting in clinical trials proposed in 2013, suggest that PROs are still in the beginning phases of implementation into the field [
      • Eliya Y.
      • et al.
      Temporal Trends and Factors Associated With the Inclusion of Patient-Reported Outcomes in Heart Failure Randomized Controlled Trials: A Systematic Review.
      ,
      • Calvert M
      • Blazeby J
      • Altman DG
      • Revicki DA
      • Moher D
      • Brundage MD
      • Group CONSORT PRO
      Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.
      ]. As such, there are still limitations to their uniform use and interpretation. Though the FDA broadly approved PROs as a valid outcome measure in 2007, specific PROs require validation in each study population for which they are used before full integration into a clinical trial [
      • Thompson L.E.
      • et al.
      Patient-reported outcomes in heart failure: existing measures and future uses.
      ]. This requirement, in addition to the fact that many different PROs exist, add to the complexity of their interpretation.

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