Increasing the Patient-Centeredness of Health Economics and Outcomes Research Through Patient Engagement in Core Outcome
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PRACTICAL APPLICATION
Increasing the Patient‑Centeredness of Health Economics and Outcomes Research Through Patient Engagement in Core Outcome Set Development Elizabeth Clearfield1 · Ellen Tambor1 · Ellen M. Janssen1 · Donna A. Messner1
© Springer Nature Switzerland AG 2020
Abstract Core outcome sets (COS) are becoming increasingly popular in clinical research and can provide important inputs for further health economics and outcomes research (HEOR) studies. Use of standard, consistently reported outcomes can demonstrate and allow differentiation of the effectiveness and value of different treatments. Incorporating patient values during COS development increases the patient centeredness of evidence available across decision-making contexts. However, the approach to meaningful patient engagement in the COS process is evolving and poses both unique challenges and opportunities. We describe an approach to patient-centered COS development and discuss challenges and adaptations to improve engagement across COS projects. We provide examples from our experience in patient engagement for COS development using three completed COS projects. This approach includes patient engagement in terms of partnering with patient organizations, orientation and training, and the consensus process. Including COS in clinical development programs and HEOR will ensure that relevant, consistent outcomes are available for healthcare decision making and should result in faster access to high-value and novel therapies for patients. Patient-centered COS development increases the likelihood that further HEOR studies and decisions made using the COS are relevant to patients.
Key Points for Decision Makers Including core outcome sets (COS) in clinical development programs and health economics and outcomes research will ensure that consistent outcomes are available for healthcare decisions and should result in faster access to high-value and novel therapies for patients. Patient-centered COS development is essential to ensure that research captures patient-relevant outcomes and that regulatory, market access, and clinical decisions are made using patient-relevant outcomes. COS development requires careful study design to overcome barriers to patient engagement. Engagement approaches might need to be adapted based on the therapeutic area of interest and patient population.
* Ellen M. Janssen [email protected] 1
Center for Medical Technology Policy, 401 E Pratt St, Suite 631, Baltimore, MD 21202, USA
1 Introduction A core outcome set (COS) is a minimum agreed-upon set of outcomes that should be measured and reported in all clinical trials for a specific condition [1]. Consistent use and reporting of core outcomes can improve the quality of clinical studies and health economics and outcomes research (HEOR) by providing transparency around which outcomes are expected for regulatory and post-regulatory decision making [2]. In addition, if patients are involved in the development process, the use of COS can ensure that outcomes are rele
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