Editorial

The Case for a Comparative, Value-Based Alternative to the Patient-Centered Outcomes Research Model for Comparative Effectiveness Research

Nicholas F. Marko, M.D.; Robert J. Weil, M.D.

Disclosures

Neurosurg Focus. 2012;33(1):e8 

In This Article

Abstract and Introduction

Abstract

Considerable financial and human resources have been directed toward the emerging field of comparative effectiveness research (CER) in the US. Fundamentally, the concept of CER is so logical as to be almost self-evident; namely, that research regarding therapeutic strategies should go beyond efficacy and examine objectively their real-world effects and outcomes. In practice, however, reluctance to consider difficult questions related to the many dimensions of value in health care delivery and corresponding legislative constraints placed on the US CER enterprise risk limiting the ultimate utility of this investigative model. Significant constraints have been codified into the patient-centered outcomes research (PCOR) model of CER, which is emerging as the de facto method for conducting CER in the US. The experience of the authors as clinicians attempting to use CER to improve complex management decisions, for which multidimensional considerations of value represent a critical component of the overall effectiveness of alternate strategies, highlight the inability of PCOR to comprehensively inform this process. This suggests that PCOR may be a suboptimal approach for performing clinically relevant CER. In this editorial, the authors use clinical examples to highlight the limitations of the PCOR approach to CER and to propose an alternate approach, which they term "comparative, value-based effectiveness research" (CVER). The authors believe that the narrow scope and fundamental limitations of PCOR mitigate its overall value to medical decision-makers attempting to optimize overall effectiveness in the real-world setting, while a more comprehensive approach like CVER has greater potential to realize practical benefits for patients, clinicians, and society as a whole.

Introduction

Comparative effectiveness research has been broadly defined as research to generate and synthesize "evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care."[5] The purpose of CER is "to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care."[5] The initial federal investment of $1.1 billion[1] in CER reflects a recognition that effective health care delivery is a societal mandate.

Superficially, the mission of CER appears so logical as to be self-evident; namely, to provide comprehensive resources for patients and clinicians to better inform decisions between alternate management strategies for disease. In practice, however, legislative constraints on the US CER enterprise risk limiting the ultimate utility of this investigative model. In this editorial, we use two clinical examples to highlight the limitations of the current embodiment of CER in the US, and to propose an alternate approach with greater potential benefit for patients, clinicians, and society as a whole.

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