scholarly journals From comparative effectiveness research to patient-centered outcomes research: policy history and future directions

2012 ◽  
Vol 33 (1) ◽  
pp. E7 ◽  
Author(s):  
Laura P. D'Arcy ◽  
Eugene C. Rich

Containing growth in health care expenditures is considered to be essential to improving both the long-term fiscal outlook of the federal government and the future affordability of health care in the US. As health care expenditures have increased, so too have concerns about the quality of health care. Better information on the clinical effectiveness of alternative treatments and other interventions is needed to improve the quality of care and restrain growth in expenditures. This article explains the key role played by the federal government in defining the context and process of comparative effectiveness research as well as its funding. Subsequently, the article explores the mission, priorities, and research agenda of the Patient-Centered Outcomes Research Institute, which is an independent, nonprofit corporation established in 2010 by the Patient Protection and Affordable Care Act.

2020 ◽  
Vol 35 (S2) ◽  
pp. 875-881 ◽  
Author(s):  
Laura C. Esmail ◽  
Rebecca Barasky ◽  
Brian S. Mittman ◽  
David H. Hickam

Abstract Introduction Complex health interventions (CHIs) are increasingly studied in comparative effectiveness research (CER), and there is a need for improvements in CHI research practices. The Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee (MC) launched an effort in 2016 to develop formal guidance on this topic. Objective To develop a set of minimal standards for scientifically valid, transparent, and reproducible CER studies of CHIs. The standards are intended to apply to research examining a broad range of healthcare interventions including delivery system, behavior change, and other non-pharmacological interventions. Methods We conducted a literature review, reviewed existing methods guidance, and developed standards through an iterative process involving the MC, two panels of external research methods experts, and a 60-day public comment period. The final standards were approved by the PCORI MC and adopted by the PCORI Board of Governors on April 30, 2018. Results The final standards include the following: (1) fully describe the intervention and comparator and define their core functions, (2) specify the hypothesized causal pathways and their theoretical basis, (3) specify how adaptations to the form of the intervention and comparator will be allowed and recorded, (4) plan and describe a process evaluation, and (5) select patient outcomes informed by the causal pathway. Discussion The new standards offer three major contributions to research: (1) they provide a simple framework to help investigators address the major methodological features of a CHI study, (2) they emphasize the importance of the causal model and the need to understand how a CHI achieves its effects rather than simply measuring these effects, and (3) they require description of a CHI using the concepts of core functions and forms. While these standards apply formally to PCORI-funded CER studies, they have broad applicability.


2012 ◽  
Vol 33 (1) ◽  
pp. E6 ◽  
Author(s):  
Edie E. Zusman

Comparative effectiveness research (CER) is the basis for some of the fiercest rhetoric of the current political era. While it is a relatively old and previously academic pursuit, CER may well become the foundation upon which the future of health care in the US is based. The actual impact of CER on—and uptake among—doctors, patients, hospitals, and health insurers, however, remains to be seen. Political considerations and compromises have led to the removal of key aspects of CER implementation from policy legislation to prevent alienating stakeholders critical to the success of health care reform. Health care providers, including specialists such as neurosurgeons, will need to understand both the policies and political implications of CER as its practices becomes an indelible part of the future health care landscape.


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