Person-centered health policy in the US: the case of the Patient-Centered Outcomes Research Institute (PCORI)

2016 ◽  
Vol 4 (2) ◽  
pp. 396
Author(s):  
Sandra Tanenbaum
Keyword(s):  
Affordable Care Act ◽  
Outcomes Research ◽  
Comparative Effectiveness ◽  
Healthcare Reform ◽  
Patient Centeredness ◽  
Patient Centered ◽  
Reform Legislation ◽  
The Us ◽  
Research Institute

The Patient-Centered Outcomes Research Institute, known as PCORI, was created by the U.S. healthcare reform legislation of 2010. The Affordable Care Act (ACA), sometimes referred to as “Obamacare,” provided for a public-private institute concerned primarily with funding and guiding comparative effectiveness research. Through a uniquely American blend of anti-statist ideology, corporate interest and disability activism, the determination of comparative effectiveness would also be tasked with patient-centeredness, a concept which PCORI has defined and operationalized. This represents a step toward person-centered healthcare, but unresolved issues of true personalization remain.

scholarly journals Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered Outcomes Research Institute (PCORI)

2020 ◽  
Vol 35 (S2) ◽  
pp. 875-881 ◽  
Author(s):  
Laura C. Esmail ◽  
Rebecca Barasky ◽  
Brian S. Mittman ◽  
David H. Hickam
Keyword(s):  
Comparative Effectiveness Research ◽  
Outcomes Research ◽  
Comparative Effectiveness ◽  
Health Interventions ◽  
Effectiveness Research ◽  
Patient Centered ◽  
Causal Pathways ◽  
Causal Pathway ◽  
Healthcare Interventions ◽  
Research Institute

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.

scholarly journals The Impact of Comparative Effectiveness Research on Interventional Pain Management: Evolution from Medicare Modernization Act to Patient Protection and Affordable Care Act and the Patient-Centered Outcomes Research Institute

2011 ◽  
Vol 3;14 (3;5) ◽  
pp. E249-E282
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
United States ◽  
Pain Management ◽  
Affordable Care Act ◽  
Comparative Effectiveness Research ◽  
Outcomes Research ◽  
Comparative Effectiveness ◽  
The United States ◽  
Effectiveness Research ◽  
Patient Centered ◽  
Interventional Pain Management

The Patient-Centered Outcomes Research Institute (PCORI) was established by the Affordable Care Act of 2010 to promote comparative effectiveness research (CER) to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis. The development of PCORI is vested in the Medicare Modernization Act (MMA) and the American Recovery and Reinvestment Act (ARRA). The framework of CER and PCORI describes multiple elements which are vested in all 3 regulations including stakeholder involvement, public participation, and open transparent decision-making process. Overall, PCORI is much more elaborate with significant involvement of stakeholders, transparency, public participation, and open decision-making. However, there are multiple issues concerning the operation of such agencies in the United States including the predecessor of Agency for Healthcare Research and Quality (AHRQ), the Agency for Healthcare Policy and Research (AHCPR), AHRQ Effectiveness Health Care programs, and others. The CER in the United States may be described at cross-roads or at the beginnings of a scientific era of CER and evidence-based medicine (EBM). However the United States suffers as other countries, including the United Kingdom with its National Health Services (NHS) and National Institute for Health and Clinical Excellence (NICE), with major misunderstandings of methodology, an inordinate focus on methodological assessment, lack of understanding of the study design (placebo versus active control), lack of involvement of clinicians, and misinterpretation of the evidence which continues to be disseminated. Consequently, PCORI and CER have been described as government-driven solutions without following the principles of EBM with an extensive focus on costs rather than quality. It also has been stated that the central planning which has been described for PCORI and CER, a term devised to be acceptable, will be used by third party payors to override the physician’s best medical judgement and patient’s best interest. Further, stakeholders in PCORI are not scientists, are not balanced, and will set an agenda with an ultimate problem of comparative effectiveness and PCORI that it is not based on medical science, but rather on political science and not even under congressional authority, leading to unprecedented negative changes to health care. Thus, PCORI is operating in an ad hoc manner that is incompatible with the principles of evidence-based practice. This manuscript describes the framework of PCORI, and the role of CER and its impact on interventional pain management. Key words: Patient-Centered Outcomes Research Institute (PCORI), comparative effectiveness research (CER), National Institute for Health and Clinical Excellence (NICE), Patient Protection and Affordable Care Act (ACA), Medicare Modernization Act (MMA), American Recovery and Reinvestment Act (ARRA), interventional pain management, interventional techniques, evidencebased medicine, systematic reviews.

scholarly journals Patient Protection and Affordable Care Act of 2010: Reforming the Health Care Reform for the New Decade

2011 ◽  
Vol 1;14 (1;1) ◽  
pp. E35-E67
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Health Care ◽  
Health Insurance ◽  
Health Care Reform ◽  
Health Care System ◽  
Affordable Care Act ◽  
Outcomes Research ◽  
Patient Centered ◽  
Patient Protection ◽  
Care System ◽  
Research Institute

The Patient Protection and Affordable Care Act (the ACA, for short) became law with President Obama’s signature on March 23, 2010. It represents the most significant transformation of the American health care system since Medicare and Medicaid. It is argued that it will fundamentally change nearly every aspect of health care, from insurance to the final delivery of care. The length and complexity of the legislation and divisive and heated debates have led to massive confusion about the impact of ACA. It also became one of the centerpieces of 2010 congressional campaigns. Essentials of ACA include: 1) a mandate for individuals and businesses requiring as a matter of law that nearly every American have an approved level of health insurance or pay a penalty; 2) a system of federal subsidies to completely or partially pay for the now required health insurance for about 34 million Americans who are currently uninsured – subsidized through Medicaid and exchanges; 3) extensive new requirements on the health insurance industry; and 4) numerous regulations on the practice of medicine. The act is divided into 10 titles. It contains provisions that went into effect starting on June 21, 2010, with the majority of provisions going into effect in 2014 and later. The perceived major impact on practicing physicians in the ACA is related to growing regulatory authority with the Independent Payment Advisory Board (IPAB) and the Patient Centered Outcomes Research Institute (PCORI). In addition to these specifics is a growth of the regulatory regime in association with further discounts in physician reimbursement. With regards to cost controls and projections, many believe that the ACA does not fix the finances of our health care system – neither public nor private. It has been suggested that the Congressional Budget Office (CBO) and the administration have used creative accounting to arrive at an alleged deficit reduction; however, if everything is included appropriately and accounted for, we will be facing a significant increase in deficits rather than a reduction. When posed as a global question, polls suggest that public opinion continues to be against the health insurance reform. The newly elected Republican congress is poised to pass a bill aimed at repealing health care reform. However, advocates of the repeal of health care reform have been criticized for not providing a meaningful alternative approach. Those criticisms make clear that it is not sufficient to provide vague arguments against the ACA without addressing core issues embedded in health care reform. It is the opinion of the authors that while some parts of the ACA may be reformed, it is unlikely to be repealed. Indeed, the ACA already is growing roots. Consequently, it will be extremely difficult to repeal. In this manuscript, we look at reducing the regulatory burden on the public and providers and elimination of IPAB and PCORI. The major solution lies in controlling the drug and durable medical supply costs with appropriate negotiating capacity for Medicare, and consequently for other insurers. Key words: Affordable Care Act, health care costs, health care regulation, health care reform, Patient Centered Outcomes Research Institute, health exchanges, health care subsidies, health insurance premiums, uninsured, Medicare, cost control

Editorial: The case for a comparative, value-based alternative to the patient-centered outcomes research model for comparative effectiveness research

2012 ◽  
Vol 33 (1) ◽  
pp. E8 ◽  
Author(s):  
Nicholas F. Marko ◽  
Robert J. Weil
Keyword(s):  
Comparative Effectiveness Research ◽  
Real World ◽  
Outcomes Research ◽  
Comparative Effectiveness ◽  
Care Delivery ◽  
Medical Decision ◽  
Effectiveness Research ◽  
Patient Centered ◽  
The Us ◽  
Overall Effectiveness

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.

scholarly journals How different is research done by the Patient-centered Outcomes Research Institute, and what difference does it make?

2019 ◽  
Vol 8 (14) ◽  
pp. 1239-1251 ◽  
Author(s):  
Bryan R Luce ◽  
Jason C Simeone
Keyword(s):  
Real World ◽  
Outcomes Research ◽  
Survival Function ◽  
Healthcare Research ◽  
Study Patient ◽  
Patient Centeredness ◽  
Patient Centered ◽  
Real World Setting ◽  
Outcomes Study ◽  
Research Institute

Aim: To determine whether research funded by the Patient-centered Outcomes Research Institute (PCORI) is consistent with the original aims of Congress and unique among other major USA funders. Methods: We compared a sample of funded projects from PCORI, NIH (Phase IV) and agency for healthcare research and quality (AHRQ; American Recovery and Reinvestment Act [ARRA]-based comparative effectiveness research funding) from 2014 to 2018 on number of outcomes/study, patient-centeredness of outcomes (those related to survival, function, symptoms and health-related quality of life) and other features that may characterize patient-centered research (e.g., whether conducted in a real-world setting) using PCORI portfolio data and ClinicalTrials.gov. Results: The mean number of outcomes in PCORI studies (≥9) appeared higher than NIH (≥3)/AHRQ (5.5); a higher percentage of outcomes/study were patient-centered: >85% PCORI versus 50% AHRQ and ≤30% NIH. The majority of PCORI studies (≥74%) were conducted in a real-world setting; this characteristic could not be identified for NIH/AHRQ studies. Conclusion: PCORI-funded studies appear to have unique aspects relative to NIH and AHRQ that are consistent with PCORI’s aims of patient-centeredness.

Sign in / Sign up

Export Citation Format

Share Document