scholarly journals A Patient-Centered Approach to Comparative Effectiveness Research Focused on Older Adults: Lessons From the Patient-Centered Outcomes Research Institute

2018 ◽  
Vol 67 (1) ◽  
pp. 21-28 ◽  
Author(s):  
Noah R. Mason ◽  
Harold C. Sox ◽  
Evelyn P. Whitlock
Keyword(s):  
Older Adults ◽  
Comparative Effectiveness Research ◽  
Outcomes Research ◽  
Comparative Effectiveness ◽  
Effectiveness Research ◽  
Patient Centered ◽  
Research Institute

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 Training in patient-centered outcomes research for specific researcher communities

2017 ◽  
Vol 1 (5) ◽  
pp. 278-284
Author(s):  
Douglas P. Landsittel ◽  
Larry Kessler ◽  
Christopher H. Schmid ◽  
Paul Marantz ◽  
Maria E. Suarez-Almazor ◽  
...  
Keyword(s):  
Comparative Effectiveness Research ◽  
Outcomes Research ◽  
Comparative Effectiveness ◽  
Training Programs ◽  
Healthcare Research ◽  
Lessons Learned ◽  
Effectiveness Research ◽  
Patient Centered ◽  
Experiential Training ◽  
Number Of Publications

A number of publications have discussed approaches to training the scientific workforce in comparative effectiveness research (CER) and patient-centered outcomes research (PCOR). To meet this need, funders have offered resources for developing educational materials and establishing training programs. To extend these efforts into specific researcher communities, the Agency for Healthcare Research and Quality developed an R25 Funding Opportunity Announcement that called for basic, advanced, and experiential training for a specific researcher community in collaboration with associated program partners. This paper describes the strategies developed by the 5 subsequently funded programs, their specific researcher communities and program partners, and the challenges associated with developing in-person and online programs. We focus on lessons learned that can be translated into developing training programs nationwide and on training for the special populations of interest. We also discuss the creation of a sustainable network for training and the conduct of comparative effectiveness research/patient-centered outcomes research in targeted communities.

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.

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