The Price of Practice Change: Assessing the Cost of Integrating Research Findings Into Clinical Practice.

BACKGROUND: Clinicians, health care administrators, and implementation scientists know that it takes intentional effort, resources, and implementation strategies to integrate research findings into routine clinical practice. An oft-cited concern for those considering whether and how to implement an evidence-based program is how much it will cost to implement the change. Yet information about the cost of implementation is not often available to health care decision-makers. Teams that received Implementation Award funding from PCORI are conducting implementation projects to promote the uptake of evidence-based practices in health care settings. As part of their implementation efforts, a number of teams have examined the costs of implementation. In this Topical Collection, 5 teams will report their findings on implementation costs and discuss their methods for data collection and analysis. DISCUSSION: The teams' costing efforts provide specific information about the costs sites can expect to incur in promoting the uptake of specific evidence-based programs. In addition, the papers illuminate 3 key features of the teams' approaches to measuring the cost of implementation: (1) the use of specific micro-costing methods with time-driven activity-based costing serving as the most popular method; (2) different ways to categorize and organize costs, including a site-based and non-site-based framework; and (3) cost collection challenges experienced by the teams. CONCLUSION: The cost of implementation is a critical consideration for organizations seeking to improve practice in accordance with research findings. This Topical Collection describes detailed approaches to providing this type of cost information and highlights insights to be gained from a rigorous focus on implementation cost.

Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine.

IMPORTANCE: Since publication of the report by the Panel on Cost-Effectiveness in Health and Medicine in 1996, researchers have advanced the methods of cost-effectiveness analysis, and policy makers have experimented with its application. The need to deliver health care efficiently and the importance of using analytic techniques to understand the clinical and economic consequences of strategies to improve health have increased in recent years. OBJECTIVE: To review the state of the field and provide recommendations to improve the quality of cost-effectiveness analyses. The intended audiences include researchers, government policy makers, public health officials, health care administrators, payers, businesses, clinicians, patients, and consumers. DESIGN: In 2012, the Second Panel on Cost-Effectiveness in Health and Medicine was formed and included 2 co-chairs, 13 members, and 3 additional members of a leadership group. These members were selected on the basis of their experience in the field to provide broad expertise in the design, conduct, and use of cost-effectiveness analyses. Over the next 3.5 years, the panel developed recommendations by consensus. These recommendations were then reviewed by invited external reviewers and through a public posting process. FINDINGS: The concept of a "reference case" and a set of standard methodological practices that all cost-effectiveness analyses should follow to improve quality and comparability are recommended. All cost-effectiveness analyses should report 2 reference case analyses: one based on a health care sector perspective and another based on a societal perspective. The use of an "impact inventory," which is a structured table that contains consequences (both inside and outside the formal health care sector), intended to clarify the scope and boundaries of the 2 reference case analyses is also recommended. This special communication reviews these recommendations and others concerning the estimation of the consequences of interventions, the valuation of health outcomes, and the reporting of cost-effectiveness analyses. CONCLUSIONS AND RELEVANCE: The Second Panel reviewed the current status of the field of cost-effectiveness analysis and developed a new set of recommendations. Major changes include the recommendation to perform analyses from 2 reference case perspectives and to provide an impact inventory to clarify included consequences.

Return of aggregate results to study participants: Facilitators, barriers, and recommendations.

Background: Most researchers and study participants believe that the summary, or aggregate, results of health research should be returned to study participants. However, researchers often do not return aggregate results. A better understanding of the impediments to results return could support improvements in this practice. Methods: This qualitative study convened eight virtual focus groups, four with investigators and four with patient partners from research studies funded by the Patient-Centered Outcomes Research Institute (PCORI). In total, 23 investigators and 20 partners participated. We explored perspectives, experiences, influences, and recommendations related to aggregate results return. Results: Focus group participants described the ethical importance of returning aggregate results, as well as the benefits to study participants. They also noted important impediments to results return, emphasizing IRB and logistical challenges and describing a lack of support for the practice both on the part of institutions and the field at large. Participants highlighted the value of patients and caregivers' perspectives and contributions to results return, which focused on returning the most relevant findings through effective channels and formats. They further emphasized the importance of planning and identified resources that could support results return. Conclusion: Researchers, funders, and the field can better facilitate results return by promoting standardized processes in research, such as the earmarking of funds for results return and inclusion of results returns milestones in research plans. More intentional policies, infrastructures, and resources that support results return may lead to more widespread return of study results to those who make these studies possible.

Lessons Learned from Developing Plain Language Summaries of Research Studies.

BACKGROUND: Plain language translation may facilitate the public's ability to understand and use results of scientific research. Brief description of activity: This article describes the Patient-Centered Outcomes Research Institute's (PCORI) approach to and lessons learned from developing plain language summaries of PCORI-funded research for the lay public. IMPLEMENTATION: We developed and tested a standard template for the summaries, incorporating feedback in the template design from focus groups with members of the public. Between February 2017 and March 2020, we completed translation of 272 plain language summaries of PCORI-funded studies, covering topics including cardiovascular disease, obesity, cancer, mental health, asthma, HIV/AIDS, and comparative effectiveness research methods. RESULTS: Templates use a question-and-answer format, with sections on the rationale, methods, results, limitations, and how the research will help inform decisions. In addition to feedback on template heading wording and order, focus group participants stressed the importance of establishing relevance and conveying credibility and limitations. LESSONS LEARNED: Lessons learned relate to supporting consistency across individual summaries, carefully prioritizing content to include in the summaries, and balancing plain language and reading level with precision. These lessons learned from template development and implementation may be useful to other organizations or publishers contemplating similar efforts to make scientific research results more accessible. [HLRP: Health Literacy Research and Practice. 2021;5(2):e155-e161.] Plain Language Summary: The Patient-Centered Outcomes Research Institute (PCORI) funds comparative effectiveness research. This research compares the benefits and harms of two or more health care choices. In this article, we describe lessons learned from PCORI's efforts to develop plain language summaries of results from the research it funds. These lessons may help other organizations that want to share research results in plain language.

Future Directions for Cost-effectiveness Analyses in Health and Medicine.

OBJECTIVES: In 2016, the Second Panel on Cost-effectiveness in Health and Medicine updated the seminal work of the original panel from 2 decades earlier. The Second Panel had an opportunity to reflect on the evolution of cost-effectiveness analysis (CEA) and to provide guidance for the next generation of practitioners and consumers. In this article, we present key topics for future research and policy. METHODS: During the course of its deliberations, the Second Panel discussed numerous topics for advancing methods and for improving the use of CEA in decision making. We identify and consider 7 areas for which the panel believes that future research would be particularly fruitful. In each of these areas, we highlight outstanding research needs. The list is not intended as an exhaustive inventory but rather a set of key items that surfaced repeatedly in the panel's discussions. In the online Appendix , we also list and expound briefly on 8 other important topics. RESULTS: We highlight 7 key areas: CEA and perspectives (determining, valuing, and summarizing elements for the analysis), modeling (comparative modeling and model transparency), health outcomes (valuing temporary health and path states, as well as health effects on caregivers), costing (a cost catalogue, valuing household production, and productivity effects), evidence synthesis (developing theory on learning across studies and combining data from clinical trials and observational studies), estimating and using cost-effectiveness thresholds (empirically representing 2 broad concepts: opportunity costs and public willingness to pay), and reporting and communicating CEAs (written protocols and a quality scoring system). CONCLUSIONS: Cost-effectiveness analysis remains a flourishing and evolving field with many opportunities for research. More work is needed on many fronts to understand how best to incorporate CEA into policy and practice.

Can we better prioritize resources for cost-utility research?

PURPOSE: We examined 512 published cost-utility analyses (CUAs) in the U.S. and other developed countries from 1976 through 2001 to determine: 1) the types of interventions studied; 2) whether they cover diseases and conditions with the highest burden; and, 3) to what extent they have covered leading health concerns defined by the Healthy People 2010 report. DATA AND METHODS: We compared rankings of the most common diseases covered by the CUAs to rankings of U.S. disease burden. We also examined the extent to which CUAs covered key Healthy People 2010 priorities. RESULTS: CUAs have focused mostly on pharmaceuticals (40%) and surgical procedures (16%). When compared to leading causes of DALYs, the data show overrepresentation of CUAs in cerebrovascular disease, diabetes, breast cancer, and HIV/AIDS, and underrepresentation in depression and bipolar disorder, injuries, and substance abuse disorders. Few CUAs have targeted Healthy People 2010 areas, such as physical activity. CONCLUSIONS: Published CUAs are associated with burden measures, but have not covered certain important health problems. These discrepancies do not alone indicate that society has been targeting resources for research inefficiently, but they do suggest the need to formalize the question of where each CUA research dollar might do the most good.

Federal sponsorship of cost-effectiveness and related research in health care: 1997-2001.

OBJECTIVES: To describe recent federal sponsorship of cost-effectiveness and related health economics research to provide insight into the functioning of existing research support systems and assess the roles of federal health agencies. METHODS: Using the PubMed database, we identified cost-effectiveness and related publications citing support from a US government entity and published during the period of 1997 through 2001, and audited them for information on funding sources, study type, and content focus. RESULTS: Five Department of Health and Human Services agencies and centers and the Veterans Administration are cited as funders in 74% of 520 federally supported health economics publications we identified. Three-fourths of federally supported publications address five areas of high disease burden: infections, cancer, HIV/AIDS, cardiovascular disease, and substance abuse. Other high burden diseases, including mental health, diabetes, and injuries, receive less attention. Federal support of health economics studies of health education and care delivery-intervention types underexamined in the field-is relatively strong but most often focuses on substance abuse or mental health services. Each of the top federal funders has a distinct funding pattern, but there are substantial areas of overlap within which we could not identify content domains specific to one funder or another. CONCLUSIONS: Federal support of health economics research has paralleled growth in the field. Federal funders support projects consistent with their mission and focus on high-burden disease areas. However, overlapping funding areas, ambiguity concerning agency interests within overlapping content areas, and gaps in some disease and intervention areas suggest that the coordination of health economics research funding could be improved.