Economic Evaluation Design within the HEAL Prevention Cooperative.

The rapid rise in opioid misuse, disorder, and opioid-involved deaths among older adolescents and young adults is an urgent public health problem. Prevention is a vital part of the nation's response to the opioid crisis, yet preventive interventions for those at risk for opioid misuse and opioid use disorder are scarce. In 2019, the National Institutes of Health (NIH) launched the Preventing Opioid Use Disorder in Older Adolescents and Young Adults cooperative as part of its broader Helping to End Addiction Long-term (HEAL) Initiative ( https://heal.nih.gov/ ). The HEAL Prevention Cooperative (HPC) includes ten research projects funded with the goal of developing effective prevention interventions across various settings (e.g., community, health care, juvenile justice, school) for older adolescent and young adults at risk for opioid misuse and opioid use disorder (OUD). An important component of the HPC is the inclusion of an economic evaluation by nine of these research projects that will provide information on the costs, cost-effectiveness, and sustainability of these interventions. The HPC economic evaluation is integrated into each research project's overall design with start-up costs and ongoing delivery costs collected prospectively using an activity-based costing approach. The primary objectives of the economic evaluation are to estimate the intervention implementation costs to providers, estimate the cost-effectiveness of each intervention for reducing opioid misuse initiation and escalation among youth, and use simulation modeling to estimate the budget impact of broader implementation of the interventions within the various settings over multiple years. The HPC offers an extraordinary opportunity to generate economic evidence for substance use prevention programming, providing policy makers and providers with critical information on the investments needed to start-up prevention interventions, as well as the cost-effectiveness of these interventions relative to alternatives. These data will help demonstrate the valuable role that prevention can play in combating the opioid crisis.

Using economic evaluations in implementation science to increase transparency in costs and outcomes for organizational decision-makers.

BACKGROUND: Economic evaluations frequently are utilized to compare the value of different interventions in medicine and health in concrete terms. Implementation science also would benefit from the incorporation of economic evaluations, but such studies are rare in the literature. The National Cancer Institute has supported a special collection of articles focusing on economic evaluations in implementation science. Even when interventions are supported by substantial evidence, they are implemented infrequently in the field. Implementation costs are important determinants for whether organizational decision-makers choose to adopt an intervention and whether the implementation process is successful. Economic evaluations, such as cost-effectiveness analyses, can help organizational decision-makers choose between implementation approaches for evidence-based interventions by accounting for costs and succinctly presenting cost/benefit tradeoffs. MAIN TEXT: This manuscript presents a discussion of important considerations for incorporating economic evaluations into implementation science. First, the distinction between intervention and implementation costs is presented, along with an explanation of why the comprehensive representation of implementation costs is elusive. Then, the manuscript describes how economic evaluations in implementation science may differ from those in medicine and health intervention studies, especially in terms of determining the perspectives and outcomes of interest. Finally, referencing a scale-up trial of an evidence-based behavioral health intervention, concrete case examples of how cost data can be collected and used in economic evaluations targeting implementation, rather than clinical outcomes, are described. CONCLUSIONS: By gaining a greater understanding of the costs and economic impact associated with different implementation approaches, organizational decision-makers will have better transparency for future replication and scale-up. The use of economic evaluations can help to advance this understanding and provide researchers, purveyors or third-party intermediaries, and organizational decision-makers with essential information to facilitate implementation.

The NICE Evidence Standards Framework for digital health and care technologies - Developing and maintaining an innovative evidence framework with global impact.

OBJECTIVE: In 2018, the UK National Institute for Health and Care Excellence (NICE), in partnership with Public Health England, NHS England, NHS Improvement and others, developed an evidence standards framework (ESF) for digital health and care technologies (DHTs). The ESF was designed to provide a standardised approach to guide developers and commissioners on the levels of evidence needed for the clinical and economic evaluation of DHTs by health and care systems. METHODS: The framework was developed using an agile and iterative methodology that included a literature review of existing initiatives and comparison of these against the requirements set by NHS England; iterative consultation with stakeholders through an expert working group and workshops; and questionnaire-based stakeholder input on a publicly available draft document. RESULTS: The evidence standards framework has been well-received and to date the ESF has been viewed online over 55,000 times and downloaded over 19,000 times. CONCLUSIONS: In April 2021 we published an update to the ESF. Here, we summarise the process through which the ESF was developed, reflect on its global impact to date, and describe NICE's ongoing work to maintain and improve the framework in the context for a fast moving, innovative field.

Impact of COVID-19 on service delivery for an evidence-based behavioral treatment for families involved in the child welfare system.

The novel coronavirus, COVID-19, has dramatically impacted clinical service delivery, particularly substance use treatment. The Families Actively Improving Relationships (FAIR) program is an action-oriented, evidence-based behavioral treatment for opioid and methamphetamine disorders in parents involved in the child welfare (CW) system. A seven-clinician team operates out of a Medicaid-funded clinic, primarily delivering services in the community. Attending to underlying mechanisms of FAIR's intervention strategies that promote client engagement and clinical outcomes, FAIR rapidly adapted procedures in response to COVID-19-onset disruptions. This study analyzed administrative records and Medicaid claims data from January 2019 to July 2020, including 157 clients and 17,449 claims. Analyses considered COVID-19 presence as March-July 2020. The study examined changes in the frequency and reimbursement volume of FAIR service delivery pre- and postonset of COVID-19. Although average monthly reimbursement per clinician did not significantly decline, reimbursement per client significantly declined by 31% (pre: $1005 [$732]; post: $698 [$546], p < .001). Clinicians delivered services on significantly more days per month during COVID-19 (mean (sd) = 16.73 (6.33); 20.26 (7.24), t(127) = -2.70, p < .01). Average clinician caseload size was stable, as was the average monthly service receipt days for clients. Thus, this study attributes reductions in reimbursement per client when FAIR provided services remotely to the elimination of in-person billable services and reductions in session length, but not in frequency. Medicaid-funded clinics and community-based substance use treatment interventions such as FAIR can successfully sustain and implement substance use treatment practices with deliberate, rapid adaptation to ensure that families receive needed supports in the face of contextual crises.

Trends in Orthopedic Surgery Reimbursement From 2000 to 2015.

Understanding trends in reimbursement for orthopedic surgery is important, especially considering the changing landscape of health care delivery and payment models. Although other studies have examined these trends using a sampling of common orthopedic procedures compared with non-orthopedic specialties, robust examination across all orthopedic specialties is not available in the current literature. This study aimed to critically analyze the trends in reimbursement in the field of orthopedic surgery. Inflation-adjusted Medicare reimbursement and work relative value units (RVUs) between 2000 and 2016 for more than 200 individual Current Procedural Terminology codes across all major orthopedic subspecialties were analyzed, and inherent value of work RVUs was assessed by dividing reimbursement dollar values by work RVUs annually and tracking the changes. Between 2000 and 2016, reimbursement decreased across all orthopedic subspecialties by an average of 29%, except oncology, which showed a 6% increase. Work RVUs increased by an average of 10%, but the inherent value of work RVUs decreased across all orthopedic subspecialties by an average of 39%. Increased active involvement of orthopedic attending physicians and residents in coding documentation and fee-schedule representation is needed. [Orthopedics. 2020;43(3):187-190.].

Replication of an emergency department-based recovery coaching intervention and pilot testing of pragmatic trial protocols within the context of Indiana's Opioid State Targeted Response plan.

Solving the opioid crisis requires immediate, innovative, and sustainable solutions. A number of promising strategies are being carried out by U.S. states and territories as part of their Opioid State Targeted Response (STR) plans funded through the 21st Century Cures Act, and they provide an opportunity for researchers to assess effectiveness of these interventions using pragmatic approaches. This paper describes a pilot study of Project Planned Outreach, Intervention, Naloxone, and Treatment (POINT), the intervention that served as the basis for Indiana's STR-funded, emergency department (ED)-based peer specialist expansion that was conducted in preparation for a larger, multisite pragmatic trial. Through the pilot, we identified, documented, and corrected for challenges encountered while implementing planned study protocols. Per the project's funding mechanism, the ability to move to the larger trial was determined by the achievement of 3 milestones: (1) successful replication of the intervention; (2) demonstrated ability to obtain the necessary sample size; and (3) observe a higher level of engagement in medication for addiction treatment in the POINT group compared to standard care. Overall implementation of the study protocols was successful, with only minor refinements to proposed procedures being required in light of challenges with (1) data access, (2) recruitment, and (3) identification of the expansion hospitals. All three milestones were reached. Challenges in implementing protocols and reaching milestones resulted in refinements that improved the study design overall. The subsequent trial will add to the limited but growing evidence on ED-based peer supports. Capitalizing on STR efforts to study an already scaling and promising intervention is likely to lead to faster and more sustainable results with greater generalizability than traditional, efficacy-focused clinical research.

Scaling Implementation of Collaborative Care for Depression: Adaptation of the Stages of Implementation Completion (SIC).

Tools to monitor implementation progress could facilitate scale-up of effective treatments. Most treatment for depression, a common and disabling condition, is provided in primary care settings. Collaborative Care Management (CoCM) is an evidence-based model for treating common mental health conditions, including depression, in this setting; yet, it is not widely implemented. The Stages of Implementation Completion (SIC) was adapted for CoCM and piloted in eight rural primary care clinics serving adults challenged by low-income status. The CoCM-SIC accurately assessed implementation effectiveness and detected site variations in performance, suggesting key implementation activities to aid future scale-ups of CoCM for diverse populations.

Long-Term Economic Benefit of Treatment Foster Care Oregon (TFCO) for Adolescent Females Referred to Congregate Care for Delinquency.

Treatment Foster Care Oregon (TFCO) is an alternative to congregate care, for youth involved in the juvenile justice and/or child welfare systems. Though demonstrated as clinically-and cost-effective across multiple rigorous trials, the long-term cost benefit of TFCO has not been considered. This study follows n = 166 females from adolescence to young adulthood, who were involved in both systems and referred for out-of-home-care. Records of arrest, court, incarceration (juvenile, jail, and prison), monitoring (parole and probation) and child-welfare services were included in a long-term cost-benefit analysis. Outcomes highlight ongoing benefit of the TFCO intervention, nearly 10 years post-intervention.

ASSESSING THE VALUE OF INNOVATIVE MEDICAL DEVICES AND DIAGNOSTICS: THE IMPORTANCE OF CLEAR AND RELEVANT CLAIMS OF BENEFIT.

OBJECTIVES: Large numbers of new medical devices and diagnostics are developed and health services need to identify which ones offer real advantages. The National Institute for Health and Care Excellence (NICE) has introduced a system for assessing technologies that are often notified by companies, based on claims made for their benefits to patients, the National Health Service, and the environment. METHODS: Detailed scrutiny of claims made for the benefits of products and the corresponding evidence, seeking associations between these and the selection of products for full evaluation to produce NICE guidance. RESULTS: Between 2009 and 2015 a NICE committee considered 169 technologies, of which it selected 74 (44 percent) for full evaluation, based on the claims of benefit and the evidence available. An average of 7.5 claims were made per technology; the total number did not influence selection but presence of studies supporting all the claims (p < .001) or any of the claims (p < .05) had a positive influence, as did claims for quicker patient recovery (p < .001). A greater number of studies to support the claims made selection more likely (p < .001), as did cohort studies (p < .05) and surveys (p < .05) but, unexpectedly, not randomized trials. The Medical Device Directive class had no influence. CONCLUSIONS: This study presents categories of claims that may be useful to those developing new products and to others engaged in health technology assessment. It illustrates the importance of relevant evidence and of having a clear vision of the place of new products in care pathways from an early stage.

The Cost of Implementing New Strategies (COINS): A Method for Mapping Implementation Resources Using the Stages of Implementation Completion.

OBJECTIVE: Illustrate the value of a strategy used for measuring the costs and resources used in the implementation process over and above the costs of the intervention itself in the context of a two-arm randomized controlled trial. METHODS: Counties in California and Ohio (sites) were invited to implement Multidimensional Treatment Foster Care (MTFC), an alternative to congregate care for youth. Participating sites (n=53) were randomized to one of two implementation = sites share information and move through the implementation process as a cohort facilitated by an MTFC purveyor or (2) Individual Implementation (IND: "as usual") where sites work individually with the MTFC purveyor. The implementations were monitored using the Stages of Implementation Completion (SIC) measure of a number of observable activities, developed as part of the trial to segment the implementation process into 8 stages of implementation. Resource data gathered from the implementation purveyors and site participants were used to map costs onto each of the 8 stages to generate total cost measures stratified by type of resource and stage of implementation for each of the study arms. RESULTS: The SIC provided a feasible costing template to map costs onto observable activities and to enable the examination of important differences in implementation strategies for an evidence-based practice. The average total implementation cost prior to program start-up of CDT was $133,106; IND cost $118,699. While CDT cost more in a number of stages, it resulted in fewer county staff hours being used and shorter mean times to implementation than IND. In cases where rapidity of implementation of reducing staff time required for implementation is valued, then CDT would be the preferable implementation approach. CONCLUSIONS: The SIC is a useful tool for determining implementation resources needed for new evidence-based practice programs for youth and particularly for comparing different implementation strategies that might be tried in pilot programs.

Trauma sonography for use in microgravity.

Sonography is the only medical imaging modality aboard the ISS, and is likely to remain the leading imaging modality in future human spaceflight programs. While trauma sonography (TS) has been well recognized for terrestrial trauma settings, the technique had to be evaluated for suitability in spaceflight prior to adopting it as an operational capability. The authors found the following four-phased evaluative approach applicable to this task: 1) identifying standard or novel terrestrial techniques for potential use in space medicine; 2) developing and testing these techniques with suggested modifications on the ground (1 G) either in clinical settings or in animal models, as appropriate; 3) evaluating and refining the techniques in parabolic flight (0 G); and 4) validating and implementing for clinical use in space. In Phase I of the TS project, expert opinion and literature review suggested TS to be a potential screening tool for trauma in space. In Phase II, animal models were developed and tested in ground studies, and clinical studies were carried out in collaborating trauma centers. In Phase III, animal models were flight-tested in the NASA KC-135 Reduced Gravity Laboratory. Preliminary results of the first three phases demonstrated the potential clinical utility of TS in microgravity. Phase IV studies have begun to address crew training issues, onboard imaging protocols, and data transfer procedures necessary to offer the modified TS technique for space use.

Focused Assessment with Sonography for Trauma in weightlessness: a feasibility study.

BACKGROUND: The Focused Assessment with Sonography for Trauma (FAST) examines for fluid in gravitationally dependent regions. There is no prior experience with this technique in weightlessness, such as on the International Space Station, where sonography is currently the only diagnostic imaging tool. STUDY DESIGN: A ground-based (1 g) porcine model for sonography was developed. We examined both the feasibility and the comparative performance of the FAST examination in parabolic flight. Sonographic detection and fluid behavior were evaluated in four animals during alternating weightlessness (0 g) and hypergravity (1.8 g) periods. During flight, boluses of fluid were incrementally introduced into the peritoneal cavity. Standardized sonographic windows were recorded. Postflight, the video recordings were divided into 169 20-second segments for subsequent interpretation by 12 blinded ultrasonography experts. Reviewers first decided whether a video segment was of sufficient diagnostic quality to analyze (determinate). Determinate segments were then analyzed as containing or not containing fluid. A probit regression model compared the probability of a positive fluid diagnosis to actual fluid levels (0 to 500 mL) under both 0-g and 1.8-g conditions. RESULTS: The in-flight sonographers found real-time scanning and interpretation technically similar to that of terrestrial conditions, as long as restraint was maintained. On blinded review, 80% of the recorded ultrasound segments were considered determinate. The best sensitivity for diagnosis in 0 g was found to be from the subhepatic space, with probability of a positive fluid diagnosis ranging from 9% (no fluid) to 51% (500 mL fluid). CONCLUSIONS: The FAST examination is technically feasible in weightlessness, and merits operational consideration for clinical contingencies in space.