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Translation of research discoveries into health impact can take many years, creating delays in improving clinical outcomes. One approach to promoting timely translation is to examine successful cases in order to understand facilitators and strategies for overcoming barriers. We examined the development of evidence-based management for neonatal abstinence syndrome (NAS) at one academic medical center, with a primary focus on pharmacologic treatment. Despite a substantial increase in NAS case incidence starting in the early 2000s, significant sociocultural, policy, and regulatory barriers limited collaborative NAS research. Facilitators for translation encompassed: 1) pursuing research of societal interest, 2) building an effective interdisciplinary team, 3) intentionally linking clinical, research, and advocacy efforts, 4) broad stakeholder engagement across clinical, policy, and research arenas, and 5) leveraging local resources. Challenges included lack of commercially available U.S. Food and Drug Administration approved neonatal drug formulations, legal and regulatory barriers related to off-label and illicit use of opioids, recruitment for a treatment associated with drug withdrawal syndromes, misalignment of research design needs with real-world scenarios, and episodic funding. Benefits of successful translation included improvements in clinical care, reduced healthcare costs related to NAS, and enhanced legislative, policy, and research strategies to support broader neonatal investigations.
The Clinical and Translational Science Awards (CTSA) Consortium, a network of academic health care institutions with CTSA hubs, is charged with improving the national clinical and translational research enterprise. The CTSA Consortium and the NIH National Center for Advancing Translational Sciences implemented the Common Metrics Initiative comprised of standardized metrics and a shared performance improvement framework. This article summarizes hubs’ perspectives on its value during the initial implementation.
The value was assessed across 58 hubs. Survey items assessed change in perceived ability to manage performance and advance clinical and translational science. Semi-structured interviews elicited hubs’ perspectives on meaningfulness and value-added of the Common Metrics Initiative and hubs’ recommendations.
Hubs considered their abilities to manage performance to have improved, but there was no change in perceived ability to advance clinical and translational science. The initiative added value by providing a formal structured process, enabling strategic conversations, facilitating improvements in processes, providing an external impetus for improvement, and providing justification for funds invested. Hubs were concerned about the usefulness of the metrics chosen and whether the value-added was sufficient relative to the effort required. Hubs recommended useful benchmarking, disseminating best practices and promoting peer-to-peer learning, and expanding the use of data to inform the initiative.
Implementing Common Metrics and a performance improvement framework yielded concrete short-term benefits, but concerns about usefulness remained, particularly considering the effort required. The Common Metrics Initiative should focus on facilitating cross-hub collaboration around metrics that address high-priority impact areas for individual hubs and the Consortium.
The Common Metrics Initiative aims to develop and field metrics to improve research processes within the national Clinical and Translational Science Award (CTSA) Consortium. A Median Accrual Ratio (MAR) common metric was developed to assess the results of efforts to increase subject accrual into a set of clinical trials within the expected time period. A pilot test of the MAR was undertaken at Tufts Clinical and Translational Science Institute (CTSI) with eight CTSA Consortium hubs. Post-pilot interviews were conducted with 9 CTSA Principal Investigators (PIs) and 23 pilot team members. Over three-quarters (78%) of respondents reported that the MAR could be useful for performance improvement, but also described limitations or concerns. The most commonly cited barrier to MAR use for performance improvement was difficulty in interpreting the single value that is produced. Most respondents were interested in using the MAR to assess recruitment at an individual trial level. Majority of respondents (63%) had mixed opinions about aggregating metric results across the CTSA Consortium for comparison or benchmarking. Collecting data about additional contextual factors, and comparing accrual between subgroups, were cited as potentially helping address concerns about aggregation. Significant challenges remain in ensuring that the MAR can be sufficiently useful for collaborative process improvement. We offer recommendations to potentially improve metric usefulness.
The Clinical and Translational Science Awards (CTSA) Consortium, about 60 National Institutes of Health (NIH)-supported CTSA hubs at academic health care institutions nationwide, is charged with improving the clinical and translational research enterprise. Together with the NIH National Center for Advancing Translational Sciences (NCATS), the Consortium implemented Common Metrics and a shared performance improvement framework.
Initial implementation across hubs was assessed using quantitative and qualitative methods over a 19-month period. The primary outcome was implementation of three Common Metrics and the performance improvement framework. Challenges and facilitators were elicited.
Among 59 hubs with data, all began implementing Common Metrics, but about one-third had completed all activities for three metrics within the study period. The vast majority of hubs computed metric results and undertook activities to understand performance. Differences in completion appeared in developing and carrying out performance improvement plans. Seven key factors affected progress: hub size and resources, hub prior experience with performance management, alignment of local context with needs of the Common Metrics implementation, hub authority in the local institutional structure, hub engagement (including CTSA Principal Investigator involvement), stakeholder engagement, and attending training and coaching.
Implementing Common Metrics and performance improvement in a large network of research-focused organizations proved feasible but required substantial time and resources. Considerable heterogeneity across hubs in data systems, existing processes and personnel, organizational structures, and local priorities of home institutions created disparate experiences across hubs. Future metric-based performance management initiatives across heterogeneous local contexts should anticipate and account for these types of differences.
Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs).
SRC implementation at 10 AHCs was assessed pre/post-intervention using quantitative and qualitative methods. Pre-intervention, four AHCs had no SRC, and six had at least one SRC needing modifications to better align with Consensus Group recommendations.
Facilitators of successful SRC implementation included broad-based communication, an external motivator, senior-level support, and committed SRC reviewers. Barriers included limited resources and staffing, variable local mandates, limited SRC authority, lack of anticipated benefit, and operational challenges. Research protocol quality did not differ significantly between study periods, but respondents suggested positive effects. During intervention, median total review duration did not lengthen for the 40% of protocols approved within 3 weeks. For the 60% under review after 3 weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. Site interviews recommended designing locally effective SRC processes, building buy-in by communication or by mandate, allowing time for planning and sharing best practices, and connecting SRC and IRB procedures.
The CTSA SRC Consensus Group recommendations appear feasible. Although not conclusive in this relatively short initial implementation, sites perceived positive impact by SRCs on study quality. Optimal benefit will require local or federal mandate for implementation, adapting processes to local contexts, and employing SRC stipulations.
The Clinical and Translational Science Award (CTSA) Consortium and the National Center for Advancing Translational Science (NCATS) undertook a Common Metrics Initiative to improve research processes across the national CTSA Consortium. This was implemented by Tufts Clinical and Translational Science Institute at the 64 CTSA academic medical centers. Three metrics were collaboratively developed by NCATS staff, CTSA Consortium teams, and outside consultants for Institutional Review Board Review Duration, Careers in Clinical and Translational Research, and Pilot Award Publications and Subsequent Funding. The implementation program included training on the metric operational guidelines, data collection, data reporting system, and performance improvement framework. The implementation team provided small-group coaching and technical assistance. Collaborative learning sessions, driver diagrams, and change packages were used to disseminate best and promising practices. After 14 weeks, 84% of hubs had produced a value for one metric and about half had produced an initial improvement plan. Overall, hubs reported that the implementation activities facilitated their Common Metrics performance improvement process. Experiences implementing the first three metrics can inform future directions of the Common Metrics Initiative and other research groups implementing standardized metrics and performance improvement processes, potentially including other National Institutes of Health institutes and centers.
A core challenge of a multidisciplinary and multi-organizational translational research enterprise such as a Clinical and Translational Research Award (CTSA) is coordinating and integrating the work of individuals, workgroups, and organizations accustomed to working independently and autonomously. Tufts Clinical and Translational Science Institute (CTSI) undertook and studied a multifacted intervention to address this challenge and to create a culture of systems thinking, process awareness, responsive to others' needs, and shared decision-making.
The intervention, based on relational coordination, included 1) relational interventions, in three staff retreats and a diagnostic survey to provide feedback on the current quality of relational coordination, and 2) structural interventions, in the launching of five new cross-functional teams with regular meeting structures.
A mixed-methods evaluation yielded quantitative data via two types of team surveys and qualitative data via interviews and meeting observations.
The findings suggest that interventions to improve relational coordination are feasible for CTSAs, including good fidelity to the model and staff/physician engagement. Survey and interview data suggest model improvements in coordination and alignment. Further research about their optimal design is warranted.