Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment.

Recently, there has been a growing interest in understanding how decentralized clinical trial (DCT) solutions can mitigate existing challenges in clinical development, particularly participant burden and access, and the collection, management, and quality of clinical data. This paper examines DCT deployments, emphasizing how they are integrated and how they may impact clinical trial oversight, management, and execution. We propose a conceptual framework that employs systems thinking to evaluate the impact on key stakeholders through a reiterative assessment of pain points. We conclude that decentralized solutions should be customized to meet patient needs and preferences and the unique requirements of each clinical trial. We discuss how DCT elements introduce new demands and pressures within the existing system and reflect on enablers that can overcome DCT implementation challenges. As stakeholders look for ways to make clinical research more relevant and accessible to a larger and more diverse patient population, further robust and granular research is needed to quantify the impact of DCTs empirically.

Aortic stenosis post-COVID-19: a mathematical model on waiting lists and mortality.

OBJECTIVES: To provide estimates for how different treatment pathways for the management of severe aortic stenosis (AS) may affect National Health Service (NHS) England waiting list duration and associated mortality. DESIGN: We constructed a mathematical model of the excess waiting list and found the closed-form analytic solution to that model. From published data, we calculated estimates for how the strategies listed under Interventions may affect the time to clear the backlog of patients waiting for treatment and the associated waiting list mortality. SETTING: The NHS in England. PARTICIPANTS: Estimated patients with AS in England. INTERVENTIONS: (1) Increasing the capacity for the treatment of severe AS, (2) converting proportions of cases from surgery to transcatheter aortic valve implantation and (3) a combination of these two. RESULTS: In a capacitated system, clearing the backlog by returning to pre-COVID-19 capacity is not possible. A conversion rate of 50% would clear the backlog within 666 (533-848) days with 1419 (597-2189) deaths while waiting during this time. A 20% capacity increase would require 535 (434-666) days, with an associated mortality of 1172 (466-1859). A combination of converting 40% cases and increasing capacity by 20% would clear the backlog within a year (343 (281-410) days) with 784 (292-1324) deaths while awaiting treatment. CONCLUSION: A strategy change to the management of severe AS is required to reduce the NHS backlog and waiting list deaths during the post-COVID-19 'recovery' period. However, plausible adaptations will still incur a substantial wait to treatment and many hundreds dying while waiting.

Opportunities to improve the value of outpatient surgical care.

OBJECTIVES: Nearly 57 million outpatient surgeries-invasive procedures performed on an outpatient basis in hospital outpatient departments (HOPDs) or ambulatory surgery centers (ASCs)-produced annually in the United States account for roughly 7% of healthcare expenditures. Although moving inpatient surgeries to outpatient settings has lowered the cost of care, substantial opportunities to improve the value of outpatient surgery remain. To exploit these remaining opportunities, we composed an evidence-based care delivery composite for national discussion and pilot testing. STUDY DESIGN: Evidence-based care delivery composite. METHODS: We synthesized peer-reviewed publications describing efforts to improve the value of outpatient surgical care, interviewed patients and clinicians to understand their most deeply felt discontents, reviewed potentially relevant emerging science and technology, and observed surgeries at healthcare organizations nominated by researchers as exemplars of efficiency and effectiveness. Primed by this information, we iterated potential new designs utilizing criticism from practicing clinicians, health services researchers, and healthcare managers. RESULTS: We found that 3 opportunities are most likely to improve value: 1) maximizing the appropriate use of surgeries via decision aids, clinical decision support, and a remote surgical coach for physicians considering a surgical referral; 2) safely shifting surgeries from HOPDs to high-volume, multi-specialty ASCs where costs are much lower; and 3) standardizing processes in ASCs from referral to recovery. CONCLUSIONS: Extrapolation based on published studies of the effects of each component suggests that the proposed 3-part composite may lower annual national outpatient surgical spending by as much as one-fifth, while maintaining or improving outcomes and the care experience for patients and clinicians. Pilot testing and evaluation will allow refinement of this composite.

Age of blood as a limitation for transfusion: potential impact on blood inventory and availability.

BACKGROUND: Evolving concerns about storage lesions for red blood cells (RBCs) have led to ongoing trials evaluating the benefits of transfusing fresher blood to acutely ill patients. STUDY DESIGN AND METHODS: We evaluated several RBC maximum shelf lives (MSLs) and their impact on RBC availability and outdate rate. First, we determined the mean age of the RBC units in our inventory by analyzing the data set of 18,987 nonirradiated RBC units transfused at our institution from April 2008 to March 2009. Second, we determined the feasibility of issuing RBC units of a designated age to patients using the same data set. We defined six scenarios where RBC units have different MSLs: Scenarios 1, 2, 3, 4, and 5 used a MSL of 7, 14, 21, 28, and 35 days, respectively. Scenario 6 used a combination of different MSLs depending on the category of patients. RESULTS: RBC units spent on average 8.6 days on the shelf with a mean age of 10.2 days at delivery and 18.8 days at issue for transfusion. Using the original 18,987 data points, we observed a shortfall in the availability of RBC units, decreased by 51, 20, 10, 4, 1, and 0% and an increase in the outdate rate to 3.2, 2.2, 1.0, 0.6, 0.4, and 4.5% for Scenarios 1, 2, 3, 4, 5, and 6, respectively, compared to baseline. CONCLUSION: Changing the MSL for RBC units would require novel approaches to RBC inventory management to meet hospital demands with acceptable outdate rates.

Improving platelet supply chains through collaborations between blood centers and transfusion services.

BACKGROUND: Blood centers and hospital transfusion services are challenged with maintaining an adequate platelet (PLT) inventory to minimize the number of outdated units without risking a major shortage. A novel approach to inventory management was established at our institution through a collaboration between the Stanford University Medical Center (SUMC) Transfusion Service, the Stanford Blood Center (SBC), and the Department of Management Science and Engineering. STUDY DESIGN AND METHODS: An analysis of the supply chain performance between SBC and SUMC Transfusion Service was performed. First, the interaction between processes, such as blood collection, rotation, and inventory management, was studied. Second, changes were implemented based on the recommendations from the analysis team. Finally, a postanalysis was performed reflecting on the improvement of the operations between SUMC and SBC. RESULTS: A comprehensive data analysis of the PLT supply chain allowed the identification of three series of improvements to be implemented: 1) on SBC's PLT collection, 2) on SBC's rotation process, and 3) on the PLT inventory management policy at SUMC. A postimplementation analysis showed a reduction in the overall PLT outdate rate from 19% in the first quarter of 2006, down to 9% in the third quarter of 2008. CONCLUSION: A multidisciplinary effort among SUMC Transfusion Service, SBC, and experts in supply chain management resulted in a process improvement, which reduced the rate of PLT outdate at both SBC and SUMC Transfusion Service down to 9%, with a significant cost reduction of more than half a million dollars per year.