Healthcare systems, utilization, coverage, reimbursement
1. Opportunities and Risks of UK Medical Device Reform
This study aims to identify the potential opportunities and risks around future UK regulatory reform of medical devices. Opportunities relating to regulatory independence were identified, including the potential to create and implement a regulatory framework that ensures availability of medical devices; innovation and investment potential; and safety to the citizens of the UK. The most significant risks identified included threats to the safety of individual patients and the wider health system arising from the delay in awaiting regulatory approval due to the shortage of approved bodies; and reduced competitiveness of UK market and device manufacturers.
2. Reimbursement of Digital Therapeutics: Future Perspectives in Korea
Although the global digital therapeutics (DTx) market is rapidly growing and whether the health insurance system will cover DTx is a very important issue, there are currently no standards in Korea after the approval stage of the Ministry of Food and Drug Safety. Regarding this issue, this study examined the concepts and characteristics of DTx and compared major countries (the U.S., the U.K., Germany, Japan, and Australia) reimbursement policies for DTx, thus clarifying the political implications for introducing DTx in Korea.
Clinical value
The study explored health professionals' views on the utility of circulating tumor DNA (ctDNA) testing in hereditary cancer syndrome (HCS) management. 35 professionals participated. They described ctDNA as "transformative" and a "game-changer". However, they were divided on its use in HCS management, with some being optimistic (optimists) while others were hesitant (pessimists). Differences were driven by views on 3 factors: (1) clinical utility, (2) ctDNA's role in cancer screening, and (3) ctDNA's invasiveness. Providers anticipated ctDNA testing will transform early cancer detection for HCS families.
Multiple approaches based on cell-free DNA (cfDNA) have been applied to detect minimal residual disease (MRD) and to predict prognosis or recurrence. However, a comparison of the approaches used in different cohorts and studies is difficult. This study aimed to compare multiple approaches for MRD analysis after neoadjuvant therapy (NAT) in patients with locally advanced rectal cancer (LARC). The study concluded that the combination of mutation profiling and CNA (copy number alterations) profiling can improve the detection of MRD, which may help optimize the treatment strategies for patients with LARC.
A meta-analysis was performed to assess the predictive value of biomarkers for imaging abnormalities on CT. A total of 2939 citations were identified, and 38 studies were included. Thirty-two studies reported data for S100B. There is evidence to support the use of S100B as a screening tool in mild TBI, and potential advantages to the use of GFAP, which requires further investigation.
Remote cognitive assessments are increasingly needed to assist in the detection of cognitive disorders, but the diagnostic accuracy of telephone- and video-based cognitive screening remains unclear. The study aims to assess the test accuracy of any multidomain cognitive test delivered remotely for the diagnosis of any form of dementia. The Author concluded that despite the common and increasing use of remote cognitive assessment, supporting evidence on test accuracy is limited. Remote testing is complex, and this is reflected in the heterogeneity seen in tests used, their application, and their analysis. More research is needed to describe accuracy of contemporary approaches to remote cognitive assessment.
This review summarizes some latest research on the diagnosis of early-stage NSCLC via liquid biopsy, including circulating DNA, circulating tumor cells, exosomes, and tumor-educated platelets, as well as their detection technologies, such as fluorescence in-situ hybridization-based, polymerase chain reaction-based, next-generation sequencing-based, Chip-based, and microfluidic methods. Additionally, we outline the existing challenges and possible solutions for liquid-biopsy biomarkers. The study mainly highlights the merits of liquid biopsy as a promising biomarker for non-invasive detection in the future, particularly for the early detection of NSCLC, thereby benefitting human health.
This review aimed to assess brief digital behavior change solutions (i.e., solutions that require limited engagement or contact) for T2D, including use of behavior change techniques (BCTs) and their impact on self-care and glycemic control. Brief digital solutions can improve clinical and behavioral outcomes while reducing patient burden, fitting more easily in patients' lives and potentially improving usability. As T2D patients increasingly expect access to self-care assistance between face-to-face encounters, digital support tools will play a greater role in effective diabetes management programs.
Cost-effectiveness, HTA, real world data
Clinical pathways with multiple diagnostic tests are complex to model, but problematic and simplistic approaches are often used in economic evaluations. The researchers analyzed statistical methods of handling multiple diagnostic tests and provided guidance on applying these methods in economic modeling. They first introduced a statistical model to quantify the correlations between 2 tests and how those correlations can be incorporated within an economic model. They also presented the general form of conditional dependence among multiple tests. They then introduced net reclassification improvement (NRI), a measure that evaluates the added value of a new risk factor (e.g., biomarker) for risk prediction. They further provided 2 examples to illustrate the application of these methods.
10. Use and Cost Analysis of Comprehensive Respiratory Panel Testing in a Pediatric Emergency Department
Although comprehensive respiratory viral panels can quickly identify causative organisms, cost to the hospital and patient may be significant. The objective of this study was to analyze the financial impact of comprehensive respiratory viral panel use in relation to associated clinical outcomes. This study demonstrates that the utilization of comprehensive respiratory viral panels in pediatric emergency department patients with bronchiolitis, unspecified fever, and/or acute upper respiratory infection adds significant cost to patient care without a decrease in their length of stay or antimicrobial use. Further studies are needed to determine the appropriate targeted use of comprehensive respiratory viral panels.
This study is a cost-effectiveness analysis comparing comprehensive genomic profiling (CGP) of 10 oncogenes, targeted gene panel testing (TGPT) of 4 oncogenes, and no tumor profiling over the lifetime for patients with metastatic lung adenocarcinoma. Compared with no tumor profiling in patients with metastatic lung adenocarcinoma, tumor profiling (TGPT, CGP) improves quality-adjusted survival but is not cost-effective.
12. Health Technology Assessment to assess value of biomarkers in the decision-making process
The study aims to clarify the multidisciplinary interactions required to properly measure the cost-effectiveness of biomarkers with regard to the risk-benefit of the patients and how Health Technology Assessment (HTA) approach may assess value of biomarkers integrated within the decision-making process. The biostatistical methodology is relevant to HTA but only meta-analysis is covered in depth, whereas proper approaches are needed to estimate the benefit-risk balance ratio. Several biomarkers underwent HTA evaluation and the final reports have pragmatically addressed: 1) a redesign of the screening based on biomarker; 2) a de-implementation/replacement of the test in clinical practice; 3) a selection of biomarkers with potential predictive ability and prognostic value; and 4) a stronger monitoring of the appropriateness of test request.