Health Technology Assessment in China's Health Care Sector: Development and Applications.

China's health system is facing severe challenges from social transition and the double burden of population aging and non-communicable diseases. Addressing the tension between the public's increasing demand for health services and the limited availability of medical resources has become a critical issue for health care policymakers and medical insurance fund administrators. In promoting its medical insurance system reform, China is actively developing health technology assessment (HTA) with principles and applications adapted to the Chinese context. This study aims to analyze the evolution of HTA in China with a focus on context, actors, process, content, and challenges encountered through applying a modified verson of Walt and Gilson's policy triangle framework. Currently, HTA plays an indispensable part in the reform of China's health care and medical insurance system, especially in the formulation and adjustment of the National Reimbursement Drug List (NRDL). While HTA is increasingly used in China, there remain challenges, such as the slow development of HTA related disciplines, lack of an independent national HTA authority, and limited scope in the use of HTA. Despite the identified challenges, HTA has the potential to support a wide range of applications in China's health care sector, building on the progress achieved over the last three decades.

An Evaluation Guide and Decision Support Tool for Journey Maps in Healthcare and Beyond.

The journey map concept evolved out of the service design field and is still relatively new in the healthcare landscape [1]. Journey maps are visualizations that effectively highlight organizational issues and allow stakeholder groups to be depicted by interest or function for a comparative visual analysis [2]. There are five journey map approaches: 1) Mental (Cognitive) Model Map, 2) Customer Journey Map, 3) Experience Map, 4) Service Blueprint Map, 5) Spatial Map. The objective of this article is three-fold: 1) quantify and delineate the journey mapping visualization techniques utilized from the phase 1 scoping review [2], 2) create a Journey Map Evaluation Guide, 3) create a Journey Map Decision Support Tool to facilitate a standardized method for journey map selection. For those less familiar with journey mapping, this framework can serve as a decision-making tool to facilitate the most effective choice among the different journey mapping visualization approaches. The tools presented in this study can provide a mechanism to standardize the assessment, classification and utilization of journey maps in the healthcare sector and industries abound.

Association of a Medicare Outpatient Payment Reform With Hospital-Primary Care Integration: Heterogeneity Across Markets and Physicians.

BACKGROUND: Hospital-physician integration increased rapidly in the past decade, threatening the affordability of care with minimal gains in quality. Medicare recently reformed its facility fee payments to hospitals for office consultations delivered by hospital-integrated physicians. This policy reform, affecting 200 million office visits annually, may have inadvertently encouraged hospitals to integrate with certain primary care physicians. OBJECTIVE: The objective of this study was to determine whether the policy reform was associated with hospital-primary care integration. RESEARCH DESIGN: I used a large sample of primary care physicians (n=98,884) drawn from Medicare claims data. I estimated cross-sectional multivariable linear probability models to measure whether the change in physicians' value-to-hospitals was associated with integration. RESULTS: The reform created heterogenous results: some physicians' value-to-hospitals decreased, while others increased (first percentile to 99th percentile, -$16,000 to $47,000). This change in value had a small association with integration: for every $10,000 increase, a physician was about 0.34 percentage points (95% confidence interval: 0.16-0.52) more likely to become integrated. Among high-volume physicians, the reform had larger effects: physicians whose value-to-hospitals grew by $20,000 or more were nearly 3 percentage points more likely to become integrated. Changes in value had no effect in concentrated hospital markets and rural areas. CONCLUSIONS: Effects of Medicare's site-based payments on hospital-primary care integration were concentrated among a small subset of physicians. Reforms to Medicare payment policy could influence integration among this group.

An evaluation of coupling coordination between sports industry and health service industry in China.

Depending on the strategy of "Healthy China", more and more people pay attention to health issues. The integration and development of sports industry and health service industry is an inevitable outcome of industrial transformation and upgrading and healthy life in the new era. Through constructing the evaluation index system of the coupling and coordination development degree between sports industry and health service industry, using entropy evaluation method and coupling and coordination degree model, this paper explore the comprehensive level and coupling and coordination development status of sports industry and health service industry in thirty-one provinces, municipality cities and autonomous regions of China from 2013 to 2017. The results of this paper show that the comprehensive China's sports industry and health service industry both present an incremental development trend year by year, and are characterized by the distribution of "high in the east and low in the west" in space. The government's policy support provides superior industrial supporting conditions for the development of sports industry. However, it is not conducive to the promotion of industrial economic benefits. In the health service industry, the rapid development of health insurance is beneficial to the integration of industrial resources and the perfection of industrial chain. Whereas as the core content of health service industry, health service has greater space for development; the coupling and coordination degree between the two industries rises from mild maladjustment to basic coordination, which is characterized by the distribution of "high in the east and low in the west" in space; among provinces, with Beijing, the Yangtze River Delta and Guangdong as the three development center points, it shows the spatial evolutionary process from "dispersion-type plaques" to "gathering type scattered surfaces".

Perspectives on statistical strategies for the regulatory biomarker qualification process.

Qualification of a biomarker for use in a medical product development program requires a statistical strategy that aligns available evidence with the proposed context of use (COU), identifies any data gaps to be filled and plans any additional research required to support the qualification. Accumulating, interpreting and analyzing available data is outlined, step-by-step, illustrated by a qualified enrichment biomarker example and a safety biomarker in the process of qualification. The detailed steps aid requestors seeking qualification of biomarkers, allowing them to organize the available evidence and identify potential gaps. This provides a statistical perspective for assessing evidence that parallels clinical considerations and is intended to guide the overall evaluation of evidentiary criteria to support a specific biomarker COU.

Moving somatic gene editing to the clinic: routes to market access and reimbursement in Europe.

Somatic gene editing (SGE) holds great promise for making genetic therapy possible for many monogenic conditions very soon. Is our current system of European market authorization and reimbursement ready for the expected tsunami of gene therapies? At a recent workshop of the Netherlands ZonMw consortium on ethical, legal, and social implications of personalized medicine, we discussed the current possibilities for bringing new gene therapies to the clinic. In Europe, it is not yet clear whether the route via the European medicines agency as an advanced therapy medicinal product is the most appropriate for evaluation of highly personalized SGE applications, although this may optimally guarantee safety and effectiveness. Compassionate use may ensure faster access than the centralized procedure but does not stimulate the commercial development of products. Prescription to named patients may only provide adequate access for single patients. Temporary authorization of use may allow access to medication half a year before formal market authorization has been granted, but may also have large budget impacts. Magistral compounding under a hospital exemption may be an attractive solution for rare, tailor-made applications at an acceptable price. To approve local experimental use of a therapy on a case-by-case basis may be fast, but does not guarantee optimal safety, effectiveness, and broad implementation. We argue that alternative routes should be considered for products developed for a market of large groups of patients versus unique personalized treatments. A balance between scientific evidence for safety and effectiveness, affordability, and fast access may demand a range of alternative solutions.

The impact of COVID-19 on the cell and gene therapies industry: Disruptions, opportunities, and future prospects.

Coronavirus 2019 (COVID-19) has caused significant disruption to the cell and gene therapy (CGT) industry, which has historically faced substantial complexities in supply of materials, and manufacturing and logistics processes. As decision-makers shifted their priorities to COVID-19-related issues, the challenges in market authorisation, and price and reimbursement of CGTs were amplified. Nevertheless, it is encouraging to see that some CGT developers are adapting their efforts toward the development of promising COVID-19-related therapeutics and vaccines. Manufacturing resilience, digitalisation, telemedicine, value-based pricing, and innovative payment mechanisms will be increasingly harnessed to ensure that market access of CGTs is not severely disrupted.

Relationships among Healthcare Digitalization, Social Capital, and Supply Chain Performance in the Healthcare Manufacturing Industry.

Due to the impact of coronavirus disease 2019 (COVID-19), automation and artificial intelligence (AI) have attracted renewed interest in multiple industrial fields. Global manufacturing bases were affected strongly by workforce shortages associated with the spread of COVID-19, and are working to increase productivity by embracing digital manufacturing technologies that take advantage of artificial intelligence and the Internet of Things (IoT) that offer the promise of improved connectivity among supply chains. This trend can increase and smooth the flow of social capital, which is a potential resource in supply chains and can affect supply chain performance in healthcare industry. However, such an issue has not been properly recognized as the best practice in healthcare industry. Thus, this study investigates empirically the relationship between digitalization and supply chain performance in healthcare manufacturing companies based on previous research that proposed a role for social capital. We surveyed the staff of domestic small and medium-sized healthcare manufacturing companies in South Korea currently operating or planning to deploy digital manufacturing technologies. Online and email surveys were utilized to collect the data. Invalid responses were excluded and the remaining 130 responses were analyzed using a structural equation model in SPSS with the AMOS module. We found that digitalization has a positive effect on the formation of social capital, which in turn has a positive effect on supply chain performance. The direct effect of digitalization on supply chain performance is small, and relatively large portions are mediated and influenced by social capital. The establishment of strategic relationships in the healthcare manufacturing industry is significant, as supply chain networks and production processes can influence the intended use of factory output. Companies should, therefore, secure timely and accurate information to manage the flow of products and services. The formation of social capital in the supply chain can help visualize entire supply chains and has a positive effect on real-time information-sharing among key elements of those chains.

Drug development post COVID-19 pandemic: toward a better system to meet current and future global health challenges.

Introduction: Despite advances in drug research and development, our knowledge of the underlying molecular mechanisms of many diseases remains inadequate. This have led to limited effective medicines for several diseases. To address these challenges, efficient strategies, novel technologies, and policies are urgently needed. The main obstacles in drug discovery and development are the mounting cost, risk, and time frame needed to develop new medicines. Fair pricing and accessibility is another unmet global challenge.Areas covered: Here, the authors cover the pace, risks, cost, and challenges facing drug development processes. Additionally, they introduce disease-associated data which demand global attention and propose solutions to overcome these challenges.Expert opinion: The massive challenges encountered during drug development urgently call for a serious global rethinking of the way this process is done. A partial solution might be if many consortiums of multi-nations, academic institutions, clinicians, pharma companies, and funding agencies gather at different fronts to crowdsource resources, share knowledge and risks. Such an ecosystem can rapidly generate first-in-class molecules that are safe, effective, and affordable. We think that this article represents a wake-up call for the scientific community to immediately reassess the current drug discovery and development procedures.

Nationwide patterns in industry payments to academic vascular surgeons.

OBJECTIVE: Financial relationships between vascular surgeons and industry are essential to the development and adoption of innovative technology. However, these relationships may establish competing interests. Our objective was to describe publicly available financial transactions between industry and academic vascular surgeons. METHODS: Academic vascular surgeons were identified and characterized on the basis of publicly available data correlated with Accreditation Council for Graduate Medical Education and Association of American Medical Colleges data to identify academic practice settings. Vascular surgeons were linked to Open Payments data for 2017 as reported by the Centers for Medicare & Medicaid Services. Univariate and nonparametric tests were used for analysis. RESULTS: Of 1158 academic vascular surgeons identified, 997 (86%) received industry payments totaling $8,548,034. Overall, the median of total payments received was $814 (interquartile range [IQR], $124-$2863). The top paid decile of vascular surgeons received $29,645 (IQR, $16,128-$61,701). Payments to the top decile accounted for 81% of all payments. Payments did not vary by academic rank but did vary by sex, with male vascular surgeons (n = 954) receiving $889 (IQR, $146-$3217) vs female vascular surgeons (n = 204) receiving $467 (IQR, $87-$1533; P = .002). By leadership role, division chiefs received the highest median payment amount ($1571; IQR, $368-$11,281) compared with department chairs ($424; IQR, $56-$2698) and vascular surgeons without leadership role ($769; IQR, $117-$2592; P = .002). Differences in payments were also seen on the basis of U.S. census region: Northeast, $571 (IQR, $90-2462); Midwest, $590 (IQR, $75-$2364); South, $1085 (IQR, $241-$3405); and West, $1044 (IQR, $161-$4887; P = .001). The most common categories of payments were food and beverage (paid to 85% of all vascular surgeons), travel and lodging (35%), and consulting fees (13%). Among the top decile of vascular surgeons, median payments exceeded $10,000 for three categories: consulting fees, compensation, and honoraria. Payments were made by 178 distinct entities with median total payments of $286 (IQR, $70-$6285). The three top entities paid a total of $5,004,061, which accounted for 59% of all payments. Payments from at least one of the top three entities reached 76% of vascular surgeons. CONCLUSIONS: Most academic vascular surgeons receive publicly reported industry payments that are paid by a limited number of entities, typically for food and beverage or travel and lodging. The top 10% of vascular surgeons received higher median payment amounts, totaling 81% of all industry payments. Vascular surgeons should be aware of publicly reported payment information and the potential for conflicts of interest.

Nursing students' perspectives on observed weight bias in healthcare settings: A qualitative study.

BACKGROUND: Weight bias continues to be problematic within the healthcare setting among practicing healthcare providers (HCPs). These HCPs serve as influential role models for nursing students when immersed in the clinical environment. However, if HCPs are demonstrating bias toward patients with obesity, this may influence nursing students' beliefs and practices. AIMS: This study aimed to explore nursing students' reflections of observed weight bias within the healthcare setting. MATERIALS & METHODS: A descriptive qualitative study design was used involving reflective journaling and qualitative content analysis. Two cohorts of third-year baccalaureate nursing students (n = 197) participated in weight sensitivity training and submitted reflective journals over one academic semester. RESULTS: Reports of weight bias were categorized into three themes-(1) Direct Impact: Observed Implicit and Explicit Provider Weight Bias; (2) Indirect Impact: Weight Bias Due to Skills, Equipment, or Staffing/Environmental Deficits; and (3) Reactions toward HCP Weight Bias: Conflict Between Weight Bias Training and Real-World Healthcare Experiences. DISCUSSION: Weight bias was observed in some HCPs within the healthcare setting. Student reflections explored weight bias and the opposing messages between weight sensitivity training and real-world practices. CONCLUSION: Preventing bias through continuing education for HCPs is crucial to provide compassionate care and instill ethical values in the next generation nurses.

Regional Market Competition is Associated with Aneurysm Diameter at the Time of EVAR.

BACKGROUND: Local market competition has been previously associated with more aggressive surgical decision-making. For example, more local competition for organs is associated with acceptance of lower quality kidney offers in transplant surgery. We hypothesized that market competition would be associated with the size of an abdominal aortic aneurysm (AAA) at the time of elective endovascular aneurysm repair (EVAR). METHODS: We included all elective EVARs reported in the Vascular Quality Initiative database (2012-2018). Small AAAs were defined as a maximum diameter <5.5 cm in men or <5.0 cm in women. We calculated the Herfindahl-Hirschman Index (HHI), a measure of physician market concentration (higher HHI = less market competition), for each US census region. Multilevel regression was used to examine the association between the size of AAA at EVAR and HHI, clustering by region. RESULTS: Of 37,914 EVARs performed, 15,379 (40.6%) were for small AAAs. There was significant variation in proportion of EVARs performed for small AAAs across regions (P < 0.001). The South had both the highest proportion of EVARs for small AAAs (44.2%) as well as the highest market competition (HHI 50), whereas the West had the lowest proportion of EVARs for small AAAs (35.0%) and the lowest market competition (HHI 107). Adjusting for patient characteristics, each 10 unit increase in HHI was associated with a 0.1 mm larger maximum AAA diameter at the time of EVAR (95% CI 0.04-0.24 mm, P = 0.005). CONCLUSIONS: Physician market concentration is independently associated with AAA diameter at time of elective EVAR. These data suggest that physician decision-making for EVAR is impacted by market competition.

Developing Medical Affairs Leaders Who Create the Future.

Medical affairs has evolved over recent years from a support, to a partner, to a strategic leadership function. In the future, there will be significant changes in healthcare and pharmaceutical industries, and many of these will be due to technological advances and digitalisation. Medical affairs will be largely influenced by these developments in terms of partnerships with key stakeholders, embracing innovation and patient-centric healthcare, and demonstrating value for novel treatment options. In order to secure future success within their roles, medical affairs professionals will have to demonstrate specific capabilities founded on communications and behavioural change, business leadership acumen, knowledge acquisition and self-development, and the ability to generate real-world evidence from insights and expertise within data science and analytics. It will be our responsibility as medical affairs leaders to create this foundation for the leaders of tomorrow.