护理领域文献阅读汇编

The rapid expansion of immuno-oncology (I-O) and other advanced therapies is reshaping the complexity of early-phase clinical development. While core Phase I principles remain fundamental across oncology, emerging modalities introduce additional requirements for translational integration, specialized safety management, and therapeutic-specific infrastructure. However, the organizational functions of Phase I units have not evolved at the same pace and remain largely centered on conventional operational responsibilities. Drawing on the practices of leading Phase I units across the USA, Europe, and China, and comparing evolving regulatory frameworks of the US Food and Drug Administration, European Medicines Agency/Medicines and Healthcare products Regulatory Agency, and China's National Medical Products Administration, we propose a global perspective on the future development of Phase I units. We present a three-layer framework encompassing core Phase I foundations applicable across oncology, advanced translational capabilities, and ecosystem-level functions supporting emerging therapeutic development. Beyond ensuring patient safety and high-quality trial conduct, modern Phase I units should integrate translational research, artificial intelligence-enabled and model-informed drug development, regulatory science, and public engagement, while specialized centers may additionally support advanced therapy infrastructure, such as point-of-care manufacturing. Recognizing the diversity of institutional resources, we further propose a collaborative network model to facilitate scalable implementation and international harmonization. This framework positions Phase I units as integrated platforms connecting clinical investigation, translational science, regulatory innovation, and emerging therapy development, providing practical guidance for building future-ready early-phase clinical research infrastructure worldwide.

Administrative costs account for nearly one-quarter of US hospital expenditures and are substantially higher than those in other high-income countries. Although mandatory value-based payment programs implemented by the Centers for Medicare & Medicaid Services (CMS) aim to improve quality and efficiency, they may be associated with increased administrative burden. To evaluate the association between participation in CMS mandatory value-based payment programs and hospital administrative costs. This cohort study used a synthetic difference-in-differences design to compare hospital administrative costs obtained from the Medicare cost report data from fiscal years 2006 to 2020. The sample included Medicare-certified general acute care hospitals, critical access hospitals, and long-term acute care hospitals. Administrative costs at hospitals participating in mandatory value-based payment programs, including the Hospital Value-Based Purchasing (HVBP) program, Hospital Readmissions Reduction Program (HRRP), and Hospital-Acquired Condition Reduction Program (HACRP), were compared with hospitals not participating in these programs. In addition, hospitals participating in the Comprehensive Care for Joint Replacement (CJR) model were compared with hospitals not participating in this model. Data were analyzed between July 5 and December 25, 2025. Hospital participation in CMS mandatory value-based payment programs initiated under the Affordable Care Act (HVBP, HRRP, and HACRP) or the CJR model. The primary outcome was hospital administrative costs, defined as the sum of administrative and general, nursing administration, and medical records costs reported in Medicare cost report data. A total of 4332 hospitals were included in the sample. Of these hospitals, 2820 (65.1%) participated in the mandatory value-based payment programs (HVBP, HRRP, and HACRP). Nonparticipating hospitals included 42 general acute care hospitals in Maryland (0.9%), 1159 critical access hospitals (26.8%), and 311 long-term acute care hospitals (7.2%). In addition, 357 hospitals participated in the CJR model compared with 2029 that did not participate in the model. Participation in the 3 mandatory value-based programs was associated with annual increases in administrative costs of $1.23 (95% CI, $0.11-$2.36) million per hospital compared with general acute care hospitals in Maryland, $0.93 (95% CI, $0.27-$1.59) million compared with critical access hospitals, and $0.65 (95% CI, $0.01-$1.29) million compared with long-term acute care hospitals. Participation in the CJR model was associated with an annual increase in administrative costs of $1.40 (95% CI, $0.30-$2.49) million per hospital. Aggregated nationally, these increases corresponded to more than $3 billion in additional annual administrative costs. In this cohort study, participation in mandatory value-based payment programs was associated with increased hospital administrative costs. These findings suggest that policymakers should consider administrative burden when designing and evaluating payment reforms to ensure that anticipated improvements in cost, quality, and access are not offset by increased complexity.

High-risk medical devices approved through the US Food and Drug Administration (FDA) premarket approval (PMA) pathway may be supported by limited premarket clinical evidence, leaving uncertainties about safety. Whether device, premarket clinical evidence, or regulatory characteristics are associated with subsequent device recalls is unknown. To examine the association between device, premarket clinical evidence, and regulatory characteristics and serious recalls among high-risk therapeutic devices. This cross-sectional study reviewed 193 high-risk therapeutic medical devices approved through the FDA's PMA pathway between January 1, 2014, and December 31, 2023. Data were analyzed between August 2025 and December 2025. Device characteristics, premarket pivotal clinical study characteristics, and regulatory characteristics. The main outcome was occurrence of serious recall (Class I or II) and Class I (highest severity) recall. From 2014 to 2023, the FDA approved 193 original high-risk therapeutic medical devices through the PMA pathway. As of July 31, 2025, a total of 68 (35.2%) were subject to at least 1 serious recall, with a median (IQR) of 2.6 (1.5-4.6) years from approval to first recall; 20 (10.4%) devices were subject to at least 1 Class I recall. Life-supporting or life-sustaining devices more often had serious recalls (28 of 60 [46.7%] vs 40 of 133 [30.1%]; P = .02) and Class I recalls (14 of 60 [23.3%] vs 6 of 133 [4.5%]; P < .001) than non-life-supporting and life-sustaining devices. Cardiovascular devices more often had Class I recalls than noncardiovascular devices (16 of 99 [16.2%] vs 4 of 94 [4.3%]; P = .004). Class I recalls differed by pivotal study design: single-arm with no controls, 3 of 9 (33.3%); single-arm with nonconcurrent controls, 11 of 89 (12.4%); and multiple-arm with concurrent controls, 6 of 95 (6.3%) (P = .03). Devices with required postapproval studies had more serious recalls (56 of 140 [40.0%] vs 12 of 53 [22.6%]; P = .04) than those without. Other characteristics were not associated with recall likelihood. In this cross-sectional study, more than one-third of high-risk therapeutic medical devices were subject to serious recalls. Because device, premarket clinical evidence, and regulatory characteristics were not consistently associated with serious recalls, robust postmarket surveillance is needed to ensure patient safety.