By dividing the evolution of the U.S. clinical trial registration system into three phases—emergence, inception, and maturity—this study systematically traces its half-century development and reveals the underlying tensions and institutional logic. The U.S. clinical trial registration system is not merely a technical instrument, but a comprehensive institutional platform reconciling the conflicts among scientific rationality, commercial interests, and the public’s right to know. The emergence phase (1971—1985) originated from the establishment and public disclosure of the International Cancer Database to meet cancer research needs and safeguard patients’ survival rights. The inception phase (1986—2004) unfolded against the backdrop of the FDA’s drug approval crisis, with the construction of major disease registration systems breaking the regulatory deadlock and achieving an "incremental revolution". The maturity phase (2004—2016) centered on controlling publication bias and advancing institutionalization and legalization. The 2004 paroxetine incident galvanized global consensus on trial registration, and the 2007 U.S. Congressional mandate marked the pivotal turning point toward a fully mature system. Today, China still faces low registration rates and insufficient legal constraints. Drawing on the U.S. experience, China should prioritize institutional publicness, legal enforceability, and the containment of publication bias to strategically upgrade its clinical trial registration system.
In the American Heart Association’s Scientific Sessions 2021, the results of six clinical trials related to cardiovascular surgery were revealed. The PALACS trial demonstrated that posterior left pericardiotomy during open heart surgery was associated with a significant reduction in postoperative atrial fibrillation; the EPICCURE study found that injection of mRNA encoding vascular endothelial growth factor (VEGF-A mRNA) directly into the myocardium of patients undergoing elective coronary artery bypass grafting (CABG) improved patients’ heart function; the VEST trial once again proved the safety and potential value of external stent for vein graft. This article will interpret the above-mentioned three studies.
ObjectiveTo analyze the gender-specific distribution patterns of the disease burden of tracheal, bronchial, and lung cancer (hereinafter referred to as lung cancer) attributed to tobacco from 1990 to 2021 globally and in China and the United States (US), and to predict the trend of disease burden changes from 2022 to 2031, aiming to provide multi-dimensional evidence-based support for optimizing tobacco control strategies and precise lung cancer prevention and control systems. MethodsData on the disease burden of lung cancer attributed to tobacco from 1990 to 2021 globally and in China and the US were extracted and integrated from the Global Burden of Disease (GBD) 2021 database. The Joinpoint 4.9.1.0 software was used to analyze the corresponding trends in disease burden. The Bayesian age-period-cohort (BAPC) prediction model was employed to forecast the disease burden of lung cancer from 2022 to 2031. ResultsIn 2021, China had the highest number of deaths and disability-adjusted life years (DALYs) due to lung cancer attributed to tobacco, followed by the US. The top three risk factors for lung cancer globally and in China and the US from 1990 to 2021 were tobacco, air pollution, and occupational risks. The disease burden of lung cancer patients attributed to tobacco has been decreasing year by year in the global and US populations [the average annual percentage change (AAPC) values of age-standardized mortality rate and DALYs rate were: globally: −0.96%, −1.28%; US: −2.33%, −2.72%], while it has been increasing in China (the AAPC values of age-standardized mortality rate and DALYs rate were 0.28% and −0.02%, respectively). From a gender perspective, the disease burden of male patients with lung cancer attributed to tobacco was much higher than that of female patients from 1990 to 2021. Compared to the global average, the disease burden of lung cancer attributed to tobacco in China and the US from 1990 to 2021 was still heavy, with China’s burden being higher than that of the US. The elderly population aged ≥65 years in the global context and in China and the US was the primary group affected by the disease burden of lung cancer attributed to tobacco. The BAPC prediction model indicated that from 2022 to 2031, the age-standardized rates of lung cancer attributed to tobacco in the global context and in China and the US would show a declining trend. ConclusionFrom 1990 to 2021, the disease burden of lung cancer attributed to tobacco in China and the US was still heavy compared to the global average, with China’s burden being significantly higher than that of the US. The focus on prevention and control for both countries remains among the middle-aged and elderly population (especially males), which is a key challenge for tobacco-related lung cancer prevention and treatment work in the next 10 years.
The development and application of health decision support system (HDSS) in clinical service and health management is efficient in controlling health expenditure rising from overlapped examinations, and in reducing medical errors rising from insufficient decision-making support tools. Typical HDSS in America includes CPOE, MYCIN, QMR, NEDSS etc., which are mainly used in disease diagnosis and treatment, public health emergency management, hospital management, and health insurance management. The successful experiences accumulated in the development of the US health decision support system are worth referring to, such as, integration of management system, decision-makers and ICT, meeting the urgent needs of clinical service and health management, effective E-health construction, and rational development pathway from clinical decision support system to health management decision support system.
ObjectiveTo establish a sound management system for day surgery under the Joint Commission International (JCI) standard.MethodsFrom 2013, according to the provisions of JCI standard, a sound management system was established in the Second Affiliated Hospital of Zhejiang University School of Medicine by establishing the organizational structure of day surgery management, standardizing the operation process of day surgery, formulating standard operating rules and regulations, clarifying work responsibilities, strengthening the supervision of medical quality indicators at both hospital and department levels, and providing guidance for continuous performance.ResultsThe number of day operations in the hospital increased gradually, accounting for 25% of elective operations. During this period, there was no death of the patient, and these indexes remained low: the reservation cancellation rate of the patient was 0.9%, the transfer hospitalization rate was 0.23%, the unplanned reoperation rate was 0.012%, and the postoperative serious complications (bleeding, wound opening, etc.) was 0.03%.ConclusionThe establishment of day surgery management system under the JCI standard can standardize the development of day surgery and ensure the safety of patients.
Objective To investigate the efficacy of systemic immune inflammation index (SII) at admission and National Institutes of Health Stroke Scale (NIHSS) score immediately after thrombolysis on evaluating the short-term prognosis of neurological function in patients with acute ischemic stroke (AIS) receiving intravenous thrombolysis. Methods Patients with AIS treated with intravenous thrombolysis in the Second People’s Hospital of Chengdu between March 2022 and March 2023 were retrospectively analyzed. The basic data of the patients, NIHSS score at emergency admission, NIHSS score immediately after thrombolysis, modified Rankin Scale (mRS) score 3 months after discharge, and laboratory data at admission were collected, and SII at admission was calculated. According to the mRS score 3 months after discharge, the patients were divided into the good prognosis group (mRS≤2) and the poor prognosis group (mRS>2). Multivariate logistic regression analysis was used to screen out the factors affecting the prognosis of patients, and the receiver operating characteristic curve was drawn to analyze the evaluation effect of SII at admission and NIHSS score immediately after thrombolysis on the poor prognosis of neurological function of patients in the short term. Results A total of 213 patients were enrolled, and the prognosis was poor in 88 patients. Multivariate logistic regression analysis showed that age, onset-to-needle time, uric acid at admission, SII at admission, fasting blood glucose after admission, and NIHSS score immediately after thrombolysis were independent risk factors for poor prognosis in AIS patients (P<0.05). The area under the receiver operating characteristic curve (AUC) of SII at admission for predicting poor prognosis was 0.715, the sensitivity was 55.7%, and the specificity was 84.0%. The AUC of NIHSS score immediately after thrombolysis for predicting poor prognosis of patients was 0.866, the sensitivity was 87.5%, and the specificity was 72.8%. The AUC of SII at admission combined with NIHSS score immediately after thrombolysis for predicting poor prognosis of patients was 0.875, the sensitivity was 84.1%, the specificity was 77.6%, the positive predictive value was 72.5%, and the negative predictive value was 87.4%. SII at admission was positively correlated with NIHSS score at emergency admission, NIHSS score immediately after thrombolysis, and mRS score 3 months after discharge (P<0.05). Conclusion SII at admission can predict the short-term prognosis of neurological function of patients with AIS after thrombolysis therapy, and the combination of SII at admission and NIHSS score immediately after thrombolysis can improve the prediction efficiency.
Brain injury after cardiopulmonary resuscitation is closely related to the survival rate and prognosis of neurological function of cardiac arrest (CA) patients. Recently, the American Academy of Neurology (AAN) published a practice guideline which had updated the evaluation of different treatments for reducing brain injury following cardiopulmonary resuscitation. In order to master and transmit AAN 2017 practice guideline on reducing brain injury following cardiopulmonary resuscitation, this paper interprets the new AAN clinical practice guideline to assist Chinese clinicians for better studying the guideline.
The National Comprehensive Cancer Network (NCCN) has updated and released the NCCN esophageal and esophagogastric junction cancers clinical practice guidelines in oncology (version 3. 2022). Compared with the version 4 of the guidelines in 2021, the 3 versions in 2022 have some updates and revisions, mainly focusing on molecular marker detection, perioperative treatment, advanced immunotherapy, radiotherapy and other aspects. This article will interpret the main content of the new edition of the guidelines, in order to enhance the understanding of the guidelines and guide the clinical practice of diagnosis and treatment.
Cutaneous squamous cell carcinoma (cSCC) is the second most common human skin tumor. In recent years, the incidence of cSCC is increasing annually. Although most cSCC is curable after basic treatment, the advanced cSCC progresses rapidly and poses a significant risk for the impact on quality of life and death. In 2017, the latest version of cSCC management guideline was developed by the American Academy of Dermatology (AAD) based on extensive evidence-based medical evidence, including cSCC biopsy techniques, histopathological assessment, clinical staging and grading, surgical and nonsurgical treatment, follow-up, recurrence prevention, and management of the advanced cSCC. The purpose of this article is to briefly introduce and interpretate this guideline.
In the late-breaking trials session of the American Heart Association’s Scientific Sessions 2021, which took place in November 2021, six clinical trials in cardiac surgery published their primary results. This review will look into three of them including the management of patients with moderate or less-than-moderate tricuspid regurgitation at the time of surgery for degenerative mitral regurgitation, timing of ticagrelor cessation before coronary artery bypass grafting, and long-term outcomes of ticagrelor-based antiplatelet therapy for secondary prevention of coronary artery bypass grafting.