BACKGROUND: On-site monitoring is a crucial component of quality control in clinical trials. However, many cast doubt on its cost-effectiveness due to various issues, such as a lack of monitoring focus that could assist in prioritizing limited resources during a site visit. Consequently, an increasing number of trial sponsors are implementing a hybrid monitoring strategy that combines on-site monitoring with centralised monitoring. One of the primary objectives of centralised monitoring, as stated in the clinical trial guidelines, is to guide and adjust the extent and frequency of on-site monitoring. Quality tolerance limits (QTLs) introduced in ICH E6(R2) and thresholds proposed by TransCelerate Biopharma are two existing approaches for achieving this objective at the trial- and site-levels, respectively. The funnel plot, as another threshold-based site-level method, overcomes the limitation of TransCelerate\'s method by adjusting thresholds flexibly based on site sizes. Nonetheless, both methods do not transparently explain the reason for choosing the thresholds that they used or whether their choices are optimal in any certain sense. Additionally, related Bayesian monitoring methods are also lacking.
METHODS: We propose a simple, transparent, and user-friendly Bayesian-based risk boundary for determining the extent and frequency of on-site monitoring both at the trial- and site-levels. We developed a four-step approach, including: 1) establishing risk levels for key risk indicators (KRIs) along with their corresponding monitoring actions and estimates; 2) calculating the optimal risk boundaries; 3) comparing the outcomes of KRIs against the optimal risk boundaries; and 4) providing recommendations based on the comparison results. Our method can be used to identify the optimal risk boundaries within an established risk level range and is applicable to continuous, discrete, and time-to-event endpoints.
RESULTS: We evaluate the performance of the proposed risk boundaries via simulations that mimic various realistic clinical trial scenarios. The performance of the proposed risk boundaries is compared against the funnel plot using real clinical trial data. The results demonstrate the applicability and flexibility of the proposed method for clinical trial monitoring. Moreover, we identify key factors that affect the optimality and performance of the proposed risk boundaries, respectively.
CONCLUSIONS: Given the aforementioned advantages of the proposed risk boundaries, we expect that they will benefit the clinical trial community at large, in particular in the realm of risk-based monitoring.

The extraction process plays a crucial role in the production of Tibetan medicines. This study focused on assembling a set of online near-infrared (NIR) spectroscopy detection devices for the extraction of medicinal herbs. The original infrared device was transformed into an online detection system. After evaluating the stability of the system, we applied online NIR spectroscopy monitoring to the flavonoid contents (total flavonoids, quercetin-3-O-sophoroside, and luteolin) of Meconopsis quintuplinervia Regel. during the ultrasonic extraction process and determined the extraction endpoint. Nine batches of samples were employed to construct quantitative and discriminant models, half of the remaining two batches of samples are used for external verification. Our research shows that the residual predictive deviation (RPD) values of total flavonoids, quercetin-3-O-sophoroside and luteolin models exceeded 2.5. The R values for external verification of the three ingredients were above 0.9, with RPD values generally exceeding 2 and RSEP values within 10 %, demonstrating the model\'s strong predictive performance. Most of the extraction endpoints of the flavonoid components in M. quintuplinervia ranged from 18 to 58 min, with high consistency between the predicted extraction endpoints of the external validation, suggesting accurate determination of extraction endpoints based on predicted values. This study can provide a reference for the online NIR spectroscopy quality monitoring of the extraction process of Chinese and Tibetan herbs.

Objective  Our objective was to investigate the basic information of the personnel and facilities of nuclear medicine in Beijing. Methods  This survey was performed by the Beijing Quality Control Center in 2018. The investigation included personnel, equipment, and clinical applications, and data were then compared with previous surveys. The paper questionnaires were used for the survey, which required information about the personnel, devices, and clinical applications. Results  About 38 nuclear medicine departments in Beijing were involved in the survey. The number of nuclear medicine staff was 531 in 2018, showing an increase of 58.7% over the past decade. Positron emission tomography/computed tomography (PET/CT), single-photon emission computed tomography (SPECT), and single-photon emission computed tomography/computed tomography (SPECT/CT) represented the main nuclear medicine facilities, and the total number of surveyed departments was 18, 24, and 34, respectively. The quality control results showed significant improvement from the 2005 levels. The total number of scintigraphy procedures was estimated at 199,607 (153,185 SPECT and 46,422 PET/CT). The estimated annual number of scintigraphy images was 8.9 per 1,000 population for SPECT and 2.7 per 1,000 population for PET/CT during 2018. The most frequent radioiodine-targeted therapy was 131 I-targeted therapy for hyperthyroidism in 2018. Conclusion  Nuclear medicine has experienced rapid growth in the past 10 years in Beijing, either in personnel, equipment, and scintigraphy. Future efforts will focus on the use of new isotopes in the diagnosis, implementing quality strategy, and enhancing training.

OBJECTIVE: This study aimed to develop and validate a quantitative index system for evaluating the data quality of Electronic Medical Records (EMR) in disease risk prediction using Machine Learning (ML).
METHODS: The index system was developed in four steps: (1) a preliminary index system was outlined based on literature review; (2) we utilized the Delphi method to structure the indicators at all levels; (3) the weights of these indicators were determined using the Analytic Hierarchy Process (AHP) method; and (4) the developed index system was empirically validated using real-world EMR data in a ML-based disease risk prediction task.
RESULTS: The synthesis of review findings and the expert consultations led to the formulation of a three-level index system with four first-level, 11 second-level, and 33 third-level indicators. The weights of these indicators were obtained through the AHP method. Results from the empirical analysis illustrated a positive relationship between the scores assigned by the proposed index system and the predictive performances of the datasets.
CONCLUSIONS: The proposed index system for evaluating EMR data quality is grounded in extensive literature analysis and expert consultation. Moreover, the system\'s high reliability and suitability has been affirmed through empirical validation.
CONCLUSIONS: The novel index system offers a robust framework for assessing the quality and suitability of EMR data in ML-based disease risk predictions. It can serve as a guide in building EMR databases, improving EMR data quality control, and generating reliable real-world evidence.

The healthy benefits of seaweed have increased its market demand in recent times. Quality control is crucial for seaweed to ensure the customers\' interest and the sustainable development of seaweed farming industry. This study developed a quality control method for seaweed Sargassum fusiforme, rapid and simple, using near-infrared spectroscopy (NIR) and chemometrics for the prediction of antioxidant capacity of S. fusiforme from different growth stages, S. fusiforme was distinguished according to growth stage by partial least squares-discriminant analysis (PLS-DA) and particle swarm optimization-support vector machine (PSO-SVM). The antioxidant properties including 2,2\'-azinobis-3-ethylbenzothiazoline-6-sulfonic acid (ABTS) scavenging capacity, 2,2-diphenyl-1-picrylhydrazyl (DPPH) scavenging capacity, and ferric reducing antioxidant power (FRAP) were quantified using competitive adaptive reweighted sampling (CARS)-PLS model. Based on the spectra data preprocessed by multiplicative scatter and standard normal variate methods, the PSO-SVM models can accurately identify the growth stage of all S. fusiforme samples. The CARS-PLS models exhibited good performance in predicting the antioxidant capacity of S. fusiforme, with coefficient of determination (RP2) and root mean square error (RMSEP) values in the independent prediction sets reaching 0.9778 and 0.4018 % for ABTS, 0.9414 and 2.0795 % for DPPH, and 0.9763 and 2.4386 μmol L-1 for FRAP, respectively. The quality and market price of S. fusiforme should increase in the order of maturation < growth < seedling regarding the antioxidant property. The overall results indicated that the NIR spectroscopy accompanied by chemometrics can assist for the quality control of S. fusiforme in a more rapid and simple manner. This study also provided a customer-oriented concept of seaweed quality grading based on deep insight into the antioxidant capability of S. fusiforme at different growth stages, which is highly valuable for precise quality control and standardization of seaweed market.

Du Zhong is a valuable Chinese medicinal herb unique to China. It is a national second- class precious protected tree, known as \"plant gold\", which has been used to treat various diseases since ancient times. The main active ingredients are lignans, phenylprophetons, flavonoids, iridoids and steroids and terpenoids, which have pharmacological effects such as lowering blood pressure, enhancing immunity, regulating bone metabolism, protecting nerve cells, protecting liver and gallbladder and regulating blood lipids. In this paper, a comprehensive review of Eucommia ulmoides Oliv. was summarized from the processing and its compositional changes, applications, chemical components, pharmacological effects, and pharmacokinetics, and the Q-marker of Eucommia ulmoides Oliv. is preliminarily predicted from the aspects of traditional efficacy, medicinal properties and measurability of chemical composition, and the pharmacodynamic substance basis and potential Q-marker of Eucommia ulmoides Oliv. are further analyzed through network pharmacology. It is speculated that quercetin, kaempferol, β-sitosterol, chlorogenic acid and pinoresinol diglucoside components are selected as quality markers of Eucommia ulmoides Oliv., which provide a basis for the quality control evaluation and follow-up research and development of Eucommia ulmoides Oliv.

The quality control of the surgical pathway for colorectal cancer is closely related to reducing the incidence of postoperative complications, recurrence and metastasis, prolonging survival, and preserving functions. This pathway involves multiple disciplines, stages, and contents: standardizing the diagnosis and treatment process for colorectal cancer is crucial to ensuring medical quality and safety. Strengthening perioperative management is an important essential step for accelerating postoperative recovery and improving patient prognosis. Establishing a standard training program and effective inspection system is guarantee for the quality of colorectal cancer surgery.
规范化的结直肠癌诊治流程是保障医疗质量和安全的关键。结直肠癌手术实施路径的质量控制与器官功能保留、避免术后出现并发症、降低术后复发转移率以及延长患者生存期密切相关。而手术实施路径的质量控制的具体实施过程涉及多学科和诊治的多阶段，其中强化围手术期管理是加速患者术后康复、改善患者预后的重要环节；建立规范的培训与有效的督查体系是结直肠癌手术质量的重要保障。.

As a rapid developing rectal cancer procedure that has been in existence for more than a decade, transanal total mesorectal excision (taTME) has had a rough experience along the way, suggesting the importance of improving its surgical quality. In the current view of quality control of taTME, its main advantages are that it could increase the distance of distal margins, reduce the positive rate of circumferential margins, and improve the quality of total mesorectal excision. As few high-quality clinical studies have been conducted, the limitations brought about by confounding bias and publication bias that could not be excluded in current published studies call for a cautious interpretation of the current conclusions. At this stage taTME is only recommended in highly selective patients and centers. Under these circumstances, we aim to discuss the quality assessment of the taTME procedure and the selection of patients and centers. Based on current evidence and practical experience, we typically select patients with difficult pelvis, low rectal cancer, and/or those requiring direct visual recognition of the distal margin after neoadjuvant chemoradiation to perform taTME in our center.
经肛全直肠系膜切除术（taTME）作为一种诞生十余年的新兴直肠癌手术入路，其发展过程中的坎坷经历提示着我们提升其手术质量的重要性。针对目前taTME的质量评估，其主要优势在于可以增加远切缘距离、降低环周切缘阳性率，并提升全直肠系膜标本的切除质量。由于目前高质量临床研究开展仍然较少，且已发表的研究仍不能除外混杂偏倚以及发表偏倚所带来的局限性，故对于当前结论仍需审慎看待。现阶段，仅推荐taTME在具有高度选择性的患者和中心进行开展。因此，本文对于taTME手术质量的评估及在此基础上的患者与医疗中心的筛选进行探讨。根据目前研究结果和我中心实践经验，我们通常选择具有困难骨盆特征、低位直肠癌和（或）行新辅助放化疗需直视下确定远切缘的患者开展taTME手术。.

Surgery is the main means of achieving cure for colorectal cancer. Minimally invasive surgery, represented by laparoscopy and robotic surgery, has gradually become the mainstream approach for colorectal cancer at present. At the same time, the concept of surgery has appeared from simply emphasizing oncological radical treatment to emphasizing both radical treatment and function preservation. The quality control of colorectal cancer surgery includes the qualification admission system and assessment system, surgical approaches and indications, key surgical techniques (correct plain extension, lymph node dissection and resection range, nerve protection and function preservation, digestive tract reconstruction, and intraoperative prevention and treatment of complications). Unified and standardized quality control of surgery is not only a key factor in determining patient prognosis and quality of life, but also an important prerequisite for ensuring the accuracy of clinical trial.
手术是结直肠癌获得根治的主要手段。以腹腔镜和机器人手术为代表的微创外科治疗已逐渐成为现阶段结直肠肿瘤手术的主流方式。与此同时，功能保留手术治疗理念的兴起，使人们从单纯强调肿瘤学根治转变为强调根治与器官功能保护两者并重的治疗目的。结直肠肿瘤手术实施的质量化控制包括手术资质准入制度、考核制度、手术方式和指征、手术关键技术（正确层面拓展、淋巴结清扫区域和切除范围、神经保护与功能保留以及消化道重建和术中并发症防治）等。统一规范的手术实施质量控制不仅是决定患者预后和生活质量的关键因素，也是确保相关临床研究结论准确性的重要前提。.

BACKGROUND: Patient-Based Real-Time Quality Control (PBRTQC) has emerged as a supplementary programme to traditional internal quality control (iQC) mechanisms. Despite its growing popularity, practical applications in clinical settings reveal several challenges. The primary objective of this research is to introduce and develop an Artificial Intelligence (AI)-based method, named Voting algorithm based iQC (ViQC), designed to enhance the precision and reliability of existing PBRTQC systems.
METHODS: In this study, we conducted a retrospective analysis of 111,925 inpatient serum glucose test results from Nanjing Drum Tower Hospital, Nanjing, China, to provide an unbiased data set. The Voting iQC (ViQC) algorithm, established by the principles of the Voting algorithm, was then developed. Its analytical performance was evaluated through the calculation of random errors (RE). Subsequently, its clinical efficacy was assessed by comparison with five statistical algorithms: Moving Average (MA), Exponentially Weighted Moving Average (EWMA), Moving Median (movMed, MM), Moving Quartile (MQ), and Moving Standard Deviation (MovSD).
RESULTS: The ViQC model incorporates a variety of machine learning models, including logistic regression, Bayesian methods, K-Nearest Neighbor, decision trees, random forests, and gradient boosting decision trees, to establish a robust predictive framework. This model consistently maintains a false positive rate below 0.002 across all six evaluated error factors, showcasing exceptional precision. Notably, its performance further excels with an error factor of 3.0, where the false positive rate drops below 0.001, and achieves an accuracy rate as high as 0.965 at an error factor of 2.0. The classification effectiveness of ViQC model is evaluated by an area under the curve (AUC) exceeding 0.97 for all error factors. In comparison to five conventional PBRTQC statistical methods, ViQC significantly enhances error detection efficiency, maximum reducing the trimmed average number of patient samples required for detecting errors from 724 to 168, thereby affirming its superior error detection capability.
CONCLUSIONS: The new established PBRTQC using artificial intelligence yielded satisfactory performance compared to the traditional PBBTQC in real world setting.