Preventing secondary influenza transmission in households is challenging, as antiviral prophylaxis is constrained by cost, access and resistance concerns. Lianhua Qingwen (LHQW), an over-the-counter traditional Chinese medicine with reported antiviral and immunomodulatory activity, may represent an accessible alternative for household influenza prophylaxis. Here, in this multicentre, randomized, double-blind, placebo-controlled trial conducted at 55 centres in China between November 2023 and March 2024, we enroled 556 laboratory-confirmed index influenza cases and 1,428 influenza-negative close contacts. Close contacts were randomized 1:1 to receive LHQW (4 × 0.35-g capsules, three times daily for 5 days) or placebo and were followed for 9 days with serial real-time PCR testing. The primary end point was a reduction in the risk of secondary influenza infection among close contacts. The trial met its primary outcome. Secondary influenza infection occurred in 53 of 728 contacts (7.28%) in the LHQW group and 104 of 700 (14.86%) in the placebo group (odds ratio, 0.33; 95% confidence interval, 0.17–0.61; P < 0.001). Risk reduction was consistent across prespecified subgroups, including age, sex, antiviral use in index cases, symptom-onset timing and high-risk contacts. Adverse events were infrequent and comparable between groups, with no severe events reported. ( ChiCTR2300074385 ). In a multicentre, double‑blind, randomized trial including 556 laboratory‑confirmed index influenza cases and 1,428 household contacts in China, an over-the-counter traditional Chinese medicine, Lianhua Qingwen capsules, reduced the rate of secondary household influenza infections to 7.3% versus 14.9% with placebo, with a safety profile comparable to that of placebo.

本讲座介绍真实世界研究和随机对照试验的来龙去脉，说明如今学术界提倡两者相辅相成乃历史之进步。

本讲座借助若干近期文献，推介国内外先行者基于临床大数据进行真实世界研究的成果与方法，以期激励更多临床医生利用主场优势，将真实世界研究与临床实践融为一体。

本讲座介绍临床试验与真实世界证据相结合，国外最早通过药品评审的3个范例，推荐监管部门所认可的3类混合设计，并建议通力合作迎接药物研发的春天。

中医药真实世界研究成果喜人；望继续努力，将人用经验升华为真实世界证据，将中医辨证论治的千年智慧融入全球向往的精准医学。

本讲座介绍真实世界研究中通过基线的组间差异识别混杂变量的方法，以及利用倾向性评分消除混杂偏倚的两个常用方法：倾向性匹配和逆概率加权。

目的:立足整体探讨代谢综合征(MS)中医证候与微观理化指标的相关性.方法:采用标准化四诊信息采集量表收集MS患者中医证候信息,选取出现频率＞10％的条目47项.同时,收集患者理化指标共21项.采用典型相关分析探讨MS中医证候信息与微观理化指标间的整体相关性.结果:共收集符合纳入标准对象450例,提取出4对MS中医证候与微观指标典型相关组合,相关系数分别为0.690、0.577、0.518、0.505(P＜0.01).其中,脉弦与身高、心烦与体质量、脉沉与BMI、嗜烟与体质量等呈较明显的正相关关系,并且部分微观理化指标的组合与中医证候具有一定相关性.结论:微观理化指标与中医证候之间具有较为明显的典型相关关系,立足整体,将微观指标与中医证候变量结合,可为全面客观、中西医结合辨证提供一定参考.

Objective: The aim of this study was to develop a general method to estimate the minimal number of repeated examinations needed to detect patients with random responsiveness, given a limited rate of missed diagnosis.Methods: Basic statistical theory was applied to develop the method. As an application, 100 patients with disorders of consciousness (DOC) were assessed with the Coma Recovery Scale–Revised (CRS-R). DOC patients were supposed to be examined for 13 times over 20 days, while anyone who was diagnosed as a minimally conscious state (MCS) in a round would no longer be examined in the subsequent rounds. To test the validation of this method, a series of the stochastic simulation was completed by computer software under all the conditions of possible combinations of three kinds of distributions for p, five values of p, and four sizes of the sample and repeated for 100 times.Results: A series of formula was developed to estimate the probability of a positive response to a single examination given by a patient and the minimal number of successive examinations needed based on the numbers of patients detected in the first i (i =1, 2,.) rounds of repeated examinations. As applied to the DOC patients assessed with the CRS-R, with a rate of missed diagnosis < 0.0001, the estimate of the minimal number of examinations was six in traumatic brain injury patients and five in non-traumatic brain injury patients. The outcome of the simulation showed that this method performed well under various conditions possibly occurring in practice.Interpretation: The method developed in this paper holds in theory and works well in application and stochastic simulation. It could be applied to any other kind of examinations for random responsiveness, not limited to CRS-R for detecting MCS; this should be validated in further research.

辨证论治结局评价是中医临床疗效评价的难点.中医医生为辨证论治过程的主导,但其对疗效评价的影响则未见明确阐释.以中医医生报告结局为议题,利用定性研究方法,采用文献回顾、对比分析、病历回顾、访谈及现场调查等方法,对中医医生报告结局概念进行界定,分解其域体系,明晰对中医医生报告结局的认识,探讨其在辨证论治结局评价中的地位和意义,为后续研究提供思路.

Objective . The aim of this study was to evaluate the effectiveness of traditional Chinese medicine- (TCM-) guided dietary interventions in improving yang-qi deficiency and yin-blood deficiency TCM syndromes according to the principles of TCM syndrome differentiation theory in male youths undergoing drug detoxification during the rehabilitation period who stayed in a compulsory isolation detoxification center. Methods . Male youths undergoing drug detoxification who met the criteria to be included in the study were randomly divided into the intervention group ( n = 62) and the control group ( n = 61) according to a random number table in a 1 : 1 ratio. The intervention group received a TCM-guided diet, and the control group received routine food support. Over an intervention period of 3 months, we observed changes in the TCM syndrome element scores in the two groups before and after intervention. Results . After 3 months, the qi deficiency, yin deficiency, blood deficiency, and yin-blood deficiency syndrome in the intervention group improved significantly (P values 0.009, 0.000, 0.005, and 0.001, respectively). In the control group, yang deficiency, qi deficiency, and yang-qi deficiency syndromes worsened significantly (P values 0.003, 0.032, and 0.009, respectively). The differences (post-pre) in yang deficiency, qi deficiency, yang-qi deficiency, yin deficiency, blood deficiency, and yin-blood deficiency syndromes between the two groups were statistically significant (P values 0.003, 0.003, 0.003, 0.001, 0.005, and 0.002, respectively). Conclusion . A TCM-guided diet can delay the worsening of yang-qi deficiency syndrome symptoms and improve yin-blood deficiency syndrome and the prognosis of male youth undergoing drug detoxification during the rehabilitation period.

Background Both doctors' and patients' opinions are important in the process of treatment and healthcare of Chinese medicine. This study is to compare patients' and doctors' treatment satisfaction over the course of two visits in a Chinese medicine outpatient setting, and to explain their respective views. Methods Patients' chief complaints were collected prior to the outpatient encounter. The doctor was then asked (through a questionnaire) to state what complaints he or she was prioritizing during the process of diagnosing disease and making a prescription for herbal medicine or acupuncture treatment. On the next visit, both the patient and the doctor completed a questionnaire assessing satisfaction with the treatment of Chinese medicine prescribed in the first visit and administered by the patient at home. A 5-point Likert scales was used to assess the patients' and doctors' satisfaction with treatment. The timing of the follow-up appointment was determined by the doctor. One chief specialist, one associate chief specialist and one attending practitioner in Chinese medicine, and 60 patients having a follow-up appointment with one of the doctors, participated in the study. Results For 11 patients, their most urgent complaint was different from what the doctor's choose to focus on in his or her treatment. And only one patient refused to comply due to his or her dissatisfaction with the treatment focus of the doctor. Overall, 59 patients completed the satisfaction assessment, and 53 patients visited their doctors for a follow-up appointment. Patients' total satisfaction was higher than their doctors' (mean 3.55 vs. 3.45), and correlation of patients' and doctors' treatment satisfaction was moderate (r = 0.63, P < 0.01). Both of the patients' and doctors' satisfaction ratings were correlated with treatment adherence (P < 0.001). The predictors of their treatment satisfaction were different. Doctors' satisfaction with treatment was a significant factor in the process of making further clinical decisions. Conclusion Patients and doctors form their opinion about the treatment effects in different ways. When evaluating treatment satisfaction, doctor's opinions are also an important indicator of positive or negative clinical effects and affect the subsequent decisions-making.

Background There are no generally accepted standards for evaluation of treatment outcomes in traditional Chinese medicine (TCM). Pattern differentiation and individual treatments are recognized as the most distinguishing features of TCM. Therefore, how practitioners determine curative effects is an issue worthy of research, though little has been done in this area up to this point. This study examines perceptions of the effectiveness of TCM treatments and the means of evaluating clinical outcomes from the practitioners’ perspective. Methods Qualitative analysis of semi-structured interviews. Results A total of nine TCM practitioners from three university-affiliated hospitals and two scientific institutions participated in the interviews in August 2013. Participants reported evaluation of periodical treatment as an important part of the process of individual treatment based on pattern differentiation. Themes included (1) ways of evaluating treatment outcomes; (2) relationships between treatment outcomes and pathological transformation; and (3) distinguishing manifestations of the healing process from true adverse reactions. These considerations helped determine the optional treatment principles for further follow-up. An additional theme emerged related to the characteristics of diagnosis and treatment in TCM. Conclusions Health professionals considered all of the following as important ways of evaluating TCM treatment outcomes: patients’ input and subjective experience, physicians’ intake and examination, laboratory tests and medical device measurements. Pathological conditions were determined based on all the above factors, and no single factor determined the effectiveness from the practitioners’ perspectives. If the patients felt no significant beneficial effects, then it was necessary to judge the effectiveness from adverse effect. The follow-up measures were usually based on the previous treatment, and physicians’ satisfaction with each phase of TCM treatment was a significant factor in the process of making further decisions.

目的 当核心家系中无父母信息时,经典的传递不平衡检验(TDT)已不再适用,本文针对患病-未患病同胞家系数据,提出相应的关联分析方法,并校正协变量的影响.方法 我们把家系中的受累同胞作为病例,未受累同胞作为匹配的对照,建立非均衡的条件logistic回归模型或分层Cox回归模型.我们把模型应用到96个华人原发性高血压核心家系的基因定位数据,分析校正协变量后ACE的VD多态性、钠盐摄入水平与高血压的关系.结果 ACE与高血压的关联性受到钠盐摄入量高低的影响,ACE与钠盐摄入程度存在交互作用,较高的钠盐摄入患者其ACE的I/D多态性与高血压的关联性更强.结论 条件logistic回归模型或分层Cox回归模型能校正协变量的影响,有效分析基因的主效应和基因与协变量的交互作用.

The classification tree is a valuable methodology for predictive modeling and data mining. However, the current existing classification trees ignore the fact that there might be a subset of individuals who cannot be well classified based on the information of the given set of predictor variables and who might be classified with a higher error rate; most of the current existing classification trees do not use the combination of variables in each step. An algorithm of a logistic regression–based trichotomous classification tree (LRTCT) is proposed that employs the trichotomous tree structure and the linear combination of predictor variables in the recursive partitioning process. Compared with the widely used classification and regression tree through the applications on a series of simulated data and 2 real data sets, the LRTCT performed better in several aspects and does not require excessive complicated calculations.

Background: A negative attitude toward disability is one of the potential barriers for people with disability (PWD) to achieve social equality. Although numerous studies have investigated attitudes toward disability, few have evaluated personal attitudes toward disability among PWD, and made comparisons with attitudes of healthy respondents. This study was to investigate and compare the attitudes of PWD, caregivers, and the public toward disability and PWD in China, to identify discrepancies in attitude among the three groupsand to examine potential influencing factors of attitude within each group.Methods: A cross-sectional study was conducted among 2912 PWD, 507 caregivers, and 354 members of the public in Guangzhou, China. Data were collected on participants' socio-demographic information and personal attitudes toward disability using the Attitude to Disability Scale (ADS). ANOVA and ANCOVA were applied to compare the level of attitude among the three groups. Simple and multiple linear regression analyses were used to investigate the relationship between each background factor and attitude within each group.Results: Over 90 % of caregivers were PWD's family members. After controlling the socio-demographic characteristics, caregivers had the lowest total scores of ADS (caregivers: 47.7; PWD: 52.3; the public: 50.5). Caregivers who had taken care of PWD for longer durations of time had a more negative attitude toward disability. In contrast, PWD who had been disabled for longer times had a more positive attitude toward disability.Conclusions: The current national social security system of China does not adequately support PWD's familymember caregivers who may need assistance coping with their life with PWDs. More research is needed, and the development of a new health-care model for PWD is warranted.

Advanced Medical Statistics, pp. 227-263 (2015) No AccessCHAPTER 8: QUALITY OF LIFE: ISSUES CONCERNING ASSESSMENT AND ANALYSISJIQIAN FANG and YUANTAO HAOJIQIAN FANGDepartment of Medical Statistics and Community Medicine, School of Public Health, Sun Yat-Sen University, 74 Zhongshan Road II, Guangzhou 510080, People's Republic of China and YUANTAO HAODepartment of Medical Statistics and Community Medicine, School of Public Health, Sun Yat-Sen University, 74 Zhongshan Road II, Guangzhou 510080, People's Republic of Chinahttps://doi.org/10.1142/9789814583312_0008Cited by:0 PreviousNext AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsRecommend to Library ShareShare onFacebookTwitterLinked InRedditEmail Abstract: The following sections are included: The Concept of QOL and its Components Methods of Developing QOL Measurements Linguistic Validation of QOL Instrument Design Issues Relating to QOL Study Characteristics of QOL Data and Statistical Issues The Validation Process: Psychometric Testing References About the Authors FiguresReferencesRelatedDetails Advanced Medical StatisticsMetrics History PDF download

Advanced Medical Statistics, pp. 1339-1378 (2015) No AccessCHAPTER 34: STOCHASTIC PROCESSES AND THEIR APPLICATIONS IN MEDICAL SCIENCECAIXIA LI and JIQIAN FANGCAIXIA LIDepartment of Statistics, School of Mathematics and Computational Science, Sun Yat-Sen University, Guangzhou 510275, P.R. China and JIQIAN FANGDepartment of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-Sen University, Guangzhou 510080, P.R. Chinahttps://doi.org/10.1142/9789814583312_0034Cited by:0 PreviousNext AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsRecommend to Library ShareShare onFacebookTwitterLinked InRedditEmail Abstract: A stochastic process X = {X(t), t ∈ T} is a t-indexed collection of random variables. That is to say, for any t ∈ T, X(t) is a random variable. t is a parameter. We often interpret t as time. If the set T is a countable set, we call the process a discrete-time stochastic process, usually denoted by {Xn, n = 1, 2,…}. If T is continuum, we call it a continuous-time stochastic process, usually denoted by {X(t), t ≥ 0}. X(t) is called the state of process at time t. The collection of possible values of X(t) is called state space. If the state space is a countable set, we call the process a discrete-state process, and if the space is a continuum, we call the process a continuous-state process. Stochastic processes have always been applied in many fields. Now we introduce some important stochastic processes and their applications in medical science. FiguresReferencesRelatedDetails Advanced Medical StatisticsMetrics History PDF download