Overview Of Stability Study Designs

Stability requirements for the worldwide registration of pharmaceutical products have changed dramatically in the past few years. A series of guidelines on the design, conduct, and data analysis of stability studies of pharmaceuticals have been published by the International Conference on Harmonization (ICH); however, the statistical discussion on study design is limited. In this paper, stability designs including full, bracketing, and matrixing designs will be exemplified. The statistical aspects of these stability designs will be discussed in relation to the recent ICH guidelines. The statistical and regulatory considerations on the selection of stability design will also be presented. The stability study should be well designed so the shelf life of the drug product can be estimated with a high degree of accuracy and precision. Several commonly used criteria for design comparison will be presented. Finally, a case study is presented to illustrate the potential problems of an overreduced design from the statistical and regulatory perspectives.

     

A new concept for the non-invasive treatment of Adolescent Idiopathic Scoliosis: The Corrective Movement© principle integrated in the SpineCor System

Purpose. To evaluate the change in spinal curvature and posture of Idiopathic Scoliosis patients when a curve specific ‘Corrective Movement^© Principle’ (CMP) is applied.

Methods. This prospective interventional study was carried out on a group of 639 patients (92.3% females) having idiopathic scoliosis treated with the SpineCor brace. All girls were premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness followed the SRS outcome criteria for bracing. The clinical, radiological and postural evaluations assisted to define the patient classification, which guided the unique application of the CMP to each type of curvature.

Results. A total of 583 patients met the outcome criteria. Overall, 349 patients have a definitive outcome. Successful treatment was achieved in 259 (74.2%) of the 349 patients from the fitting to the weaning of the brace. Some 51 immature patients (14.6%) required surgical fusion while receiving treatment. Eight mature patients out of 298 (2.7%) required surgery within 2 years of follow-up beyond skeletal maturity.

Conclusion. The SpineCor brace is effective for the treatment of adolescent idiopathic scoliosis. Moreover, positive outcomes are maintained after 2 years because 151 (93.2%) of 162 patients stabilized or corrected their end of bracing Cobb angle up to 2 years after bracing.     

Processus,procédures et critères d’évaluation conduisant à la mise sur la liste d’aptitude aux fonctions de Maître de conférences des universités – praticien hospitalier (MCU-PH) et de professeur des universités – praticien hospitalier (PU-PH) en anesthésie-réanimation

Since several decades, anesthesia care and intensive care, as well, are engaged in the way of excellence in clinical care and research. This requirement is also applied for the selection of professor and academic workers. The goals of this article are twice: first to diffuse this knowledge at the medical community and second to describe in details the long process leading to the final appointment.     

目标性培训在消毒供应中心培训中的应用

目的 探讨目标性培训方法在消毒供应中心岗位人员器械培训中的应用效果。方法 本研究为随机对照试验。选取2021年4月至7月在揭阳市人民医院消毒供应中心从事手术组工作的 20名 33～45岁女性岗位人员作为培训对象，采用随机数字表法将其分为对照组和观察组，各 10名。 对照组应用传统的培训方法，观察组应用目标性培训方法。培训后比较两组人员操作技能考核成绩、 培训满意度、负责清洗包装腹腔镜基础器械包的清洗质量和包装质量合格率。符合正态分布的计量资料采用均数±标准差（xˉ ± s）表示，组间比较采用独立样本t检验；计数资料采用例数或率（%）表示， 组间比较采用卡方检验；P＜0.05为差异有统计学意义。结果 观察组考核成绩、培训满意度及其负责清洗包装的腹腔镜基础器械包清洗质量、包装质量合格率明显高于对照组［（90.2±6.1）分比（77.0± 7.5）分、（90.0±6.0）分比（72.1±9.8）分、487（97.4%）比453（90.6%）、492（98.4%）比472（94.4%）］，差异有统计学意义（均P＜0.05）。结论 在消毒供应中心岗位人员器械培训时应用目标性培训方法，可有效提高岗位人员考核成绩及培训满意度及其负责清洗包装的腹腔镜基础器械包清洗质量、包装质量合 格率，保障患者安全。     

Towards clinical data-driven eligibility criteria optimization for interventional COVID-19 clinical trials

ObjectiveThis research aims to evaluate the impact of eligibility criteria on recruitment and observable clinical outcomes of COVID-19 clinical trials using electronic health record (EHR) data.Materials and MethodsOn June 18, 2020, we identified frequently used eligibility criteria from all the interventional COVID-19 trials in ClinicalTrials.gov (n = 288), including age, pregnancy, oxygen saturation, alanine/aspartate aminotransferase, platelets, and estimated glomerular filtration rate. We applied the frequently used criteria to the EHR data of COVID-19 patients in Columbia University Irving Medical Center (CUIMC) (March 2020–June 2020) and evaluated their impact on patient accrual and the occurrence of a composite endpoint of mechanical ventilation, tracheostomy, and in-hospital death.ResultsThere were 3251 patients diagnosed with COVID-19 from the CUIMC EHR included in the analysis. The median follow-up period was 10 days (interquartile range 4–28 days). The composite events occurred in 18.1% (n = 587) of the COVID-19 cohort during the follow-up. In a hypothetical trial with common eligibility criteria, 33.6% (690/2051) were eligible among patients with evaluable data and 22.2% (153/690) had the composite event.DiscussionBy adjusting the thresholds of common eligibility criteria based on the characteristics of COVID-19 patients, we could observe more composite events from fewer patients.ConclusionsThis research demonstrated the potential of using the EHR data of COVID-19 patients to inform the selection of eligibility criteria and their thresholds, supporting data-driven optimization of participant selection towards improved statistical power of COVID-19 trials.     

Irritable bowel syndrome in Asia: Pathogenesis,natural history,epidemiology, and management

Historically, the epidemiology of gastrointestinal diseases in Asia was different from that in Western countries. Early studies suggested a low prevalence of irritable bowel syndrome (IBS) in Asia. As the diagnosis of IBS is symptom‐based and as symptom perception, expression, and interpretation are influenced by sociocultural perspectives including language, the presentation of IBS is expected to vary in different communities. Furthermore, the pathogenesis is multifactorial with psychosocial (stress, illness, behavior, and diet) and biological (infection, gut microbiota, and immune activation) variables interacting, and so, the present study can anticipate that the development of IBS will vary in different environments. In recognition of this aspect of functional gastrointestinal disorders, the recently published Rome IV documents have provided greater focus on cross‐cultural factors. In this review, the present study seeks to highlight Asian perspectives by identifying historical trends and recent publications from the region and comparing these with the observations from Western societies.