Implementing Real-World RECIST-based Tumor Response Assessment in Patients With Metastatic Non-small Cell Lung Cancer

BackgroundTo accelerate drug approvals while maintaining scientific rigor in the evaluation of a therapeutic's efficacy and safety, the United States Food and Drug Administration now considers real-world data (RWD) to support New Drug Applications and expanded indications. Response Evaluation Criteria in Solid Tumors (RECIST) are the gold standard in clinical trials, but the derivation of RECIST-based treatment response from RWD is unproven. This study investigated the feasibility of implementing RECIST criteria in RWD by comparing lung cancer response assessments from RECIST-based measurement of lesions on archived radiologic films with results from medical oncologist and radiologist narratives recorded in electronic health records (EHR).Materials and MethodsResponse to index treatment via different assessment approaches was compared among 30 metastatic non-small cell lung cancer (mNSCLC) patients receiving systemic treatment (index) after progression on a platinum or anti-PD(L)-1-containing regimen. Specifically, responses based on assessments documented in the medical oncologists’ narratives were compared to a radiologist's assessments of archived images using RECIST v1.1 criteria. Each patient's best overall response was characterized as complete or partial (CR/PR), stable disease (SD), progressive disease (PD), or not evaluable (NE).ResultsSimilar distributions of best overall response and substantial concordance (77%) between medical oncologist-reported and radiologist re-assessed responses were observed. There were no instances of CR/PR to PD or PD to CR/PR discordance.ConclusionsResults suggest that accurate treatment responses, similar to RECIST, may be derived using RWD. Further validation and improvement of real-world response assessment are needed to develop a scalable real-world approach for response assessment.     

Murine models of posterolateral spinal fusion: A systematic review

BackgroundRodent models are commonly used experimentally to assess treatment effectiveness in spinal fusion. Certain factors are associated with better fusion rates. The objectives of the present study were to report the protocols most frequently used, to evaluate factors known to positively influence fusion rate, and to identify new factors.MethodA systematic literature search of PubMed and Web of Science found 139 experimental studies of posterolateral lumbar spinal fusion in rodent models. Data for level and location of fusion, animal strain, sex, weight and age, graft, decortication, fusion assessment and fusion and mortality rates were collected and analyzed.ResultsThe standard murine model for spinal fusion was male Sprague Dawley rats of 295 g weight and 13 weeks’ age, using decortication, with L4-L5 as fusion level. The last two criteria were associated with significantly better fusion rates. On manual palpation, the overall mean fusion rate in rats was 58% and the autograft mean fusion rate was 61%. Most studies evaluated fusion as a binary on manual palpation, and only a few used CT and histology. Average mortality was 3.03% in rats and 1.56% in mice.ConclusionsThese results suggest using a rat model, younger than 10 weeks and weighing more than 300 grams on the day of surgery, to optimize fusion rates, with decortication before grafting and fusing the L4-L5 level.     

药物饲料添加剂吉他霉素耐药性风险评估

目的 为给兽药减量政策的制定、动物源性食品安全的维护提供理论依据。方法 利用每日允许摄入量（ADI）、估算每日摄入量（EDI）及慢性风险熵（CRQ），对中国居民通过摄入肉蛋乳等动物性食品暴露于吉他霉素的耐药性风险进行点评估。结果 随着年龄增长，中国居民的吉他霉素膳食暴露量逐渐降低。2～7岁人群吉他霉素的膳食暴露量最高，男女分别为2.17和2.29 μg/ ( kg·bw·d)；＞65岁人群膳食暴露量最低，男女分别为0.45和0.46 μg/ ( kg·bw·d)。2～7岁人群通过摄入乳制品的吉他霉素的膳食暴露量最大，男女分别为1.15和1.22 μg/ ( kg·bw·d)，8岁以上人群通过摄入肉类食品的吉他霉素的膳食暴露量最大。中国居民通过摄入肉蛋乳等动物性食品暴露于吉他霉素，各年龄段CRQ均小于1。其中2～7岁人群CRQ值最高，风险最大；65岁以上人群CRQ值最低，风险最小。结论 中国居民通过摄入动物性食品的吉他霉素耐药性风险较低，危害程度较小，但儿童通过摄入乳制品的吉他霉素耐药性风险较高，有必要制定乳制品中吉他霉素残留的限量标准。     

Frailty in Adults With HIV: Identification,Assessment, and Management

The number of persons living with HIV who are aging is increasing. Frailty, a concept of geriatric medicine that is gaining recognition in HIV care, is associated with decreased quality of life and a greater chance of death. Tools are available for identifying prefrail and frail individuals. Clinicians caring for older persons living with HIV should be familiar with these tools and integrate frailty assessment as part of comprehensive care. This article provides a brief overview of the principles of frailty and discusses strategies to identify prefrail or frail individuals.     

Bio-accumulation and health risk assessment of heavy metals in different edible fish species from Hurghada City,Red Sea,Egypt

BackgroundHeavy metal contamination has become a serious issue in this century especially detected in fish organs. Due to the presence of radioactive compounds in agricultural and sewage effluent, which destroys aquatic ecosystems, threatening human livelihoods. Health hazards associated with low and high consumption consumers assessed in five commercial fish species collected from Hurghada City, Egypt, during winter and summer, 2020. Atomic absorption spectrophotometer technique used for determination heavy meals in different organs and expressed as μg/g wet weight.ResultsHeavy metal concentrations in muscle ranged between:(0.054–0.109), (0.260–1.043), (0.264–0.897), (5.895–11.898), (0.381–0.970), (13.582–29.133) and (0.332–0.589) µg/g for Cd, Pb, Mn, Zn, Cu, Fe and Ni respectively, which were lower than those of gills and liver. These concentrations were within WHO, FAO/WHO, and EU standards. Consumption of edible species was lower than the (TDIs) established by the (JECFA) and Egyptian Standards. Even though THQ and TTHQ values were < 1 while, in children with highly consumer were> 1.ConclusionThis study concluded that intake of Red Sea fish is safe for human health. It is critical for consumers to be aware of the consequences of excessive fish consumption, particularly children with highly consumer, which represent possible health risks.     

Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force

ObjectivesDeliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR—The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap.MethodsThe joint Task Force consisted of 15 members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to 2 rounds of peer review.ResultsA deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation.ConclusionsThe guidance and the checklist contain a series of questions, grouped by 6 phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.     

The measurement of neck strength: A guide for sports medicine clinicians

This masterclass aims to provide an overview of the measurement of neck strength and the factors which can increase the ecological validity of the testing protocol within an athletic population. Adopting a ‘gold standard’ method for measuring neck strength is of vital importance when determining strength differences across sports, ages and sexes. Without a ‘gold standard’ method current variations in testing procedure and equipment have created challenges in establishing normative neck strength data. With encouraging evidence that higher neck strength can have a protective effect against sports-related head and neck injuries, including concussion, new injury prevention knowledge may be impeded by a lack of consensus on how to accurately measure neck strength, with a number of different methods available. This masterclass will outline the factors clinicians should consider when selecting a device and measurement protocol when measuring maximal neck strength as well as how to interpret the results.