Differences in Evidentiary Requirements Between European Medicines Agency and European Health Technology Assessment of Oncology Drugs—Can Alignment Be Enhanced?

ObjectivesNational health technology assessments (HTAs) across Europe show differences in evidentiary requirements from assessments by the European Medicines Agency (EMA), affecting time to patient access for drugs after marketing authorization. This article analyzes the differences between EMA and HTA bodies’ evidentiary requirements for oncology drugs and provides recommendations on potential further alignment to minimize and optimally manage the remaining differences.MethodsInterviews were performed with representatives and drug assessment experts from EMA and HTA bodies to identify evidentiary requirements for several subdomains and collect recommendations for potentially more efficiently addressing differences. A comparative analysis of acceptability of the evidence by EMA and the HTA bodies and for potential further alignment between both authorities was conducted.ResultsAcceptability of available evidence was higher for EMA than HTA bodies. HTA bodies and EMA were aligned on evidentiary requirements in most cases. The subdomains showing notable differences concerned the acceptance of limitation of the target population and extrapolation of target populations, progression-free survival and (other) surrogate endpoints as outcomes, cross-over designs, short trial duration, and clinical relevance of the effect size. Recommendations for reducing or optimally managing differences included joint early dialogues, joint relative effectiveness assessments, and the use of managed entry agreements.ConclusionsDifferences between assessments of EMA and HTA bodies were identified in important areas of evidentiary requirements. Increased alignment between EMA and HTA bodies is suggested and recommendations for realization are discussed.     

基于SF-36的学术期刊编辑生存质量初步调查及影响因素探析

【目的】 初步了解学术期刊编辑生存质量状况,并探析其可能的影响因素,为改善学术期刊编辑身心健康、促进期刊可持续发展提供参考。【方法】 基于SF-36健康调查量表,在问卷星网站创建《学术期刊编辑生存质量调查问卷》,并发送至多个期刊编辑QQ群和微信群,在线下载答卷后进行分析。【结果】 在SF-36量表的8个维度中,生理角色维度的得分最高,总体健康维度的得分最低,与常模一致;生理职能维度的得分高于常模,躯体疼痛和精神健康维度的得分低于常模。多因素分析结果表明,每周加班频次≥3次、男性、工作年限在0~<10年、无职务、未与家人同住,以及所在期刊未被《中文核心期刊要目总览(2017年版)》、中国科学引文数据库、《中国科技论文统计源期刊》中的任一种收录可能是编辑生存质量的关键影响因素。【结论】 学术期刊编辑生存质量状况总体与国内常模接近,男性、独居、编龄短、加班频次高、期刊未被任一国内核心数据库收录可能与学术期刊编辑生存质量相关。     

植物花青素对肿瘤抑制作用的研究进展

植物花青素是一类可溶于水的类黄酮,主要存在于各种蔬菜水果中。常见的植物花青素主要分为天竺葵色素(Pelargonidin)、芍药色素(Peonidin)、矢车菊色素(Cyanidin)、锦葵色素(Malvidin)、矮牵牛色素(Petunidin)、飞燕草色素(Delphinidin)六种;植物花青素分子中含有共轭双键体系,并含有碱性或酸性基团,因而具有抗氧化、抗炎、调节免疫、抗衰老和抑癌等生物学作用,尤其以抑癌作用最为突出。因此,本文将对植物花青素的抑癌作用及可能的机制进行综述。     

Collaborating toward equity in Pennsylvania: The Age-Friendly Care,PA project

Objective

To collaboratively implement the age-friendly health systems framework, known as the 4Ms: What Matters, Medication, Mentation, and Mobility, at The Primary Health Network (PHN), a federally qualified health center.

Data Sources

Data were collected from PHN electronic medical records (EMRs) for individuals over age 65 from December 30, 2019 to December 24, 2021 and from Project ECHO© attendance and evaluation surveys.

Study Design

The telementoring educational program, Project ECHO©, was used to engage PHN health care professionals working in rural areas of Pennsylvania to incorporate the 4Ms into their practice starting with the annual wellness visit (AWV). Project ECHO© was launched at three primary care sites. After 18 months, it was then disseminated to an additional 18 sites creating pilot and comparison groups. Outcomes included codesigned patient process metrics using EMR data and project ECHO© participant data.

Data Collection Methods

EMR data were generated by system reports created by PHN's quality assurance program manager. Project ECHO© data were collected and managed using REDCap electronic data capture tools. Outcomes were aggregated, analyzed for trends over time, and compared between groups.

Principal Findings

All nine process outcomes increased from baseline to follow-up at the three initial sites, ranging from 4% to 43% g. At year two, the three initial sites had higher rates on AWVs (pilot 24%, comparison 12%; p < 0.0001), Advance Care Planning (New on file, pilot 8%, comparison 2%; Discussed with patient, pilot 18%, comparison 13%; Patient declined, pilot 0%, comparison 0%; p = 0.0001), Dementia Screening (pilot 24%, comparison 12%; p < 0.0001), Fall Risk Management (pilot 43%, comparison 10%; p < 0.0001), and Mobility Goal (pilot 19%, comparison 9%; p < 0.0001); and lower rates on High-Risk Medication Elimination (pilot 54%, comparison, 63%, p < 0.02).

Conclusions

Access to high-quality geriatric care for rural older adults can be improved by increasing health care professionals' knowledge of the 4Ms, beginning with its incorporation into the AWV.     

Comparison between standard Vs. Escalated dose venous thromboembolism (VTE) prophylaxis in critically ill patients with COVID-19: A two centers,observational study

IntroductionThe risk of mortality in patients with COVID-19 was found to be significantly higher in patients who experienced thromboembolic events. Thus, several guidelines recommend using prophylactic anticoagulants in all COVID-19 hospitalized patients. However, there is uncertainty about the appropriate dosing regimen and safety of anticoagulation in critically ill patients with COVID-19. Thus, this study aims to compare the effectiveness and safety of standard versus escalated dose pharmacological venous thromboembolism (VTE) prophylaxis in critically ill patients with COVID-19.MethodsA two-center retrospective cohort study including critically ill patients aged ≥ 18-years with confirmed COVID-19 admitted to the intensive care unit (ICU) at two tertiary hospitals in Saudi Arabia from March 1st, 2020, until January 31st, 2021. Patients who received either Enoxaparin 40 mg daily or Unfractionated heparin 5000 Units three times daily were grouped under the “standard dose VTE prophylaxis and patients who received higher than the standard dose but not as treatment dose were grouped under ”escalated VTE prophylaxis dose“. The primary outcome was the occurance of thrombotic events, and the secondary outcomes were bleeding, mortality, and other ICU-related complications.ResultsA total of 758 patients were screened; 565 patients were included in the study. We matched 352 patients using propensity score matching (1:1). In patients who received escalated dose pharmacological VTE prophylaxis, any case of thrombosis and VTE were similar between the two groups (OR 1.22;95 %CI 0.52–2.86; P = 0.64 and OR 0.75; 95% CI 0.16–3.38; P = 0.70 respectively). However, the odds of minor bleeding was higher in patients who received escalated VTE prophylaxis dose (OR 3.39; 95% CI 1.08–10.61; P = 0.04). There was no difference in the 30-day mortality nor in-hospital mortality between the two groups (HR 1.17;95 %CI0.79–1.73; P = 0.43 and HR 1.08;95 %CI 0.76–1.53; P = 0.83, respectively).ConclusionEscalated-dose pharmacological VTE prophylaxis in critically ill patients with COVID-19 was not associated with thrombosis, or mortality benefits but led to an increased risk of minor bleeding. This study supports previous evidence regarding the optimal dosing VTE pharmacological prophylaxis regimen for critically ill patients with COVID-19.     

主动脉夹层术后患者心理状况及躯体症状对生活质量的影响

目的 探讨主动脉夹层术后患者心理状况、躯体症状对其生活质量的影响及作用机制，为制订干预计划提供参考。方法 采用广泛性焦虑障碍量表、患者健康问卷抑郁量表、躯体症状量表、12项简明健康状况调查表对327例主动脉夹层术后患者进行调查，根据相关性分析结果提出假设，应用AMOS软件进行结构方程模型分析。结果 主动脉夹层术后患者生活质量得分（81.56±7.36）分，焦虑得分2.00(0, 3.00)分，抑郁得分2.00(0, 3.00)分，躯体症状得分5.00(2.00, 8.00)分；焦虑、抑郁、躯体症状对生活质量有直接影响，焦虑、抑郁通过躯体症状对生活质量有间接影响（均P<0.05）。结论 主动脉夹层术后患者生活质量处于中等偏上水平，应早期对主动脉夹层术后患者的心理状况与躯体症状进行动态评估与监测，及时进行心理干预和症状管理，以改善其生活质量。