Health Planning Guidelines

健康规划指南
  • 文章类型: Journal Article
    目的:综合现有痴呆护理临床指南中关于评估和管理痴呆行为和心理症状(BPSD)的建议,以学习和适应加拿大描述BPSD的背景和语言。
    方法:系统评价。
    方法:关于痴呆症护理的中度至高质量临床实践指南,对BPSD评估或管理提出了1项或多项建议。
    方法:我们搜索了MEDLINE,Embase,JBIEBM,PsycINFO,AgeLine,和灰色文献关于痴呆症护理的临床指南,对BPSD提出建议,在2011年1月1日至2022年10月13日之间发布。两名独立的审查员进行了研究筛选和数据抽象。四名独立审查员使用研究与评估指南(AGREE)II工具完成了质量评估;包括的指南的平均总体AGREEII评分≥4。
    结果:我们的系统评价确定了23个中、高质量指南(264个建议)。AGREEII工具的平均总体质量评分为4至6.5。建议被清楚地呈现(呈现分数的平均清晰度为73.5%),但指南适用性未得到一致解决(平均适用性得分为39.3%).BPSD是描述神经精神症状的最普遍的术语(指南数量[n]=14)。有生活经验的人贡献了6个指南(26.1%)。十项指南(43.5%)描述了一种或多种健康公平考虑因素。指南提出了评估和管理躁动的建议(n=12),侵略(n=10),精神病(n=11),抑郁症(n=9),焦虑(n=5),冷漠(n=6),不适当的性行为(n=3),夜间行为(n=5),和进食障碍(n=3)。建议声明存在很大差异,分配给每个陈述的证据质量,和建议的强度。
    结论:有几个中到高质量的指南对BPSD评估和管理提出了建议,但是不同指南的推荐声明的差异性以及对指南适用性的考虑不足可能会阻碍指南在临床实践中的传播和实施.
    OBJECTIVE: To synthesize recommendations on assessing and managing behavioral and psychological symptoms of dementia (BPSDs) in existing clinical practice guidelines on dementia care to learn from and adapt recommendations to a Canadian context and language for describing BPSDs.
    METHODS: Systematic review.
    METHODS: Moderate to high-quality clinical practice guidelines on dementia care that made 1 or more recommendations on BPSD assessment or management.
    METHODS: We searched MEDLINE, Embase, JBI EBM, PsycINFO, AgeLine, and gray literature for clinical practice guidelines on dementia care making recommendations on BPSD, published between January 1, 2011, and October 13, 2022. Two independent reviewers conducted study screening and data abstraction. Four independent reviewers completed quality appraisal using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool; included guidelines had a mean overall AGREE II score ≥4.
    RESULTS: Our systematic review identified 23 moderate to high-quality clinical practice guidelines (264 recommendations). The mean overall quality score on the AGREE II tool ranged from 4 to 6.5. Recommendations were clearly presented (mean clarity of presentation score 73.5%), but guideline applicability was not consistently addressed (mean applicability score 39.3%). BPSD was the most prevalent term describing neuropsychiatric symptoms (number of guidelines [n] = 14). People with lived experience contributed to 6 guidelines (26.1%). Ten guidelines (43.5%) described 1 or more health equity considerations. Guidelines made recommendations for assessing and managing agitation (n = 12), aggression (n = 10), psychosis (n = 11), depression (n = 9), anxiety (n = 5), apathy (n = 6), inappropriate sexual behavior (n = 3), nighttime behavior (n = 5), and eating disturbances (n = 3). There was substantial variability in recommendation statements, evidence quality assigned to each statement, and strength of recommendations.
    CONCLUSIONS: There are several moderate to high-quality clinical practice guidelines making recommendations on BPSD assessment and management, but variability in recommendation statements across guidelines and insufficient consideration of guideline applicability may hamper guideline dissemination and implementation in clinical practice.
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  • 文章类型: Journal Article
    目的:开发并验证预测第一和第二通气阈值(VT)下心率(HR)的公式以及心脏代谢疾病(CMD)患者的优化范围调整处方。将他们的表现与基于指南的运动强度域进行比较。
    方法:横断面研究涉及来自9个国家的2,868名CMD患者。使用多元线性回归和975个循环测功机心肺运动测试(CPET)建立了第一和第二VT(VT1,VT2)的HR预测方程。从该组中得出峰值HR(%HRpeak)和HR储备(%HRR)的调整百分比。使用1,893CPET(自行车测力计或跑步机)进行外部验证,评估准确性,协议,以及使用平均绝对百分比误差(MAPE)的基于指南的%HRpeak和%HRR处方的可靠性,Bland-Altman分析,类内相关系数(ICC)。
    结果:HR预测方程(R²:0.77VT1,0.88VT2)和调整后的%HRR(VT1:42%,VT2:77%)被开发。外部验证表明,对于%HRpeak和%HRR,优于广泛使用的指南指导强度域。新方法在具有较低MAPE的两个VT中显示出一致的性能(VT1:7.1%,VT2:5.0%),\'好\'ICC为VT1(0.81,0.82)和\'优秀\'为VT2(0.93)。基于指南的运动强度域具有较高的MAPE(VT1:6.8%-21.3%,VT2:5.1%-16.7%),对于VT1,\'poor\'到\'good\'ICC,对于VT2,\'poor\'到\'优秀\',表明与指南中特定VT相关的不一致。
    结论:为CMD患者开发并验证了HR预测方程和优化的%HRR,用于确定VT1和VT2优于基于指南的运动强度域,并显示了测力计的互换性。当CPET不可用时,它们为处方中等强度运动提供了更好的选择。
    制定了预测通气阈值心率的公式,并进行了外部验证。当心肺运动测试无法准确确定有氧运动强度域时,提供了一个新的观点。此外,提供了基于心率储备百分比(%HRR)的运动强度处方的调整范围,利用来自八个国家的大样本。所提出的方程和范围调整后的%HRR显著优于指南指导的确定运动强度的方法,表现出更高的准确性,协议,和可靠性。运动强度处方根据心率峰值的百分比显示出更高的误差,引起人们对其临床适用性的担忧。当无法进行气体交换分析时,我们的研究可能会增强运动训练和身体活动建议的功效,可能导致改善临床结果,即使在低资源环境中。在研究中采用这些方法可以促进更有针对性和一致性的干预措施,为比较运动强度处方的研究引入当代视角。
    OBJECTIVE: To develop and validate equations predicting heart rate (HR) at the first and second ventilatory thresholds (VTs) and an optimized range-adjusted prescription for patients with cardiometabolic disease (CMD). To compare their performance against guideline-based exercise intensity domains.
    METHODS: Cross-sectional study involving 2,868 CMD patients from nine countries. HR predictive equations for first and second VTs (VT1, VT2) were developed using multivariate linear regression with 975 cycle-ergometer cardiopulmonary exercise tests (CPET). \'Adjusted\' percentages of peak HR (%HRpeak) and HR reserve (%HRR) were derived from this group. External validation with 1,893 CPET (cycle-ergometer or treadmill) assessed accuracy, agreement, and reliability against guideline-based %HRpeak and %HRR prescriptions using mean absolute percentage error (MAPE), Bland-Altman analyses, intraclass correlation coefficients (ICC).
    RESULTS: HR predictive equations (R²: 0.77 VT1, 0.88 VT2) and adjusted %HRR (VT1: 42%, VT2: 77%) were developed. External validation demonstrated superiority over widely used guideline-directed intensity domains for %HRpeak and %HRR. The new methods showed consistent performance across both VTs with lower MAPE (VT1: 7.1%, VT2: 5.0%), \'good\' ICC for VT1 (0.81, 0.82) and \'excellent\' for VT2 (0.93). Guideline-based exercise intensity domains had higher MAPE (VT1: 6.8%-21.3%, VT2: 5.1%-16.7%), \'poor\' to \'good\' ICC for VT1, and \'poor\' to \'excellent\' for VT2, indicating inconsistencies related to specific VTs across guidelines.
    CONCLUSIONS: Developed and validated HR predictive equations and the optimized %HRR for CMD patients for determining VT1 and VT2 outperformed the guideline-based exercise intensity domains and showed ergometer interchangeability. They offer a superior alternative for prescribing moderate intensity exercise when CPET is unavailable.
    Equations to predict heart rate at ventilatory thresholds were developed and externally validated, offering a new perspective when a cardiopulmonary exercise test is unavailable to accurately determine the aerobic exercise intensity domains. Additionally, an adjusted range for exercise intensity prescription based on the percentage of heart rate reserve (%HRR) was provided, utilizing a large sample from eight countries. The proposed equations and the range-adjusted %HRR significantly outperformed the guideline-directed methods for determining exercise intensity, exhibiting higher accuracy, agreement, and reliability. Exercise intensity prescription based on the percentage of heart rate peak showed higher errors, raising concerns about its clinical applicability. Our study may enhance the efficacy of exercise training and physical activity advice when gas exchange analysis is unavailable, potentially leading to improved clinical outcomes, even in low-resource settings. Employing these approaches in research could facilitate more tailored and consistent interventions, introducing a contemporary perspective for studies comparing exercise intensity prescriptions.
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  • 文章类型: Journal Article
    目的: 脊髓电刺激(SCS)已成为脊髓损伤(SCI)后感觉运动和自主神经功能障碍恢复的一种有前途的疗法。尽管使用SCS治疗SCI并发症的研究有所增加,在研究出版物中没有报告SCS参数的标准指南,使比较具有挑战性,解释或重现实验研究中报告的影响。
方法:
为临床前和临床SCI研究中SCS参数的最低报告标准制定指南,我们聚集了一个由临床医生和科学家组成的国际专家小组。使用Delphi方法,我们制定了指导方针项目,并调查了小组对每个项目的协议水平。
主要结果:
在确定为建立SCS研究的最低报告标准的29个项目中,有26个项目达成了强烈共识。该指南包括三个主要的SCS类别:硬件,配置和当前参数,和干预。
意义:
刺激参数的标准化报告将确保可以轻松分析SCS研究,已复制,并由科学界解释,从而扩大SCS知识库并提高报告透明度。 .
    Objective.Electrical spinal cord stimulation (SCS) has emerged as a promising therapy for recovery of motor and autonomic dysfunctions following spinal cord injury (SCI). Despite the rise in studies using SCS for SCI complications, there are no standard guidelines for reporting SCS parameters in research publications, making it challenging to compare, interpret or reproduce reported effects across experimental studies.Approach.To develop guidelines for minimum reporting standards for SCS parameters in pre-clinical and clinical SCI research, we gathered an international panel of expert clinicians and scientists. Using a Delphi approach, we developed guideline items and surveyed the panel on their level of agreement for each item.Main results.There was strong agreement on 26 of the 29 items identified for establishing minimum reporting standards for SCS studies. The guidelines encompass three major SCS categories: hardware, configuration and current parameters, and the intervention.Significance.Standardized reporting of stimulation parameters will ensure that SCS studies can be easily analyzed, replicated, and interpreted by the scientific community, thereby expanding the SCS knowledge base and fostering transparency in reporting.
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  • 文章类型: Journal Article
    目的:为了确定失眠的差异,在紧急怀疑癌症预约之前和之后,患有良性和恶性疾病的ENT患者之间的抑郁和焦虑。
    方法:有癌症紧急嫌疑的门诊患者在预约前和诊断后两到四周完成了三份心理测量问卷。
    结果:在患者预约之前,恶性和良性患者的问卷得分没有显着差异(所有问卷的p>0.05)。在良性患者中,所有问卷的评分均有显著改善(p<0.01),在恶性肿瘤患者中,随访时所有问卷的评分均有显著恶化(p<0.01).
    结论:在任命之前,良性和恶性疾病的患者经历了相似程度的失眠,抑郁和焦虑。诊断后,癌症患者的评分明显较差,表明这些症状恶化。在良性诊断的患者中,所有问卷得分都有所提高,表明他们的症状的解决以及预约和基线评分之间可能的关联。
    OBJECTIVE: To determine differences in insomnia, depression and anxiety between ENT patients with benign and malignant conditions prior to and after an urgent suspicion of cancer appointment.
    METHODS: Out-patients with urgent suspicion of cancer completed three psychometric questionnaires prior to their appointment and at two to four weeks post-diagnosis.
    RESULTS: There was no significant difference in questionnaire scores between malignant and benign patients prior to the patients\' appointments (p > 0.05 for all questionnaires). In benign patients, there was significant improvement in scores for all questionnaires (p < 0.01) and in malignant patients there was significant worsening of scores for all questionnaires (p < 0.01) at follow-up appointments.
    CONCLUSIONS: Prior to appointments, patients with benign and malignant conditions experienced similar levels of insomnia, depression and anxiety. Following diagnosis, cancer patients had significantly poorer scores, indicating worsening of these symptoms. In patients with benign diagnoses, all questionnaire scores improved, indicating resolution of their symptoms and possible association between the appointment and their baseline scores.
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  • 文章类型: Journal Article
    目的:描述自2021年将HPV疫苗接种指南扩展到男性以来,家庭医生(FP)的做法和态度,并确定在所有青少年中促进HPV疫苗接种的杠杆。
    方法:2021年在法国建立的FP的横断面研究。我们收集了社会人口统计数据,实践,意见,以及对疫苗接种的态度,以及FPs关于HPV培训和信息的要求。我们使用逻辑回归模型来确定与HPV疫苗接种建议相关的变量。
    结果:包括530个FP,469(88.5%)报告说,他们系统地提出了HPV疫苗的女孩与男孩335(63.2%)。自法国指南建议将HPV疫苗接种扩展到男性以来,共有366(69.0%)FP报告了所有青少年的HPV疫苗提案增加。然而,与HPV疫苗接种建议相关的因素因目标女性和目标男性而异.设置和实践模式,关于推荐疫苗和HPV疫苗数量的意见,HPV疫苗培训需求与针对女性的HPV疫苗接种建议相关.而学术地位,关于HPV疫苗接种指南扩展到男性的意见,使用继续医学教育作为HPV疫苗的主要信息来源,HPV疫苗培训需求与针对男性的HPV疫苗接种建议相关.
    结论:在法国指南中,将HPV疫苗接种扩展到男性可能对FPs对青少年的HPV疫苗接种建议产生有利影响。然而,促进HPV疫苗接种的杠杆可能根据目标人群的性别而有所不同。
    OBJECTIVE: To describe family physicians\' (FP) practices and attitudes towards HPV vaccination guidelines since its extension to males in 2021, and to identify levers to promote HPV vaccination in all adolescents.
    METHODS: Cross-sectional study among FPs established in France in 2021. We collected sociodemographic data, practices, opinions, and attitudes towards vaccination, and FPs\' demands regarding training and information about HPV. We used logistic regression models to identify the variables associated with HPV vaccination proposal.
    RESULTS: Of 530 FPs included, 469 (88.5%) reported that they systematically proposed HPV vaccines to girls vs 335 (63.2%) to boys. A total of 366 (69.0%) FPs reported an increase in HPV vaccines proposal to all adolescents since the extension of HPV vaccination to males recommended by French guidelines. However, factors associated with HPV vaccination proposal differed by target females and target males. Setting and mode of practice, opinion about the number of recommended vaccines and HPV vaccines, and demands of training on HPV vaccines were associated with HPV vaccination proposal to target females. Whereas academic status, opinion about HPV vaccination guidelines extension to males, using continuing medical education as the main source of information on HPV vaccines, and demands for training on HPV vaccines were associated with HPV vaccination proposal to target males.
    CONCLUSIONS: Extension of HPV vaccination to males in French guidelines might have had a favorable impact on HPV vaccination proposal by FPs to adolescents. However, levers to promote HPV vaccination might differ according to the target population sex.
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  • 文章类型: Journal Article
    背景:术后早期活动度低(LEPOM)已被证明与住院时间增加有关,并发症发生率,以及非家庭出院的可能性。然而,很少有研究在成人脊柱畸形(ASD)患者中检查与LEPOM相关的术前特征.
    目的:探讨ASD手术后哪些患者的术前特征可能与LEPOM相关。
    方法:回顾性回顾患者样本:包括86例ASD患者,其融合水平≥5级,术后即刻获得AM-PAC基本流动性住院患者简短形式(6次点击)评分。
    方法:这项研究的主要结果是LEPOM的可能性,定义为AM-PAC评分≤15,这与无法站立超过1分钟有关。
    方法:通过阈值线性回归确定与LEPOM相关的术前特征的显著截止值。多变量逻辑回归用于评估术前特征对LEPOM可能性的影响。
    结果:在38例患者中记录了LEPOM(44.2%)。阈值回归确定了以下与LEPOM相关的截止值:术前患者报告的结果测量信息系统(PROMIS)疼痛评分≥68,<28.3对于身体功能,焦虑≥63.4;术前Oswestry残疾指数(ODI)评分≥60;体重指数(BMI)≥35.2。在多变量分析中,术前疼痛的PROMIS评分≥68分(比值比[OR]5.3,置信区间[CI]1.2-22.8,P=0.03),物理功能<28.3(OR10.1,CI1.8-58.2,P=0.01),焦虑≥63.4(OR4.7,CI1.1-20.8,P=.04);术前ODI评分≥60(OR38.8,CI4.0-373.6,P=.002);BMI≥35.2(OR14.2,CI1.3-160.0,P=0.03),男性(OR5.4,CI1.2-23.7,P=0.03)与LEPOM的几率增加相关。
    结论:术前PROMIS疼痛,身体功能,焦虑评分、ODI评分、BMI和男性与LEPOM相关。这些特征中的一些是可改变的风险因素,因此可以是在手术前进行优化的候选。
    Low early postoperative mobility (LEPOM) has been shown to be associated with increased length of hospital stay, complication rates, and likelihood of nonhome discharge. However, few studies have examined preoperative characteristics associated with LEPOM in adult spinal deformity (ASD) patients.
    To investigate which preoperative patient characteristics may be associated with LEPOM after ASD surgery.
    Retrospective review.
    Included were 86 ASD patients with fusion of ≥5 levels for whom immediate-postoperative AM-PAC Basic Mobility Inpatient Short Form (6-Clicks) scores had been obtained.
    The primary outcome of this study was the likelihood of LEPOM, defined as an AM-PAC score ≤15, which is associated with inability to stand for more than 1 minute.
    Significant cutoffs for preoperative characteristics associated with LEPOM were determined via threshold linear regression. Multivariable logistic regression was used to assess the impact of preoperative characteristics on the likelihood of LEPOM.
    LEPOM was recorded in 38 patients (44.2%). Threshold regression identified the following cutoffs to be associated with LEPOM: preoperative Patient Reported Outcomes Measurement Information System (PROMIS) scores of ≥68 for Pain, <28.3 for Physical Function, and ≥63.4 for Anxiety; preoperative Oswestry disability index (ODI) score of ≥60; and body mass index (BMI) of ≥35.2. On multivariate analysis, preoperative PROMIS scores of ≥68 for Pain (odds ratio [OR] 5.3, confidence interval [CI] 1.2-22.8, p=.03), <28.3 for Physical Function (OR 10.1, CI 1.8-58.2, p=.01), and ≥63.4 for Anxiety (OR 4.7, CI 1.1-20.8, p=.04); preoperative ODI score ≥60 (OR 38.8, CI 4.0-373.6, p=.002); BMI ≥35.2 (OR 14.2, CI 1.3-160.0, p=.03), and male sex (OR 5.4, CI 1.2-23.7, p=.03) were associated with increased odds of LEPOM.
    Preoperative PROMIS Pain, Physical Function, and Anxiety scores; ODI score; BMI; and male sex were associated with LEPOM. Several of these characteristics are modifiable risk factors and thus may be candidates for optimization before surgery.
    III.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    简介2019年新型冠状病毒病(COVID-19)大流行是国际公共卫生紧急情况。卫生系统必须为COVID-19大流行期间日益增长的重症监护需求做好计划。本文的目的是为手外科医师提供策略,以在COVID-19大流行期间以及随后的阶段规划和实施其应对措施,以保持医疗保健系统的功能。材料和方法评估与COVID-19管理相关的管理原则,以制定与患者相关的大流行准备和应对方案,医护人员,和卫生系统。结果提出了重组手外科实践的策略以及一系列建议,这些建议应有助于在COVID-19及其后续阶段重新安排门诊服务和手术活动的过程。结论在COVID-19大流行期间,需要对手部疾病进行专科护理的患者的管理应进行调整,以限制与病毒相关的风险,而不会危及预后。随着COVID-19大流行的发展,这些在特殊情况下的权宜之计的建议为进一步讨论该主题奠定了基础。
    Introduction  The novel coronavirus disease 2019 (COVID-19) pandemic is an international public health emergency. Health systems must plan for the increasing requirements for critical care during the COVID-19 pandemic. The aim of this article is to offer strategies for hand surgeons to planning and implementing their response during the COVID-19 pandemic and in the subsequent phases to preserve health care system functioning. Materials and Methods  Assessment of the principles of management related to COVID-19 management to develop pandemic preparedness and response protocols pertinent to patients, health care workers, and health systems. Results  Strategies for the reorganizing hand surgery practice and a set of recommendations that should facilitate the process of rescheduling both out-patient service and surgical activities during the COVID-19 and its subsequent phases are suggested. Conclusion  During the COVID-19 pandemic, management of patients requiring specialist care for hand conditions should be adapted to limit the risks associated with the virus without jeopardizing outcomes. These expedient recommendations during extraordinary circumstances are a foundation for further discussion on the topic as the COVID-19 pandemic evolves.
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  • 文章类型: Journal Article
    世界范围内进行的美学程序数量之间的差异,文献中描述的并发症是显著的。关于漏报的怀疑是合理的,应该予以考虑。这项研究的目的是证明与全世界进行的大量手术相比,有关美学手术并发症的科学出版物的稀缺性。基于这些知识,将向卫生当局证明在需要医疗护理的美学程序中强制通知并发症的重要性,以便现有数据能够预防并发症。关于并发症的知识的局限性在2018年发表的“与巴西吸脂相关的死亡”论文的数据收集中得到了证明,该论文于2020年发表在《外科和美容皮肤病学》上。审美程序中并发症的定义需要客观,以防止不同的和主观的解释。随着美学程序并发症的强制通知,旨在了解他们的原因,以制定预防他们的指导方针。
    The disparity between the number of aesthetic procedures performed worldwide, and the complications described in the literature is remarkable. Doubts regarding the underreporting are reasonable and should be considered. The aim of this study is to demonstrate the scarcity of scientific publications on complications in aesthetic procedures compared to the abundance of these procedures performed worldwide. Based on this knowledge, it will be demonstrated to the health authorities the importance of compulsory notification of complications in aesthetic procedures that require medical attention so that the available data will allow their prevention. The limitation of knowledge regarding complications was demonstrated in the data collection for the preparation of the thesis \"Deaths Related to Liposuction in Brazil\" presented in 2018 and published in Surgical and Cosmetical Dermatology in 2020. The definition of complication in aesthetic procedures needs to be objective to prevent different and subjective interpretations. With the compulsory notification of complications in aesthetic procedures, it is intended to learn about their causes to develop guidelines for their prevention.
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  • 文章类型: Technical Report
    mRNA-1273(Moderna)COVID-19疫苗是一种脂质纳米颗粒,核苷修饰的mRNA疫苗编码SARS-CoV-2的稳定融合前尖峰糖蛋白,SARS-CoV-2是导致COVID-19的病毒。在2020年12月,该疫苗获得了食品和药物管理局(FDA)的紧急使用授权(EUA)。免疫实践咨询委员会(ACIP)发布了一项临时建议,供18岁以上的人使用(1),被CDC采纳。在2020年12月19日至2022年1月30日期间,美国施用了约2.04亿剂ModernaCOVID-19疫苗(2),主要系列为2剂肌肉内剂量(每剂100μg[0.5mL]),间隔4周。2022年1月31日,FDA批准了使用ModernaCOVID-19疫苗(Spikevax,ModernaTX,Inc.)年龄≥18岁(3)的人。2022年2月4日,ACIPCOVID-19疫苗工作组在一次公开会议上向ACIP提交了关于使用ModernaCOVID-19疫苗的建议的结论。工作组的审议基于建议证据(EtR)框架,*其中包含了建议的分级,评估,开发和评估(等级)方法对证据质量进行排名。除了最初的临床试验数据,ACIP考虑了自发布临时建议以来的12个月内收集的新信息,包括临床试验中的额外随访时间,真实世界的疫苗有效性研究,和授权后的疫苗安全监测。ACIP还考虑了在实际环境中mRNA疫苗有效性和安全性的比较,当第一剂间隔8周而不是临床试验中使用的原始间隔时(BNT162b2[辉瑞-BioNTech]COVID-19疫苗为3周,ModernaCOVID-19疫苗为4周)。根据这些证据,疾病预防控制中心提供的指导是,对于一些青少年和成年人来说,8周的间隔可能是最佳的。自临时建议发布以来收集的额外信息增加了确定性,即预防有症状和无症状的SARS-CoV-2感染的益处,住院治疗,死亡超过了ModernaCOVID-19疫苗的疫苗相关风险。2022年2月4日,ACIP将其临时建议修改为标准建议§,以便在≥18岁的人群中使用完全许可的ModernaCOVID-19疫苗。
    The mRNA-1273 (Moderna) COVID-19 vaccine is a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. During December 2020, the vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA), and the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use among persons aged ≥18 years (1), which was adopted by CDC. During December 19, 2020-January 30, 2022, approximately 204 million doses of Moderna COVID-19 vaccine were administered in the United States (2) as a primary series of 2 intramuscular doses (100 μg [0.5 mL] each) 4 weeks apart. On January 31, 2022, FDA approved a Biologics License Application (BLA) for use of the Moderna COVID-19 vaccine (Spikevax, ModernaTX, Inc.) in persons aged ≥18 years (3). On February 4, 2022, the ACIP COVID-19 Vaccines Work Group conclusions regarding recommendations for the use of the Moderna COVID-19 vaccine were presented to ACIP at a public meeting. The Work Group\'s deliberations were based on the Evidence to Recommendation (EtR) Framework,* which incorporates the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach† to rank evidence quality. In addition to initial clinical trial data, ACIP considered new information gathered in the 12 months since issuance of the interim recommendations, including additional follow-up time in the clinical trial, real-world vaccine effectiveness studies, and postauthorization vaccine safety monitoring. ACIP also considered comparisons of mRNA vaccine effectiveness and safety in real-world settings when first doses were administered 8 weeks apart instead of the original intervals used in clinical trials (3 weeks for BNT162b2 [Pfizer-BioNTech] COVID-19 vaccine and 4 weeks for Moderna COVID-19 vaccine). Based on this evidence, CDC has provided guidance that an 8-week interval might be optimal for some adolescents and adults. The additional information gathered since the issuance of the interim recommendations increased certainty that the benefits of preventing symptomatic and asymptomatic SARS-CoV-2 infection, hospitalization, and death outweigh vaccine-associated risks of the Moderna COVID-19 vaccine. On February 4, 2022, ACIP modified its interim recommendation to a standard recommendation§ for use of the fully licensed Moderna COVID-19 vaccine in persons aged ≥18 years.
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