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Physical activity knows no age limit 体育活动没有年龄限制。
IF 13.4 Q1 GERIATRICS & GERONTOLOGY Pub Date : 2024-07-01 DOI: 10.1016/S2666-7568(24)00115-6
The Lancet Healthy Longevity
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引用次数: 0
Adapted EXTREME regimen in the first-line treatment of fit, older patients with recurrent or metastatic head and neck squamous cell carcinoma (ELAN-FIT): a multicentre, single-arm, phase 2 trial 改良EXTREME疗法用于复发或转移性头颈部鳞状细胞癌老年患者的一线治疗(ELAN-FIT):一项多中心、单臂、2期试验。
IF 13.1 Q1 GERIATRICS & GERONTOLOGY Pub Date : 2024-06-01 DOI: 10.1016/S2666-7568(24)00048-5
Prof Joël Guigay MD , Hervé Le Caer MD , François-Régis Ferrand MD , Lionel Geoffrois MD , Esma Saada-Bouzid MD , Jérôme Fayette MD , Christian Sire MD , Didier Cupissol MD , Emmanuel Blot MD , Pierre Guillet MD , Julien Pavillet MD , Laurence Bozec MD , Olivier Capitain MD , Frédéric Rolland MD , Philippe Debourdeau MD , Yoann Pointreau MD , Claire Falandry MD , Stéphane Lopez MD , Alexandre Coutte MD , Thierry Chatellier MD , Anne Aupérin PhD
<div><h3>Background</h3><p>A standard treatment for fit, older patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) is yet to be established. In the previous EXTREME trial, few older patients were included. We aimed to evaluate the efficacy and tolerance of an adapted EXTREME regimen in fit, older patients with recurrent or metastatic HNSCC.</p></div><div><h3>Methods</h3><p>This single-arm, phase 2 study was done at 22 centres in France. Eligible patients were aged 70 years or older and assessed as not frail (fit) using the ELAN Geriatric Evaluation (EGE) and had recurrent or metastatic HNSCC in the first-line setting that was not eligible for local therapy (surgery or radiotherapy), and an Eastern Cooperative Oncology Group performance status of 0–1. The adapted EXTREME regimen consisted of six cycles of fluorouracil 4000 mg/m<sup>2</sup> on days 1–4, carboplatin with an area under the curve of 5 on day 1, and cetuximab on days 1, 8, and 15 (400 mg/m<sup>2</sup> on cycle 1–day 1, and 250 mg/m<sup>2</sup> subsequently), all intravenously, with cycles starting every 21 days. In patients with disease control after two to six cycles, cetuximab 500 mg/m<sup>2</sup> was continued once every 2 weeks as maintenance therapy until disease progression or unacceptable toxicity. Granulocyte colony-stimulating factor was systematically administered and erythropoietin was recommended during chemotherapy. The study was based on the two-stage Bryant and Day design, combining efficacy and toxicity endpoints. The primary efficacy endpoint was objective response rate at week 12 after the start of treatment, assessed by central review (with an unacceptable rate of ≤15%). The primary toxicity endpoint was morbidity, defined as grade 4–5 adverse events, or cutaneous rash (grade ≥3) that required cetuximab to be discontinued, during the chemotherapy phase, or a decrease in functional autonomy (Activities of Daily Living score decrease ≥2 points from baseline) at 1 month after the end of chemotherapy (with an unacceptable morbidity rate of >40%). Analysis of the coprimary endpoints, and of safety in the chemotherapy phase, was based on the per-protocol population, defined as eligible patients who received at least one cycle of the adapted EXTREME regimen. Safety in the maintenance phase was assessed in all patients who received at least one dose of cetuximab as maintenance therapy. The study is registered with <span>ClinicalTrials.gov</span><svg><path></path></svg>, <span>NCT01864772</span><svg><path></path></svg>, and is completed.</p></div><div><h3>Findings</h3><p>Between Sept 27, 2013, and June 20, 2018, 85 patients were enrolled, of whom 78 were in the per-protocol population. 66 (85%) patients were male and 12 (15%) were female, and the median age was 75 years (IQR 72–79). The median number of chemotherapy cycles received was five (IQR 3–6). Objective response at week 12 was observed in 31 patients (40% [95% CI 30–51]) and morbidit
背景:针对身体健康、年龄较大的复发性或转移性头颈部鳞状细胞癌(HNSCC)患者的标准治疗方法尚未确立。在之前的 EXTREME 试验中,很少有老年患者参与。我们旨在评估经调整的 EXTREME 方案对身体健康的复发性或转移性 HNSCC 老年患者的疗效和耐受性:这项单臂 2 期研究在法国 22 个中心进行。符合条件的患者年龄在70岁或70岁以上,通过ELAN老年评估(EGE)被评估为不虚弱(身体健康),且患有复发性或转移性HNSCC,在一线治疗中不符合接受局部治疗(手术或放疗)的条件,东部合作肿瘤学组(Eastern Cooperative Oncology Group)的表现状态为0-1。调整后的EXTREME疗法包括:第1-4天使用氟尿嘧啶4000毫克/平方米,第1天使用曲线下面积为5的卡铂,第1、8和15天使用西妥昔单抗(第1周期第1天使用400毫克/平方米,随后使用250毫克/平方米),共6个周期,均为静脉注射,每21天开始一个周期。对于 2 至 6 个周期后疾病得到控制的患者,西妥昔单抗 500 mg/m2 作为维持疗法每 2 周继续治疗一次,直到疾病进展或出现不可接受的毒性。在化疗期间,系统地使用粒细胞集落刺激因子,并建议使用促红细胞生成素。该研究采用 "布莱恩特和日 "两阶段设计,将疗效终点和毒性终点相结合。主要疗效终点是治疗开始后第12周的客观反应率,由中央审查评估(不可接受率≤15%)。主要毒性终点是发病率,定义为在化疗阶段出现4-5级不良事件,或出现需要停用西妥昔单抗的皮疹(≥3级),或在化疗结束后1个月出现功能自主性下降(日常生活活动评分比基线下降≥2分)(不可接受的发病率>40%)。主要终点和化疗阶段安全性的分析基于按方案人群,即接受至少一个周期的改良EXTREME方案治疗的合格患者。所有接受至少一次西妥昔单抗维持治疗的患者均接受了维持治疗阶段的安全性评估。该研究已在ClinicalTrials.gov(NCT01864772)上注册,并已完成:2013年9月27日至2018年6月20日期间,共有85名患者入组,其中78人属于按方案人群。66例(85%)患者为男性,12例(15%)为女性,中位年龄为75岁(IQR 72-79)。化疗周期的中位数为 5 个(IQR 3-6)。31例患者(40% [95% CI 30-51])在第12周出现客观反应,24例患者(31% [22-42])出现发病事件。没有出现致命的不良反应。化疗结束1个月后,有4名患者的自主功能较基线有所下降。化疗期间,最常见的3-4级不良事件是血液学事件(白细胞减少[22例;28%]、中性粒细胞减少[20例;26%]、血小板减少[15例;19%]和贫血[12例;15%])、口腔黏膜炎(14例;18%)、疲劳(11例;14%)、痤疮样皮疹(10例;13%)和低镁血症(9例;12%)。在44名接受西妥昔单抗治疗的患者中,最常见的3-4级不良反应是低镁血症(6人;14%)和痤疮样皮疹(6人;14%):该研究达到了客观反应和发病率方面的主要目标,并显示总生存期与接受标准方案治疗的年轻患者一样好,这表明经改良的EXTREME方案可用于复发或转移性HNSCC老年患者,这些患者通过使用经改良的头颈癌患者老年评估工具(如EGE),被认为适合接受EXTREME方案治疗:法国 PAIR-VADS 2011 计划(由法国国家癌症研究所、ARC 基金会和 Ligue Contre le Cancer 赞助)、Sandoz、GEFLUC 和 GEMLUC 翻译:摘要的法文译文见 "补充材料 "部分。
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引用次数: 0
Eldecalcitol for sarcopenia prevention in adults with prediabetes 艾地骨化醇用于预防糖尿病前期成人肌肉疏松症。
IF 13.1 Q1 GERIATRICS & GERONTOLOGY Pub Date : 2024-06-01 DOI: 10.1016/S2666-7568(24)00091-6
Honglian Luo , Jiafeng Zhang , Xianhua Li , Tuo Li , Wei Shen
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引用次数: 0
Understanding the needs of forcibly displaced people 了解被迫流离失所者的需求。
IF 13.1 Q1 GERIATRICS & GERONTOLOGY Pub Date : 2024-06-01 DOI: 10.1016/S2666-7568(24)00097-7
The Lancet Healthy Longevity
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引用次数: 0
Are mobile health applications the answer to dementia risk reduction? 移动健康应用程序是降低痴呆症风险的答案吗?
IF 13.1 Q1 GERIATRICS & GERONTOLOGY Pub Date : 2024-06-01 DOI: 10.1016/S2666-7568(24)00095-3
Janice M Ranson
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引用次数: 0
Long-term effects of APOEε4 on mortality APOEε4 对死亡率的长期影响。
IF 13.1 Q1 GERIATRICS & GERONTOLOGY Pub Date : 2024-06-01 DOI: 10.1016/S2666-7568(24)00093-X
Ya-Ru Zhang , Jin-Tai Yu
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引用次数: 0
Value-based motivational strategies combined with technology to encourage a lifestyle that helps to prevent dementia 以价值为基础的激励策略与技术相结合,鼓励有助于预防痴呆症的生活方式。
IF 13.1 Q1 GERIATRICS & GERONTOLOGY Pub Date : 2024-06-01 DOI: 10.1016/S2666-7568(24)00069-2
Prof Stefan Klöppel MD , Esther Brill MSc , Prof Giovanni B Frisoni MD , Prof Dag Aarsland PhD , Prof Verena Klusmann-Weißkopf PhD

Lifestyles aimed at reducing dementia risk typically combine physical and cognitive training, nutritional adaptations, and, potentially, an augmentation in social interactions. Interventions at the population level are essential but should be complemented by individual efforts. For efficacy, lasting changes to an individual's lifestyle are needed, necessitating robust motivation and volition. Acting in accordance with one's values is assumed to be rewarding, leading to improved motivation and volition, and produces stable behaviour–outcome relationships. To this end, future preventive endeavours might first evaluate an individual's extant lifestyle, preferences, and values, including considerations of age-related changes to ensure these values remain a motivational source. Digital technology can support lifestyle goals and be targeted to support an individual's values. A digital platform could implement situation-specific, sensing-based feedback to alert users to a target situation (eg, opportunity for exercise) coupled with (smartphone-based) feedback on the extent of accomplished behavioural change to support individually set goals and facilitate their adjustment depending on whether these goals are achieved. This use of the motivational impetus of values, coupled with interpersonal techniques, such as motivational interviewing and SMART goal setting, in combination with sensor technology and just-in-time adaptive interventions, is assumed to hold high potential for dementia prevention.

旨在降低痴呆症风险的生活方式通常结合了体能和认知训练、营养调整以及潜在的社会交往。人群层面的干预措施至关重要,但也应辅以个人努力。要想取得成效,就必须持久地改变个人的生活方式,这就需要强有力的动机和意志。按照自己的价值观行事被认为是有回报的,会提高动机和意志,并产生稳定的行为-结果关系。为此,未来的预防工作可能会首先评估个人现有的生活方式、偏好和价值观,包括考虑与年龄有关的变化,以确保这些价值观仍然是动力来源。数字技术可以支持生活方式目标,并有针对性地支持个人的价值观。数字平台可以针对具体情况,通过传感反馈来提醒用户注意目标情况(例如,锻炼机会),同时提供(基于智能手机的)关于已完成行为改变程度的反馈,以支持个人设定的目标,并根据这些目标是否实现来促进其调整。这种利用价值观的动机推动力,再加上动机访谈和 SMART 目标设定等人际交往技术,结合传感器技术和及时适应性干预的方法,被认为在预防痴呆症方面具有很大的潜力。
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引用次数: 0
The need to include older patients with head and neck cancer in clinical trials 将老年头颈癌患者纳入临床试验的必要性。
IF 13.1 Q1 GERIATRICS & GERONTOLOGY Pub Date : 2024-06-01 DOI: 10.1016/S2666-7568(24)00067-9
Leandro Luongo Matos , Luiz Paulo Kowalski
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引用次数: 0
Prevention of dementia using mobile phone applications (PRODEMOS): a multinational, randomised, controlled effectiveness–implementation trial 利用手机应用软件预防痴呆症(PRODEMOS):一项多国随机对照有效性实施试验。
IF 13.1 Q1 GERIATRICS & GERONTOLOGY Pub Date : 2024-06-01 DOI: 10.1016/S2666-7568(24)00068-0
Prof Eric P Moll van Charante MD , Marieke P Hoevenaar-Blom PhD , Manshu Song PhD , Prof Sandrine Andrieu MD , Linda Barnes RGN , Cindy Birck PhD , Rachael Brooks BA , Nicola Coley PhD , Esmé Eggink PhD , Jean Georges PhD , Melanie Hafdi PhD , Prof Willem A van Gool MD , Ron Handels PhD , Haifeng Hou PhD , Prof Jihui Lyu MD , Prof Yixuan Niu MD , Libin Song BSc , Prof Wenzhi Wang PhD , Prof Youxin Wang PhD , Anders Wimo PhD , Xi Wei

Background

The expected increase of dementia prevalence in the coming decades will mainly be in low-income and middle-income countries and in people with low socioeconomic status in high-income countries. This study aims to reduce dementia risk factors in underserved populations at high-risk using a coach-supported mobile health (mHealth) intervention.

Methods

This open-label, blinded endpoint, hybrid effectiveness–implementation randomised controlled trial (RCT) investigated whether a coach-supported mHealth intervention can reduce dementia risk in people aged 55–75 years of low socioeconomic status in the UK or from the general population in China with at least two dementia risk factors. The primary effectiveness outcome was change in cardiovascular risk factors, ageing, and incidence of dementia (CAIDE) risk score from baseline to after 12–18 months of intervention. Implementation outcomes were coverage, adoption, sustainability, appropriateness, acceptability, fidelity, feasibility, and costs assessed using a mixed-methods approach. All participants with complete data on the primary outcome, without imputation of missing outcomes were included in the analysis (intention-to-treat principle). This trial is registered with ISRCTN, ISRCTN15986016, and is completed.

Findings

Between Jan 15, 2021, and April 18, 2023, 1488 people (601 male and 887 female) were randomly assigned (734 to intervention and 754 to control), with 1229 (83%) of 1488 available for analysis of the primary effectiveness outcome. After a mean follow-up of 16 months (SD 2·5), the mean CAIDE score improved 0·16 points in the intervention group versus 0·01 in the control group (mean difference –0·16, 95% CI –0·29 to –0·03). 1533 (10%) invited individuals responded; of the intervention participants, 593 (81%) of 734 adopted the intervention and 367 (50%) of 734 continued active participation throughout the study. Perceived appropriateness (85%), acceptability (81%), and fidelity (79%) were good, with fair overall feasibility (53% of intervention participants and 58% of coaches), at low cost. No differences in adverse events between study arms were found.

Interpretation

A coach-supported mHealth intervention is modestly effective in reducing dementia risk factors in those with low socioeconomic status in the UK and any socioeconomic status in China. Implementation is challenging in these populations, but those reached actively participated. Whether this intervention will result in less cognitive decline and dementia requires a larger RCT with long follow-up.

Funding

EU Horizon 2020 Research and Innovation Programme and the National Key R&D Programmes of China.

Translation

For the Mandarin translation of the abstract see Supplementary Materials section.

背景:预计未来几十年痴呆症患病率的增长将主要出现在低收入和中等收入国家,以及高收入国家中社会经济地位较低的人群中。本研究旨在利用教练支持的移动医疗(mHealth)干预措施,减少服务不足的高危人群中的痴呆症风险因素:这项开放标签、终点盲法、效果-实施混合随机对照试验(RCT)调查了由教练支持的移动医疗干预能否降低英国 55-75 岁社会经济地位低下人群或中国普通人群中至少有两种痴呆风险因素的痴呆风险。主要有效性结果是心血管风险因素、老龄化和痴呆症发病率(CAIDE)风险评分从基线到干预 12-18 个月后的变化。实施结果包括覆盖率、采用率、可持续性、适宜性、可接受性、忠实性、可行性和成本,采用混合方法进行评估。所有拥有主要结果完整数据的参与者均被纳入分析(意向治疗原则),未对缺失结果进行估算。该试验已在 ISRCTN(ISRCTN15986016)上注册,并已完成:2021年1月15日至2023年4月18日期间,1488人(601名男性和887名女性)被随机分配(734人接受干预,754人接受对照),1488人中有1229人(83%)可用于主要疗效分析。经过平均 16 个月的随访(SD 2-5),干预组的 CAIDE 平均得分提高了 0-16 分,而对照组的 CAIDE 平均得分提高了 0-01 分(平均差异 -0-16,95% CI -0-29~-0-03)。1533(10%)名受邀者做出了回应;在干预参与者中,734 人中有 593(81%)人采取了干预措施,734 人中有 367(50%)人在整个研究期间继续积极参与。干预的适宜性(85%)、可接受性(81%)和忠实性(79%)均较好,总体可行性尚可(53%的干预参与者和 58% 的教练),成本较低。各研究臂之间的不良事件没有差异:在英国,由教练支持的移动医疗干预对降低社会经济地位较低人群和中国任何社会经济地位人群的痴呆症风险因素效果一般。在这些人群中实施具有挑战性,但受众积极参与。这项干预措施能否减少认知能力下降和痴呆症的发生,还需要进行更大规模的RCT研究和长期随访:资金来源:欧盟 "地平线2020 "研究与创新计划和中国国家重点研发计划:摘要的普通话翻译见补充材料部分。
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引用次数: 0
Population attributable fractions of modifiable risk factors for dementia: a systematic review and meta-analysis 痴呆症可改变风险因素的人口可归因分数:系统回顾和荟萃分析。
IF 13.1 Q1 GERIATRICS & GERONTOLOGY Pub Date : 2024-06-01 DOI: 10.1016/S2666-7568(24)00061-8
Prof Blossom C M Stephan PhD , Louie Cochrane MSc , Aysegul Humeyra Kafadar MSc , Jacob Brain MSc , Elissa Burton PhD , Prof Bronwyn Myers PhD , Prof Carol Brayne MD , Aliya Naheed PhD , Prof Kaarin J Anstey PhD , Ammar W Ashor PhD , Prof Mario Siervo PhD
<div><h3>Background</h3><p>More than 57 million people have dementia worldwide. Evidence indicates a change in dementia prevalence and incidence in high-income countries, which is likely to be due to improved life-course population health. Identifying key modifiable risk factors for dementia is essential for informing risk reduction and prevention strategies. We therefore aimed to estimate the population attributable fraction (PAF) for dementia associated with modifiable risk factors.</p></div><div><h3>Methods</h3><p>In this systematic review and meta-analysis, we searched Embase, MEDLINE, and PsycINFO, via Ovid, from database inception up to June 29, 2023, for population-derived or community-based studies and reviews reporting a PAF value for one or more modifiable risk factor for later-life dementia (prevalent or incident dementia in people aged ≥60 years), with no restrictions on dementia subtype, the sex or baseline age of participants, or the period of study. Articles were independently screened for inclusion by four authors, with disagreements resolved through consensus. Data including unweighted and weighted PAF values (weighted to account for communality or overlap in risk) were independently extracted into a predefined template by two authors and checked by two other authors. When five or more unique studies investigated a given risk factor or combination of the same factors, random-effects meta-analyses were used to calculate a pooled PAF percentage estimate for the factor or combination of factors. The review protocol was registered on PROSPERO, CRD42022323429.</p></div><div><h3>Findings</h3><p>4024 articles were identified, and 74 were included in our narrative synthesis. Overall, PAFs were reported for 61 modifiable risk factors, with sufficient data available for meta-analysis of 12 factors (n=48 studies). In meta-analyses, the highest pooled unweighted PAF values were estimated for low education (17·2% [95% CI 14·4–20·0], p<0·0001), hypertension (15·8% [14·7–17·1], p<0·0001), hearing loss (15·6% [10·3–20·9], p<0·0001), physical inactivity (15·2% [12·8–17·7], p<0·0001), and obesity (9·4% [7·3–11·7], p<0·0001). According to weighted PAF values, low education (9·3% [6·9–11·7], p<0·0001), physical inactivity (7·3% [3·9–11·2], p=0·0021), hearing loss (7·2% [5·2–9·7], p<0·0001), hypertension (7·1% [5·4–8·8], p<0·0001), and obesity (5·3% [3·2–7·4], p=0·0001) had the highest pooled estimates. When low education, midlife hypertension, midlife obesity, smoking, physical inactivity, depression, and diabetes were combined (Barnes and Yaffe seven-factor model; n=9 studies), the pooled unweighted and weighted PAF values were 55·0% (46·5–63·5; p<0·0001) and 32·0% (26·6–37·5; p<0·0001), respectively. The pooled PAF values for most individual risk factors were higher in low-income and middle-income countries (LMICs) versus high-income countries.</p></div><div><h3>Interpretation</h3><p>Governments need to invest in a li
背景:全世界有 5700 多万人患有痴呆症。有证据表明,在高收入国家,痴呆症的流行率和发病率有所变化,这可能是由于生活过程中人口健康状况的改善。确定痴呆症的主要可改变风险因素对于制定降低风险和预防策略至关重要。因此,我们旨在估算与可改变风险因素相关的痴呆症人口可归因分数(PAF):在本系统综述和荟萃分析中,我们通过 Ovid 对 Embase、MEDLINE 和 PsycINFO 进行了检索,检索时间从数据库建立之初到 2023 年 6 月 29 日,检索对象为报告了晚年痴呆(年龄≥60 岁人群中的流行性痴呆或偶发性痴呆)的一个或多个可改变风险因素的 PAF 值的人群衍生或基于社区的研究和综述,对痴呆亚型、参与者的性别或基线年龄或研究时间没有限制。文章由四位作者独立筛选后纳入,如有异议,则通过协商一致的方式解决。包括非加权和加权 PAF 值在内的数据(加权以考虑共性或风险重叠)由两位作者独立提取到预定义的模板中,并由另外两位作者进行检查。如果有五项或五项以上独特的研究调查了某一特定风险因素或相同因素的组合,则采用随机效应荟萃分析来计算该因素或因素组合的集合 PAF 百分比估计值。综述方案已在 PROSPERO 注册,编号为 CRD42022323429:共发现 4024 篇文章,其中 74 篇被纳入我们的叙述性综述。总体而言,61 个可改变的风险因素被报道为 PAFs,其中 12 个因素(n=48 项研究)的荟萃分析数据充足。在荟萃分析中,教育程度低的非加权PAF值最高(17-2% [95% CI 14-4-20-0],p解释:各国政府需要对预防痴呆症的终生方法进行投资,包括制定能够提供优质教育、促进健康的环境和改善健康状况的政策。这种投资在低收入和中等收入国家尤为重要,因为这些国家的预防潜力很大,但资源、基础设施、预算以及针对老龄化和痴呆症的研究却很有限:英国研究与创新(医学研究委员会)。
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引用次数: 0
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Lancet Healthy Longevity
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