Pub Date : 2024-10-30DOI: 10.1016/j.lanhl.2024.100648
Tone Rubak, Simon Mark Dahl Baunwall, Merete Gregersen, Sara Ellegaard Paaske, Malene Asferg, Ishay Barat, Joanna Secher-Johnsen, Mikael Groth Riis, Jeppe Bakkestrøm Rosenbæk, Troels Kjærskov Hansen, Marianne Ørum, Claire J Steves, Hanne Veilbæk, Christian Lodberg Hvas, Else Marie Skjøde Damsgaard
Background: Clostridioides difficile infection causes diarrhoea and colitis. Older patients with C difficile infection are often frail and have comorbidities, leading to high mortality rates. The frailty burden in older people might restrict access to treatments, such as C difficile infection-specific antibiotics and faecal microbiota transplantation. We aimed to investigate the clinical effects of early comprehensive geriatric assessment (CGA) and frailty evaluation, including home visits and assessment for faecal microbiota transplantation, in older patients with C difficile infection.
Methods: In this randomised, quality improvement trial with a pragmatic design, patients from the Central Denmark Region aged 70 years or older with a positive PCR test for C difficile toxin were randomly assigned (1:1) to CGA or standard care, both with equal access to faecal microbiota transplantation. Patients and investigators were unmasked to treatment. The primary outcome was 90-day mortality, and was compared in the study groups according to the intention-to-treat principle. The study is registered with ClinicalTrials.gov, NCT05447533.
Findings: Between Sept 1, 2022, and May 3, 2023, we randomly assigned 217 patients to CGA (n=109) or standard care (n=108). The median patient age was 78 years (IQR 74-84). 116 (53%) of 217 patients were female and 101 (47%) were male. 16 (15%; 95% CI 9-23) of 109 patients in the CGA group and 22 (20%; 14-29) of 108 patients in the standard-care group died within 90 days (odds ratio 0·66, 95% CI 0·32-1·38. No serious adverse events or deaths related to patient assessment or faecal microbiota transplantation were recorded in either group. Deaths directly attributable to C difficile infection were lower in the CGA group (seven [44%] of 16 deaths vs 18 [82%] of 22 deaths in the standard-care group; p=0·020).
Interpretation: Older patients who received CGA had a 90-day mortality rate similar to that of patients who received standard care, but with fewer deaths directly attributable to C difficile infection.
Funding: Innovation Fund Denmark, Novo Nordisk Foundation, and Helsefonden.
背景:艰难梭菌感染会导致腹泻和结肠炎:艰难梭菌感染会导致腹泻和结肠炎。感染艰难梭菌的老年患者通常体弱多病,死亡率很高。老年人的虚弱负担可能会限制艰难梭菌感染特异性抗生素和粪便微生物群移植等治疗方法的使用。我们旨在研究早期老年综合评估(CGA)和虚弱评估(包括家访和粪便微生物群移植评估)对艰难梭菌感染老年患者的临床效果:在这项采用实用设计的随机质量改进试验中,丹麦中部地区 70 岁或以上、艰难梭菌毒素 PCR 检测呈阳性的患者被随机分配(1:1)接受 CGA 或标准护理,两者均可接受粪便微生物群移植。患者和研究人员在接受治疗时均未蒙面。主要结果是90天死亡率,根据意向治疗原则对研究组进行比较。该研究已在ClinicalTrials.gov注册,编号为NCT05447533.研究结果:2022年9月1日至2023年5月3日期间,我们将217名患者随机分配至CGA(109人)或标准护理(108人)。患者年龄中位数为 78 岁(IQR 74-84)。217 名患者中有 116 名(53%)女性,101 名(47%)男性。CGA组109名患者中有16人(15%;95% CI 9-23)在90天内死亡,标准护理组108名患者中有22人(20%;14-29)在90天内死亡(几率比0-66,95% CI 0-32-1-38)。两组患者均未发生与患者评估或粪便微生物群移植相关的严重不良事件或死亡。CGA组直接因艰难梭菌感染导致的死亡人数较少(16例死亡中的7例[44%]与标准护理组22例死亡中的18例[82%];P=0-020):接受CGA治疗的老年患者的90天死亡率与接受标准治疗的患者相似,但因艰难梭菌感染直接导致的死亡人数较少:资金来源:丹麦创新基金、诺和诺德基金会和Helsefonden。
{"title":"Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial.","authors":"Tone Rubak, Simon Mark Dahl Baunwall, Merete Gregersen, Sara Ellegaard Paaske, Malene Asferg, Ishay Barat, Joanna Secher-Johnsen, Mikael Groth Riis, Jeppe Bakkestrøm Rosenbæk, Troels Kjærskov Hansen, Marianne Ørum, Claire J Steves, Hanne Veilbæk, Christian Lodberg Hvas, Else Marie Skjøde Damsgaard","doi":"10.1016/j.lanhl.2024.100648","DOIUrl":"https://doi.org/10.1016/j.lanhl.2024.100648","url":null,"abstract":"<p><strong>Background: </strong>Clostridioides difficile infection causes diarrhoea and colitis. Older patients with C difficile infection are often frail and have comorbidities, leading to high mortality rates. The frailty burden in older people might restrict access to treatments, such as C difficile infection-specific antibiotics and faecal microbiota transplantation. We aimed to investigate the clinical effects of early comprehensive geriatric assessment (CGA) and frailty evaluation, including home visits and assessment for faecal microbiota transplantation, in older patients with C difficile infection.</p><p><strong>Methods: </strong>In this randomised, quality improvement trial with a pragmatic design, patients from the Central Denmark Region aged 70 years or older with a positive PCR test for C difficile toxin were randomly assigned (1:1) to CGA or standard care, both with equal access to faecal microbiota transplantation. Patients and investigators were unmasked to treatment. The primary outcome was 90-day mortality, and was compared in the study groups according to the intention-to-treat principle. The study is registered with ClinicalTrials.gov, NCT05447533.</p><p><strong>Findings: </strong>Between Sept 1, 2022, and May 3, 2023, we randomly assigned 217 patients to CGA (n=109) or standard care (n=108). The median patient age was 78 years (IQR 74-84). 116 (53%) of 217 patients were female and 101 (47%) were male. 16 (15%; 95% CI 9-23) of 109 patients in the CGA group and 22 (20%; 14-29) of 108 patients in the standard-care group died within 90 days (odds ratio 0·66, 95% CI 0·32-1·38. No serious adverse events or deaths related to patient assessment or faecal microbiota transplantation were recorded in either group. Deaths directly attributable to C difficile infection were lower in the CGA group (seven [44%] of 16 deaths vs 18 [82%] of 22 deaths in the standard-care group; p=0·020).</p><p><strong>Interpretation: </strong>Older patients who received CGA had a 90-day mortality rate similar to that of patients who received standard care, but with fewer deaths directly attributable to C difficile infection.</p><p><strong>Funding: </strong>Innovation Fund Denmark, Novo Nordisk Foundation, and Helsefonden.</p>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.4,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142565117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-24DOI: 10.1016/j.lanhl.2024.08.007
Ruoyu Yin, Laura Martinengo, Helen Elizabeth Smith, Mythily Subramaniam, Konstadina Griva, Lorainne Tudor Car
This systematic review aimed to synthesise qualitative evidence on the views and experiences of older adults in using digital mental health interventions (DMHIs) for the prevention or self-management of mental disorders. We searched PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science, PsycINFO, and the first 100 results of Google Scholar for eligible studies and we included 37 papers reporting 35 studies in this Review. Most DMHIs were delivered using mobile apps (n=11), websites (n=6), and video-conferencing tools (n=6). The use of DMHIs in older adults was affected by negative perceptions about ageing and mental health, the digital divide (eg, insufficient digital literacy), personal factors (eg, motivation) and health status, interpersonal influences (eg, guidance and encouragement), intervention features (eg, pace and content), technology-related factors (eg, accessibility), and the perceived benefits and risks of using DMHIs. Future DMHIs for older adults should involve other stakeholders such as health-care professionals, provide content relevant to the needs of older people, be more accessible, and address concerns about privacy and confidentiality.
本系统性综述旨在综合老年人在使用数字心理健康干预措施(DMHIs)预防或自我管理精神障碍方面的观点和经验的定性证据。我们检索了 PubMed、Embase、Cumulative Index to Nursing and Allied Health Literature、Web of Science、PsycINFO 和 Google Scholar 的前 100 条结果,以查找符合条件的研究。大多数 DMHI 使用移动应用程序(11 篇)、网站(6 篇)和视频会议工具(6 篇)提供。影响老年人使用 DMHIs 的因素包括:对老龄化和心理健康的负面看法、数字鸿沟(如数字素养不足)、个人因素(如动机)和健康状况、人际影响(如指导和鼓励)、干预特点(如节奏和内容)、技术相关因素(如可及性)以及使用 DMHIs 的感知收益和风险。未来针对老年人的 DMHI 应让其他利益相关者(如医疗保健专业人员)参与进来,提供与老年人需求相关的内容,使其更易于使用,并解决隐私和保密问题。
{"title":"The views and experiences of older adults regarding digital mental health interventions: a systematic review ofqualitative studies.","authors":"Ruoyu Yin, Laura Martinengo, Helen Elizabeth Smith, Mythily Subramaniam, Konstadina Griva, Lorainne Tudor Car","doi":"10.1016/j.lanhl.2024.08.007","DOIUrl":"https://doi.org/10.1016/j.lanhl.2024.08.007","url":null,"abstract":"<p><p>This systematic review aimed to synthesise qualitative evidence on the views and experiences of older adults in using digital mental health interventions (DMHIs) for the prevention or self-management of mental disorders. We searched PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science, PsycINFO, and the first 100 results of Google Scholar for eligible studies and we included 37 papers reporting 35 studies in this Review. Most DMHIs were delivered using mobile apps (n=11), websites (n=6), and video-conferencing tools (n=6). The use of DMHIs in older adults was affected by negative perceptions about ageing and mental health, the digital divide (eg, insufficient digital literacy), personal factors (eg, motivation) and health status, interpersonal influences (eg, guidance and encouragement), intervention features (eg, pace and content), technology-related factors (eg, accessibility), and the perceived benefits and risks of using DMHIs. Future DMHIs for older adults should involve other stakeholders such as health-care professionals, provide content relevant to the needs of older people, be more accessible, and address concerns about privacy and confidentiality.</p>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.4,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142568575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Oral health has previously shown associations with functional disability and mortality. We aimed to explore the associations of various aspects of oral health status with functional disability and mortality using survival analysis, as well as the relative magnitudes of the impact of these aspects on outcomes.
Methods: We obtained data for individuals aged 75 years and older in Shimane, Japan, who had at least one oral health check-up between April 1, 2016, and March 31, 2022 under Japan's long-life medical care system insurance system. Those with missing data or with functional disability at baseline were excluded. 13 aspects of oral health status were assessed by dentists or dental hygienists as part of the check-up (using protocols provided by the Japan Dental Association and the Japanese Ministry of Health, Labour and Welfare): number of remaining teeth, subjective masticatory performance, objective masticatory performance, periodontal tissue status, functional dysphagia, tongue mobility, articulation, oral hygiene, number of decayed teeth, inadaptation of dentures of the upper jaw and lower jaw (considered separately), oral mucosal disease, and dry mouth. Multivariate Cox proportional hazards models were used to analyse the associations between each aspect of oral health and functional disability and mortality, with fully adjusted models adjusting for sex, age, BMI, medical history, or a propensity score derived from these covariates. Population-attributable fractions (PAFs) were calculated to assess the differential impacts of these oral health status aspects on outcome occurrence.
Findings: Of the 24 619 individuals who had an oral health check-up during the study period, 21 881 individuals were included in the analysis of functional disability (9175 [41·93%] men, 12 706 [58·07%] women, mean age 78·31 years [SD 2·88], mean follow-up 41·43 months [20·80]), and 22 747 individuals in the analysis of mortality (9722 [42·74%] men, 13 025 [57·26%] women, mean age 78·34 years [2·89], mean follow-up 42·63 months [20·58]). All 13 aspects of oral health status showed significant associations with the occurrence of mortality, while functional disability was associated with 11 aspects (excluding oral mucosal disease and dry mouth) in the fully adjusted model. Based on PAFs, of all oral health aspects assessed, objective masticatory performance had the greatest impact on both functional disability (PAF 23·10% [95% CI 20·42-25·69] for the lowest and 10·62% [8·18-12·99] for the second-lowest quartile of performance) and mortality (16·47% [13·44-19·40] and 8·90% [5·87-11·82]).
Interpretation: Various aspects of oral health are associated with mortality and functional disability. Maintaining good oral health in older adults might help to reduce these outcomes.
{"title":"Effect of oral health on functional disability and mortality in older adults in Japan: a cohort study.","authors":"Takafumi Abe, Kazumichi Tominaga, Hisaaki Saito, Jun Shimizu, Norikuni Maeda, Ryouji Matsuura, Yukio Inoue, Yuichi Ando, Yuhei Matsuda, Takahiro Kanno, Shozo Yano, Minoru Isomura","doi":"10.1016/j.lanhl.2024.08.005","DOIUrl":"https://doi.org/10.1016/j.lanhl.2024.08.005","url":null,"abstract":"<p><strong>Background: </strong>Oral health has previously shown associations with functional disability and mortality. We aimed to explore the associations of various aspects of oral health status with functional disability and mortality using survival analysis, as well as the relative magnitudes of the impact of these aspects on outcomes.</p><p><strong>Methods: </strong>We obtained data for individuals aged 75 years and older in Shimane, Japan, who had at least one oral health check-up between April 1, 2016, and March 31, 2022 under Japan's long-life medical care system insurance system. Those with missing data or with functional disability at baseline were excluded. 13 aspects of oral health status were assessed by dentists or dental hygienists as part of the check-up (using protocols provided by the Japan Dental Association and the Japanese Ministry of Health, Labour and Welfare): number of remaining teeth, subjective masticatory performance, objective masticatory performance, periodontal tissue status, functional dysphagia, tongue mobility, articulation, oral hygiene, number of decayed teeth, inadaptation of dentures of the upper jaw and lower jaw (considered separately), oral mucosal disease, and dry mouth. Multivariate Cox proportional hazards models were used to analyse the associations between each aspect of oral health and functional disability and mortality, with fully adjusted models adjusting for sex, age, BMI, medical history, or a propensity score derived from these covariates. Population-attributable fractions (PAFs) were calculated to assess the differential impacts of these oral health status aspects on outcome occurrence.</p><p><strong>Findings: </strong>Of the 24 619 individuals who had an oral health check-up during the study period, 21 881 individuals were included in the analysis of functional disability (9175 [41·93%] men, 12 706 [58·07%] women, mean age 78·31 years [SD 2·88], mean follow-up 41·43 months [20·80]), and 22 747 individuals in the analysis of mortality (9722 [42·74%] men, 13 025 [57·26%] women, mean age 78·34 years [2·89], mean follow-up 42·63 months [20·58]). All 13 aspects of oral health status showed significant associations with the occurrence of mortality, while functional disability was associated with 11 aspects (excluding oral mucosal disease and dry mouth) in the fully adjusted model. Based on PAFs, of all oral health aspects assessed, objective masticatory performance had the greatest impact on both functional disability (PAF 23·10% [95% CI 20·42-25·69] for the lowest and 10·62% [8·18-12·99] for the second-lowest quartile of performance) and mortality (16·47% [13·44-19·40] and 8·90% [5·87-11·82]).</p><p><strong>Interpretation: </strong>Various aspects of oral health are associated with mortality and functional disability. Maintaining good oral health in older adults might help to reduce these outcomes.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.4,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142476501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-04DOI: 10.1016/j.lanhl.2024.100644
Matteo Cesari, Jotheeswaran Amuthavalli Thiyagarajan, Antonio Cherubini, Miguel Angel Acanfora, Prasert Assantachai, Mario Barbagallo, Mamadou Coume, Theresa Diaz, Nicholas Fuggle, Sonia Ouali Hammami, Kenneth Madden, Radmila Matijevic, Jean-Pierre Michel, Mirko Petrovic, Cornel Sieber, Nicola Veronese, Finbarr C Martin, Anshu Banerjee, John W Rowe
Population ageing is a global occurrence. Unfortunately, the shortage of health professionals with geriatric competencies is a major factor restricting high-quality care for older people worldwide. Strengthening the knowledge and skills of the health workforce to better respond to the needs of older people is a major global priority. Geriatricians can play a pivotal role in reorienting care for older people towards an integrated and person-centred care system focused on functional ability, preventive strategies, and age-friendly services. The current scenario requires efforts to be directed towards establishing a standardised competency-based definition of a geriatrician to allow for an accurate estimation of the existing workforce with adequate training in geriatrics as crucial resources to facilitate the paradigm shift. This Personal View, supported by the International Association of Gerontology and Geriatrics and the European Geriatric Medicine Society, proposes a standardised definition of a geriatrician based on expected competencies and roles and a precise description of the essential features of geriatric medicine. By reducing ambiguities and offering a competency-based framework, the current standardisation approach is expected to facilitate better support, monitoring, and allocation of resources for improving care for older people worldwide.
{"title":"Defining the role and reach of a geriatrician.","authors":"Matteo Cesari, Jotheeswaran Amuthavalli Thiyagarajan, Antonio Cherubini, Miguel Angel Acanfora, Prasert Assantachai, Mario Barbagallo, Mamadou Coume, Theresa Diaz, Nicholas Fuggle, Sonia Ouali Hammami, Kenneth Madden, Radmila Matijevic, Jean-Pierre Michel, Mirko Petrovic, Cornel Sieber, Nicola Veronese, Finbarr C Martin, Anshu Banerjee, John W Rowe","doi":"10.1016/j.lanhl.2024.100644","DOIUrl":"https://doi.org/10.1016/j.lanhl.2024.100644","url":null,"abstract":"<p><p>Population ageing is a global occurrence. Unfortunately, the shortage of health professionals with geriatric competencies is a major factor restricting high-quality care for older people worldwide. Strengthening the knowledge and skills of the health workforce to better respond to the needs of older people is a major global priority. Geriatricians can play a pivotal role in reorienting care for older people towards an integrated and person-centred care system focused on functional ability, preventive strategies, and age-friendly services. The current scenario requires efforts to be directed towards establishing a standardised competency-based definition of a geriatrician to allow for an accurate estimation of the existing workforce with adequate training in geriatrics as crucial resources to facilitate the paradigm shift. This Personal View, supported by the International Association of Gerontology and Geriatrics and the European Geriatric Medicine Society, proposes a standardised definition of a geriatrician based on expected competencies and roles and a precise description of the essential features of geriatric medicine. By reducing ambiguities and offering a competency-based framework, the current standardisation approach is expected to facilitate better support, monitoring, and allocation of resources for improving care for older people worldwide.</p>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.4,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142393896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-04DOI: 10.1016/j.lanhl.2024.100643
Giovanni Guaraldi, Jovana Milic, Eduardo Gnoatto Perondi, Ana Catarina Rodrigues Gonçalves, Cristina Mussini, Marco Antonio de Avila Vitoria, Matteo Cesari
The Decade of Healthy Ageing (2021-30; the Decade), proclaimed by the UN in 2020, is a global initiative aimed at fostering collaborations to transform the world into a better place to live and grow older in. The Decade presents a positive vision of ageing, discarding the stereotypes of diseases and disabilities and promoting focus on capacities and abilities. This approach will help to foster a more inclusive world and, consequently, care systems, which value the dignity of each individual. Although the initiative represents a resource for the global population, the Decade also provides a unique opportunity for the large community of people living with HIV in terms of increased visibility and long-term solutions for their specific ageing-related health issues. This Personal View focuses on the relevance of the Decade in improving the lives of people in the HIV community, the rationale for a stronger engagement of people living with HIV in this initiative, and the potential to reduce global disparities between the HIV community and the general population and among different global regions.
{"title":"The UN Decade of Healthy Ageing (2021-30) for people living with HIV.","authors":"Giovanni Guaraldi, Jovana Milic, Eduardo Gnoatto Perondi, Ana Catarina Rodrigues Gonçalves, Cristina Mussini, Marco Antonio de Avila Vitoria, Matteo Cesari","doi":"10.1016/j.lanhl.2024.100643","DOIUrl":"https://doi.org/10.1016/j.lanhl.2024.100643","url":null,"abstract":"<p><p>The Decade of Healthy Ageing (2021-30; the Decade), proclaimed by the UN in 2020, is a global initiative aimed at fostering collaborations to transform the world into a better place to live and grow older in. The Decade presents a positive vision of ageing, discarding the stereotypes of diseases and disabilities and promoting focus on capacities and abilities. This approach will help to foster a more inclusive world and, consequently, care systems, which value the dignity of each individual. Although the initiative represents a resource for the global population, the Decade also provides a unique opportunity for the large community of people living with HIV in terms of increased visibility and long-term solutions for their specific ageing-related health issues. This Personal View focuses on the relevance of the Decade in improving the lives of people in the HIV community, the rationale for a stronger engagement of people living with HIV in this initiative, and the potential to reduce global disparities between the HIV community and the general population and among different global regions.</p>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.4,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142393897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.lanhl.2024.08.006
Background
Heart failure is a substantial global health concern that severely affects patients' quality of life. We aimed to compare the effects of early integration of palliative care (EIPC) and standard cardiac care on health status and mood of patients with non-terminal heart failure.
Methods
EPCHF was a multicentre, parallel, two-arm, open-label, randomised controlled trial carried out at University Hospital Bonn and University Hospital Düsseldorf in Germany. Eligible patients (aged 18 years or older) had heart failure, with New York Heart Association class II or more and NT-proBNP concentrations greater than or equal to 400 pg/mL. Patients were randomly assigned (1:1) to receive EIPC with standard cardiac care or standard cardiac care alone. Randomisation was computer-generated with allocation concealment, variable block sizes, and stratification by investigational site. The primary endpoints were health status and mood, measured every 3 months over 12 months using the Functional Assessment of Chronic Illness Therapy–Palliative Care (FACIT–PAL) and the Kansas City Cardiomyopathy Questionnaire (KCCQ), analysed by intention to treat. This trial is registered with DRKS.de, DRKS00013922.
Findings
Between May 21, 2019, and Nov 15, 2021, 843 patients were assessed for eligibility, 205 of whom were enrolled (100 assigned to EIPC and 105 assigned to standard cardiac care). 143 (70%) patients were male and 62 (30%) were female. Over 12 months, both groups significantly improved in FACIT–PAL and KCCQ Overall Summary Score (OSS) with no significant differences between the groups (FACIT–PAL adjusted mean difference 0·98 points [95% CI –1·28 to 3·23]; p=0·40; KCCQ-OSS adjusted mean difference –2·06 points [–7·89 to 3·78]; p=0·49). Nine (9%) patients in the EIPC group and seven (7%) patients in the standard cardiac care group died from any cause, with no significant differences in time to death between the two groups (hazard ratio [HR] 1·32 [95% CI 0·49 to 3·54]; p=0·58). 22 (22%) patients in the EIPC group and 21 (21%) patients in the standard cardiac care group were hospitalised at least once due to heart failure, with no significant differences in time to heart-failure-related hospitalisation between the two groups (HR 1·09 [0·61 to 1·98]; p=0·77). 70 (70%) patients in the EIPC group and 62 (59%) in the standard cardiac care group had any adverse events (p=0·10).
Interpretation
In this open-label, randomised clinical trial, standard cardiac care, featuring guideline-directed optimisation of medical therapy and regular 3-monthly follow-ups was found to be as effective as when combined with EIPC in improving health status and mood in patients with non-terminal heart failure. Future clinical practices should consider EIPC based on individual patient needs.
Funding
Federal Ministry of Education and Research.
背景:心力衰竭是一个严重影响患者生活质量的全球性健康问题。我们旨在比较早期整合姑息治疗(EIPC)和标准心脏治疗对非终末期心力衰竭患者健康状况和情绪的影响:EPCHF是一项多中心、平行、双臂、开放标签、随机对照试验,在德国波恩大学医院和杜塞尔多夫大学医院进行。符合条件的患者(18 岁或以上)均患有心力衰竭,纽约心脏协会分级为 II 级或以上,NT-proBNP 浓度大于或等于 400 pg/mL。患者被随机分配(1:1)接受 EIPC 和标准心脏治疗,或仅接受标准心脏治疗。随机分配由计算机生成,采用分配隐藏、可变区块大小和按研究地点分层的方式。主要终点是健康状况和情绪,在12个月内每3个月使用慢性疾病治疗-姑息治疗功能评估(FACIT-PAL)和堪萨斯城心肌病问卷(KCCQ)进行测量,并按意向治疗进行分析。该试验已在DRKS.de注册,编号为DRKS00013922.Findings:2019年5月21日至2021年11月15日期间,843名患者接受了资格评估,其中205名患者入选(100名被分配至EIPC,105名被分配至标准心脏护理)。143名患者(70%)为男性,62名患者(30%)为女性。在12个月内,两组患者的FACIT-PAL和KCCQ综合评分(OSS)均有明显改善,组间无明显差异(FACIT-PAL调整后平均差异为0-98分[95% CI -1-28 to 3-23];P=0-40;KCCQ-OSS调整后平均差异为-2-06分[-7-89 to 3-78];P=0-49)。EIPC组有9名(9%)患者因任何原因死亡,标准心脏护理组有7名(7%)患者因任何原因死亡,两组患者的死亡时间无显著差异(危险比[HR] 1-32 [95% CI 0-49 to 3-54]; p=0-58)。EIPC组22(22%)名患者和标准心脏护理组21(21%)名患者因心衰至少住院一次,两组患者因心衰住院的时间无显著差异(HR 1-09 [0-61 to 1-98]; p=0-77)。EIPC组有70名(70%)患者出现不良事件,标准心脏护理组有62名(59%)患者出现不良事件(P=0-10):在这项开放标签、随机临床试验中发现,标准心脏治疗,包括以指南为指导的优化药物治疗和3个月定期随访,在改善非终末期心力衰竭患者的健康状况和情绪方面与EIPC联合治疗同样有效。未来的临床实践应根据患者的个体需求考虑EIPC:联邦教育与研究部。
{"title":"Early integration of palliative care versus standard cardiac care for patients with heart failure (EPCHF): a multicentre, parallel, two-arm, open-label, randomised controlled trial","authors":"","doi":"10.1016/j.lanhl.2024.08.006","DOIUrl":"10.1016/j.lanhl.2024.08.006","url":null,"abstract":"<div><h3>Background</h3><div>Heart failure is a substantial global health concern that severely affects patients' quality of life. We aimed to compare the effects of early integration of palliative care (EIPC) and standard cardiac care on health status and mood of patients with non-terminal heart failure.</div></div><div><h3>Methods</h3><div>EPCHF was a multicentre, parallel, two-arm, open-label, randomised controlled trial carried out at University Hospital Bonn and University Hospital Düsseldorf in Germany. Eligible patients (aged 18 years or older) had heart failure, with New York Heart Association class II or more and NT-proBNP concentrations greater than or equal to 400 pg/mL. Patients were randomly assigned (1:1) to receive EIPC with standard cardiac care or standard cardiac care alone. Randomisation was computer-generated with allocation concealment, variable block sizes, and stratification by investigational site. The primary endpoints were health status and mood, measured every 3 months over 12 months using the Functional Assessment of Chronic Illness Therapy–Palliative Care (FACIT–PAL) and the Kansas City Cardiomyopathy Questionnaire (KCCQ), analysed by intention to treat. This trial is registered with DRKS.de, DRKS00013922.</div></div><div><h3>Findings</h3><div>Between May 21, 2019, and Nov 15, 2021, 843 patients were assessed for eligibility, 205 of whom were enrolled (100 assigned to EIPC and 105 assigned to standard cardiac care). 143 (70%) patients were male and 62 (30%) were female. Over 12 months, both groups significantly improved in FACIT–PAL and KCCQ Overall Summary Score (OSS) with no significant differences between the groups (FACIT–PAL adjusted mean difference 0·98 points [95% CI –1·28 to 3·23]; p=0·40; KCCQ-OSS adjusted mean difference –2·06 points [–7·89 to 3·78]; p=0·49). Nine (9%) patients in the EIPC group and seven (7%) patients in the standard cardiac care group died from any cause, with no significant differences in time to death between the two groups (hazard ratio [HR] 1·32 [95% CI 0·49 to 3·54]; p=0·58). 22 (22%) patients in the EIPC group and 21 (21%) patients in the standard cardiac care group were hospitalised at least once due to heart failure, with no significant differences in time to heart-failure-related hospitalisation between the two groups (HR 1·09 [0·61 to 1·98]; p=0·77). 70 (70%) patients in the EIPC group and 62 (59%) in the standard cardiac care group had any adverse events (p=0·10).</div></div><div><h3>Interpretation</h3><div>In this open-label, randomised clinical trial, standard cardiac care, featuring guideline-directed optimisation of medical therapy and regular 3-monthly follow-ups was found to be as effective as when combined with EIPC in improving health status and mood in patients with non-terminal heart failure. Future clinical practices should consider EIPC based on individual patient needs.</div></div><div><h3>Funding</h3><div>Federal Ministry of Education and Research.</div></div>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142376138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.lanhl.2024.100639
People with intellectual disability are a vulnerable cohort who face challenges accessing health care. Compared with the general population, people with intellectual disability have an elevated risk of developing dementia, which often presents at a younger age and with atypical symptoms. The lifelong cognitive and functional difficulties faced by people with intellectual disability further complicate the diagnostic process. Specialised intellectual disability memory services and evaluation using reliable biomarkers of neurodegeneration are needed to improve diagnostic and prognostic certainty in this group. Inadequate specialist services and paucity of research on biomarkers in this population hinders progress and impedes the delivery of adequate health care. Although cerebrospinal fluid-based biomarkers and radiological biomarkers are used routinely in the evaluation of Alzheimer’s disease in the general population, biological variation within the clinically heterogenous group of people with intellectual disability could affect the clinical utility of existing biomarkers. As disease-modifying therapies become available for the treatment of early Alzheimer’s disease, and hopefully other neurodegenerative conditions in the future, biomarkers will serve as gatekeepers to establish the eligibility for such therapies. Inadequate representation of adults with intellectual disability in biomarker research will result in their exclusion from treatment with disease-modifying therapies, thus perpetuating the inequity in health care that is already faced by this group. The aim of this Series paper is to summarise current evidence on the application of biomarkers for Alzheimer’s disease in a population with intellectual disability (that is not attributable to Down syndrome) and suspected cognitive decline.
{"title":"Use of biomarkers in the diagnosis of Alzheimer’s disease in adults with intellectual disability","authors":"","doi":"10.1016/j.lanhl.2024.100639","DOIUrl":"10.1016/j.lanhl.2024.100639","url":null,"abstract":"<div><div>People with intellectual disability are a vulnerable cohort who face challenges accessing health care. Compared with the general population, people with intellectual disability have an elevated risk of developing dementia, which often presents at a younger age and with atypical symptoms. The lifelong cognitive and functional difficulties faced by people with intellectual disability further complicate the diagnostic process. Specialised intellectual disability memory services and evaluation using reliable biomarkers of neurodegeneration are needed to improve diagnostic and prognostic certainty in this group. Inadequate specialist services and paucity of research on biomarkers in this population hinders progress and impedes the delivery of adequate health care. Although cerebrospinal fluid-based biomarkers and radiological biomarkers are used routinely in the evaluation of Alzheimer’s disease in the general population, biological variation within the clinically heterogenous group of people with intellectual disability could affect the clinical utility of existing biomarkers. As disease-modifying therapies become available for the treatment of early Alzheimer’s disease, and hopefully other neurodegenerative conditions in the future, biomarkers will serve as gatekeepers to establish the eligibility for such therapies. Inadequate representation of adults with intellectual disability in biomarker research will result in their exclusion from treatment with disease-modifying therapies, thus perpetuating the inequity in health care that is already faced by this group. The aim of this Series paper is to summarise current evidence on the application of biomarkers for Alzheimer’s disease in a population with intellectual disability (that is not attributable to Down syndrome) and suspected cognitive decline.</div></div>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142381805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.lanhl.2024.100650
{"title":"Mental health deserves attention at all ages","authors":"","doi":"10.1016/j.lanhl.2024.100650","DOIUrl":"10.1016/j.lanhl.2024.100650","url":null,"abstract":"","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142476502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.lanhl.2024.08.004
Background
Sleep disturbances are common and distressing for people with dementia and their families. Non-pharmacological interventions should be first-line management, avoiding harmful pharmacological side-effects, but there is none with known effectiveness. We aimed to establish whether DREAMS START, a multicomponent intervention, reduced sleep disturbance in people with dementia living at home compared with usual care.
Methods
We conducted a phase 3, two-arm, multicentre, parallel-arm, superiority randomised controlled trial with masked outcome assessment, recruiting dyads of people with dementia and sleep disturbance and family carers from community settings. Randomisation to the DREAMS START intervention (plus usual treatment) or usual treatment was conducted at dyadic level, blocked, and stratified by site, with a web-based system assigning allocation. DREAMS START is a six-session, manualised intervention delivered face to face or remotely by non-clinically trained graduates over an approximately 3-month period. The primary outcome was sleep disturbance measured by the Sleep Disorders Inventory (SDI) at 8 months. Analyses were on the intention-to-treat population. This trial is registered with ISRCTN 13072268.
Findings
Between Feb 24, 2021, and March 5, 2023, 377 dyads were randomly assigned (1:1), 189 to usual treatment and 188 to intervention. The mean age of participants with dementia was 79·4 years (SD 9·0), and 206 (55%) were women. The mean SDI score at 8 months was lower in the intervention group compared with the usual treatment group (15·16 [SD 12·77], n=159, vs 20·34 [16·67], n=163]; adjusted difference in means –4·70 [95% CI –7·65 to –1·74], p=0·002). 17 (9%) people with dementia in the intervention group and 17 (9%) in the control group died during the trial; the deaths were unrelated to the intervention.
Interpretation
To our knowledge, DREAMS START is the first multicomponent intervention to improve the sleep of people living at home with dementia more than usual clinical care. It had sustained effectiveness beyond intervention delivery. The intervention’s delivery by non-clinically trained graduates increases the potential for implementation within health services, adding to usual clinical care.
Funding
National Institute for Health and Care Research Health Technology Assessment.
{"title":"Clinical effectiveness of DREAMS START (Dementia Related Manual for Sleep; Strategies for Relatives) versus usual care for people with dementia and their carers: a single-masked, phase 3, parallel-arm, superiority randomised controlled trial","authors":"","doi":"10.1016/j.lanhl.2024.08.004","DOIUrl":"10.1016/j.lanhl.2024.08.004","url":null,"abstract":"<div><h3>Background</h3><div>Sleep disturbances are common and distressing for people with dementia and their families. Non-pharmacological interventions should be first-line management, avoiding harmful pharmacological side-effects, but there is none with known effectiveness. We aimed to establish whether DREAMS START, a multicomponent intervention, reduced sleep disturbance in people with dementia living at home compared with usual care.</div></div><div><h3>Methods</h3><div>We conducted a phase 3, two-arm, multicentre, parallel-arm, superiority randomised controlled trial with masked outcome assessment, recruiting dyads of people with dementia and sleep disturbance and family carers from community settings. Randomisation to the DREAMS START intervention (plus usual treatment) or usual treatment was conducted at dyadic level, blocked, and stratified by site, with a web-based system assigning allocation. DREAMS START is a six-session, manualised intervention delivered face to face or remotely by non-clinically trained graduates over an approximately 3-month period. The primary outcome was sleep disturbance measured by the Sleep Disorders Inventory (SDI) at 8 months. Analyses were on the intention-to-treat population. This trial is registered with ISRCTN 13072268.</div></div><div><h3>Findings</h3><div>Between Feb 24, 2021, and March 5, 2023, 377 dyads were randomly assigned (1:1), 189 to usual treatment and 188 to intervention. The mean age of participants with dementia was 79·4 years (SD 9·0), and 206 (55%) were women. The mean SDI score at 8 months was lower in the intervention group compared with the usual treatment group (15·16 [SD 12·77], n=159, <em>vs</em> 20·34 [16·67], n=163]; adjusted difference in means –4·70 [95% CI –7·65 to –1·74], p=0·002). 17 (9%) people with dementia in the intervention group and 17 (9%) in the control group died during the trial; the deaths were unrelated to the intervention.</div></div><div><h3>Interpretation</h3><div>To our knowledge, DREAMS START is the first multicomponent intervention to improve the sleep of people living at home with dementia more than usual clinical care. It had sustained effectiveness beyond intervention delivery. The intervention’s delivery by non-clinically trained graduates increases the potential for implementation within health services, adding to usual clinical care.</div></div><div><h3>Funding</h3><div>National Institute for Health and Care Research Health Technology Assessment.</div></div>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142376125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/S2666-7568(24)00109-0
{"title":"A retinal biomarker of biological age based on composite clinical phenotypic information","authors":"","doi":"10.1016/S2666-7568(24)00109-0","DOIUrl":"10.1016/S2666-7568(24)00109-0","url":null,"abstract":"","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142373108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}