自我管理支持干预对老年哮喘预后的影响：SAMBA研究随机临床试验
2019/10/17
摘要
重要性：年长的哮喘患者较年轻患者的哮喘控制和预后较差。解决老年哮喘患者自我管理不佳的干预措施通常不能满足患者个性化的需求。
目的：检验针对老年患者的全面、个性化哮喘自我管理支持干预措施对临床和自我管理结果的影响。
设计，设置和参加者：本研究为三臂随机临床试验，研究时间为2014年2月至2017年12月，干预地点为纽约市的初级保健机构和个人住宅。研究人群为通过电子医疗记录在学术医疗中心和联邦认证的医疗中心中筛选出的60岁及以上的持续性未控制哮喘患者。接受筛选的1349名患者中，有406名符合入组标准并同意参加研究，随后被随机分为3组：家庭干预，基于临床的干预或对照（常规护理）。共有391名患者接受了分配的治疗。
干预措施：筛查哮喘控制和自我管理的社会心理，身体，认知和环境障碍，并采取行动解决已确定的障碍。干预由哮喘护理指导员在家庭或基层护理机构提供。
主要终点和检测：主要结果是哮喘控制测试，小型哮喘生活质量问卷，药物依从性评分量表，计量吸入器技术和哮喘急诊科就诊。主要分析为干预措施（基于家庭或诊所）与常规护理进行比较。
结果：391名接受治疗的患者中，有58名（15.1％）为男性，平均（SD）年龄为67.8（7.4）岁。计入基线分数后，干预组的哮喘控制测试得分优于对照组（3个月时差异为1.2； 95％CI为0.2-2.2； P = .02； 6个月， 1.0； 95％CI，0.0-2.1； P = .049； 12个月，0.6； 95％CI，-0.5至1.8； P = .28；总体，χ2= 13.4，具有4个自由度； P =.01）。干预组的急诊就诊率在12个月时低于对照组（16 [6.2％] vs 17 [12.7％]； P = .03；调整后的优势比为0.8； 95％CI为0.6-0.99； P = .03）。与对照组相比，干预组患者的生活质量（总体影响：χ2= 10.5，具有4个自由度； P = .01），药物依从性（总体影响：χ2= 9.5，具有4个自由度； P = .049）和吸入器技术（定量吸入器技术，正确完成12个月的操作步骤，中位[范围]：75％[0％-100％]对58％[0％-100％]）均有显着改善。在家庭和机构环境中接受干预的患者之间未观察到结局的显著差异。
结论和相关性：由患者的需求和障碍指导的干预措施可改善老年哮喘患者疾病预后和自我管理行为。
(中日友好医院呼吸与危重症医学科 顾宪民 摘译 林江涛 审校)
(JAMA Intern Med. 2019 Jun 10. doi: 10.1001/jamainternmed.2019.1201.)
Effect of a Self-management Support Intervention on Asthma Outcomes in Older Adults: The SAMBA Study Randomized Clinical Trial.
Federman AD, O'Conor R, Mindlis I, Hoy-Rosas J, Hauser D, Lurio J, Shroff N, Lopez R, Erblich J, Wolf MS, Wisnivesky JP.
Abstract
IMPORTANCE:Older adults with asthma have worse control and outcomes than younger adults. Interventions to address suboptimal self-management among older adults with asthma are typically not tailored to the specific needs of the patient.
OBJECTIVE:To test the effect of a comprehensive, patient-tailored asthma self-management support intervention for older adults on clinical and self-management outcomes.
DESIGN, SETTING, AND PARTICIPANTS:Three-arm randomized clinical trial conducted between February 2014 and December 2017 at primary care practices and personal residences in New York City. Adults 60 years and older with persistent, uncontrolled asthma were identified from electronic medical records at an academic medical center and a federally qualified health center. Of 1349 patients assessed for eligibility, 406 met eligibility criteria, consented to participate, and were randomized to 1 of 3 groups: home-based intervention, clinic-based intervention, or control (usual care). A total of 391 patients received the allocated treatment.
INTERVENTIONS:Screening for psychosocial, physical, cognitive, and environmental barriers to asthma control and self-management with actions to address identified barriers. The intervention was delivered in the home or primary care practices by asthma care coaches.
MAIN OUTCOMES AND MEASURES:Primary outcomes were the Asthma Control Test, Mini Asthma Quality of Life Questionnaire, Medication Adherence Rating Scale, metered dose inhaler technique, and emergency department visits for asthma care. Primary analyses compared intervention (home or clinic based) with usual care.
RESULTS:Of the 391 patients who received treatment, 58 (15.1%) were men, and the mean (SD) age was 67.8 (7.4) years. After accounting for baseline scores, scores on the asthma control test were better in the intervention groups vs the control group (difference-in-differences at 3 months, 1.2; 95% CI, 0.2-2.2; P = .02; 6 months, 1.0; 95% CI, 0.0-2.1; P = .049; 12 months, 0.6; 95% CI, -0.5 to 1.8; P = .28; and overall, χ2 = 13.4, with 4 degrees of freedom; P = .01). Emergency department visits were lower at 12 months for the intervention groups vs the control group (16 [6.2%] vs 17 [12.7%]; P = .03; adjusted odds ratio, 0.8; 95% CI, 0.6-0.99; P = .03). Statistically significant improvements were observed for the intervention vs control patients in quality of life (overall effect: χ2 = 10.5, with 4 degrees of freedom; P = .01), medication adherence (overall effect: χ2 = 9.5, with 4 degrees of freedom; P = .049), and inhaler technique (metered-dose inhaler technique, correctly completed steps at 12 months, median [range]: 75% [0%-100%] vs 58% [0%-100%]). No significant differences in outcomes were observed between patients receiving the intervention in home vs practice settings.
CONCLUSIONS AND RELEVANCE:An intervention directed by patients' needs and barriers improved asthma outcomes and self-management behaviors among older adults.
重要性：年长的哮喘患者较年轻患者的哮喘控制和预后较差。解决老年哮喘患者自我管理不佳的干预措施通常不能满足患者个性化的需求。
目的：检验针对老年患者的全面、个性化哮喘自我管理支持干预措施对临床和自我管理结果的影响。
设计，设置和参加者：本研究为三臂随机临床试验，研究时间为2014年2月至2017年12月，干预地点为纽约市的初级保健机构和个人住宅。研究人群为通过电子医疗记录在学术医疗中心和联邦认证的医疗中心中筛选出的60岁及以上的持续性未控制哮喘患者。接受筛选的1349名患者中，有406名符合入组标准并同意参加研究，随后被随机分为3组：家庭干预，基于临床的干预或对照（常规护理）。共有391名患者接受了分配的治疗。
干预措施：筛查哮喘控制和自我管理的社会心理，身体，认知和环境障碍，并采取行动解决已确定的障碍。干预由哮喘护理指导员在家庭或基层护理机构提供。
主要终点和检测：主要结果是哮喘控制测试，小型哮喘生活质量问卷，药物依从性评分量表，计量吸入器技术和哮喘急诊科就诊。主要分析为干预措施（基于家庭或诊所）与常规护理进行比较。
结果：391名接受治疗的患者中，有58名（15.1％）为男性，平均（SD）年龄为67.8（7.4）岁。计入基线分数后，干预组的哮喘控制测试得分优于对照组（3个月时差异为1.2； 95％CI为0.2-2.2； P = .02； 6个月， 1.0； 95％CI，0.0-2.1； P = .049； 12个月，0.6； 95％CI，-0.5至1.8； P = .28；总体，χ2= 13.4，具有4个自由度； P =.01）。干预组的急诊就诊率在12个月时低于对照组（16 [6.2％] vs 17 [12.7％]； P = .03；调整后的优势比为0.8； 95％CI为0.6-0.99； P = .03）。与对照组相比，干预组患者的生活质量（总体影响：χ2= 10.5，具有4个自由度； P = .01），药物依从性（总体影响：χ2= 9.5，具有4个自由度； P = .049）和吸入器技术（定量吸入器技术，正确完成12个月的操作步骤，中位[范围]：75％[0％-100％]对58％[0％-100％]）均有显着改善。在家庭和机构环境中接受干预的患者之间未观察到结局的显著差异。
结论和相关性：由患者的需求和障碍指导的干预措施可改善老年哮喘患者疾病预后和自我管理行为。
(中日友好医院呼吸与危重症医学科 顾宪民 摘译 林江涛 审校)
(JAMA Intern Med. 2019 Jun 10. doi: 10.1001/jamainternmed.2019.1201.)
Effect of a Self-management Support Intervention on Asthma Outcomes in Older Adults: The SAMBA Study Randomized Clinical Trial.
Federman AD, O'Conor R, Mindlis I, Hoy-Rosas J, Hauser D, Lurio J, Shroff N, Lopez R, Erblich J, Wolf MS, Wisnivesky JP.
Abstract
IMPORTANCE:Older adults with asthma have worse control and outcomes than younger adults. Interventions to address suboptimal self-management among older adults with asthma are typically not tailored to the specific needs of the patient.
OBJECTIVE:To test the effect of a comprehensive, patient-tailored asthma self-management support intervention for older adults on clinical and self-management outcomes.
DESIGN, SETTING, AND PARTICIPANTS:Three-arm randomized clinical trial conducted between February 2014 and December 2017 at primary care practices and personal residences in New York City. Adults 60 years and older with persistent, uncontrolled asthma were identified from electronic medical records at an academic medical center and a federally qualified health center. Of 1349 patients assessed for eligibility, 406 met eligibility criteria, consented to participate, and were randomized to 1 of 3 groups: home-based intervention, clinic-based intervention, or control (usual care). A total of 391 patients received the allocated treatment.
INTERVENTIONS:Screening for psychosocial, physical, cognitive, and environmental barriers to asthma control and self-management with actions to address identified barriers. The intervention was delivered in the home or primary care practices by asthma care coaches.
MAIN OUTCOMES AND MEASURES:Primary outcomes were the Asthma Control Test, Mini Asthma Quality of Life Questionnaire, Medication Adherence Rating Scale, metered dose inhaler technique, and emergency department visits for asthma care. Primary analyses compared intervention (home or clinic based) with usual care.
RESULTS:Of the 391 patients who received treatment, 58 (15.1%) were men, and the mean (SD) age was 67.8 (7.4) years. After accounting for baseline scores, scores on the asthma control test were better in the intervention groups vs the control group (difference-in-differences at 3 months, 1.2; 95% CI, 0.2-2.2; P = .02; 6 months, 1.0; 95% CI, 0.0-2.1; P = .049; 12 months, 0.6; 95% CI, -0.5 to 1.8; P = .28; and overall, χ2 = 13.4, with 4 degrees of freedom; P = .01). Emergency department visits were lower at 12 months for the intervention groups vs the control group (16 [6.2%] vs 17 [12.7%]; P = .03; adjusted odds ratio, 0.8; 95% CI, 0.6-0.99; P = .03). Statistically significant improvements were observed for the intervention vs control patients in quality of life (overall effect: χ2 = 10.5, with 4 degrees of freedom; P = .01), medication adherence (overall effect: χ2 = 9.5, with 4 degrees of freedom; P = .049), and inhaler technique (metered-dose inhaler technique, correctly completed steps at 12 months, median [range]: 75% [0%-100%] vs 58% [0%-100%]). No significant differences in outcomes were observed between patients receiving the intervention in home vs practice settings.
CONCLUSIONS AND RELEVANCE:An intervention directed by patients' needs and barriers improved asthma outcomes and self-management behaviors among older adults.
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重度哮喘患者共患病的经济负担:一项20年的基于人群的研究
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青少年哮喘自我效能问卷（AASEQ）的开发与验证
