SCI

1June 2024

Early Diagnosis and Treatment of COPD and Asthma — A Randomized, Controlled Trial

(The New England journal of medicine;IF:158.5)

  • Aaron SD, Vandemheen KL, Whitmore GA, Bergeron C, Boulet LP, Côté A, McIvor RA, Penz E, Field SK, Lemière C, Mayers I, Bhutani M, Azher T, Lougheed MD, Gupta S, Ezer N, Licskai CJ, Hernandez P, Ainslie M, Alvarez GG, Mulpuru S; UCAP Investigators. Early Diagnosis and Treatment of COPD and Asthma - A Randomized, Controlled Trial. N Engl J Med. 2024 May 19. doi:10.1056/NEJMoa2401389. Epub ahead of print. PMID: 38767248.

  • Correspondence:Dr. Aaron can be contacted at saaron@ohri.ca or at the Ottawa Hospital, General Campus, 501 Smyth Rd., Ottawa, ON K1H 8L6, Canada.

Background 背景

Many persons with chronic obstructive pulmonary disease (COPD) or asthma have not received a diagnosis, so their respiratory symptoms remain largely untreated.

许多患有慢性阻塞性肺疾病(COPD)或哮喘的人尚未得到诊断,因此他们的呼吸道症状在很大程度上仍未得到有效的治疗。

 

Methods 方法

We used a case-finding method to identify adults in the community with respiratory symptoms without diagnosed lung disease. Participants who were found to have undiagnosed COPD or asthma on spirometry were enrolled in a multicenter, randomized, controlled trial to determine whether early diagnosis and treatment reduces health care utilization for respiratory illness and improves health outcomes. Participants were assigned to receive the intervention (evaluation by a pulmonologist and an asthma-COPD educator who were instructed to initiate guideline-based care) or usual care by their primary care practitioner. The primary outcome was the annualized rate of participant-initiated health care utilization for respiratory illness. Secondary outcomes included changes from baseline to 1 year in disease-specific quality of life, as assessed with the St. George Respiratory Questionnaire (SGRQ; scores range from 0 to 100, with lower scores indicating better health status); symptom burden, as assessed with the COPD Assessment Test (CAT; scores range from 0 to 40, with lower scores indicating better health status); and forced expiratory volume in 1 second (FEV1).

我们使用病例发现法在社区中筛选出具有呼吸系统症状但未被诊断为肺部疾病的成年人。对在肺功能检查中发现未诊断的COPD或哮喘的参与者,我们将其纳入一项多中心、随机、对照试验,以确定早期诊断和治疗是否能减少呼吸系统疾病的卫生服务利用并改善健康状况。参与者被分配接受干预措施(由呼吸科专家和哮喘-COPD教育者进行评估,并基于指南进行治疗)或由其初级保健医生提供常规护理。主要观察指标是参与者每年因呼吸系统疾病而引发的年度化医疗保健利用率。次要观察指标包括疾病特异性生活质量的变化(使用圣·乔治呼吸问卷评估,评分范围为0到100,分数越低表示健康状况越好);症状负担(使用COPD评估测试评估,评分范围为0到40,分数越低表示健康状况越好);以及1秒钟用力呼气量(FEV1)的变化。

 

Results 结果

Of 38,353 persons interviewed, 595 were found to have undiagnosed COPD or asthma and 508 underwent randomization: 253 were assigned to the intervention group and 255 to the usual-care group. The annualized rate of a primary-outcome event was lower in the intervention group than in the usual-care group (0.53 vs. 1.12 events per person-year; incidence rate ratio, 0.48; 95% confidence interval [CI], 0.36 to 0.63; P<0.001). At 12 months, the SGRQ score was lower than the baseline score by 10.2 points in the intervention group and by 6.8 points in the usual-care group (difference, -3.5 points; 95% CI, -6.0 to -0.9), and the CAT score was lower than the baseline score by 3.8 points and 2.6 points, respectively (difference, -1.3 points; 95% CI, -2.4 to -0.1). The FEV1increased by 119 ml in the intervention group and by 22 ml in the usual-care group (difference, 94 ml; 95% CI, 50 to 138). The incidence of adverse events was similar in the trial groups.

在参与研究的38,353人中,有595人被发现患有未诊断的COPD或哮喘,其中508人进行了随机分组:253人被分配到干预组,255人被分配到常规护理组。主要结果事件的年化发生率在干预组中低于常规护理组(每人每年0.53次 vs. 1.12次;发生率比,0.48;95%置信区间[CI],0.36至0.63;P<0.001)。在12个月时,干预组的SGRQ评分较基线评分下降了10.2分,常规护理组下降了6.8分(差异为-3.5分;95% CI,-6.0至-0.9),CAT评分分别下降了3.8分和2.6分(差异为-1.3分;95% CI,-2.4至-0.1)。FEV1在干预组增加了119ml,在常规护理组增加了22ml(差异为94ml;95% CI,50至138)。两组的不良事件发生率相似。

 

Conclusions 结论

In this trial in which a strategy was used to identify adults in the community with undiagnosed asthma or COPD, those who received pulmonologist-directed treatment had less subsequent health care utilization for respiratory illness than those who received usual care. (Funded by Canadian Institutes of Health Research; UCAP ClinicalTrials.gov number, NCT03148210.).

在这项试验中,使用策略筛选社区中未诊断的哮喘或COPD的成年人,那些接受肺部疾病专家指导治疗的患者比接受常规护理的患者在随后因呼吸系统疾病的医疗利用率更少。(由Canadian Institutes of Health Research资助;UCAP临床试验注册号,NCT03148210)。