Gatheral Timothy L, Rushton Alison, Evans David Jw, Mulvaney Caroline A, Halcovitch Nathan R, Whiteley Gemma, Eccles Fiona Jr, Spencer Sally
Respiratory Medicine, University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, UK.
Education, Training and Professional Development, Nursing & Quality Directorate, Lancashire Care NHS Foundation Trust, Preston, UK.
Cochrane Database Syst Rev. 2017 Apr 10;4(4):CD011859. doi: 10.1002/14651858.CD011859.pub2.
A key aim of asthma care is to empower each person to take control of his or her own condition. A personalised asthma action plan (PAAP), also known as a written action plan, an individualised action plan, or a self-management action plan, contributes to this endeavour. A PAAP includes individualised self-management instructions devised collaboratively with the patient to help maintain asthma control and regain control in the event of an exacerbation. A PAAP includes baseline characteristics (such as lung function), maintenance medication and instructions on how to respond to increasing symptoms and when to seek medical help.
To evaluate the effectiveness of PAAPs used alone or in combination with education, for patient-reported outcomes, resource use and safety among adults with asthma.
We searched the Cochrane Airways Group Specialised Register of trials, clinical trial registers, reference lists of included studies and review articles, and relevant manufacturers' websites up to 14 September 2016.
We included parallel randomised controlled trials (RCTs), both blinded and unblinded, that evaluated written PAAPs in adults with asthma. Included studies compared PAAP alone versus no PAAP, and/or PAAP plus education versus education alone.
Two review authors independently extracted study characteristics and outcome data and assessed risk of bias for each included study. Primary outcomes were number of participants reporting at least one exacerbation requiring an emergency department (ED) visit or hospitalisation, asthma symptom scores on a validated scale and adverse events (all causes). Secondary outcomes were quality of life measured on a validated scale, number of participants reporting at least one exacerbation requiring systemic corticosteroids, respiratory function and days lost from work or study. We used a random-effects model for all analyses and standard Cochrane methods throughout.
We identified 15 studies described in 27 articles that met our inclusion criteria. These 15 included studies randomised a total of 3062 participants (PAAP vs no PAAP: 2602 participants; PAAP plus education vs education alone: 460 participants). Ten studies (eight PAAP vs no PAAP; two PAAP plus education vs education alone) provided outcome data that contributed to quantitative analyses. The overall quality of evidence was rated as low or very low.Fourteen studies lasted six months or longer, and the remaining study lasted for 14 weeks. When reported, mean age ranged from 22 to 49 years and asthma severity ranged from mild to severe/high risk. PAAP alone compared with no PAAPResults showed no clear benefit or harm associated with PAAPs in terms of the number of participants requiring an ED visit or hospitalisation for an exacerbation (odds ratio (OR) 0.75, 95% confidence interval (CI) 0.45 to 1.24; 1385 participants; five studies; low-quality evidence), change from baseline in asthma symptoms (mean difference (MD) -0.16, 95% CI -0.25 to - 0.07; 141 participants; one study; low-quality evidence) or the number of serious adverse events, including death (OR 3.26, 95% CI 0.33 to 32.21; 125 participants; one study; very low-quality evidence). Data revealed a statistically significant improvement in quality of life scores for those receiving PAAP compared with no PAAP (MD 0.18, 95% CI 0.05 to 0.30; 441 participants; three studies; low-quality evidence), but this was below the threshold for a minimum clinically important difference (MCID). Results also showed no clear benefit or harm associated with PAAPs on the number of participants reporting at least one exacerbation requiring oral corticosteroids (OR 1.45, 95% CI 0.84 to 2.48; 1136 participants; three studies; very low-quality evidence) nor on respiratory function (change from baseline forced expiratory volume in one second (FEV): MD -0.04 L, 95% CI -0.25L to 0.17 L; 392 participants; three studies; low-quality evidence). In one study, PAAPs were associated with significantly fewer days lost from work or study (MD -6.20, 95% CI -7.32 to - 5.08; 74 participants; low-quality evidence). PAAP plus education compared with education aloneResults showed no clear benefit or harm associated with adding a PAAP to education in terms of the number of participants requiring an ED visit or hospitalisation for an exacerbation (OR 1.08, 95% CI 0.27 to 4.32; 70 participants; one study; very low-quality evidence), change from baseline in asthma symptoms (MD -0.10, 95% CI -0.54 to 0.34; 70 participants; one study; low-quality evidence), change in quality of life scores from baseline (MD 0.13, 95% CI -0.13 to 0.39; 174 participants; one study; low-quality evidence) and number of participants requiring oral corticosteroids for an exacerbation (OR 0.28, 95% CI 0.07 to 1.12; 70 participants; one study; very low-quality evidence). No studies reported serious adverse events, respiratory function or days lost from work or study.
AUTHORS' CONCLUSIONS: Analysis of available studies was limited by variable reporting of primary and secondary outcomes; therefore, it is difficult to draw firm conclusions related to the effectiveness of PAAPs in the management of adult asthma. We found no evidence from randomised controlled trials of additional benefit or harm associated with use of PAAP versus no PAAP, or PAAP plus education versus education alone, but we considered the quality of the evidence to be low or very low, meaning that we cannot be confident in the magnitude or direction of reported treatment effects. In the context of this caveat, we found no observable effect on the primary outcomes of hospital attendance with an asthma exacerbation, asthma symptom scores or adverse events. We recommend further research with a particular focus on key patient-relevant outcomes, including exacerbation frequency and quality of life, in a broad spectrum of adults, including those over 60 years of age.
哮喘护理的一个关键目标是使每个人都能自主控制自己的病情。个性化哮喘行动计划(PAAP),也称为书面行动计划、个体化行动计划或自我管理行动计划,有助于实现这一目标。PAAP包括与患者共同制定的个体化自我管理指导,以帮助维持哮喘控制,并在病情加重时恢复控制。PAAP包括基线特征(如肺功能)、维持用药以及关于如何应对症状加重和何时寻求医疗帮助的指导。
评估单独使用PAAP或与教育相结合,对成年哮喘患者的患者报告结局、资源使用和安全性的有效性。
我们检索了Cochrane气道组专业试验注册库、临床试验注册库、纳入研究和综述文章的参考文献列表,以及截至2016年9月14日的相关制造商网站。
我们纳入了平行随机对照试验(RCT),包括单盲和非盲试验,这些试验评估了成年哮喘患者的书面PAAP。纳入研究比较了单独使用PAAP与不使用PAAP,和/或PAAP加教育与单独教育的效果。
两位综述作者独立提取研究特征和结局数据,并评估每个纳入研究的偏倚风险。主要结局是报告至少一次需要急诊就诊或住院的加重发作的参与者数量、经过验证的量表上的哮喘症状评分以及不良事件(所有原因)。次要结局是经过验证的量表上测量的生活质量、报告至少一次需要全身使用糖皮质激素的加重发作的参与者数量、呼吸功能以及工作或学习损失天数。我们在所有分析中使用随机效应模型,并始终采用标准的Cochrane方法。
我们在27篇文章中确定了15项符合我们纳入标准的研究。这15项纳入研究共随机分配了3062名参与者(PAAP与不使用PAAP:2602名参与者;PAAP加教育与单独教育:460名参与者)。十项研究(八项PAAP与不使用PAAP;两项PAAP加教育与单独教育)提供了有助于定量分析的结局数据。证据的总体质量被评为低或极低。十四项研究持续了六个月或更长时间,其余一项研究持续了14周。报告的平均年龄范围为22至49岁,哮喘严重程度范围为轻度至重度/高风险。
单独使用PAAP与不使用PAAP的比较
结果显示,在因加重发作需要急诊就诊或住院的参与者数量方面,PAAP没有明显的益处或危害(优势比(OR)0.75,95%置信区间(CI)0.45至1.24;1385名参与者;五项研究;低质量证据),哮喘症状与基线相比的变化(平均差(MD)-0.16,95%CI -0.25至-0.07;141名参与者;一项研究;低质量证据),或严重不良事件的数量,包括死亡(OR 3.26, 95%CI 0.33至32.21;125名参与者;一项研究;极低质量证据)。数据显示,与不使用PAAP相比,接受PAAP的参与者的生活质量评分有统计学显著改善(MD 0.18,95%CI 0.05至0.30;441名参与者;三项研究;低质量证据),但这低于最小临床重要差异(MCID)阈值。结果还显示,在报告至少一次需要口服糖皮质激素的加重发作的参与者数量方面,PAAP没有明显的益处或危害(OR 1.45,95%CI 0.84至2.48;1136名参与者;三项研究;极低质量证据),在呼吸功能方面也没有(一秒用力呼气量(FEV)与基线相比的变化:MD -0.04L,95%CI -0.25L至0.17L;392名参与者;三项研究;低质量证据)。在一项研究中,PAAP与工作或学习损失天数显著减少相关(MD -6.20,95%CI -7.32至-5.