干预措施以提高慢性阻塞性肺疾病(COPD)药物治疗的依从性。

Interventions to improve adherence to pharmacological therapy for chronic obstructive pulmonary disease (COPD).

机构信息

Cochrane Airways, Population Health Research Institute, St George's, University of London, London, UK.

Bristol Royal Hospital for Children, Bristol, UK.

出版信息

Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD013381. doi: 10.1002/14651858.CD013381.pub2.

Abstract

BACKGROUND

Chronic obstructive pulmonary disease (COPD) is a chronic lung condition characterised by persistent respiratory symptoms and limited lung airflow, dyspnoea and recurrent exacerbations. Suboptimal therapy or non-adherence may result in limited effectiveness of pharmacological treatments and subsequently poor health outcomes.

OBJECTIVES

To determine the efficacy and safety of interventions intended to improve adherence to single or combined pharmacological treatments compared with usual care or interventions that are not intended to improve adherence in people with COPD.

SEARCH METHODS

We identified randomised controlled trials (RCTs) from the Cochrane Airways Trials Register, CENTRAL, MEDLINE and Embase (search date 1 May 2020). We also searched web-based clinical trial registers.

SELECTION CRITERIA

RCTs included adults with COPD diagnosed by established criteria (e.g. Global Initiative for Obstructive Lung Disease). Interventions included change to pharmacological treatment regimens, adherence aids, education, behavioural or psychological interventions (e.g. cognitive behavioural therapy), communication or follow-up by a health professional (e.g. telephone, text message or face-to-face), multi-component interventions, and interventions to improve inhaler technique.

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methodological procedures. Working in pairs, four review authors independently selected trials for inclusion, extracted data and assessed risk of bias. We assessed confidence in the evidence for each primary outcome using GRADE. Primary outcomes were adherence, quality of life and hospital service utilisation. Adherence measures included the Adherence among Patients with Chronic Disease questionnaire (APCD). Quality of life measures included the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT) and Clinical COPD Questionnaire (CCQ).

MAIN RESULTS

We included 14 trials (2191 participants) in the analysis with follow-up ranging from six to 52 weeks. Age ranged from 54 to 75 years, and COPD severity ranged from mild to very severe. Trials were conducted in the USA, Spain, Germany, Japan, Jordan, Northern Ireland, Iran, South Korea, China and Belgium. Risk of bias was high due to lack of blinding. Evidence certainty was downgraded due to imprecision and small participant numbers. Single component interventions Six studies (55 to 212 participants) reported single component interventions including changes to pharmacological treatment (different roflumilast doses or different inhaler types), adherence aids (Bluetooth inhaler reminder device), educational (comprehensive verbal instruction), behavioural or psychological (motivational interview). Change in dose of roflumilast may result in little to no difference in adherence (odds ratio (OR) 0.67, 95% confidence interval (CI) 0.22 to 1.99; studies = 1, participants = 55; low certainty). A Bluetooth inhaler reminder device did not improve adherence, but comprehensive verbal instruction from a health professional did improve mean adherence (prescription refills) (mean difference (MD) 1.00, 95% CI 0.46 to 1.54). Motivational interview improved mean adherence scores on the APCD scale (MD 22.22, 95% CI 8.42 to 36.02). Use of a single inhaler compared to two separate inhalers may have little to no impact on quality of life (SGRQ; MD 0.80, 95% CI -3.12 to 4.72; very low certainty). A Bluetooth inhaler monitoring device may provide a small improvement in quality of life on the CCQ (MD 0.40, 95% CI 0.07 to 0.73; very low certainty). Single inhaler use may have little to no impact on the number of people admitted to hospital compared to two separate inhalers (OR 1.47, 95% CI 0.75 to 2.90; very low certainty). Single component interventions may have little to no impact on the number of people expereincing adverse events (very low certainty evidence from studies of a change in pharmacotherapy or use of adherence aids). A change in pharmacotherapy may have little to no impact on exacerbations or deaths (very low certainty). Multi-component interventions Eight studies (30 to 734 participants) reported multi-component interventions including tailored care package that included adherence support as a key component or included inhaler technique as a component. A multi-component intervention may result in more people adhering to pharmacotherapy compared to control at 40.5 weeks (risk ratio (RR) 1.37, 95% CI 1.18 to 1.59; studies = 4, participants = 446; I = 0%; low certainty). There may be little to no impact on quality of life (SGRQ, Chronic Respiratory Disease Questionnaire, CAT) (studies = 3; low to very low certainty). Multi-component interventions may help to reduce the number of people admitted to hospital for any cause (OR 0.37, 95% CI 0.22 to 0.63; studies = 2, participants = 877; low certainty), or COPD-related hospitalisations (OR 0.15, 95% CI 0.07 to 0.34; studies = 2, participants = 220; moderate certainty). There may be a small benefit on people experiencing severe exacerbations. There may be little to no effect on adverse events, serious adverse events or deaths, but events were infrequently reported and were rare (low to very certainty).

AUTHORS' CONCLUSIONS: Single component interventions (e.g. education or motivational interviewing provided by a health professional) can help to improve adherence to pharmacotherapy (low to very low certainty). There were slight improvements in quality of life with a Bluetooth inhaler device, but evidence is from one study and very low certainty. Change to pharmacotherapy (e.g. single inhaler instead of two, or different doses of roflumilast) has little impact on hospitalisations or exacerbations (very low certainty). There is no difference in people experiencing adverse events (all-cause or COPD-related), or deaths (very low certainty). Multi-component interventions may improve adherence with education, motivational or behavioural components delivered by health professionals (low certainty). There is little to no impact on quality of life (low to very low certainty). They may help reduce the number of people admitted to hospital overall (specifically pharmacist-led approaches) (low certainty), and fewer people may have COPD-related hospital admissions (moderately certainty). There may be a small reduction in people experiencing severe exacerbations, but evidence is from one study (low certainty). Limited evidence found no difference in people experiencing adverse events, serious adverse events or deaths (low to very low certainty). The evidence presented should be interpreted with caution. Larger studies with more intervention types, especially single interventions, are needed. It is unclear which specific COPD subgroups would benefit, therefore discussions between health professionals and patients may help to determine whether they will help to improve health outcomes.

摘要

背景

慢性阻塞性肺疾病(COPD)是一种慢性肺部疾病,其特征为持续性呼吸道症状和有限的肺气流、呼吸困难和反复恶化。治疗不佳或不依从可能导致药物治疗的效果有限,进而导致健康结果不佳。

目的

确定旨在提高对单一或联合药物治疗的依从性的干预措施的疗效和安全性,与常规护理相比或与不旨在提高 COPD 患者依从性的干预措施相比。

检索方法

我们从 Cochrane Airways 试验注册中心、CENTRAL、MEDLINE 和 Embase(检索日期为 2020 年 5 月 1 日)中确定了随机对照试验(RCT)。我们还搜索了基于网络的临床试验登记处。

入选标准

RCT 纳入了通过既定标准(例如全球倡议对阻塞性肺病)诊断为 COPD 的成年人。干预措施包括改变药物治疗方案、依从性辅助、教育、行为或心理干预(例如认知行为疗法)、由卫生专业人员进行的沟通或随访(例如电话、短信或面对面)、多组分干预以及改善吸入器技术的干预。

数据收集和分析

我们使用标准的 Cochrane 方法学程序。四位审查员共同选择试验进行纳入、提取数据并评估偏倚风险。我们使用 GRADE 评估每个主要结局的证据信心。主要结局包括依从性、生活质量和医院服务利用情况。依从性测量包括慢性疾病患者依从性问卷(APCD)。生活质量测量包括圣乔治呼吸问卷(SGRQ)、COPD 评估测试(CAT)和临床 COPD 问卷(CCQ)。

主要结果

我们分析了 14 项试验(2191 名参与者),随访时间从 6 周到 52 周不等。年龄从 54 岁到 75 岁不等,COPD 严重程度从轻度到非常严重不等。试验在 美国、西班牙、德国、日本、约旦、北爱尔兰、伊朗、韩国、中国和比利时进行。由于缺乏盲法,偏倚风险较高。由于不精确和参与者人数少,证据确定性被降级。

单一成分干预措施 六项研究(55 至 212 名参与者)报告了单一成分干预措施,包括改变药物治疗(不同罗氟米特剂量或不同吸入器类型)、依从性辅助(蓝牙吸入器提醒装置)、教育(全面口头指导)、行为或心理(动机访谈)。改变罗氟米特的剂量可能对依从性几乎没有影响(比值比(OR)0.67,95%置信区间(CI)0.22 至 1.99;研究=1,参与者=55;低确定性)。蓝牙吸入器提醒装置不能提高依从性,但卫生专业人员的全面口头指导确实提高了处方 refill 的平均依从性(平均差异(MD)1.00,95%CI 0.46 至 1.54)。动机访谈提高了 APCD 量表的平均依从性评分(MD 22.22,95%CI 8.42 至 36.02)。与使用两个单独的吸入器相比,使用单个吸入器可能对生活质量(SGRQ)几乎没有影响(MD 0.80,95%CI -3.12 至 4.72;非常低确定性)。蓝牙吸入器监测装置可能对 CCQ 的生活质量有小的改善(MD 0.40,95%CI 0.07 至 0.73;非常低确定性)。与使用两个单独的吸入器相比,使用单个吸入器对住院人数的影响可能很小(OR 1.47,95%CI 0.75 至 2.90;非常低确定性)。单一成分干预措施对经历不良事件的人数可能几乎没有影响(非常低确定性证据来自药物治疗改变或使用依从性辅助的研究)。药物治疗的改变可能对恶化或死亡几乎没有影响(非常低确定性)。

多组分干预措施 八项研究(30 至 734 名参与者)报告了多组分干预措施,包括包含依从性支持作为关键组成部分的量身定制的护理包,或包含吸入器技术作为组成部分。多组分干预措施可能会使更多的人在 40.5 周时坚持药物治疗,而不是对照组(RR 1.37,95%CI 1.18 至 1.59;研究=4,参与者=446;I=0%;低确定性)。对生活质量(SGRQ、慢性呼吸系统疾病问卷、CAT)几乎没有影响(研究=3;低至非常低确定性)。多组分干预可能有助于减少因任何原因(OR 0.37,95%CI 0.22 至 0.63;研究=2,参与者=877;低确定性)或 COPD 相关住院治疗(OR 0.15,95%CI 0.07 至 0.34;研究=2,参与者=220;中等确定性)而住院的人数。可能对严重恶化的人有小的益处。对经历严重恶化的人数可能几乎没有影响,对不良事件、严重不良事件或死亡也几乎没有影响,但事件报告频率较低,且很少发生(低至非常确定性)。

作者结论

单一成分干预措施(例如,由卫生专业人员提供的教育或动机访谈)可以帮助提高对药物治疗的依从性(低至非常低确定性)。蓝牙吸入器装置有轻微改善生活质量的作用,但证据来自一项研究,且确定性非常低。药物治疗的改变(例如,使用单一吸入器而不是两个,或不同剂量的罗氟米特)对住院或恶化几乎没有影响(非常低确定性)。没有差异的人经历不良事件(所有原因或 COPD 相关)或死亡(非常低确定性)(非常低确定性)。多组分干预措施可能会改善教育、动机或行为成分由卫生专业人员提供的依从性(低确定性)。对生活质量几乎没有影响(低至非常低确定性)。它们可能有助于减少因药物治疗(特定于药剂师的方法)而住院的人数(低确定性),并且可能会减少 COPD 相关住院人数(中度确定性)。可能会减少经历严重恶化的人数,但证据来自一项研究(低确定性)。有限的证据表明,经历不良事件、严重不良事件或死亡的人数没有差异(低至非常低确定性)。提出的证据应谨慎解释。需要更大的、更多干预类型的研究,特别是单一干预措施的研究。目前还不清楚哪些特定的 COPD 亚组会受益,因此卫生专业人员和患者之间的讨论可能有助于确定这些干预措施是否有助于改善健康结果。

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