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心理干预对改善囊性纤维化患者吸入治疗依从性的作用。

Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis.

机构信息

Wolfson Cystic Fibrosis Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.

Staffordshire Centre for Psychological Research, School of Health, Science and Wellbeing, Staffordshire University, Stoke-on-Trent, UK.

出版信息

Cochrane Database Syst Rev. 2023 Mar 29;3(3):CD013766. doi: 10.1002/14651858.CD013766.pub2.


DOI:10.1002/14651858.CD013766.pub2
PMID:36989170
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10054300/
Abstract

BACKGROUND: Adherence to treatment, including inhaled therapies, is low in people with cystic fibrosis (CF). Although psychological interventions for improving adherence to inhaled therapies in people with CF have been developed, no previous published systematic review has evaluated the evidence for efficacy of these interventions. OBJECTIVES: The primary objective of the review was to assess the efficacy of psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (CF). The secondary objective was to establish the most effective components, or behaviour change techniques (BCTs), used in these interventions. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis Trials Register, which is compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched databases (PubMed; PsycINFO; EBSCO; Scopus; OpenGrey), trials registries (World Health Organization International Clinical Trials Registry Platform; US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov), and the reference lists of relevant articles and reviews, with no restrictions on language, year or publication status. Date of search: 7 August 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing different types of psychological interventions for improving adherence to inhaled therapies in people with CF of any age, or comparing psychological interventions with usual care. We included quasi-RCTs if we could reasonably assume that the baseline characteristics were similar in both groups. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility and completed data extraction, risk of bias assessments, and BCT coding (using the BCT Taxonomy v1) for all included trials. We resolved any discrepancies by discussion, or by consultation with a third review author as necessary. We assessed the certainty of the evidence using GRADE. MAIN RESULTS: We included 10 trials (1642 participants) in the review (children and adolescents in four trials; adults in five trials; and children and adults in one trial). Nine trials compared a psychological intervention with usual care; we could combine data from some of these in a number of quantitative analyses. One trial compared a psychological intervention with an active comparator (education plus problem-solving (EPS)). We identified five ongoing trials. Psychological interventions were generally multi-component and complex, containing an average of 9.6 BCTs (range 1 to 28). The two most commonly used BCTs included 'problem-solving' and 'instruction on how to perform the behaviour'. Interventions varied in their type, content and mode of delivery. They included a problem-solving intervention; a paper-based self-management workbook; a telehealth intervention; a group training programme; a digital intervention comprising medication reminders and lung function self-monitoring; a life-coaching intervention; a motivational interviewing (MI) intervention; a brief MI intervention (behaviour change counselling); and a digital intervention combined with behaviour change sessions. Intervention duration ranged from 10 weeks to 12 months. Assessment time points ranged from six to eight weeks up to 23 months. Psychological interventions compared with usual care We report data here for the 'over six months and up to 12 months' time point. We found that psychological interventions probably improve adherence to inhaled therapies (primary outcome) in people with CF compared with usual care (mean difference (MD) 9.5, 95% confidence interval (CI) 8.60 to 10.40; 1 study, 588 participants; moderate-certainty evidence). There was no evidence of a difference between groups in our second primary outcome, treatment-related adverse events: anxiety (MD 0.30, 95% CI -0.40 to 1.00; 1 study, 535 participants), or depression (MD -0.10, 95% CI -0.80 to 0.60; 1 study, 534 participants), although this was low-certainty evidence. For our secondary outcomes, there was no evidence of a difference between groups in terms of lung function (forced expiratory volume in one second (FEV) % predicted MD 1.40, 95% CI -0.20 to 3.00; 1 study, 556 participants; moderate-certainty evidence); number of pulmonary exacerbations (adjusted rate ratio 0.96, 95% CI 0.83 to 1.11; 1 study, 607 participants; moderate-certainty evidence); or respiratory symptoms (MD 0.70, 95% CI -2.40 to 3.80; 1 study, 534 participants; low-certainty evidence). However, psychological interventions may improve treatment burden (MD 3.90, 95% CI 1.20 to 6.60; 1 study, 539 participants; low-certainty evidence). The overall certainty of the evidence ranged from low to moderate across these outcomes. Reasons for downgrading included indirectness (current evidence included adults only whereas our review question was broader and focused on people of any age) and lack of blinding of outcome assessors. Psychological interventions compared with an active comparator For this comparison the overall certainty of evidence was very low, based on one trial (n = 128) comparing an MI intervention to EPS for 12 months. We are uncertain whether an MI intervention, compared with EPS, improves adherence to inhaled therapies, lung function, or quality of life in people with CF, or whether there is an effect on pulmonary exacerbations. The included trial for this comparison did not report on treatment-related adverse events (anxiety and depression). We downgraded all reported outcomes due to small participant numbers, indirectness (trials included only adults), and unclear risk of bias (e.g. selection and attrition bias). AUTHORS' CONCLUSIONS: Due to the limited quantity of trials included in this review, as well as the clinical and methodological heterogeneity, it was not possible to identify an overall intervention effect using meta-analysis. Some moderate-certainty evidence suggests that psychological interventions (compared with usual care) probably improve adherence to inhaled therapies in people with CF, without increasing treatment-related adverse events, anxiety and depression (low-certainty evidence). In future review updates (with ongoing trial results included), we hope to be able to establish the most effective BCTs (or 'active ingredients') of interventions for improving adherence to inhaled therapies in people with CF. Wherever possible, investigators should make use of the most objective measures of adherence available (e.g. data-logging nebulisers) to accurately determine intervention effects. Outcome reporting needs to be improved to enable combining or separation of measures as appropriate. Likewise, trial reporting needs to include details of intervention content (e.g. BCTs used); duration; intensity; and fidelity. Large trials with a longer follow-up period (e.g. 12 months) are needed in children with CF. Additionally, more research is needed to determine how to support adherence in 'under-served' CF populations.

摘要

背景:囊性纤维化 (CF) 患者的治疗依从性(包括吸入疗法)较低。尽管已经开发出用于提高 CF 患者吸入疗法依从性的心理干预措施,但以前没有发表过系统评价评估这些干预措施的疗效。

目的:本综述的主要目的是评估心理干预措施对提高囊性纤维化 (CF) 患者吸入疗法依从性的疗效。次要目的是确定这些干预措施中最有效的组成部分或行为改变技术 (BCT)。

检索方法:我们检索了 Cochrane 囊性纤维化试验注册库,该注册库是从电子数据库搜索和期刊以及会议摘要书籍的手工搜索中编制而成的。我们还检索了数据库(PubMed;PsycINFO;EBSCO;Scopus;OpenGrey)、临床试验注册处(世界卫生组织国际临床试验注册平台;美国国立卫生研究院正在进行的临床试验注册ClinicalTrials.gov)和相关文章和综述的参考文献列表,对语言、年份或发布状态没有限制。检索日期:2022 年 8 月 7 日。

选择标准:我们纳入了比较不同类型心理干预措施以提高 CF 患者吸入疗法依从性的随机对照试验 (RCT),或比较心理干预与常规护理的 RCT。如果我们可以合理地假设两组的基线特征相似,我们也纳入了准 RCT。

数据收集和分析:两名综述作者独立评估试验的纳入标准和完成数据提取、风险偏倚评估以及所有纳入试验的 BCT 编码(使用 BCT 分类学 v1)。我们通过讨论或必要时咨询第三位综述作者来解决任何分歧。我们使用 GRADE 评估证据的确定性。

主要结果:我们纳入了 10 项试验(1642 名参与者)的综述(四项试验比较了儿童和青少年;五项试验比较了成年人;一项试验比较了儿童和成年人)。九项试验将心理干预与常规护理进行了比较;我们可以在一些试验中对一些数据进行定量分析。一项试验将心理干预与积极对照(教育加解决问题 (EPS))进行了比较。我们确定了五项正在进行的试验。心理干预通常是多成分和复杂的,包含平均 9.6 个 BCT(范围为 1 至 28)。最常用的两个 BCT 包括“解决问题”和“如何执行行为的说明”。干预措施在类型、内容和交付方式上有所不同。它们包括解决问题的干预措施;纸质自我管理工作簿;远程医疗干预;小组培训计划;包含药物提醒和肺功能自我监测的数字干预;生活指导干预;动机访谈 (MI) 干预;简短的 MI 干预(行为改变咨询);以及结合行为改变会议的数字干预。干预持续时间从 10 周到 12 个月不等。评估时间点从 6 周到 8 周不等,最长可达 23 个月。

心理干预与常规护理:我们在此报告“超过六个月至 12 个月”时间点的数据。我们发现,与常规护理相比,心理干预可能会提高 CF 患者对吸入疗法的依从性(主要结局;平均差异 (MD) 9.5,95%置信区间 (CI) 8.60 至 10.40;1 项研究,588 名参与者;中等确定性证据)。在我们的第二个主要结局,治疗相关不良事件(焦虑:MD 0.30,95% CI -0.40 至 1.00;1 项研究,535 名参与者)或抑郁(MD -0.10,95% CI -0.80 至 0.60;1 项研究,534 名参与者)方面,两组之间没有证据表明存在差异,尽管这是低确定性证据。对于我们的次要结局,在肺功能(用力呼气量占预计值的百分比 (FEV) % MD 1.40,95% CI -0.20 至 3.00;1 项研究,556 名参与者;中等确定性证据)、肺功能恶化(调整后的发病率比 0.96,95% CI 0.83 至 1.11;1 项研究,607 名参与者;中等确定性证据)或呼吸道症状(MD 0.70,95% CI -2.40 至 3.80;1 项研究,534 名参与者;低确定性证据)方面,两组之间没有证据表明存在差异。然而,心理干预可能会减轻治疗负担(MD 3.90,95% CI 1.20 至 6.60;1 项研究,539 名参与者;低确定性证据)。这些结局的证据整体确定性范围从低到中等。降级的原因包括间接性(当前证据仅包括成年人,而我们的综述问题更广泛,侧重于任何年龄的人)和结局评估者缺乏盲法。

心理干预与积极对照:对于这种比较,由于一项试验(n = 128)将 MI 干预与 EPS 比较 12 个月,证据的整体确定性非常低。我们不确定 MI 干预与 EPS 相比,是否能改善 CF 患者对吸入疗法的依从性、肺功能或生活质量,或者是否对肺功能恶化有影响。纳入的试验未报告治疗相关不良事件(焦虑和抑郁)。我们对所有报告的结局进行了降级,原因是参与者人数少、间接性(试验仅包括成年人)和偏倚风险不明确(例如选择和失访偏倚)。

作者结论:由于本综述纳入的试验数量有限,以及临床和方法学的异质性,我们无法使用荟萃分析确定总体干预效果。一些中等确定性证据表明,与常规护理相比,心理干预(与常规护理相比)可能会改善 CF 患者对吸入疗法的依从性,而不会增加治疗相关的不良事件、焦虑和抑郁(低确定性证据)。在未来的综述更新(包括正在进行的试验结果)中,我们希望能够确定改善 CF 患者吸入疗法依从性的最有效心理干预措施(或“有效成分”)。只要有可能,研究人员应使用最客观的依从性测量方法(例如数据记录雾化器)来准确确定干预效果。需要改进结局报告,以便能够根据需要对措施进行组合或分离。同样,试验报告应包括干预内容(例如使用的 BCT)的详细信息;持续时间;强度;和保真度。需要更大规模的试验,随访时间更长(例如 12 个月),纳入 CF 儿童。此外,还需要更多的研究来确定如何为“服务不足”的 CF 人群提供支持。

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