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改善眼压降低治疗依从性的干预措施。

Interventions for improving adherence to ocular hypotensive therapy.

作者信息

Waterman Heather, Evans Jennifer R, Gray Trish A, Henson David, Harper Robert

机构信息

School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.

出版信息

Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD006132. doi: 10.1002/14651858.CD006132.pub3.

Abstract

BACKGROUND

Poor adherence to therapy is a significant healthcare issue, particularly in patients with chronic disease such as open-angle glaucoma. Treatment failure may necessitate unwarranted changes of medications, increased healthcare expenditure and risk to the patient if surgical intervention is required. Simplifying eye drop regimes, providing adequate information, teaching drop instillation technique and ongoing support according to the patient need may have a positive effect on improving adherence.

OBJECTIVES

To summarise the effects of interventions for improving adherence to ocular hypotensive therapy in people with ocular hypertension (OHT) or glaucoma.

SEARCH METHODS

We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 6), MEDLINE (June 1946 to June 2012), EMBASE (June 1980 to June 2012), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (June 1937 to June 2012), PsycINFO (1806 to June 2012), PsycEXTRA (1908 to June 2012), Web of Science (1970 to June 2012), ZETOC (1993 to June 2012), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 26 June 2012. We did not search the National Research Register (NNR) as this resource has now been now archived. We contacted pharmaceutical manufacturers to request unpublished data and searched conference proceedings for the Association for Research in Vision and Ophthalmology (ARVO), and the Annual Congress for the Royal College of Ophthalmologists (RCO).

SELECTION CRITERIA

We included randomised controlled trials (RCTs) and quasi-RCTs that compared interventions to improve adherence to ocular hypotensive therapy for patients with OHT or glaucoma.

DATA COLLECTION AND ANALYSIS

At least two authors independently assessed the search results for eligibility and extracted data for included trials onto specifically designed forms. We did not pool data due to clinical and methodological heterogeneity.

MAIN RESULTS

Sixteen trials (1565 participants) met the inclusion criteria. Seven studies investigated some form of patient education. In six of these studies this education was combined with other behavioural change interventions including tailoring daily routines to promote adherence to eye drops. Eight studies compared different drug regimens (one of these trials also compared open and masked monitoring) and one study investigated a reminder device. The studies were of variable quality and some were at considerable risk of bias; in general, the length of follow-up was short at less than six months with only two studies following up to 12 months. Different interventions and outcomes were reported and so it was not possible to produce an overall estimate of effect. There was some evidence from three studies that education combined with personalised interventions, that is, more complex interventions, improved adherence to ocular hypotensive therapy. There was less information on other outcomes such as persistence and intraocular pressure, and no information on visual field defects, quality of life and cost. There was weak evidence as to whether people on simpler drug regimens were more likely to adhere and persist with their ocular hypotensive therapy. A particular problem was the interpretation of cross-over studies, which in general were not reported correctly. One study investigated a reminder device and monitoring but the study was small and inconclusive.

AUTHORS' CONCLUSIONS: Although complex interventions consisting of patient education combined with personalised behavioural change interventions, including tailoring daily routines to promote adherence to eye drops, may improve adherence to glaucoma medication, overall there is insufficient evidence to recommend a particular intervention. The interventions varied between studies and none of the included studies reported on the cost of the intervention. Simplified drug regimens also could be of benefit but again the current published studies do not provide conclusive evidence. Future studies should follow up for at least one year, and could benefit from standardised outcomes.

摘要

背景

治疗依从性差是一个重大的医疗保健问题,尤其在患有诸如开角型青光眼等慢性病的患者中。治疗失败可能需要不必要地更换药物、增加医疗保健支出,并且如果需要手术干预,还会给患者带来风险。简化滴眼剂用药方案、提供充分信息、教授滴眼剂滴注技术以及根据患者需求提供持续支持,可能对提高依从性产生积极影响。

目的

总结改善高眼压症(OHT)或青光眼患者对降眼压治疗依从性的干预措施的效果。

检索方法

我们检索了Cochrane中心对照试验注册库(CENTRAL)(其中包含Cochrane眼科和视力组试验注册库)(《Cochrane图书馆》2012年第6期)、MEDLINE(1946年6月至2012年6月)、EMBASE(1980年6月至2012年6月)、护理学与健康相关文献累积索引(CINAHL)(1937年6月至2012年6月)、心理学文摘数据库(PsycINFO)(1806年至2012年6月)、心理学额外数据库(PsycEXTRA)(1908年至2012年6月)、科学引文索引(Web of Science)(1970年至2012年6月)、ZETOC(1993年至2012年6月)、OpenGrey(欧洲灰色文献信息系统)(www.opengrey.eu/)、对照试验元注册库(mRCT)(www.controlled-trials.com)、临床试验.gov(www.clinicaltrials.gov)以及世界卫生组织国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en)。在电子检索试验时,我们未使用任何日期或语言限制。电子数据库的最后一次检索时间为2012年6月26日。我们未检索国家研究注册库(NNR),因为该资源现已存档。我们联系了制药厂商以索取未发表的数据,并检索了视觉与眼科学研究协会(ARVO)和皇家眼科医学院年会的会议记录。

选择标准

我们纳入了比较改善OHT或青光眼患者对降眼压治疗依从性的干预措施的随机对照试验(RCT)和半随机对照试验(quasi-RCT)。

数据收集与分析

至少两名作者独立评估检索结果的合格性,并将纳入试验的数据提取到专门设计的表格中。由于临床和方法学的异质性,我们未合并数据。

主要结果

16项试验(1565名参与者)符合纳入标准。7项研究调查了某种形式的患者教育。在其中6项研究中,这种教育与其他行为改变干预措施相结合,包括调整日常安排以促进滴眼剂的依从性。8项研究比较了不同的药物治疗方案(其中一项试验还比较了公开监测和隐蔽监测),1项研究调查了提醒装置。这些研究质量参差不齐,有些存在相当大的偏倚风险;总体而言,随访时间较短,不到6个月,只有两项研究随访至12个月。报告了不同的干预措施和结果,因此无法得出总体效应估计值。三项研究提供了一些证据,表明教育与个性化干预措施(即更复杂的干预措施)相结合可提高对降眼压治疗的依从性。关于其他结果,如持续性和眼压,信息较少,关于视野缺损、生活质量和成本则没有信息。关于采用更简单药物治疗方案的患者是否更有可能坚持降眼压治疗,证据不足。一个特别的问题是交叉试验的解读,总体而言,这些试验的报告并不正确。一项研究调查了提醒装置和监测,但该研究规模较小且结果不明确。

作者结论

尽管由患者教育与个性化行为改变干预措施(包括调整日常安排以促进滴眼剂的依从性)组成的复杂干预措施可能会提高青光眼药物治疗的依从性,但总体而言,没有足够的证据推荐某一特定干预措施。各研究中的干预措施各不相同,且纳入的研究均未报告干预措施的成本。简化的药物治疗方案可能也有益处,但目前已发表的研究同样未提供确凿证据。未来的研究应至少随访一年,并可从标准化结局中获益。

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