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患者与医疗服务提供者之间的电子症状报告以提高医疗服务质量:随机对照试验的系统评价。第2部分:方法学质量和效果。

Electronic symptom reporting between patient and provider for improved health care service quality: a systematic review of randomized controlled trials. part 2: methodological quality and effects.

作者信息

Johansen Monika Alise, Berntsen Gro K Rosvold, Schuster Tibor, Henriksen Eva, Horsch Alexander

机构信息

Norwegian Centre for Integrated Care and Telemedicine, University Hospital of North Norway, Tromsø, Norway.

出版信息

J Med Internet Res. 2012 Oct 3;14(5):e126. doi: 10.2196/jmir.2216.

Abstract

BACKGROUND

We conducted in two parts a systematic review of randomized controlled trials (RCTs) on electronic symptom reporting between patients and providers to improve health care service quality. Part 1 reviewed the typology of patient groups, health service innovations, and research targets. Four innovation categories were identified: consultation support, monitoring with clinician support, self-management with clinician support, and therapy.

OBJECTIVE

To assess the methodological quality of the RCTs, and summarize effects and benefits from the methodologically best studies.

METHODS

We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles between 1990 and November 2011. Risk of bias and feasibility were judged according to the Cochrane recommendation, and theoretical evidence and preclinical testing were evaluated according to the Framework for Design and Evaluation of Complex Interventions to Improve Health. Three authors assessed the risk of bias and two authors extracted the effect data independently. Disagreement regarding bias assessment, extraction, and interpretation of results were resolved by consensus discussions.

RESULTS

Of 642 records identified, we included 32 articles representing 29 studies. No articles fulfilled all quality requirements. All interventions were feasible to implement in a real-life setting, and theoretical evidence was provided for almost all studies. However, preclinical testing was reported in only a third of the articles. We judged three-quarters of the articles to have low risk for random sequence allocation and approximately half of the articles to have low risk for the following biases: allocation concealment, incomplete outcome data, and selective reporting. Slightly more than one fifth of the articles were judged as low risk for blinding of outcome assessment. Only 1 article had low risk of bias for blinding of participants and personnel. We excluded 12 articles showing high risk or unclear risk for both selective reporting and blinding of outcome assessment from the effect assessment. The authors' hypothesis was confirmed for 13 (65%) of the 20 remaining articles. Articles on self-management support were of higher quality, allowing us to assess effects in a larger proportion of studies. All except one self-management interventions were equally effective to or better than the control option. The self-management articles document substantial benefits for patients, and partly also for health professionals and the health care system.

CONCLUSION

Electronic symptom reporting between patients and providers is an exciting area of development for health services. However, the research generally is of low quality. The field would benefit from increased focus on methods for conducting and reporting RCTs. It appears particularly important to improve blinding of outcome assessment and to precisely define primary outcomes to avoid selective reporting. Supporting self-management seems to be especially promising, but consultation support also shows encouraging results.

摘要

背景

我们分两部分对患者与医疗服务提供者之间用于改善医疗服务质量的电子症状报告随机对照试验(RCT)进行了系统评价。第一部分回顾了患者群体类型、医疗服务创新及研究目标。确定了四个创新类别:咨询支持、有临床医生支持的监测、有临床医生支持的自我管理以及治疗。

目的

评估随机对照试验的方法学质量,并总结方法学上最佳研究的效果和益处。

方法

我们检索了Medline、EMBASE、PsycINFO、Cochrane对照试验中心注册库和IEEE Xplore,以查找1990年至2011年11月期间英文文章中发表的原始研究。根据Cochrane推荐判断偏倚风险和可行性,并根据改善健康的复杂干预措施设计与评估框架评估理论证据和临床前测试。三位作者评估偏倚风险,两位作者独立提取效果数据。关于偏倚评估、提取和结果解释的分歧通过共识讨论解决。

结果

在识别出的642条记录中,我们纳入了代表29项研究的32篇文章。没有文章满足所有质量要求。所有干预措施在现实环境中实施都是可行的,并且几乎所有研究都提供了理论证据。然而,只有三分之一的文章报告了临床前测试。我们判断四分之三的文章随机序列分配的风险较低,大约一半的文章在以下偏倚方面风险较低:分配隐藏、不完整的结局数据和选择性报告。略多于五分之一的文章被判断为结局评估盲法的风险较低。只有1篇文章在参与者和人员盲法方面偏倚风险较低。我们从效果评估中排除了12篇在选择性报告和结局评估盲法方面显示高风险或风险不明确的文章。其余20篇文章中有13篇(65%)作者的假设得到证实。关于自我管理支持的文章质量较高,使我们能够在更大比例的研究中评估效果。除一项自我管理干预措施外,所有自我管理干预措施与对照选项同样有效或优于对照选项。自我管理方面的文章记录了对患者有实质性益处,部分对医疗专业人员和医疗保健系统也有益处。

结论

患者与医疗服务提供者之间的电子症状报告是医疗服务一个令人兴奋的发展领域。然而,该研究总体质量较低。该领域将受益于对随机对照试验实施和报告方法的更多关注。改善结局评估的盲法以及精确界定主要结局以避免选择性报告似乎尤为重要。支持自我管理似乎特别有前景,但咨询支持也显示出令人鼓舞的结果。

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