Devi Reena, Singh Sally J, Powell John, Fulton Emily A, Igbinedion Ewemade, Rees Karen
School of Medicine, Department of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK, NG7 2UH.
Cochrane Database Syst Rev. 2015 Dec 22;2015(12):CD009386. doi: 10.1002/14651858.CD009386.pub2.
The Internet could provide a means of delivering secondary prevention programmes to people with coronary heart disease (CHD).
To determine the effectiveness of Internet-based interventions targeting lifestyle changes and medicines management for the secondary prevention of CHD.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, in December 2014. We also searched six other databases in October 2014, and three trials registers in January 2015 together with reference checking and handsearching to identify additional studies.
Randomised controlled trials (RCTs) evaluating Internet-delivered secondary prevention interventions aimed at people with CHD.
Two review authors independently assessed risk of bias and extracted data according to the Cochrane Handbook for Systematic Reviews of Interventions. We assessed evidence quality using the GRADE approach and presented this in a 'Summary of findings' table.
Eighteen trials met our inclusion criteria. Eleven studies are complete (1392 participants), and seven are ongoing. Of the completed studies, seven interventions are broad, targeting the lifestyle management of CHD, and four focused on physical activity promotion. The comparison group in trials was usual care (n = 6), minimal intervention (n = 3), or traditional cardiac rehabilitation (n = 2).We found no effects of Internet-based interventions for all-cause mortality (odds ratio (OR) 0.27, 95% confidence interval (CI) 0.04 to 1.63; participants = 895; studies = 6; low-quality evidence). There was only one case of cardiovascular mortality in a control group (participants = 895; studies = 6). No incidences of non-fatal re-infarction were reported across any of the studies. We found no effects for revascularisation (OR 0.69, 95% CI 0.37 to 1.27; participants = 895; studies = 6; low-quality evidence).We found no effects for total cholesterol (mean difference (MD) 0.00, 95% CI -0.27 to 0.28; participants = 439; studies = 4; low-quality evidence), high-density lipoprotein (HDL) cholesterol (MD 0.01, 95% CI -0.06 to 0.07; participants = 437; studies = 4; low-quality evidence), or triglycerides (MD 0.01, 95% CI -0.17 to 0.19; participants = 439; studies = 4; low-quality evidence). We did not pool the data for low-density lipoprotein (LDL) cholesterol due to considerable heterogeneity. Two out of six trials measuring LDL cholesterol detected favourable intervention effects, and four trials reported no effects. Seven studies measured systolic and diastolic blood pressure; we did not pool the data due to substantial heterogeneity. For systolic blood pressure, two studies showed a reduction with the intervention, but the remaining studies showed no effect. For diastolic blood pressure, two studies showed a reduction with the intervention, one study showed an increase with the intervention, and the remaining four studies showed no effect.Five trials measured health-related quality of life (HRQOL). We could draw no conclusions from one study due to incomplete reporting; one trial reported no effect; two studies reported a short- and medium-term effect respectively; and one study reported both short- and medium-term effects.Five trials assessed dietary outcomes: two reported favourable effects, and three reported no effects. Eight studies assessed physical activity: five of these trials reported no physical activity effects, and three reported effectiveness. Trials are yet to measure the impact of these interventions on compliance with medication.Two studies measured healthcare utilisation: one reported no effects, and the other reported increased usage of healthcare services compared to a control group in the intervention group at nine months' follow-up. Two trials collected cost data: both reported that Internet-delivered interventions are likely to be cost-effective.In terms of the risk of bias, the majority of studies reported appropriate randomisation and appropriate concealment of randomisation processes. A lack of blinding resulted in a risk of performance bias in seven studies, and a risk of detection bias in five trials. Two trials were at risk of attrition bias, and five were at risk for reporting bias.
AUTHORS' CONCLUSIONS: In general, evidence was of low quality due to lack of blinding, loss to follow-up, and uncertainty around the effect size. Few studies measured clinical events, and of those that did, a very small number of events were reported, and therefore no firm conclusions can be made. Similarly, there was no clear evidence of effect for cardiovascular risk factors, although again the number of studies reporting these was small. There was some evidence for beneficial effects on HRQOL, dietary outcomes, and physical activity, although firm conclusions cannot yet be made. The effects on healthcare utilisation and cost-effectiveness are also inconclusive, and trials are yet to measure the impact of Internet interventions on compliance with medication. The comparison groups differed across trials, and there were insufficient studies with usable data for subgroup analyses. We intend to study the intensity of comparison groups in future updates of this review when more evidence is available. The completion of the ongoing trials will add to the evidence base.
互联网可为冠心病(CHD)患者提供二级预防项目的实施途径。
确定针对冠心病二级预防中生活方式改变和药物管理的基于互联网的干预措施的有效性。
我们于2014年12月检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE。我们还于2014年10月检索了其他六个数据库,并于2015年1月检索了三个试验注册库,同时进行参考文献核对和手工检索以识别其他研究。
评估针对冠心病患者的基于互联网的二级预防干预措施的随机对照试验(RCT)。
两位综述作者根据Cochrane干预措施系统评价手册独立评估偏倚风险并提取数据。我们使用GRADE方法评估证据质量,并将其呈现在“结果总结”表中。
18项试验符合我们的纳入标准。11项研究已完成(1392名参与者),7项正在进行中。在已完成的研究中,7项干预措施较为宽泛,针对冠心病的生活方式管理,4项侧重于促进身体活动。试验中的对照组为常规护理(n = 6)、最小干预(n = 3)或传统心脏康复(n = 2)。我们发现基于互联网的干预措施对全因死亡率无影响(比值比(OR)0.27,95%置信区间(CI)0.04至1.63;参与者 = 895;研究 = 6;低质量证据)。对照组中仅1例心血管死亡(参与者 = 895;研究 = 6)。所有研究均未报告非致命性再梗死的发生情况。我们发现对血管重建无影响(OR 0.69,95% CI 0.37至1.27;参与者 = 895;研究 = 6;低质量证据)。我们发现对总胆固醇(平均差(MD)0.00,95% CI -0.27至0.28;参与者 = 439;研究 = 4;低质量证据)、高密度脂蛋白(HDL)胆固醇(MD 0.01,95% CI -0.06至0.07;参与者 = 437;研究 = 4;低质量证据)或甘油三酯(MD 0.01,95% CI -0.17至0.19;参与者 = 439;研究 = 4;低质量证据)无影响。由于异质性较大,我们未汇总低密度脂蛋白(LDL)胆固醇的数据。六项测量LDL胆固醇的试验中有两项检测到干预有有利影响,四项试验报告无影响。七项研究测量了收缩压和舒张压;由于异质性较大,我们未汇总数据。对于收缩压,两项研究显示干预后降低,但其余研究无影响。对于舒张压,两项研究显示干预后降低,一项研究显示干预后升高,其余四项研究无影响。五项试验测量了健康相关生活质量(HRQOL)。由于报告不完整,我们无法从一项研究中得出结论;一项试验报告无影响;两项研究分别报告了短期和中期影响;一项研究报告了短期和中期影响。五项试验评估了饮食结果:两项报告有有利影响,三项报告无影响。八项研究评估了身体活动:其中五项试验报告对身体活动无影响,三项报告有效。试验尚未测量这些干预措施对药物依从性的影响。两项研究测量了医疗保健利用率:一项报告无影响,另一项报告在九个月随访时干预组与对照组相比医疗保健服务使用增加。两项试验收集了成本数据:均报告基于互联网的干预措施可能具有成本效益。
就偏倚风险而言,大多数研究报告了适当的随机化和随机化过程的适当隐藏。缺乏盲法导致七项研究存在实施偏倚风险,五项试验存在检测偏倚风险。两项试验存在失访偏倚风险,五项存在报告偏倚风险。
总体而言,由于缺乏盲法、失访以及效应大小的不确定性,证据质量较低。很少有研究测量临床事件,即便测量了报告的事件数量也非常少,因此无法得出确切结论。同样,对于心血管危险因素也没有明确的效应证据,尽管报告这些的研究数量也很少。有一些证据表明对HRQOL、饮食结果和身体活动有有益影响,尽管尚未得出确切结论。对医疗保健利用率和成本效益的影响也尚无定论,试验尚未测量互联网干预对药物依从性的影响。各试验中的对照组不同,且缺乏足够的具有可用数据的研究进行亚组分析。我们打算在本综述的未来更新中,当有更多证据时研究对照组的强度。正在进行的试验完成后将增加证据基础。