Adler Alma J, Martin Nicole, Mariani Javier, Tajer Carlos D, Owolabi Onikepe O, Free Caroline, Serrano Norma C, Casas Juan P, Perel Pablo
Department of Non-communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, Keppel Street, London, UK, WC1E 7HT.
Farr Institute of Health Informatics Research, University College London, 222 Euston Road, London, UK, NW1 2DA.
Cochrane Database Syst Rev. 2017 Apr 29;4(4):CD011851. doi: 10.1002/14651858.CD011851.pub2.
Worldwide at least 100 million people are thought to have prevalent cardiovascular disease (CVD). This population has a five times greater chance of suffering a recurrent cardiovascular event than people without known CVD. Secondary CVD prevention is defined as action aimed to reduce the probability of recurrence of such events. Drug interventions have been shown to be cost-effective in reducing this risk and are recommended in international guidelines. However, adherence to recommended treatments remains sub-optimal. In order to influence non-adherence, there is a need to develop scalable and cost-effective behaviour-change interventions.
To assess the effects of mobile phone text messaging in patients with established arterial occlusive events on adherence to treatment, fatal and non-fatal cardiovascular events, and adverse effects.
We searched CENTRAL, MEDLINE, Embase, the Conference Proceedings Citation Index - Science on Web of Science on 7 November 2016, and two clinical trial registers on 12 November 2016. We contacted authors of included studies for missing information and searched reference lists of relevant papers. We applied no language or date restrictions.
We included randomised trials with at least 50% of the participants with established arterial occlusive events. We included trials investigating interventions using short message service (SMS) or multimedia messaging service (MMS) with the aim to improve adherence to medication for the secondary prevention of cardiovascular events. Eligible comparators were no intervention or other modes of communication.
We used standard methodological procedures expected by Cochrane. In addition, we attempted to contact all authors on how the SMS were developed.
We included seven trials (reported in 13 reports) with 1310 participants randomised. Follow-up ranged from one month to 12 months. Due to heterogeneity in the methods, population and outcome measures, we were unable to conduct meta-analysis on these studies. All seven studies reported on adherence, but using different methods and scales. Six out of seven trials showed a beneficial effect of mobile phone text messaging for medication adherence. Dale 2015a, reported significantly greater medication adherence score in the intervention group (Mean Difference (MD) 0.58, 95% confidence interval (CI) 0.19 to 0.97; 123 participants randomised) at six months. Khonsari 2015 reported less adherence in the control group (Relative Risk (RR) 4.09, 95% CI 1.82 to 9.18; 62 participants randomised) at eight weeks. Pandey 2014 (34 participants randomised) assessed medication adherence through self-reported logs with 90% adherence in the intervention group compared to 70% in the control group at 12 months. Park 2014a (90 participants randomised) reported a greater increase of the medication adherence score in the control group, but also measured adherence with an event monitoring system for a number of medications with adherence levels ranging from 84.1% adherence to 86.2% in the intervention group and 79.7% to 85.7% in the control group at 30 days. Quilici 2013, reported reduced odds of non-adherence in the intervention group (Odds Ratio (OR) 0.43, 95% CI 0.22 to 0.86, 521 participants randomised) at 30 days. Fang 2016, reported that participants given SMS alone had reduced odds of being non-adherent compared to telephone reminders (OR 0.40 95% CI 0.18 to 0.63; 280 patients randomised). Kamal 2015 reported higher levels of adherence in the intervention arm (adjusted MD 0.54, 95% CI 0.22 to 0.85; 200 participants randomised). Khonsari 2015 was the only study to report fatal cardiovascular events and only reported two events, both in the control arm. No study reported on the other primary outcomes. No study reported repetitive thumb injury or road traffic crashes or other adverse events that were related to the intervention.Four authors replied to our questionnaire on SMS development. No study reported examining causes of non-adherence or provided SMS tailored to individual patient characteristics.The included studies were small, heterogeneous and included participants recruited directly after acute events. All studies were assessed as having high risk of bias across at least one domain. Most of the studies came from high-income countries, with two studies conducted in an upper middle-income country (China, Malaysia), and one study from a lower middle-income country (Pakistan). The quality of the evidence was found to be very low. There was no obvious conflicts of interest from authors, although only two declared their funding.
AUTHORS' CONCLUSIONS: While the results of this systematic review are promising, there is insufficient evidence to draw conclusions on the effectiveness of text message-based interventions for adherence to medications for secondary prevention of CVD. Sufficiently powered, high-quality randomised trials are needed, particularly in low- and middle-income countries.
据估计,全球至少有1亿人患有心血管疾病(CVD)。与无心血管疾病的人相比,这一人群发生心血管事件复发的几率高出五倍。二级心血管疾病预防是指旨在降低此类事件复发概率的行动。药物干预已被证明在降低这种风险方面具有成本效益,并在国际指南中得到推荐。然而,对推荐治疗的依从性仍然不理想。为了影响不依从行为,需要开发可扩展且具有成本效益的行为改变干预措施。
评估手机短信对已发生动脉闭塞事件的患者在治疗依从性、致命和非致命心血管事件以及不良反应方面的影响。
我们于2016年11月7日检索了Cochrane中心对照试验注册库(CENTRAL)、医学期刊数据库(MEDLINE)、荷兰医学文摘数据库(Embase)、科学网会议论文引文索引 - 科学版,以及于2016年11月12日检索了两个临床试验注册库。我们联系了纳入研究的作者以获取缺失信息,并检索了相关论文的参考文献列表。我们未设语言或日期限制。
我们纳入了至少50%的参与者已发生动脉闭塞事件的随机试验。我们纳入了调查使用短信服务(SMS)或多媒体信息服务(MMS)进行干预的试验,目的是提高对心血管事件二级预防用药的依从性。合格的对照为无干预或其他沟通方式。
我们采用了Cochrane预期的标准方法程序。此外,我们试图就短信的开发方式联系所有作者。
我们纳入了7项试验(在13篇报告中报道),共1310名参与者被随机分组。随访时间从1个月到12个月不等。由于方法、人群和结局测量的异质性,我们无法对这些研究进行荟萃分析。所有7项研究都报告了依从性,但使用了不同的方法和量表。7项试验中有6项显示手机短信对药物依从性有有益影响。戴尔2015a报告称,在6个月时,干预组的药物依从性得分显著更高(平均差(MD)0.58,95%置信区间(CI)0.19至0.97;123名参与者被随机分组)。孔萨里2015报告称,在8周时,对照组的依从性较低(相对风险(RR)4.09,95%CI 1.82至9.18;62名参与者被随机分组)。潘迪2014(34名参与者被随机分组)通过自我报告日志评估药物依从性,在12个月时,干预组的依从性为90%,而对照组为70%。帕克2014a(90名参与者被随机分组)报告称对照组的药物依从性得分增加幅度更大,但也使用事件监测系统测量了多种药物的依从性,在30天时,干预组的依从性水平为84.1%至86.;对照组为79.7%至85.7%。奎利西2013报告称,在30天时,干预组不依从的几率降低(优势比(OR)0.43,95%CI 0.22至0.86,521名参与者被随机分组)。方2016报告称,与电话提醒相比,仅接受短信的参与者不依从的几率降低(OR 0.40,95%CI 0.18至0.63;280名患者被随机分组)。卡迈勒201报告称干预组的依从性水平更高(调整后的MD 0.54,95%CI 0.22至0.85;200名参与者被随机分组)。孔萨里2015是唯一报告致命心血管事件的研究,仅报告了两起事件,均在对照组。没有研究报告其他主要结局。没有研究报告重复性拇指损伤或道路交通事故或与干预相关的其他不良事件。四位作者回复了我们关于短信开发的问卷。没有研究报告检查不依从的原因或提供针对个体患者特征的短信。纳入的研究规模较小、异质性较大,且纳入的参与者是在急性事件后直接招募的。所有研究在至少一个领域被评估为具有高偏倚风险。大多数研究来自高收入国家,两项研究在中高收入国家(中国、马来西亚)进行,一项研究来自中低收入国家(巴基斯坦)。证据质量被发现非常低。作者没有明显的利益冲突,尽管只有两人声明了他们的资金来源。
虽然本系统评价的结果很有前景,但没有足够的证据就基于短信的干预措施对心血管疾病二级预防用药依从性的有效性得出结论。需要有足够样本量、高质量的随机试验,特别是在低收入和中等收入国家。