Kew Kayleigh M, Malik Poonam, Aniruddhan Krishnan, Normansell Rebecca
British Medical Journal Technology Assessment Group (BMJ-TAG), BMJ Knowledge Centre, BMA House, Tavistock Square, London, UK, WC1H 9JR.
Cochrane Database Syst Rev. 2017 Oct 3;10(10):CD012330. doi: 10.1002/14651858.CD012330.pub2.
BACKGROUND: Asthma is a chronic inflammatory disease that affects the airways and is common in both adults and children. It is characterised by symptoms including wheeze, shortness of breath, chest tightness, and cough. People with asthma may be helped to manage their condition through shared decision-making (SDM). SDM involves at least two participants (the medical practitioner and the patient) and mutual sharing of information, including the patient's values and preferences, to build consensus about favoured treatment that culminates in an agreed action. Effective self-management is particularly important for people with asthma, and SDM may improve clinical outcomes and quality of life by educating patients and empowering them to be actively involved in their own health. OBJECTIVES: To assess benefits and potential harms of shared decision-making for adults and children with asthma. SEARCH METHODS: We searched the Cochrane Airways Trials Register, which contains studies identified in several sources including CENTRAL, MEDLINE, and Embase. We also searched clinical trials registries and checked the reference lists of included studies. We conducted the most recent searches on 29 November 2016. SELECTION CRITERIA: We included studies of individual or cluster parallel randomised controlled design conducted to compare an SDM intervention for adults and children with asthma versus a control intervention. We included studies available as full-text reports, those published as abstracts only, and unpublished data, and we placed no restrictions on place, date, or language of publication. We included interventions targeting healthcare professionals or patients, their families or care-givers, or both. We included studies that compared the intervention versus usual care or a minimal control intervention, and those that compared an SDM intervention against another active intervention. We excluded studies of interventions that involved multiple components other than the SDM intervention unless the control group also received these interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently screened searches, extracted data from included studies, and assessed risk of bias. Primary outcomes were asthma-related quality of life, patient/parent satisfaction, and medication adherence. Secondary outcomes included exacerbations of asthma, asthma control, acceptability/feasibility from the perspective of healthcare professionals, and all adverse events. We graded and presented evidence in a 'Summary of findings' table.We were unable to pool any of the extracted outcome data owing to clinical and methodological heterogeneity but presented findings in forest plots when possible. We narratively described skewed data. MAIN RESULTS: We included four studies that compared SDM versus control and included a total of 1342 participants. Three studies recruited children with asthma and their care-givers, and one recruited adults with asthma. Three studies took place in the United States, and one in the Netherlands. Trial duration was between 6 and 24 months. One trial delivered the SDM intervention to the medical practitioner, and three trials delivered the SDM intervention directly to the participant. Two paediatric studies involved use of an online portal, followed by face-to-face consultations. One study delivered an SDM intervention or a clinical decision-making intervention through a mixture of face-to-face consultations and telephone calls. The final study randomised paediatric general practice physicians to receive a seminar programme promoting application of SDM principles. All trials were open-label, although one study, which delivered the intervention to physicians, stated that participants were unaware of their physicians' involvement in the trial. We had concerns about selection and attrition bias and selective reporting, and we noted that one study substantially under-recruited participants. The four included studies used different approaches to measure fidelity/intervention adherence and to report study findings.One study involving adults with poorly controlled asthma reported improved quality of life (QOL) for the SDM group compared with the control group, using the Asthma Quality of Life Questionnaire (AQLQ) for assessment (mean difference (MD) 1.90, 95% confidence interval (CI) 1.24 to 2.91), but two other trials did not identify a benefit. Patient/parent satisfaction with the performance of paediatricians was greater in the SDM group in one trial involving children. Medication adherence was better in the SDM group in two studies - one involving adults and one involving children (all medication adherence: MD 0.21, 95% CI 0.11 to 0.31; mean number of controlled medication prescriptions over 26 weeks: 1.1 in the SDM group (n = 26) and 0.7 in the control group (n = 27)). In one study, asthma-related visit rates were lower in the SDM group than in the usual care group (1.0/y vs 1.4/y; P = 0.016), but two other studies did not report a difference in exacerbations nor in prescriptions for short courses of oral steroids. Finally, one study described better odds of reporting no asthma problems in the SDM group than in the usual care group (odds ratio (OR) 1.90, 95% CI 1.26 to 2.87), although two other studies reporting asthma control did not identify a benefit with SDM. We found no information about acceptability of the intervention to the healthcare professional and no information on adverse events. Overall, our confidence in study results ranged from very low to moderate, and we downgraded outcomes owing to risk of bias, imprecision, and indirectness. AUTHORS' CONCLUSIONS: Substantial differences between the four included randomised controlled trials (RCTs) indicate that we cannot provide meaningful overall conclusions. Individual studies demonstrated some benefits of SDM over control, in terms of quality of life; patient and parent satisfaction; adherence to prescribed medication; reduction in asthma-related healthcare visits; and improved asthma control. Our confidence in the findings of these individual studies ranges from moderate to very low, and it is important to note that studies did not measure or report adverse events.Future trials should be adequately powered and of sufficient duration to detect differences in patient-important outcomes such as exacerbations and hospitalisations. Use of core asthma outcomes and validated scales when possible would facilitate future meta-analysis. Studies conducted in lower-income settings and including an economic evaluation would be of interest. Investigators should systematically record adverse events, even if none are anticipated. Studies identified to date have not included adolescents; future trials should consider their inclusion. Measuring and reporting of intervention fidelity is also recommended.
背景:哮喘是一种影响气道的慢性炎症性疾病,在成人和儿童中都很常见。其特征症状包括喘息、气短、胸闷和咳嗽。哮喘患者可通过共同决策(SDM)来帮助管理病情。共同决策至少涉及两名参与者(医生和患者),并相互分享信息,包括患者的价值观和偏好,以就首选治疗达成共识,最终形成商定的行动方案。有效的自我管理对哮喘患者尤为重要,共同决策可通过教育患者并使其积极参与自身健康管理来改善临床结局和生活质量。 目的:评估共同决策对哮喘成人和儿童的益处及潜在危害。 检索方法:我们检索了Cochrane气道试验注册库,其中包含从多个来源(包括CENTRAL、MEDLINE和Embase)识别出的研究。我们还检索了临床试验注册库,并检查了纳入研究的参考文献列表。我们于2016年11月29日进行了最新检索。 选择标准:我们纳入了采用个体或整群平行随机对照设计的研究,以比较针对哮喘成人和儿童的共同决策干预与对照干预。我们纳入了全文报告、仅以摘要形式发表的研究以及未发表的数据,且对发表地点、日期或语言没有限制。我们纳入了针对医疗保健专业人员或患者、其家人或护理人员或两者的干预措施。我们纳入了比较干预措施与常规护理或最小对照干预的研究,以及比较共同决策干预与另一种积极干预的研究。我们排除了涉及共同决策干预以外多个组成部分的干预措施的研究,除非对照组也接受了这些干预措施。 数据收集与分析:两位综述作者独立筛选检索结果,从纳入研究中提取数据,并评估偏倚风险。主要结局为哮喘相关生活质量、患者/家长满意度和药物依从性。次要结局包括哮喘发作、哮喘控制、医疗保健专业人员视角下的可接受性/可行性以及所有不良事件。我们在“结果总结”表中对证据进行分级和呈现。由于临床和方法学异质性,我们无法汇总任何提取的结局数据,但在可能的情况下在森林图中呈现结果。我们对偏态数据进行了描述性叙述。 主要结果:我们纳入了四项比较共同决策与对照的研究,共1342名参与者。三项研究招募了哮喘儿童及其护理人员,一项研究招募了哮喘成人。三项研究在美国进行,一项在荷兰进行。试验持续时间为6至24个月。一项试验将共同决策干预提供给医生,三项试验直接将共同决策干预提供给参与者。两项儿科研究使用了在线平台,随后进行面对面咨询。一项研究通过面对面咨询和电话相结合的方式提供共同决策干预或临床决策干预。最后一项研究将儿科全科医生随机分组,使其接受促进共同决策原则应用的研讨会项目。所有试验均为开放标签,尽管一项将干预措施提供给医生的研究表示参与者不知道其医生参与了试验。我们对选择、失访偏倚和选择性报告存在担忧,并注意到一项研究招募的参与者大幅不足。四项纳入研究采用了不同的方法来测量保真度/干预依从性并报告研究结果。一项涉及哮喘控制不佳的成人的研究报告称,与对照组相比,共同决策组使用哮喘生活质量问卷(AQLQ)评估的生活质量(QOL)有所改善(平均差(MD)1.90,95%置信区间(CI)1.24至2.91),但其他两项试验未发现益处。在一项涉及儿童的试验中,共同决策组对儿科医生表现的患者/家长满意度更高一点。在两项研究中,共同决策组的药物依从性更好——一项涉及成人,一项涉及儿童(所有药物依从性:MD 0.21,95% CI 0.11至0.31;26周内控制药物处方的平均数量:共同决策组为1.1(n = 26),对照组为0.7(n = 27))。在一项研究中,共同决策组的哮喘相关就诊率低于常规护理组(1.0次/年对1.4次/年;P = 0.016),但其他两项研究未报告哮喘发作或口服类固醇短期疗程处方方面的差异。最后,一项研究描述了共同决策组报告无哮喘问题的几率高于常规护理组(优势比(OR)1.90,95% CI 1.26至2.87),尽管其他两项报告哮喘控制情况的研究未发现共同决策有任何益处。我们未找到关于该干预措施对医疗保健专业人员的可接受性的信息,也未找到关于不良事件的信息。总体而言,我们对研究结果的信心从极低到中等不等,由于偏倚风险、不精确性和间接性,我们对结局进行了降级。 作者结论:四项纳入的随机对照试验(RCT)之间存在显著差异,这表明我们无法提供有意义的总体结论。个别研究表明,在生活质量、患者和家长满意度、遵医嘱用药、减少哮喘相关医疗就诊以及改善哮喘控制方面,共同决策比对照有一些益处。我们对这些个别研究结果的信心从中等到极低不等,需要注意的是,这些研究未测量或报告不良事件。未来的试验应有足够的样本量和持续时间,以检测患者重要结局(如发作和住院)的差异。尽可能使用核心哮喘结局和经过验证的量表将有助于未来的荟萃分析。在低收入环境中进行的研究以及包括经济评估的研究将很有意义。研究人员应系统地记录不良事件,即使预计不会出现不良事件。迄今为止确定的研究未纳入青少年;未来的试验应考虑纳入青少年。还建议测量和报告干预保真度。
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