Patients' preferences within randomised trials: systematic review and patient level meta-analysis.

Patients' preferences within randomised trials: systematic review and patient level meta-analysis.
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DOI:
10.1136/bmj.a1864
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发表时间:
2008-10-31
期刊:
BMJ (Clinical research ed.)
影响因子:
--
通讯作者:
Preference Collaborative Review Group
Preference Collaborative Review Group
中科院分区:
其他
文献类型:
--
作者:
Preference Collaborative Review Group

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目的 系统回顾完全随机的患者偏好试验,并通过患者水平数据的荟萃分析探讨偏好对自然流失和结果的影响。数据来源 使用 Science Citation Index 和 Google Scholar 进行引文检索,并结合关键词对主要电子数据库(Medline、CINAHL、Embase 和 AMED)进行检索。研究选择 包括比较任何临床病症的治疗方法的完全随机的患者偏好试验。其他类型的偏好试验和交叉试验被排除在外。其他入选标准:参加者年龄16岁及以上;以连续数字尺度衡量的主要自我报告结果。在确定和筛选的 167 项研究中,有 17 项被确定为完全随机的患者偏好试验。数据综合 在确定的 17 项试验中,11 位作者为荟萃分析提供了原始数据。收集的数据是主要结果的基线和随访数据、随机分配数据、偏好数据和人口统计数据。主要结果的基线和首次干预后随访数据已标准化。为了提高同质性,仅合并了八项肌肉骨骼试验 (n=1594) 的数据。为了估计偏好对结果和自然流失的影响,对三组进行了比较:有偏好并被随机分配到其偏好治疗的患者;有偏好并被随机分配到他们不喜欢的治疗的患者;以及没有偏好的患者。结果 被随机分配至首选治疗的患者的标准化效应值大于那些对治疗分配无差异的患者(效应值 0.162,95% 置信区间 0.011 至 0.314;P=0.04)。接受首选治疗的参与者也比未接受首选治疗的参与者表现更好(效应大小 0.152,-0.035 至 0.339),尽管这没有统计学意义(P=0.11)。分配到他们不想要的治疗的参与者的结果与那些无动于衷的人没有什么不同。与无关的参与者相比,被分配到不想要的治疗的参与者首次随访失访的可能性较小(比值比 1.70、1.076 至 2.693;P=0.02)。分配到他们偏好的患者和那些不感兴趣的患者之间的流失没有发现差异。结论 肌肉骨骼试验中患者的偏好与治疗效果相关。在开放随机试验中,应在随机化之前确定偏好。
Objective To systematically review fully randomised patient preference trials and to explore the impact of preferences on attrition and outcome by meta-analysis of patient level data. Data sources Citation search using Science Citation Index and Google Scholar and search of the main electronic databases (Medline, CINAHL, Embase, and AMED) with a combination of key words. Study selection Fully randomised patient preference trials that compared treatments for any clinical condition were included. Other types of preference trials and crossover trials were excluded. Other inclusion criteria: participants aged 16 years and over; primary, self-reported outcomes measured on a continuous numerical scale. From 167 studies identified and screened, 17 were identified as fully randomised patient preference trials. Data synthesis Of the 17 trials identified, 11 authors provided raw data for the meta-analysis. Data collected were baseline and follow-up data for the main outcome, randomised allocation data, preference data, and demographic data. Baseline and first post-intervention follow-up data for the main outcome were standardised. To improve homogeneity, data for only the eight musculoskeletal trials (n=1594) were combined. To estimate the effects of preferences on outcomes and attrition, three groups were compared: patients who had a preference and were randomly allocated to their preferred treatment; patients who had a preference and were randomly allocated to the treatment they did not prefer; and patients who had no preference. Results Patients who were randomised to their preferred treatment had a standardised effect size greater than that of those who were indifferent to the treatment assignment (effect size 0.162, 95% confidence interval 0.011 to 0.314; P=0.04). Participants who received their preferred treatment also did better than participants who did not receive their preferred treatment (effect size 0.152, −0.035 to 0.339), although this was not statistically significant (P=0.11). Participants allocated to their undesired treatment had outcomes that were no different from those who were indifferent. Participants who were allocated to their undesired treatment were less likely to be lost to first follow-up compared with indifferent participants (odds ratio 1.70, 1.076 to 2.693; P=0.02). No difference was found in attrition between patients allocated to their preference and those who were indifferent. Conclusions Preferences among patients in musculoskeletal trials are associated with treatment effects. In open randomised trials, preferences should be ascertained before randomisation.
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发表时间: 2003-02-01
影响因子: 7.2
作者:
Halpern, SD
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