Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France.
PLoS One. 2013 May 28;8(5):e63677. doi: 10.1371/journal.pone.0063677. Print 2013.
Older adults are underrepresented in clinical research. To assess therapeutic efficacy in older patients, some randomized controlled trials (RCTs) include older adults only.
To compare treatment effects between RCTs including older adults only (elderly RCTs) and RCTs including all adults (adult RCTs) by a meta-epidemiological approach.
All systematic reviews published in the Cochrane Library (Issue 4, 2011) were screened. Eligible studies were meta-analyses of binary outcomes of pharmacologic treatment including at least one elderly RCT and at least one adult RCT. For each meta-analysis, we compared summary odds ratios for elderly RCTs and adult RCTs by calculating a ratio of odds ratios (ROR). A summary ROR was estimated across all meta-analyses.
We selected 55 meta-analyses including 524 RCTs (17% elderly RCTs). The treatment effects differed beyond that expected by chance for 7 (13%) meta-analyses, showing more favourable treatment effects in elderly RCTs in 5 cases and in adult RCTs in 2 cases. The summary ROR was 0.91 (95% CI, 0.77-1.08, p = 0.28), with substantial heterogeneity (I(2) = 51% and τ(2) = 0.14). Sensitivity and subgroup analyses by type-of-age RCT (elderly RCTs vs RCTs excluding older adults and vs RCTs of mixed-age adults), type of outcome (mortality or other) and type of comparator (placebo or active drug) yielded similar results.
The efficacy of pharmacologic treatments did not significantly differ, on average, between RCTs including older adults only and RCTs of all adults. However, clinically important discrepancies may occur and should be considered when generalizing evidence from all adults to older adults.
老年人在临床研究中代表性不足。为了评估老年患者的治疗效果，一些随机对照试验（RCT）仅纳入老年人。
采用meta-流行病学方法比较仅纳入老年人的 RCT（老年 RCT）和纳入所有成年人的 RCT（成年 RCT）的治疗效果。
筛选 Cochrane 图书馆（2011 年第 4 期）发表的所有系统评价。纳入的研究是至少纳入一项老年 RCT 和一项成年 RCT 的药物治疗二分类结局的 meta 分析。对于每个 meta 分析，我们通过计算比值比（OR）的比值（ROR）来比较老年 RCT 和成年 RCT 的汇总 OR。通过对所有 meta 分析的汇总来估计汇总 ROR。
我们选择了 55 项 meta 分析，共纳入 524 项 RCT（17%为老年 RCT）。有 7 项（13%）meta 分析的治疗效果超出了预期的随机差异，其中 5 项老年 RCT 的治疗效果更好，2 项成年 RCT 的治疗效果更好。汇总 ROR 为 0.91（95%CI，0.77-1.08，p=0.28），存在显著的异质性（I²=51%和 τ²=0.14）。敏感性分析和亚组分析按 RCT 类型（老年 RCT 与排除老年人的 RCT 与混合年龄成年人的 RCT）、结局类型（死亡率或其他）和比较药物类型（安慰剂或活性药物）进行，结果相似。
在平均水平上，仅纳入老年人的 RCT 和纳入所有成年人的 RCT 的药物治疗效果没有显著差异。然而，可能会出现临床上重要的差异，在将所有成年人的证据推广到老年人时应予以考虑。
