Characteristics of Published Comparative Effectiveness Studies of Medications
Characteristics of Published Comparative Effectiveness Studies of Medications
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DOI：
10.1001/jama.2010.240
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发表时间：
2010-03-10
影响因子：
120.7
通讯作者：
McCormick, Danny
中科院分区：
文献类型：
--
作者：
Hochman, Michael;McCormick, Danny
背景政策制定者和医生组织最近呼吁进行更多的比较有效性（CE）研究，但对现有的CE研究知之甚少。目的描述最近发表的评价药物的CE研究的特点。设计，设置和参与者分析所有随机试验，观察性研究，以及荟萃分析，涉及2008年6月1日至9月30日期间在6种影响因子最高的普通医学和内科杂志上发表的药物，2009.Main Outcome Measures CE研究（比较现有的活性治疗）和非CE研究（涉及新疗法或使用非活性对照的研究）的患病率和特征。在CE研究中，45（43%; 95%置信区间[CI]，34%-53%）比较不同药物，11（11%; 95% CI，5%-18%）比较药物治疗与非药物干预，32（31%; 95% CI，22%-41%）比较了不同的药理学策略，16例（15%; 95% CI，9%-24%）比较了不同的药物给药方案。20项（19%; 95% CI，12%-28%）CE研究关注安全性，2项（2%; 95% CI，0%-7%）包括成本-效果分析。与非CE研究相比，比较有效性研究不太可能完全由商业资助：分别为13%（95% CI，8%-22%）和45%（95% CI，38%-52%）（P < .001）。总共有90项（87%; 95% CI，78%-92%）CE研究接受了非商业资助，包括66项接受了政府资助（63%; 95% CI，53%-73%）。在212项随机试验中，97项（46%; 95% CI，39%-63%）使用活性对照;其余使用非活性对照。活性对照试验报告阳性结果的可能性低于非活性对照试验：分别为44%（95%CI，33%-55%）和66%（95%CI，57%-75%）（P=.002）。在这些研究中，只有少数比较了药物和非药物治疗，很少关注安全性或成本，大多数由非商业资金来源资助。美国医学会杂志2010;303（10）：951-958
Context Policy makers and physician organizations have recently called for more comparative effectiveness (CE) research, yet little is known about existing CE studies.Objective To describe the characteristics of recently published CE studies evaluating medications.Design, Setting, and Participants Analysis of all randomized trials, observational studies, and meta-analyses involving medications published in the 6 general medicine and internal medicine journals with the highest impact factor between June 1, 2008, and September 30, 2009.Main Outcome Measures The prevalence and characteristics of CE studies (those comparing existing, active treatments) and non-CE studies (those involving novel therapies or those using an inactive control).Results We identified 328 studies evaluating medications, 104 of which were CE studies. Among the CE studies, 45 (43%; 95% confidence interval [CI], 34%-53%) compared different medications, 11 (11%; 95% CI, 5%-18%) compared medications with nonpharmacologic interventions, 32 (31%; 95% CI, 22%-41%) compared different pharmacologic strategies, and 16 (15%; 95% CI, 9%-24%) compared different medication dosing schedules. Twenty (19%; 95% CI, 12%-28%) CE studies focused on safety and 2 (2%; 95% CI, 0%-7%) included cost-effectiveness analyses. Comparative effectiveness studies were less likely than non-CE studies to have been exclusively commercially funded: 13% (95% CI, 8%-22%) vs 45% (95% CI, 38%-52%), respectively (P < .001). In total, 90 (87%; 95% CI, 78%-92%) of the CE studies received noncommercial funding, including 66 that received government funding (63%; 95% CI, 53%-73%). Of 212 randomized trials, 97 (46%; 95% CI, 39%-63%) used an active comparator; the rest used an inactive control. Active-comparator trials were less likely than trials with inactive controls to report positive results: 44% (95% CI, 33%-55%) vs 66% (95% CI, 57%-75%), respectively (P=.002).Conclusions In these high-impact general medicine journals, approximately one-third of studies evaluating medications were CE studies. Of these studies, only a minority compared pharmacologic and nonpharmacologic therapies, few focused on safety or cost, and most were funded by noncommercial funding sources. JAMA. 2010;303(10):951-958