Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis
Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis
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DOI：
10.1001/jama.290.8.1062
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发表时间：
2003-08-27
影响因子：
120.7
通讯作者：
Ravaud, P
中科院分区：
文献类型：
--
作者：
Boutron, I;Tubach, F;Ravaud, P
背景随机对照试验基本上是在药物治疗（即口服药物、关节内注射、局部、肌肉注射和静脉注射治疗）的背景下开发的，但对非药物治疗（即手术、关节镜检查、关节灌洗、康复、针灸和教育）有效性的评估提出了具体问题。非药物治疗。 设计和设置 我们检索了 MEDLINE 和 Cochrane 对照试验中心注册库，查找 1992 年 1 月 1 日至 2002 年 2 月 28 日期间发表在 28 种具有高影响因子的普通医学和专业期刊上的随机对照试验文章，并评估髋关节或膝骨关节炎患者的非药物和药物治疗。 主要结果指标 所选文章中报告的方法的质量由 2 位独立人士进行评估审稿人使用 Jadad 量表、Delphi 列表以及医学文献用户指南中的指南。研究人员还使用作者制定的项目清单来分析研究特征。 结果 分析中总共包含 110 篇文章； 50 名（45.5%）评估了非药物治疗，60 名（54.5%）评估了药物治疗。根据 Jadad 量表（平均 [SD] 评分，1.4 [1.3] vs 3.0 [1.3]）和德尔菲列表（平均 [SD] 评分，5.2 [1.5] vs 7.5 [1.1]）衡量，非药物治疗报告的总体质量评分低于药物治疗报告。在非药理学和药理学文章中都发现缺乏报告足够的随机序列生成和意向治疗分析。与安慰剂相比，非药物治疗的频率低于药物治疗（28.0% 的文章 vs 71.7%）。与药理学文章相比，非药理学文章较少描述患者（26.0% vs 96.7%）、护理人员（6.0% vs 81.7%）和结果评估者（68.0% vs 98.3%）的盲法。护理人员的技能水平可以影响 84.0% 的非药理学文章的治疗效果，而 23.3% 的药理学文章会影响治疗效果。 结论 在对髋关节和膝骨关节炎治疗报告的分析中，非药理学文章的质量得分低于药理学文章。非药物治疗的评估必须考虑其他方法学问题。
Context Randomized controlled trials have been developed essentially in the context of pharmacological treatments (ie, oral drugs; intra-articular injection; and topical, intramuscular, and intravenous treatments), but assessment of the effectiveness of non pharmacological treatments (ie, surgery, arthroscopy, joint lavage, rehabilitation, acupuncture, and education) presents specific issues.Objectives To compare the quality of articles of non pharmacological and pharmacological treatments of hip and knee osteoarthritis and to identify specific methodological issues related to assessment of nonpharmacological treatments.Design and Setting We searched MEDLINE and the Cochrane Central Register of Controlled Trials for articles of randomized controlled trials published between January 1, 1992, and February 28, 2002, in 28 general medical and specialty journals with high impact factors and assessing nonpharmacological and pharmacological treatments in patients with hip or knee osteoarthritis.Main Outcome Measures The quality of the methods reported in the selected articles was assessed by 2 independent reviewers using the Jadad scale, the Delphi list, and guidelines found in the Users' Guides to the Medical Literature. Investigators also used a checklist of items developed by the authors to analyze study characteristics.Results A total of 110 articles were included in the analysis; 50 (45.5%) assessed non pharmacological treatments and 60 (54.5%) assessed pharmacological treatments. Reports of non pharmacological treatments had a lower global quality score than did reports of pharmacological treatments as measured by the Jadad scale (mean [SD] score, 1.4 [1.3] vs 3.0 [1.3]) and the Delphi list (mean [SD] score, 5.2 [1.5] vs 7.5 [1.1]). Lack of reporting adequate random sequence generation and intention-to-treat analyses were found in both non pharmacological and pharmacological articles. Non pharmacological treatments were less often compared with a placebo than were pharmacological treatments (28.0% of articles Vs 71.7%). Compared with pharmacological articles, non pharmacological articles less often described blinding of patients (26.0% vs 96.7%), care providers (6.0% Vs 81.7%), and outcome assessors (68.0% vs 98.3%). Care providers' skill levels could influence treatment effect in 84.0% of non pharmacological articles vs 23.3% of pharmacological articles.Conclusions In this analysis of reports of hip and knee osteoarthritis therapy, nonpharmacological articles scored lower than pharmacological articles in terms of quality. Assessments of nonpharmacological treatments must take into consideration additional methodological issues.