Department of Otorhinolaryngology, Institute of Clinical Medicine, University of Oulu, Oulu, Finland.
Clin Otolaryngol. 2012 Dec;37(6):436-45. doi: 10.1111/coa.12048.
The Cochrane database of systematic reviews is an evidence-based medicine (EBM) database that provides the highest quality evidence of the effect of various treatments. Quality of life (QoL) is an important aspect when treatment effect is considered.
To assess how often patient-reported outcome measures (PROM), and specifically the quality of life aspect, were evaluated in the randomised controlled trial projects (RCTs) included in the Cochrane database of systematic reviews of the most common ear, throat and nose operations. Also, to explore the same in ongoing trials registered in ClinicalTrials.gov.
Structured literature search. SEARCH STRATEGY AND EVALUATION METHOD: The Cochrane database of systematic reviews that evaluated the effects of ventilation tube insertion, adenoidectomy, tonsillectomy and endoscopic sinus surgery was assessed. The RCTs on which the reviews' conclusions were based were explored, and the outcome variables were recorded. A similar search was carried out in the ClinicalTrials.gov trial register.
In the Cochrane database, we identified seven systematic reviews with 30 RCT projects. Fourteen (49%) collected some sort of PROM and of those, three (10%) used a validated QoL instrument. After the year 2000, the respective figures were 12 of 15 (80%) and 3 of 15 (20%). In ClinicalTrials.gov, we found 500 ongoing studies on the most common ENT operations, nine being RCTs relevant to this review. Five (55%) and three (30%) of the ongoing RCTs in ClinicalTrial.gov assess PROM and QoL topics in ENT surgery, respectively.
Since the introduction of QoL instruments in the 1990s, their use has gradually increased, but validated QoL instruments have been used in only one of 10 RCTs included in EBM databases. Ongoing RCTs consider QoL only slightly more often.
Cochrane 系统评价数据库是循证医学（EBM）数据库，提供各种治疗效果的最高质量证据。当考虑治疗效果时，生活质量（QoL）是一个重要方面。
评估在 Cochrane 系统评价数据库中最常见的耳、喉和鼻手术的随机对照试验项目（RCT）中，患者报告的结果测量（PROM），特别是生活质量方面，被评估的频率。并探索在 ClinicalTrials.gov 注册的正在进行的试验中也存在同样的情况。
进行了系统的文献检索。搜索策略和评价方法：评估了评估通气管插入、腺样体切除术、扁桃体切除术和内窥镜鼻窦手术效果的 Cochrane 系统评价数据库。探索了基于这些综述结论的 RCT，并记录了结果变量。在 ClinicalTrials.gov 试验登记处进行了类似的搜索。
在 Cochrane 数据库中，我们确定了 7 篇系统评价，其中包含 30 项 RCT 项目。其中 14 项（49%）收集了某种形式的 PROM，其中 3 项（10%）使用了经过验证的 QoL 工具。2000 年后，相应的数字分别为 15 项中的 12 项（80%）和 15 项中的 3 项（20%）。在 ClinicalTrials.gov 中，我们发现了 500 项正在进行的耳鼻喉手术最常见的研究，其中 9 项是与本综述相关的 RCT。ClinicalTrial.gov 中正在进行的 5 项（55%）和 3 项（30%）RCT 分别评估耳鼻喉手术中的 PROM 和 QoL 主题。
自 20 世纪 90 年代引入 QoL 工具以来，其使用逐渐增加，但在纳入 EBM 数据库的 10 项 RCT 中，只有一项使用了经过验证的 QoL 工具。正在进行的 RCT 仅稍微更频繁地考虑 QoL。
