How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease?
How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease?
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DOI：
10.1016/j.rmed.2004.03.026
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发表时间：
2005-01-01
影响因子：
4.3
通讯作者：
Bjermer, L
中科院分区：
文献类型：
--
作者：
Herland, K;Akselsen, JP;Bjermer, L
循证医学是治疗决策的基石，大型随机临床试验的设计通常是为了提供高度显著的结果。进行本研究的目的是为了找出阻塞性肺病患者人群的“真实的生活”延长到何种程度才符合临床研究试验中常用的标准。作为研究的第二个目的，eve想比较分别从全科医生和专科门诊招募的老年人。纳入870例前瞻性老年患者。选择哮喘患者参加临床试验的标准是，无合并症，FEV为预测值的50-85%，去年的当前或历史可逆性为12%，不吸烟或吸烟者的吸烟负担小于10包年。只有5.4%的哮喘患者符合这些标准。其他标准如有症状和定期使用吸入性皮质类固醇将符合条件的哮喘患者数量减少至3.3%，占整个人群的1.3%。同样的程序应用于COPD患者，要求FEV 1 < 70%的预测正常值，显著吸烟史（> 15包年）和无特应性。这选择了17%的COPD人群，占整个人群的7%。我们的结论是，“循证”治疗老年痴呆症的决定是基于研究，其中包括一个非常小的和高度选择的部分，这一患者群体。这些数据是否能外推到更大的“真实的生活”中的阻塞性肺病患者群体中，这是值得怀疑的。此外，Eve还发现专家和GP人群之间存在令人惊讶的微小差异。(C)2004爱思唯尔有限公司保留所有权利。
Evidence-based medicine is a corner stone in treatment decision making and large randomised, clinical trials are usually designed in order-to provide highly significant results. This study was conducted in order to find out to what extend a "real life" patient population with obstructive lung disease could fit into criteria commonly used in clinical research trials. As a secondary aim of the study, eve wanted to compare the OLD population recruited from GP's and specialist outpatient clinics, respectively. Eight-hundred and seventy prospective OLD patients were included. Criteria's for selecting asthma patients to a clinical trial were, absence of co-morbidity, FEV 50-85% of predicted, present or historical reversibility 12% last year, non-smoke or if ex-smoke a smoke burden less then 10 pack years. Only 5.4% of the study asthma patients met with these criteria. Additional criteria's as being symptomatic and regular use of inhaled corticosteroids reduced the numbers of eligible asthma patients to 3.3% representing 1.3% of the entire population. The same procedure was applied for the COPD patients, requesting a FEV1 < 70% of predicted normal, significant smoke history (> 15 pack years) and absence of atopy. This selected 17% of the COPD population, representing 7% of the entire population. We conclude that "evidence based" treatment decisions for OLD are based on studies which include a very small and highly selected fraction of this patient population. It is questionable whether such data can extrapolated to a larger, "real life" population of patients with obstructive lung disease. Moreover, eve found surprisingly minor differences between the Specialist and GP populations. (C) 2004 Elsevier Ltd. All rights reserved.