Randomized controlled trials: Do they have external validity for patients with multiple comorbidities?
Randomized controlled trials: Do they have external validity for patients with multiple comorbidities?
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DOI：
10.1370/afm.516
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发表时间：
2006-03-01
影响因子：
4.4
通讯作者：
Lapointe, L
中科院分区：
文献类型：
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作者：
Fortin, M;Dionne, J;Lapointe, L
许多随机对照试验（RCT）排除了有多种合并症的患者。本研究的目的是说明在初级保健随访的患者中合并症的患病率，这些患者符合特定疾病治疗的选定RCT的入选标准。我们使用高血压作为一个例子，一个特定的慢性conditions.METHODS，我们使用了现有的数据库980例（660名妇女），这是一个代表人口咨询初级保健家庭医生，并包含有关所有慢性疾病的信息。我们随机选择了5个针对高血压患者的RCTS。将5项RCT中使用的入选和排除标准应用于我们数据库中的患者（每次1项研究）。从我们的数据集的患者谁满足给定的RCT的纳入标准被认为是合格的RCT.RESULTS从我们的数据集谁是合格的每个RCT的患者，89%至100%有多种慢性疾病。每个随机对照试验中符合条件的患者的平均慢性疾病数范围为5.5 +/- 3.3至11.7 +/-5.3。结论本研究的结果表明，针对慢性疾病如高血压的随机对照试验可以发现，在从家庭医疗中抽取的样本中，大多数符合条件的患者患有共病。应报告这些患者是否被抽样或排除。旨在应用于医疗实践的研究结果应考虑到有效治疗这些患者的复杂现实。
PURPOSE Many randomized controlled trials (RCTs) exclude patients who have multiple comorbidities. The aim of this study was to illustrate the prevalence of comorbidities among patients followed up in primary care who would have met the inclusion criteria of selected RCTs focusing on treatment of a particular condition. We used hypertension as an example of a particular chronic condition.METHODS We used an existing database of 980 patients (660 women) that was representative of a population consulting primary care family doctors and that contained information about all chronic conditions. We randomly selected 5 RCTS that focused on patients with hypertension. The inclusion and exclusion criteria used in each of the 5 RCTs were applied (I study at a time) to the patients in our database. The patients from our data set who met the inclusion criteria of a given RCT were considered eligible for that RCT.RESULTS Of the patients from our data set who were eligible for each of the RCTs, 89% to 100% had multiple chronic conditions. The mean number of chronic conditions of patients eligible for each RCT ranged from 5.5 +/- 3.3 to 11.7 +/- 5.3.CONCLUSIONS Results from this study suggest that RCTs targeting a chronic medical condition such as hypertension could find that, in a sample taken from family practice, most eligible patients have comorbid conditions. Whether these patients are sampled or excluded should be reported. Research results intended to be applied in medical practice should take the complex reality of effective treatment of these patients into consideration.