BACKGROUND Clinicians are less likely to prescribe guideline-recommended treatments to people with multimorbidity than to people with a single condition. Doubts as to the applicability of clinical trials of drug treatments (the gold standard for evidence-based medicine) when people have co-existing diseases (comorbidity) may underlie this apparent reluctance. Therefore, for a range of index conditions, we measured the comorbidity among participants in clinical trials of novel drug therapies and compared this to the comorbidity among patients in the community. METHODS Data from industry-sponsored phase 3/4 multicentre trials of novel drug therapies for chronic medical conditions were identified from two repositories: Clinical Study Data Request and the Yale University Open Data Access project. We identified 116 trials (n = 122,969 participants) for 22 index conditions. Community patients were identified from a nationally representative sample of 2.3 million patients in Wales, UK. Twenty-one comorbidities were identified from medication use based on pre-specified definitions. We assessed the prevalence of each comorbidity and the total number of comorbidities (level of multimorbidity), for each trial and in community patients. RESULTS In the trials, the commonest comorbidities in order of declining prevalence were chronic pain, cardiovascular disease, arthritis, affective disorders, acid-related disorders, asthma/COPD and diabetes. These conditions were also common in community-based patients. Mean comorbidity count for trial participants was approximately half that seen in community-based patients. Nonetheless, a substantial proportion of trial participants had a high degree of multimorbidity. For example, in asthma and psoriasis trials, 10-15% of participants had ≥ 3 conditions overall, while in osteoporosis and chronic obstructive pulmonary disease trials 40-60% of participants had ≥ 3 conditions overall. CONCLUSIONS Comorbidity and multimorbidity are less common in trials than in community populations with the same index condition. Comorbidity and multimorbidity are, nevertheless, common in trials. This suggests that standard, industry-funded clinical trials are an underused resource for investigating treatment effects in people with comorbidity and multimorbidity.

中文翻译：

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在新型药物疗法的临床试验中代表患有合并症和多重疾病的人：个体水平的参与者数据分析。

背景 与患有单一疾病的人相比，临床医生不太可能为患有多种疾病的人开出指南推荐的治疗方法。当人们患有共存疾病（合并症）时，对药物治疗临床试验（循证医学的金标准）的适用性的怀疑可能是这种明显不情愿的基础。因此，对于一系列指标条件，我们测量了新药物疗法临床试验参与者的合并症，并将其与社区患者的合并症进行了比较。方法 来自行业赞助的针对慢性疾病的新型药物疗法的 3/4 期多中心试验的数据来自两个存储库：临床研究数据请求和耶鲁大学开放数据访问项目。我们确定了 116 项试验（n = 122，969 名参与者）用于 22 个指数条件。社区患者是从英国威尔士的 230 万患者的全国代表性样本中确定的。根据预先指定的定义，从药物使用中确定了 21 种合并症。我们评估了每项试验和社区患者的每种合并症的患病率和合并症的总数（多发病水平）。结果 在试验中，最常见的合并症按患病率递减顺序依次为慢性疼痛、心血管疾病、关节炎、情感障碍、酸相关疾病、哮喘/慢性阻塞性肺病和糖尿病。这些情况在社区患者中​​也很常见。试验参与者的平均合并症计数约为社区患者的一半。尽管如此，很大一部分试验参与者有高度的多重疾病。例如，在哮喘和银屑病试验中，10-15% 的参与者总体有 ≥ 3 种疾病，而在骨质疏松症和慢性阻塞性肺病试验中，40-60% 的参与者总体有 ≥ 3 种疾病。结论 与具有相同指数条件的社区人群相比，试验中的共病和多病少见。然而，合并症和多重疾病在试验中很常见。这表明，标准的、由行业资助的临床试验是一种未充分利用的资源，用于调查患有合并症和多种疾病的人的治疗效果。而在骨质疏松症和慢性阻塞性肺病试验中，40-60% 的参与者总体上患有 ≥ 3 种疾病。结论 与具有相同指数条件的社区人群相比，试验中的共病和多病少见。然而，合并症和多重疾病在试验中很常见。这表明，标准的、由行业资助的临床试验是一种未充分利用的资源，用于调查患有合并症和多种疾病的人的治疗效果。而在骨质疏松症和慢性阻塞性肺病试验中，40-60% 的参与者总体上患有 ≥ 3 种疾病。结论 与具有相同指数条件的社区人群相比，试验中的共病和多病少见。然而，合并症和多重疾病在试验中很常见。这表明，标准的、由行业资助的临床试验是一种未充分利用的资源，用于调查患有合并症和多种疾病的人的治疗效果。