当前位置： SCI文献检索 > BMC Medicine期刊下所有文献 > Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis.

Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis.

Abstract：

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.

journal_name

BMC Med

journal_title

BMC medicine

authors

Hanlon P,Hannigan L,Rodriguez-Perez J,Fischbacher C,Welton NJ,Dias S,Mair FS,Guthrie B,Wild S,McAllister DA

doi

10.1186/s12916-019-1427-1

subject

Has Abstract

pub_date

2019-11-12 00:00:00

pages

201

issue

issn

1741-7015

pii

10.1186/s12916-019-1427-1

journal_volume

pub_type

杂志文章

在线工具

Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis.