对正在进行的、针对10种常见慢性病且在ClinicalTrials.gov上注册的随机对照试验中伴有慢性病患者的排除情况：注册详情的系统评价
Exclusion of patients with concomitant chronic conditions in ongoing randomised controlled trials targeting 10 common chronic conditions and registered at ClinicalTrials.gov: a systematic review of registration details.
作者信息
Buffel du Vaure Céline, Dechartres Agnès, Battin Constance, Ravaud Philippe, Boutron Isabelle
机构信息
Faculté de Médecine, Département de médecine générale, Université Paris Descartes, Sorbonne Paris Cité, Paris, France Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France METHODS Team, Epidemiology and Statistics Sorbonne Paris Cité Research Center UMR 1153, INSERM, Paris, France.
Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France METHODS Team, Epidemiology and Statistics Sorbonne Paris Cité Research Center UMR 1153, INSERM, Paris, France Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Epidémiologie Clinique, Paris, France French Cochrane Center, Paris, France.
出版信息
BMJ Open. 2016 Sep 27;6(9):e012265. doi: 10.1136/bmjopen-2016-012265.
OBJECTIVES
To systematically assess registration details of ongoing randomised controlled trials (RCTs) targeting 10 common chronic conditions and registered at ClinicalTrials.gov and to determine the prevalence of (1) trial records excluding patients with concomitant chronic condition(s) and (2) those specifically targeting patients with concomitant chronic conditions.
DESIGN
Systematic review of trial registration records.
DATA SOURCES
ClinicalTrials.gov register.
STUDY SELECTION
All ongoing RCTs registered from 1 January 2014 to 31 January 2015 that assessed an intervention targeting adults with coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease, painful condition, depression and dementia with a target sample size ≥100.
DATA EXTRACTION
From the trial registration records, 2 researchers independently recorded the trial characteristics and the number of exclusion criteria and determined whether patients with concomitant chronic conditions were excluded or specifically targeted.
RESULTS
Among 319 ongoing RCTs, despite the high prevalence of the concomitant chronic conditions, patients with these conditions were excluded in 251 trials (79%). For example, although 91% of patients with CHD had a concomitant chronic condition, 69% of trials targeting such patients excluded patients with concomitant chronic condition(s). When considering the co-occurrence of 2 chronic conditions, 31% of patients with chronic pain also had depression, but 58% of the trials targeting patients with chronic pain excluded patients with depression. Only 37 trials (12%) assessed interventions specifically targeting patients with concomitant chronic conditions; 31 (84%) excluded patients with concomitant chronic condition(s).
CONCLUSIONS
Despite widespread multimorbidity, more than three-quarters of ongoing trials assessing interventions for patients with chronic conditions excluded patients with concomitant chronic conditions.
目的
系统评估在ClinicalTrials.gov注册的、针对10种常见慢性病的正在进行的随机对照试验（RCT）的注册详情，并确定（1）排除合并慢性病患者的试验记录以及（2）专门针对合并慢性病患者的试验记录的比例。
设计
对试验注册记录进行系统评价。
数据来源
ClinicalTrials.gov注册库。
研究选择
2014年1月1日至2015年1月31日期间注册的所有正在进行的RCT，这些试验评估了针对患有冠心病（CHD）、高血压、心力衰竭、中风/短暂性脑缺血发作、心房颤动、2型糖尿病、慢性阻塞性肺疾病、疼痛性疾病、抑郁症和痴呆症的成年人的干预措施，目标样本量≥100。
数据提取
2名研究人员从试验注册记录中独立记录试验特征和排除标准数量，并确定合并慢性病患者是被排除还是被专门纳入。
结果
在319项正在进行的RCT中，尽管合并慢性病的患病率很高，但251项试验（79%）排除了患有这些疾病的患者。例如，尽管91%的冠心病患者合并有其他慢性病，但针对此类患者的试验中有69%排除了合并慢性病的患者。当考虑两种慢性病同时存在的情况时，31%的慢性疼痛患者也患有抑郁症，但针对慢性疼痛患者的试验中有58%排除了患有抑郁症的患者。只有37项试验（12%）评估了专门针对合并慢性病患者的干预措施；其中31项（84%）排除了合并慢性病的患者。
结论
尽管普遍存在多种疾病并存的情况，但超过四分之三的正在进行的评估慢性病患者干预措施的试验排除了合并慢性病的患者。
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