Where are persons with intellectual disabilities in medical research? A survey of published clinical trials
Where are persons with intellectual disabilities in medical research? A survey of published clinical trials
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DOI：
10.1111/jir.12091
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发表时间：
2014-09-01
影响因子：
3.6
通讯作者：
Burnham-Riosa, P.
中科院分区：
文献类型：
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作者：
Feldman, M. A.;Bosett, J.;Burnham-Riosa, P.
背景智力残疾人（ID）与其他人一样受到相同的医疗干预。鉴于许多ID患者的独特健康状况，不能假设他们对医疗的反应与没有ID的人相同。目前尚不清楚医学临床试验是否常规包括ID患者。这项研究调查的目的是检查ID患者是否包括在医学研究试验中，并确定是否可以进行调整和/或研究修改，以促进更多地纳入医学研究。方法随机选取2007年至2011年发表在6种影响力最大的医学期刊上的300篇随机对照和临床试验。对每项研究进行了审查，以纳入有ID的人，以及在不影响研究完整性的情况下可能采取的措施。通讯作者接受了一项随访调查，以确定是否包括ID患者，但文章中没有提到。结果在300项随机选择的研究中，只有6项（2%）明确包括ID患者。超过90%的研究设计的方式，将自动排除ID患者参与。作者调查显示，另外三项研究，包括ID的人。大多数ID的人可以参加至少70%的研究与简单的住宿和/或轻微的程序修改。讨论-研究结果突出了在医学研究中排除ID的人。需要努力通过研究、政策倡议和教育来增加包容性。
Background Persons with intellectual disabilities (ID) are exposed to the same medical interventions as everyone else. Given the unique health profiles of many persons with ID, it cannot be assumed that they will react to medical treatments the same as persons without ID. It is not clear if medical clinical trials routinely include persons with ID. The purpose of this research survey was to examine the inclusion of persons with ID in medical research trials, and to determine whether accommodations and/or study modifications could have been made to promote greater inclusion in medical research. Method Three hundred randomised control and clinical trials published between 2007 and 2011 in the six highest impact medical journals were randomly selected. Each study was reviewed for inclusion of persons with ID, and possible accommodations that could have been put in place without compromising research integrity. Corresponding authors received a follow-up survey to determine whether persons with ID were included, but were not mentioned in the article. Results Only 6 (2%) of 300 randomly chosen studies clearly included persons with ID. Over 90% of studies were designed in ways that would automatically exclude persons with ID from participating. The author survey revealed three additional studies including persons with ID. Most persons with ID could have participated in at least 70% of the studies with simple accommodations and/or minor procedural modifications. Discussion The findings highlight the exclusion of persons with ID in medical research. Efforts are needed to increase inclusion through research policy initiatives and education.