Lema V M
Family Health International, Africa Regional Office, Valley Road, P.O. Box 38835-00623, Nairobi, Kenya.
East Afr Med J. 2009 Jun;86(6):291-9. doi: 10.4314/eamj.v86i6.54142.
To identify possible existence of therapeutic misconception and its effects on clinical trials in sub-Saharan Africa.
Original research findings and reviews published in the English literature and author's professional experience with clinical trials in some East, Central and West African countries.
Review of peer-reviewed articles.
Online searches and requests for reprints from corresponding authors and institutional subscription.
Information categorised accordingly.
Therapeutic misconception, defined as a conflation by research subjects of research goals and those of routine health care is considered widely prevalent globally. The subjects misunderstand the disclosures during consenting process and enroll hoping to derive personal benefits from the study. Though no study has looked at therapeutic misconception specifically in sub-Saharan Africa, available evidence suggests that it is prevalent. Therapeutic misconception is incompatible with informed voluntary consent. It may affect participation in clinical trials, subjects' safety and well-being and possibly the research findings.
There is need for studies to identify the prevalence and effects of therapeutic misconception in the region. Researchers in sub-Saharan Africa should be aware of its existence, thus design trials in which it will not have significant effects and strengthen the consent process to reduce it.
确定在撒哈拉以南非洲地区治疗性误解的可能存在情况及其对临床试验的影响。
发表在英文文献中的原始研究结果和综述，以及作者在一些东非、中非和西非国家进行临床试验的专业经验。
对同行评审文章的综述。
在线搜索、向通讯作者请求重印件以及机构订阅。
信息按相应类别分类。
治疗性误解被定义为研究对象将研究目标与常规医疗保健目标混为一谈，在全球范围内被广泛认为普遍存在。研究对象在同意过程中误解了披露内容，并怀着从研究中获得个人益处的期望参与试验。尽管尚无研究专门针对撒哈拉以南非洲地区的治疗性误解进行调查，但现有证据表明其普遍存在。治疗性误解与知情自愿同意不相容。它可能会影响临床试验的参与、受试者的安全和福祉，甚至可能影响研究结果。
有必要开展研究以确定该地区治疗性误解的患病率及其影响。撒哈拉以南非洲地区的研究人员应意识到其存在，从而设计出不会产生重大影响的试验，并加强同意过程以减少这种误解。
