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招募地点和方法对入组患者人群特征的可能影响:肠易激综合征临床试验设计

Likely impacts of recruitment site and methodology on characteristics of enrolled patient population: irritable bowel syndrome clinical trial design.

作者信息

Jones R

机构信息

Department of General Practice and Primary Care, Guy's, King's, and St. Thomas' School of Medicine, London, United Kingdom.

出版信息

Am J Med. 1999 Nov 8;107(5A):85S-90S. doi: 10.1016/s0002-9343(99)00085-6.

DOI:10.1016/s0002-9343(99)00085-6
PMID:10588178
Abstract

Approximately 15-20% of the general population of many western countries fulfill clinical diagnostic criteria for irritable bowel syndrome (IBS) and nearly 50% of referrals and follow-up appointments in hospital gastroenterology clinics are for functional bowel disorders. IBS is a common problem in the community, in primary care (general practice) and in secondary care (hospital, usually ambulatory) settings, and is also seen in tertiary (referral) centers, providing at least four potential settings for recruitment of patients into clinical trials. However, little is known about the influences that cause patients to choose different health-care settings or to stay away from the health-care system as "nonconsulters." Also, it is not known if patients seen at different health-care settings differ from each other. The aim of this review is to address the following questions: To what extent do subjects identified and enrolled in these settings differ from each other? What is the likely impact of different recruitment methods on subject selection? What problems for the interpretation and generalizability of data from clinical trials might these differences pose? What is the role of the sociomedical context (cultural beliefs and values and the structure of the health-care system) in different countries on the interpretation of clinical studies?

摘要

在许多西方国家,约15% - 20%的普通人群符合肠易激综合征(IBS)的临床诊断标准,医院胃肠病诊所近50%的转诊和随访预约是关于功能性肠病的。IBS在社区、初级保健(全科医疗)和二级保健(医院,通常为门诊)环境中都是常见问题,在三级(转诊)中心也有出现,这至少为将患者纳入临床试验提供了四个潜在场所。然而,对于促使患者选择不同医疗保健场所或作为“未就诊者”远离医疗保健系统的影响因素知之甚少。此外,在不同医疗保健场所就诊的患者彼此是否存在差异也不清楚。本综述的目的是解决以下问题:在这些场所确定并纳入研究的受试者在多大程度上彼此不同?不同招募方法对受试者选择可能产生什么影响?这些差异可能给临床试验数据的解释和推广带来哪些问题?不同国家的社会医学背景(文化信仰和价值观以及医疗保健系统的结构)在临床研究的解释中起什么作用?

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Likely impacts of recruitment site and methodology on characteristics of enrolled patient population: irritable bowel syndrome clinical trial design.招募地点和方法对入组患者人群特征的可能影响:肠易激综合征临床试验设计
Am J Med. 1999 Nov 8;107(5A):85S-90S. doi: 10.1016/s0002-9343(99)00085-6.
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Do patients with irritable bowel syndrome in primary care really differ from outpatients with irritable bowel syndrome?基层医疗中肠易激综合征患者与门诊肠易激综合征患者真的存在差异吗?
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Gut. 2007 Feb;56 Suppl 1(Suppl 1):1-113. doi: 10.1136/gut.2006.117598.
2
Autonomic nervous system function in women with irritable bowel syndrome.
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