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招募临床试验参与者:对参与原因的研究的元民族志综合分析。

Recruitment to clinical trials: a meta-ethnographic synthesis of studies of reasons for participation.

机构信息

Research Fellow, Health Services Research Unit, University of Aberdeen, UK.

出版信息

J Health Serv Res Policy. 2013 Oct;18(4):233-41. doi: 10.1177/1355819613483126. Epub 2013 Aug 28.

DOI:10.1177/1355819613483126
PMID:23986530
Abstract

OBJECTIVES

Randomized controlled trials are important for evaluating health care interventions, but recruitment can be difficult. Studies of potential participants' perspectives on trial participation are accumulating, but their collective contribution is not obvious. In 2007, we conducted a meta-ethnographic synthesis of people's reasons for accepting or declining participation. This paper reports a second synthesis, conducted separately on the same topic, using studies published subsequently. It discusses both the substantive findings and the methodological implications for updating meta-ethnographies.

METHODS

Systematic searches identified relevant papers published between 1996 and 2005 (first synthesis), then 2005 and 2010 (second synthesis). We used a meta-ethnographic interpretive process of translation to examine the relationships between study findings.

FINDINGS

The two syntheses were broadly compatible, but the line of argument developed in the second more clearly highlighted how potential participants' health states and health care situations at the time of recruitment could interact with other considerations. In particular, they could influence the nature and significance for trial entry decisions of people's judgements about: their communication and relationship with trial recruiters; the personal implications of trial interventions and processes; and the 'common good' (helping others) and what their non/participation might say about their identity.

CONCLUSIONS

Our work highlights the need for trialists to consider potential participants' health and health care situations when designing recruitment approaches. It also provides the first empirical insights on the process of updating meta-ethnographies that we are currently aware of. Approaches to updating meta-ethnographies need further investigation.

摘要

目的

随机对照试验对于评估医疗干预措施非常重要,但招募可能会很困难。越来越多的研究关注潜在参与者对参与试验的看法,但它们的综合贡献并不明显。我们于 2007 年对人们接受或拒绝参与试验的原因进行了元人种学综合分析。本文报告了使用随后发表的研究资料进行的主题相同的第二次综合分析。本文既讨论了实质性发现,也讨论了更新元人种学的方法学意义。

方法

系统检索确定了 1996 年至 2005 年(第一次综合分析)和 2005 年至 2010 年(第二次综合分析)期间发表的相关论文。我们采用了元人种学解释性翻译方法来检验研究结果之间的关系。

发现

这两次综合分析基本一致,但第二次综合分析中提出的论点更清晰地突出了招募时潜在参与者的健康状况和医疗状况如何与其他因素相互作用。特别是,它们可能影响人们对以下方面的判断及其对试验参与决策的性质和意义:他们与试验招募人员的沟通和关系;试验干预措施和过程的个人影响;以及“共同利益”(帮助他人)和他们的参与/不参与可能对他们的身份意味着什么。

结论

我们的工作强调了试验设计者在设计招募方法时需要考虑潜在参与者的健康和医疗状况。它还提供了我们目前所了解的更新元人种学的过程的首批实证见解。更新元人种学的方法需要进一步研究。

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