QUAlitative Research in Trials - the QUART Study

随着时间的推移，研究人员看待医疗保健有效性的方式发生了变化。他们更有可能使用随机对照试验（rct）的定性方法（访谈、焦点小组、观察）。例如，与患者的访谈可以用来帮助开发完全满足他们需求的治疗和服务，探索患者和工作人员在现实世界中如何使用治疗，或帮助解释研究结果。在实践中，研究人员可能会使用定性研究来“增加随机对照试验的价值”，或者作为只关注疾病或患者群体的额外研究。如果我们要了解转向混合方法方法（这种定性方法和随机对照试验的结合）可能提供的好处，则需要更仔细地检查定性研究方法的使用。我们将讨论“定性方法在随机对照试验中有什么作用？”在试验中或与试验同时使用定性方法的例子将从两个来源确定。首先，我们将对关键数据库进行系统搜索，以找到报道在随机对照试验中使用定性方法的期刊文章。其次，我们将搜索研究数据库，找到使用定性方法的报告和协议。后一种方法将确定在随机对照试验中采用定性方法的最新方法。初步搜索表明，我们将找到大约100-200个相关研究。我们将从文章、提案和报告中提取信息，以描述和分类目前使用定性方法的不同方式。该研究将提供在随机对照试验中成功使用定性方法的例子；提高对如何使用定性方法来辅助（或不辅助）试验产生的证据基础的认识；并确定研究人员可以在试验中最好地使用定性方法的方法。总体目标是告知我们如何进行研究以改善医疗保健。

The way in which researchers look at the effectiveness of health care has changed over time. They are more likely to use qualitative methods (interviews, focus groups, observation) with randomised controlled trials (RCTs). For example interviews with patients might be used to help develop treatments and services which fully meet their needs, explore how treatments are used by both patients and staff in the real world, or help to interpret the study results. In practice, researchers may be using qualitative research to ‘add value to RCTs‘, or as an additional piece of research focused solely on the disease or patient group. The use of qualitative research methods requires closer inspection if we are to understand the benefits that a shift to a mixed methods approach (this combination of qualitative methods and RCTs) might offer. We will address the question ‘what work do qualitative methods do in RCTs?‘Examples of the use of qualitative methods in or alongside trials will be identified from two sources. First, we will undertake a systematic search of key databases to find journal articles that report the use of qualitative methods in the context of an RCT. Second, we will search databases of studies to find reports and protocols that use qualitative methods. This latter approach will identify the most up to date approach taken to qualitative methods in RCTs. Initial searches suggest that we will find around 100-200 relevant studies.We will extract information from the articles, proposals and reports to describe and categorise the different ways in which qualitative methods are currently used. The study will provide examples of the successful use of qualitative methods in RCTs; raise awareness of how qualitative methods are used to assist (or not) the evidence base produced by trials; and identify ways in which researchers can best use qualitative methods within trials. The overall aim is to inform how we do research to improve health care.