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Evaluating the effectiveness of using PROs in clinical practice: a role for cluster-randomised trials

机译：评估在临床实践中使用PRO的有效性：集群随机试验的作用

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摘要

Many of us believe there are major benefits to be gained by using patient-reported outcomes (PROs) in routine clinical practice. However, demonstrating tangible benefits has frequently proved elusive. Although randomised clinical trials (RCTs) have become accepted as the standard for comparing alternative forms of clinical interventions, when evaluating the effectiveness of PROs there are a number of challenges both in terms of study design and the subsequent analysis. Despite this, to date, of those investigators who have used RCTs, relatively few have used anything other than simple two-group randomisation and comparisons. Most of these trials have also failed to demonstrate convincing benefits to patient outcomes. We suggest that the use of PROs may result in modest yet important improvements to patient outcomes, and that these benefits may be obscured in conventional individual patient trials because of contamination effects. The advantages of alternative designs such as cross-over studies and in particular cluster-randomised trials are illustrated.
机译：我们中的许多人相信，在常规临床实践中使用患者报告的结局（PRO）可带来重大好处。但是，证明有形的收益常常难以捉摸。尽管随机临床试验（RCT）已成为比较其他形式的临床干预措施的标准，但在评估PRO的有效性时，在研究设计和后续分析方面都存在许多挑战。尽管如此，迄今为止，在使用RCT的研究者中，很少有人使用简单的两组随机化和比较以外的方法。这些试验中的大多数也未能证明对患者预后的令人信服的益处。我们建议使用PRO可能会对患者的预后产生适度但重要的改善，并且由于污染的影响，在常规的单个患者试验中可能无法掩盖这些益处。说明了交叉设计等替代设计的优势，尤其是集群随机试验。

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