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Pragmatic trials in primary care. Methodological challenges and solutions demonstrated by the DIAMOND-study

机译：初级保健的务实试验。 DIAMOND研究证明了方法论上的挑战和解决方案

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Background Pragmatic randomised controlled trials are often used in primary care to evaluate the effect of a treatment strategy. In these trials it is difficult to achieve both high internal validity and high generalisability. This article will discuss several methodological challenges in designing and conducting a pragmatic primary care based randomised controlled trial, based on our experiences in the DIAMOND-study and will discuss the rationale behind the choices we made. From the successes as well as the problems we experienced the quality of future pragmatic trials may benefit. Discussion The first challenge concerned choosing the clinically most relevant interventions to compare and enable blinded comparison, since two interventions had very different appearances. By adding treatment steps to one treatment arm and adding placebo to both treatment arms both internal and external validity were optimized. Nevertheless, although blinding is essential for a high internal validity, it should be warily considered in a pragmatic trial because it decreases external validity. Choosing and recruiting a representative selection of participants was the second challenge. We succeeded in retrieving a representative relatively large patient sample by carefully choosing (few) inclusion and exclusion criteria, by random selection, by paying much attention to participant recruitment and taking the participant's reasons to participate into account. Good and regular contact with the GPs and patients was to our opinion essential. The third challenge was to choose the primary outcome, which needed to reflect effectiveness of the treatment in every day practice. We also designed our protocol to follow every day practice as much as possible, although standardized treatment is usually preferred in trials. The aim of this was our fourth challenge: to limit the number of protocol deviations and increase external validity. Summary It is challenging to design and conduct a pragmatic trial. Thanks to thorough preparation, we were able to collect highly valid data. To our opinion, a critical deliberation of where on the pragmatic – explanatory spectrum you want your trial to be on forehand, in combination with consulting publications especially on patient recruitment procedures, has been helpful in conducting a successful trial.
机译：背景实用随机对照试验通常用于初级保健，以评估治疗策略的效果。在这些试验中，很难同时实现较高的内部有效性和较高的通用性。本文将根据我们在DIAMOND研究中的经验，讨论在设计和进行实用的基于初级护理的随机对照试验中遇到的一些方法学挑战，并将讨论我们做出选择的背后原因。从成功和问题中我们可以体验到未来实用测试的质量。讨论第一个挑战涉及选择临床上最相关的干预措施以进行比较并进行盲目比较，因为两种干预措施的外观非常不同。通过向一个治疗组添加治疗步骤，并向两个治疗组添加安慰剂，可以优化内部和外部有效性。尽管如此，尽管盲目性对于提高内部效度是必不可少的，但在务实的试验中应谨慎考虑，因为盲法会降低外部效度。选择和招募具有代表性的参与者是第二个挑战。我们通过精心选择（很少）纳入和排除标准，通过随机选择，高度重视参与者招募并考虑参与者参与的原因，成功地获得了代表性的相对较大的患者样本。在我们看来，与全科医生和患者保持良好且定期的联系至关重要。第三个挑战是选择主要结果，这需要反映每天实践中治疗的有效性。尽管在试验中通常首选标准化治疗，但我们还设计了尽可能遵循日常实践的方案。这样做的目的是我们的第四个挑战：限制协议偏差的数量并提高外部有效性。总结设计和进行务实的尝试具有挑战性。经过周密的准备，我们得以收集高度有效的数据。我们认为，关键的考虑是希望在实用的解释性频谱上让您先进行研究，再结合咨询出版物，尤其是有关患者招募程序的咨询出版物，对成功进行试验很有帮助。

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