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首页> 外文期刊>Drug and alcohol review >Implications of enrolment eligibility criteria in alcohol treatment outcome research: Generalisability and potential bias in 1-and 6-year outcomes
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Implications of enrolment eligibility criteria in alcohol treatment outcome research: Generalisability and potential bias in 1-and 6-year outcomes

机译：入组资格标准对酒精治疗结果研究的意义：1年和6年结果的普遍性和潜在偏见

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Introduction and Aims. It has been acknowledged that participants in clinical trials differ from real-world service users, primarily due to the extensive use of research eligibility criteria (EC). Generalisability and outcome bias become pressing issues when evidence-based treatment guidelines, crystallised from outcome research, influence treatment provision. This study reports on the effects of EC on generalisability and short- and long-term outcomes among real-world treatment-seekers. Design and Methods. Ten of the most commonly used EC were operationalised and applied to a large representative service user sample (n = 1125) from Stockholm County, Sweden, to determine the percentage of real-world problem alcohol users that would have been excluded by each EC and the extent to which EC bias the 1 and 6-year alcohol outcomes. Results. Individual EC excluded between 5% and 80% of real-world service users and 96% would have been excluded by at least one EC. Most of the EC introduced a positive/upwards bias in 1- and 6-year outcomes. Most notably, the removal of the unmotivatedon-compliant service users caused an upwards bias that would considerably boost estimates of treatment effectiveness. Other bias effects were smaller. Six-year effects were generally higher than for 1 year. Discussion and Conclusions. Outcome studies that exclude complex and non-compliant cases are not representative of real-world service users, and thus effectiveness estimates from clinical trials are biased by several commonly used EC. EC should be used judiciously and be taken into account in practice guidelines. This burgeoning research area should be further developed.
机译：简介和目的。已经认识到，临床试验的参与者不同于现实世界的服务用户，这主要是由于广泛使用了研究资格标准（EC）。当从结果研究中得出的循证治疗指南影响治疗方案时，可推广性和结果偏倚成为迫切的问题。这项研究报告了EC对现实世界寻求治疗者的普遍性以及短期和长期结果的影响。设计和方法。十个最常用的EC已投入运营，并应用于来自瑞典斯德哥尔摩县的大型代表性服务用户样本（n = 1125），以确定每个EC和EC偏向1年和6年饮酒结果的程度。结果。单个EC排除了5％至80％的实际服务用户，而至少有一个EC排除了96％。大多数EC在1年和6年结果中引入了积极/向上的偏见。最值得注意的是，无心/不合规的服务使用者的撤离造成了向上的偏见，这将大大提高对治疗效果的估计。其他偏见影响较小。六年的影响通常高于一年。讨论和结论。排除复杂和不合规病例的结果研究不能代表现实世界中的服务使用者，因此临床试验的有效性评估受到几种常用EC的偏见。应谨慎使用EC，并在实践准则中予以考虑。这个新兴的研究领域应进一步发展。

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