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首页> 外文期刊>Controlled clinical trials >Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery.
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Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery.

机译：在整形外科的多中心随机试验中将损失限制在随访范围内。

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Even the best-designed, randomized controlled trials suffer when patients are lost to follow-up. Incomplete follow-up biases the results of a trial when patients who drop out are different from those who complete follow-up. This is exaggerated further when there are differential dropout rates between study groups. Previous randomized controlled trials in orthopedic trauma have reported up to 28% loss to follow-up. Only by striving to achieve a 0% loss to follow-up rate can we be certain that this type of bias does not affect our results. In our ongoing multicenter, randomized controlled trial comparing reamed and nonreamed intramedullary nailing of tibial shaft fractures, we have implemented several innovative strategies to minimize loss to follow-up. The exclusion criteria and consent process are designed to minimize losses. Study staff are carefully trained in communication and negotiation with patients. Additionally, a central methods center monitors all patient follow-up and aids in finding lost patients. Through these primary, secondary, and tertiary interventions, we have achieved 94% complete 1-year follow-up for the first 440 patients enrolled in the trial. Eleven patients withdrew consent, and we are unable to locate 17 patients. We have successfully minimized the loss to follow-up rate in our trial by incorporating innovative prevention and retention strategies into its design and conduct. Through planning, organization, and committing time and resources to minimizing loss to follow-up, other orthopedic trauma trials can hope to achieve the same high rates of follow-up.
机译：当患者失去随访时，即使是最佳设计的随机对照试验也会受到影响。如果辍学的患者与完成随访的患者不同，则随访不完全会使试验结果产生偏差。当研究组之间的辍学率存在差异时，这一点会进一步扩大。先前在骨科创伤方面的随机对照试验报告，随访损失高达28％。只有努力使追踪率降低0％，我们才能确定这种偏见不会影响我们的结果。在我们正在进行的多中心，随机对照的比较胫骨干骨折的扩髓和非扩髓髓内钉试验中，我们已经实施了几种创新策略，以最大程度地减少后续手术的损失。排除标准和同意流程旨在最大程度地减少损失。研究人员经过与患者沟通和谈判方面的认真培训。此外，中央方法中心会监控所有患者的随访情况，并帮助找到失踪的患者。通过这些一级，二级和三级干预，我们对参与该试验的前440名患者进行了94％的完整1年随访。 11位患者撤回了同意书，我们无法找到17位患者。通过将创新的预防和保留策略纳入其设计和行为，我们成功地将试验中的失访率降至最低。通过计划，组织和投入时间和资源以最大程度地减少随访损失，其他骨科创伤试验可以希望达到同样高的随访率。

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