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Inaccuracies Describing Results of a Lung Cancer Screening Demonstration Project
JAMA Internal Medicine ( IF 39.0 ) Pub Date : 2017-09-01 , DOI: 10.1001/jamainternmed.2017.3120
Linda L. Humphrey 1 , Mark Deffebach 1 , David E. Midthun 2
Affiliation  

In Reply We welcome this opportunity to make some clarifications, and to direct readers to previous publications that address many of the concerns raised by Zhang et al. There has been substantial interest from the scientific community in a complete picture of the net balance of benefits and harms of intensive blood pressure control.1 Because physical function represents one component of this evaluation, our study2 examined changes in gait speed in the subgroup of SPRINT participants 75 years or older at baseline.3 While procedures for the measurement of gait speed were specified in the SPRINT protocol, the authors are correct that gait speed and mobility limitation were not prespecified as outcomes in the protocol or on clinicaltrials.gov. However, gait speed is wellestablished, well-accepted measure of physical function, and so we reject any allusion that there was selective reporting of the outcomes in our study.2 Our article2 and other SPRINT publications3 have clearly acknowledged limitations in the generalizability of SPRINT. While there are certainly segments of the adult population to which the SPRINT results may not apply, estimates from the National Health and Nutrition Examination Survey have indicated that a large segment of older adults in the United States would be eligible for SPRINT, 34.6% of adults older than 75 years, or approximately 5.8 million adults.4 SPRINT2 did not systematically collect information on hearing and visual problems or balance disorders. However, we disagree that these issues, along with functional limitations and cognitive impairment, represent a concerning source of bias. While randomization does not guarantee covariate balance, for a trial the size of SPRINT (n > 2600 for participants 75 years or older), the likelihood of an important imbalance for any given covariate, measured or unmeasured, is very small. Using cognitive function as an example, there was no difference in baseline Montreal Cognitive Assessment scores across the treatment groups (median score of 22 for both groups) within the subgroup of participants 75 years or older.3 We included self-reported information about mobility in our analyses to try to address the concern that participants with poor physical function may not be able to complete the 4-meter walk test. In addition, we used multiple imputation to examine the impact of missing gait speed measurements. These analyses did not appreciably change our results in any of the scenarios we considered. Our study2 did not present any information on serious adverse events in the subgroup of participants 75 years and older because these results have been published and discussed previously.3,5,6 Therefore we do not recapitulate those discussions here.

中文翻译:

描述肺癌筛查示范项目结果的不准确之处

在回复中,我们欢迎有机会澄清一些问题,并将读者引向以前的出版物,这些出版物解决了 Zhang 等人提出的许多问题。科学界对强化血压控制的利弊净平衡的全貌非常感兴趣。 1 因为身体功能是该评估的一个组成部分,我们的研究 2 检查了 SPRINT 亚组中步态速度的变化参与者的基线年龄为 75 岁或以上。3 虽然 SPRINT 协议中规定了测量步态速度的程序,但作者是正确的,即步态速度和活动受限并未预先指定为协议或临床试验.gov 上的结果。然而,步态速度是公认的、公认的身体机能测量标准,因此,我们拒绝任何关于我们的研究中对结果进行选择性报告的暗示。2 我们的文章 2 和其他 SPRINT 出版物 3 明确承认 SPRINT 的普遍性存在局限性。虽然 SPRINT 结果可能不适用于某些成年人群,但根据国家健康和营养检查调查的估计,美国有很大一部分老年人有资格获得 SPRINT,即 34.6% 的成年人75 岁以上,或大约 580 万成年人。4 SPRINT2 没有系统地收集有关听力和视力问题或平衡障碍的信息。然而,我们不同意这些问题,连同功能限制和认知障碍,是一个令人担忧的偏见来源。虽然随机化并不能保证协变量的平衡,但对于 SPRINT 规模的试验(对于 75 岁或以上的参与者,n > 2600),任何给定协变量(测量的或未测量的)出现严重失衡的可能性非常小。以认知功能为例,在 75 岁或以上的参与者亚组中,各治疗组之间的基线蒙特利尔认知评估评分(两组的中位评分均为 22 分)没有差异。3 我们将有关活动能力的自我报告信息纳入我们的分析试图解决身体机能不佳的参与者可能无法完成 4 米步行测试的担忧。此外,我们使用多重插补来检查丢失步态速度测量值的影响。在我们考虑的任何场景中,这些分析都没有明显改变我们的结果。我们的研究 2 没有提供任何关于 75 岁及以上参与者亚组中严重不良事件的信息,因为这些结果之前已经发表和讨论过。3,5,6 因此我们不在这里重述这些讨论。
更新日期:2017-09-01
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