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整合纵向分析不会影响精确度并减少成像结果研究中的偏差:DESIR 队列的 5 年比较分析。

Integrated longitudinal analysis does not compromise precision and reduces bias in the study of imaging outcomes: A comparative 5-year analysis in the DESIR cohort.

机构信息

Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal.

Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; Zuyderland Medical Center, Heerlen, the Netherlands.

出版信息

Semin Arthritis Rheum. 2020 Dec;50(6):1394-1399. doi: 10.1016/j.semarthrit.2020.02.017. Epub 2020 Mar 3.

DOI:10.1016/j.semarthrit.2020.02.017
PMID:32209237
Abstract

OBJECTIVE

To assess if an integrated longitudinal analysis using all available imaging data affects the precision of estimates of change in patients with axial spondyloarthritis (axSpA), with completers analysis as reference standard.

METHODS

Patients from the DESIR cohort fulfilling the ASAS axSpA criteria were included. Radiographs and MRIs of the sacroiliac joints and spine were obtained at baseline, 1, 2 and 5 years. Each image was scored by 2 or 3 readers in 3 'reading-waves' (or campaigns). Each outcome was analyzed: i. According to a 'combination algorithm' (e.g. '2 out of 3' for binary scores); and ii. Per reader. Change over time was analyzed with generalized estimating equations by 3 approaches: (a)'integrated-analysis' (all patients with ≥1 score from ≥1 reader from all waves); (b1)Completers-only analysis (patients with 5-year follow-up, using scores from individual readers); (b2)Completers analysis using a 'combination algorithm' (as (b1) but with combined scores). Approaches (b1) and (b2) were considered the 'reference'.

RESULTS

In total, 413 patients were included. The 'integrated analysis' was more inclusive with similar levels of precision of the change estimates as compared to both completers analyses. In fact, for low-incident outcomes (e.g.% mNY-positive over 5-years), an increased incidence was 'captured', with more precision, by the 'integrated analysis' compared to the completers analysis with combined scores (% change/year (95%CI): 1.1 (0.7; 1.5) vs 1.2 (0.5; 1.8), respectively).

CONCLUSION

An efficient and entirely assumption-free 'integrated analysis' does not jeopardize precision of the estimates of change in imaging parameters and may yield increased statistical power for detecting changes with low incidence.

摘要

目的

评估使用所有可用成像数据进行综合纵向分析是否会影响强直性脊柱炎(axSpA)患者变化估计的精度,以完成者分析作为参考标准。

方法

纳入符合 ASAS axSpA 标准的 DESIR 队列患者。在基线、1 年、2 年和 5 年时获取骶髂关节和脊柱的 X 线片和 MRI。由 2 或 3 名读者在 3 个“阅读波”(或活动)中对每张图像进行评分。对每个结果进行了分析:i. 根据“组合算法”(例如,二进制评分的“2 出 3”);和 ii. 每个读者。通过 3 种方法使用广义估计方程分析随时间的变化:(a)“综合分析”(所有患者在≥1 个波次中至少有 1 位读者的≥1 个评分);(b1)仅完成者分析(具有 5 年随访的患者,使用单个读者的评分);(b2)使用“组合算法”的完成者分析(与(b1)相同,但为组合评分)。方法(b1)和(b2)被认为是“参考”。

结果

共纳入 413 例患者。与两种完成者分析相比,“综合分析”更具包容性,且变化估计的精度相似。实际上,对于低发生率结局(例如,5 年内% mNY 阳性),“综合分析”比使用组合评分的完成者分析更能准确地“捕捉”到更高的发生率(年变化率/年(95%CI):1.1(0.7;1.5)比 1.2(0.5;1.8))。

结论

高效且完全无假设的“综合分析”不会危及成像参数变化估计的精度,并且可能为检测低发生率的变化提供更高的统计效力。

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