Extending the floor and the ceiling for assessment of physical function.

Extending the floor and the ceiling for assessment of physical function.
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DOI:
10.1002/art.38342
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发表时间:
2014-05
影响因子:
13.3
通讯作者:
Krishnan, Eswar
Krishnan, Eswar
中科院分区:
医学1区
文献类型:
--
作者:
Fries, James F.;Lingala, Bharathi;Siemons, Liseth;Glas, Cees A. W.;Cella, David;Hussain, Yusra N.;Bruce, Bonnie;Krishnan, Eswar

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当前研究的目的是通过提高健康连续体的下限(功能极差)和上限(健康状况极好)的评估精度来改进身体功能的评估。根据 NIH PROMIS 计划,我们开发了新的物理功能地板和天花板项目来补充现有的项目库。使用项目反应理论 (IRT) 和标准 PROMIS 方法,我们开发了 30 个最低项目和 26 个最高项目,并在对 737 名处于极端健康状况的个体进行的为期 12 个月的前瞻性观察研究中进行管理。通过效果大小的方式比较不同锚定工具和不同项目随时间的变化。利用观察到的分数变化,我们反算了新措施和比较措施的样本量要求。我们研究了 444 名患有慢性病和/或高龄的受试者,以及 293 名一般健康受试者,包括正在训练的运动员。 IRT 分析证实,新的地板和天花板项目优于参考项目 (p<0.001)。估计的事后样本量要求在下限减少了二到四倍,在上限减少了两倍。扩大身体机能测量范围可以大幅提高测量质量,可以减少样本量要求并提高研究效率。从残疾到身体功能的范式转变包括整个身体功能范围,标志着结果评估概念基础的改进,并且随着医疗目标更加接近社会健康目标,可能会带来变革。
The objective of the current study was to improve the assessment of physical function by improving the precision of assessment at the floor (extremely poor function) and at the ceiling (extremely good health) of the health continuum. Under the NIH PROMIS program, we developed new physical function floor and ceiling items to supplement the existing item bank. Using item response theory (IRT) and the standard PROMIS methodology, we developed 30 floor items and 26 ceiling items and administered them during a 12-month prospective observational study of 737 individuals at the extremes of health status. Change over time was compared across anchor instruments and across items by means of effect sizes. Using the observed changes in scores, we back-calculated sample size requirements for the new and comparison measures. We studied 444 subjects with chronic illness and/or extreme age, and 293 generally fit subjects including athletes in training. IRT analyses confirmed that the new floor and ceiling items outperformed reference items (p<0.001). The estimated post-hoc sample size requirements were reduced by a factor of two to four at the floor and a factor of two at the ceiling. Extending the range of physical function measurement can substantially improve measurement quality, can reduce sample size requirements and improve research efficiency. The paradigm shift from Disability to Physical Function includes the entire spectrum of physical function, signals improvement in the conceptual base of outcome assessment, and may be transformative as medical goals more closely approach societal goals for health.
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