Fuller Rebecca L M, McNamara Cynthia W, Lenderking William R, Edgar Chris, Rylands Angela, Feaster Todd, Sabatino Donald, Miller David S
1 Bracket, Wayne, PA, USA.
2 Evidera, Lexington, MA, USA.
Ther Innov Regul Sci. 2016 Jan;50(1):30-36. doi: 10.1177/2168479015618693.
Electronic administration of clinician-reported outcomes (eClinROs) has advantages over paper-based methods, but the mode of administration change has the potential to affect the validity of the scale. The literature on migration of patient-reported outcomes (PROs) suggests that there are different levels of modification, which necessitate different approaches to demonstrating mode equivalence. However, little has been written on the migration of ClinROs to electronic administration.
We propose a method of comparing paper and electronic versions of scales that includes a comparison based on content and a comparison based on format. The determination of whether the eClinRO has undergone minor, moderate, or substantial modification will drive the necessary studies required for validation.
The unique characteristics of ClinROs suggest 2 additional types of modifications, including functionality adaptation and adaptation of instructions.
In many respects, the migration of a ClinRO to electronic administration is similar to that of a PRO. This article has explored the ways in which there might be special considerations for ClinROs that have not been elaborated for PROs.
临床医生报告结局（eClinROs）的电子化管理相较于纸质方法具有优势，但管理方式的改变有可能影响量表的效度。关于患者报告结局（PROs）转换的文献表明，存在不同程度的修改，这需要采用不同的方法来证明方式等效性。然而，关于ClinROs转换为电子化管理的文献较少。
我们提出一种比较纸质版和电子版量表的方法，包括基于内容的比较和基于格式的比较。确定eClinRO是经历了轻微、中度还是重大修改，将推动验证所需的必要研究。
ClinROs的独特特征表明还有另外两种修改类型，包括功能调整和说明调整。
在许多方面，ClinROs转换为电子化管理与PROs类似。本文探讨了ClinROs可能需要特殊考虑的方面，而这些方面在PROs中并未详细阐述。
Zotero 插件