Department of Orthopaedics, University Hospital RWTH Aachen, Aachen, Germany.
Klinikum Darmstadt, Department of Orthopaedics Trauma and Hand Surgery, Darmstadt, Germany.
Knee. 2021 Oct;32:112-120. doi: 10.1016/j.knee.2021.08.010. Epub 2021 Aug 27.
Existing patient-reported outcome measures (PROMs) that assess knee pain and symptoms show insufficient quality regarding their psychometric properties. We developed and validated a new PROM assessing knee pain and especially patellofemoral pathologies, the COMPrehensive AaChen Knee Score (COMPACK).
We followed a three-phase process of development and validation. (1) Scale development: we conducted a systematic literature research to collect and analyse the most commonly used PROMs for knee and patellofemoral pathologies to identify appropriate items. (2) Pilot testing: we assessed the content validity of the COMPACK based on interviews with patients and health experts regarding relevance, comprehensibility and comprehensiveness of the used items. (3) Field testing: we used the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines to evaluate the structural validity, internal consistency and test-retest reliability of the COMPACK.
The COMPACK scale showed good structural validity, with two subscales measuring pain intensity and frequency. Further, scores of the COMPACK correlated positively with those obtained from the International Knee Documentation Committee Subjective Knee Form (IKDC) (r = 0.64) and the 12-item Short Form Health Survey subscale of physical function: (r = 0.43). Both the total scale and the two subscales showed good internal consistency (Cronbach's α > 0.82) and good to excellent test-retest reliability (Cronbach's α > 0.82).
The final COMPACK score was shown to be a valid and reliable instrument and thus meets the most important psychometric quality criteria. In its development, we specifically focused on its content validity, structural validity and applicability.
现有的评估膝关节疼痛和症状的患者报告结局测量（PROM）在心理测量学特性方面显示出不足的质量。我们开发并验证了一种新的 PROM，用于评估膝关节疼痛，特别是髌股关节疾病，即 COMPrehensive AaChen Knee Score（COMPACK）。
我们遵循了一个三阶段的开发和验证过程。（1）量表开发：我们进行了系统的文献研究，以收集和分析最常用于膝关节和髌股关节疾病的 PROM，以确定合适的项目。（2）预试验：我们根据患者和健康专家对使用项目的相关性、可理解性和全面性的访谈，评估了 COMPACK 的内容有效性。（3）现场测试：我们使用基于共识的健康测量仪器选择标准（COSMIN）指南来评估 COMPACK 的结构有效性、内部一致性和重测信度。
COMPACK 量表显示出良好的结构有效性，有两个子量表分别测量疼痛强度和频率。此外，COMPACK 的评分与国际膝关节文献委员会主观膝关节评分（IKDC）（r=0.64）和 12 项短式健康调查身体功能子量表（r=0.43）呈正相关。总量表和两个子量表均显示出良好的内部一致性（Cronbach's α>0.82）和良好至优秀的重测信度（Cronbach's α>0.82）。
最终的 COMPACK 评分被证明是一种有效且可靠的工具，因此符合最重要的心理测量学质量标准。在其开发过程中，我们特别关注其内容有效性、结构有效性和适用性。
