背景:为退行性颈椎病(DCM)开发新的临床措施是一项AO脊柱RECODE-DCM研究,国际和多方利益攸关方伙伴关系,优先级。检测DCM及其变化的困难导致临床环境中的诊断和治疗延迟,以及由于招募目标提高而导致的临床试验成本增加。数字结果测量可以解决这些挑战,因为它们能够远程测量疾病,反复,更经济。
目的:本研究的目的是评估MoveMed电池性能结果指标的可靠性。
方法:在英格兰进行了一项分散二级保健的前瞻性观察研究,联合王国。主要结果是使用协议的组内相关性(ICC)确定MoveMed性能结果的重测可靠性。次要结果是使用协议的平均值(SEM)和协议的最小可检测变化(SDC)来确定MoveMed性能结果的测量误差。使用基于共识的健康测量仪器选择标准(COSMIN)手册中的标准来确定足够的可靠性(即,协议的ICC≥0.7)和偏差风险。使用2个最小临床重要差异(MCID)阈值控制疾病稳定性,该阈值是从患者衍生的改良日本骨科协会(p-mJOA)评分的文献中获得的,即,MCID≤1点,MCID≤2点。
结果:总计,7名年龄在59.5(SD12.4)岁,患有DCM并拥有批准的智能手机的成年人参与了该研究。所有测试均显示中等至出色的重测系数和较低的测量误差。在MCID≤1组中,在快速点击测试中,一致值的ICC为0.84-0.94,保持试验中的0.89-0.95,在打字测试中为0.95,站立和行走测试为0.98。一致值的SEM为±1抽头,±1%-3%稳定性得分点,每秒±0.06个按键,每分钟±10步,分别。一致值的SDC为±3个抽头,±4%-7%稳定性得分点,每秒±0.2键,每分钟±27步,分别。在MCID≤2组中,一致值的ICC分别为0.61-0.91、0.75-0.77、0.98和0.62;一致值的SEM为±1分,±2%-4%稳定性得分点,每秒±0.06个按键,每分钟±10步,协议值的SDC分别为±3-7抽头,±7%-10%稳定性得分点,每秒±0.2键,每分钟±27步,分别。此外,快速的水龙头,Hold,在MCID≤1组和MCID≤2组中,分型测试获得了足够的评级(符合≥0.7的ICC)。没有记录COSMIN偏差风险检查表中的偏差风险因素。
结论:COSMIN的标准为患有DCM的成年人群中MoveMed测试的可靠性提供了“非常好”的质量证据。
BACKGROUND: Developing new clinical measures for degenerative cervical myelopathy (DCM) is an AO Spine RECODE-DCM Research, an international and multi-stakeholder partnership, priority. Difficulties in detecting DCM and its changes cause diagnostic and treatment delays in clinical settings and heightened costs in clinical trials due to elevated recruitment targets. Digital outcome measures can tackle these challenges due to their ability to measure disease remotely, repeatedly, and more economically.
OBJECTIVE: The aim of this
study is to assess the reliability of the MoveMed battery of performance outcome measures.
METHODS: A prospective observational
study in decentralized secondary care was performed in England, United Kingdom. The primary outcome was to determine the test-retest reliability of the MoveMed performance outcomes using the intraclass correlation (ICC) of agreement . The secondary outcome was to determine the measurement error of the MoveMed performance outcomes using both the SE of the mean (SEM) of agreement and the smallest detectable change (SDC) of agreement . Criteria from the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) manual were used to determine adequate reliability (ie, ICC of agreement ≥0.7) and risk of bias. Disease stability was controlled using 2 minimum clinically important difference (MCID) thresholds obtained from the literature on the patient-derived modified Japanese Orthopaedic Association (p-mJOA) score, namely, MCID ≤1 point and MCID ≤2 points.
RESULTS: In total, 7 adults aged 59.5 (SD 12.4) years who live with DCM and possess an approved smartphone participated in the
study. All tests demonstrated moderate to excellent test-retest coefficients and low measurement errors. In the MCID ≤1 group, ICC of agreement values were 0.84-0.94 in the fast tap test, 0.89-0.95 in the hold test, 0.95 in the typing test, and 0.98 in the stand and walk test. SEM of agreement values were ±1 tap, ±1%-3% stability score points, ±0.06 keys per second, and ±10 steps per minute, respectively. SDC of agreement values were ±3 taps, ±4%-7% stability score points, ±0.2 keys per second, and ±27 steps per minute, respectively. In the MCID ≤2 group, ICC of agreement values were 0.61-0.91, 0.75-0.77, 0.98, and 0.62, respectively; SEM of agreement values were ±1 tap, ±2%-4% stability score points, ±0.06 keys per second, and ±10 steps per minute, respectively; and SDC of agreement values were ±3-7 taps, ±7%-10% stability score points, ±0.2 keys per second, and ±27 steps per minute, respectively. Furthermore, the fast tap, hold, and typing tests obtained sufficient ratings (ICC of agreement ≥0.7) in both MCID ≤1 and MCID ≤2 groups. No risk of bias factors from the COSMIN Risk of Bias checklist were recorded.
CONCLUSIONS: The criteria from COSMIN provide \"very good\" quality evidence of the reliability of the MoveMed tests in an adult population living with DCM.