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Abstract：
BACKGROUND: The Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP).
METHODS: This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation.
RESULTS: Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0-42) was recommended, including a more specific responder definition of 10-point improvement.
CONCLUSIONS: The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.
METHODS: This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation.
RESULTS: Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0-42) was recommended, including a more specific responder definition of 10-point improvement.
CONCLUSIONS: The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.
摘要：
背景：近视视力问卷（NAVQ-P）是一种患者报告的结果（PRO）测量，在有眼老视人群中开发，用于评估近视力功能影响。该研究完善并探索了NAVQ-P的心理测量特性和得分可解释性以及评估近视力矫正独立性（NVCI）的其他PRO项目，近视力满意度（NVS），和近视力矫正偏好（NVCP）。
方法：这是一项心理测量验证研究，使用作为IIb期临床试验（CUN8R44A2202）的一部分收集的PRO数据进行，该临床试验由235名来自美国的随机老花眼成年人组成，Japan,澳大利亚,和加拿大。基线时收集的数据，在3个月的试验治疗期间的第2周和第1、2和3个月被包括在分析中，以评估项目（问题）属性，NAVQ-P维度和评分，可靠性,有效性，和分数解释。
结果：对于大多数NAVQ-P和其他PRO项目，项目响应分布在整个响应量表中。验证性因素分析支持预定义的一维结构和NAVQ-P总分的计算作为近视力功能的量度。项目响应分布通知的项目删除，维度分析，项目反应理论，和以前的定性发现，包括临床输入，支持保留14个NAVQ-P项目。14项NAVQ-P总分具有优异的内部一致性(α=0.979)和较高的重测信度(组内相关系数>=0.898)。有很好的证据表明，与并发措施的强相关性支持所有PRO的结构相关有效性。还证明了已知组有效性和检测变化分析能力的优异结果。基于锚点和基于分布的方法通过生成有意义的变化阈值的组水平和个体内估计来支持分数的解释。建议在NAVQ-P总分（0-42分）的8-15分改善范围内进行有意义的患者内部变化，包括对10点改进的更具体的响应者定义。
结论：NAVQ-P，NVCI和NVS是有效且可靠的仪器，能够检测随时间的变化。研究结果强烈支持在临床/研究研究和老花眼人群的临床实践中使用这些措施作为结果评估。
方法：这是一项心理测量验证研究，使用作为IIb期临床试验（CUN8R44A2202）的一部分收集的PRO数据进行，该临床试验由235名来自美国的随机老花眼成年人组成，Japan,澳大利亚,和加拿大。基线时收集的数据，在3个月的试验治疗期间的第2周和第1、2和3个月被包括在分析中，以评估项目（问题）属性，NAVQ-P维度和评分，可靠性,有效性，和分数解释。
结果：对于大多数NAVQ-P和其他PRO项目，项目响应分布在整个响应量表中。验证性因素分析支持预定义的一维结构和NAVQ-P总分的计算作为近视力功能的量度。项目响应分布通知的项目删除，维度分析，项目反应理论，和以前的定性发现，包括临床输入，支持保留14个NAVQ-P项目。14项NAVQ-P总分具有优异的内部一致性(α=0.979)和较高的重测信度(组内相关系数>=0.898)。有很好的证据表明，与并发措施的强相关性支持所有PRO的结构相关有效性。还证明了已知组有效性和检测变化分析能力的优异结果。基于锚点和基于分布的方法通过生成有意义的变化阈值的组水平和个体内估计来支持分数的解释。建议在NAVQ-P总分（0-42分）的8-15分改善范围内进行有意义的患者内部变化，包括对10点改进的更具体的响应者定义。
结论：NAVQ-P，NVCI和NVS是有效且可靠的仪器，能够检测随时间的变化。研究结果强烈支持在临床/研究研究和老花眼人群的临床实践中使用这些措施作为结果评估。
