Tatlock Sophi, Arbuckle Rob, Sanchez Robert, Grant Laura, Khan Irfan, Manvelian Garen, Spertus John A
Adelphi Values Ltd., Bollington, Cheshire, UK.
Adelphi Values Ltd., Bollington, Cheshire, UK.
Value Health. 2017 Mar;20(3):430-440. doi: 10.1016/j.jval.2016.09.2410. Epub 2016 Dec 1.
Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, significantly reduces low-density lipoprotein cholesterol, but requires subcutaneous injections rather than oral pills. To measure patients' acceptance of this treatment modality, a new patient-reported outcome, the Injection-Treatment Acceptance Questionnaire (I-TAQ), was developed.
To psychometrically evaluate the I-TAQ with patients at high risk of cardiovascular events receiving alirocumab.
The 22-item, 5-domain I-TAQ was administered cross-sectionally to 151 patients enrolled in alirocumab clinical trials. Item response distributions, factor and multitrait analyses, interitem correlations, correlations with an existing measure of acceptance (convergent validity), and comparison of known-groups were performed to assess the I-TAQ's psychometric properties.
Completion rates were high, with no patients missing more than two items and 91.4% missing no data. All items displayed high ceiling effects (>30%) because of high treatment acceptance. Factor analysis supported the a priori hypothesized item-domain structure with good fit indices (root mean square error approximation = 0.070; comparative fit index = 0.988) and high factor loadings. All items demonstrated item convergent validity (item-scale correlation ≥0.40), except for the side effects domain, which was limited by small numbers (n = 46). Almost all items correlated most highly with the domain to which they were assigned (item discriminant validity). Internal reliability was acceptable for all domains (Cronbach α range 0.72-0.88) and convergent validity was supported by a logical pattern of correlations with the Chronic Treatment Acceptance Questionnaire.
These findings provide initial evidence of validity and reliability for the I-TAQ in patients treated with subcutaneous alirocumab. The I-TAQ could prove to be a valuable patient-reported outcome for therapies requiring subcutaneous injection.
阿利西尤单抗是一种前蛋白转化酶枯草溶菌素9型抑制剂，可显著降低低密度脂蛋白胆固醇，但需要皮下注射而非口服片剂。为了衡量患者对这种治疗方式的接受程度，开发了一种新的患者报告结局指标——注射治疗接受度问卷（I-TAQ）。
对接受阿利西尤单抗治疗的心血管事件高危患者进行I-TAQ的心理测量学评估。
对151名参与阿利西尤单抗临床试验的患者进行横断面调查，使用包含22个项目、5个领域的I-TAQ。进行项目反应分布、因子分析和多特质分析、项目间相关性分析、与现有接受度测量指标的相关性分析（收敛效度）以及已知组比较，以评估I-TAQ的心理测量学特性。
完成率很高，没有患者漏答超过两项，91.4%的患者无数据缺失。由于治疗接受度高，所有项目均显示出较高的天花板效应（>30%）。因子分析支持了先验假设的项目-领域结构，拟合指数良好（均方根误差近似值 = 0.070；比较拟合指数 = 0.988）且因子载荷较高。除副作用领域因样本量较小（n = 46）受限外，所有项目均显示出项目收敛效度（项目-量表相关性≥0.40）。几乎所有项目与其所属领域的相关性最高（项目区分效度）。所有领域的内部信度均可接受（克朗巴赫α系数范围为0.72 - 0.88）且与慢性治疗接受度问卷的相关性逻辑模式支持收敛效度。
这些发现为皮下注射阿利西尤单抗治疗的患者中I-TAQ的有效性和可靠性提供了初步证据。I-TAQ可能被证明是一种适用于需要皮下注射治疗的有价值的患者报告结局指标。
