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醋酸格拉替雷治疗多发性硬化症患者的持续率(而非依从性)可通过健康相关生活质量和自我效能进行预测:一项基于网络的前瞻性以患者为中心的研究(CAIR研究)

Glatiramer acetate treatment persistence - but not adherence - in multiple sclerosis patients is predicted by health-related quality of life and self-efficacy: a prospective web-based patient-centred study (CAIR study).

作者信息

Jongen Peter Joseph, Lemmens Wim A, Hoogervorst Erwin L, Donders Rogier

机构信息

University Medical Centre Groningen, Department of Community and Occupational Medicine, University Groningen, Antonius Deusinglaan 1, 9713, AV, Groningen, The Netherlands.

MS4 Research Institute, Ubbergseweg 34, 6522, KJ, Nijmegen, The Netherlands.

出版信息

Health Qual Life Outcomes. 2017 Mar 14;15(1):50. doi: 10.1186/s12955-017-0622-z.

Abstract

BACKGROUND

In patients with relapsing remitting multiple sclerosis (RRMS) the persistence of and adherence to disease modifying drug (DMD) treatment is inadequate. To take individualised measures there is a need to identify patients with a high risk of non-persistence or non-adherence. As patient-related factors have a major influence on persistence and adherence, we investigated whether health-related quality of life (HRQoL) and self-efficacy could predict persistence or adherence.

METHODS

In a prospective web-based patient-centred study in 203 RRMS patients, starting treatment with glatiramer acatete (GA) 20 mg subcutaneously daily, we measured physical and mental HRQoL (Multiple Sclerosis Quality of Life-54 questionnaire), functional and control self-efficacy (Multiple Sclerosis Self-Efficacy Scale), the 12-month persistence rate and, in persistent patients, the percentage of missed doses. HRQoL and self-efficacy were compared between persistent and non-persistent patients, and between adherent and non-adherent patients. Logistic regression analysis was used to assess whether persistence and adherence were explained by HRQoL and self-efficacy.

RESULTS

Persistent patients had higher baseline physical (mean 58.1 [standard deviation, SD] 16.9) and mental HRQoL (63.8 [16.8]) than non-persistent patients (49.5 [17.6]; 55.9 [20.4]) (P = 0.001; P = 0.003) with no differences between adherent and non-adherent patients (P = 0.46; P = 0.54). Likewise, in persistent patients function (752 [156]) and control self-efficacy (568 [178]) were higher than in non-persistent patients (689 [173]; 491 [192]) (P = 0.009; P = 0.004), but not in adherent vs. non-adherent patients (P = 0.26; P = 0.82). Logistic regression modelling identified physical HRQoL and control self-efficacy as factors that explained persistence. Based on predicted scores from the model, patients were classified into quartiles and the percentage of non-persistent patients per quartile was calculated: non-persistence in the highest quartile was 23.4 vs. 53.2% in the lowest quartile. Risk differentiation with respect to adherence was not possible. Based on these findings we propose a practical work-up scheme to identify patients with a high risk of non-persistence and to identify persistence-related factors.

CONCLUSIONS

Findings suggest that pre-treatment physical HRQoL and control self-efficacy may identify RRMS patients with a high risk of early discontinuation of injectable DMD treatment. Targeting of high-risk patients may enable the efficient use of persistence-promoting measures.

TRIAL REGISTRATION

Nederlands Trial Register code: NTR2432 .

摘要

背景

在复发缓解型多发性硬化症(RRMS)患者中,疾病修饰药物(DMD)治疗的持续性和依从性不足。为采取个体化措施,有必要识别出持续性或依从性低风险的患者。由于患者相关因素对持续性和依从性有重大影响,我们研究了健康相关生活质量(HRQoL)和自我效能是否能预测持续性或依从性。

方法

在一项针对203例RRMS患者的前瞻性网络患者中心研究中,患者开始每日皮下注射20mg醋酸格拉替雷(GA)治疗,我们测量了身体和心理HRQoL(多发性硬化症生活质量-54问卷)、功能和控制自我效能(多发性硬化症自我效能量表)、12个月的持续率,以及持续治疗患者的漏服剂量百分比。比较了持续治疗和未持续治疗患者之间,以及依从和不依从患者之间的HRQoL和自我效能。采用逻辑回归分析评估持续性和依从性是否由HRQoL和自我效能来解释。

结果

持续治疗的患者基线身体(平均58.1[标准差,SD]16.9)和心理HRQoL(63.8[16.8])高于未持续治疗的患者(49.5[17.6];55.9[20.4])(P = 0.001;P = 0.003),依从和不依从患者之间无差异(P = 0.46;P = 0.54)。同样,持续治疗患者的功能(752[156])和控制自我效能(568[178])高于未持续治疗的患者(689[173];491[192])(P = 0.009;P = 0.004),但依从和不依从患者之间无差异(P = 0.26;P = 0.82)。逻辑回归模型确定身体HRQoL和控制自我效能是解释持续性的因素。根据模型预测分数,将患者分为四分位数,并计算每个四分位数中未持续治疗患者的百分比:最高四分位数中的未持续性为23.4%,而最低四分位数中为53.2%。关于依从性的风险区分是不可能的。基于这些发现,我们提出了一个实用的检查方案,以识别未持续性高风险患者并确定与持续性相关的因素。

结论

研究结果表明,治疗前的身体HRQoL和控制自我效能可能识别出RRMS患者中早期停用注射用DMD治疗的高风险患者。针对高风险患者可能有助于有效利用促进持续性的措施。

试验注册

荷兰试验注册代码:NTR2432 。

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