Hatswell Anthony James, Vegter Stefan
BresMed, 84 Queen Street, S1 2DW, Sheffield, UK.
University College London, London, UK.
Health Econ Rev. 2016 Dec;6(1):14. doi: 10.1186/s13561-016-0091-9. Epub 2016 Apr 21.
In health economic evaluations, quality of life should be measured with preference-based utilities, such as the EuroQol 5 Dimension 3-level (EQ-5D-3 L). Non-preference-based instruments (often disease-specific questionnaires) are commonly mapped to utilities. We investigated if the relationship observed between the Patient Assessment of Constipation Quality of Life (PAC-QOL) and the EQ-5D-3 L in patients with chronic idiopathic constipation (CIC) also applies in opioid-induced constipation (OIC).
EQ-5D-3 L patient-level data from a clinical study of lubiprostone in OIC (n = 439) were scored using the UK tariff. A published mapping between the PAC-QOL and the EQ-5D-3 L was tested using these data. New mapping formulas were analysed, including PAC-QOL total and subscale scores. The root mean square error (RMSE), the adjusted R(2) and predicted/observed plots were used to test the fit.
The utility measured with the EQ-5D-3 L was 0.450 ± 0.329, with a distinctly bimodal distribution. This significantly improved if patients responded to treatment (defined as an increase of three spontaneous bowel movements per week, with no rescue medication taken). The published mapping in CIC performed poorly in this OIC population, and the PAC-QOL could not be reliably mapped on to the EQ-5D-3 L even when re-estimating coefficients. This was shown in our two mappings (using PAC-QOL total score, and subscale scores) by a high RMSE (0.317 and 0.314) and a low R(2) (0.068 and 0.080), with high utilities underestimated and low utilities overestimated.
Patients with OIC have a low quality of life which does improve with the resolution of symptoms. However the PAC-QOL cannot be used to estimate the EQ-5D-3 L utility - potentially as the PAC-QOL does not capture the all relevant aspects of the patients quality of life (for example the cause of the opioid use).
在卫生经济评估中，生活质量应以基于偏好的效用进行衡量，例如欧洲五维度健康量表3级（EQ - 5D - 3L）。非基于偏好的工具（通常是疾病特异性问卷）通常被映射到效用值。我们研究了在慢性特发性便秘（CIC）患者中观察到的便秘生活质量患者评估量表（PAC - QOL）与EQ - 5D - 3L之间的关系是否也适用于阿片类药物引起的便秘（OIC）。
使用英国关税对来自阿片类药物引起的便秘患者中鲁比前列酮的一项临床研究（n = 439）的EQ - 5D - 3L患者水平数据进行评分。使用这些数据测试已发表的PAC - QOL与EQ - 5D - 3L之间的映射关系。分析了新的映射公式，包括PAC - QOL总分和子量表分数。使用均方根误差（RMSE）、调整后的R²以及预测/观察图来检验拟合度。
用EQ - 5D - 3L测量的效用值为0.450±0.329，具有明显的双峰分布。如果患者对治疗有反应（定义为每周自发排便增加三次且未使用急救药物），则该效用值会显著改善。在CIC中已发表的映射在该OIC人群中表现不佳，并且即使重新估计系数，PAC - QOL也无法可靠地映射到EQ - 5D - 3L。这在我们的两个映射（使用PAC - QOL总分和子量表分数）中表现为高RMSE（0.317和0.314）和低R²（0.068和0.080），高效用值被低估，低效用值被高估。
阿片类药物引起的便秘患者生活质量较低，症状缓解后生活质量会有所改善。然而，PAC - QOL不能用于估计EQ - 5D - 3L效用值 - 可能是因为PAC - QOL没有涵盖患者生活质量的所有相关方面（例如使用阿片类药物的原因）。
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