Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, 11562, Egypt.
EuroQol Research Foundation, Rotterdam, The Netherlands.
Pharmacoeconomics. 2023 Mar;41(3):329-338. doi: 10.1007/s40273-022-01208-9. Epub 2022 Nov 25.
OBJECTIVES: To investigate the effect of an extensive pilot phase in improving protocol compliance, face validity, reduction of interviewer effect and prediction errors in the composite time trade-off (cTTO) data elicited as part of the EQ-5D-5L valuation study in Egypt. METHODS: This study used the cTTO data and quality control (QC) reports from the Egyptian EQ-5D-5L valuation study. Three-level mixed models were estimated to test whether interviewer effects were reduced during the pilot phase and subsequent rounds of collected cTTO data. Ordinary least square (OLS) regression analysis was conducted for each interviewer separately to test whether the mean absolute error (MAE) improved as interviewers completed more interviews. Moreover, improvement in protocol compliance, face validity and reduction of prediction errors in the cTTO data were tested. RESULTS: 1180 interviews were conducted by nine interviewers and included in the final analysis, of which 206 interviews were pilot and 974 interviews were actual. There was substantial improvement in the face validity and reduction of prediction errors in the cTTO data where the MAE of the actual data was 0.37, which is much lower than that of the pilot data, which was 0.44. However, there was an initial high level of protocol compliance in terms of the four indicators of the QC tool and the variance attributed to the interviewers was small throughout the whole study. CONCLUSIONS: This study clarified the benefits of the pilot phase and the strict implementation of the QC tool in improving the face validity and the prediction accuracy of the cTTO data. However, a more extensive pilot phase may be more beneficial in EQ-5D-5L valuation studies that have issues initially with protocol compliance and interviewer effects.
目的:研究广泛的试点阶段对提高复合时间权衡(cTTO)数据的方案依从性、表面有效性、减少访谈者效应和预测误差的影响,该数据是埃及 EQ-5D-5L 估值研究的一部分。
方法:本研究使用了埃及 EQ-5D-5L 估值研究的 cTTO 数据和质量控制(QC)报告。采用三级混合模型来检验在试点阶段和随后收集的 cTTO 数据的轮次中,访谈者效应是否减少。对每位访谈者分别进行普通最小二乘(OLS)回归分析,以检验随着访谈者完成更多访谈,平均绝对误差(MAE)是否得到改善。此外,还测试了 cTTO 数据的方案依从性、表面有效性和预测误差的减少。
结果:9 名访谈者共进行了 1180 次访谈,其中 206 次为试点访谈,974 次为实际访谈,最终纳入分析。cTTO 数据的表面有效性和预测误差都有显著改善,实际数据的 MAE 为 0.37,明显低于试点数据的 0.44。然而,QC 工具的四个指标在方案依从性方面的初始水平很高,并且整个研究过程中访谈者的方差很小。
结论:本研究阐明了试点阶段和严格执行 QC 工具在提高 cTTO 数据的表面有效性和预测准确性方面的益处。然而,在 EQ-5D-5L 估值研究中,对于最初在方案依从性和访谈者效应方面存在问题的研究,更广泛的试点阶段可能更有益。
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