The Egyptian EQ-5D-5L Extensive Pilot Study: Lessons Learned

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.