Abstract
ObjectivesThe objectives were to investigate the impact of ‘time‐effect’ on the estimation of quality‐adjusted life years (QALYs) along prospective clinical trials’ outcomes using an assumed fixed time duration versus the actual time durations for each case. The ‘time’ duration is the length of time in a health state.MethodsTwo methods were used in the estimation of QALYs based using EQ‐5D 3L scores collected at specific time‐point intervals. One method used the actual time durations for each case based on CRF records, and the other used an assumed time duration and globally applied it to all the cases. Using SPSS ® software program, we used paired‐sample t‐tests to assess whether the ‘time‐effect’ can potentially affect trial results using CONSTRUCT trial data as reported in the trial results publications. The trial compared use of Infliximab with Cyclosporine for patients with Ulcerative Colitis and it involved some 270 participants.Key findingsThe results largely indicate statistically significant differences between the two methods of QALY estimations. QALYs at the respective time‐points indicate no statistical difference between the two approaches. However, the difference in terms of total QALYs between the two QALY estimation approaches is statistically significant with considerable impact on costs/QALY.ConclusionsConsidering the possible impact of the time‐effect on QALY estimations, the result implies that it can have significant implications for resources allocations decisions. In this respect, researchers have to pay due considerations to the approach they use and where possible, actual time durations must be used in QALY estimations along prospective clinical trials.
Highlights
EQ-5D-3L is a generic preference-based patient-reported outcome measure which can be used to provide estimations of quality-adjusted life years (QALYs) gained
The two approaches are the application of the same fixed period of time between visits for all participants, for example 3 months, if data were supposed to be collected at 3-month interval for participants or using the actual period between visits using the actual dates when the EQ-5D-3L data were collected as recorded on Case Report Forms (CRFs) or Patient Follow-up Questionnaires (PFQs) in the estimation of QALYs
270 participants with acute severe Ulcerative Colitis who failed to respond to intravenous steroid and did not need surgery were randomised to participate in the two-arm non-blinded clinical trial
Summary
EQ-5D-3L is a generic preference-based patient-reported outcome measure which can be used to provide estimations of quality-adjusted life years (QALYs) gained. Estimations of QALYs from EQ-5D utility scores collected at different time-points along clinical trials can be made using two approaches. The two approaches are the application of the same fixed period of time between visits for all participants, for example 3 months (converted to years), if data were supposed to be collected at 3-month interval for participants or using the actual period between visits using the actual dates when the EQ-5D-3L data were collected as recorded on Case Report Forms (CRFs) or Patient Follow-up Questionnaires (PFQs) in the estimation of QALYs. In the second method, the time period would be the difference between the recorded dates on the CRFs or PFQs. For example, the period/time (in years) between two time-points for CRFs/PFQs with dates 05/10/2012 and 21/01/2013 would be 0.29589 assuming 1 year to be 365 days
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