Thesis (M.Ing. (Electrical Engineering))--North-West University, Potchefstroom Campus, 2007.

Electronic data capture technologies, such as interactive voice response (IVR) systems, are emerging as important alternatives for collecting self-reported data. The purpose of this research was to assess the measurement equivalence between the original paper-based versions and the adapted interactive voice response (IVR) versions of the EQ-5D and the QLQ-C30. Furthermore, we examined the test-retest reliability of two consecutive administrations of the IVR versions of the EQ-5D and the QLQ-C30. The comparison of the paper and IVR versions of the EQ-5D was conducted utilizing a crossover design with subjects randomly assigned to one of two assessment orders: 1) paper then IVR or 2) IVR then paper. A convenience sample of in-treatment outpatient cancer clinic patients (n=139) were asked to complete each assessment two days apart. For the test-retest component, outpatient cancer clinic patients (n=127) were asked to complete the IVR-based EQ-5D twice, two days apart. The analyses tested for mean differences (paired t-test) and test-retest reliability (ICC).In the crossover analysis, ten of the fifteen mean differences analyzed for the scales and items of the QLQ-C30 were within the equivalence interval set a priori. The ICCs for the scales and items of the QLQ-C30 ranged from 0.698 to 0.899. Two of the items, insomnia and appetite loss, did not meet our threshold of being statistically different from an ICC of 0.70. The EQ-5D index score means were equivalent between paper and IVR, however the EQ VAS score differences were not wholly contained in the equivalence interval. The ICCs were above 0.890 for the index and the EQ VAS. In the test-retest analysis, the ICCs for the nine multi-item scales for the QLQ-C30 were all above 0.69, ranging from 0.698 to 0.891. Ten of the fifteen mean differences analyzed were within the equivalence interval set a priori. For the EQ-5D, the mean differences were wholly contained within the equivalence intervals for both the index and the EQ VAS and the ICCs were significantly different from 0.70. Overall, the IVR version of the questionnaires provided psychometrically equivalent results to those obtained on the original paper version and showed good stability over time.

The pharmaceutical industry is spending more and more on Research and Development (R&D) every year. In addition, these R&D costs are increasing at a faster rate than sales. In order to resolve this dilemma a significant increase in R&D productivity is required. One of the main contributions to these R&D costs is the acquisition of data during clinical trials. The most important objective of a clinical trial is the collection of high quality data. No matter how well a clinical trial is conducted, if the data quality is poor, a meaningful analysis is not possible. The data acquisition method therefore plays a significant role in the overall outcome of a clinical trial. In this study a Mobile Clinical Data Acquisition System (MCDAS) was developed for the electronic collection of high-quality Patient-Reported Outcome (PRO) data. The system consisted of a cellular phone based electronic Diary (eDiary) for capturing data, and a website for administering the collected data. The system was designed so that it could be implemented on any clinical trials, no matter what data was collected. The MCDAS was successfully implemented on two clinical trials. The study shows that electronically capturing clinical data improves the quality of data obtained, thereby reducing the time and costs associated with clinical trials. / Thesis (M.Ing. (Electrical Engineering))--North-West University, Potchefstroom Campus, 2007.

The pharmaceutical industry is spending more and more on Research and Development (R&D) every year. In addition, these R&D costs are increasing at a faster rate than sales. In order to resolve this dilemma a significant increase in R&D productivity is required. One of the main contributions to these R&D costs is the acquisition of data during clinical trials. The most important objective of a clinical trial is the collection of high quality data. No matter how well a clinical trial is conducted, if the data quality is poor, a meaningful analysis is not possible. The data acquisition method therefore plays a significant role in the overall outcome of a clinical trial. In this study a Mobile Clinical Data Acquisition System (MCDAS) was developed for the electronic collection of high-quality Patient-Reported Outcome (PRO) data. The system consisted of a cellular phone based electronic Diary (eDiary) for capturing data, and a website for administering the collected data. The system was designed so that it could be implemented on any clinical trials, no matter what data was collected. The MCDAS was successfully implemented on two clinical trials. The study shows that electronically capturing clinical data improves the quality of data obtained, thereby reducing the time and costs associated with clinical trials. / Thesis (M.Ing. (Electrical Engineering))--North-West University, Potchefstroom Campus, 2007.