| Faced with the shift from simple biomedical model toward bio-psycho-social medical model, the awareness of the significance of Patient Reported Outcome (PRO) is rising up. Now that chronic diseases have become the main diseases, increasing attention is paid to the subjective symptoms and their impact on Quality of Life (QOL) which patients expect to alleviate. Consequently, electronic Patient Reported Outcome (ePRO) emerges in clinical research with the increasing importance of PRO, and it becomes a new focus in pharmaceutical industry.Focused on neuroscience area where ePRO is widely used, this research will look deep into the application status and influencing factors of ePRO from the perspective of clinical data management for the first time. Based on the comparison with paper-based PRO, the practical issues and application strategies of ePRO will be further explored so as to provide reference and recommendations for its use and development in the future.Two typical PRO instruments are picked up for parallel analysis, the Subjective Sleep Questionnaire (SSQ) and Western Ontario and McMaster Universities Arthritis Index (WOMAC). The analysis is based on real patients’ data from the clinical database of Pfizer Company. Compliance index and integrity index are defined as the two indicators for the evaluation of PRO’s application. The analysis will be done through the comparison of the difference of the two indicators and potential influencing factors between ePRO and paper-based PRO. Then the practical problems of ePRO will be explored accordingly.The results are as follows:1. For SSQ which is used in high frequency:A. The compliance index of ePRO (Mean:99.37%, Median:100.00%, similarly hereinafter) is better than paper-based PRO (94.99%,98.23%). while the integrity index (92.24%,100.00%) is worse than paper-based PRO (98.29%.100.00%)B. The compliance index of paper-based PRO is positively correlated with days of administration (r=0.11), and integrity index negatively correlated (r=-0.28); while both the compliance index and integrity index of ePRO are negatively correlated with days of administration (r=-0.22,-0.17).C. Gender mainly affects the compliance index of paper-based PRO. Female subjects (92.94%,100.00%) have better compliance index than male subjects (91.21%,98.21%).D. Age is not so influential for ePRO, but it has significant impact on both the compliance index and integrity index of paper-based PRO. The compliance indexes of the elderly, middle-aged, and young subjects are respectively:(97.45%,99.74%),(98.48%,100.00%),(98.79%,100.00%).E. Race only significantly affects the integrity index of ePRO, and "White"(95.39%,98.58%) is better than "Black"(93.92%,96.83%). For paper-based PRO, there are significant differences of both compliance index and integrity index among different racial subjects."Black"(93.38%,100.00%) has better compliance index than "White"(92.38%,99.11%);"Black"(99.55%,100.00%) and "Asian"(99.77%,100.00%) have better integrity index than "White"(98.78%,100.00%) and "Other"(97.00%,100.00%).2. For WOMAC which is used in low frequency:A. There is no significant difference of compliance index between ePRO and paper-based PRO. But "Skip over forbidden", the new function of ePRO makes its integrity index come up to100.00%, which is significantly better than paper-based PRO.B. The influential factors mainly affect the integrity index of paper-based PRO. Higher using frequency brings worse integrity index. For "Weekly", the proportion of subjects whose integrity index is less than100.00%is11.64%, which is twice as much as "Biweekly" and "Once at first and once in the end" The proportion of elderly, middle-aged, and young subjects whose integrity index is less than100.00%are respectively6.91%.4.12%.2.84%, the elderly has the worst integrity index. The proportion of Asian people whose integrity index is less than100.00%is0.49%, but for White people the proportion is as much as6.02%.The following conclusions can be made based on the results:1. ePRO has higher compliance index than paper-based PRO, but its advantage is not significant when it’s used in low frequency;2. ePRO has lower integrity index than paper-based PRO, but its variance is smaller, and when it takes up the "Skip over forbidden" function, its integrity index is significantly better than paper-based PRO;3. The advantages of ePRO are not absolute, when used for long time, the compliance index and integrity index may decrease because of the increase of the burden of patients;4. In the following situation, choosing to use ePRO will make the best of its use:A. PRO instrument is frequently used; B. Male subjects are more than females; C. There are a large number of old subjects; D. White people are more than Black people and Asian people. |
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