Objectives: Patient engagement and adherence are critical to the success of clinical trials. Electronic patient-reported outcomes (ePROs) are increasingly used to evaluate clinical trial endpoints. This study characterized how subjects prefer to use various types of technology to report ePROs in a clinical trial. Considering patient preference during trial design may reduce patient burden and improve patient engagement. MethOds: 416 subjects with osteoarthritis (OA, n= 104), type 2 diabetes (n= 102), chronic obstructive pulmonary disease (COPD, n= 103), or depression (n= 107) were surveyed regarding their preferences for using computers, smartphones, and internet in clinical trials. Results: Subjects were diverse in age, sex, ethnicity, and technology use. 52% reported having a computer at home, 46% reported using the internet daily, and 45% reported owning a smartphone. Subjects reported that they would be willing to participate in a clinical trial using the internet for up to 1 month (25%), 2-6 months (19%), 1-2 years (14%), or 5+ years (15%). Similarly, subjects were willing to participate in a clinical trial using a smartphone for up to 1 month (25%), 2-6 months (22%), 1-2 years (12%), or 5+ years (14%). When asked what time of day they would prefer to complete a daily electronic diary, subjects preferred 8pm-midnight (26%), 8am-noon (21%), or 4pm-8pm (15%). Subjects thought it would be necessary (14%) or helpful (69%) to have an audible alarm to remind them to record their symptoms. In a multi-select question, subjects preferred to report their symptoms once a day for a clinical trial using a provisioned smartphone (49%), internet (46%), or an application on their personal smartphone (42%). cOnclusiOns: Subjects are willing to use computers, smartphones, and internet in a clinical trial setting. Trial sponsors should consider patient preferences for specific technology features to reduce patient burden and improve engagement and adherence when using ePRO assessments. PIH39develoPment and evalUatIon of a crosswalk between tHe eq-5d-5l and menoPaUse-sPecIfIc qUalIty of lIfe (menqol) qUestIonnaIre In PostmenoPaUsal women

Objectives: Patient engagement and adherence are critical to the success of clinical trials. Electronic patient-reported outcomes (ePROs) are increasingly used to evaluate clinical trial endpoints. This study characterized how subjects prefer to use various types of technology to report ePROs in a clinical trial. Considering patient preference during trial design may reduce patient burden and improve patient engagement. MethOds: 416 subjects with osteoarthritis (OA, n= 104), type 2 diabetes (n= 102), chronic obstructive pulmonary disease (COPD, n= 103), or depression (n= 107) were surveyed regarding their preferences for using computers, smartphones, and internet in clinical trials. Results: Subjects were diverse in age, sex, ethnicity, and technology use. 52% reported having a computer at home, 46% reported using the internet daily, and 45% reported owning a smartphone. Subjects reported that they would be willing to participate in a clinical trial using the internet for up to 1 month (25%), 2-6 months (19%), 1-2 years (14%), or 5+ years (15%). Similarly, subjects were willing to participate in a clinical trial using a smartphone for up to 1 month (25%), 2-6 months (22%), 1-2 years (12%), or 5+ years (14%). When asked what time of day they would prefer to complete a daily electronic diary, subjects preferred 8pm-midnight (26%), 8am-noon (21%), or 4pm-8pm (15%). Subjects thought it would be necessary (14%) or helpful (69%) to have an audible alarm to remind them to record their symptoms. In a multi-select question, subjects preferred to report their symptoms once a day for a clinical trial using a provisioned smartphone (49%), internet (46%), or an application on their personal smartphone (42%). cOnclusiOns: Subjects are willing to use computers, smartphones, and internet in a clinical trial setting. Trial sponsors should consider patient preferences for specific technology features to reduce patient burden and improve engagement and adherence when using ePRO assessments. PIH39develoPment and evalUatIon of a crosswalk between tHe eq-5d-5l and menoPaUse-sPecIfIc qUalIty of lIfe (menqol) qUestIonnaIre In PostmenoPaUsal women

No abstract

were 32.3%, 22.0%, 13.9%, and 13.0%, respectively. These rates were similar to those in non-responders. Respondents with PBA symptoms (CNS-LS≥ 13) reported significantly poorer HRQOL in all EQ-5D domains. Mean scores were worse for anxiety/ depression, pain/discomfort, and usual activities; 85% reported at least moderate pain or anxiety/depression; 50% reported at least moderate problems with usual activities. ConClusions: PBA symptoms assessed by either CNS-LS or the "involuntary episodes" question are prevalent among Veterans with TBI who responded to the survey. PBA symptoms were correlated with worse HRQOL.

Objectives: The current prevalence of Total Hip Replacement (THR) in adult patients in Slovakia ranges in about 5 200 cases per year with expenditures about 10.545.600 €. The THR has a great impact on the quality of life (QoL) and the physical ability too. Till now in the Slovak Republic was not realised the study like this one. MethOds: 118 patients, 59 men and 59 women, with THR were studied. The average age was 62,24 y., the average duration of illness was 7,75 y. and the average waiting time to surgery was 0,73 y. QoL and the taking care about himself (TCaH) was evaluated after THR on the numeric scale from 0 to 10 (0 for the worst, 10 for the best) and pain (0 for the best, 10 for the worst) by patients themselves Results: QoL has increased from 4,24 to 6,30 after THR. The ability to take care about himself has decreased from 6,38 to 3,45 after THR. Pain has decreased from 7,85 to 3,32 after THR, and after spa stay from 3,04 to 2,03. The loss of money in productive age patients was 216,63 €. The score of physical health by SF 36 questionnaire was 50,94 points and score of mental health was 65,41 points, the average score was 57,98 points. 35 patients from 45 patients were able to come back to work after THR. cOnclusiOns: THR has a great impact on QoL, pain and on the TCaH too. There was not statistical difference between men and women in all evaluated parameters. The early/earlier made THR could have an important influence on better QoL and pain development. There is a good correlation between results from numeric scale and SF 36.