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SA32 Adapting PROs Evaluation to COVID Context – The Case of ASCEND Study

2022; Elsevier BV; Volume: 25; Issue: 12 Linguagem: Inglês

10.1016/j.jval.2022.09.2426

1524-4733

Inês Moital, Daniel Brás, Sílvia Portugal, Vanessa S. Lourenço, Carlos Bento,

Chronic Disease Management Strategies

Covid-19 pandemic imposed changes on disease management and follow-up namely with reduction on number of clinical appointments and use of telemedicine. Sickle cell disease (SCD) is a genetic blood disorder that is characterized by painful episodes caused by vaso-occlusion, with a significant impact on Quality of Life (QoL). This abstract aims to describe the adaptation of ASCEND study from a Face to Face (F2F) methodology to a fully digital patient reported outcome (PRO) study and its impact on SCD patients' recruitment, based on clinicians and patients' representatives feedback. The primary objective of ASCEND study is to characterize the physical impact of SCD on patients, through collection of PROs. The study also aims to characterize SCD patients' demographics and clinical history, as well as to describe the social and emotional impact of SCD on patients and SCD patient pathway in the healthcare system. ASCEND is non-interventional cross-sectional study of 2 cohorts of SCD adult patients. The study sample is 200 (recruited by hospitals) + 50 patients (recruited by the patient association - APPDH). Due to COVID pandemic, all study procedures (informed consent, clinical and PRO collection) will be exclusively done with digital resources. PRO questionnaires include both EQ-5D-5L and ASCQ-Me (Pain Episodes Frequency and Severity). Selected Portuguese patients and Social Studies investigators participated in the validation process. The study was initiated in February 2022. Recruitment rates were 16%, 19%, 22% and 23% from month 1 to month 4. The study is actively recruiting (84% patients; 99,4% PROs completeness rate). Final study results are expected by the end of 2022. ASCEND methodology changes revealed to be very enriching. Although digital data collection can be seen as a challenge for patient participation, the recruitment and completeness rate for this study showed the positive impact digital tools can have on study execution.