Feasibility and acceptability of TRANSFoRm to improve clinical trial recruitment in primary care.

BACKGROUND: Recruitment of study participants is a challenging process for health professionals and patients. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) clinical trial tools enable automated identification, recruitment and follow-up in clinical trials, potentially saving time, effort and costs for all parties involved. OBJECTIVES: This study evaluates the acceptability and feasibility of TRANSFoRm to improve clinical trial recruitment in primary care. METHODS: A feasibility study was conducted in three general practices in Poland. Participants were physicians and patients with gastro-oesophageal reflux disease. Semi-structured interviews were held to obtain feedback about the usefulness, ease of use and overall experience with the TRANSFoRm tools and to identify potential usability issues. Data were analysed thematically. RESULTS: A total of 5 physicians and 10 patients participated in the study. Physicians were satisfied with the usefulness of the system, as it enabled easier and faster identification, recruitment and follow-up of patients compared with existing methods. Patients found the TRANSFoRm apps easy to use to report patient outcomes. However, they also felt that the apps may not be useful for patients with limited exposure to smartphone and web technologies. Two main usability issues were identified: physicians could not access the result of the randomization at the end of each visit, and participants could not locate the follow-up reminder email. CONCLUSIONS: This study provides new evidence on the acceptability and feasibility of TRANSFoRm to enable automated identification, recruitment and follow-up of study participants in primary care trials. It also helps to better understand and address users' requirements in eHealth-supported clinical research.

TRANSFoRm eHealth solution for quality of life monitoring.

Patient Recorded Outcome Measures (PROMs) are an essential part of quality of life monitoring, clinical trials, improvement studies and other medical tasks. Recently, web and mobile technologies have been explored as means of improving the response rates and quality of data collected. Despite the potential benefit of this approach, there are currently no widely accepted standards for developing or implementing PROMs in CER (Comparative Effectiveness Research). Within the European Union project Transform (Translational Research and Patient Safety in Europe) an eHealth solution for quality of life monitoring has been developed and validated. This paper presents the overall architecture of the system as well as a detailed description of the mobile and web applications.