Publication date

Transform: assessing the potential of e-health to transform patient recruitment and follow-up in primary care studies.

Mastellos, N., Andreasson, A., Curcin, V., Verheij, R., Hek, K., Car, J., Delaney, B. Transform: assessing the potential of e-health to transform patient recruitment and follow-up in primary care studies.: , 2014.
Background: Opportunistic recruitment to clinical studies is a particularly demanding process for GPs, patients and researchers. To date, this is performed manually using paper-based administration methods. The EU FP7-funded TRANSFoRm project team is currently finalising the tools to enable automated identification, randomisation and follow-up of eligible patients in primary care studies, potentially saving time and costs for all parties involved. This will be achieved using electronic case report forms (eCRFs) completed by general practitioners and patient mobile/web applications collecting patient-reported outcomes (PRO). Like any new intervention, TRANSFoRm will undergo rigorous testing and evaluation. In this conference, we aim to present the methods and early results from a study assessing the feasibility of TRANSFoRm to carry out patient recruitment and follow-up data collection. Following successful testing, the effectiveness of the tools will be evaluated in a cluster RCT investigating the question “what gives most symptom relief and improvement in quality of life in patients with Gastro-Oesophageal Reflux Disease (GORD), on demand or continuous use of proton pump inhibitors?”. Methods: The feasibility study is a mixed-methods study conducted in two general practices in the Netherlands. Participants will include six GPs, twenty GORD patients and a researcher. Data collection and analysis will take place April-June 2014. This will involve comparison of the results generated by TRANSFoRm against those identified through manual audit to assess the sensitivity and specificity of the TRANSFoRm case finding algorithms. The accuracy of data captured into the eCRFs and patient-facing tools will be also assessed by comparing the data extracted from the eHR and the mobile/web tools to prospectively defined eHR and PRO data. Usability will be tested through observation of users performing recruitment and follow-up data collection and any issues will be explored through follow-up semi-structured interviews. Results and plan for the conference: The findings from the study will be discussed and linked to the overall aim of the project to improve the conduct of clinical research in primary care through the use of technology. This will include early lessons around GP and patient acceptability of eHealth-supported recruitment and follow-up. The methods for the evaluation study will be presented as a way forward. (aut. ref.)