MULTI-STEP CLINICAL PROTOCOL FOR NOVEL PHARMACOLOGICAL DOSAGE MONITORING DEVICE RESEARCH

Objectives. A range of tools and methods are currently used to measure patient adherence. However, even after decades of research in this area, there are no unambiguous guidelines on the preferred method of measuring it. Recommendations mostly point to a combination of several methods and tools and call for a tailor-made methodology. This research was aimed to develop a multi-step clinical protocol for novel pharmacological dosage monitoring device research and apply it in daily clinical praxis.
Materials and Methods. A protocol for testing a prototype of an autonomous, portable device for drug usage monitoring was described and subsequently assessed by implementation in clinical research. It was evaluated by the results of the impact of the device use and monitoring activity on the actual adherence measures, disease control measures and preferences of patients and medical staff.
Results. Our protocol divided treatment subjects into three groups – receiving a functional device, a dummy device and a control group. For treatment adherence testing MMAS-8 was used and disease control measurements included ACT test and spirography. As an important part focus group interviews were performed, which recorded preferences and user experience of patients and medical professionals. A graphic description of our protocol logic was developed, to represent all crucial steps.
Conclusions. We observed that our protocol led to obtaining homogenous and reproducible research data with which valuable and novel insights were achieved. We consider that the success of this protocol is attributable to using a combination of objective and subjective parts and investing time in understanding and respecting real-life patient pathways and motivations.