ImProving procEss data collection and intervention delivery systeMs in pragmatic trials to addrEss THe needs Of Diverse users (PE-METHOD)

Development work question: How can systems be designed to maximise the efficiency of process data collection and management for diverse users including patients, healthcare professionals and exercise professionals? Background: A genuine opportunity exists to maximise how process data (e.g. routine data) that are collected for research serve the needs of diverse users. Currently, guidance around process data collection focusses only on the needs of researchers. However, in modern applied research, intervention delivery staff and patients may also use process data for purposes beyond research data collection. For example, in the STAMINA PGfAR, community-based exercise professionals and patients had a significant role in data collection and shared in interviews their desire for a multi-purpose digital system to i) collect high quality process data, ii) support intervention delivery, monitoring, and communication and iii) facilitate implementation. However: Process data collection systems are not designed for non-research staff, patients or organisations that play a significant role as users and collectors of process data in pragmatic studies. Consideration of stakeholder needs is vital for embedding interventions in real-world settings. There is limited guidance about the practical matters of quality control and quality assurance when collecting process data. Such principles are needed to enhance data collection efficiency and quality. Aims and objectives: We aim to develop principles to optimise the collection and management of process data for diverse users and apply these principles to build a prototype system using STAMINA as an exemplar intervention. This will be achieved by conducting three bespoke work packages (WP6A –C) over 20-months. Development work plan: In WP6A, we will perform a rapid review of process data collection methods to inform an e-Delphi study. We aim to reach consensus on a set of principles for the design of process data collection systems for diverse users via consultation with expert panellists (month 1–11). In WP6B, software experts will apply the principles to build a digital system with widespread use in mind. The prototype and design principles will be iteratively refined based on feedback from STAMINA intervention delivery staff in think-aloud interviews (month 7–15). In WP6C, we will conduct patient focus groups to explore their views about how data is collected about them and how the data could best be used to serve patient needs (month 16–17). Focus group findings will inform final refinements of the principles and process data system (month 18). Anticipated impact and dissemination: The principles will support research and implementation communities to reduce research waste by designing more efficient process data collection and management systems. The customisable system will strike a balance between maximising quality assurance and facilitating intervention delivery. This will make it easier for intervention delivery staff and patients to collect and use process data to serve their unique needs (e.g. monitoring and communicating progress). The principles will also be relevant to the routine monitoring of many services rolled out across health and social care. Our PPI group will support the dissemination of findings in academic publications, conference presentations and online via infographics.