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

Rapid review complete, E-Delphi underway.

NIHR Programme Development Grant in collaboration with Sheffield Teaching Hospitals and Nuffield Health.

PE-METHOD is an NIHR funded programme development grant that builds upon the STAMINA programme.

It aims to address the 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?

Collecting high quality process data is essential for understanding how complex interventions work and to inform future policy and implementation (French et al., 2020; Moore et al., 2015; Skivington et al., 2021). However, currently, there is little guidance about how best to collect process data (Moore et al., 2015; Skivington et al., 2021) despite well-established standards for the collection, processing and reporting of trial outcome data (European Medicines Agency, 2016).

Though some considerations are made in the guidance about validity of data and sources of bias there is no guidance on the practical matters of quality control and quality assurance. Such principles are needed to enhance data collection efficiency and quality.

Furthermore, the guidance scarcely considers non-research staff, patients and organisations who play a significant role as users and collectors of process data in pragmatic studies (e.g., exercise professionals, health and social care professionals and patients). Consideration of the needs of these stakeholders is vital to embed interventions in real-world settings.

The PE-METHOD project aims 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.

• Conducting a rapid review and an E-Delphi study to devise principles for the collection and management of process data.

• Building a prototype digital system and conducting interviews with STAMINA intervention delivery staff

• Focus groups with patients, to inform refinements of the system.

NIHR Programme Development Grant with interdigitating work packages:

• Rapid review

• E-Delphi

• Development of a prototype digital system

• Qualitative interviews

• Focus groups

The principles will support research and implementation communities to reduce research waste by designing more efficient process data collection and management systems. The customisable digital 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.

Dr Alison Scope

alison.scope@shu.ac.uk