Research Design Service: West Midlands

RESEARCH DESIGN SERVICE (RDS)
West Midlands

Example of the Added Value of NIHR RDS INPUT


DETAILS OF THE PROJECT

Title: PREhabilitation for PAtients With Abdominal aoRtic anEurysms awaiting elective repair (PREPAWARE)
Advisor: JH (Warwick)


BACKGROUND, CONTEXT AND HOW RDS CONTRIBUTED

The client found out about the RDS through previous knowledge of working with the RDS Yorkshire & Humber. The client found the local RDS contact through the RDS website. The proposed project, for RfPB, is to undertake a feasibility randomised controlled study of a prehabilitation programme with patients with abdominal aortic aneurysms. The feasibility study involves a 24 month mixed-methods study, which consists of a prehabiliation programme. The prehabilitation programme includes education, nutrition and an exercise programme in order to improve patient fitness pre-surgery and reduce the chance of complications post-surgery. The study will focus on acceptability, uptake and adherence to the programme with additional clinical and cost-effective measures to help determine and define a potential full randomised controlled trial. A PPI advisory group will meet twice to help develop the initial application and advise particularly regarding the feasibility and acceptability of the proposed programme. A public contributor will also be recruited as co-applicant and as representative to the study steering group. The RDS contribution included PPI support, qualitative methods design, study design and statistics support, and health economics advice.

OUTCOME, IMPACT, OR POTENTIAL IMPACT OF RDS INPUT

An initial virtual meeting was held with the client to understand the objective of the proposed project, to identify the support required (e.g. study design, PPI support, quantitative and qualitative design and analyses), and the team composition and skills needed to be able to successfully deliver the proposed study. The client was supported to develop their PPI plans. The client had begun to explore recruitment of potential patient advisors via their existing networks, but was unsure how best to invite, facilitate and carry out PPI activities. Advice was provided regarding the development of recruitment materials and conducting two virtual workshops with patients. An expanded role for a public contributor as co-researcher and steering committee member was discussed to ensure patient voices were embedded within the project team, and to advise on specific aspects of the research process such as recruitment of patients and ethical issues, development of research instruments, and dissemination.

The RDS then worked with the client to refine the research objective and to design the trial as appropriate. The discussion led the client to decide on a feasibility randomised trial. The client wanted to include a health economics component but did not have a health economic co-applicant nor experience in conducting health economic research. The client was supported in helping design a health economic component that was congruent with the scope of the research question. A health economic co-applicant was sourced from the RDS network to then integrate the health economic component into the study design and support the application through the process.

The RDS statistical advisor provided input to the statistical design and analysis to the application, and supporting decision-making regarding a set of reasonable parameters to inform the sample size calculation.

Qualitative expertise was provided to help the client clarify the sampling strategy for interviews, the aims of the interviews, procedures for thematic analysis and how to use the interviews to interrogate the wider study findings. A qualitative co-applicant team member was sourced from RDS networks.

All the advisors also tried to help to identify and introduce a dietetic expert as a co-applicant.