Improving outcome measure selection in physical activity research.

Supervisors

• Dr Thomas Wilkinson (tjw26@le.ac.uk)
• Professor Kamlesh Khunti (kk22@le.ac.uk)
• Dr Daniel March (dsm12@le.ac.uk)
• Dr Anneka Welford (aew32@leicester.ac.uk)

Project description

Impaired physical fitness and function is highly prevalent in people with chronic kidney disease (CKD), associating with an increased risk of mortality, falls, and hospitalization [1]. Patients with CKD experience greater rates of functional decline and accelerated ageing compared to the general population [1]. Research into physical activity and lifestyle interventions continues to grow exponentially in people with CKD in an effort to prevent functional decline and improve outcomes [2]. Yet, this evidence is not being readily translated into clinical practice. The outcomes currently measured and reported in trials of physical activity and lifestyle interventions in CKD are particularly heterogeneous, often poorly chosen and assessed, irrelevant, and measured in a variety of ways [3]. A recent systematic review by Jegatheesan et al. [1] found that across 111 trials, 87 tests/measurements were used to evaluate 23 outcomes, categorized into five domains of physical fitness. Although physical activity-based interventions to improve physical fitness and function have been assessed in randomized controlled trials (RCTs), outcomes must be consistent, standardized, and patient-important to allow meaningful comparisons across studies. This variability contributes to research waste and hinders the ability to synthesize evidence to establish clinical usefulness and to inform clinical decision-making.

A way of addressing this is to develop a core outcome set (COS), the minimum number of outcomes that should be reported in clinical trials. Although nephrology is advantaged by the Standardised Outcomes in Nephrology (SONG) initiative, these outcome sets are not developed around interventions and are not always relevant for studies based around improving physical activity and physical fitness. Research into physical activity COS is limited across all clinical populations [4], including CKD [3]. The aim of the project is to develop a COS useful for measuring and reporting outcomes in physical activity and lifestyle studies, including multicomponent interventions in CKD.

Aims and objectives

The methodology is based on guidance from the COMET initiative [5] and the objectives for this studentship are:

1. To complete a review of systematic reviews and meta-analyses to identify a list of outcomes relevant to physical activity/exercise trials (conducted in accordance with the Cochrane handbook of systematic reviews and PRISMA methodology).
2. To complete a mixed method study involving a modified e-Delphi study [6] of key international stakeholders (participants identified through NIHR DART Collaboration, local Leicester Kidney Group, Kidney Lifestyle Team, and Global Renal Exercise (GREX) Network) including patients, researchers, policy makers, funders etc.) to establish a COS – supplemented by qualitative semi-structured interviews at each stage and virtual consensus meeting using Nominal Group Techniques.
3. To determine recommended measurement instruments/tools, through a systematic literature review of validated, reliable, and available tools matched to the COS developed and final virtual consensus meeting.

This studentship will suit those with an interest in clinical research methodology, study design, outcome science, and physical activity/lifestyle research in chronic disease.

Potential impact/sustainability

This PhD studentship is linked to the NIHR Applied Research Collaboration East Midlands and in collaboration with other research groups based at the Diabetes Research Centre (e.g., Biomedical Research Centre) and Department of Cardiovascular Sciences. Successful completion by the right candidate is likely to lead to submission of an NIHR (or similar) fellowship application. The student will be supported to apply for further grant funding through NIHR, MRC, Wellcome or similar. The proposed work has significant potential to impact future research in the area and lead into further study into the uptake of the COS into trials, as well as establishing COS in other clinical populations.

References

• [1] Jegatheesan et al. A systematic review of scope and consistency of outcome measures for physical fitness in chronic kidney disease trials. Kidney Int Reports. 2021
• [2] Wilkinson et al. Advances in exercise therapy in predialysis chronic kidney disease, hemodialysis, peritoneal dialysis, and kidney transplantation. Curr Opin Nephrol Hypertens. 2020
• [3] Wilkinson et al. Making the Case for Standardized Outcome Measures in Exercise and Physical Activity Research in Chronic Kidney Disease. Kidney Dial. 2023, 3, 219-228
• [4] Crocker et al. A core outcome set for randomised controlled trials of physical activity interventions: development and challenges. BMC Public Health. 2022
• [5] Kirkham et al. COS-STAP Group. Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement. Trials. 2019
• [6] Hunter et al. Development of a checklist of standard items for processing individual participant data from randomised trials for meta-analyses: Protocol for a modified e-Delphi study. PLoS One. 2022