Health Sciences
Development of a Patient Reported Outcome measure for Lower LImb reconsTruction: PROLLIT.
What is a patient reported outcome measure (PROM) and why are they important?
Patient reported outcome measures (PROMs) are designed and developed to assess health outcomes from the patient perspective. PROMs are used to measure whether a treatment works, to monitor and improve care, and to inform care management and health policy. Patients are considered to be experts in their own condition(s) and care and are therefore best-placed to identify which health outcomes are most important and relevant to them. Despite this, patients often have limited input in the development of PROMs and in these cases, it is likely that these measures are not effectively or accurately capturing patient experiences.
What is the PROLLIT study?
In the PROLLIT study we are focusing on PROMs for adult patients who are requiring, undergoing, or who have undergone reconstructive surgery for a lower limb condition or injury. We are investigating whether current PROMs used in this patient group are fit for purpose and, if not, whether a new PROM may be needed.
Patients will be included if they are adults (16+) who require, are undergoing or have undergone reconstructive surgery for a lower limb condition (leg, ankle or foot). Surgery may be as a result of a congenital or acquired condition, trauma, infection, or nonunion or malunion of a fracture. Patients will be excluded if they have experienced a condition in a part of the body that is not a lower limb, they have had a lower limb amputation, and/or if they are under the age of 16.
The protocol for the PROLLIT study has been published; Leggett H, Scantlebury A, Sharma H, et al Quality of life following a lower limb reconstructive procedure: a protocol for the development of a conceptual framework BMJ Open 2020;10:e040378. doi: 10.1136/bmjopen-2020-040378
What will the study involve?
Phase 1 – Develop a conceptual framework
Phase 1 of the PROLLIT study is now completed. Citations for peer-reviewed publications are provided below.
To develop a conceptual framework to identify the outcomes important to people who are requiring, undergoing or who have undergone reconstructive surgery for a lower limb condition, and therefore should be included in a PROM for this group. A three-phase approach will be undertaken:
- Step 1: A systematic review of current research to identify what is important to patients who are requiring, undergoing or who have undergone reconstructive surgery for a lower limb condition in terms of their quality of life (QOL).
Leggett, H., Scantlebury, A., Byrne, A. et al. Exploring what is important to patients with regards to quality of life after experiencing a lower limb reconstructive procedure: a qualitative evidence synthesis. Health Qual Life Outcomes 19, 158 (2021). https://doi.org/10.1186/s12955-021-01795-9 - Step 2: The findings from step 1 will be used to inform the development of a qualitative study, which will explore the importance of these issues further through interviews and focus groups with patients and staff at five sites in England. We will involve patients who have had different types of injury and are at different stages in their recovery.
- Step 3: The key factors identified in steps 2 and 3 will help to refine a conceptual framework regarding patient QOL and any other important outcome measures identified. To achieve this, an interdisciplinary panel (consisting of the Advisory Panel and other relevant stakeholders) will be established with the aim of refining the framework of outcomes that are important.
Leggett, H., Scantlebury, A., Hewitt, C. et al. What is important to adults after lower limb reconstruction surgery: a conceptual framework. Qual Life Res 32, 1671–1682 (2023). https://doi.org/10.1007/s11136-022-03340-7
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Phase 2 – Determine if we need to develop a new PROM
Phase 2 of PROLLIT is currently underway, with Step 1 completed in 2024.
- Step 1: We mapped the content of 47 existing PROMs onto the areas identified in the conceptual framework as being important and relevant to patients undergoing lower limb reconstruction. This allowed us to determine whether the content of current PROMs is adequate. We also carried out a formal content validity assessment of the PROMs.
Lister J, James S, Sharma HK, Hewitt C, Fulbright H, Leggett H, McDaid C. A systematic review and mapping exercise to assess the content validity of patient-reported outcome measures for adults having reconstructive surgery of the lower limb. Bone Jt Open. 2024 Dec 1;5(12):1049-1066. doi: 10.1302/2633-1462.512.BJO-2024-0074.R1. PMID: 39615521; PMCID: PMC11608108. - Step 2: We plan to undertake a reliability and validity assessment of promising PROMs, to ascertain whether they can be effectively used with all adult patients undergoing lower limb reconstruction. A decision can then be reached as to whether it is necessary to proceed and develop a new PROM.
Phase 3 – Develop a new PROM
If results from Phase 2 suggest a new PROM is required, Phase 3 will involve the development of a PROM designed for (and with) patients undergoing lower limb reconstruction surgery. The PROM will be robustly developed according to best-practice and will undergo formal psychometric evaluation
Trial Details
| Funder |
The University of York and Hull University Teaching Hospitals |
|---|---|
| Sponsor | University of York |
| Start Date | June 2019 |
| End Date (Phase 1) | August 2021 |
| End Date (Phase 2 & 3) | TBC |
Outputs
Members
YTU Team:
- Professor Catherine Hewitt, Professor of Trials and Statistics, Director of York Trials Unit and Deputy Head of Department for Research with the Department of Health Sciences.
- Dr Catriona McDaid, Professor of Applied Health Research, with experience in the evaluation of complex interventions, including surgical interventions.
- Dr Arabella Scantlebury, a mixed methods researcher with experience of conducting quantitative and qualitative research
- Dr Heather Leggett, a Research Fellow with experience of conducting quantitative and qualitative research across a range of projects in public health and medical education.
- Dr Jennie Lister: a Research Fellow with experience working across a range of quantitative and qualitative projects, and a particular interest in applied quantitative methods.
External
- Professor Hemant Sharma, an orthopaedic surgeon at Hull University Teaching Hospitals, specialising in lower limb.
Advisory Panel Members
- Dr Kim Cocks
- Professor Georgina Jones
- Professor Joel Gagnier
- Professor Joy Adamson
- Mr Nando Ferreira
- Mr Reggie Hamdy
- Mr Dave Ferguson
- Mr Dr Paul Harwood
We also have a patient and public involvement and engagement (PPIE) group who will meet at key stages during the project to review patient facing documentation and to discuss early patient related findings.
Contact Us
Please contact Dr Heather Leggett (heather.leggett@york.ac.uk) or Dr Jennie Lister (jennie.lister@york.ac.uk) if you have any queries or would like any further information about the PROLLIT study.
