Development of a Patient Reported Outcome measure for Lower LImb reconsTruction: PROLLIT.
What is a Patient Reported Outcome Measure and why is this study needed?
Patient reported outcome measures (known as PROMs) are designed and developed to assess patients’ health outcomes from the patient’s 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 experts in their own care and are best placed to identify which health outcomes are most relevant to them. Despite this, patients often have limited input in the development of PROMS. This has led to concerns over the extent to which existing PROMS used with patients who are requiring, undergoing or who have undergone reconstructive surgery for a lower limb condition, are fit for the purpose of accurately capturing these patients’ important experiences.
Study Aims
PROLLIT aims to undertake research to investigate whether a new PROM is needed for use in research involving people who are requiring, undergoing or who have undergone reconstructive surgery for a lower limb condition. Patients will be included if they are adults (16+) requiring, undergoing or undergone reconstructive surgery for a lower limb condition (leg, ankle or foot) which may be as a result of a congenital or acquired condition, from trauma, infection, nonunion or malunion. 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 if they are under the age of 16.
What will the study involve?
Show all / Hide all
Phase 1 – Develop a conceptual framework
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 should be contained 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). The systematic review has been completed. Findings are being considered for publication.
- 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 2 is currently in progress.
- 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.
Phase 2 – Determine if we need to develop a new PROM
We will map the content of existing PROMS onto the needs identified in the conceptual framework to determine whether the content of current measures is adequate. We will also assess the psychometric properties (how consistent and accurate they are) of PROMS currently used. If there is a discrepancy between the domains and outcomes identified in the conceptual framework and the content and psychometric properties of existing PROMS a decision will be reached as to whether it is necessary to proceed and develop a new PROM.
Phase 3 – Develop a new PROM
Phase 3 will involve the development of the new PROM, which will undergo formal psychometric evaluation, subject to the results of phase 2.
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 |
|---|
Members
YTU Team:
- Professor Catherine Hewitt, Senior Statistician and Deputy Director of the York Trials Unit
- Dr Catriona McDaid, an applied health researcher with experience in the evaluation of complex interventions
- Dr Arabella Scantlebury, a mixed methods researcher with experience of conducting quantitative and qualitative research
- Dr Heather Leggett, a mixed methods psychologist with a background in medical education and public health.
External
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 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, 01904326387 if you have any queries or would like an further information.
