Quality of life following a lower limb reconstructive procedure

Plain English summary of protocol

Background and study aims
Patient reported outcome measures (PROMs) are designed and developed to assess patients’ health outcomes from their perspective (Black 2013; Bredart et al., 2014). Patients are best placed to identify which health outcomes are most relevant to them (Paterson, 2004; Trujols et al., 2013). Therefore, to ensure that patients’ perspectives are fully captured in a manner that is relevant and understandable to them, it is vital that they are central to the development of PROMs (McKenna, 2011; Paterson, 2004). Despite increased awareness of the need to include patients in the development of PROMS, patients are still being underused (Wiering, de Boer, Delnoij, 2017) and there is concern 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 important patient experiences.

Aim: To explore what is most important to patients requiring, undergoing or who have undergone reconstructive surgery for a lower limb condition with regards to quality of life, important outcomes and measurable impacts.

Who can participate?
Participant are patients and staff.
The patient participants will be 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.
Conditions may include:
• Infection - A fracture fixation which becomes infected
• Nonunion - A fracture which does not heal
• Malunion / Deformity - A fracture which does not heal in correct position.
• Any acquired or congenital condition leading to bone deformity.
• Leg length discrepancy or bone loss
• Congenital lower limb deformities
• Joint contracture
• Lower limb injuries where further limb reconstruction is required.
• Poly-trauma patients (as long as one of the above criteria are met).

The staff participants will be orthopaedic clinicians and physiotherapists who treat patients meeting the above inclusion criteria and who work at one of the five participating sites.

What does the study involve?
In order to explore important outcomes to patients after a lower limb condition, patients will be invited to take part in a semi-structured interview or a focus group and staff will be invited to take part in a semi-structured interview. Patients: Interviews and focus groups will be undertaken with patients who are requiring, undergoing or who have undergone reconstructive surgery for a lower limb condition, and will have received care through the NHS at one of the participating sites. Patient interviews will explore key health-related quality of life factors and other relevant factors to patients who have experienced a lower limb condition that requires or required reconstructive surgery. Important factors may include physical, social and psychological well-being as well as job and lifestyle related factors. Staff: Interviews will be undertaken with Orthopaedic staff (clinicians and physiotherapists) at each site. The staff will be asked to discuss, from their perspective, what they believe to be important outcomes and goals for patients.

What are the possible benefits and risks of participating?
Participants may not benefit from taking part in this research. However what they tell us may help us to understand what patients go through during a lower limb condition and reconstruction and its consequences. There are no physical risks to participating and we anticipate that the interviews/focus groups will not cause distress. However participants will be made aware that they can refuse to answer any questions which they feel uncomfortable with and can stop the interview at any time.

Where is the study run from?
University of York (UK)

When is the study starting and how long is it expected to run for?
May 2020 to August 2021

Who is funding the study?
Hull University Teaching Hospitals NHS Trust (UK)

Who is the main contact?
Dr Heather Leggett
heather.leggett@york.ac.uk

Contact information

Dr Heather Leggett
Public

ARC/006
Alcuin Building
Department of Health Sciences
Faculty of Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom

ORCID ID	0000-0001-8708-9842
Phone	+44 (0)1904326387
Email	heather.leggett@york.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

Funders

Funder type

Hospital/treatment centre

Results and Publications

Study outputs

Editorial Notes

28/03/2023: Publication reference added.
08/03/2021: The following changes have been made:
1. The ethics approval has been updated.
2. The recruitment start date has been changed from 01/05/2020 to 04/11/2020.
3. The recruitment end date has been changed from 01/08/2020 to 01/08/2021.
4. The overall trial end date has been changed from 01/06/2021 to 01/08/2021 and the plain English summary updated accordingly.
5. The intention to publish date has been changed from 01/01/2021 to 01/01/2022.
6. St James's University Hospital has been removed from the trial participating centres and Leeds General Infirmary has been added.
03/03/2020: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2020 to 01/05/2020.
2. The plain English summary was updated to reflect these changes.
25/02/2020: Trial’s existence confirmed by NHS HRA.