Condition category
Musculoskeletal Diseases
Date applied
30/01/2020
Date assigned
28/02/2020
Last edited
03/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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?
1. Hull Royal Infirmary (UK)
2. St James's University Hospital (UK)
3. James Cook University Hospital (UK)
4. King's College Hospital NHS Foundation Trust (UK)
5. Royal Liverpool University Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2020 to June 2021 (updated 03/03/2020, previously: March 2020 to June 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

Trial website

Contact information

Type

Public

Primary contact

Dr Heather Leggett

ORCID ID

https://orcid.org/0000-0001-8708-9842

Contact details

ARC/006
Alcuin Building
Department of Health Sciences
Faculty of Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904326387
heather.leggett@york.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 269088

Study information

Scientific title

A qualitative approach to exploring what is important to patients with regards to quality of life when requiring, undergoing or after undergoing reconstructive surgery for a lower limb condition.

Acronym

PROLLIT

Study hypothesis

The principle research objective is to explore what is most important to patients who are requiring, undergoing or who have undergone reconstructive surgery for a lower limb condition, with regards to quality of life, important outcomes and measurable impacts. This information will be used to determine whether patient priorities in terms of outcomes are currently being met by existing patient reported outcome measures.

Ethics approval

Approval pending South Central - Berkshire Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)20 7972 2545; nrescommittee.southcentral-berkshire@nhs.net), ref: 20/SC/0114.

Study design

Qualitative study design using interviews and focus groups

Primary study design

Other

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format. Please use contact details to request a participant information sheet.

Condition

Lower limb conditions which require or required reconstructive surgery.

Intervention

Interviews and focus groups will be undertaken with patients and staff.
Patients:
Patients will be identified and invited to participate in the research by orthopaedic clinicians, physiotherapists or research nurses at participating NHS hospitals in the first instance. Interviews will be at the hospital or over the telephone. Participants will be provided with an information sheet before consent is obtained. We will ensure that participants have read the information sheet and have a full understanding of the study before consent is obtained. Participants will not be pressured to take part and will be reminded of their right to withdraw at any time. Verbal consent will be obtained on an on-going basis during interviews. 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. Topic guides will be used to guide the conversation. The interview will last between 30 minutes to 1 hour and the focus groups will last between 1-2 hours. Interviews will be audio recorded and transcribed verbatim. Participants will be informed that quotations may be used and published, but that all identifiable information will be removed. All participants will be provided with a unique ID to maintain their anonymity.

Staff:
Staff (orthopaedic clinicians or physiotherapists) will be invited to participate in the study by either direct contact from the researcher if they meet the clinician when visiting the hospital for patient interviews or through the lead contact at each site. Participants will be provided with an information sheet before consent is obtained. We will ensure that participants have read the information sheet and have a full understanding of the study before consent is obtained. Participants will not be pressurised to take part and will be reminded of their right to withdraw at any time. Verbal consent will be obtained on an on-going basis during interviews. The interview will be guided by a topic guide and staff will be asked to discuss, from their perspective, what they perceive to be important outcomes and goals for patients. The interview will last between 30 minutes to 1 hour. Interviews will be audio recorded and transcribed verbatim. Participants will be informed that quotations may be used and published, but that all identifiable information will be removed. All participants will be provided with a unique ID to maintain their anonymity.


Sampling quotas will not be applied but, in order to obtain a wide range of views, recruitment will aim to target a range of participants with regards to age, gender, different lower limb conditions, condition severity, treatment received and stage of reconstructive treatment. A sampling frame will be developed to streamline this process. The sampling frame will be developed through collaboration with lead clinicians from the participating sites. Recruitment will continue until the interviews provide no new information. We anticipate this to be around 50-75 patient participants (10-15 from each site) and around 10 (2 from each site) staff interviews.

The topic guides will be developed from a literature review of the area and reviewed by experts in the field and our patient, public involvement and engagement group. A systematic review on the same topic is currently being undertaken and if appropriate may also inform the topic guides. The topic guides will be used to guide the conversation, to ensure that it stays on track and to provide prompts to facilitate discussion.

Concept elicitation will be undertaken in the interview/focus group by asking the participants questions which explore their thoughts, attitudes and beliefs surrounding important goals and outcomes what is important to them with regards to quality of life in relation to requiring, undergoing or after reconstructive surgery for a lower limb condition.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Qualitative methods will be used to explore what is important to patients who are requiring, undergoing or who have undergone reconstructive surgery for a lower limb condition, with regards to quality of life, important outcomes and measurable impacts

Secondary outcome measures

N/A

Overall trial start date

01/06/2019

Overall trial end date

01/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patient:
1. Adults (16+) requiring, undergoing or have 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:
1.1. Infection - A fracture fixation which becomes infected
1.2. Nonunion - A fracture which does not heal
1.3. Malunion / Deformity - A fracture which does not heal in correct position. Any acquired or congenital condition leading to bone deformity.
1.4. Leg length discrepancy or bone loss
1.5. Congenital lower limb deformities
1.6. Joint contracture
1.7. Lower limb injuries where further limb reconstruction is required
1.8. Poly-trauma patients (as long as one of the above criteria are met)

Staff:
2. 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

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

85

Participant exclusion criteria

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.

Staff will be excluded if they do not have direct contact/involvement with the care of patients who are requiring, undergoing or who have undergone reconstructive surgery for a lower limb condition.

Recruitment start date

01/05/2020

Recruitment end date

01/08/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hull Royal Infirmary
Hull and East Yorkshire Hospital NHS Trust. Anlaby Road
Hull
HU3 2JZ
United Kingdom

Trial participating centre

St James's University Hospital
Leeds Teaching Hospitals NHS Trust Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

James Cook University Hospital
South Tees Hospital NHS Foundation Trust Martin Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

King's College Hospital NHS Foundation Trust
Denmark Hill London
Greater London
SE5 9RS
United Kingdom

Trial participating centre

Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Sponsor information

Organisation

University of York

Sponsor details

The University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 328693
Michael.barber@york.ac.uk

Sponsor type

University/education

Website

https://www.york.ac.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Hull University Teaching Hospitals NHS trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We aim to publish the systematic review protocol and qualitative study protocol in a peer-reviewed scientific journal. We also intend to publish the systematic review findings and the findings from the qualitative study in a peer-reviewed journal in 2020. All members of the research team will be involved in manuscript preparation and revisions. The advisory panel will also be invited to contribute to papers where appropriate. The advisory panel will be acknowledged in papers. We also anticipate the attendance of the research team members at any relevant conferences over the course of the project.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.