Item refinement for SSiDU questionnaire
Research type
Research Study
Full title
Evaluation and refinement of candidate items for a novel patient reported outcome instrument for assessing the severity/impact of digital ulcers in systemic sclerosis
IRAS ID
323402
Contact name
Michael Hughes
Contact email
Sponsor organisation
Northern Care Alliance NHS Foundation Trust
Clinicaltrials.gov Identifier
1.0, 22MSK18-S
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Digital ulcers occurring on the fingers and toes are common in patients with systemic sclerosis (often called 'scleroderma'). These ulcers are very painful and often slow to heal and difficult to treat sometimes needing hospital admission and even amputation. Assessment of digital ulcer status (e.g. healing or worsening)) can be very challenging and is typically based upon clinician opinion based on visual inspection of the ulcer alone. We have devised a new questionnaire for assessing the severity and impact of digital ulcers in systemic sclerosis (SSc). It is hoped that the questionnaire shall be used in future clinical trials and help deliver new treatments for people affected by SSc-RP. The purpose of this "cognitive de-briefing" patient interview study is to ensure the question wording of the draft questionnaire is easily and fully understood by people with SSc-DUs. This step in the development of this new PRO instrument is critical to the scientific validity and success of the eventual tool.
To undertake detailed patient (‘cognitive debriefing’) interviews of the draft questions comprising the Systemic Sclerosis Impact of Digital Ulcer (SSiDU) questionnaire.
Background: Digital ulcers occurring on the fingers and toes are common in patients with systemic sclerosis (often called 'scleroderma'). These ulcers are very painful and often slow to heal and difficult to treat sometimes needing hospital admission and even amputation. Assessment of digital ulcer status (e.g. healing or worsening)) can be very challenging and is typically based upon clinician opinion based on visual inspection of the ulcer alone. We have devised a new (‘SSiDU’) questionnaire for assessing the severity and impact of digital ulcers in systemic sclerosis. It is hoped that the questionnaire shall be used in future clinical trials and help deliver new treatments for people with systemic sclerosis affected by digital ulcers.
Methods: We conducted 5 cognitive interviews with people with systemic sclerosis living in the UK (and 2 further interviews held in the USA). Each interview took no longer than one hour to complete, and all the questions were reviewed individually by multiple participants.
Key findings: Careful review and discussion of the questions resulted in many important potential changes to the content (particularly the wording) of the questions. Including, improvements to the questionnaire readability to ensure that the lived patient experience of digital ulcers is captured. These changes will be reviewed by the overseeing steering board to refine the final question bank ready for a final larger (international) study to validate the SSiDU questionnaire ready for use in clinical trials and day-to-day clinical practice. We plan to share the results in due course detailing the development of the SSiDU questionnaire through scientific publications and presentations, and importantly to patients themselves including through collaboration with patient-led organisations.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: N/A
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: No
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected:
If no, explain why you didn't follow it: Data analyses are complete. The SSiDU draft item question bank (questionnaire) has been revised based on our study findings.It is unlikely that this work will receive a separate dedicated publication. Instead, it may be included in larger comprehensive publication/s concerning the development (and validation) of the SSiDU questionnaire.
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: Participants receive feedback on their contribution to this work at the time of the interviews. We shall also send participants a short description of the major study findings and how these have influenced future work on completion of the study.
If pending, date when feedback is expected:
If no, explain why they haven't:
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: We have no current plans to share the study data. However, we are open to considering and discussing data access requests from other researchers within the community for specific analyses.
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: No tissue was collected as part of this study.
Submitted on: 20/09/2024REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0073
Date of REC Opinion
25 May 2023
REC opinion
Further Information Favourable Opinion