Perspectives on CPPD Outcome Domains

OMERACT Core Domain Set Selection for Calcium Pyrophosphate Deposition (CPPD): Exploring Patient and Stakeholder Perspectives on Outcome Domains

The purpose of this study is to obtain patient and stakeholder perspectives on what outcome measures should be included in future trials on CPPD (Calcium PyroPhosphate Deposition), a common form of inflammatory arthritis. This will form part of a wider OMERACT (Outcome Measures in Rheumatology) study, involving multiple international sites, to determine a core domain set (an agreed set of outcome measures) for this disease.

In the UK, up to 10 patients with CPPD and their caregivers, healthcare professionals who care for patients with CPPD, and other stakeholders, which may include government organisations, non-government organisations, pharmaceutical representatives and health advocacy groups, will be invited to participate in a single, semi-structured interview.

Interviews will be face-to-face or telephone, last up to one hour and digitally audio-recorded. For patients and their caregivers, interviews will explore their lived experience of CPPD, its impact on their daily lives, and the perceived relevance of outcome measures used in previous studies. For healthcare professionals and other stakeholders, interviews will explore their experience dealing with patients with CPPD, how they perceive CPPD impacts patient lives, and the perceived relevance of the outcome measures used in previous studies.

Following analysis of the data, participants will be sent a short report with the researchers' findings, and asked to check the accuracy of these and provide brief written feedback.

Interviews will also take place with patients, caregivers, healthcare practitioners and stakeholders at the other international sites where ethics committee approval will be sought locally. It is anticipated that around 30 participants will be recruited across all sites. Analysis of all interviews will be primarily conducted and managed at the UK site.

Study Overview

• Status: Completed
• Conditions: CPPD - Calcium Pyrophosphate Deposition Disease
• Intervention / Treatment: Other: Qualitative interview; Other: Member checking

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Academic Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with CPPD, healthcare practitioners who work with patients with CPPD, and stakeholders who work on behalf of those with CPPD

Description

Inclusion Criteria:

Patients:

• People with a diagnosis of CPPD of any form and/or their caregiver (includes acute CPP crystal arthritis (pseudogout), chronic CPP crystal arthritis, crowned dens syndrome, and osteoarthritis with CPPD)
• Ability to give informed consent
• Age over 18 years

Healthcare professionals:

• A healthcare professional (nurse, GP or hospital doctor) who cares or has cared for patients with CPPD

Other stakeholders:

• Government organisations, non-government organisations, pharmaceutical representatives and health advocacy groups

Exclusion Criteria:

• Dementia
• Terminal illness
• Unable to give informed consent
• Stroke with receptive or expressive dysphasia
• Severe enduring mental illness
• Autoimmune rheumatic disease such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout
• Total joint replacement in the previous 3 months

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with CPPD	Other: Qualitative interview; Qualitative interview to explore experiences and perceptions of living with CPPD, and outcome measures to use in future studies; Other: Member checking; Participants will be sent a short report with the researchers' findings from the qualitative interview, and asked to check the accuracy of these and provide brief written feedback.
Healthcare professionals working with CPPD patients	Other: Qualitative interview; Qualitative interview to explore experiences and perceptions of living with CPPD, and outcome measures to use in future studies; Other: Member checking; Participants will be sent a short report with the researchers' findings from the qualitative interview, and asked to check the accuracy of these and provide brief written feedback.
Stakeholders working on behalf of CPPD patients	Other: Qualitative interview; Qualitative interview to explore experiences and perceptions of living with CPPD, and outcome measures to use in future studies; Other: Member checking; Participants will be sent a short report with the researchers' findings from the qualitative interview, and asked to check the accuracy of these and provide brief written feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and stakeholders perception of core outcome domains identified from a systematic literature review of clinical studies of patients with CPPD	This is a qualitative interview study, the primary aim is to collect patient and stakeholder perspectives on existing outcome measures of CPPD. Currently there are no recommended core outcome measure sets for CPPD and this work is being undertaken within the framework of OMERACT. Thematic analysis will be undertaken of interview transcripts and therefore there is no defined outcome measure.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience of living with and perceptions of CPPD, and perceived impact of symptoms on daily life	This is a qualitative interview study, the secondary aim is to collect patients' experiences of living with CPPD as well as their and stakeholders perception of the impact of CPPD symptoms, to identify any further outcome measures that could be used in studies of CPPD. Currently there are no recommended core outcome measure sets for CPPD and this work is being undertaken within the framework of OMERACT. Thematic analysis will be undertaken of interview transcripts and therefore there is no defined outcome measure. There is no specific recall period for which experiences will be assessed as this will be dependent on each individual's disease duration.	1 day

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: A Abhishek, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Outcome measures; Qualitative research; Calcium Pyrophosphate Deposition Disease
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Crystal Arthropathies; Chondrocalcinosis
• Other Study ID Numbers: 19061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No