Self-assessment of Flare in Osteoarthritis of Lower Limbs (FLARE-OA)

Development of a Tool for the Self-assessment of Flare in Patients With Osteoarthritis of Lower Limbs

The need for a tool to measure flare in lower limb osteoarthritis (OA of the hip and knee) is justified by the opportunities for development of clinical trials targeting hip and knee OA long-term treatment (slow acting drug, disease modifying drug) and short-term treatment of symptoms. Such treatments are currently under development and will likely bring important changes in the treatment of patients. The development of a Flare-OA tool would be essential to capture the occurrence of flare, and to implement and adapt treatment strategies.

This project was elaborated with the aims to:

1. define the construct through development of a conceptual framework
2. use the conceptual framework to inform the development of a patient-reported outcome measure, Flare-OA tool, for people with OA
3. evaluate the psychometric properties of the new measure using the OMERACT (Outcome Measures in Rheumatology) filter 2.0 and Rasch measurement methods.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis

Detailed Description

Chronologically, the development of a Flare-OA (osteoarthritis) tool will be addressed in the first part of the project (Part 1) and its psychometric validity was evaluated in the second part (Part 2).

Part 1 of the project: The development of the Flare-OA tool will be conducted in several steps, and needs multiple proficiencies in qualitative research (health psychologist), in quantitative research (epidemiologist, psychometrician), in experience of the disease (patients), and in experience of care of the disease (health care professionals).

Two approaches will be taken to define the construct of a flare in lower limb OA: A review of the literature, and the development of a conceptual framework informed by the results of the literature. To help define/conceptualize the construct "Flare in OA" a procedure will be implemented to identify (what are the key variables, or symptoms, that get worse) and clarify (how exactly these variables are described in the literature, by patients, and by clinicians.

Participants :

1. - Patients should be representative of the disease spectrum, i.e. of prevalent cases. They will be recruited in clinical settings and epidemiological sources.
2. - Health care professionals (HCP) will include General Practitioners, Rheumatologists, Rehabilitation specialists, Orthopaedic surgeons, Nurse in general practice or orthopedic wards, Physiotherapists.

• Study Type: Observational
• Enrollment (Actual): 398

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • Institute of Bone and Joint Research - University of Sydney
• Canada
  • Toronto, Canada
    • University of Toronto
• France
  • Besançon, France, 25030
    • CHU Jean Minjoz
  • Brest, France, 29607
    • CHU La Cavale Blanche
  • Dijon, France, 21033
    • CHU Hôpital Général
  • Grenoble, France, 38043
    • CHU Hôpital Sud A. Michallon
  • Nantes, France, 44093
    • CHRU Hôtel Dieu
  • Paris, France, 75571
    • AP-HP Saint Antoine
  • Paris, France, 75651
    • AP-HP La Pitié
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Vandoeuvre-les-Nancy, France, 54511
    • CHRU, Rhumatologie
• Martinique
  • Fort-de-France, Martinique, 97261
    • CHU Fort de France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with knee or hip osteoarthritis (OA).

France: several sources will be sollicited including:

• investigators in rheumatology and general practitioner network in each participating centre,
• Patients participating in the KHOALA cohort, a representative prevalent case cohort study followed-up in 6 centres.

Australia: patients participating in the online cohort SPARK-web study Canada : patients will be recruited in Toronto osteoarthritis center.

Description

Inclusion Criteria:

• with clinical and radiological hip or knee OA confirmed by a physician,
• whatever their status regarding flare of OA. The intention of the Flare-OA tool is not to detect current flare only, but also a flare that may have occurred before the encounter with the health care professional. Therefore patient will not be selected on flare, and patients with flare will not be excluded.

Exclusion Criteria:

• Patients who never experienced nor currently report having a flare of OA
• Patients with both hip and knee OA

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of a FLARE-OA self-questionnaire to detect flare episodes in knee or hip osteoarthritis	patient-reported outcome questionnaire for the self-assessment of flare in osteoarthritis. The questionnaire will be developed during the first part of the study.	Baseline
Change in ability of a FLARE-OA self-questionnaire to detect flare episodes in knee or hip osteoarthritis during a 6 months period	patient-reported outcome questionnaire for the self-assessment of flare in osteoarthritis. The questionnaire will be developed during the first part of the study.	At 3 and 6 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the quality of life during a 6 months period with the standardized OAKHQOL questionnaire	Osteoarthritis knee and hip quality of life questionnaire (OAKHQOL) self-assessment questionnaire	up to 3 and 6 month
Evolution of the functional limitation related to knee osteoarthritis during a 6 months period with the standardized KOOS questionnaire	Knee injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4.	up to 3 and 6 month
Evolution of the functional limitation related to hip osteoarthritis during a 6 months period with the standardized HOOS questionnaire	Hip disability and Osteoarthritis Outcome Score (HOOS) patient questionnaire. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4.	up to 3 and 6 month
Pain intensity measure	Self-reported pain intensity using a numerical rating scale	up to 3 and 6 month

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Francis GUILLEMIN, CHRU NANCY, CIC 1433 Epidémiologie Clinique

Publications and helpful links

General Publications

• King LK, Epstein J, Cross M, Buzzi M, Buttel T, Cembalo SM, Spitz E, Adams CL, Adebajo A, Bennell K, Blanco B, Courage U, Decary S, Gill M, Gill TK, Hajji R, Hinman RS, Jones A, Li LC, Mather K, Mani R, Nasef SI, Oo WM, Osteras N, Otobo TM, Ramiro S, Sharma S, April KT, Touma Z, Whittaker JL, Wluka AE, Grosskleg S, Hunter DJ, Shea B, Hawker GA, Callahan LF, March L, Guillemin F. Endorsement of the domains of knee and hip osteoarthritis (OA) flare: A report from the OMERACT 2020 inaugural virtual consensus vote from the flares in OA working group. Semin Arthritis Rheum. 2021 Jun;51(3):618-622. doi: 10.1016/j.semarthrit.2021.03.010. Epub 2021 Mar 20.
• Guillemin F, Ricatte C, Barcenilla-Wong A, Schoumacker A, Cross M, Alleyrat C, Buttel T, Cembalo M, Manseur H, Urban H, Fautrel B, Conaghan PG, Hawker G, Rutherford C, March L, Spitz E, Hunter DJ. Developing a Preliminary Definition and Domains of Flare in Knee and Hip Osteoarthritis (OA): Consensus Building of the Flare-in-OA OMERACT Group. J Rheumatol. 2019 Sep;46(9):1188-1191. doi: 10.3899/jrheum.181085. Epub 2019 May 15.
• Traore Y, Epstein J, Spitz E, March L, Maillefert JF, Rutherford C, Ricatte C, Alleyrat C, Cross M, King LK, Callahan LF, Fautrel B, Buttel T, Hawker G, Hunter DJ, Guillemin F. Development and validation of the Flare-OA questionnaire for measuring flare in knee and hip osteoarthritis. Osteoarthritis Cartilage. 2022 May;30(5):689-696. doi: 10.1016/j.joca.2021.12.011. Epub 2022 Jan 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2015
• Primary Completion (ACTUAL): December 1, 2022
• Study Completion (ACTUAL): December 1, 2022

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (ESTIMATE): September 8, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: FLARE-OA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO