Conception of an ICF Core Set for Systemic Sclerosis (SCISCIF)

The purpose of this study is to create and validate an ICF core Set for Systemic sclerosis

Study Overview

• Status: Completed
• Conditions: Systemic Sclerosis

Detailed Description

In 2002 was published WHO's International Classification of Functioning, Disability and Health (ICF). ICF defines disability as "the negative aspects of the interaction between an individual (with a health condition) and that individual's contextual factors (personal and environmental factors)". Interactions are specified in five domains, classified from body, individual and societal perspectives by means of two lists: a list of body functions and structure, and a list of domains of activity and participation. Since an individual's functioning and disability occurs in a context, the ICF also includes a list of environmental factors.

ICF core sets, which are short lists of ICF categories relevant for specific conditions, serve as practical tools for clinical practice and allow standardisation of data for health information and research. Core sets have already been developed and validated for several musculoskeletal diseases, such as low back pain, osteoarthritis, or osteoporosis, but not yet for systemic sclerosis.

• Study Type: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Cochin Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Male or female aged 18 and older with a diagnosis of ScS made according to ACR and/or Leroy et Medsger criteria

Description

Inclusion Criteria:

• Male or female aged 18 and older
• Diagnosis of ScS made according to ACR and/or Leroy et Medsger criteria
• Patient giving his informed consent to participate in the study

Exclusion Criteria:

• Severe chronic disease associated with ScS : stroke, multiple sclerosis, Parkinson's disease,…
• Cognitive or behavioral disorders making assessment impossible
• Inability to speak and write French

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of an ICF core Set for Systemic sclerosis	Submit the list of items to a cohort of 100 patients and experts.	Between the 13th and 24th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Translation of concepts identified such as items ICF (linking).	Translation of extracted data and set up the core set	Between the 10th and 12th month
Creation of a database from a qualitative survey	This database will be elaborated considering information from a qualitative survey of 100 patients, a consultation with experts and a review of the literature	During the first 9 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin; Ecole des Hautes Etudes en Santé Publique; Cabinet d'étude INTERLIS
• Investigators: Principal Investigator: Agathe Papelard, MD, Cochin Hospital

Publications and helpful links

General Publications

• Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustun B, Stucki G. ICF linking rules: an update based on lessons learned. J Rehabil Med. 2005 Jul;37(4):212-8. doi: 10.1080/16501970510040263.
• Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustun BT, Stucki G. Identification of candidate categories of the International Classification of Functioning Disability and Health (ICF) for a Generic ICF Core Set based on regression modelling. BMC Med Res Methodol. 2006 Jul 27;6:36. doi: 10.1186/1471-2288-6-36.
• Clements PJ. Systemic sclerosis (scleroderma) and related disorders: clinical aspects. Baillieres Best Pract Res Clin Rheumatol. 2000 Mar;14(1):1-16. doi: 10.1053/berh.1999.0074.
• Coenen M, Cieza A, Stamm TA, Amann E, Kollerits B, Stucki G. Validation of the International Classification of Functioning, Disability and Health (ICF) Core Set for rheumatoid arthritis from the patient perspective using focus groups. Arthritis Res Ther. 2006;8(4):R84. doi: 10.1186/ar1956.
• Daste C, Abdoul H, Foissac F, Papelard A, Alami S, Kwakkenbos L, Carrier ME, Lefevre-Colau MM, Thombs BD, Poiraudeau S, Rannou F, Mouthon L, Nguyen C. Development of a new patient-reported outcome measure to assess activities and participation in people with systemic sclerosis: the Cochin 17-item Scleroderma Functional scale. Br J Dermatol. 2020 Oct;183(4):710-718. doi: 10.1111/bjd.18922. Epub 2020 Mar 18.
• Papelard A, Daste C, Alami S, Sanchez K, Roren A, Segretin F, Lefevre-Colau MM, Rannou F, Mouthon L, Poiraudeau S, Nguyen C. Construction of an ICF core set and ICF-based questionnaire assessing activities and participation in patients with systemic sclerosis. Rheumatology (Oxford). 2019 Dec 1;58(12):2260-2272. doi: 10.1093/rheumatology/kez209.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2012
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: May 3, 2013
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimated): May 7, 2013

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ICF; Evaluation; Function; Systemic sclerosis; Core sets
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic
• Other Study ID Numbers: K091102; AOR - 10050 (Other Identifier: AOR)

Plan for Individual participant data (IPD)

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