Cross-cultural Adaptation and Validation of the CISS and the PWES Questionnaire in Patients With Hand Pathologies.

NCT04646343 | Unknown

• 1 other identifier: CliniqueRR-08
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to do translation, cross-cultural adaptation and validation of the CISS and PWES questionnaire in French. No available translation exist in French. In the first part of the study, the investigators will use clinical guidelines for translation and cross-cultural adaptation of questionnaire (Beaton and al).The content validity will be evaluated also in this first step. In the second part of the study the French version of CISS and PWES (F-CISS and F-PWES) will be validated. Different psychometric properties (internal consistency, test retest reliability, construct validity, floor and ceiling effects) will be study. The investigators use the recommendation of COSMIN (COnsensus- based Standards for the selection of health Measurement INstruments) group.

Conditions

Hand Injuries and Disorders

Keywords

cold intolerance; questionnaire; cross cultural adaptation

Outcome Measures

Primary Outcomes (2)

• Number of items of the two questionnaires considered as unclear by the patients

  if more of 20 % of the patients considered item as unclear it should be revised

  3 months (February 2021)

• Percentage of patients with cold intolerance assessed by the CISS questionnaire

  the cold intolerance is defined by a score more than 30 points (possible score from 0 to 100).

  one year (December 2021)

Study Arms (2)

group for cross cultural adaptation of questionnaire

Pre final French version of the CISS and PWES will be administered to French native speaking patients suffering from various hand injuries. 30 patients are sufficient. They will be asked to write commentaries on difficulties of questionnaire's items, especially comprehension of the different items (clear or unclear).If the item is considered unclear, the patient is asked to provide suggestions for making the item clearer .The distribution of the responses will be examined for searching missing responses. An item considered unclear by 20 % or more of the patients must be re-evaluated . The definitive version of French-CISS and French PWES (F-CISS and F- PWES) and the verification of the different stages of the cross-cultural adaptation will be validated during a new consensus meeting.

Other: administration of F-CISS and F-PWES pre version

group for validation of questionnaire

For the second part (validation study) we will administered F-CISS, F-PWES, F-DASH, F-HFS, F-SF 36 questionnaires and a pain VAS to a population of in and outpatients with hand injuries. We aim to include patients during one year for a total expected of 100 patients.

Other: administration of definitive version of F-CISS and F-PWES plus F-DASH, F-HFS and F-SF 36

Interventions

administration of F-CISS and F-PWES pre version OTHER

the CISS questionnaire is a 6 items questionnaire, the PWES is a 3 items questionnaire. Only 10 minutes are required to fulfilled the questionnaires.

group for cross cultural adaptation of questionnaire

administration of definitive version of F-CISS and F-PWES plus F-DASH, F-HFS and F-SF 36 OTHER

The administration will required 25 minutes

group for validation of questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the studied population will be in and out patients. Inpatients are patients hospitalized with hand injuries for a vocational rehabilitation in our clinic.. There are mainly men, with a mean age of 45 years, working in the secondary sector. All the patients which speak French will be invited to participate to the study. Outpatients are ambulatory patients seen in consultation with various hand problems (injuries or not). The mean age will be higher than in the first group and there will be more women. All the patients consulting for hand problems will be invited to participate to the study.

You may qualify if:

• Age ≥ 18 years.
• Hand injury or hand pathology with or without CRPS. The CRPS patients will have to meet the Budapest criteria
• Good French comprehension.

You may not qualify if:

• Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc.

Sponsors & Collaborators

• Clinique Romande de Readaptation: lead

Study Sites (1)

Clinique romande de réadaptation

Sion, Valais, 1950, Switzerland

RECRUITING

Related Publications (16)

• Nancarrow JD, Rai SA, Sterne GD, Thomas AK. The natural history of cold intolerance of the hand. Injury. 1996 Nov;27(9):607-11. doi: 10.1016/s0020-1383(96)00110-6.

  PMID: 9039355 BACKGROUND

• Vaksvik T, Hetland K, Rokkum M, Holm I. Cold hypersensitivity 6 to 10 years after replantation or revascularisation of fingers: consequences for work and leisure activities. J Hand Surg Eur Vol. 2009 Feb;34(1):12-7. doi: 10.1177/1753193408094440. Epub 2008 Dec 17.

  PMID: 19091739 BACKGROUND

• Graham B, Schofield M. Self-reported symptoms of cold intolerance in workers with injuries of the hand. Hand (N Y). 2008 Sep;3(3):203-9. doi: 10.1007/s11552-008-9116-0. Epub 2008 Jul 3.

  PMID: 18780096 BACKGROUND

• Carlsson IK, Nilsson JA, Dahlin LB. Cut-off value for self-reported abnormal cold sensitivity and predictors for abnormality and severity in hand injuries. J Hand Surg Eur Vol. 2010 Jun;35(5):409-16. doi: 10.1177/1753193409354184. Epub 2009 Dec 23.

  PMID: 20031998 BACKGROUND

• Gustafsson M, Hagberg L, Holmefur M. Ten years follow-up of health and disability in people with acute traumatic hand injury: pain and cold sensitivity are long-standing problems. J Hand Surg Eur Vol. 2011 Sep;36(7):590-8. doi: 10.1177/1753193411408186. Epub 2011 May 18.

  PMID: 21593072 BACKGROUND

• Craigen M, Kleinert JM, Crain GM, McCabe SJ. Patient and injury characteristics in the development of cold sensitivity of the hand: a prospective cohort study. J Hand Surg Am. 1999 Jan;24(1):8-15. doi: 10.1053/jhsu.1999.jhsu24a0008.

  PMID: 10048510 BACKGROUND

• Novak CB, McCabe SJ. Prevalence of cold sensitivity in patients with hand pathology. Hand (N Y). 2015 Jun;10(2):173-6. doi: 10.1007/s11552-014-9694-y.

  PMID: 26034426 BACKGROUND

• McCabe SJ, Mizgala C, Glickman L. The measurement of cold sensitivity of the hand. J Hand Surg Am. 1991 Nov;16(6):1037-40. doi: 10.1016/s0363-5023(10)80065-6.

  PMID: 1748748 BACKGROUND

• Carlsson I, Cederlund R, Hoglund P, Lundborg G, Rosen B. Hand injuries and cold sensitivity: reliability and validity of cold sensitivity questionnaires. Disabil Rehabil. 2008;30(25):1920-8. doi: 10.1080/09638280701679705.

  PMID: 19061118 BACKGROUND

• Ruijs AC, Jaquet JB, Daanen HA, Hovius SE. Cold intolerance of the hand measured by the CISS questionnaire in a normative study population. J Hand Surg Br. 2006 Oct;31(5):533-6. doi: 10.1016/j.jhsb.2006.04.013. Epub 2006 Jun 30.

  PMID: 16808991 BACKGROUND

• Magistroni E, Ferriero G, Peri E, Parodi G, Massazza G, Franchignoni F. Psychometric properties of the Italian version of the Cold Intolerance Symptom Severity questionnaire in upper-extremity nerve repair. Eur J Phys Rehabil Med. 2019 Oct;55(5):627-633. doi: 10.23736/S1973-9087.19.05555-2. Epub 2019 Jan 8.

  PMID: 30621369 BACKGROUND

• Tore NG, Gomussoy M, Oskay D. Validity and reliability of the Turkish version of the Cold Intolerance Symptom Severity Questionnaire. Turk J Med Sci. 2019 Aug 8;49(4):1221-1227. doi: 10.3906/sag-1808-170.

  PMID: 30866612 BACKGROUND

• Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.

  PMID: 17161752 BACKGROUND

• Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018 May;27(5):1147-1157. doi: 10.1007/s11136-018-1798-3. Epub 2018 Feb 12.

  PMID: 29435801 BACKGROUND

• Polit DF, Beck CT. The content validity index: are you sure you know what's being reported? Critique and recommendations. Res Nurs Health. 2006 Oct;29(5):489-97. doi: 10.1002/nur.20147.

  PMID: 16977646 BACKGROUND

• Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

  PMID: 11124735 RESULT

MeSH Terms

Conditions

Hand Injuries; Disease

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bertrand Léger, PhD

  institut de recherche en réadaptatation

  STUDY DIRECTOR

Central Study Contacts

Michel Konzelmann, MD

CONTACT

+41 79 314 84 84; michel.konzelmann@crr-suva.ch

Bertrand Léger, PhD

CONTACT

+41 27 603 20 76; bertrand.leger@crr-suva.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 27, 2020
• Study Start: December 1, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2024
• Last Updated: August 29, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)