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

Hand Injuries and Disorders Clinical Trial

Official title:

Cross-cultural Adaptation and Validation of the "Cold Intolerance Symptom Severity Questionnaire" (CISS) and the "Potential Work Exposure Scale" (PWES) in Patients With Hand Pathologies.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04646343
• Other study ID #: CliniqueRR-08
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2023
• Source: Clinique Romande de Readaptation
• Contact: Michel Konzelmann, MD
• Phone: +41 79 314 84 84
• Email: michel.konzelmann[@]crr-suva.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study in the first part has a cross-cultural adaptation design. The investigators will use the CISS questionnaire modified by Ruijs, because the total score is between 0 and 100. For the PWES questionnaire the investigators will use the original version .For translation and cross-cultural adaptation, no consensus exists. The investigators choose the guidelines of AAOS outcomes committee which are widely used and accepted in the literature.

The following five steps will be documented in a written report: (1) forward translation from English to French by two translators whose native language is French and fluent in English (T1 and T2). One of the translators is informed about the aims of the study and the other received only limited information (so-called naive translator).Moreover, none of the translators are physicians. (2) Synthesis of T1 and T2 will be done to form a unique translated version T12 by resolving any discrepancies under supervision of a methodologist not involved in the translation process. (3) Back translation of the T12 version from French to English by two English native speaking who are fluent in French (BT1 and BT2). These two translators are naive to the study and not linked to the medical domain. (4) Consensus meeting with all the involved subjects (translators, methodologist, specialist physicians in rehabilitation) in order to resolve any discrepancies and doubts met during the translation and to establish the pre final French version of the CISS and PWES (5).

The investigators will verify content validity which is the ability to an instrument to reflect the domain of interest and the conceptual definition of a construct i.e. cold intolerance. For this purpose, the instructions, response format and the items of F-CIIS and F-PWES questionnaire will be evaluated by a panel of 10 people for conceptual equivalence (clarity). The expert panel will have knowledge's about the content areas of the construct of the questionnaire and the target population of the questionnaire. The mother language tongue of the expert panel is French. The experts have to rate if instructions, response format and items are clear or unclear. If unclear they are asked to provide suggestions for making the language clearer. If instructions, response format and items are found to be unclear by at least 20 % of the panel, they have to be revised. The minimum inter rater agreement among the experts panel is 80%.

Then the expert panel evaluate each item of the instrument for content equivalence, using the following scale (1=not relevant, 2=somewhat relevant, 3=quite relevant, 4=highly relevant). Items classified as 1 or 2 should be revised. Content validity index at the item level (I-CVI) and at the scale level (S-CVI) should be calculated. The averaging calculation of S-CVI (S-CVI/Ave) is the preferred method. With 10 experts, the I-CVI of 0.78 or above and an S-CVI/Ave of 0.90 or above are the minimum acceptable indices. Items that do not achieve the minimum acceptable indices are revised and re-evaluated.

This part of the study which not concerned patients run from November 2019 to September 2020.

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[50]. 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 .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.

For the second part (validation study) the investigators will administered F-CISS, F-PWES, F-DASH, F-HFS, F-SF 36 questionnaires and a pain VAS to a population of 100 in and outpatients with hand injuries. For F-CISS and F-PWES test-retest reliability, the first 50 patients consecutively included will be asked to answer questionnaires 7 days later .

The investigators propose to choose the cut-off of 30 points in the study to separate which patient has a CI or not.

For the second part of the study, validation, different statistics will be made.

For internal consistency:

Exploratory factor analysis: 7 to 10 subjects per item are recommended with preference for a sample ≥ 100 . To select the appropriate number of factors, many criteria might be used. We can look at the screeplot, or take all components with an eigenvalue > 1 (Kaiser Criterion). To interpret the factors, an orthogonal varimax rotation will be applied. After that, items will be associated with a given factor if their loadings are higher than 0.5 for the latter.

Calculation of Cronbach's α for the entire questionnaire and for the different dimensions. A Cronbach's α ≥0.70 for the entire questionnaire and for the subscales is required .

For test-retest reliability or reproducibility:

Intraclass Correlation Coefficient (ICC) are used. Since systematic difference is not expected between test and retest, a two-way random effect model will be applied, so that systematic difference are included in the measurement error. The investigators will study 50 patients with an interval of 7 days . The value of ICC should be >0.70 .

For construct validity: only the F-CISS will be studied. The F-PWES is only a scale for screening people which are exposed to cold in their work and doesn't explore the same dimensions. Pearson's correlation coefficient will be used.

Different hypotheses are posed.

1. The F-CIIS is well correlated with the F-DASH. A correlation ≥ 0.5 is expected.

2. The F-CISS is well correlated with the F-HFS. A correlation≥ 0.5 is expected.

3. The F-CISS is well correlated with pain VAS. A correlation ≥ 0.5 is expected. For pain VAS the question will be: when you are exposed to cold how much is your pain? We will use a 100 mm horizontal VAS.

4. The F-CISS is weakly correlated with SF36-PC. A correlation between 0.30 and 0.5 is expected.

5. The F-CISS is not associated with SF36-MC. A correlation < 0.3 is expected. To have a good construct validity, 75 % of the hypotheses should be satisfied .

Floor or ceiling effects: the distribution of scores will be observed and the investigators expected no floor or ceiling effects (less than 15 % of respondents achieved the highest or lowest possible scores).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 28, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• 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.

Exclusion Criteria

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

Related Conditions & MeSH terms

• Hand Injuries
• Hand Injuries and Disorders

Intervention

Other:
• administration of F-CISS and F-PWES pre version
the CISS questionnaire is a 6 items questionnaire, the PWES is a 3 items questionnaire. Only 10 minutes are required to fulfilled the questionnaires.
• administration of definitive version of F-CISS and F-PWES plus F-DASH, F-HFS and F-SF 36
The administration will required 25 minutes

Locations

Country	Name	City	State
Switzerland	Clinique romande de réadaptation	Sion	Valais

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Romande de Readaptation

Country where clinical trial is conducted

Switzerland, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)