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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.
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria
Exclusion Criteria
-Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Bertrand Léger, PhD | institut de recherche en réadaptatation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique romande de réadaptation | Recruiting | Sion | Valais | 1950 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9039355 | Background | 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. | |
| 19091739 | 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. |
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| 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 |
|
| 18780096 | 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. |
| 20031998 | 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. |
| 21593072 | 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. |
| 10048510 | 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. |
| 26034426 | 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. |
| 1748748 | 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. |
| 19061118 | 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. |
| 16808991 | 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. |
| 30621369 | 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. |
| 30866612 | 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. |
| 17161752 | 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. |
| 29435801 | 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. |
| 16977646 | 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. |
| 11124735 | Result | 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. |
| ID | Term |
|---|---|
| D006230 | Hand Injuries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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