Clinical trial NCT04646343: Cross-cultural Adaptation and Validation of the CISS and the PWES Questionnaire in Patients With Hand Pathologies.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hand Injuries and Disorders
Keywords: cold intolerance
questionnaire
cross cultural adaptation
Lead sponsor: Clinique Romande de Readaptation
Sponsor class: NETWORK
First posted: 2020-11-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of items of the two questionnaires considered as unclear by the patients
timeFrame: 3 months (February 2021)
measure: Percentage of patients with cold intolerance assessed by the CISS questionnaire
timeFrame: one year (December 2021)
Secondary outcomes:
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Clinique romande de réadaptation
state: Valais
Study officials:
affiliation: institut de recherche en réadaptatation
name: Bertrand Léger, PhD
role: STUDY_DIRECTOR
References:
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