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

August 28, 2024 updated by: Clinique Romande de Readaptation

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Valais
      • Sion, Valais, Switzerland, 1950
        • Recruiting
        • Clinique romande de réadaptation
        • Contact:
        • Principal Investigator:
          • Bertrand Léger, PhD
        • Sub-Investigator:
          • Cyrille Burrus, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 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
The administration will required 25 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of items of the two questionnaires considered as unclear by the patients
Time Frame: 3 months (February 2021)
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
Time Frame: one year (December 2021)
the cold intolerance is defined by a score more than 30 points (possible score from 0 to 100).
one year (December 2021)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Romande de Readaptation

Investigators

  • Study Director: Bertrand Léger, PhD, institut de recherche en réadaptatation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

August 31, 2023

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

November 11, 2020

First Submitted That Met QC Criteria

November 20, 2020

First Posted (Actual)

November 27, 2020

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CliniqueRR-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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