Indolent Systemic Mastocytosis Clinical Trial
Official title:
Adaptation of the Questionnaire "Regarding Patient's Quality of Life With Mastocytosis" in the French Language
Mastocytosis is a heterogeneous rare disease. A 27-item questionnaire to assess the quality
of life of patients with cutaneous/ indolent systemic mastocytosis was developed in the
German language and validated in the English language in 2015.
The team of the University Charité Berlin and the company Moxie - intellectual proprietor of
the questionnaire - proposed the use of the recommendations of Baiardini et al. 2010, for
linguistic adaptation of this questionnaire in other languages.
The first two steps of the program of linguistic translation have already been carried out
under the direction and supervision of teams from Charité University, Berlin and Moxie
Company. The result of these two steps is a secondary version of the Mc-QoL questionnaire in
French. The last step of this adaptation process in the target language (French, France)
needs to be carried out and it is the subject of this study.
The objective of this study is the French language adaptation of the Mc-QoL questionnaire in
adult patients with indolent cutaneous and / or indolent systemic mastocytosis.
During this study, the second version of the Mc-QoL questionnaire in French will be evaluated
on 10 adult patients, with cutaneous and / or indolent systemic mastocytosis and native in
the French language. The comprehension tests will be carried out by means of the structured
interviews during which the investigator will ask if the patient has had difficulties to
understand the recommendations, the questionnaires, will verify the interpretation of all the
items and the understanding of each word by the patient. In case of problems, the
investigator will propose and / or test translation alternatives, or will ask the patient to
propose alternatives.
Revisions to the second version of the Mc-QoL questionnaire in French will be done to rectify
the problems identified in the conceptual equivalence. The result will be a third French
version of the Mc-QoL questionnaire, which will be the final version.
A report on the interviews will be written in English: it will describe the number of
respondents, their age, the time required to complete the questionnaire, the difficulties
encountered, the solutions suggested and retained and how the third version of the
questionnaire was produced.
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