Transcultural Validation of MSTS and TESS Questionnaire
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Validation of psychometric properties of questionnaire MSTS in French translation
研究概览
简要总结
Reference treatment for soft tissue or bone sarcoma is the Monobloc resection surgery, with a margin of one to many millimeters removing the entire tumor leaving no cancer cells, associated or not with other treatments. Other musculoskeletal malignant tumors, some of them with secondary origins (metastases), are treated the same way. Patients with soft tissue and bone tumor could have heavy sequels of this surgery procedure, depending on the localization and size of the initial tumor. Those functional sequels are evaluated by specific questionnaires: the questionnaire TESS for upper limbs and TESS for lower limbs which are completed by the patient (depending on the localization of the tumor) and the questionnaire MSTS which is completed by the medical doctor.
Those English validated questionnaires are frequently used by French surgeons in standard practice as well as scientific research. The translations done have never been validated by an official methodology.
The aim of this trial is to validate the TESS and MSTS questionnaires linguistically, culturally (questions must be adapted for each target population: occidental adults and adolescents population, male and female population and adapted to the current era), and scientifically (repeatability).
The validation of those questionnaires will permit to have functional and reference questionnaires in French language which could be used for the follow up of operated patient in the context of the care and clinical research.
详细描述
The methodology will follow the guidelines of Dorcas E. Beaton, Claire Bombardier, Francis Guillemin and Marcos Bosi Ferraz (approved in particular by the American Academy of Orthopedic Surgeons):
Step 1: Author's agreement Step 2: Translation with cultural adaptation in addition to literal translation Step 3: 2 first translations English to French (2 different translators T1 and T2) Step 4: Synthesis (T12) Step 5: 2 reverse translations of T12 French to English (BT1 and BT2) Step 6: Submission to a committee of experts of the final translation Step 7: Clinical study based on a sample of patients (questionnaires, interview and analysis of the distribution of responses) The investigators planned the recruitment of 250 adults and adolescents patients over 15 years old, who will answers to the questionnaires (MSTS-TESS) as well as control-questionnaires (WOMAC or DASH) during a follow-up consultation, in Nantes, Rennes, Tours or Marseille centers. A study of repeatability will be performed with 30 to 50 patients for whom 2 filling will be necessary, the first time during the consultation and the second time at home, 15 days later.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Patients who has accepted and be informed of the protocol or minor patient over 15 years old who has accepted and be informed of the protocol, with the agreement of one legal representative
- •Patients over 15 years old who had a surgical procedure for a musculoskeletal tumor which could result in functional sequels. (at the appreciation of the surgeon)
- •Patients in the capacity to answer and understand the questionnaire and for whom the French is the native language
排除标准
- •Patients refusing to participate
- •Patient under guardianship
- •Patient inappropriate for entry into this study according to the judgment of the investigator
结局指标
主要结局
Validation of psychometric properties of questionnaire MSTS in French translation
时间窗: one day
次要结局
- Define questionnaires construction validity: coherent evolution of scoring with the clinical status of the patients (ANOVA)(3 months (after study completion))
- Define criteria validity: coherence with other scores (correlation with WOMAC-long form >0.4)(one day)
- Verify the repeatability of the questionnaire MSTS on 30 to 50 patients : concordance between answers of two surgeons on the same consultation(one day)
- Define questionnaires content validity : evaluation of translation quality (expert consensus).(one day)
- Define score reliability: intern coherence and responses coherence (Cronbach's alpha > 0.7 and Loevinger's H > 0.3)(3 months (after study completion))
- Verify the repeatability of the questionnaire TESS on 30 to 50 patients: concordance between answers of the same patient completing twice the same questionnaires (first during the consultation and then 15 days after at home).(two weeks)
- Define face validity : evaluate the comprehension of the questionnaire by 5 to 10 patients (qualitative analysis)(one day)
- Define criteria validity for upper limbs: coherence with DASH score (correlation with DASH >0.4)(one day)