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临床试验/NCT04527588
NCT04527588撤回不适用

Italian Translation and Cross-cultural Adaptation of the Michigan Hand Outcomes Questionnaire

University of Zurich0 个研究点开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Validity

研究概览

简要总结

Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. Some of the most used Questionnaires, unfortunately, are not available in Italian.

详细描述

Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. Some of the most used Questionnaires, unfortunately, are not available in Italian. This poses a problem when evaluating Italian speaking patients. Our aim is to develop a culturally adapted Italian version of the Michigan Hand Questionnaire. There is no risk involved for the patients, as the task of the recruited patients is to answer a survey (online and in clinics).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years
  • native Italian speakers
  • wrist/hand pathology
  • trauma (fractures, tendon injuries, etc.)
  • chronic pathology, the pathology has been present for at least 1 month (tenosynovitis, chronic arthrosis pain, rheumatic hand or wrist disorders)
  • in case of hand/wrist surgery: at least 4 weeks have elapsed since surgery to avoid that the patient could not perform certain actions evaluated by the scale, for example lifting a pan or shopping bags, due to normal post-operative precautions.
  • full possession of mental capacity

排除标准

  • age < 18 years
  • non-native Italian speakers of Italian, thus also excluding second generation Swiss Italians ("secundo")
  • mental incapacity
  • upper limb in cast/locked by splint (criterion in Chung's article 98) at the time of the evaluation

结局指标

主要结局

Validity

时间窗: 3 months

Validity will be assessed as structural validity, i.e., "the degree to which the scores of the Health-Related Patient Reported Outcome (HR-PRO) are an adequate reflection of the dimensionality of the construct to be measured" (Mokkink et al., 2010).

次要结局

  • Reliability(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maurizio Calcagni

MD

University of Zurich

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