Validation of the Foot Health Status Questionnaire in French Language

Condition(s) studied

Investigational drug(s) / intervention(s)

Questionnaires: Patients will complete various questionnaires at J0: FHSQ-Fr, EQ-5D-5L, Foot Function Index, Visual analog pain scale, SF-12. Patients who needs to come back for a visit at Day 7 (+ 3 days) will complete the FHSQ-Fr questionnaire for a second time

Study summary

A French foot health survey showed that 73% of people examined felt pain and 38% don't left their home, which suggest a reduction in their life's quality and autonomy. Developed by Paul Bennett, FHSQ is a foot health-specific self administrated questionnaire. It sensitively detects changes in patients' foot health status, whatever their pathology, across multidimensional concepts of their quality of life. Actually, more than 150 scientific publications have cited it. Reliable and valid, it has already been translated and validated in multiple languages, but not in French. The subject of this study is to validate the translated and cross-cultural adapted French version FHSQ-fr through its psychometric results of validity and reliability. The study follows a 2-stage methodology.

The first, already completed, consisted of (back)translating the Australian FHSQ questionnaire into French by a scientific committee in order to obtain a pre-final version.

The second is to validate this final version using appropriate statistical analysis, including correlations studies with other French validated questionnaires, to determine its psychometric characteristics.

Eligibility

Primary outcome measure(s)

• Internal consistency — Day 0
  It is evaluated using Cronbach's alpha coefficient "α", which measures the internal consistency of a set of items, scales or sub-scales for a single clinical dimension. The value of this index is less than or equal to 1, and the closer alpha is to 1, the stronger it is. α" \> 0.7 or \>0.8 is considered fairly high. However, the coefficient must not be too close to 1, otherwise the items are redundant and duplicate each other.
• Temporal stability of patients' questionnaire scores FHSQ-en V 1.02 — Day 0 and day 7
  It is measured by the Intraclass Correlation Coefficient (ICC) and its 95% confidence interval, and/or the Pearson Correlation Coefficient. By convention, fidelity is said to be: * Very good if ICC ≥0 91 * Good if 0.9 ≤ ICC ≤ 0.71 * Moderate if 0.70 ≤ ICC ≤ 0.51 * Poor if 0.5 ≤ ICC ≤ 0.31 * Very poor or nil if ICC ≤ 0.3
• Measurement error — Day 0
  To apply the criterion of good measurement error, the MIC (Minimal Important Change), the SDC (Smallest Detectable Change) or the LoA (Limits of Agreement) load will be calculated using a longitudinal approach based on anchoring.

Trial sites (1)

More Centre Hospitalier Régional d'Orléans trials in France