Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability Clinical Trial
Official title:
Psychometric Validation of the Multi-INdependency Dimensions (MIND) Score for Patients Under Prolonged Mechanical Ventilation
It was decided to develop a comprehensive disability score specifically designed for
patients receiving prolonged mechanical ventilation (PMV); the collection of information
included in the score should not impose any further intervention beyond what is routinely
performed. So a new questionnaire was created (called the Multi-INdependency Dimensions
(MIND) that included 3 sections (nurse, physiotherapist and medical doctor), 11 categories
and 18 items. Each question was adapted to have a 5 item Likert scale.
The primary objective of the study will be to evaluate the psychometric performance of the
MIND score in terms of validity, reliability and sensitivity to change over time. The
secondary objective will be to assess the inclusion of biological markers on the overall
performance of the MIND score
Following recruitment all participants will be assessed by a medical doctor or respiratory
therapist (trained on the study) who will fill out the MIND questionnaire on admission and
make sure the other scales/questionnaires are also completed. On the same day of the
collection of MIND, MRC score for quadriceps and biceps strength, Sequential Organ Failure
Assessment (SOFA) score, Glasgow coma scale, Hospital Anxiety-depression scale (HADS),
EuroQol-5D, Gussago Dependence Nursing Scale (GNS) will be also gathered. After 1 day and 30
days the MIND questionnaire will be also evaluated. Index of ADL-(Katz index) will be
evaluated on discharge as well as weaning rate and survival.
Sample Size Determination
Based on the method of Rouquette A et al (1) we estimated a sample size of 200 patients to
allow for the Rasch modelling to be applied.
Statistical analysis
Assessment of construct validity:
Confirmation of the structure (e.g. multitrait analysis), clinical validity (comparison of
disability score according to external clinical criteria)
Assessment of reliability:
Internal consistency reliability (using Cronbach's alpha), test-retest reliability (using
intraclass correlations)
Assessment of sensitivity to change over time:
Comparison of change in disability score according to change in external clinical criteria
Guidance for interpretation of disability score: Estimation of thresholds for patients'
classification
1-Rouquette A, Falissard B Sample size requirements for the internal validation of
psychiatric scales Int J Methods Psychiatr Res. 2011 Dec;20(4):235-49. doi: 10.1002/mpr.352.
Epub 2011 Oct 24.
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Observational Model: Cohort, Time Perspective: Prospective