MIND Score for Prolonged Mechanical Ventilation
Condition: Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability
MeSH terms: Neuromuscular Diseases
Study type: Observational

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): The study is a Prospective observational cohort study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with Prolonged mechanical Ventilation and a Diagnosis of Acute lung injury,
        COPD/Chronic Lung Disease, Neuromuscular Disorders, Post-Operative, Cardiovascular
        Disorders, Trauma, Other.