Intensive Care (ICU) Myopathy Clinical Trial
Official title:
Physical Function in Critical Care (PaciFIC): An Multi-centre Observational Study
Impairment in physical function is a significant problem for survivors of critical illness.
There is a growing urgency to develop a core set of outcome measures, which can be adopted in
clinical and research practice to evaluate efficacy in response to interventions such as
rehabilitation.
Phase 1: Development of a new outcome measure. This study aims to examine the development of
a single outcome measure which may be able to be utilised across the continuum of recovery of
critical illness in the evaluation of physical function. The study will involve examination
of two common physical function measures - the Physical Function in intensive care test
scored (PFIT-s) and De Morton Mobility Index (DEMMI) and the development of a new measure
based on rasch principles which may be able to capture physical functioning changes in
individuals with critical illness. Aims: (1) To determine the clinical utility of two
physical function measures (DEMMI and PFIT-s) when used in isolation across the hospital
admission; and (2) To transform the (15-item) DEMMI and (4-item) PFIT-s into a single measure
to evaluate function in intensive care survivors using Rasch analytical principles.
Phase 2: Measurement properties of the PACIFIC physical function outcome measure in an
independent validation sample.
Consecutive eligible patients will be recruited into the study.
Phase 1: Two outcome measures - PFIT-s and DEMMI will be performed within 24 hour period.
Order of testing will be randomised to minimise testing bias. Time-points of assessment are:
awakening, ICU discharge and hospital discharge. Weekly measures will also be performed if
required in ICU and/or ward settings for up to a maximum of 30 days in each setting. The
measurement properties of the individual tools PFIT-s and DEMMI will be examined (e.g.
validity, responsiveness).
Phase 2: Based on the findings in Phase 1 a new single outcome measure will be developed. In
the second phase examination of the measurement properties of the tool will be undertaken
including (reliability, validity, responsiveness).
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