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Adherence and persistence measures will be derived from patient self-report, metabolic outcomes (indirect measure), and pharmacy records.
Two primary outcome measures will be derived from the hyperglycemic clamp, namely, the mean C-peptide concentration at steady-state glucose adjusted for the prevailing insulin sensitivity at steady state and the maximal arginine plus hyperglycemia stimulated C-peptide responses.
These specific bacteria as well as alpha- and beta-diversity measures will be derived from barcoded amplicon libraries of the V4 hypervariable region (517 F-803R) of the prokaryote rrs genes present in each sample, using protocols similar to those described by Caporaso et al. [ 54].
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This measure will be derived from the subscale Employment/Occupation of the self-report Birchwood Social Functioning Scale (SFS) [ 44 ] using a hierarchical index to dichotomise whether or not there is an increase in societal participation at 6 and/or 12 months.
4) A preference-based measure of HRQOL will be derived from the Short-form 36 (SF-36), a generic quality of life measure which is validated in COPD [ 39].
A preference-based measure of health will be derived from the SF-36 to produce a summary health score (multi-attribute utility score) for individuals at each time point.
Primary outcome measures for the infant will be derived from the overnight sleep study (amount of time head covered, amount of time in thermal comfort zone, number of hypoxic events and amount of time in the sleep device) and from surveys (full or exclusive breastfeeding at 3 and 6 months).
A measure of social advantage/disadvantage will be derived from postcode of residence using the Index of Relative Socio-economic Advantage/Disadvantage from the Australian Bureau of Statistics. 100 Deciles will be reported on a continuum with lower scores reflecting greater socioeconomic disadvantage and higher scores reflecting socioeconomic advantage.
Additionally, a cost-utility analysis will be performed to enable comparisons to be drawn with other areas of health care; utility will be measured using QALY values, which will be derived separately from (i) the EuroQoL EQ5D, and (ii) the SF-12 SF-6D.
A preference-based single utility measure, using Australian preference weights, will be derived from SF-36 using the Short Form-6 Dimensions (SF-6D) as described by Norman et al. 41 A supplementary analysis using the EQ-5D-5L will also be conducted.
Augmentation index (AIx) is regarded as a measure of systemic arterial stiffness that will be derived from the central and radial pressure waveforms as previously described [ 29].
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