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Clinical measures with greater sensitivity than standard trial instruments might represent another strategy applicable to POC studies.
Many indigenous persons have extremely simple life styles unencumbered by utilities and conveniences; the usual trial instruments will not effectively quantify functional changes in these circumstances.
There have been numerous local translations of clinical trial instruments, often with little attempt at harmonization or consideration of the impact of the differences on trial outcomes.
Nearly all widely used clinical trial instruments for AD were developed in North America, and they may not be well suited for use in other countries, especially those with different cultural heritages.
Normative data for trial instruments are often lacking in cultures where clinical trials are conducted and cutoff scores for study entry as well as expected performances for healthy elderly persons may be difficult to extrapolate from Western experience.
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Outcome Measures: Global QOL and the QOL dimensions of physical function, emotional distress, social health, and general health were measured using the Ladder of Life, items from the Profile of Mood States Inventory, the Functional Status Questionnaire, the β-Blocker Heart Attack Trial instrument, and an item from the RAND Medical Outcomes Study instrument.
For clinical trials, instruments need to be based on a clear conceptual framework, have evidence supporting content validity and acceptable psychometric qualities.
In the INSPiRED trial, several instruments will be implemented to assess adherence.
Accurately diagnosing a malposition of the fetal head prior to instrumental delivery may lead to appropriate use of senior support, transfer to theatre for trial of instruments or indeed abandoning the procedure in favour of a caesarean section.
Two studies have applied a design allowing three-way analyses of variance between subjects, trials and instruments [ 11, 14].
Although the focus of this review will be functional assessment tools for stroke trials, these instruments also have utility in clinical practice.
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