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Researchers in the USA developed and tested a standardised instrument to measure patients' concerns and experience.
The CIDI 2.1 is a highly standardised instrument designed to be administered by lay interviewers.
Changes in HRQL (e.g. pain relief) should preferably be reported directly from patients, using a standardised instrument such as EQ-5D, if possible.
For instance, two of the studies were small and retrospective [10], [17], two studies collected data from proxies (such as GPs) in addition to or instead of patients [10], [19], and the studies based on the zanamivir trial did not use standardised instrument and only estimated the difference in QALYs lost when on antivirals [11].
Perceived social support was operationalised using a standardised instrument.
The questionnaire developed by the group was not a standardised instrument.
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Data sources were standardised instruments and a study-specific questionnaire.
We used standardised instruments and administration guidelines where these were specified.
In this way, automated methods could be used to complement standardised instruments.
For data collection and medical examinations standardised instruments will be applied, and detailed SOPs will be used in all centres.
This questionnaire includes standardised instruments targeting health related quality of life, physical activity, cardiovascular disease questions, and OA disease specific instruments [ 71- 79] (Table 2).
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