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Therefore, process indicators will be collected partly from existing registrations.
Information on more than 20 of the MDG indicators will be collected through MICS4 alone.
Quality-of-care indicators will be collected from databases and patient medical files.
Data on outcome and process indicators will be collected separately for the trial.
Process indicators will be collected from health care providers' data registries and measured via physician and staff questionnaires.
Data about the outcome indicators will be collected using questionnaires 1 week, 6 months and 12 months after discharge.
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The methodology will include agreements on the indicators for which data will be collected and the development of specific data collection tools, for subsequent adaptation in each country.
1 Secondary indicators of worthwhile improvement will be collected via the Treatment Review Questionnaire completed after third treated cycle, and will address 'satisfaction' with treatment (self-reported 'lighter' or 'much lighter bleeding', and generally feeling 'much better' during period), improvement in period pain ('less' or 'much less severe'); and freedom from unacceptable side effects.
FALLS measures including quality indicators (process measures) and fall rates will be collected for the six months prior to baseline and the six months after the end of the intervention.
Additional indicators of health to be determined will be collected at ages 24 and 36 months.
Furthermore a random sample of 3 resident records per participating institution (T0, T1, T2) will be collected and reviewed for indicators of successful implementation of PCC.
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