The questions about hormone replacement arose last spring, when an independent group of experts that periodically examined accumulating data from the Women's Health Initiative, a federal study, decided that it had to stop.
An expert group reviewing mammography studies decided that it could no longer say that the test prevents breast cancer deaths.
A study, he had decided, that was doomed to no conclusion.
At the beginning of the study, we decided that we would choose cutoff points based on values deriving from data analysis (receiver operating characteristic [ROC] curves).
While nurses provided necessary fluids to prevent dehydration, the study physicians decided that none of the volunteers required rehydration with oral rehydration salts solution or with intravenous fluids.
To ensure that the results of the trial would be reported accurately without possible bias due to missing data, the study leadership decided that no outcome results would be reported until the vital status at the end of the study was known for at least 97% of the study participants.
The study investigators decided that no modifications to the interview protocols were needed, and data collection proceeded with the remaining 22 alumni.
A further limitation is that before we were able to ask patients to take part in the study by completing the questionnaire, there was a degree of 'gate-keeping' by general practitioners who could either not engage with the study or decided that their patient wasn't suitable to be included.
Based on existing data and a priori knowledge of the exposure and outcome of interest in all the studies, we decided that maternal age and gestational age were the main "important" potential confounders for all the included studies.
When we planned the present study, we decided that the overall design should be as similar as possible to that of the study from 1994 1997.
