Section H

H.1 Visit Completion

Description

This section contains information regarding the timing, conduct and completeness of data collection for each six-month phone call and annual visit following randomisation, including the timing of basic ADL reassessment at baseline and basic ADL and cognitive reassessment (3MS and CES-D 10) at each annual visit (if reassessment occurred). Also included is the conduct of each cognitive reassessment, which may have been via phone call during ASPREE-XT. The following measures have been included in this section: the timing of any basic ADL reassessments at baseline, the timing of any basic ADL or cognitive reassessments at each annual visit, the timing of each six-month phone call and annual visit, whether each six-month or annual visit was possible to complete on the due date and whether each contact was conducted in person, by phone or by medical record review. Data relating to the completion of concomitant medication data collection at each annual visit has also been included. We have also indicated where a scheduled annual visit was replaced by the Milestone Visit, whether a participant consented to ASPREE-XT and the maximum potential follow-up time from randomisation during the ASPREE Clinical Trial.

Timing of Data Collection

The timing and nature of each contact was recoded at the time of visit conduct through AWARD-Data. For example, upon administration of a six-month phone call visit, a six-month phone call visit was created by study staff in AWARD-Data via the web application and annotated with the day’s date.

Summary of Data Dictionary

This section contains discrete and nominal data. Data regarding the timing of any reassessments and other contact have been presented as “days since randomisation” to indicate when the reassessment or visit occurred. Each variable is linked with a commentary code that aims to provide additional data with regard to missing data, out of range data, alterations to data collection methods and other special considerations.