European Diploma

Focus points of this programme:

Q. We enrolled a patient and discovered soon afterwards that the patient has a DVT. The doctor ordered bed rest for over a week. How do we handle this?

A. This should be reported in the database as an adverse event. Please refer to section 1.14, Adverse Event Reporting, in the SIRRACT Database Instructions Manual for detailed instructions.

Although our protocol allows the subject to participate if the complication resolves within 7 days of admission screening, a physician’s order for more than a week of bed rest implies that the patient should be withdrawn from the study. To do this, please refer to the section 1.6, Changing Patient Status to Inactive, in the Database Instruction Manual.

Q. How many data files will an MDAWN sensor gather in a typical day?

A. Usually 20-35 files for 8 hours of data collection.

Q. Our MDAWN sensors sometimes contain a very large number of files; Why?

A. Your sensors continue to collect data until they are plugged back into a live power supply or until they run out of charge, whichever comes first. If your MDAWNs have many files, it is likely that the sensor was left unplugged for a long time.

For best results, plug in your sensors each evening after removing, upload files with the MDAWN Uploader and allow to charge overnight.

Q. If a patient has an outside appointment or is very sick on a Monday, Wednesday, or Friday, do we provide feedback and perform the 10m assessment the next day, or is that day skipped?

A. We need one timed walk with sensors on each week, so that cannot be skipped. If the patient is unable to do it on a Wednesday, he/she can do it on Thursday. Please let us know about the change. It is acceptable if a subject misses one day of feedback as long as the subject gets at least 2 days of feedback that week.