In addition to antidepressant and antipsychotic medication history, this study did not collect adherence data to evaluate whether or not adherence correlated with weight gain or explained findings inconsistent with the literature, such as greater weight gain from FGA compared to SGA.
Although microbicide trials have routinely collected adherence data, their utilization in trial design, implementation, and interpretation has been inconsistent.
The Travalert® dosing aid (TDA, Alcon Laboratories, Inc., Forth Worth, TX, USA) was used to collect adherence data from all participants.
We are collecting electronic adherence data for 2 months in both study arms.
The objective data collected on adherence provide an excellent basis for further exploration of predictors of adherence and have great value in guiding footwear prescription practice and diabetic foot treatment.
The objective data collected on adherence have great value in guiding clinical practice and provide an excellent basis to further explore predictive factors of adherence, to perform comparative research, and to investigate interventions that aim to improve adherence.
Outcome measures are collected annually; adherence is assessed and prescriptions updated semiannually.
The venous blood was centrifuged at 4,000 g for 20 min at 20 °C, PBMC were isolated by dextran sedimentation and centrifugation on Nycoprep cushions, and monocytes were collected by adherence as described above.
The data are collected in adherence to ethical standards and all individual identifiers removed.
As part of our ongoing mind-body medicine research program, we created iMINDr, a custom monitoring software program to collect objective adherence data.
