Using daily interactive voice response assessments: to measure onset of symptom improvement with duloxetine.
Most clinical trials measure patient responses weekly, requiring patients to accurately recall and report their symptoms from the previous six days. More frequent assessments would be less susceptible to recall errors and recency effects as weekly assessments, but increased office visits burden clinicians and patients and can lead to higher attrition or non compliance. Interactive voice response (IVR) technology permits data collection at greater frequencies with minimal reporting burdens. An ancillary study within a randomized clinical trial evaluated the use of IVR to gather measures of patients' ratings of emotional and painful symptoms of depression on a daily basis. Unmedicated patients randomized to a starting dose of duloxetine of 30 mg QD (n=67) or 60 mg QD (n=70) called an IVR system daily to complete Verbal Numeric Scales for pain and Patient Global Impression of Improvement for both physical and emotional changes. Patients' compliance with daily IVR assessments was examined, and the IVR data obtained showed that patients started at 60 mg reported less pain and greater physical and emotional improvements than patients started at 30 mg. Dose related differences were evident as early as one day after the start treatment. This study provides new data about the usefulness of daily IVR assessments in clinical research and supports other studies regarding early symptom improvement with duloxetine.
Moore
Heidi K
HK
Healthcare Technology Systems, Inc., Madison, Wisconsin, USA. hmoore@healthtechsys.com
Wohlreich
Madelaine M
MM
Wilson
Michael G
MG
Mundt
James C
JC
Fava
Maurizio
M
Mallinckrodt
Craig H
CH
Greist
John H
JH
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