New
Research on the Use of Interactive Voice Response (IVR) Technology and the
Validation of Rating Scales in Clinical Trials Presented at the December
meeting of the American College of Neuropsychopharmacology (ACNP)
6th
January 2003 Madison, WI At the American College of
Neuropsychopharmacology (ACNP) 41st Annual Meeting December 8-12 in San
Juan, Puerto Rico, studies were presented substantiating the value of
Interactive Voice Response (IVR) technology in gathering patient
self-report data in clinical trials. In addition to the IVR
research, a new assessment shows promise for discriminating Alzheimer’s
Disease from Vascular Dementia.
Reports by
several investigators presented new evidence that administration of
psychiatric outcome measures directly to patients by way of innovative
computer-based IVR programs utilizing the touchtone telephone provides
data as good as, if not better, than obtained by clinician raters.
The technology offers advantages in data collection and processing that
promises to reduce the cost of clinical trials and shorten the time to
bring a drug to market.
Douglas
Feltner, MD of Pfizer, Inc. presented a poster entitled “Evaluation Of
An Interactive Voice-Response (IVR) HAM-A in a Generalized Anxiety
Disorder (GAD) Relapse Prevention Trial” that compared data from IVR-administered
and clinician-administered versions of the Hamilton Anxiety Rating Scale
(HAM-A). Since entry into the study required a clinician HAM-A score
of at least 20, all participating patients met this standard. The
IVR-generated scores from the very same patients, however, showed that a
substantial number rated themselves lower than the entry criterion of
> 20, raising issues that cut to the very heart of patient
recruitment for clinical trials.
Feltner et
al. acknowledged that adding an IVR HAM-A patient-self report score “as
an inclusion requirement would have reduced the number of subjects
eligible for enrollment” and “using IVR HAM-A criteria for response in
open label resulted in fewer responders than using OBS (observer) HAM-A
criteria.” On the other hand, he also concluded: “Using
IVR-HAM-A criteria for patient selection might have allowed for the
detection of relapse prevention with fewer patients in both open label and
double blind.”
A poster
presentation by Bernice Kuca from Sepracor Inc. entitled “Interactive
Voice Response (IVR) Diary Methods to Reduce Retrospective Recall Bias In
Sleep Studies,” showed that collecting sleep diary information by IVR
from adult and elderly outpatients was “feasible in both short and
long-term studies.” As concluded in the poster, “the sponsor
reported significantly fewer data queries and reduced (data) cleaning
time. (IVR) technology allows for more frequent data collection
between office visits, places minimal burden on subjects, and enables
convenient, real-time, valid recording of symptoms versus retrospective
recall.”
A poster
presentation summarizing results from research conducted on the new
paper-based Symptoms of Dementia Screener (SDS) was made by David J.
Katzelnick, MD of Healthcare Technology Systems, Inc., entitled “Can a
Short Dementia Screener Help Discriminate Alzheimer’s Disease from
Vascular Dementia?” This 11-item informant-based screening questionnaire
has previously “demonstrated good sensitivity and specificity for
discriminating cognitively normal from cognitively impaired elderly
patients.” This new study showed the SDS may be helpful in
discriminating Alzheimer’s Disease from Vascular Dementia.
The
clinical IVR systems discussed in the first two posters above were
created, developed, and delivered by Healthcare Technology Systems, Inc. (HTS),
a Madison, Wisconsin based research and technology firm led by three
physicians, John H. Greist, MD, James W. Jefferson, MD and David J.
Katzelnick, MD. HTS is the world leader in creating, developing and
implementing clinical IVR systems to gather data directly from patients.
HTS currently offers more than 30 IVR rating scales, and has the research
and clinical expertise to create others. The following are some of
the more commonly used scales that have been adapted to IVR
administration: Hamilton Depression Rating Scale (HAM-D), Hamilton
Anxiety Rating Scale (HAM-A), Liebowitz Social Anxiety Scale (LSAS),
Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Mental Health Screener® (MHS),
McGill Pain Questionnaire, and Changes in Sexual Functioning Questionnaire
(CSFQ). HTS also performs a variety of research with and for the
pharmaceutical industry, including creation and validation of standardized
scales, collection of patient diary data, health services research, and
protocol analysis.
(###)
For more information
contact:
Kristin Brand
Healthcare Technology Systems, Inc.
7617 Mineral Point Road, Suite 300
Madison, WI 53717
Phone: 608-827-2478; Fax: 608-827-2444
E-mail: kbrand@healthtechsys.com
Web site: www.healthtechsys.com
January 6, 2003
