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<h1>Health-Related Quality of Life & Patient Reported Outcomes Oct 2008 </h1>
<p>The ABS team has extensive experience developing,
validating, and selecting instruments for studies involving Health-related
Quality of Life (HRQL) and other Patient Reported Outcomes (PROs), and in designing and conducting HRQL and PRO studies
in multiple therapeutic areas. Examples of this work are presented here.</p>
<h2>Instrument Development and Validation</h2>
<ul>
<li> Development
and validation in multiple countries of a new measure of men’s sexual health
</p>
</li>
<li>Development
and validation of a new HRQL measure in laryngopharyngeal reflux
</p>
</li>
<li> Development
and validation of an instrument to measure HRQL issues for acute cough
</p>
</li>
<li> Development
of a measure of patient satisfaction with treatment for migraine
</p>
</li>
<li> Validation
of an HRQL instrument for use in patients with acromegaly,
a rare pediatric disorder (for inclusion in a Phase II / III trial)
</p>
</li>
<li> Validation
of an instrument in a new (pediatric) patient population
</p>
</li>
<li> Development
and validation of a new PRO instrument (addressing HRQL, functional status, and
satisfaction) in Hunter syndrome
</p>
</li>
<li> Development
of a measure of satisfaction with treatment for migraine</li>
<li>Development
of a survey instrument to assess patients and physician preferences for
diabetes treatments
</p>
</li>
</ul>
<p></p>
<h2>Pro Data Collection and Analysis</h2>
<ul>
<li>HRQL
and productivity assessment in patients with hemophilia and inhibitors and
their caregivers
</p>
</li>
<li> HRQL
analysis in Phase III clinical trial in prostate cancer
</p>
</li>
<li>First-ever
assessment of HRQL in patients with Fabry disease
</p>
</li>
<li>Prospective,
multi-national clinical and PRO (HRQL and satisfaction) evaluation of the
burden of postoperative ilius
</p>
</li>
<li> Study
of the impact of anemia on patients with HIV
</p>
</li>
<li>Observational
study of the care and outcomes (clinical and HRQL) of anemia in cancer patients
undergoing chemotherapy
</p>
</li>
<li>Analysis
of HRQL using data from multiple clinical trials for a neurology agent
</p>
</li>
<li>Studies
of physician and patient preferences for hemophilia treatments
</p>
</li>
<li>Survey
of patient preferences for medications and patient adherence in bipolar
disorder
</p>
</li>
<li>Survey
of treatment preferences of colorectal patients for chemotherapy agents
</p>
</li>
<li>Study
of patient preferences and other factors on breast cancer treatment patterns
</p>
</li>
<li>National
survey of the utilization of colorectal screening tests, as well as related
demographics, awareness, attitudes, and beliefs
</p>
</li>
</ul>
<h2>Strategic Support for Pro Assessments In Clinical Studies</h2>
<ul><li> Strategic
PRO research for an HIV therapy, including recommendations for the U.S. and
Europe on generic and disease specific instruments (including HRQL, satisfaction,
and symptom bother)</li>
<li>Assessment
of the positive and negative characteristics of available HRQL instruments for
ovarian cancer worldwide</li>
<li> Identification
and selection of HRQL instruments for insomnia therapy</li>
<li> Battery/instrument
and symptom instrument selection for a post-approval prospective study for a
postoperative indication
</p>
</li>
<li>Instrument
selection for an observational study in the U.S. and Europe to examine the
humanistic burden of postoperative GI dysfunction</li>
<li> PRO
instrument selection for clinical trials of influenza vaccine</li>
<li> Strategic
review of patient- and caregiver-reported outcomes instruments in Alzheimer’s
disease</li>
<li> Systematic
review of studies of the effect of beta-blockers on HRQL in patients with heart
failure</li>
<li> Design
of HRQL components of European clinical trial in atrial fibrillation</li>
<li> Design
of PRO / HRQL components of multinational clinical trial in diabetes</li>
<li>
Integration
of HRQL data in dossiers for submission and presentation to European
authorities
</p>
</li>
</ul>
<h2> </h2>
<p></p>
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