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Testimony on Comparative Effectiveness Research

Elisa Cascade,

On April 3, 2009, public testimony on comparative effectiveness research was given at a meeting of the National Advisory Council for Healthcare Research and Quality. The testimony represents the views of the presenter and not necessarily those of the Agency for Healthcare Research and Quality (AHRQ) or the Department of Health and Human Services (HHS).

Patient-centric research conducted using very large, highly profiled patient communities such as can play an important role in improving the efficiency of comparative effectiveness studies. Among other activities, these communities provide a mechanism for rapidly achieving the following:

  1. Hypothesis testing for comparative effectiveness studies—through direct administration of questionnaires to patients, researchers can identify potential domains for separation and sample size required to demonstrate significance on patient-reported endpoints. Regression analyses are used to control for differences in baseline characteristics between treatment groups. The attached poster abstract will be presented at ISPOR 2009 and DIA 2009 on this topic.
  2. Patient Protocol Acceptability Assessments—conducting a patient survey on protocol elements prior to finalizing the protocol can improve overall study feasibility and timelines by collecting data on: restrictiveness of study inclusion/exclusion criteria, potential barriers to entry, messages to facilitate enrollment, and overall patient interest in study participation. Several posters have been presented on this topic including the attached poster abstract accepted for DIA 2009.
  3. Development and validation of patient reported outcomes instruments—contacting patients and consenting them directly for instrument development and validation eliminates the time and cost associated with recruitment of physician sites and patients through these sites. As an example, over the past year, has surveyed nearly 27,000 patients using a validated instrument known as the Treatment Satisfaction Questionnaire for Medications (TSQM).

We would welcome the opportunity to speak with AHRQ and its supporting research organizations about our experience in working with Patient Communities to support clinical research activities which is based on the conduct of over 30 Patient Protocol Assessments with 2,000+ patients in the past 6 months.

Thank you,
Elisa Cascade

Vice President
3130 Fairview Park Dr. Suite 501
Falls Church, VA 22042

Page last reviewed April 2009
Internet Citation: Testimony on Comparative Effectiveness Research: Elisa Cascade, April 2009. Agency for Healthcare Research and Quality, Rockville, MD.


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