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AHRQ Publishes Third Edition of Quintiles-Led Registries User’s Guide

Updated User’s Guide includes 11 new chapters, contributions from 240 individuals

2014-05-05 16:46
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RESEARCH TRIANGLE PARK, N.C.--()--Quintiles today announced that the U.S. Agency for Healthcare Research and Quality (AHRQ) has published the third edition of “Registries for Evaluating Patient Outcomes: A User’s Guide.” Quintiles’ Real-World & Late Phase Research division, a leading provider of patient registries, studies and technologies for evaluating patient outcomes, has led this effort to create the patient registries reference since 2005. This publication provides a comprehensive guide to the design, operation, analysis and evaluation of patient registries.

“The handbook is a widely used reference in the United States, Europe and Asia, and previous editions have been cited extensively in the peer-reviewed literature as the standard for designing, conducting and evaluating patient registries,” said Nancy A. Dreyer, MPH, Ph.D., senior editor of the handbook and global chief of Scientific Affairs at Quintiles. “Many thanks to all stakeholders who have contributed – including, for the first time, patient representatives – and to AHRQ for supporting the initiative. The third edition represents a significant expansion, from 14 to 25 chapters.”

Quintiles’ Real-World & Late Phase Research division has led the effort to create and edit the registries user’s guide since 2005. Dr. Dreyer served as a senior editor for the project. In addition, Dr. Dreyer and Dr. Priscilla Velentgas, senior director of Epidemiology at Quintiles, are also senior editors of a second AHRQ User’s Guide, titled “Developing a Protocol for Observational Comparative Effectiveness Research.”

The third edition of the registries user’s guide was created in collaboration with more than 240 individuals, representing industry, academia, government and patients. In total, there were 100 chapter contributors, 76 invited peer reviewers, plus public comment, and 109 case example contributors, with some individuals participating in multiple ways. The 11 new chapters address challenges related to design, operations, ethics, analysis, and legal and technical concerns, with topics including:

  • Best practices for including patient reported outcomes in registries
  • Special considerations for informed consent in patient registries
  • Practical advice for setting up and managing a registry through a public-private partnership
  • Technological options for managing patient identities across data sources
  • Considerations for modifying existing registries
  • Special applications for registries, such as quality improvement, pregnancy, rare disease and medical device registries

The latest edition also features 34 new case examples – for a total of 64 – including 16 international examples, eight device registries, four public-private partnerships, six rare disease registries, nine quality improvement registries and five pregnancy registries.

To obtain a complimentary copy of the user’s guide, please visit the AHRQ website.

About Quintiles

Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 28,000 employees conducting business in approximately 100 countries. We have helped develop or commercialize all of the top-50 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com.

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