Therapeutic and Diagnostic Device Outcomes Research

An outcomes research primer for those in the therapeutic and diagnostic device field with the purpose to inform:

1) Health outcomes researchers on the unique characteristics of therapeutic and diagnostic devices, and

2) Medical device developers and researchers on the basic principles of clinical, economic, and patient-reported outcomes research for therapeutic and diagnostic devices

Reliability and Validity of Data SOURCES for OUTCOMES Research & Disease and Health Management PROGRAMS

This handbook for practitioners, payers, decision-makers and students provides an overview of the sources of data for conducting ‘real world’ outcomes research, how to assess the reliability & validity of these data, and approaches for experimental and retrospective research designs.  This book is a guide on how to evaluate claims & medication databases, electronic medical records & medical charts, patient-reported outcomes (PROs) & other self-reported data, alternative population-based data sources.  A chapter on the adaptation of foreign data for local analysis, data transferability, and the ISPOR International Digest of Databases conclude the book. 

Publication is expected Fall 2012.

ISPOR Taxonomy of Patient Registries: Classification, Characteristics and Terms

The Patient Registry Taxonomy describes characteristics & classification of registries and terms used in the design, development, implementation of registries and terms used in the analysis, reporting & publishing of registry data.  Each term will include a brief definition, a broader explanation, the associated values & uses, and conclude with a discussion of issues or conflicts related to the term.  The target audience is health care professionals, students and decision-makers, as well as outcomes research practitioners.

Publication expected Summer 2012.