Multinational registries : challenges and opportunities : addendum to Registries for evaluating patient outcomes : a user's guide / Michelle B. Leavy.

Format:

Book

Author/Creator:

Leavy, Michelle B., author.

Language:

English

Subjects (All):

Outcome assessment (Medical care).

Physical Description:

1 online resource

Edition:

Third edition.

Place of Publication:

Rockville, MD : Agency for Healthcare Research and Quality, 2018.

Summary:

Multinational registries can provide valuable data to address multiple types of research objectives, but, in order to do so, they must be planned, designed, and operated with several special considerations in mind. While much of the information contained in the document, Registries for Evaluating Patient Outcomes: A User's Guide, applies to multinational registries, these registries face unique issues resulting from variations in treatment patterns, patient populations, cultural norms, and regulatory and ethical environments. The purpose of this paper is to discuss unique considerations for the planning and conduct of multinational registries, as well as explore the challenges with regards to operational, ethical, and regulatory considerations. Where appropriate, reference is made to other chapters in the User's Guide.

Contents:

Reviewers (alphabetical)

Introduction

Multinational Registry Models

Planning and Design Considerations

Treatment Patterns

Patient Populations

Patient Perspectives

Data Sources

Variations In How Observational Studies Are Defined

Data Protection

Informed Consent

Additional Considerations

Regulations and Guidelines Applicable to Observational Studies

Operational Considerations

Recruitment and Retention of Patients and Providers

Data Quality Assurance and Data Management

Risk Management

Special Considerations: Emerging Markets

Conclusion

References.

Notes:

Description based on publisher supplied metadata and other sources.