Evaluating the safety of anticoagulant medications from electronic medical record data : a case study of observational cohort designs with survival analysis / Pavel Goriacko.

Format:

Book

Author/Creator:

Goriacko, Pavel, author.

Series:

SAGE Research Methods Cases : Medicine and Health.

SAGE Research Methods Cases: Medicine and Health

Language:

English

Subjects (All):

Medical records--Data processing--Case studies.

Medical records.

Anticoagulants (Medicine)--Case studies.

Anticoagulants (Medicine).

Drugs--Safety measures--Case studies.

Drugs.

Cohort analysis--Case studies.

Cohort analysis.

Physical Description:

1 online resource : illustrations.

Place of Publication:

London : SAGE Publications Ltd, 2020.

Summary:

The efficacy and safety of medications is most commonly assessed in large randomized clinical trials which are required to gain approval of a regulatory agency. However, most trials enroll a homogeneous patient population, use strict exclusion criteria, compare active medication to a placebo, and assess only the efficacy and safety outcomes required for gaining approval. To fill the gaps in knowledge left by clinical trials, clinicians must often undertake medication research using observational data from the electronic health record. This approach is prone to challenges such as incomplete documentation, loss to follow-up, and confounding bias. These challenges require researchers to use appropriate methodology to preserve validity of their study results. The case study presented here describes the conduct of a retrospective study of anticoagulant medication safety in a high-risk patient population with chronic liver disease. It reviews commonly used observational research designs, practicalities of extracting and optimizing electronic medical record data, and analyzing a cohort with incomplete documentation and variable follow-up times.

Notes:

Includes bibliographical references and index.

Description based on XML content.

ISBN:

1-5297-3529-7

9781529735291

OCLC:

1151026559