Article type
Year
Abstract
Objectives: To:
1. describe the clinical study report (CSR) and differentiate it from other data sources;
2. navigate through CSRs and identify data to be abstracted;
3. apply a systematic approach that allows for high-quality and efficient data abstraction (DA).
Description: The CSR is a detailed description of a single study in which the methods, results, and conclusions are integrated into one report. The European Medicines Agency has pledged to release CSRs, which would yield extensive information not always available in published reports. The level of detail in CSRs can allow for a more complete account of the study design, outcome, and adverse event (AE) data. CSR DA can be a challenge to systematic reviewers due to an overwhelming amount of data organized in unfamiliar ways. For example, a CSR may have 3000 pages with 200 outcomes and 400 AEs, while a published report on the same trial may only have six outcomes and 15 AEs. After a short presentation introducing CSRs and DA using CSRs, we will guide participants through the partial abstraction of a CSR by setting up a DA 'scavenger hunt'. Participants will be divided into teams and work through different steps of the CSR DA process. We will provide instructions and tips to encourage high-quality and efficient DA of this important data source. Following the activity, we will discuss findings and experiences, allowing participants to share their experience and build upon our CSR DA guidance.
1. describe the clinical study report (CSR) and differentiate it from other data sources;
2. navigate through CSRs and identify data to be abstracted;
3. apply a systematic approach that allows for high-quality and efficient data abstraction (DA).
Description: The CSR is a detailed description of a single study in which the methods, results, and conclusions are integrated into one report. The European Medicines Agency has pledged to release CSRs, which would yield extensive information not always available in published reports. The level of detail in CSRs can allow for a more complete account of the study design, outcome, and adverse event (AE) data. CSR DA can be a challenge to systematic reviewers due to an overwhelming amount of data organized in unfamiliar ways. For example, a CSR may have 3000 pages with 200 outcomes and 400 AEs, while a published report on the same trial may only have six outcomes and 15 AEs. After a short presentation introducing CSRs and DA using CSRs, we will guide participants through the partial abstraction of a CSR by setting up a DA 'scavenger hunt'. Participants will be divided into teams and work through different steps of the CSR DA process. We will provide instructions and tips to encourage high-quality and efficient DA of this important data source. Following the activity, we will discuss findings and experiences, allowing participants to share their experience and build upon our CSR DA guidance.