Format Check
Introduction
In clinical research, it's crucial to ensure that tables summarizing participant data include a comprehensive overview. A critical aspect of this is verifying the presence of a 'Total' column in specific types of tables, such as demography, baseline characteristics, or completion/withdrawal tables. The 'Total' column provides a complete aggregation across all subgroups, allowing for accurate interpretation and comparison. This check ensures that any table meeting predefined criteria includes a clearly labelled 'Total' column, supporting consistency and completeness in the reporting of clinical data.
Purpose
Validates the presence of a ’Total’ column in the specified table types. If the ‘Total’ column is missing, the table is automatically flagged with suspected discrepancy.
Note: The Total Column check is automatically skipped for demographic tables that contain the term 'COVID-19' (in any format or capitalization) in their title.
Applicability
Inclusion conditions
Table of type demography, baseline characteristics, or completion/withdrawal. Identify by one of the following:
- File name containing 'SIDEM' or 'SIDS' - case-insensitive
- The title includes the term 'Baseline Characteristics' - case-insensitive
- Option to add more wording, separator.
Exclusion
- Listings and figures
- Tables that are not of type demography, baseline characteristics, or completion/withdrawal
- Empty table
- Demographic table contains the term “COVID-19” in the title
Discrepancies
- “Total” column is missing from applicable table types.
Discrepancy Example
Details:
- Keywords: SIDEM in the file name
- Missing total column
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