Guide- Economic burden review

TABLE OF CONTENTS

Scope of Use for This Data Extraction Form
Overview of the Data Extraction Form
Data extraction process
Tabs description

Scope of Use for This Data Extraction Form

This data extraction form is designed for use in reviews that aim to:

Assess the burden of disease, including:
Economic burden (e.g. costs and resource use)
Treatment pattern (e.g. number of patients with concomitant treatment)

Overview of the Data Extraction Form

There are two categories of tabs in the Data Extraction Form:

General Tab

Tab name: Study Details
This tab is used to extract data regardless of the study type or the types of data included.

Specific Data Tabs

These tabs are designed to extract specific types of data, tailored to particular aspects of the review (e.g., costs/resource use data or treatment pattern data)).

Data extraction process

Field: Results Group Label

Description: This section defines the population or study group to which the extracted results refer to. It should be completed before extracting the outcome/results data.

This section is highlighted in red.

Instructions: Before extracting any results, determine for what group(s) the data are presented in the study. Use this field to label the groups appropriately. This label should help clarify who the results apply to, and help distinguish between results for different study populations and/or treatments.

Examples of labels you can use:

Main sample – if the results refer to the overall study population (e.g. patient with ulcerative colitis)
Subgroup – [specify] – if the results refer to a subset of the main sample (e.g., “Subgroup – Females”, “Subgroup – UC mild”).
Control sample– if the results refer to a comparator population (e.g. matched cohort-patient from the same hospital without disease).
Treatment arms - Population defined by treatment
Bia scenario: Status quo, projected

Case example: In this cost-effectiveness study, there are study arms arms. The names of those groups should be extracted first, as they will be used in the section dedicated to extracting cost data.

Look carefully at tables, figures, and captions to determine which population is being analyzed. 
If it's unclear, check the Methods or Results section for clarification.
The goal is to ensure each set of extracted results is clearly labeled by the group they belong to.

Subsections with examples

In each tab you will find different Sections with data extraction fields with or without subsections. Such organised structure enables precise determination of dependencies between elements (extraction fields).

Example 1

In Tab dedicated for Economic burden data you will find section Methods dedicated for extraction of data for methodological approach s like: currency, discount rates etc. Below this section you will find a subsections (Basic) to extract data that may appear more than once in study, for example there is more than perpsective:patiens, payer.

Vocabulary fields

Most of the data extraction fields are text fields, such as those used for extracting numerical values. However, some sections include vocabulary fields, where reviewers select data from a predefined list. During extraction, each reviewer has permission to create new codes if needed.

Database-format extraction

Please note that Laser AI supports a database-driven approach to data extraction. This means, for example, that different outcomes are extracted in separate sections. You won’t find dedicated sections for direct cost, indirect cost —instead, there is a single section called Results: Costs and RU. Within this section, you should select the specific costs or resource you are extracting (e.g., hospitalizations in the first subsection, cost of diagnostic tests in the second), using the controlled vocabulary.

Connections between PDF and values in data extraction forms

The best way to extract data in Laser AI is by using the highlighting mechanism. This method makes the quality assurance process easier, as clicking on a field with an extracted value redirects you to the corresponding section in the PDF where the value was extracted. To use this mechanism, you need to:

Locate the specific data in the document and highlight it.
Click the 'Plus' button (when empty data extraction fields exist) to add the highlighted data to the corresponding data extraction field. In this way the relation between data in PDF and value in data extraction form will be established. When there are no empty fields in data extraction form, click the 'Plus' button located below the data extraction fields. The tool will create additional field and the extracted value will be automatically added to the data extraction form. Please note that this option is available only for sections with a single data extraction field

Tabs description

Study details tab

This tab is dedicated to extracting study characteristics, such as study type, funding source, country, and more.

There are three key sections that require your attention:

Results Group Label
- Read the description in the previous chapter for guidance on how to define and use result groups.
Type and Source of Data

In this section, identify the type(s) of data included in the PDF (e.g.cost, resource use, treatment pattern).
Based on this, extract information only in the relevant data-specific tabs (e.g., Cost and Resource Use or Treatment Pattern).

Patient Characteristics

Use this section to extract baseline characteristics of the study population.
It includes subsections to capture detailed demographic and clinical information for study arms. Study arms in the subsections are automatically added once they are first extracted in the "Results Group Label" section.

Recommended method: Use semi-automated table extraction where applicable.

Economic burden: Costs and RU tab

This tab is dedicated to extract primary cost and resource use data.

It includes two sections:

First section for Methods (highlighted in purple)
One section for Results (highlighted in blue):

Please extract the cost or resource as reported in the Cost and Resource Description field, and select the relevant code from the list in the 'Type of cost or RU' field. Next, extract data for the study arms in the subsections. The tool will automatically add them once you extract their names in the Results Group label section.

Recommended method: Use semi-automated table extraction where applicable.

Treatment pattern tab

This tab is dedicated to extracting treatment pattern data from primary studies—for example, the percentage of patients on treatment, time to switch therapies, percentage of patients receiving concomitant treatments, etc.

It includes one section:

One section for Results (highlighted in blue)

Recommended method: Use semi-automated table extraction where applicable.