EORTC Quality of Life Group Item Library: Technical guidelines

Q Item Library: Technical guidelines on behalf of the EORTC Quality of Life Group Dagmara Kuliś Claire Piccinin Bonnie Pacheco Mogens Groenvold Second edition 2025 Version 2.0 – Page 1 Table of Contents Table of Contents ................................................................................................................................. 1 Abbreviations used in the document ........................................................................................... 3 Introduction to the Item Library: history and development ................................................................... 4 Item Library overview ............................................................................................................................... 4 Access ........................................................................................................................................................ 4 Types of accounts ................................................................................................................................. 5 Logging in .................................................................................................................................................. 5 Item Library home page ........................................................................................................................... 6 Footer .................................................................................................................................................... 7 Overview of the Official questionnaires library ....................................................................................... 8 Types of views ....................................................................................................................................... 8 Questionnaire view ........................................................................................................................... 8 Detailed questionnaire view ...................................................................................................... 10 Item view ......................................................................................................................................... 12 Basic information view ............................................................................................................... 12 Detailed item view ...................................................................................................................... 13 Other elements – response scales, time scales, conditions, instructions, domain scales .......... 14 Searching ............................................................................................................................................ 16 Home page search box ................................................................................................................... 16 Search results ................................................................................................................................. 17 Keywords ........................................................................................................................................ 18 Overview of the Custom questionnaires library .................................................................................... 18 Types of custom questionnaires ........................................................................................................ 18 My questionnaires .......................................................................................................................... 19 Questionnaires from community ................................................................................................... 19 Custom item list flow .......................................................................................................................... 19 Make your own item list ..................................................................................................................... 19 Custom item list details .................................................................................................................. 22 Add items to a custom item list .......................................................................................................... 23 Version 2.0 – Page 2 Delete items from a custom item list ................................................................................................. 23 Re-order items .................................................................................................................................... 24 Add response and time scales ............................................................................................................ 24 Submit an item list for approval ........................................................................................................ 25 Modify a submitted item list ............................................................................................................... 26 Published item lists ............................................................................................................................ 26 Custom questionnaire translations ................................................................................................... 26 Use of custom item lists ......................................................................................................................... 27 Item classification ................................................................................................................................... 27 Standard classification ....................................................................................................................... 28 CTCAE classification ........................................................................................................................... 29 Version 2.0 – Page 3 Abbreviations used in the document CAT – Computerised Adaptive Testing CTCAE – Common Terminology Criteria for Adverse Events EORTC – European Organisation for Research and Treatment of Cancer IL – Item Library QLD – Quality of Life Department QLG – Quality of Life Group Version 2.0 – Page 4 Introduction to the Item Library: history and development The main aim of the Item Bank, as it was originally called, was to create a database of items that could be used, mainly by the QLG members, during the process of new questionnaire development. It enabled investigators to browse through validated items, identify questions covering relevant issues that they wanted to include, and use them in new instruments with consistent wording. This way, the Item Bank also saved time and effort spent on the translation process by re-using previously translated items. With technological advances requiring updates of the software, the Item Bank underwent subsequent refurbishments in 2009 and 2016. In 2017, the Item Bank was renamed as the Item Library and gained a new functionality: the option of making a custom item list from the items available in the database. All such usermade item lists are available for browsing and re-using. In further stages of development, two classifications of items were added to facilitate item selection based on their content and relation to the Common Terminology Criteria for Adverse Events (CTCAE). Item Library overview In its current form, the IL enables users to: 1. Browse through the existing official EORTC instruments (including EORTC CAT Core item banks and short forms) as well as user-created custom item lists, 2. Find existing items for new item lists from the pool of items developed by the QLG, consult information about the items and language availability, 3. Make a custom item list from selected items. Access How to get access to the Item Library: 1. Go to https://itemlibrary.eortc.org/ 2. Fill the request access form in, specifying your name, institution/company where you work, your e-mail address, motivation for accessing the IL and the type of account you are requesting (academic, commercial or for an active QLG member). Version 2.0 – Page 5 3. Your request is automatically sent to the IL admin, who will prepare an access agreement and send it to you for signature. Access to the IL is free of charge for all users. 4. Upon receipt of a fully executed agreement, the IL admin activates the account. Types of accounts There are three types of accounts with a different level of access to the IL’s functionalities: 1. QLG: full access to all features (searching English items and all translations), limited in time by the duration of the active membership in the QLG 2. Academic: full access to all features (searching English items and all translations), valid for 6 months from activation 3. Commercial: access to English items, valid for 3 months from activation Logging in The login page’s address is https://itemlibrary.eortc.org/ On the login page, you can: 1. Request access by filling in the access form, 2. Log in with your e-mail address and password chosen during the registration process, Version 2.0 – Page 6 3. Receive a new temporary password by clicking on “Forgot your password?”. The process is fully automatic and is the only way to get a new password, since the IL admin does not have access to the password database. Item Library home page The home page of the IL consists of the following elements: - The total number of questionnaires (official EORTC instruments) and unique items included in the Item Library - Search box - Tab allowing switching between the view of the official EORTC questionnaires, the custom-made questionnaires library, and the item classification - List of types of official questionnaires – clicking on the category acts as a filter to display only the chosen category: Version 2.0 – Page 7 ▪ Core – the C30 as the core questionnaire with 30 items relevant to the general population of cancer patients and the C15-PAL, an abbreviated version of the C30 for palliative patients. The C15-PAL questionnaire is shorter to focus on the issues relevant in a palliative setting and to diminish patient burden ▪ Stand-alone questionnaires – questionnaires which can be used on their own, without the C30 ▪ Modules – site-, populationand symptom-specific questionnaires that complement the C30 and should always be used together with the core ▪ Previous versions – previously developed questionnaires which have been updated ever since ▪ CAT – the EORTC Computer-Adaptive Testing (CAT) Core version of the 15 domains of the QLQ-C30 questionnaire. This category includes full item banks (all items comprising the item banks) ▪ CAT short forms – the EORTC CAT Core short forms created from the CAT item banks Footer The footer consists of two columns: • Information on how to obtain official questionnaires – both for academic and commercial use • Contact information for sending suggestions of items that were not found in the existing pool of questions Version 2.0 – Page 8 Overview of the Official questionnaires library Types of views Questionnaire view You can see the full questionnaire in its validated form by clicking the icon on the homepage or the title of a questionnaire. You can also search with the name or other keywords in the search box and select the questionnaire of choice. If you want to see all questionnaires in a certain category – for example, Modules – you can use the list of categories to filter the list of questionnaires on the left. Version 2.0 – Page 15 The full information page includes: - Name and code - Category - Language versions - Wordings – all wordings used for the particular element in all questionnaires. The recommended wording is marked for the wording that should be used in new item lists - List of items this element specifies - Similarly worded elements Version 2.0 – Page 16 Searching Searching is the basic function of the Item Library. It enables you to find items or questionnaires that are of interest and cover the relevant issues. General searching in the Item Library can be done two-fold: - With the search box on the home page, or - By browsing through the questionnaires and items. Home page search box The search box on the Item Library home page can be used in several ways. When you start typing your search words, a drop-down list appears with the following options: - Existing keywords - Items that match the typed word(s) because the name or wording includes them or the word matches one of the keywords associated with this item - Questionnaires that match the typed word(s) - Other elements of questionnaires that match the typed word(s). When you type a search word, you can do two things: 1. Type your search term and click Enter to get search results; 2. Choose from the list of the existing keywords and items/questionnaires/etc. the one that matches your search criteria. If you choose a keyword (term with a looking glass), Version 2.0 – Page 17 you will arrive at the results page for a search performed with that term. If you choose a matching item/questionnaire/etc., you will see a page with the information on that item/questionnaire/etc. The icons to the left of the term represent the category of the entry: Condition (CS) Instruction (IN) Question (Q) Questionnaire (code derived from the title) Response scale (RS) Domain scale (DS) Time scale (TS) Each entry in the IL has its code based on its type as listed above (for example, Q151, RS5, TS3), and it is possible to use it as a search term. Search results Search results are displayed with a predefined filter on questionnaires and items, so that only questionnaires and items that fulfil the search criteria are shown. It is possible to show other types of results by enabling and disabling filters by ticking respective boxes on the right-hand side. Version 2.0 – Page 18 Keywords Each item has a list of associated keywords that help the search engine. Keywords are shown in the item view and can be used to trigger a search action. Clicking on a keyword leads to a search results page listing all elements associated with this keyword. Overview of the Custom questionnaires library Types of custom questionnaires The Custom questionnaire library is divided into two sections: - My questionnaires - Questionnaires from community. Version 2.0 – Page 19 My questionnaires There are three types of item lists in the My questionnaires section: - Drafts – visible only to the user who created them - Waiting for approval – visible to the user who created it and to the content manager/IL admin - Approved – visible to all users Questionnaires from community The Questionnaires from community section includes two types of questionnaires: - Approved custom item lists made by other users, - Approved custom item lists made by you. Custom item list flow In order to make a new custom item list you should follow these steps: 1. Make a new questionnaire – fill in the basic information form 2. Add items 3. Add response scale, time scale, instructions, conditions if necessary 4. Submit for approval 5. Content manager/admin checks the information and the questionnaire – in case of problems contacts the user and edits if necessary. There is also a user agreement sent for signature. 6. Questionnaire is approved – it becomes visible to all users and can be downloaded as a .csv file. Make your own item list There are a few ways to create a custom item list. 1. By making a copy of an existing questionnaire and adding/deleting items – in order to make a copy you should choose the questionnaire to be copied and click on the “Copy as new custom questionnaire” button visible in the questionnaire’s view Version 2.0 – Page 20 2. By creating a new questionnaire from the home page – simply click on the “Create a new questionnaire” button 3. By creating a new item list in the “Custom questionnaires” library 4. By adding search results to a new questionnaire – once search results have been selected, you can click on “Add X selected to questionnaire” and from the drop-down list chose “New questionnaire” Version 2.0 – Page 21 5. By adding an item from the questionnaire view – if an item from a particular questionnaire seems of interest, you can click on the three dots and add it to an empty item list by selecting “New questionnaire” 6. By adding a wording from the item view – if a particular wording in an item view seems of interest, you can click on the three dots and add it to an empty item list by selecting “New questionnaire” Version 2.0 – Page 22 Custom item list details When creating a new item list, you have to fill in some basic information about your questionnaire. The following information can be filled in: - Name – chosen name (can be changed later) - Type – a drop-down list to choose, Item list is set as the default type. - Gender – gender of the population for which the item list is intended. - Molecule – name of the molecule that will be tested with the item list. It is not obligatory. - Description – place for any information deemed necessary. The more information you can provide, the easier it is for the IL admin to review your item list. NOTE: names of the authors of custom item lists are not stored or visible to other users, regardless of their profile and status of the questionnaire. If the author wants to mark authorship, any information on the questionnaire can be added in the description but is subject to review and change by the IL admin. Version 2.0 – Page 23 Add items to a custom item list There are various ways to add an item to an already created item list: 1. In the custom item list view in the Custom Questionnaires library 2. From search results by clicking the three dots icon and selecting the item list of choice 3. From questionnaire view by clicking the three dots icon and selecting the item list of choice 4. From item view by clicking the three dots icon and selecting the item list of choice Delete items from a custom item list In order to delete any item from an item list you have to click on the item you want to delete and then click on the garbage bin icon. You will be then asked to confirm that the item should be deleted. Version 2.0 – Page 24 Re-order items While it is not advisable to change the order of items if multiple items from one questionnaire/scale are used, it is possible to re-order them in a custom item list. In order to move an item to another location in the list, you have to click on the dots to the left of the wording and drag the item to its new place. The numbering of the list should update on its own, but in case it has not, it will be updated when you reload the page. Add response and time scales It is important to add the correct response options and time frames to the item list. It is recommended to use the response options and time frames with which the items were originally validated. In order to add the response options and time frames you should: 1. Click on Choose a response scale to see the available options 2. Select the appropriate option and click +Add