UNITY – What's new?

With release 9.25.0, we've made improvements to the medical image upload and management modules in the UNITY platform. Here's what you can do with them:

Retrieve and dig into imaging data faster. We upped the performance of the image overview page so that you can browse images in studies with large amounts of images faster.
Enhance the utility of imaging data. Now you can assign the same DICOM image to multiple studies.
Upload more DICOM formats. UNITY now supports DICOM images in the JPEG 2K compressed format.

For our EHR-integrated users, you can now access longitudinal PROM and PREM results directly on the patient level to get an overview of a patient's questionnaire history in medical oncology. You won't need to access individual cases to view these results.

Additionally, we've made UNITY's user interface more flexible in the following ways:

UNITY now supports browser-based translations.
Sponsor-level users can now define automatic log out times on the study-level, from 10 minutes up to 1500 minutes. The default value is 20 minutes.

Improvements for our DICOM image viewer and manager, as well as pdf-creation and pdf-transfer next to some UI improvements:

The modification of patients, cases and DICOMs with queries attached is now possible.
The load of the large tables with image analysis results is much faster now.
Backup radiologists can jump in now for image assessment in case the first reviewer or reviewer for decision is not availble.
UNITY application logs are separated from the user activity logs, so that sponsors can surf a large amount of log data more easily and fast.
The customer logo on the UNITY welcome screens now adapts nicely to any screen size.
We made some desired UI improvements for matrix questions.
We fixed some errors in creating pdf-files and are transferring all desired questionnaires as .pdf to the correct patient ID in the hospital archive system.

Multiple UI improvements for patient screens and fixes, including:

We adapted the welcome screen of our questionnaires for patients that fill in their PROMs/PREMs from home by reducing information and eliminating the data confirmation step.
Matrix questions are mobile-adaptive for easy completion by patients now.
The German/English language mix in patient screens is eliminated.
We switched technology for our help files. Incorporation of the help articles in German language is not completed yet. Until completed, the help articles show the English version.
For certain user groups, the information shown in the table "Excluded Images" was shifted by one column against the header, which is resolved now.
The testing system ("staging") allows all test scenarios to be completed again, after a wrong URL in "start ePro" (live data capture) was deleted.
If a user tries to change study settings of a finished study, the right error message is displayed again.
As promised, we have enabled radiologists to sign their assessments once they are completed and to add evidence images documenting their findings.
The error message on patient centric view has been resolved.

Variety of improvements and bug fixes:

Bug-fix: The occurring "400 errors" when saving information in different UNITY spaces (e.g. patient centric view, patient, study and sponsor administration) are resolved.
Bug-fix: Logos for newly created sponsors can be saved now.
Bug-fix: Under certain conditions, a second table showing "images excluded from evaluation" was not visible for admin users anymore. This is resolved.
Bug-fix: ZIP files can now also be created if they are missing the direction metadata.
Bug-fix: Preventing sponsor users giving other sponsor users access to a study.
Bug-fix: If certain validation rules were added, the added relationship prevented deletion of examination period.
Technology change to improve loading speed of certain overview pages, and in particular, audit trial / audit log pages.

Variety of improvements and fixes, including:

Answers to questions that trigger dependent questions are now saved the first time they were completed.
If the language selected by the user (who completes the questionnaire) does not match the language of the questionnaire, the user can skip the questionnaire with the intention of editing and completing it later. Such questionnaires can be edited afterwards on the overview page of the questionnaire.
Now also CT images (large files) can be archived as ZIP.
The performance of the "Image Overview" page has been improved so that studies that have a large number of images do not suffer from poor performance when browsing the images on this page.
The UNITY application now provides a health status endpoint so that you can automatically monitor the status and take action if necessary.
When creating a ZIP archive from images, a number of performance and usability improvements have been made. The progress of the ZIP creation is now visible to the user, whereas in the past it ran in the background and there was no feedback on the UNITY interface.
When creating a ZIP archive for image files, we give the file a name with the necessary information about the content. If the file name is too long, the ZIP creation may fail. With this extension, we have shortened the format of the file name so that it still contains all the necessary information and is short enough not to interfere with the file creation process.7 Update operations.

Variety of technical improvements and fixes, including:

In the event of a patient's decease, UNITY now understands this even if only the date of death is given. It also understands when the date of death is removed that the patient status "died" should be changed back. (Applicable to EHR integration only).
Email notifications and reminders are not sent to the patients, if there are no PROM questionnaires open. This is relevant for the scenario when CRF questionnaires are open, but since these are not relevant for the patient, the emails are not sent to them.
DICOM Image Manager is now supported for modern browsers of MS Edge, version 96 and above.
Special characters, such as new lines, would break the structure of exported CSV files. The issue is now solved and those problematic characters are escaped, so that the structure of the export files does not suffer.
Patient states "Lost" and "Completed", which are represented in blue color in the questionnaire overview page are now exported with the exact same status (Lost, Completed) in the questionnaire result export file.

Additional languages, improved image upload and regulatory changes:

New languages for UNITY Outcome: Russian (Uzbekistan) and Uzbek (Uzbekistan) are now available, so that questionnaires can be created and answered in these languages.
Parameter designer and the image viewer could not accommodate the modality "Mammography." This has been repaired - Image upload is now possible with the aforementioned image modality.
RayView is no longer a medical product. The European Medical Device Regulation (EU-MDR) also has impacts for our RayView medical software. After careful evaluation of its use and the effort required to establish future compliance for medical software, we decided to voluntarily remove the European class 1 medical software designation of RayView.

For regulatory clarity, we renamed this module to DICOM Image Manager, which better reflects the actual use of the module. The visualization, anonymization, and upload functionality of images remains unchanged. The existing, rudimentary measurement functionality, however, cannot be used for any medical purposes.

Note: RayView did not have a medical software designation in other territories outside the EU, so this change has no impact outside Europe. Our UNITY Outcome EDC module will keep it’s EU class 1 medical software designation.

Technical improvements, such as:

Appointments getting processed again. Appointment messages coming to UNITY didn't create cases. After fixing this defect, the failing messages will be processed again, so that the respective cases are created. Applicable to EHR integration only
Study creation fixed. Applicable to one specific user only. A study could not be created, when logged in as the one problematic user.
Patients were wrongfully tagged as excluded from a study, when they indeed were not. Applicable to EHR integration only.

Technical improvements and bugfixes, such as:

When composing a question in the questionnaire designer, one can insert a hyperlink in a simple HTML format (a href=). And when the questionnaire is being answered, the link can be clicked on and will open the specified URL.
UNITY is now connected to a new version of the Terminology Browser that supports searching and adding terms in the various supported terminologies. The terms can be used in for medical coding in the same way as with older versions.
A new message type "modify" is introduced, which is to re-process previously sent encounter messages. Additional parameters are introduced to the encounter messages, which will help analyse the completion patterns of PROMs. Applicable to EHR integration only.
Email alerts can be setup, so that the users are informed about "text input" type answers, as soon as these are filled in.

Richer details about unscheduled questionnaires

Easily identify the category (eCRF, ePROM) and date of completion of unscheduled questionnaires.

Manual notifications for unscheduled questionnaires

Manually trigger email notifications to patients to prompt them to complete unscheduled questionnaires.

Minor feature upgrades in web-based mode

When downloading questionnaire results, PROM dimensional scores appear in a separate column.
End messages can now be created and edited in the questionnaire designer.
For admin users: Remove user access to specific studies.
Additional access security measures to ensure users possess the right combination of permissions when accessing certain resources.

Automatic enrollment of transferred patients in a study in EHR-integrated mode

UNITY and CLIO now support the inclusion of patients in a study that the clinic receives from other internal clinics, known as transfer.

Automatic enrollment of admitted patients in a study in EHR-integrated mode

UNITY and CLIO support the inclusion of patients in a study that enter the clinic from other external clinics, known as admission

Questionnaire scores accessible within patient-centric view

Patient-centric view is enhanced to display questionnaire scores.

Minor feature upgrades

Real-time validation of numeric fields when designing a questionnaire: Previously when designing a questionnaire, numeric fields were validated upon submission of a questionnaire. Now, they are validated in real-time.
No differentiation between interim- and incompletely saved questionnaires: All questionnaires are handled identically, allowing users with sponsor role and certain permissions to review incomplete questionnaires.

Limit password reset

To protect users from misuse of the password reset function, the maximum number of password reset requests within 15 minutes has been limited to five.

Dose unit nanogram

The physical unit nanogram is now available to capture dose information.

Additional validation rules

Comparison of responses within multi-select questions and across multi- and single-select question types are now available.

Minor feature upgrades

Security: Update of several 3rd party software libraries and reinforced encryption - via AES256 CTR encrypted URLs - to invite patients to PROM surveys.
Alerts for questionnaire status - such as upcoming, completed, or edited - are now configurable for all users with access to a particular study.

Assigning discharge messages to PREM studies

Patients often need to complete patient-reported experience measures (PREMs) at the end of their hospital stay. In the EHR-integrated version, UNITY 9.8.0 automatically processes hospital discharge information to support conducting PREM surveys.

Patient email notifications

UNITY 9.8.0 contains advanced customizability for patient email notifications:
- Now, there the maximum number of patient email notifications can be capped.
- Lead time can be introduced between case assignment and the case assignment notification.
- There is the ability to switch off notifications on the patient level.

Differentiate primary and secondary interventions

UNITY now also considers the appointment code of a specific appointment to create cases and distinguish them from each other (before: only organ and laterality). This allows the separation of multiple interventions at the same organ/laterality, such as primary and revision surgeries of the left hip

Upgraded medical coding functionalities

Version 9.7.0 allows users to search for autocoding conflicts and helps resolve these conflicts in large studies.
Additionally, medical codings of a study can be exported for storage or data exchange.

Autoselecting answers in single & multiselect questions

Auto-selected questionnaires can now be submitted automatically if all questions are automatically filled based on database content.
If available database content does not match the expected information, hidden questions are displayed to the responder in order to answer the question.

Adding PDFs to alert E-Mails

Upon receiving alers for questionnaires that are completed or updated, users now also receive a PDF result form of the affected questionnaire.

Technical fixes

Improving the readability of audit trail exports
Alerts created by clinic users can now be made available to sponsor users

Cross form validation

rules now also available for text input fields. Use this feature to detect or enforce text input - for example to not miss any feedback from responders.
rules now also available for the assessment time of a questionnaire. Use this feature to detect questionnaire fillings before or after a certain date - such as the date of surgery.
definition of rules for multiple points in time. Use this feature to define the same validation rule for multiple points in time to avoid labor-intensive copying of equal rules.

E-mail patient notifications

up to version 9.5.0, UNITY allows to contact patients with individual messages upon the initial study assignment and via reminders. In 9.6.0, a third notification is added that is triggered at the opening of an examination period. Use this email notification to invite your users to the surveys

Auto-select answers from database

use this feature to select answers automatically based on information stored in the database. In 9.6.0, UNITY offers to auto-select the gender of a patient - for example to allow gender-specific dependent questions in your questionnaire.

Improved medical coding

Within its Medical Coding Overview, UNITY now enables users to assign missing medical codes to verbatim terms based on existent data in their studies. Autocoding is able to account for synonyms and also detects coding conflicts. We implemented the feature to manually or automatically code via the Medical Coding Guidelines (MedDRA).

Query export

UNITY facilitates the tracking of data queries. Query histories can now be downloaded in a compact, XLS format e.g., for further processing and reporting.

Group signing

Up until now, users had to sign every single data data point per patient individually. With our newly added group signing feature, users are now able to sign a patients’ full dataset in one step.

This release included the following highlights:

faster processing of questionnaire submissions
Medical Coding Overview: List all coded verbatim terms as well as those missing a code

as well as minor feature upgrades:

Cross Form Validation: highlight rule-breaking questions in Result Overview
vertical Visual Analogue Scale for more flexibility in visualization
Source Data Verification: Users assigned to the role data manager are now able to differentiate between a plausibility check of a given answer or a check that included explicit source data verification.

Many questionnaires ask for similar or related information. However, patients, clinicians and clinical staff may answer inconsistently, which is reflected in the collected data.

The solution: Cross Form Validation. UNITY can now be configured to automatically compare and validate answers provided within questionnaires as well as across different questionnaires. By automatically detecting inconsistent answers, high data quality is ensured, while error-prone and time-consuming cross-checks are avoided.

A patient may be receiving more than one clinical intervention, even within a clinical trial. To correctly document and track multiple interventions per patient, we are introducing the concept of “cases”.

A case is defined by a treated organ, joint or other anatomical region and depends on the configuration additional to the treatment (e.g., date of surgery, type of treatment). This can be adjusted to match the definition of medical registries for tracking e.g., the lifetime of medical implants.

UNITY distinguishes between site ID (01, 02, 03, …), patient ID (001, 002, 003, …) and case ID (1, 2, 3, …). When a site (e.g., site 05) registers a patient, the patient ID (e.g., 008) and a case ID (e.g., 1) can automatically be assigned in sequential mode, resulting in a combined ID per patient (e.g., 05-008-1).

When reviewing data entered in UNITY, data monitors may identify mistakes, inconsistencies or abnormalities. UNITY now facilitates the tracking of data queries and their resolution. Users are now able to comment, revise, correct and approve a specific data entry. Different labels identify the status of a query as “open”, “answered” or “resolved”, prompting action by the responsible staff.

By tracking queries exactly where data is collected and reviewed, UNITY ensures that the complete history of any data entry, the process resulting in corrections, reviews and approvals, is captured and reportable for compliance to regulatory requirements. Source documents uploaded in UNITY allow for effective remote monitoring with substantially reduced cost.