Introduction

A series of frequently asked questions around certain audit trails and their interpretation.

How do I know if data was collected using a device?

Observation

Item audit stamps do not indicate source of data (e.g. device vs user). For example: An audit stamp of User: “Jane Doe” with Reason: “User Entry” appears to be used for both direct data entry and externally sourced data.

Response

Critical to this question is an understanding that data is not automatically imported from medical devices used at the bedside. It typically requires a user to initiate a measurement (Invoke Device) in order for the data to be imported from the configured device.

Open

Invoke Device

For this reason the audit trail appropriately lists the user name for that member of staff responsible for the procedure.

Once captured, inspecting the Item Data and Item Group Data associated with a form will reveal that specific data was designed, and intended to be collected, using a device interface.

For Item Data Details there is a ‘Device Parameter' field that will indicate the item values were meant to be collected by way of a specific interface parameter.

Open

Item Data Details

When reviewing the related Item Group Data on the form, you will see a Device Profile listed...

The Device Parameter and Device Profile attributed are not present when there is no intended device interface for that data.

Under certain circumstances, the operator may need to over-ride the device integration and submit data manually…

Every time this occurs an unlocking Annotation is created, capturing the ‘unlock reason’ provided by the user.

When using device connected forms, the logged in user responsible for operating the equipment is recorded in the Audits...

In every case, it is always possible to determine whether an Item was collected manually or by means of a device integration.

Additional Notes

• In certain scenarios, a user may invoke a device multiple times on a form prior to save. Each successful invocation will bring in the latest values from the device into the form.

• In order for a user to change any Item values associated with device parameters in the form, the user must unlock the item group and record an annotation.

How do I know if data is a calculated or derived rather than entered by hand?

Observation

Non-user entries (e.g., Calculations, device, and imported data) appear to be stamped as user instead of systems

Response

With newer releases of ClinSpark calculations such as Methods are clearly flagged as such.

In this case the response to the question Are Vital Signs Out of Range? has been derived by a Method and determined to be No.

This is clearly shown here at item 1.

In addition, an Annotation (2) shows that the Item is a Calculated Entry.

As always, the logged in user responsible for triggering the Method is recorded in the Audits (3)…

In summary, where you see Calculated Via Method or Calculated Entry this denotes that the value has been determined programmatically by the system.

What time is shown on a form when data is collected using a device?

Observation

For device uploaded data, the collection date/time shown in ClinSpark represents when the user performed the upload rather than the actual collection

Response

This is not strictly true and will vary depending on the design of the form, and the particular device that may be integrated with the form.

Vital Signs - example

In the following example we see a Vital Signs device integration being used. Due to technical limitations, the device itself does not pass a measurement time to ClinSpark. For that reason, the form was designed without any specific Items intended to capture and use a datetime from the device and attribute to the collection time.

When a user Saves the form, the collection time is recorded with that action.

When inspecting the form Item Group Details, recorded is the time that the form is saved (at 1 and 2)…

When relying on this kind of device and form design, it is incumbent upon users to complete the procedure smoothly and quickly and to save the form as soon as the measurement has been captured and thus best representing the measurement time. With typical workflows it is expected that this should occur within seconds of the measurement being performed.

ECG - example

In another example we see a device integration where the device captures a measurement time and is capable of transferring this to ClinSpark. This device measurement time can be used as the form collection time.

The design of the ECG form contains a particular Item called EGDTC intended to be used as the time the measurement occurred. This item will represent the acquisition time of the ECG, provided from the device.

When inspecting the ECG form after it’s been collected on, it can be confirmed that this Item datetime value was collected as part of a device parameter…

… and that the corresponding Item Group is using that Item datetime as the collection time of the form.

Additionally, collection times shown in (1) and (2) can be seen on the ’source’ ECG waveform as well by clicking View (3)…

What times are represented in Item audit trail views?

Observation

Certain times observed in Item audit trail views appear different from the collection times associated with the form.

Response

The ‘Time’ column in Audit views represent when specific user actions took place against the form. These come by way of interactions that occur within the application and may not always correlate with what is documented to represent the time of collection on a form.

With the above example:

1. The first audit record on an Item represents when the Item data field was established. The time of 21 Sept2023 14:22:44 CEST represents when the form was first created, making it available for use. Typically this time is associated with actions that come by way of the form being created by cohort assignment activations, or, the action of manually adding a new form via Data Collection workflows.

2. The second audit record shows the time of 21Sept2023 14:23:45 CESTwhen the user performed a successful barcode scan on the form Item. In this particular example, the Item in question was setup to require a successful barcode verification first in order to perform data collection against the item.

3. The third audit record contains two datetime values. In the annotated screenshot, Time column (3) shows when the item value was saved successfully on 21Sep2023 14:29:54 CEST. The Value column (4) shows 21 Sep 2023 14:29:47 as the collected item value at the time of save. This same value of 21 Sep 2023 14:29:47 is also shown as the collected value in the Item Details area (5).

Further Reading

You may find the following articles useful…

• ClinSpark Timing Variables

• What will be reported as the "Collection time" for my Data?