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101.4 Record Visits

101.4 Record Visits

Visit-level data fields are designed to record clinical details specific to that point in time. Each visit has its own unique characteristics, such as date, site at which the visit occurred, clinical diagnoses, and clinical status.

Planned longitudinal studies are usually pre-programmed with expected visit descriptions and the expected samples to be collected based upon each study’s unique design. In some cases, the processed specimens derived from the primary samples are also pre-set. This saves time for the study team as fields are autofilled with expected values which can be overridden if necessary.

Documenting Visit Details

Each visit will have different characteristics (e.g., date of visit, diagnosis, visit site, etc.). These are recorded on the visit page. It is possible to record visit data at the time of sample collection or record it later.

Visit Fields

Visit level fields capture clinical information that can change over time for a participant, such as clinical diagnosis and status. These values will be associated with a unique visit ID and date.

The standard fields associated with a visit include:

  1. Visit date

  2. Status: defaults to ‘Complete’, but visits may also be marked as Pending, Missed, or Not Collected

  3. Visit Site can be used to capture the collection site

  4. Clinical Diagnosis

    1. OpenSpecimen uses ICD 10 diagnosis codes to record clinical disease descriptions which enables data querying and manipulation across studies.

    2. This field is a multiple select and consists of a list of ICD 10 codes. Select as many conditions as you need.

    3. Typing any part of the description of the clinical disease will display the matching choices in the dropdown.

    4. Typing the ICD 10 code will display the matching diagnoses.

    5. Example: typing ‘diabetes’ will display all subtypes of any ICD 10 containing ‘diabetes’.

      screenshot of the Clinical Diagnosis field with the word 'diabetes' hihglighted along with the first several matching choices available to choose in the dropdown menu.
      Example of clinical diagnoses containing text ‘diabetes’

  5. Clinical Status can be used to record if a participant is a No Diagnosis / Control or to record their clinical status as related to the specific study. Each study will choose their own usage of these terms.

    Screenshot of the dropdown list of available values to choose from in the Clinical Status field.

  6. Cohort currently records only Case vs. Control. If your study has different designations for Cohort, these can be recorded with a custom field.

  7. Surgical Pathology Number may be entered, if available.

  8. Comments is a text field available for free typing.

Additional Custom fields available

If your process involves splitting out the clinical diagnoses into the primary diagnosis, the chief complaint, or comorbidities, these can be recorded in distinct fields. The available values are still the same list of ICD 10 codes.

Additionally there are fields that provide standard values to capture Surgical Procedures, Orphanet codes for rare diseases, and Human Phenotype Ontology terms to capture information that is not available in standard ICD 10 codes. These fields allow multiple values to be recorded under each field.

Screenshot of the additional custom fields available to record custom values for additional clinical fields

Collecting a Visit

To record the information for a visit, you must first ‘collect’ the visit. There are several ways to collect a visit depending upon your workflow.

  1. The visit page can be accessed immediately after manually registering a participant by choosing ‘Proceed to Collection’ from the bottom of the registration page. If mulitple visits are configured, you must choose the 'event’ to collect.

    Screenshot of the participant registration page with the 'Proceed to Collection' button and the first event (Baseline) highlighted in red.

  2. Alternatively, visits can be collected from the participant overview page, if the patient registration already exists due to a configured REDCap sync or if collecting subsequent visits after the initial registration.

    1. To collect a Pending Visit, click the ‘Collect’ button in the Pending Visit table on the Participant overview page.

    2. Image of participant overview page showing the participant fields, the Occurred Visits table, with the Pending Visits table highlighted and the Collect button highlighted on the Treatment Event.

      To repeat a collected visit, choose ‘New Visit’ from the kabob button (3 vertical dots) on the right side of the Occurred Visits table.

    screenshot of the Occurred Visits table highlighting the kabob that displays the available choices for the selected visit. New Visit is highlighted.

  3. Either of these options will navigate to the Visit page where you will complete the necessary fields as described.

    Image of the fields available on the Visit page, highlighting Clinical Diagnosis, Clinical Status, Cohort, and Surg Path number fields. The Proceed to Collection button is circled in red at the bottom of the page.

  4. Visit data are saved by selecting Submit.

  5. ‘Submit’ navigates to the Collect Specimens page which displays the table of planned specimens. See Collect Samples for details on this process.

  6. If there are multiple visits, each visit will have its own Overview Page and its own forms attached if any are attached at the Visit Level.

    1. For each visit, the menu bar on the left shows 3 tabs and defaults to ‘Overview’:

      Screenshot of the menu bar icons on the left side of the visit overview page. Overview is shown in blue with an eyeball icon to indicate the current view

    2. If a Path Report is available as a .pdf, it may be uploaded from the Path Report tab.

    3. If Form-specific data is to be entered, any attached forms can be accessed from the Forms tab. (As as example, patient’s medications usually change over time and a different form can be completed at each visit for medications.)

Editing clinical data after specimen collection

It is common that clinical diagnoses or pathology is not obtained until after specimen collection occurs. If this is the case, the clinical information can be added or updated at any time using ‘Edit’ on the Visit page.

  1. The Visit page can be accessed after collection by selecting the ‘Event Label’ in the ‘Occurred Visits’ table for the visit that needs to be edited or updated.

    Image shows the occurred visit table highlighting the Event Label value in red on the left with the other fields displayed
    Choose an existing Visit to add/edit data

  2. Choose ‘Edit’ for the Completed Visit.

  3. screenshot of visit overview page with the edit button highlighted

    Edit or update any fields as described above.

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