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ENABLE (Exportable Notation and Bookmark List Engine): an Interface to Manage Tumor Measurement Data from PACS to Cancer Databases

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Abstract

Oncologists evaluate therapeutic response in cancer trials based on tumor quantification following selected “target” lesions over time. At our cancer center, a majority of oncologists use Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 quantifying tumor progression based on lesion measurements on imaging. Currently, our oncologists handwrite tumor measurements, followed by multiple manual data transfers; however, our Picture Archiving Communication System (PACS) (Carestream Health, Rochester, NY) has the ability to export tumor measurements, making it possible to manage tumor metadata digitally. We developed an interface, “Exportable Notation and Bookmark List Engine” (ENABLE), which produces prepopulated RECIST v1.1 worksheets and compiles cohort data and data models from PACS measurement data, thus eliminating handwriting and manual data transcription. We compared RECIST v1.1 data from eight patients (16 computed tomography exams) enrolled in an IRB-approved therapeutic trial with ENABLE outputs: 10 data fields with a total of 194 data points. All data in ENABLE’s output matched with the existing data. Seven staff were taught how to use the interface with a 5-min explanatory instructional video. All were able to use ENABLE successfully without additional guidance. We additionally assessed 42 metastatic genitourinary cancer patients with available RECIST data within PACS to produce a best response waterfall plot. ENABLE manages tumor measurements and associated metadata exported from PACS, producing forms and data models compatible with cancer databases, obviating handwriting and the manual re-entry of data. Automation should reduce transcription errors and improve efficiency and the auditing process.

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Acknowledgements

The authors are grateful to Donna Bernstein, Isabel Palacios-Yance for facilitating data management workflow information and patient data as well, and Nicole Davarpanah for intellectual input in the realization of this paper.

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Authors and Affiliations

  1. Radiology and Imaging Sciences, CC, NIH, Building 10, 9000 Rockville Pike, Bethesda, MD, 20892, USA

    Nikhil Goyal, Mohammad Hadi Bagheri, Laura B. Machado & Les R. Folio

  2. Genitourinary Malignancies Branch, NCI, NIH, Building 10, 9000 Rockville Pike, Bethesda, MD, 20892, USA

    Andrea B. Apolo & Eliana D. Berman

  3. Center for Cancer Research, NCI, NIH, Building 10, 9000 Rockville Pike, Bethesda, MD, 20892, USA

    Jason E. Levine

  4. Pediatric Oncology Branch, CCR, NCI, NIH, Building 10, 9000 Rockville Pike, Bethesda, MD, 20892, USA

    John W. Glod & Rosandra N. Kaplan

Authors
  1. Nikhil Goyal
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  2. Andrea B. Apolo
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  3. Eliana D. Berman
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  4. Mohammad Hadi Bagheri
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  5. Jason E. Levine
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  6. John W. Glod
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  7. Rosandra N. Kaplan
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  8. Laura B. Machado
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  9. Les R. Folio
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Corresponding author

Correspondence to Les R. Folio.

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Disclosures

Les R. Folio and Laura Machado are associate investigators in a research agreement with Carestream Health (Rochester, NY). This research was supported [in part] by the Intramural Research Program of the NIH Clinical Center. The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This is an HIPAA-compliant IRB exempt study. This study was submitted to SIIM 2017.

Appendices

Appendix 1

Explanation of the example estimate 12,000-data point calculation in an example clinical trial.

Assume the following:

  1. A.

    10 data points per lesion

  2. B.

    17 data points per CT exam required for organizational purposes

  3. C.

    An average of 3 lesions per CT

  4. D.

    With 5 CT exams (average) per subject in the study

  5. E.

    With a total of 50 study subjects per trial

Thus:

(((17 data points per CT + (10 data points per lesion * 3 lesions per CT)) * 5 CT exams per patient) * 50 patients per study) = 11,750 data points per study

Appendix 2: Technical Details

In compliance with HIPAA, a single copy of ENABLE (the interface) is stored on a secure server accessible from workstations at the NIH CC. Patient bookmark lists are exported and stored on this server after being saved with the proper naming convention. Users can launch ENABLE from the server and input to its bookmark lists stored on the secure server. Outputs of the interface are stored in a common location on the server as well.

Appendix 3

The following outline reviews the steps taken from exporting the patient Bookmark List from PACS to generating and accessing the outputs produced by ENABLE. These instructions are specific to our PACS:

  1. 1.

    Exporting the PACS Bookmark List:

    1. a.

      Open PACS, open patient exam

      1. i.

        Could be current or not

    2. b.

      Open bookmark list (stored as a database in PACS, not yet DICOM structured)

    3. c.

      Right click: export visible columns

      1. i.

        Set baseline date

      2. ii.

        Select and verify target and non-target lesions

      3. iii.

        Verify follow-up sets to correspond correct lesions, especially for target/non-target lesions

      4. iv.

        Check “Study layout” box

      5. v.

        “Show only mine” box should not be checked

      6. vi.

        If patient has bookmarks in exams prior to baseline

        1. 1.

          These cannot be labeled as target or non-target even if the lesions were from before

          1. a.

            If this is the case, they need to be detached from the target/non-target follow-up set

      7. vii.

        If patient has bookmarks in exams after patient is off study

        1. 1.

          These cannot be labeled as target or non-target even if these lesions are still present

          1. a.

            If this is the case, they need to be detached from the target/non-target follow-up set

      8. viii.

        File is saved in a common location, to facilitate next/other file location

        1. 1.

          Verify that Medical Record Number is followed by protocol number in the file name as follows:

          1. a.

            MRN#1234567_01-C-2345

    4. d.

      Open the interface (ENABLE)

      1. i.

        Define output folder name

        1. 1.

          It is set as “Default”

        2. 2.

          Change it as desired, e.g., user’s last name

      2. ii.

        Select “Run”

      3. iii.

        Select input folder

        1. 1.

          Within these, select single file or a group (as large as desired)

      4. iv.

        After running, interface initial window will appear

      5. v.

        Select “Show folder”

        1. 1.

          It will prompt you to output folder (common location called Master Folder”

          1. a.

            Within these, a folder named “Outputs” was created

            1. i.

              Within these, folders with “Default” or user’s last name (as was set up in point d.i.1) was created

            2. ii.

              Inside these, folders with the date when interface was used

            3. iii.

              Then, the exact time when the interface run

            4. iv.

              Inside this, three folders named “Labmatrix,” “Output Sheets,” and “WordDocs”

              1. 1.

                Within these, each file is named with the patient’s name.

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Goyal, N., Apolo, A.B., Berman, E.D. et al. ENABLE (Exportable Notation and Bookmark List Engine): an Interface to Manage Tumor Measurement Data from PACS to Cancer Databases. J Digit Imaging 30, 275–286 (2017). https://doi.org/10.1007/s10278-016-9938-1

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  • DOI: https://doi.org/10.1007/s10278-016-9938-1

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