Development of a Uniform Apheresis Case Report Form for Standardized Collection of Apheresis Data
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2024
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| author | Andrew D. Johnson Zbigniew M. Szczepiorkowski Rasheed A. Balogun Oliver Karam Marianne Nellis Jennifer Schneiderman Joseph Schwartz Jeffrey L. Winters Yanyun Wu Tomas Armendariz Edwin Burgstaler Laura Collins Kira Geile Katerina Pavenski Amber P. Sanchez Volker Witt Amutha Muthusamy Thomas Pederson Vidhyalakshmi Ramesh Mai Thao Therese Chlebeck Nicole D. Zantek |
| author_facet | Andrew D. Johnson Zbigniew M. Szczepiorkowski Rasheed A. Balogun Oliver Karam Marianne Nellis Jennifer Schneiderman Joseph Schwartz Jeffrey L. Winters Yanyun Wu Tomas Armendariz Edwin Burgstaler Laura Collins Kira Geile Katerina Pavenski Amber P. Sanchez Volker Witt Amutha Muthusamy Thomas Pederson Vidhyalakshmi Ramesh Mai Thao Therese Chlebeck Nicole D. Zantek Andrew D. Johnson Zbigniew M. Szczepiorkowski Rasheed A. Balogun Oliver Karam Marianne Nellis Jennifer Schneiderman Joseph Schwartz Jeffrey L. Winters Yanyun Wu Tomas Armendariz Edwin Burgstaler Laura Collins Kira Geile Katerina Pavenski Amber P. Sanchez Volker Witt Amutha Muthusamy Thomas Pederson Vidhyalakshmi Ramesh Mai Thao Therese Chlebeck Nicole D. Zantek |
| collection | Wiley Open Access |
| contents | Development of a Uniform Apheresis Case Report Form for Standardized Collection of Apheresis Data Andrew D. Johnson Zbigniew M. Szczepiorkowski Rasheed A. Balogun Oliver Karam Marianne Nellis Jennifer Schneiderman Joseph Schwartz Jeffrey L. Winters Yanyun Wu Tomas Armendariz Edwin Burgstaler Laura Collins Kira Geile Katerina Pavenski Amber P. Sanchez Volker Witt Amutha Muthusamy Thomas Pederson Vidhyalakshmi Ramesh Mai Thao Therese Chlebeck Nicole D. Zantek Journal of Clinical Apheresis ABSTRACTApheresis is performed worldwide for an increasing number of indications. The development of common data elements (CDE) for apheresis related areas may facilitate conduct of new research, enhance quality initiatives including benchmarking, and improve patient care. This report describes the systematic development of the Uniform Apheresis Case Report Form (UACRF) as part of the Apheresis in the United States (ApheresUS) program. A consensus panel of 17 diverse experts in apheresis, related specialties, and electronic case report form (eCRF), and database development was assembled. The panel met via online conferencing from November 17, 2020 to December 1, 2021. A draft document was posted online for public comment from October 11, 2021 to November 10, 2021. Feedback was collected using an online survey tool. The consensus panel revised the UACRF. This version was converted to an eCRF with additional changes made to improve usability in this format. The final version of the UACRF was created on August 24, 2023. The UACRF contains 16 modules: procedure and subject eligibility, patient demographics, general procedure information, laboratory parameters, vascular access, common procedure elements, eight procedure specific modules (mononuclear cell collection and seven therapeutic modalities), outcomes, and site information. A total of 137 data elements were created, including 57 with one or more subelements. The UACRF is the first systematic attempt to develop CDE for therapeutic apheresis and white blood cell collections. Further validation of the UACRF is necessary to confirm the tool's ability to collect the relevant data elements and determine the usability of the form. 10.1002/jca.22146 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| doi_str_mv | 10.1002/jca.22146 |
| format | Artículo Open Access |
| id | wiley_oa_10_1002_jca_22146 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| publishDate | 2024 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | Development of a Uniform Apheresis Case Report Form for Standardized Collection of Apheresis Data Andrew D. Johnson Zbigniew M. Szczepiorkowski Rasheed A. Balogun Oliver Karam Marianne Nellis Jennifer Schneiderman Joseph Schwartz Jeffrey L. Winters Yanyun Wu Tomas Armendariz Edwin Burgstaler Laura Collins Kira Geile Katerina Pavenski Amber P. Sanchez Volker Witt Amutha Muthusamy Thomas Pederson Vidhyalakshmi Ramesh Mai Thao Therese Chlebeck Nicole D. Zantek Journal of Clinical Apheresis Development of a Uniform Apheresis Case Report Form for Standardized Collection of Apheresis Data Andrew D. Johnson Zbigniew M. Szczepiorkowski Rasheed A. Balogun Oliver Karam Marianne Nellis Jennifer Schneiderman Joseph Schwartz Jeffrey L. Winters Yanyun Wu Tomas Armendariz Edwin Burgstaler Laura Collins Kira Geile Katerina Pavenski Amber P. Sanchez Volker Witt Amutha Muthusamy Thomas Pederson Vidhyalakshmi Ramesh Mai Thao Therese Chlebeck Nicole D. Zantek Journal of Clinical Apheresis ABSTRACTApheresis is performed worldwide for an increasing number of indications. The development of common data elements (CDE) for apheresis related areas may facilitate conduct of new research, enhance quality initiatives including benchmarking, and improve patient care. This report describes the systematic development of the Uniform Apheresis Case Report Form (UACRF) as part of the Apheresis in the United States (ApheresUS) program. A consensus panel of 17 diverse experts in apheresis, related specialties, and electronic case report form (eCRF), and database development was assembled. The panel met via online conferencing from November 17, 2020 to December 1, 2021. A draft document was posted online for public comment from October 11, 2021 to November 10, 2021. Feedback was collected using an online survey tool. The consensus panel revised the UACRF. This version was converted to an eCRF with additional changes made to improve usability in this format. The final version of the UACRF was created on August 24, 2023. The UACRF contains 16 modules: procedure and subject eligibility, patient demographics, general procedure information, laboratory parameters, vascular access, common procedure elements, eight procedure specific modules (mononuclear cell collection and seven therapeutic modalities), outcomes, and site information. A total of 137 data elements were created, including 57 with one or more subelements. The UACRF is the first systematic attempt to develop CDE for therapeutic apheresis and white blood cell collections. Further validation of the UACRF is necessary to confirm the tool's ability to collect the relevant data elements and determine the usability of the form. 10.1002/jca.22146 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| title | Development of a Uniform Apheresis Case Report Form for Standardized Collection of Apheresis Data |
| topic | Journal of Clinical Apheresis |
| url | https://onlinelibrary.wiley.com/doi/10.1002/jca.22146 |