How do we achieve blinding in modern electronic and paper medical records during the conduct of transfusion trials?-Reference-Cited by-同舟云学术

How do we achieve blinding in modern electronic and paper medical records during the conduct of transfusion trials?

Published:2024-02 Issue: Volume: Page:
ISSN:0041-1132
Container-title:Transfusion
language:en
Short-container-title:Transfusion

Author:

Santos Sean¹,Gupta Akash²^ORCID,Tinmouth Alan³⁴,Butt Amir⁵^ORCID,Berry Brian⁶⁷,Musuka Charles⁸,Cserti‐Gazdewich Christine⁹¹⁰^ORCID,Leung Elaine¹¹¹²,Duncan Jennifer¹³,Mack Johnathan¹⁴,Yan Matthew T. S.⁶¹⁵¹⁶,Bahmanyar Mohammad⁶¹⁷,Shehata Nadine⁹¹⁸,Prokopchuk‐Gauk Oksana¹⁹²⁰^ORCID,Onell Rodrigo⁶¹⁷,Nahirniak Susan²¹²²,Covello Thomas⁶¹⁶,Lin Yulia⁹²³^ORCID,Solh Ziad²⁴²⁵^ORCID,Callum Jeannie²⁶,Shih Andrew W.¹⁶^ORCID

Affiliation:

1. Department of Pathology and Laboratory Medicine Vancouver Coastal Health Authority Vancouver British Columbia Canada

2. Department of Laboratory Medicine and Pathobiology Sunnybrook Health Science Centre Toronto Ontario Canada

3. Benign Hematology and Transfusion Medicine, Division of Hematology Ottawa Hospital Ottawa Ontario Canada

4. OHRI Centre for Transfusion Research Clinical Epidemiology Program, Ottawa Hospital Research Institute Ottawa Ontario Canada

5. Department of Anesthesiology University of Oklahoma Health Sciences Center Oklahoma City Oklahoma USA

6. Department of Pathology and Laboratory Medicine University of British Columbia Vancouver British Columbia Canada

7. Department of Pathology Royal Jubilee Hospital Victoria British Columbia Canada

8. Department of Transfusion Medicine Shared Health Manitoba Winnipeg Manitoba Canada

9. Department of Laboratory Medicine and Pathobiology University of Toronto Toronto Ontario Canada

10. Blood Transfusion Laboratory and Blood Disorders Clinic (Division of Medical Oncology and Hematology) University Health Network Toronto Ontario Canada

11. Division of Hematology and Transfusion Medicine Children's Hospital of Eastern Ontario Ottawa Ontario Canada

12. Department of Pathology and Laboratory Medicine University of Ottawa Ottawa Ontario Canada

13. Vancouver Island Health Authority Courtenay British Columbia Canada

14. Department of Medicine Ottawa General Hospital, University of Ottawa Ottawa Ontario Canada

15. Canadian Blood Services Vancouver British Columbia Canada

16. Fraser Health Authority New Westminster British Columbia Canada

17. Department of Pathology and Laboratory Medicine St. Paul's Hospital, Providence Health Care Vancouver British Columbia Canada

18. Department of Laboratory Medicine and Pathology Mount Sinai Hospital Toronto Ontario Canada

19. Department of Pathology and Laboratory Medicine University of Saskatchewan Saskatoon Saskatchewan Canada

20. Saskatchewan Health Authority Saskatoon Saskatchewan Canada

21. Department of Laboratory Medicine and Pathology, Faculty of Medicine University of Alberta Edmonton Alberta Canada

22. Transfusion and Transplantation Medicine Alberta Precision Laboratories Edmonton Alberta Canada

23. Division of Transfusion Medicine and Tissue Bank Sunnybrook Health Sciences Centre Toronto Ontario Canada

24. Department of Pathology and Laboratory Medicine University of Western Ontario London Ontario Canada

25. Transfusion Medicine Laboratories London Health Sciences Centre London Ontario Canada

26. Department of Pathology and Molecular Medicine Kingston Health Sciences Centre, Queen's University Kingston Ontario Canada

Abstract

AbstractBackgroundRegulatory aspects of transfusion medicine add complexity in blinded transfusion trials when considering various electronic record keeping software and blood administration processes. The aim of this study is to explore strategies when blinding transfusion components and products in paper and electronic medical records.MethodsSurveys were collected and interviews were conducted for 18 sites across various jurisdictions in North America to determine solutions applied in previous transfusion randomized control trials.ResultsSixteen responses were collected of which 11 had previously participated in a transfusion randomized control trial. Various solutions were reported which were specific to the laboratory information system (LIS) and electronic medical record (EMR) combinations although solutions could be grouped into four categories which included the creation of a study product code in the LIS, preventing the transmission of data from the LIS to the EMR, utilizing specialized stickers and labels to conceal product containers and documents in the paper records, and modified bedside procedures and documentation.DiscussionLIS and EMR combinations varied across sites, so it was not possible to determine combination‐specific solutions. The study was able to highlight solutions that may be emphasized in future iterations of LIS and EMR software as well as procedural changes that may minimize the risk of unblinding.

Publisher

Wiley

Subject

Hematology,Immunology,Immunology and Allergy

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/trf.17738

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