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

Sean Santos; Akash Gupta; Alan Tinmouth; Amir Butt; Brian Berry; Charles Musuka; Christine Cserti-Gazdewich; Elaine Leung; Jennifer Duncan; Johnathan Mack; Matthew T S Yan; Mohammad Bahmanyar; Nadine Shehata; Oksana Prokopchuk-Gauk; Rodrigo Onell; Susan Nahirniak; Thomas Covello; Yulia Lin; Ziad Solh; Jeannie Callum; Andrew W Shih

doi:10.1111/trf.17738

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

Transfusion. 2024 Mar;64(3):428-437. doi: 10.1111/trf.17738. Epub 2024 Feb 1.

Authors

Sean Santos¹, Akash Gupta², Alan Tinmouth^{3

4}, Amir Butt⁵, Brian Berry^{6

7}, Charles Musuka⁸, Christine Cserti-Gazdewich^{9

10}, Elaine Leung^{11

12}, Jennifer Duncan¹³, Johnathan Mack¹⁴, Matthew T S Yan^{6

15

16}, Mohammad Bahmanyar^{6

17}, Nadine Shehata^{9

18}, Oksana Prokopchuk-Gauk^{19

20}, Rodrigo Onell^{6

17}, Susan Nahirniak^{21

22}, Thomas Covello^{6

16}, Yulia Lin^{9

23}, Ziad Solh^{24

25}, Jeannie Callum²⁶, Andrew W Shih^{1

6}

Affiliations

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.

PMID: 38299710
DOI: 10.1111/trf.17738

Abstract

Background: Regulatory 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.

Methods: Surveys 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.

Results: Sixteen 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.

Discussion: LIS 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.

Keywords: health research methodology; regulatory and QA; transfusion practices (adult).

MeSH terms

Blood Component Transfusion
Blood Transfusion*
Electronic Health Records*
Humans
North America
Randomized Controlled Trials as Topic
Research Design