How do we achieve blinding in modern electronic and paper medical records during the conduct of transfusion trials?
Transfusion
; 64(3): 428-437, 2024 Mar.
Article
in En
| MEDLINE
| ID: mdl-38299710
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Blood Transfusion
/
Electronic Health Records
Type of study:
Clinical_trials
Limits:
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Transfusion
Year:
2024
Type:
Article
Affiliation country:
Canada