Version: 1.0.0 | Published: 8 Oct 2024 | Updated: 425 days ago
COMPARE
Dataset
Documentation
Associated Media:
Description:
The COMPARE dataset comprises of genomic and blood data from the COMPARE clinical trial run by the University of Cambridge and NHS Blood and Transplant.
Background: To safeguard donors, blood services measure haemoglobin concentration in advance of each donation. NHS Blood and Transplant's (NHSBT) customary method have been capillary gravimetry (copper sulphate), followed by venous spectrophotometry (HemoCue) for donors failing gravimetry. However, NHSBT's customary method results in 10% of donors being inappropriately bled (ie, with haemoglobin values below the regulatory threshold).
Methods: We compared the following four methods in 21 840 blood donors (aged ≥18 years) recruited from 10 NHSBT centres in England, with the Sysmex XN-2000 haematology analyser, the reference standard: (1) NHSBT's customary method; (2) "post donation" approach, that is, estimating current haemoglobin concentration from that measured by a haematology analyser at a donor's most recent prior donation; (3) "portable haemoglobinometry" (using capillary HemoCue); (4) non-invasive spectrometry (using MBR Haemospect or Orsense NMB200). We assessed sensitivity; specificity; proportion who would have been inappropriately bled, or rejected from donation ("deferred") incorrectly; and test preference.
Results: Compared with the reference standard, the methods ranged in test sensitivity from 17.0% (MBR Haemospect) to 79.0% (portable haemoglobinometry) in men, and from 19.0% (MBR Haemospect) to 82.8% (portable haemoglobinometry) in women. For specificity, the methods ranged from 87.2% (MBR Haemospect) to 99.9% (NHSBT's customary method) in men, and from 74.1% (Orsense NMB200) to 99.8% (NHSBT's customary method) in women. The proportion of donors who would have been inappropriately bled ranged from 2.2% in men for portable haemoglobinometry to 18.9% in women for MBR Haemospect. The proportion of donors who would have been deferred incorrectly with haemoglobin concentration above the minimum threshold ranged from 0.1% in men for NHSBT's customary method to 20.3% in women for OrSense. Most donors preferred non-invasive spectrometry.
Conclusion: In the largest study reporting head-to-head comparisons of four methods to measure haemoglobin prior to blood donation, our results support replacement of NHSBT's customary method with portable haemoglobinometry.
Coverage
Spatial:
United Kingdom,England
Typical Age Range:
18-80
Follow Up:
Other
Pathway:
Blood donors in England were invited to take part in the study. The inclusion
and exclusion criteria were as follows: Key inclusion criteria 1. Age
≥18 years and fulfilling all normal criteria for blood
donation with the exception of pre-donation haemoglobin levels measured using
the current NHSBT methods 2. Willing to undergo additional haemoglobin
measurement 3. Willing to donate an extra blood sample for measurement of
haemoglobin using an automated cell counter 4. Willing to come back for a
subsequent appointment at standard donation interval (ie 12-wk and 16-wk for men
and women respectively) Key exclusion criteria 1. Participants who do not have
internet access and/or are not willing to provide an email address for study
correspondence (as the study will aim to be almost
“paper-less” and will involve remote
web-based data collection) 2. Donors already enrolled in the INTERVAL randomised
trial will be excluded
Provenance
Origin
Purposes:
Trial
Sources:
- EPR
- Electronic survey
- Other
Collection Situations:
Cohort, study, trial
Temporal
Accrual Periodicity:
Other
Start Date:
02 January 2016
End Date:
20 March 2017
Time Lag:
Not applicable
Accessibility
Access
Access Rights:
Access Service:
Researchers around the world can enquire about accessing the data from COMPARE
which forms part of the Blood Donors Studies BioResource for their own research
projects. Access to all samples and de-identified data (without any identifiable
details such as the participant's name or date of birth) is
strictly controlled by a formal Data Access Committee, comprising individuals
responsible for the studies and members of the public. Full information on how
to access the dataset can be found on the Donor Health website:
https://www.donorhealth-btru.nihr.ac.uk/research/blood-donors-bioresource/
Access Request Cost:
Cost recovery.
Delivery Lead Time:
2-6 months
Data Controller:
The University of Cambridge
Data Processor:
The University of Cambridge
Usage
Data Use Limitations:
General research use
Data Use Requirements:
- Not for profit use
- Return to database or resource
- User-specific restriction
Resource Creators:
COMPARE must be acknowledged in all publications using these data. Further details will be issued through the Data Access Committee.
Format and Standards
Languages:
en
Observations
Statistical Population
Population Description
Population Size
Measured Property
Observation Date
Persons
29021
Count
01 January 2016