Cardiff University | Prifysgol Caerdydd ORCA
Online Research @ Cardiff 
WelshClear Cookie - decide language by browser settings

Measurement of HbA1c in multicentre diabetes trials – should blood samples be tested locally or sent to a central laboratory: an agreement analysis

Arch, Barbara N., Blair, Joanne, McKay, Andrew, Gregory, John Welbourn ORCID: https://orcid.org/0000-0001-5189-3812, Newland, Paul and Gamble, Carrol 2016. Measurement of HbA1c in multicentre diabetes trials – should blood samples be tested locally or sent to a central laboratory: an agreement analysis. Trials 17 , 517. 10.1186/s13063-016-1640-6

[thumbnail of art_10.1186_s13063-016-1640-6.pdf]
Preview
PDF - Published Version
Available under License Creative Commons Attribution.

Download (863kB) | Preview

Abstract

Background Glycated haemoglobin (HbA1c) is an important outcome measure in diabetes clinical trials. For multicentre designs, HbA1c can be measured locally at participating centres or by sending blood samples to a central laboratory. This study analyses the agreement between local and central measurements, using 1-year follow-up data collected in a multicentre randomised controlled trial (RCT) of newly diagnosed children with type I diabetes. Methods HbA1c measurements were routinely analysed both locally and centrally at baseline and then at 3, 6, 9 and 12 months and the data reported in mmol/mol. Agreement was assessed by calculating the bias and 95 % limits of agreement, using the Bland-Altman analysis method. A predetermined benchmark for clinically acceptable margin of error between measurements was subjectively set as ±10 % for HbA1c. The percentage of pairs of measurements that were classified as clinically acceptable was calculated. Descriptive statistics were used to examine the agreement within centres. Treatment group was not considered. Results Five hundred and ninety pairs of measurement, representing 255 children and 15 trial centres across four follow-up time points, were compared. There was no significant bias: local measurements were an average of 0.16 mmol/mol (SD = 4.5, 95 % CI −0.2 to 0.5) higher than central. The 95 % limits of agreement were −8.6 to 9.0 mmol/mol (local minus central). Eighty percent of local measurements were within ±10 % of corresponding central measurements. Some trial centres were more varied in the differences observed between local and central measurements: IQRs ranging from 3 to 9 mmol/mol; none indicated systematic bias. Conclusions Variation in agreement between HbA1c measurements was greater than had been expected although no overall bias was detected and standard deviations were similar. Discrepancies were present across all participating centres. These findings have implications for the comparison of standards of clinical care between centres, the design of future multicentre RCTs and existing quality assurance processes for HbA1c measurements. We recommend that centralised HbA1c measurement is preferable in the multicentre clinical trial setting.

Item Type: Article
Date Type: Published Online
Status: Published
Schools: Medicine
Subjects: R Medicine > R Medicine (General)
Publisher: BioMed Central
ISSN: 1745-6215
Funders: NIHR HTA
Date of First Compliant Deposit: 29 March 2017
Date of Acceptance: 4 October 2016
Last Modified: 02 May 2023 19:35
URI: https://orca.cardiff.ac.uk/id/eprint/99491

Citation Data

Cited 9 times in Scopus. View in Scopus. Powered By Scopus® Data

Actions (repository staff only)

Edit Item Edit Item

Downloads

Downloads per month over past year

View more statistics