Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2018 Nov 10:12:176-181.
doi: 10.1016/j.conctc.2018.11.002. eCollection 2018 Dec.

Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: Secondary analysis and simulation

Peter J Godolphin  1   2 , Trish Hepburn  2 , Nikola Sprigg  1 , Liz Walker  1 , Eivind Berge  3 , Ronan Collins  4 , John Gommans  5 , George Ntaios  6 , Stuart Pocock  7 , Kameshwar Prasad  8 , Joanna M Wardlaw  9 , Philip M Bath  1 , Alan A Montgomery  2
Affiliations
Review

Central masked adjudication of stroke diagnosis at trial entry offered no advantage over diagnosis by local clinicians: Secondary analysis and simulation

Peter J Godolphin et al. Contemp Clin Trials Commun. .

Abstract

Background: Central adjudication of stroke type is commonly implemented in large multicentre clinical trials. We investigated the effect of central adjudication of diagnosis of stroke type at trial entry in the Efficacy of Nitric Oxide in Stroke (ENOS) trial.

Methods: ENOS recruited patients with acute ischaemic or haemorrhagic stroke, and diagnostic adjudication was carried out using cranial scans. For this study, diagnoses made by local site clinicians were compared with those by central, masked adjudicators using kappa statistics. The trial primary analysis and subgroup analysis by stroke type were re-analysed using stroke diagnosis made by local clinicians, and simulations were used to assess the impact of increased non-differential misclassification and subgroup effects.

Results: Agreement on stroke type (Ischaemic, Intracerebral Haemorrhage, Unknown stroke type, No-stroke) was high (κ = 0.92). Adjudication of stroke type had no impact on the primary outcome or subgroup analysis by stroke type. With misclassification increased to 10 times the level observed in ENOS and a simulated subgroup effect present, adjudication would have affected trial conclusions.

Conclusions: Stroke type at trial entry was diagnosed accurately by local clinicians in ENOS. Adjudication of stroke type by central adjudicators had no measurable effect on trial conclusions. Diagnostic adjudication may be important if diagnosis is complex and a treatment-diagnosis interaction is expected.

Keywords: Adjudication; Clinical trial; Diagnosis; Stroke.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Flow diagram showing diagnosis of stroke type in ENOS.
See this image and copyright information in PMC

References

    1. Walter S.D., Cook D.J., Guyatt G.H., King D. Outcome assessment for clinical trials: how many adjudicators do we need? Contr. Clin. Trials. 1997;18(1):27–42. - PubMed
    1. Granger C.B., Vogel V., Cummings S.R., Held P., Fiedorek F., Lawrence M. Do we need to adjudicate major clinical events? Clin. Trials. 2008;5(1):56–60. - PubMed
    1. Pogue J., Walter S.D., Yusuf S. Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs. Clin. Trials. 2009;6(3):239–251. - PubMed
    1. Stuck A.K., Fuhrer E., Limacher A., Méan M., Aujesky D. Adjudication-related processes are underreported and lack standardization in clinical trials of venous thromboembolism: a systematic review. J. Clin. Epidemiol. 2014;67(3):278–284. - PubMed
    1. Dechartres A., Boutron I., Roy C., Ravaud P. Inadequate planning and reporting of adjudication committees in clinical trials: recommendation proposal. J. Clin. Epidemiol. 2009;62(7):695–702. - PubMed

LinkOut - more resources