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Pharmacy Diabetes Screening Trial: protocol for a pragmatic cluster-randomised controlled trial to compare three screening methods for undiagnosed type 2 diabetes in Australian community pharmacy

Krass, Ines, Carter, Rob, Mitchell, Bernadette, Mohebbi, Mohammadreza, Shih, Sophy T. F., Trinder, Peta, Versace, Vincent L., Wilson, Frances and McNamara, Kevin 2017, Pharmacy Diabetes Screening Trial: protocol for a pragmatic cluster-randomised controlled trial to compare three screening methods for undiagnosed type 2 diabetes in Australian community pharmacy, BMJ Open, vol. 7, no. 12, pp. 1-13, doi: 10.1136/bmjopen-2017-017725.

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Title Pharmacy Diabetes Screening Trial: protocol for a pragmatic cluster-randomised controlled trial to compare three screening methods for undiagnosed type 2 diabetes in Australian community pharmacy
Author(s) Krass, Ines
Carter, RobORCID iD for Carter, Rob orcid.org/0000-0002-1586-5619
Mitchell, Bernadette
Mohebbi, MohammadrezaORCID iD for Mohebbi, Mohammadreza orcid.org/0000-0001-9713-7211
Shih, Sophy T. F.ORCID iD for Shih, Sophy T. F. orcid.org/0000-0003-0049-2888
Trinder, Peta
Versace, Vincent L.ORCID iD for Versace, Vincent L. orcid.org/0000-0002-8514-1763
Wilson, Frances
McNamara, KevinORCID iD for McNamara, Kevin orcid.org/0000-0001-6547-9153
Journal name BMJ Open
Volume number 7
Issue number 12
Article ID e017725
Start page 1
End page 13
Total pages 13
Publisher BMJ Open
Place of publication London, Eng.
Publication date 2017-12
ISSN 2044-6055
Keyword(s) general diabetes
health economics
organisation of health services
public health
Summary INTRODUCTION: With the rising prevalence of type 2 diabetes in Australia, screening and earlier diagnosis is needed to provide opportunities to intervene with evidence-based lifestyle and treatment options to reduce the individual, social and economic impact of the disease. The objectives of the Pharmacy Diabetes Screening Trial are to compare the clinical effectiveness and cost-effectiveness of three screening models for type 2 diabetes in a previously undiagnosed population.

METHODS AND ANALYSIS: The Pharmacy Diabetes Screening Trial is a pragmatic cluster randomised controlled trial to be conducted in 363 community pharmacies across metropolitan, regional and remote areas of Australia, randomly allocated by geographical clusters to one of three groups, each with 121 pharmacies and 10 304 screening participants. The three groups are: group A: risk assessment using a validated tool (AUSDRISK); group B: AUSDRISK assessment followed by point-of-care glycated haemoglobin testing; and group C: AUSDRISK assessment followed by point-of-care blood glucose testing. The primary clinical outcome measure is the proportion of newly diagnosed cases of type 2 diabetes. Primary outcome comparisons will be conducted using the Cochran-Mantel-Haenszel test to account for clustering. The secondary clinical outcomes measures are the proportion of those who (1) are referred to the general practitioner (GP), (2) take up referral to the GP, (3) are diagnosed with pre-diabetes, that is, impaired glucose tolerance or impaired fasting glucose and (4) are newly diagnosed with either diabetes or pre-diabetes. The economic outcome measure is the average cost (direct and indirect) per confirmed new case of diagnosed type 2 diabetes based on the incremental net trial-based costs of service delivery and the associated incremental longer term health benefits from a health funder perspective.

ETHICS AND DISSEMINATION: The protocol has been approved by the Human Research Ethics Committees at University of Sydney and Deakin University. Results will be available on the Sixth Community Pharmacy Agreement website and will be published in peer reviewed journals.
Language eng
DOI 10.1136/bmjopen-2017-017725
Field of Research 111799 Public Health and Health Services not elsewhere classified
Socio Economic Objective 920499 Public Health (excl. Specific Population Health) not elsewhere classified
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2017, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution non-commercial licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30105731

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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.