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.

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. 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. 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. ACTRN12616001240437; Pre-results.

Krass I ，Carter R ，Mitchell B ，Mohebbi M ，Shih STF ，Trinder P ，Versace VL ，Wilson F ，Namara KM ... -  《BMJ Open》

Pharmacy diabetes screening trial (PDST): Outcomes of a national clustered RCT comparing three screening methods for undiagnosed type 2 diabetes (T2DM) in community pharmacy.

To compare the effectiveness of three pharmacy-based screening methods for type 2 diabetes (T2DM): (1) risk assessment (AUSDRISK) alone (Group A); AUSDRISK followed by a point of care test if AUSDRISK ≥12; either (2) HbA1c (Group B); or (3) small capillary blood glucose test (Group C). A cluster RCT with a nationally representative sample of Australian pharmacies was implemented with random allocation of eligible pharmacies to Groups A, B or C. GP referral was based on prespecified cut offs. Diagnoses were considered positive if confirmed by a GP, pathology laboratory, or national diabetes register. Of the 14,093 people screened in 339 pharmacies, 3059 participants met group-specific referral criteria: 1775 (45%) (Group A); 893 (17%) (Group B); and 391 (8%) (Group C). For the total screened population rates of T2DM diagnoses were significantly higher in Group B (1.5%), compared with Groups A (< 0.8%) and C (< 0.6%) with the odds of detection in Group B compared with Group A (1.8 [1.0;3.0]), and no difference between Groups A and C. In community pharmacy, the most effective method to uncover undiagnosed T2DM was a stepwise approach; initial risk assessment; and if appropriate an HbA1C POC test and referral.

Krass I ，Carter R ，Mitchell B ，Mohebbi M ，Shih STF ，Trinder P ，Versace VL ，Wilson F ，Mc Namara KP ... -  《-》

Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol.

Tesfaye W ，Krass I ，Sud K ，Johnson DW ，Van C ，Versace VL ，McMorrow R ，Fethney J ，Mullan J ，Tran A ，Robson B ，Vagholkar S ，Kairaitis L ，Gisev N ，Fathima M ，Tong V ，Coric N ，Castelino RL ... -  《BMJ Open》

Screening for type 2 diabetes: literature review and economic modelling.

Waugh N ，Scotland G ，McNamee P ，Gillett M ，Brennan A ，Goyder E ，Williams R ，John A ... -  《HEALTH TECHNOLOGY ASSESSMENT》

Participant and GP perspectives and experiences of screening for undiagnosed type 2 diabetes in community pharmacy during the Pharmacy Diabetes Screening Trial.

Krass I ，Twigg MJ ，Mitchell B ，Wilson F ，Mohebbi M ，Trinder P ，Shih STF ，Carter R ，Versace VL ，McNamara K ... -  《BMC HEALTH SERVICES RESEARCH》