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. 2019 Dec 6;2019(12):CD011207. doi: 10.1002/14651858.CD011207.pub2

Mehuys 2011.

Methods Design: cluster‐RT
Groups: intervention group (self‐management of type 2 diabetes); control group (usual care)
Participants Pharmacies: 66
Pharmacy worker: pharmacists
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Pharmacy user: 288 patients with type 2 diabetes (153 intervention; 135 control)
  • mean age: intervention 63.0 (range 40 to 84) years; control 62.3 (range 45 to 79) years

  • % female: intervention 49%; control 46.3%


Setting: urban
Country: Belgium
Interventions Pharmacy worker‐directed intervention: a training session about type 2 diabetes (pathophysiology), its non‐pharmacological and pharmacological management (current guidelines), and the study protocol
  • Delivered by: unclearType: education material; education meeting; based on clinical practice guidelines

  • Mode of delivery: not clear

  • TDF: knowledge, skills, behavioural regulation

  • Duration: unclear


Pharmacy worker control: only received training on the study protocol
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Pharmacy user‐directed intervention: patients received protocol‐defined intervention at start of the study and at each prescription refill visit (for hypoglycaemic medication) during the course of the study; received education on disease and medication management, lifestyle and annual reviews.
  • Delivered by: pharmacists

  • Type: self‐management; education; based on clinical practice guidelines; medication management; study protocol defined

  • Mode of delivery: individual face‐to‐face (unclear)

  • TDF: knowledge

  • Duration: the intervention was implemented on each prescription refill visit

  • Length of follow‐up: 6 months (end of intervention period)


Pharmacy user control: usual treatment
Outcomes Pharmacy worker: not assessed
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Pharmacy user:
  • Clinical: fasting plasma glucose (FPG); HbA1c

  • Psychological health: not assessed

  • Behavioural: adherence to treatment (using 2 widely used measures: prescription refill rates and self‐report); self‐management via validated Dutch translation of the Summary of Diabetes Self‐Care Activities (SDSCA) questionnaire

  • Quality of life: not assessed

  • Process: knowledge about type 2 diabetes (validated Dutch translation of the Brief Diabetes Knowledge Test of the Michigan Diabetes Research and Training Center)

  • Costs: not assessed

Notes Study/intervention name: none given
Funding source: Ghent University
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The sequence of allocation to control or intervention group was predetermined by the investigators based on randomisation table generated using SPSS.
Allocation concealment (selection bias) Low risk Sequence of allocation predetermined by randomisation table.
Baseline outcome measures similar Low risk No differences between groups
Baseline characteristics similar Low risk No differences between groups
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Minimal attrition
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Objective primary outcome
Protection against contamination Low risk Randomisation at pharmacy level
Selective reporting (reporting bias) Low risk Nothing noted
Other bias Unclear risk Potential selection bias, as only regular clients recruited.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Unclear whether participants or pharmacists were aware of grouping, but likely.