Rubak 2011.

Methods	Randomized controlled trial
Participants	The study location was Denmark 37 practices and 307 participants were randomized to the intervention group and 41 practices and 321 participants were randomized to the control group The inclusion criteria were 40‐ to 69‐year‐old people with screen‐detected type 2 diabetes. The exclusion criteria were contraindications or intolerance to study medication; a history of alcoholism, drug abuse, psychosis, or other emotional problems likely to invalidate informed consent or adherence to treatment; malignant disease with a poor prognosis; pregnant or lactating
Interventions	Intervention: MOTIVATIONAL INTERVIEWING The courses in "motivational interviewing" (MI) for the GPs in the I‐group were conducted by a trained teacher introducing a manual which together with "Motivational interviewing, preparing people to change addictive behaviour" constituted the theoretical part of the course curriculum. The intervention group was coached in the key points of MI. The training also included the use of specific skills, e.g. empowerment, ambivalence, the decisional balance schedule, the visual analog scale, stage of change, and reflective listening, all of which are described in detail in the book MI. The intervention group courses consisted of a 1½ ‐day training sessions with a half‐day follow‐up twice during the first year. None of the GPs in intervention and control group had previously participated in an MI course. All GPs in the intervention and the control group participated in the same half‐day course on intensive treatment of type 2 diabetes. During these diabetes training sessions, it was stressed that GPs should act as counselors for the patients, allowing treatment decisions to be based on mutual understanding between the patient and the GP. In Denmark, GPs' consultation encounters average 15 minutes and the County Health Insurance has agreed to one longer preventive consultation encounter of 45 minutes per patient. In this study the County Health Insurance agreed to allow the GPs in the intervention and control group to undertake 3 consultations of 45 minutes per patient, in which the intervention group could use MI Control: CONTROL None of the GPs in the control group had previously participated in an MI course. All GPs in the control group participated in the same half‐day course on intensive treatment of type 2 diabetes. During these diabetes training sessions, it was stressed that GPs should act as counselors for the patients, allowing treatment decisions to be based on mutual understanding between the patient and the GP. In Denmark, GPs' consultation encounters average 15 minutes and the County Health Insurance has agreed to one longer preventive consultation encounter of 45 minutes per patient. In this study the County Health Insurance agreed to allow the GPs in the control group to undertake 3 consultations of 45 minutes per patient
Outcomes	The measures of adherence were based on the number of prescriptions cashed in at the pharmacy by the patient, drawn from the National Health Service Registry The patient outcomes were data obtained at baseline and at the 1‐year follow‐up. Outcomes included a risk profile that included HbA1c, analyzed using a BioRad Variant, and serum cholesterol/HDL‐cholesterol/triglycerides analyzed using a Hitachi 912. LDL‐cholesterol was calculated using Fridewald's formula. All blood samples were analyzed according to the Danish quality assurance for laboratories. BMI and blood pressure (systolic and diastolic) was measured at rest at the GP's surgery. The number of encounters and blood samples was obtained from register data files from the National Health Service Registry. Data on smoking and exercise in leisure time and at work were obtained from patient questionnaires. The questions on physical activity had previously been validated in the "International Physical Activity Questionnaire (IPAQ)", the questions on smoking had previously been validated in the "Summary of Diabetes Self Care Activities" (SDSCA) questionnaire. The questionnaires were designed and processed in Teleform. This study included the "intermediate endpoints" and "process‐of‐care endpoints" from the ADDITION trial
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"This study included practices/GPs from the intensive arm of ADDITION Denmark from two counties in DK (Figure 1) randomized by the project manager using the method " drawing lots " into an intervention group (I‐group) comprising GPs who completed an MI training course and a control group (C‐group) of GPs who received no formal training in MI. Randomization was stratified by county, size of practices, and by numbers of full‐time GPs." (pg 93)
Allocation concealment (selection bias)	Unclear risk	Drawing lots, cluster‐randomized, no mention allocation concealment. "Study included practices/GPs from the intensive arm of ADDITION Denmark from two counties in DK (Figure 1) randomized by the project manager using the method " drawing lots " into an intervention group (I‐group) comprising GPs who completed an MI training course and a control group (C‐group) of GPs who received no formal training in MI. Randomization was stratified by county, size of practices, and by numbers of full‐time GPs." (pg 93)
Selective reporting (reporting bias)	Unclear risk	The study on which this study is based (ADDITION) reports more outcomes and measures more outcomes than this study
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) PHARMACY REFILL DATA ‐ No information about blinding of personnel who collected these data. However, this is an objective measure of adherence; numbers drawn from national health service registry
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) RISK PROFILE ‐ No mention of blinding but objective outcomes should not be influenced by blinding
Blinding of participants (performance bias) Adherence measure	Low risk	(PRIMARY) PHARMACY REFILL DATA ‐ No information about blinding of patients. However, this is an objective measure of adherence; numbers drawn from national health service registry
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) RISK PROFILE ‐ No mention of blinding but objective outcomes should not be influenced by blinding
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) PHARMACY REFILL DATA ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) RISK PROFILE ‐ No mention of blinding but objective outcomes should not be influenced by blinding
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) PHARMACY REFILL DATA ‐ No missing data: "acquisition of a 100% data rate from the National Health Service Registry." (pg 95)
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) RISK PROFILE ‐ it only seems to include patients who completed the 12‐month study; no mention of baseline number of patients included