Tinsel 2013.
Methods |
Study design: cluster‐randomized trial Unit of allocation: practice Unit of analysis: patient Power calculation: done |
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Participants |
Care setting: primary care and ambulatory care; Germany
Health professionals: number unknown; general practitioners; fully trained Patients: 1120; hypertension; male and female |
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Interventions |
Multifaceted intervention: distribution of educational material, educational meeting Quote: "Those GPs who had been allocated to the intervention group took part in an SDM training programme... which had been evaluated in various studies...The training included the following elements: (1) information on arterial hypertension, (2) physician‐patient communication and risk communication, (3) the process steps of SDM, (4) motivational interviewing [40,41], (5) introduction of a decision table listing options to lower CVR, and (6) use of case vignettes for role plays simulating physician‐patient consultations. Additionally, we recommended implementing a cardiovascular risk calculator for GPs which included elements of SDM... Furthermore we delivered patient information flyers...to the GPs of the intervention group." page 3 Usual care (control) Quote: "GPs of the control group treated their patients as usual." page 3 |
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Outcomes | SDM‐Q‐9 (continuous) | |
Notes |
Additional information Number of approached practices (eligible): 115 Number of patients per practices: 32.5 in intervention group, 29.9 in control group |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: not reported in the paper. |
Allocation concealment (selection bias) | Low risk | Comment: randomization at the GP practice level. |
Blinding (performance bias and detection bias) Participant‐reported outcome | Low risk | Quote: "The patients were blinded to the allocation of the intervention (single‐blinded study)." page 3 column 2 paragraph 1 |
Incomplete outcome data (attrition bias) Participant‐reported outcome | Unclear risk | Comment: lost to follow‐up at T3 and non response to outcomes is higher in higher in control group than in intervention group. Was the follow up in the 2 groups comparable? Are the principal reason for missing data related to outcomes (patient desire)? What is the pattern of reasons for discontinuation across groups? There is no clear pattern of missing data. |
Selective reporting (reporting bias) | Low risk | Commment: tables 1,2,3 and study protocol. |
Other bias | Low risk | Comment: no evidence of other risk of biases. |
Baseline measurement? Participant‐reported outcome | Low risk | Comment: see table 2. |
Protection against contamination? | Low risk | Comment: randomization at the GP practice level. |
Baseline characteristics patients | Low risk | Comment: reported and similar (See table 2). |
Baseline characteristics healthcare professionals | Unclear risk | Comment: no information about professionals. |