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. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

Hamann 2014.

Methods Study design: patient‐randomized trial
Unit of allocation: patient
Unit of analysis: patient
Power calculation: not clear
Participants Care setting: specialized and ambulatory care; Germany
 Health professionals: 1, specialist, fully trained
Patients: 100; affective disorders; male and female
Interventions Single intervention: patient‐mediated intervention
Quote: "The QPS for outpatients with an affective disorder was developed by four experienced clinicians (two psychiatrists, two psychologists)...The final version of the QPS was a one‐page leaflet in which patients were encouraged to behave actively in the
 consultation (‘Make the best out of the consultation’), to write down notes about their wishes for today’s consultation and to tick up to 15 standard questions that were provided on the QPS (e.g. ‘What is my diagnosis?’, ‘What treatment options are still available for my complaints?’ etc.). Finally, the QPS stated that patients could refer to the leaflet during the consultation..." page 228
Usual care (Control): patient‐mediated intervention (cognitive training)
Quote: "Patients in the control condition went to the consultation without receiving the QPS." page 228
Outcomes Patients self‐report of who made the decision during the day's consultation (continuous); Third‐party assessment of who made the decision during the day's consultation (continuous).
Notes Additional information
Number of approached patients (eligible): 152
Number of patients per physician: 100 (only one physician)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: insufficient information to make a judgement
Allocation concealment (selection bias) Low risk Quote: "Every patient was given a numbered, sealed, allocation concealment envelope that contained allocation to their group and all study materials." page 228 column 2
Blinding (performance bias and detection bias) 
 Observer‐based outcome Unclear risk Comment: insufficient information to permit judgement
Blinding (performance bias and detection bias) 
 Participant‐reported outcome Unclear risk Comment: insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 Observer‐based outcome Low risk Quote: "All consultations were audio‐taped and subsequently analysed." page 229 column 1
Incomplete outcome data (attrition bias) 
 Participant‐reported outcome Unclear risk Comment: I cannot assume that all patient replied to all questions related to outcomes. Missing outcome data were not specified.
Selective reporting (reporting bias) High risk Comment: participant flow was not fully drawn and missing outcomes data were not specified.
 One outcome was not specified but reported in table 2: Quote: "what influence did you have on what had been decided during the consultation?"
 Oucomes like: number of questions ticked among the 15, number of patients who ticked at least 1 question in the QPS, topics raised in the QPS and factors associated with the number of questions ticked were not pre‐specified in the paper.
 As median and range are mostly reported, it will be difficult to compute an effect size for a meta‐analysis.
Other bias Low risk Comment: no evidence of other risk of biases.
Baseline measurement? 
 Observer‐based outcome Unclear risk Comment: no baseline measure of our primary outcome.
Baseline measurement? 
 Participant‐reported outcome Unclear risk Comment: no baseline measure of our primary outcome.
Protection against contamination? Low risk Quote: "All patients in the intervention group were provided with the QPS prior to the consultation… and were asked to work through it in a separate room." page 228 column 2
Baseline characteristics patients Low risk Comment: reported and similar (table 1).
Baseline characteristics healthcare professionals Unclear risk Comment: no report of characteristics.