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

Rise 2012.

Methods Study design: patient‐randomized trial
Unit of allocation: patient
Unit of analysis: patient
Power calculation: not done
Participants Care setting: specialized care; ambulatory care; Norway
Health professionals: 25; various type; fully trained
Patients: 75; mental health; male and female
Interventions Multifaceted intervention: Patient mediated intervention (PCOMS), Educational meeting (training of therapists)
Quote: "The intervention therapists were trained to administer the feedback system Partners for Change Outcome Management
 System (PCOMS) [30] during the treatment they usually provide. PCOMS therapists received 12 h of training during two days, with four weeks apart, with respectively eight and four hours of training...The use of the PCOMS consisted of administering two
 feedback scales in every treatment session, one at the beginning of the session (the Outcome Rating Scale, or ORS), and one at the end (the Session Rating Scale, or SRS)... In the ORS the patients rate their own functioning during the last week, or since the last treatment session, individually, interpersonally, socially, and generally. On the SRS, the patients rate the current session on relations with the therapist and the degree of agreement on goals, methods, and treatment approach...The intervention thus consisted of systematically using the ORS and SRS scales to assess feedback from the patient on treatment outcome and the quality of the session." page 4
Usual care (control): Quote: "The controls received treatment as usual." page 4
Outcomes Treatment Alliance Scale (continuous), Patient Activation Measure (continuous), Patient Participation (continuous)
Notes Additional information
Number of approached patients (eligible): 395
Number of patients per therapist (median): 5 in the intervention group, 1.5 in the control group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "University internet based computerised randomisation service" page 6
Allocation concealment (selection bias) Unclear risk Comment: insufficient information to make a judgement.
Blinding (performance bias and detection bias) 
 Participant‐reported outcome High risk Quote: "This was an open study and no blinding was performed." page 6
Incomplete outcome data (attrition bias) 
 Participant‐reported outcome Low risk Comment: there are missing data, but sensitivity analysis was performed comparing intention‐to‐treat analyses to per‐protocol analyses and the results of the outcomes were similar. Number lost to follow‐up and reasons for loss to follow‐up were well‐balanced between groups.
Selective reporting (reporting bias) Low risk The protocol was registered (Identifier: NCT01083225) The main outcomes pre‐specified in the protocol were reported in the results.
Other bias Low risk Comment: no evidence of other risk of biases.
Baseline measurement? 
 Participant‐reported outcome Unclear risk Comment: no applicable for Treatment Alliance Scale, done for Patient Activation Measure, but not done for Patient Participation
Protection against contamination? Unclear risk Quote: "To fortify fidelity of the treatment as usual group the therapists were repeatedly instructed to avoid using any feed‐back scales during treatment" Page 4
Baseline characteristics patients Unclear risk Comment: Table 1: imbalance between groups for some factors (gender (female), living alone, can confide in 2 or more persons, level of education, working). But it is not specified if some of those factors are known risk factors of the issues. Moreover, The sample size is not that large.
Baseline characteristics healthcare professionals Unclear risk Comment: No report of characteristics