Rise 2012.
Methods |
Study design: patient‐randomized trial Unit of allocation: patient Unit of analysis: patient Power calculation: not done |
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Participants |
Care setting: specialized care; ambulatory care; Norway Health professionals: 25; various type; fully trained Patients: 75; mental health; male and female |
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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 |
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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 |
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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 |