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. 2021 Oct 12;2021(10):CD011589. doi: 10.1002/14651858.CD011589.pub2

Amble 2014.

Study characteristics
Methods Multisite randomised trial, Norway
Participants 377 adult patients with moderate to severe dysfunction in and outpatient in Norwegian naturalistic psychiatric setting. mean age 35.8 years (SD: 11.66, Range: 18‐65), 68% female
Interventions All patients were asked to online fill out the OQ‐45 prior to each session. Both patients and physicians in the intervention arm received feedback about their OQ‐45 outcome.
 
Intervention features
Multiple simple feedback (one PROM at multiple times)
PROM(s) used as intervention: The Outcome Questionnaire‐45.2
Constructs measured: Symptoms, Functioning
Instrument categories/domains: Domain/Disease specific
 
Administration features
Where PROMs administered: Unclear
How administered: Self‐administered
Format of PROMs questionnaire(s): Electronic
 
Feedback features
Format of PROMs feedback: Electronic
How often information fed back: Before each session with therapist
Who information fed back to: Clinicians, Patients
Information fed back: Scores, Interpretation guidance
Outcomes Main outcomes: number of sessions; proportion of signal cases
Other outcomes: recovery rate (OQ‐45 score)
Notes Funding information not stated. The study ran from June 2010 until September 2013. No conflicts of interest were reported. 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients randomised in blocks of 8 and by gender
Allocation concealment (selection bias) High risk Patients notified of their status.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not possible due to study design (crossed design; study looking at feedback).
Blinding of outcome assessment (detection bias)
All outcomes High risk Due to nature of the intervention blinding of outcomes not possible: PROM used for feedback also used to assess outcome, patients were aware they received the intervention.
Baseline outcome measurements similar Low risk Table 2 provided similar outcome measurements for the first scores
Baseline characteristics similar High risk Table 1 provided the characteristics across the clinics and there were big differences between the number of feedback sessions, gender breakdown and other characteristics
Incomplete outcome data (attrition bias)
All outcomes Unclear risk There was no discussion on missing data.
Was study protected against contamination High risk No blinding.
Selective reporting (reporting bias) Low risk None apparent.