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

Hansson 2013.

Study characteristics
Methods Randomised trial, Sweden
Participants 374 patients from a psychiatric outpatient clinic
Mean age 39 years (SD 13)
Female 73%
Interventions Feedback of treatment progress with OQ‐45 scores to the patient and therapist.
 
Intervention features
Multiple simple feedback (one PROM at multiple times)
PROM(s) used as intervention: Outcome Questionnaire 45 (OQ‐45) Swedish version
Constructs measured: Symptoms, Functioning
Instrument categories/domains: Domain/Disease specific (mental health)
 
Administration features
Where PROMs administered: Clinical setting
How administered: Self‐administered
Format of PROMs questionnaire(s): Paper
 
Feedback features
Format of PROMs feedback: Electronic
How often information fed back: Weekly
Who information fed back to: Clinicians, Patients
Information fed back: Scores, Previous scores
Outcomes Main outcome: efficacy in patients regarding changes in the total OQ‐45 scale
Other outcomes: changes in the OQ‐45 subscales of psychiatric symptoms, interpersonal problems and social functioning, frequency of OQ‐45 scores indicating alert status
Notes The study was funded by Improved process for reporting of illness (grant), Skåne, Skåne County Council; Skåne County Council’s Research and Development Foundation; Swedish Social Insurance Agency, Malmö. The study period was not reported. The authors reported no conflicts of interest. 
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation performed using a pre‐prepared list
Allocation concealment (selection bias) Low risk Paper reads:quote: 'Everyone involved—patient, receptionist, therapist and researcher—were blinded to the allocation."
Blinding of participants and personnel (performance bias)
All outcomes High risk Due to nature of intervention not possible to blind patients and personnel.
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 presented similar baseline scores between groups
Baseline characteristics similar Low risk Table provided and paper states:quote: "'No significant differences were found between first visits and other study participants concerning the number of visits during the study year, sex and age."
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Intention‐to‐treat analysed performed with last value carried forward for missing data.
Was study protected against contamination Unclear risk Unsure whether patients were able to access information on intervention and control groups. All the therapists in the intervention group were trained but there was no info about the control group
Selective reporting (reporting bias) Low risk None apparent