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

Wikberg 2017.

Study characteristics
Methods Randomised trial, Sweden
Participants The trial took place at 22 Swedish PHCCs between March 2010 and December 2013. All 98 PHCCs in the region were invited to participate in the intervention; 22 agreed to participate. 258 Study participants were patients aged 18 and up who visited the PHCCs and were identified and diagnosed by a GP with a new episode of mild/moderate depressive disorder.
Interventions The intervention consisted of using a patient depression self‐rating scale (MADRS‐S) in recurrent monthly consultations during the 3‐month intervention. Patients made 4 visits to their GPs, at which time they completed MADRS‐S to monitor changes in their depressive symptoms that were then discussed in the person‐centred consultation. MADRS‐S was used as a supplement to, rather than as a substitute for, TAU.
 
Intervention features
Multiple complex feedback (multiple PROMs at multiple times) 
PROM(s) used as intervention: Beck Depression Inventory‐II (BDI‐II), EQ‐5D, 12‐ item General Health Questionnaire (GHQ‐12)
Constructs measured: Health related Quality of Life, Symptoms, Functioning
Instrument categories/domains: Generic, Domain/Disease specific (mental health)
 
Administration features
Where PROMs administered: Clinical setting (e.g. waiting room, office, etc) 
How administered: Self‐administered
Format of PROMs questionnaire(s): Unclear
 
Feedback features
Format of PROMs feedback: Unclear
How often information fed back: 4 times over 3 months
Who information fed back to: Clinicians, Patients
Information fed back: Scores, Previous scores, Interpretation guidance, Management recommendations
 
Outcomes Main outcome: depression severity (BDI‐II), depression remission, quality of life (EQ‐5D), overall psychological well‐being (GHQ‐12), prescriptions for antidepressants, prescriptions for sedatives, sick leave, healthcare use.
Notes The study was supported by the Department of Health. The study period was not reported. The authors declared no conflicts of interest.
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The participants in the experimental and control groups were divided into groups based on random assignment.
Allocation concealment (selection bias) High risk Allocation concealment not possible due to cluster randomisation
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 Unclear risk Not reported.
Baseline characteristics similar Unclear risk Not reported.
Incomplete outcome data (attrition bias)
All outcomes High risk 1339 randomised, of whom 358 (26.7%) excluded due to not completing an outcome measure, or not returning for a second session.
Was study protected against contamination High risk Therapists was aware that the patient was a participant in the study.
Selective reporting (reporting bias) Low risk None apparent.