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

Bastiaansen 2018.

Study characteristics
Methods Pragmatic randomised trial, the Netherlands.
Participants 161 patient with a primary diagnosis of depression. Mean age 32 years (12), 54% female. 
Interventions Systematic self‐monitoring in combination with digital feedback reports and face‐to‐face discussion. 
 
Intervention features
Multiple simple feedback (one PROM at multiple times) 
PROM(s) used as intervention: Routine Outcome Monitoring web application (RoQua)
Constructs measured: Symptoms, Functioning, Other (Empowerment)
Instrument categories/domains: Generic
 
Administration features
Where PROMs administered: Clinical setting (e.g. waiting room, office, etc)
How administered: Self‐administered
Format of PROMs questionnaire(s): Electronic
 
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, Interpretation guidance, Management recommendations
Outcomes Main outcome: change in depression symptom severity.
Other outcomes: psychological functioning, empowerment, and costs.  
Notes Funded by grants from the Gratama, Stichting tot Steun VCVGZ, and the Dutch Depression Foundation. The study ran from 1 March 2016 until 31 July 2018. The authors did not report any conflicts of interest. 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sequential block allocation using randomisation tool. 
Allocation concealment (selection bias) Low risk Sequentially‐numbered sealed envelopes. 
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding impossible due to nature of intervention. 
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported. 
Baseline outcome measurements similar Low risk Baseline measurement identical. 
Baseline characteristics similar Low risk Characteristics all similar. 
Incomplete outcome data (attrition bias)
All outcomes Low risk Intention‐to‐treat analysis. Multiple imputation of missing data. 
Was study protected against contamination High risk Multi‐site study with randomisation at the patient level. 
Selective reporting (reporting bias) Low risk Published protocol.