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

Puschner 2009.

Study characteristics
Methods Randomised trial, USA
Participants 294 adults receiving inpatient mental health care.
Interventions Continous feedback of patient‐reported treatment outcome information to physicians in the intervention arm.
 
Intervention features
Multiple complex feedback (multiple PROMs at multiple times) 
PROM(s) used as intervention: EB‐45, the German version of the Outcome Questionnaire 45.2 (OQ‐45.2)
Constructs measured: Symptoms, Functioning
Instrument categories/domains: 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): Electronic
 
Feedback features
Format of PROMs feedback: Paper
How often information fed back: Administered weekly, feedback continuous until discharge
Who information fed back to: Clinicians, Patients
Information fed back: Scores, Previous scores, Interpretation guidance, Management recommendations
 
Outcomes Main outcome: measured by the (German version of OQ‐45)
Notes The study was funded by German Federal Ministry of Education and Research (grant number: 01GL0504). 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) Low risk An independent unit (Ulm Universitys Institute for Biometrics) randomised all clinicians at the wards where the study took place to either intervention or control group.
Allocation concealment (selection bias) High risk Cluster‐randomisation with the therapists
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 High risk Statistically significant differences were found for the outcomes
Baseline characteristics similar High risk Statistical differences were found for education and diagnosis
Incomplete outcome data (attrition bias)
All outcomes Low risk Low dropout
Was study protected against contamination Low risk Cluster‐randomisation with clinicians as the unit of randomisation. there were changes of patients between clinicians during inpatient treatment
Selective reporting (reporting bias) Low risk None reported