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 |
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Outcomes | Main outcome: change in depression symptom severity. Other outcomes: psychological functioning, empowerment, and costs. |
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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. |