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 |
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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. |
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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. |