Boyer 2013.
Study characteristics | ||
Methods | Prospective, randomised open‐label trial, France | |
Participants | 124 adult patients with the diagnosis schizophrenia and a stable disease status. Mean age 41.1 years (SD 11.8), 67.7% male. | |
Interventions | Patients with schizophrenia were assigned to one of three groups: patients completed the standard face‐to‐face psychiatric assessment (PANSS, CDSS, ESRS, GAF), patients completed a QoL questionnaire (S‐QOL) in addition to the standard psychiatric assessment, feedback regarding the QoL scores was presented to clinicians in addition to the standard psychiatric assessment.
Evaluations were performed at three different time points: (a) at randomisation (baseline; T0) as well as 3 months (T1) and at 6 months (T2). The effect of QOL assessments and feedback on patient’s satisfaction was measured. Intervention features Multiple complex feedback (multiple PROMs at multiple times) PROM(s) used as intervention: S‐QoL (Schizophrenia Quality of Life) questionnaire 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): Completed on paper, item scores entered on computer by researcher Feedback features Format of PROMs feedback: Unclear How often information fed back: At each evaluation session Who information fed back to: Clinicians Information fed back: Scores, Previous scores, Interpretation guidance, Management recommendations |
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Outcomes | Main outcome: patient satisfaction (QSH‐45) Other outcomes: psychotic symptomatology (PANSS), depression (CDSS), drug‐induced movement disorder (ESRS), global Functioning (GAF). | |
Notes | The study was supported by Institutional grants ‐ 2005 Programme Hospitalier Recherche Clinique National. Sponsor: Assistance Publique, Hopitaux de Marseille, France. 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 | Computer‐generated randomisation. |
Allocation concealment (selection bias) | Low risk | Computer generated randomisation using permuted block design |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible due to study design (crossed design; study looking at feedback). |
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 | Low risk | None apparent |
Baseline characteristics similar | Low risk | No significant differences (table of sociodemographics and clinical characteristics provided) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 2 patients out of 124 did not complete follow up assessments |
Was study protected against contamination | Low risk | None apparent |
Selective reporting (reporting bias) | Low risk | All outcome measurements mentioned in methods section was reported in results |