Shapiro 1987.
| Study characteristics | ||
| Methods | Randomised trial, USA | |
| Participants | Adult patients that filled out the general health questionnaire (GHQ), home interview and DIS | |
| Interventions | Feedback of GHQ or DIS results Intervention features Single simple feedback (one PROM at a single time) PROM(s) used as intervention: General Health Questionnaire (GHQ) 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): Paper Feedback features Format of PROMs feedback: Paper How often information fed back: Once Who information fed back to: Clinicians Information fed back: Scores, Interpretation guidance |
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| Outcomes | Main outcome: effect of feedback information on detection and management of psychiatric disorders | |
| Notes | The study was funded by National Institute of Mental health, USA (contract 278‐81‐0025). The study was run from 1st December 1981 until 31st March 1982. Conflicts of interest were not reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No mention of how randomisation was done |
| Allocation concealment (selection bias) | Unclear risk | No mention of who knew about the allocations |
| 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 | Low risk | Baseline measurements were similar between groups |
| Baseline characteristics similar | Low risk | Characteristics of both groups similar |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | no mention of how missing data was managed |
| Was study protected against contamination | Unclear risk | Not sure whether there was contamination |
| Selective reporting (reporting bias) | Low risk | none apparent |