Whooley 2000.
| Study characteristics | ||
| Methods | Randomised trial, USA | |
| Participants | 13 primary care medical clinics (7 intervention, 6 control). | |
| Interventions | Feedback of Geriatric Depression Scale (GDS) Intervention features Single simple feedback (one PROM at a single time) PROM(s) used as intervention: Geriatric Depression Scale (GDS‐15) Constructs measured: Symptoms Instrument categories/domains: Domain/Disease specific (geriatric mental health) Administration features Where PROMs administered: Clinical setting (e.g. waiting room, office, etc) How administered: Interviewer‐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, Previous scores, Interpretation guidance, Management recommendations |
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| Outcomes | Main outcomes: patient‐reported GDS outcomes, physician diagnosis of depression, antidepressant use, prevalence of depression | |
| Notes | The study was supported by the Garfield Memorial Fund (grant). The study recruited between June 1994 and October 1995. Conflicts of interest were not reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation occurred for practices |
| 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 | Low risk | No sig difference in outcome scores between the groups |
| Baseline characteristics similar | Low risk | Only significant differences in income and education between the groups |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No mention of missing data handling |
| Was study protected against contamination | Unclear risk | Practices were in different groups |
| Selective reporting (reporting bias) | Unclear risk | Unclear whether selective reporting took place |