Wasson 1992.
| Study characteristics | ||
| Methods | Randomised trial, USA | |
| Participants | 56 clinicians were randomised (29 intervention vs 27 control). | |
| Interventions | Self‐developed health assessment form Intervention features Single simple feedback (one PROM at a single time) PROM(s) used as intervention: Dartmouth COOP Charts Constructs measured: Health related Quality of Life, Symptoms, Functioning 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): Paper Feedback features Format of PROMs feedback: Paper How often information fed back: Once Who information fed back to: Clinicians, Patients Information fed back: Scores, Interpretation guidance, Management recommendations |
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| Outcomes | Main outcomes: effect of short‐term health‐assessment on the process of care (self‐developed clinician form) and patients' satisfaction (self‐developed 10‐item patient satisfaction questionnaire) | |
| Notes | The study was supported by the Epilepsy Foundation of America. The study period was not reported. Conflicts of interest were not reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Clinicians were randomised by blocks |
| 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 | Baseline data on Table 1 were similar between chart and control groups |
| Baseline characteristics similar | Low risk | Little or no differences between the groups |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No mention of how missing data were handled |
| Was study protected against contamination | Unclear risk | No mention about potential contamination |
| Selective reporting (reporting bias) | Unclear risk | Unclear whether selective reporting took place |