Gossec 2018.
Study characteristics | ||
Methods | Randomised trial, France | |
Participants | 320 rheumatoid arthritis (RA) patients in 13 rheumatology centres across France. | |
Interventions | Online interactive electronic e‐health platform developed to allow patient self‐assessment and self‐monitoring. Intervention features Multiple complex feedback (multiple PROMs at multiple times) PROM(s) used as intervention: RAPID3 Health Assessment Questionnaire, RA Impact of Disease scores, as well as symptoms as free text Constructs measured: Health related Quality of Life, Symptoms, Functioning Instrument categories/domains: Generic, Domain/Disease specific (rheumatoid arthritis) Administration features Where PROMs administered: Non‐clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Electronic Feedback features Format of PROMs feedback: Electronic How often information fed back: Patients not prompted, at their discretion how many times they recorded information and received feedback. Who information fed back to: Patients (who can share with clinicians at their instigation) Information fed back: Scores, Previous scores, Interpretation guidance |
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Outcomes | Main outcome: change in patient‐physician inter‐ actions, assessed using the Perceived Efficacy in Patient–Physician Interactions questionnaire (PEPPI‐5), over 12 months. | |
Notes | The study was funded by UCB France and e‐Health Services Sanoia. The study period was between June 2014 and April 2016. Conflicts of interest were not reported. |
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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 information about 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 | Outcome scores in Table 2 similar at baseline. |
Baseline characteristics similar | Low risk | No sig differences between groups. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Missing data were imputed using last observation carried forward. |
Was study protected against contamination | Low risk | Control group not informed of the intervention. |
Selective reporting (reporting bias) | Low risk | Primary and secondary outcomes reported in the results. |