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. 2021 Oct 12;2021(10):CD011589. doi: 10.1002/14651858.CD011589.pub2

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
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. 
 
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.