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

Myasoedova 2019.

Study characteristics
Methods Randomised trial, USA. 
Participants Adult patients with rheumatoid arthritis. 
Interventions Flare Assessment in Rheumatoid Arthritis (FLARE‐RA) PROM assessment with  nurse‐led counselling or an expedited visit with a rheumatology provider offered to patients in the intervention arm who indicated they were in flare versus usual care.
 
Intervention features
Multiple simple feedback (one PROM at multiple times)
PROM(s) used as intervention: FLARE‐RA (devised and validated to improve the detection of current and recent flares in rheumatoid arthritis)
Constructs measured: Health related Quality of Life, Symptoms, Functioning, other (social and emotional wellbeing)
Instrument categories/domains: Generic, Domain/Disease specific (cancer)
 
Administration features
Where PROMs administered: Unclear
How administered: Self‐administered
Format of PROMs questionnaire(s): Paper
 
Feedback features
Format of PROMs feedback: Unclear
How often information fed back: 4 times
Who information fed back to: Clinicians
Information fed back: Scores, Management recommendations
Outcomes Primary outcome: Flare rate by OMERACT 9 definition.
Secondary outcomes: disease activity, remission, flare by provider opinion, treatment change, patient satisfaction, musculoskeletal ultrasound. 
Notes This work was financially supported by a grant from Pfizer (Grant ID 15322005). The study period was not reported. Conflicts of interest were reported as follows: Disclosures Elena Myasoedova: no disclosures or COI
Cynthia S. Crowson: no disclosures or COI
Rachel E. Giblon: no disclosures or COI
Kathleen McCarthy‐Fruin: no disclosures or COI
Daniel E. Schaffer: no disclosures or COI
Kerry Wright: no disclosures or COI
Eric L. Matteson: Grant/Research/Clinical Trial Support (rheumatoid
arthritis)
Genentech, Mesoblast, Novartis, Pfizer, Sun Pharmaceutical
Industries, Ltd
Editorial functions: UpToDate
John M. Davis, III: Grant/Research/Clinical Trial Support (rheumatoid
arthritis) Pfizer
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation was by a computer‐generated random number algorithm prepared by a statistician
Allocation concealment (selection bias) Unclear risk Not reported. 
Blinding of participants and personnel (performance bias)
All outcomes High risk Unblinded by nature of intervention. 
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported. 
Baseline outcome measurements similar Low risk Adjusted analysis. 
Baseline characteristics similar Low risk Baseline characteristics similar. 
Incomplete outcome data (attrition bias)
All outcomes Low risk Intention‐to‐treat protocol. 
Was study protected against contamination Unclear risk Not reported. 
Selective reporting (reporting bias) Unclear risk Protocol not published.