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. |