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

Kroenke 2018.

Study characteristics
Methods Randomised trial, USA
Participants 300 patients in general internal medicine and family practice clinics in an academic healthcare system.
Interventions After completing the PROMIS symptom measures electronically immediately prior to their visit, the 300 study participants were randomised to a feedback group in which their clinician received a visual display of symptom scores or a control group in which scores were not provided to clinicians.
 
Intervention features
Single simple feedback (one PROM at a single time)
PROM(s) used as intervention: PROMIS (Patient‐Reported Outcome Measure Information System)
Constructs measured: Symptoms
Instrument categories/domains: Generic
 
Administration features
Where PROMs administered: Clinical setting
How administered: Self‐administered
Format of PROMs questionnaire(s): Electronic
 
Feedback features
Format of PROMs feedback: Paper
How often information fed back: Once
Who information fed back to: Clinicians
Information fed back: Scores, Interpretation guidance
Outcomes Main outcome: 3‐month change in composite SPADE score
Other outcomes: individual symptom scores, symptom documentation in the clinic note, symptom‐specific clinician actions, and patient satisfaction
Notes Supported by Patient‐Centered Outcomes Research Institute (PCORI) Contract ME‐1403‐12043. The study period was not reported. The authors declared no conflicts of interest.
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated. participants were allocated to the feedback or control group in randomly alternating computer‐generated blocks of 2 and 4.
Allocation concealment (selection bias) Unclear risk Not reported.
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 variables were well balanced between groups.
Baseline characteristics similar Low risk Baseline charactereistics reported in text and table.
Incomplete outcome data (attrition bias)
All outcomes Low risk 85.3% follow‐up at 3‐month period.
Was study protected against contamination Unclear risk Clinicians were allocated within a clinic or clinics and it is possible that communication between intervention and control professionals could have occurred.
Selective reporting (reporting bias) Low risk None apparent.