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 |
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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 |
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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. |
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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. |