Nipp 2019.
Study characteristics | ||
Methods | Pilot randomised trial, USA. | |
Participants | Hospitalised patients with cancer. | |
Interventions | Daily symptom reports using the Edmonton Symptom Assessment System and Patient Health Questionnaire‐4 with graphical feedback including alerts to clinical team during daily rounds. Intervention features Multiple simple feedback (one PROM at multiple times) PROM(s) used as intervention: Edmonton Symptom Assessment System and Patient Health Questionnaire‐4 Constructs measured: Symptoms Instrument categories/domains: Domain/Disease specific (cancer) Administration features Where PROMs administered: Clinical setting (e.g. waiting room, office, etc) How administered: Self‐administered Format of PROMs questionnaire(s): Electronic Feedback features Format of PROMs feedback: Electronic How often information fed back: Daily Who information fed back to: Clinicians Information fed back: Scores, Previous scores, Interpretation guidance, Management recommendations |
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Outcomes | Primary outcome: feasibility defined as >75% of patients hospitalised for 3 days or longer completing >2 symptom reports. Secondary outcome: preliminary assessment of feasibility. |
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Notes | Funded by National Cancer Institute (USA), Massachusetts General Hospital Cancer Centre, and Schullen Centre for Cancer Data Analysis. 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 | Block randomisation using a computer. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded by design. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded by design. |
Baseline outcome measurements similar | Low risk | Adjusted for within analysis. |
Baseline characteristics similar | Low risk | Baseline values were similar. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis. |
Was study protected against contamination | High risk | Chance that control arm patients can report symptoms. |
Selective reporting (reporting bias) | Unclear risk | Protocol not published. |