Dueck 2015.
| Study characteristics | ||
| Methods | Cluster‐randomised trial, USA. | |
| Participants | 269 patients with rectal cancer. | |
| Interventions | Symptom feedback to clinicians using the PRO‐CTCAE. Intervention features Multiple simple feedback (one PROM at multiple times) PROM(s) used as intervention: National Cancer Institute’s Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE) Constructs measured: Symptoms Instrument categories/domains: Domain/Disease specific (cancer) Administration features Where PROMs administered: Non‐clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Electronic Feedback features Format of PROMs feedback: Electronic How often information fed back: At time of toxicity assessments Who information fed back to: Clinicians Information fed back: Unclear |
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| Outcomes | Clinician reporting of adverse events. | |
| Notes | The study was sponsored by the Alliance for Clinical Trials in collaboration with the National Cancer Institute (NCI) and the Canadian Cancer Trials Group. The study period was not reported. Conflicts of interest were not reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information provided. |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information provided. |
| 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 | Insufficient information provided. |
| Baseline outcome measurements similar | Unclear risk | Insufficient information provided. |
| Baseline characteristics similar | Unclear risk | Insufficient information provided. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information provided. |
| Was study protected against contamination | Unclear risk | Insufficient information provided. |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information provided. |