Cleeland 2011.
Study characteristics | ||
Methods | Randomised trial, USA | |
Participants | 100 adult patients receiving thoracotomy for lung cancer or lung metastasis Mean age intervention group: 59.2 years (SD 13.6) and 44.7% female. Mean age control group: 60.9 years (SD 11.8) and 48.8% female. | |
Interventions | This study examines whether at‐home symptom monitoring plus feedback to clinicians about severe symptoms contributes to more effective postoperative symptom control.
After hospital discharge, patients rated symptoms twice weekly for 4 weeks via automated telephone calls. For intervention group patients, an e‐mail alert was forwarded to the patient’s clinical team for response if any of a subset of symptoms (pain, disturbed sleep, distress, shortness of breath, or constipation) reached a predetermined severity threshold using the M.D. Anderson Symptom Inventory (MDASI). Intervention features Multiple simple feedback (one PROM at multiple times) PROM(s) used as intervention: M.D. Anderson Symptom Inventory (MDASI) Constructs measured: Symptoms, Functioning Instrument categories/domains: Domain/Disease specific (cancer) Administration features Where PROMs administered: Non‐clinical setting How administered: Self‐administered by telephone Format of PROMs questionnaire(s): Electronic Feedback features Format of PROMs feedback: Electronic How often information fed back: Patients rated symptoms twice weekly for 4 weeks via automated telephone calls Who information fed back to: Clinicians Information fed back: Scores |
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Outcomes | Main outcomes: number of symptom threshold events (MDASI); mean symptom severity between discharge and follow‐up(MDASI) Other outcomes: mean symptom interference (MDASI), patient satisfaction (AD HOC) | |
Notes | American Cancer Society, Atlanta, GA (grant# RSGPB‐03‐244‐01‐BBP); National Cancer Institute, Bethesda, MD (grant# R01CA026582). The study period was not reported. The authors indicated no potential conflicts of interest. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Paper only states randomisation was performed electronically using the medical centre's 'protocol management system'. |
Allocation concealment (selection bias) | Unclear risk | Not clear whether allocation concealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Clinicians knew about intervention patients due to their email alert system |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Clinicians and surgical nurses were informed of symptoms through the IVR‐alerts which was an outcome |
Baseline outcome measurements similar | Low risk | None apparent |
Baseline characteristics similar | Low risk | No significant differences (patient demographics provided) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None apparent |
Was study protected against contamination | High risk | In the discussion the authors highlighted the possibility of the intervention patients knowing their symptoms were being monitored possibly affecting their results |
Selective reporting (reporting bias) | Low risk | All the outcomes were reported in the results section |