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

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
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