Grunfeld 2006.

Methods	RCT; Unit of allocation: Patient; Stratified by: N/A
Participants	Women with initial stage I, II, or III breast cancer and no distant metastases, in remission, and receiving regular follow‐up care. Setting / country: Two district general hospitals in England / UK Type of cancer: Breast Phase of care: Discharge, surveillance Sample size at randomisation: 296
Interventions	Routine follow‐up from general practitioners (GP): Discharge letter sent from hospital to general practitioner to transfer primary responsibility for follow‐up of women with breast cancer in remission from hospital to general practice. The discharge letter outlined the patient's breast cancer history, described the follow‐up routine recommended and assured the GP that rapid referral was possible if problems developed. Letter was accompanied by an educational handbook on breast cancer follow‐up care. Control: Continued routine follow‐up in outpatient clinics according to usual practice.
Outcomes	Patient: QoL, anxiety and depression (distress), incidence rate of recurrence‐related serious clinical events, survival, number of women with recurrence and nature of recurrence.
Notes	Length of follow‐up: 18 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from reference #1: "After patients provided informed consent, they were randomly allocated to treatment groups by a telephone call to the trial coordinating centre of the Ontario Clinical Oncology Group. Randomisation was conducted using a computer‐generated centre‐specific schedule."
Allocation concealment (selection bias)	Low risk	See quote first item
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote from reference #1 "All SCEs were adjudicated by a committee, the members of which were unaware of treatment allocation." Comment: No details on the other outcomes
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quotes: "All available data were included without imputation. Polynomial growth curve models as a function of the actual time from randomisation to assessment were fit to the data." "The MIXED procedure in SAS version 9.1 (SAS Institute, Cary,NC) was used. Using this approach, missing data were assumed to be missing at random." Comment: No details on the proportion of missing data, except for SF‐36 (Table 3).
Selective reporting (reporting bias)	Low risk	All outcomes in the methods section are reported in the results section.
Other bias	Low risk	No evidence of any other bias
Baseline outcomes similar?	Unclear risk	No details provided
Baseline characteristics similar?	Low risk	Quote: "The two groups were reasonably well balanced for baseline characteristics (Table 1)." Comment: Statistical analysis were not performed but baseline characteristics seem well‐balanced between groups.
Protected against contamination?	Low risk	Unit of randomisation was the patient, but there is no contamination possible since the 2 groups are followed in distinct settings by distinct care providers.