Grunfeld 1996.

Methods	RCT; Unit of allocation: Patient
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: Satisfaction, QoL, anxiety and depression (distress), QoL, number of women with recurrence, survival Process: Time to diagnosis of recurrence, frequency of follow‐up visits, time for appointment
Notes	Length of follow‐up: 18 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from reference #3: "Follow‐up groups were assigned by a telephone call to the trial coordination centre in Oxford. Random allocation was in blocks of eight."
Allocation concealment (selection bias)	Low risk	See quote first item.
Blinding (performance bias and detection bias) Functional status	Low risk
Blinding (performance bias and detection bias) Physical status	Low risk
Blinding (performance bias and detection bias) Psychological status	Low risk
Blinding (performance bias and detection bias) Accessibility	Low risk
Blinding (performance bias and detection bias) Continuity	Low risk
Blinding (performance bias and detection bias) Quality of life	High risk	Quality of life was assessed using 3 self administered instruments; the assessor being the patient in these cases, he was not blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote from reference #3: "the denominator was adjusted for patients who had died or gone away,"  Comment: Proportion of missing data are similar in intervention (5%) and control groups (3%) at the onset of the intervention. However, sample sizes presented in the Table 4 suggest more attrition and remain unexplained. There seems to have been some imputation, but it is unclear.
Selective reporting (reporting bias)	Low risk	All outcomes in the methods section are reported in the results section.
Other bias	High risk	Quote from reference #3: "However, the trial has one important limitation which must be recognised: as there was no common clinical examination at the end of the trial, it could be argued that there were unrecognised cases of recurrence in the general practice group which would have been elicited by examination at the hospital. With respect to local recurrence, women in both groups were receiving mammography and there were more cases of locoregional recurrence detected in the general practice group than the hospital group. With respect to metastatic recurrence, most distant recurrences are symptomatic at the time of diagnosis, although the possibility that hospital clinics are better at eliciting metastatic symptoms cannot be excluded by our design." Quote from reference #3: "Of the 148 participants randomised to the general practice group, 141 (95.7%) received the intervention as allocated, 5 (3.4%) referred themselves back to hospital, and 2 (1.4%) were registered with general practitioners who had refused to provide follow up. Of the 148 participants randomised to the hospital group, 5 (3.4%) requested discharge to general practice follow up so that 143 (96.6%) received the intervention as allocated." Comment: Analysis "per treatment" performed. Patients that switched from control to intervention group after randomisation were included in the intervention group.
Baseline outcomes similar?	Low risk	Quote from reference #3: "The general practice group was younger at diagnosis (mean age 55.6 v 59.0 years) and at entry to the study (mean age 59.1 v 62.4 years). There were more stage I patients in the hospital group (50.3% v 40.4%). Otherwise the two groups were very similar in clinical characteristics and in baseline scores on all sub‐scales of the quality of life instruments." Comment: In addition to the above quote, baseline outcome measures are presented in the Table 4.
Baseline characteristics similar?	High risk	Quote from reference #3: "The general practice group was younger at diagnosis (mean age 55.6 v 59.0 years) and at entry to the study (mean age 59.1 v 62.4 years). There were more stage I patients in the hospital group (50.3% v 40.4%). Otherwise the two groups were very similar in clinical characteristics and in baseline scores on all sub‐scales of the quality of life instruments." Comment: These differences were not taken into account in the analysis. Recurrence might be affected by the staging of cancer, with an increased risk of recurrence in the group with later cancer stage (control group).
Protected against contamination?	Low risk	Comments: there were no possibility for contamination from healthcare professionals since the settings were different in control and intervention groups.