Koinberg 2004.

Methods	RCT; Unit of allocation: Patient; Stratified by: Centre
Participants	Women with newly diagnosed breast cancers (UICC classification: p‐TNM stage I or stage II) receiving radiotherapy. Setting / country: Three Swedish hospitals / Sweden Type of cancer: Breast Phase of care: Surveillance Sample size at randomisation: 400 (n = 264 in main analyses, see text)
Interventions	Nurse‐led follow‐up on demand: approximately 3 months after surgery, the patient met with an experienced nurse and received information about how to recognize a recurrence in breast, skin, axilla and scar. The nurse also arranged mammography at 1‐year intervals. The nurse gave advice on aspects of self‐care (medication, breast self‐examination) and provided time for talking about the patient's psycho social situation. The patient could contact the nurse any time for questions or symptoms related to the breast cancer. The nurse coordinated the healthcare resources and had rapid access to specialists in surgery and /or oncology within her own hospital, if needed. The nurse informed patient of mammography results by telephone or letter. After 3 years, the patients were referred back to the routine mammography‐screening program. Control: Physician‐led follow‐up: routine medical follow‐up by the physician. A specialist in oncology or surgery examined the patients four times per year during the first 2 years after surgery, followed by biannual examinations for up to 5 years, and yearly after 5 years. At the follow‐up visits, the examination included history taking concerning symptoms that could signal a loco‐regional relapse or distant metastases as well as a clinical examination of the breasts, chest wall and regional lymph nodes. Mammography was carried out at 1‐year intervals. Blood tests, chest X‐ray or other imaging techniques were only performed on clinical indication.
Outcomes	Patient: Anxiety and depression (distress), satisfaction, number of loco‐regional recurrences to distant metastases or any first breast cancer recurrence, survival Process: Number of physician and nurse contacts, number of evaluations
Notes	Length of follow‐up: 60 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from ref #1: "Randomisation was achieved by means of telephone contact with an external secretariat. The random selection was computer‐generated and stratified by centre. The block size was unknown to the study co‐ordinators at the centres."
Allocation concealment (selection bias)	Low risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	High risk	Comment: Data were collected via self‐report questionnaire, so the assessor (i.e. the patient) could not be blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: Proportion of missing data in the whole sample reached 32% for some measures. Proportion in each group were not reported. There is no mention in the publications of any type of imputation used. Because we do not know if the proportions of missing data were similar in the 2 groups, then we cannot judge if there is a risk of bias due to incomplete data.
Selective reporting (reporting bias)	Low risk	All outcomes described in Methods are reported in Results.
Other bias	Unclear risk	Quote from ref #1: In the monitoring process of the study, we found that, at one of the centres, the women randomised to the nurse based system were scheduled to see a surgeon or oncologist each year in conjunction with the mammography. Before the data were scrutinised and any analyses undertaken, the 135 women from this clinic were excluded, since we deemed the two study arms at this centre to be too similar. However after all analyses and our first interpretation of data, we ran all analyses with the third centre included. One woman taking part in the study had experienced a recurrence of breast cancer before randomisation  and was thus excluded. Finally, in the main analysis based on two centres 131 patients had routine follow‐up visits to a physician (PG), and 133 patients had contact with a nurse (NG) on demand. Comment: The authors do not mention if the results from the excluded centre were different from the other ones before re‐including it in the analyses.
Baseline outcomes similar?	Unclear risk	Quote from ref #2: "The participants were asked to answer the Hospitality and Depression Scale (HAD) and Satisfaction and Accessibility (SaaC) scales at baseline and twice a year over a period of five years." Comment: The outcomes were measured at baseline, but results are not presented.
Baseline characteristics similar?	Low risk	Quote from ref #1: "Marital status and age group were very similar in the study groups. The distributions of patients according to the UICC classification and treatment received were also similar in the two groups. About 8% of the women in NG stated that they had no support person available, whereas all women in PG had persons to confide in (Table 1)." Comment: No statistical analysis performed. All baseline characteristics appear similar except for the "axillary metastases present". We retested for differences between groups using the difference of proportions test and found a significant difference between groups (P = 0.04). However, the clinical significance of this difference seems small.
Protected against contamination?	Low risk	Comment: Randomisation was stratified by centre.