McArdle 1996.

Methods	RCT; Unit of allocation: Patient
Participants	Patients undergoing breast cancer surgery. Setting / country: Three teaching hospitals in Glasgow / UK Type of cancer: Breast Phase of care: Treatment, discharge, surveillance Sample size at randomisation: 272
Interventions	(1) Routine support from ward staff + support from breast care nurse: The support from breast care nurse included information about surgery, symptoms, treatments, and the option of a joint interview with husband or other relatives. The nurse emphasised that the patients would be seen again at their subsequent clinic visits and that they could make an appointment to see her at any time. The patients were given a contact telephone number. (2) Routine support from ward staff + support from voluntary organization (Tak Tent). Tak Tent  support consisted in an introductory leaflet and subsequent contact by one of the counsellors after discharge from hospital. The individual counsellor was left to decide the level of support required: maintaining contact by telephone or post, arranging one to one meetings for counselling, and encouraging attendance at Tak Tent group meetings with fellow cancer sufferers. The counselling was based on the transactional analysis theory. (3) Routine support from ward staff + support from the breast care nurse + support from voluntary organization (Tak Tent). Control: Routine support from ward staff + an information booklet on breast cancer: Routine support consisted in care from three consultant surgeons with a strong interest in the management of breast cancer. The extent of surgery and the choice of adjuvant treatment were defined by a standard joint protocol.
Outcomes	Patient: Psychological morbidity, anxiety and depression (distress)
Notes	Length of follow‐up: 12 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Before surgery, patients were randomised by telephone to one of four groups:..." Quote from author email message: "The allocation sequence was generated by using random numbers from a computer, with a range from 1 to 4 corresponding to the four treatment options. A list of the random allocations was printed out and kept secure by a secretary in the Royal Infirmary. Other than keeping the list, the secretary had nothing to do with the study. The study was carried out in three Glasgow hospitals with established breast clinics (Royal Infirmary, Western Infirmary and Victoria Infirmary). The first author (June McArdle) went round the three hospitals to identify eligible patients for the study. On identifying each eligible patient, she phoned the secretary at the Royal Infirmary who told her the next treatment allocation on the list. She was the only person who phoned the secretary to get treatment allocations. Since June McArdle never saw the list, she had no means of juggling the patients so as to get a particular treatment for a particular patient."
Allocation concealment (selection bias)	Low risk	See quote first item
Blinding (performance bias and detection bias) All outcomes	High risk	The outcomes were evaluated with self‐administered questionnaires, and patients were not blinded, so assessment could not possibly be blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: It is difficult to understand if attrition was similar in the four groups from the way data are presented.
Selective reporting (reporting bias)	Low risk	All outcomes described in Methods are reported in Results.
Other bias	Low risk	No evidence of any other bias
Baseline outcomes similar?	Unclear risk	Comment: No baseline data collection was performed. Breast care nurse met with patients before surgery whereas the first baseline test was done 1 month after surgery.
Baseline characteristics similar?	Low risk	Quote: "The overall number of patients and the number in each institution were similar in each group, and the groups were well matched for the various baseline characteristics recorded." Comment: Table 1 presents the baseline characteristics. No statistics were performed but the groups seem to be well matched.
Protected against contamination?	High risk	Comment: Allocation was not by institution. It is possible the booklet became available to the other groups, or that the practitioners involved modified their practice when aware of the intervention.