Drury 2000.

Methods	RCT; Unit of allocation: Patient
Participants	Patients with cancer attending radiotherapy clinics. Setting / country: Radiotherapy clinics run by the Oxford Radcliffe National Health Service (NHS) Trust / UK Type of cancer: Any type Phase of care: Treatment Sample size at randomisation: 650
Interventions	Patient‐held record: Patient‐held record consisted of A4‐size plastic wallet containing communication/diary sheets for use by the patient, their family, health professionals and carers, as well as pages for appointments, medication, addresses and telephone numbers. The study nurse explained the use of the record as a means of communication and as an aide memoire. Patients were encouraged to read it and write in it and to show it to anyone concerned with their care. The record explicitly invited carers to use it as an aid for communication. It was explained to record holders that the supplementary record was intended to improve communication with health professionals and act as a reminder. Control: Normal care
Outcomes	Patient: QoL Process: number of contacts with health professionals, clinic attendance
Notes	Length of follow‐up: 6 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The allocations, generated using random numbers and in blocks of 10, were in sealed, numbered, opaque envelopes, which were opened sequentially."
Allocation concealment (selection bias)	Low risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	High risk	Quote: "Patients in both groups received an information sheet about the trial." Comment: Questionnaire were mailed, so the patient becomes the assessor, and patients were not blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "After three months, the response rate to the questionnaire was much lower among the record holders than the normal care group, and record holders more often failed to complete all the questions, particularly those concerning the record itself." Quote: "574 patients were sent the three month questionnaire, of whom 450 responded: 206/284 (72.5%) in the RH group and 244/290 (84.1%) in the NC group, a difference of 11.6% (95% confidence interval = 4.9 to 18.3; P = 0.001)." Comment: Missing outcome data do not balance across the 2 groups, no imputation of missing data was done and no results were adjusted. However, missing data were found not have an impact on the observed effect size (constipation) (Cochrane Handbook; Section 8.12.2.1.).
Selective reporting (reporting bias)	Low risk	Relevant outcome (QoL) in the methods section is reported in the results section.
Other bias	Low risk	No evidence of any other bias.
Baseline outcomes similar?	Unclear risk	No baseline measure of outcomes.
Baseline characteristics similar?	Low risk	Quote: "There were no statistically significant differences in age, sex, or diagnosis between those who responded to the questionnaire and those who did not, and these characteristics were comparable in the two groups of responders (Table 2)."
Protected against contamination?	Low risk	It is not possible that control patients were contaminated, since the control patient simply did not receive the record.