Williams 2001.

Methods	RCT; Unit of allocation: Patient; Stratified by: N/A
Participants	Patients under care of the Department of Oncology. Setting / country: Singleton Hospital, Swansea in south west Wales / UK Type of cancer: Except basal cell carcinoma of the skin Phase of care: Any phase Sample size at randomisation: 504
Interventions	Patient held record (PHR) used by the patient and healthcare professionals. The PHR contained instructions for its use printed inside the front cover. The PHR was A6 size with four different coloured sections for (i) free text entries by the patient, (ii) free text entries by health professionals, (iii) details of medications, and (iv) dates of appointments. The patients could use it to note questions they wanted to ask, all current medication, problems with changes of medication, anything else they  felt important as a memory aid. The patients were invited to bring the booklet to any hospital, to surgery or to show it to doctors or nurses that visited their home. Control: No details provided
Outcomes	Patient: QoL Process: Number of contacts with health professionals, booklet use
Notes	Length of follow‐up: 6 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomisation after consent and study registration was by an independent computer randomised schedule."
Allocation concealment (selection bias)	Low risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Outcomes were collected by interview, but no details on blinding are provided.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Attrition and reasons for attrition were comparable between groups.
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?	Low risk	Quotes: "There was no difference between the two groups in baseline demographic data or diagnoses (table 1) or in quality of life, except for the nausea and vomiting sub‐scale of the EORTC (mean score patient held record group 10.09; control group 14.20; p = 0.03; table 2)." "To counteract the effect of possible differences in baseline health related quality of life scores, changes in individual score from baseline were analysed using t tests."
Baseline characteristics similar?	Low risk	See quotes item G.
Protected against contamination?	High risk	Patients were the unit randomised. Intervention seemed to be taking place in general practice, but no details available to judge if professionals treating control and intervention group patient could be in contact.