Mills 2009.

Methods	RCT; Unit of allocation: Patient
Participants	Patients newly diagnosed of inoperable lung cancer. Setting / country: Three hospitals in Northern Ireland / UK Type of cancer: Lung Phase of care: Palliative care Sample size at randomisation: 115
Interventions	Patient‐held quality‐of‐life diary: The intervention involved the weekly completion by the patient of a QoL questionnaire in a diary format. The questionnaire was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and the related lung cancer module LC13. Patients kept their diary at home and were requested to complete it at a regular time each week and to share the information with any health professional involved in their care. A new diary was posted to the patient each month with a self‐addressed envelope in which the previous diary could be returned to the researcher via mail or at their next hospital appointment. Relevant healthcare professionals were informed about the study and that patients may wish to share their diary information during consultations. The hospital team received basic training sessions from the researcher on the content and layout of the diary, whereas the primary care team received this information in written form via mail. Control: Standard care: patients did not receive QOL questionnaires in a diary format.
Outcomes	Patient: QoL, satisfaction Process: Discussion of patient problems
Notes	Length of follow‐up: 4 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from ref #1: "Patients providing written informed consent were assigned randomly to the diary group or standard care using block randomisation with computer‐generated random numbers."
Allocation concealment (selection bias)	Unclear risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	High risk	Comment: Outcomes were measured using self‐report questionnaire. Because the patients were not blinded and they were the ones performing the assessment, then the assessors were not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Proportions of missing data were similar in control group (53%) and in intervention group (47%). Reasons for dropping out were also similar.
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	Quote from ref #1: "Groups were comparable regarding age, sex, diagnosis, WHO performance status, treatment received, and baseline QOL scores."
Baseline characteristics similar?	Low risk	See quote item G.
Protected against contamination?	Low risk	Comment: Allocation was not performed by practice or by care professionals. However, since the intervention did not require any particular action of the care professionals involved, but to check patients' diary of participants in the intervention group, then we judged the risk of contamination was minimal.