Vallieres 2006.

Methods	RCT; Unit of allocation: Patient
Participants	Patients with cancer experiencing pain or taking analgesics and being treated by radiotherapy for more than 1 week (> 5 fractions) on an outpatient basis. Setting / country: Radiation Oncology Department of Centre Hospitalier Universitaire de Québec (CHUQ‐L'Hôtel‐Dieu de Québec Hospital, a tertiary care centre affiliated to Laval University / Canada Type of cancer: Any type Phase of care: Treatment Sample size at randomisation: 64
Interventions	Multi component clinical intervention to reduce pain: the clinical intervention included a patient education session, a patient pain diary, and the possibility to contact a physician to adjust the pain medication. The educational component consisted of giving patients an information brochure which covered the general principles and philosophy of analgesic treatment as well as the major myths and misconceptions surrounding the use of opioid analgesics to relieve cancer pain. The patient pain diary was developed and validated in Quebec City for French‐speaking patients. Patients had to record (a) the intensity of the pain they experienced, twice a day and (b) the number of rescue doses of prescribed analgesics taken in 24 h. The patients recorded this information by themselves and were asked to bring the diary to the investigating radiation oncologist at each visit to the radiation therapy centre, or when meeting any of their regular care providers (nurse, family doctor, and regular staff oncologist). Patients were recommended to call or visit the investigating radiation oncologist or any of their other healthcare providers if their pain level reached 2/5 twice in a row or if they took at least three rescue doses of prescribed analgesics in 24 h. Adjustments of the analgesics regimen was based on WHO guidelines after consultation of the patient's pain diary. Control: Usual treatment of pain by the staff radiation oncologist, i.e. pain treatment at the discretion of the staff, without a systematic pain assessment or any patient education.
Outcomes	Patient: Pain
Notes	Length of follow‐up: 0.75 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Eligible patients who agreed to participate were then randomly assigned to the experimental (intervention) or control group and referred to the investigating physician (or research nurse) for the baseline visit." Comment: Method of random allocation not specified
Allocation concealment (selection bias)	Unclear risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Quote: "Measures Information on patients’ pain levels was collected by the investigating radiation oncologist at baseline and then after 2 and 3 weeks of follow‐up."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: Losses to follow‐up were not specified.
Selective reporting (reporting bias)	Low risk	Comment: Main outcomes are reported.
Other bias	Low risk	Comment: There is no evidence of other bias.
Baseline outcomes similar?	Low risk	Quote: "At baseline, there were no significant differences in average, worst, weakest, and “at present” pain levels (Table 2)."
Baseline characteristics similar?	Low risk	Quote: "There were a few differences between control and experimental groups, but none were statistically significant (Table 1)."
Protected against contamination?	Low risk	Comment: It is unlikely that the control group received the intervention