Wells 2003.

Methods	RCT; Unit of allocation: Patient‐primary caregiver dyad
Participants	Patients with cancer‐related pain and their primary caregivers. Setting / country: Comprehensive cancer centre and a cancer clinic located in a Veterans' Administration Medical Center / USA Type of cancer: Any type Phase of care: Any phase Sample size at randomisation: 64
Interventions	Baseline pain education program for patient and family: The pain education program included structured and tailored components. The structured component was a 15‐minute videotape (Taking Charge of Your Pain, Purdue Frederick) that included information about pain, methods to control pain, and emphasised the importance of communicating pain to providers. It also discussed the low risk of addiction to opioids used to control cancer pain and the variety of medications available to manage side effects. Information in the videotape was presented both by experts (e.g. physician and nurse) and by patients. The tailored component consisted of individualised consultation regarding the videotape, written information about analgesics and side effect management, and discussion of the patients present pain regimen. Patients kept the printed materials, which were written at an 8th grade level, for future use at home. This education program took 20 to 30 minutes. Two types of follow‐up care were tested: (1) Baseline pain education program + access to a pain hotline: The participants in the pain hotline group received a toll‐free number they could call with questions or concerns about pain control. These patients were encouraged to call the hot line from the clinic to ensure that they were familiar with using the service. Patients were free to call their oncologist with questions. (2) Baseline pain education program + weekly telephone calls: The weekly calls group received four telephone calls over the month following the education program from an oncology nurse specialist. The oncology nurse assessed the patients' understanding of their prescribed analgesic regimens, probed for any difficulties attributed to the analgesics, and encouraged patients to contact the treating oncologist if problems were identified. The study nurse did not alter opioid prescriptions or adjust medications. This was left to the treating physicians and their staff. Patients were free to call their oncologist with questions. Control: A baseline pain education program + usual care: the usual care group received no additional follow‐up information after the pain education program. Patients were free to call their oncologist with questions.
Outcomes	Patient: Pain, pain relief, pain interference, patients beliefs Informal carer: Pain beliefs and experience Professional: Pain management Process: Number of patient‐initiated telephone calls
Notes	Length of follow‐up: 6 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from author e‐mail message: "In the patient and family education study we began with a table of random numbers and made group assignment from that table. The subject ID number was tied to the random assignment and we kept them in sealed envelopes (this was a while ago ‐ seems antiquated now).   The envelope had the subject ID on the outside and the group assignment on the inside.  The person doing the recruiting and consent process was unaware of group assignment until the consent process was finished". Comment: the author confirmed in an further message that the envelopes were opaque.
Allocation concealment (selection bias)	Low risk	See quote first item
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Quote: "Follow‐up data collection began 1 month after the pain education program. Follow‐up data were collected with monthly telephone calls using an interview format." Comment: Data were collected via interviews but no details were provided about the interviewer.
Incomplete outcome data (attrition bias) All outcomes	High risk	Many patients had one or more missing follow‐up data points. Therefore, a decision was made to include patients with a minimum of three (baseline + 2 follow‐ups) in the analyses. Slopes of the pain outcomes were computed for individual patients who had three or more data points. All available data points from each patient were included in the calculation of slopes. Of the 64 patients enrolled in the study, 54 (82%) had at least three data points. Approximately half of each of the intervention groups completed five or six follow‐up data points, and all available data points were included in the calculation of each subject’s slope. Additionally, between 10% (hotline) to 25% (control) of patients completed four follow‐up data points. Four patients each were eliminated from the hotline and usual care groups, and two from the weekly calls group because they had less than three data points. Of the 10 patients who did not complete three data points, 8 died over the six months of enrolment in the study. Patients who did not complete three data points were not significantly different from patients who did by group or on the demographic variables of age, education, race, and work status. There was a trend toward more women and single patients to complete less than three data points and, therefore, these were eliminated from the analyses (Ps = 0.06). There were no differences between patients who did and did not complete three or more data points on any clinical variable. Comment: We don't know the attrition in each of the three groups, neither the reasons for withdrawals. The study researchers took the decision to restrict analyses to patients who had three or more data points collection.
Selective reporting (reporting bias)	Low risk	All main outcomes are reported.
Other bias	Low risk	No evidence of any other bias.
Baseline outcomes similar?	Low risk	Quote: "Using slopes controls for differences in baseline values and provides an indication of improvement or decline in outcomes measured." Comment: According to table 5, no statistical differences between outcomes of patients in the 3 study groups at baseline were significant.
Baseline characteristics similar?	Low risk	Quote: "The information groups were comparable on all demographic variables except current work status. Patients in the weekly calls group were more likely to be working than patients in the other groups (Table 3). Students t‐tests indicated, however, that work status was not related to any outcome variable (Ps > 0.05)."
Protected against contamination?	High risk	All patients had access to professional within the same oncology clinic.