Schumacher 2002.

Methods	RCT; Unit of allocation: Patient; Stratified by: Site and on the basis of whether they participated by themselves or with a family caregiver
Participants	Oncology outpatients with pain from bone metastasis. Setting / country: Outpatient settings in Northern California: university‐based cancer centre, community‐based oncology practices, health maintenance organisation, outpatient radiation therapy centre, veteran's affairs facility, military hospital / USA Type of cancer: Not mentioned Phase of care: Any phase Sample size at randomisation: 212
Interventions	PRO‐SELF Pain Control Program: patients were seen by specially trained intervention nurses and received a psycho educational intervention, were taught how to use a pillbox, and were given instructions on how to communicate with their physician about unrelieved pain and the need for changes in their analgesic prescriptions. Patients were coached during two follow‐up home visits and three phone calls on how to improve their cancer pain management. At the week 1 visit, the PRO‐SELF nurse conducted the academic detailing session with the patient and family caregiver. The nurse identified the specific areas of knowledge deficit and focused the education in these areas. During weeks 2, 4, 5, the PRO‐SELF nurse contacted patients by phone and reviewed their pain intensity scores and pain medication intake. The PRO‐SELF nurse made home visits during weeks 3 and 6. Previous teaching was reinforced and patients were coached about how to make changes in their pain management plan. Control: Standard care: patients were seen by a research nurse three times (at weeks 1, 3, 6) and were called three times by phone between the home visits (at weeks 2, 4, 5). These patients received the patient version of the Cancer Pain Guideline published by the Agency for Health Care Policy and Research (AHCPR). The focus of the visits and phone calls was on monitoring patients' level of adherence with completing the diary.
Outcomes	Patient: Pain, mood state, QoL, pains level of interference with function, pain knowledge Professional: Pain management, pain management
Notes	Length of follow‐up: 1.5 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from ref #8: "Patients were stratified by site and on the basis of whether they participated by themselves or with a family caregiver. Both patients and clinicians at the study sites were blinded to the patients group assignment. Patients were randomly assigned to either the PRO‐SELF© or the standard care group." Quote from author email message: "Identification numbers (IDs) were assigned to prospective patients in each of the unique strata before the patients were recruited.  Using the SPSS (Statistical Package for the Social Sciences) computer program, that has the ability to select true random samples, each identification number was randomly assigned to correspond to one of the two study groups.  Envelopes were created for each identification number with the ID number on the outside of the envelope and the study group assignment on a folded paper inside the envelope.  As patients were recruited into the study and assigned ID numbers appropriate to their strata, the research nurse was able to open the envelope specific to that patients ID number and discover to which study group that patient had been randomly assigned." Other email: "Yes, the envelopes were opaque.  They were that buff colour that you cannot see through."
Allocation concealment (selection bias)	Low risk	See quote first item.
Blinding (performance bias and detection bias) Physical status	High risk
Blinding (performance bias and detection bias) Pain belief	High risk
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quotes from ref #8: "Thirty‐eight patients (i.e. 22 in the PRO‐SELF© group and 16 in the standard care group) did not complete the entire study for a variety of reasons, including: increased severity of illness or intervening cancer treatments that required hospitalisation (n = 28; 16 in the PRO‐SELF© group and 12 in the standard care group) and death (n = 10; six in the PRO‐SELF© group and four in the standard care group). No differences were found in any of the demographic, disease, or baseline pain characteristics between patients who did and did not complete the study. The percentage of patients who did not complete the entire study did not differ significantly by treatment group (i.e. 19% in the PRO‐SELF© group and 17% in the standard care group)." "All calculations used actual values. Adjustments were not made for missing data." Comment: Proportions and reasons for attrition are similar in the 2 treatment 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	Comment ref #8: All outcomes were controlled for with scores at baseline. Quote from ref #7: "As shown in Table 2, no significant differences in any of the baseline pain characteristics or analgesic prescriptions were found between patients in the PRO‐SELF and the standard care groups." Quote from ref #9: "No significant differences were found in any of the baseline pain characteristics among patients in the PRO‐SELF© and standard care groups (see Table 3). All of the participants experienced moderate to severe pain from bone metastasis that lasted almost half of the day."
Baseline characteristics similar?	Low risk	Quote from ref #8: "No significant differences were found in any of the demographic or disease characteristics between patients in the standard care and PRO‐SELF© groups or among the patients in the three responder groups."
Protected against contamination?	Low risk	Quote from ref #8: "Both patients and clinicians at the study sites were blinded to the patients group assignment. " Comment: The patients were the units of randomisation, but the clinicians were blinded.