McDonald 2005.

Methods	Cluster‐RCT; Unit of allocation: Nurse
Participants	Patients admitted with a primary diagnosis of cancer, self‐reporting daily or constant pain at admission and their home health nurses. Setting / country: A large urban, non‐profit home care organisation / USA Type of cancer: Any type Phase of care: Any phase Sample size at randomisation: 336 (673 patients)
Interventions	(1) Basic home care: consisted of a patient‐specific, one‐time e‐mail reminder sent to nurses within 10 days of each new eligible patient's admission to home care. The e‐mail identified the patient by name, indicated that the patient reported pain at admission, and highlighted six pain‐specific clinical recommendations; the first letter of each practice spelling out the acronym "RELIEF" for: R Reassess pain E Eliminate Barriers L Learn more about analgesics I Intervene to limit side effects E Encourage the use of complementary (non‐medication) therapies F Follow up with MD/Nurse practitioner if pain is not relieved; (2) Augmented home care: In addition to the basic e‐mail, it included a laminated pocket card that directed the nurses how to complete a comprehensive pain assessment, including a 0 to 10 visual scale to use with patients, a prompter card to help nurses improve communication with physicians, a self‐care guide to review with patients and open a dialogue about pain control, and follow‐up by an oncology Clinical Nurse  Specialist (CNS) who served as an expert peer. The CNS was employed by the agency and available to all staff requesting a consultation. The augmented intervention outreach was a more pro‐active approach. It consisted of an e‐mail sent by the CNS to the nurse a week after the first e‐mail and reminded the augmented group nurse that the CNS was available for consultation. Control: Usual care: the control group nurses did not receive any intervention materials and provided usual care.
Outcomes	Patient: pain, QoL, patient‐related barriers to pain management, nurses estimation of patients pain intensity Professional: pain management
Notes	Length of follow‐up: 18 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Each nurse was randomly assigned to either the control group or one of two treatment groups (basic intervention or augmented intervention) the first time s/he began caring for an eligible patient." "Although nurses were randomly assigned to treatment or control groups, random assignment of patients to nurses was not feasible. Patients referred to the study agency, however, are assigned to a specific nurse based primarily on where the patient lives and the nurse's overall caseload."
Allocation concealment (selection bias)	Low risk	Quote: "Furthermore, agency staff responsible for assigning patients to nurses were blinded to the study."
Blinding (performance bias and detection bias) All outcomes	Low risk	Quotes: "Record abstractions were completed by trained nurse reviewers who were blinded to the intervention group assignment of study nurses and their patients." "All interviews, which took place over an 18‐month period, were conducted by trained interviewers blinded to the study groups."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote: "Two conditions are necessary for the intervention estimates to be biased: (i) the pattern of attrition differs by treatments and controls and (ii) attrition is correlated with the outcome measure being examined. Because there was evidence of differential attrition among the groups in the study, we followed the traditional econometric approach of estimating outcome models jointly with a sample retention equation to produce attrition‐corrected estimates of the interventions on nurse process measures and patient outcomes. Specifically, a bivariate probit specification was used to model process and outcome measures that were binary in nature (yes/no) while a two‐stage Heckman selection correction specification was used to model continuous outcome variables". Comment: The authors seem to have used quite sophisticated statistical methods to take into account missing outcomes, but we were not able to judge whether they were appropriate.
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: "In addition to the main variables of interest ‐ membership in the basic or augmented treatment group ‐ all regressions included pre‐intervention, aggregate measures of pain frequency and intensity, age, level of disability, and number of comorbid chronic conditions of each nurses patients; the nurses age, sex,  race/ethnicity, educational level, experience, employment status, and overall caseload; and county of practice."
Baseline characteristics similar?	High risk	Quotes: "There were no statistically significant differences between control and basic intervention nurses or between control and augmented intervention nurses" "The groups differed, however, with respect to whether the patient had surgery immediately prior to home care admission and time since cancer diagnosis." "In particular, we controlled for patient‐level baseline measures of health and functional status assessed by the nurse during the initial visit, including frequency and intensity of pain, ADL and IADL limitations, limitations in cognitive functioning, and the presence and number of certain pre‐existing medical conditions; the patients demographic characteristics, including age, sex, race/ethnicity, marital status, education, expected payment source, and baseline measures of social support; the provider nurses baseline characteristics; and an indicator of the reimbursement environment (pre‐Prospective Payment System or otherwise). Finally, measures of the nurses caseload at the time of patient assignment and county of practice were also included to control for factors simultaneously affecting patient assignment to a specific nurse and patient outcomes. Comment: There is no mention that the results were adjusted to take into account baseline differences in surgery prior/after home care admission or time since cancer diagnosis.
Protected against contamination?	Low risk	Quote: "A nurses initial random assignment to a specific group (usual care, basic intervention, or augmented intervention)  determined the status for all new patients allocated to that particular nurses care for the duration of the study." Comment; Because nurses worked in the patient homes, then the risk of contamination between nurses was negligible.