de Wit 2001.

Methods	RCT; Unit of allocation: Patient; Stratified by: With/without district nursing, and by gender, age, metastatic sites
Participants	Patients experiencing pain related to cancer, cancer therapy, or illness, admitted to a hospital, and expected to live for at least 3 months. Setting / country: A 180‐bed cancer centre (Antoni van Leeuwenhoek Hospital) / Netherlands Type of cancer: Any type Phase of care: Any phase Sample size at randomisation: 313
Interventions	Pain Education Program (PEP): The Pain Education Program included the use of multiple teaching methods, which were provided both in the hospital and post‐discharge by telephone. The PEP was started in the hospital and consisted of pain information and instruction that was tailored to the needs and abilities of the individual patient. The purposes of the pain education program for patients were: (1) to improve knowledge of their pain and pain treatment; (2) to enhance motivation to adhere to the drug regimen; (3) to monitor pain daily by means of a pain diary; and (4) to stimulate help‐seeking behaviour (how to communicate about pain and how to contact healthcare providers). Topics discussed included: the definition of pain, pharmacological pain management, side‐effects, myths and misconceptions related to pain management, non‐adherence, use of non‐pharmacological pain treatment and pain assessment. The verbal instruction, which was provided in the hospital, was audio‐taped on a cassette so that it could be listened to at home. Patients were called at home at three and seven days postdischarge by the same nurse to determine whether the pain information and instruction provided in the hospital was fully understood, and to offer the opportunity to ask questions. Shared care: The second part of the intervention consisted of informing district nurses about the PEP that patients received. District nurses of intervention group patients received additional information about patients' pain complaints by telephone and by means of a written summary. By informing district nurses about patients' pain treatment, the purpose of the PEP was to improve their knowledge and understanding regarding patients' pain experience, to enhance their involvement in the pain treatment, and to ensure optimal continuity of care. Control: Regular pain treatment provided to patients; district nurses of control group patients received no additional information and instruction.
Outcomes	Patient: QoL, pain, pain knowledge, pain cognition, pain experience, nurses estimation of patient's pain intensity, nurses assessment of patient's pain relief Professional: Pain management, nurse satisfaction with the pain treatment Process: Number of visits at home to the patients by the district nurses (after discharge), number of district nurses who contacted another healthcare provider, frequency of contacts with the general practitioner, extent of information provided by hospital nurse
Notes	Length of follow‐up: 2 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from reference #2: "Patients were randomised by an independent trial office by means of a computer."
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) Psychological status	High risk
Blinding (performance bias and detection bias) Quality of life	High risk
Blinding (performance bias and detection bias) Use of services	Low risk
Incomplete outcome data (attrition bias) All outcomes	High risk
Selective reporting (reporting bias)	Low risk	All relevant outcomes in the methods section are reported in the results section.
Other bias	Low risk	No evidence of other bias.
Baseline outcomes similar?	Low risk	Quote from reference #1: "Finally, pretest differences were found between the control and intervention groups with district nursing regarding the use of pain medication, patient’s cognitive functioning, and patient’s physical  functioning. To correct for this latter imbalance, BMDP’s unbalanced repeated measures analysis of covariance (5V) was used (Jennrich and Schluchter, 1986)." Comment: BMDP is a general purpose statistics package for Bio‐medical Data Processing, including complex ANOVA designs, non‐linear and stepwise regression, time series, survival analysis, maximum likelihood estimation, various multivariate analyses.
Baseline characteristics similar?	Low risk	Quote from reference #1: "There were no differences with respect to demographic variables between the two control and two intervention groups, and between the separated control and intervention groups with and without district nursing."
Protected against contamination?	Unclear risk	Comment: Allocation was performed at the patient level. Additional professionals (nurses) were providing the intervention but did not have any contact with control group patients. If some of the district nurses were with control and intervention group patients, then they might have caused some contamination. In the intervention group, nurses received more information on their patients by telephone and by means of a written summary.