Rawl 2002.

Methods	RCT; Unit of allocation: Patient‐caregiver dyad; Stratified by: Site of recruitment, site of the patients' cancer, and caregivers' employment status.
Participants	Patients newly diagnosed with breast, colorectal, or lung cancer receiving chemotherapy and having an identified caregivers. Setting / country: A large, urban, mid‐western, tertiary‐cancer centre and a community‐based cancer centre in a medium‐sized mid‐western city / USA Type of cancer: Breast, lung, colorectal Phase of care: Treatment Sample size at randomisation: 120
Interventions	Computer‐based nursing intervention: A master's‐prepared oncology nurse specialist contacted each patient on nine occasions, five in person and four by telephone, every two weeks. The intervention was computer‐based to guide the nurse's clinical assessment, problem identification, selection of interventions, and measurement of outcomes. The computer‐based nursing‐intervention program was loaded on laptop computers, which allowed nurse specialists to input quantified assessments of patients physical and psychosocial functioning (including anxiety and depression) and symptom experiences. Nurses asked patients to rate on a four‐point scale the frequency, intensity, limitations, and degree of bother or distress caused by each symptom or problem. From the symptom assessment protocol, a computerised plan of care was developed in collaboration with the patient and caregiver, tailored specifically to address the identified patient needs. In all subsequent encounters, whether in person or via telephone, nurses evaluated the effectiveness of interventions, assessed new problems, and provided concrete, objective information about disease and treatment, symptom management, and availability of community resources. In addition, nurses provided emotional support and counseling to patients and caregivers at each visit. Intervention nurse training: Nurse specialists were trained intensively, focusing on delivery of the intervention protocol and use of the computer‐based nursing intervention system. Researchers developed an intervention manual that outlined policies and procedures and detailed all elements of the protocol to be delivered. A clinical nurse manager conducted training sessions onsite and prepared simulated cases to facilitate development of skills in problem assessment, implementation of appropriate interventions, and evaluation of intervention outcomes. Participants were encouraged  to telephone the intervention nurses between scheduled meetings if questions of concerns arose. Control: Conventional cancer care (any education normally delivered during chemotherapy but no attention outside of medical visits). Standard care consisted of verbally telling the patients about what they might expect from chemotherapy and symptoms that should be reported to the doctor.
Outcomes	Patient: QoL, depression, state‐trait anxiety
Notes	Length of follow‐up: 6 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "After completion of a baseline telephone interview, patients were assigned randomly to receive the computer‐based nursing intervention or conventional cancer care (control group). Group assignment was generated via computer and stratified according to (a) site of recruitment, (b) site of the patients cancer, and (c) caregivers employment status."
Allocation concealment (selection bias)	Unclear risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "Each interview took approximately one hour to complete, and interviewers were blind to respondents’ group assignments."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quotes: "About the same number of dyads dropped out at each site (15 and 16); however, attrition from the intervention group was twice that of the standard care group (21 versus 10)." "Because the attrition or dropout rate was higher in the intervention group than in the control group, baseline differences between patients who dropped out and those who completed the study were examined. Attrition status was defined as those who left the study for whatever reason at time 2 and time 3. Two‐way ANOVA were run to compare baseline SF‐36 sub‐scale scores, anxiety, and depression scores. Significant main effects were found for attrition on depression scores (F = 5.34, P = 0.02), the SF‐36 vitality sub‐scale scores (F = 10.64, P = 0.001), and SF‐36 social functioning sub‐scale scores (F = 4.13, P = 0.04). Patients who left the study had significantly higher depression scores at baseline (X = 14.3) than those who completed the study (X = 10.6). Similarly, those who left the study had lower SF‐36 vitality scores (X = 36.9) than those who completed the study (X = 51.5), and lower SF‐36 social functioning scores (X = 61.5) than those who completed the study (X = 73.0), indicating that those who left the study had worse functioning at baseline. Researchers observed no main effects for group, and although more patients were lost from the intervention group, researchers found no group‐by‐attrition status interactions." Comment: Proportion of attrition was different between control (19%) and intervention groups (38%). The statistical analysis allowed to demonstrate that there were no differences in outcomes scores for the participants who left between 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	Quote: Repeated measures analyses  of variance (ANOVA) were used to analyze the effect of the treatment over time on each of the following outcomes: (a) SF‐36 psychosocial functioning sub‐scales of vitality, social functioning, role emotional, and mental health, (b) depression, and (c) anxiety." Comment: Baseline outcomes measures are presented and seem to be similar (no statistics performed). Statistical analysis chosen takes into account baseline differences in outcomes.
Baseline characteristics similar?	Low risk	Quote: "Researchers compared demographic characteristics of the standard care (n = 54) and intervention groups (n = 55) using t tests and chi‐square analyses and found no significant differences."
Protected against contamination?	High risk	Quote: "Another limitation of the study relates to the possibility of diffusion of the intervention to the standard care group. After the study had been completed, one resourceful participant who had been randomised to the standard care group confessed that she had actively sought information about the intervention from patients who were receiving it. After learning what the intervention entailed, she hired an oncology clinical nurse specialist to provide similar services. The researchers do not know how many other patients or caregivers in the standard care group may have been as resourceful."