McCorkle 1989.

Methods	RCT; Unit of allocation: Patient
Participants	Homebound subjects with newly diagnosed lung cancer (stage II or higher) and their spouses. Setting / country: Medical centres, hospitals and radiation outpatient facility in King County, Washington / USA Type of cancer: Lung Phase of care: Treatment, discharge, surveillance, palliative care Sample size at randomisation: 166 + 46 patient‐spouse dyads
Interventions	(1) Oncology home care group (OHC): Received care from oncology home care nurses trained to give personalised care to persons with advanced cancer and to their families. The advanced training background included: knowledge of symptom management, cancer treatments, pain management, physical assessment, psycho social assessment, grief and mourning theory, communications systems, community resources and agencies, systems analysis, self support, professional role development, pathophysiology of death, and research theory and methodology. Specialised services by other disciplines were called upon as needed. (2) Standard home care group (SHC): received care from an interdisciplinary team of health professionals (comprising registered nurses, physical therapist, home health aides, medical social work, occupational therapist, speech pathologist) that discussed treatment and case management plans, coordination of visits, length and intensity of services, need for consultation, coordination with physician, family and community resources. Control: Traditional treatment (referred to as an office care group (OC) in the paper): patients received whatever care they needed except for home care. This program was provided by the patients physician.
Outcomes	Patient: Symptoms, current concerns, perception of health, mood state, social dependency, pain Informal carer: Psychological distress during bereavement Process: Use of hospital services, number of visits to physician within the last 6 weeks
Notes	Length of follow‐up: Until death or the end of follow‐up (min. < 1; max. 6), but bereaved spouses continued to receive follow‐up for 25 months after the patient's death
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from Ref #1: "Subjects were assigned randomly to one of the three treatment groups after the initial interview was completed. The project director contacted the appropriate agency and made a referral for home care services for the assigned patient."
Allocation concealment (selection bias)	Unclear risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Comment: No mention was made on the way the interviews were performed.
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote from Ref #1:"78 subjects who completed four interviews were used to complete the substantive analyses, for which complete data (i.e. with no attrition) were required. The fifth occasion data were not included because of the small sample size at that data collection interval." Comment: Number of losses and reasons for attrition are reported in the whole sample but not in each study group. The way chosen to deal with missing data seems unacceptable.
Selective reporting (reporting bias)	High risk	Comment: Two measures listed in Methods were not reported in the Results section: pain and mood state.
Other bias	Low risk	No evidence of any other bias.
Baseline outcomes similar?	Low risk	Quotes from Ref #1: "The three groups did not differ significantly with respect to McGill‐Melzack Pain Questionnaire, ICC, and POMS scores. There were significant differences found on the Symptom Distress Scale, the Enforced Social Dependency Scale, and the Health Perceptions Questionnaire". "When the means for the core measures were plotted by occasion, it was apparent that the groups differed notably on the first occasion, with the oncology home care group tending to do better on most of the variables. See Figure I as an illustration of this tendency. This is unusual because randomisation did not occur until after Occasion 1. Because group assignment was nonexistent at Occasion 1, the study was effectively double‐blind at this point, and there was no way group assignment could have had an effect on the outcome measures" "In an attempt to adjust for this problem, the following analyses treat data from Occasion 1 as covariates in predicting scores on Occasions 2,3, and 4. Thus, the principal analyses pertain to three levels of Occasion adjusted for initial level at Occasion 1, as if the groups had in fact been matched at Occasion 1. Although this kind of adjustment can be questionable when there is reason to believe that the covariate and treatment are confounded, the current conditions are precisely those that minimize this danger: Since Occasion 1 preceded group assignment, there is every reason to believe that the initial differences were due to chance sampling error." Comment: Significant differences were found at baseline on three outcome variables, but analysis was adjusted consequently, by using results at baseline as covariates.
Baseline characteristics similar?	Low risk	Quote from Ref #1: "Chi‐square tests indicated no statistically significant group differences on demographic variables indicating that randomisation resulted in equal distribution of potentially confounding variables across treatment groups."
Protected against contamination?	Low risk	Patients were assigned to different healthcare providers when they were assigned to the various treatment groups, so contamination is unlikely.