Oleske 1988.

Methods	Cluster‐RCT; Unit of allocation: Home health agency; Stratified by: Cancer patient volume per year, size of RN staff, organisation type
Participants	Cancer patients referred to home health agencies. Setting / country: Medicare‐certified home health agencies in two health planning regions of Illinois / USA Type of cancer: Any type Phase of care: Any phase Sample size at randomisation: 29
Interventions	(1) Oncology nurse specialist + continuing education on cancer: a new nursing personnel called "Areawide Oncology Nurse Coordinators" (AONC) was added to home care. One AONC was assigned to each region to serve the home health agencies. The AONCs were professional nurses who had completed at least some graduate education, had advanced training in oncology, and were experienced in follow‐up care of the cancer patient. AONC's functions were multifaceted, but their primary function was to serve as a role model and consultant to home health nurses on the care of the cancer patients and their families. AONC nurses spent approximately 60% of their time in consultant‐practitioner activities, 20% in education and 20% in community activities and coordination of resources. Consultant‐practitioner activities consisted in receiving referrals from the agency nursing staff. Each AONC attempted to see all patients referred to assess patient/family needs and problems, to propose nursing interventions and goals, using forms. This visit was performed together with the agency nurse, where the AONC assist the agency nurse in assessing the patient, family and environment, and in developing a plan of care. Once filled, these forms became part of the patient's agency chart, and a copy was routinely sent to the patient's physician(s). Social workers or discharge coordinators also received a copy if they had specifically requested oncology nursing consultation. Subsequent visits by the AONC to the patient were also made with the agency nurse and were scheduled on an individual basis depending on the needs and/or problems existing. An exchange of all consultation forms between the two AONC's and the principal investigator of the project provided a means for peer review. The agency nurse remained responsible for communicating specific patient problems and/or needs to the physician, and for requesting medical orders. On occasion, after consultation with the agency nurse, the AONC may have contacted the physician to discuss problems or observations specific to the patient's disease process, treatment or other specific procedure. Educational activities comprised the provision of consultation to home health nurses in the field. Continuing education on cancer was also offered as didactic sessions over a two and one‐half year period to home health nurses. Community activities and coordinating resources comprised carrying on outreach and liaison activities aimed at cancer patients and health professionals to increase rates of utilization and the acceptability of home services. (2) Continuing education on cancer: continuing education on cancer was offered as didactic sessions to home health nurses. Control: "Observation only"
Outcomes	Patient: Physiologic complications Process: Duration of care, number of visits by the home health nurse, number of episodes of hospitalisation, referral rate to home care, status at the last nurse contact, use of home care services
Notes	Length of follow‐up: 36 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Of the remaining agencies within each Region, home health agencies were stratified according to cancer patient volume per year, size of RN staff, and organization type, and then randomly assigned to one of three intervention groups: (1) oncology nurse specialist plus continuing education on cancer, (2) continuing education on cancer alone, and (3) observation only." Comment: Agencies were the unit randomised, but the patients were not the same at baseline and follow‐up. The professionals were the same between baseline and follow up, so all process measures followed a RCT design. However, the patient measures do not follow a RCT design.
Allocation concealment (selection bias)	Unclear risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "All the data reported here were abstracted from the participating home health agency. To abstract this information, research assistants were trained by the principal investigator (D.M.O.) on location at a home health agency." Comment: No details are given relative to blinding. However, because of the objective nature of the results the risk of bias appears to be small.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: " Excluded from the computation of the referral rates are a total of 54 individuals who resided out of the study regions, but who received their care through one of the participating agencies." Comment: None of the participating agency withdrew from the study.
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	Quotes: "The data concerning nurse performance (number of home health nurse visits and duration on agency caseload) were evaluated by analysis of variance using the software package, SAS; the variables, physiologic complications, disposition at discharge and hospitalisation rates, were evaluated with log‐linear analyses using BMDP." "Our primary statistical question is whether the observed change from 1980 to 1982 of a specified outcome differed by intervention group, i.e. we were looking for an intervention group by year interaction. Comment: All baseline outcome values are presented in the article, but not the between‐groups statistical comparison. However, the statistics used took into account baseline outcome values.
Baseline characteristics similar?	Unclear risk	Quote: "Except for physiologic complications, all our analyses of variance and log‐linear analyses included region and the patient's disability level at referral." Comment: Patient characteristics are presented for the whole sample or by region, but not for the study groups.
Protected against contamination?	Low risk	The home health agency were the units of randomisation.