Ritz 2000.

Methods	RCT; Unit of allocation: Patient
Participants	Women with newly diagnosed breast cancer. Setting / country: Integrated healthcare system in a large mid‐western suburban community / USA Type of cancer: Breast Phase of care: Treatment, discharge, pre‐treatment, surveillance Sample size at randomisation: 210
Interventions	Advanced nursing care +  standard medical care: Brootens cost quality model and ONSs advanced standards of practice were used as conceptual framework. Advanced Practice Nurse (APN) interventions included assessments, diagnosis, outcome identification, planning, care coordination, symptom management, patient education, consultation and referrals. Follow‐up APN care was provided during clinic, hospital, telephone, and home care visits. Contacts were based on need as determined by the patient, family, and APNs. One APN was on call 8 am to 8 pm every week day and from 8 to noon on week ends. Control: Standard medical care
Outcomes	Patient: QoL‐ uncertainty, mood state, QoL ‐ well‐being Process: Number of inpatient visits, use of services (hospital, community and home care)
Notes	Length of follow‐up: 24 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: " After eligibility criteria were verified and informed consents obtained, the women were assigned randomly to one of two groups: women in the control group received standard medical care, and women in the intervention group received standard medical care plus APN care."
Allocation concealment (selection bias)	Unclear risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	High risk	Comment: Outcomes were measured using self‐administered questionnaires. Because the patients were not blinded to treatment allocation, than assessors could not be blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: Proportions of attrition were different between control (24% at baseline; 48% at 24 months) and intervention groups (5% at baseline; 24% at 24 months). The authors chose not to use the 24 months data because of the important attrition. No details on imputation of QOL data were given in the article.
Selective reporting (reporting bias)	Low risk	All outcomes described in Methods are reported in Results.
Other bias	Low risk	No evidence of other bias.
Baseline outcomes similar?	Low risk	Quote: "Intervention and control groups did not differ significantly on any of the QOL scales at baseline" Comment: In addition, the statistical analysis took into account baseline outcomes differences.
Baseline characteristics similar?	Low risk	Quote: " The randomisation process produced intervention and control groups that were similar demographically and in characteristics of disease at diagnosis and treatment (see Table 2) with two exceptions: women in the intervention group were significantly more likely to have a lower histology (P = 0.04) and to receive adjuvant hormone therapy (P = 0.03) than women in the control group." "Other factors were included as covariates if they affected the QOL scale being analysed." "The intervention group showed significantly less uncertainty than the control group (P = 0.043) after adjustment for baseline, extent of disease, and hormone therapy." Comment: There were differences at baseline, but these were taken into account in the analysis.
Protected against contamination?	High risk	Comment: Patients were the unit of allocation. Professionals in charge of control and intervention groups were located in the same setting so contamination cannot be overruled.