McLachlan 2001.

Methods	RCT; Unit of allocation: Patient; Stratified by: Clinic of origin
Participants	Patients having a diagnosis of cancer attending the ambulatory clinics at Peter MacCallum Cancer Institute. Setting / country: Peter MacCallum Cancer Institute, Melbourne / Australia Type of cancer: Any type Phase of care: Any phase Sample size at randomisation: 450
Interventions	Coordinated psychosocial care based on patient self‐assessment: patients completed a self‐report questionnaire about their cancer needs, quality of life and psychosocial information via a touch screen computer. A computer‐generated one‐page summary of the questionnaire results was then made available immediately for consideration during the consultation with the doctor, where the coordination nurse was also present. After discussion with the patient and doctor, the coordination nurse formulated an individualised management plan based on the issues raised in the summary report, and pre‐specified psychosocial guidelines formulated by a group of multidisciplinary experts. The guidelines were developed to be linear single pathways broadening to multiple options, but the coordination nurse was encouraged to apply her clinical expertise in prioritising and negotiating referrals. The nurses were responsible to implement the plan and involve other members of the healthcare team as appropriate. Control: Patients underwent a conventional clinical encounter, and the self‐reported information was not made available to the healthcare professionals at any time. However, for ethical reasons, if a control group patient reported a serious concern (e.g. suicidal ideation), then the care coordination nurse was allowed to inform the appropriate health professionals.
Outcomes	Patient: Cancer needs, QoL, depression Process: Number of services offered and accepted by patients
Notes	Length of follow‐up: 6 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Before randomisation, patients were stratified by clinic of origin (lung, gynaecology, medical oncology, head and neck cancer, or skin cancer). Computer‐generated randomisation charts were prepared for each clinic and held in the statistical office. The probability of a patient being assigned to a particular arm depended on the imbalance in the number of preceding patients assigned to the two arms in that clinic."
Allocation concealment (selection bias)	Low risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	High risk	Quote: "Patients completed self‐reported questionnaires via a touch‐screen computer (see Measures)." Comment: The outcomes were evaluated with self‐administered questionnaires, and patients were not blinded, so assessment could not possibly be blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Overall, 385 patients (86%) completed the 2‐month questionnaires and 318 (71%) completed the 6‐month questionnaires. The percentage of patients completing the questionnaires was very similar in both arms: 84% of control patients compared with 86% of intervention patients at 2 months (P < 0.48) and 69% compared with 72% respectively at 6 months (P < 0.59). The reasons for not completing the questionnaires were also similar and included death, patient refusal, poor health, and lost to follow‐up."
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: "Patients in the intervention arm tended to have more psychologic needs, physical and daily living needs, and patient care and support needs as measured by the CNQ, but a similar proportion were moderately or severely depressed on the BDI (Table 3). Both groups had very similar functional scores and global health status/QOL scores on the QLQ‐C30 (data not shown)." "Each primary outcome variable was analysed using a linear model for the change from baseline, where the model also included the baseline value as a factor. Other changes from baseline were analysed in the same way."
Baseline characteristics similar?	Low risk	Quote: "Patient demographics were well balanced in the two arms (Table 2)."
Protected against contamination?	High risk	Quote: "Another possible design limitation of this study was the potential for contamination between the groups. Doctors and clinic nurses were involved in seeing both intervention and control patients in the ambulatory care clinics. The health professionals behavior may have changed as a result of a heightened awareness of the study purposes and issues raised by patients in the intervention group. The usual care patients could then have benefited from this shift, resulting in the high levels of satisfaction in both groups"