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. 2021 Oct 12;2021(10):CD011589. doi: 10.1002/14651858.CD011589.pub2

McCusker 2001.

Study characteristics
Methods Multicentre randomised trial, Canada
Participants 388 older adults (65.2% male).
Interventions Feedback and notification to primary care and home care teams.
 
Intervention features
Multiple complex feedback (multiple PROMs at multiple times) 
PROM(s) used as intervention: Older American Resources and Services scale (OARS), Geriatric Depression Scale (GDS)
Constructs measured: Symptoms, Functioning
Instrument categories/domains: Domain/Disease specific (mental health, physical health ‐ functional decline)
 
Administration features
Where PROMs administered: Clinical setting (ED waiting room) and non clinical setting (by telephone)
How administered: Interviewer‐administered
Format of PROMs questionnaire(s): Paper
 
Feedback features
Format of PROMs feedback: Unclear
How often information fed back: 3 times
Who information fed back to: Clinicians
Information fed back: Scores, Previous scores
Outcomes Main outcomes: functional decline (OARS ADL), depressive symptoms (GDS‐SF)
Notes The study was supported by the Health Transition Fund, Health Canada. The study was conducted from 14th September 1998 to 1st April 1999. Conflicts of interest were not reported. 
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Patients were randomised to the intervention or usual care group by day of recruitment.
Allocation concealment (selection bias) Low risk Each of two intervention nurses was assigned to two hospitals and rotated between them on a schedule assigned by the statistician, using blocked randomisation
Blinding of participants and personnel (performance bias)
All outcomes High risk Research assistants did not inform staff which patients were recruited into the study. However, the intervention nurses coordinated the intervention with other staff, who were therefore
aware of certain intervention group patients.
Blinding of outcome assessment (detection bias)
All outcomes High risk Due to nature of the intervention blinding of outcomes not possible: PROM used for feedback also used to assess outcome, patients were aware they received the intervention.
Baseline outcome measurements similar Low risk Adjusted for analysis
Baseline characteristics similar High risk There was a significant difference by study group in the proportion of patients with a family caregiver: 76.4% in the intervention group and 65.2% in the control group.
Incomplete outcome data (attrition bias)
All outcomes Low risk Of 2,166 eligible patients, 63 (2.9%) declined the screening and 11 could not be found to complete the screening.
Was study protected against contamination Low risk Research assistants did not inform staff which patients were recruited into the study.
Selective reporting (reporting bias) Low risk Not reported