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

Richardson 2008.

Study characteristics
Methods Randomised trial, Canada
Participants 265 community‐dwelling people from family practice units. Mean age of participants was 73.89 years for the control group and 73.61 for the intervention group and were mainly female for both groups (55.1% and 53.6%, respectively)
Interventions Participants in the intervention group attended a functional status lab at baseline, 9 months and 18 months post baseline. The intervention group received feedback (approximately 30 minutes) from a physiotherapist or occupational therapist about the results of their assessments.
 
Intervention features
Multiple complex feedback (multiple PROMs at multiple times) 
PROM(s) used as intervention: Self‐Reported Task Modification and Disability Scale, Health Utilities Index – Mark III, Short Form‐36 (SF‐36) 
Constructs measured: Symptoms, Functioning 
Instrument categories/domains: Generic, Domain/Disease specific (physical health – older adults)
 
Administration features
Where PROMs administered: Clinical setting (e.g. waiting room, office, etc) 
How administered: Unclear
Format of PROMs questionnaire(s): Paper
 
Feedback features
Format of PROMs feedback: Paper
How often information fed back: 3 times: baseline, 9 months and 18 months post baseline
Who information fed back to: Clinicians, Patients
Information fed back: Scores, Previous scores, Interpretation guidance
Outcomes Main outcomes: health status (SF‐36), functional status (Task Modification and Disability Scale)
Other outcomes: utilisation of health services, number of falls or exercise programme attendance, equipment purchase or medication change and were recorded in the encounter log
Notes The study was funded by Change Foundation, Toronto, Ontario. The study period was not reported. Conflicts of interest were not reported. 
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated numbers were used to randomise participants to either intervention or control groups
Allocation concealment (selection bias) Low risk Sealed envelopes were used
Blinding of participants and personnel (performance bias)
All outcomes High risk The assessors were not blinded to the group allocation as they were collecting the outcome measurements
Blinding of outcome assessment (detection bias)
All outcomes High risk Outcome assessments were collected by the therapist delivering the intervention
Baseline outcome measurements similar Low risk Table 2 in the study showed baseline measurements were similar between intervention and control
Baseline characteristics similar Low risk Paper states quote: "Participants were similar with respect to age, sex, education and income." Table provided and no significant differences identified.
Incomplete outcome data (attrition bias)
All outcomes Low risk Intention‐to‐treat analysed performed.
Was study protected against contamination Low risk The participants and physicians in the control group did not see the information about the intervention
Selective reporting (reporting bias) Unclear risk None apparent.