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

Goldsmith 1989.

Study characteristics
Methods Cluster‐randomised trial, USA
Participants 62 older adults (mean age 70 years) with at least one chronic illness attending a family physicians.
Interventions Feedback of score from the SIP immediately before a visit.
 
Intervention features
Single simple feedback (one PROM at a single time)
PROM(s) used as intervention: Sickness Impact Profile (SIP)
Constructs measured: Functioning
Instrument categories/domains: Domain/Disease specific (physical health)
 
Administration features
Where PROMs administered: Clinical setting
How administered: Interviewer‐administered
Format of PROMs questionnaire(s): Paper
 
Feedback features
Format of PROMs feedback: Paper
How often information fed back: Once
Who information fed back to: Clinicians
Information fed back: Scores, Interpretation guidance
Outcomes Main outcome: physician and patient agreement on the presence of disabilities.
Notes The study was funded by American Academy of Family Physicians. 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 Startified randomisation method
Allocation concealment (selection bias) High risk Due to cluster‐randomised design not possible to conceal allocation from clinicians.
Blinding of participants and personnel (performance bias)
All outcomes High risk Due to nature of intervention not possible to blind patients and personnel.
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 Unclear risk Not clearly reported
Baseline characteristics similar Low risk There were no statistically significant differences between the intervention and control groups
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Not reported
Was study protected against contamination Unclear risk Not reported
Selective reporting (reporting bias) Unclear risk All relevant outcomes in the methods section are reported in the results section