Callahan 1996.

Study characteristics
Methods	Cluster‐randomised trial
Participants	222 adults aged over 60 in primary care.
Interventions	Feedback plus additional interventions for patients and clinicians   Intervention features Multiple simple feedback (one PROM at multiple times) PROM(s) used as intervention: Patient depression (measured with the HAM‐D); Patient function (measured with the SIP) Constructs measured: Symptoms, Functioning Instrument categories/domains: Domain/Disease specific (mental health)   Administration features Where PROMs administered: Unclear 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, Management recommendations
Outcomes	Main outcome: diagnosis of depression Other outcomes: discontinue medications associated with depression, initiate antidepressants, referral to psychiatry, patient depression (measured with the HAM‐D), patient function (measured with the SIP)
Notes	The study was supported in part by a grant from the John A. Hartford Foundation, New York, New York. Dr. Callahan was supported by grant K08 AG00538‐02 from the National Institutes of Health. Dr. Tierney was supported by grants HS07632, HS07763, and HS07719 from the Agency for Health Care Policy and Research. The study period is not reported. Conflicts of interest are not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only mentioned randomly assigned
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	Low risk	There were no statistically significant differences between the intervention and control groups
Baseline characteristics similar	Low risk	There were no significant differences by study group
Incomplete outcome data (attrition bias) All outcomes	High risk	An ‘intention‐to‐treat’ analysis was performed
Was study protected against contamination	Low risk	Control group had no access to the intervention. No physician had both intervention and control patients.
Selective reporting (reporting bias)	Low risk	All relevant outcomes in the methods section are reported in the results section