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

Zung 1983.

Study characteristics
Methods Randomised trial, USA
Participants 143 adults (mean age years) attending a family medical practice with a positive screen for depression
Interventions Feedback and prompts to evaluate further depending on need.
Intervention features
Multiple simple feedback (one PROM at multiple times)
PROM(s) used as intervention: Zung self rating depression scale (SDS)
Constructs measured: Symptoms
Instrument categories/domains: Domain/Disease specific (mental health)
 
Administration features
Where PROMs administered: Clinical setting (e.g. waiting room, office, etc) 
How administered: Interviewer‐administered
Format of PROMs questionnaire(s): Paper
 
Feedback features
Format of PROMs feedback: Paper
How often information fed back: 2 times (second time after 4 weeks)
Who information fed back to: Clinicians
Information fed back: Scores, Previous scores
 
Outcomes Main outcome: depression recognition
Notes Funding source not reported. 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) High risk Random assignment ‐ not reported
Allocation concealment (selection bias) Unclear risk Not reported
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 High risk Not clear
Baseline characteristics similar Low risk Statistically significant differences were found for sex
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Not clearly reported
Was study protected against contamination High risk Clinicians were allocated within a clinic or clinics and it is possible that communication between intervention and control professionals could have occurred
Selective reporting (reporting bias) Low risk None reported

AEP: Adverse Events Profile;ASC: Assessment for Signal Clients; AUC: area under the curve; BDI: Beck Depression Inventory; CAGE: cut‐annoyed‐guilty‐eye; CDSS: Calgary Depression Scale for Schizophrenia; CES‐D: Center for Epidemiologic Studies Depression Scale; CG: control group; COOP: Dartmouth Cooperative Functional Assessment Charts; DIS: Diagnostic Interview Schedule; ED: eating disorder; EDept: emergency department; EORTC: European Organisation for Research and Treatment of Cancer; EQ‐5D: EuroQol 5 Dimensions; ESRA‐C: Electronic Self‐Report Assessment‐Cancer; ESRS: Manual for the Extrapyramidal Symptom Rating Scale; FACIT: Functional Assessment of Chronic Illness Therapy; FACT: Functional Assessment of Cancer Therapy; FSQ: Functional Status Questionnaire; G‐QoL: Global Quality of Life; GAF: Global Assessment of Functioning; GAS: Global Anxiety Score; GDS‐SF: Geriatric Depression Scale, short form; GHQ: General Health Questionnaire; GPs: general practitioners; HADS: Hospital Anxiety and Depression Scale; HASS: Highest Anxiety Subscale Score; HAM‐D: Hamilton Depression Rating Scale; HbA1c: glycated haemoglobin; HRS: Health risk assessment; HRQL/HRQOL: health‐related quality of life; IG: intervention group; IVR: interactive voice response; MDAS: Modified Dental Anxiety Scale; MDASI: M.D. Anderson Symptom Inventory; MQS: Medication Quantification Scale; NYHA: New York Heart Association; O/GP: oncologist/general practitioner; OARS ADL: Older Americans Resources and Services Activities of Daily Living Scale; OQ‐45: Outcome questionnaire 45; ORS: Outcome Rating Scale; PANSS: Positive and Negative Syndrome Scale; PC‐SAD: Primary Care Screener for Affective Disorders; PCP: primary care physician; PHQ: Patient Health Questionnaire; PRIME‐MD: Primary Care Evaluation of Mental Disorders; PROM: patient‐reported outcome measure; PROMIS: Patient‐Reported Outcomes Measurement Information System; QLQ‐C30: Quality of Life Questionnaire‐Core 30; QoL: quality of life; QOLIE: Quality of LIfe in Epilepsy Inventory; R&D: Research and Development; S‐QOL: Schizophrenia Quality of Life Questionnaire; SCL: Symptom Checklist; SD: standard deviation; SDS: Zung Self‐rating Depression Scale; SF‐36: Short Form Health Survey; SIP: Sickness Impact Profile; SPADE: Sleep disturbance, pain, anxiety, depression and low energy/fatigue; STAI‐S: Spielberger State Anxiety Inventory for State Anxiety; TAU: treatment as usual; TC; W: telephone caseworker; WCL: wait control list; WHOQOL: World Health Organization Quality of Life; WONCA: World Organization of Colleges, Academies and Academic Associations of General Practitioners/Family Physicians.