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

Christensen 2005.

Study characteristics
Methods Randomised trial, Denmark
Participants 1785 adult patients with a new health problem consult their primary care doctor.
Mean age (SD): IG: 39.3 years (12.9); CG: 38.2 years (12.9)
Gender (% female): IG: 59%; CG: 61%
Interventions Patient were screened before consultation using a screening questionnaire (SQ): including SCL‐90R, SCL‐SOM, Whiteley‐7, SCL‐8, CAGE and SF‐36). In the intervention group the questionnaires were disclosed and scored by GPs before consultation, and in the control group the results were not scored and thus blinded.
Immediately after the consultation, the GPs completed a questionnaire on their own assessment, subjects of conversation, actions taken, and self‐reported benefit from disclosed screening results, if any.
 
Intervention features
Single complex feedback (multiple PROMs at a single time) 
PROM(s) used as intervention: SCL‐90R somatisation subscale (SCL‐SOM), Whiteley‐7 scale, anxiety and depression (SCL‐8) subscale, alcohol abuse scale (CAGE), SF‐36     
Constructs measured: Health related Quality of Life, Symptoms, Functioning
Instrument categories/domains: Generic, Domain/Disease specific (mental health, alcohol abuse)
 
Administration features
Where PROMs administered: Clinical setting (e.g. waiting room, office, etc)
How administered: Self‐administered
Format of PROMs questionnaire(s): Paper
 
Feedback features
Format of PROMs feedback: Unclear
How often information fed back: Once
Who information fed back to: Clinicians
Information fed back: Scores, Management recommendations
Outcomes Main outcome: GPs recognition and provision of care
Other outcomes: outline useful strategies for case‐finding
Notes Interdisciplinary Research Programme of the Danish National Research Council: Quote: “Sundhedsfremme og forebyggelsesforskning” (grant# 9801278). GPs training participation, data collection and use of SQs* by The Regional Health Assurance in Aarhus County through a local pay agreement (project# 0871). The study recruited from 3 March to 1 May 2000. The authors reported no conflicts of interest. 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk How randomisation was done was not discussed
Allocation concealment (selection bias) Low risk Colour‐coded allocation used by medical secretaries only.
Blinding of participants and personnel (performance bias)
All outcomes High risk Medical secretaries aware of allocation arm.
Blinding of outcome assessment (detection bias)
All outcomes High risk Not possible due to study design (disclosure of questionnaire versus not)
Baseline outcome measurements similar Low risk None apparent
Baseline characteristics similar Low risk No significant differences (table of baseline characteristics provided)
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Unanswered questions were scored zero and analysis was based on random allocation
Was study protected against contamination High risk Study design not optimal enough so contamination likely.
Selective reporting (reporting bias) Low risk None apparent.