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% |
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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 |
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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. |