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. 2017 Sep 27;2017(9):CD011469. doi: 10.1002/14651858.CD011469.pub2

Summary of findings for the main comparison. Psychological interventions versus usual care for diabetes‐related distress in adults with type 2 diabetes mellitus.

Psychological interventions versus usual care for diabetes‐related distress in adults with type 2 diabetes mellitus
Patient: type 2 diabetes participants with diabetes‐related distress
 Settings: mostly community‐based primary care and general practicesaIntervention: psychological interventions
Comparison: usual care
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No. of participants
 (trials) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
Usual
 care Psychological interventions
Diabetes‐related distress
PAID and DDS scales
 Follow‐up: median 10 months
No meaningful estimate for baseline score possible The standardised mean difference for diabetes‐related distress in the intervention groups was 0.07 standard deviations lower (0.16 lower to 0.03 higher) 3315 (12) ⊕⊕⊝⊝
 Lowb A standard deviation of 0.07 represents a very small difference between groups
Health‐related quality of life 
 Various questionnaires
 Follow‐up: median 11 months No meaningful estimate for baseline score possible The standardised mean difference for health‐related quality of life in the intervention groups was 0.01 standard deviations higher (0.09 lower to 0.11 higher) 1932 (5) ⊕⊕⊝⊝
 Lowb A standard deviation of 0.01 represents a very small difference between groups
Adverse events 
 Self‐reported outcomes
 Follow‐up: median 9 months 17 per 1000 41 per 1000 (13 to 125) RR 2.40 
 (0.78 to 7.39) 438 (3) ⊕⊕⊝⊝
 Lowc
Self‐efficacy 
 Various questionnaires
 Follow‐up: median 10 months No meaningful estimate for baseline score possible The standardised mean difference for self‐efficacy in the intervention groups was 0.15 standard deviations higher (0.00 higher to 0.30 higher) 2675 (6) ⊕⊕⊝⊝
 Lowb A standard deviation of 0.15 represents a small difference between groups
HbA1c (%) 
 Follow‐up: median 11 months The mean HbA1c ranged across control groups from 6.8% to 9.4% The mean Hba1c in the intervention groups was 0.14% lower (−0.27% lower to 0.0% lower) 3165 (11) ⊕⊕⊝⊝
 Lowd
Diabetes‐related complications Not reported
All‐cause mortality 
 Medical records or reported by family members
 Follow‐up: median 10 months 11 per 1000 11 per 1000 (2 to 66) RR 1.01 
 (0.17 to 6.03) 1376 (3) ⊕⊕⊝⊝
 Lowc Reported on data with mostly < 12 months follow‐up, only 1 trial had data > 12 months
*The basis for the assumed risk was the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
 CI: confidence interval; DDS: Diabetes Distress Scale; HbA1c: glycosylated haemoglobin A1c;PAID: Problem Areas In Diabetes; RR: risk ratio
GRADE Working Group grades of evidence
 High quality: further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: we are very uncertain about the estimate.

aEight trials at general practices, outpatient clinics and community‐based setting; three trials at hospital‐based clinics.
 bDowngraded two levels for trial limitations (attrition and other biases). There was no blinding of participants and personnel, and no blinding of outcome assessment, but we judged the influence of these biases on this outcome as minimal (see Appendix 14).
 cDowngraded by two levels: one level for trial limitations (attrition bias) and one level for imprecision (low sample size and small trials) (see Appendix 14).
 dDowngraded by two levels: one level for trial limitations (attrition bias) and one level for imprecision (see Appendix 14).