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 practicesa
Intervention: 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).