Table 2.

Summary of findings table with GRADE evaluation for self-determination interventions compared with usual care (follow-up timepoint: end of intervention)

Certainty assessment							No. of patients		Effect	Certainty	Importance
No. of studies	Study design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Self-determination theory	Usual care	Relative (95% CI)
Quality of life 3	RCTs	Seriousa	Seriousb	Seriousc	Not serious	None	128	97	MD 0 (−4.85, 4.86)	⨁◯◯◯ Very low	Critical
All-course mortality 1	Cluster RCTs	Very seriousd	Not serious	Seriouse	Seriousf	None	2005	2021	RR 1.13 (0.73, 1.74)	⨁◯◯◯ Very low	Critical
SAEs 0	-	-	-	-	-	-	-	-	-		Critical
Diabetes distress 3	RCTs	Seriousg	Serioush	Not serious	Not serious	None	128	96	MD −0.10 (−6.17, 5.97)	⨁⨁◯◯ Low	Important
Depressive symptoms 2	RCTs	Very seriousi	Seriousj	Not serious	Seriousk	None	10	10	MD −3.0 (−3.75, 9.74)	⨁◯◯◯ Very low	Important
Adverse events 0	-	-	-	-	-	-	-	-	-	-	Important

RCTs randomized clinical trials, SAEs serious adverse events, CI confidence interval, MD mean difference

Explanations:

^aThe three trials reporting on quality of life at the end of intervention were all rated as high risk of bias on the domains: “blinded outcome assessment” and “incomplete outcome data”

^bInconsistency regarding the direction of effect of included trials

^cDowngraded due to indirectness caused by Mathiesen et al. including elderly persons with type 2 diabetes and Zoffmann et al. (2015) [16, 33] including young people with type 1 diabetes, and Husted et al. include adolescents. The three trials also apply slightly diverse versions of the guided self-determination intervention

^dThis outcome was rated as high risk of bias on the domain “blinded outcome assessor” as the first, and the last author analyzed the data in the trial. On the domain “incomplete outcome data,” it was unclear whether there where participants lost to follow-up on this domain

^eThe nurses were trained in advanced communication techniques, but the reflection sheets in the guided self-determination method were not provided to the patients

^fTSA showed lack of data because only 3.99% of optimal information size had been reached

^gAll trials have a minimum of three high risk-of-bias domains

^hDowngraded due to heterogeneity of the included populations (type 1 diabetes) in the trials of Zoffmann (2015) and Husted et al. (2014) [31] and type 2 diabetes in the trial of Mathiesen et al. (2019) [59]

ⁱDowngraded due to “high risk of bias on blinded outcome assessor,” “incomplete outcome data,” “and selective reporting” on this outcome (only data from Mathiesen (2019) [35])

^jDowngraded due to heterogeneity of the provided interventions

^kWide confidence intervals in the trial of Mathiesen et al. (2019) [59]