Abstract
BackgroundExisting self-management and behavioural interventions for diabetes vary widely in their content, and their sustained long-term effectiveness is uncertain. Autonomy supporting interventions may be a prerequisite to achieve ‘real life’ patient engagement and more long-term improvement through shared decision-making and collaborative goal setting. Autonomy supportive interventions aim to promote that the person with diabetes’ motivation is autonomous meaning that the person strives for goals they themselves truly believe in and value. This is the goal of self-determination theory and guided self-determination interventions. Self-determination theory has been reviewed but without assessing both benefits and harms and accounting for the risk of random errors using trial sequential analysis. The guided self-determination has not yet been systematically reviewed. The aim of this protocol is to investigate the benefits and harms of self-determination theory-based interventions versus usual care in adults with diabetes.Methods/designWe will conduct the systematic review following The Cochrane Collaboration guidelines. This protocol is reported according to the PRISMA checklist. A comprehensive search will be undertaken in the CENTRAL, MEDLINE, EMBASE, LILACS, PsycINFO, SCI-EXPANDED, CINAHL, SSCI, CPCI-S and CPCI-SSH to identify relevant trials. We will include randomised clinical trials assessing interventions theoretically based on guided self-determination or self-determination theory provided face-to-face or digitally by any healthcare professional in any setting. The primary outcomes will be quality of life, mortality, and serious adverse events. The secondary will be diabetes distress, depressive symptoms and adverse events not considered serious. Exploratory outcomes will be glycated haemoglobin and motivation. Outcomes will be assessed at the end of the intervention and at maximum follow-up. The analyses will be performed using Stata version 16 and trial sequential analysis. Two authors will independently screen, extract data from and perform risk of bias assessment of included studies using the Cochrane risk of bias tool. Certainty of the evidence will be assessed by GRADE.DiscussionSelf-determination theory interventions aim to promote a more autonomous patient engagement and are commonly used. It is therefore needed to evaluate the benefit and harms according to existing trials.Systematic review registrationPROSPERO CRD42020181144
Highlights
Existing self-management and behavioural interventions for diabetes vary widely in their content, and their sustained long-term effectiveness is uncertain
Data synthesis Meta-analysis We will undertake the meta-analysis according to the recommendations stated in the Cochrane Handbook for Systematic Reviews of Interventions [52], Keus et al [87] and the eight-step assessment suggested by Jakobsen et al [88]
The predefined methodology is based on the Cochrane Handbook for Systematic Reviews of Interventions [52], the eight-step assessment suggested by Jakobsen et al [88], trial sequential analysis [66] and GRADE assessment [52, 100]
Summary
This is a protocol for a systematic review that aims at synthesising the evidence for the beneficial and harmful effects of guided self-determination or selfdetermination theory interventions for people with diabetes and comorbidity in any healthcare setting assessed in randomised clinical trials. The predefined methodology is based on the Cochrane Handbook for Systematic Reviews of Interventions [52], the eight-step assessment suggested by Jakobsen et al [88], trial sequential analysis [66] and GRADE assessment [52, 100] As such, this protocol considers both risks of random errors and risks of systematic errors. If we show a difference between the interventions applying selfdetermination or self-determination method compared strategies, it will be difficult to conclude what exactly caused the difference in effect To minimise this limitation, ten subgroup analyses are planned, but results of subgroup analyses should always be interpreted with great caution. Even though blinding of participants should be relatively easy, blinding of treatment providers is theoretically possible but problematic to carry out, especially in psychosocial interventions [57]
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