背景:支持自治的干预措施,如自决理论和指导自决干预,可以改善糖尿病患者的自我管理以及临床和社会心理结果。从未使用试验序贯分析方法对此类干预措施进行过系统的评估,以评估其益处和危害,并同时控制随机误差的风险。本系统综述调查了基于自决理论的干预措施与糖尿病患者常规护理相比的益处和危害。
方法:我们使用Cochrane方法。在任何情况下,基于指导的自决或自决理论从理论上评估干预措施的随机临床试验都是合格的。在CENTRAL进行了全面搜索(最新搜索2022年4月),MEDLINE,Embase,LILACS,PsycINFO,SCI-扩展,CINAHL,SSCI,CPCI-S,和CPCI-SSH来确定相关试验。两位作者独立筛选,提取的数据,并使用Cochrane偏倚风险工具1.0对纳入的试验进行偏倚风险评估.我们的主要结果是生活质量,全因死亡率,和严重不良事件。我们的次要结果是糖尿病困扰,抑郁症状,和不认为严重的非严重不良事件。探索性结果是糖化血红蛋白和动机(自主性,控制,动机)。在干预结束时(主要时间点)和最大随访时评估结果。使用审查管理器5.4和试验顺序分析0.9.5.10进行分析。证据的确定性按等级进行了评估。
结果:我们的搜索确定了5578项可能符合条件的研究,其中包括11项随机试验(6059名参与者)。所有试验均评估为总体偏倚高风险。我们发现,与常规护理相比,基于自决理论的干预措施对生活质量没有影响(平均差0.00分,95%CI-4.85,4.86,I2=0%;225名参与者,3试验,TSA-adjustedCI-11.83,11.83),全因死亡率,严重不良事件,糖尿病困扰,抑郁症状,不良事件,糖化血红蛋白A1c,或动机(受控)。对于所有结果,证据的确定性都很低。我们发现了对动机的有益影响(自主和无动机;低确定性证据)。
结论:我们发现基于自决的干预措施对我们的主要或次要结局没有影响。证据的确定性很低。
背景:PROSPEROCRD42020181144.
Autonomy-supporting interventions, such as self-determination theory and guided self-determination interventions, may improve self-management and clinical and psychosocial outcomes in people with diabetes. Such interventions have never been systematically reviewed assessing both benefits and harms and concurrently controlling the risks of random errors using
trial sequential analysis methodology. This systematic review investigates the benefits and harms of self-determination theory-based interventions compared to usual care in people with diabetes.
We used the Cochrane methodology. Randomized clinical trials assessing interventions theoretically based on guided self-determination or self-determination theory in any setting were eligible. A comprehensive search (latest search April 2022) was undertaken in CENTRAL,
MEDLINE, Embase, LILACS, PsycINFO, SCI-EXPANDED, CINAHL, SSCI, CPCI-S, and CPCI-SSH to identify relevant trials. Two authors independently screened, extracted data, and performed risk-of-bias assessment of included trials using the Cochrane risk-of-bias tool 1.0. Our primary outcomes were quality of life, all-cause mortality, and serious adverse events. Our secondary outcomes were diabetes distress, depressive symptoms, and nonserious adverse events not considered serious. Exploratory outcomes were glycated hemoglobin and motivation (autonomy, controlled, amotivation). Outcomes were assessed at the end of the intervention (primary time point) and at maximum follow-up. The analyses were conducted using Review Manager 5.4 and
Trial Sequential Analysis 0.9.5.10. Certainty of the evidence was assessed by GRADE.
Our search identified 5578 potentially eligible studies of which 11 randomized trials (6059 participants) were included. All trials were assessed at overall high risk of bias. We found no effect of self-determination theory-based interventions compared with usual care on quality of life (mean difference 0.00 points, 95% CI -4.85, 4.86, I2 = 0%; 225 participants, 3 trials, TSA-adjusted CI -11.83, 11.83), all-cause mortality, serious adverse events, diabetes distress, depressive symptoms, adverse events, glycated hemoglobulin A1c, or motivation (controlled). The certainty of the evidence was low to very low for all outcomes. We found beneficial effect on motivation (autonomous and amotivation; low certainty evidence).
We found no effect of self-determination-based interventions on our primary or secondary outcomes. The evidence was of very low certainty.
PROSPERO CRD42020181144.