Byrne Molly, O'Connell Anthony, Egan Aoife M, Dinneen Sean F, Hynes Lisa, O'Hara Mary Clare, Holt Richard I G, Willaing Ingrid, Vallis Michael, Hendrieckx Christel, Coyne Imelda
Health Behaviour Change Research Group, School of Psychology, National University of Ireland, Galway, Ireland.
School of Medicine, National University of Ireland, Galway, Ireland.
Trials. 2017 Dec 19;18(1):602. doi: 10.1186/s13063-017-2364-y.
Achieving consensus from a range of relevant stakeholders about an agreed set of core outcomes to be measured and reported as a minimum in clinical trials has the potential to enhance evidence synthesis and make findings more relevant and applicable. Intervention research to improve outcomes for young adults with type 1 diabetes (T1DM) is hampered by inconsistent use of outcome measures. This population frequently struggles to manage their condition and reports suboptimal clinical outcomes. Our aim was to conduct an international, e-Delphi consensus study to identify a core outcome set (COS) that key stakeholders (young adults with T1DM, diabetes health professionals, diabetes researchers and diabetes policy makers) consider as essential outcomes for future intervention research.
Using a list of 87 outcomes generated from a published systematic review, we administered two online surveys to a sample of international key stakeholders. Participants in the first survey (survey 1; n = 132) and the second survey (survey 2; n = 81) rated the importance of the outcomes. Survey 2 participants received information on total mean rating for each outcome and a reminder of their personal outcome ratings from Survey 1. Survey 2 results were discussed at a consensus meeting and participants (n = 12: three young adults with T1DM, four diabetes health professionals, four diabetes researchers and one diabetes policy maker) voted on outcomes. Final core outcomes were included provided that 70% of consensus group participants voted for their inclusion.
Eight core outcomes were agreed for inclusion in the final COS: measures of diabetes-related stress; diabetes-related quality of life; number of severe hypoglycaemic events; self-management behaviour; number of instances of diabetic ketoacidosis (DKA); objectively measured glycated haemoglobin (HbA); level of clinic engagement; and perceived level of control over diabetes.
This study is the first to identify a COS for inclusion in future intervention trials to improve outcomes for young adults with T1DM. Use of this COS will improve the quality of future research and increase opportunities for evidence synthesis. Future research is necessary to identify the most robust outcome measure instruments.
就一系列相关利益相关者商定的一套核心结局达成共识，以便在临床试验中进行测量和报告，这至少有可能加强证据综合，并使研究结果更具相关性和适用性。1型糖尿病（T1DM）青年成人结局测量方法不一致，阻碍了改善其结局的干预研究。这一人群常常难以控制病情，临床结局不理想。我们的目的是开展一项国际电子德尔菲共识研究，以确定一个核心结局集（COS），主要利益相关者（T1DM青年成人、糖尿病健康专业人员、糖尿病研究人员和糖尿病政策制定者）将其视为未来干预研究的基本结局。
利用已发表的系统评价生成的87项结局列表，我们对国际主要利益相关者样本进行了两次在线调查。第一次调查（调查1；n = 132）和第二次调查（调查2；n = 81）的参与者对结局的重要性进行评分。调查2的参与者收到了每个结局的总平均评分信息以及对其在调查1中个人结局评分的提醒。在一次共识会议上讨论了调查2的结果，参与者（n = 12：三名T1DM青年成人、四名糖尿病健康专业人员、四名糖尿病研究人员和一名糖尿病政策制定者）对结局进行投票。最终核心结局只有在70%的共识小组参与者投票赞成纳入的情况下才会被纳入。
八项核心结局被一致同意纳入最终的COS：糖尿病相关压力测量；糖尿病相关生活质量；严重低血糖事件数量；自我管理行为；糖尿病酮症酸中毒（DKA）发作次数；客观测量的糖化血红蛋白（HbA）；门诊参与程度；以及对糖尿病的感知控制水平。
本研究首次确定了一个COS，用于纳入未来的干预试验，以改善T1DM青年成人的结局。使用这个COS将提高未来研究的质量，并增加证据综合的机会。有必要开展进一步研究，以确定最可靠的结局测量工具。
