PDF(Sci-hub)
Abstract：
Chronic Kidney Disease (CKD) is an important cause of feline morbidity and mortality. There is currently no agreement on which outcomes are most important in CKD treatment trials to assist evidence-based decision making. Core Outcome Sets (COSs) originated in human healthcare and are an agreed set of outcomes to be measured and reported as a minimum in any trial conducted relating to a particular disease. To establish a COS for feline CKD, this study used a systematic review and two consensus methodologies (an electronic Delphi (eDelphi), and an in-person consensus meeting), with an international panel of key stakeholders. The systematic review identified 104 unique published parameters, which were rated by panellists in round 1 of the eDelphi. Panellists were also asked to suggest additional parameters. In round 2 these additional parameters were rated and any parameters not understood by >10 % of panellists in round 1 were redefined and re-rated. Parameters reaching consensus in rounds 1 and 2 were removed from round 3, when all remaining parameters were re-rated by panellists who could view their own previous rating alongside the median rating of the whole panel. To reach inclusion in the COS, parameters had to be rated 8 or 9 on a Likert scale of 1-9 (where 1 was not important and 9 was very important) by more than 80 % of panellists. In the consensus meeting, panellists discussed and re-rated borderline parameters and streamlined the final COS. Borderline parameters were those that had been closest to, but not achieved, the 80 % threshold for inclusion. The eDelphi panel (n = 73) rated 24/104 parameters highly enough for inclusion and proposed an additional 20 parameters, of which 3 reached the inclusion threshold. This totalled 27 parameters for inclusion. The consensus meeting panel (n = 16) rated an additional 6/20 borderline parameters highly enough for inclusion. During the streamlining process, 4 parameters were removed as one was considered not an outcome, and three were already addressed by other parameters. The remaining COS totalled 29 parameters. These were grouped into 9 core themes: clinical examination, quality of life, serum biochemistry, complete blood count, urinalysis, total amount of food eaten, CKD progression, survival time and cause of death. This is the first COS for feline medicine. In future treatment efficacy trials the COS will strengthen the evidence-base for this condition, by facilitating easier comparison of results between studies, and reduce research waste.
摘要：
慢性肾脏病(CKD)是猫发病和死亡的重要原因。目前尚未就CKD治疗试验中哪些结果最重要，以协助循证决策达成一致。核心结果集（COSs）起源于人类医疗保健，是一套商定的结果，在与特定疾病有关的任何试验中，作为最低限度进行测量和报告。为了建立猫科动物CKD的COS，本研究使用了系统综述和两种共识方法(电子德尔菲(eDelphi)，和面对面的共识会议)，与一个由主要利益相关者组成的国际小组。系统审查确定了104个独特的已发布参数，在eDelphi的第1轮中由小组成员进行评级。小组成员还被要求提出其他参数。在第2轮中,对这些另外的参数进行评级,并且在第1轮中>10%的小组成员不理解的任何参数被重新定义和重新评级。在第1轮和第2轮中达成共识的参数已从第3轮中删除，所有其余参数均由小组成员重新评估，他们可以查看自己的先前评级以及整个小组的中位数评级。为了纳入COS，超过80％的小组成员必须以1-9的Likert量表将参数评为8或9（其中1不重要，9非常重要）。在协商一致的会议上,小组成员讨论并重新评估了边界参数，并简化了最终的COS。边界线参数是那些最接近的，但没有实现，纳入的80%门槛。eDelphi面板（n=73）评估了24/104个参数，足以包含在内，并提出了另外20个参数，其中3个达到了纳入阈值。这总共有27个参数供列入。共识会议小组（n=16）对额外的6/20边界线参数进行了评估，足以包含在内。在精简过程中，4个参数被删除，因为一个被认为不是结果，还有三个已经被其他参数解决了。其余的COS共有29个参数。这些被分为9个核心主题：临床检查，生活质量,血清生物化学,全血细胞计数,尿液分析,吃的食物总量，CKD进展,生存时间和死亡原因。这是第一个用于猫科动物药物的COS。在未来的治疗效果试验中，COS将加强这种情况的证据基础，通过更容易地比较研究之间的结果，减少研究浪费。
