Quality of Reporting of Clinical Trials of Dogs and Cats and Associations with Treatment Effects
Quality of Reporting of Clinical Trials of Dogs and Cats and Associations with Treatment Effects
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DOI：
10.1111/j.1939-1676.2009.0386.x
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发表时间：
2010-01-01
影响因子：
2.6
通讯作者：
Snedeker, K.
中科院分区：
文献类型：
--
作者：
Sargeant, J. M.;Thompson, A.;Snedeker, K.
背景为了解决人们对随机对照试验报告质量的担忧，以及在报道不佳的试验中可能出现的偏颇治疗效果，医学期刊采用了一套通用的报告指南，即报告试验的综合标准(COSORT)声明，以改进随机对照试验的报告。假设涉及狗和猫的临床试验的报告可能不理想，这可能与偏颇的治疗效果有关。通过广义线性模型评估试验特征报告与试验中阳性治疗效果比例之间的关系。结果在报告关键试验特征方面存在实质性缺陷。试验中阳性治疗效果的增加与不报告有关：用于生成随机分配序列的方法(P<；.001)、双盲试验的使用(P<；.001)、研究对象的纳入标准(P=.003)、治疗组之间的基线差异(P=.006)、用于所有结果的测量(P=.002)以及可能的研究限制(P=.03)。结论和临床重要性文献中许多涉及猫狗的临床试验没有报告与方法学质量和评估外部有效性所必需的方面有关的细节。有一些证据表明，这些缺陷与治疗效果有关。有必要改进临床试验的报告，而指南，如CONTORT声明，可以为满足这一需求提供宝贵的工具。
BackgroundTo address concerns about the quality of reporting of randomized controlled trials, and the potential for biased treatment effects in poorly reported trials, medical journals have adopted a common set of reporting guidelines, the Consolidated Standards of Reporting Trials (CONSORT) statement, to improve the reporting of randomized controlled trials.HypothesisThe reporting of clinical trials involving dogs and cats might not be ideal, and this might be associated with biased treatment effects.AnimalsDogs and cats used in 100 randomly selected reports of clinical trials.MethodsData related to methodological quality and completeness of reporting were extracted from each trial. Associations between reporting of trial features and the proportion of positive treatment effects within trials were evaluated by generalized linear models.ResultsThere were substantive deficiencies in reporting of key trial features. An increased proportion of positive treatment effects within a trial was associated with not reporting: the method used to generate the random allocation sequence (P < .001), the use of double blinding (P < .001), the inclusion criteria for study subjects (P = .003), baseline differences between treatment groups (P = .006), the measurement used for all outcomes (P = .002), and possible study limitations (P = .03).Conclusions and Clinical ImportanceMany clinical trials involving dogs and cats in the literature do not report details related to methodological quality and aspects necessary to evaluate external validity. There is some evidence that these deficiencies are associated with treatment effects. There is a need to improve reporting of clinical trials, and guidelines, such as the CONSORT statement, can provide a valuable tool for meeting this need.