Multivariate meta-analysis is increasingly utilized in biomedical research to combine data of multiple comparative clinical studies for evaluating drug efficacy and safety profile. When the probability of the event of interest is rare or when the individual study sample sizes are small, a substantial proportion of studies may not have any event of interest. Conventional meta-analysis methods either exclude such studies or include them through ad-hoc continuality correction by adding an arbitrary positive value to each cell of the corresponding 2 by 2 tables, which may result in less accurate conclusions. Furthermore, different continuity corrections may result in inconsistent conclusions. In this article, we discuss a bivariate Beta-binomial model derived from Sarmanov family of bivariate distributions and a bivariate generalized linear mixed effects model for binary clustered data to make valid inferences. These bivariate random effects models use all available data without ad hoc continuity corrections, and accounts for the potential correlation between treatment (or exposure) and control groups within studies naturally. We then utilize the bivariate random effects models to reanalyze two recent meta-analysis data sets.
Introduction: Assessing an individual’s level of Yang deficiency (Yang-Xu) by its manifestations is a frequent issue in traditional Chinese medicine (TCM) clinical trials. To this end, an objective, reliable and rigorous diagnostic tool is required. This study aimed to develop a first final version of the Yang-Xu Constitution Questionnaire. Methods: We conducted 3 steps to develop such an objective measurement tool: 1) the research team was formed and a panel of 26 experts was selected for the Delphi process; 2) items for the questionnaire were generated by literature review and a Delphi process; items were reworded into colloquial questions; face and content validity of the items were evaluated through a Delphi process again; 3) the difficulty of the questionnaire was evaluated in a pilot study with 81 subjects aged 20–60 years. Results: The literature review retrieved 35 relevant items which matched the definition of ‘constitution’ and ‘Yang-Xu’. After a first Delphi process, 22 items were retained and translated into colloquial questions. According to the second part of the Delphi process, the content validity index of each of the 22 questions ranged between 0.85–1. These 22 questions were evaluated by 81 subjects, 2 questions that were hard to tell the difference were combined; 3 questions were modified after the research team had discussed the participants’ feedback. Finally, the questionnaire was established with 21 questions. Conclusions: This first final version of a questionnaire to assess Yang-Xu constitution with considerable face and content validity may serve as a basis to develop an advanced Yang-Xu questionnaire.
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