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Letter Report
Pages 1-5

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From page 1...
... The committee recognizes the many challenges faced by the VA study team in the execution of a complex and important clinical trial, such as the logistics of standardizing the breeding, acquisition, training, and pairing of canines for Veterans across multiple study sites. The dog supply and quality issues are recognized as major challenges that impacted the timeliness of the study (and had additional impact on the data, analysis, and inference, in part due to withdrawals in participation)
From page 2...
... The committee will prepare a consensus report that critiques the draft monograph and addresses the following questions:  Are the research design and methods well documented, scientifically rigorous, and reasonable approaches to answer the research questions?  Does the data analysis systematically apply appropriate statistical and sound reasoning techniques to evaluate the data on the therapeutic outcomes of service dogs and emotional support dogs for Veterans with PTSD?
From page 3...
... As PCL-5 is a secondary outcome, following at least three primary tests of association for the primary outcomes (World Health Organization Disability Assessment Schedule 2.0; Veterans RAND 12 Item Health Survey [VR-12] Physical Component Score, VR-12 Mental Component Score)
From page 4...
... These points are raised in the spirit of considering the monograph as a stand-alone document that contains all of the needed information in one place. For example, there are details about the construction of the imputation model included in the VA response document that should be incorporated into the monograph, including a more complete description of the statistical model, the covariates included in the model, the number of iterations generated, and the software and version utilized.
From page 5...
... Attachments: A Statement of Task B Committee Membership and Biographies C References D Reviewers E Additional Minor Points for the VA Study Team to Consider 5


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