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We attempted to contact selected authors of included studies for clarification of methods and to obtain additional data, where required.
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We believe that the individual comments by the reviewers do not point to major shortcomings of our methodology but mainly request clarifications of methods and results.
The draft Food and Drug Administration guidance on patient reported outcomes for labeling and promotional claims raises a number of method and measurement issues that require further clarification, including methods of determining responsiveness and minimal important differences.
The draft FDA guidance on PROs for labeling and promotional claims raises a number of method and measurement issues that require further clarification [ 4].
Authors whose studies made reference to systematic data collection tools or approaches but did not include them in the manuscript were contacted for copies of these assessments and clarification of the methods used.
I have no major reservations, rather a few minor comments regarding clarification of the methods along with some questions and considerations for future discussion and research.
In addition, the authors reviewed the three studies and emailed for clarification of the methods used to produce the published results.
However, there is a need for some clarification of the methods before the significance of the authors' findings can be determined.
The authors of the included studies were contacted via email for clarification of study methods or data wherever there was insufficient detail reported (17 authors were contacted, 10 authors provided information).
I, and I think most Biology Direct readers, would like more detail on some of the methods, and some clarification of some of the statements in the manuscript.
For clarification of the method, the study by Johnson et al [23] is used as an example throughout this paper.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com