How Can a Clinical Data Modelling Tool Be Used to Represent Data Items of Relevance to Paediatric Clinical Trials? Learning from the Conect4children (c4c) Consortium
, Avril Palmeri 1, Victoria Hedley 1, Anando Sen 1, Rahil Qamar Siddiqui 2, Dipak Kalra 3 and Volker Straub 1,*Round 1
Reviewer 1 Report
This work introduces the clinical data modeling tool Direcht, especially the pilot studies for Paediatric Clinical Trials. It is believed superior to the conventional excel ways to define and structure the clinical data items represented in the conect4children (c4c) Cross-Cutting Paediatric Data 16 Dictionary (CCPDD).
Two simple pilot studies were conducted. The primary goal of the first pilot study was to test whether the clinical data modeling tool could be used to represent data items from the CCPDD. The key objective of the second pilot study was to determine whether a small team with little or no experience in clinical data modeling could use Direcht to extend the CCPDD. According to the pilot studies, the authors believe that Direcht has unique advantages and potential for clinical data modeling while comparing with conventional excels.
It is meaningful to develop a tool that helps to maintain and represent the Digital Records and models for clinic scenarios. However, the so-called Direcht has neither been widely accepted by society nor been proved superior to other paperless medical recorders or digital medical hints illustrators. Moreover, the work is more a flyer or storybook for Direcht than research work. Specifically, the pilot study was raw, and nothing statistically appeared in the work. Well, actually the figures are of low resolution which is none professional.
To further discussion regarding the concerns, please refer to the following,
- Relevant references in lines 161-167 are needed to support your point.
- The original material from the users (team with no previous experience), and discussions about reusability of data items, as well as how to structure models, shall be discussed at the beginning of the "Facilitation of Good Quality Model Design" section.
- Relevant references that support the viewpoints in lines 345-347 are needed.
- Discussions regarding the state-of-art data collection in pediatric research, and the unique advantages and potential of this tool to solve the problem of data collection in pediatric research, are needed. Other digital tools? Other paperless? How about Direcht’s competitors?
Author Response
Please see attachment
Author Response File: 
Author Response.docx
Reviewer 2 Report
Thank you for the chance of reviewing a manuscript about how the Direcht tools facilitate clinical modelling to the paediatric data. This article demonstrated the usability of the clinical data modelling tool in representing the items from the CCPDD. This study is a significant work to enhance the development of better medicines for babies, children, and young people. I appreciate your efforts. However, several issues you have to address.
- Could you explain more about the impacts of c4c in the introduction part? For example, from the perspective of design and planning of studies, opening sites, education and patient and public involvement., a complete background of c4c can be demonstrated.
- The insights and contributions of this study seem missed in this study. A section of “Practical implications” can be added after the discussion to explain how your work makes a huge contribution to the related parties and practitioners.
Author Response
Please see attachment
Author Response File: Author Response.docx
Round 2
Reviewer 1 Report
Most of the concerns have been addressed. As a technical notes, the work is ok.
