Advancing child health research through evidence-based guidance for pediatric clinical trial protocols
CPS ePoster Library. Clyburne-Sherin A. Jun 25, 2015; 99171; 109
April Clyburne-Sherin
April Clyburne-Sherin
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Abstract
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Background:
Complete reporting of clinical trial protocols is essential to allow stakeholders to critically assess trial methodology, ethics, and validity. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) initiative aims to standardize protocol reporting guidelines and tackle inadequate reporting. However, SPIRIT does not offer guidance on the scientific, ethical and safety considerations unique to trials with children.

Objective:
To address this gap in guidance and advance child health research, we present SPIRIT-Children (SPIRIT-C): an evidence-based SPIRIT extension for pediatric clinical trial protocols.

Design / Methods:
Potential reporting items to be included in the SPIRIT-C extension were identified through environmental scans of existing reporting recommendations and a three-stage Delphi process. A systematic literature review was conducted to gather empirical evidence regarding the importance of potential reporting items in pediatric clinical trial protocols, as well as to identify additional reporting recommendations. The results of the Delphi process and systematic review, along with feedback from youth advisors, were presented to an international group of pediatric clinical trial experts and stakeholders, who subsequently reached consensus on potential reporting items using nominal group techniques.

Results:
The SPIRIT-C pediatric protocol reporting guideline includes nine additional reporting items that are recommended be addressed in all pediatric clinical trial protocols:
1.Title: Title identifying a pediatric clinical trial with age group(s) stated
2. Roles and responsibilities: Description of the involvement of parents or children in designing the study, if any
3. Background and rationale: Description of potential for extrapolation from adult data, or why extrapolation is not considered possible; and why a trial is considered necessary in the pre-specified age group(s)
4. Eligibility criteria: Justification of the selected age group(s) and subgroups, addressing potential age-related differences in treatment effects
5. Outcomes: Explanation of the clinical relevance of the selected outcomes (benefits and harms) for the pre-specified age group(s)
6. Data collection methods: Explanation of the validity, feasibility, and responsiveness of the outcome measures for the pre-specified age group(s)
7. Harms: Plans for assessing outcomes and harms beyond the formal study completion date
8. Harms: Description of efforts to reduce risk of participation
9. Ancillary and post-trial care: Plans, if any, for post-trial care beyond the pediatric age range

Conclusions:
SPIRIT-C is the first evidence-based reporting guideline for pediatric clinical trial protocols, filling a gap in existing research guidance, thus helping researchers to improve their trials’ impact and child health outcomes.
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