Methods for 2026 HELPinKids&Adults Clinical Practice Guideline for Reducing Distress During Vaccination.

Area of Science:

• Public Health
• Clinical Practice Guidelines
• Evidence-Based Medicine

Background:

• Vaccination is crucial for public health, but can cause distress in recipients.
• Previous clinical practice guidelines (CPGs) aimed to reduce vaccination-related distress.
• A 10-year update was needed to incorporate new evidence and refine recommendations.

Purpose of the Study:

• To update the 2015 CPG on reducing distress during vaccination.
• To summarize the updated methodological approach for guideline development.
• To characterize the clinical questions and included studies for the guideline.

Main Methods:

• Guideline development followed AGREE-II, GRADE, GIN, and Cochrane frameworks.
• Clinical questions were structured using PICO and the 5P framework (process, procedural, physical, pharmacological, psychological).
• Systematic literature search and risk of bias assessment (Cochrane tool) were performed; evidence certainty was rated (high, moderate, low, very low).

Main Results:

• 47 clinical questions were addressed, focusing on process, procedural, physical, pharmacological, and psychological aspects of vaccination distress.
• Distress was the critical outcome for all questions.
• 201 articles were included from 29,301 identified; most studies were in high-income countries, focused on infants, and had a high risk of bias.

Conclusions:

• Methodological refinements enhance the usability of the updated guideline.
• The evidence base for vaccination distress interventions has grown, but study quality remains low.
• The updated guideline provides actionable recommendations for practice, despite evidence limitations.