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

We conducted a 10-year update of our 2015 clinical practice guideline (CPG) about reducing distress during vaccination. This article summarizes the methodological approach, the included clinical questions, and the characteristics of the evidence base.

The project was guided by several processes and frameworks, including AGREE-II, GRADE, GIN, and Cochrane. Eligible panel members voted on clinical questions and outcomes. Clinical questions were structured using PICO (Population, Intervention, Comparison, Outcome) and grouped according to the 5P framework (process, procedural, physical, pharmacological, psychological), considering the target user (eg, clinician, vaccine recipient) and mechanism/site of action. Relevant trials were identified from our prior work and an updated interim literature search across 5 databases. Screening and extraction occurred in multiple steps, involving at least 2 individuals at each step. Quality was assessed using the Cochrane Risk of Bias tool (version 1.0). Point estimates and 95% Confidence Intervals were calculated using a random effects model. Overall certainty of evidence was assessed using 4 levels: high, moderate, low, and very low. The results and other prioritized factors were used to draft recommendations.

Altogether, 47 clinical questions were included: 4 on process, 4 procedural, 23 physical, 2 pharmacological, and 14 psychological. Distress was selected as the critical outcome across all questions. The search identified 29,301 articles; 201 were eligible for inclusion. The majority of studies were conducted in high-income countries and evaluated the effectiveness of interventions in infant vaccine recipients. Most were associated with a high risk of bias.

Refinements to our updated methodology streamline the presentation and enable users to easily identify specific interventions that are relevant to their practice. While the evidence base for overlapping clinical questions increased substantially since the last review, the quality of the trials remains low. The results of the systematic reviews and guideline recommendations are available elsewhere.