HELPinKids&Adults Knowledge Synthesis of the Management of Vaccination Pain and High Levels of Needle Fear: Limitations of the Evidence and Recommendations for Future Research.

The HELPinKids&Adults knowledge synthesis for the management of vaccination-related pain and high levels of needle fear updated and expanded upon the 2010 HELPinKIDS knowledge synthesis and clinical practice guideline for pain mitigation during vaccine injections in childhood. Interventions for vaccine pain management in adults and treatment of individuals with high levels of needle fear, phobias, or both were included, thereby broadening the reach of this work. The present paper outlines the overarching limitations of this diverse evidence base and provides recommendations for future research. Consistent with the framing of clinical questions in the systematic reviews, the Participants, Intervention, Comparison, Outcome, Study design (PICOAS) framework was used to organize these predominant issues and research directions. The major limitations we identified across systematic reviews were an overall dearth of trials on vaccination, lack of methodological rigor, failure to incorporate important outcomes, poor study reporting, and various sources of heterogeneity. Future research directions in terms of conducting additional trials in the vaccination context, improving methodological quality and rigor, assessment of global acceptability and feasibility of interventions, and inclusion of outcomes that stakeholders consider to be important (eg, compliance) are recommended. Given concerns about pain and fear are known contributors to vaccine hesitancy, improving and expanding this evidence base will be integral to broader efforts to improve vaccine compliance and public health worldwide.