Methodology for Knowledge Synthesis of the Management of Vaccination Pain and Needle Fear.
BACKGROUND
A knowledge synthesis was undertaken to inform the development of a revised and expanded clinical practice guideline about managing vaccination pain in children to include the management of pain across the lifespan and the management of fear in individuals with high levels of needle fear. This manuscript describes the methodological details of the knowledge synthesis and presents the list of included clinical questions, critical and important outcomes, search strategy, and search strategy results.


METHODS
The Grading of Assessments, Recommendations, Development and Evaluation (GRADE) and Cochrane methodologies provided the general framework. The project team voted on clinical questions for inclusion and critically important and important outcomes. A broad search strategy was used to identify relevant randomized-controlled trials and quasi-randomized-controlled trials. Quality of research evidence was assessed using the Cochrane risk of bias tool and quality across studies was assessed using GRADE. Multiple measures of the same construct within studies (eg, observer-rated and parent-rated infant distress) were combined before pooling. The standardized mean difference and 95% confidence intervals (CI) or relative risk and 95% CI was used to express the effects of an intervention.


RESULTS
Altogether, 55 clinical questions were selected for inclusion in the knowledge synthesis; 49 pertained to pain management during vaccine injections and 6 pertained to fear management in individuals with high levels of needle fear. Pain, fear, and distress were typically prioritized as critically important outcomes across clinical questions. The search strategy identified 136 relevant studies.


CONCLUSIONS
This manuscript describes the methodological details of a knowledge synthesis about pain management during vaccination and fear management in individuals with high levels of needle fear. Subsequent manuscripts in this series will present the results for the included questions.
*Clinical Social and Administrative Pharmacy, Leslie Dan Faculty of Pharmacy, University of Toronto ¶Health Policy Management and Evaluation, Faculty of Medicine, University of Toronto †Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children ∥Department of Pediatrics, Mount Sinai Hospital #Maternal-Infant Care (MiCare) Research Centre, Mount Sinai Hospital **Department of Psychology, York University, Toronto ‡Department of Psychology, University of Guelph, Guelph, Guelph Ontario §Children's Health Research Institute and Department of Paediatrics, Western University, London, ON ††Alberta Health Services, Fort McMurray ‡‡Cumming School of Medicine, University of Calgary, Calgary, AB ∥∥Department of Pediatrics/Psychology, IWK Health Centre §§Faculty of Science ##Department of Paediatrics, IWK Health Centre and Dalhousie University ***Canadian Center for Vaccinology, Halifax, NS, Canada ¶¶Department of Psychology, University of Calgary, AB, Canada.
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D001007:Anxiety / Q000209:etiology / Q000517:prevention & control / Q000523:psychology; D016206:Databases, Bibliographic / Q000706:statistics & numerical data; D005239:Fear / Q000523:psychology*; D006801:Humans; D019359:Knowledge; D009339:Needles / Q000009:adverse effects*; D010146:Pain / Q000209:etiology* / Q000517:prevention & control; D059408:Pain Management; D014611:Vaccination / Q000009:adverse effects*