Feasibility of implementation of CARD™ for school-based immunizations in Calgary, Alberta: a cluster trial

Background: Negative experiences with school-based immunizations can contribute to vaccine hesitancy in youth and adulthood. We developed an evidence-based, multifaceted and customizable intervention to improve the immunization experience at school called the CARD™ (C-Comfort, A-Ask, R-Relax, D-Distract) system. We evaluated the feasibility of CARD™ implementation for school-based immunizations in Calgary, Canada. Methods: In a mixed methods study, two Community Health Centres providing immunization services, including 5 schools each with grade 9 students (aged approximately 14 years), were randomized to CARD™ or control (usual care). In the CARD™ group, public health staff and students were educated about coping strategies prior to immunization clinics. Clinics were organized to reduce fear and to support student’s choices for coping strategies. Public health staff in the CARD™ group participated in a focus group discussion afterwards. We sought a recruitment rate of 80% for eligible schools, an external stakeholder focus group (e.g., school staff) with 6 or more individuals, 85% of individual injection-related data acquisition (student and immunizer surveys), and 80% absolute agreement between raters for a subset of data that were double-coded. Across focus groups, we examined perceptions of acceptability, appropriateness, feasibility and fidelity of CARD™. Results: Nine (90%) of eligible schools participated. Of 219 students immunized, injection-related student and immunizer data forms were acquired for 195 (89.0%) and 196 (89.5%), respectively. Reliability of data collection was high. Fifteen public health and 5 school staff participated in separate focus groups. Overall, attitudes towards CARD™ were positive and compliance with individual components of CARD™ was high. Public health staff expressed skepticism regarding the value of student participation in the CARD™ system. Suggestions were made regarding processes to refine implementation. Conclusion: While most outcome criteria were satisfied and overall perceptions of implementation outcomes were positive, some important challenges and opportunities were identified. Feedback is being used to inform a large cluster trial that will evaluate the impact of CARD™ during school-based immunizations. Trial registration: The trial is registered at ClinicalTrials.gov (NCT03948633); Submitted April 24, 2019

Outcome reporting in randomised controlled trials and meta-analyses of appendicitis treatments in children: a systematic review

Background: Acute appendicitis is the most common surgical emergency in children. Despite this, there is no core outcome set (COS) described for randomised controlled trials (RCTs) in children with appendicitis and hence no consensus regarding outcome selection, definition and reporting. We aimed to identify outcomes currently reported in studies of paediatric appendicitis. / Methods: Using a defined, sensitive search strategy, we identified RCTs and systematic reviews (SRs) of treatment interventions in children with appendicitis. Included studies were all in English and investigated the effect of one or more treatment interventions in children with acute appendicitis or undergoing appendicectomy for presumed acute appendicitis. Studies were reviewed and data extracted by two reviewers. Primary (if defined) and all other outcomes were recorded and assigned to the core areas ‘Death’, ‘Pathophysiological Manifestations’, ‘Life Impact’, ‘Resource Use’ and ‘Adverse Events’, using OMERACT Filter 2.0. / Results: A total of 63 studies met the inclusion criteria reporting outcomes from 51 RCTs and nine SRs. Only 25 RCTs and four SRs defined a primary outcome. A total of 115 unique and different outcomes were identified. RCTs reported a median of nine outcomes each (range 1 to 14). The most frequently reported outcomes were wound infection (43 RCTs, nine SRs), intra-peritoneal abscess (41 RCTs, seven SRs) and length of stay (35 RCTs, six SRs) yet all three were reported in just 25 RCTs and five SRs. Common outcomes had multiple different definitions or were frequently not defined. Although outcomes were reported within all core areas, just one RCT and no SR reported outcomes for all core areas. Outcomes assigned to the ‘Death’ and ‘Life Impact’ core areas were reported least frequently (in six and 15 RCTs respectively). / Conclusions: There is a wide heterogeneity in the selection and definition of outcomes in paediatric appendicitis, and little overlap in outcomes used across studies. A paucity of studies report patient relevant outcomes within the ‘Life Impact’ core area. These factors preclude meaningful evidence synthesis, and pose challenges to designing prospective clinical trials and cohort studies. The development of a COS for paediatric appendicitis is warranted

Student Feedback to Tailor the CARD™ System for Improving the Immunization Experience at School

Increasing the comfort of vaccine delivery at school is needed to improve the immunization experience for students. We created the CARD™ (C—Comfort, A—Ask, R—Relax and D—Distract) system to address this clinical care gap. Originally designed for grade 7 students, this study examined the perceptions of grade 9 students of CARD™. Grade 9 students who had experience with school-based immunizations, either as recipients or onlookers (n = 7; 100% females 14 years old) participated. Students answered pre–post surveys, reviewed CARD™ educational materials and participated in a semi-structured focus group discussion. The Consolidated Framework for Implementation Research (CFIR) was used as the framework for analysis of qualitative data. Participants reported positive perceptions of CARD™ educational materials and that CARD™ could fit into the school immunization process. CARD™ improved knowledge about effective coping interventions and was recommended for education of both nurses and students. The results provide preliminary evidence that CARD™ is acceptable and appropriate for implementation in grade 9 school-based immunizations

Student Feedback to Tailor the CARD™ System for Improving the Immunization Experience at School

Increasing the comfort of vaccine delivery at school is needed to improve the immunization experience for students. We created the CARD™ (C—Comfort, A—Ask, R—Relax and D—Distract) system to address this clinical care gap. Originally designed for grade 7 students, this study examined the perceptions of grade 9 students of CARD™. Grade 9 students who had experience with school-based immunizations, either as recipients or onlookers (n = 7; 100% females 14 years old) participated. Students answered pre–post surveys, reviewed CARD™ educational materials and participated in a semi-structured focus group discussion. The Consolidated Framework for Implementation Research (CFIR) was used as the framework for analysis of qualitative data. Participants reported positive perceptions of CARD™ educational materials and that CARD™ could fit into the school immunization process. CARD™ improved knowledge about effective coping interventions and was recommended for education of both nurses and students. The results provide preliminary evidence that CARD™ is acceptable and appropriate for implementation in grade 9 school-based immunizations