The Impact of Patient and Family Engagement in Child Health Research: A Scoping Review.

OBJECTIVE: To identify impacts of patient and family engagement in child health research on the research process, research teams, and patient and family partners. STUDY DESIGN: A scoping review was conducted using the MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, and Web of Science databases. English-language studies were included if they described ≥1 impact of patient and family engagement on child health research (age <18 years), researchers, or patient and family partners. Data were retrieved by 2 independent extractors. RESULTS: Of the 7688 studies identified, 25 were included in our analysis. Impacts of patient and family engagement were mostly on the research process (n = 24 studies; 96%), 11 (44%) determined impacts on the research team, and 17 (68%) reported impacts on patient and family partners. Less than one-half (n = 11; 44%) had a primary purpose of determining the impact of patient engagement, and no study used a specific evaluation tool. CONCLUSIONS: Patient and family engagement can strengthen the relevance and feasibility of research and empower researchers and patient partners. Measuring and reporting the impact of engagement is rare. Systematic and standardized evaluation of engagement is needed to understand how, when, and why to engage patients and families.

Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial.

The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset ( NCT04348656 ). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm-relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94-1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02-1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57-0.95 and OR = 0.66, 95% CI 0.50-0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14-2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.

Validation of diagnostic codes for intussusception and quantification of childhood intussusception incidence in Ontario, Canada: a population-based study.

OBJECTIVES: To validate an algorithm to identify cases of intussusception using the health administrative data of Ontario, Canada, and to apply the algorithm to estimate provincial incidence of intussusception, preceding the introduction of the universal rotavirus vaccination program. STUDY DESIGN: We determined the accuracy of various combinations of diagnostic, procedural, and billing codes using the chart-abstracted diagnoses of patients of the Children's Hospital of Eastern Ontario as the reference standard. We selected an algorithm that maximized positive predictive value while maintaining a high sensitivity and used it to ascertain annual incidence of intussusception for fiscal years 1995-2010. We explored temporal trends in incidence using Poisson regression. RESULTS: The selected algorithm included only the International Classification of Diseases (ICD)-9 or ICD-10 code for intussusception in the hospitalization database and was sensitive (89.3%) and highly specific (>99.9%). The positive predictive value of the ICD code was 72.4%, and the negative predictive value was >99.9%. We observed the highest mean incidence (34 per 100000) in male children <1 year of age. Temporal trends in incidence varied by age group. There was a significant mean decrease in incidence of 4% per year in infants (<1 year) until 2004 and rates stabilized thereafter. CONCLUSIONS: We have demonstrated that intussusception can be accurately identified within health administrative data using validated algorithms. We have described changes in temporal trends in intussusception incidence in Ontario and established a baseline to allow ongoing monitoring as part of vaccine safety surveillance.